Commission Implementing Regulation (EU) 2024/2463 of 12 September 2024 laying down analytical methods applicable to official controls performed for the verification of compliance of food business operators with Regulation (EC) No 2073/2005

1 When analysing samples taken during official controls performed to verify compliance with the rules and criteria laid down in Regulation (EC) No 2073/2005, official laboratories designated by the competent authorities in accordance with Article 37 of Regulation (EU) 2017/625 shall use the analytical reference methods referred to in Annex I to Regulation (EC) No 2073/2005.

2 By way of derogation from paragraph 1, the competent authorities may authorise designated official laboratories to use alternative analytical methods, including proprietary methods, provided these alternative analytical methods are validated against the analytical reference methods referred to in Annex I to Regulation (EC) No 2073/2005 in accordance with the protocol set out in standard EN ISO 16140-2 and are validated either for the food category specified in the relevant microbiological criterion set in Annex I to Regulation (EC) No 2073/2005 or for a broad range of food as referred to in standard EN ISO 16140-2. The competent authorities may also authorise designated official laboratories to use alternative analytical methods if these alternative analytical methods are validated in accordance with other internationally accepted scientific protocols.

3 When alternative methods referred to in paragraph 2 are proprietary methods, they shall be certified by an independent certification body. The certification shall include a summary of or a reference to the validation results of the proprietary method and a statement on the quality management of the production process of the method. The certification shall show that the production process assurance of the manufacturer was evaluated and be subject, at least every 5 years, to reassessment through renewal procedures.

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.