reach&clp: current status and next steps of the … · entries (10th atp clp) (voted in reach...

REACH&CLP: CURRENT STATUS AND NEXT STEPS OF THE DIFFERENT PROCEDURES Chamber of Commerce, 8 December 2016 Arno P. BIWER, REACH&CLP Helpdesk Luxembourg

REACH

• Registration

• Evaluation

• Authorisation

• Restriction

CLP

• Adaptation to technical and scientific progress

• Classification of mixtures

• Poison centre

Enforcement

CONTENT

Luxembourg (as of May 2016):

• 293 (+26) registrations for 171 (+15) substances

• 0.64% of all registrations

• Still few SMEs:

• 258 registrations by large companies

• 35 by SMEs

• Rather unique distribution of roles:

• 169 by Only Representatives (58%)

• 105 by importer (36%)

• 19 by manufacturer (and partly also importer, 6%)

Statistics

REGISTRATION

EU (May 2016) Registrations Unique substances

TOTAL 45,373 (+2,866) 9,472 (+859)

Phase-in 41,834 7,905

Non phase-in 3,539 1,567

• Final deadline 31 May 2018: 1-10t, 10-100t

• If you haven't yet pre-registered your substance, late

pre-registration may still be an option until 31 May 2017

• Steps to be taken:

1. Known your portfolio

2. Find your co-registrants

3. Get organised with your co-registrants

4. Assess hazard and risk

5. Prepare your registration as a IUCLID dossier

6. Submit your registration dossier

7. Keep your registration up to date

Find information on: https://echa.europa.eu/reach-2018

REACH 2018

REGISTRATION

https://echa.europa.eu/reach-2018





REACH 2018: Relevant new regulations

REGISTRATION

Data requirements:

• Commission Regulation (EU) 2016/266 amending Test Method Regulation

(EC) No 440/2008 (17 new, three updated; physicochemical properties,

ecotox, e-fate)

• Commission Regulation (EU) 2016/863 and 2016/1688 on Annex VII-VIII

REACH: In vitro studies (skin corrosion/irritation, serious eye damage/eye

irritation, skin sensitisation); option to waive the dermal testing for acute

toxicity

Data sharing:

• Commission Implementing Regulation (EU) 2016/9 on joint submission of

data and data-sharing laying down specific duties and obligations for parties

to agreements where the sharing of information and associated costs are

required under Regulation (EC) No 1907/2006.

REACH

• Registration

• Evaluation

• Authorisation

• Restriction

CLP



• Poison centre

Enforcement

CONTENT

Procedures

EVALUATION

Evaluation

Testing

proposals

Compliance

check

Substance

evaluation

Dossier

evaluation

+ some other measures like letter campaigns + Follow up evaluations (e.g. SONC process*)

* SONC = Statement of Non Compliance

• 853 higher tier human health and environment endpoints

• Regular public consultations for vertebrate tests (nine running, overall

1,007)

• So far 476 ECHA decisions published (Nov 2016)

Dossier evaluation - Testing proposals (ECHA)

EVALUATION

Evaluation report 2015: Types of information

requested as a percentage of the 194

Testing Proposal evaluation decisions

taken in 2015

• So far 568 ECHA decisions published (full and targeted compliance checks)

• Concluded 2015 without information request: 34% (full), 15% (targeted)

• Evaluation Report 2015 with recommendations (Feb 2016): https://echa.europa.eu/documents/10162/13628/evaluation_report_2015_en.pdf

• Since 2015: High priority substances i.e. high-tonnage registration

dossiers with important data gaps and with a high potential for worker,

consumer or environmental exposure. -> Higher tier studies

Dossier evaluation - Compliance checks (ECHA)

EVALUATION

Information requested as a percentage of the 144

Compliance check decisions taken in 2015

https://echa.europa.eu/documents/10162/13628/evaluation_report_2015_en.pdf

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 registrations during evaluation (formal and informal)

• Current status of substance evaluations started in 2012-2015: Data request fro 99 of 182

substances:

Substance evaluation (Member States)

EVALUATION

Percentage of the 29 substance evaluation decisions adopted by ECHA in 2015 containing each type of request

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













REACH

• Registration

• Evaluation

• Authorisation

• Restriction

CLP



• Poison centre

Enforcement

CONTENT

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!

Authorisation - Procedural steps

AUTHORISATION

• Candidate List: 169 substances

• Last updates:

• December 2015 (5): ED: Nitrobenzene, Perfluorononan-1-oic-acid and its sodium and ammonium salts; vPvB: UV-327, UV-350; CMR: 1,3-propanesultone,

• June 2016 (1): CMR: Benzo[def]chrysene

• November 2016: COM decision not to include hexamethylene diacrylate skin sent.)

• Submitted proposals (10, since November 2015): • Equivalent level of concern: 4-Heptylphenol, branched and linear; 4-tert-butylphenol;

Benzene-1,2,4-tricarboxylic acid 1,2-anhydride (trimellitic anhydride; TMA); p-(1,1-dimethylpropyl)phenol;

• CMR/ PBT/ ED: Bisphenol A,4,4'-isopropylidenediphenol; Nonadecafluorodecanoic acid (PFDA) and its sodium and ammonium salts; (±)-1,7,7-trimethyl-3-[(4-methylphenyl)methylene]bicyclo[2.2.1]heptan-2-one; 1,7,7-trimethyl-3-(phenylmethylene)bicyclo[2.2.1]heptan-2-one; Benzo[def]chrysene Benzo[a]pyrene); Dicyclohexyl phthalate

• Withdrawn submissions: • (±)-1,7,7-trimethyl-3-[(4-methylphenyl)methylene]bicyclo[2.2.1]heptan-2-one (DE, June

2016)

• Registry of intentions (for submission in February 2017):

• ED: 4,4’-isopropylidenediphenol (bisphenol A; BPA)

Identification of substances of very high concern (SVHC)

AUTHORISATION

CMR = carcinogenicity, germ cell mutagenicity, reproductive toxicity; PBT = persistent, bio-accumulative, toxic; vPvB

= very persistent and very bio-accumulative, ED = Endocrine disruptor

• No Annex XIV inclusions in 2016 (currently 31 substances)

• Submitted recommendations (to be decided by the Commission):

• 7th ECHA recommendation (Nov 2016): 11 substances, e.g. Dihexyl phthalate,

Orange lead (lead tetroxide), Pentalead tetraoxide sulphate

• 6th ECHA recommendation (July 2015): 15 substances, e.g. anthracene oil,

several boron compounds -> Draft Regulation today in REACH Committee

• Draft proposal for ECHA Recommendation (Nov 2016): 9 substances,

public consultation until February 2016

• Sunset dates (no use without authorisation):

• 2016: Trichloroethylene (process solvent, e.g. for degreasing)

• 2017: 1,2-dichloroethane (EDC), 2,2'-dichloro-4,4'-methylenedianiline (MOCA), Acids

generated from chromium trioxide and their oligomers, Ammonium dichromate, Arsenic

acid, Bis(2-methoxyethyl) ether, Chromium trioxide, Formaldehyde, oligomeric reaction

products with aniline, Potassium chromate, Potassium dichromate, Sodium chromate,

Sodium dichromate

Annex XIV REACH (SVHC with authorisation obligation)

AUTHORISATION

• Latest application dates 2017 (12 in 2016):

• Dichromium tris(chromate)

• Pentazinc chromate octahydroxide

• Potassium hydroxyoctaoxodizincatedichromate

• Strontium chromate

• Granted authorisations: http://ec.europa.eu/DocsRoom/documents/9827

• Downstream users: Notification of uses covered by a REACH

authorisation (Article 66) via Webform within three months (http://echa.europa.eu/support/dossier-submission-tools/reach-it/downstream-user-authorised-use)

• Under preparation: Simplified authorisation procedure for low volumes,

spare parts

Applications for authorisation

AUTHORISATION

http://ec.europa.eu/DocsRoom/documents/9827

http://echa.europa.eu/support/dossier-submission-tools/reach-it/downstream-user-authorised-use













New/updated restrictions:

• Regulation (EU) 2016/26 Nonylphenol ethoxylates (NPE) (in textile articles)

• Regulation (EU) 2016/217 Cadmium and its compounds (in paints)

• Regulation (EU) 2016/1005 Asbestos fibres (chrysotile)

• Regulation (EU) 2016/1017 inorganic ammonium salts (in cellulose insulation

mixtures or cellulose insulation articles)

In comitology:

• 1-Methyl-2-pyrrolidone (NMP),

• Bis(pentabromophenyl) ether (decabromodiphenyl ether) (DecaBDE) (already in

REACH Committee in September),

• Bisphenol A,4,4'-isopropylidenediphenol,

• Methanol (already in REACH Committee in October),

• Octamethylcyclotetrasiloxane (D4),Decamethylcyclopentasiloxane (D5),

Perfluorooctanoic acid (PFOA) (already in REACH Committee in October)

New/updated restrictions and proposals in comitology

RESTRICTION

• Commission's Regulatory Fitness and Performance Programme (REFIT) and

REACH review 2017 according to Article 117(4) REACH

• The five evaluation criteria of REFIT:

• Effectiveness

• Efficiency

• Relevance

• Coherence

• EU Added value

• Online public consultation to “obtain stakeholder views on the general

approach to the 2017 REACH REFIT evaluation and to collect stakeholder

views on the strengths and weaknesses of REACH as well as any potentially

missing elements.” until the 28th of January 2017.

(http://ec.europa.eu/growth/sectors/chemicals/reach/review_en)

• Please contact us to discuss your questions…

(Re-)Evaluation REACH Regulation (Fitness Check)

REACH REFIT / REVIEW 2017

http://ec.europa.eu/growth/sectors/chemicals/reach/review_en

http://ec.europa.eu/growth/sectors/chemicals/reach/review_en

REACH

• Registration

• Evaluation

• Authorisation

• Restriction

CLP



• Poison centre

Enforcement

CONTENT

• Regulation (EU) 2016/918: New and updated harmonised classification and

labelling (CLH) (8th ATP)

• Regulation (EU) 2016/1179: New and updated harmonised classification and

labelling (CLH) (9th ATP; new classification for lead in its solid state and in powder

form; new classification for copper)

ATP under preparation:

• Draft Regulation sent to REACH Committee in July 2016: amendment of Annex VI

entries (10th ATP CLP) (voted in REACH Committee in October)

• Draft Regulation sent to REACH Committee in July 2016: Translation of chemical

names in Table 3.1 in Annex VI CLP (11th ATP CLP)

Further CLH under preparation:

• Opinion by ECHA’s Risk Assessment Committee: 16 substances in 2016 (218 in

total)

• Public consultations: 36 in 2016, four still on-going

• Submitted CLH proposals: 35 substances

• Registry of intention: 50 substances

• Withdrawn from Registry of intention: 2 substances

ADAPTATION TO TECHNICAL AND

SCIENTIFIC PROGRESS (ATP)

• Since 1 June 2015: Classification and labelling of substances and

mixtures according to CLP

• Transitional period for mixtures classified, labelled and packaged

in accordance with Directive 1999/45/EC and already placed on the

market before 1 June 2015

• End of the transitional period: 1 June 2017

• From 1 June 2017: Relabel and repackage

End of transitional period 2017

CLASSIFICATION OF MIXTURES

• Company declaration of hazardous mixtures: Body responsible for

receiving information relating to emergency health response according to

Article 45 CLP for all hazardous mixtures placed on the market in

Luxembourg

• Emergency telephone number in the Safety Data Sheet (section 1.4):

8002 5500

Cooperation Agreement Luxembourg – Belgium June 2015

POISON CENTRE

http://www.centreantipoisons.be/entreprises/comment-d-clarer-au-centre-antipoisons/d-clarations-pour-le-grand-duch-de-luxembourg



























• Draft Regulation amending CLP by adding an Annex on harmonised

information relating to emergency health response (Article 45(1))

• Implementation deadlines:

• 2020 (consumer uses)

• 2021 (professional uses)

• 2024 (industrial uses)

• Adaptation of CLP labels

• Publication Q1 2017

Harmonisation of requirements

POISON CENTRE

Enforcement of REACH & CLP in Luxembourg

Unité substances chimiques et produits

Enforcement activities 2016 (examples)

REF-4 : Inspection of compliance of mixtures or articles with the following entries from Annex XVII of the REACH Regulation :

Entry 23: Cadmium in plastic material

Entry 27: Nickel in jewelry and metal parts of clothes (rivet buttons, rivets, zippers…)

Entry 47: Chromium VI in leather articles

Entry 48: Toluene in glues

Entry 51: Phthalates in toys and childcare articles

Entry 63: Lead in jewelry

→ several non-compliances (chemical analysis done by LNS still on-going)

ECHA Pilot Project to check that the packaging of chemical products available to the general public have appropriate child resistant fastenings where needed

Compliance check of SDS with CLP requirements

« Reactive surveillance » : Transfers of non-compliances followed by controls and administrative measures from ILNAS, other Member States or other units from our administration

28

Enforcement activities 2017 (examples)

REF-4: Restrictions (ongoing)

REF-5: Inspections of extended safety data sheets (e-SDSs), exposure scenarios (CSR), risk management measures (RMM) and operational conditions (OCs)

ECHA Pilot Project: Focus on internet sales of chemicals

Biocidal Products Regulation: Focus on products for industrial sale

Compliance check of SDS with CLP requirements

29

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.

Thank you for your attention!

reach&clp: current status and next steps of the … · entries (10th atp clp) (voted in reach...

Documents