Directive 1996/23 - Measures to monitor certain substances and residues thereof in live animals and animal products - Main contents

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

SUMMARY OF:

Directive 96/23/EC on measures to monitor certain substances and residues thereof in live animals and animal product

WHAT IS THE AIM OF THE DIRECTIVE?

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:

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  substances having anabolic effect (the process of building up tissues) and unauthorised substances; and
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  veterinary drugs and contaminants.

KEY POINTS

National monitoring plans

EU countries assign to a central public department or body the task of drawing up plans to monitor the detection of residues or substances in:

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  live animals;
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  their excrement;
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  tissue and animal products;
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  animal feed; and
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  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 European Commission.

EU countries 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 EU countries within the Standing Committee on Plants, Animals, Food and Feed. 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 EU level.

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

EU countries must in particular ensure that their legislation establishes the principle of quality monitoring of the production chain by the different parties involved and that the self-monitoring measures (to be included in the specifications for trade marks or labels) are stepped up.

Official control measures

EU countries may conduct official random checks:

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  from the manufacture of pharmaceutical substances having anabolic effect to their sale;
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  from the production of animal feed to their distribution; and
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  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 EU 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 EU country demonstrate the need for an investigation or other action in one or more EU or non-EU countries, that/those countries must inform the other EU countries and the Commission.

The EU countries, in which an investigation or other action proves necessary, must take the appropriate measures.

Where a EU country considers that in another EU country the controls are not being, or have ceased to be, carried out, it must inform the competent central authority of that EU country 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:

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  slaughtering 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 EU or national regulations;
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  suspending or withdrawing the authorisations or official approval arrangements;
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  imposing criminal and/or administrative penalties and, in the event of non-cooperation with the competent authority or of obstruction, excluding any possibility of EU aid being received for a period of 12 months.

Imports from non-EU countries

EU countries may import animals and animals products covered by this Directive from the non-EU countries specified on the lists provided in the EU legislation.

The non-EU 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.

EU countries may return a batch/part of a batch concerned to the country of origin in the event of unauthorised substances being present in the batch.

This Directive imposes a fee to cover any monitoring of animals/animal products.

FROM WHEN DOES THE DIRECTIVE APPLY?

The directive has applied since 23 May 1996. It had to become law in the EU countries by 30 June 1997.

The directive is repealed and replaced by Regulation (EU) 2017/625 with effect from 14 December 2019.

Background

For more information, see:

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  Residues of Veterinary Medicinal Products (European Commission)

MAIN DOCUMENT

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 (OJ L 125, 23.5.1996, pp. 10-32)

Successive amendments to Council Directive 96/23/EC have been incorporated into the original document. This consolidated version is of documentary value only.

RELATED DOCUMENTS

Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, pp 1-142)

See consolidated version.

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 (OJ L 16, 20.1.2005, pp. 61-63)

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 (OJ L 221, 17.8.2002, pp. 8-36)

See consolidated version

Commission 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 (OJ L 65, 5.3.1998, pp. 31-34)

See consolidated version

Commission 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 (OJ L 303, 6.11.1997, pp. 12-15)

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 (OJ L 47, 18.2.1998, p.17) (France), Decision 98/152/EC (OJ L 47, 18.2.1998, p.18) (United Kingdom), Decision 98/153/EC (OJ L 47, 18.2.1998, p. 19) (Austria), Decision 98/154/EC (OJ L 47, 18.2.1998, p. 20) (Finland), Decision 98/155/EC (OJ L 47, 18.2.1998, p. 21) (Sweden), Decision 98/458/EC (OJ L 201, 17.7.1998, p. 117) (Belgium), Decision 98/459/EC (OJ L 201, 17.7.1998, p. 118) (Netherlands), Decision 98/460/EC (OJ L 201, 17.7.1998, p. 119) (Spain), Decision 98/390/EC (OJ L 175, 19.6.1998, p. 34) (Italy), Decision 98/391/EC (OJ L 175, 19.6.1998, p. 35) (Ireland), Decision 98/492/EC (OJ L 223, 11.8.1998, p. 7) (Luxembourg), Decision 98/493/EC (OJ L 223, 11.8.1998, p. 8) (Germany), Decision 98/494/EC (OJ L 223, 11.8.1998, p. 9) (Denmark), Decision 98/495/EC (OJ L 223, 11.8.1998, p. 10) (Greece), Decision 98/496/EC (OJ L 223, 11.8.1998, p. 11) (Portugal), Decision 98/497/EC (OJ L 223, 11.8.1998, p. 12) (Italy)

Monitoring plans in non-EU 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 (OJ L 154, f 30.4.2004, pp. 44-50). Text republished in corrigendum (OJ L 189, 27.5.2004, pp. 33-39)

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 (OJ L 251, 11.9.1998, pp. 39-42)

See consolidated version

last update 22.09.2010

This summary has been adopted from EUR-Lex.