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.
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
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
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).
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.
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.
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
REACH regulation revision to be postponed till end of 2023
On 18 October 2022, the European Commission adopted its 2023 Commission work programme
REACH revision is postponed to the end of 2023 (legislative, incl. impact assessment, Article 114 TFEU, Q4 2023).
„After consultations with key stakeholders, we will propose a targeted revision of the legislation on the registration, evaluation and authorisation of chemicals (REACH) with the aim of securing European competitive advantages and innovation by promoting sustainable chemicals, simplifying and streamlining the regulatory process, reducing burden and protecting human health and the environment.“
As a high number of authorisation applications are expected for hexavalent chromium (Cr(VI)) uses in the coming years, the way of information sessions for these uses will be changed. In the future, will organised for groups of several applicants.
The first group session will take place on 15 February 2023, and more will be organised after that based on need. Future dates will be announced in the bulletin.
Safety Data Sheets (SDS) are documents for communicating information on the hazards of chemicals and mixtures and the risks they pose to human health and the environment.
The European Commission amended Annex II of REACH, concerning the compilation of Safety Data Sheets (SDS):
COMMISSION REGULATION (EU) 2020/878 of 18 June 2020, amending Annex II to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
31st December 2022 – after this date, all safety data sheets will need to be updated to the new requirements.
The new requirements include:
Alignment of SDS with the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Revisions 7 and 8;
Inclusion of Unique Formula Identifiers (UFIs) to Section 1 (in line with Regulation (EU) 2017/542);
Additional information requirements for substances placed on the market as a nanoform (in line with Regulation (EU) 2018/1881) and for substances and mixtures with endocrine-disrupting properties;
Addition of the Specific Concentration Limits (SCLs), multiplying factors and acute toxicity estimates (ATE), if available, set in accordance with CLP 1272/2008.
The main sections of the SDS which have undergone revision are 1, 2, 3, 9, 11 and 12.
Chromium trioxide (EC No. 215-607-8; CAS No. 1333-82-0) is widely used in plating and surface treatment.
Notifications from 1 026 sites across Europe submitted by May 2021 confirm that chromium trioxide is still widely used in functional or hard chrome plating and surface treatment. The annual usage is estimated to be 7 000 tonnes. The substance of very high concern was placed on the Authorisation List in 2013 and its use has needed a specific authorisation in the EU since 2017.
By notifying the uses to ECHA, companies confirm that they follow the conditions for use set in the authorisation decisions granted to their suppliers. As part of the conditions, they must inform ECHA by the end of 2021 how their workers are exposed to chromium trioxide. This information will help companies to protect their workers even better by minimising their exposure to the carcinogen.
In December 2020 European Commission published 2 decisions granting authorisation to use the chemical until September 2024.
Enforcement authorities can now carry out inspections as necessary.
There are 2 principal duties for companies using chromium trioxide:
Apply for REACH authorisation in time;
Comply with the conditions comunicated by suppliers through extended safety data sheets.
The chromium trioxide applications for REACH authorisation by companies is now accelerating.
Joint authorisation originally applied by CETAC consortium (and others) will be ineffective after September 2024.
Ekotox Centers offer complex services to prepare all necessary documents on behalf of the customers. To stay on the market there is need for immediate action!
On the same time there is a duty to comply with the safety measures and operational conditions – requirements defined for downstream users by eSDS. To be sure that all is in compliance Ekotox Centers provide support to manage „Internal Dossiers for REACH Authorisation Compliance“ (IDRAC).