Changes to Labelling Requirements Under Review

    The Spanish Royal Decree on Accessible Labelling – available on the TRIS system under TRIS Notification (2025/0311/ES) – introduces mandatory requirements to ensure that essential consumer products are labelled in formats accessible to people with disabilities, particularly those with visual impairments.  

    The type of products identified as essential is included in its Annexes and encompasses cosmetics, food, hazardous substances and mixtures.

    The Decree:

          • Mandates the use of Braille, QR codes with tactile markers, or other accessible technologies to communicate key product information clearly and comprehensibly. 

          • Applies to manufacturers, importers, and distributors placing products on the Spanish market (but excludes bulk goods and goods packaged at the point of sale).

          • Outlines specific labelling content requirements, including product identity, composition, usage instructions, and allergen information, with much of this information required to be in Spanish.

    The deadline for submitting contributions is 23 September 2025 (next Tuesday).

    Below is a summary of the major concerns identified for the Food Supplements business:

          • Conflict with the EU Harmonised Framework & Infringement of EU Single Market Principles

            The proposed Decree adds additional labelling conditions at the national level, which go beyond the objectives of the EU harmonised framework and create fragmentation within the Union market. 

            It also conflicts with the Treaty on the Functioning of the European Union (TFEU) by requiring food business operators to create and adapt packaging exclusively for the Spanish market.

          • Technical Challenges

            There are inherent space limitations for the amount of Braille information that can fit on a package. The Braille standard requires each character to be at least 6.2 to 6.6 mm wide, and that the lines be 1 cm in height.

            Given that the labels for Food Supplements are subject to an extensive mandatory information requirements, replicating all of this information in Braille is technically impossible. Additionally, Braille embossing is not feasible on many common packaging materials used in Food Supplements, such as flexible plastics, blisters or metallic foils. 

            Braille labelling must also be included in a way that does not overlap with the existing texts, requiring larger labels and potentially leading to overpackaging, which would increase packaging waste and contradict the objectives of the European Packaging and Packaging Waste Regulation (PPWR).

          • Transition Period 

            The proposed Decree foresees immediate entry into force, with a two-year sell-off period for existing stock.

            Since production lines would require significant technical modifications to accommodate Braille embossing and tactile codes, this situation would likely promote packaging waste, substantially increase costs, and potentially force operators to withdraw certain products from the Spanish market.