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Highlights from March RAC and SEAC meetings
The Committee for Risk Assessment (RAC) adopted its opinion supporting Norway’s proposal to restrict Dechlorane Plus.
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The Committee for Socio-Economic Analysis (SEAC) also supports the restriction in its draft opinion, which is open for consultation until 16 May 2022. The proposal aims to address risks for human health and the environment from emissions of the substance.
More | Annex
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REACH
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Member States plan to evaluate 27 substances in 2022-2024
ECHA lists 27 substances for evaluation by EU Member States under the Community rolling action plan (CoRAP) for 2022-2024. Four of the substances are planned to be evaluated in 2022, while 23 substances are listed for evaluation in 2023 and 2024.
Based on the opinion of its Member State Committee, ECHA adopted and published the CoRAP for 2022-2024 on 22 March 2022.
Registrants should check if their dossiers need to be updated with new relevant information, for example, on hazard, tonnages, use and exposure.
CoRAP 2022-2024 | CoRAP list | Registrants' guide - How to act in
substance evaluation
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Commission decisions on applications for authorisation
The European Commission has granted 19 authorisations for uses of the following substances (review period expiry dates are in brackets):
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4-(1,1,3,3-Tetra methylbutyl)phenol, ethoxylated (4-tert-OPnEO) (EC -, CAS -)
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5 uses applied for by Octapharma AB and 4 other co-applicants
(4 January 2033 and 4 January 2025);
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3 uses applied for by SEBIA (4 January 2033);
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1 use applied for by Sanquin Reagents B.V. (4 January 2028); and
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1 use applied for by Eli Lilly Kinsale Limited (4 January 2033).
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4-Nonylphenol, branched and linear, ethoxilated (4-NPnEO)
(EC -, CAS -)
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Pitch, coal tar, high temperature (EC 266-028-2, CAS 65996-93-2)
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1 use applied for by Rain Carbon bvba (4 October 2023);
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1 use applied for by Bilbaina de Alquitranes S.A (4 October 2032);
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1 use applied for by Koppers Denmark ApS (4 October 2032); and
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1 use applied for by Industrial Quimica del Nalon, S.A.
(4 October 2032).
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Anthracene oil (‘AO’) (EC 292-602-7, CAS 90640-80-5)
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1 use applied for by Rain Carbon bvba (4 October 2023);
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1 use applied for by Bilbaina de Alquitranes S.A (4 October 2032); and
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1 use applied for by Koppers Denmark ApS (4 October 2032).
The Commission has rejected two authorisation requests for uses of:
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Changes to authorisation web pages
New substance-specific notes are now included in the substances table on the Authorisation List web page. There is also a direct link to the Official Journal of the EU for each substance.
The new list of ECHA’s recommendations for authorisation replaces the old “Submitted recommendations” page. The new page includes some additional information from ECHA’s original recommendations and these are also included in the public activities coordination tool (PACT).
ECHA is currently running a consultation on its proposal to include eight new substances of very high concern in the REACH Authorisation List. Comments can be given by 2 May 2022.
Authorisation List | Recommendations for inclusion in the Authorisation List | PACT | Consultation
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Enforcement Forum discusses projects and shares experiences
The Enforcement Forum met remotely on 15-17 March and the Forum’s Biocidal Products Regulation Subgroup (BPRS) on 22-23 March 2022.
The Forum and BPRS reviewed the progress and gave steer to many enforcement projects. Members also discussed plans and experiences from national enforcement actions such as restrictions for substances used in tattooing inks and diisocyanates, control of registration of recovered UVCB substances in oil terminals and enforcement of dossier evaluation decisions.
The BPRS also discussed potential national investigation of biocidal product (devices) with in situ generated active substances as well as experience with - still existing - national legislation on biocidal products.
The next Forum meeting will take place from 14-17 June 2022.
Enforcement Forum
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Consultation on proposed restriction of PFASs in firefighting foams
ECHA has submitted a proposal to restrict per- and polyfluoroalkyl substances (PFAS) in firefighting foams.
A consultation on the proposal is open from 23 March to 23 September 2022 (23:59, Helsinki time). ECHA’s scientific committees welcome early comments by 24 May 2022 to assist them in the first discussion of the proposal in June 2022.
Submitted restrictions under consideration
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Consultation on SEAC's draft opinion on restricting Dechlorane Plus™
We invite stakeholders to comment on the draft opinion of the Committee for Socio-Economic Analysis (SEAC) concerning Norway's restriction proposal on the manufacture, use and placing on the market of 1,6,7,8,9,14,15,16,17,17,18,18-Dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15-diene (“Dechlorane Plus”™) (EC 236-948-9, CAS 13560-89-9) as substances, constituents of other substances, mixtures and articles.
The deadline for comments is 16 May 2022 (23:59, Helsinki time).
Give comments
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Reminder - Webinar: REACH restriction of hazardous substances in tattoo inks and permanent make-up
29 March 2022, 14:30-16:30 Helsinki time
We are organising an online info session together with the European Commission to address technical questions that industry, such as ink formulators and tattoo artists, might have on the implementation of the restriction.
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The aim is to help those impacted to meet the new legal requirements set by Annex XVII to REACH.
More | Register
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CLP
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New proposal to harmonise classification and labelling
The Netherlands has submitted a proposal for barium chromate
(EC 233-660-5, CAS 10294-40-3).
Registry of CLH intentions until outcome
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Consultation on harmonised classification and labelling
We are looking for comments on harmonised classification and labelling proposals for:
The deadline for comments is 20 May 2022, 23:59 Helsinki time (EET).
Give comments
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Occupational exposure limits
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Amendment to Directive (EU) 2022/431 includes three substances under the CMD evaluated by ECHA
A fourth amendment to Directive (EU) 2022/431 was published in the Official Journal on 16 March 2022. The amendment includes three substances under the Carcinogens and Mutagens Directive (CMD) that were evaluated by ECHA's Committee for Risk Assessment (RAC) under a pilot project assessing occupational exposure limits for five substances in 2017-2018:
Official Journal | OEL activities | ECHA's pilot project for five OELs
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Last call to help us develop a new Chesar Platform
We are currently developing a new Chesar Platform, the chemical risk assessment tool combining the Chesar and EUSES.
The survey is open until 25 March 2022 so now is your last chance to answer and tell us how you use Chesar 3 and its different functionalities in your daily work.
This will help us develop a Chesar Platform that meets your needs.
Survey | Chesar Platform
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Board of Appeal
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Appeals against three substance evaluation decisions dismissed
The Board of Appeal has dismissed appeals in Cases A-003-2020, A-004-2020, and A-005-2020 concerning substance evaluation decisions on three separate antimony compounds.
In the first two cases, the appellants were required to perform a 90-day (sub-chronic) inhalation toxicity study (OECD TG 413). In the other case, the appellant was required to perform a 90-day (sub-chronic) toxicity study, oral route (OECD TG 408).
The Board of Appeal rejected the appellants’ arguments that the requested studies were not necessary or appropriate to clarify the concerns identified by ECHA. The appellants’ argument that ECHA should have first completed a compliance check on the substances before carrying out the substance evaluations was also rejected.
Following the dismissal of the appeals, the appellants are required to provide the requested information by 30 December 2023.
Decisions in cases A-003-2020 | A-004-2020 | A-005-2020
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