Commission Implementing Decision of 12 November 2013 on the monitoring and reporting of antimicrobial resistance in zoonotic and commensal bacteria (notified under document C(2013) 7145) (Text with EEA relevance) (2013/652/EU)

Article 1 U.K. Subject matter [F1 , definitions] and scope

1. This Decision lays down detailed rules for the F2 ... monitoring and reporting of antimicrobial resistance (AMR) F3 ....

That monitoring and reporting shall cover the following bacteria obtained from samples from certain food-producing animal populations and certain food:

(a) Salmonella spp.;

(b) Campylobacter jejuni and Campylobacter coli (C. jejuni and C. coli);

(c) Indicator commensal Escherichia coli (E. coli);

(d) Indicator commensal Enterococcus faecalis and Enterococcus faecium (E. faecalis and E. faecium).

2. This Decision lays down specific requirements for the F4 ... monitoring and reporting of the Salmonella spp., and E. coli producing the following enzymes in certain food-producing animal populations and in certain food:

(a) Extended-Spectrum β-Lactamases (ESBL);

(b) AmpC β-Lactamases (AmpC);

(c) Carbapenemases.

[F5 3. In this Decision, ‘appropriate authority’ means—

(a) in relation to England, the Secretary of State;

(b) in relation to Wales, the Welsh Ministers;

(c) in relation to Scotland, the Scottish Ministers;

(d) in relation to Northern Ireland, the Department for Agriculture, Environment and Rural Affairs;

but, in relation to Scotland, the appropriate authority is the Secretary of State if consent is given by the Scottish Ministers.]

Textual Amendments

F1 Word in Art. 1 heading inserted (31.12.2020) by The Zoonotic Disease Eradication and Control (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/740), regs. 1, 11(2)(a); 2020 c. 1, Sch. 5 para. 1(1)

F2 Word in Art. 1(1) omitted (31.12.2020) by virtue of The Zoonotic Disease Eradication and Control (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/740), regs. 1, 11(2)(b)(i); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in Art. 1(1) omitted (31.12.2020) by virtue of The Zoonotic Disease Eradication and Control (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/740), regs. 1, 11(2)(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F4 Word in Art. 1(2) omitted (31.12.2020) by virtue of The Zoonotic Disease Eradication and Control (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/740), regs. 1, 11(2)(c); 2020 c. 1, Sch. 5 para. 1(1)

F5 Art. 1(3) inserted (31.12.2020) by The Zoonotic Disease Eradication and Control (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/740), regs. 1, 11(2)(d); 2020 c. 1, Sch. 5 para. 1(1)

Article 2 U.K. Sampling framework and collection of isolates F6 ...

1. [F7 The appropriate authority must] ensure the sampling for the monitoring of AMR in accordance with the technical requirements set out in Part A of the Annex.

2. [F8 The appropriate authority must] collect representative isolates of the following bacteria in accordance with the technical requirements set out in the part A of the Annex:

(a) Salmonella spp.;

(b) C. jejuni;

(c) Indicator commensal E. coli; and

(d) ESBL- or AmpC- or carbapenemase-producing Salmonella spp. and E. coli.

3. [F9 The appropriate authority] may collect representative isolates of the following bacteria provided that they do so in accordance with the technical requirements set out in Part A of the Annex:

(a) C. coli;

(b) Indicator commensal E. faecalis and E. faecium.

Textual Amendments

F6 Words in Art. 2 heading omitted (31.12.2020) by virtue of The Zoonotic Disease Eradication and Control (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/740), regs. 1, 11(3)(a); 2020 c. 1, Sch. 5 para. 1(1)

F7 Words in Art. 2(1) substituted (31.12.2020) by The Zoonotic Disease Eradication and Control (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/740), regs. 1, 11(3)(b); 2020 c. 1, Sch. 5 para. 1(1)

F8 Words in Art. 2(2) substituted (31.12.2020) by The Zoonotic Disease Eradication and Control (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/740), regs. 1, 11(3)(b); 2020 c. 1, Sch. 5 para. 1(1)

F9 Words in Art. 2(3) substituted (31.12.2020) by The Zoonotic Disease Eradication and Control (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/740), regs. 1, 11(3)(c); 2020 c. 1, Sch. 5 para. 1(1)

Article 3 U.K. Isolates of Salmonella spp. obtained by food business operators

Where, due to a low bacterial prevalence or a low number of epidemiological units in [F10 the United Kingdom] the minimum number of Salmonella spp. isolates collected by the competent authority during official controls in accordance with point 1(a) of Part A of the Annex is not sufficient to achieve the minimal required number of isolates to be tested for antimicrobial susceptibility, the competent authority may use isolates obtained by food business operators provided that such isolates have been obtained by the food businesses operator in accordance with the following provisions:

(a)

the F11 ... control programme provided for in Article 5 of Regulation (EC) No 2160/2003;

(b)

the process hygiene criteria set out in points 2.1.3, 2.1.4 and 2.1.5 of Chapter 2 of Annex I to Regulation (EC) No 2073/2005.

Textual Amendments

F10 Words in Art. 3 substituted (31.12.2020) by The Zoonotic Disease Eradication and Control (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/740), regs. 1, 11(4)(a); 2020 c. 1, Sch. 5 para. 1(1)

F11 Word in Art. 3(a) omitted (31.12.2020) by virtue of The Zoonotic Disease Eradication and Control (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/740), regs. 1, 11(4)(b); 2020 c. 1, Sch. 5 para. 1(1)

Article 4 U.K. Analysis by national reference laboratories

1. National reference laboratories for AMR shall perform the following analysis:

(a) the antimicrobial susceptibility testing of the isolates set out in points 2 and 3 of Part A of the Annex;

(b) the specific monitoring of ESBL- or AmpC- or carbapenemase-producing Salmonella spp. and E. coli set out in point 4 of Part A of the Annex.

2. The competent authority may designate laboratories other than the national reference laboratory for AMR in accordance with Article 12 of Regulation (EC) No 882/2004 to perform the analysis provided for in paragraph 1.

Article 5 U.K. Assessment and reporting

[F12 The appropriate authority must] assess the results of the AMR monitoring provided for in Articles 2 and 3 and [F13 publish an annual report on that assessment].

Textual Amendments

F12 Words in Art. 5 substituted (31.12.2020) by The Zoonotic Disease Eradication and Control (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/740), regs. 1, 11(5)(a); 2020 c. 1, Sch. 5 para. 1(1)

F13 Words in Art. 5 substituted (31.12.2020) by The Zoonotic Disease Eradication and Control (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/740), regs. 1, 11(5)(b); 2020 c. 1, Sch. 5 para. 1(1)

F14 Article 6 U.K. Publication and confidentiality of the data

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Textual Amendments

F14 Arts. 6-9 omitted (31.12.2020) by virtue of The Zoonotic Disease Eradication and Control (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/740), regs. 1, 11(6); 2020 c. 1, Sch. 5 para. 1(1)

F14 Article 7 U.K. Repeal

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Textual Amendments

F14 Arts. 6-9 omitted (31.12.2020) by virtue of The Zoonotic Disease Eradication and Control (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/740), regs. 1, 11(6); 2020 c. 1, Sch. 5 para. 1(1)

F14 Article 8 U.K. Application

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Textual Amendments

F14 Arts. 6-9 omitted (31.12.2020) by virtue of The Zoonotic Disease Eradication and Control (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/740), regs. 1, 11(6); 2020 c. 1, Sch. 5 para. 1(1)

F14 Article 9 U.K. Addressees

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Textual Amendments

F14 Arts. 6-9 omitted (31.12.2020) by virtue of The Zoonotic Disease Eradication and Control (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/740), regs. 1, 11(6); 2020 c. 1, Sch. 5 para. 1(1)

Done at Brussels, 12 November 2013.

For the Commission

Tonio Borg

Member of the Commission