News

SCIP duty kicks in: 5 million notifications received for harmful chemicals in products

Since 5 January, companies have had to submit data to ECHA on chemicals of concern in their products. Over five million notifications have already been received in the SCIP database, and the data will be published in the coming months.

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REACH

REACH authorisation has positive health and environmental impacts

The EU-wide requirement for companies to obtain authorisation from the European Commission before using harmful chemicals has sped up substitution and reduced risks to people’s health and the environment - at a reasonable cost.

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Guidance on authorisation applications updated

The updated guidance reflects the 2019 General Court judgments on interpreting the suitability of alternatives in the application process. It clarifies the need for applicants to include substitution plans in their applications if the analysis of alternatives shows that suitable alternatives are available in the EU – although these alternatives might not be technically or economically feasible for the applicant.

The document will be made available in 23 EU languages.

Guidance

New intention to identify a substance of very high concern

A new intention has been received for glutaraldehyde (EC 203-856-5, CAS 111-30-8).

Registry of SVHC intentions

Online info session: Consultation on proposed restriction of substances in single-use baby diapers

26 January, 11:00 – 13:00 Helsinki time

French authorities are proposing to restrict polycyclic aromatic hydrocarbons (PAHs), furans, dioxins, formaldehyde and polychlorinated bisphenols (PCBs) in single-use baby diapers. The aim is to minimise health risks associated with wearing single-use diapers for children and infants under the age of three.

A consultation on the proposal was launched on 21 December 2020. This info session gives an update on the proposed restriction, and explains the specific questions posed in the consultation and how to submit comments. The deadline for comments is 21 June 2021.

Watch the webinar on our home page on the day of the event at 11:00 Helsinki time (GMT +2). Join a Q&A chat from 11:00 to 13:00 (GMT +2).

Webinar | Give comments

Commission’s decision on restriction available

The REACH restriction on substances in tattoo inks and permanent make up has been adopted and the final text is published in the Official Journal of the European Union.

Registry of restriction intentions

Court confirms bisphenol A as an endocrine disrupter to environment

On 16 December 2020, the General Court issued a judgment in case T-207/18 dismissing in its entirety an action brought against ECHA’s decision to include bisphenol A in the Candidate List on the basis that it is a substance of a very high concern with endocrine-disrupting properties for the environment. The Court found that the applicant failed to demonstrate any legal or scientific error by ECHA rendering the identification as unlawful or implausible.

Judgment

Committees’ opinions on application for authorisation available

The consolidated opinions of the Committees for Risk Assessment and Socio-economic Analysis for uses of the following substances are now available:

use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (EC -, CAS -) by Baxter AG and Baxalta Belgium Manufacturing SA;
use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (EC -, CAS -) by Yposkesi;
use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (EC -, CAS -) by Vetter Pharma-Fertigung GmbH & Co. KG;
use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (EC -, CAS -) by Sanquin Reagents B.V;
use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (EC -, CAS -) by LFB BIOMEDICAMENTS;
five uses of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (EC -, CAS -) by Abbott Ireland, Abbott GmbH and Abbott Diagnostics GmbH;
use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (EC -, CAS -) by Lilly France and Eli Lilly Italia S.p.A.;
five uses of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (EC -, CAS -) and 4-nonylphenol, branched and linear, ethoxylated (EC -, CAS -) by Beckman Coulter Ireland, Beckman Coulter GmbH, Immunotech s.r.o., Immunotech S.A.S., Beckman Coulter France S.A.S., BC Distribution B.V.,Beckman Coulter Česká republika s.r.o., Beckman Coulter UK, Beckman Coulter S.L.U and Beckman Coulter SPA Italy;
two uses of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (EC -, CAS -) by AGC Biologics A/S and AGC Biologics GmbH;
two uses of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (EC -, CAS -) by MERCK MILLIPORE LIMITED;
use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (EC -, CAS -) by Wallac Oy;
three uses of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (EC -; CAS -) by BioMérieux SA;
use of pitch, coal tar, high-temp. (EC 266-028-2, CAS 65996-93-2) by BILBAINA DE ALQUITRANES, S.A.;
use of pitch, coal tar, high-temp. (EC 266-028-2, CAS 65996-93-2) and anthracene oil (EC 292-602-7, CAS 90640-80-5) by BILBAINA DE ALQUITRANES, S.A.;
use of pitch, coal tar, high-temp. (EC 266-028-2, CAS 65996-93-2) by Industrial Quimica del Nalon, S.A.;
use of pitch, coal tar, high-temp. (EC 266-028-2, CAS 65996-93-2) by DEZA a.s.;
use of pitch, coal tar, high-temp. (EC 266-028-2, CAS 65996-93-2) and anthracene oil (EC 292-602-7, CAS 90640-80-5) by Koppers Denmark ApS.

Opinions

Authorisations granted for uses of chromium trioxide

The European Commission has granted authorisations for uses of chromium trioxide (EC 215-607-8, CAS 1333-82-0) (review period expiry dates in brackets) for:

three uses by REACHLaw Ltd. (21 September 2024); summary in Official Journal;
one use by Cromomed S.A., Cronor S.A., Cromo Europa S.A., Chromatlantique Industriel S.A. and Vila Electroquímica S.A. (21 September 2024); summary in Official Journal; and
five uses by Chemservice GmbH, Atotech Deutschland GmbH, Boeing Distribution Inc., Prospere Chemical Logistic OÜ, CROMITAL S.P.A., Elementis Chromium LLP and MacDermid Enthone GmbH (21 September 2024); summary in Official Journal.

New substance evaluation conclusions published

New documents are now available for:

trimethoxyvinylsilane (EC 220-449-8; CAS 2768-02-7) added to the CoRAP list in 2013 and evaluated by Sweden;
sodium dithionite (EC 231-890-0; CAS 7775-14-6) added to the CoRAP list in 2016 and evaluated by Austria; and
hexafluoropropene (EC 204-127-4; CAS 116-15-4) added to the CoRAP list in 2015 and evaluated by Italy.

Community rolling action plan | Substance evaluation

CLP

Consultation on harmonised classification and labelling

ECHA is looking for comments on harmonised classification and labelling proposals for:

methyl 5-(2,4-dichlorophenoxy)-2-nitrobenzoate; bifenox (EC 255-894-7, CAS 42576-02-3); and
reaction mass of N,N'-ethane-1,2-diylbis(decanamide) and 12-hydroxy-N-[2-[(1-oxodecyl)amino]ethyl]octadecanamide and N,N'-ethane-1,2-diylbis(12-hydroxyoctadecanamide) (EC 430-050-2, CAS -).

The deadline for comments is 12 March 2021.

Give comments

New proposals to harmonise classification and labelling

Six new proposals have been submitted for:

sodium 3-(allyloxy)-2-hydroxypropanesulphonate (EC 258-004-5, CAS 52556-42-0);
2,3-epoxypropyl neodecanoate (EC 247-979-2, CAS 26761-45-5);
copper (EC 231-159-6, CAS 7440-50-8);
2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one (EC 438-340-0, CAS 119344-86-4) and acetone oxime (EC 204-820-1, CAS 127-06-0); and
aqueous extract from the seeds of Lupinus albus (Fabaceae), germinated (EC -, CAS -).

Registry of CLH intentions until outcome

New poison centre requirements take effect: notify in harmonised format

Since 1 January 2021, importers and downstream users are obligated to notify their mixtures in a harmonised format and unique formula identifiers (UFIs) must be included on mixture labels. This is an important change for companies placing hazardous mixtures on the market.

Revised template for overview of biocidal product families

The template takes into account the updated biocidal product family concept. Applicants should use the revised template for new applications submitted as of 11 April 2021. Before this date, they can choose to continue with the current template or use the revised one. However, national authorities may ask applicants to submit the overview of their product family in the new template, if that is more suitable to display the information.

More information about the updated biocidal product family concept is available in the Note for Guidance.

Supporting documents | Product family

List of notifications updated

We have updated the list of substance and product-type combinations for which a compliant notification for inclusion in the Review Programme has been made. The list also includes the names of the notifying companies to help you collaborate when submitting an application for approval of the active substance and to help avoid unnecessary testing on animals.

List of compliant notifications

Refresh your knowledge on how to manage your biocidal product family

This webinar, broadcasted for the first time in October 2020, gives an overview of the state of play on biocidal product families in the EU. It also shows the practical experience gained by a national authority and industry on the revised biocidal product family concept. Have a look at our questions and answers as well.

Webinar

Drinking Water Directive

Clean tap water for all EU citizens – ECHA’s work on new directive begins

The revised Drinking Water Directive came into effect on 12 January 2021. It aims to protect people, improve access to water and ensure uniform safety standards for industry. ECHA’s task is to set up lists of chemicals that can be safely used in materials that come into contact with drinking water.

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Brexit

Transfer of UK registrations to the EU to be completed by end of March 2021

Around 20 % of REACH registrations in the United Kingdom have not been transferred to the EU and will be revoked. To complete the ongoing transfers, EU companies receiving the UK registrations should accept the transfers as soon as possible.

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IT tools

Introducing Chesar 3.6

20 January 2021, 11:00 Helsinki time

This webinar describes the new functionalities of Chesar 3.6, focusing on the implementation of a set of harmonised conditions of use for workers’ assessments. This set is the result of a mapping exercise which has taken place with the owners of the most used workers’ assessment tools (i.e. ECETOC TRA, ART, Stoffenmanager, MEASE and EMKG-expo-tool).

Webinar

Board of Appeal

Appeal against a substance evaluation decision dismissed

The Board of Appeal has rejected an appeal in Case A-007-2019 concerning a substance evaluation decision on ammonium 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy) propanoate requesting a carcinogenicity study in mice (OECD TG 451). The request for information was based on a concern for carcinogenicity.

The Board rejected the appellant’s arguments that the Agency made errors of assessment regarding the necessity of the requested study based on an existing carcinogenicity study in rats.

The appellant now has to provide the carcinogenicity study in mice by 21 October 2024.

Decision

Nanomaterials

Last chance: Have your say on the EUON website

We want to improve the European Observatory of Nanomaterials website to better meet your expectations. The aim is to gain more insight on your thoughts and ideas about the website and how it can be improved. Fill in a short survey and give us your ideas.

Survey