REACH&CLP Coffee: : My substance is on Annex XIV what to do next? 1. REACH&CLP Helpdesk LU: Ruth Moeller process for substances of very high concern 2. ECHA: Christina Loukou (Helpdesk Unit) Application for Authorisation and ECHA s supporting activities 3. Q&A with support of ECHA Helpdesk and Risk Management Implementation Unit (Christina Loukou and Denis Mottet) 17 October 2013 REACH&CLP Helpdesk Luxembourg - www.reach.lu www.clp.lu
process for Substances of Very High Concern REACH&CLP Coffee - 17 October 2013 Dr. Ruth Moeller, Dr. Arno P. Biwer REACH&CLP Helpdesk Luxembourg www.reach.lu www.clp.lu
Content Introduction: Procedural steps of Authorisation 1. Identification of SVHC* 2. Prioritisation of SVHC for Annex XIV Inclusion 3. Authorisation Application Outlook * SVHC = Substance of very high concern 3
Introduction: 4
o Good functioning of internal market, risk control and replacement of SVHC Pre-cautionary principle: ensure sufficiently high level of protection Compulsory substitution introduced with REACH Commission is the granting authority, no disparity between MS Tool for complete (phase-out) or partial restriction Consideration of risk, socio-economic reasons, and availability of technically and economic viable alternatives o No tonnage threshold! o Manufacturers, importers, downstream users, Only Representatives o Use of a substance as such, in a mixture or in an article o Placement and use in European market o Exemptions due to already existing stringent procedures by other EU legislation 5
o Criteria for substances that may be included in Annex XIV (Art. 57 REACH): (a) carcinogenicity category 1A/1B (according to CLP) (b) germ cell mutagenicity cat. 1A/1B (acc. CLP) (c) reproductive toxicity cat. 1A/1B (acc. CLP) (d) persistent, bio-accumulative, toxic (PBT acc. Annex XIII) (e) very persistent and very bio-accumulative (vpvb acc. Annex XIII) (f) equivalent level of concern, e.g. endocrine disrupters or PBT/vPvB not meeting criteria of Art. 57(d, e) 6
Procedural steps o Step 1: Identification of substances of very high concern (SVHC) Actors: ECHA and Member States Result: Candidate list (Art. 59 REACH) o Step 2: Inclusion of SVHC in Annex XIV REACH Actors: ECHA and Member States, EU Commission Result: Authorisation obligation for SVHC o Step 3: Application for authorisation to use Annex XIV SVHC Actors: Applicants, ECHA and Member States, EU Commission Result: Authorised use(s) or no granting Public consultations in all steps! 7
Procedural Steps: 1. SVHC Identification and Inclusion in the Candidate List o Formal procedure to identify SVHC = Art. 59 REACH o Candidate List: for eventual inclusion in Annex XIV RMO Analysis Registry of Intention Annex XV Dossier SVHC 1. Dossier according to Annex XV REACH prepared by ECHA or Member State (MS) competent authority 2. Public consultation on dossier and commenting by MS 3. Decision by Member States Committee (if comments were received) 4. Identification as substance of very high concern RMO = Risk Management Option 8
Procedural Steps: 1. SVHC Identification and Inclusion in the Candidate List o Today 144 SVHC included in the Candidate List: Ten with environmental concern (PBT or/and vpvb) only Seven with equivalent level of concern only (three HH, 4 ENV) 127 CMR: 36 carcinogenic (C), 58 toxic to reproduction (R), two mutagenic (M); 21 CMR, Eight CMR + PBT/vPvB, two CMR + equivalent level of concern (HH) o Equivalent level of concern: Human Health: Respiratory Sensitizer, STOT RE Environment: EDC o Next SVHC identification in December 2013: Seven SVHC ENV = environment, HH = Human Health, STOT RE = Specific Target Organ Toxicity Repeated Exposure CMR = carcinogenic, mutagenic, toxic to reproduction, EDC = Endocrine Disrupting Chemicals PBT/ vpvb = persistent, bioaccumulative and toxic / very persisitent and very bioaccumulative 9
Procedural Steps: 1. SVHC Identification and Inclusion in the Candidate List o Roadmap for SVHCs identification and implementation of REACH Risk Management measures from now to 2020 Draft prepared by EU Commission in cooperation with ECHA and MS Identify all relevant and currently known SVHC until 2020 At least 440 substances to be screened Properties: CMR, PBT, vpvb, EDC, respiratory and dermal sensitisers, Screening to be build on Risk Management Options (RMO) Assessment Relevant : 1. Registration dossiers (production and use, not only as intermediate) 2. RMO assessment Excluded SVHC to be considered after 2020 RMO = Risk Management Option CMR = carcinogenic, mutagenic, toxic to reproduction; EDC = Endocrine Disrupting Chemicals PBT/ vpvb = persistent, bioaccumulative and toxic / very persisitent and very bioaccumulative 10
Procedural steps: 2. Prioritisation and Annex XIV inclusion o Prioritisation for inclusion taking into account ECHA s capacity o ECHA s General Approach for Prioritisation of SVHC : Recital 78 REACH: ECHA to provide advice on prioritisation Risk-based approach and consideration of regulatory effectiveness Draft Recomm -endation Recommen dation Decision Annex XIV inclusion 1. Draft recommendation by ECHA (= selection of substances from the candidate list by prioritisation) 2. Public consultation 3. Opinion of the Member States Committee (non-binding) 4. Final recommendation by ECHA to the Commission 5. Inclusion of substances in Annex XIV via comitology 11
Procedural steps: 2. Prioritisation and Annex XIV inclusion o Art. 58(3) Priority shall normally be given to substances with : PBT or vpvb properties, Wide dispersive use (WDU) High volumes o Regulatory effectiveness: Category approach: inclusion of analogues or substitutes although not prioritised based on risk criteria (e.g. certain arsenic compounds) o Revision of ECHA s prioritisation approach To enhance predictability and transparency by end of 2013 Registration dossier primary information source, Revise WDU assessment 12
Procedural steps: 2. Prioritisation and Annex XIV inclusion o Specific exemptions to be included in Annex XIV: Not covered by general exemptions of Art. 2 and Art. 56 REACH Can be requested during public consultation (no separate procedure) If there is existing Community legislation for the specific use in place that properly controls the risk Product and Process Oriented R&D (PPORD) o Transitional periods to be specified in Annex XIV: Sunset date: by when a substance can no longer be used without authorisation (ca. 3.5 to 4 years after inclusion) Latest Application Date (LAD): min. 1.5 years before sunset date; application before LAD allows to continue the use after Sunset date until a decision has been taken o Review periods for certain uses, if appropriate 13
Procedural steps: 2. Prioritisation and Annex XIV inclusion o Today: 22 SVHC in Annex XIV o ECHA recommendation January 2013: Ten SVHC Decision via comitology approximately end of 2013 o Next recommendation: 5th Draft recommendation to be finalised end of 2013 Five SVHC prioritised 14
Procedural steps: 3. Application for Authorisation o Formal procedure for authorisation decisions = Art. 64 REACH Application Opinion of RAC, SEAC Decision Review 1. Notification + submission of application by the applicant, fee payment 2. Compliance check by ECHA 3. Public consultation on alternative substances or technologies 4. Opinion of RAC and SEAC (consultation of applicant on draft opinion) 5. Decision by the Commission (via comitology procedure) based on final RAC/SEAC opinion 6. If granted: downstream user (DU): notification of use 7. If granted: EU Com, applicant: Review of authorisation RAC = Risk Assessment Committee, SEAC = Committee for Socio-Economic Analysis 15
Procedural steps: 3. Application for Authorisation o Who applies for what to ECHA? Manufacturer, importer, Only Representative, and/or downstream user: own use or for which he intends to place a SVHC on the market (one or several substance / one or several uses / one or several companies) Authorisation also valid for DU down the same supply chain for that use (Art. 56(2)) and for the immediate supplier up the supply chain from the authorisation holder (Art. 56(1e) REACH) o Application for authorisation content: Identity of the substances and identity of the applicant Use(s) for which authorisation is sought Chemical safety report Analysis of the alternatives considering their risks and the technical and economic feasibility of substitution, including possible R&D activities Substitution plan, if suitable alternatives are available Socio-economic analysis (optional) 16
Procedural steps: 3. Application for Authorisation o Adequate control route: CMR substances for which it is possible to set a DNEL Chemical safety report has to show that the risk from the substance is properly controlled o Socio-economic route PBT and vpvb substances; CMR substances for which it is not possible to determine a threshold (no DNEL) The socio-economic analysis has to show: Socio-economic benefits outweigh the risk to human health or the environment, and No suitable alternative substances or technologies available DNEL = Derived No Effect Level 17
Procedural steps: 3. Application for Authorisation o The authorisation specifies: Holder of the authorisation Identity of the substance(s) Authorised use(s) Any conditions under which the authorisation is granted Time-limited review period Any monitoring arrangement 18
Thank you for your attention! 19
Outlook o Anticipation of the authorisation obligation for substances of concern Intention for Harmonised Classification and Labelling Intention for SVHC identification ECHA s registries of intention: http://echa.europa.eu/web/guest/addressing-chemicals-of-concern/registry-ofintentions Presentation Tudor 20
Outlook o Substitution of hazardous chemicals Aim of REACH authorisation Substitution happens! Substitution support activities SUBSPORT: Substitution Support Portal ECHA/OECD activities launched, output 2015 Substitution Event 2014 by CRP Henri Tudor 21
Outlook o Next Event: Annual REACH&CLP conference 5 December 2013, Chambre de Commerce, Luxembourg-Kirchberg Draft program: Priorities after REACH 2013 Nanomaterials under REACH SVHC Roadmap by EU Com Impact of Authorisation on companies 22