‘Free of’ claims – guidance and recommendations from the French Competent Authority (ANSM)

The French National Agency for the Safety of Medicines and Health Products (ANSM) has supported the Directorate-General for Competition, Consumption and the Suppression of Fraud (DGCCRF) in the development of joint recommendations on the affixing of certain claims on cosmetic products. The recommendations focus on claims concerning the absence of various substances in the composition of cosmetic products [1].

This article intends to guide manufacturers, importers and distributors of cosmetic products sold in France on the use of this type of claims, but it is highly recommended for it to be taken into consideration by the other EU Member States as well.

Claims are statements that can appear under the form of a text, image or symbol on the label or packaging of a product.

In addition to the list of ingredients, certain “free of” claims can help consumers choose a product, in particular with regards to their possible health problems: allergies, skin sensitized by treatments, accidents or simply due to their lifestyle.

On July 3, 2017, the sub-working group on claims released the updated Technical document on cosmetic claims [2] and, as of July 1, 2019, the guidance related to “free from” and hypoallergenic claims has become applicable to all Member States. Despite its purpose of clarifying the proper use of certain claims, the document has raised many questions from professionals.

In order to address some of these questions, the document presents multiple examples [3] of claims that cannot be accepted and explains the existing exceptions as per the below:

  • “Free of” banned substances claims and claims on characteristics already required by the regulation (such as ‘not tested on animals’) are not allowed;
  • “Free of” claims which cannot be verified are contrary to criteria of “Truthfulness” and “Evidential support” of Regulation n ° 655/2013 (such as ‘’free of endocrine disruptors’’, ‘’free of allergens’’ and others);
  • Claims “free of [name of substance]” for controlled or authorized substances, but which are controversial, should be avoided, if the absence of these substances is clearly identifiable by consulting the INCI list. These claims could lead consumers to switch to other products less suitable for the intended use (ex: “free of triclosan”, “free of paraffin”, “free of sodium laureth sulfate” – substances identifiable by their INCI name);
  • Claims which relate to a chemical family of substances, some of which are prohibited and others permitted, are not allowed so as not to create unfounded fear or confusion to the consumers (ex: ‘’free of parabens’’, ‘’free of phthalates’’, ‘’free of nanomaterials’’ and others).

Claims providing useful information that is not easily detectable in the list of ingredients are allowed. These claims, which must be assessed on a case-by-case basis according to the target public and their relevance with regard to criterion  “Informed choice” of the Regulation (EU) No 655/2013, may relate to a substance in particular or a group of substances. Some of the examples are: “free of sulfates”, “free of mineral oils”, “free of alcohol”, “free of/without soap”, “free of GMO”, “free of ingredients / substances of animal origin” or “vegan”, “free of preservatives” (provided that the product does not contain any substance with antimicrobial effect), “fragrance-free” (provided that no fragrance substance is present), “acetone-free” (for nail polish and others).

Please feel free to consult the entire document by accessing this link.

Bianca Sofian

Junior Consultant, Regulatory Affairs & Quality Assurance Department

26th of June 2020

If you wish to know more about the Cosmetics Regulation and the novelties therein, please do not hesitate to contact us.

Obelis Expert Consultants, with more than 30 years of experience with EU Regulations, will gladly answer any question you may have and will assist you in safeguarding your products’ compliance.

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[1] Article of ANSM ‘L’ANSM et la DGCCRF publient des recommandations à destination de l’industrie cosmétique pour une meilleure utilisation des allégations “sans“, 16/04/2020

[2] It should be noted that the technical document is not a normative text of the European Commission and, as such, not legally enforceable. However, this document is used as a strong basis of claims use and application by the Competent Authorities of the EU Member States.

[3] Allégations “sans” dans les produits cosmétiques : précisions des autorités de contrôle

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