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

• Celex Number: 31996L0023
• Coming into Force: 23 May 1996,01 July 1997
• End of Effective Date: 13 December 2019
• ELI: http://data.europa.eu/eli/dir/1996/23/oj
• Published date: 23 May 1996
• Date: 29 April 1996
• Official Gazette Publication: Diario Oficial de las Comunidades Europeas, L 125, 23 de mayo de 1996,Gazzetta ufficiale delle Comunità europee, L 125, 23 maggio 1996,Journal officiel des Communautés européennes, L 125, 23 mai 1996

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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

Official Journal L 125 , 23/05/1996 P. 0010 - 0032

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

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 43 thereof,

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the European Parliament (2),

Having regard to the opinion of the Economic and Social Committee (3),

(1) Whereas by Directive 96/22/EC (4) the Council decided to maintain the prohibition on the use of certain substances having a hormonal or thyrostatic action, by extending it to beta-agonists having an anabolic effect;

(2) Whereas on 9 March 1995 the European Parliament pointed out, inter alia, that the Community urgently needed an effective and uniform monitoring system and asked the Member States to reinforce supervision and monitoring with regard to the use of illegal substances in meat;

(3) Whereas, by Directive 85/358/EEC (5), the Council adopted certain rules on the detection and monitoring of substances having a hormonal or thyrostatic action; whereas those rules should be extended to cover other substances which are used in stockfarming to promote growth and productivity in livestock or for therapeutic purposes and which may prove dangerous to the consumer on account of their residues;

(4) Whereas by Directive 86/469/EEC (6), the Council introduced certain rules on the monitoring of a certain number of residues of pharmacological substances and of environmental contaminants in farm animals and in the fresh meat obtained from such animals; whereas such monitoring should be extended to cover other animal species and all animal products for human consumption;

(5) Whereas Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (7) laid down in its Annexes limits for certain veterinary medicinal products;

(6) Whereas the Community legislation on monitoring residues in meat lacks clarity, giving rise to varying interpretations in the different Member States;

(7) Whereas there is a need to reinforce the controls carried out by and in the Member States;

(8) Whereas producers and others involved in the stockfarming industry should take greater responsibility in future for the quality and safety of meat for human consumption;

(9) Whereas the specific penalties in respect of stockfarmers not complying with Community legislation in particular prohibiting the use of certain hormonal and anabolic substances in stockfarming are to be incorporated in the separate provisions governing particular product groups;

(10) Whereas Article 4 of Directive 71/118/EEC (8) requires Member States to ensure that checks are conducted to detect residues of substances having a pharmacological action, their derivatives and other substances which may be transmitted to poultrymeat and which may make the consumption of fresh poultrymeat dangerous or harmful to human health;

(11) Whereas Directive 91/493/EEC (9) requires a monitoring system to be established by the Member States to detect contaminants present in the aquatic environment;

(12) Whereas Directive 92/46/EEC (10) provides that, by 30 June 1993 at the latest, national measures for the detection of residues in raw milk, heat-treated milk and milk-based products shall have been submitted to the Commission by the Member States, the residues to be detected being those in Part A, group III, and Part B, group II, of Annex I to Directive 86/469/EEC;

(13) Whereas Directive 89/437/EEC (11) requires Member States to ensure that checks are conducted to detect residues of substances having a pharmacological or hormonal action, antibiotics, pesticides, detergents and other substances harmful or likely to alter the organoleptic characteristics of egg products or make the consumption of such products dangerous or harmful to human health;

(14) Whereas Directive 92/45/EEC (12) requires Member States to extend their residue detection plans in order to make wild-game meat subject, where necessary, to sampling checks with a view to detecting the presence of contaminants from the environment and to include rabbits and farmed game in such monitoring;

(15) Whereas, if the illegal use of growth and productivity promoters in stockfarming is to be combated effectively in all Member States, action will have to be organized at Community level;

(16) Whereas systems of self-regulation by producer groups can play an important role in combating the illegal use of growth promoters; whereas it is essential for consumers that these systems adequately guarantee the absence of such promoters and whereas a general European approach is essential to safeguard and support self-regulation systems;

(17) Whereas, to that end, producer groups should be assisted in developing self-regulation systems to ensure that their meat is free of unauthorized substances or products;

(18) Whereas a certain number of provisions of Directives 86/469/EEC and 85/358/EEC and of Decisions 89/187/EEC (13) and 91/664/EEC (14) require clarification in the interests of the effective application of controls and residue detection in the Community; whereas, with a view to immediate and uniform application of the controls provided for, the present rules and amendments to them should be assembled in a single text repealing the aforesaid instruments,

HAS ADOPTED THIS DIRECTIVE:

CHAPTER I Scope and definitions

Article 1

This Directive lays down measures to monitor the substances and groups of residues listed in Annex I.

Article 2

For the purposes of this Directive, the definitions in Directive 96/22/EC shall apply. In addition:

(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 (15);

(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.

CHAPTER II Monitoring plans for the detection of residues or substances

Article 3

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.

Article 4

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:

(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.

3. This Article shall not affect more specific rules applicable to the monitoring of animal nutrition.

Article 5

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:

(a) provide for detection of groups of residues or substances...