November 5, 2021 – On November 3, 2021, the European Commission published the Omnibus Act IV. 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 May 19, 2020.
The bans will apply as of March 1, 2022! They will affect not only new products but also cosmetics already on shelves on the EU market that will need to be withdrawn.
Even though the prohibition of using CMR substances automatically applies to cosmetic products (Article 15 of Regulation EU 1223/2009), their incorporation in Annex II ensures legal certainty: all the relevant information is available in a single document.
Let’s see which ingredients will be banned – Read the paragraphs below to be prepared for the deadline of March 1, 2022!
Butylphenyl Methylpropional (Lilial) – CAS No. 80-54-6
Lilial is an allergen commonly used in cosmetic formulations. Currently, it is included in Annex III to the EU Cosmetics Regulation: it 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, it has been classified as CMR 1B because, based on animal studies, it could be toxic for reproduction, as it may damage fertility. Hence, according to Omnibus Act IV, it is moved to Annex II (prohibited substances) to the EU Cosmetics Regulation.
As of March 1, 2022, cosmetics containing Butylphenyl Methylpropional must be off shelves. It is time for manufacturers to reformulate their cosmetics with Lilial-free fragrances.
Zinc Pyrithione – CAS No. 13463-41-7
Until now, Zinc Pyrithione was listed in Annexes III and V to the EU Cosmetics Regulation. Thus, it was allowed to be used:
- In leave-on hair products at a maximum concentration of 0,1% when it is not used as a preservative;
- 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 is not allowed to be used in oral hygiene products.
Zinc Pyrithione has been classified as CMR 1B (toxic for reproduction) and on April 11, 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.
According to Article 15.2 of the EU Cosmetics Regulation, the use of CMR 1B substances in cosmetic products may be exceptionally permitted if:
- They meet the food safety requirements foreseen in the Regulation (EC) 178/2002;
- No suitable alternative substances are available;
- The request concerns a specific use with a known product exposure;
- The Scientific Committee on Consumer Safety (SCCS) has declared safe the use of the ingredient for that specific use.
In light of the above, in its opinion of March 03-04, 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 – specifically, the lack of available alternative substances has not been demonstrated – therefore, its use in cosmetics cannot be granted by way of exception. In conclusion, also 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 March 1, 2022, cosmetics containing Zinc Pyrithione will not be allowed on the EU market – Manufacturers must act now to be compliant with the EU Law.
In addition to Lilial and Zinc Pyrithione, Omnibus IV 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.
Do not get caught unprepared! Take action now and reformulate your cosmetics that contain any of the substances mentioned in this article.
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- 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. Retrieved on 03/11/2021 from https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32021R1902&from=EN
- (2021). Lilial classified as a CMR substance. Retrieved on 03/11/2021 from https://www.obelis.net/news/lilial-classified-as-a-cmr-substance/
- 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. Retrieved on 03/11/2021 from https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020R1182&from=EN
- Scientific Committee on Consumer Safety. (2020). Opinion on Zinc Pyrithione (ZPT) – Submission III. Retrieved on 03/11/2021 from https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_236.pdf
- European Chemicals Agency. (2019). Committee for Risk Assessment RAC Opinion proposing harmonised classification and labelling at EU level of 2-(4-tert-butylbenzyl)propionaldehyde. Retrieved on 03/11/2021 from https://echa.europa.eu/documents/10162/9b07d500-5c11-4e47-9c30-57a203f9f644