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.
Document | Short decription | Contents | Link |
Dir. 96/23/EC | on measures to monitor certain substances and residues in live animals and animal products no longer in force, repealed and replaced by 2017/625 | 1) Scope and definitions 2) Monitoring plans for the detection of residues or substances 3) Self-monitoring and co-responsibility on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/EC | on the communitiy code relating veterinary medicinal products | Annex I: Requirements and analytical protocol, safety tests, pre-clinical and clinical for tests of veterinary medicinal products | http://data.europa.eu/eli/dir/2001/82/oj |
CD 2002/657/EC | information 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. 1831/2003 | on additives for use in animal nutrition | 1) 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. 124/2009 | setting 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 | Annex: MLs in foodstuff | http://data.europa.eu/eli/reg/2009/124/oj |
Reg. (EC) No. 470/2009 | procedures for the establishment of residues limits of pharmacologically active subtances in foodstuff of animal origin | 1) 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. 37/2010 | on pharmacologically active substances and their classification regarding maximum residue limits (MRLs) in foodstuff of animal origin | Annex: Table 1: Allowed substances Table 2: Prohibited substances | http://data.europa.eu/eli/reg/2010/37(1)/oj |
Commission Reg. (EU) No. 610/2012 | setting 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 foodstuff | http://data.europa.eu/eli/reg/2012/610/oj |
Reg. (EU) No. 2017/625 | on 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. 2018/470 | on detailed rules on the MRLs to be considered for control purposes for foodstuff derived from animals which have been treated in the EU | cascade-MRL | http://data.europa.eu/eli/reg_impl/2018/470/oj |
Commission Reg. (EU) No. 2019/1871 | on 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. 2021/808 | on 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/EC | 1) 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) 2022/1644 | specific 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 thereof | information 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) 2022/1646 | uniform practical arrangements for the performance of official controls | information on the preparation of the multi-annual national control plans (MANCP) | https://eur-lex.europa.eu/eli/reg_impl/2022/1646/oj |