Comparisson between NMKL and ISO methods

Comparisons between NMKL and ISO methods are performed based on the results from PT schemes organized by the National Food Agency in Uppsala, Sweden. See the comparisons here.

The evaluation of the PT illustrate that the NMKL and EN/ISO methods for Listeria monocytogenes, Salmonella, Enterobacteriaceae, aerobic microorganisms, Bacillus cereus, E.coli and coagulase positive Staphylococcus provide equivalent results.

From time to time, NMKL gets questions from private and public laboratories regarding NMKL methods versus ISO methods. They wonder if they can continue using NMKL methods, or if they need to incorporate ISO methods at the laboratory. The reason for the questions is that the methods of analysis referred to in the European Commission Regulation EC 2073/2005 are ISO methods only. However, the Regulation does allow the use of other analytical methods. Article 5, section 5, third and forth paragraph states:

(III) The use of alternative analytical methods is acceptable when the methods are validated against the reference method in Annex I [i.e. ISO standards]  and if a proprietary method, certified by a third party in accordance with the protocol set out in EN/ ISO standard 16140 or other internationally accepted similar protocols, is used.

(IV) If the food business operator wishes to use analytical methods other than those validated and certified as described in paragraph 3 the methods shall be validated according to internationally accepted protocols and their use authorised by the competent authority.

According to (III), methods certified by NordVal International or other certification bodies can be used.

According to (IV), methods validated by standard developing organisations such as NMKL and AOAC International, can be used, as the methods are validated according to internationally accepted protocols, - if authorised by the competent authority. Being linked to the Nordic Council of Ministers, NMKL therefore asked to the Nordic countries to authorise the use of NMKL methods.  

The following responses are received:

From Finland: Evira maintains a list of recommended practices on its website. The above NMKL methods can be used within the limits specified in the table of studies under the Regulation 2073/2005. See the list here.

From Iceland: With reference to Article 5, section 5, fourth paragraph of Commission Regulation (EC) 2073/2005, the Food Safety Authority in Iceland (Matvælastofnun / Icelandic Food and Veterinary Authority) allows that NMKL methods are used in line with ISO methods in microbiological analysis of foodstuffs.

From 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.

National Food Agency, Sweden allows NMKL methods used as an alternative to ISO methods for analysis and sampling pursuant to Regulation 2073/2005.