Chamber of Commerce, 14 December 2017

Dr. Arno P. BIWER, REACH&CLP Helpdesk Luxembourg

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

REACH• Registration• Evaluation• Authorisation• Restriction

CLP• Transitional periods and adaptation to technical and scientific progress• Poison centre

Enforcement

CONTENT

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%)

REGISTRATION

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EVALUATION:PROCEDURES

Evaluation

Testing proposals

Compliance check

Substance evaluation

Dossier evaluation

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):

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EVALUATION:DOSSIER EVALUATION (ECHA)

Information requested in the 152 adopted ECHA compliance check decisions taken in 2016.

Community Rolling Action (CoRAP) (http://echa.europa.eu/information-on-chemicals/evaluation/community-rolling-action-plan/corap-table)

• Last annual update 2016-2018 (March): 138 substances (54 newly selected)

• Draft update 2017-2019 (October): 117 substances (22 newly selected)

Substance evaluation:• Interaction with registrants during

evaluation (formal and informal)• Current status of substance evaluations

started in 2012-2016:

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EVALUATION:SUBSTANCE EVALUATION (MEMBER STATES)

Status of all substance evaluations started in 2012-2016 at the end of 2016

• 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), Tricobalttetraoxide 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

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AUTHORISATION:SUBSTANCES OF VERY HIGH CONCERN

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 2018

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AUTHORISATION:LATEST APPLICATION AND SUNSET DATES

• 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-di-tert-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

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AUTHORISATION:AUTHORISATION LIST (ANNEX XIV REACH)

• 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).

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AUTHORISATION:THE EXAMPLE OF PITCH, COAL TAR, HIGH TEMPERATURE

PBT = Persistent, Bio-accumulative and ToxicvPvB = very Persistent and very Bio-accumulative

• 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

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RESTRICTION:NEW RESTRICTIONS

• DecaBDE (bis(pentabromophenyl)ether):• Additive flame retardant• Not manufactured in Europe anymore but imported in quantities of 10,000-100,000 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)

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RESTRICTION:THE EXAMPLE OF DecaBDE

• 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)

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RESTRICTION:END OF TRANSITIONAL PERIODS

REACH• Registration• Evaluation• Authorisation• Restriction

CLP• Transitional periods and adaptation to technical and scientific progress• Poison centre

Enforcement

CONTENT

• 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

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TRANSITIONAL PERIOD AND ADAPTATION TO TECHNICAL AND SCIENTIFIC PROGRESS

• 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 (https://poisoncentres.echa.europa.eu/)

• General information• Different tools and links available:

• Poison Centres Notification format and editor• Poison Centres Notification portal• UFI Generator• EU Product Categorisation System

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POISON CENTRE:NEW ANNEX VIII CLP

REACH• Registration• Evaluation• Authorisation• Restriction

CLP• Transitional periods and adaptation to technical and scientific progress• Poison centre

Enforcement

CONTENT

Enforcement of REACH, CLP and Biocides in Luxembourg

Unité substances chimiques et produits

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 (alsospecific obligations for biocidal products)

ECHA Project REF‐5 on Extended Safety Data Sheets. Inspections incollaboration 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

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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)

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• 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).

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VARIOUS

• ECHA published a new website on the UK’s withdrawal from the EU:

https://echa.europa.eu/uk-withdrawal-from-the-eu

https://ecs.echa.europa.eu/cloud/home.html

Arno Biwer | Laurène Chochois | Anna‐Lisa Heinevetter | Ruth Moeller | Clémence VarretREACH&CLP Helpdesk Luxembourg | 41, rue du Brill | L4422 Belvaux Phone : + 352 275 8881

Email : reach@list.lu |clp@list.luInternet: www.reach.lu

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THANK YOUR FOR YOUR ATTENTION!

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 onlylegally 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.