Cosmetic Product Rules Revamped

On March 19, 2025, Decree-Law No. 23/2025 was published which establishes the new legal framework for the introduction of cosmetic products in the Portuguese market.

This Decree-Law, which repealed Decree-Law No. 189/2008, of September 24, is primarily aimed at bolstering the implementation of Regulation (EC) No. 1223/2009, that sets forth the standards that cosmetic products must adhere to in order to ensure the smooth operation of the internal market and to provide a high level of protection for human health, within the Portuguese market.

The new regime brings a complete shift to the current reality of the cosmetics sector in Portugal, as the activities related to the introduction of cosmetics into the market are now regulated and subject to Infarmed’s supervisory powers. Thus, the regime is no longer focused solely on the conformity of the cosmetic products themselves, but also on the activity related to the products.

Activities Subject to Notification and Associated Special Obligations

In this regard, all those who engage in the activities of manufacturing, importation, or first introduction into the market of cosmetic products must register their activity on the platform of Infarmed, created for this purpose.

Furthermore, Decree-Law No. 23/2025 stipulates that all those engaged in the activities of manufacturing, importing, or distributing cosmetic products must fulfill special obligations such as:

• Having suitable facilities and equipment capable of manufacturing, storing, and preserving cosmetic products;
• Storing and transporting cosmetic products separately from other products;
• Ensure the availability of qualified and authorized personnel for the functions to be performed;
• For subcontracted activities, have written contracts that describe the subcontracted activities and define the different responsibilities;
• Draft and maintain SOPs that outline the company's activities;
• Among other obligations specified in the regime.

It should be noted that there is a transitional period for companies to adapt to this new reality. The Decree-Law provides that the registration of the activities must take place within 180 days from the launching of the electronic platform that will be created by Infarmed for this purpose. Considering that this transition period only begins to count from the moment the platform is created by Infarmed, the adaptation period to this new reality may be extensive.

In this regard, specific measures are now foreseen that Infarmed may adopt whenever the entity that manufactures and distributes cosmetics does not comply with the obligations stipulated for the activity. In particular, Infarmed can suspend or close the establishment, manufacturing sites, or storage sites.

In addition to the foregoing, there are further changes brought by the new regime worth highlighting:

• Good Distribution Practices: wholesale distributors, as well as retailers who sell directly to the final consumer, will have to comply with the Good Distribution Practices of Cosmetic Products, which will be established for this purpose by Infarmed.
• Availability in Bulk: the regime defines that only retailers can make non-prepackaged cosmetic products available at the point of sale at the buyer's request or prepackaged for sale. For this purpose, it is required that the material used is demonstrated to be suitable, with an indication of the responsible person, to ensure that the material is sanitized and clean. Also, in any operation where products are made available individually, it is important to include on the labeling of the fractionated product the information related to the correct identification of the original product, including the list of ingredients and the batch code.
• Sanctions Framework: the Decree-Law introduces an update to the penalty regime, not only by increasing the penal framework for very serious and serious administrative offenses, but also by introducing the possibility for Infarmed to enforce accessory sanctions whenever justified, considering the severity of the offense and the agent’s fault.

In summary, Decree-Law No. 23/2025 marks a crucial reinforcement in the regulation of cosmetic products in Portugal, aligning national standards more closely with the requirements established by European legislation. By ensuring that the regulation now covers not only the cosmetic products, but the activities related thereto, it is expected that this Decree-Law will bring much novelty to the sector, ultimately ensuring the safety and quality of the activities and cosmetic products in the Portuguese market.