The European Commission has updated its internal guidance document on the implementation of Regulation (EC) No. 853/2004, which sets forth rules for the hygiene of food of animal origin, to clarify how cultivated meat (also known as “cell-based” or “cultured” meat) and other foods for which no detailed requirements are established should be regulated in accordance with the provision’s requirements.

For certain products of animal origin, (e.g., honey, insects, reptile meat, cultivated meat, and aquatic mammals), Regulation (EC) No. 853/2004 does not establish specific requirements. The guidance clarifies that these foods should be handled in accordance with the relevant requirements laid down in the regulation and with the general rules for products of animal origin.

However, to determine food safety requirements for novel foods of animal origin like cultivated meat and insects, there remains the need for an assessment to be conducted within the novel food authorization framework by the European Food Safety Authority (EFSA). Laying down specific requirements in Annex III of Regulation (EC) No. 853/2004 may be considered in the future if the market share of the foods would increase and significant, specific hazards that need to be addressed are identified, or if new techniques have sufficiently evolved to lay down common, specific requirements without hindering further innovation.

Since these products do not have specific requirements in Annex III of Regulation (EC) No. 853/2004, establishments handling the products do not need to be approved or to apply an identification mark on the food.