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.
Main topics: selected news from chemical and related legislation:
Maintaining the authorisation to place biocidal products on the market in Germany
New ECHA recommendations on registration requirements in REACH Regulation
Restriction of PFAS substances
Non-binding guidance for the physical substances sector
Rapid Consultation for S-Metachlor
New cosmetic restrictions for methyl-N-methylanthranilate
New developments concerning the approval of biocidal products
New developments concerning the approval of plant protection products
Notification to undertakings intending to place fluorocarbons on the EU market in large quantities in 2023
EU REACH Reform Web Meetings
* Maintenance of the authorisation to place biocidal products on the market in Germany
The BAuA (Federal Institute for Occupational Safety and Health) in Germany has published new requirements for national authorisations of biocidal products: ‘Neues Meldeverfahren für Biozidprodukte’. Based on the new requirements, biocidal products placed on the German market before 26 August 2021 must be confirmed/re-notified by 31 March 2022 if the product is to remain on the market.
New information and documents are required as part of the new notification. Ignoring the notification obligation means that the product should not be placed on the German market.
New Guideline: https://ekotox.eu/news/biocides-germany-new-rules-on-national-notification/
* New ECHA recommendations on registration requirements in REACH Regulation
ECHA has updated its recommendations on the information to be submitted when registering chemicals to help companies improve the quality of their registration dossiers. The Agency has added further advice on how to apply the read-across approach and on the weight of evidence to be submitted. Specifically, the improvements relate to provisions on how to apply the read-across approach and the weight of evidence and how to combine both approaches, allowing animal testing to be dispensed with.
Registrants should update their REACH registration as necessary to ensure that their dossier meets the information requirements.
The European Chemicals Agency has put forward a proposal for an EU-wide restriction on all per- and polyfluoroalkyl substances (PFAS) in firefighting foams. The proposal is based on information available at the time of its preparation and may be updated in the light of technological progress and new information. The consultation is due to start on 23 March 2022 and will run for a further 6 months.
In addition to the use of PFAS in firefighting foams, five European countries (the Netherlands, Germany, Denmark, Sweden and Norway) are working on a draft restriction that will apply to all PFAS in other applications. They plan to submit their proposal to ECHA in January 2023.
PFAS in firefighting foams : vytvoriť
* Non-binding guidance for the physical substances sector
The preparation of non-binding guidelines for the hairdressing industry is part of a set of commonly agreed measures to support the autonomous implementation of the European Framework Agreement on health and safety at work in the hairdressing industry. In addition to the agreed content, this document provides some information on guidelines on workplace challenges in the context of the COVID-19 pandemic.
Germany notified a draft harmonised classification and labelling (CLH) for S-metolachlor (ISO) and submitted it for consultation, which closed on 3 September 2021, but in the meantime further data on carcinogenicity have emerged.
ECHA has launched a rapid consultation for clarification, which will run until 7 March 2022.
* New cosmetic restrictions for methyl-N-methylanthranilate
On 1 February 2022, the European Commission published Commission Regulation (EU) 2022/135 imposing certain restrictions on the use of methyl-N-methylanthranilate (M-N-MA) in cosmetics. Until now, there were no restrictions on M-N-MA, but the 49th amendment to the IFRA standards limited its use to 0.1% in several product categories due to its phototoxic effects. According to the new entry in Annex III of the EU Cosmetics Regulation, M-N-MA can be used: in leave-on products up to 0.1%; in rinse-off products up to 0.2%. Cosmetics that do not comply with the new restrictions may not be placed on the market after 21 August 2022. In addition, from 21 November 2022, non-compliant products must disappear from shop shelves.
New developments concerning the approval of biocidal products
Biocidal product Mydis – The UK Health and Safety Executive has extended the measure authorising the making available on the Northern Ireland market and use of the biocidal product Mydis until 23 February 2023. (COMMISSION IMPLEMENTING DECISION (EU) 2022/137)
Product containing alkyl (C12-16)benzyldimethylammonium chloride – used as a long-lasting cleaner to remove layers of deposits on wood, brickwork, roofing, paving stone and other surfaces. The product is designed to prevent the growth of unwanted algae and protect against algae. Outdoor application. The product containing the active substance at a concentration of 2,4 % is considered a biocidal product within the meaning of Article 3(1)(a) of Regulation (EU) No 528/2012 and belongs to product type 2. (COMMISSION IMPLEMENTING REGULATION (EU) 2022/146)
Biocidal product Clinisept + Skin Disinfectant – contains as active substance active chlorine released from sodium hypochlorite. Sodium hypochlorite-released active chlorine is approved for use in biocidal products of Type 1 (human personal care) as defined in Annex V to Regulation (EU) No 528/2012. The UK Health and Safety Executive, authorises the making available on the market and use of the biocidal product, until 6 May 2023. (COMMISSION IMPLEMENTING REGULATION (EU) 2022/155)
Biocide product identified in the Register for Biocidal Products by the number BC-RW058475-96 – the label of the biocidal product must include the information: ‘The wearing of chemical resistant protective gloves (glove material to be specified by the authorisation holder in the product information) and disposable protective clothing, at least type 6 of EN 13034 or equivalent protective clothing, is required for handling the product. Where the applicant for authorisation or the authorisation authority identifies measures that achieve a level of exposure reduction equivalent to or greater than that achieved by wearing the protective equipment listed, those measures shall be used in place of the personal protective equipment listed and shall be specified on the biocidal product label and in the authorisation.
Creosol – extension of the measure to restrict the use and placing on the market in France of certain wood treated with creosote and creosote-related substances. The expiry date of the approval of creosote for use in biocidal products of type 8 was 8 September 2021. The approval was extended from the original 27 months to 59 months. (COMMISSION IMPLEMENTING REGULATION (EU) 2022/326)
* New developments concerning the approval of plant protection products
Low-risk active substance Bacillus amyloliquefaciens strain IT-45 – the active substance was approved on 27 February 2022 and the expiry date is 27 February 2037. (COMMISSION IMPLEMENTING REGULATION (EU) 2022/159)
Notification to undertakings intending to place fluorocarbons on the EU market in large quantities in 2023
Fluorocarbons are substances listed in Section 1 of Annex I to Regulation (EU) No …/… HFC-23, HFC-32, HFC-41, HFC-125, HFC-125, HFC-134, HFC-134a, HFC-143, HFC-143a, HFC-152, HFC-152a, HFC-161, HFC-227ea, HFC-236cb, HFC-236ea, HFC-236fa, HFC-245ca, HFC-245fa, HFC-365mfc, HFC-43-10mee.
Any placing on the market of these substances (except where the total annual quantity is less than 100 tonnes of CO2. equivalent per year) is subject to limits under the quota system.
Importers are required to have a valid registration on the F-Gas .portal and the fluorocarbon licensing system at the time of release of the fluorocarbons into free circulation. Such registration shall be considered as a compulsory import licence. A similar licence is required for the export of fluorocarbons.
As of 1 January 2022, importers are required under the European Communities’ Integrated. Tariff (TARIC) to indicate on the Single Customs Document (SAD) the quantities of fluorocarbons in CO2. equivalents at the time of release for free circulation, . and importers should be listed as “consignee”.
Companies must submit a declaration. of estimated quantities for 2023 on the F-Gas portal and in the fluorocarbon. licensing system during the notification period from March 14, 2022 to April 13, 2022, 1 p.m. (CET).
(EUROPEAN COMMISSION, Notice to undertakings. intending to place hydrofluorocarbons in bulk on the market in the European Union in 2023, 2022/C 44/13)
EU REACH Reform Web Meetings
Ecotox Centers invites you to 3 online events to which we have invited representatives of ECHA, Cefic and Eurometalux. The first, April meeting will take place on 26.04.2022r. At the meeting we will discuss the proposed changes to REACH regulation. Participation in the event is free, however the number of places is limited.
Main topics:
new information requirements in the EU REACH registration process;
The Community rolling action plan (CoRAP) update for the years 2022–2024. lists 27 substances suspected of posing a risk to human health or the environment, for evaluation. by 10 Member State competent authorities, under. the substance evaluation process of the REACH Regulation (EC) No 1907/2006 (Articles 44 to 48).
The plan contains two newly allocated substances and 25 substances already included in the previous CoRAP 2021-2023 update, published on 17 March 2021.
For 20 out of these 25 substances the evaluation year has been postponed, mainly to await submission of new information.
Between others Propyl acetate, Diethyl Ether, Carbon black or Benzaldehyde are in recent revised CoRAP while Benzyl salicylate or Xylene were withdrawn.
The full list link: https://echa.europa.eu/documents/10162/879660/corap_update_2022-2024_en.pdf/13898cd4-e4ce-4448-fe7a-0e5027156043?t=1647951716519&utm_medium=email&utm_campaign=weekly&utm_content=20210323
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.
During the meeting, the committee adopted 3 opinions for active substances:
The use of methylene dithiocyanate in slimicides (PT12). has not been supported as it presents an unacceptable risk to the environment the effects of which cannot be mitigated. The substance is widely used in papermaking processes to prevent or control the growth of slime.
The approval of (13Z) -hexadec-13-en-11-yn-1-yl acetate in group 19 (PT19), a pheromone. used to repel or attract harmful organisms (invertebrates and vertebrates) was supported.
On the renewal of the use of propiconazole in wood preservatives (PT8), the committee concluded that, as a reproductive toxicant and endocrine disruptor, it meets the exclusion criteria. The European Commission will take further action to obtain more information on the derogation from the exclusion criteria, in particular on suitable and sufficient alternatives for different classes of use.
Moreover, the committee adopted the following four positive opinions on Union authorisations:
Propan-1-ol – PT1
Propan-2-ol – PT2 and PT4
L-(+) Lactic acid – PT2
Active chlorine released from sodium hypochlorite – PT2
One Union authorisation opinion concerning active chlorine released from sodium hypochlorite was postponed and will be adopted through a written procedure.
Now, the European Commission together with the EU Member States will take the final decision on approval of active substances and on Union authorisation of biocidal product families.
Entrepreneurs using the substances listed in the above product groups, after their official approval, will have to apply for registration in European procedures in order to keep the products on the market.
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.
This report takes a detailed look at the impacts of REACH authorisation on trichloroethylene (TCE) from its inclusion on the Candidate List in 2010 until January 2022.
The need to obtain authorisation significantly reduced the use of TCE. The annual use of TCE in the EU has dropped more than 95 % in the past 12 years.
Biocidal products placed on the German market before 26 August 2021, must be confirmed/notified by 31 March 2022 if the product is to remain on the market.
BAuA (the Federal Institute for Occupational Safety and Health ) in Germany has published a new requirements for national product authorisation of biocidal products: “Neues Meldeverfahren für Biozidprodukte“.
In addition to the information that had to be submitted as part of the previous notification, all new notifications must include the following:
Concentration of the active substance in the biocidal product;
Information on compliance with article 95 of the EU Biocidal Products Regulation (BPR);
Evidence of the attributed effectiveness of the biocidal product.
Ignoring the requirement for the notification will mean that the product should not be placed on the German market.
Ekotox Centers provides consultancy services and support for the customers placing biocidal products on merkets in EU member states.
ECHA has updated its recommendations to help companies improve their registration dossiers and has added more advice on using read-across and weight of evidence.
ECHA has further developed its recommendations to registrants on how they can improve their registrations, based on observations during compliance checks and following recent changes in information requirements under REACH.
The improvements particularly concern rules for adaptations such as how to apply read-across and weight of evidence, or combine the two approaches. These approaches should be used to fulfil legal requirements without further testing on animals if they can be justified in a robust manner.
The recommendations also cover suggestions on how to address a read-across between substances of unknown or variable composition, complex reaction products or of biological materials (UVCBs) as well as additional advice on dose setting for toxicity testing.
Registrants should check the amended REACH annexes as well as the latest recommendations and make their dossiers comply with the information requirements, where needed.
When you use our website, we may collect information to operate and improve your experience through cookies. By closing or accepting, you agree this use of cookies.Accept cookiesDeclinePrivacy policy
