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ECHA ready to help the EU achieve its ambitions for safe and sustainable chemicals
The European Commission has published its chemicals strategy for sustainability as part of the European Green Deal. ECHA welcomes the strategy and looks forward to supporting its implementation.
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REACH
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Deadlines for updating registration dossiers clarified
The European Commission has clarified when companies need to update their REACH registration dossiers. The requirement to update ‘without undue delay’ is in most cases specified as three months and, in more complex cases, up to 12 months.
More | Read ECHA Newsletter article
Call for evidence: restriction of bisphenol A
Germany is preparing an Annex XV restriction dossier on 4,4’-isopropylidenediphenol (bisphenol A, BPA) and structurally related bisphenols of similar concern (EC -, CAS -) where it will assess the associated risks to the environment.
Interested parties are invited to submit any relevant information to help with the dossier preparation. The deadline is 15 January 2021.
Current calls for comments and evidence
Restriction dossier for substances in single-use nappies submitted
France has submitted a proposal to restrict formaldehyde, PAHs, dioxins, furans and PCBs in single-use baby nappies. The proposal will now be evaluated by ECHA’s scientific Committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC), and will be subject to a stakeholder consultation.
We will shortly ‘pre-publish’ the Annex XV report describing the proposal on our website. However, it will formally be published after RAC and SEAC have agreed that it conforms with the legal requirements for a restriction report. The stakeholder consultation will be launched at the same time.
Registry of restriction intentions
Investigation report on analytical methods to measure PAHs in consumer articles
The report evaluates new scientific information on available analytical methods for measuring the content and migration of polycyclic-aromatic hydrocarbons (PAHs) in plastic and rubber articles – taking into account the availability, practicality and cost of these methodologies in commercial labs.
It also reviews alternative low-PAH raw materials used to manufacture these articles and gives advice on the validity of current PAH content limits in articles covered in paragraphs 5 and 6 of entry 50 to Annex XVII to REACH, in the light of new scientific information.
Report
Consultations start on authorisation substitution plans
The substitution plans of four applications for authorisation to use a substance of very high concern will open for consultation on 21 October 2020. ECHA’s Committee for Socio-economic Analysis (SEAC) will evaluate the plans and the information received during the consultation to provide scientific underpinning for the European Commission to decide whether or not to grant the authorisations.
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Committees’ opinions on applications for authorisation available
The consolidated opinions of the Committees for Risk Assessment and Socio-economic Analysis are now available for:
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use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (EC -, CAS -) by Siemens Healthcare Diagnostics Products Ltd;
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use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (EC -, CAS -) by Hospira Zagreb d.o.o., a Pfizer company;
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use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (EC -, CAS -) by Merck KGaA;
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use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (EC -, CAS -) by Rousselot bvba;
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use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (EC -, CAS -) by Pfizer Manufacturing Belgium NV;
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five uses (1, 2, 3, 4, 5) of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (EC -, CAS -) by Siemens Healthcare Diagnostics Products GmbH;
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three uses (1, 2, 3) of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (EC - CAS -) and three uses (1, 2, 3) of 4-nonylphenol, branched and linear, ethoxylated (EC -, CAS -) by Roche Diagnostics GmbH;
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use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (EC -, CAS -) by DiaSorin S.p.A.; and
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use of 4-nonylphenol, branched and linear, ethoxylated (EC -, CAS -) by Abbott Diagnostics GmbH.
Opinions
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CLP
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RAC adopts harmonised classification and labelling opinions on 10 substances
The Committee for Risk Assessment (RAC) adopted CLH opinions on 10 substances during its virtual meeting which was held from 6 to 8 October 2020. Five of the substances do not have an existing harmonised classification, while for the other five RAC recommends additional classifications or amending existing classifications. The substances are:
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isoflucypram;
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ammonium bromide;
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dimoxystrobin (ISO);
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diethylene glycol monomethyl ether;
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2,4,6-tri-tert-butylphenol;
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sodium pyrithione;
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bisphenol A;
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pendimethalin (ISO);
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pyridalyl (ISO) – an insecticide with no existing entry; and
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methyl methacrylate.
The European Commission takes into account the RAC opinions when deciding whether to include the proposal for harmonised classification and labelling in Annex VI to the CLP Regulation, where all hazardous substances with harmonised classification and labelling are listed.
Details of opinions | RAC
New proposals and intentions to harmonise classification and labelling
Two intentions have been submitted for:
Three proposals have been received for:
Registry of CLH intentions until outcome
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Occupational exposure limits
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RAC opinions on occupational exposure limits for two substances available
The opinions on scientific evaluations of occupational exposure limits for diisocyanates (EC -, CAS -) and lead and its compounds (EC -, CAS -) are now available on our website.
In addition, we invite you to give comments on ECHA’s scientific report for occupational exposure limits of cadmium and its inorganic compounds. The deadline is 12 November 2020.
RAC opinions | Give comments
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Biocides
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Biocides committee backs approval of two active substances used in disinfectants
ECHA’s Biocidal Products Committee (BPC) also supports a Union-wide authorisation for an insecticide containing clothianidin and pyriproxyfen.
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Do you want to continue using this biocidal substance?
Companies have withdrawn their interest in getting (benzyloxy)methanol (EC 238-588-8, CAS 14548-60-8) approved under the biocides Review Programme for use in product-type 13. Notify us by 8 October 2021 to keep it in the Review Programme.
Upcoming deadlines | Product-types
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Don’t miss our webinar on managing your biocidal product family
15 October 2020, 11:00-13:00 Helsinki time
The webinar will give you an overview of the state of play on biocidal product families in the EU. You will also hear about practical experience gained by a national authority and industry on the revised biocidal product family concept. Our speakers include the European Commission, German Federal Institute for Occupational Safety and Health (BAuA), and Ecolab representing industry.
The webinar will be published on our home page on the day of the event at 11:00 Helsinki time (EEST, GMT +3). Join our live Q&A where the speakers will be answering your questions until 13:00.
Programme | Join the Q&A | Biocidal product families
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EU chemicals legislation finder
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EU chemicals legislation finder: more EU laws coming in 2021
EUCLEF will be updated with 16 additional pieces of EU chemicals legislation in 2021. These include general product safety laws, recycled plastic materials, aerosol dispensers and many more. With this addition, you will be able to search for altogether 51 EU laws to find out what substances they regulate and how.
EUCLEF comes with a regulatory support service that helps you with the content of different legislation and regulatory obligations.
Visit EUCLEF | EUCLEF regulatory support | Get the EUCLEF banner | Leaflet: What is EUCLEF?
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Persistent organic pollutants
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Consultation on POP proposal for chlorpyrifos
We are looking for comments on the draft EU proposal for listing chlorpyrifos (EC 220-864-4, CAS 2921-88-2) in the Stockholm Convention on Persistent Organic Pollutants. The substance is prohibited in the EU, but is widely used globally as an insecticide in agriculture and as a biocide to control non-agricultural pests.
The deadline for comments is 9 December 2020.
Give comments
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Nanomaterials
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Public consultation: scientific advice on safety of nanomaterials in cosmetics
The Scientific Committee on Consumer Safety (SCCS) has published its advice on the safety of nanomaterials in cosmetics for consultation. This advice outlines certain aspects of nanomaterials that are a basis for safety concerns for consumers’ health when used in cosmetic products. It also includes a review of previous inconclusive opinions on three nanomaterials to identify whether there is a scientific basis for concern over their safety.
Deadline for comments is 2 November 2020.
Give comments | Scientific Advice on the safety of nanomaterials in cosmetics [PDF] [EN] | EUON: catalogue of cosmetic ingredients
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Using non-animal approaches for the assessment of nanomaterials
Read our latest Nanopinion guest column from Dr Monita Sharma and Dr Andreas Stucki from Peta International Science Consortium Ltd. (PISC) who talk about alternatives to animal testing for nanomaterials.
Read the full article | More Nanopinions
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ECHA
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ECHA drives changes to support for future EU Member States
To provide tailored support to (pre-)candidate countries, ECHA will carry out a second study to assess the legal and institutional capacities of Albania, Bosnia and Herzegovina, North Macedonia, Kosovo and Turkey to implement EU chemicals laws.
The work will provide the Agency and the countries with specific action plans stipulating how identified gaps should be filled in the lead up to future accession to the EU. The important work on chemicals safety is a joint effort between ECHA, the Member States and stakeholders. Therefore, the support of future member states under IPA is important to ensure that these are fully aligned and have the necessary capacity to contribute upon their accession.
The study is expected to be finalised next year and is part of ECHA’s fifth Instrument for Pre-accession Assistance (IPA) project.
Capacity building in third countries
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