EKOTOX CENTERS
EkotoxInfo 06/2022
We encourage you to read the current issue of EkotoxInfo chemical news. In the summary of last month you will find the following topics:
- DDAC – biocidal active substance approval is coming
- Legal procedure for implementing changes to the CLP Regulation
- Update of the Blue Guide
- Skin sensitizing substances in consumer mixtures
- SSbD – Safe and sustainable design
- New concerning the authorisation of biocidal products
- News on cosmetic products
DDAC – biocidal active substance approval is coming
There is already a draft Commission Implementing Regulation (EU) approving didecyldimethylammonium chloride as an active substance for use in biocidal products of product groups 1 and 2, in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council. If you sell DDAC products for PT1 PT 2 product groups, you must apply under the new European procedures before the indicated deadline.
Legal procedure for implementing changes to the CLP Regulation
The last meeting raised the question of whether the European Commission has the power to adopt amendments under the current CLP legislation. The Commission plans to adopt some changes to its mandate under the CLP revision by means of a delegated act without the involvement of the European Parliament.
https://ekotox.eu/news/clp-regulation-legal-procedure-for-implementing-changes/
Update of the Blue Guide
The European Commission has published an update of the Blue Guide, which provides information on the implementation of EU product rules and their implementation on the European market. The guide aims to better understand EU rules on products and to facilitate their uniform application in all sectors across the single market.
https://ekotox.eu/news/update-of-the-blue-guide/
Skin sensitizing substances in consumer mixtures
France, Ireland and Germany invite interested parties to submit information on skin sensitisers in mixtures intended for consumers. Deadline for data delivery: 30/09/2022.
https://ekotox.eu/news/skin-sensitising-substances-in-consumer-mixtures/
SSbD – Safe and sustainable design
The JRC technical report has been published. “Safe and sustainable design of chemicals and materials” containing a framework of criteria and definitions for the safety assessment of chemicals and materials.
https://ekotox.eu/news/ssbd-safe-and-sustainable-by-design/
New concerning the authorisation of biocidal products
Germany has requested the European Commission to approve the authorisation for the biocidal product group L+R Propanol PT1 Family for professional use only. The evaluating country was Switzerland. L+R Propanol PT1 Family contains propane-1-ol and propane-2-ol as active substances which are included in the Union list of approved active substances pursuant to Article 9(2) of Regulation (EU) No 528/2012 for product-type 1. The authorisation for PT 1 (Human personal care) has been granted until 30 June 2032.
(COMMISSION IMPLEMENTING REGULATION (EU) 2022/1186) Link: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R1186&from=SK
Belgium has requested the European Commission to approve the authorisation for the Contec Hydrogen Peroxide Biocidal Product Family for professional use only. The evaluating country was Slovenia. Contec Hydrogen Peroxide Biocidal Product Family contains hydrogen peroxide as an active substance which is included in the Union list of approved active substances under Article 9(2) of Regulation (EU) No 528/2012 for product type 2 . The authorisation for PT 2 (Disinfectants and algaecides not intended for direct application to humans or animals) has been granted until 30 June 2032.
(COMMISSION IMPLEMENTING REGULATION (EU) 2022/1185) Link: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R1185&from=SK
Germany has requested the European Commission to approve the authorisation of the biocidal product Bioquell HPV-AQ for professional use only. The Netherlands was the evaluating country. Bioquell HPV-AQ contains hydrogen peroxide as an active substance which is included in the list of approved active substances
Union’s list of approved active substances under Article 9(2) of Regulation (EU) No 528/2012 for product types 2, 3 and 4. Authorisations for PT2 (Disinfectants and algaecides not intended for direct application to humans or animals), PT 3 (Veterinary hygiene) and PT 4 (Food and feed area) were granted until 31 July 2032.
(COMMISSION IMPLEMENTING REGULATION (EU) 2022/1226) Link: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R1226&qid=1658908585508&from=en
Belgium has requested the European Commission to approve the authorisation for INTEROX Biocidal Product Family 1 for professional use only. The evaluating country was Finland. INTEROX Biocidal Product Family 1 contains hydrogen peroxide as an active substance, as an active substance included in the Union list of approved active substances under Article 9(2) of Regulation (EU) No 528/2012 for product types 2, 3 and 4. Authorisations for PT2 (Disinfectants and algicides not intended for direct application to humans or animals), PT 3 (Veterinary hygiene) and PT 4 (Food and feed area) were granted until 30 July 2032.
(COMMISSION IMPLEMENTING REGULATION (EU) 2022/1232) Link: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R1232&qid=1658908634534&from=EN
Germany has requested the European Commission to approve the authorisation for the Knieler & Team Propanol Family of biocidal products for industrial and professional use. The evaluating country was Switzerland. Knieler & Team Propanol Family contains propane-1-ol and propane-2-ol as active substances which are included in the Union list of approved active substances pursuant to Article 9(2) of Regulation (EU) No 528/2012 for product types 1, 2 and 4. Authorisations for PT 1 (Human personal care), PT 2 (Disinfectants and algicides not intended for direct application to humans or animals) and PT 4 (Food and feed area) were granted until 31 July 2032.
(COMMISSION IMPLEMENTING REGULATION (EU) 2022/1282) Link: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R1282&qid=1658908677868&from=EN
News on cosmetic products
Commission Regulation (EU) 2022/1181 regulates the threshold for formaldehyde-releasing substances as a preservative in both non-washable and washable cosmetic products.
The use of formaldehyde is prohibited in cosmetic products due to its classification as a carcinogen (category 1B). Annex V to Regulation (EC) No 1223/2009 lists the substances that are allowed to be used as preservatives in cosmetic products. Some of the substances listed release formaldehyde gradually to perform the function of preservative in the final cosmetic product. In order to inform formaldehyde-sensitive consumers about the presence of formaldehyde, which can cause an allergic reaction, a threshold of 0,05 % (500 ppm) is set in the finished product and the product must be labelled with a specific warning ‘contains formaldehyde’.
The Scientific Committee on Consumer Safety concluded that the current threshold does not sufficiently protect formaldehyde-sensitive consumers and therefore proposed to lower the current threshold to 0.001% (10 ppm), regardless of whether the product contains one or more formaldehyde-releasing substances.
All finished products containing formaldehyde-releasing substances that comply with the requirements of Regulation (EC) No 1223/2009 as applicable from 30 July 2022 may be placed on the Union market until 31 July 2024 and may be made available on the Union market until 31 July 2026.
Commission Regulation (EU) 2022/1176, based on the opinion of the Scientific Committee on Consumer Safety, tightens the concentrations for Benzophenone-3 and Octocrylene used as UV filters in cosmetic products due to their properties as potential endocrine disruptors.
The substance Benzophenone-3 is safe for the consumer when used as a UV filter:
- in concentrations up to 2.2 %: Cosmetic body products including in aerosol spray and pump spray form
- in concentrations up to 6 %: Cosmetic products for face, hands and lips, excluding aerosol spray and pump spray products
- When used at a concentration of 0,5 % to protect the composition of the product, the content used as a UV filter shall not exceed 1,7 %.
The substance Octocrylene is safe for the consumer when used as a UV filter:
- at a concentration of up to 10 % alone
- in concentrations up to 10 %: Cosmetic products for face, hand and lip, except aerosol spray and pump spray products
- in concentrations up to 9 %: Aerosol spray products
EkotoxInfo is the free of charge selection of actual information from EU chemicals legislation.
In case you have an interest to get Ekotoxinfo to your e-mail, please let us know – send a request to: ekotox(at)ekotox.eu
