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)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC (1), and in particular Article 7(3) and the fourth subparagraph of Article 9(1) thereof,
Whereas:
(1)
Directive 2003/99/EC provides that Member States are to ensure that monitoring provides comparable data on the occurrence of antimicrobial resistance (AMR) in zoonotic agents and, in so far they present a threat to public health, other agents.
(2)
Directive 2003/99/EC also provides that Member States are to assess the trends and sources of AMR in their territory and transmit to the Commission every year a report covering data collected in accordance with that Directive.
(3)
In the Communication of 15 November 2011 from the Commission to the European Parliament and the Council - Action Plan against the rising threats from Antimicrobial Resistance (2), the Commission proposes to put in place a five-year action plan to fight against AMR based on 12 key actions, including strengthened surveillance systems on AMR.
(4)
In the Council Conclusions of 22 June 2012 on the impact of antimicrobial resistance in the human health sector and in the veterinary sector - a One Health Perspective (3), that Institution calls upon the Commission to follow up on its Communication of 15 November 2011 through concrete initiatives to implement the 12 actions set out in that Communication, and to collaborate closely with the European Centre for Disease Prevention and Control (ECDC), the European Food Safety Authority (EFSA) and the European Medicines Agency (EMA) in strengthening the assessment and evaluation of the occurrence of AMR in humans, in animals and in food in the Union.
(5)
During its plenary sitting of 11 December 2012, the Parliament adopted a Report on the Microbial Challenge - Rising threats from Antimicrobial Resistance (4). In that Report, the Parliament welcomes the Commission’s five-year action plan on tackling AMR and considers that the measures recommended in it need to be implemented as soon as possible. The Parliament, in particular, calls on the Commission and the Member States to seek greater cooperation and coordination on the early detection, alert and coordinated response procedures regarding pathogenic antimicrobial resistant bacteria in humans, animals, fish and foodstuffs in order to continuously monitor the extent and growth of AMR.
(6)
Under its Joint FAO/WHO Food Standards Programme, the Codex Alimentarius Commission adopted, during its 34th session in Geneva, the Guidelines for the Risk Analysis of Foodborne Antimicrobial Resistance (5) which highlight AMR as a major global public health concern and a food safety issue. The use of antimicrobial agents in food-producing animals and crops is a potentially important risk factor for the selection and dissemination of AMR microorganisms and determinants from animals and food crops to humans via the consumption of food.
(7)
Those Codex Guidelines conclude, inter alia, that surveillance programmes on the prevalence of foodborne AMR provide information that is useful for all parts of the AMR risk analysis process. The methodology of surveillance programmes should be internationally harmonised as far as possible. The use of standardised and validated antimicrobial susceptibility testing methods and harmonised interpretive criteria are essential to ensure that data are comparable.
(8)
The Terrestrial Animal Health Code of the World Animal Health Organisation (OIE) (6) in its Chapter 6.7 on ‘Harmonisation of National AMR Surveillance and Monitoring programmes’, underlines the need for the surveillance and monitoring of AMR in order to assess and determine the trends and sources of AMR in bacteria, to detect the emergence of new AMR mechanisms, to provide the data necessary for conducting risk analyses that are relevant to animal and human health, to provide a basis for policy recommendations for animal and human health and to provide information for evaluating antimicrobial prescribing practices and for prudent use recommendations.
(9)
On 9 July 2008, the EFSA adopted a Scientific Opinion on Foodborne antimicrobial resistance as a biological hazard (7). On 28 October 2009, the ECDC, the EFSA, the EMA and the Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) published a joint scientific opinion on antimicrobial resistance focused on infections transmitted to humans from animals and food (zoonoses) (8). On 5 March 2009, the EFSA adopted a scientific opinion on the assessment of the public health significance of meticillin resistant Staphylococcus aureus (MRSA) (9). On 7 July 2011, the EFSA adopted a scientific opinion on the public health risks of bacterial strains producing extended-spectrum β-lactamases (ESBL) and/or AmpC β-lactamases (AmpC) in food and food-producing animals (10). On 3 October 2011, the EFSA adopted a technical report on EFSA approaches to risk assessment in the area of antimicrobial resistance, with an emphasis on commensal microorganisms (11). The main conclusion of all those opinions and reports is that, in view of the increasing public health concern regarding AMR, the use of harmonised methods and epidemiological cut-off values is necessary to ensure the comparability of data over time at Member State level, and also to facilitate the comparison of the occurrence of AMR between Member States.
(10)
On 14 June 2012, the EFSA published a scientific report on technical specifications on the harmonised monitoring and reporting of antimicrobial resistance in Salmonella, Campylobacter and indicator commensal Escherichia coli and Enterococcus spp. bacteria transmitted through food (12). On 5 October 2012, the EFSA published a scientific report on technical specifications on the harmonised monitoring and reporting of antimicrobial resistance in methicillin-resistant Staphylococcus aureus (MRSA) in food-producing animals and food (13). Those scientific reports recommend detailed rules for harmonised monitoring and reporting on the prevalence of resistant microorganisms in food-producing animals and food, in particular as regards the microorganisms to be included, the origin of the isolates of the microorganisms, the number of isolates to be tested, the antimicrobial susceptibility tests to be used, the specific monitoring of MRSA and ESBL- or AmpC-producing bacteria and the collection and reporting of the data. The involvement of the ECDC in this work will ensure the comparison between the data of the food-producing animals and food sector and the data of the human sector.
(11)
In accordance with the findings of those reports and opinions, when defining the combinations of bacterial species, food-producing animal species and food products to be included in the harmonised monitoring and reporting of AMR, it is important to prioritise the most relevant from a public health perspective. In order to minimise the burden, the monitoring should be derived as much as possible from biological samples or isolates collected in the framework of national control programmes that have already been established.
(12)
Regulation (EC) No 2160/2003 of the European Parliament and of the Council (14) provides that Member States are to establish national control programmes which are to include sampling for the testing of Salmonella spp. at different stages of the food chain. Commission Regulation (EC) No 2073/2005 (15) lays down the microbiological criteria for certain microorganisms and the rules to be complied with by food business operators. In particular the competent authority is to ensure that food businesses operators comply with the rules and criteria laid down in that Regulation in accordance with Regulation (EC) No 882/2004 of the European Parliament and of the Council (16). The monitoring of AMR in Salmonella spp. should be focused on isolates obtained from the national control programmes and from the testing and verification of compliance set up by the competent authority in accordance with Article 1 of Regulation (EC) No 2073/2005.
(13)
Commission Decision 2007/407/EC (17) lays down detailed rules for monitoring AMR to be carried out by Member States, covering Salmonella spp. in fowl, turkeys and slaughter pigs for the period from 2007 to 2012. Such harmonised monitoring should be continued to follow the evolution of trends and be extended to AMR in other pathogens and commensals in line with the increasing public health concern on the role of these microorganisms in the overall risk of AMR referred to in scientific opinions. Monitoring and reporting in accordance to Article 7 and 9 of Directive 2003/99/EC should therefore be in compliance with provisions and technical requirements on the harmonised monitoring and reporting of AMR which takes into account the recommendations set out in the EFSA reports.
(14)
For the sake of clarity of Union legislation, Decision 2007/407/EC should be repealed.
(15)
In order to allow Member States to organise themselves and to facilitate the planning of the monitoring and reporting provided for in this Decision, it should apply from 1 January 2014.
(16)
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS DECISION:
Article 1
Subject matter and scope
1. This Decision lays down detailed rules for the harmonised monitoring and reporting of antimicrobial resistance (AMR) to be carried out by Member States in accordance with Article 7(3) and 9(1) of Directive 2003/99/EC and Annex II (B) and Annex IV thereto.
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 harmonised 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.
Article 2
Sampling framework and collection of isolates by Member States
1. Member States shall ensure the sampling for the monitoring of AMR in accordance with the technical requirements set out in Part A of the Annex.
2. Member States shall 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. Member States 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.
Article 3
Isolates of Salmonella spp. obtained by food business operators
Where, due to a low bacterial prevalence or a low number of epidemiological units in a Member State 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 national 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.
Article 4
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
Assessment and reporting
Member States shall assess the results of the AMR monitoring provided for in Articles 2 and 3 and include that assessment in the report on trends and sources of zoonoses, zoonotic agents and antimicrobial resistance provided for in Article 9(1) of Directive 2003/99/EC.
Article 6
Publication and confidentiality of the data
The European Food Safety Authority shall publish in accordance with Article 9(2) of Directive 2003/99/EC the national isolate-based quantitative antimicrobial resistance data and results of the analyses reported in accordance to Article 4.
Article 7
Repeal
Decision 2007/407/EC is hereby repealed.
Article 8
Application
This Decision shall apply from 1 January 2014.
Article 9
Addressees
This Decision is addressed to the Member States.
Done at Brussels, 12 November 2013.