Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC
Modified by
- Council Regulation (EC) No 806/2003of 14 April 2003adapting to Decision 1999/468/EC the provisions relating to committees which assist the Commission in the exercise of its implementing powers laid down in Council instruments adopted in accordance with the consultation procedure (qualified majority), 303R0806, May 16, 2003
- Actconcerning the conditions of accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic and the adjustments to the Treaties on which the European Union is founded, 103T, September 23, 2003
- Regulation (EC) No 882/2004 of the European Parliament and of the Councilof 29 April 2004on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules, 304R0882, May 28, 2004
(a) "unauthorized substances or products" shall mean substances or products the administering of which to animals is prohibited under Community legislation; (b) "illegal treatment" shall mean the use of unauthorized substances or products or the use of substances or products authorized under Community legislation for purposes or under conditions other than those laid down in Community legislation or, where appropriate, in the various national legislations; (c) "residue" shall mean a residue of substances having a pharmacological action, of their metabolites and of other substances transmitted to animal products and likely to be harmful to human health; (d) "competent authority" shall mean the central authority of a Member State competent in veterinary matters or any authority to which such central authority has delegated such competence; (e) "official sample" shall mean a sample taken by the competent authority which bears, for the purposes of examination of the residues or substances listed in Annex I, a reference to the species, the type, the quantity concerned, the method of collection and particulars identifying the sex of the animal and the origin of the animal or of the animal product; (f) "approved laboratory" shall mean a laboratory approved by the competent authorities of a Member State for the purposes of examining an official sample in order to detect the presence of residues; (g) "animal" shall mean the species covered by Directive 90/425/EEC OJ No L 224, 18. 8. 1990, p. 29 . Directive as last amended by Directive 92/65/EEC (OJ No L 268, 14. 9. 1992, p. 54 ).(h) "batch of animals" shall mean a group of animals of the same species, in the same age range, reared on the same holding, at the same time and under the same conditions of rearing; (i) "beta-agonist" shall mean a beta adrenoceptor agonist.
(a) drawing up the plan provided for in Article 5 to enable the competent departments to carry out the required inspections; (b) coordinating the activities of the central and regional departments responsible for monitoring the various residues. Such coordination shall extend to all departments working to prevent the fraudulent use of substances or products on stock farms; (c) collecting the data needed to evaluate the means used and the results obtained in carrying out the measures provided for in this Chapter; (d) sending the Commission, by not later than 31 March of each year, the data and results referred to in (c), including the results of any surveys undertaken.
(a) provide for detection of groups of residues or substances according to type of animal, in accordance with Annex II; (b) specify in particular the measures for detection of the presence of: (i) the substances referred to in (a) in the animals, in the drinking water of the animals and in all places where the animals are bred or kept; (ii) residues of the aforementioned substances in live animals, their excrement and body fluids and in animal tissues and products such as meat, milk, eggs and honey;
(c) comply with the sampling rules and levels laid down in Annexes III and IV.
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 OJ No L 221, 7. 8. 1986, p. 43 . Directive as last amended by Directive 95/39/EC (OJ No L 197, 22. 8. 1995, p. 29 ).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.
the implementation of national plans, developments in the situation in the various regions of the Community.
A. Member States shall ensure that: 1. any farms which place farm animals on the market and any natural or legal person engaged in trade in such animals register beforehand with the competent authorities and undertake to abide by the relevant Community and national rules, in particular the provisions laid down in Articles 5 and 12 of Directive 90/425/EEC; 2. the owners or persons in charge of the establishment of initial processing of primary products of animal origin take all necessary measures, in particular by carrying out their own checks, to (a) accept — whether by direct delivery or through an intermediary — only those animals for which the producer is able to guarantee that withdrawal times have been observed; (b) satisfy themselves that the farm animals or products brought into the establishment (i) do not contain residue levels which exceed maximum permitted limits; (ii) do not contain any trace of prohibited substances or products;
3. (a) the producers or persons in charge referred to in points 1 and 2 place on the market only: (i) animals to which no unauthorized substances or products have been administered or which have not undergone illegal treatment within the meaning of this Directive; (ii) animals in respect of which, where authorized products or substances have been administered, the withdrawal periods prescribed for these products or substances have been observed; (iii) products derived from the animals referred to in (i) and (ii);
(b) where an animal is presented at a first-stage processing establishment by a natural or legal person other than the producer, the obligations laid down in (a) are incumbent on the latter.
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).
(a) during the manufacture of the substances included in Group A in Annex I and during their handling, storage, transport, distribution and sale or acquisition; (b) at any point in the animal feedingstuffs production and distribution chain; (c) throughout the production chain of animals and raw materials of animal origin covered by this Directive.
(a) where illegal treatment is suspected, ask the owner or person having charge of the animals or the veterinarian in charge of the farm to provide any documentation justifying the nature of the treatment; (b) where this inquiry confirms illegal treatment or where unauthorized substances or products have been used, or where there are grounds for suspecting their use, conduct or have conducted: spot checks on animals on their farms of origin or departure, in particular with a view to detecting such use and in particular any traces of implants; these checks may include official sampling, checks to detect substances the use of which is prohibited or of unauthorized substances or products on the farms where the animals are being reared, kept or fattened (including holdings administratively connected with such farms) or on the animals' farms of origin or departure. Official samples of drinking water and feedingstuffs are necessary for that purpose. spot checks on animals' feedingstuffs on their farms of origin or departure, and on their drinking water or — for aquaculture animals — from the waters in which they are caught, the checks provided for in Article 11 (1) (a), any check required to clarify the origin of the unauthorized substances or products or that of the treated animals;
(c) where the maximum levels laid down by Community rules or, pending such legislation, the levels set by national legislation have been exceeded, carry out any measure or investigation which it may deem appropriate in relation to the finding in question.
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.
1. the competent authority shall obtain without delay: (a) all the information required to identify the animal and farm of origin or departure; (b) full details of the examination and its result. If the controls carried out in a Member State demonstrate the need for an investigation or other action in one or more Member States or third countries, the Member State concerned shall inform the other Member States and the Commission. The Commission shall coordinate the appropriate measures taken in Member States where an investigation or other action proves necessary;
2. the appropriate authority shall carry out: (a) an investigation on the farm of origin or departure, as appropriate, to determine the reasons for the presence of residues; (b) in the case of illegal treatment, an investigation of the source or sources of the substances or products concerned at the stage of manufacture, handling, storage, transport, administration, distribution or sale, as appropriate; (c) any other further investigations which the authority considers necessary;
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.
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: (a) arrange for the animals to be slaughtered separately from other batches of animals arriving at the slaughterhouse; (b) impound the carcases and offal and carry out all sampling procedures necessary to detect the substances in question; (c) if positive results are obtained, send the meat and offal to a high-risk processing plant as defined by Directive 90/667/EEC, without indemnity or compensation. In that event, Articles 20 to 23 shall apply;
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.
it shall inform the Commission of the nature of the products used and the batch concerned; the Commission shall forthwith inform all frontier posts, 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 checks demonstrate the presence of unauthorised substances or products or when maximum limits have been exceeded, the provisions of Articles 19 to 22 of Regulation (EC) No 882/2004 shall apply. 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.
(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.
potential toxicity of residues in foodstuffs of animal origin, likelihood of residues occurring in foodstuffs of animal origin.
(a) Article 4 (3) of Directive 71/118/EEC; (b) Article 5 (3) and (4) of Directive 89/437/EEC; (c) the last subparagraph of point II.3.B of Chapter V of the Annex to Directive 91/493/EEC; (d) Article 11 (1) of Directive 92/45/EEC; (e) Article 15 (1) of Directive 92/46/EEC.
(1) Stilbenes, stilbene derivatives, and their salts and esters (2) Antithyroid agents (3) Steroids (4) Resorcylic acid lactones including zeranol (5) Beta-agonists (6) Compounds included in Annex IV to Council Regulation (EEC) No 2377/90 of 26 June 1990
(1) Antibacterial substances, including sulphonomides, quinolones (2) Other veterinary drugs (a) Anthelmintics (b) Anticoccidials, including nitroimidazoles (c) Carbamates and pyrethroids (d) Sedatives (e) Non-steroidal anti-inflammatory drugs (NSAIDs) (f) Other pharmacologically active substances
(3) Other substances and environmental contaminants (a) Organochlorine compounds including PcBs (b) Organophosphorus compounds (d) Chemical elements (d) Mycotoxins (e) Dyes (f) Others
| Bovine, ovine, caprine, porcine, equine animals | Poultry | Aquaculture animals | Milk | Eggs | Rabbit meat and the meat of wild | Honey | |
|---|---|---|---|---|---|---|---|
| A 1 | X | X | X | X | |||
| 2 | X | X | X | ||||
| 3 | X | X | X | X | |||
| 4 | X | X | X | ||||
| 5 | X | X | X | ||||
| 6 | X | X | X | X | X | X | |
| B 1 | X | X | X | X | X | X | X |
| 2a | X | X | X | X | X | ||
| b | X | X | X | X | |||
| c | X | X | X | X | |||
| d | X | ||||||
| e | X | X | X | X | |||
| f | |||||||
| 3a | X | X | X | X | X | X | X |
| b | X | X | X | ||||
| c | X | X | X | X | X | X | |
| d | X | X | X | X | |||
| e | X | ||||||
| f |
one half of the samples are to be taken from live animals on the holding; (by derogation, 25 % of samples analysed for the research of Group A 5 substances can be taken from appropriate material (feedingstuffs, drinking water, etc.)) one half of the samples are to be taken at the slaughterhouse.
| 50 % of the total samples, | |
| 30 % must be checked for Group B 1 substances, | |
| 30 % must be checked for Group B 2 substances, | |
| 10 % must be checked for Group B 3 substances. |
|
(a) For the residues listed in Annex I, Group A 1, 2, 3, 4, Group B 2 (d) and Group B 3 (d) Rijksinstituut voor Volksgezondheid en Milieuhygiëne (RIVM) A. van Leeuwenhoeklaan, 9 NL-3720 BA Bilthoven (b) For the residues listed in Annex I, Group B 1 and B 3 (e) and carbadox residues and olaquindox residues Laboratories des médicaments vétérinaires (CNEVA-LMV) La Haute Marche, Javene F-35135-Fougères (c) For the residues listed in Annex I, Group A 5 and Group B 2 (a), (b), (e) Bundesinstitut für Gesundheitlichen Verbraucherschutz und Veterinärmedizin (BGVV) Diedersdorfer Weg, 1 D-12277-Berlin (d) For the residues listed in Annex I, Group B 2 (c) and Group B 3 (a), (b), (c): Istituto Superiore di Sanità Viale Regina Elena, 299 I-00161-Roma
1. The functions of Community reference laboratories shall be: (a) to promote and coordinate research into new analytical methods and to inform national reference laboratories of advances in analytical methods and equipment; (b) to help the national reference laboratories (NRLs) for residues to implement an appropriate quality assurance scheme system based on good laboratory practice (GLP) principles and EN 45000 criteria;(c) to approve validated methods as reference methods, to be integrated into a collection of methods; (d) to provide the national reference laboratories with the routine analytical methods accepted during the MRL procedure; (e) to provide national reference laboratories with details of analytical methods and the comparative tests to be conducted, and to inform them of the results of the tests; (f) to provide national reference laboratories, at their request, with technical advice on the analysis of the substances for which they have been designated the Community reference laboratory; (g) to organize comparative tests for the benefit of the national reference laboratories, the frequency of which shall be determined in agreement with the Commission. Consequently, the Community reference laboratories shall distribute blank samples and samples containing known amounts of analyte to be analysed; (h) to identify residues and determine their concentration in cases where the results of an analysis give rise to a disagreement between Member States; (i) to conduct initial and further training courses for the benefit of analysts from national laboratories; (j) to provide the Commission services, including the standards, measurements and testing programme, with technical and scientific assistance; (k) to compile a report on each year's work and transmit it to the Commission; (l) to liaise, in the field of analytical methods and equipment, with the national reference laboratories designated by third countries in the plans to be submitted in accordance with Article 11 of this Directive.
2. In order to perform the functions specified in paragraph 1, Community reference laboratories must satisfy the following minimum requirements: (a) have been designated as a national reference laboratory in a Member State; (b) have suitable qualified staff who are adequately trained in analytical methods used for the residues for which they have been designated the Community reference laboratory; (c) possess the equipment and substances needed to carry out the analysis for which they are responsible; (d) have an adequate administrative infrastructure; (e) have sufficient data-processing capacity to produce statistics based on their findings and to enable rapid communication of those statistics and other information to national reference laboratories and the Commission; (f) ensure that their staff respect the confidential nature of certain issues, results or communications; (g) have sufficient knowledge of international standards and practices; (h) have available an up-to-date list of certified reference material and reference material held by the Institute for Reference Material and Methods, and an up-to-date list of manufacturers and vendors of that material.
| This Directive | Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC | |
|---|---|---|
| Article 1 | — | |
| Article 2 | Article 2 | 86/469/EEC |
| Article 3 | Article 1 | 86/469/EEC |
| Article 2 | 85/358/EEC | |
| Article 4 | Article 3 | 86/469/EEC |
| Article 5 | Article 4 (1) first and second indents | 86/469/EEC |
| Article 6 | — | |
| Article 7 | Article 4 (1) except first and second indents | 86/469/EEC |
| Article 8 | Article 4 (2) to 4 (5) | 86/469/EEC |
| Article 12 | 86/469/EEC | |
| Article 9 | 85/358/EEC | |
| Article 9 | — | |
| Article 10 | — | |
| Article 11 | Article 1 | 85/358/EEC |
| Article 12 | — | |
| Article 13 | Article 3 | 85/358/EEC |
| Article 10 | 86/469/EEC | |
| Article 14 (1) | Article 8 (1) (b) | 86/469/EEC |
| Article 14 (2) | Article 8 (2) | 86/469/EEC |
| Decision 91/664/EEC | ||
| Decision 89/187/EEC | ||
| Article 15 (1) | Article 8 (3) | 86/469/EEC |
| Article 5 (2) | 85/358/EEC | |
| Article 15 (2) | Article 8 (3) | 86/469/EEC |
| Article 5 (3) | 85/358/EEC | |
| Article 15 (3) | Article 9 | 86/469/EEC |
| Article 16 | Article 9 (1) and Article 9 (2) | 86/469/EEC |
| Article 6 (1) and Article 6 (2) | 85/358/EEC | |
| Article 17 | Article 9 (3) (a) | 86/469/EEC |
| Article 6 (3) (a) | 85/358/EEC | |
| Article 18 | Article 9 (3) (c) and (d) | 86/469/EEC |
| Article 19 | — | |
| Article 20 (1) | — | |
| Article 20 (2) | Article 11 | 86/469/EEC |
| Article 21 | Article 5 | 86/469/EEC |
| Article 22 | Article 7 | 85/358/EEC |
| Article 23 | Articles 9 (3) (b) (c) (d) and 9 (4), 9 (5) | 86/469/EEC |
| Articles 6 (3) (b) (c) (d) and 6 (4) | 85/358/EEC | |
| Article 24 | Article 4 | 85/358/EEC |
| Article 25 | — | |
| Article 26 | — | |
| Article 27 | — | |
| Article 28 | — | |
| Article 29 | Article 7 | 86/469/EEC |
| Article 13 | 85/358/EEC | |
| Article 30 | — | |
| Article 31 | Article 12 | 85/358/EEC |
| Article 32 | Article 14 | 86/469/EEC |
| Article 11 | 85/358/EEC | |
| Article 33 | Article 15 | 86/469/EEC |
| Article 10 | 85/358/EEC | |
| Article 34 | Article 13 | 86/469/EEC |
| Article 35 | — | |
| Article 36 | — | |
| Article 37 | — | |
| Article 38 | — | |
| Article 39 | — | |
| Annex I | Annex I | 86/469/EEC |
| Annex II | — | |
| Annex III | — | |
| Annex IV | Annex II | 86/469/EEC |
| Annex V Chapter 1 | Decision 91/664/EEC | |
| Annex V Chapter 2 | Decision 89/187/EEC | |
| Annex VI | — | |