Helsinki, 21 Febuary 2023 – On 29 June 2021, ECHA’s Board of Appeal (BoA) issued a decision on a compliance check case (A-001-2020) regarding registration obligations for polymer importers.
The Board of Appeal’s decision affects registration requirements for monomer and polymer importers and manufacturers.
ECHA’s Guidance on monomers and polymers has been revised to align with the BoA’s decision and includes changes to the description of registration obligations for those importing and manufacturing polymers and monomers.
The key changes relate to:
the monomer that needs to be registered by the manufacturer or importer of a polymer;
the calculation of registration tonnages of monomers ending up in the final polymer as a reacted substance;
the information that registrants of monomers must include in a registration chemical safety report.
ECHA encourages all importers and manufacturers of polymers and monomers to examine the updated guidance and review their registrations to make sure they are complying with these minimum requirements.
REACH Registrations – ECHA will start checking both new registrations and updates to existing ones against the revised requirements.
ECHA carries out a completeness check on each incoming registration as set out in Article 20(2) of the REACH Regulation.
The new and amended checks will take effect as of 1 May 2023 and will apply to both new registrations and updates of existing ones. Registrants should, therefore, prepare for the changes as registrations submitted before may no longer pass the completeness check.
The new and amended checks concern:
Substance identity: ensuring correct and consistent identification of a substance’s boundary composition and its constituents and additives based on clarifications made to Annex VI.
Standard information requirements based on Annexes VII-XI: supporting registrants in reporting information for endpoints concerning mutagenicity, degradation and aquatic toxicity based on Annex VII-XI information requirements. Registrants adding a new weight-of-evidence adaptation will be prompted to provide arguments for the approach in a more structured format.
We encourage you to read the current issue of EkotoxInfo chemical legislation news. In the summary in January 2023 EkotoxInfo you will find the following topics:
REACH Candidate List +9 = 233 entries
PFASs restriction proposal
2,4-dinitrotoluene restriction proposal
International Panel on Chemical Pollution (IPCP)
Metals and Inorganics Sectoral Approach (MISA)
EU RoHS Pack-23 Exemption Recommendations Published
Biocides – SPC editor – IUCLID
REACH Conference will be held in Bratislava 22-23 of May 2023
REACH Candidate List + 9 = 233 entries
ECHA has added nine chemicals to the Candidate List because of their hazardous properties.
Under REACH, companies have legal obligations when their substance is included – either on its own, in mixtures or in articles – in the Candidate List.
European Chemical Agency: The national authorities of Denmark, Germany, the Netherlands, Norway and Sweden have submitted a proposal to ECHA to restrict per- and polyfluoroalkyl substances (PFASs) under REACH. ECHA will publish the detailed proposal, one of the broadest in the EU’s history, on 7 February 2023.
European Chemical Agency: The compiled opinion of the Committees for Risk Assessment and Socio-Economic Analysis for 2,4-dinitrotoluene (EC 204-450-0, CAS 121-14-2) is available.
In 2022, the United Nations Environment Assembly (UNEA) decided to establish a science-policy panel to contribute further to the sound management of chemicals and waste and to prevent pollution.
A possible wording for the scope could be “to strengthen the science-policy interface on the sound management of chemicals, waste, and pollution and associated impacts at global and regional scales to safeguard human and ecosystem health.”
The first session of the ad hoc Open-Ended Working Group on the Science Policy Panel (OEWG-1.2) will be held in Bangkok, Thailand, from the 30th of January to the 3rd of February 2023.
The four-year Metals and Inorganics Sectoral Approach (MISA) programme concluded at the end of 2022. The final report summarising the results of the cooperation between ECHA, Eurometaux and 29 industry associations to resolve metal-specific technical and scientific issues is now available.
EU RoHS Pack-23 Exemption Recommendations Published
New report published with recommendations on commonly used EU RoHS exemptions
On December 19, 2022, a report summarizing the assessment of EU RoHS exemptions and recommending a course of action for the European Commission to take on those exemptions was published.
Twelve exemptions to Annex III of the EU RoHS Directive, known as Pack-23, were studied under a joint effort by the Fraunhofer-Institute for Reliability and Microintegration (IZM), the United Nations Institute for Training and Research (UNITAR), and BIO Innovation Services (Bio IS).
Application for biocidal product authorisation needs to include a summary of product characteristics (SPC). So far, this file has been prepared using the SPC Editor.
In the future, this will change and you will need to use IUCLID to prepare your SPC. To prepare for the transition, you can already find support materials on ECHA’s website. Have a look!
REACH Conference will be held in Bratislava 22-23 of May 2023
Ekotox Centers together with partners and representatives of Cefic, Eurometaux, EPMF kindly willing to participate on the REACH Conference Bratislava 2023 are delighted to announce the conference topics for discussion: please ref REACH Conference 2023 webpages:
EKOTOX CENTERS – consultancy and advisory group focused primarily on legal requirements on EU market in case of products (articles), mixtures and chemical substances, hazard and risk assessment. We cover wide range of regulatory areas to help our customers to comply with specific requirements for their products on EU market.
EKOTOX CENTERS:
Ekotox Hungary Kft., HUNGARY
Ekotoxikologické centrum CZ s.r.o., CZECHIA
Centrum Ekotoksykologiczne Sp. z o.o., POLAND
Ekotoxikologické centrum Bratislava s.r.o., SLOVAKIA
ЕКОТОКС ЦЕНТР УКРАЇНА, Ekotox Center Ukraine LLC., UKRAINE
Helsinki, 17 January 2023 – ECHA has added nine chemicals to the Candidate List because of their hazardous properties. They are used for example in flame retardants, paints and coatings, inks and toners, coating products, plasticisers and in the manufacture of pulp and paper.
Entries added to the Candidate List on 17 January 2023:
Bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof
–
–
Isobutyl 4-hydroxybenzoate
224-208-8
4247-02-3
Melamine
203-615-4
108-78-1
Perfluoroheptanoic acid and its salts
–
–
reaction mass of 2,2,3,3,5,5,6,6-octafluoro-4-(1,1,1,2,3,3,3-heptafluoropropan-2-yl)morpholine and 2,2,3,3,5,5,6,6-octafluoro-4-(heptafluoropropyl)morpholine
473-390-7
–
ECHA’s Member State Committee confirmed the addition of these substances to the Candidate List. The Candidate List now has 233 entries – some are groups of chemicals so the overall number of impacted chemicals is higher.
These substances may be placed on the Authorisation List in the future. If a substance is on that list, its use will be prohibited unless companies apply for authorisation and the European Commission authorises them to continue its use.
Consequences of the Candidate List
Under REACH, companies have legal obligations when their substance is included – either on its own, in mixtures or in articles – in the Candidate List.
Suppliers of articles containing a Candidate List substance above a concentration of 0.1 % (weight by weight) have to give their customers and consumers information to be able to use them safely. Consumers have the right to ask suppliers whether the products they buy contain substances of very high concern.
Importers and producers of articles will have to notify ECHA if their article contains a Candidate List substance within six months from the date it has been included in the list (17 January 2023). Suppliers of substances on the Candidate List, supplied either on their own or in mixtures, have to provide their customers with a safety data sheet.
Under the Waste Framework Directive, companies also have to notify ECHA if the articles they produce contain substances of very high concern in a concentration above 0.1 % (weight by weight). This notification is published in ECHA’s database of substances of concern in products (SCIP).
A reform of Europe’s chemical regulatory framework (REACH) delayed
A reform of Europe’s chemical regulatory framework, known as REACH, has been delayed by a year, causing consternation about the European Union’s progress on controlling and harmful chemicals impacting human and environmental health. This effectively means that the reform will not be completed during the current European Commission’s term.
CLP Regulation revision proposal COM(2022) 748 final
The CLP Regulation revision package aims to:
(i)ensure that all hazardous chemicals, including those with ED, PBT, vPvB, PMT and vPvM properties, are classified adequately and uniformly throughout the EU;
(ii)improve the efficiency of hazard communication by making labels more accessible and understandable for users of chemicals, and provide companies with more flexibility, thereby reducing the administrative burden without lowering safety levels;
(iii)make sure that the rules on chemical hazard classification and communication are applied by all relevant actors in the supply chain.
REGULATION (EU) 2022/2400 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 23 November 2022 amending Annexes IV and V to Regulation (EU) 2019/1021 on persistent organic pollutants
Corap: 24 substances were listed for evaluation by EU Member States under the Community rolling action plan (CoRAP) for 2023-2025. Five are planned to be evaluated in 2023, with 19 listed for evaluation in 2024 and 2025.
REACH Conference will be held in Bratislava 22-23 of May 2023
Ekotox Centers together with partners and representatives of Cefic, Eurometaux, EPMF kindly willing to participate on the REACH Conference Bratislava 2023 are delighted to announce the conference topics for discussion: please ref REACH Conference 2023 webpages:
EKOTOX CENTERS – consultancy and advisory group focused primarily on legal requirements on EU market in case of products (articles), mixtures and chemical substances, hazard and risk assessment. We cover wide range of regulatory areas to help our customers to comply with specific requirements for their products on EU market.
EKOTOX CENTERS:
Ekotox Hungary Kft., HUNGARY
Centrum Ekotoksykologiczne Sp. z o.o., POLAND
Ekotoxikologické centrum CZ s.r.o., CZECH REPUBLIC
Ekotoxikologické centrum Bratislava s.r.o., SLOVAKIA
ЕКОТОКС ЦЕНТР УКРАЇНА, Ekotox Center Ukraine LLC., UKRAINE
EU inspections to control safety data sheets (SDS) in the EU-wide enforcement project in 2023
The EU-wide enforcement project (REF-11) in 2023 will look at the quality of information in safety data sheets.
SDS – Safety data sheets are the main vehicles for communicating safety information in the supply chain. If they are deficient, workers and professionals may not receive adequate information to use hazardous substances and mixtures safely.
The poor quality of information in safety data sheets is a long-standing issue detected also in many earlier enforcement projects – up to 52 % were found to be deficient in the Forum’s REF-2 project in 2013. Experience from enforcement activities in Member States confirms that the issue persists.
SDSs quality
The project will check compliance with the revised requirements under Annex II. to REACH, which sets the content and format required for safety data sheets. With the revised requirements entering into force in 2023, this is a timely opportunity to have a harmonised project to check that companies across the EU are fulfilling this duty.
Any SDSs that were compiled according to the old Annex II requirements will have to be rewritten to comply with the updated requirements by 31 December 2022.
The European Commission published their proposal for CLP Regulation on the 19th December.
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND. OF THE COUNCIL amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council
on classification, labelling and packaging of substances and mixtures.
As part of the CLP Regulation revision package, a delegated act will add definitions and scientific and technical criteria to enable substances and mixtures that have endocrine disrupting. (‘ED’), persistent, bioaccumulative and toxic (‘PBT’), very persistent and very bioaccumulative (‘vPvB’), persistent, mobile and toxic (‘PMT’), or very persistent and very mobile (‘vPvM’) properties to be classified into established hazard classes.
The impact of adding these new hazard classes has been assessed as part of the overall impact assessment on the revision of the CLP Regulation.
The CLP Regulation revision package aims to:
(i) ensure that all hazardous chemicals, including those with ED, PBT, vPvB, PMT and vPvM. properties, are classified adequately and uniformly throughout the EU;
(ii) improve the efficiency of hazard communication by making labels more accessible and. understandable for users of chemicals, and provide companies with more flexibility, thereby reducing the administrative burden without lowering safety levels;
(iii) make sure that the rules on chemical hazard classification and communication. are applied by all relevant actors in the supply chain.
POPs – Persistent Organic Pollutants – REGULATION (EU) 2022/2400 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 23 November 2022
amending Annexes IV and V to Regulation (EU) 2019/1021 on persistent organic pollutants
Member States plan to evaluate 24 substances in 2023-2025
Corap: 24 substances were listed for evaluation by EU Member States under the Community rolling action plan (CoRAP) for 2023-2025.
Five are planned to be evaluated in 2023, with 19 listed for evaluation in 2024 and 2025.
Corap 2023-2023 substances are:
2-Propenoic acid, methyl ester, reaction products with mixed O,Obis(branched and linear pentyl and iso-Bu) phosphorodithioates
Butanoic acid, 4-amino-4-oxosulfo-, N-coco alkyl derivs., monosodium salts, compds. with triethanolamine
tert-butylphenyldiphenyl phosphate (tBuTPP)
N-methylaniline
Sodium 3-(2H-benzotriazol-2-yl)-5-sec-butyl-4-hydroxybenzenesulfonate
3,3′-[methylenebis(oxymethylene)]bisheptane
1,3-diisopropylbenzene
1,4-diisopropylbenzene
Dioctyltin oxide
Bis(2,6-diisopropylphenyl) carbodiimide
Tris[2-chloro-1-(chloromethyl)ethyl] phosphate
A mixture of: triphenylthiophosphate and tertiary butylated phenyl derivatives
Reaction mass of 1,3-diisopropylbenzene and 1,4-diisopropylbenzene
Benzaldehyde
α-trimethylsilanyl-ω-trimethylsiloxypoly[oxy(methyl-3-(2-(2-methoxypropoxy)propoxy)propylsilanediyl]-co-oxy(dimethylsilane))
Acrylic acid, monoester with propane-1,2-diol
Octene, hydroformylation products, low-boiling
Diethyl Ether
Sodium hydroxymethanesulphinate
Carbon black
4,4′-Isopropylidenediphenol, ethoxylated
Betaines, C12-14 (even numbered)-alkyldimethyl
5-Isobenzofurancarboxylic acid, 1,3-dihydro-1,3-dioxo-, reaction products with 1-nonanol
4-(4-isopropoxyphenylsulfonyl)phenol
2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate
Sodium 3-nitrobenzene sulphonate
4,4′-methylene bis(dibutyldithiocarbamate)
Propyl acetate
Oxirane, mono[(C12-14-alkyloxy)methyl] derivs
In May 2021, the European Commission asked ECHA for an opinion on the comparative assessment of anticoagulant and antivitamin rodenticides. These agents work by interfering with the activation of vitamin K and blood clotting, thereby causing the internal bleeding.
At the last meeting, the Biocidal Products Committee. (BPC) concluded that, due to the identified risk to the environment and human health, these agents should be. handled with care.
Based on the studies carried out, the BPC Committee concluded that mechanical rodent traps are effective enough to control mice indoors. He also cited carbon dioxide as a safer chemical alternative, which when used by trained professionals has a much lower overall hazard profile.
Based on the opinion of the BPC Committee, the European Commission will prepare its decision. It is also expected that Member States and biocidal authorization authorities will be provided with appropriate instructions on how to authorize anticoagulant rodenticides.
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