1. No category

NEW ZEALAND FISHING INDUSTRY
AGREED IMPLEMENTATION STANDARDS
AMENDMENT COVER SHEET
To:
Seafood Premises
Seafood Exporters
Authorised Persons
Travelling Technical Supervisor
Agency Technical Manager
Technical Service Managers
Subject:
Issue 23 of the IAIS’s
Enclosures: Amendment Cover Sheet
Issue 23 of the IAIS’s
Background
The IAISs were issued on 1 May 1995. This circular contains an amendment to the IAIS’s.
IAIS 001, The General Information Section has been updated to include further details on the
current legislation and standards under the Animal Products Act 1999 and the Meat Act 1981.
IAIS 002.4 Specific Country Requirements Circular 1995, EU section has been updated.
There have been amendments to the listing requirements for fish premises in regards to the
procedures for initial listing and changes to listings. There have been amendments to EEC 3
and EEC 9 to update the hyperlinks. EEC 5.1 has been updated to reflect current EU
maximum permitted levels for mercury, lead, cadmium and marine biotoxins these levels take
effect on the 5th April 2002.
IAIS 002.4 Specific Country Requirements Circular 1995, USA 2.1 has been updated to
reflect the current situation in regards to listing of approved fish packing houses (including
Limited Processing Fishing Vessels). There has been an amendment to USA 2.7 to update the
wording used on certificates for Pacific Broadbill swordfish destined for the USA. USA 5 has
been updated and renumbered to include a section on Vacuum-packed/modified atmosphere
packed fish. There have been amendments to USA 8 and USA 10 to update the hyperlinks.
IAIS 003.5 Fish Processing Circular 1995, Section 2 has been updated to include details of
the new Hazard ID unit standard that is now formally registered on the NZQA framework.
Details have also been updated for canning of fish and fish products.
IAIS 004.2, Part B, Page L.4. This page has been updated to reflect current Australian
labeling requirements for Lookdown dory. King dory is now an approved foreign name
(Australia) for Lookdown dory.
IAIS 005.1 Shellfish Quality Assurance Circular 1995, Appendices I and II. Details of the
currently approved laboratories for microbiological analyses and marine biotoxin analyses
have been updated.
IAIS 005.1 Shellfish Quality Assurance Circular 1995, Section 3.2.4. The collection of
samples for the sanitary survey shall demonstrate the time taken for the faecal coliform MPN
levels of shellfish to return to 300/100g or less. The faecal coliform MPN level has been
changed from 230/100g or less to 300/100g or less.
Procedure
Please sign off and date the Amendment record, and file this update letter in the back of your
manual for quick reference.
Remove Old Pages
IAIS 001, General Information, Prelims, Page
P.4
IAIS 001, General Information, Pages 1.12, 2.1
and 2.2
IAIS 002.4, Pages EEC.2-17
IAIS 002.4, Pages FRA.1 and FRA. 2
IAIS 002.4, Pages USA. 1, 2, 4, 5, 8, 10-36
IAIS 003.5, Section 2, Pages 2.2, 2.3 and 2.5
IAIS 003.5, Section 4, Page 4.13
IAIS 004.2, Part B, Page L.4
IAIS 005.1, Section 2.4, Page 2.3
IAIS 005.1, Section 3.2.4, Page 3.2
IAIS 005.1, Appendix I, Pages I.1-I.2
IAIS 005.1, Appendix II, Page II.1
Insert New Pages
IAIS 001, General Information, Prelims,
Page P.4
IAIS 001, General Information, Pages 1.12,
2.1, 2.2 and 2.3
IAIS 002.4, Pages EEC.2-19
IAIS 002.4, Pages FRA.1 and FRA. 2
IAIS 002.4, Pages USA. 1, 2, 4, 5, 8, 10-35
IAIS 003.5, Section 2, Pages 2.2, 2.3 and 2.5
IAIS 003.5, Section 4, Page 4.13
IAIS 004.2, Part B, Page L.4
IAIS 005.1, Section 2.4, Page 2.3
IAIS 005.1, Section 3.2.4, Page 3.2
IAIS 005.1, Appendix I, Pages I.1-I.2
IAIS 005.1, Appendix II, Page II.1
Regulatory Statement
This circular:
• Is issued pursuant to Regulation 19 of the Fish Export Processing Regulations 1995.
Dated at Wellington this 11th day of April 2002.
Judy Barker
Acting Director Animal Products
Craig Ellison
Chairman New Zealand Seafood Standards
Council
General Information
New Zealand Fishing Industry Agreed Implementation Standards
General Information
Section: Prelims
Issue 22: January 2001
Page: P.2
Amendments
Suggestions are welcomed for alterations, deletions or additions to this section to improve it or
to make it better suited to the needs of the fishing industry and inspection staff. Suggestions
should be forwarded to the co-ordinator, together with reasons for the change.
Amendments do not become part of this section until they have been issued with an amendment
form. Amendments are numbered in sequence.
#
Amendments to these guidelines can be identified by the issue number in the page header and
a hatch by the changes which have been made.
The co-ordinator of these guidelines is:
#
Programme Manager (Animal Products)
MAF Food Assurance Authority
ASB Bank House
101-103 The Terrace
P.O. Box 2526
Wellington
Phone: (04) 474 4100
Fax:
(04) 474 4239
New Zealand Fishing Industry Agreed Implementation Standards
General Information
Section: Prelims
Issue 22: January 2001
Page: P.3
Amendment Record
It is important that these guidelines are kept up-to-date by the prompt incorporation of
amendments.
To update these guidelines when you receive an amendment, remove the appropriate outdated
pages, destroy them, and replace them with the pages from the new issue. Complete instructions
will be given on the covering letter accompanying the amendment. File the covering letter at the
back of the guidelines and sign off and date this page.
#
If you have any queries, please ask your local MAF VA.
Issue No.
1
Date
May 1995
Initials
MAF RA
Issue No.
13
2
14
3
15
4
16
5
17
6
18
7
19
8
20
9
21
10
22
11
23
12
24
Date
Initials
New Zealand Fishing Industry Agreed Implementation Standards
General Information
Section: Prelims
Issue 23: April 2002
Page: P.4
Contents
#
Page
Amendments
Amendment Record
Contents
#
P.2
P.3
P.4
1.
1.1
1.2
1.3
1.4
New Zealand Seafood Standards Council
Terms of Reference
Overarching Commitments and Principles
Strategic Plan 2000-2005
Council Members and Regular Attendees
1.1
1.4
1.6
1.11
2.
2.1
2.2
2.3
2.4
2.5
2.6
Legislation and Standards
Animal Products Act 1999
Meat Act 1981
Fish Export Processing Regulations 1995
Industry Agreed Implementation Standards
Technical Directives
Guidelines
2.1
2.1
2.2
2.2
2.2
2.3
New Zealand Fishing Industry Agreed Implementation Standards
General Information
Section 1: New Zealand Seafood Standards Council
#
Issue 22: January 2001
1.
New Zealand Seafood Standards Council
1.1
Terms of Reference
1.1.1
Purpose
Page: 1.1
To be the consultative forum between the New Zealand seafood industry and
government (Ministry of Agriculture and Forestry) in the preparation of food
safety standards, other technical standards, and protocols that are necessary for
market access of seafood.
To provide leadership, analysis and advice that contribute to the development of cost
effective sustainable standards and risk-mitigating strategies that achieve
performance comparable to international best practice in risk management and
consumer protection.
1.1.2
Role
To ensure delivery of efficient and practical strategic direction, policy formulation
and priority setting that meets the seafood industry’s needs.
To assist in the establishment of industry standards, specifications and codes of
practice based on full industry consultation and advice to decision-making bodies
taking full account of commercial and other risks to marketing, and innovation in
products and processing.
To help achieve practical solutions of relevant technical issues, factors that impinge
on processing costs and efficiency, and non-MAF regulatory requirements.
To foster open communication with the seafood industry and seek practical and cost
effective solutions to seafood food safety problems.
1.1.3
Functions
A. Industry Standards
To act as the consultative organisation, representing people and businesses in the NZ
seafood industry in relation to MAF’s administration of the Meat Act 1981 and the
Animal Products Act 1999.
To develop seafood handling and processing codes of practice and strategies to
address risks to the industry, including any requirements imposed by importing
countries.
To act in an advisory capacity to government in the formulation of agreed strategies
to be pursued in the negotiation of requirements with importing countries regulatory
authorities.
New Zealand Fishing Industry Agreed Implementation Standards
General Information
Section 1: New Zealand Seafood Standards Council
Issue 22: January 2001
Page: 1.2
To give advice and take part, where practicable, in negotiations with importing
country’s regulatory authorities, and participate where possible, in multilateral
organisations when international standards are being set or agreed.
To provide policy advice to government on seafood food safety, and other associated
market access issues, and on risk management strategies.
To keep industry informed of developments in national and international food safety
standards, and market access issues.
B. General
To participate in the development of risk management strategies.
To agree, on behalf of the seafood industry, operational plans of MAF Food
Assurance Authority.
To communicate with the seafood industry on developments and trends in food
safety and other market access issues, that could be relevant to strategy formulation
and forward planning by seafood farmers, harvesters and processors.
To evaluate special projects that may arise during the contract year and recommend
appropriate actions.
1.1.4
Composition
The Council will consist of:
SeaFIC Director (1)
SeaFIC Executive (1)
Seafood industry members (5)
MAF Food Assurance Authority (1)
Consumers representative (1)
An independent Chairman appointed by SeaFIC.
Observers
The Council is responsible for establishing observer status of organisations and
may invite participation by organisations to address specific issues.
MAF Verification Agency is awarded permanent observer status while it remains
the sole provider of verification services.
The Ministry of Health is awarded permanent observer status until the time that
a single Food Agency is established.
Seafood industry members are offered 2 observer places at each meeting, to be
allocated on a first come first served basis.
SeaFIC will provide the secretariat for the Council.
New Zealand Fishing Industry Agreed Implementation Standards
General Information
Section 1: New Zealand Seafood Standards Council
1.1.5
Issue 22: January 2001
Page: 1.3
Authority
The Council and it’s role are agreed by the New Zealand Seafood Industry Council
and the Ministry of Agriculture and Forestry who are the parties to these Terms of
Reference.
Council recommendations for significant amendments the modus operandi, in
relation to industry standards and risk management strategies, will be submitted for
agreement by the SeaFIC Board of Directors.
The Council will not be a party to the resolution of differences between individual
seafood processors and MAF Food Assurance Authority or MAF Verification
Agency.
1.1.6
Funding
The Council’s reasonable expenses will be met by SeaFIC, and confirmed in the
SeaFIC Business Plan each year.
Industry members of Council will be reimbursed for travel, accommodation and
meals, in accordance with SeaFIC policy.
The Chairman will receive a separate fee approved by SeaFIC.
1.1.7
Review
The Council’s terms of reference may be reviewed at any time if requested by
SeaFIC Directors, the SeaFIC Policy Council or MAF Food.
New Zealand Fishing Industry Agreed Implementation Standards
General Information
Section 1: New Zealand Seafood Standards Council
1.2
Overarching Commitments and Principles
1.2.1
MAF Food Commitment
Issue 22: January 2001
Page: 1.4
MAF Food is committed to maximising industry involvement in the regulatory
process and encouraging industry ownership. MAF Food is committed to working
in a partnership relationship with industry to the maximum extent possible. MAF
Food will consult with the New Zealand Seafood Standards Council over the
development and formulation of:
(a) The regulatory standards, specifications and codes of practice to be promulgated
under the Animal Products Act and
(b) The generally accepted means of meeting the regulatory requirements
(c) The interpretation and definition of the official market access requirements of
importing countries.
In each case the intent of the consultation is to reach agreement so that the sum of
the published documents and their interpretations can genuinely be described as
“Industry Agreed Implementation Standards”. It is not expected that there will be
failure to agree but in that event, and provided that best endeavours have been made
to reach agreement, MAF Food reserves the right to ensure that it’s statutory
responsibilities are met where the issues involve food safety or the credibility of New
Zealand’s regulatory systems.
MAF Food is committed to ensuring that the standards, specifications and codes of
practice are limited to the scope defined within the Animal Products Act. Standards,
specifications and codes of practice will be scientifically based and incorporate risk
analysis philosophy. Cost efficiency and cost effectiveness will be key features in
the process of designing standards, specifications and codes of practice and the
accepted means of meeting them.
MAF Food is equally committed to the concept of performance based verification
whereby high performance receives less direct audit involvement, while poor
performance increases audits.
MAF Food is committed to enterprises having the greatest autonomy appropriate to
discharging their obligations to produce clean, safe and truthfully labelled fish and
fish products.
MAF Food is committed to ensuring that sanctions required to respond to non
compliance are applied consistently and fairly.
New Zealand Fishing Industry Agreed Implementation Standards
General Information
Section 1: New Zealand Seafood Standards Council
1.2.2
Issue 22: January 2001
Page: 1.5
SeaFIC Commitment
SeaFIC is committed to ensuring that the provisions of the Animal Products Act
are observed and maintained with respect to seafood and seafood products.
SeaFIC will provide a consultative committee (NZ Seafood Standards Council)
which enables appropriate representation from the industry, to facilitate the
consultation process necessary to maintain the commitments noted above.
1.2.3
Agreed Principles
MAF Food and SeaFIC have agreed to the following principles and will endeavour
to apply them at all times:
(a) Maximum benefits will accrue to the seafood industry and New Zealand by MAF
Food working in a partnership relationship with industry and the parties are
committed to working in this manner to the maximum extent, consistent with
MAF Food’s statutory responsibilities.
(b)MAF Food and SeaFIC are committed to ensuring the profile of the NZ seafood
Standards Council is such that industry has a sense of ownership of the standards
and systems that operate to ensure compliance with the standards.
(c) Where practicable circulars, directives and IAIS’s will be issued by the Seafood
Standards Council and jointly signed by Director Animal Products and the
Chairperson of the Council.
(d)For market access, MAF Food will involve the Seafood Standards Council to the
maximum extent possible, including participation in “government to government”
and multilateral negotiations, providing this is not deemed prejudicial to the direct
outcome nor New Zealand’s more general interests.
(e) The MAF Food Compliance and Investigation Unit, which audits the delivery
agencies to ensure industry compliance with standards and regulatory
requirements, will provide the Seafood Standards Council with regular status
reports.
(f) Regulatory costs and mechanisms for their recovery will be negotiated and
recovered in accordance with the provisions of the Animal Products Act.
New Zealand Fishing Industry Agreed Implementation Standards
General Information
Section 1: New Zealand Seafood Standards Council
Issue 22: January 2001
Page: 1.6
(g)Verification of operations by verification agencies will be adjusted according to
agreed performance criteria.
(h)In standard setting and in the enforcement of requirements, MAF Food will
endeavour to operate in such a way as to maintain food safety and truthful
certification while seeking to maximise returns to industry.
(i) MAF Food and the Seafood Standards Council may agree on the general rules that
verification agencies will apply in terms of sanctions in various non-compliance
situations.
1.3
1.3.1
New Zealand Seafood Standards Council
Strategic Plan 2000-2005
The Seafood Standards Council's Business
The Seafood Standards Council is in the business of assuring seafood
safety*.
* Safety is defined in relation to “fitness for intended purpose” as per the Animal
Products Act 1999.
The Seafood Standards Council will be an Advisory Council to Government and
act as the NZ "Officially recognised technical authority" in:
•
•
•
•
•
•
•
•
Setting standards of seafood safety.
Specifying competence and diligence requirements.
Identifying training requirements and facilitating the provision of
training.
Keeping the industry well informed on seafood safety.
Developing negotiating strategies for access to overseas markets.
Providing policy advice to Government and industry organisations on
seafood safety.
Specifying compliance regimes and use of sanctions at the delivery
level.
Advising MAF Food Assurance Authority on the sanctions required
under the Animal Products Act.
The Seafood Standards Council is a committee of the NZ Seafood Industry
Council. It has adopted the following operating Principles and Policies:
1. Beyond specified delegated authorities it's role is advisory to the Fishing
Industry Board.
New Zealand Fishing Industry Agreed Implementation Standards
General Information
Section 1: New Zealand Seafood Standards Council
Issue 22: January 2001
Page: 1.7
2. Standards will be the minimum required to meet accepted international
standards and guidelines.
3.
Common standards will be set for domestic and export trades.
4. Commitment, competence and diligence must be demonstrated to retain the
right to certify product.
5. Industry ownership of the Seafood Standards Council system will be
encouraged and maintained in partnership with MAF Food.
6.
Costs of audit will be recovered directly from companies by the contractor.
7. The standards required should be clear and the criteria for compliance should
be transparent.
8. Comprehensive, cost effective and auditable outcome based standards will be
used to ensure the safety of all seafood products.
1.3.2
Situation Analysis
During the period 2000 - 2005, the Seafood Standards Council expects assuring
seafood safety to be influenced by the following changes.
1. Consumer Changes
Increased public awareness and expectations of the purity and safety of
seafood.
•
Consumers will demand safety guarantees of the food they purchase.
•
Credibility of safety assurance systems will be under constant media scrutiny
especially if breakdowns occur.
•
Breakdowns will produce prolonged buyer resistance across the whole
seafood sector.
•
Consumers will demand more information about the products they are
purchasing.
New Zealand Fishing Industry Agreed Implementation Standards
General Information
Section 1: New Zealand Seafood Standards Council
Issue 22: January 2001
Page: 1.8
2. Controlling Authorities
Government administration of food safety has been reorganised.
•
Delivery of seafood safety audit will become contestable.
•
Domestic and export market standards will be progressively aligned.
•
Harmonisation of New Zealand / Australian domestic food standards will be
achieved.
•
New standards and systems will require higher competency levels of
controlling authority staff.
•
Responsibility for designing, operating and maintaining risk management
systems has shifted to processors and is subject to performance based
verification.
3. Food Safety Environment
Increasing awareness of the risks in seafood safety breakdowns has shifted
the focus towards integrated process control and risk management systems.
•
Importing countries (especially the more affluent) will continue to develop
more sophisticated safety assurance systems including HACCP, and demand
equivalent standards of exporting countries.
•
Political intervention can be expected if public health risks are perceived.
•
There will be an expectation of increased competence and diligence of all
parties involved in seafood processing and marketing.
•
Large multiple retailers further processors and branch owners are setting 'nonregulatory' food safety process control criteria of their own.
4. International
The World Trade Organisation SPS Committee Agreement will enable the
adoption of international food safety standards and their use in equivalence
assessments.
•
Zero risk policies are no longer sustainable under the SPS agreement.
•
Opportunities now exist to influence the setting of international standards
especially through Codex.
New Zealand Fishing Industry Agreed Implementation Standards
General Information
Section 1: New Zealand Seafood Standards Council
•
Issue 22: January 2001
Page: 1.9
New Zealand will have to invest further in research and databases required to
justify its own 'science based' standards and defend equivalence.
5. Industry
The range of products, markets and processing technologies will increase
and become more complex.
•
Processing at sea will stabilise at present levels.
•
Declining state of available charter vessels will continue to create compliance
problems.
•
Illegal operations will threaten certification credibility.
•
Small operations will continue to be significant and will face rising cost
pressures.
•
Industry will need to keep up with technical change.
•
Industry will need to remain aware of public perceptions of environmental,
sustainability and welfare issues.
•
Increased acceptance and responsibility for risk management systems by
industry will be required.
•
There will be an increasing need for processed product to move up the “value
chain” and this will result in an increased proportion of ready-to-eat products
and more sophisticated processing.
•
Competency based training will play an increasing role in seafood processing
operations.
•
Industry will increase market development into non-traditional markets.
6. Quality Management Environment
•
Financial and human resources for systems and their development will remain
scarce.
•
Keeping industry informed of developments/changes will be an increasing
need.
•
Electronic documentation is rapidly replacing paper systems.
New Zealand Fishing Industry Agreed Implementation Standards
General Information
Section 1: New Zealand Seafood Standards Council
•
Issue 22: January 2001
Page: 1.10
Implementation of the Animal Products Bill will require a shift of
responsibilities and changes to current systems.
The Seafood Standards Council will need to respond by:
a. Standards
- Developing codes of practice to support outcome based standards and the risk
management regime.
- Ensuring domestic and/or common New Zealand/Australian standards
harmonise with those met by NZ’s export industry.
b. Risk Management Systems
- Ensuring maintenance of risk management systems.
- Facilitating the transfer of operational experience between companies.
c. Compliance
- Ensuring that personnel involved in certification have the required
competency.
- Developing fair and credible procedures with MAF Food and MAF VA.
- Ensuring sanctions fairly reflect the level of performance.
d. Industry Training
- Specifying the maintenance of industry seafood safety training and
competency requirements.
- Maintaining close liaison with the Seafood ITO.
e. International Equivalence
- Working with MAF Food to influence Codex Standards.
- Working with MAF Food in the development of bilateral equivalence
agreements and other market access issues.
- Encouraging industry to participate in further research and database building to
justify New Zealand standards.
New Zealand Fishing Industry Agreed Implementation Standards
General Information
Section 1: New Zealand Seafood Standards Council
Issue 22: January 2001
Page: 1.11
f. Communication
- Keeping industry informed of all relevant aspects of the Seafood Standards
Council Seafood Safety Programme.
- Providing opportunities for industry feedback on seafood safety.
- Increasing awareness of the Seafood Standards Council Seafood Safety
Programme.
- Working with MAF and Industry to develop and implement a strategy for Risk
Communication.
#
1.4
NZ Seafood Standards Council Members and Regular
Attendees
Name
Postal Address
Courier Address
Phone/
Fax
Email
04 479 0452
[email protected]
09 302 0872
[email protected]
09 379 5930
[email protected]
Mobile
Craig Ellison
34 B Calcutta St
34 B Calcutta St
04 479 0451
Chairman
Wellington
Wellington
021 363 898
Bruce Young
C/- Moana Pacific
Fisheries
138 Halsey St
09 302 1520
Auckland
025 434 482
SeaFIC
Director
PO Box 445
Auckland
Francisco Blaha
31 Sale St
31 Sale St
09 303 1007
Industry
Freeman’s Bay
Freemans Bay
025 290 2297
Auckland
Auckland
C/- Pakihi Marine Farms
Kawakawa Bay Rd
09 292 8017
RD 5
Papakura
Clevedon RD 5
09 292 8023
Papakura
025 786 113
C/- Southfish
Island Harbour
03 2128 726
PO Box 143
Bluff
025 229 7185
Callum
McCallum
Industry
Auckland
Marie
McDonald
Industry
Bluff
[email protected]
09 292 8389
[email protected]
03 2128 267
[email protected]
New Zealand Fishing Industry Agreed Implementation Standards
General Information
Section 1: New Zealand Seafood Standards Council
Name
Postal Address
Courier Address
Issue 23: April 2002
Page: 1.12
Phone/
Fax
Email
03 546 0930
[email protected]
09 309 1190
[email protected]
04 474 4240
[email protected]
Mobile
Dennis Thomas
C/- Sealord Group
Vickerman St
03 546 0929
Industry
PO Box 11
Nelson
025 361 494
Nelson
Shane Walsh
C/- Sanford
22 Jellicoe St
09 379 4720
Industry
PO Box 443
Auckland
025 919 707
04 474 4100
Auckland
Tony Zohrab
PO Box 2526
Level 5, ASB House
MAF Food
Wellington
101 – 103 The
Terrace
[email protected]
Wellington
Consumers
TBA
Rachel Harvie
Private Bag 24 901
74 Cambridge Tce
04 385 4005
Executive
Officer, SeaFIC
Wellington
Wellington
025 464 468
Regular
Attendees
Postal Address
Courier Address
Phone/
Judy Barker
PO Box 2526
Level 6, ASB House
04 474 4100
MAF Food
Wellington
101 – 103 The
Terrace
025 975 811
Phil Busby
PO Box 2526
Level 6, ASB House
MAF Food
Wellington
101 – 103 The
Terrace
Brian Roughan
04 385 2727
[email protected]
Fax
Email
04 474 4239
[email protected]
04 474 4100
04 474 4239
[email protected]
PO Box 517
03 577 5752
03 578 0944
[email protected]
MAF VA
Blenheim
025 337 102
Jim Sim
PO Box 5013
133 Molesworth St
04 496 2000
04 496 2340
[email protected]
Min. of Health
Wellington
Wellington
Alastair
Macfarlane
Private Bag 24 901
74 Cambridge Tce
04 385 4005
04 385 2727
[email protected]
Wellington
Wellington
021 687 537
SeaFIC
Mobile
New Zealand Fishing Industry Agreed Implementation Standards
General Information
Section 2: Legislation and Standards
#
2.
Legislation and Standards
2.1
Animal Products Act 1999
Issue 23: April 2002
Page: 2.1
The Animal Products Act 1999 reforms the New Zealand law that regulates the
production and processing of animal material and products to:
•
•
manage the risks to human or animal health, and
facilitate overseas market access requirements.
The Animal Products Act potentially applies to all animal material and products that
are traded and used in New Zealand or exported from New Zealand. The Act replaces
the Meat Act 1981.
Further information on the Animal Products Act can be found on the MAF website
www.maf.govt.nz/animalproducts.
#
2.2
Meat Act 1981
The Meat Act 1981 governs the slaughter, processing and sale of meat, farmed
venison, wild game, fish and shellfish for human consumption. The Act imposes
licensing requirements for premises, and confers the powers of Inspectors as defined
in the Act.
The expected outcomes of compliance with the Act are products and byproducts,
which are fit for purpose and do not present a health risk to animals or humans.
The Act makes provision for the implementation of regulations, the promulgation of
directives, and penalties for offences against the Act.
The Meat Act 1981 will be replaced by the Animal Products Act.
In relation to fish the Meat Act 1981 covers:
•
•
•
•
•
the appointment, qualifications, and powers of the Government appointed
Inspectors
the requirement that diseased or defective fish or fish product cannot be sold
the requirement that all premises (including vessels) associated with seafood
be licensed
general provisions such as a licence register and record keeping
the offences and penalties.
New Zealand Fishing Industry Agreed Implementation Standards
General Information
Section 2: Legislation and Standards
#
2.3
Issue 23: April 2002
Page: 2.2
Fish Export Processing Regulations 1995
The Meat Act 1981 is supported by the Fish Export Processing Regulations 1995.
These regulations cover the following:
• requirements for the construction and standards of plant and equipment in fish
premises
• obligations on the licensee to maintain hygiene and quality
• requirements that any fish and shellfish accepted at a fish packing house be fit for
human consumption
• requirements for operation of a premises, storage and transportation
• requirements that companies carry out regular checks on compliance with the
requirements, results are recorded and corrective action taken
• the Director-General can declare a species or type of fish or an area where fish is
taken unsafe due to contamination
• requirement that no fish and shellfish is exported from NZ unless accompanied
by an export certificate
• providing Inspectors with power to examine and sample fish and to remove and
dispose of unfit fish, and to prohibit the use of equipment or premises
• providing for exemption from licensing for whole fish processing premises and
limited processing fishing vessels.
#
2.4
Industry Agreed Implementation Standards (IAISs)
The regulations contain the standards that need to be met by companies, e.g. in
relation to construction of premises or operation of the fish premises. The IAISs
contain a means of meeting those standards. Companies may, if they wish, apply to
the Director-General for an alternative approval to meet a particular standard.
The IAISs are issued as circulars under the Regulations (Regulation 19) and have
legal backing. The IAISs, including amendments are available to all currently
licensed premises and exporters on the MAF website www.maf.govt.nz/seafood.
For printed copies of the IAISs, please contact Manor House Press Limited,
Wellington (04) 568 6071.
2.5
Technical Directives
Technical directives contain the same type of requirements and information that is
contained in IAISs, but they can be issued in a very short time frame.
Technical directives will be issued in the following situations:
New Zealand Fishing Industry Agreed Implementation Standards
General Information
Section 2: Legislation and Standards
Issue 23: April 2002
Page: 2.3
• when it is necessary to issue changes to or clarification of specifications within
a short time frame;
•
when it is necessary to provide information to the industry or Inspectors within
a short time frame.
Changes to or clarification of specifications will be followed up by an amendment
to the relevant IAISs.
Information issued by technical directives will be incorporated into the FIICC
Newsletter where appropriate.
Technical directives automatically expire 3 years after the date of issue, unless
previously cancelled or incorporated into an IAIS or some other official notification.
Technical directives are available to all currently licensed premises and exporters on
the MAF website www.maf.govt.nz. If you have any queries, contact your local
Inspector.
The technical directives issued by MAF are sequentially numbered. The directives
cover both the seafood and meat industries, but the seafood industry will only receive
those that relate to seafood.
2.6
Guidelines
Guidelines on various topics have been developed by FIICC to assist companies with
particular issues.
Guidelines are intended as recommendations for companies. The guidelines are
available to all currently licensed premises and exporters on the MAF website
www.maf.govt.nz/seafood.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
European Union
Issue 5: September 1996
Page: EEC.1
EU (European Union)
Special Features
Authorised Signatory
Signatory
Official Inspector
See the specific
countryHs
requirements
Official Veterinarian
Prohibited Imports
Endorsements
See the specific countryHs requirements.
Note: The members of the European Union are Austria, Belgium, Denmark, Finland,
France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal,
Spain, Sweden and the United Kingdom.
#
#
The specific section for each European Union member state to which exports are
being sent shall also be consulted.
EEC.1
Mercury Level
0.5 ppm.
1 ppm for certain species of fish (sharks, tunas, rays, swordfish and eels, and
some other European species).
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
European Union
EEC.2
Certification
EEC.2.1
Listing of fish premises for the EU
Issue 23: April 2002
Page: EEC.2
Fish premises (including export stores, limited processing fishing vessels and
wholefish processing fishing vessels which export direct) exporting fish and fish
products to the EU shall be listed as approved for export to the EU (see Section
EEC.9). Fish premises not on the list that wish to export to the EU shall apply to
MAF (see Section EEC.2.2 for details).
EEC.2.2
#
Initial listing
Licensed fish premises wishing to be included on the list for the EU shall in the first
instance apply to the inspector (Technical Supervisor). Where the inspector is
satisfied that the premises can meet the requirements for export to the EU the
inspector will consult with the Technical Specialist, MAF Verification Agency. A
written assurance that the premises meets the required standard shall be supplied to
the Technical Communications Manager, MAF Food by the Technical Specialist,
MAF Verification Agency.
On the first working day of each month MAF Food forwards listing requests to
Brussels.
#
Requests for listing from the Technical Specialist, MAF Verification Agency must
be received by the Technical Communications Manager, MAF Food before the last
working day each month. Requests not received by MAF Food before the last
working day of the month will miss the deadline and will not be submitted to the EC
until the first working day of the following month.
Applicant premises should be aware that the listing process in the EU should take 4 –
6 weeks, however, extensive delays beyond 6 weeks are experienced at times. These
are outside the control of MAF Food.
From the date the technical Specialist, MAF Verification Agency, provides a written
assurance to MAF Food premises can save product as being eligible for the EU. No
exports can be made to the EU until official written notification of gazetting by the
EU has been received from MAF Food. The Commission has never formally
accepted this arrangement. No certification can be provided until the written
notification of gazetting by the EU has been received.
Note: It may take some time for notifications of new premises to reach ports of
entry in individual member states. MAF Food accepts no responsibility for product
held up as a result of this.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
European Union
EEC.2.3
Issue 23: April 2002
Page: EEC.3
Changes to listings
Any changes to the details about the listing for fish premises (e.g. premises name,
official number, address) shall be notified to the EC. This applies particularly to
changes to the premises name or official number.
#
Requests for changes to the listing for fish premises, identifying the details of the
change, shall be notified to MAF Food (Attention: Technical Specialist, MAF VA,
Invercargill) before the last working day of the month. The relevant information will
be forwarded to MAF Food and notification of the changes will be forwarded to
Brussels on the first working day of the month following receipt of the notification.
#
Where a change of premises name has occurred, the new premises name may be used
on packaging for the EU. Product can be saved and held in storage at the premises
pending notification of the modification by the EU. Once notification has been
received this product may be exported. Premises wishing to transfer this detained
product to another premises prior to notification of listing, must obtain prior approval
to do so from the Technical Supervisor MAF VA.
#
Once official listing of the changed name has occurred then the product packaged
under the old name would become ineligible for entry to the EU.
#
Experience in other sectors has shown that product collected under the
changed name while awaiting official notification of listing, has subsequently
been permitted entry to the EU when certified and exported following official
notification.
The EC should make changes within 4 – 6 weeks, however, extensive delays beyond
6 weeks are experienced. These are beyond the control of MAF Food.
Premises will be notified in writing when the changes have been gazetted by the EC.
Until this written notification has been received by the premises the old details shall
continue to be used.
EEC.2.4
Voluntary delisting of fish premises for the EU
MAF Food shall be advised in writing (via the local Inspector) about any fish
premises that wishes to have its listing to the EU removed. This covers situations
such as the company is no longer interested in EU market, premises closed, etc. MAF
Food shall notify Brussels about the delisting (at the beginning of each month) and
will advise fish premises in writing that they have been removed from the list by the
EC.
Fish premises which request voluntary delisting shall not export to the EU any
product processed on or after the date of request for delisting. Fish premises may
export product produced prior to the date of request for delisting provided it will
arrive in the EU before the premises is removed from the list by the EU. Any
product arriving in the EU after the premises name has been removed from the list by
the EC is very likely to be refused entry to the EU.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
European Union
EEC.2.5
Issue 23: April 2002
Page: EEC.4
Delisting of fish premises for the EU by MAF
EEC.2.5.1 Delisting by the delivery agency
If the level of compliance in a fish premises is unacceptable, certification of fish
and fish product to the EU may be suspended until such time as the Inspector
considers a satisfactory level of compliance has been attained. Notification of
suspension and reinstatement of certification shall be given in writing.
EEC.2.5.2 Suspension by MAF Food Assurance Authority
If, during a MAF Food compliance review or any other MAF Food review,
unsatisfactory management of either a critical deficiency in a system or cumulative
deficiencies over several systems is encountered, delisting may occur. When the
Director (Compliance and Investigation Group) receives a recommendation from the
Technical Services Manager, MAF Verification Agency, that a satisfactory level of
compliance has been achieved, a follow-up Compliance Group review shall be
conducted. If the outcome of the review is satisfactory, certification to the EU will
be restored. The Director (Compliance and Investigation Group) shall advise MAF
Verification Agency via the Technical Services Manager. MAF VA shall notify the
fish premises.
Where a premises has had certification to the EU suspended, the following statement
shall appear on all transfer documents issued for fish or fish product during the
period of suspension:
“The product [or state name of the product if only part of the
consignment is not eligible] described in this certificate is not
eligible for export to the EU.”
Note:
Where only part of a consignment is not eligible for export to the EU then
the details of the product that is not eligible for that market shall be
specified.
EEC.2.5.3 Formal delisting
If suspension to the EU (either by the delivery agency or MAF Food) remains in
effect for greater than 30 days, MAF Food will notify the EU and the premises will
be formally delisted. Premises shall be advised in writing of the delisting. Note that
once a fish premises has been removed from the list by the EC, no product will be
accepted into the EU even if it was produced before the date of delisting.
EEC.2.6
Certificates
EEC.2.6.1 General requirements
Specific certificates have been developed for each country for all fish products (other
than live bivalve molluscan shellfish). See the individual country for details.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
European Union
Issue 23: April 2002
Page: EEC.5
Note that these certificates have a number of declarations about compliance with EU
requirements. The requirements of the declaration are considered to be met if the
requirements of the Regulations and the IAISs have been met.
The certificate used shall be in English and the official language where the border
checks occurs (i.e. first port of entry), but the country of destination will still need to
be typed in the space marked “name of EU member state”. Where product is
transhipped to another port within the EU, a check should be made with the
importer/agent to determine at which port border checks will occur. The inspector’s
signature and official stamp shall not be in black ink.
#
Export certificates for fish and fish products for the EU have a box at the top left of
the certificate labelled “Name of consignee and address at place of destination.”
This box shall contain the name and address of the consignee. Note that “To order”
is not acceptable and consignments are likely to be rejected at the border.
Export certificates for fish and fish products for the EU have a box at the bottom of
the certificate labelled “Approved processing premises”. The official number of the
processing premises and the name of the processing premises shall be included in
this box. Note: The name of the processing premises is to be as on the licence.
Where a premises has changed its name, the requirements about name changes in
Section EEC.2.3. shall be followed.
Note that some member states need the product description to also appear in their
official language. Our information is that France and Spain require this and
Germany prefers it.
EEC.2.6.2 Live bivalve molluscan shellfish
For live bivalve molluscan shellfish, checks will occur in the country of destination.
The language required is English and the official language of the country where the
checks occur (i.e. county of destination).
For export certification for live bivalve molluscan shellfish, see the specific country
for requirements.
EEC.2.6.3 Consignments for personal consumption
Consignments of less than 1 kg which are intended for personal consumption do not
require certification. Certification is required for all other consignments.
EEC.2.7
Sealing of containers
Each export shipping container of fish and fish products (including live shellfish)
exported to the EU shall on completion of loading be sealed with a MAF bolt
container seal or MAF Tyden seal (obtained from the MAF Inspector) and the MAF
bolt container seal or MAF Tyden seal number included on the certificate.
The MAF bolt container seal or MAF Tyden seal shall be placed in a position on the
container door that the seal must be broken or removed in order to open the door.
Fish packing house supervisory staff may seal shipping containers.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
European Union
EEC.2.8
Issue 23: April 2002
Page: EEC.6
Fishing vessels
Note that the EU requires all fishing vessels supplying fish (via a fish
premises) to meet minimum standards and be inspected. This also applies to any
fishing vessel not registered in New Zealand which is landing fish into a New
Zealand fish premises for processing and/or packing and export. The specific
requirements for this are given in Sections EEC.10 and EEC.11.
EEC.3
Shellfish
Some EU countries have specific requirements for shellfish (see the entry for the
particular country).
#
For an updated version of the Shellfish Growing Areas approved for export to the EU
click here.
EEC.4
Labelling
EEC.4.1 Some EU countries have specific labelling requirements (see the entry for the
particular country).
EEC.4.2 General labelling requirements for consumer packs and for packs for mass caterers
(e.g. restaurants, hospitals, canteens)
A Name of the product
Descriptions such as “frozen” or “smoked” should be included if the omission
would mislead the consumer.
A List of ingredients
The list of ingredients is to be in descending order of proportion. Note that
food additives must be declared by the class name (e.g. preservative, colour)
followed by the specific name or EU number.
A Nett weight (for prepackaged product)
For liquids use volume, for other products use mass. Nett quantities shall be in
metric units.
If a solid foodstuff is presented in a liquid medium (e.g. mussels in brine), then
a drained weight is required.
A Date mark
The shelf life of the product must be indicated using the date of minimum
durability (i.e. the date until which the product retains its specific properties
when properly stored).
In general a “best before” date mark shall be used. A “use by date” is required
for highly perishable products.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
European Union
Issue 23: April 2002
Page: EEC.7
A Name and address
The name and address of manufacturer or packer or seller established within
the EU.
A Any special storage conditions or conditions of use
Note:
Where prepackaged product is intended for the consumer but sold at a stage prior
to the ultimate sale to the consumer or sold to mass caterers for preparation,
processing, splitting or retail sale, some of the labelling information may be on the
documentation (accompanying the product or sent to the buyer).
The following information must appear on the external packaging:
A name of the product,
A date mark,
A special storage conditions/conditions of use.
#
#
EEC.5
Contaminants, Toxins, Chemical Levels and Additives
EEC.5.1
Heavy metals and toxins
Heavy Metal
Product
Maximum level
(mg/kg wet weight)
Lead (Pb)
1. Muscle meat of fish.
a) This meat may be fresh, frozen or
chilled fish, fish fillets and other fish
meat (whether or not minced)
b) Fish, dried, salted or in brine; smoked
fish, whether or not cooked before or
during the smoking process; flours,
meals and pellets of fish, fit for
human consumption
c) Prepared or preserved fish; caviar and
caviar substitutes prepared from fish
eggs
d) Excluding fish species listed in 2
below.
0.2
2. Muscle meat of Dicologoglossa
cuneata, Anguilla anguilla,
Dicentrarchus punctatus, Trachurus
trachurus, Mugil labrosus labrosus,
Diplodus vulgaris, Pomadasys
benneti, Sardina pilchardus.
0.4
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
European Union
#
#
Cadmium (Cd)
Mercury (Hg)
Issue 23: April 2002
Page: EEC.8
3. Crustaceans, excluding brown meat
of crab
0.5
4. Bivalve molluscan shellfish
1.0
1. Muscle meat of fish.
a) This meat may be fresh, frozen or
chilled fish, fish fillets and other fish
meat (whether or not minced)
b) Fish, dried, salted or in brine; smoked
fish, whether or not cooked before or
during the smoking process; flours,
meals and pellets of fish, fit for
human consumption
c) Prepared or preserved fish; caviar and
caviar substitutes prepared from fish
eggs
d) Excluding fish species listed in 2
below.
0.005
2. Muscle meat of Dicologoglossa
cuneata, Anguilla anguilla, Engraulis
encraischolus, Luvarus imperialis,
Trachurus trachurus, Mugil labrosus
labrosus, Diplodus vulgaris, Sardina
pilchardus
0.1
3. Crustaceans, excluding brown meat
of crab
0.5
4. Bivalve molluscan shellfish
1.0
1. Fishery products, except those in 2
below
0.5
2. all species of shark, Lophius spp,
Anarhichas lupus, Dicentrarchus
labrax, Molva dipterygia, Sarda spp.,
Anguilla spp., Hippoglossus
hippoglossus, Euthynnus spp.,
Makaira spp., Esox lucius,
Orcynopsis unicolor, Centroscymnes
coelolepis, Raja spp., Sebastes
marinus, Sebastes mentella, Sebastes
viviparus, Istiophorus platypterus,
Lepidopus caudatus, Aphanopus
carbo, Lepidocybium flavobrunneum,
Ruvettus pretiosus, Gempylus
serpens, Acipenser spp., Xiphias
gladius, Thunnus spp.
1.0
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
European Union
#
Paralytic Shellfish
Poisons
Shellfish Total PSP content in the edible
parts of molluscs must not exceed 80 µg
per 100g of mollusc flesh in accordance
with the biological testing method
#
Diarrhetic Shellfish
Poisons
Shellfish The customary biological
testing methods must not give a positive
result to the presence of DSP in the
edible parts of molluscs
#
Amnesic Shellfish
Poisons
Shellfish Total ASP content in the edible
parts of molluscs must not exceed 20
mg/kg using the HPLC method
EEC.5.2
Issue 23: April 2002
Page: EEC.9
80 µg per 100g
20 mg/kg
Histamine
Nine samples to be taken from each batch. These must meet the following
requirements:
A the mean value must not exceed 100 ppm;
A two samples may have a value of more than 100 ppm but less than 200 ppm;
A no sample may have a value exceeding 200 ppm.
These limits apply only to fish species of the families Scombridae (e.g. tunas,
mackerels) and Clupeidae (e.g. sardines, herrings). However, fish belonging to these
families which have undergone enzyme ripening treatment in brine may have higher
histamine levels, but not more than twice the above values. Examinations must be
carried out in accordance with reliable, scientifically recognised methods, such as
high-performance liquid chromatography (HPLC).
EEC.5.3
TVB-N
Limits have been set for a limited number of species. Some of interest to New
Zealand are given below. For other species contact MAF Food.
30 mg/100 g
30 mg/100 g
Species from the Pleuronectidae family (e.g. soles, flounders)
except halibut
Species from the Gadidae and Merlucciidae families
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
European Union
EEC.5.4
Issue 23: April 2002
Page: EEC.10
Food additives that can be used in fish and fish products
Sorbates (Sa), benzoates and p-hydroxybenzoates (Ba)
Additive
Fish product
Max level (mg/kg)
Sa + Ba
Semi-preserved fish products,
including fish roe products
2000
Sa + Ba
Salted, dried fish
200
Sa + Ba
Shrimps, cooked
2000
Sulphur dioxide and sulphites
Max level (mg/kg)
(expressed as SO2)
Additive
Fish product
E220-228
Fresh crustaceans (a) and
cephalopods, frozen and deep-frozen
150 (b)
Cooked crustaceans (a) and
cephalopods
50 (b)
(a) Specific requirements apply for some prawns I contact MAF Food for
further details.
(b) In edible parts.
Other preservatives
Additive
Fish product
E251 Sodium nitrate
Pickled herring and sprats
Residual amount
(mg/kg)
200 (a)
(a) Residual amount, nitrite formed from nitrate included, expressed as NaNo2.
Antioxidants
Additive
Fish product
Max level (mg/kg)
E315 Erythorbic acid
E316 Sodium erythorbate
Preserved and semipreserved fish products
1500 expressed as
erythorbic acid
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
European Union
Issue 23: April 2002
Page: EEC.11
Other permitted additives
Additive
Fish product
Max level
E331 Sodium citrates
E332 Potassium citrates
E333 Calcium citrates
Unprocessed fish,
crustaceans and molluscs
including such products
frozen and deep frozen
Good
manufacturing
practice (GMP)
E452 Polyphosphates
(sodium polyphosphate,
potassium polyphosphate,
sodium calcium polyphosphate, calcium
polyphosphates)
Surimi
Fish and crustacean paste
Frozen and deep-frozen
fillets of unprocessed fish
Frozen and deep-frozen
crustacean product,
cephalopods and molluscs
1 g/kg (a)
5 g/kg (a)
5 g/kg (a)
E385 Calcium disodium
ethylene diamine
tetra-acetate
(calcium disodium
EDTA)
Canned and bottled
crustaceans and molluscs
Canned and bottled fish
Frozen and deep-frozen
crustaceans
75 mg/kg
E420 Sorbitol (sorbitol
and sorbitol syrup)
E421 Mannitol
E953 Isomalt
E965 Maltitol
(maltitol and maltitol
syrup)
E966 Lactitol
E967 Xylitol
Frozen and deep-frozen
unprocessed fish,
crustaceans, molluscs and
cephalopods
GMP
(for purposes other
than sweetening)
5 g/kg (a)
75 mg/kg
75 mg/kg
(a) Expressed as P2O5.
For processed fish products there are a number of additives permitted covering the
following classes.
A
A
A
A
A
A
A
A
A
acids and bases,
some antioxidants,
stabilisers,
thickeners,
gelling agents,
emulsifiers,
inert gases,
modified starches,
flavour enhancers,
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
European Union
Issue 23: April 2002
Page: EEC.12
A sugar alcohols.
Contact MAF Food for specific details.
EEC.6
Microbiological Requirements for Cooked Crustaceans and Molluscan
Shellfish
EEC.6.1
Pathogens
Salmonella
n=5, c=0, 25 g sample
EEC.6.2
Organisms indicating poor hygiene (shelled or shucked products)
Staphylococcus aureus (per g)
n=5, c=2, m=102, M=103
Either
Thermotolerant coliforms (44 oC on solid medium; per g)
n=5, c=2, m=10, M=102
or
Escherichia coli (on solid medium; per g)
n=5, c=1, m=10, M=102
The quality of a batch is considered to be:
EEC.6.3
A
satisfactory where all the values observed are 3m or less,
A
acceptable where the values observed are between 3m and 10m (=M) and
where c/n is 2/5 or less.
Indicator organisms (guidelines)
Mesophilic aerobic bacteria (30 oC; per g)
Whole products
n=5, c=2, m=104, M=105
Shelled or shucked product (except crabmeat)
n=5, c=2, m=5 x 104, M=5 x 105
Crabmeat
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
European Union
Issue 23: April 2002
Page: EEC.13
n=5, c=2, m=105, M=106
EEC.7
Parasites
EEC.7.1
Background
The European Commission Directive 91/493/EEC requires that there are no
visible parasites in fish. The directive requires that checks be made of fish and
fish products to detect any visible parasites and the EU have developed specific
rules for this inspection.
This section sets out the procedures that companies exporting fish to the EU
should follow in order to meet the requirements of the EU directive. Companies
are required to determine which species of fish they process are likely to contain
parasites. For those species likely to contain parasites, monitoring must take
place.
EEC.7.2
Definitions
For the purposes of Section EEC.7, “visual inspection” means a non-destructive
examination of fish or fishery products without an optical means of magnification
and under good light conditions for human vision, including, if necessary,
candling. “Batch” shall be defined by each premises but generally it means a
quantity of fish obtained under practically identical circumstances. Factors such as
the species of fish, catching area and methods of processing should be considered
when defining the batch.
EEC.7.3
Procedure
EEC.7.3.1 Fish premises exporting fish to the EU shall implement a documented programme
for the visual inspection of fish for parasites (see Section EEC.7.5 for a list of fish
known to contain parasites).
EEC.7.3.2 Each fish premises shall examine a sample of each species of fish exported to the
EU to determine if parasites are present. The sample shall consist of at least 10
fish. It should be noted that the area in which the fish are caught and the time of
year can have an effect on the presence of parasites.
EEC.7.3.3 Where fish exported to the EU are determined to be likely to contain parasites
(based on the examination outlined in Section EEC.7.3.2), during production:
•
either each fish is to be examined for visible parasites as it is eviscerated or
filleted;
•
or a representative number of samples are to be examined for visible parasites.
Where a sampling method is carried out, at least 10 fish per batch shall be
examined.
Where visible parasites are found, these shall be removed from the fish.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
European Union
Issue 23: April 2002
Page: EEC.14
Where sampling is carried out and visible parasites are found in the sample, the
entire batch is to be checked for parasites and visible parasites removed from the
fish.
Note: The EU standard is no visible parasites in the fish.
ECC.7.3.4 All staff involved in examining fish for parasites shall be trained to the extent of
being able to visually recognise parasites. Training records shall be available to
demonstrate the training provided.
EEC.7.4
Records
A record is to be kept of:
•
a description of the sampling plan used;
•
a definition of the batch used;
•
the fish examined under Section EEC.7.3.1, including details of the type of
fish, source of the fish and the results found; and
the monitoring of fish under Section EEC.7.3.2, including details of the type of
fish, the results found and the action taken when parasites are found.
EEC.7.5
Fish known to contain parasites
Likely to contain parasites
Barracouta (Thyrsites atun)
Black cod (Paranotothenia angustata)
Grenadiers (Caelorinchus spp.)
Hake (Merluccius australis)
Ling (Genypterus blacodes)
May contain parasites
Black dory (Allocyttus niger)
Blue cod (Parapercis colias)
Blue warehou (Seriolella brama)
Cardinal fish (Epigonus telescopus)
Hoki (Macruronus novaezelandiae)
Orange roughy (Hoplostethus atlanticus)
Red cod (Pseudophycis bachus)
Silverside (Argentina elongata)
EEC.8
#
Fish Byproducts
Specific conditions exist for the export of fish byproducts (e.g. fishmeal) to the
EU. Contact MAF Food for further information.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
European Union
EEC.9
#
Issue 23: April 2002
Page: EEC.15
Premises listed for Export to the EU
For an updated version of the premises listed for export to the EU click here.
EEC.10
Requirements for Fishing Vessels Supplying Fish Via a Fish Premises to
the EU
This section applies to fishing vessels supplying fish or fish product to a
fish premises before export to the EU. Fishing vessels licensed as a fish
packing house (PH), a limited fishing vessel (L) or a whole fish processing
premises (W) must meet the requirements of the Fish Export Processing
Regulations 1995 and IAISs. Non-licensed fishing vessels must meet the
standard in Section EEC.11.
EEC.10.1
Definitions
The register means the list of fishing vessels (other than PH, L or W) which
are able to supply fish to premises for export to the EU.
The standard means the standard given in Section EEC.11.
EEC.10.2
Requirements for fishing vessels (other than PH, L or W)
EEC.10.2.1
All fish which is exported to the EU shall have been taken by a fishing vessel
which meets the standard and is on the register.
EEC.10.2.2
Each fish premises which exports fish or fish product to the EU shall keep
sufficient records to demonstrate that any fish or fish product intended for
export to or exported to the EU has been taken by a fishing vessel which meets
the standard and is on the register. The information required to be kept by the
premises is:
EEC.10.2.3
•
the name and registration number of the fishing vessel
•
the name and address of the owner/operator.
Prior to a fishing vessel being placed on the register, the fish premises shall
obtain a statement from the owner/operator of the fishing vessel stating that:
•
an Inspector may board the fishing vessel at any reasonable time and
inspect the fishing vessel and any fish for compliance with the standard;
and
•
the information required in Section EEC.10.2.2 can be released by the
Ministry of Fisheries to the Inspector for inclusion on the Register.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
European Union
Issue 23: April 2002
Page: EEC.16
EEC.10.2.4
The fish premises shall supply a copy of the information required in Section
EEC.10.2.2 and a copy of the statement required in Section EEC.10.2.3 to the
local Inspector for inclusion on the Register when initial listing takes place and
update them as appropriate.
EEC.10.3
Requirements for fishing vessels licensed as a PH, L or W
EEC.10.3.1
All fish which is exported to the EU shall have been taken by a fishing vessel
which meets the standard and is on the register.
EEC.10.3.2
Each fish premises which exports fish or fish product to the EU shall keep
sufficient records to demonstrate that any fish or fish product intended for
export to or exported to the EU has been taken by a fishing vessel which meets
the Fish Export Processing Regulations 1995 and IAISs. The information
required to be kept is:
•
the name and licence number of the fishing vessel.
EEC.10.4
Inspection of fishing vessels (other than PH, L or W)
ECC.10.4.1
All fishing vessels wishing to be placed on the register shall be inspected by an
Inspector and shall meet the standard prior to being placed on the register.
ECC.10.4.2
A proportion of fishing vessels shall be inspected annually for compliance with
the standard. MAF Food shall provide the delivery agency with the
requirements for the inspections.
If non-compliances are detected, a
programme to correct the non-compliances (including target dates) shall be
agreed between the Inspector and the owner/operator of the fishing vessel.
Follow-up inspections shall be undertaken to ensure that any non-compliances
not corrected at the time of inspection have been corrected. If the fishing
vessel is not in compliance after the agreed time, it shall be removed from the
register.
EEC.10.5
Delivery agency requirements
The delivery agency shall:
•
keep a register of the fishing vessels (other than PH, L or W) which are
able to supply fish for the EU;
•
keep a copy of fishing vessels licensed as PH, L or W which are able to
supply fish to premises for export to the EU, i.e. all licensed fishing
vessels;
•
keep a copy of the statement from the owner/operator for each fishing
vessel on the register;
•
keep records of inspections including the:
—
date of the inspection,
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
European Union
—
—
EEC.10.6
Issue 23: April 2002
Page: EEC.17
result of the inspection,
action taken on any non-compliances.
The Register
To view the current EU vessel register click here.
#
EEC.11
Standard for Fishing Boats (other than PH, L or W)
EEC.11.1
Introduction
In developing this standard the following documents were considered:
• EC directive 92/48,
• Canadian standards for fishing boats,
• the FIB code of practice for deep sea trawled fish,
•
EEC.11.2
the Fish (Packing for Export) Regulations Modification Notice 1982 (plus
amendments).
Definitions
Chilling means the placing of fish or fish products (other than live molluscan
bivalve shellfish) in ice or under refrigeration so that the fish or fish product is
being reduced in temperature to, and held at a temperature of, between -1 °C
and +1 °C (inclusive), and chilled has a corresponding meaning.
Freezing means the placing of fish or fish products under refrigerated
conditions so that the fish or fish product is reduced to, and held at a
temperature of, -18 °C or colder, and freeze or frozen have corresponding
meanings.
EEC.11.3
Construction
EEC.11.3.1
The parts of the fishing boats where fish or fish products are handled or stored
and any appliances used during the processing, storage or transportation of fish
or fish products shall be designed, constructed and maintained in such a
manner and of such materials so as to:
• permit easy and effective cleaning and sanitising; and
• minimise contamination of the fish or fish products.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
European Union
Issue 23: April 2002
Page: EEC.18
Materials should be either non-corrodible or be protected against
corrosion by non-toxic surfaces.
Surfaces and materials must be well maintained.
EEC.11.3.2
The fishing boat shall have facilities available for the storage of fish under
iced, chilled or frozen conditions. The holds or containers in which fish or fish
products are held under ice shall be constructed so that meltwater can be
drained.
EEC.11.4
Operational standards
EEC.11.4.1
Any section of the fishing boat, or any appliance used during the processing,
storage or transportation of fish, shall before use be thoroughly cleaned and
where necessary sanitised. Potable water or clean seawater shall be used for
cleaning and sanitation. Only detergents and sanitisers listed in MAF Manual
15 shall be used.
EEC.11.4.2
Precautions shall be taken to prevent the contamination of food contact
surfaces with fuel, bilge water or other contaminants.
EEC.11.4.3
Ice used for the chilling of fish shall be made from potable water to which salt
may be added or from clean seawater. Before use, the ice shall be stored in a
manner to minimise contamination.
The salt used must be food grade.
EEC.11.4.4
Brine used for the chilling or freezing of fish shall be made from clean seawater or potable water to which salt has been added.
The salt used must be food grade.
EEC.11.4.5
All fish (except fish that is to be landed live into a fish packing house) shall be
held in a chilled, iced or frozen state between the time of catching and the time
of delivery to the fish packing house.
EEC.11.4.6
Processing of the fish (e.g. heading and gutting) shall be carried out under
conditions which minimises the possibly of contamination or deterioration of
the fish or fish product.
EEC.11.4.7
Where fish or fish products are washed on the fishing boat, the water used for
washing shall be potable water or clean seawater.
EEC.11.4.8
Chemicals including detergents and sanitisers that are stored on board the
fishing boat shall be stored in a manner to preclude contamination of the fish.
EEC.11.4.9
Product handlers shall ensure a good standard of personal cleanliness and
cleanliness of their protective clothing.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
European Union
Issue 23: April 2002
Page: EEC.19
EEC.11.5
Specific provisions relating to fishing boats which are at sea for more than
24 hours
EEC.11.5.1
Where chilled seawater is used to store fish, the temperature of the seawater, at
the place that is likely to be warmest, shall be measured on a regular basis.
Records of the temperature measurements shall be kept for a period of 2 years.
EEC.11.5.2
Appropriate steps shall be taken to preclude vermin.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4 Specific Country Requirements Circular 1995
France
Issue 23: April 2002
Page: FRA.1
France
Special Features
Signatory:
Authorised Signatory
Official Inspector
AgM 430 *
Official Veterinarian
* If the border checks are to be carried out in France (see Section EEC.2.2).
#
Prohibited Imports:
None
.
Endorsements:
Shellfish: See Appendix II.5.
Note:
France is a member of the European Union (EU). The EU section should also be
consulted.
FRA.1
Mercury Level
See Section EEC.1.
FRA.2
Certification
French regulations governing the importation of seafoods and fish products of all
kinds intended for human consumption apply in France, including Sardinia and
Corsica, and in the Overseas Territories of Guadeloupe, Guiana, Martinique and
Reunion.
The law applies to sea animal and fresh water animal foods of all kinds, whether
alive, chilled, frozen, salted, dried, smoked, canned or processed in any way and
includes meat and oil extracts of fish and marine mammals.
Quantities of less than 2 kg are also exempted from inspection and presentation of
certificates if:
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4 Specific Country Requirements Circular 1995
France
Issue 23: April 2002
Page: FRA.2
A they enter France through parcel post and are not intended for sale; or
A they are brought in for personal consumption by travellers or tourists.
Companies must be listed for export to the EU (see Section EEC.9).
Containers must be sealed with a MAF bolt seal or a MAF Tyden seal (see
Section EEC.2.7).
FRA.3
Shellfish
#
The export of live shellfish is permitted. Product must be fully packaged/labelled
for direct retail sale, from New Zealand to France.
#
All shellfish exported to France must be obtained from an approved Shellfish
Growing Area. See EEC.3 for an updated version.
See Sections EEC.5 and EEC.6 for heavy metal and microbiological limits.
See IAIS 004.2 for French common names for shellfish.
For scallops, the French authorities require a humidity protein test to be carried
out (to determine if the scallops contain added water). All results must be 5 or
below.
FRA.4
Labelling
FRA.4.1
Background
All export containers of fish and the associated documentation destined for France
must show the acceptable French name for the appropriate species.
The problem of nomenclature of all commercial fish species in the world has been
the subject of a study by a French inter-professional committee for some time
now. They have issued us a list of acceptable French names for New Zealand fish
species.
The list of the acceptable French names is given in IAIS 004.2.
MAF will enforce only the requirements for the labelling of inner and outer
cartons required by IAIS 004.1 and the French requirements for the common
name (refer to the acceptable French names in IAIS 004.2).
All other French requirements for the labelling of inner and outer containers are
the responsibility of the producer/exporter. However, MAF will not certify
product that is misleadingly labelled.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4 Specific Country Requirements Circular 1995
France
Issue 1: May 1995
Page: FRA.3
The labelling requirements also apply to French Overseas Departments, i.e.
French Guiana, Martinique, Reunion, St Pierre and Miquelon. They do not apply
to French Territories, i.e. New Caledonia and French Polynesia (Tahiti).
FRA.4.2
Summary of labelling requirements
FRA.4.2.1 Consumer packs (packages intended for direct retail sale to the consumer)
The following items are to be indicated in French on the labels of consumer packs
(for the labelling of outer (shipping) containers, refer to Section FRA.4.2.2):
A
A
A
A
A
A
A
name of product
list of ingredients
nett weight
expiry date, and storage requirements
name of packer or manufacturer, or distributor
country of origin
conditions of utilisation.
The labelling should be clear, legible, and indelible. It can be applied by stencil,
stamp or stick-on label.
It is the responsibility of the producer to ensure that the French terms used on the
label are correct, appropriate to the product and the market concerned, and not
misleading. Liaison with the French buyer is strongly advised before the French
label is finalised.
Product name
The common name of the product is required. The accepted French names for
fish species are listed in IAIS 004.2. These names are to be used.
The product description is also required to show the form of the product, e.g.
powdered, lyophilised, frozen, chilled, thawed, sterilised, reconstituted,
concentrated, smoked, etc.
List of ingredients
A list of all ingredients of the packed product, in order of the decreasing amounts
present, is required.
Single-ingredient products, e.g. fillets, are exempt from this requirement.
Note: Products treated with salt, seasoning, etc., are not single-ingredient
products.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4 Specific Country Requirements Circular 1995
France
Issue 1: May 1995
Page: FRA.4
Nett weight
This is to be indicated in grams and/or kilograms.
Expiry date
Date labelling for perishable foods which have a maximum length of time
allowable under preservation, as set down by French regulations, must state this
date in clear as a final date for consumption.
i.e.
“Date limite de consommation...........”
(“Use by .............”)
This is the type of date-marking required for chilled product.
For other foods, e.g. frozen product, the date stated (in clear) is a limit indicating
optional utilisation.
i.e.
“A consumer de preference avant...........”
(“Best before...........”)
It is a matter for the producer and importer to determine which category a
particular foodstuff is in, and if in the second category, how long the expiry period
should be.
Note: Date labelling for consumption must indicate a specific date (e.g. “use by
March 1986”) rather than a more general indication of “use within 6 months of
packing date”.
All expiry dates on perishable foodstuffs are to be accompanied by information on
the required storage conditions (temperatures, etc.).
As a guide, the following list provides the abbreviations for the months which
should be used.
English
French
Recommended
abbreviation
(to be in capitals)
January
February
March
April
May
June
July
August
September
October
November
December
Janvier
Fevrier
Mars
Avril
Mai
Juin
Juillet
Aôut
Septembre
Octobre
Novembre
Decembre
JAN
FEV
MARS
AVR
MAI
JUIN
JUIL
AOUT
SEP
OCT
NOV
DEC
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4 Specific Country Requirements Circular 1995
France
Issue 1: May 1995
Page: FRA.5
Name of packer or distributor
The name or trade name of the producer or packer, or of an established
seller/distributor within the European Community, is required on each package.
Country of origin
The words “Produit de Nouvelle Zélande” are required on each package.
Conditions of utilisation
These are to describe special conditions under which the foodstuff is to be
prepared
for consumption, noting in particular any precautions to be taken.
FRA.4.2.2 Labelling of outer (shipping) containers
The outer containers of both consumer packs and bulk-packed product are
required to show:
A the name of the producer/packer
A the product description (in French)
A the expiry date (“use by” or “best before” in French).
Note:
FRA.5
The date of freezing is required to be shown clearly on the outer
containers of frozen products (in addition to the expiry date).
Food Additives
Phosphates are not permitted.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
United States of America
Issue 23: April 2002
Page: USA.1
United States of America
Special Features
Authorised Signatory
Signatory:
Official Inspector
*
Shellfish #
Swordfish
Official Veterinarian
* Except shellfish - see Sections USA.2.6 and USA.3.
Swordfish – see Section 2.7
Shellfish covered by the NSSP Programme.
Swordfish
Prohibited Imports:
•
•
Mussel essence, powder or mussels, if intended or sold for therapeutic reasons. See
Section USA.6.
Cold smoked salmon (to all or some states).
Endorsements:
Required for shellfish (see Section USA.2 and Appendix II.5).
Required for swordfish (see Section USA.4).
USA.1
Mercury Level
1.0 ppm.
USA.2
#
USA.2.1
Certification for the Continental USA, Hawaii, American Samoa, Guam and US
Territories
Listing of fish premises (other than those producing bivalve molluscan
shellfish) for the USA
Fish packing houses (including PH licensed/registered fishing vessels and also
vessels registered under the Animal Products (Regulated Control Scheme Limited Processing Fishing Vessels) Regulations 2001 who wish to export
directly to the USA) exporting fish to the USA shall be listed as approved for
export to the USA. For an updated version of the ‘New Zealand Premises for
Export of Seafood (IAISs) to HACCP standards, USA’ click here.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
United States of America
Issue 23: April 2002
Page: USA.2
For premises to be eligible for consideration for listing to the USA, Hazard
Analysis Critical Control Point (HACCP) must be fully implemented in
accordance with the requirements of IAIS 003.5, Section 2, Processing.
Premises wishing to become listed must contact their Travelling Technical
Supervisor (MAF VA) in the first instance to initiate the listing process.
#
USA.2.2
Initial listing
Licensed fish premises wishing to be listed for the USA shall in the first instance
apply to the local Inspector. Where the Inspector is satisfied that the premises can
meet the requirements for export to the USA the Inspector will consult with the
Technical Specialist (Seafood), MAF Verification Agency. A written assurance that
the premises meets the required standards shall be supplied to the Technical
Communications Manager, MAF Food Assurance Authority by the Technical Services
Manager, MAF VA. Fish premises can export product to the USA from the date
notified in writing by MAF Food Assurance Authority.
#
USA.2.3
Changes to listings
Any changes to the listing details (e.g. premises name, address) shall be notified to the
Technical Communications Manager, MAF Food Assurance Authority.
USA.2.4
Voluntary delisting of fish premises for the USA
Any licenced premises that wishes to have its listing for the USA removed shall
advise the local Inspector in writing. This covers situations such as the company being
no longer interested in the USA market, premises closed, etc.
Licenced premises which request voluntary delisting shall not export to the USA any
product processed on or after the date of request for delisting.
USA.2.5
Delisting of fish premises for the USA
USA.2.5.1 Delisting by the delivery agency
If the level of compliance in a fish premises (subsequent to following the procedures
in IAIS 003.8) is unacceptable, certification of fish and fish product to the USA may
be suspended until such time as the Inspector considers a satisfactory level of
compliance has been attained. Notification of suspension and reinstatement of
certification shall be given in writing.
Where a premises has had certification to the USA suspended, the following statement
shall appear on all transfer documents issued for fish or fish product during the period
of suspension:
“The product [or state name of the product if only part of the consignments is
not eligible] described in this certificate is not eligible for export to the USA.”
Note:
Where only part of a consignment is not eligible for export to the USA, then
the details of the product that is not eligible for that market shall be
specified.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
United States of America
Issue 11: July 1999
Page: USA.3
Where Section 4.1.2 of IAIS 002.1 is used, i.e. no transfer documents are
issued, assurances about market eligibility shall be met.
#
USA.2.5.2 Suspension by MAF Food Assurance Authority
If, during a MAF Food Assurance Authority compliance review or any other MAF
Food Assurance Authority review, unsatisfactory management of either a critical
deficiency in a system or cumulative deficiencies over several systems is encountered,
delisting may occur. When the Director Compliance and Investigation Group receives
a recommendation from the Regional Technical Services Manager, MAF Verification
Agency, that a satisfactory level of compliance has been achieved, a follow-up
Compliance Group review shall be conducted. If the outcome of the review is
satisfactory, certification to the USA will be restored. The Director shall advise MAF
Verification Agency via the Technical Services Manager. MAF Verification Agency
shall notify the fish premises.
#
#
#
#
#
#
#
Where a premises has had certification to the USA suspended, the following statement
shall appear on all transfer documents issued for fish or fish product during the period
of suspension:
“The product [or state name of the product if only part of the
consignments is not eligible] described in this certificate is not eligible
for export to the USA.”
Note: Where only part of a consignment is not eligible for export to the USA, then
the details of the product that is not eligible for that market shall be specified.
Where Section 4.1.2 of IAIS 002.1 is used, i.e. no transfer documents are
issued, assurances about market eligibility shall be met.
USA.2.5.3 Formal delisting
#
#
If suspension to the USA remains in effect for greater than 30 days, MAF Food
Assurance Authority will formally delist the premises. The premises shall be advised
in writing of the delisting.
USA.2.6
Certification for shellfish
Shellfish shall be certified in the following way:
•
Shellfish certification shall be provided on AgM 400 or 401 certificates.
•
The ICSS number (or numbers) shall be included on the certificate.
•
All certificates for shellfish shall be endorsed with the following statement:
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
United States of America
Issue 23: April 2002
Page: USA.4
“I hereby certify that the shellfish in this consignment have been grown,
harvested and exported in accordance with the United States Food and Drug
Administration Shellfish Sanitation Programme Standards.”
•
Where an exporter of shellfish to the USA:
−
−
−
acts as a broker only (i.e. does not actually handle the product); and
is not listed as a reshipper; and
is named as the consignor of the product on the export certificate
the words “broker only” shall be included after the name of the company in the
consignor box on the export certificate.
See also the Special Features box at the start of the USA section.
#
USA.2.7
Certification for swordfish
The following endorsement is to be included in the main panel: “The Pacific Broadbill
swordfish in this consignment were caught by a vessel registered under the Fisheries
Act 1996 to fish in New Zealand territorial waters. The vessel carries the (insert the
name of country) flag.” The certificate shall be stamped with the Inspector’s Official
stamp, signed by an official Inspector and their name and title shall be written above
their signature.
USA.3
Shellfish
USA.3.1
Background
A memorandum of understanding between MAF and the US Food and Drug
Administration was signed in 1980. The memorandum affirmed the intention of MAF
to assure that molluscan bivalves exported to the USA were safe and wholesome, and
had been harvested, transported, processed and labelled in accordance with the
USFDA National Shellfish Sanitation Programme (NSSP) requirements.
USA.3.2
US reviews of the New Zealand programme
Biennial reviews of the New Zealand Shellfish Sanitation Programme are conducted
by FDA Officers. These reviews involve a detailed evaluation of our entire shellfish
programme, from the classification of growing waters, through controls of harvesting
and transport, to processing and storage facilities. US-certified shellfish plants are
inspected by the FDA during these reviews.
The reviews are conducted to determine the level of compliance with the NSSP
manuals.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
United States of America
USA.3.3
Issue 23: April 2002
Page: USA.5
Major requirements of the programme
Exporters shall ensure the main requirements are complied with.
The major requirements of the programme are:
•
•
•
•
#
obtaining shellfish from approved growing waters;
transporting and handling shellfish in such a manner that they are protected from
contamination, especially in accordance with the requirements of the NSSP
Manuals Parts I and II;
processing and packing shellfish in US-certified shellfish plants;
accurate labelling of product and record keeping by plant management to permit,
where necessary, traceback to the source of the shellfish.
The export of fresh and fresh/frozen shellfish to the USA is permitted only from New
Zealand premises which have been notified to the US Food and Drug Administration
and appear on the “Interstate Certified Shellfish Shippers List” which is published
monthly by the FDA (see Section USA.8). For further information refer to the NSSP
manual, Part II, Section A2.
The Hawaii Department of Agriculture has advised that they may reject shellfish that
are found with attached organisms such as parasitic worms, limpets, snails and other
marine animals.
Companies exporting shellfish to the North American Market in general (not just
Hawaii) should ensure that all shipments are free of the above organisms.
Information on the labelling of shellfish is given in Section USA.4.
USA.4
Labelling
USA.4.1
Background
The USA labelling requirements are spelled out in the US Federal Food, Drug and
Cosmetic Act and the Code of Federal Regulations Title 21 Part 101 and specific
shellfish requirements are in the current editions of the NSSP manual Part II.
This section is only a synopsis of the principal requirements of the Act and
Regulations with emphasis on the labelling of outer and inner (retail) containers for
fish and fish products destined for the USA. Exporters should consult the text of the
Act and Regulations and ensure full compliance with them before exporting fish and
fish products to that country.
Prior label approval by the FDA is not required for fish products. If in doubt,
exporters should send a draft label to the FDA for comments.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
United States of America
Issue 11: July 1999
Page: USA.6
Unlabelled fish and fish product which is to be processed, labelled or repacked in the
US may be exported to the US under a written agreement which allows the receiving
party to comply with FDA labelling requirements when processing, labelling and/or
repacking the fish or fish product. See 21 CFR 101.100(d) for details. Note that the
fish or fish product must still be labelled in accordance with IAIS 004.
USA.4.2
USA labelling requirements
USA.4.2.1 Labels shall not contain false information or be misleading.
USA.4.2.2 Required label information shall not only be conspicuously displayed, but it must also
be in terms that the ordinary consumer is likely to read and understand under ordinary
conditions of purchase and use.
USA.4.2.3 If the product is packaged (either in bulk cartons or in retail packages) the following
statements in English must appear on the label:
•
The name, city (and street address, unless listed in a current city or phone
directory) and country of either the manufacturer, packer or distributor. Where
applicable, such expressions as “manufactured for” or “distributed by” must be
used.
•
An accurate statement of the net weight of fish in the package. The quantity
declaration must be in a type size based upon the area of the principal display
panel of the package (i.e. the part of a label that is most likely to be displayed,
presented, shown or examined under customary conditions of display for sale) and
must be separated from other information. If the area of the principal display is
larger than 5 square inches, the quantity declaration must appear within the lower
30% of the label.
The label must show the net weight in both the metric and the US customary
system (ounces and pounds), e.g. net weight 1 lb 8 oz (680 g).
The net weight on packages containing less than 1 pound must be expressed as
total avoirdupois ounces.
Between 1 and 4 pounds, the net weight must be declared first in total ounces
followed by a second statement in parenthesis () in terms of pounds and ounces.
For example:
Net Weight 24 ounces (1½ pounds or 1.5 lb).
Packages which are 4 pounds or larger need only have their contents expressed in
terms of the largest unit of weight, with any remainder in ounces, or common or
decimal fractions of the pound.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
United States of America
Issue 11: July 1999
Page: USA.7
Companies should also be aware that the Weights and Measures Amendment Act
1976 (administered by the Labour Department) requires that all weights on
packages of food sold in New Zealand for domestic consumption be marked in the
metric system.
Drained weight rather than net weight must be declared on the label of product
packed in a liquid that is not consumed as food.
If the label of any fish package also represents the content in terms of the number
of servings, the size of each serving must be indicated.
•
The common name of the fish on the principal display panel, and in bold type and
in lines generally parallel to the base of the package as it is displayed.
Words like “fish” are not sufficient. The name of the species (e.g. “orange
roughy”) shall be used. The authorities do not accept a New Zealand common
name which either conflicts with a common or usual name already in use in the
USA for a different species of fish, or is misleading (e.g. use of the word “clam”
to describe New Zealand green mussel).
See IAIS 004.2 for acceptable common names.
#
#
•
The common name “Pacific Broadbill Swordfish” shall be used in the product
description as well as the scientific name Xiphias gladius.
•
A list of all ingredients using their common or usual names listed in descending
order by weight. This information is to be on the principal display panel or
information panel.
•
A conspicuous statement of all food additives (e.g. spices, flavourings, colourings,
preservatives, etc.) present in the product. Only additives permitted by US Food
and Drug Administration may be used.
•
The labelling of food intended for special dietary uses must bear certain prescribed
additional information concerning its vitamin, mineral and other dietary
properties.
•
The word “Imitation” where applicable.
•
The country of origin shall be clearly labelled on the front of the cartons.
•
Frozen shucked shellfish shall be labelled with the word “frozen” in equal
prominence to the name of the shellfish.
•
If the term “fresh” or “fresh frozen” is used on the label to describe a food, it must
not have undergone any thermal processing (other than blanching) or any other
form of preservation.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
United States of America
#
USA.4.3
Issue 23: April 2002
Page: USA.8
•
Packaged fish and fish product (retail packs and institutional packs that may be
sold to the consumer) arriving in the USA after 8 August 1994 require detailed
nutrition labelling (see Sections USA.11, USA.12 and USA 13 for a summary of
the requirements).
•
The US Certified Interstate Shellfish Shipper registration number (e.g. New
Zealand 22 RP) and the lot identification number (or in its place the marine farm
licence/lease number, dates of harvest and packing), if the product is fresh, chilled
or frozen shellfish.
•
If fresh or frozen (not cooked) shucked shellfish is packed in a container with a
capacity of less than 1873 ml (one-half gallon, 64 ounces), the principal display
panel shall contain the certification number of the packer and the words “Sell by
...” followed by a recommended last date of sale of the product which provides a
reasonable shelf life or the words “Best if used by ...” followed by a date when the
product would be expected to reach the end of its shelf life. The date should
consist of the common abbreviation for the month and number of the day of the
month. For frozen shellfish, the year should also be added.
•
If fresh or frozen (not cooked) shucked shellfish are packed in a container of more
than 1873 ml (one-half gallon, 64 ounces), the word “shucked ...” followed by the
actual shucking date must appear on the lid and on the side wall or bottom of
durable containers. The date should consist of the common abbreviation for the
month and number of the day of the year. For frozen shellfish, the year should
also be added.
Health claims
Claims for a relationship between a nutrient or a food and the risk of a disease or
health-related condition are allowed in certain circumstances. The claim must be
phrased so that consumers can understand the relationship between the nutrient and
the disease and the nutrient’s importance in relationship to a daily diet.
Some specific nutrient-disease relationships that are allowed are:
•
Fat and cancer. To use this claim the fish product must meet the descriptor
requirement for “extra lean”.
•
Saturated fat and cholesterol and coronary heart disease (CHD). This claim may
be used if the fish product meets the descriptor requirement for “extra lean”. It
may mention the link between reduced risk of CHD and lower saturated fat and
cholesterol intakes to lower blood cholesterol levels.
It should be noted that the FDA has determined that existing publicly available
scientific evidence does not support a label claim on a fish product that Omega 3 fatty
acids are associated with a reduced risk of coronary heart disease. The FDA does not
authorise any such claims in food labelling.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
United States of America
Issue 11: July 1999
Page: USA.9
Companies wishing to use health claims on labels are advised to consult the FDA
regulations (21 CFR) for details.
USA.4.4
Dietary supplements
USA.4.4.1 Dietary supplements are regulated under the Food, Drug & Cosmetic Act, as amended
by the Dietary Supplement Health & Education Act 1994 and under the Fair
Packaging and Labelling Act.
A summary of the requirements is outlined below. The requirements relating to
nutritional support statements are effective immediately. Other provisions come into
effect on 31 December 1996, although products may be labelled with these provisions
before that date.
USA.4.4.2 A dietary supplement is
•
a product that is intended to supplement the diet that contains one or more of the
following dietary ingredients: a vitamin, a mineral, a herb or other botanical, an
amino acid, a dietary substance for use by man to supplement the diet by
increasing the total daily intake, or a concentrate, metabolite, constituent, extract,
or combinations of these ingredients;
•
intended for ingestion in pill, capsule, tablet or liquid form;
•
not represented for use as a conventional food or as the sole item of a meal or diet;
•
labelled as a “dietary supplement”.
USA.4.4.3 Like other foods, dietary supplements must meet the mandatory labelling
requirements. See Section USA.4.2.
USA.4.4.4 The manufacturer of a dietary supplement may make a nutritional support statement
that:
•
claims a benefit related to a classical nutrient deficiency disease and discloses the
prevalence of the disease in the USA;
•
makes a claim describing the supplement’s effects on the “structure and function”
of the body, or on the general “well-being” achieved by consuming the dietary
ingredient.
Note: This claim must not relate to the supplement’s ability to diagnose, prevent,
mitigate, treat, or cure a specific disease. This would be a health claim and, as
such, would have to be authorised by the FDA before use.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
United States of America
Issue 23: April 2002
Page: USA.10
USA.4.4.5 To make the nutritional support claims in Section 4.4.3, the manufacturer must be able
to substantiate that the claim is truthful and not misleading. However, unlike health
claims, a statement of nutritional support does not have to be authorised by FDA, but
the FDA must be notified within 30 days of the labelled product being released for
sale.
Contact address:
Office of Food Labelling
Center for Food Safety and Applied Nutrition
Food and Drug Administration
200 C Street, S W
Washington, DC 20204
USA
USA.4.4.6 If a nutritional support claim is made, the label must carry in boldface type:
“This statement has not been evaluated by the Food and Drug Administration. This
product is not intended to diagnose, treat, cure, or prevent any disease”.
#
USA.5
Vacuum-Packed/Modified Atmosphere Packed Fish
Vacuum-packed or any modified atmosphere packed fish or fish products must be
exported frozen to –18 OC or less. This is based upon concerns held by the FDA in
relation to the presence of any Clostridium botulinum spores in fish or fish product
packed in this manner.
#
USA.6
Guidelines and Tolerances Applied by the FDA
#
USA.6.1
Microbiological guidelines for processed seafood
Generally 10 sub-samples are taken of processed seafood (a product that requires none
to minimal processing by the consumer).
The limits are:
Listeria monocytogenes
—
Absent in two composites
Staphylococcus aureus
—
—
104/g (MPN)
Staphylococcal enterotoxin absent
Enterotoxigenic E. coli
—
103/g
Vibrio cholerae
(toxigenic 01 or non-01)
—
Absent
Vibrio parahaemolyticus
—
104/g
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
United States of America
# USA.6.2
Issue 23: April 2002
Page: USA.11
Vibrio vulnificus
—
Pathogenic organisms absent
Clostridium botulinum
spores
—
Toxin type “E” not detected.
Tolerances applied by the FDA for decomposition of fresh or frozen fish
The limits are:
•
5% or more of the fish or fillets in the sample (but not less than five) show Class
3 decomposition over at least 25% of their areas;
•
or 20% or more of the fish or fillets in the sample (but not less than five) show
Class 2 decomposition over at least 25% of their areas;
•
or the percentage of fish or fillets showing Class 2 decomposition as above, plus
four times the percentage of those showing Class 3 decomposition as above,
equals at least 20% and there are at least five decomposed fish or fillets in the
sample.
Note: This guide only applies to fish or fillets averaging 3 lb or less.
Classes of decomposition:
1. No odour of decomposition
2. Slight odour of decomposition
3. Definite odour of decomposition
#
USA.6.3
Histamine
Tuna, mahi mahi ≥ 500 ppm — rejection
≥ 50 ppm — may result in action.
# USA.6.4
Contaminants (environment chemical and pesticide residues)
Substance
a
Aldrin/Dieldrin
Chlordane
Chlordeconeb
DDT, TDE, DDEc
Diquatd
Fluridoned
Glyphosated
Level
Product
0.3 ppm
0.3 ppm
0.3 ppm
0.4 ppm
5.0 ppm
0.1 ppm
0.5 ppm
0.25 ppm
3.0 ppm
All fish
All fish
All fish
Crabmeat
All fish
All fish
Fin fish and crayfish
Fin fish
Shellfish
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
United States of America
Toxic elements:
Arsenic
Cadmium
Chromium
Lead
Nickel
76 ppm
86 ppm
3 ppm
4 ppm
12 ppm
13 ppm
1.5 ppm
1.7 ppm
70 ppm
80 ppm
0.3 ppm
0.1 ppm
Issue 23: April 2002
Page: USA.12
Crustacea
Molluscan bivalves
Crustacea
Molluscan bivalves
Crustacea
Molluscan bivalves
Crustacea
Molluscan bivalves
Crustacea
Molluscan bivalves
All fish
All fish
Heptachlor/Heptachlor epoxidee
Mirex
Polychlorinated
biphenyls (PCBs)
2.0 ppm
All fish
d
Simazine
12 ppm
Fin fish
2, 4-Dd
1.0 ppm
All fish
a The guidance level for aldrin and dieldrin are for residues of the pesticides individually or in
combination. However, in adding amounts of aldrin and dieldrin, do not count aldrin or dieldrin
found at below 0.1 ppm.
b Previously listed as Kepone, the trade name of chlordecone.
c The guidance level for DDT, TDE and DDE are for residues of the pesticides individually or in
combination. However, in adding amounts of DDT, TDE and DDE, do not count any of the three
found below 0.2 ppm.
d The levels published in 21 CFR & 40 CFR represent tolerances, rather than guidance levels.
e The guidance level for heptachlor and heptachlor epoxide are for the pesticides individually or in
combination. However, in adding amounts of heptachlor and heptachlor epoxide, do not count
heptachlor or heptachlor epoxide found below 0.1 ppm.
#
USA.6.5
Toxins
PSP
NSP
ASP
All fish
Molluscan bivalves
All fish
#
USA.7
Prohibited Imports
#
USA.7.1
Background
80 µg/100 g
20 mouse units/100 g
20 ppm
On or about 19 November 1980, the US Food and Drug Administration posted an
Import Alert requiring immediate detention on entry to the USA of all freeze-dried,
green-lipped mussel powder from New Zealand. The reason quoted was “a
therapeutic reputation exists for the powder and it is thus a non-approved and hence
illegal drug, not a foodstuff”.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
United States of America
#
USA.7.2
Issue 23: April 2002
Page: USA.13
Further developments
It has now been advised that green-lipped mussel powder may gain access to the
US market if it is clearly labelled as a dietary supplement and conforms to the
requirements for dietary supplements (Section USA.4.4). Note that any product
entering as a drug or with drug claims such as a cure, or to prevent or mitigate
disease, will still face immediate detention on entry to the US.
#
USA.7.3
Action
All samples or commercial shipments of green-lipped mussels bound for the US
market should, therefore, be clearly identified as being foodstuff for human
consumption only.
#
USA.8
US Interstate Certified Shellfish Shippers List
For an updated version of the premises listed on the US interstate certified shellfish
shippers list click here.
#
USA.9
Low Acid or Acidified Canned Food
Before any low acid or acidified canned food can be exported to the USA, the
processor is required to file with the FDA information on the scheduled process. The
information is required to be filed on official forms.
See FDA Regulations 21 CFR Parts 108, 113 and 114 for details.
#
USA.10
Premises Listed for Export to the USA
For an updated version of the premises listed for export to the USA click here.
#
USA.11
Mandatory Nutritional Labelling
#
USA.11.1
Background
#
USA.11.1.1 The US Nutrition Labelling and Education Act of 1990 (NLEA) required nutrition
labelling of all foods under the jurisdiction of the Food and Drug Administration
(FDA) which will be sold at retail level in the USA.
#
USA.11.1.2 All New Zealand fish and fish products on sale in the USA on or after 8 August 1994
will have to comply with the requirements for nutritional labelling.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
United States of America
#
Issue 23: April 2002
Page: USA.14
USA.11.1.3 The regulations are very comprehensive and very detailed in all respects. This
section advises the basic requirements for nutrition labelling. Any manufacturer who
may want to depart from the basic requirements is advised to consult the full text of
the regulations. The regulations were published in the Federal Register, Vol. 58, No.
3 on Wednesday 6 January 1993. The regulations summarised here relate to the
Code of Federal Regulations Title 21 (21CFR) Parts 101.9 and 101.13.
#
USA.11.2
#
USA.11.2.1 All products that comprise more than one type of food (more than one ingredient)
must be labelled with nutritional information when offered for sale to the consumer
on or after 8 August 1994.
Mandatory requirements
# USA.11.2.2 All single ingredient products must contain nutritional information when any
particular nutritional claim is made (statements such as “reduced salt”, “low
cholesterol”, “health”, etc., will be nutritional claims).
# USA.11.2.3 When the food is packaged, the nutritional information is to be presented in the
#
format outlined in Section USA.12.
# USA.11.2.4 When the food is not packaged, the nutritional information shall be displayed clearly
at the point of sale by the use of tags, counter signs or booklets, etc.
# USA.11.2.5 All manufactured products (e.g. with more than one ingredient) must be labelled
with nutritional information so that the retailer can meet his obligations to provide
nutritional information at the point of sale.
# USA.11.3
Exemptions from mandatory labelling requirements
# USA.11.3.1 Small businesses are exempt from the labelling requirements provided that no
nutritional claim or nutritional information appears on the label of that product.
Further, that the business done by the manufacturer, packer or distributor:
•
is not more than US $500,000 in gross annual sales, or
•
is not more than US $50,000 in sales of food.
For New Zealand processors and exporters the business done means the total of all
sales, food and non-food, made to the USA. Calculations shall be the average of the
most recent 2-year period.
# USA.11.3.2 Products which are intended to be served in restaurants, institutional food service
establishments, transportation carriers and food outlets, where the food is normally
consumed immediately after sale on or from the premises, are exempt from the
requirements of mandatory labelling except when there is a reasonable possibility
that these products might be purchased directly by the consumer.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
United States of America
Issue 23: April 2002
Page: USA.15
# USA.11.3.3 Products which contain an insignificant amount of all of the nutrients and food
components that are listed in Section USA.12 and are normally required to be
declared. For total carbohydrate, dietary fibre and protein this shall mean less than
1 g. For all other nutrients an insignificant amount shall mean zero where the
labelling rule permits this statement to be made.
# USA.11.3.4 Products intended for further processing, e.g. bulk packs, provided that no
nutritional claim or nutritional information appears on the label.
# USA.11.3.5 Products in packages that have a total surface area available to bear labelling of less
than 12 square inches provided, that no nutritional claim or nutritional information
appears on the label. In these instances, the label shall include an address or
telephone number that can be used by a consumer to obtain nutritional information.
# USA.11.3.6 Packaged single ingredient fish products may provide the required nutritional
information for a 3-ounce cooked edible portion, i.e. on an “as prepared basis”,
unless any other claim is made for any values (nutrient, energy, etc.) on an “as
packaged” basis.
# USA.11.4
Label format
The label format may be modified if the food package has a total surface area of less
than 40 square inches on which to attach a label. In these cases the nutritional
information may be presented in one or more of the following formats:
•
A tabular or linear fashion rather than vertical columns. The linear format of
presentation may only be used if the label will not accommodate a tabular
display or if the surface area available to bear labelling is less than 12 square
inches. See Section USA.12 for an example of a modified format using a
tabular display.
•
By using the following abbreviations: serving size = Serv. Size, servings per
container = Servings, calories from fat = Fat Cal, saturated fat = Sat Fat,
cholesterol = Cholest, total carbohydrate = Total Carb, dietary fibre = Fiber.
•
Omitting the footnote and caloric conversion information and substituting the
following phrase “*Percent Daily Values as based on a 2000 calorie diet”. “DV”
may be used instead of the words “Daily Value”.
•
Presenting the required nutritional information on any other label panel rather
than the principal display panel.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
United States of America
# USA.11.5
Issue 23: April 2002
Page: USA.16
Compliance
# USA.11.5.1 Compliance with the requirements for nutritional labelling will be determined as
follows.
# USA.11.5.2 Analysis of the nutrients in a product shall be performed on the composite of 12
subsamples taken each from one shipping container of consumer units. The
shipping containers shall be representative of a production lot and shall be selected
by random methods.
# USA.11.5.3 Analysis must be performed by a competent laboratory using methods specified in
#
Section USA.13.
# USA.11.5.4 Compliance will be based on the metric measure of the serving size declared on the
label. No regulatory action will be taken for nutrient analyses which fall below or
#
above specified values (Sections USA.11.5.7 and USA.11.5.8) by an amount less
than the variability generally recognised for the analytical method used and the
matrix involved.
# USA.11.5.5 Reasonable excesses of vitamins, minerals, protein, total carbohydrate, dietary fibre,
other carbohydrate, polyunsaturated or monounsaturated fat, or potassium, and
deficiencies of calories, sugars, total fat, saturated fat, cholesterol or sodium, are
acceptable within current good manufacturing practice
# USA.11.5.6 Product will be assessed as either Class I: added nutrients in fortified or fabricated
foods, or Class II: products with naturally occurring nutrients.
# USA.11.5.7 Products with label declarations of vitamins, minerals, protein, total carbohydrate,
dietary fibre, other carbohydrate, polyunsaturated or monounsaturated fat, or
potassium will be misbranded unless:
•
for Class I foods the vitamin, mineral, protein, dietary fibre or potassium content
is at least equal to the declared label value;
•
for Class II foods the vitamin, mineral, protein, total carbohydrate, dietary fibre,
other carbohydrate, polyunsaturated or monounsaturated fat, or potassium
content is at least equal to 80% of the declared label value.
# USA.11.5.8 Products with a label declaration of calories, sugars, total fat, saturated fat,
cholesterol or sodium will be misbranded if the nutrient content is greater than
120% of the declared label value.
# USA.11.5.9 Compliance may be provided by use of an FDA approved database for products
where a clear need is presented, e.g. raw produce and seafood. FDA approval of a
database will be granted only after the Center for Food Safety and Applied
Nutritional has agreed to all aspects of the database in writing.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
United States of America
Issue 23: April 2002
Page: USA.17
FDA guideline procedures for computing and submitting requests for approval of
databases may be found in the “FDA Nutritional Labelling Manual — A Guide for
Developing and Using Data Bases” available from the Division of Nutrition, Center
for Food Safety and Applied Nutrition (HFF-260), Food and Drug Administration,
200 C St. SW., Washington, DC 20204.
# USA.11.6
Nutrient content claims
# USA.11.6.1 The company should consult the full text of the regulation when contemplating any
nutrient content claim.
# USA.11.6.2 Nutritional labelling shall be provided for any food for which a nutrient content
claim is either stated or is implied. A stated claim is a direct statement about the
level (or range) of a nutrient, e.g. “low sodium” or “contains 100 calories”. An
implied claim suggests that a nutrient is either present or absent, e.g. “high in oat
bran”, or suggests that the product may be useful in maintaining healthy dietary
practice, e.g. “healthy, contains 3 grams (g) of fat”.
# USA.11.6.3 Information which is mandatory and appears as part of the nutritional label is not a
nutrient claim unless that information is declared elsewhere on the label.
# USA.11.6.4 A claim for “free” or “low” before the name of the food can only be made if the food
has been formulated and processed to lower the amount of nutrient.
# USA.11.6.5 When a nutrient content claim appears on a label, the referral statement, “See
<identify the panel> for nutritional information” shall also appear in close proximity
to the claim.
# USA.11.6.6 Claims may be made about the amount or percentage of a nutrient.
# USA.11.6.7 Statements may be made which compare the level of a nutrient in a product with
that of a reference food. These are “relative claims”; claims for “less” or “more”
may be made on dissimilar products. Claims for “light”, “reduced”, “added” or
“fortified” shall be made relative to similar foods.
# USA.11.6.8 A “meal-type product” or “main dish product” which is represented in a commonly
understood form such as breakfast, lunch, dinner or meal must weigh at least 10
ounces per serving (6 ounces for a main dish) and contain not less than 40 g for
each fish combined with two or more of the following three food groups:
•
bread, cereal, rice or pasta;
•
fruit or vegetables;
•
milk, yoghurt or cheese.
# USA.11.6.9 The reference amount customarily consumed shall be used in determining whether
a product meets the criteria for a nutrient content claim.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
United States of America
Issue 23: April 2002
Page: USA.18
# USA.11.6.10 Nutrient content claims which have not been defined by regulation and that
appeared as a part of a brand name that was in use before 25 October 1989 may
continue to be used provided the claim is not false or misleading.
# USA.11.6.11 Requirements for nutrient content claims using the terms: “good source”, “high”,
“more”, “light” or “lite”, calorie content, sodium, fat, fatty acid and cholesterol are
prescribed in 21 CFR 101.54, 101.56, 101.60, 101.61 and 101.62.
# USA.11.6.12 The requirements for implied nutrient content claims and the use of the descriptive
terms “fresh”, “freshly frozen”, “fresh frozen” or “frozen fresh” are prescribed in
21 CFR 101.65 and 101.95.
# USA.11.6.13 Petitions for nutrient content claims which are stated or implied must be supported
with technical data obtained from clinical and/or non-clinical studies which are
sufficiently comprehensive to validate the claim being made. Applications,
including technical data, must be submitted to the Department of Health and
Human Services, Food and Drug Administration.
# USA.12
Nutritional Label Format
# USA.12.1
Background
# USA.12.1.1 This is an abbreviation of the regulations relating to the nutritional information
which must appear on labels of food, when required. The requirements outlined in
this section are applicable to fish and shellfish. These requirements are intended
to give sufficient information to enable processors to comply with the requirements
for mandatory labelling for foods intended for consumption by people 4 years and
over and for which no special nutritional claim is made or implied.
# USA.12.1.2 The nutritional labelling of food is based on the daily intake of 2000 calories per
person and a recommended daily intake for a range of principal nutrients. These
basic needs for nutrition are linked to an amount of a food type ordinarily consumed
by people at a sitting. The amount of food deemed to be consumed at a sitting is
the basic reference called the “reference amount”.
# USA.12.1.3 Food labels must declare how many servings are contained in the package, the
serving size, the quantities of nutrients present and to what extent the available
nutrients satisfy the recommended daily needs of people.
# USA.12.1.4 The serving size will relate directly to the reference amount, and the number of
servings will be a factor of the serving size and the weight of food in the package.
The specific quantities of nutrients in each serving size will have to be determined
for the type of food in the package, and the contribution to the recommended daily
requirement that this quantity of nutrients can be calculated from the table of
recommended daily values.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
United States of America
# USA.12.2
Issue 23: April 2002
Page: USA.19
Reference amount
# USA.12.2.1 The reference amounts for food types have been calculated from extensive
population surveys carried out in the USA. Reference amounts (RAs) of types of
food customarily consumed at each eating occasion have been calculated for:
#
•
persons 4 years of age and older,
•
children between 1 and 3 years of age, and
•
infants under 1-year-old.
Reference amounts customarily consumed per eating occasion for types of foods
generally appropriate to the fish processing industries is presented in Section
USA.12.2.2.
#
Note: The information given here relates only to RAs for persons 4 years of age
and older. If products are specifically intended for younger children, the criteria
will be different. In some cases, the listing of nutrient will differ from that
described in the nutritional facts (see Section USA.12.3). Processors intending to
produce products specifically intended for young children should contact the
Director (Animal Products), MAF Food Assurance Authority for information about
the appropriate criteria.
# USA.12.2.2
Product category
Reference amount
Fish and shellfish
Snacks, e.g. food sticks
30 g
Entrées with sauce, e.g. fish with cream sauce
Entrées without sauce, e.g. plain or fried fish and
shellfish marinated fish
140 g
cooked = 85 g
ready to cook = 114 g
Fish or shellfish, canned
55 g
Smoked or pickled fish or shellfish, fish or shellfish spread
55 g
Mixed dishes
Measurable with a cup, e.g. casseroles, hash, macaroni and
cheese, pot pies, spaghetti with sauce, stews, meat hash, goulash
1 cup
(240 ml)
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
United States of America
Not measurable with a cup, e.g. burritos, enchiladas, pizza,
pizza rolls, quiche, sandwiches, burgers, stuffed
vegetables and meat, shish kebab
Issue 23: April 2002
Page: USA.20
140 g
add 55 g
for products
with gravy or
topping sauce
Soups, all varieties
245 g
Major main entrée type sauce, e.g. spaghetti sauce with meat
125 g
Minor main entrée type sauce, e.g. pizza sauce with meat, gravy
1/4 cup
(60 ml)
Seasoning mixes dry
e.g. freeze dried, FD trail mix with meat, dehydrated, bases, extracts;
as reconstituted (amount to make one reference amount of final dish):
Gravy
1/4 cup
Major main entrée type sauce
125 g
Soup
245 g
Entrée measurable with a cup
1 cup
# USA.12.2.3 The reference amounts:
•
are based on the major intended use of the food and only on the edible portion
of the food, i.e. bone, shell or other non-edible components are not included;
•
for products that are consumed as an ingredient of other foods, but may also be
consumed in the form in which they are purchased, are based on their use in the
form as purchased;
•
of a product that requires cooking, the addition of water or the addition of other
ingredients shall be the amount required to prepare one reference amount of the
final product as established in Section USA.12.2.2;
•
for an imitation food or an altered food such as a “low calorie” variation shall
be the same as for the base food which is being substituted (the reference
amounts in Section USA.12.2.2 shall be used to determine if a product meets
the criteria for a nutritional claim such as “low calorie”);
#
#
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
United States of America
•
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Issue 23: April 2002
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for a product that contains two or more foods packaged together, and is not
listed in Section USA.12.2.2 as a product category, shall be the sum of the RAs
for the individual foods.
# USA.12.2.4 The term serving or serving size means an amount of food customarily consumed
per eating occasion by persons 4 years of age or older expressed in common
household units, e.g. cups, tablespoons or teaspoons (for nutritional labelling
purposes, a teaspoon = 5 ml, a tablespoon = 15 ml, a cup = 240 ml, 1 fluid ounce
= 30 ml, 1 ounce = 28 g). If common household units are not applicable, then units
such as piece, slice, tray and fraction may be used. The serving size declared on a
product shall be determined from the reference amounts presented in Section
#
USA.12.2.2.
If a product is prepared in discrete units, e.g. sliced products or individually
packaged products within a multi-serving package, one serving size shall be the
number of whole units that most closely approximates the reference amount for the
product category. However, one serving size shall be one unit if that unit weighs
less than 200% but equal or greater than 67% of the reference amount. A product
may be described as one serving size if it weighs more than 200% of the reference
amount, provided it can be reasonably consumed at a single eating occasion.
If a product naturally varies in size, e.g. whole fish, fish fillets and shellfish, the
serving size is to be expressed in an amount in ounces that most closely
approximates the reference amount for the product category.
# USA.12.3
Nutritional facts
# USA.12.3.1 The following is a description of the information which must appear on every label.
All nutrient information shall be presented using the nutrient names as they appear
in this section and in the specimen label.
#
The information is limited to that listed immediately below or that listed in the
section on voluntary nutritional information. No other nutritional information can
appear on a nutritional label. A specimen label and a specification on type size,
spacing and other graphic elements are in Sections USA.12.4 - USA.12.6.
# USA.12.3.2 Servings
The serving size is to be expressed in common household measures where
applicable. The metric weight, in parenthesis, must follow the declared serving
size.
The number of servings in the container is to be declared based on the serving size
of product.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
United States of America
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Issue 23: April 2002
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USA.12.3.3 Energy information
Total calories
The total caloric content of each serving expressed to the nearest 5 calorie
increment up to 50 calories and in 10 calorie increments thereafter. Less than 5
calories per serving may be expressed as zero. The energy content may also be
expressed in kilojoules per serving, added in parenthesis after the calorie
information. The number of calories may be calculated or measured.
Calories from fat
The caloric content of each serving derived from total fat expressed to the nearest
10 calorie increment over 50 calories, in 5 calorie increments up to 50 calories and
less than 5 calories per serving may be expressed as zero. The number of calories
may be calculated or measured.
If the product contain less than 0.5 calories from total fat per serving then it is not
necessary to declare calories from fat. If a statement of calorie content is not
declared then the words “Not a significant source of calories from fat” must be
stated at the bottom of the table of nutrient values.
# USA.12.3.4 Nutrient information
Nutrient information must be expressed as percentages of the recommended daily
values in addition to measures of weight per serving. The percentage of daily
values is calculated according to weight of nutrient in the product and the table of
recommended daily values.
Total fat
The number of grams per serving defined as total lipid fatty acids and expressed as
triglycerides in 1 gram increments if the amount is greater then 3 grams, 0.5 gram
increments if the amount is below 3 grams and zero if the amount is less than 0.5
grams.
Saturated fat
The number of grams per serving defined as the sum of all fatty acids containing
no double bonds and expressed in 1 gram increments if the amount is greater then
3 grams, 0.5 gram increments if the amount is below 3 grams and zero if the
amount is less than 0.5 grams. Saturated fat information must be indented.
If the label makes no claim about fat or cholesterol content and if calories from
saturated fat is not declared and there is less than 0.5 grams of total fat per serving,
then it is not necessary to declare saturated fat. If a statement of saturated fat is not
required or not declared, then “Not a significant source of saturated fat” must be
stated at the bottom of the table of nutrient values.
Cholesterol
The number of milligrams per serving expressed to the nearest 5 milligram
increment. Declare as less than 5 milligrams when the content is between 2 and 5
milligrams and declare zero where there is less than 2 milligrams per serving.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
United States of America
Issue 23: April 2002
Page: USA.23
If the label makes no claim about fat, fatty acids, or cholesterol content and there
is less than 2 milligrams cholesterol per serving then it is not necessary to declare
cholesterol. If a statement of cholesterol is not required or not declared, then “Not
a significant source of cholesterol” must be stated at the bottom of the table of
nutrient values.
Sodium
The number of milligrams per serving expressed to the nearest 10 milligram
increment when the serving contains greater than 140 milligrams, to the nearest
5 milligram increment when the serving contains 5-140 milligrams and declare
as zero where there is less than 5 milligrams per serving.
Total carbohydrate
The number of grams per serving expressed to the nearest gram. Declare “contains
less than 1 gram” when the serving contains less than 1 gram and declare zero
where there is less than 0.5 grams per serving. Total carbohydrate shall be
calculated.
Dietary fibre
The number of grams per serving expressed to the nearest gram. Declare “contains
less than 1 gram” when the serving contains less than 1 gram and declare zero
where there is less than 0.5 grams per serving. Dietary fibre information must be
indented.
If there is less than 1 gram per serving, then it is not necessary to declare dietary
fibre. If a statement of dietary fibre is not declared then “Not a significant source
of dietary fibre” must be stated at the bottom of the table of nutrient values.
Sugars
The number of grams per serving defined as the sum of all free mono- and
disaccharides (glucose, fructose, lactose and sucrose) expressed to the nearest gram.
Declare “Contains less than 1 gram” when the serving contains less than 1 gram and
declare zero where there is less than 0.5 grams per serving. Sugar information must
be indented.
If the label makes no claim about sweeteners, sugars or sugar alcohol and there is
less than 1 gram per serving, then it is not necessary to declare sugar. If a statement
of sugar is not declared then “Not a significant source of sugar” must be stated at
the bottom of the table of nutrient values.
Protein
The number of grams per serving expressed to the nearest gram. Declare “Contains
less than 1 gram” when the serving contains less than 1 gram and declare zero
where there is less than 0.5 grams per serving. Protein content may be calculated
based on 6.25 times the nitrogen content of the food.
If a protein claim is made for the product then the corrected amount of protein per
serving calculated as a percentage of daily reference value and expressed as a
percent of the daily value is to be listed under the column headed “% Daily Value”.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
United States of America
Issue 23: April 2002
Page: USA.24
If the protein quality value is less than 20 %, then either “Not a significant source
of protein” must be stated at the bottom of the table of nutrient values or the
corrected amount of protein per serving calculated as a percentage of the daily
reference value and expressed as a percent of the daily value is to be listed under
the column headed “% Daily Value”.
Protein quality value is a protein digestibility-corrected amino acid score expressed
as a percent.
Corrected amount of protein per serving is equal to the actual amount of protein
(gram) per serving multiplied by the amino acid score corrected for protein
digestibility.
The protein digestibility-corrected amino acid score shall be determined by methods
described in “Protein Quality Evaluation, Report of the Joint FAO/WHO Expert
Consultation on Protein Quality Evaluation”, Rome, 1990.
#
USA.12.3.5 Vitamin and mineral information
The amount of Vitamin A, Vitamin C, calcium and iron per serving shall be
calculated as a percent of the recommended daily intake and shall be expressed as
a percentage of the daily value. The vitamins and minerals must be declared in the
order as shown.
The percentages shall be expressed to the nearest 10% increment when levels are
greater than 50%, to the nearest 5% increment at levels between 10 and 50%, 2%
when levels are less than 10% and zero when levels are less than 2%. Amounts less
than 2% of the RDI are not required to be declared. If a statement of vitamins and
minerals is not declared then “Not a significant source of _______ (listing the
vitamins and minerals omitted)” must be stated at the bottom of the table of nutrient
values.
# USA.12.3.6 Footnote
The footnote shall state the following educational information:
“Percent Daily Values are based on a 2000 calorie diet. Your daily value may be
higher or lower depending on your calorie needs”.
Calories
Total fat
Saturated fat
Cholesterol
Sodium
Total carbohydrate
Dietary fibre
Less than
Less than
Less than
Less than
2000
2500
65 g
20 g
300 mg
2400 mg
300 g
25 g
80 g
25 g
300 mg
2400 mg
375 g
30 g
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
United States of America
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Issue 23: April 2002
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USA.12.3.7 Calorie conversion information
Calorie conversion information on a per gram basis for fat, carbohydrate, and
protein shall be presented beneath the educational information footnote. For the
purposes of labelling, 1 g fat = 9 calories, 1 g carbohydrate = 4 calories and 1 g
protein = 4 calories.
# USA.12.3.8 Voluntary nutritional facts
The following list of nutrients may be voluntarily added to the nutritional facts
panel on the labels of products. These nutrients must appear on the label of
products if any claim is made about the food having any special qualities in respect
of these nutrients:
•
polyunsaturated fat
•
monounsaturated fat
•
potassium
•
soluble fibre
•
insoluble fibre
•
sugar alcohol
•
other carbohydrate
•
other minerals and vitamins.
Specifications for the placement and format, and the declaration and expression,
may be obtained from the Director (Animal Products) of MAF Food Assurance
Authority.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
United States of America
# USA.12.4
Specimen label - basic information
Issue 23: April 2002
Page: USA.26
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
United States of America
#
USA.12.5
Specimen label — modified format using a tabular display
#
USA.12.6
Graphic enhancements
#
USA.12.6.1 Overall
The “Nutrition Facts” label is boxed with
all black or one colour type printed on a
white or neutral ground.
#
USA.12.6.2 Typeface and size
•
The “Nutrition Facts” label uses 6 point
or larger Helvetica Black and/or
Helvetica Regular type. In order to fit
some formats the typography may be
kerned as much as -4 (tighter kerning
reduces legibility).
•
Key nutrients and their % Daily Value
are set in 8 point Helvetica Black (but
“%” should be set in Helvetica
Regular).
• “Nutrition Facts” is set in either
Franklin Gothic Heavy or Helvetica
Black to fit the width of the label flush
left and flush right.
•
“Serving Size” and “Servings per
container” are set in 8 point Helvetica
Regular with 1 point of leading.
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Page: USA.27
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
United States of America
Issue 23: April 2002
Page: USA.28
•
The table labels (for example, “Amount per Serving”) are set in 6 point
Helvetica Black.
•
Absolute measures of nutrient content (e.g. “1 g”) and nutrient subgroups are
set in 8 point Helvetica Regular, with 4 points of leading.
•
Vitamins and minerals are set in 8 point Helvetica Regular, with 4 points of
leading, separated by 10 point bullets.
•
All type that appears under vitamins and minerals is set in 6 point Helvetica
Regular with 1 point leading.
# USA.12.6.3 Rules
•
A 7 point rule separates large groupings as shown in the example. A 3 point
rule separates calorie information from nutrient information.
•
A hairline or 1/4 point rule separates individual nutrients, as shown in the
example. Descenders should not touch the rule. The top half of the label
(nutrient information) has 2 points of leading between the type and the rules;
the bottom half of the label (footnotes) has 1 point of leading between the type
and the rules.
# USA.12.6.4 Box
•
All labels are enclosed by a 1/2 point box rule within 3 points of text measure.
# USA.13
Nutritional Analytical Methods
# USA.13.1
Introduction
# USA.13.1.1 The FDA does not regulate how manufacturers should conduct analyses or require
that analyses be performed in approved, registered or accredited laboratories.
However, the producer responsible for labelling the food is accountable for the
accuracy of the nutrient analysis and ensuring the product compiles with the
nutrient declaration. The FDA will determine compliance using methods specified
below.
# USA.13.1.2 In the event of non-compliance, producers will be expected to provide reputable and
verifiable evidence to support their label data. Under these circumstances it would
be advisable to have some analyses performed by approved, registered or accredited
laboratories which use the methods specified in the regulations.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
United States of America
# USA.13.2
Issue 23: April 2002
Page: USA.29
Analytical methods: General
Unless a particular method is otherwise specified, analyses shall be performed by
appropriate methods for the nutrient according to the Official Methods of Analysis
of the AOAC International (formerly Association of Official Analytical Chemists),
15th Edtn, 1990. If no AOAC or specified method is available and/or appropriate,
then analyses are to be performed by other reliable and appropriate procedures.
Copies of the official methods may be purchased from the AOAC International,
2200 Wilson Blvd, Suite 400, Arlington, VA 22201.
# USA.13.3
Protein
Protein content may be calculated on the basis of the factor of 6.25 times the
nitrogen content of the food as determined by the appropriate Official Methods of
Analysis of the AOAC International (formerly the Association of Official Analytical
Chemists), 15th Edtn, 1990, except when the official procedure for a specific food
requires another factor.
The protein digestibility-corrected amino acid score shall be determined by methods
given in Sections 5.4.1, 7.2.1 and 8.00 in Protein Quality Evaluation, Report of the
Joint FAO/WHO Expert Consultation on Protein Quality Evaluation, Rome, 1990
except when a specific food factor other than 6.25 is required, that factor shall also
be used. Copies of the report may be obtained from the Division of Nutritional,
Center for Food Safety and Applied Nutritional (HFF-260), Food and Drug
Administration, 200 C Street SW., Washington, DC 20204.
# USA.13.4
Calories
Caloric content of a food may be calculated by:
•
Using specific Atwater factors given in Table 13, Energy Value of Foods - Basis
and Derivation, by A.L. Merrill and B.K. Watt, United States Department of
Agriculture (USDA) Handbook No. 74 (slightly revised, 1973), which is
available from the Division of Nutritional, Center for Food Safety and Applied
Nutritional.
•
Using the general factors of 4, 4, and 9 calories per gram for protein, total
carbohydrate and total fat respectively, as described in USDA Handbook No.
74 (slightly revised, 1973), pp. 9-11.
•
Using the general factors of 4, 4, and 9 calories per gram for protein, total
carbohydrate less the amount of insoluble dietary fibre, and total fat
respectively, as described in USDA Handbook No. 74 (slightly revised 1973),
pp. 9-11.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
United States of America
#
USA.13.5
Issue 23: April 2002
Page: USA.30
•
Using data for specific food factors for particular foods or ingredients approved
by the Food and Drug Administration (FDA) and provided in 21 CFR 172 or
184.
•
Using bomb calorimetry data and subtracting 1.25 calories per gram protein to
correct for incomplete digestibility, as described in USDA Handbook No. 74
(slightly revised 1973), p.10.
Total carbohydrate
Total carbohydrate content shall be calculated by subtraction of the sum of the
crude protein, total fat, moisture and ash from the total weight of the food. This
calculation method is described in A.L. Merrill and B.K. Watt, Energy Value of
Foods - Basis and Derivation, USDA Handbook No. 74 (slightly revised, 1973),
pp. 2 and 3.
# USA.13.6
Note
The regulations specify that the methods contained in Official Methods of Analysis
of the AOAC International, 15th Edtn, 1990 will be used by the FDA. Some of the
methods required by the regulations may not be immediately available, accurate or
appropriate. Official Methods of Analysis does not cover all the methods required
and the US authorities have conceded that new methods are required. The AOAC
International have just published a new book, Methods of Analysis for Nutritional
Labelling, which covers the availability and selection of appropriate methods.
Further work on method development and official acceptance of new methods is
required. In the mean time, if there is no official procedure, laboratories should:
•
use the best method available, and
•
seek advice from the FDA on the methods which they will use for compliance
tests.
#
USA.14
Small Business Extension for Mandatory Nutritional Labelling Requirements
#
USA.14.1
Background
The FDA has published regulations providing that companies with less than 300
employees can obtain a 1 year extension to mandatory nutrition labelling
requirements (until 8 May 1995) for food products whose volume to consumers is
less than 600 000 units annually. The extension can be obtained by filing
certification with the FDA.
Further extensions beyond 8 May 1995 can be obtained on an annual basis for
smaller firms and for smaller volumes.
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IAIS 002.4: Specific Country Requirements Circular 1995
United States of America
Issue 23: April 2002
Page: USA.31
#
USA.14.2
#
USA.14.2.1 The term food product means “food in any sized package which is manufactured
by a single manufacturer, which bears the same brand name, which bears the same
statement of identity, and which has similar preparation methods”.
Conditions
Thus, in determining whether the low volume requirement is met, a packer of 1 and
2 pound packages of the same item would total their production.
The private label packer must count the entire production of the same food product.
#
USA.14.2.2 The term unit means the packaging in which a good product is sold to consumers.
A firm which produces for food service use would determine whether a product’s
volume is less than the 600,000 units on the basis of the number of units sold to
consumers (i.e. retail), not on the basis of the entire production of the food product.
Thus, depending on the unit volume of given food products sold to consumers, a
company who meets the employment criteria may file for extensions for labelling
on some products, but not on others.
# USA.14.2.3 Employees — The number of employees is determined by counting employees at
all domestic and foreign affiliates of a corporation. Part-time employees are
included on the basis of full time equivalents (2080 hours worked equals one full
time employee).
# USA.14.2.4 Products which already carry nutritional information, such as in the voluntary format
which was applicable under prior law, are not eligible for the extension.
# USA.14.2.5 The unit count (600, 000) applies to the 8 May 1993 — 8 May 1994 period. If a
product was not in production for the full year, the extension can be obtained if it
is reasonably anticipated that fewer than 600, 000 units will be sold to consumers
between 8 May 1994 and 7 May 1995.
# USA.14.2.6 For overseas packers, the volume requirement is for products sold in the United
States to consumers.
# USA.14.2.7 Extensions can be obtained for successive 12-month periods by firms with less than
100 employees for products with less than 100, 000 units.
It appears that each subsequent year’s extension will require a new request, as the
extension is based on the current year’s history.
# USA.14.3
Food service packs
A most important impact of this regulation is on food service packs which may
occasionally turn up at retail. The basic rules call for such product to carry the
nutrition labelling information. By virtue of this new small business extension,
packers who meet the employment criteria can claim extension of the requirements
if they certify that less than 600, 000 units of the product are sold to consumers.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
United States of America
#
USA.14.4
#
USA.14.4.1 Procedure for claiming an extension
#
Issue 23: April 2002
Page: USA.32
Applications for the extension
Use the form in Section USA.14.4.3 to claim an extension.
The extension is effective upon filing the claim. There is no requirement for FDA
action, review or approval before the extension is effective.
Companies seeking the exemption are advised to maintain copies of their claims.
Send the completed forms to: Office of Food Labelling (HFS - 150), Centre for
Food Safety and Applied Nutrition, Food and Drug Administration, 200 C Street,
S.W., Washington, D.C. 20204, United States.
# USA.14.4.2 Instructions for completion of the form
1. Name of firm: Enter the recognised legal name of the firm.
2. Firm address: Enter the mailing address for the principal place of business.
3. Name of the food product for which exemption is claimed: Enter the name of
each food product for which an exemption is claimed. Continuation sheets may
be used if necessary.
4. Name and address of manufacturer: Provide the names and addresses of the
manufacturers of the food products for which an exemption is being claimed if
they are different from the firm that is submitting the claim for exemption.
5. Number of full-time equivalent employees: Enter the approximate average
number of persons employed by the firm for the year preceding the year for
which an exemption is claimed. The average number should include all persons
employed by the firm and affiliates. The average number of employees may be
calculated by using the following formula: Total number of employee-hours
paid divided by 2080 hours a year = average number of full-time equivalent
employees. Employee hours should include overtime paid to employees.
6. Approximate total number of units sold in the United States between 8 May
1993 and 7 May 1994: Enter the total number of units sold in the United States
between 8 May 1993 and 7 May 1994 for each product listed under item 3 for
which a small business exemption is being claimed. Continuation sheets may
be used if necessary. A food product is a food in any sized package which is
manufactured by a single manufacturer, or which bears the same brand name;
which bears the same statement of identity; and which has similar preparation
methods. The approximate total number of units is the summation of all units
of the various package sizes of the food product in the form in which the food
product is sold to consumers (i.e. retail), not the total volume of food service and
retail.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
United States of America
Issue 23: April 2002
Page: USA.33
7. Certification: The form is to be signed by a responsible individual for the firm
that can certify the authenticity of the information presented on the form. The
individual signing the form will commit to notify the Office of Food Labelling
when the numbers of full-time equivalent employees or total numbers of units
of product sold in the United States exceed the applicable numbers for an
exemption.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
United States of America
#
Issue 23: April 2002
Page: USA.34
USA.14.4.3 The application form
TO:
Office of Food Labelling (HFS - 150),
Centre for Food Safety and Applied Nutrition,
FDA,
200 C Street, S.W.,
Washington, D.C. 20204,
United States
Labelling Exemption Notice
(Please Type or Clearly Print)
1.
Name of firm
2.
Firm address
State
Zip
3.
Name of food products for which exemption is claimed. (Use continuation sheets as
necessary.)
4.
Name and address of manufacturers of the products listed in item 3 if different from
the firm listed in item 1. (Use continuation sheets as necessary.)
5.
Average number of full-time equivalent employees
(for the time period from 8 May 1993 to 7 May 1994)
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 002.4: Specific Country Requirements Circular 1995
United States of America
6.
Page: USA.35
Approximate total number of units sold in the United States between 8 May 1993
and 7 May 1994. (Use continuation sheets as necessary.)
No. of Units of Product
7.
Issue 23: April 2002
No. of Units of Product
The undersigned certifies that the above information is a true and accurate
representation of the operations.
(Name of firm)
The undersigned will notify the Office of Food Labelling of the date on which the
average number of full-time equivalent employees or the number of units of food
products sold in the United States exceeds the applicable number for the exemption
which is being claimed herein.
(Signature)
(Title)
IAIS 003.5
Fish Processing Circular 1995
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section: Prelims
Issue 10: August 1998
Page: P.2
Promulgatory Statement
This circular:
•
is issued pursuant to Regulation 19 of the Fish Export Processing Regulations 1995
•
may be referred to as the Fish Processing Circular 1995
•
comes into force on 1 May 1995
•
applies to all licensees of fish premises.
Tony Zohrab
Chief Meat Veterinary Officer
(acting pursuant to delegated authority)
Malcolm Cameron
Chairman
Fishing Industry Inspection and
Certification Council
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section: Prelims
Issue 10: August 1998
Page: P.3
Explanatory Note
This circular is issued under the Fish Export Processing Regulations 1995.
This note and other explanatory notes found boxed in bold italics are not part of the
circular, but are intended to explain the circular.
The circular sets out certain “industry agreed implementation standards” concerning
processing fish.
To comply with the fish processing standards set out in Clauses 20-24 of Part II of the
First Schedule to the Regulations, you must either comply with this circular or have an
alternative proposal approved by the Chief Meat Veterinary Officer under delegation
from the Director-General of Agriculture and Forestry.
You must still comply with any other relevant law or by-law.
If you have any questions about this circular, you should ask your local Inspector.
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section: Prelims
Issue 10: August 1998
Page: P.4
Amendments
Suggestions are welcomed for alterations, deletions or additions to this circular to improve it
or to make it better suited to the needs of the fishing industry and inspection staff.
Suggestions should be forwarded to the co-ordinator, together with reasons for the change and
any relevant experimental or documentary data.
Amendments do not become part of a circular until they have been issued pursuant to the Fish
Export Processing Regulations 1995, along with an amendment form. Amendments are
numbered in sequence.
Amendments to the circular can be identified by the issue number in the page header and a
background screen over the changes which have been made. Deletions are marked with a
background screen appearing where the entry has been deleted.
The co-ordinator of this circular is:
John Lee
Programme Manager (Seafood and Poultry)
MAF Regulatory Authority (Meat and Seafood)
ASB Bank House
101-103 The Terrace
P.O. Box 2526
Wellington
Phone: (04) 474 4100
Fax: (04) 474 4239
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section: Prelims
Issue 10: August 1998
Page: P.5
Amendment Record
It is important that this circular is kept up-to-date by the prompt incorporation of amendments.
To update this circular when you receive an amendment, remove the appropriate outdated
pages, destroy them, and replace them with the pages from the new issue. Complete
instructions will be given on the covering letter accompanying the amendment. File the
covering letter at the back of the circular and sign off and date this page.
If you have any queries, please ask your local Inspector.
Issue No.
Date
Initials
Issue No.
1
11
2
12
3
13
4
14
5
15
6
16
7
17
8
18
9
19
10
Aug 1998
MAF Reg
20
Date
Initials
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section: Prelims
Issue 10: August 1998
Page: P.6
Contents
Page
Promulgatory Statement
Explanatory Note
Amendments
Amendment Record
Contents
P.2
P.3
P.4
P.5
P.6
1.
1.1
1.2
Introduction
Subject Matter of the Circular
Definitions
1.1
1.1
1.1
2.
2.1
2.2
2.3
2.4
2.5
2.6
2.7
2.8
Processing
Regulatory Requirements
Competency Requirements
Identification of Hazards and Development of HACCP Plans
Specific Requirements for Limited Processing Fishing Vessels
Specific Requirements for ICSS-Listed Shellfish Premises
Mandatory Market Access Requirements
General Requirements for All Process Approvals
Inspector’s Procedures
3.
3.1
3.2
3.3
3.4
3.5
3.6
3.7
3.8
3.9
3.10
3.11
Approved Processes
Wetfish, Including Whole Fish, Fish Fillets, Headed Fish
and Gutted Fish
Thawing Fish, Including Air and Water Thawing
Shucking Shellfish (Other than Molluscan Bivalve Shellfish)
Shucking, Washing and Packing Paua
Temperature Requirements for Paua for Canning
Shucking Bivalve Molluscan Shellfish
Processing Rock Lobsters
Processing Eels
Packing Live Fish (Other than Live Molluscan Bivalve Shellfish)
Packing Live Molluscan Bivalve Shellfish
Whole Fish Processing
4.
4.1
4.2
4.3
4.4
4.5
4.6
4.7
4.8
Specific Requirements for Certain Processes
Cooked Whole Rock Lobsters
Drying Fish and Fish Products (Other than Sun Drying)
Sun Drying Fish and Fish Products
Salting Fish and Fish Products
Marinating Fish and Fish Products
Smoking Fish and Fish Products
Canning Fish and Fish Products
Further Processed Fish Products
2.1
2.1
2.2
2.2
2.7
2.7
2.9
2.10
2.10
3.1
3.1
3.1
3.1
3.1
3.2
3.2
3.3
3.4
3.5
3.5
3.5
4.1
4.1
4.1
4.1
4.2
4.3
4.4
4.4
4.16
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section: Prelims
Issue 10: August 1998
Page: P.7
Page
5.
5.1
5.2
5.3
Training of Product Handlers
Regulatory Requirements
Training Programme
Individual Training Requirements
5.1
5.1
5.1
5.2
6.
6.1
6.2
Notification of Non-Complying Fish and Fish Product
Regulatory Requirements
Approved Quality Control Programme
6.1
6.1
6.1
7.
7.1
7.2
Recall of Product
Regulatory Requirements
Approved Quality Control Programme
7.1
7.1
7.1
Appendix I: Raw Material Food Safety Hazards and Control Measures
I.1
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section 1: Introduction
1.
Introduction
1.1
Subject Matter of the Circular
Issue 20: March 2000
Page: 1.1
This circular sets out the general criteria for attaining the fish processing standards
referred to in Clauses 20-24, Part II of the First Schedule to the Regulations.
1.2
Definitions
In this circular:
Canned means:
• Pack into clean containers and hermetically seal; and
•
Process by heat to ensure preservation, whether before or after being sealed in a
container;
and canning has a corresponding meaning.
Chilling means:
For whole fish means the placing of fish (other than live molluscan bivalve shellfish
and prepared fish products) in ice or under refrigeration so that the fish is being
reduced in temperature to and held at a temperature of, -1oC and +1oC (inclusive); and
chilled has a corresponding meaning.
For fish product which has undergone a form of preparation (e.g. fish fillets, fish
fingers, fish soups) means placing the fish product under ice or refrigeration so that
the fish product is reduced in temperature to and held at a temperature between –1oC
and +4oC (inclusive).
Corrective action means action to be taken when the results of monitoring at the CCP
indicate a loss of control.
Critical Control Point (CCP) means a step at which control can be applied (and is
essential) to prevent or eliminate a food safety hazard or reduce it to an acceptable
level.
Critical Limit means a criterion which separates acceptability from unacceptability.
Food safety objective means a description of the expectations of hygiene measures
that are applied during a particular segment of a food production process. These
objectives should include measurable outcomes expected for the final product and
may have a qualitative or quantitative association with the level of risk to the
consumer.
Freezing means the placing of fish or fish products under refrigerated conditions so
that the fish or fish product is reduced to, and held at a temperature of –18oC or colder;
and freeze or frozen have corresponding meanings.
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section 1: Introduction
Issue 10: August 1998
Page: 1.2
Hazard means a biological, chemical or physical agent in, or condition of, food with
the potential to cause an adverse health effect.
Hazard analysis means the process of collecting and evaluating information on
hazards and conditions leading to their presence to decide which are significant for
food safety and therefore should be addressed in the HACCP plan.
Prerequisite programmes means a documented programme covering an activity
which may interact within and across various processes and has the potential to
influence the food safety outcome. (These may also be referred to in other documents
as good hygienic practices, good manufacturing practices, standard operating
procedures, umbrella programmes or satellite programs).
Regulations means the Fish Export Processing Regulations 1995, and a reference to a
Regulation is to a provision of the Regulations.
Step means a point, procedure, operation, or stage in the food chain which
encompasses raw materials from primary production through to final consumption.
Validation of HACCP plan means initial confirmation that the HACCP plan is
complete and can deliver the expected food safety outcomes (objectives).
Verification
For the processor, verification means the application of methods, procedures
(review/audit) and tests in addition to those used in monitoring to determine:
•
that the HACCP plan is complete and effective in delivering expected outcomes
(food safety objectives), i.e. validation;
•
compliance with the HACCP plan;
•
whether the HACCP plan, or its application, needs modification;
For the Inspector, verification means the audit of the validated/revalidated HACCP
plan in order to recognise the validity of the plan, or, determine the level of
compliance with the valid HACCP plan.
Your local Inspector means the Inspector who inspects your premises or the
Inspector’s deputy.
All words and expressions defined in Regulation 2 of the Regulations have the same
meanings when used in the circular, except where the context requires otherwise.
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section 2: Processing
2.
Issue 10: August 1998
Page: 2.1
Processing
The process approval comprises two steps. The first consists of the identification
of food safety hazards and, if necessary, developing a HACCP plan (see Section
2.3). A hazard identification will need to be done for each process. The second
step applies to some processes only and consists of requirements for mandatory
market access requirements (see Section 2.6). You should check Section 2.6 to
determine if this applies to your product.
Companies should use the hazard analysis critical control point (HACCP) system
as a tool for process control for ensuring food safety. The HACCP approach
systematically assesses hazards, develops control systems and focuses on
preventative measures. Information on the HACCP process and the application
of the HACCP system is given in “A Guide to Hazard Analysis Critical Control
Point Systems (HACCP) in the Seafood Industry” which was issued by FIICC.
A number of codes of practice covering various types of seafood processing have
been developed. Contact the New Zealand Seafood Industry Council for
information regarding their availability. These can be used to assist companies
to produce safe seafood.
2.1
Regulatory Requirements
2.1.1
The regulations state:
“All fish shall be processed in accordance with approved processes carried out in
accordance with any conditions attached to that approval.
All steps in any approved process, including packing, shall be performed without
unnecessary delay and under conditions (including time and temperature parameters)
that minimises the possibility of contamination or deterioration of fish or fish
products.
Where required as part of an approved process, a licensee shall ensure that its
employees are competent and, if required, have qualifications to an approved level.”
2.1.2
Clause 20, Part II, First Schedule to the Regulations, requires all fish to be
processed in accordance with an approved process. The requirements for approved
processes are given in Section 3.
Specific requirements for certain processes are given in Sections 4.1-4.8. Where
appropriate these shall be incorporated into the process approval.
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section 2: Processing
2.2
Issue 23: April 2002
Page: 2.2
Competency Requirements
The following standards are referred to in the body of this circular:
#
•
Hazard ID Standard
Attainment of the Seafood Industry Training Organisation (SITO) Hazard ID
Standard (National Qualification Framework Unit Standard No 17996 “Develop
and review a hazard identification and analysis for a seafood product”)
•
Co-ordinator Standard
Attainment of the Seafood Industry Training Organisation (SITO) HACCP Coordinator Standard (National Qualification Framework Unit Standard No 12316
“Co-ordinate the development and verification of a HACCP plan for a seafood
processing operation”).
•
Supervisor Standard
Attainment of the Seafood Industry Training Organisation (SITO) HACCP
Supervisor Standard (National Qualification Framework Unit Standard No 12315
“Supervise a seafood processing operation under a HACCP system”).
2.3
Identification of Hazards and Development of HACCP Plans
Before identifying hazards, companies should ensure that all prerequisite
programmes are documented and confirmed as effective. The hazards which are
controlled within prerequisite programmes which are already documented for the
premises in accordance with the requirements of the IAISs (e.g. cleaning and
sanitation, potable water) will not generally need to be repeated in the process
approval. There may be some instances where prerequisite hygiene requirements
may be critical at a particular process step, because of their direct impact on the
product. These should then be included in the HACCP plan.
For some types of processes a generic food safety hazard identification has been
undertaken. The tables in Appendix I identify the potential range of hazards that
may occur and the associated control measures that are already covered by an IAIS.
Each company should recognise the food safety hazards reasonably likely to be
associated with the product and process in their premises. The company should
ensure that there is an appropriate control measure already identified in the IAISs
(see Appendix I).
Where a food safety hazard is identified and no adequate control measures exist in
the IAISs, then the development of a HACCP plan as required by Section 2.3 will be
necessary.
A hazard may remain unaddressed by the process. Such hazards should be
highlighted for consideration elsewhere in the food chain
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section 2: Processing
2.3.1
#
Issue 23: April 2002
Page: 2.3
For each process that a company has, the following shall be undertaken:
•
Food safety hazards that may reasonably be associated with the product (including
raw material) and the process shall be identified along with their control measures.
(Examples of raw material hazards for some products are given in Appendix I).
•
As of 1 September 1998, all new hazard identifications shall be confirmed by a
person, on behalf of the licensee, who has attained the competency requirements of
the Hazard ID standard or the HACCP Co-ordinator standard (see Section 2.2).
Any review of previously approved hazard identifications shall be confirmed by a
person, on behalf of the licensee, who has attained the competency requirements of
the Hazard ID standard or the HACCP Co-ordinator standard (see Section2.2).
•
A HACCP plan shall be developed according to Section 2.3.3 for any additional
food safety hazards that are identified and/or where there is no adequate control
measure identified. This is subject to at least one or more critical control points
being identified.
•
A description of the process shall be documented and shall include all process
criteria relating to food safety control measures that have been established. Where
relevant to food safety and not covered my other prerequisite programmes, inputs
and edible outputs shall be included.
The process description can be in the form of a flow diagram or may be a brief
description of what is happening and what is being controlled at each step in the
process, or some other format which accurately represents the process.
The chart on the next page provides additional guidance on whether a company
needs to develop a HACCP plan. In general, products such as dried, marinated
and cooked products will need to have a HACCP plan developed.
It is important that when a product HACCP plan is designed, consideration is
given to the appropriate shelf-life of the product. Validation trials should be
undertaken to ensure that the product will comply with the applicable
microbiological and chemical standards at the time of shelf-life expiration,
when stored according to consumer storage instructions.
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section 2: Processing
Issue 10: August 1998
Page: 2.4
Figure 2.3.1: Flowchart for guidance on whether seafood premises will require
HACCP plans
All premises are required to
identify the food safety
hazards relevant for their
products and processes.
Where generic identification of
hazard exists, use this and
adapt it as required
Have
hazards
been
identified which are not
addressed by FIICC
programmes?
No
Yes
A HACCP
plan is not
required
A HACCP plan is not
required where no CCPs are
determined
Verify
Verify
or
A HACCP plan is required,
where a CCP is determined
as detailed in Section 2.3.3
Verify
Is the process listed
in Section 2.6?
No
End
Yes
A process approval for
market
access
requirements
is
needed, See Section
2.6
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section 2: Processing
Issue 23: April 2002
Page: 2.5
2.3.2 Products which are variations of the one type of product, and where the food safety
hazards are expected to be the same, may be grouped together under one process
approval, e.g. different flavoured fish portions.
2.3.3
2.3.4
#
Where Section 2.3.1 indicates that the development of a HACCP plan is required, the
following elements shall be included:
•
the scope of the HACCP plan;
•
a description of the product and its intended use;
•
a description of the process (as required by Section 2.3.1);
•
the food safety objectives that have been set for the product, taking into
consideration its intended use;
•
the hazard analysis (including identification of those additional hazards as carried
out in Section 2.3.1);
•
identification of the critical control points, if any, needed to reduce or eliminate
those significant food safety hazards;
•
the critical limits that have been established for each critical control point;
•
the monitoring required to assess whether each critical control point is under
control;
•
the corrective action developed for any non-compliances;
•
the procedures developed to verify that the process is meeting food safety
objectives;
•
the documentation and record keeping requirements appropriate to the above
elements (including the records mentioned in Section 2.3.8).
Where a hazard has been identified that is not controlled by FIICC programmes, and
no critical control points have been identified, no HACCP plan is required.
Documentation supporting the decision-making process up to and including the
element identifying the possible critical control points shall be maintained. This shall
be confirmed by a person, on behalf of the licensee, who has attained the competency
requirements of the Hazard ID standard or the HACCP Co-ordinator standard (see
Section 2.2).
2.3.5 Development and ongoing verification of the HACCP plan and any modifications to
the plan which impact on food safety shall be co-ordinated by a person who has
attained the competency requirements of HACCP Co-ordinator standard (see Section
2.2).
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section 2: Processing
Issue 11: July 1999
Page: 2.6
2.3.6
The HACCP plan shall be signed and dated by the licensee or the person who has
authority to act for the licensee to signify that the HACCP plan has been accepted for
implementation and has been validated by the licensee.
2.3.7
Where a process is required to have a HACCP plan, verification procedures should
include the following:
•
validation of the HACCP plan;
•
ongoing independent review /audit of all components of the HACCP system, its
documentation and records, including corrective actions taken;
•
product tests where appropriate;
•
revalidation of the HACCP plan when significant changes/modifications take
place to the product/process (including addressing new food safety concerns) or
when a significant design fault becomes evident.
Process records shall be reviewed by a person who has attained the competency
requirements of the HACCP Supervisor standard or the HACCP Co-ordinator standard
(see Section 2.2).
2.3.8
The following validation steps shall occur in the case of a new premises or a
completely new process for which little or no data is available.
•
Each premises shall ensure that its HACCP plan(s), where required, is developed
and documented according to the existing standard in IAIS 003.5, Section 2
“Processing” and any subsequent amendments.
•
The HACCP plan shall be validated by the licensee on a provisional/initial basis.
•
Once this process has been completed, the Verification Agency (VA) shall be
notified so that provisional/initial recognition of validity of the documentation of
the HACCP plan can take place.
•
Following provisional/initial recognition of validity, the premises can commence
production for export.
•
Confirmation of the validation process as meeting FSOs on an ongoing basis
should be carried out by the licensee over the first 10 working days of operation or
within a time frame agreed by the VA Inspector.
•
The licensee shall then notify the VA of successful confirmation so that full
recognition of the validity of the HACCP plan can take place as soon as possible.
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section 2: Processing
Issue 11: July 1999
Page: 2.7
2.3.9 Adequate records shall be kept to demonstrate compliance with the hazard
identification and, where appropriate the HACCP plan.
2.4
Specific Requirements for Limited Processing Fishing Vessels
Limited processing fishing vessels exporting fish or fish products directly to the USA
(i.e. without processing and/or packing in a land based fish premises) shall carry out a
hazard identification and if necessary develop a HACCP plan in accordance with the
requirements of this standard.
2.5
Specific Requirements for ICSS-Listed Shellfish Premises
The Seafood Arrangement, including the recent HACCP agreement, does not
apply to the USFDA ICSS-listed companies.
Under the 1980 Shellfish Memorandum of Understanding, MAF assured the FDA
that only shellfish that are safe, wholesome, and have been harvested, transported,
processed and labelled in accordance with the provisions of the National Shellfish
Program (NSSP) and will be certified to the United States of America.
Shellfish includes scallops in any form, except where the final product form is the
adductor muscle only.
Thus, under the MOU, the ICSS-listed premises are required to meet the NSSP
HACCP requirements, as specified below. The NSSP requirements apply to all
USA and foreign country ICSS-listed premises.
For New Zealand ICSS-listed premises, this mans that the ICSS-listed shellfish
packing houses must comply with the general requirements of this circular PLUS
the special NSSP shellfish requirements below (which includes preparing a full
HACCP plan).
The main differences between the general HACCP requirements and the NSSP
are that the NSSP requires a HACCP plan for all shellfish processes and specifies
certain critical control points and critical limits which must be included in the
plan.
2.5.1
HACCP plan
2.5.1.1 Each ICSS-listed company (being a Repacker (RP), Shellstock Shipper (SS) or
Shucker Packer (SP)) shall develop a HACCP plan in accordance with the
requirements of this standard.
2.5.1.2 When addressing the hazard analysis, consideration shall be given to the following:
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section 2: Processing
•
natural toxins;
•
microbiological contamination;
•
chemical contamination;
•
pesticides;
•
drug residues;
•
food additives;
•
physical hazards.
Issue 11: July 1999
Page: 2.8
2.5.1.3 When addressing the critical control points/critical limits for Shucker Packers and
Shellstock Shippers, the following shall be included:
•
•
the fish packing house entry requirements stated in Section 5.10 of IAIS 005.1;
the time, temperature and container closing/covering requirements of Sections 5.9,
8.3 and 8.4 of IAIS 005.1.
2.5.1.4 When addressing the critical control points/critical limits for Repackers, the following
critical control points/critical limits shall be included:
•
•
•
shellfish are only sourced from an ICSS-licensed premises that is listed in IAIS
002.4, Section USA.8;
shellfish are correctly labelled in accordance with IAIS 002.4, Section USA.4,
IAIS 004, IAIS 005.1, Section 8.6 and the Guide for the Control of Molluscan
Shellfish, 1997 Revision, Chapter VIII, Section 02.E;
the time and temperature requirements of IAIS 005.1, Sections 8.3 and 8.5.4.
2.5.1.5 When addressing the verification element, the following shall be included:
•
•
•
•
a review of consumer complaints and non-conferences to determine whether they
relate to the performance of a critical control point or reveal the existence of
unidentified critical control points;
the calibration of process monitoring instruments;
annual review of the HACCP plan;
weekly review of the records relating to the monitoring of critical control points
and the taking of corrective actions.
2.5.1.6 The HACCP competency requirements, as stated in Sections 2.2 and 2.3, shall apply
to all HACCP plans required to be developed under Section 2.3.1 of this circular.
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section 2: Processing
Issue 11: July 1999
Page: 2.9
However, for other processes, such as shellstock shipping and oyster processing,
which Section 2.3 does not require to have a HACCP plan, following ICSS job
experience option will also be acceptable for the HACCP plan development, review
and verification activities. This option will become redundant as premises review
their hazard identification according to the second bullet of Section 2.3.1.
“Job experience will qualify a person to perform these functions if it has provided
knowledge at least equivalent to that provided through the FDA curriculum.”
The knowledge and application of the contents of the Guide to Hazard Analysis
Critical Control Point Systems in the Seafood Industry, published by the Fishing
Industry Inspection and Certification Council and MAF Regulatory Authority in June
1997, meets this latter opinion.
2.5.2
Certification
The FDA has advised that no additional endorsements will be required on export
certificates for shellfish. There will be no letter for the US importers, as was the
case for processes covered by the 1995 Seafood Arrangement. The inclusion of a
packing house on the ICSS list means that the packing house is in conformance
with the FDA HACCP requirements.
2.6
Mandatory Market Access Requirements (e.g. deterioration of product,
temperature requirements for frozen product, food additive requirements)
2.6.1
For the following processes, the process approval shall also cover any mandatory
market access requirements:
•
•
•
•
•
•
•
•
•
canning,
drying,
marinating/curing/semi preserves,
salting,
smoking,
surimi production,
cooking,
processed fish products (i.e. those fish products which have undergone a form of
preparation in addition to that normally associated with the trimming, gutting,
filleting, skinning, boning, or mincing of fish, e.g. fish fingers, fish pate, fish
soups, fish cakes, jellied fish),
phosphate treating of fillets.
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section 2: Processing
Issue 11: July 1999
Page: 2.10
2.6.2 This section of the process approval shall be documented and contain the following
elements:
• all raw materials, including food additive and amounts of the raw material and/or
food additives,
• the type of packaging and labelling for the fish or fish product,
• the markets to which the fish or fish product is to be exported.
• the criteria required to ensure compliance with any mandatory market access
requirements (e.g. food additive requirements, storage temperatures),
• the actions to correct any non-compliances.
2.6.3
Adequate records shall be kept to demonstrate compliance with the approved process.
2.6.4
The process approval shall be signed and dated by the licensee or the person who has
the authority to act for the licensee to signify that mandatory market access
requirements have been met.
2.7
General Requirements for All Process Approvals
Each process approval (including hazard identification, HACCP plan, market access
requirements) shall be reviewed by the company:
•
•
•
whenever any changes occur which could affect the food safety requirements of
the fish or fish product.
whenever any changes occur which could affect the validity of the process
approval.
at least once per year to ensure it is correct.
2.8
Inspector’s Procedures
2.8.1
The hazard identification shall be audited by the Inspector. The Inspector shall have
obtained the competency requirements of the HACCP Co-ordinator standard (see
Section 2.2).
2.8.2
Where a HACCP plan is required, the Inspector shall undertake an audit with the aim
of recognising the validity of the HACCP plan after the requirements of Section 2.3.6
have been met and undertake a review of the validity when modifications which
impact on food safety are made to the HACCP plan. The Inspector shall have
obtained the competency requirements of the HACCP Co-ordinator standard (see
Section 2.2).
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section 2: Processing
Issue 11: July 1999
Page: 2.11
2.8.3
Where a HACCP plan is required the Inspector shall carry out ongoing compliance
audits of the plan. The inspector shall have a recognised audit qualification (i.e.
recognised by JASANZ or an equivalent accreditation body).
2.8.4
The market access requirements of the process approval (Section 2.6) shall be verified
by the Inspector.
2.8.5
A copy of each signed process approval for ICSS-listed premises shall be sent by the
Inspector to MAF Food (Meat and Seafood) for inclusion on the central files.
2.8.6 Any alterations to the process approval (including hazard identification, HACCP plan,
market access requirements) shall be actioned as required in Sections 2.8.1 and 2.8.2.
2.8.7
Adequate records shall be kept to demonstrate compliance with Section 2.8.
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section 3: Approved Processes
Issue 19: December 1999
Page: 3.1
3.
Approved Processes
3.1
Wetfish, Including Whole Fish, Fish Fillets, Headed Fish and Gutted Fish
3.1.1
Process criteria such as temperature and time parameters shall be established and
followed so that the fish and fish product are processed without unnecessary delay and
in a manner which minimised deterioration of the fish or fish product.
3.1.2
Where fish is gutted, this shall be carried out in a manner to minimise contamination
of the fish. After gutting, fish shall be washed with potable water or clean seawater.
3.1.3
Operations such as skinning and filleting shall be carried out in a manner to minimise
contamination of the fish or fish product.
3.1.4
Wetfish shall be stored chilled or frozen unless they are to be processed immediately.
3.2
Thawing Fish, Including Air and Water Thawing
3.2.1
Process criteria, such as air temperature, water temperature, time of thawing and
temperature of the fish at the completion of thawing, shall be established and followed
to minimise deterioration and contamination of the fish or fish product.
3.2.2
Fish that has been thawed shall be processed without unnecessary delay or shall be
held under chilled conditions.
3.3
Shucking Shellfish (Other Than Molluscan Bivalve Shellfish)
3.3.1
Shellfish to be shucked (other than by heat or freezing) shall be:
•
Alive and undamaged;
•
Shall be held in cool conditions;
•
Protected from the sun and wind prior to shucking.
3.3.2
Shellfish, which are shucked by, heat or freezing shall be alive immediately before the
start of the heating or freezing process.
3.3.3
The shucking process shall be separated from other processes (e.g. packing) by
adequate space, time or barriers so as to minimise contamination.
3.3.4
Shucked shellfish shall be stored chilled or frozen unless they are to be further
processed immediately.
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section 3: Approved Processes
3.4
Issue 10: August 1998
Page: 3.2
Shucking, Washing and Packing Paua
3.4.1 In addition to the requirements for shucking shellfish in Section 3.3, the following
requirements apply for paua.
3.4.2
Immediately after shucking, paua (other than paua that is to be canned in a fish
packing house) shall be washed in potable water or clean seawater and drained.
3.4.3
Where the paua is to be canned in a fish packing house, the washing may be carried
out by that fish packing house.
3.4.4
When the unwashed paua is transferred to the fish packing house for canning:
3.5
•
the containers of paua shall bear a label or tag stating that the paua is unwashed
and is for canning only in New Zealand;
•
the FIICC transfer document accompanying the paua shall be endorsed with the
following statement “For canning only in New Zealand”.
Temperature Requirements for Paua for Canning
Shucked paua that is intended for canning in New Zealand may be stored and
transported at a temperature not exceeding 6oC provided the following conditions are
met:
3.6
•
storage of transport of the paua at temperatures above 1oC shall be for a period not
exceeding 3 days;
•
the containers of paua shall bear a label or tag stating that the paua is for canning
only in New Zealand;
•
the FIICC transfer document accompanying the paua shall be endorsed with the
following statement “For canning only in New Zealand”.
Shucking Bivalve Molluscan Shellfish
See Sections 8.3 and 8.4 of IAIS 005.
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section 3: Approved Processes
3.7
Processing Rock Lobsters
3.7.1
Tailing rock lobsters aboard a fishing boat
Issue 10: August 1998
Page: 3.3
Rock lobsters may be tailed aboard a fishing boat where it is lawful, in terms of the
Rock Lobster Regulations 1969, to tail rock lobsters in an uncooked state.
3.7.2
Rock lobsters to be alive immediately before the process of tailing
No rock lobster tail shall be processed or packaged if the rock lobster from which it is
derived was dead or moribund prior to the tail being removed. (“Moribund” means
that state, recognised by the best practices of the fishing trade, in which the rock
lobster is near to death.)
IAIS 003.4 contains information on the acceptable methods for killing and
tailing rock lobsters.
3.7.3
Processing tails
Where rock lobsters are tailed aboard a fishing boat, the tails shall:
•
have all foreign matter removed;
•
have the intestine removed completely during the tailing operation;
•
be washed until all visible blood is removed;
•
be effectively drained before further handling;
•
be packed in clean containers;
•
be taken to a fish packing house, and if not already frozen or processed
immediately on arrival, there frozen;
•
be thawed in a fish packing house and rewashed and trimmed before being
packaged;
•
be held, after final packing, in refrigeration facilities in which the air temperature
is –18oC or colder.
Where rock lobsters are tailed in a fish packing house, the tails shall:
•
•
•
•
have all foreign matter removed;
have the intestine removed completely during the tailing operation;
be washed until all visible blood is removed;
be effectively drained before further handling;
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section 3: Approved Processes
•
Issue 10: August 1998
Page: 3.4
be wrapped individually in clean packaging material in such a manner that all
exposed flesh is covered and protected, before being packaged and frozen.
Rock lobster tails on which the shell is broken shall not be processed or packed.
3.7.4
Processing whole rock lobsters
Whole rock lobsters shall be killed in the manner outlined in IAIS 003.4.
Whole rock lobsters that are to be packed in an uncooked state shall have all foreign
matter removed and, where necessary, be effectively drained of water.
3.7.5
Rock lobsters to be dealt with in a separate area
Subject to the following, no other fish or fish product shall be processed, packed,
handled, held, or stored in an area of any fish premises where rock lobsters are
processed, packed, handled, held, or stored. Rock lobsters and other fish or fish
product may be held or stored together when the rock lobsters are sufficiently wrapped
to minimise the risk of contamination.
Notwithstanding this:
•
other fish or fish product may be processed, packed, handled, held, or stored in a
part of a fish packing house that is physically separated to the satisfaction of an
Inspector from that part of the fish packing house in which rock lobster is
processed, packed, handled, held or stored;
•
other fish may be processed, packed, handled, held, or stored at a time when rock
lobster is not being processed, packed, handled, held or stored in the fish packing
house, if an Inspector has given this his prior approval and is satisfied that the fish
packing house, and its plant and equipment have been thoroughly cleaned and
sanitised before and after the other fish or fish product have been dealt with.
3.8
Processing Eels
3.8.1
Eels intended for processing and packing in a fish packing house, except migrating
eels and eels that are to be eviscerated, shall before processing be held alive at the fish
packing house or in running water until the eels are empty at holding facilities
approved by the Director-General as being suitable for the purpose.
3.8.2
Eels shall be killed in the manner outlined in IAIS 003.4.
3.8.3
No method shall be used for desliming eels that will cause contamination or
deterioration of the eels. Desliming shall be carried out with coarse food grade salt.
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section 3: Approved Processes
Issue 10: August 1998
Page: 3.5
See IAIS 003.4 for further requirements on desliming eels. Other methods of
desliming may be used, but must have specific approval from the CMVO.
3.8.4
Eels shall be eviscerated in a manner, which minimises contamination.
3.8.5
Eels shall be stored chilled or frozen unless they are to be further processed
immediately.
3.9
Packing Live Fish (Other than Live Molluscan Bivalve Shellfish)
3.9.1
All fish shall be alive at the time of packing and in condition where, under normal
circumstances, they would be expected to remain alive during transit to the market.
3.9.2
The fish, in particular the outer surfaces of paua, whelks, etc, shall be free from dirt,
sand, weed and marine organisms.
3.9.3
The fish shall be packed at the optimum temperature to maintain the species in a live
state during transit to the market. Where appropriate, cooling media shall be added to
the container to maintain the required conditions during transit.
Each container should be clearly labelled with “live…” and a statement
indicating the storage temperature required.
3.10
Packing Live Molluscan Bivalve Shellfish
See Sections 8.3 and 8.5 of IAIS 005.
3.11
Whole Fish Processing
The regulations state:
“Whole fish processing’ means the chilling, freezing, or packing of approved fish
species or any combination of such processing where any of the fish is intended to be
exported for human consumption without gutting, scaling, shelling, deheading, tailing,
or any other form of processing”.
Under Regulation 2(1), the following species are approved for whole fish processing:
•
all species of finfish,
•
squid (Nototodarus gouldi, Nototodarus sloanii, Sepioteuthis australis),
•
scampi (Netanephrops challengeri).
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section 4: Specific Requirements for Certain Processes
4.
Specific Requirements for Certain Processes
4.1
Cooked Whole Rock Lobsters
Issue 10: August 1998
Page: 4.1
Whole rock lobsters that are to be packed in a cooked state shall:
•
have all foreign matter removed;
•
be cooked according to the best practices of the trade;
•
be washed and cooled, after cooking, in an ice slurry (made from potable water)
and/or in fresh running potable water.
4.2
Drying Fish and Fish Products (Other than Sun Drying)
4.2.1
These requirements apply to the drying of fish by mechanical means. It includes the
use of tunnel dryers and freeze drying.
The drying process removes a significant amount of water from the fish. A 15%
moisture, the growth of micro-organisms (bacteria, yeasts, moulds) is prevented
in unsalted fish. Where a higher moisture content is required in the final
product, other means of preservation (e.g. salting, chilling, freezing) must also be
used.
4.2.2
The moisture content for the final product shall be established.
4.2.3
Processing criteria such as room temperature, relative humidity and time parameters
shall be established and followed for each fish product so the required moisture
content in the final fish product is achieved.
4.2.4
Where fish is marinated prior to drying, the marination process shall be controlled by
factors such as time, temperature and age of marinade to prevent microbial growth.
Process criteria such as time and temperature parameters shall be established and
followed for each fish product.
4.3
Sun Drying Fish and Fish Products
4.3.1
The following provisions apply to the sun drying of fish and fish products; fish and
products, which are dried by mechanical means, are not covered by these
requirements.
4.3.2
All provisions of the Regulations and the Circulars which relate to the sanitation of the
fish premises and the handling , processing, transportation, storage and labelling of
fish or fish products before the drying process begins and after the drying process is
completed shall apply.
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section 4: Specific Requirements for Certain Processes
4.3.3
Issue 10: August 1998
Page: 4.2
The fish or fish product shall be dried in a designated area which shall meet the
following requirements:
•
The floor of the area shall be paved or sealed, graded or sloped to drain freely and
shall be free from apparent cracks, crevices, or gaps that create sanitary problems
or interfere with drainage.
•
The area shall be adequately protected against the entry of rodents, cats and dogs.
•
The area shall be constructed so that there is free air flow and the area is not
shaded.
•
Personnel shall not enter or pass through the area unless it is necessary for them to
do so. Any personnel entering the area shall wear protective clothing.
•
The area shall be located such that it is reasonably free from objectionable odours,
smoke, dust, flies and birds that may contaminate the fish or fish product.
4.3.4
The fish and fish product to be dried shall be placed in direct sunlight on racks, tables
or frames which shall be elevated off the floor to allow the free flow of air around the
fish or fish product.
4.3.5
The racks, tables and frames shall comply with the requirements of Clause 21, Part I,
First Schedule to the Regulations. Untreated dressed timber may, with the approval
of the Inspector, be used to construct racks, tables and frames to dry fish and fish
products for certain markets.
4.3.6
The area used for drying shall be provided with a means of protecting fish and fish
product from adverse weather. The means of protection (e.g. covers, etc.) shall be
constructed of an easily cleanable material and shall be capable of quickly and easily
protecting the fish or fish product from adverse weather.
4.3.7
Sun drying operations shall only be carried out in conditions of low humidity and
bright sunlight. If fish or fish products cannot be dried within a reasonable time, the
fish or fish product shall either be dried by mechanical means or discarded.
4.3.8
The moisture content of the final dried fish product shall be not more than 20%.
4.4
Salting Fish and Fish Products
4.4.1 These requirements apply to salted fish produced by a variety of methods, including
dry salting, brining, and curing.
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section 4: Specific Requirements for Certain Processes
Issue 10: August 1998
Page: 4.3
Salt is used to preserve food products, and salting is used to produce smoked fish.
It is also a traditional process generally used in combination with drying to
produce a product, which is relatively, stable but which should be stored in cool
conditions to eliminate spoilage.
Traditional products have a high salt content (20% or more). Adjustment of the
salting process to reduce the final salt content would reduce the shelf life and
require chilling or freezing to be used to preserve the product.
4.4.2
The salt content for the final fish product shall be established.
4.4.3
Process criteria such as salt levels in brine shall be clearly defined and followed for
each fish product to achieve the required salt content in the final fish product.
4.4.4
Salted fish, which is not shelf stable, shall be stored chilled or frozen.
4.5
Marinating Fish and Fish Products
4.5.1
These requirements apply to cold marinated fish produced by the addition of acid to
fish or fish products.
In marinated product, acid is used as a preservative, often in combination with
salt and temperature. A number of food grade acids can be used, in particular
acetic acid and lactic acid. Other ingredients may be added for flavouring or as
antioxidants.
In New Zealand, a cold marinade, process is generally used where marinade and
prepared seafood is combined and there is not a heating step.
It is essential that the process be controlled to ensure that the final pH of the fish
product is less that pH 4.5. This ensures that food poisoning bacteria cannot
grow. The growth of most other bacteria is prevented. The product is not shelfstable and must be stored under refrigeration.
4.5.2
In preparing the marinade, process criteria such as acid levels shall be established.
4.5.3
Process criteria such as the ratio of fish product to marinade shall be clearly defined
and followed for each fish product so that the pH in the final fish product after
equilibration is less than 4.5.
4.5.4
The equilibrated pH of a representative sample of each batch of marinated fish product
shall be measured and recorded.
4.5.5
Marinated fish product shall be stored chilled or frozen.
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section 4: Specific Requirements for Certain Processes
4.6
Issue 10: August 1998
Page: 4.4
Smoking Fish and Fish Products
There are two basic procedures for producing smoking fish: cold smoking and
hot smoking. In cold smoking, the fish is not cooked and the maximum
temperature of the process is 30oC. The flavour of the fish is modified by the
smoke. Salt is also generally used in combination with the smoke and, as well as
providing flavour, the salt and drying nature of the smoking process results in
firmer texture. In hot smoking, the temperature is raised to 70oC of hotter
during smoking and the fish is cooked.
Hot smoked products and some cold smoked products are recognised as being
high risk food products with respect to food safety. The products are ready-to-eat
and, if they become contaminated with pathogens during the process, the risk of
causing food poisoning to consumers is great. This is because there is generally
no further heat treatment given to the products before consumption. For this
reason, careful monitoring of critical points in the process must be carried out to
prevent or reduce the risk of contamination.
4.6.1
Process criteria such as temperature and time parameters at each stage of the process
and the relative humidity of the air in the smoker shall be clearly defined. Hot smoked
fish and fish product shall be processed at a temperature and for a time to give a
listericidal treatment.
4.6.2
Hot smoked fish and fish products shall be cooled quickly after processing to stop the
cooking process. Smoked fish and fish products shall be chilled to below 4oC within 4
hours of smoking.
4.6.3
Smoked fish and fish products shall be stored either chilled or frozen.
4.7
Canning Fish and Fish Products
4.7.1
Canning terms
In this section, canning includes the canning of fish and fish products in cans, glass,
or flexible pouches.
Bleeders – Very small vents in a retort through which steam escapes throughout the
entire heat process. Bleeding provides a circulation of steam within the retort and
ensures elimination of any air that enters the retort with the steam.
Buckle – A sealed and heat-processed metal container that has become permanently
distorted by internal pressure during heat processing or cooling or as a result of the
formation of gas in the container.
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section 4: Specific Requirements for Certain Processes
Issue 10: August 1998
Page: 4.5
Come up time – The time required to bring a loaded retort up to the specified
processing temperature.
F0 – is often known as the sterilisation value. It varies considerably between different
foods and the same food in different can sizes.
Processes for food sterilisation are based on the heat resistance of Clostridium
botulinum spores, since they are the most heat-resistant pathogenic organisms known.
Fo is defined at the time in minutes, at 121.1oC that gives the same kill of C. botulinum
as the process under evaluation, e.g. an Fo of 3 means that the sum of all the lethal
effects within a can during the process in question is equivalent to 3 minutes at
121.1oC with instantaneous heating and cooling.
Instantaneous heating and cooling does not occur in a can of food and the calculation
of Fo requires accurate knowledge of the temperature history of the slowest heating
point in the can as well as data on the heat resistance of C. botulinum.
The Fo value for a “safe” process may prove to be inadequate if high standards of plant
hygiene and product preparation are not maintained. This is because the severity of
the heat process to produce the required kill of organisms must increase as the
numbers of heat-resistant organisms increase.
Flipper – A sealed and heat-processed container which is normal in appearance but
whose cover or bottom may bulge outward if given a sharp jolt. A light inward
pressure will cause the cover or bottom to spring back to the normal flat or slightly
concave position.
Headspace – The space left in a container to allow for the expansion of the contents
during heat processing. In agitating retorts, the headspace bubble assists mixing.
Heat Processing Time – The time that that sealed containers are exposed to the
specified processing temperature.
Hermetically sealed – Air tight; completely sealed and impermeable to gas.
Initial temperature (IT) – The average temperature of the can contents of the coldest
cans to be retorted when heat processing begins, i.e. at the start of the come-up time –
usually the first can to be prepared for processing.
Leaker – A sealed and heat processed container which has a defect that allows the
passage of water, gas or microbes into the can.
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section 4: Specific Requirements for Certain Processes
Issue 10: August 1998
Page: 4.6
Panelled container – A sealed and heat-processed cylindrical metal container, the
body wall of which has partly collapsed because it is not rigid enough to resist the
vacuum within or has been subjected to excessive internal negative pressure during
cooling.
Retort – A pressure vessel designed for heat processing food packed in hermetically
sealed containers, either by saturated steam or by heated water with superimposed air
pressure.
Saturated steam – Pure steam in equilibrium with water at the same temperature.
Under these conditions, the temperature of the steam is entirely dependent on its
pressure.
Springer – A sealed and heat-treated metal container which has one bulging end. If
this end is pushed into place the other end will bulge.
Stackburn – A quality fault resulting from inadequate or slow cooling after the heat
process. This usually occurs in products, which have been either stacked closely or
cased while still warm.
Swell – A sealed metal container which has both ends bulged by internal gas pressure.
Vacuum – The negative internal pressure in the container produced during the
seaming process.
Venting – Flushing air out of steam retorts at the beginning of a heat process. It is
done by allowing large volumes of steam to flow through the retort to drive and carry
air out through open vents in the retort.
4.7.2
Specifications
4.7.2.1 The following information shall be included in the documented process approval:
•
the preparation of fish and fish products, container used, can cleaning, filling and
closure, retorting and type of retort;
•
the detailed formulation of the fish product (fish used, other ingredients used,
particle size, fat content, additives, % composition, % solids, pH, net weight);
•
the size of the containers;
•
the headspace in the containers;
•
the initial temperature;
•
the come-up time;
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section 4: Specific Requirements for Certain Processes
Issue 11: July 1999
Page: 4.7
•
the fish or fish product processing temperature-time parameters;
•
the cooling procedure;
•
the date marking and labelling;
•
for containers of different sizes, a process approval for each container size of that
fish product.
4.7.2.2 The heat processing time shall be sufficient to provide a commercially sterile fish
product.
4.7.2.3 It is recommended that processing schedules are checked by calculation of the Fo
value.
4.7.2.4 Approval of the heat processing for a fish product in containers of a certain size shall
apply to containers of that size only.
4.7.2.5 Personnel operating processing systems, retorts and container closure checkers shall
be under the direct operating supervision of a person who has satisfactorily completed
the relevant sections of the following course:
•
School for supervisors of low-acid canned food thermal processing systems:
Course on “Principles of Thermal Process Control and Container Closure
Evaluation” for low-acid canned foods; presented by Massey University.
If you wish another course to be considered, specific approval must be given by the
CMVO.
The following publication provides useful information on the processing of low
acid canned foods:
“Canned Foods: Principles of Thermal Process Control, Acidification and
Container Closure Evaluation” by The Food Processors Institute, Washington,
DC.
4.7.2.6 Persons designing and determining the thermal process shall have one of the following
qualifications:
•
passed the Qualified Cannery Persons (thermal processes) Course, University of
Western Sydney (Hawkesbury);
•
passed the Introduction to the Fundamentals of Thermal Process Evaluation
course, Massey University (no longer available);
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section 4: Specific Requirements for Certain Processes
Issue 11: July 1999
Page: 4.8
•
passed a university course of instruction of not less than 3 years, including the
fundamentals of thermal processing, which leads to a degree in Food Technology
or similar; the person shall also have relevant practical experience in the thermal
processing which is acceptable to the Director (Animal Products):
•
any relevant equivalent qualification which is acceptable to the Director (Animal
Products).
The licensee shall verify the competency of the person designing and determining the
thermal process.
4.7.3
Can filling and closure
4.7.3.1 Before filling, cans shall be washed thoroughly clean in an inverted position either in
running water at a temperature of not less than 82oC or through a steam jet cabinet
which effectively cleans and sterilises them.
4.7.3.2 During can filling, cans shall be:
•
filled with the correct weight of product.
•
filled to the correct level, i.e. sufficient headspace (as applicable) shall be left and
sufficient vacuum produced by the methods specified in the processing schedule.
4.7.3.3 During can closure:
•
Every can shall be dated either in clear or in code with the date of packing, e.g. at
the time of closure or immediately after.
It is desirable to state the retort load.
A company may date a day’s production, instead of individual retort loads, on the
clear understanding that the whole day’s production is involved if a rejection
occurs.
4.7.4
•
All containers shall be hermetically sealed.
•
The quality control checks in Sections 4.7.7.7 and 4.7.7.8 shall be carried out.
•
The containers shall be washed after closure, e.g. with sprays of water at 60oC or
through a continuous flow water bath. This water may contain an approved
detergent.
Heat processing and cooling
4.7.4.1 Cans shall be heat processed promptly. The maximum time from the cans being
sealed to being processed shall be specified.
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section 4: Specific Requirements for Certain Processes
Issue 11: July 1999
Page: 4.9
4.7.4.2 It shall be impossible for cans to accidentally by-pass heat processing. Mark the retort
baskets, trolleys or containers with acceptable temperature change indicators (e.g.
cards, strips) which change colour permanently if they are heated to a specific
temperature. Their colour change will indicate the batch has been heat processed.
(These indicators are not to be used to confirm that heat treatment has been sufficient
to fulfil the process schedule). For permanent process records, refer to Section
4.7.4.9.
4.7.4.3 Retorts shall be equipped with:
•
a pressure gauge;
•
automatic temperature recording;
•
a standardised mercury-in-glass thermometer.
4.7.4.4 An accurate clock shall be readily visible in the retorting room.
4.7.4.5 Properly trained retort operators shall continually check the equipment, retorts, and
operations.
4.7.4.6 During retort loading:
•
different sized containers shall bot be loaded in the same retort load, except for
multi-chain hydrostatic retorts;
•
if a water retort is only partly filled, the process schedule for part-filled retorts
shall be used.
4.7.4.7 Timing of the heat process shall not be started until after the come-up-time, i.e. until
the minimum safe venting for the particular retort has occurred and the temperature
has been raised to that specified.
4.7.4.8 Heat processing shall be kept to the specification. This ensures adequate heat
processing to inactivate any organisms, which might be present.
4.7.4.9 Permanent records shall be kept for each retort load.
The following information shall be recorded at the time of processing:
•
the date;
•
the tort number;
•
the fish or fish product;
•
the code;
•
the container size;
New Zealand Fishing Industry Agreed Implementation Standard
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Section 4: Specific Requirements for Certain Processes
•
the time steam was turned on;
•
the time processing temperature was reached;
•
the temperature;
•
the pressure (if processing with overpressure);
•
the time steam was turned off;
•
the water cooling time;
•
a cross reference to the automatic temperature record chart.
Issue 11: July 1999
Page: 4.10
Cans may be washed with water at the process schedule temperature after retorting
and before cooling, provided the water has been prechlorinated (0.5 ppm) before it is
heated.
4.7.4.9.1
Water cooling shall take place according to the specification. The water used shall
contain:
• either
not less that 0.5 ppm of residual free chlorine at the time of
delivery to the retort or the can cooling tank, having had a
“contact time” of at least 20 minutes, i.e. the water shall not be
used until at least 20 minutes after the chlorine is added.
• or
measurable residual free chlorine after the retorting process.
The chlorine level shall be measured after each batch at the
point where the cooling water exits from the retort. Where the
cooling water fails to show a detectable amount of free residual
chlorine, the production batch must be completely reprocessed
or condemned.
The can cooling water may be re-used for further cooling purposes provided the water
is treated by a method approved my the CMVO to meet in full the physicochemical
and microbiological standards for potable water and is rechlorinated to meet the
requirements above.
Cans shall not be washed after cooling.
Only single-use sterile paper towels shall be used for wiping.
4.7.5
Labelling and storage
4.7.5.1 The handling of cans shall be avoided until they are cool.
4.7.5.2 Adhesives and labels which do not attract water if the containers could corrode (e.g.
rusting of tin-plate) shall be used.
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Section 4: Specific Requirements for Certain Processes
Issue 11: July 1999
Page: 4.11
4.7.5.3 Stored canned fish product shall be kept dry, and not subjected to extremes of
temperature and humidity.
4.7.6
Retorting product packed in glass containers
4.7.6.1 Most of the general cannery requirements apply.
4.7.6.2 Glass containers shall be processed and cooled under water with super-imposed air
pressure.
4.7.6.3 When compressed air is provided to the retort, traditional venting and bleeding is
unnecessary.
4.7.6.4 A pressure valve shall be fitted on the retort overflow to maintain adequate pressure
during processing.
4.7.6.5 The retort temperature shall be controlled independently from pressure.
4.7.6.6 An accurate method of determining the water level in the retort (preferably a sight
gauge) shall be installed.
4.7.6.7 Glass containers shall not be exposed to sudden marked temperature changes.
4.7.6.8 The retort shall be half-filled with water heated to the IT before product is lowered
into the retort. This prevents the IT falling on immersion.
4.7.6.9 Air or water shall be continuously circulated during the whole process so there is
uniform temperature throughout the retort.
4.7.6.10
If the water level drops below the top layer(s) of containers, the operator shall
note the exact level. When the retort is opened, all exposed jars (i.e. those above or
partly above the water level) shall be discarded as being under-processed.
4.7.7
Company quality control
4.7.7.1 All test results shall be recorded.
4.7.7.2 The approved process schedule for each canned fish product shall be available to
personnel with the responsibility for quality control.
4.7.7.3 Quality control procedures shall ensure the fish product container size and retorts
correspond to the processing schedule.
4.7.7.4 Quality control staff shall ensure that no changes are made in product formulation,
container size or retorting unless approved by the CMVO.
4.7.7.5 During preparation of the product, quality control staff shall:
New Zealand Fishing Industry Agreed Implementation Standard
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Section 4: Specific Requirements for Certain Processes
Issue 11: July 1999
Page: 4.12
•
check that standard operating procedures for the measurement, weighing, mixing,
blending, and rehydration of ingredients is maintained;
•
where product consistency is specified, take product from the filler before filling
begins, to measure its consistency;
•
check the consistency at sufficient intervals during filling to ensure it is correct
and record findings.
4.7.7.6 Quality control staff shall ensure that:
•
cans are washed in accordance with Section 4.7.3.3;
•
lids are correctly coded.
4.7.7.7 During can filling and closure, quality control staff shall:
•
ensure the provisions in Sections 4.7.3.2 and 4.7.3.3 are met;
•
check that competent employees regularly inspect the operation of each seaming
machine head to ensure it is functioning correctly;
•
measure the minimum closing machine vacuum, maximum drained weight,
minimum net weight and percent solids at sufficient intervals to ensure the process
schedule is adhered to;
•
if heat processing is in an agitating retort, check the positive displacement
mechanism (e.g. paddle, splasher) used before closure to ensure the specified
headspace is correct.
4.7.7.8 Quality control staff shall evaluate can closure by:
•
carrying out the following procedures for cans from each head of each filling
machine:
-
a visual examination, including measurement of seams, every 30 minutes,
a tear down examination every 4 hours, ensuring the headspace specified in the
processing schedule is obtained;
•
reviewing and evaluating the recording of measured seams to ensure they are
within acceptable tolerances recommended by the can manufacturer;
•
ensuring the can wash is functioning effectively.
4.7.7.9 During heat processing, quality control staff shall:
•
ensure heat processing starts within the specified time;
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section 4: Specific Requirements for Certain Processes
Issue 23: April 2002
Page: 4.13
•
ensure accidental by-passing of heat treatment does not occur (refer to Section
4.7.4.2);
•
monitor instruments such as mercury-in-glass thermometers, automatic
temperature recording devices and pressure gauges periodically with the known
standard of their function and accuracy;
•
repair or replace mercury-in-glass thermometers with divided mercury columns or
if the deviation from the standard is more than 0.5oC;
•
adjust automatic temperature recording devices to read no higher than the known
accurate mercury-in-glass thermometer;
•
ensure the process schedule for the batch being retorted is either prominently
displayed or otherwise obviously readily available for the operator;
•
ensure competent employees supervise retorting operations during all operating
hours (see Section 4.7.2.5).
4.7.7.10
Quality control staff shall:
•
Check and record the initial temperature of the coldest can(s) in a retort load (e.g.
the first can closed), thoroughly mixing the contents of the can before measuring
the temperature;
•
Ensure the IT is never lower than that specified in the process schedule.
The IT shall be measured:
#
•
For still and discontinuous agitating retorts, by removing the can intended to be
loaded first, or the coldest, from those being loaded into the retort. When the
retort is loaded, closed, and the steam turned on , the IT of the can set aside is
measured.
•
For continuous agitating retorts and hydrostatic retorts, by periodically selecting a
can just before it enters the retort.
If the IT is below that specified in the processing schedule and heat processing has
started, the heat processing time shall be recalculated based on the new IT and the
time of retorting extended as calculated. The retort load shall be retained and handled
in accordance with the requirements under 4.7.7.20.
4.7.7.11
•
During venting and come-up time, the quality control staff shall ensure:
the vents are open so air is completely displaced;
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section 4: Specific Requirements for Certain Processes
Issue 11: July 1999
Page: 4.14
•
bleeder holes are open and emit steam continuously during the entire process,
including come-up-time;
•
a standard venting procedure within a minimum venting time is carried out;
•
operators record the time steam is introduced to a retort, the time the vents are
closed and the temperature in the retort when the vents were closed.
4.7.7.12
During heat processing, the quality control staff shall ensure that:
•
timing of the heat processing does not begin until venting is complete and the
stated processing temperature is reached on the mercury-in-glass thermometer;
•
the stated processing temperature is maintained throughout the stated processing
period;
•
if the time and temperature of a process is not maintained , the retort load in
question is retained, pending investigation be the Inspector;
•
the retort cooker speed (chain, carrier, rotational mechanism) is checked and
recorded at the start of operations and at least once every 4 hours during
operations.
4.7.7.13
During cooling, quality control staff shall:
•
ensure cooling takes place according to the processing schedule;
•
sample and test the cooling water for residual free chlorine and ensure that the
chlorination is sufficient.
4.7.7.14
The minimum vacuum headspace of container shall be measured and recorded
after cooling by opening the cans to make the measurement at sufficient
intervals to ensure the headspace is specified.
4.7.7.15
All cans shall be inspected after they have been cooled to atmospheric
temperature and every defective can shall be rejected.
4.7.7.16
Quality control staff shall ensure:
•
cans are correctly labelled;
•
cartons are marked with the same date in clear or code as on the cans they contain,
unless otherwise agreed by the CMVO.
4.7.7.17
•
Quality control staff shall:
set aside at least one, and preferably two, cans from each retort load and incubate
it for 10 days at 37oC;
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section 4: Specific Requirements for Certain Processes
Issue 11: July 1999
Page: 4.15
•
for continuous retorts (chain, carrier, rotational mechanism), take one can per
elapsed heat processing time;
•
record the temperature of the incubator by an automatic temperature recording
device, and a mercury-in-glass thermometer (these devices shall be standardised as
those used in retorts – refer to Section 4.7.7.9);
•
hold in store the retort load from which the can was taken or the lot from which
cans were taken, until satisfactory incubation tests have been completed (if the
Inspector is satisfied that control of product can be maintained elsewhere, the
Inspector may permit storage elsewhere than in the cannery, e.g. a warehouse
notified to the Inspector).
Canned fish product shall not be exported until it has been cleared to the
satisfaction of the Inspector upon the completion of satisfactory incubation
tests. No export certificate shall be signed unless the canned fish product is
cleared by the Inspector.
If an incubation test is unsatisfactory, the retort load/lot from which the can(s)
came shall be disposed of as directed by the Inspector. “Unsatisfactory” refers
to any organoleptic and pH changes, gas formation or lack of vacuum. This
shall lead to retention of canned fish product, tightened sampling and
microbiological tests.
4.7.7.18
Processing records shall be verified within 24 hours by management.
4.7.7.19
Quality control staff shall keep full and accurate records of the entire canning
operation so that compliance with this circular can be demonstrated. All
processes and checks shall be recorded in writing at the time of observation.
Records verify that the establishment meets the requirements and enables
ready traceback.
4.7.7.20
Any product lot(s) affected by non-complying process shall be detained and a
full assessment of the processing records and condition of the product shall be
made by a competent person (see Section 4.7.2.6).
The assessment shall be based on detailed information of the conditions
prevailing during the non-complying process and on the heat transfer
characteristics of the product, and shall be in accordance with procedures
adequate to detect any potential hazard to public health.
The competent person shall make a decision regarding the disposition of the
product based on the outcome of this assessment. The impact on public health
shall be the primary consideration in any decision taken.
A full report of the assessment and corrective actions taken in the event of a
non-complying process shall be prepared and shall include the following:
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section 4: Specific Requirements for Certain Processes
Issue 11: July 1999
Page: 4.16
•
a complete description of the deviation along with all necessary supporting
documentation;
•
the assessment report, including and associated reprocessing records;
•
and a description of any product disposition actions taken.
Where the decision is made to release the affected lot(s), the product shall be held
pending verification of the safety of the product by a competent person.
4.7.8 Inspection staff
4.7.8.1 The Inspector shall complete the training requirements in Section 4.7.2.5.
4.7.8.2 The Inspector shall maintain surveillance of the company quality control programme,
including critical control point checks and company records, by;
•
confirming that personnel carrying out the quality control programme have been
specifically trained and perform their duties competently;
•
having all processing schedules readily available and consulting them frequently;
•
checking all the quality control operations given in Section 4.7.7 as often as is
necessary to confirm they are being correctly carried out;
•
checking the measurement of recording equipment and processes to ensure that
company records are genuine, e.g.
-
the automatic temperature recording device with the mercury-in-glass
thermometer against the known standard,
water testing for residual free chlorine,
incubator temperature recording devices and automatic record.
-
4.7.8.3 During surveillance of the company records, the Inspector shall:
•
ensure full and accurate records of the entire canning operation are kept;
•
review and initial the records to determine that satisfactory safe standards are
being maintained.
4.8
Further Processed Fish Products
4.8.1
This section covers fish products that are not covered in Sections 4.1-4.7. It includes
fish products such as crumbed and battered fish products, fish cakes, fish pates, jellied
fish and fish in sauce.
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section 4: Specific Requirements for Certain Processes
Issue 11: July 1999
Page: 4.17
4.8.2
For each fish product, appropriate process criteria such as the time-temperature
regime, pH, acidity level, salt level and water activity (aw), shall be established and
followed, to ensure the final fish product is safe and appropriate to use.
4.8.3
Further processed fish products, which are not shelf-stable, shall be stored chilled or
frozen.
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section 5: Training of Product Handlers
5.
Training of Product Handlers
5.1
Regulatory Requirements
Issue 10: August 1998
Page: 5.1
The regulations state:
“All fish premises shall have in place an approved quality control programme that
provides for –
(a)
The education and instruction of product handlers in correct product handling,
personal hygiene, and sanitary practices”.
5.2
Training Programmes
5.2.1
Under Clause 22(a), Part II, First Schedule to the Regulations, a programme
providing for the education and instruction of product handlers is required. The
approved programme shall be documented and shall satisfy the requirements of
Sections 2.5.2-5.2.4.
5.2.2
Every fish premises shall have present in the fish premises at all times while
processing is carried out at least one person who is competent in the following SITO
unit standards:
•
5331 Handle fish products or 15344 Handle shellfish products;
•
5332 Maintain personal hygiene and use hygienic work practices working with
seafood;
•
6212 Clean and sanitise plant and equipment in a seafood processing plant;
or can demonstrate equivalent competency.
5.2.3
Equivalent competency to Section 5.2.2 would include:
•
•
5.2.4
on the job or in house training given by personnel qualified to undertake such
training;
employment in a supervisory or higher operational role within a premises for 6
months or longer.
The key areas of learning include:
•
aspects of food safety and the spoilage of food;
•
personal hygiene;
•
how to control food safety and the spoilage of food (e.g. by an HACCP approach).
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section 5: Training of Product Handlers
Issue 10: August 1998
Page: 5.2
5.3
Individual Training Requirements
5.3.1
Every product handler shall receive regular training about proper food handling, and
personal hygiene and sanitary practices.
5.3.2
For each employee, a record shall be kept of the training given. The record shall
include:
•
the type of training/course undertaken;
•
the date the training/course was undertaken;
•
a copy of any certificates/results.
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section 6: Notification of Non-Complying Fish and Fish Product
Issue 10: August 1998
6.
Notification of Non-Complying Fish and Fish Product
6.1
Regulatory Requirements
Page: 6.1
The regulations state:
“All fish premises shall have in place an approved quality control programme that
provides for –
(b)
The licensee to notify an Inspector where –
(i)
Any fish or fish products have been rejected by an Inspector or other authority
in New Zealand or overseas after the fish or fish products have left the fish
premises;
(ii)
An Inspector or other authority in New Zealand or overseas has notified the
licensee that any fish or fish products that have left the fish premises do not
comply with the requirements of any law in New Zealand or overseas; and
(c)
The licensee to investigate any case referred to in paragraph (b) of this clause
and to notify an Inspector of the results of the investigation”.
6.2
Approved Quality Control Programme
6.2.1
Under Clause 22(b), Part II, First Schedule to the Regulations, the approved
programme for the notification and investigation of non-complying fish and fish
product is outlined in Sections 6.2.2-6.2.4.
6.2.2
Where a fish or fish product has been shown to be non-complying by a country
(including New Zealand), the company or exporter shall immediately notify the
Inspector of the non-compliance and record the non-compliance in the company
checklist. This applies to non-complying product from land-based premises as well as
PH, L and W vessels.
6.2.3
The notification shall include:
•
the type of fish or fish product (including brand, pack size, batch codes, etc., if
appropriate);
•
the quantity of fish or fish product;
•
production dates for the fish or fish product;
•
the company who processed the fish or fish product (if different from the
exporter);
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section 6: Notification of Non-Complying Fish and Fish Product
6.2.4
6.2.5
•
a copy of the export certificate if the product has been exported;
•
the action to be taken on the fish or fish product.
Issue 10: August 1998
Page: 6.2
The Inspector shall investigate the non-conformance and provide a report for the
company and the CMVO which shall include the following:
•
the possible causes of the non-conformance;
•
corrective actions being taken by the company to prevent a reoccurrence;
•
actions to be taken on any known fish or fish product in the system;
•
recommendations on any changes to procedures or standards for consideration by
the FIICC (if necessary);
•
recommendations on action against the company (if required).
Reports shall be provided in a timely manner.
Each company should have a written plan which outlines the procedures to be
followed if non-complying product is found by any country.
The plan should include:
•
the person responsible for notifying the Inspector of the non-conformance
and co-ordinating the investigation;
•
roles and procedures for investigation of the non-conformance;
•
implementation of any necessary corrective actions;
•
a recall procedure for known or potentially non-complying fish or fish
product in the system;
•
notification to the Inspector of the non-complying fish or fish product;
•
recording of process control changes.
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Section 7: Recall of Product
7.
Recall of Product
7.1
Regulatory Requirements
Issue 10: August 1998
Page: 7.1
The regulations state:
“All fish premises shall have in place an approved quality control programmes that
provides for –
The steps to be taken in the event that any fish or fish product is found to be
contaminated or otherwise unsafe for human consumption”.
7.2
Approved Quality Control Programme
7.2.1
Under Clause 22(d), Part II, First Schedule to the Regulations, an approved
programme outlining the steps to be taken when fish or fish product is found to be
contaminated or otherwise unsafe for human consumption shall satisfy the
requirements of Sections 7.2.2-7.2.3.
7.2.2
The plan shall be documented and contain the following elements:
•
the person responsible for co-ordinating the following elements:
•
procedures to be followed in the event of a recall;
•
the responsibilities and actions of the company staff involved in the recall;
•
notification to the Inspector of the recall.
7.2.3
Information on product recalls is provided in the FIICC Guidelines Guidelines for
Seafood Recall Programmes.
7.2.4
The recall plan should be reviewed and if necessary updated after any recall.
7.2.5
The Inspector shall provide timely notification to the CMVO of any recalls where fish
or fish product has been found to be contaminated or otherwise unfit for human
consumption.
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Appendix I: Food Safety Hazards
Issue 10: August 1998
Page: I.1
Appendix I: Raw Material Food Safety Hazards and Control Measures
The following tables identify examples of food safety hazards associated with raw material
and the control measures which apply. The process may reduce, add or enhance hazards
which may be present. These need to be considered.
Table I.1:
Hazard identification for wetfish
Raw material
Finfish
Hazard
Biological
Control
Whole H&G fillets
B1 – Intrinsic microbiological hazards
(more information required for off-shore
species). For estuarine species of fish,
consider Vibrio, Listeria, Aeromonas,
Clostridium botulinum
IAIS 003.3 Reception of Fish
IAIS 003.5 Fish Processing
IAIS 003.3 Storage and Transportation
B2 – Microbiological hazards associated
with seabird and rodent excreta and
other extraneous material, e.g.
Salmonella spp., Listeria
monocytogenes
IAIS 003.3 Reception of Fish
B3 – Parasites, e.g. Anisakis
Specific control measure required when
identified, such as freezing product at –
20oC for 24 hours
B4 – Preformed toxins, e.g. Ciguatera
toxin, tetrodotoxin
For NZ waters, not a problem. For
imported fish , consider specific species
and location (tropical/subtropical)
B5 – Histamine
IAIS 003.3 Reception of Fish
IAIS 003.5 Fish Processing
IAIS 003.6 Storage and Transportation
Specific to some fish species
Chemical
IAIS 003.3 Reception of Fish
C1 – Pollutants, e.g. pesticides,
radioactivity, toxic elements, industrial
chemicals, derived from catching area
or process of catching
C2 – Mercury
IAIS 002.2
System
Mercury
Classification
IAIS 003.1, Section 13: Treated fish
C3 – Aquaculture drugs
C4 – Food additives
IAIS 003.1, Section 14: Additives and
ingredients
Physical
P1 – Foreign matter, e.g. metal, glass
IAIS 003.3 Reception of Fish
P2 - Bones
Where applicable to meet final product
specifications
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Appendix I: Food Safety Hazards
Table I.2:
Raw material
Oysters
Page: I.2
Hazard identification for thawing of finfish
Raw material
Finfish – see Table I.1 plus this table
Table I.3:
Issue 10: August 1998
Hazard
Biological
Control
B1 – Microbiological hazards from the
water, e.g. faecal coliforms
IAIS 001.2 and IAIS 003.1 Potable
Water and Clean Seawater Programme
B2 – Increase in microbiological hazards
due to temperature abuse
Premises – specific criteria for thawing
Hazard identification for whole, raw molluscan bivalve shellfish
Hazard
Biological
Control
B1 – Intrinsic microbiological hazards,
e.g.
faecal
coliforms,
Listeria
monocytogenes,
Norwalk
virus,
Salmonella spp.
IAIS 005.1 Sourcing from Approved
Growing Area
Temperature control
B2 – Microbiological hazards associated
with seabird and rodent excreta and
other
extraneous
material,
e.g.
Salmonella
spp.,
Listeria
monocytogenes
IAIS 003.3 Reception of Fish
IAIS 005.1, Sections 5.10 and 8.2
IAIS 005.1, Section 5: Harvesting,
handling and transport of shellfish
B3 – Biotoxins
IAIS 005.1 Sourcing from Approved
Growing Areas
Chemicals
C1 – Pollutants derived from harvest
areas,
harvesting
operation
or
transportation
IAIS 005.1 Sourcing from Approved
Growing Areas
IAIS
003.3
Programme
Reception
of
Fish
New Zealand Fishing Industry Agreed Implementation Standard
IAIS 003.5: Fish Processing Circular 1995
Appendix I: Food Safety Hazards
Table I.4:
Raw material
Live rock lobsters
Issue 10: August 1998
Page: I.3
Hazard identification for live rock lobsters
Hazard
Biological
Control
Nil – based on current information
Chemical
C1 – Pollutants, e.g. pesticides,
radioactivity, toxic elements, industrial
chemicals, derived from catching area
or process of catching
IAIS 003.3 Reception of Fish
Physical
P1 – Foreign matter, e.g. metal
Table I.5:
Raw material
Paua
IAIS 003.3 Reception of Fish
Hazard identification for raw paua
Hazard
Biological
Control
B1 – Intrinsic microbiological hazards.
Consider Vibrio, Listeria, Aeromonas,
Clostridium botulinum
IAIS 003.3 Reception of Fish
IAIS 003.5 Fish Processing
IAIS 003.6 Storage and Transportation
B2 – Microbiological hazards associated
with seabird and rodent excreta and
other extraneous materials, e.g.
Salmonella spp., Listeria
monocytogenes
IAIS 003.3 Reception of Fish
B3 – Marine biotoxins (e.g. PSP, DSP,
NSP, ASP)
Technical Directive 96/166 Export of
paua, crab, kina – biotoxin requirements
Chemical
C1 – Pollutants, e.g. pesticides,
radioactivity, toxic elements, industrial
chemicals, derived from catching area
or process of catching
IAIS 003.3 Reception of Fish
Physical
P1 – Foreign matter, e.g. metal
IAIS 003.3 Reception of Fish
P2 – Shell fragments
Controlled during shucking process
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 004.2: Authorised Fish Names Circular 1995
Part B: Finfish Names
Page: L.4
New Zealand names
Scientific names
Longnosed chimaera
Harriotta raleighana
Rhinochimaeridae
longnosed chimaeras
Approved foreign names
Non-approved (comparative) names
(CIS)
(Fr)
(Jap)
(Ger)
#
Issue 23: April 2002
=
=
=
=
Kharriota
Chimere-spatule
Azumaginzame
Langnasenchimare
New Zealand names
Scientific names
Lookdown dory
Cyttus traversi
Zeidae
dories
Approved foreign names
Non-approved (comparative) names
King dory
San Pietro neozelandese
(provisionally approved)
(Aus)
(It)
(Jap)
=
Rukku doori
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 005.1: Shellfish Quality Assurance Circular 1995
Section 2: Administration
#
Issue 23: April 2002
Page: 2.3
2.4.3
The approved editions of the manuals of the APHA and the Association of
Official Analytical Chemists shall be followed for the examination of shellfish,
shellfish waters, process water and water used for processing for chemical and
physical analyses.
2.4.4
Analytical methods approved by the Ministry of Agriculture and Forestry, Food
Assurance Authority, shall be used for the examination of shellfish for marine
biotoxins. The seafood industry agreed guideline, ‘A Guide for the Validation and
Approval of New Marine Biotoxin Test Methods’, must be followed by
laboratories seeking approval to use a new marine biotoxin test method. To view
this guide click here.
2.4.5
Laboratories performing marine biotoxin or microbiological examinations for the
New Zealand Shellfish Quality Assurance Programme shall be evaluated by a
United States Food and Drug Administration-certified New Zealand laboratory
evaluation officer at least every 3 years and receive written approval from MAF
prior to performing marine biotoxin or microbiological examinations required by
this circular.
2.4.6
A schedule of approved laboratories for microbiological examinations is shown in
Appendix I.
2.4.7
A schedule of approved laboratories for marine biotoxin examinations is shown in
Appendix II.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 005.1: Shellfish Quality Assurance Circular 1995
Section 3: Control of Growing Areas
Issue 23: April 2002
Page: 3.2
A determine whether each potential pollution source is likely to have a direct or
indirect impact on growing area water quality;
A assess the effectiveness and reliability of sewage treatment systems which may
affect the growing area;
A ascertain the levels of toxic substances in shellfish;
A determine the effects on the growing area quality of small sources of pollution
such as boats, feral and domestic animals, birds, penguins and seals;
A evaluate any meteorological and hydrographic effects and geographic
characteristics that may affect the distribution of pollutants over the growing
area to determine their maximum effect on the water quality;
A include the collection of growing water and shellfish samples and their analysis
for bacteriological quality.
#
The number and location of sampling stations selected shall be adequate to
produce the data necessary to effectively evaluate all point and non-point sources
of pollution, including all freshwater discharges into the growing area catchment.
The collection of samples shall provide adequate data to form a profile for periods
defining adverse pollution conditions which reflect adverse meteorological,
hydrographic, seasonal and point sources of pollution to assure that the
requirements for the respective classifications of growing areas are met. It is
expected that the collection of such data will cover a period of at least 12 months
to ensure that all seasonal factors are addressed. The collection of samples for the
sanitary survey shall also demonstrate the time taken for the faecal coliform MPN
levels of the polluted waters to return to 14/100 ml or less and the faecal coliform
MPN levels of the shellfish to return to 300/100 g or less.
In an area not previously classified a minimum of 30 samples shall be collected
from each sample station. The 30 samples shall be collected under various
environmental conditions whereby adverse conditions and the impact of their
interrelationships can be determined.
3.2.5
A complete sanitary survey, including a full shoreline survey, shall be conducted
on each classified shellfish growing area (apart from those classified as
prohibited) at least once every 12 years.
3.2.6
To maintain the sanitary survey and classification of a growing area, each sanitary
survey shall be reviewed annually in writing by an authorised health officer and
the classification and harvesting criteria evaluated to assure their validity.
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 005.1: Shellfish Quality Assurance Circular 1995
Appendix I: Approved Microbiological Laboratories
Issue 23: April 2002
Page: I. 1
Appendix I. Approved Laboratories for Microbiological Analyses
The following laboratories have been approved in accordance with Section 2.4 of this
circular:
•
Amdel (NZ) Ltd
35 O’Rorke Road
Penrose
Auckland
Postal Address: PO Box 12-545, Penrose, Auckland
Contact: Adrienne Burnie
Phone: (09) 579-2669
Fax: (09) 579-9044
#
•
Cawthron Institute
98 Halifax Street East
Nelson
Postal Address: Private Bag 2, Nelson
Contact: Ron Fyfe/Brett Hogue
Phone: (03) 548-2319 or 0800 809 898
Fax: (03) 546-9464
•
Citilab
10 Tahuna Road
Dunedin
Postal Address: PO Box 781, Dunedin
Contact: Graham Mason
Phone: (03) 455 7940
Fax: (03) 455 7940
Email: [email protected]
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 005.1: Shellfish Quality Assurance Circular 1995
Appendix I: Approved Microbiological Laboratories
#
•
Issue 23: April 2002
Page: I. 2
Waikato Environmental Health Laboratory Ltd (EnviroHealth Waikato)
Cnr. Knox and Angelsea Streets
Hamilton
Postal Address: PO Box 52, Hamilton
Contact: Gordana Aleksic/Donna Clarke
Phone: (07) 834 –0712
Fax: (07) 834-0709
New Zealand Fishing Industry Agreed Implementation Standards
IAIS 005.1: Shellfish Quality Assurance Circular 1995
Appendix II: Approved Marine Biotoxin Laboratories
Issue 23: April 2002
Page: II.1
Appendix II. Approved Laboratories for Marine Biotoxin Analyses
The following laboratories have been approved in accordance with Section 2.4 of this
circular:
•
#
AquaBiotox™ Laboratory (AgriQuality NZ/ Crop and Food)
AgriQuality Lab Network
131 Boundary Rd
Blockhouse Bay
AUCKLAND
Postal Address: PO Box 41, AUCKLAND
Contact: Cliff Bancroft
Phone: 64 09 626 6026
Fax: 64 09 627 9750
Biotoxin Analyses Approved: ASP/PSP/DSP/NSP
#
•
Cawthron Institute (Cawthron/ Crop and Food)
98 Halifax Street East
NELSON
Postal Address: Private Bag 2, NELSON
Contact: Paul McNabb/ Lorraine MacIntosh/ Patrick Holland
Phone: 0800 80 98 98
Fax: 64 04 546 9464
Biotoxin Analyses Approved: ASP/PSP/DSP/NSP
# •
Food Evaluation Unit, Crop and Food Research
Food Industry Science Centre
Batchelar Road
Palmerston North 5301
Postal Address: Private Bag 11-600
Contact: Aaron Miller
Phone: (06) 353 0962
Biotoxin Analyses Approved: PSP/DSP/NSP (mouse bioassay only)