ECHA: Main alternatives to harmful substances subject to REACH authorisation
Companies applying for an authorisation under REACH need to provide information on potential alternatives to the Annex XIV substance(s) they use. This information is presented in the Analysis of Alternatives (AoA) submitted as part of their authorisation application. The public version of the AoA is published on ECHA’s website.
The main information on these alternatives has been extracted from AoAs and is available in the Shortlisted Alternatives Table. The file contains data available as of 30 June 2023.
The restriction on formaldehyde and formaldehyde-releasing substances has been adopted by the Commission on July 14, 2023 and was published on July 17 in the OJEU: Regulation No. 2023/1464.
This new entry, n° 77 of annex XVII of REACH, aims to prohibit the placing on the market of articles containing formaldehyde or formaldehyde-releasing substances, for which the formaldehyde concentrations emitted exceed 0.062 mg/m3 for wood-based articles, furniture and 0.08 mg/m3 for other articles. A special provision is mentioned therein for the interior of road vehicles in which the concentration of formaldehyde emitted must not exceed 0.062 mg/m3.
Commission Regulation (EU) 2023/1464 of 14 July 2023 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards formaldehyde and formaldehyde releasers.
ECHA has added two new chemicals to the Candidate List.
One is toxic for reproduction and the other has very persistent and very bioaccumulative hazardous properties. They are used, for example, in inks and toners and in the production of plastic products.
Entries added to the Candidate List on 14 June 2023:
#
Substance name
EC number
CAS number
Reason for inclusion
Examples of use(s)
1
Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide
278-355-8
75980-60-8
Toxic for reproduction (Article 57c)
Inks and toners, coating products, photo-chemicals, polymers, adhesives and sealants and fillers, putties, plasters, modelling clay.
2
Bis(4-chlorophenyl) sulphone
201-247-9
80-07-9
vPvB
(Article 57 e)
Manufacture of chemicals, plastic products and rubber products.
The Candidate List now has 235 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. Companies must apply for authorization from the European Commission to continue its use.
Consequences of the Candidate List
Under REACH, companies must fulfill legal obligations. These obligations apply when their substance is included in the Candidate List, either on its own, in mixtures, or in articles.
Suppliers of articles containing a substance listed in the Candidate List above a concentration of 0.1% (w/w) are obligated to furnish their customers and consumers with information necessary for safe usage. Consumers have the right to ask suppliers whether the products they buy contain substances of very high concern.
Importers and producers of articles must notify ECHA if their article contains a substance from the Candidate List within six months of its inclusion (14 June 2023). Suppliers of substances listed must provide safety data sheets to their customers, whether supplied alone or in mixtures.
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).
We are organizing the REACH conference for the 13th time and it brings together speakers and participants from various sectors of industry, authorities, academia, non-governmental organizations and other interested parties.
We are pleased to once again bring together top experts in the field of chemical legislation and mediate discussions on topics that will affect our lives for at least the next decade.
The REACH Bratislava 2024 conference primarily targets the new requirements of the REACH regulation and their potential impact on companies and member states. The program of the REACH Conference 2024 is spread over two days in the following sections:
SECTION 1 Anticipated new requirements affecting registration and demonstration of safe use for registrants and downstream users;
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
–
–
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).
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.
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.“
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