Regulation of chemical-unlike biological substances used in food-producing species

On 3 June 2025, the EU Commission published a number of legal acts relating to the regulation of residues of chemical-unlike biological substances. This development will help applicants involved in the development of biological substances intended for food-producing species. 

• Commission Regulation (EU) 2025/1101 of 3 June 2025 amending Regulation (EU) 2018/782 concerning the assessment by the European Medicines Agency of maximum residue limits for chemical-unlike biological substances
• Commission Implementing Regulation (EU) 2025/1102 of 3 June 2025 amending Regulation (EU) No 37/2010 as regards chemical-unlike biological substances
• Commission Implementing Regulation (EU) 2025/1103 of 3 June 2025 amending Implementing Regulation (EU) 2017/12 as regards the requirements for applications and requests for the establishment of a no MRL required classification for chemical-unlike biological substances