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Authorities and ECHA push for compliance with authorisation duties
The Enforcement Forum’s EU-wide project on inspections of REACH authorisation duties found that the majority of users, mainly SMEs, already comply with the authorisation requirement to control risks.
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Enforcement measures taken by authorities during the project aim to push companies towards compliance.
Read more | Project report
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Biocides
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Highlights from March BPC meeting
ECHA’s Biocidal Products Committee (BPC) supports the approval of nitrogen generated from ambient air as a low-risk active substance for Annex I to the Biocidal Products Regulation (BPR).
More details
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New guidance helps analyse alternatives to biocidal active substances
The guidance helps companies and authorities analyse alternatives to biocidal active substances that meet the substitution criteria under the Biocidal Products Regulation. A new template to report the analysis is also available.
The guidance provides a flexible approach and can be adapted depending on the case and the needs of the actors performing the analysis.
If your active substance is a candidate for substitution, follow the guidance and include the analysis of alternatives as part of your application.
Guidance | Analysis of alternatives template | Competent authority note
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REACH
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Committee opinions on lead in outdoor shooting and fishing restriction available
The consolidated opinions of the Committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC) and the supplementary opinion of RAC on the restriction proposal on lead in outdoor shooting and fishing submitted by ECHA are now available.
Registry of restriction intentions until outcome
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Hexavalent chromium in electroplating: material from info session available
We have published the conclusions and presentations from the information session for companies applying for authorisation to use Cr(VI) in electroplating.
The event was held on 15 February 2023 with around 260 participants.
Material
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Commission decisions on applications for authorisation
The European Commission has granted eight authorisations for uses of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (‘4-tert-OPnEO’)
(EC -, CAS -). Review period expiry dates are in brackets:
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1 use applied for by Yposkesi (4 January 2028);
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1 use applied for by Rousselot bvba (4 January 2033);
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1 use applied for by Takeda Manufacturing Austria AG (4 January 2033);
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1 use applied for by Baxalta Belgium Manufacturing SA (4 January 2033);
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2 uses applied for by Wallac Oy (4 January 2026); and
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2 uses applied for by Pfizer Ireland Pharmaceuticals (4 January 2033, 4 January 2028).
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Substance evaluation: decisions soon sent to registrants
Member States will finalise the 2022 substance evaluation for four substances on 22 March 2023.
We will send the finalised draft decisions to registrants for commenting as they arrive, and wherever possible, within two weeks of their receipt. Companies will then have 30 days to submit their comments.
The draft decisions address these two substances, for which further information is needed to clarify identified concerns:
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2-furaldehyde (EC 202-627-7, CAS 98-01-1) by Denmark; and
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1,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethylindeno[5,6-c]pyran (EC 214-946-9, CAS 1222-05-5), by France.
Substance evaluation does not require further information for:
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CLP
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New intentions and proposals to harmonise classification and labelling
One intention has been received for:
Four proposals have been submitted for:
Registry of CLH intentions until outcome
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Consultations on harmonised classification and labelling
We are looking for comments on the harmonised classification and labelling proposals for:
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Calcium tetraborate (EC 234-511-7, CAS 12007-56-6);
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Calcium metaborate (Ca(BO2)2) and calcium tetraborate (CaB4O7), amorphous reaction products of boric acid with lime (EC -, CAS -);
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Pentaboron sodium octaoxide (EC 234-522-7, CAS 12007-92-0) ;
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Sodium metaborate, anhydrous [1]; boric acid (HBO2), sodium salt, tetrahydrate [2]; and any other hydrated form (EC 231-891-6 [1]; - [2], CAS 7775-19-1 [1]; 10555-76-7 [2]);
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Diammonium decaborate (EC 234-521-1, CAS 12007-89-5) ;
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Potassium metaborate (EC 237-262-2, CAS 13709-94-9) ;
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Dipotassium tetraborate (EC 215-575-5, CAS 1332-77-0);
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Magnesium metaborate (EC 237-235-5, CAS 13703-82-7) ;
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Dipotassium octaborate (EC -, CAS 12008-39-8); and
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Potassium pentaborate (EC 234-371-7, CAS 11128-29-3).
The deadline for comments is 5 May 2023.
Give comments
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Occupational exposure limits
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Five new substances to be evaluated
The European Commission has asked ECHA to evaluate the health effects of the following substances on workers:
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1,3-Butadiene (EC 203-450-8, CAS 106-99-0);
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4,4-Isopropylidenediphenol (Bisphenol A) (EC 201-245-8,
CAS 80-05-7) and other bisphenols relevant to occupational health;
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Compounds releasing boric acid including:
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Boric acid (EC 233-139-2, CAS 10043-35-3);
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Borates such as dipotassium tetraborate (EC 215-575-5, CAS 1332-77-0) and disodium tetraborate (EC 215-540-4,
CAS 1330-43-4); and
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Boric oxide (EC 215-125-8, CAS 1303-86-2);
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1,2-Dihydroxybenzene (Pyrocatechol) (EC 204-427-5,
CAS 120-80-9); and
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Silicon carbide fibres (EC 206-991-8; CAS 409-21-2).
These scientific evaluations are carried out under the Carcinogens, Mutagens or Reprotoxic substances Directive (CMRD).
The evaluations will be finalised by February 2025 and will, where appropriate, include proposals for occupational exposure limit values, biological limit and biological guidance values or notations.
OEL pages
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ECHA
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ECHA welcomes European Chemistry for Textile and Leather as accredited stakeholder
European Chemistry for Textile and Leather (EUCTL) is now one of our 153 accredited stakeholder organisations.
More on EUCTL | Our accredited stakeholders
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European Commission
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New safety test methods approved
The European Commission has adopted some 100 new and updated test methods for the regulatory safety testing of chemicals under REACH.
Under these new rules, internationally approved methods (e.g. OECD test guidelines) for the new test methods are referred to directly in the regulation.
Lengthy procedures previously used for reproducing and translating test guidelines into all EU official languages are no longer needed and any approved new test methods will be included in REACH much faster.
Read more
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