COMMISSION DECISION
of 5 November 2010
concerning a financial contribution from the Union towards a coordinated monitoring programme on the prevalence of Listeria monocytogenes in certain ready-to-eat foods to be carried out in the Member States
(notified under document C(2010) 7516)
(2010/678/EU)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (1), and in particular Article 66 thereof,
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 (2), and in particular Article 5 thereof,
Whereas:
(1)
Regulation (EC) No 882/2004 lays down, among others, procedures governing a financial support from the Union to conduct measures necessary to ensure the application of Regulation (EC) No 882/2004.
(2)
Directive 2003/99/EC provides that coordinated monitoring programmes may be established, especially when specific needs are identified, to assess risks and to establish baseline values related to zoonoses and zoonotic agents.
(3)
Reports on trends and sources of zoonoses, zoonotic agents and antimicrobial resistance in the Union were issued by the European Food Safety Authority (EFSA) and the European Centre for Disease Prevention and Control in 2006 (3) and 2007 (4) (EFSA-ECDC reports). According to those reports, a total of 1 588 cases of listeriosis (Listeria monocytogenes) in humans were registered in 25 Member States in 2006. In addition, 1 558 such cases were registered in 26 Member States in 2007. The reports further demonstrated a significant increase in the incidence of such cases in humans over the period 2001-2006. Illness is often severe and mortality is high.
(4)
The fact that Listeria monocytogenes is able to multiply in various foods at temperatures as low as 2 to 4 °C makes the occurrence of Listeria monocytogenes in ready-to-eat foods with a relatively long shelf-life of particular concern.
(5)
Pursuant to Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs (5), food business operators are to comply with Listeria monocytogenes food safety criteria for ready-to-eat foods within the framework of good hygiene practices and hazard analysis of critical control point (HACCP) programmes.
(6)
The EFSA-ECDC reports showed that the highest proportions of non-compliance with the Listeria monocytogenes criteria were registered in ready-to-eat cheese and in ready-to-eat fishery and heat-treated meat products.
(7)
The exposure of humans to Listeria monocytogenes is mainly food-borne. Therefore the prevalence and level of Listeria monocytogenes contamination in ready-to-eat fishery products, cheeses and heat-treated meat products should be estimated in a harmonised and comparable way by means of a coordinated monitoring programme at retail level in all Member States.
(8)
The growth of Listeria monocytogenes in a ready-to-eat product is influenced significantly by the pH, water activity and storage temperature of the product. A modelling can be used for the estimation of the growth of Listeria monocytogenes in a ready-to-eat product under various temperature conditions.
(9)
Where there are no relevant definitions in the Union legislation, the definitions in the Codex General Standard for Cheese (CODEX STAN 283-1978, amendment 2008) and in the Codex Group Standard for Unripened Cheese including Fresh Cheese (CODEX STAN 221-2001, amendment 2008) issued by the Codex Alimentarius Commission should be used to guarantee the harmonised approach in defining ready-to-eat cheeses.
(10)
In May 2009, the Task Force on Monitoring of Zoonoses Data Collection of EFSA adopted a Report on proposed technical specifications for a coordinated monitoring programme for Listeria monocytogenes in certain categories of RTE foods at retail in the EU (6).
(11)
In order to further harmonise the sampling stage the samples shall be taken at retail level covering shops, supermarkets and other similar outlets that sell directly to the final consumer.
(12)
Data collected within the frame of the coordinated monitoring programme should not be used for other purposes than this programme without a prior agreement of the Member States in order to guarantee confidentiality of the data.
(13)
Given the importance of collecting comparable data on the prevalence of Listeria monocytogenes in ready-to-eat foods, a financial contribution from the Union for carrying out such coordinated monitoring programme should be granted.
(14)
In order to allow the sampling and analyses within the frame of the coordinated programme to be performed in a harmonised way but taking into account the possible differences in the time frame of it between the Member States it is appropriate to lay down the starting time and duration of the programme.
(15)
A financial contribution from the Union should be granted insofar as the coordinated monitoring programme is carried out in accordance with this Decision and provided that the competent authorities furnish all the necessary information within the time limits provided for therein.
(16)
For reasons of administrative efficiency all expenditure presented for a financial contribution from the Union should be expressed in euro. In accordance with Council Regulation (EC) No 1290/2005 of 21 June 2005 on the financing of the common agricultural policy (7), the conversion rate for expenditure in a currency other than euro should be the rate most recently set by the European Central Bank prior to the first day of the month in which the application for reimbursement is submitted by the Member State concerned.
(17)
The present Decision constitutes a financing Decision within the meaning of Article 75 of the Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (8) (Financial Regulation), Article 90 of the detailed rules for the implementation of the Financial Regulation, and Article 15 of the Internal Rules on the Implementation of the general budget of the European Communities.
(18)
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
This Decision establishes a coordinated monitoring programme on the prevalence of Listeria monocytogenes in certain ready-to-eat food categories provided for in Article 2 at retail level, and lays down rules on a financial contribution from the Union to the Member States for its implementation.
Article 2
Scope and duration of the coordinated monitoring programme
1. The Member States shall carry out a coordinated monitoring programme to assess the prevalence of Listeria monocytogenes in the following ready-to-eat food categories in samples selected at random at retail level:
(a)
packaged (not frozen) hot or cold smoked or gravad fish;
(b)
soft or semi-soft cheeses, excluding fresh cheeses;
(c)
packaged heat-treated meat products.
2. The sampling activities in the framework of the coordinated monitoring programme provided for in paragraph 1 shall be carried out starting in 2010 and covering at least 12 months.
Article 3
Definitions
For the purposes of this Decision, the following definitions shall apply:
1.
‘ready-to-eat food’ means ready-to-eat food as defined in Article 2(g) of Regulation (EC) No 2073/2005.
2.
‘shelf-life’ means shelf-life as defined in Article 2(f) of Regulation (EC) No 2073/2005.
3.
‘batch’ means batch as defined in Article 2(e) of Regulation (EC) No 2073/2005.
4.
‘retail’ means retail as defined in Article 3(7) of Regulation (EC) No 178/2002 of the European Parliament and 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 (9); however, for the purposes of this Decision, retail covers only shops, supermarkets and other similar outlets that sell directly to the final consumer; it does not include distribution terminals or centres, catering operations, institutional catering, factory canteens, restaurants and other similar food service operations and wholesale outlets.
5.
‘processing’ means processing as defined in Article 2(1)(m) of Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (10).
6.
‘meat products’ means meat products as defined in point 7.1 of Annex I to Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (11).
7.
‘country of production’ means the country indicated on the identification mark as provided for in point 6 of part B of Section I of Annex II to Regulation (EC) No 853/2004.
8.
‘packaged food’ means food that has its entire surface covered in order to prevent direct contact of the food with the environment, either by permeable or impermeable wrapping.
9.
‘modified atmosphere packaged food’ means food that was packaged and hermetically sealed after the removal of air from the package and the replacement of that air with a strictly controlled gaseous mixture of carbon dioxide, oxygen, and/or nitrogen.
10.
‘vacuum packaged food’ means food that was packaged and hermetically sealed after the removal of the air from the package.
11.
‘smoked fish’ means fish cured by smoking.
12.
‘gravad fish’ means fish that has been cured in salt and sugar without thermal treatment.
13.
‘ripened cheeses’ means cheeses which are not ready for consumption shortly after manufacture but which must be held for such time, at such temperature, and under such other conditions as will result in the necessary biochemical and physical changes characterising the cheese in question.
14.
‘soft cheeses’ means cheeses that have a percentage moisture, on a fat-free basis, higher than 67 %.
15.
‘semi-soft cheeses’ means cheeses that have a texture which is only slighter harder than the soft cheese category. These cheeses have a percentage moisture, on a fat-free basis, ranging from 62 to 67 %. Semi-soft cheeses are characterised by their firm but elastic feel.
16.
‘mould-ripened cheeses’ means cheeses in which the ripening has been accomplished primarily by the development of characteristic mould growth throughout the interior and/or on the surface of the cheese.
17.
‘smear-ripened cheeses’ means cheeses in which during or after ripening, the cheese rind is treated or naturally colonised with desired cultures of micro-organisms, for instance Penicillium candidum or Brevibacterium linens. The resulting layer or smear forms a part of the rind.
18.
‘brine-matured cheeses’ means cheeses matured and stored in brine until they are sold or packed.
19.
‘fresh cheeses’ means curd-style cheeses which do not undergo any ripening, for example cottage cheese, mozzarella, ricotta and quark. Fresh cheeses are not included in this coordinated monitoring programme.
Article 4
Sampling, analyses and recording of data by the Member States
1. Sampling shall be performed by the competent authority or under its supervision.
2. National reference laboratories for Listeria monocytogenes shall perform the Listeria monocytogenes, pH and water activity analyses.
3. The competent authority may designate other laboratories than the national reference laboratories which are accredited for and involved in official controls of Listeria monocytogenes to perform the Listeria monocytogenes, pH and water activity analyses.
4. The sampling and analyses provided for in paragraphs 1, 2 and 3, as well as recording of all relevant data, shall be performed in accordance with the technical specifications set out in Annex I.
5. The number of samples to be taken per ready-to-eat food category in each Member State is set out in Annex II.
Article 5
Collection, assessment, reporting and use of data at Union level
1. Member State shall collect and assess the results of the sampling and Listeria monocytogenes, pH and water activity analyses provided for in Article 4(1), (2) and (3) of this Decision.
Those results and their assessment, together with all relevant data, shall be included in a final report on the completion of the coordinated monitoring programme that shall be transmitted to the Commission before 31 May 2012.
2. The Commission shall establish by the 30 November 2010 the format of the Data Dictionary and data collection forms to be used in the drawing up of the report referred to in paragraph 1 by the competent authorities.
3. The Commission shall forward the final reports provided for in paragraph 1 to the European Food Safety Authority (EFSA), which shall examine them, develop predictive models for the compliance with the Listeria monocytogenes food safety criteria and for the microbial growth under various storage conditions and issue a Summary Report within 6 months.
4. Any use of the data submitted by the Member States for purposes other than the coordinated monitoring programme shall be subject to prior agreement of the Member States.
5. Data and results shall be made publicly available in a form that ensures confidentiality of the individual results.
Article 6
Conditions for granting a Union financial contribution
1. A financial contribution from the Union of a total amount of 1 555 300 euro from budget line 17 04 07 01 towards the costs of collection, assessment and reporting provided for in Article 5(1) which are related to the analyses of Article 4(2) shall be granted to the Member States up to the maximum total amount for co-financing set out in Annex III.
2. The financial contribution from the Union provided for in paragraph 1 shall be paid to the Member States provided that the coordinated monitoring programme is carried out in accordance with the relevant provisions of Union law, including rules on competition and on the award of public contracts, and subject to compliance with the following conditions:
A final report on the completion of the coordinated monitoring programme must be submitted to the Commission before 31 May 2012; that report must contain:
(i)
all the information set out in Part D of Annex I;
(ii)
supporting evidence for the costs incurred by the Member States for the analyses; that evidence must comprise at least the information set out in Annex IV.
3. In the case of late submission of the final report referred to in paragraph 2 the financial contribution from the Union shall be reduced by 25 % on 1 July 2012, 50 % on 1 August 2012 and 100 % on 1 September 2012.
Article 7
Maximum amounts to be reimbursed
The maximum amounts of the financial contribution from the Union towards the costs to be reimbursed to the Member States for the collection, assessment and reporting provided for in Article 5(1) shall not exceed the following:
(a)
up to EUR 60 for each sample collected, assessed and reported of for the detection of Listeria monocytogenes;
(b)
up to EUR 60 for each sample collected, assessed and reported of for the enumeration of Listeria monocytogenes;
(c)
up to EUR 15 for each sample collected, assessed and reported related to the pH level analysis;
(d)
up to EUR 20 for each sample collected, assessed and reported for the water activity (aw) analysis.
Article 8
Conversion rate for expenditure
Where a Member State’s expenditure is in a currency other than euro, the Member State concerned shall convert it into euro by applying the most recent exchange rate set by the European Central Bank prior to the first day of the month in which the application is submitted by the Member State.
Article 9
Addressees
This Decision is addressed to the Member States.
Done at Brussels, 5 November 2010.