Reach webinar additional information assent april 2015

Krystal Cameron Regulatory Affairs krystal.cameron@assentcompliance.com
REACH is Constantly Changing
For Once, it is not an SVHC Update

info@assentcompliance.com | www.assentcompliance.com | TEL: 1(866)964-6931 Slide 3
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

Introduction - About Assent

The World is Becoming More Regulated - Assent Helps

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

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

So Many Lists...how do they all fit?

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-rolling-
action-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
X

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 CAS Number Notification of
intention
Expected date of
submission
Scope
Dicyclohexyl phthalate 201-545-9 84-61-7 20/03/2015 03/08/2015 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
0.01 % by weight.]
200-028-5 50-32-8 16/11/2011
CMR;
PBT

Proposed SVHCs
http://echa.europa.eu/web/guest/proposals-to-identify-substances-of-very-high-
concern-previous-consultations
Name EC Number CAS Number Proposing authority Reason for proposing
1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters; 1,2-
benzenedicarboxylic 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

Authorisation List Recommendations
http://echa.europa.eu/addressing-chemicals-of-
concern/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

Authorisation Applications and Sunset Dates
http://echa.europa.eu/addressing-chemicals-of-
concern/authorisation/recommendation-for-inclusion-in-the-authorisation-
list/authorisation-list
❖ 31 Substances
❖ Application Date has passed for 15
❖ Sunset Date passed for 6
❖ 5 - May of 2015
❖ 3 - August 2015

Restriction Proposal Decisions
FULL LIST:
http://echa.europa.eu/addressing-chemicals-of-concern/restrictions/list-of-
restrictions
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

Compliance Implications
❖ Measure Impact
➢ Substances/Mixtures
➢ Articles
➢ Business vs. Regulatory
❖ Supplier Education
❖ Yearly Audits
❖ Supplier Data Gathering, Testing and Risk Assessment
❖ FMDs?

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...
✓
✓
✓
✓
✓

CANADA
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Ottawa | ON | K1J 1A4
USA
244 Fifth Avenue | Suite
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New York | NY | 10001 | USA
UNITED KINGDOM
Longcroft House,
2-8 Victoira Avenue, Bishopgate
London | UK | EC2M 4NS
Krystal Cameron
1-866-964-6931
krystal.cameron@assentcompliance.com
613-882-1429

Reach webinar additional information assent april 2015

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