Legal provisions of COM(2001)452-3 - Control of salmonella and other food-borne zoonotic agents

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dossier COM(2001)452-3 - Control of salmonella and other food-borne zoonotic agents.
document COM(2001)452 EN
date November 17, 2003


Contents

CHAPTER I - INTRODUCTORY PROVISIONS

Article 1 - Subject matter and scope

1. The purpose of this Regulation is to ensure that proper and effective measures are taken to detect and to control salmonella and other zoonotic agents at all relevant stages of production, processing and distribution, particularly at the level of primary production, including in feed, in order to reduce their prevalence and the risk they pose to public health.

2. This Regulation shall cover:

(a) the adoption of targets for the reduction of the prevalence of specified zoonoses in animal populations:

(i) at the level of primary production; and

(ii) where appropriate for the zoonosis or zoonotic agent concerned, at other stages of the food chain, including in food and feed;

(b) the approval of specific control programmes established by Member States and food and feed business operators;

(c) the adoption of specific rules concerning certain control methods applied in the reduction of the prevalence of zoonoses and zoonotic agents;

(d) the adoption of rules concerning intra-Community trade and imports from third countries of certain animals and products thereof.

3. This Regulation shall not apply to primary production:

(a) for private domestic use; or

(b) leading to the direct supply, by the producer, of small quantities of primary products to the final consumer or to local retail establishments directly supplying the primary products to the final consumer.

4. Member States shall establish, under national law, rules governing the activities referred to in paragraph 3(b). Such national rules shall ensure that the objectives of this Regulation are achieved.

5. This Regulation shall apply without prejudice to more specific Community provisions on animal health, animal nutrition, food hygiene, communicable human diseases, health and safety in the workplace, gene technology and transmissible spongiform encephalopathies.

Article 2 - Definitions

For the purposes of this Regulation the following definitions shall apply:

1. the definitions laid down in Regulation (EC) No 178/2002;

2. the definitions laid down in Directive 2003/99/EC; and

3. the following definitions:

(a) 'herd' means an animal or group of animals kept on a holding as an epidemiological unit; and

(b) 'flock' means all poultry of the same health status kept on the same premises or in the same enclosure and constituting a single epidemiological unit; in the case of housed poultry, this includes all birds sharing the same airspace.

Article 3 - Competent authorities

1. Each Member State shall designate a competent authority or competent authorities for the purpose of this Regulation and notify the Commission thereof. If a Member State designates more than one competent authority, it shall:

(a) notify the Commission of the competent authority that will act as a contact point for contacts with the Commission; and

(b) ensure that the competent authorities cooperate so as to guarantee the proper implementation of the requirements of this Regulation.

2. The competent authority or authorities shall be responsible in particular for:

(a) drawing up the programmes provided for in Article 5(1) and preparing any amendments thereto which prove necessary, in particular in the light of data and results obtained;

(b) collecting the data needed to evaluate the means used and the results obtained in carrying out the national control programmes provided for in Article 5 and for submitting those data and results yearly, including the results of any surveys undertaken, to the Commission, having regard to the rules laid down pursuant to Article 9(1) of Directive 2003/99/EC;

(c) carrying out regular checks on the premises of food and, if needed, feed businesses for the purpose of checking compliance with this Regulation.

CHAPTER II - COMMUNITY TARGETS

Article 4 - Community targets for the reduction of the prevalence of zoonoses and zoonotic agents

1. Community targets shall be established for the reduction of the prevalence of zoonoses and zoonotic agents listed in Annex I, column 1, in the animal populations listed in Annex I, column 2, taking account, in particular, of:

(a) the experience gained under existing national measures; and

(b) information forwarded to the Commission or to the European Food Safety Authority under existing Community requirements, in particular in the framework of information provided for in Directive 2003/99/EC, in particular Article 5 thereof.

The targets, and any amendments to them, shall be established in accordance with the procedure referred to in Article 14(2).

2. The targets referred to in paragraph 1 shall consist at least of:

(a) a numerical expression of:

(i) the maximum percentage of epidemiological units remaining positive; and/or

(ii) the minimum percentage of reduction in the number of epidemiological units remaining positive;

(b) the maximum time limit within which the target must be achieved;

(c) the definition of the epidemiological units referred to in (a);

(d) the definition of the testing schemes necessary to verify the achievement of the target; and

(e) the definition, where relevant, of serotypes with public health significance or of other subtypes of zoonoses or zoonotic agents listed in Annex I, column 1, having regard to the general criteria listed in paragraph 6(c) and any specific criteria laid down in Annex III.

3. Community targets shall be established for the first time before the relevant dates indicated in Annex I, Column 4.

4. (a) When defining each Community target, the Commission shall provide an analysis of its expected costs and benefits. This analysis shall take account, in particular, of the criteria laid down in paragraph 6(c). Member States shall, on request, provide the Commission with all the assistance necessary to enable it to prepare the analysis.

(b) Before proposing each Community target, the Commission shall consult Member States within the committee referred to in Article 14(1) on the results of its analysis.

(c) In the light of the results of that analysis and the consultation of Member States, the Commission shall propose Community targets where appropriate.

5. However, by way of derogation from paragraphs 2(e) and 4, the following rules shall apply to poultry for a transitional period.

The Community target established for breeding flocks of Gallus gallus for this transitional period shall cover the five most frequent salmonella serotypes in human salmonellosis, which shall be identified on the basis of data collected through EC monitoring systems. The Community targets established for laying hens, broilers and turkeys for the transitional period shall cover Salmonella enteritidis and Salmonella typhimurium. However, if necessary, these targets may be extended to other serotypes on the basis of the results of an analysis carried out in accordance with paragraph 4.

The transitional period shall apply to each Community target for the reduction of the prevalence of salmonella in poultry. It shall last for three years in each case, starting on the date mentioned in column 5 of Annex I.

6. (a) Annex I may be amended, in accordance with the procedure laid down in Article 14(2), for the purposes listed in subparagraph (b), after taking account in particular of the criteria listed in subparagraph (c).

(b) Amendments to Annex I may alter the scope of the requirements regarding the establishment of Community targets by supplementing, restricting or modifying:

(i) the zoonoses or zoonotic agents;

(ii) the stages of the food chain; and/or

(iii) the animal populations concerned.

(c) The criteria to be considered before amending Annex I include, with respect to the zoonosis or zoonotic agent concerned:

(i) its frequency in animal and human populations, feed and food;

(ii) the gravity of its effects for humans;

(iii) its economic consequences for animal and human health care and for feed and food businesses;

(iv) epidemiological trends in animal and human populations, feed and food;

(v) scientific advice;

(vi) technological developments, particularly relating to the practicality of the available control options; and

(vii) requirements and trends concerning breeding systems and production methods.

7. Annex III may be amended or supplemented in accordance with the procedure referred to in Article 14(2).

8. The Commission shall review the implementation of Community targets and take account of this review when proposing further targets.

9. Measures taken to reduce the prevalence of zoonoses and zoonotic agents listed in Annex I shall be implemented in accordance with the rules laid down in this Regulation and any rules adopted pursuant thereto.

CHAPTER III - CONTROL PROGRAMMES

Article 5 - National control programmes

1. To achieve the Community targets provided for in Article 4, Member States shall establish national control programmes for each zoonosis and zoonotic agent listed in Annex I. National control programmes shall have regard to the geographical distribution of zoonoses within each Member State and to the financial implications for primary producers and feed and food business operators of establishing effective controls.

2. National control programmes shall be continuous and cover a period of at least three consecutive years.

3. National control programmes shall:

(a) provide for the detection of zoonoses and zoonotic agents in accordance with the requirements and minimum sampling rules laid down in Annex II;

(b) define the respective responsibilities of competent authorities and food and feed business operators;

(c) specify the control measures to be taken following the detection of zoonoses and zoonotic agents, in particular to protect public health, including implementation of the specific measures laid down in Annex II;

(d) allow for the progress under their provisions to be evaluated and for those programmes to be reviewed, in particular in the light of results obtained from the detection of zoonoses and zoonotic agents.

4. National control programmes shall cover at least the following stages of the food chain:

(a) feed production;

(b) primary production of animals;

(c) processing and preparation of food of animal origin.

5. National control programmes shall contain, where relevant, the provisions laid down in relation to testing methods and criteria against which the results of these tests shall be assessed, for testing animals and hatching eggs despatched within the national territory, as part of the official controls provided for in Annex II, part A.

6. The requirements and minimum sampling rules laid down in Annex II may be amended, adapted or supplemented, in accordance with the procedure referred to in Article 14(2), after taking account in particular of the criteria listed in point (c) of Article 4(6).

7. Within six months of the establishment of the Community targets provided for in Article 4, Member States shall submit their national control programmes to the Commission and set out the measures to be implemented.

Article 6 - Approval of the national control programmes

1. After a Member State submits a national control programme in accordance with Article 5, the Commission shall have two months within which to request any further relevant and necessary information from that Member State. The Member State shall provide such further information within two months of receiving such a request. The Commission shall, within two months of receiving such further information or, if it did not request further information, within six months of the submission of the control programme, establish whether it complies with relevant rules, including this Regulation in particular.

2. When the Commission has established the conformity of a national control programme, or at the request of the Member State that submitted it, the programme shall be considered without undue delay with a view to approval in accordance with the procedure referred to in Article 14(2).

3. Amendments to a programme previously approved pursuant to paragraph 2 may be approved, in accordance with the procedure referred to in Article 14(2), to take account of the evolution in the situation in the Member State concerned, in particular in the light of the results referred to in Article 5(3)(d).

Article 7 - Food and feed business operators' control programmes

1. Food and feed business operators, or organisations representing such operators, may establish control programmes, covering, as far as possible, all stages of production, processing and distribution.

2. If they wish their control programmes to form part of a national control programme, food and feed business operators, or their representative organisations, shall submit their control programmes, and any amendments thereto, to the competent authority of the Member State in which they are located for approval. If the operations concerned take place in different Member States, the programmes shall be approved separately for each Member State.

3. The competent authority may approve control programmes submitted pursuant to paragraph 2 only if it is satisfied that the control programmes comply with the relevant requirements set out in Annex II and with the objectives of the relevant national control programme.

4. Member States shall maintain up-to-date lists of approved control programmes of food and feed business operators or their representative organisations. The lists shall be made available to the Commission upon request.

5. Food and feed business operators or their representative organisations shall communicate regularly the results of their control programmes to the competent authorities.

CHAPTER IV - CONTROL METHODS

Article 8 - Specific control methods

1. At the initiative of the Commission or at the request of a Member State and in accordance with the procedure referred to in Article 14(2):

(a) it may be decided that specific control methods may or shall be applied for the reduction of prevalence of zoonoses and zoonotic agents at the stage of the primary production of animals and other stages in the food chain;

(b) rules may be adopted concerning the conditions for the use of the methods referred to in subparagraph (a);

(c) detailed rules may be adopted concerning necessary documents and procedures as well as minimum requirements for the methods referred to in subparagraph (a); and

(d) it may be decided that certain specific control methods shall not be used as a part of control programmes.

2. The provisions referred to in paragraph 1(a), (b) and (c) shall not apply to methods using substances or techniques covered by Community legislation on animal nutrition, food additives or veterinary medicinal products.

CHAPTER V - TRADE

Article 9 - Intra-Community trade

1. As from the dates mentioned in Annex I, column 5, at the latest, flocks and herds of origin of the species listed in column 2 shall be tested for the zoonoses and zoonotic agents listed in column 1 prior to any dispatching of the live animals, or hatching eggs, from the food business of origin. The date and the result of testing shall be included in the relevant health certificates provided for in Community legislation.

2. The Member State of destination may, in accordance with the procedure referred to in Article 14(2), be authorised for a transitional period to require that the results of the tests to be referred to in the relevant health certificates for consignments of animals and hatching eggs subject to testing in the Member State of dispatch fulfil the same criteria as regards salmonella as those laid down under its approved national programme, in accordance with Article 5(5), for consignments despatched within its territory.

The authorisation may be withdrawn in accordance with the same procedure.

3. The special measures concerning salmonella that applied to live animals dispatched to Finland and Sweden prior to the entry into force of this Regulation shall continue to apply as if they had been authorised in accordance with paragraph 2.

4. Without prejudice to Article 5(6), specific rules concerning the setting by Member States of the criteria referred to in Article 5(5) and in paragraph 2 above, may be laid down in accordance with the procedure referred to in Article 14(2).

Article 10 - Imports from third countries

1. As from the dates mentioned in Annex I, column 5, admission to or retention on the lists of third countries provided for in Community legislation, for the relevant species or category, from which Member States are authorised to import those animals or hatching eggs covered by this Regulation shall be subject to submission to the Commission by the third country concerned of a programme equivalent to those provided for under Article 5 and its approval in accordance with this Article. The programme shall give details of the guarantees offered by that country as regards inspections and controls for zoonoses and zoonotic agents. Those guarantees must be at least equivalent to the guarantees provided for by this Regulation. The Food and Veterinary Office of the Commission shall be closely involved in monitoring to verify whether equivalent control programmes exist in third countries.

2. These programmes shall be approved in accordance with the procedure referred to in Article 14(2), provided that the equivalence of the measures described under the programme, with the relevant requirements applicable under Community rules, is objectively demonstrated. Alternative guarantees to those provided for in this Regulation may be allowed in accordance with that procedure, provided that they are not more favourable than those applicable to intra-Community trade.

3. For third countries with which a regular trade flow is established, the provisions of Article 5(7) and Article 6(1) concerning time periods for the submission and approval of programmes shall apply. For third countries establishing or resuming a trade flow, the time periods provided for in Article 6 shall apply.

4. Flocks and herds of origin of species listed in Annex I, column 2, shall be tested prior to any dispatching of the live animals or hatching eggs from the food business of origin. Flocks and herds shall be tested for the zoonoses and zoonotic agents listed in Annex I, column 1, or, if necessary to achieve the objective of equivalent guarantees laid down in paragraph 1, such zoonoses and zoonotic agents as may be specified in accordance with the procedure referred to in Article 14(2). The date and the result of testing shall be included in the relevant import certificates, for which the models laid down by Community legislation shall be amended accordingly.

5. The Member State of final destination may be authorised, in accordance with the procedure referred to in Article 14(2), to require for a transitional period that the results of the testing referred to in paragraph 4 fulfil the same criteria as those laid down under its national programme, in accordance with Article 5(5). The authorisation may be withdrawn and, without prejudice to Article 5(6), specific rules concerning such criteria may be laid down, in accordance with the procedure referred to in Article 14(2).

6. Admission to or retention on the lists of third countries provided for in Community legislation, for the relevant category of products, from which Member States are authorised to import those products covered by this Regulation shall be subject to submission to the Commission by the third country concerned of guarantees equivalent to those provided for by this Regulation.

CHAPTER VI - LABORATORIES

Article 11 - Reference laboratories

1. Community reference laboratories for the analysis and testing of zoonoses and zoonotic agents listed in Annex I, column 1, shall be designated in accordance with the procedure referred to in Article 14(2).

2. The responsibilities and tasks of the Community reference laboratories, in particular with regard to coordination of their activities and those of the national reference laboratories, shall be laid down in accordance with the procedure referred to in Article 14(2).

3. Member States shall designate national reference laboratories for the analysis and testing of zoonoses and zoonotic agents listed in Annex I, column 1. The names and addresses of laboratories shall be communicated to the Commission.

4. Certain responsibilities and tasks of the national reference laboratories, in particular with regard to coordination of their activities and those of the relevant laboratories in the Member States designated under Article 12(1)(a), may be laid down in accordance with the procedure referred to in Article 14(2).

Article 12 - Approval of laboratories, quality requirements and approved testing methods

1. Laboratories participating in control programmes pursuant to Articles 5 and 7 shall, for the purposes of analysing samples to test for the presence of zoonoses and zoonotic agents referred to in Annex I, column 1:

(a) be designated by the competent authority; and

(b) apply quality assurance systems that conform to the requirements of the current EN/ISO standard at the latest within 24 months of entry into force of this Regulation or within 24 months of the addition of new zoonoses or zoonotic agents to Annex I, column 1.

2. Laboratories shall regularly participate in collaborative testing organised or coordinated by the national reference laboratory.

3. Testing for the presence of zoonoses and zoonotic agents referred to in Annex I, column 1, shall be carried out using the methods and protocols recommended by international standardisation bodies, as reference methods.

Alternative methods may be used if they have been validated in accordance with internationally recognised rules and offer equivalent results to those obtained by the relevant reference method.

Where necessary, other methods for testing may be approved in accordance with the procedure referred to in Article 14(2).

CHAPTER VII - IMPLEMENTATION

Article 13 - Implementing and transitional measures

Appropriate transitional or implementing measures, including the necessary amendments to the relevant health certificates, may be adopted in accordance with the procedure referred to in Article 14(2).

Article 14 - Committee procedure

1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health instituted by Regulation (EC) No 178/2002 (hereinafter referred to as 'the Committee').

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3. The Committee shall adopt its rules of procedure.

Article 15 - Consultation of the European Food Safety Authority

The Commission shall consult the European Food Safety Authority on any matter within the scope of this Regulation that could have a significant impact on public health and, in particular, before proposing Community targets in accordance with Article 4 or specific control methods in accordance with Article 8.

Article 16 - Report on financial arrangements

1. The Commission shall, within three years of the entry into force of this Regulation, submit a report to the European Parliament and to the Council.

2. The report shall discuss:

(a) the arrangements in place, at Community and national level, to finance measures taken to control zoonoses and zoonotic agents; and

(b) the effect that such arrangements have on the effectiveness of those measures.

3. The Commission shall, if appropriate, accompany its report with relevant proposals.

4. Member States shall, on request, provide the Commission with all the assistance necessary to enable it to prepare its report.

CHAPTER VIII - GENERAL AND FINAL PROVISIONS

Article 17 - Community controls

1. Experts from the Commission shall carry out on-the-spot checks, in cooperation with the competent authorities of Member States, in order to ensure that the provisions of this Regulation, rules adopted pursuant thereto and any safeguard measures are applied uniformly. A Member State on whose territory checks are made shall provide the experts with all the assistance necessary for carrying out their duties. The Commission shall inform the competent authority of the results of the checks made.

2. Rules for the implementation of this Article, in particular those governing the procedure for cooperation with national competent authorities, shall be laid down under the procedure referred to in Article 14(2).

Article 18 - Entry into force

This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.

It shall apply as from six months following its entry into force.


This Regulation shall be binding in its entirety and directly applicable in all Member States.