EU Commission publishes an amendment: Regulation (EU) 2021/1902.

The list of prohibited substances for cosmetics grows.

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;
– Ipconazole;
– Bis(2-(2-methoxyethoxy)ethyl)ether; tetraglyme;
– Paclobutrazol;
– 2,2-bis(bromomethyl) propane-1,3-diol;
– Diisooctyl phthalate;
– 2-methoxyethyl acrylate;
– Sodium N-(hydroxymethyl)glycinate; [formaldehyde released from sodium N-(hydroxymethyl)glycinate];
– Flurochloridone;
– 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;
– Iprovalicarb;
– Dichlorodioctylstannane;
– Mesotrione;
– Hymexazol;
– Imiprothrin;
– 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.


Place your cosmetic products into the EU & the UK market

Are you interested in exporting your cosmetic products to Europe and the United Kingdom?

Have you already registered your cosmetic products in compliance with the EU & the UK Regulations?

Make it easy! We can help you with everything you may need when placing your cosmetic products in the EU and the UK!

Cosmeservice is pleased to announce this useful webinar to make the export process to the EU & the UK in an easy way. It would be a great opportunity to know the complete process for the registration of cosmetic products in compliance with the new United Kingdom requirements and the European Cosmetic Regulation (EC) document No. 1223/2009.

2 Sessions available:

08:30 CET

17:30 CET

Below, you will find the main steps we will be talking about to complete the registration for your cosmetic products:

1. Designate a RESPONSIBLE PERSON located in Europe and/or the UK:

Cosmeservice offers these services because we are located in these two territories. At the beginning of this year, Cosmeservice established a new office in the UK to provide this service to companies that are interested in it. Do not hesitate to contact us to request more information from our experts.

The Responsible Person service will include:

  • A legal or natural person with a legal identity in the EU and the UK.
  • Compliance guarantor for Regulation requirements.
  • Expert in the registration process and preparing the required reports.
  • First point of contact for competent Health Authorities, in the case of an Inspection, or consumers in the case of a complaint.

A single annual fee covers all the products we assess and notify into the EU CPNP and the UK SCPN under our name as Responsible Person, limited to just five brands.

2. Product Information File (PIF) or Cosmetic Product Safety Report (CPSR)

The PIF must be available at the address of the Responsible Person within the EU and the UK. Every cosmetic product must have its Product Information File in English, containing all the information about the product, its manufacturing method and the UK or the EU Responsible Person.

This document must be kept up-to-date at all times and follow any changes in regulations, and it has to be available to the Health AUTHORITIES up to ten years after the last product was commercialized.

At Cosmeservice, our internal Safety Assessors perform the Product Information File (PIF or CPSR) with the highest quality and professionalism.

3. Notification of the product into the EU CPNP or The UK SCNP

One of the responsibilities of the Responsible Person is to notify the assessed products into the corresponding portals. The Responsible Person will carry out the notifications into the EU CPNP (European Cosmetic Product Notification Portal) and UK SCNP (British Submit Cosmetic Products Notification).

4. Labelling of the products

The name and address of the EU and UK Responsible Person must be indicated on the label of cosmetic products.

We recommend you to choose a professional Responsible Person in Europe and the United Kingdom in order to unify all regulatory services in the same consulting company.

5. Mandatory Testing… and much more!

The Safety Assessor in charge of the assessment of the cosmetic products should have favourable results about the following mandatory tests to justify the safety of the products. These compulsory tests would be Patch or Open Test, Challenge Test and Stability & Compatibility Test.

Cosmeservice could perform all of these tests in our labs to assess product safety according to the requirements. But, if your company or your manufacturer have already performed these mandatory tests, we would only need to receive the final reports with the results to check them and include the reports in the Product Information File (PIF).

If you have any questions or you need additional information about Cosmeservice and the registration process, please do not hesitate to contact us. We will be pleased to help you.