1. No category

REACH is Constantly Changing
For Once, it is not an SVHC Update
Krystal Cameron
Regulatory Affairs
[email protected]
AGENDA
Introduction
What has changed?
❖ Article Interpretation Issue
❖ CoRAP - 134 Substance Evaluations
❖ Registry of Intentions
❖ Proposed SVHCs
❖ Recommendations for the Authorisation List
❖ Authorisation Applications and Sunset Dates
❖ Restriction Proposal Decisions
➢
FOCUS POINTS and KEY TIPS For Compliance
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Slide 3
Introduction - About Assent
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Slide 4
The World is Becoming More Regulated - Assent Helps
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Slide 5
Introduction
❖
REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL of 18 December 2006
❖
2 Major Responsibility Sectors
➢ Articles vs. Substances and Mixtures
❖
Scope
❖
The General Perception of REACH
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Slide 6
Article Interpretation Changing?
❖
Obligations to report SVHCs in articles applies to components incorporated into
articles, not the whole article.
❖
Not legally Binding, tends to influence
❖
Communication – suppliers of entire articles must provide information on SVHCs if
they are present in any of its components and relevant information is “available.”
❖
Notification - producer vs importer responsibilities, notification is rarely in play
❖
Where did this come from?
❖
What now?
➢
We wait on the the Court of Justice ruling
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Slide 7
So Many Lists...how do they all fit?
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Slide 8
CoRAP - 134 Substance Evaluations
PACT-RMOA (http://echa.europa.eu/addressing-chemicals-of-concern/substances-of-potential-concern/pact)
CoRAP - Community Action Rolling Plan (http://echa.europa.eu/information-on-chemicals/evaluation/community-rollingaction-plan/corap-table)
❖
Final CoRAP was adopted Mar 17
❖
Next 3 years (2015-2017) = 66 newly elected + 68 from the previous update
http://echa.europa.eu/documents/10162/13628/corap_list_2015-2017_en.pdf
❖
48 Substances for 2015 - Due by Mar 2016
❖
Substance evaluation mechanism
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X
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Slide 9
Registry of Intentions
http://echa.europa.eu/web/guest/registry-of-current-svhc-intentions
7 in total
5 have been on the list since 2008, 1 since 2011
Name
EC Number
Dicyclohexyl phthalate
CAS Number
Notification of
Expected date of
intention
submission
201-545-9
84-61-7
20/03/2015
200-028-5
50-32-8
16/11/2011
03/08/2015
Scope
ED
Benzo[def]chrysene (Benzo[a]pyrene) [Benzo[a]
pyrene and all substances that contain benzo[a]
pyrene at a concentration equal to or greater than
CMR;
PBT
0.01 % by weight.]
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Slide 10
Proposed SVHCs
http://echa.europa.eu/web/guest/proposals-to-identify-substances-of-very-highconcern-previous-consultations
Name
EC Number
CAS Number
Proposing authority
Reason for proposing
1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters; 1,2benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters
with ≥ 0.3% of dihexyl phthalate (EC No. 201-559-5)
271-094-0
272-013-1
68515-51-5
68648-93-1
Sweden
Toxic for Reproduction
(Article 57 c)
5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [1],
5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [2]
[covering any of the individual isomers of [1] and [2] or any
combination thereof]
-
-
Netherlands
vPvB (Article 57 e)
Next SVHC List - June 2015
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Slide 11
Authorisation List Recommendations
http://echa.europa.eu/addressing-chemicals-ofconcern/authorisation/recommendation-for-inclusion-in-the-authorisation-list
❖
22 Substances
❖
Remember! All currently on the SVHC List
❖
Not applicable to imported articles if already “integral”
➢ Authorisation affects producers in the EU
➢ Consider Business Risk
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Slide 12
Authorisation Applications and Sunset Dates
http://echa.europa.eu/addressing-chemicals-ofconcern/authorisation/recommendation-for-inclusion-in-the-authorisationlist/authorisation-list
❖
31 Substances
❖
Application Date has passed for 15
❖
Sunset Date passed for 6
❖
5 - May of 2015
❖
3 - August 2015
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Slide 13
Restriction Proposal Decisions
FULL LIST:
http://echa.europa.eu/addressing-chemicals-of-concern/restrictions/list-ofrestrictions
Under Consideration:
http://echa.europa.eu/web/guest/restrictions-under-consideration
Registry of Intentions:
http://echa.europa.eu/web/guest/registry-of-current-restriction-proposal-intentions
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Slide 14
Compliance Implications
❖ Measure Impact
➢ Substances/Mixtures
➢ Articles
➢ Business vs. Regulatory
❖ Supplier Education
❖ Yearly Audits
❖ Supplier Data Gathering, Testing and Risk Assessment
❖ FMDs?
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Slide 15
SUMMARY
❖
Waiting on the article interpretation - SVHC Communication could change significantly
❖
Many lists to track but only a select few have actual legal implications
❖
The volume of substances going into the SVHC Process (Authorisation Process) is substantial
To be reactive will be too late. Assent Compliance can help you:
✓ Assess your areas of risk
❏
✓ Assess the impact to your products
❏
✓ Educate your suppliers
❏
✓ Test where required
❏
✓ Prepare for the update to the relevant documentation
❏
You must be tracking all of these changes and the impact to your products to stay in compliance, meet
the needs of your customers and stay...
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Slide 16
CANADA
5300 Canotek, Suite 30
Ottawa | ON | K1J 1A4
Krystal Cameron
1-866-964-6931
[email protected]
613-882-1429
USA
244 Fifth Avenue | Suite
1717
New York | NY | 10001 | USA
UNITED KINGDOM
Longcroft House,
2-8 Victoira Avenue, Bishopgate
London | UK | EC2M 4NS