Legislation

The table below lists several EU documents related to veterinary medicinal products. For more in-depth information, please refer to the listing available on the FIS-VL.

DocumentShort decriptionContentsLink
Dir. 96/23/ECon measures to monitor certain substances and residues in live animals and animal products
no longer in force, repealed and replaced by 2017/625
1) Scope and definitions
2) Monitoring plans for the detection of residues or substances
3) Self-monitoring and co-responsibility on the part of operators
4) Official control measures
5) Measures to be taken in the event of infringement
6) Import from third countries
7) General provisions
 
Annex I: Classification in group A/B
A – prohibited or unauthorised pharmacologically active substances
B – authorised pharmacologically active substances
Annex II: Residue or substance group to be detected by type of animal
Annex III/IV: Sampling procedures		http://data.europa.eu/eli/dir/1996/23/oj
CD 2001/82/ECon the communitiy code relating veterinary medicinal productsAnnex I: Requirements and analytical protocol, safety tests, pre-clinical and clinical for tests of veterinary medicinal productshttp://data.europa.eu/eli/dir/2001/82/oj
CD 2002/657/ECinformation on performance of analytical methods and the interpretation of results
implements Dir. 96/23/EC		Annex:
1) Definitions
2) Performance criteria (screening and confirmatory methods)
Validation (conventional, alternative models)		http://data.europa.eu/eli/dec/2002/657/oj
Commission Reg. (EU) No. 1831/2003on additives for use in animal nutrition1) Scope and definitions
2) Authorisation, use, monitoring and transitional measures aplicable for feed additives
3) Labelling and packaging
4) General and final provisions
Annex I: Additive groups
Annex II: Duties and tasks of the community reference laboratory
Annex III: Specific labelling requirements for certain additives and for premixtures
Annex IV: General conditions of use		https://eur-lex.europa.eu/eli/reg/2003/1831/2019-07-26
Reg. (EC) No. 124/2009setting maximum levels (MLs) fo the presence of coccidiostats or histomonostats in food resulting from the unavoidable carry-over of these substances in non-target feedAnnex: MLs in foodstuffhttp://data.europa.eu/eli/reg/2009/124/oj
Reg. (EC) No. 470/2009procedures for the establishment of residues limits of pharmacologically active subtances in foodstuff of animal origin1) General provisions
2) Maximum residue levels (MRLs)
3) Reference point of action (RPAs)		http://data.europa.eu/eli/reg/2009/470/oj
Commission Reg. (EU) No. 37/2010on pharmacologically active substances and their classification regarding maximum residue limits (MRLs) in foodstuff of animal originAnnex:
Table 1: Allowed substances
Table 2: Prohibited substances		http://data.europa.eu/eli/reg/2010/37(1)/oj
Commission Reg. (EU) No. 610/2012setting maximum levels (MLs) fo the presence of coccidiostats or histomonostats in food resulting from the unavoidable carry-over of these substances in non-target feed
amending Reg. (EC) No. 124/2009		Annex: MLs in foodstuffhttp://data.europa.eu/eli/reg/2012/610/oj
Reg. (EU) No. 2017/625on official control and other acitivities
to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products
repeals and replaces e.g. Dir. 96/23/EC and Reg. (EC) No. 882/2004		1) Subject matter, scope and definitions
2) Official controls and other official activities in MS: Art. 4: Designation of competent authorities
3) Reference laboratories and reference centres:
Art. 92/93/94: European Union reference laboratories;
Art. 100/101: National reference laboratories
4) Administrative assistance and cooperation: Art. 102: General rules
5) Planning and reporting: Art. 109: Multi-annual national control plans (MANCP)
6) Union activities: Art. 116: Commission controls in MS
7) Enforcement action
8) Common provisions
Annex I: Territories referred
Annex II: Training of staff of the competent authorities
Annex III: Characterisation of methods of analysis
Annex IV: Fees or charges		http://data.europa.eu/eli/reg/2017/625/oj
Commission Implementing Reg. (EU) No. 2018/470on detailed rules on the MRLs to be considered for control purposes for foodstuff derived from animals which have been treated in the EUcascade-MRLhttp://data.europa.eu/eli/reg_impl/2018/470/oj
Commission Reg. (EU) No. 2019/1871on RPAs for non-allowed pharmacologically active substances present in food of animal origin
repeals CD 2005/34/EC		Rules for the establishment of RPAs, for which no MRL has been laid down in accordance with Reg. (EC) No. 470/2009
Annex: RPAs		http://data.europa.eu/eli/reg/2019/1871/oj
Commission Implementing Reg. (EU) No. 2021/808on the performance of analytical methods for residues of pharmacologically active substances used in food-producing animals and on the interpretation of results as well as on the methods to be used for sampling and repealing Decisions 2002/657/EC and 98/179/EC1) Subject matter and scope
2) Definitions
3) Methods of analysis
4) Quality control
5) Interpretation of results
6) Methods of sampling
7) Repeals ans transitional measures
8) Entry into force
ANNEX I
ANNEX II		 http://data.europa.eu/eli/reg_impl/2021/808/oj
Commission Delegated Regulation (EU) 2022/1644specific requirements for the performance of official controls on the use of pharmacologically active substances authorised as veterinary medicinal products or as feed additives and of prohibited or unauthorised pharmacologically active substances and residues thereofinformation on substance groups and commodity groups to be controlled

criteria for sampling strategies		https://eur-lex.europa.eu/eli/reg_del/2022/1644/oj
Commission Implementing Regulation (EU) 2022/1646uniform practical arrangements for the performance of official controlsinformation on the preparation of the multi-annual national control plans (MANCP)https://eur-lex.europa.eu/eli/reg_impl/2022/1646/oj