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Veterinary Medicines and Inspections STATUS OF MRL PROCEDURES
MRL assessments in the context of Council Regulation (EEC) No 2377/90

Background and legislative framework
In order to protect the safety of the consumer of foodstuffs of animal origin, one of the most important
principles laid down in the European Union (EU) legislation with regard to the marketing authorisation of
veterinary medicines is that foodstuffs obtained from animals treated with veterinary medicinal products
must not contain residues which might constitute a health hazard for the consumer. Before a veterinary
medicinal product intended for food producing animals can be authorised in the EU, all
pharmacologically active substances contained in the product have to undergo a safety and residues
evaluation, and have to be included in Annex I, II, or III of Council Regulation (EEC) No 2377/901.
The safety and residue evaluation in accordance with Regulation 2377/90 is carried out by the Committee
for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency (EMEA),
supported by safety and residues experts, upon receipt of a valid application for the establishment of
maximum residue limits (MRLs).
Substances for which definitive MRLs have been established are included in Annex I of Regulation
2377/90. MRLs can be proposed as provisional, if all aspects are not yet fully addressed. In this case the
substance is inserted in Annex III with an expiry date defining for the termination of the provisional
status. However, no provisional MRLs can be proposed, if major issues with regard to safety remain to be
addressed, as it must be assured that residues at the proposed levels do not present a hazard to the health
of the consumer. Only, once the applicant has satisfactorily answered the outstanding questions, the
substance can be included in Annex I. These questions are likely to relate to the provision of fully
validated analytical methods.
Where, following the evaluation, it appears that it is not necessary for the protection of public health to
establish MRLs, such substance is included in Annex II. It should be noted that an entry in Annex II is not
equivalent to the status “generally recognised as safe”. In fact only a sub-group of Annex II substances do
fall under this category. For further details on the assessment of a substance you are advised to consult the
MRL Summary report of the substances concerned. Please also note that Annex II comprises a specific
entry, which provides that certain substances approved in the EU as food additives with a valid E-number
are considered included in Annex II without listing the substances specifically. Relevant substances
falling under these provisions are e.g. vitamin C, citric acid or several sodium and potassium salts, and
these substances are only mentioned in the enclosed list if an MRL application was submitted.
1 Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits for veterinary medicinal products in foodstuffs of animal origin (O.J. NO L 224, 18.8.1990, p.1), as amended by Commission Regulation (EEC) No 762/92 (O.J. No. L 83, 28.3.1992, p.14), Council Regulation (EC) No 434/97 (O.J. No L 67, 7.3.1997, p. 1), and Council Regulation (EC) No 1308/99 (O.J. L 156, 23.6.1999, p.1) Public 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: [email protected] www.emea.europa.eu EMEA 2006 Reproduction and/or distribution of this document is authorised for non-commercial purposes only provided the EMEA is acknowledged
A safety and residue evaluation may also result in the recommendation to include a substance in Annex
IV of Regulation 2377/90, which means that the substance is prohibited from use in veterinary medicinal
products for food producing animals. Another conclusion may be that due to the deficiencies of the data
provided, no recommendation for inclusion in any of the annexes could be made; the net result in the
latter case is the same as an inclusion in Annex IV, as no medicinal product containing such a substance
can be authorised for food producing animals in the EU.
During the period from 1992 to January 2005 over 700 “old” substances were reviewed and applications
concerning 58 “new” substances and 87 extensions and modifications have been submitted to the CVMP;
MRLs recommendations for inclusion in Annex, I, II or III were made for 645 substances in total. 115
substances were recommended for inclusion in Annex I of Regulation 2377/90, 513 in Annex II and 6
remain currently in Annex III. For 11 substances it was considered that their residues, at whatever limit,
in foodstuffs of animal origin constitute a hazard to the health of the consumer, and they have been placed
in Annex IV. For 40 substances, the CVMP was unable to make a recommendation for inclusion in any
of the annexes and for further 57 substances the applicants withdrew their applications after the receipt of
the list of questions.
Procedure for MRL opinions
Following the evaluation of an MRL application the CVMP issues an opinion which includes the
recommendation regarding the establishment of MRLs for the substances considered and a Summary
Opinion is published on the EMEA website (http://www.emea.eu.int/index/indexv1.htm). On the basis of
the scientific recommendation of the CVMP for inclusion of a substance in Annex I, II, III or IV of
Regulation 2377/90, the Commission prepares a draft regulation amending the respective Annex(es)
accordingly. Any such Regulation requires a favourable opinion by qualified majority of the EU Member
States, before the European Commission can adopt it. Once adopted, the European Commission publishes
the Regulation amending the annexes of Regulation 2377/90 in the Official Journal of the European
Communities. Following this publication the EMEA publishes the CVMP Summary Reports on the
EMEA website: http://www.emea.eu.int/index/indexv1.htm. The European Commission services also
provides access to all adopted Regulations amending the annexes of Regulation 2377/90
(http://europa.eu.int/eur-lex/) and a non-official consolidated list of the annexes of the Regulation listing
all MRLs established, on the following web-site: (http://pharmacos.eudra.org/F2/mrl/index.htm).
Substances with MRLs assessments in the EU
Attached is an alphabetical list of all substances included in Annex I, II, III or IV of Regulation 2377/90
with the indication of the respective annex and the number of the Regulation which established these
MRLs. In addition, the list includes substances for which MRL recommendations have been made by the
CVMP and are now undergoing the decision-making procedure by the European Commission . The list
also includes the substances for which the CVMP concluded that due to insufficient data provided a
recommendation for inclusion of the substance in Annex I, II, III of Regulation 2377/90 could not be
made.
Any enquiries regarding this connection may be directed to the attention of Dr Kornelia Grein, Head of Sector (Safety of Veterinary Medicines) at the EMEA, 7 Westferry Circus, Canary Wharf, London E14 4HB, telephone +44 20 7 418 8432; email: [email protected] MRL assessments in the EU in the context of Council Regulation (EEC) No
Substance
Regulation amending Annex of
Regulation 2377/90
Regs 1286/2000 ; 77/2002; 75/2005; 1518/2005 Regs 3093/92; 1798/96; 1191/98; 1646/2004 Aloe vera gel and whole leaf extract of Annex II Aloe vera Aloes, Barbados and Capae Aminoethanol glucoronate) Aminoethyl dihydrogenphosphate [2- Regs 3093/92; 1430/94; 1742/96; 1916/98; 1836/97; 2395/99; 1646/2004 Substance
Regulation amending Annex of
Regulation 2377/90
Anisi stellati fructus, standardised extracts and preparations thereof Apis mellifica Aristolochia spp. And preparations Substance
Regulation amending Annex of
Regulation 2377/90
Annex II proposal – Rejected by the Commission Substance
Regulation amending Annex of
Regulation 2377/90
meat) Cefazolin (bovine, ovine and caprine Cefquinome (bovine, porcine, Equidae) Annex I Regs 895/93; 282/96; 954/99; 1931/99; 2145/2003 Regs 1837/97; 804/99, 1752/2002; 1231/2006 Substance
Regulation amending Annex of
Regulation 2377/90
Cimicifugae racemosae rhizoma Cinchonae cortex, standardised extracts Annex II and preparations thereof Cinnamomi cassiae aetheroleum Cinnamomi cassiae cortex, standardised Annex II extracts and preparations thereof Cinnamomi ceylanici aetheroleum standardised extracts and preparations thereof Citri aetheroleum extracts and preparations thereof Convallaria majalis Substance
Regulation amending Annex of
Regulation 2377/90
Regs 954/99 ; 77/2002; 869/2002; 1029/2003; 1490/03; 1646/2004 Regs 1442/95; 1837/97; 121/98; 1942/99; 953/99; 1942/99; 1181/2002 Regs 1942/99; 1960/2000; 1815/2001; 2162/2001; 1646/2004 Regs 1441/95; 749/97; 1837/97; 1646/2004 Regs 1311/96; 749/97, 997/99; 2908/2000; 1181/2002 Regs 1140/96; 1960/2000; 1530/2002; 6/2006 Substance
Regulation amending Annex of
Regulation 2377/90
Regs 1430/94; 270/97;1836/97; 2728/99; 1478/2001 Regs 2901/93; 2728/98; 2593/99; 1181/2002 hexanediol]
Ethylenediaminetetraacetic acid and
Annex II proposal – Rejected by the Commission Regs. 675/92; 1441/95; 1837/97; 1646/2004 Regs 675/92; 1441/95; 1837/97; 1646/2004 Regs 2703/94; 613/98; 1942/99; 2385/99; 1322/2001; 1181/2002 Regs 895/93; 1798/96; 1000/98; 2385/99; 1055/2006 Regs 2584/2001; 665/2003; 739/2003; 1911/2005 Substance
Regulation amending Annex of
Regulation 2377/90
Follicle Stimulating Hormone (natural Annex II FSH from all species and their synthetic analogues) Formaldehyde Frangulae cortex, standardised extracts Annex II and preparations thereof Fumagillin No Gentianae radix, standardised extracts Annex II and preparations thereof Ginkgo biloba (natural HCG and its synthetic analogues) Human menopausal urinary gonadotrophin Humic acid and its sodium salt Substance
Regulation amending Annex of
Regulation 2377/90
Iodine and iodine inorganic compounds Annex II including: – Sodium and potassium – iodide – Sodium and potassium – iodate – Iodophors Iodine organic compounds – Iodoform – Polyvinylpyrrolidine – iodine Iron ammonium citrate Regs 675/92; 2901/93; 716/97; 2728/98; 869/2005 No recommendation for final Regs 282/96; 953/99; 2338/2000 MRLs Substance
Regulation amending Annex of
Regulation 2377/90
Luteinizing Hormone (natural LH from Annex II all species and their synthetic analogues) Lysine Substance
Regulation amending Annex of
Regulation 2377/90
Regs 1569/98; 2393/99; 1274/2001; 1530/2002 Menthae arventis aetheroleum viscosity including microcrystalline waxes, approximately C10-C60; aliphatic, branched aliphatic and salicyclic compounds Monothioglycerol Reg. 997/99; 1322/2001; 1851/2004; 1356/2005 Regs 2703/94; 748/97; 613/98; 1942/99; 1553/2001; 75/2005 Regs 1850/97; 804/99; 807/2001; 546/2004 Substance
Regulation amending Annex of
Regulation 2377/90
Regs 675/92; 1441/95; 1837/97; 1646/2004 Oxidation products of terebinthinae Regs 804/99; 807/2001; 739/2003; 546/2004; 1356/2005 Regs 997/99; 2338/2000; 1181/2002; 1646/2004 Regs 1311/96; 2034/96; 121/98; 2757/99; 1148/2005 Substance
Regulation amending Annex of
Regulation 2377/90
Regs 2385/99; 2391/2000; 807/2001; 1299/2005 Piceae turiones recentes extractum Polyethylene glycol stearates with 8-40 Annex II oxyethylene units Polyethylene glycol-15-hydroxystearate Annex II Polyethylene glycol-7-glyceryl-cocoate Annex II Polyethylene glycols (molecular weight Annex II ranging from 200 to 10.000) Polymixin B sulphate Polyoxyethylene sorbitan monolaurate Annex II (E-number 432) (polysorbate 20) Polyoxyethylene sorbitan monooleate Annex II (E-number 433) monopalmitate (polysorbate 40) Polyoxyethylene sorbitan monostearate Annex II (E-number 435) (polysorbate 60) Polyoxyethylene sorbitan tristearate (polysorbate 65) Polyoxyl castor oil with 30 to 40 oxyethylene units Polyoxyl hydrogenated castor oil with 40 to 60 oxyethylene units (Fatty acid polyethylene glycol ester) Polysulphated glycosaminoglycan Substance
Regulation amending Annex of
Regulation 2377/90
Propyleneglycol alginate (Propane-1,2- Annex II (E-number 405) Sodium 2-methyl-2-phenoxypropanoate Annex II Substance
Regulation amending Annex of
Regulation 2377/90
Substance
Regulation amending Annex of
Regulation 2377/90
mono- and di-basic salt of sodium, potassium and calcium Tau-fluvalinate Terebinthinae aetheroleum rectificatum Annex II Regs 3093/92; 1311/96; 1000/98; 1646/2004 Regs 955/94; 1102/95; 1917/98; 2338/2000; 2391/2000; 1274/2001; 1181/2002 Regs 1916/98; 2593/99; 2908/2000; 2232/2004; 205/2006 Substance
Regulation amending Annex of
Regulation 2377/90
Regs 3093/92; 1442/95; 1838/97; 1960/2000; 1181/2002

Source: http://www.vif.dk/VIFDokumenter/MRL%20liste.pdf

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