Use of NMKL microbiology methods and NordVal certified methods in line with EC 2073/2005
- The microbiology methods certified by the certification body NordVal International can be used since the process meets the requirements in subparagraphs III, IV and V.
- The NMKL microbiology methods that are validated in an interlaboratory study according to internationally accepted protocols and can be used, according to subparagraph VI, if authorised by the competent authority.
Authorization of NMKL methods in Nordic-Baltic countries
With respect to the EU Regulation 2073/2005 Article 5, Paragraph 5, the respective national food safety authorities can authorize that interlaboratory validated microbiology methods from NMKL can be used as an alternative methods for food analyses.
Norway: The Norwegian Food Safety Authority allows that NMKL methods are used as an alternative to the ISO methods in accordance with EU Regulation 2073/2005. A comparison of EN/ISO methods and NMKL methods has been presented to ESA on several occasions, and ESA has accepted the comparison. Generally, NMKL methods are at least as well tested as EN/ISO methods before being accepted. Authorization year: 2022.
NMKL microbiology methods and conformity
Comparisons of NMKL microbiology methods to ISO methods have been performed using results from PT schemes organized by the National Food Agency in Uppsala, Sweden. The evaluation of the PT illustrates that the NMKL and EN/ISO methods for Listeria monocytogenes, Salmonella, Enterobacteriaceae, aerobic microorganisms, Bacillus cereus, E. coli and coagulase positive Staphylococcus provided equivalent results.
EC 2073/2005 on microbiological criteria for foodstuffs
The methods of analysis referred to in the European Commission Regulation EC 2073/2005 on microbiological criteria for foodstuffs are ISO methods only.
However, EC 2073/2005 allows for the use of other validated analytical methods according to Article 5, Paragraph 5, third, forth, fifth and sixth subparagraph (Amendment (EU) 2019/229):
III
The use of alternative analytical methods is acceptable provided they are:
— validated against the specific reference method provided for in Annex I in accordance with the protocol set out in standard EN ISO 16140-2, and
— validated for the food category specified in the relevant microbiological criterion set in Annex I the compliance with which is verified by the food business operator, or validated for a broad range of food as referred to in EN ISO 16140-2.
IV
Proprietary methods may be used as alternative analytical methods, provided they are:
— validated, in accordance with the protocol set out in standard EN ISO 16140-2, against the specific reference method provided for verifying compliance with the microbiological criteria laid down in Annex I, as provided for in the third subparagraph, and
— certified by an independent certification body.
V
The certification of the proprietary method referred to in the second indent of the fourth subparagraph shall:
— be subject, at least every 5 years, to reassessment through renewal procedures,
— show that the production process assurance of the manufacturer was evaluated, and
— 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.
VI
Food business operators may use other analytical methods than those validated or certified as provided for in the third, fourth and fifth subparagraphs, where such methods have been validated in accordance with internationally accepted protocols and their use has been authorised by the competent authority.