EkotoxInfo

EkotoxInfo 3/2022

EkotoxInfo 3/2022

EkotoxInfo 3/2022

Main topics: selected news from chemical and related legislation:

  1. Maintaining the authorisation to place biocidal products on the market in Germany
  2. New ECHA recommendations on registration requirements in REACH Regulation
  3. Restriction of PFAS substances
  4. Non-binding guidance for the physical substances sector
  5. Rapid Consultation for S-Metachlor
  6. New cosmetic restrictions for methyl-N-methylanthranilate
  7. New developments concerning the approval of biocidal products
  8. New developments concerning the approval of plant protection products
  9. Notification to undertakings intending to place fluorocarbons on the EU market in large quantities in 2023
  10. 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.

https://echa.europa.eu/pl/recommendations-to-registrants

Ekotox REACH

* Restriction of PFAS substances

 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.

https://osha.europa.eu/en/publications/non-binding-guidelines-hairdressing-sector?fbclid=IwAR1XyyL9JPRFpuEkBW3YKVs5Jsw6Q6Ww5ZZLnI7JTRE5gA8WGjuEQWfdERQ

  • Rapid Consultation for S-Metachlor

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.

https://echa.europa.eu/pl/harmonised-classification-and-labelling-targeted-consultations

* 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.

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R0135

  • 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.

(COMMISSION IMPLEMENTING REGULATION (EU) 2022/323)

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;
  • more info on use and exposure;
  • Mixture assessment factor (MAF).

More information on https://ekotoxtraining.com/events/eu-reach-registration-changes-covering/