European Union (Microbiological Criteria for Foodstuffs) (Amendment) Regulations 2020.
Statutory Instruments
Source: Statutory Instruments

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paragraphs: (1) These Regulations may be cited as the European Union (Microbiological Criteria for Foodstuffs) (Amendment) Regulations 2020.
(2) The Principal Regulations, the European Union (Microbiological Criteria for Foodstuffs) (Amendment) Regulations 2013 ( S.I. No. 301 of 2013 ), the Regulations of 2014 and these Regulations may be cited together as the European Union (Microbiological Criteria for Foodstuffs) Regulations 2012 to 2020.
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paragraphs: In these Regulations—
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paragraphs: Regulation 2(1) (as amended by Regulation 3 of the Regulations of 2014) of the Principal Regulation is amended by substituting for the definition of “EU Regulation” the following:
“‘EU Regulation’ means Commission Regulation (EC) No. 2073/2005 of 15 November 200510 , as amended by Commission Regulation (EC) No. 1441/2007 of 5 December 20074 (as affected by Corrigendum of 20 July 20165 ), Commission Regulation (EU) No. 365/2010 of 28 April 201011 , Commission Regulation (EU) No. 1086/2011 of 27 October 20111 (as affected by Corrigendum of 13 March 20152 ), Commission Regulation (EU) No. 209/2013 of 11 March 201312 , Commission Regulation (EU) No. 1019/2013 of 23 October 20136 (as affected by Corrigendum of 20 July 20167 ), Commission Regulation (EU) 2015/2285 of 8 December 20153 , Commission Regulation (EU) 2019/229 of 7 February 20198 and Commission Regulation (EU) 2020/205 of 14 February 20209 ;”.
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paragraphs: Regulation 8 of the Principal Regulations is amended—
(a) in paragraph (1), by substituting “paragraphs (3), (5), (7), (7A), (7B) and (8)” for “paragraphs (3), (5), (7) and (8)”,
(b) by substituting for paragraph (2)(c) the following:
“(c) 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.”,
(c) by substituting for paragraph (7) the following paragraphs:
“(7) The use of alternative analytical methods is acceptable provided they are—
(a) validated against the specific reference method provided for in Annex I to the EU Regulation in accordance with the protocol set out in standard EN ISO 16140-2, and
(b) validated for the food category specified in the relevant microbiological criterion set in Annex I to the EU Regulation 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.
(7A) Proprietary methods may be used as alternative analytical methods, provided they are—
(a) 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 to the EU Regulation, as provided for in paragraph (7), and
(b) certified by an independent certification body.
(7B) The certification of the proprietary method referred to in paragraph (7A)(b) shall—
(a) be subject, at least every 5 years, to reassessment through renewal procedures,
(b) show that the production process assurance of the manufacturer was evaluated, and
(c) 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.”,
(d) in paragraph (8), by substituting “paragraphs (7), (7A) and (7B)” for “paragraph (7)”, and
(e) in paragraph (9) —
(i) by substituting “paragraphs (3), (5), (7), (7A), (7B) and (8)” for “paragraphs (3), (5), (7) and (8)”, and
(ii) by substituting for subparagraph (c) the following:
“(c) to monitor the processing areas and equipment for Enterobacteriaceae as part of its sampling scheme in the case of a food business operator manufacturing dried infant formulae or dried foods for special medical purposes intended for infants below six months which pose a Cronobacter spp. risk,”.
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paragraphs: The Principal Regulations are amended by inserting after Regulation 21 the following Regulation:
“22. Notwithstanding Regulations 8 and 17(1), a food business operator is not guilty of an offence if, on or before 31 December 2021, he or she uses the alternative analytical methods referred to in Regulation 8(7) prior to its amendment by Regulation 4(c) of the European Union (Microbiological Criteria for Foodstuffs) (Amendment) Regulations 2020 (S.I. No. 425 of 2020).”.