reach webinar additional information assent april 2015
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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
AGENDAIntroduction
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
info@assentcompliance.com | www.assentcompliance.com | TEL: 1(866)964-6931 Slide 4
Introduction - About Assent
info@assentcompliance.com | www.assentcompliance.com | TEL: 1(866)964-6931 Slide 5
The World is Becoming More Regulated - Assent Helps
info@assentcompliance.com | www.assentcompliance.com | TEL: 1(866)964-6931 Slide 6
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
info@assentcompliance.com | www.assentcompliance.com | TEL: 1(866)964-6931 Slide 7
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
info@assentcompliance.com | www.assentcompliance.com | TEL: 1(866)964-6931 Slide 8
So Many Lists...how do they all fit?
info@assentcompliance.com | www.assentcompliance.com | TEL: 1(866)964-6931 Slide 9
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 updatehttp://echa.europa.eu/documents/10162/13628/corap_list_2015-2017_en.pdf
❖ 48 Substances for 2015 - Due by Mar 2016
❖ Substance evaluation mechanism X
info@assentcompliance.com | www.assentcompliance.com | TEL: 1(866)964-6931 Slide 10
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 16/11/2011CMR; PBT
info@assentcompliance.com | www.assentcompliance.com | TEL: 1(866)964-6931 Slide 11
Proposed SVHCshttp://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)
271-094-0272-013-1
68515-51-568648-93-1
SwedenToxic 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
info@assentcompliance.com | www.assentcompliance.com | TEL: 1(866)964-6931 Slide 12
Authorisation List Recommendationshttp://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
info@assentcompliance.com | www.assentcompliance.com | TEL: 1(866)964-6931 Slide 13
Authorisation Applications and Sunset Dateshttp://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
info@assentcompliance.com | www.assentcompliance.com | TEL: 1(866)964-6931 Slide 14
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
info@assentcompliance.com | www.assentcompliance.com | TEL: 1(866)964-6931 Slide 15
Compliance Implications❖ Measure Impact
➢ Substances/Mixtures
➢ Articles
➢ Business vs. Regulatory
❖ Supplier Education
❖ Yearly Audits
❖ Supplier Data Gathering, Testing and Risk Assessment
❖ FMDs?
info@assentcompliance.com | www.assentcompliance.com | TEL: 1(866)964-6931 Slide 16
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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