ECHA Weekly - 30 January 2019

REACH

Have your say on future studies on nanomaterials

The European Union Observatory for Nanomaterials (EUON) conducts up to three studies every year to address knowledge gaps relating to nanomaterials that are of interest to the general public and the research community. We are now looking for suggestions for topics that could be addressed in its upcoming studies. Submit your proposal by 7 February 2019.

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Provide feedback on the EU nanomaterials observatory

The European Observatory for Nanomaterials (EUON) provides information on nanomaterials to a wide audience on subjects ranging from safety to innovation. It also covers the existing EU legislation on nanomaterials and the presence and uses of specific substances on the EU market.

We would like to hear your views on how the EUON is performing and how it could be developed to better meet your needs. Have your say by completing our short questionnaire.

Participate | EUON | Follow us on LinkedIn

Restriction reports published

On 30 January 2019, ECHA published the restriction reports on:

• formaldehyde and formaldehyde releasers (EC -);
• octamethylcyclotetrasiloxane (D4) (EC 209-136-7), decamethylcyclopentasiloxane (D5) (EC 208-764-9) and dodecamethylcyclohexasiloxane (D6) (EC 208-762-8), details; and
• intentionally added microplastics.

Registry of restriction intentions

Need to report legal personality changes?

A new practical guide on how to report changes in identity under REACH and CLP has been published. The guide replaces ‘Practical guide 8: How to report changes in identity of legal entities’. It is currently available in English, but translations are expected at a later date.

Read the guide

Reminder: Public consultation on SEAC draft opinion

ECHA is looking for comments on the draft opinion of the Committee for Socio-economic Analysis (SEAC) on the proposed restriction of hazardous substances in tattoo inks and permanent make-up.

The restriction proposal was prepared by ECHA, in collaboration with Denmark, Italy and Norway.

The deadline for comments is 11 February 2019.

Give comments

Court judgment on identification of DEHP as SVHC

On 23 January, the European Court of Justice issued a judgment dismissing in its entirety an appeal brought by DEZA against the General Court’s judgment in case T-115/15 concerning the substance bis(2-ethylhexyl) phthalate (DEHP) (EC 204-211-0, CAS 117-81-7). In the case, the General Court dismissed DEZA’s action for annulment against ECHA’s decision to identify DEHP as an endocrine disruptor to the environment.

The European Court of Justice confirmed that ECHA can supplement existing Candidate List entries of a substance with new properties. Furthermore, the Court considered that ECHA could identify DEHP as a substance of very high concern (SVHC) without waiting for the outcome of various other regulatory and policy processes addressing endocrine disruptors.

Judgment of the Court

New practical guide on dossier evaluation

The practical guide 'How to act in dossier evaluation' explains how ECHA processes dossiers and how registrants should act after receiving the draft or adopted decision. The guide clarifies the revised dossier evaluation decision practices, where from 1 January 2019, decisions are sent to all non-compliant registrants of a substance. It also highlights the opportunities and obligations for registrants in making sure that their dossier complies with REACH.

Practical guide | Background

Testing proposals

ECHA has launched five new public consultations on testing proposals. The deadline for comments is 11 March 2019.

Give comments

CLP

Targeted public consultations on harmonised classification and labelling

ECHA has launched targeted public consultations on additional information provided for two proposals for harmonised classification and labelling.

• Study reports containing additional information on toxicity to reproduction have been submitted by ECHA for the substance flumioxazin (ISO); N-(7-fluoro-3,4-dihydro-3-oxo-4-prop-2-ynyl-2H-1,4-benzoxazin-6-yl)cyclohex-1-ene-1,2-dicarboximide (EC -, CAS 103361-09-7).
• The lead registrant of the substance 1-isopropyl-4-methylbenzene; p-cymene (EC 202-796-7, CAS 99-87-6) has indicated the availability of an unpublished acute toxicity study in Daphnia magna that would potentially change the classification proposal for hazards to the aquatic environment. The study has been provided in the form of a robust study summary in IUCLID format.

Interested parties are invited to submit their comments to both targeted public consultations by 11 February 2019.

Targeted CLH consultations

New proposals and intentions to harmonise classification and labelling

Proposals to harmonise the classification and labelling have been submitted for:

• N,N-dimethyl-p-toluidine (EC 202-805-4, CAS 99-97-8); and
• 6-[C12-18-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid (EC/CAS -).

New intentions have also been received for:

• silver nitrate (EC 231-853-9, CAS  7761-88-8);
• 2-ethyl-2-[[(1-oxoallyl)oxy]methyl]-1,3-propanediyl diacrylate; 2,2-bis(acryloyloxymethyl)butyl acrylate; trimethylolpropane triacrylate (EC 239-701-3, CAS 15625-89-5); and
• metribuzin (ISO); 4-amino-6-tert-butyl-3-methylthio-1,2,4-triazin-5(4H)-one (EC 244-209-7, CAS 21087-64-9).

Registry of CLH intentions

Board of Appeal

Decision concerning the joint submission obligation published

In case A-005-2017 an appeal was brought against an ECHA communication addressed to all registrants of the substance tetrakis(hydroxymethyl)phosphonium chloride, oligomeric reaction products with urea (EC 500-057-6). According to ECHA’s communication, the joint submission obligation had been breached because separate registrations had been submitted for the same substance.

The Board of Appeal considered that the communication was in fact a decision and annulled it on the grounds that ECHA had not followed the procedures set out in REACH. The Board of Appeal found that, as a result, the Appellant’s right to be heard had been breached.

Decision

Announcements of new appeals

The Board of Appeal has published announcements on cases A-023-2018 and A-024-2018 related to data-sharing disputes.

Announcements

ECHA

More targeted capacity building for EU candidate countries

ECHA continues to support the accession process of EU candidate countries with capacity building through bilateral visits, specific trainings and events. To increase the impact of these efforts, an in-depth assessment of the status and needs of two candidate countries, Montenegro and Serbia, will be carried out between 2019 and 2021.

News

Communications package on UK withdrawal from EU

Next week ECHA will publish a communications package to help all companies placing chemical substances on the EU market to prepare for the UK’s withdrawal from the EU. The package will include new Q&As and step-by-step instructions for using the ‘Brexit window’ for UK-based companies to transfer their REACH registrations.

Cefic/CIA briefing note: Preparing for a future 'UK out of REACH scenario' | ECHA's UK withdrawal from the EU web pages

Maintenance