Phenoxyethanol’s labelling requirements in France and the Omnibus V regulation

Cosmetics regulatory updates in the European Union

The European Union is constantly changing or adding new legal requirements ruling over cosmetics. A thorough legal watch is a must in Europe, and it is one of the first duties of the EU Responsible Person. Expert in regulatory affairs, BIORIUS is keeping track of every update as a Responsible Person, but also as a consultant. Here are some of the most important latest cosmetics regulatory news.

1) FRANCE – Cancellation of Cosmetics Labelling Requirements for Leave-on Products Containing Phenoxyethanol

In 2019, the French Authorities published a legal requirement related to Phenoxyethanol containing leave-on products, also known as the “ANSM Decision March 13th, 2019”. Product labels of all leave-on cosmetic products intended to the French market (with some exceptions) were requested to display the warning “Not to be used on the nappy-skin area of children under 3 years of age”.

This administrative decision led to a dispute between the Federation of Beauty Companies (the FEBEA) and the National Agency for the Safety of Medicinal Products and Health Products (ANSM). It escalated finally up to the EU Court of Justice, to clarify the interpretation of Article 27 of Regulation 1223/2009.

Following the The Judgment of the Court (Second Chamber) of 15 September 2022,

an important decision which sets a legal precedent, BIORIUS no longer recommends displaying the warning “Not to be used on the nappy-skin area of children under 3 years of age” on labels of leave-on cosmetic products containing Phenoxyethanol intended to the French market.

If you want to have more details about the Judgement of the Court of 15 September 2022, do not hesitate to contact us at info@biorius.com.

2) What is the Omnibus V regulation for Cosmetic, and what are the changes?

We already wrote several articles on the content of the Omnibus regulation, with an emphasize on some prohibited or limited ingredients.

The Commission Regulation (EU) 2022/1531 has been published on September 15, 2022. The so-called Omnibus V Regulation will enter into force on December 17th, 2022. From this date, only compliant products will be placed and made available on the EU market. After this date, products still on the market will be considered as non-compliant. To dig deeper, the new prohibited ingredients are included in the Annex II, and the restricted ingredients in the Annex III.

⚠️Since the regulatory proposal, a change took place concerning Methyl Salicylate. The final version of the regulation authorizes it in toothpastes for children under 6 years old. However, this ingredient will remain prohibited in other preparations intended to children under 6 years of age. Since Methyl Salicylate is a fragrance ingredient usually not disclosed by fragrance suppliers, we advise you to check directly with them (or your contract manufacturer) to ensure the compliance of your cosmetic formulae.

For more details, our team of toxicologists, cosmetologists and regulatory affairs specialists are at your service to ensure your company a safe growth by alleviating your regulatory burden and preventing any legal threat.

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