This Directive lays down measures to monitor the substances and groups of residues listed in Annex I.
For the purposes of this Directive, the definitions in Directive 96/22/EC shall apply. In addition:
The production process of animals and primary products of animal origin shall be monitored in accordance with this Chapter for the purpose of detecting the presence of the residues and substances listed in Annex I in live animals, their excrement and body fluids and in tissue, animal products, animal feed and drinking water.
1. Member States shall assign the task of coordinating the implementation of the inspections provided for in this Chapter, which are carried out within their national territory, to a central public department or body.
2. The department or body referred to in paragraph 1 shall be responsible for:
3. This Article shall not affect more specific rules applicable to the monitoring of animal nutrition.
1. By 30 June 1997 at the latest, Member States shall submit a plan to the Commission setting out the national measures to be implemented during the initial year of the plan and subsequently any update of plans previously approved in accordance with Article 8 on the basis of the experience of the preceding year, or years by 31 March at the latest of the year of the update.
2. The plan provided for in paragraph 1 shall:
1. The plan must conform to the sampling levels and frequencies laid down in Annex IV. However, at the request of a Member State the Commission may, in accordance with the procedure provided for in Article 32, adjust the minimum control requirements laid down in Annex IV provided that it is clearly established that such adjustments increase the overall effectiveness of the plan in respect of the Member State concerned and in no way reduce its ability to identify residues of, or cases of illegal treatment with, substances listed in Annex I.
2. Re-examination of the groups of residues to be checked for in accordance with Annex II and determination of the sampling levels and frequencies covering the animals and products referred to in Article 3 and not already laid down in Annex IV shall take place in accordance with the procedure provided for in Article 33 and on the first occasion within a maximum of 18 months of the adoption of this Directive. In doing so, account shall be taken of experience gained under existing national measures and information forwarded to the Commission under existing Community requirements making such specific product groups subject to monitoring for residues.
The initial plan shall take into account the specific situation of each Member State and specify in particular:
- legislation on the use of the substances listed in Annex I and, in particular, provisions on their prohibition or authorization, distribution and placing on the market and the rules governing their administration, in so far as such legislation is not harmonized.
- the infrastructure of the relevant departments (in particular, giving details of the type and size of the bodies involved in implementing the plans),
- a list of approved laboratories with details of their capacity for processing samples,
- national tolerances for authorized substances where no maximum Community residue levels have been set under Regulation (EEC) No 2377/90 and Directive 86/363/EEC (1),
- a list of the substances to be detected, methods of analysis, standards for interpreting the findings and, in the case of the substances listed in Annex I, the number of samples to be taken, giving reasons for this number,
- the number of official samples to be taken in relation to the number of animals of the species concerned slaughtered in preceding years in accordance with the sampling levels and frequencies laid down in Annex IV,
- details of the rules governing the collection of official samples, and in particular the rules concerning the particulars to appear on such official samples,
- the type of measures laid down by the competent authorities with regard to animals or products in which residues have been detected.
1. The Commission shall examine the initial plans forwarded pursuant to Article 5 (1) to ascertain whether they conform to this Directive. The Commission may ask a Member State to modify or supplement these plans to make them conform.
Once the Commission has established their conformity, it shall submit the plans for approval in accordance with the procedure provided for in Article 33.
In order to take account of changes in the situation in a given Member State or in a region thereof, of the results of national surveys or of investigations carried out in the framework of Articles 16 and 17, the Commission may, at the request of the Member State concerned or on its own initiative, decide, in accordance with the procedure provided for in Article 32, to approve an amendment or addition to a plan previously approved pursuant to paragraph 2.
2. Annual amendments to the initial plans communicated by the Member States, in particular in the light of the results referred to in Article 4 (2) (d), shall be forwarded by the Commission to the other Member States once the Commission has established their conformity with this Directive.
Member States shall have 10 working days from receipt of those amendments in which to inform the Commission of any comments.
If there are no comments from Member States, the amendments to the plans shall be deemed to be approved.
The Commission shall inform the Member States of such approval immediately.
Where there are comments from Member States or where the Commission deems the update not to be in conformity or insufficient, the Commission shall submit the updated plans to the Standing Veterinary Committee, which must act under the procedure laid down in Article 33.
The provisions laid down in paragraph 3 and 4 shall apply to the updated plans.
3. Every six months, Member States shall inform the Commission and the other Member States within the Standing Veterinary Committee of the implementation of plans approved pursuant to paragraph 2 or of the development of the situation. Where necessary, paragraph 4 shall apply. By not later than 31 March each year, Member States shall forward to the Commission the results of their residue and substance detection plans and of their control measures.
Member States shall make public the outcome of the implementation of the plans.
The Commission shall inform Member States, within the Standing Veterinary Committee, of developments in the situation in the various regions of the Community.
4. Each year, or whenever it deems it necessary on public health grounds, the Commission shall report to Member States within the Standing Veterinary Committee on the outcome of the checks and surveys referred to in paragraph 3, in particular on:
- the implementation of national plans,
- developments in the situation in the various regions of the Community.
5. The Commission shall send the European Parliament and the Council a communication each year on the results of action taken at regional, national or Community level, bearing in mind the report and Member States' comments on it.
A. Member States shall ensure that:
B. For the purposes of applying point A, Member States shall ensure, without prejudice to compliance with the rules laid down in the Directives governing the placing on the market of the various products in question, that:
- the principle of quality monitoring of the production chain by the different parties involved is established in their legislation,
- the self-monitoring measures to be included in the specifications for trade marks or labels are stepped up.
They shall inform the Commission and the other Member States, at their request, of provisions laid down in this regard and in particular of provisions adopted for checks on point A (3) (a) (i) and (ii).
Member States shall ensure that the terms of reference and responsibilities of veterinarians monitoring farms are extended to monitoring the rearing conditions and the forms of treatment referred to in this Directive.
Within this framework, the veterinarian shall enter in a register kept on the farm the date and nature of any treatment prescribed or administered, the identification of the animals treated and the corresponding withdrawal periods.
The stockfarmer shall enter in the register, which may be the register provided for in Directive 90/676/EEC (1), the date and nature of the treatment administered. He shall satisfy himself that withdrawal periods have been observed and keep the prescriptions to prove it for five years.
Stockfarmers and veterinarians shall be required to supply any information to the competent authority, at its request, and in particular supply information to the official veterinarian of the slaughterhouse, regarding a given farm's compliance with the requirements of this Directive.
1. Without prejudice to the checks carried out in connection with implementation of the surveillance plans referred to in Article 5 or to the checks provided for in specific Directives, Member States may have official random checks conducted:
2. The checks provided for in paragraph 1 must be conducted with a view in particular to detecting the possession or presence of prohibited substances or products which it is intended to administer to animals for the purposes of fattening or illegal treatment.
3. Where fraud is suspected, and in the case of a positive result from any of the checks referred to in paragraph 1, Articles 16 to 19 and the measures provided for in Chapter V shall apply.
The checks provided for at the slaughterhouse or on the first sale of aquaculture animals and fishery products can be reduced to take account of the fact that the farm of origin or departure belongs to an epidemiological surveillance network or a quality monitoring system as referred to in the first indent of the first subparagraph of Article 9 (B).
The checks provided for in this Directive must be carried out by the competent national authorities without prior notice.
The owner, the person empowered to dispose of the animals or their representative shall be obliged to facilitate pre-slaughter inspection operations, and in particular to assist the official veterinarian or the authorized staff in any manipulation judged necessary.
The competent authority shall:
1. Each Member State shall designate at least one national reference laboratory. A given residue or residue group may not be assigned to more than one national reference laboratory.
However, until 31 December 2000, Member States may continue to entrust testing for the same residue or residue group to several national laboratories which they designated prior to the date of adoption of this Directive.
A list of such designated laboratories shall be drawn up in accordance with the procedure laid down in Article 33.
These laboratories shall be responsible for:
- coordinating the work of the other national laboratories responsible for residue analysis, in particular by coordinating the standards and methods of analysis for each residue or residue group concerned,
- assisting the competent authority in organizing the plan for monitoring residues,
- periodically organizing comparative tests for each residue or residue group assigned to them,
- ensuring that national laboratories observe the limits laid down,
- disseminating information supplied by Community reference laboratories,
- ensuring that their staff are able to take part in further training courses organized by the Commission or by Commission reference laboratories.
2. The Community reference laboratories shall be those designated in Chapter 1 of Annex V.
The powers and working conditions of the laboratories shall be as defined in Chapter 2 of Annex V.
1. Official samples must be taken in accordance with Annexes III and IV in order to be examined in approved laboratories.
The detailed rules for the taking of official samples and the routine and reference methods to be employed for the analysis of such official samples shall be specified in accordance with the procedure laid down in Article 33.
Whenever an authorization is issued for the placing on the market of a veterinary medicinal product intended for administration to a species the meat or product of which is intended for human consumption, the competent authorities shall forward the routine analysis methods as laid down in Article 5, second subparagraph, point 8 of Directive 81/851/EEC (1) and Article 7 of Regulation (EEC) No 2377/90 to the Community and national reference laboratories for detection of residues.
2. For Group A substances, all positive findings recorded following the application of a routine method instead of a reference method must be confirmed by an approved laboratory using the reference methods laid down in accordance with paragraph 1.
For all substances, if challenged on the basis of a contradictory analysis, those results must be confirmed by the national reference laboratory designated in accordance with Article 14 (1) for the substance or residue in question. Such confirmation must be carried out at the plaintiff's cost in the event of confirmation.
3. Where examination of an official sample reveals illegal treatment, Articles 16 to 19 shall apply, together with the measures laid down in Chapter V.
Where the examination reveals the presence of residues of authorized substances or contaminants exceeding the levels set by Community rules or, pending such legislation, the levels set by national legislation, Articles 18 and 19 shall apply.
Where the examination referred to in this paragraph covers animals or products of animal origin from another Member State, the competent authority of the Member State of origin shall apply Articles 16 (2), 17, 18 and 19 and the measures provided for in Chapter V to the farm or establishment of origin or departure, following the reasoned request of the competent authority having carried out the examination.
Where the examination covers products or animals imported from a third country, the competent authority having carried out that examination shall refer the matter to the Commission, which shall take the measures provided for in Article 30.
Member States shall ensure that, where positive results are obtained as described in Article 15:
1. the competent authority shall obtain without delay:
2. the appropriate authority shall carry out:
3. animals from which samples have been taken are clearly identified. They may not in any circumstances leave the farm until the results of the checks are available.
Where illegal treatment is established, the competent authority must ensure that the livestock concerned in the investigations referred to in point (b) of Article 13 is immediately placed under official control. It must furthermore ensure that all the animals concerned bear an official mark or identification and that, as a first step, an official sample is taken from a statistically representative sample, on internationally recognized scientific bases.
1. Where there is evidence of residues of authorized substances or products of a level exceeding the maximum limit for residues, the competent authority shall carry out an investigation in the farm of origin or departure, as applicable, to determine why the above limit was exceeded.
In accordance with the results of that investigation, the competent authority shall take all necessary measures to safeguard public health which may include prohibiting animals from leaving the farm concerned or products from leaving the farm or establishment concerned for a set period.
2. In the event of repeated infringements of maximum residue limits when animals are placed on the market by a farmer or products are placed on the market by a farmer or a processing establishment, intensified checks on the animals and products from the farm and/or establishment in question must be carried out by the competent authorities for a period of at least six months, products or carcases being impounded pending the results of analysis of the samples.
Any results showing that the maximum residue limit has been exceeded must lead to the carcases or products concerned being declared unfit for human consumption.
1. The costs of the investigations and checks referred to in Article 16 shall be borne by the owner or person having charge of the animals.
Where the investigation confirms that suspicion was justified, the costs of analyses carried out under Articles 17 and 18 shall be borne by the owner or person having charge of the animals.
2. Without prejudice to criminal or administrative penalties, the cost of destroying animals which have given a positive result or animals which have been deemed positive in accordance with Article 23 shall be borne by the owner of the animals without indemnity or compensation.
1. Council Directive 89/608/EEC of 21 November 1989 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of legislation on veterinary and zootechnical matters (2) shall apply for the purposes of this Directive.
2. Where a Member State considers that, in another Member State, the controls provided for in this Directive are not being, or have ceased to be, carried out, it shall inform the competent central authority of that State accordingly. Following an investigation carried out in accordance with point 2 of Article 16, that authority shall take all necessary measures and shall, at the earliest opportunity notify the competent central authority, of the first Member State of the decisions taken and the reasons for those decisions.
If the first Member State fears that such measures are not being taken or are inadequate, it shall, together with the Member State which has been challenged, seek ways and means of remedying the situation; if appropriate, this may involve an on-the-spot inspection.
Member States shall inform the Commission of disputes and of solutions arrived at.
If the Member States involved in a dispute are unable to reach agreement, one of them shall bring the matter to the notice of the Commission within a reasonable period of time, and the latter shall instruct one or more experts to deliver an opinion.
Pending that opinion, the Member State of destination may carry out checks on products coming from the establishment(s) or holding(s) to which the dispute relates and, if the result is positive, take measures similar to those provided for in Article 7 (1) (b) of Directive 89/662/EEC (3).
In the light of the experts' opinion, appropriate measures may be taken in accordance with the procedure provided for in Article 32.
Those measures may be reviewed in accordance with the same procedure, in the light of a new expert opinion delivered within 15 days.
1. To the extent necessary to ensure uniform application of this Directive, and in cooperation with the competent authorities of the Member States, the Commission's veterinary experts may verify on the spot that the plans and the system for checking the plans by the competent authorities have been uniformly implemented. A Member State within whose territory a verification is being carried out shall give all necessary
assistance to the experts in carrying out their duties. The Commission shall inform the Member State concerned of the results of the verifications carried out.
The Member State concerned shall take the measures necessary to take account of the results of these verifications and shall notify the Commission of the measures taken. Where the Commission considers that the measures taken are insufficient, it shall, after consultation with the Member State in question and having regard to the measures necessary to safeguard public health, take appropriate measures in accordance with the procedure laid down in Article 32.
2. The general rules for implementing this Article, especially as regards the frequency and method of carrying out the verifications referred to in the first subparagraph of paragraph 1 (including cooperation with the competent authorities), shall be determined in accordance with the procedure laid down in Article 33.
Where unauthorized substances or products or substances listed in Group A and Group B (1) and (2) of Annex I are discovered in the possession of non-authorized persons, those unauthorized substances or products must be placed under official control until appropriate measures are taken by the competent authority, without prejudice to the possible imposition of penalties on the offender(s).
1. During the period in which animals are impounded as provided for in Article 17, animals from the farm in question may not leave the farm of origin or be handed over to any other person except under official control. The competent authority shall take appropriate precautionary measures in accordance with the nature of the substance or substances identified.
2. After sampling has been carried out in accordance with Article 17, if there is confirmation of a case of illegal treatment, the animal or animals found to be positive shall be slaughtered immediately on the spot or taken immediately to the designated slaughterhouse or to the knacker's yard under cover of an official veterinary certificate in order to be slaughtered there. Animals so slaughtered shall be sent to a high-risk processing plant as defined by Directive 90/667/EEC (1).
In addition, samples must be taken at the farm's expense from the entire batch of animals belonging to the farm at which checks were carried out and which may be suspect.
3. However, if half or more of the samples taken by representative sampling in accordance with Article 17 are positive, the farmer may be left a choice between a check on all the animals present on the farm which may be suspect, or slaughter of these animals.
4. For a further period of at least 12 months, the farm(s) belonging to the same owner shall be subject to more stringent checks for the residues in question. Where an organized system of self-monitoring has been set up, this facility shall be withdrawn from the farmer for that period.
5. In view of the infringement recorded, the farms or establishments supplying the holding concerned shall be subject to checks in addition to those provided for in Article 11 (1) to determine the origin of the substance in question. The same shall apply to all farms and establishments in the same supply chain of animals and animal feed as the farm of origin or departure.
The official veterinarian of a slaughterhouse must:
1. if he suspects or has evidence that the animals concerned have been subjected to illegal treatment or that unauthorized substances or products have been administered to them:
2. if the suspects or has evidence that the animals concerned have been subjected to an authorized treatment but that the withdrawal periods have not been complied with, postpone slaughter of the animals until he can be satisfied that the quantity of residues does not exceed the permitted levels.
This period may in no circumstances be less than the withdrawal period laid down in point (b) of Article 6 (2) of Directive 96/22/EC for the substances in question, or than the withdrawal periods provided for in the marketing authorization.
However, in an emergency or where required for the well-being of the animals, or if the infrastructure or equipment of the slaughterhouse is such that slaughter cannot be deferred, the animals may be slaughtered before the end of the ban or postponement period. The meat and offal shall be impounded pending the outcome of the official checks carried out by the slaughterhouse's official veterinarian. Only meat and offal containing a quantity of residues not exceeding the permitted levels shall be used for human consumption;
3. declare unfit for human consumption carcases and products in which the residue level exceeds the levels authorized by Community or national regulations.
Without prejudice to criminal penalties, where the holding, use or manufacture of unauthorized substances or products in a manufacturing establishment is confirmed, any authorizations or official approval arrangements enjoyed by the establishment concerned shall be suspended for a period during which the establishment shall be subjected to more stringent checks.
In the case of a repeated offence, such authorizations or approval arrangements shall be permanently withdrawn.
Rights of appeal allowed by national legislation in force in the Member States against decisions taken by the competent authorities under Articles 23 and 24 shall not be affected by this Directive.
Without prejudice to criminal penalties, or penalties imposed by professional bodies, appropriate administrative measures must be taken against any person where he is responsible, as the case may be, for the transfer or administering of prohibited substances or products or for the administering of authorized substances or products for purposes other than those laid down in the current legislation.
Any failure to cooperate with the competent authority and any obstruction by slaughterhouse personnel or the slaughterhouse supervisor or, in the case of a private enterprise, by the slaughterhouse owner or owners, or by the owner of the animals or person having charge of them, during inspection and sampling as required for the implementation of national plans for monitoring residues and during the investigations and checks provided for in this Regulation, shall result in appropriate criminal and/or administrative penalties being imposed by the competent national authorities.
If it is proven that a slaughterhouse owner or supervisor is helping to conceal the illegal use of prohibited substances, the Member State shall deny the guilty party any opportunity of receiving or applying for Community aid for a period of 12 months.
1. Inclusion and retention on the lists of third countries provided for in Community legislation from which Member States are authorized to import animals and animal products covered by this Directive shall be subject to submission by the third country concerned of a plan setting out the guarantees which it offers as regards the monitoring of the groups of residues and substances referred to in Annex I. This plan must be updated at the request of the Commission, particularly when the checks referred to in paragraph 3 render it necessary.
The provisions of Article 8 concerning time limits for submission and updating of plans shall apply for plans to be submitted by third countries.
The guarantees must have an effect at least equivalent to those provided for in this Directive and must, in particular, meet the requirements of Article 4 and specify the particulars laid down in Article 7 of this Directive and meet the requirements of Article 11 (2) of Directive 96/22/EC.
The Commission shall approve the plan in accordance with the procedure laid down in Article 33. Under the same procedure, guarantees alternative to those resulting from the implementation of this Regulation may be accepted.
2. Where the requirements of paragraph 1 are not complied with, inclusion of a third country on the lists of third countries laid down by Community legislation or as a result of the benefit of pre-listing may be suspended in accordance with the procedure laid down in Article 33, at the request of a Member State or by the Commission on its own initiative.
3. Compliance with the requirements of and adherence to the guarantees offered by the plans submitted by third countries shall be verified by means of the checks referred to in Article 5 of Directive 72/462/EEC (1) and the checks provided for in Directives 90/675/EEC (2) and 91/496/EEC (3).
4. Member States shall inform the Commission each year of the results of residue checks carried out on animals and animal products imported from third countries, in accordance with Directives 90/675/EEC and 91/496/EEC.
1. Where the checks provided by Directives 90/675/EEC and 91/496/EEC reveal the use of unauthorized products or substances for the treatment of the animals in a given batch - batch within the meaning of Article 2 (2) (e) of Directive 91/496/EEC - or the presence of such products or substances in all or part of a batch originating in the same establishment, the competent authority shall take the following measures in respect of the animals and products involved in such use:
- it shall inform the Commission of the nature of the products used and the batch concerned; the Commission shall forthwith inform all frontierposts,
- the Member States shall carry out more stringent checks on all batches of animals or products from the same source. In particular, the next 10 batches from the same source must be impounded - and a deposit lodged against inspection costs - at the frontier inspection post for a check on residues by taking a representative sample of each batch or of the part of the batch.
Where such additional checks demonstrate the presence of unauthorized substances or products or of residues of such substances or products:
- the Commission shall be informed of the outcome of the more stringent checks and on the basis of this information shall make all necessary investigations, to identify the reasons for and origins of the infringements found.
2. Where the checks provided for by Directive 90/675/EEC reveal that the maximum residue limits have been exceeded, use shall be made of the checks referred to in the second indent of paragraph 1.
3. If, in cases involving third countries which have concluded equivalence agreements with the Community, the Commission, after making enquiries of the competent authorities of the third countries concerned, concludes that they have failed to fulfil their obligations and the guarantees given by the plans referred to in Article 29 (1), it shall cease to allow that country, under the procedure laid down in Article 32, to benefit from the said agreements for the animals and products in question until the third country in question has made good its shortcomings. The suspension shall be revoked under the same procedure.
If necessary, in order to re-establish the benefit afforded by the said agreements, a Community deputation including experts from the Member States shall visit the country concerned, at that country's expense, in order to verify that such measures have been taken.
The Council, acting on a proposal from the Commission, shall amend Directive 85/73/EEC (1) before 1 July 1997 in order to provide for the charging of a fee to cover monitoring carried out pursuant to this Directive.
Pending that decision by the Council, Member States shall be authorized to charge national fees to cover the actual costs of such monitoring.
1. Where the procedure laid down in this Article is to be followed, matters shall be referred without delay to the Standing Veterinary Committee set up by Decision 68/361/EEC (2), by its Chairman, either on his own initiative or at the request of a Member State.
2. The Commission representative shall submit a draft of the measures to be taken. The Committee shall deliver its opinion on those matters within a time limit which the Chairman may set according to the urgency of the matter submitted. Opinions shall be delivered by a majority of 62 votes.
3.
If, 15 days after the proposals were submitted to it, the Council has not adopted any measures, the Commission shall adopt the measures proposed and implement them immediately unless the Council has rejected those measures by a simple majority.
1. Where the procedure laid down in this Article is to be followed, matters shall be referred without delay to the Standing Veterinary Committee, by its Chairman, either on his own initiative or at the request of a Member State.
2. The Commission representative shall submit a draft of the measures to be taken. The Committee shall deliver its opinion on those matters within a time limit which the Chairman may set according to the urgency of the matter submitted. Opinions shall be delivered by a majority of 62 votes.
3.
(a) The Commission shall adopt the measures and implement them immediately where they are in accordance with the opinion of the Committee.
(b) Where they are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall forthwith submit to the Council a proposal concerning the measures to be taken. The Council shall adopt the measures by a qualified majority.
If, three months after the proposals were submitted to it, the Council has not adopted any measures, the Commission shall adopt the measures proposed and implement them immediately unless the Council has rejected those measures by a simple majority.
Without prejudice to Article 6 (2), Annexes I, III, IV and V may be amended or supplemented by the Council acting by a qualified majority on a proposal from the Commission.
In particular, the aforementioned Annexes may be amended within three years of the date of adoption of this Directive, with a view to risk assessment of the following factors:
- potential toxicity of residues in foodstuffs of animal origin,
- likelihood of residues occurring in foodstuffs of animal origin.
The Council, acting by a qualified majority on a proposal from the Commission, may adopt transitional measures required for the implementation of the arrangements laid down by this Directive.
1. Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC are hereby repealed as from 1 July 1997.
2. The following are also repealed as from the said date:
3. References to Directives and Decisions which have been repealed shall be deemed to be references to this Directive and shall be read in accordance with the correlation table in Annex VI.
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 July 1997.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive.
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
This Directive is addressed to the Member States.