Don’t miss our content
SubscribeOn July 14, 2025, Infarmed published an Informative Circular regarding claims in Cosmetic Products.
The use of allegations related to cosmetic products is regulated at the EU level through the Commission’s Regulation (EU) No. 655/2013, of July 10. The diploma establishes the rules and common criteria to use the claims in the labeling, marketing and advertising of cosmetic products, in their various forms, including text claims, designations, brands, photographs, images or other signs that explicitly or implicitly transmit characteristics or functions of the product.
The issuance of these guidelines comes as a result of market surveillance activities conducted by Infarmed, during which Infarmed identified several cosmetic products with the typical claims known as “free form”. In particular, these claims referred to the absence of parabens, phenoxyethanol, PED, silicones, mineral oils, sodium lauryl sulfate or ingredients of animal origin.
Infarmed has questioned the legitimacy of use of this type of claims in the past, as it considers they violate two of the common criteria set out in the Regulation, namely, Impartiality and Informed Decision-Making by Consumers.
From Infarmed’s perspective, these claims are susceptible of “denigrating ingredients that are safe and permitted for use in cosmetic products”. Since these are substances allowed in the composition of cosmetic products, stating that a given product does not contain the ingredient has a negative effect on the ingredient itself. In turn, this negative effect impacts the consumers’ ability to make informed decisions, insofar as it “creates distrust among consumers regarding authorized ingredients, preventing them from making a properly informed choice when purchasing the respective cosmetic product”.
The main novelty introduced by this Circular is that Infarmed no longer applies this reasoning to claims referring to mineral oils and ingredients of animal origin. Regarding these, Infarmed acknowledges that such claims can serve as a means to provide relevant information to the consumers which, due to medical reasons (such as allergies, skin sensitivity, accidents or medical procedures), to lifestyle choices or ethical, environmental or spiritual reasons choose to avoid such substance or group of substances.
This was already the understanding shared by the Sub-Working Group on Claims, cited by Infarmed in an Informative Circular from 2018 on the same topic, which did not consider the declaration regarding the absence of mineral oils to be contrary to the Regulation, provided it did not itself contain a value judgment about the substance, as would be the case with a claim such as “well tolerated, as it does not contain mineral oils”.
Authorities in other Member States of the European Union have also shared this understanding. In France, the ANSM – Agence Nationale de Sécurité du Médicament and the DG CCRF – Direction Générale de la Consommation, de la Concurrence et de la Répression des Fraudes had already stated that claims regarding the absence of mineral oils are admissible, as they allow relevant information to be provided to consumers who may prefer products without mineral oils.
Infarmed emphasizes that economic operators who place cosmetic products on the market must adapt their products, implementing the necessary corrective measures to ensure their compliance regarding claims, in accordance with the new guidelines from the authority. It should be noted that, since the entry into force of the new legislation on cosmetic products (Decree-Law No. 23/2025, of March 19), Infarmed has the power, within the scope of administrative offense procedures, to impose accessory sanctions, which may include the suspension of the economic operator’s activity.
Don’t miss our content
Subscribe