The European Chemicals Agency (ECHA) has recommended eight substances, including lead, for addition to the REACH Authorization List to protect workers and the environment.
Helsinki, 12 April 2023 – ECHA’s 11th recommendation includes the following substances:
• Ethylenediamine;
• 2-(4-tertbutylbenzyl)propionaldehyde and its individual stereoisomers;
• Lead;
• Glutaral;
• 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one;
• 2-benzyl-2- dimethylamino-4’-morpholinobutyrophenone;
• Diisohexyl phthalate; and
• Orthoboric acid, sodium salt.
ECHA has prioritized these substances from the Candidate List of substances of very high concern for this recommendation as they are of the highest priority, following the agreed approach of 2014. If substances are added to the list, companies will need to apply for authorization to continue using them.
The authorisation process aims to ensure proper control of risks for human health and the environment, and to enhance substitution of substances of very high concern when technically and economically viable alternatives are available.
The European Commission will decide which substances are included in the Authorisation List and what conditions apply for each substance.
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.
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.“
Five substances added to REACH Authorisation List. The Authorisation List now contains 59 entries.
The five substances are:
Tetraethyllead (TEL) (EC 201-075-4, CAS 78-00-2);
4,4′-bis(dimethylamino)-4”-(methylamino)trityl alcohol [with ≥ 0.1% w/w of Michler’s ketone (EC 202-027-5) or Michler’s base (EC 202-959-2)] (EC 209-218-2, CAS 561-41-1);
Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP) [with ≥ 0,1% w/w 4-heptylphenol, branched and linear (4-HPbl)] (EC -, CAS -);
2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE) (EC 239-622-4, CAS 15571-58-1); and
Reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (reaction mass of DOTE and MOTE) (EC -, CAS -).
The amendment of the Authorisation List (Annex XIV to REACH) was published on 11 April in the EU’s Official Journal.
Companies that want to continue using these substances after the agreed sunset dates will need to apply for authorisation.
On March 24 2022, the European Commission published amendments to Annexes VI – X of the REACH Regulation (COMMISSION REGULATION (EU) 2022/477).
The update of the annexes includes revised requirements for the registration of chemical substances in the European Union under REACH. The changes mainly concern:
determining when further in vivo and in vitro tests on the mutagenic potential of the substance are needed;
identification of the preferred animal species and administration routes in reproductive toxicity studies;
clarification of when long-term studies should be performed instead of short-term aquatic toxicity studies and terrestrial organisms studies;
identify the need for a degradation and bioaccumulation study.
In addition, the registration dossier for substances should include the description of nanoforms, identify crystal structures and UVCB substances, clarify information on impurities and additives, as well as analytical information.
In the second half of 2022, ECHA will publish an updated guide to registration requirements. Companies should start preparing to update their substance registration dossiers as the changes will apply in October 2022.
The next step in mapping potentially harmful chemicals to evaluate all registered substances by 2027.
The main source of information on chemicals is substance registration dossier submitted under REACH registration. ECHA has created a mapping tool for all registered substances where each substance is assigned to the appropriate category pool. ECHA’s goal is to review by 2027 all registered chemicals above 1 tonne per year, assign them to the appropriate category pool and evaluate the further regulatory action of each substance (or group of substances).
In 2021, ECHA assessed 250 high-tonnage substances, which so far had not been assigned any pool, taking the next step towards achieving the set goal. For the group of substances registered in the range of 1-100 tonnes, only 1300 chemicals remained not assigned to any group.
In 2021 ECHA assessed in total 1900 chemicals and made a categorization based on further regulatory needs for each substance. The results were as follows:
300 were classified for further risk management
800 requires more registration data for risk assessment
800 requires no further action
A new pool called “regulatory needs assessment” has also been introduced to show which substances are undergoing a group assessment.
In December 2021, ECHA published batch of the group assessments. This should bring entrepreneurs closer to ECHA’s activities and to enable anticipation of further steps that the committee plans to take in the future, as well as to develop a plan for replacing harmful substances with safer alternatives.
On the ECHA website you will find the full list of substances with the assigned category pool, or information on: whether the substance is subject to further regulatory needs, whether the evaluation has already been completed or is under development. For each substance, the table also shows the evaluating authority, the problem, status and suggested follow-up, and the date when the listing was last updated.
The results of the assessment are a key issue for entrepreneurs as they can affect:
inclusion of a substance in the authorization list
restrictions on the use of certain substances, including ED substances
the need to update REACH registration
The annual report of ECHA’s integrated regulatory strategy, to be published later this year, will include a thorough analysis of the mapping process and the suggested regulatory actions.
Ekotox Centers with partners invite all interested parties to join us in 3 Web Meetings concerning the EU REACH Reform proposals:
April 26, 2022 – “EU REACH Registration – proposed changes”
May 5, 2022 – “Evaluations under the EU REACH reform”
May 24, 2022 – “EU Reform of the REACH Authorisation and Restrictions system”
Presenters from European Commission and some of the EU industry associations already confirmed participation. We will be updating the Web Meetings information an a daily bases. Please check on our training portal: EKOTOX TRAINING
All three web meetings are free of charge.
Number of places is limited to 100.
Registrations will be managed on the first-come, first-served basis.
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