REACH is Constantly Changing

Krystal Cameron Regulatory Affairs [email protected]

REACH is Constantly Changing

For Once, it is not an SVHC Update

[email protected] | 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


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 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

http://echa.europa.eu/addressing-chemicals-of-concern/substances-of-potential-concern/pact

http://echa.europa.eu/information-on-chemicals/evaluation/community-rolling-action-plan/corap-table



http://echa.europa.eu/documents/10162/13628/corap_list_2015-2017_en.pdf

http://echa.europa.eu/documents/10162/13628/corap_list_2015-2017_en.pdf


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

http://echa.europa.eu/web/guest/registry-of-current-svhc-intentions

http://echa.europa.eu/web/guest/registry-of-current-svhc-intentions

http://echa.europa.eu/registry-of-current-svhc-intentions?p_p_id=viewsubstances_WAR_echarevsubstanceportlet&p_p_lifecycle=0&p_p_state=normal&p_p_mode=view&p_p_col_id=column-1&p_p_col_pos=1&p_p_col_count=3&_viewsubstances_WAR_echarevsubstanceportlet_cur=1&_viewsubstances_WAR_echarevsubstanceportlet_delta=50&_viewsubstances_WAR_echarevsubstanceportlet_keywords=&_viewsubstances_WAR_echarevsubstanceportlet_advancedSearch=false&_viewsubstances_WAR_echarevsubstanceportlet_andOperator=true&_viewsubstances_WAR_echarevsubstanceportlet_orderByCol=staticField_-104&_viewsubstances_WAR_echarevsubstanceportlet_orderByType=desc






http://echa.europa.eu/registry-of-current-svhc-intentions?p_p_id=viewsubstances_WAR_echarevsubstanceportlet&p_p_lifecycle=0&p_p_state=normal&p_p_mode=view&p_p_col_id=column-1&p_p_col_pos=1&p_p_col_count=3&_viewsubstances_WAR_echarevsubstanceportlet_cur=1&_viewsubstances_WAR_echarevsubstanceportlet_delta=50&_viewsubstances_WAR_echarevsubstanceportlet_keywords=&_viewsubstances_WAR_echarevsubstanceportlet_advancedSearch=false&_viewsubstances_WAR_echarevsubstanceportlet_andOperator=true&_viewsubstances_WAR_echarevsubstanceportlet_orderByCol=synonymDynamicField_251&_viewsubstances_WAR_echarevsubstanceportlet_orderByType=desc




http://echa.europa.eu/registry-of-current-svhc-intentions?p_p_id=viewsubstances_WAR_echarevsubstanceportlet&p_p_lifecycle=0&p_p_state=normal&p_p_mode=view&p_p_col_id=column-1&p_p_col_pos=1&p_p_col_count=3&_viewsubstances_WAR_echarevsubstanceportlet_cur=1&_viewsubstances_WAR_echarevsubstanceportlet_delta=50&_viewsubstances_WAR_echarevsubstanceportlet_keywords=&_viewsubstances_WAR_echarevsubstanceportlet_advancedSearch=false&_viewsubstances_WAR_echarevsubstanceportlet_andOperator=true&_viewsubstances_WAR_echarevsubstanceportlet_orderByCol=synonymDynamicField_248&_viewsubstances_WAR_echarevsubstanceportlet_orderByType=asc







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

http://echa.europa.eu/web/guest/proposals-to-identify-substances-of-very-high-concern-previous-consultations



http://echa.europa.eu/proposals-to-identify-substances-of-very-high-concern-previous-consultations?p_p_id=viewsubstances_WAR_echarevsubstanceportlet&p_p_lifecycle=0&p_p_state=normal&p_p_mode=view&p_p_col_id=column-1&p_p_col_pos=2&p_p_col_count=4&_viewsubstances_WAR_echarevsubstanceportlet_cur=1&_viewsubstances_WAR_echarevsubstanceportlet_delta=50&_viewsubstances_WAR_echarevsubstanceportlet_keywords=&_viewsubstances_WAR_echarevsubstanceportlet_advancedSearch=false&_viewsubstances_WAR_echarevsubstanceportlet_andOperator=true&_viewsubstances_WAR_echarevsubstanceportlet_orderByCol=staticField_-104&_viewsubstances_WAR_echarevsubstanceportlet_orderByType=desc






http://echa.europa.eu/proposals-to-identify-substances-of-very-high-concern-previous-consultations?p_p_id=viewsubstances_WAR_echarevsubstanceportlet&p_p_lifecycle=0&p_p_state=normal&p_p_mode=view&p_p_col_id=column-1&p_p_col_pos=2&p_p_col_count=4&_viewsubstances_WAR_echarevsubstanceportlet_cur=1&_viewsubstances_WAR_echarevsubstanceportlet_delta=50&_viewsubstances_WAR_echarevsubstanceportlet_keywords=&_viewsubstances_WAR_echarevsubstanceportlet_advancedSearch=false&_viewsubstances_WAR_echarevsubstanceportlet_andOperator=true&_viewsubstances_WAR_echarevsubstanceportlet_orderByCol=synonymDynamicField_705&_viewsubstances_WAR_echarevsubstanceportlet_orderByType=desc





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

http://echa.europa.eu/addressing-chemicals-of-concern/authorisation/recommendation-for-inclusion-in-the-authorisation-list




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

http://echa.europa.eu/addressing-chemicals-of-concern/authorisation/recommendation-for-inclusion-in-the-authorisation-list/authorisation-list





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

http://echa.europa.eu/addressing-chemicals-of-concern/restrictions/list-of-restrictions



http://echa.europa.eu/web/guest/restrictions-under-consideration

http://echa.europa.eu/web/guest/restrictions-under-consideration

http://echa.europa.eu/web/guest/registry-of-current-restriction-proposal-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...

✓✓✓✓✓

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Krystal Cameron

1-866-964-6931

[email protected]

613-882-1429

REACH is Constantly Changing

Business

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