June 21, 2022 – When marketing products in different parts of the world, it can be challenging to determine which ingredients are permitted and which are not in the targeted geographical area. Not all countries and regions regulate cosmetics under the same legal framework. For example, marketing cosmetics in the United States is not the same as in the European Union.
Therefore, one of the questions manufacturers must ask themselves is: where do I want to sell my product and which ingredients are not allowed on that market?
In this article, we will focus on the territory of the European Union (EU).
Background: new important bans from March 2022 in the EU
The European Commission drafted the Regulation 2021/1902 or Omnibus IV, which focuses on substances classified as CMR (carcinogenic, mutagenic, reprotoxic). Moreover, the ban covers for example:
- Butylphenyl Methylpropional (Lilial), CAS No. 80-54-6 also known as Lilial or lily aldehyde. It is used as a perfuming agent. The usage of this ingredient in cosmetics or other cleaning products can impact fertility in a negative way.
- Zinc pyrithione, CAS No. 13463-41-7. It is an active ingredient in anti-dandruff shampoos. The decision to ban this ingredient is due to its potential ability to damage DNA.
Specifically, Omnibus IV came into force on March 1, 2022. From that date, only products compliant with Omnibus IV can be placed on the market. Nevertheless, what does this mean for manufacturers? The ban affects both new products and those already on the market. Therefore, those products already on the EU market will have to be withdrawn as they will be considered non-compliant.
What to do if a cosmetic contains banned ingredients
When a product contains one or more banned ingredients, the manufacturer has to act as soon as possible to replace the concerned ingredient. In such circumstances, the product has to be reformulated if the manufacturer still wants to sell in the EU.
However, this is not a simple process. Changing the formula requires a new safety assessment process of the product. This means that the products have to undergo new tests. Moreover, the EU Authorities expect to be informed of such major changes, by updating the notification to the CPNP portal, the EU portal for cosmetics’ notification.
If you are a manufacturer of cosmetic products, Obelis can assist you in the regulatory process to place the new reformulated cosmetic on the European market. Make sure you stay always up-to-date about the latest changes and appoint Obelis as your Responsible Person.
COSlaw. (2021). Omnibus IV: new ingredients banned in cosmetics. Retrieved on 02/06/2022 from: https://www.coslaw.eu/omnibus-iv-new-ingredients-banned-in-cosmetics/
European Commision. (2021). Commission Regulation (EU) 2021/1902 of 29 October 2021. 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 09/06/2022 from: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32021R1902&from=EN
Obelis Group. (2022). Lilial & Zinc pyrithione banned in the EU as of March 1, 2022. Retrieved on 02/06/2022 from: https://www.obelis.net/news/lilial-and-zinc-pyrithionebanned-in-the-eu/