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Monitoring substances having a hormonal action and other substances in animals and animal products

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Monitoring substances having a hormonal action and other substances in animals and animal products

The European Union (EU) is harmonising measures relating to the monitoring of certain substances (substances having anabolic effect, unauthorised substances, veterinary drugs and contaminants) or their residues in farm animals, meat and primary products of animal origin (eggs, milk and honey).


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 [See amending acts].


This Directive lays down the measures for monitoring the substances and groups of residues listed in Annex I. The substances are divided into two groups:

  • substances having anabolic effect and unauthorised substances, and
  • veterinary drugs and contaminants.

National monitoring plans

Member States assign to a central public department or body the task of drawing up plans to monitor the detection of residues or substances in live animals, their excrement, in tissue and animal products, as well as in animal feed and drinking water. The public department or body coordinates the activities of the central and regional departments responsible for monitoring and collecting the results of such monitoring and the data to be sent to the Commission.

Member States must subsequently submit the monitoring plans for the detection of groups of residues or substances. The plans must conform to the sampling levels and frequencies laid down in Annex IV to the Directive.

Each year, or whenever it deems it necessary, the Commission must report to the Member States within the Standing Committee on the Food Chain and Animal Health. Each year the Commission must also send the European Parliament and the Council a communication on the results of action taken at regional, national or Community level.

Self-monitoring and co-responsibility on the part of operators

Member States must in particular ensure that the principle of quality monitoring of the production chain by the different parties involved is established in their legislation and that the self-monitoring measures to be included in the specifications for trade marks or labels are stepped up.

Official control measures

Member States may conduct official random checks:

  • from the manufacture of pharmaceutical substances having anabolic effect to their sale;
  • from the production of animal feed to their distribution; and
  • throughout the production chain of animals and raw materials of animal origin covered by this Directive.

Where examination of an official sample reveals the presence of residues of prohibited substances or quantities of authorised substances exceeding the levels set in Community rules, the competent authorities must obtain without delay all the information required to identify the animal and farm of origin as well as the results of the examination.

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 must inform the other Member States and the Commission.

The Member States in which an investigation or other action proves necessary must take the appropriate measures.

Where a Member State considers that in another Member State the controls are not being, or have ceased to be, carried out, it must inform the competent central authority of that Member State accordingly. Following an investigation, that authority must take all necessary measures. In the event of a dispute, however, the matter may be brought to the notice of the Commission, which must instruct one or more experts to deliver an opinion.

Measures to be taken in the event of infringement

The following penalties may be applied in the event of infringement:

  • possibility of slaughtering the animals separately from other batches of animals arriving at the slaughterhouse and declaring unfit for human consumption carcases and products in which the residue level exceeds the levels authorised by Community or national regulations;
  • possibility of suspending or withdrawing the authorisations or official approval arrangements;
  • possibility of imposing criminal and/or administrative penalties and, in the event of non-cooperation with the competent authority or of obstruction, excluding any possibility of Community aid being received for a period of 12 months.

Imports from third countries

Member States may import animals and animals products covered by this Directive from the third countries specified on the lists provided in the Community legislation.

The third countries concerned are obliged to submit a plan setting out the guarantees as regards the monitoring of the groups of residues and substances referred to in the Directive.

Member States have the possibility of returning a batch or part of a batch concerned to the country of origin in the event of unauthorised substances or products or of residues of such substances or products being present in the batch.

Obligation on the Council to make provision, before 1 July 1996, for the charging of a fee to cover monitoring carried out pursuant to this Directive.



Entry into force

Deadline for transposition in the Member States

Official Journal

Directive 96/23/EC



OJ L 125 of 23.5.1996

Amending act(s)

Entry into force

Deadline for transposition in the Member States

Official Journal

Regulation (EC) No 806/2003



OJ L 122 of 16.5.2003

Treaty of Accession of the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia



OJ L 236 of 23.9.2003

Regulation (EC) No 882/2004



OJ L 165 of 30.4. 2004.

Directive 2006/104/EC



OJ L 363 of 20.12.2006

Regulation (EC) No 596/2009



OJ L 188 of 18.7.2009

The successive amendments and corrections to Directive 96/23/EC have been incorporated in the original text. This consolidated version is of documentary value only.


Commission Decision 2005/34/EC of 11 January 2005 laying down harmonised standards for the testing for certain residues in products of animal origin imported from third countries [Official Journal L 16 of 20.1.2005].

Commission Decision 2002/657/EC of 12 August 2002 implementing Council Directive 96/23/EC concerning the performance of analytical methods and the interpretation of results [Official Journal L 221 of 17.8.2002].See consolidated version

Decision 98/179/EC of 23 February 1998 laying down detailed rules on official sampling for the monitoring of certain substances and residues thereof in live animals and animal products.[Official Journal L 65 of 5.3.1998].See consolidated version

Decision 97/747/EC of 27 October 1997 fixing the levels and frequencies of sampling provided for by Council Directive 96/23/EC for the monitoring of certain substances and residues thereof in certain animal products.[Official Journal L 303 of 6.11.1997].

Monitoring plans in the European Union

Commission Decisions approving the monitoring plan for the detection of residues or substances in live animals and animal products:

Decision 98/151/EC [Official Journal L 47 of 18.2.1998] (France)Decision 98/152/EC [Official Journal L 47 of 18.2.1998] (United Kingdom)Decision 98/153/EC [Official Journal L 47 of 18.2.1998] (Austria)Decision 98/154/EC [Official Journal L 47 of 18.2.1998] (Finland)Decision 98/155/EC [Official Journal L 47 of 18.2.1998] (Sweden)Decision 98/458/EC [Official Journal L 201 of 17.7.1998] (Belgium)Decision 98/459/EC [Official Journal L 201 of 17.7.1998] (Netherlands)Decision 98/460/EC [Official Journal L 201 of 17.7.1998] (Spain)Decision 98/390/EC [Official Journal L 175 of 19.6.1998] (Italy)Decision 98/391/EC [Official Journal L 175 of 19.6.1998] (Ireland)Decision 98/492/EC [Official Journal L 223 of 11.8.1998] (Luxembourg)Decision 98/493/EC [Official Journal L 223 of 11.8.1998] (Germany)Decision 98/494/EC [Official Journal L 223 of 11.8.1998] (Denmark)Decision 98/495/EC [Official Journal L 223 of 11.8.1998] (Greece)Decision 98/496/EC [Official Journal L 223 of 11.8.1998] (Portugal)Decision 98/497/EC [Official Journal L 223 of 11.8.1998] (Italy)

Monitoring plans in third countries

Commission Decision 2004/432/EC of 29 April 2004 on the approval of residue monitoring plans submitted by third countries in accordance with Council Directive 96/23/EC [Official Journal L 154 of 30.04.2004].See consolidated version

National reference laboratories

Commission Decision 98/536/EC of 3 September 1998 establishing the list of national reference laboratories for the detection of residues [Official Journal OJ L 251 of 11.9.1998].See consolidated version

Last updated: 22.09.2010