April 21 st, 2016 Webinar. registrations What is next for the industry?

Transcription

1 April 21 st, 2016 Webinar A look beyond REACH 2018 registrations What is next for the industry?

2 Some Notes It is assumed that attendees have basic knowledge about REACH. Let us make this webinar interactive, please send questions We try to answer during the webinar, if not possible, we will use 2

3 Content REACHLaw in a nutshell Look beyond the 2018 registrations SVHC roadmap What shall a company do?

4 REACHLaw in a nutshell What we do? We provide global regulatory compliance and environmental sustainability services to ensure market access and operational sustainability for global businesses KEY FACTS ABOUT US Established in Helsinki Offices in Brussels, New Delhi and Istanbul 30+ toxicologists, chemists, lawyers, socioecon. analysts, business and environmental specialists 20+ local partners in Europe, Asia, Latin-America and the USA 500+ REACH registrations Language support in 10+ different languages more info about Us: SERVICE AREAS Global chemicals regulatory compliance, e.g. REACH Biocides TCCA-Korea CLP China REACH Turkey We prepare the required dossiers to authorities, SDSs, labels and provide related business strategy, legal and monitoring support. OUR CLIENTS More than 350 customers from 40+ countries, from Fortune 100 companies to SMEs. Major industries served: Oil, chemicals, specialty chemicals, metals, space sector and other downstream users (DU) industries Our customers are manufacturers, importers, traders, DU s, industry associations and governmental organizations. 4

5 REACHLaw s Authorisation Experiences Substance(s) Activity Status As 2 O 3 DU authorisation application Authorisation granted As 2 O 3 DU authorisation application Authorisation granted MOCA Supplier authorisation application On-going Na 2 Cr 2 O 7 DU authorisation application Final opinion CrO 3 + other chromates CrO 3 Space task force use survey, scoping study and application preparation Joint DU authorisation application (CRAN) One application submitted Submitted CrO 3 DU authorisation application Submitted Na 2 CrO 4 DU authorisation application Final opinion CrO 3 DU authorisation application/csr (APEAL) On-going Na 2 Cr 2 O 7 Supplier authorisation application Submitted

6 REACHLaw s Advocacy Support Experience Substance(s) Activity Status PFOA DOTE Prepared public consultation input for the restriction proposal for two industry sectors Strategic planning and public consultation input Two derogations/ exemptions were granted. Re-classification ongoing DMTE Strategic planning for RMOA input SVHC process halted Other organotins N 2 H 4 Strategic planning for RMOA input Exemption study & position paper & SEA analysis No regulatory actions needed EC feedback pending

7 Content REACHLaw in a nutshell Look beyond the 2018 registrations SVHC roadmap What shall a company do?

8 REACH as commonly perceived Registration Courtesy of Cefic Page 8

9 REACH for advanced R 2010 R 2013 R 2018 CoRAP list? PACT list? ROI list? Candidate list? Annex XV list? Courtesy of Cefic Authorisation Screening Dossier Evaluation/ Compliance check Harmonized classification Update of dossiers Restriction Risk assessment challenged SVHC roadmap RMOA Substances in Articles Substance Evaluation ECHA? Registration D? Evaluation D? Risk managment D? European Commission? Member states? European Parliament? Page 9

10 How are all the other REACH processes linked? Registration D CoRAP list Evaluation D Candidate list Risk managment D Annex XIV list PACT list AfA Courtesy of ECHA ROI list 10 Source: ECHA(2015)

11 Decisions on Annex XIV listing and Authorisation Annex XIV Recommendation Regulatory procedure with scrutiny (Dec. 2006/512/EC) Draft decision REACH Committee Opinion Final decision RAC&SEAC Opinions on application for authorisation Examination procedure (Reg. (EU) 182/2011) Right of scrutiny* *Blocking right for Annex XIV only 11

12 REACH stands for Registration, Evaluation and Authorisation of Chemicals. The purpose is to collect information on substances and their uses; identify risks; and ultimately assure progressive replacement of substances of high concern (SVHCs) by suitable alternative substances/technologies where these are economically and technically viable.

13 Content REACHLaw in a nutshell Look beyond the 2018 registrations SVHC roadmap What shall a company do?

14 REACH timeline REACH Entry into force Preregistration Deadline 1000+/ SVHC registration Deadline 100+ registration Deadline 1+ registration Deadline Registration of Substances Evaluation by ECHA and Member States Candidate listing and Authorisation applications for SVHC SVHC Roadmap Restrictions for Chemical substances presenting an unacceptable risk NOW

15 Substance of Very High Concern (SVHC) roadmap Goal: To have all currently known SVHCs included in the candidate list by 2020 as the first step in selecting substances to be subject to authorisation. Which substances? CMRs (carcinogenic, mutagenic or toxic for reproduction), PBTs (Persistent, Bioaccumulative or Toxic for the Environment), vpvbs (very Persistent and very Bioaccumulative), substances of equivalent concern (such as endocrine disruptors or sensitisers). How to achieve this? Screening Risk Management Option Analysis (ROMA) The rest is defined by the legal text: Annex XV dossier, Candidate listing, Prioritisation and Annex XIV listing

16 # potential SVHCs Screening: Select potential SVHCs of highest priority Prioritizing potential SVHCs Estimate: Total amount of potential SVHCs for RMOA to be conducted by Member States; ~400 RMOAs in the period ~1.500 Effect Carcinogenic, mutagenic & Reprotoxic (CMR) Estimated # RMOAs 50 Manual screening potential SVHCs by Member States Short list of potential SVHCs based on hazard and non-hazard properties (ECHA IT Screening) Allergic (Sensitizing) 30 Endocrine disruption 40 PBT/vPvB 82 Petroleum streams 200

17 Annual screening Source: 17

18 RMOA Key questions: the available information does not demonstrate that there is a risk that is not adequately controlled and needs to be addressed at EU level, otherwise a restriction process should be started; the known uses of the substance are not exempted from the authorisation requirement and are not already regulated by specific EU legislation that provides a pressure for substitution Exception: PBT, vpvb, and endocrine (ED) substances Main conclusion Identification as SVHC (entering the Candidate List before prioritised for REACH authorisation) REACH restriction REACH substance evaluation CLP harmonized classification and labelling Other EU-wide measures No need for follow up regulatory action at EU level

19 IT Screening potential SVHCs Manual Screening potential SVHCs From potential SVHC to SVHC when to act Yearly 1 M Risk Management Option Analysis (RMOA) Comitology decision SVHC on Annex XIV 4M 1-6 M Start process prioritizing SVHC for Annex XIV 1 year 1 year Candidate listing SVHC Preparation Annex XV dossier SVHC 1 year 6 M 1 year Prioritizing SVHC for Annex XIV by ECHA and MSC Evaluation Annex XV dossier by MSC Authorization request by Industry PACT Publication RMOA intention 19 in Public Activity Coordination Tool Publication Annex XIV XM - X year ~5 years to Annex XIV

20 IT Screening potential SVHCs Manual Screening potential SVHCs From potential SVHC to SVHC your voice Information exchange Member State and Stakeholders Information exchange Member State and Stakeholders Risk Management Option Analysis (RMOA) Preparation Annex XV dossier SVHC Comitology decision SVHC on Annex XIV Start process prioritizing SVHC for Annex XIV Candidate listing SVHC Public consultation for CL SVHC Public consultation for Annex XIV PACT Publication RMOA intention in Public Activities Coordination 20 Tool Publication Annex XIV Authorization request by Industry

21 Content REACHLaw in a nutshell Look beyond the 2018 registrations SVHC roadmap What shall a company do?

22 What can I do? Pre-emptive RMOA approach CoRAP list PACT list Monitoring ECHA s dissemination tool Registration dossier up-todate PC: right information at the right time to the right party Intervening Analysing Information collection Mitigation of risks in supply chain Timely obsolescence management Cost-effective replacement plan Portfolio optimation Effective public communication Strategic planning

23 Contact details REACHLaw, the best partner in Global Compliance David Chatfield, VP EHS&S, Dorf Ketal REACHLaw Vänrikinkuja 3 FI Espoo Finland Ying Zhu, Ph.D, M.Sc (Econ.) COO, Partner ying.zhu@reachlaw.fi

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