Cosmetics: New rules for the reporting of undesirable effects

The approval of Decree-Law No. 23/2025, of 19 March 2025, has, as analysed in greater detail in our previous post, implemented and reinforced the application of Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of 30 November 2009, harmonising the criteria that cosmetic products must meet in order to ensure the proper functioning of the internal market, while providing a high level of protection of human health.

The previous Decree-Law No. 148/2008 (now repealed) did not provide for specific rules on the reporting of undesirable effects. Nevertheless, in Portugal, a system for reporting undesirable effects and serious undesirable effects was already in place as a result of the application of Article 23 of Regulation (EC) No. 1223/2009 and the European Commission’s Guidelines on the reporting of serious undesirable effects.

Now, with the approval of Decree-Law No. 23/2025, there is also, at national level, a provision specifically dedicated to the reporting of undesirable effects and serious undesirable effects by the responsible person, distributors, consumers, healthcare professionals and professionals who, in the course of their professional activity, apply or use cosmetic products, namely Article 11.

However, the specific rules governing the reporting of undesirable effects still had to be defined by means of a regulation. Accordingly, INFARMED, as the authority responsible for the national cosmetovigilance system, approved Regulation No. 324/2026, of 18 March, which approves the regulation on the reporting of undesirable effects related to the use of cosmetic products.

In practical terms, this Regulation puts into writing what was already standard practice in Portugal. In this context, we highlight the main points arising from the Regulation:

• Personal scope: the Regulation defines the personal scope of its application, providing that the rules on reporting undesirable effects, including serious undesirable effects, relating to cosmetic products apply to the person responsible for placing the product on the market, the distributor of cosmetic products, as well as consumers themselves, healthcare professionals or other professionals who apply/use such cosmetics in Portugal.

• Obligations of the responsible person: the Regulation provides that, upon becoming aware of potential undesirable effects, the responsible person for cosmetic products must gather and analyse the information, assess the risks and, where necessary, adopt corrective/restrictive measures to bring the cosmetic products back into compliance.

• Obligation of the distributor: it further provides that, upon becoming aware of undesirable effects of a cosmetic product, distributors must inform the responsible person or the supplier of their existence.

• Reporting of undesirable effects: the Regulation provides that the persons concerned must report through the Reporte! application available on INFARMED’s website. Nevertheless, we note that the reporting of undesirable effects is merely optional (cf. Article 11(1) of Decree-Law No. 23/2025).

• Reporting of serious undesirable effects: in turn, the reporting of serious undesirable effects – which is mandatory for the responsible person and distributors under Article 11(2) of Decree-Law No. 23/2025 – must follow the European Commission’s Guidelines on the reporting of serious undesirable effects, and in particular must be made as promptly as possible and by completing the specific “SUE A — serious undesirable effect form A” form — available on INFARMED’s website — and sending it by email to the address indicated on the website. The Regulation also provides that distributors may be exempt from complying with the obligation to report serious undesirable effects where such reporting has already been carried out by the responsible person, although the specific conditions for that exemption are not clarified.

• Minimum content of reports: the Regulation sets out the information that reports must contain, namely: (i) product identification (name, brand and batch number); (ii) description of the identified effect; (iii) details of the notifier and of the affected user (if different); and (iv) relevant additional information, namely the method of use/application and/or relevant clinical history, among other elements.

• Analysis of the information: INFARMED may, if it deems appropriate, request any additional information from any of the entities so that it can validate the causal link and the risk management measures adopted, and those entities must cooperate by providing the requested elements.

In summary, Regulation No. 324/2026 formalises, through an INFARMED Regulation, the practice already in place for the reporting of undesirable effects (including serious undesirable effects) arising from the application/use of cosmetic products. Although this Regulation does not introduce new developments regarding how undesirable effects are to be reported in the cosmetics sector, it reinforces the commitment to cosmetics market surveillance and, consequently, promotes clarity and the safe use of cosmetic products on the Portuguese market.

This Regulation will take effect 30 days after its publication, specifically on 18 April.