Amendments to Regulation (EC) No 2073/2005

Regulation (EC) No 2073/2005 is amended as follows:

in Article 2 the following points are inserted after point (m):

“a broad range of foods”, as referred to in EN ISO 16140-2, means food as defined by the first subparagraph of Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council ( *1 ) ;

“independent certification body” means a body which is independent from the organisation that manufactures or distributes the alternative method and which provides a written assurance, in the form of a certificate, testifying that the validated alternative method meets the requirements of EN ISO 16140-2;

“production process assurance of the manufacturer” means a production process whose management system guarantees that the validated alternative method remains conform to the characteristics required by EN ISO 16140-2 and ensures that mistakes and defects in the alternative method are prevented;

( *1 ) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety ( OJ L 31, 1.2.2002, p. 1 ).’;"

Article 5 is amended as follows:

the third subparagraph of paragraph 2 is replaced by the following:

‘Food business operators manufacturing dried infant formulae or dried foods for special medical purposes intended for infants below six months, which pose a Cronobacter spp. risk shall monitor the processing areas and equipment for Enterobacteriaceae as part of their sampling scheme.’;

the third and fourth subparagraphs of paragraph 5 are replaced by the following:

‘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.

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.

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.

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.’;

Annex I is amended in accordance with the Annex to this Regulation.

COMMISSION REGULATION (EU) 2019/229 of 7 February 2019 amending Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs as regards certain methods, the food safety criterion for ANNEX