REACH&CLP: Current status and next steps of the different procedures

Transcription

1 REACH&CLP: Current status and next steps of the different procedures Chamber of Commerce, 14 December 2017 Dr. Arno P. BIWER, REACH&CLP Helpdesk Luxembourg

2 CONTENT REACH Registration Evaluation Authorisation Restriction CLP Transitional periods and adaptation to technical and scientific progress Poison centre Enforcement

3 REGISTRATION Registration deadline 2018 ECHA presentation Data requirements: Commission Regulation (EU) 2017/706 amending Annex VII REACH as regards skin sensitization (in chemico/in vitro tests) Commission Regulation (EU) 2017/735 amending Test methods Regulation (new+ updated phys-chem, ecotox and tox tests) Registration statistics Luxembourg (as of November 2017): 350 (+57) registrations for 281 substances; 0.5% of all registrations 282 registrations by large companies, still few by SMEs (39) Rather unique distribution of roles: 207 by Only Representatives (59%) 120 by importer (34%) 22 by manufacturer (and partly also importer, 6%)

4 EVALUATION: PROCEDURES Evaluation Dossier evaluation Substance evaluation Testing proposals Compliance check 4

5 EVALUATION: DOSSIER EVALUATION (ECHA) Testing proposals Regular public consultations for vertebrate tests (8 running, overall 1,090) So far 513 (+37) ECHA decisions published (Dec 2017) Compliance checks (of registration dossiers) Substances potentially subject to compliance checks (request to update dossier by February 2018) (List: echa.europa.eu/regulations/reach/evaluation/compliance-checks) So far 634 (+66) ECHA decisions published (full and targeted compliance checks) Evaluation Report 2016 with recommendations (Feb 2017): Information requested in the 152 adopted ECHA compliance check decisions taken in

6 EVALUATION: SUBSTANCE EVALUATION (MEMBER STATES) Community Rolling Action (CoRAP) ( Last annual update (March): 138 substances (54 newly selected) Draft update (October): 117 substances (22 newly selected) Substance evaluation: Interaction with registrants during evaluation (formal and informal) Current status of substance evaluations started in : 6 Status of all substance evaluations started in at the end of 2016

7 AUTHORISATION: SUBSTANCES OF VERY HIGH CONCERN Five new SVHC identified (January + July 2017): 4,4 -isopropylidenediphenol (bisphenol A; BPA); Nonadecafluorodecanoic acid (PFDA) and its sodium and ammonium salts; p-(1,1-dimethylpropyl)phenol; 4-heptylphenol, branched and linear Perfluorohexane-1-sulfonic acid and its salts (PFHxS) Plus five existing entries updated Pipeline: Submitted SVHC proposal (9): Dodecachloropentacyclo-octadeca-7,15-diene (Dechlorane Plus), 4,4 -isopropylidenediphenol (bisphenol A; BPA), Benz[a]anthracene, Cadmium carbonate, Cadmium dihydroxide, Cadmium dinitrate, Chrysene, Reaction products of 1,3,4-thiadiazolidine- 2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP), Tricobalt tetraoxide containing 0.1 % w/w nickel oxides, Perfluorohexane-1-sulphonic acid and its salts. Registry of intention (7): Benzo(k)fluoranthene, Fluoranthene, Phenanthrene, Pyrene, Ethylenediamine, Lead, Terphenyl (hydrogenated), Benzo[def]chrysene (Benzo[a]pyrene) SVHC Alert by the REACH&CLP Helpdesk 7

8 AUTHORISATION: LATEST APPLICATION AND SUNSET DATES Latest application date in 2017 (sunset date: 2019): Dichromium tris(chromate) Pentazinc chromate octahydroxide Potassium hydroxyoctaoxodizincatedichromate Strontium chromate Sunset date in 2017: November: 1,2-dichloroethane (EDC), 2,2'-dichloro-4,4'-methylenedianiline (MOCA) September: Acids generated from chromium trioxide and their oligomers, Ammonium dichromate, Chromium trioxide, Potassium chromate, Potassium dichromate, Sodium chromate, Sodium dichromate August: Arsenic acid; Bis(2-methoxyethyl) ether; Formaldehyde, oligomeric reaction products with aniline None in

9 AUTHORISATION: AUTHORISATION LIST (ANNEX XIV REACH) 12 new substances in Annex XIV REACH (Regulation (EU) 2017/999, June): Latest application date (8): January 2019 / Sunset date: July 2020: 1-Bromopropane, Diisopentylphthalate, 1,2-Benzenedicarboxylic acid, di-c6-8-branched alkyl esters, C7 rich, 1,2-Benzenedicarboxylic acid, di-c7-11-branched and linear alkyl esters, 1,2- Benzenedicarboxylic acid, dipentylester, branched and linear, Bis(2-methoxyethyl) phthalate, Dipentylphthalate, N-pentyl-isopentylphthalate, LAD (2): April 2019 / Sunset date: October 2020: Anthracene oil, Pitch, coal tar, high temp. LAD (2): July 2020 / Sunset date: July 2021: 4-(1,1,3,3-Tetramethylbutyl) phenol, ethoxylated; 4-Nonylphenol, branched and linear, ethoxylated Pipeline: Draft recommendation for inclusion in Annex XIV (7): Karanal group, 1- Methyl-2-pyrrolidone (NMP), 2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328), 2,4-ditert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327), 2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6- (sec-butyl)phenol (UV-350), 2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320), 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 9

10 AUTHORISATION: THE EXAMPLE OF PITCH, COAL TAR, HIGH TEMPERATURE Pitch, coal tar is the residue from the distillation of high temperature coal tar SVHC identification: Carcinogenic category 1B, PBT, vpvb Inclusion in Authorisation list: 14 June 2017 Latest application date: 4 April 2019 Sunset date: 4 October 2020 Use: Uses at industrial sites: Formulation of mixtures; use as binding agent in metallurgic smelting, refractories and for clay pigeons; formulation and use as anti-corrosion agent in (specialty) coatings, paints and adhesives Uses by professional workers, e.g. use as anti-corrosion agent in (specialty) coatings, paints, adhesives and sealants Tonnage: Produced in large quantities (100,000 1,000,000 t/a). 10 PBT = Persistent, Bio-accumulative and Toxic vpvb = very Persistent and very Bio-accumulative

11 RESTRICTION: NEW RESTRICTIONS New and updated restriction in 2017: Regulation (EU) 2017/1510: Add new CMR substances to existing restriction Regulation (EU) 2017/1000: Perfluorooctanoic acid (PFOA) (e.g. fire-fighting foam, semiconductors, medical devices, photographic coatings, nano-coatings, textiles) Regulation (EU) 2017/227: Bis(pentabromophenyl)ether (DecaBDE) Pipeline: Final decision pending: 1-Methyl-2-pyrrolidone (NMP); Methanol; Octamethylcyclotetrasiloxane (D4),Decamethylcyclopentasiloxane (D5) ECHA Opinions adopted: Tridecafluorooctyl)silanetriol; Diisobutyl phthalate (DIBP); Dibutyl phthalate (DBP); Benzyl butyl phthalate (BBP); Bis(2-ethylhexyl) phthalate (DEHP) Submitted restrictions proposals: Diisocyanates; Lead compounds (PVC and Shot) Registry of intentions: N,N-dimethylformamide; Several Cobalt compounds; Benzo[x] compounds (BaP, BeP, BaA, BbFA, BjFA, BkFA, DBAhA); Chrysene 11

12 RESTRICTION: THE EXAMPLE OF DecaBDE DecaBDE (bis(pentabromophenyl)ether): Additive flame retardant Not manufactured in Europe anymore but imported in quantities of 10, ,000 t/a Uses: in plastics for electrical and electronic equipment, in the transportation sector (e.g. automotive and aviation industries) and in construction and building (e.g. for wires, cables and pipes). in textiles (main end uses are upholstery, window blinds, curtains, mattress textiles) in adhesives in the aeronautic sector for civil and defence applications in coatings and inks can lead to end uses in electrical and electronic equipment, and to end-uses in building and construction sector. Restriction: Substance as such, in a mixture and in an article (> 0.1%) Applies from March 2019 Specific transitional periods until 2027 (production of an aircrafts, production of spare parts for aircrafts or motor vehicles, production of electrical and electronic equipment) 12

13 RESTRICTION: END OF TRANSITIONAL PERIODS Mercury in thermometers exclusively intended to perform tests according to standards that require the use of mercury thermometers (October 2017) Inorganic ammonium salts in cellulose insulation mixtures or cellulose insulation articles only if ammonia emission results in a concentration of less than 3 ppm (July 2018) 13

14 CONTENT REACH Registration Evaluation Authorisation Restriction CLP Transitional periods and adaptation to technical and scientific progress Poison centre Enforcement

15 TRANSITIONAL PERIOD AND ADAPTATION TO TECHNICAL AND SCIENTIFIC PROGRESS End of Transitional period for mixture: June 2017 (for mixtures already been classified, labelled and packaged under the old system, and already on the market before June 2015) Adaptation to technical and scientific progress (ATP): Commission Regulation (EU) 2017/776: New entries and updates of Annex VI CLP (= substances with harmonised classification of labelling) Pipeline: Draft in REACH Committee in December 2017 amendment of Annex VI entries Further harmonised classification and labelling (CLH): Opinion by ECHA s Risk Assessment Committee (20 substances in 2017) Public consultations: 56 in 2017, seven still on-going Submitted CLH proposals: 46 substances Registry of intention: 49 substances 15

16 POISON CENTRE: NEW ANNEX VIII CLP Commission Regulation (EU) 2017/542: Adding Annex VIII CLP on harmonised information relating to emergency health response and preventative measures Harmonised information and format to be submitted to poison centres Use of unique formula identifier (UFI) (unique alphanumeric code that links the submitted information to a specific mixture or group of mixtures) Deadlines (for Importers and downstream users): Mixtures for consumer use: 1 January 2020 Mixtures for professional use: 1 January 2021 Mixtures for industrial use: 1 January 2024 Dedicated ECHA Poison Centre website ( General information Different tools and links available: Poison Centres Notification format and editor Poison Centres Notification portal UFI Generator EU Product Categorisation System 16

17 CONTENT REACH Registration Evaluation Authorisation Restriction CLP Transitional periods and adaptation to technical and scientific progress Poison centre Enforcement

18 Enforcement of REACH, CLP and Biocides in Luxembourg Unité substances chimiques et produits

19 Enforcement activities 2017 (examples) Inspection of compliance of mixtures or articles with restrictions from Annex XVII REACH ECHA Pilot Project on CLP focusing on control of internet sales (also specific obligations for biocidal products) ECHA Project REF 5 on Extended Safety Data Sheets. Inspections in collaboration with Labour inspectorate (ITM) Reactive surveillance: inspections triggered by complaints received and exchange of enforcement information Inspection of compliance of Biocidal Products: Repellant biocidal products (PT19) sold to consumers Wood protecting biocidal products (PT8) used by professionals Insecticidal biocidal products (PT8) used by professionals Biocidal products for consumer use in internet shops 19

20 Enforcement activities 2018 (examples) Inspection of compliance of mixtures or articles with restrictions from Annex XVII REACH (cont.) ECHA Project REF 6 Project on classification and labelling of mixtures (including Biocides module) ECHA Pilot Project on substances in articles (SVHC) Cooperation with ADA (Administration des douanes et accises) to inspect compliance of biocidal products sold by agriculture retailers Inspection of compliance of biocidal products sold in internet shops (cont.) Inspection of compliance of biocidal products for industrial use (PT10) 20

21 VARIOUS ECHA published the Cloud Service which is a secure online platform where you can easily access ECHA s IT applications anytime, anywhere (including IUCLID Cloud for SMEs to prepare dossiers for the REACH 2018). ECHA published a new website on the UK s withdrawal from the EU:

22 THANK YOUR FOR YOUR ATTENTION! Arno Biwer Laurène Chochois Anna Lisa Heinevetter Ruth Moeller Clémence Varret REACH&CLP Helpdesk Luxembourg 41, rue du Brill L4422 Belvaux Phone : reach@list.lu clp@list.lu Internet: The Helpdesk provides an advisory service on REACH and CLP. This advisory service, however, does not represent any legal interpretation of the existing legislation. The REACH and CLP regulations and related regulations and directives are the only legally binding sources. The information provided here is not legally binding and is provided AS IS, without any warranty or representation of any kind, given or to be implied, as to its sufficiency and accuracy. Therefore, LIST takes no legal responsibility and liability for any errors, omissions or misleading statements and the recipient of this presentation shall be entirely responsible for the use to which it puts such information. 22