Nick Kernoghan, Smithers Pira Ltd.
How to Show that Food Packaging
Complies with EU and FDA Regulations
My Presentation
• What regulations apply and very briefly what they cover
• Where to find these regulations
• What you need to check and measure to comply with
these regulations
• What documentation you need to give your customers
• What documentation you need to have yourself
• EU first then the FDA
• Summary
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EU Food Contact Regulations for Plastics
• Regulation 1935/2004 – The Framework
Regulation
– General regulations applying to all food contact articles and
materials
– Article 3 – general safety statement
– Article 6 – national laws
– Articles 8 & 9 – procedure for notifying new substances
– Article 15 – labelling
– Article 16 – declaration of compliance and supporting
documentation
– Article 17 – traceability
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EU Food Contact Regulations for Plastics
• Regulation 2023/2006 and its amendment Regulation
282/2008 – The GMP and Plastics Recycling Regulations
– Manufacture according to GMP
– Documented QA system that says what you do and what you
measure
– Documented QC system that records what you have done and
measured
– Rules for transfer of ink components to food either by migration
or set off
– Rules for manufacture and use of recycled plastics
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EU Food Contact Regulations for Plastics
• Regulation 450/2009 – The Active and Intelligent Packaging
Regulation
– Active packaging either releases substances into food or absorbs substances
to achieve a technical effect e.g. oxygen scavengers
– Intelligent packaging displays the history of the pack e.g. time-temperature
indicators
– Approval process to establish a positive list
– Labelling has to meet the requirements of both food packaging and food
Regulations (1935/2004, 79/112/EEC and 89/109/EEC)
– If the active or intelligent ingredient is in an insert inside the pack then the
insert must be labelled DO NOT EAT
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EU Food Contact Regulations for Plastics
• Regulation 10/2011 – The Plastics Regulation
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Repelled Directive 2002/72/EC and its 7 amendments
List of approved monomers and additives
Provisional positive list, now only 9 silver biocides
The overall migration limit (OML)
Specific migration limits (SML’s)
Residual quantity limits (QM’s)
Specifications
Rules for measuring overall migration
Rules for measuring specific migration
Multi-material multi-layer laminates
Key dates – 1st January 2013 and 1st January 2016
• Regulation 321/2011 – 1st amendment to 10/20011 - banned the use of
Bisphenol A in food contact articles for babies and infants
• Regulation 1282/2011 - 2nd amendment to 10/2011 – adds more approved
monomers and additives
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Where to Find the EU Regulations
• http://ec.europa.eu/food/food/chemicalsafety/foodcontact/index_eu.htm
List of all the regulations and pdf’s of them
Latest scientific opinions and advice from EFSA
News
Documents – guidance documents, lists of recycling processes, provisional list of
additives
– Food contact materials database
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What You Need To Check and Measure to
Comply with the EU Regulations
• Ensure that all your monomers and additives are listed either in
Regulation 10/2011 or on the provisional positive list
• Show compliance with the overall migration limit by migration
testing
• Show compliance with specific migration limits, or residual quantity
limits, for monomers listed with these restrictions in Regulation
10/2011. This involves experimental testing
• Show compliance with specific migration limits for additives either
by calculation of 100% migration, or, by diffusion rate calculations,
or, by experimental migration measurements
• Note that multi-material multi-layer laminates (i.e. laminates
containing both plastics and non-plastics) only have to comply with
the compositional requirements, not the OML or SML’s.
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What Documentation You Need to Give Your
Customers – Declarations of Compliance
• This is covered in Article 16 of Regulation 10/2011.
• There is no change from the position in Directive 2002/72/EC.
• However, it is important to treat this as the cornerstone of
compliance for the whole system.
• It’s purpose is to give all the companies downstream of yours a fair
chance of complying with what is now quite complicated legislation
so it is important that your Declarations of Compliance (DoC’s)
contain all the information that is required. This includes sufficient
information on substances with restrictions and dual use additives
to enable the downstream companies to write their own DoC’s.
• What should be on a declaration of compliance is outlined on the
next slide.
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Declarations of Compliance (DoC’s)
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Identity and address of manufacturer or importer
Identity of materials, articles or substances
Date of declaration
For plastics confirm compliance with Regulations 10/2011 and 282/2008
For non-plastics confirm compliance with the relevant harmonised EU legislation or
Regulation (EC) No 1935/2004 and national legislation.
Adequate information on substances with restrictions and/or specifications
Adequate information on any of the 129 substances (dual function additives) with
restrictions under food legislation should they be present
Specifications on the use
 Type or types of foods in contact
 Time and temperature of contact
 Ratio of food contact surface to volume used to establish compliance
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In presence of functional barrier, need to comply with additional relevant provisions
Renewal when substantial changes in manufacture occur.
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Declarations of Compliance – Adequate
Information
• Identity of substances that have specific migration limits, residual quantity limits
and/or specifications. May need non-disclosure agreements and/or help from us
• Your DoC’s should enable your customers to show that they comply with the limits
– Concentration of the substance in the plastic – can be over-stated, or,
– Statement of the maximum thickness of the plastic that can be used without breaching
the limits. This has to be based on either experimental migration results, diffusion
calculations or 100% migration calculation
• Identity of dual use additives that are present
• Your DoC’s should enable your customers to show that the dual use additives that
are present will not result in any limits in food legislation being breached
– Concentration of the dual use additive in the plastic – can be over-stated, or,
– Statement of the maximum amount that can migrate to food from a particular thickness
of plastic, or,
– Statement that there is not migration with a reason why e.g. inorganic additive insoluble
in food
• Please do not keep non-proprietary information secret
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What Documentation you Need to Have Yourself
• Information that enables you to trace your products one step up and
down the supply chain and a procedure for product withdrawal
• Declarations of compliance from your suppliers of plastics, additives,
masterbatches, colorants etc. including:
– Details of substances listed in Regulation 10/2011 with restrictions or
specifications and sufficient information on the amounts present or migrating to
enable you to show you comply.
– Details of dual use additives used and sufficient information on the amounts
present to enable you to pass useful information onto your customers in your
Declarations of Compliance
• A documented QA system saying how your manufacture your products
and what you measure during that process (e.g. weights of masterbatch
added, thickness, melting point, burst strength, tensile strength etc. –
any physical testing you use to control your product quantity during
manufacturing)
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What Documentation You Have to Keep
Yourself
• A documented QC system that shows you have measured the things
required by your QA system including any physical properties you
measure to show that you manufacture a consistent product
• Formulation details and manufacturing records covering substances
you add
• Records of annual overall migration measurements
• Records of annual specific migration or residual quantity
measurements on monomers
• Records showing how you know that specific migration limits are
complied with for additives – your 100% migration calculations,
diffusion calculations or migration measurements
• Correspondence with your suppliers and customers
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FDA Food Contact Regulations
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Code of Federal Regulations (CFR) Chapter 21 Parts 170 to 190:
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170 Food additives
171 Food additive petitions
172 Food additives permitted for direct addition to food for human consumption
173 Secondary direct food additives permitted for direct addition to food for human consumption
174 Indirect food additives: General
175 Adhesives and components of coatings
176 Indirect food additives: Paper and paperboard components
177 Indirect food additives: Polymers
178 Indirect food additives: Adjuvants, production aids and sanitizers
180 Food additives permitted in food or in contact with food on an interim basis pending further study
181 Prior-sanctioned food ingredients
182 Substances generally recognized as safe
184 Direct food substances affirmed as generally recognised as safe
186 Indirect food substances affirmed as generally recognised as safe
189 Substances prohibited from use in human food
190 Dietary supplements
Can buy the book or look at http://www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=201121
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FDA 21 CFR Section 177: Indirect Food
Additives Polymers
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177.1500 Nylon resins
177.1520 Olefin polymers
177.1550 Perfluorocarbon resins
177.1555 Polyacrylate resins
177.1556 Polyaryletherketone resins
177.1560 Polyarylsulfone resins
177.1570 Poly-1-butene resins and butene/ethylene copolymers
177.1580 Polycarbonate resins
177.1585 Polyestercarbonate resins
177.1590 Polyester elastomers
177.1595 Polyetherimide resins
177.1600 Polyethylene resins, carboxyl modified
177.1610 Polyethylene, chlorinated
177.1620 Polyethylene, oxidized
177.1630 Polyethylene phthalate polymers
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FDA 21 CFR Types of Regulations
• 3 general types of Regulations:
– Those covering specific polymers, e.g. 177.1520 on polyolefins, 177.1630 on
PET. These contain:
• List of permitted additives and maximum levels of use where not covered by general
lists
• Specifications such as density and melting point
• End-test extractable limits and sometimes test methods for these
• Resin needs to comply, not the finished article.
– Those covering substances by use e.g. 178.2010 on antioxidants/stabilizers for
polymers. These contain lists of permitted substances and max. levels of use
– Those listing substances used in specific types of packaging e.g. 175.105 on
adhesives, 177.300 on can coatings. These contain:
• Lists of starting components and intermediates that react together in the curing
reaction
• Permitted curing reactions for can coatings
• Restriction on adhesives such that they can only be used when a functional barrier is
present or for very low exposure at seems and edges
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FDA End Test Extractable Limits
• These are applied to resins, or sometimes finished products, to show
that your product is similar to that which was initially approved by the
FDA
• They are a little bit like the EU’s overall migration tests, except they
use quick extractions into solvents rather slower, more complex
migration measurements
• Typical solvents are heptane, 95% ethanol and water
• Either done by resin producer when the testing the resin is the key
stage or the converter when testing the finished product is the key
stage
• These tests sometimes specify testing the resin without any additives
present, but not often practical so the fully formulated resin is normally
tested instead.
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Checking Legal Status of Polymers and
Additives
• The FDA have produced a list of all indirect food additives approved in
their regulations searchable by name or CAS No. You can find it at
www.fda.gov/Food/FoodIngredientsPackaging/ucm115326
• Where a Regulation states that an additive is approved for use up to a
certain level round applies. If the Regulation states 1% as the limit
you can go to 1.5%, but if it states 1.0% you can only go to 1.05%
• Additives and resins listed in 21 CFR can be used by anyone provided
any specifications and restrictions are met. However, there are some
800 substances approved by Food Contact notifications (FCN’s) which
you can only use if you either get permission from the notifying
company or you submit your own FCN. You can find these at
www.fda.gov/Food/FoodIngredientspackaging/FoodContactSubstance
sFCS/ucm116567.htm
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Things Not Covered by FDA Regulations
and Exemptions
• Prior Sanctions - PVC, RCF, PS, BHT and BPA-Epichlorohydrin Esters
• GRAS – whether as a result of an FDA or self determination e.g. zinc oxide and zinc
stearate
• Basic Resin Doctrine excluding need to regulate substances used in trace quantities
during polymerisation such as catalysts, chain regulators, chain transfer agents etc.
• Housewares exemption excluding repeat use eating and cooking utensils in most
situations
• No migration exemption – 50 ppb for most substances provided not CMT, 10 ppb for
milk bottles, carbonated drinks bottles and biologically active molecules
• Threshold of regulation (TOR) – substances where exposure is less than 0.5 ppb in
the diet. TOR approvals are non-propriety and a list is available at
www.fda.gov/Food/FoodIngredientspackaging/FoodContactSubstance
sFCS/ucm09685.htm
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Summary of How to Show FDA Compliance
• Code of Federal Regulations Chapter 21 Sections 170 to 190 – end tests, maximum
use levels and some specifications apply
• List of effective TOR approvals
• The Lehman List of Prior Sanctions
• The list of effective FCN’s (propriety)
• Self determination of GRAS
• Self determination of no migration
• The first 2 are generic, as are some of the 3rd, and all can rely on them to establish
that substances are listed and any specifications, restrictions and compositional limits
complied with. Note substances must be listed or covered by an exclusion.
• FCN’s are propriety so need permission of notifier or your own duplicate FCN
• The last 2 can be used with self determination and self certification or with the help of
expert advisors such as Smithers Pira
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What Documentation You Need To Give
Your Customers – Compliance Statements
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Identity and address of manufacturer or importer
Identity of materials, articles or substances
Date of compliance statement
Where applicable confirm compliance with specific sections of Chapter 21 of CRF, e.g.
177.1520 for polyolefins, 177.1630 for PET, 175.105 for adhesives, 178.XXXX for
additives which are only listed under the general requirements for polymers and
sections 182, 184 and 186 for FDA certified GRAS
List applicable FCN’s and ToR approvals. Need notifier’s consent to use FCN.
Restrictions on the use such as exclusions for certain types of food or certain times
and temperatures of contact
Any exemptions from regulation claimed with an explanation of why they are valid (self
certified GRAS, Prior Sanctions, no migration, housewares)
Presence of functional barrier where it is necessary for no migration or adhesives
compliance
No need to mention specific substances unless covered by an FCN or TOR approval big difference from EU
Renewal when substantial changes in manufacture occur.
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What Documentation You Need To Keep
Yourself
Correspondence with your suppliers and customers
Compliance Statements from your suppliers
Results of any end-tests you carry out
Any compositional information you have
Any experimental details on specifications you check
Results of any physical testing you carry out to show that you
manufacture a consistent product
• Your manufacturing records to show that you manufacture a consistent
product.
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Summary on EU and FDA Compliance
• There is a lot of complicated legislation with a lot of
requirements
• Good communications along the supply chain is vital to help
everyone show they comply
• Your compliance documentation needs to tell your
customers what they need to know to enable them to show
their customers that food contact articles comply
• You need good documented QA and QC systems
• You need to keep a lot of supporting documentation and
records
• Most important of all……………DON’T PANIC!!
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Help Available From Pira
• We can help you:
Understand and interpret these Regulations
Decide what measurements you need to make
Make these measurements for you
Help you write your declarations of compliance
Help you get the information you need from your suppliers
Help you produce your QA, QC and supporting documentation
systems
– Notify new substances for food contact uses to EFSA and/or the
FDA
– Notify recycling processes to EFSA and/or prove their
effectiveness according to FDA protocols
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My Contact Details
• Nick Kernoghan
• Smithers Pira Ltd
• Cleeve Road, Leatherhead, Surrey, KT22 7RU,
United Kingdom
• +44 13 72 80 21 73
• [email protected]
• www.pira-international.com/Testing
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