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Foodlaw-Reading
Dr David Jukes, The University of
Reading, UK
Providng access to food law since May 1996 |
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Last updated:
21 June, 2021
Veterinary Drug Residues
Providing access to the EU and UK legislation
On this page:
- Summary - Brief details of the chronology of developments linked to this topic
- EU Legislation - Listing of Regulations covering the topic
- UK Legislation - Listing of Regulations covering the topic
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Summary
Legislation laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin was first adopted by the EU with Regulation 2377/90. When first adopted, the Regulation contained four annexes which were initially empty:
- List of pharmacologically active substances for which maximum residue levels have been fixed
- List of substances not subject to maximum residue levels
- List of pharmacologically active substances used in veterinary medicinal products for which maximum residue levels have been fixed
- Lists of pharmacologically active substances for which no maximum levels can be fixed
However with the first amendment, in 1992 (Regulation 675/92) additions were made to Annexes I and III. The first addition to Annex II was in 1993 (Regulation 895/93). Finally, the first addition to Annex IV was with Regulation 2901/93. Amendments continued with the final amendment being in 2009. At that time, an updated and consolidated Regulation was adopted - Regulation 470/2009. This provides a framework for the controls with the listing of Maximum Residue Limits (MRLs) being contained in a separate control - Regulation 37/2010.
This now contains just two tables - one giving MRLs for 'approved substances' and a second listing 'prohibited substances' for which no MRL can be established.
In addition, some further implementing regulations were adopted in 2017 and 2018 (see listing below).
Before the adoption and application of the above controls, due to significant concerns about the potential health risk to consumers, specific controls had been adopted in
1981 by Directive 81/602 which prohibited the used as veterinary medicines of 'substances having a thyrostatic action or substances having an oestrogenic, androgenic or gestagenic action'. It also prohibited the processing or marketing of meat derived from any animal which had been administered these substances. The substances can be used as growth promoters and have been used for this purpose outside the EU. Additional supporting measures were introduced by Directive 88/146 (including prohibition of imports) and Directive 88/299. These 3 Directives were subsequently replaced by Directive 96/22 and extended the controls to beta-agonists having an anabolic effect. These EU restrictions led to an extended dispute with, in particular, the United States, involving an assessment by the World Trade Organisation's Dispute Settlement Body. The EU maintains that the use of the substances poses a risk to health and that risk assessment has verified that the controls are justified. Other countries however believe that their use is safe and permit their use for fattening purposes. For more details of this issue, see the Commission document: Hormones in Bovine Meat.
Supporting these rules,
the EU established control requirements. These were initially in Directive 85/358 (linked to Directive 81/602) but extended to additional categories by Directive 86/469. The controls were subsequently updated and incorporated into Directive 96/23. However, with the adoption of a comprehensive official controls regulation (Regulation 2017/625), control requirements have been incorporated into that Regulation but with additional details set out in the supporting implementing measure, Regulation 2019/2090.
For the Commission's page on this topic, see: Residues of Veterinary Medicinal Products.
EU Legislation
Framework Regulation:
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Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ 152, 16.6.2009, page 11)
Implementing Measures:
- Commission Implementing Regulation (EU) 2017/12 of 6 January 2017 regarding the form and content of the applications and requests for the establishment of maximum residue limits in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council (OJ L4, 7.1.2017, page )
- Commission Regulation (EU) 2017/880 of 23 May 2017 laying down rules on the use of a maximum residue limit established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species and a maximum residue limit established for a pharmacologically active substance in one or more species for other species, in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council (OJ L135, 24.5.2017, page 1)
- Commission Regulation (EU) 2018/782 of 29 May 2018 establishing the methodological principles for the risk assessment and risk management recommendations referred to in Regulation (EC) No 470/2009 (OJ L132, 30.5.2018, page 5)
Listing of Maximum Residues:
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Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ L15, 20.1.2010, page 1)
Important Note: This Regulation has been amended over 80 times. The amendments are not listed here. At the time that this was last checked (February 2021), the latest pdf version was from December 2020. It is a document with 80 pages. It can be accessed from Regulation 37/2010 Consolidated Text (December 2020).
Specific Controls for Certain Substances - Hormones in Meat:
- Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC (OJ L125, 23.5.1996, page 3) [Consolidated Text (December 2008)] as amended by:
- Directive 2003/74/EC of the European Parliament and of the Council of 22 September 2003 amending Council Directive 96/22/EC concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists (OJ L262, 14.10.2003, page 17)
- Directive 2008/97/EC of the European Parliament and of the Council of 19 November 2008 amending Council Directive 96/22/EC concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists (OJ L318, 28.11.2008, page 9)
Official Controls:
- Commission Delegated Regulation (EU) 2019/2090 of 19 June 2019 supplementing Regulation (EU) 2017/625 of the European Parliament and Council regarding cases of suspected or established non-compliance with Union rules applicable to the use or residues of pharmacologically active substances authorised in veterinary medicinal products or as feed additives or with Union rules applicable to the use or residues of prohibited or unauthorised pharmacologically active substances (OJ L317, 9.12.2019, page 28)
UK Legislation
Brexit: Prior to the IP Completion Day (31 December 2020), the legal requirements given in the EU Regulations listed above still applied to the UK. Since IP Completion Day, the EU Regulations above have been incorporated into UK legislation but with amendments to correct deficiencies. Information on this is given below. For more details of the process of incorporating EU legislation into UK law, see the separate page: UK Food Law: EU Legislation as Amended for the UK. Provisions for the enforcement of the controls (originally the EU Regulations but now as amended) have been provided in the UK Regulations listed below. For Northern Ireland, EU rules still apply.
Guidance: Provided by the Veterinary Medicines Directorate:
EU Legislation with links to legislation.gov.uk: amended for application in Great Britain:
- Regulation (EC) No 470/2009 of the European Parliament and of the Council laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin as amended by:
- Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (SI 2019, No. 676)
- Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (SI 2019, No. 865)
- Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin revoked by:
- Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (SI 2019, No. 676)
- Commission Delegated Regulation (EU) 2019/2090 of 19 June 2019 supplementing Regulation (EU) 2017/625 of the European Parliament and Council regarding cases of suspected or established non-compliance with Union rules applicable to the use or residues of pharmacologically active substances authorised in veterinary medicinal products or as feed additives or with Union rules applicable to the use or residues of prohibited or unauthorised pharmacologically active substances as amended by:
- Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (SI 2020, No. 1461)
- Commission Implementing Regulation (EU) 2017/12 of 6 January 2017 regarding the form and content of the applications and requests for the establishment of maximum residue limits in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council as amended by:
- Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (SI 2019, No. 676)
- Commission Regulation (EU) 2017/880 of 23 May 2017 laying down rules on the use of a maximum residue limit established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species and a maximum residue limit established for a pharmacologically active substance in one or more species for other species, in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council as amended by:
- Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (SI 2019, No. 676)
- Commission Regulation (EU) 2018/782 of 29 May 2018 establishing the methodological principles for the risk assessment and risk management recommendations referred to in Regulation (EC) No 470/2009 as amended by:
- Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (SI 2019, No. 676)
Enforcement and Implementation of EU Directives:
Requirements for implementation and enforcement are provided for the four parts of the United Kingdom:
- England
/ Scotland
- Animals and Animal Products (Examination for Residues and Maximum Residue Limits)(England and Scotland) Regulations 2015 (SI 2015, No. 787) as amended by:
- Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (SI 2019, No. 676)
- Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (SI 2020, No. 1461)
- Wales
- Animals and Animal Products (Examination for Residues and Maximum Residue Limits) (Wales) Regulations 2019 (SI 2019, No. 569 (W. 125)) as amended by:
- Northern Ireland
- Animals and Animal Products (Examination for Residues and Maximum Residue Limits) Regulations (Northern Ireland) 2016 (SRNI 2016, No. 54)
This page was first provided on 17 February 2021
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