This Decree-Law repeals the former Decree-Law no. 189/2008, introducing a more stringent regulatory framework fully aligned with European Union standards. Its primary objectives are to reinforce public health protection, ensure consumer safety, and secure product compliance in the national market.

Decree-Law no. 23/2025 represents a comprehensive overhaul of the previous regime, with the following notable changes:

– Increased accountability for economic operators, with particular emphasis on the role of the “responsible person” for placing the product on the market, whose duties are now more clearly defined and broadened.

– Stricter requirements regarding labelling and consumer information, including details on product composition, expiry dates, and specific warnings.

– Explicit provisions for corrective measures and product recalls in cases of non-compliance with legal safety and conformity standards.

– Expanded powers for the ASAE (Portuguese Authority for Food and Economic Safety) and other competent supervisory authorities, particularly concerning inspection, seizure, and sanctioning.

– A new sanctioning regime, with a detailed classification of administrative offences and proportionate fines based on the severity of the infringement.

Practical Implications for Industry Stakeholders

With the entry into force of this new framework, economic operators — manufacturers, importers, distributors, and retailers — are expected to review and, where necessary, adapt their internal procedures, including:

– Ensuring technical compliance of their products, through the preparation and maintenance of the Product Information File (PIF) and the Cosmetic Product Safety Report.

– Reviewing packaging and labelling, to ensure compliance with the requirements concerning legibility, language, mandatory content, and standardized symbols.

– Updating supply and distribution agreements, to accurately reflect the new legal responsibilities of all parties involved.

– Training and raising awareness among marketing and sales teams, especially regarding the prohibition of misleading claims and the obligation to provide consumers with clear, complete, and accurate information.

Belzuz Abogados S.L.P. – Portugal Branch has a multidisciplinary team with extensive experience in the regulatory oversight of highly regulated sectors, including the cosmetic products industry. Our services include legal compliance assessments of products and operational procedures; drafting and reviewing technical documentation; contract review and adaptation in light of new legal obligations; legal assistance in administrative proceedings and sanctioning procedures before competent authorities.