The 23 newly added ingredients classified as carcinogenic, mutagenic or toxic for reproduction (CMR) under Article 15 of the Cosmetics Regulation 1223/2009 are added to Annex II, effective 1st of March 2022.
The Commissions’ Scientific Committee on Consumer Safety (SCCS), as well as various other parties, were consulted on the decision to ban the ingredients, and, on 3rd November 2021, the European Commission published the Omnibus IV, also known as Regulation (EU) 2021/1902.
This new amendment, the Regulation (EU) 2021/1902, aims at including in Annex II to the EU Cosmetics Regulation those substances that have been classified as CMR in the latest amendment of the CLP Regulation, dated 19th May 2020.
The ban will apply 1st of March 2022!
Even though the prohibition of using CMR substances automatically applies to cosmetic products (Article 15 of Regulation EU 1223/2009), their inclusion in Annex II of the cosmetic regulation ensures legal certainty, and now, all the relevant information is available in a single document.
Read the paragraphs below to know more, and be prepared for the deadline: 1st of March 2022!
Butylphenyl Methylpropional (Lilial) – CAS No. 80-54-6
Lilial is an allergen commonly used in parfums at cosmetic formulations. Previously, it was included in Annex III to the EU Cosmetics Regulation, also at the UK Regulation: before this amendment the substance must be mentioned in the list of ingredients when its concentration exceeds 0,001% in leave-on products and 0,1% in rinse-off products.
In 2020, Butylphenyl Methylpropional has been classified as CMR 1B because, based on animal studies, it could be toxic for reproduction. Hence, according to the amendment of the Regulation (EU) 2021/1902, the substance is moved to Annex II (list of prohibited substances) to the EU Cosmetics Regulation.
As of 1st of March 2022, cosmetics containing Butylphenyl Methylpropional (Lilial) must be not present at cosmetic products.
Zinc Pyrithione – CAS No. 13463-41-7
Until now, Zinc Pyrithione was listed in Annexes III and V to the EU Cosmetics Regulation, allowing the use of the substance in leave-on hair products at a maximum concentration of 0,1% when it is not used as a preservative; and as a preservative up to a maximum concentration of 1,0% in rinse-off hair products and of 0,5% in other rinse-off cosmetics. It was not allowed in oral hygiene products.
Zinc Pyrithione has been classified as CMR 1B (toxic for reproduction) and, on 11th of April 2019, a request to keep using it as an anti-dandruff in rinse-off hair products up to a maximum concentration of 1% by way of exception was submitted.
The Scientific Committee on Consumer Safety (SCCS) has declared safe the use of the ingredient for that specific use, and, in its opinion of March 2020, the SCCS concluded that Zinc Pyrithione is safe when used as an anti-dandruff in rinse-off hair products up to a maximum concentration of 1%.
However, Zinc Pyrithione does not meet all the conditions listed in Article 15.2 of the EU Cosmetics Regulation, as the lack of available alternative substances has not been demonstrated. Therefore, its use in cosmetics cannot be granted by way of exception.
In conclusion, Zinc Pyrithione has been added to Annex II of the EU Cosmetics Regulation and the related entries in Annexes III and V have been deleted. As of 1st of March 2022, cosmetics containing Zinc Pyrithione will not be allowed on the EU market after the publication of the Regulation (EU) 2021/1902.
New entries at Annex II
In addition to Lilial and Zinc Pyrithione, Omnibus IV (Regulation (EU) 2021/1902) establishes that the following substances are added to Annex II to the EU Cosmetics Regulation:
– Silicon carbide fibres (with diameter < 3 μm, length > 5 μm and aspect ratio ≥ 3:1);
– Tris(2-methoxyethoxy) vinylsilane; 6-(2-methoxyethoxy)- 6-vinyl-2,5,7,10-tetraoxa-6-silaundecane;
– Dioctyltin dilaurate and stannane, dioctyl-, bis (coco acyloxy) derivs;
– Dibenzo[def,p]chrysene; dibenzo[a,l]pyrene;
– Bis(2-(2-methoxyethoxy)ethyl)ether; tetraglyme;
– 2,2-bis(bromomethyl) propane-1,3-diol;
– Diisooctyl phthalate;
– 2-methoxyethyl acrylate;
– Sodium N-(hydroxymethyl)glycinate; [formaldehyde released from sodium N-(hydroxymethyl)glycinate];
– 3-(difluoromethyl)-1- methyl-N-(3′,4′,5′-trifluorobiphenyl-2-yl) pyrazole-4-carboxamide; fluxapyroxad;
– N-(hydroxymethyl)acrylamide; methylolacrylamide;
– 5-fluoro-1,3-dimethyl-N-[2-(4- methylpentan-2-yl) phenyl]-1H-pyrazole- 4-carboxamide; 2′- [(RS)-1,3-dimethylbutyl]-5-fluoro-1,3-dimethylpyrazole-4-carboxanilide; penflufen;
– Bis(α,α-dimethylbenzyl) peroxide.
Take action as soon as possible and reformulate your cosmetics containing any of the mentioned substances. Do not hesitate to contact us if you have any question with the Regulation (EU) 2021/1902, we will be glad to help!
– European Commission. (2021). Commission Regulation (EU) 2021/1902 of 29 October 2021 amending Annexes II, III and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use in cosmetic products of certain substances classified as carcinogenic, mutagenic or toxic for reproduction.
– European Commission. (2021). Commission Delegated Regulation (EU) 2020/1182 of 19 May 2020 amending, for the purposes of its adaptation to technical and scientific progress, Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures.
– Scientific Committee on Consumer Safety. (2020). Opinion on Zinc Pyrithione (ZPT) – Submission III.