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European Medicines Agency Veterinary Medicines and Inspections London, 13 October 2006 EMEA/CVMP/765/99-Rev.16 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
Reg. 3425/93; 2728/99; 869/2002 Absinthium extract Acacia gum (gum arabica) Annex II (E-number 414) Acetylisovaleryltylosin Regs 1286/2000 ; 77/2002; 75/2005; 1518/2005 Acetylisovaleryltylosin (poultry) Annex Annex I proposal Acetylmethionine Acetylsalicylic acid Regs 750/2001; 1029/2003 Acetylsalicylic acid DL-lysine Regs 750/2001; 1029/2003 Annex II (E-number 355) Adonis vernalis Aesculus hippocastanum Agnus castus Ailanthus altissima Regs 3093/92; 1798/96; 1191/98; 1646/2004 Albendazole oxide Regs 17/97; 613/98; 2393/99 Regs 270/97 ; 2560/98 Annex II (E-number 400) Allium cepa Aloe vera gel and whole leaf extract of Annex II Aloe vera Aloes, Barbados and Capae Alpha-cypermethrin Regs 954/99; 869/2002 ; 2011/03 Regs 2584/2001; 1530/2002; 3332/2004 Annex II (E-number 173) Aluminium distearate Aluminium hydroxide Aluminium hydroxide acetate Aluminium monostearate Aluminium phosphate Aluminium potassium sulfate Annex II (E-number 522) Aluminium salicylate, basic Regs 1286/2000; 1937/2002 Aluminium silicate (kaolin) Annex II (E-number 559) Aluminium tristearate Aminoethanol [2-Aminoethanol] Aminoethanol glucoronate (2- Aminoethanol glucoronate) Aminoethyl dihydrogenphosphate [2- Aminoethyl dihydrogenphosphate] Amitraz Regs 3093/92; 1430/94; 1742/96; 1916/98; 1836/97; 2395/99; 1646/2004 Substance
Regulation amending Annex of
Regulation 2377/90
Ammonium chloride Ammonium hydroxide Annex II (E-number 527) Ammonium lauryl sulphate Ammonium sulfate Regs 1295/2000; 1478/2001 Angelicae radix aetheroleum Anisi aetheroleum Anisi stellati fructus, standardised extracts and preparations thereof Apis mellifica No recommendation Apocynum cannabinum Apramycin (bovine) Regs 1838/97; 1931/99 Apramycin (ovine, porcine, chicken, Regs 1838/97 ; 1931/99 rabbits) Aqua levici Aristolochia spp. And preparations thereof Arnicae montana Arnicae radix Artemisia abrotanum Annex II (E-number 300) Atropa belladonna Azagly-nafarelin Regs 1140/96 ; 1836/97 ; 1931/99 Regs 675/92; 1798/96;1858/98 Bacitracin (bovine meat) Bacitracin (bovine milk and rabbits) Regs 953/99; 1478/2001; 544/2003 Balsamum peruvianum Regs 1433/96; 1838/97 Annex II Beclomethasone dipropionate Bellis perennis Annex II (E-number 558) Benzalkonium chloride Benzetimide hydrochloride No recommendation Reg. 1569/98; 868/2002 Annex II (E-number 210) Benzylideneacetone No Benzylpenicillin Berberis vulgaris No Substance
Regulation amending Annex of
Regulation 2377/90
Betaine glucoronate Bismuth subcarbonate Bismuth subgallate Bismuth subnitrate Regs 1838/97; 1286/2000 Bismuth subsalicylate Bituminosulfonates, ammonium and Regs 2393/99; 712/2005 sodium salts Boldo folium Boric acid and borates Bovine somatotropins Annex II proposal – Rejected by the Commission Bromide, sodium salt Regs 2686/98; 2162/2001 Bryonia No Regs 2728/99; 2391/2000 Butane [n-Butane] Butanilicaine No Butanol [n-Butanol] Butorphanol tartrate Butyl 4-hydroxybenzoate Butylated hydroxyanisole Annex II (E-number 320) Butylated hydroxytoluene Annex II (E-number 321) Butylscopolaminium bromide Calcium alginate Annex II (E-number 404) Calcium aspartate Calcium benzoate Calcium borogluconate Calcium carbonate Calcium chloride Calcium glucoheptonate Calcium gluconate Calcium gluconoglucoheptonate Calcium gluconolactate Calcium glutamate Calcium glycerophosphate Calcium hydroxide Calcium hypophosphite Calcium pantothenate Calcium phosphate Calcium polyphosphates Calcium propionate Substance
Regulation amending Annex of
Regulation 2377/90
Calcium silicate Calcium stearate Calcium sulphate Calendula officinalis Calendulae flos Capsici fructus Regs 675/92; 1442/95; 953/99; 1960/2000 Carbasalate calcium Regs 750/2001; 1029/2003 Carboxymethylcellulose Annex II (E-number 466) Cardamom extract Cardiospermum halicacabum Carlinae radix Regs 1311/96; 613/98; 1931/99; 869/2005 Carvi aetheroleum Caryophylli aetheroleum Cefacetrile (bovine meat) Cefacetrile (bovine milk) Regs 804/99; 807/2001; 2126/2001 Cefalonium (bovine meat) Cefalonium (bovine milk) Reg. 1931/99; 1322/2001; 61/2003 Regs 270/97; 804/99; 1553/2001 Cefazolin (bovine, ovine and caprine Regs 270/97 ; 121/98 meat) Cefazolin (bovine, ovine and caprine Regs 270/97; 121/98 milk) Cefoperazone (bovine meat) Cefoperazone (bovine milk) Regs 1943/99; 807/2001 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 No recommendation Centellae asiaticae extractum Cetostearyl alcohol Chelidonii herba No recommendation Chelidonium majus No recommendation Regs 675/92; 1430/94 Chlormadinone acetate Substance
Regulation amending Annex of
Regulation 2377/90
Chlortetracycline Regs. 3426/93; 281/96 Chrysanthemi cinerarifolii flos 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 Cinnamomi ceylanici cortex, standardised extracts and preparations thereof Citri aetheroleum Annex II (E-number 330) Citronellae aetheroleum Citrulline Regs 749/97; 1943/99; 1553/2001 Regs 1312/96; 2391/2000 Regs 1838/97; 2232/2004 Cloprostenol [R, RS-Cloprostenol] Regs 1838/97; 2232/2004 Regs 1147/96; 1942/99 Cobalt carbonate Cobalt dichloride Cobalt gluconate Coco alkyl dimethyl betaines Regs 282/96; 2338/2000; 1181/2002 Collinsonia canadensis No recommendation Condurango cortex, standardised extracts and preparations thereof Convallaria majalis Copper gluconate Copper heptanoate Copper methionate Coriandri aetheroleum Regs 1931/99; 1478/2001 Crataegus Cupressi aetheroleums Reg. 1958/98; 807/2001 Substance
Regulation amending Annex of
Regulation 2377/90
Annex III (01.07.2001) – Regs 2017/96; 1931/99 Regs 954/99 ; 77/2002; 869/2002; 1029/2003; 1490/03; 1646/2004 Regs 2593/99; 1478/2001 Regs 1442/95; 1837/97; 121/98; 1942/99; 953/99; 1942/99; 1181/2002 Regs 675/92; 3426/93 Regs 282/96; 2338/2000 Regs 1942/99; 1960/2000; 1815/2001; 2162/2001; 1646/2004 Deltamethrin (chicken) Annex III (01.07.2003) - Regs 1942/99; 1815/2001 Denaverine hydrochloride Deslorelin acetate Regs 1441/95; 749/97; 1837/97; 1646/2004 Regs 2010/96; 1101/2004 Regs 2393/99; 1960/2000; 2391/2000 Diethyl phthalate Diethyl sebacate Diethylene glycol monoethyl ether Regs. 2728/98; 205/2006 Regs 1311/96; 749/97, 997/99; 2908/2000; 1181/2002 Regs 997/99; 2593/99 Dihydrostreptomycin Regs 1140/96; 1960/2000; 1530/2002; 6/2006 thyrosine] Dimanganese trioxide Dimethyl acetamide Dimethyl phthalate Dimethyl sulfoxyde Regs 675/92 ; 3426/93 ; 1798/95 Dinoprost tromethamine Diphenhydramine (di)hydrochloride No recommendation Annex II (E-number 312) Substance
Regulation amending Annex of
Regulation 2377/90
Doramectin Annex Regs 1430/94; 270/97;1836/97; 2728/99; 1478/2001 Doxycycline Annex Regs 17/97; 1000/98 D-Phe6-luteinizing hormone releasing hormone Drosera No recommendation Echinacea Echinacea purpurea Regs 1931/99; 1490/2003 Regs 2901/93; 2728/98; 2593/99; 1181/2002 Ephedrine (hydrochloride) No recommendation Regs 17/97; 1934/99 Ergometrine maleate Regs 1442/95, 2338/2000; 1181/2002 Etamiphylline camsylate Ethyl-1, 3-hexanediol [2-Ethyl-1, 3- No recommendation hexanediol]
Ethylenediaminetetraacetic acid and
salts (EDTA) Ethyl-p-hydroxybenzoate Annex II (E-number 214) Etilefrine hydrochloride Annex II proposal – Rejected by the Commission Etiproston tromethamine Eucalypti aetheroleum Eucalyptus globulus Euphrasia officinalis Annex II (E-number 570) Regs. 675/92; 1441/95; 1837/97; 1646/2004 Regs 675/92; 1441/95; 1837/97; 1646/2004 Fenpipramide hydrochloride Annex III (01.07.2006) Regs 1937/2002; 1875/2004 Fertirelin acetate Annex III proposal Regs 2703/94; 613/98; 1942/99; 2385/99; 1322/2001; 1181/2002 Regs 1518/2005; 1451/2006 Regs 895/93; 1798/96; 1000/98; 2385/99; 1055/2006 Flugestone acetate Regs 2584/2001; 665/2003; 739/2003; 1911/2005 Regs. 17/97; 2728/99; 2338/2000; Substance
Regulation amending Annex of
Regulation 2377/90
Flumethrin (bovine, ovine) Regs 2686/98; 2391/2000 Flumethrin (honey) Reg. 2728/99; 2908/2000 Foeniculi aetheroleum 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 Regs 2901/93; 1442/95 Regs 1140/96; 1960/2000; 868/2002 Gentianae radix, standardised extracts Annex II and preparations thereof Ginkgo biloba Annex II (E-number 422) Gonadotrophin releasing hormone Regs 997/99; 2908/2000 Hamamelis virginiana Regs 1568/98; 2728/99 Harpagophytum procumbens Harunga madagascariens (1:100) Heparin and salts Hesperidin methyl chalcone Hippocastini semen Human Chorionic Gonadotrophin Regs 1102/95 ; 2796/95 (natural HCG and its synthetic analogues) Human menopausal urinary gonadotrophin Humic acid and its sodium salt Hydrochloric acid Hydrochlorothiazide Substance
Regulation amending Annex of
Regulation 2377/90
Hydrogen peroxide Regs 895/93 ; 1433/96 Hydroxyethylsalicylate Hydroxyquinoline [8- Hydroxyquinoline] Hyperici oleum Hypericum perforatum Regs 953/99; 2162/2001; 2145/2003 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 Iron glucoheptonate Annex II (E-number 579) No recommendation Regs 675/92; 2901/93; 716/97; 2728/98; 869/2005 Jecoris oleum No recommendation for final Regs 282/96; 953/99; 2338/2000 MRLs Juniperi fructus Regs 1931/99; 2162/2001; 324/2004 Ketanserin tartrate Regs 282/96 ; 1742/96 Lachnanthes tinctoria Lasalocid sodium Regs 712/2005; 1055/2006 Lauri folium aetheroleum Lauri fructus Lavandola aetheroleum Lespedeza capita Regs 675/92; 3059/94 Levomethadon Annex Substance
Regulation amending Annex of
Regulation 2377/90
Lidocaine hydrochloride Regs 804/99; 807/2001; 1181/2002 Linear alkyl benzene sulphonic acids Reg. 807/2001; 75/2005 Lini oleum Lobaria pulmonaria Lophophytum leandri No recommendation Luteinizing Hormone (natural LH from Annex II all species and their synthetic analogues) Lysine Magnesium acetate Magnesium aluminium silicate Magnesium asparate Magnesium carbonate Magnesium chloride Magnesium citrate Magnesium gluconate Magnesium glutamate Magnesium glycerophosphate Magnesium hydroxide Magnesium hypophosphite Magnesium orotate Magnesium phosphate Magnesium stearate Magnesium sulphate Magnesium trisilicate Majorana herba Manganese carbonate Manganese chloride Manganese gluconate Manganese glycerophosphate Manganese pidolate Manganese ribonucleate Manganese sulphate Regs 2017/96; 1568/98; 2338/2000 Matricaria recutita Matricariae flos [Chamomilla] Regs 2728/99; 1680/2001 Meclofenamic acid No recommendation Medicago sativa Substance
Regulation amending Annex of
Regulation 2377/90
Medroxyprogesterone acetate Melissae aetheroleum Melissae folium Regs 1569/98; 2393/99; 1274/2001; 1530/2002 Menadione [Vitamin K3] Menthae arventis aetheroleum Menthae piperitae aetheroleum Mercaptamine hydrochloride Reg. 2728/99; 1322/2001; 2011/2003 Metesculetol sodium No recommendation Methyl nicotinate Methyl salicylate Annex II (E-number 218) Methylprednisolone Regs 1286/2000; 77/2002 pyrrolidone] Metrifonate No Millefolii herba Mineral hydrocarbons, low to high 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 Myristicae aetheroleum Regs 1850/97; 804/99; 807/2001; 546/2004 Neomycin (including framycetin) Regs 1140/96; 1960/2000; 1181/2002 Regs 1102/95; 1837/97; 807/2001 Niauli aetheroleum No recommendation Nickel gluconate Nitrofurans (except furazolidone) Substance
Regulation amending Annex of
Regulation 2377/90
Regs 665/2003; 1299/2005 Novobiocin (bovine meat) Novobiocin (bovine milk) Oenanthe aquatica No recommendation Okoubaka aubrevillei Opium tincture No recommendation Regs 675/92; 1441/95; 1837/97; 1646/2004 Regs 895/93; 1798/96; 1000/98 Oxidation products of terebinthinae oleum Oxolinic acid Regs 804/99; 807/2001; 739/2003; 546/2004; 1356/2005 Regs 997/99; 2338/2000; 1181/2002; 1646/2004 Regs 3426/93; 281/96 Paromomycin (Aminosidine) Regs 2017/96; 2338/2000; 1181/2002 Annex II (E-number 131) Annex II (E-number 440) Regs 1311/96; 2034/96; 121/98; 2757/99; 1148/2005 No recommendation Reg. 1295/2000; 807/2001; 61/2003 Phenoxymethyl penicillin Regs 1286/2000; 1299/2005 Phenylbutazone No No recommendation Substance
Regulation amending Annex of
Regulation 2377/90
Annex II (E-number 338) Regs 2385/99; 2391/2000; 807/2001; 1299/2005 Phytolacca americana Phytomenadione [Vitamin K1] Piceae turiones recentes extractum Piperazine (porcine, chicken eggs) Regs 2593/99; 1478/2001; 868/2002 Piperazine dihydrochloride (chicken meat) Piperonyl butoxide Regs 953/99; 2338/2000 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 No recommendation Polyoxyethylene sorbitan monolaurate Annex II (E-number 432) (polysorbate 20) Polyoxyethylene sorbitan monooleate Annex II (E-number 433) Regs. 2034/96; 205/2006 Polyoxyethylene sorbitan trioleate Polyoxyethylene sorbitan Annex II (E-number 434) monopalmitate (polysorbate 40) Polyoxyethylene sorbitan monostearate Annex II (E-number 435) (polysorbate 60) Polyoxyethylene sorbitan tristearate Annex II (E-number 436) (polysorbate 65) Polyoxyl castor oil with 30 to 40 Reg. 2593/99 oxyethylene units Polyoxyl hydrogenated castor oil with 40 to 60 oxyethylene units (Fatty acid polyethylene glycol ester) Polysulphated glycosaminoglycan Polyvinylpyrrolidone Annex II (E-number 1201) Populeum ointment No recommendation Potassium acetate Annex II (E-number 261) Potassium alginate Annex II (E-number 402) Potassium bromide Potassium carbonates Annex II (E-number 500) Potassium chloride Annex II (E-number 508) Potassium citrates Annex II (E-number 332) Potassium DL-aspartate Potassium glucuronate Potassium glycerophosphate Potassium metabisulphite Annex II (E-number 224) Potassium nitrate Potassium phosphates Annex II (E-number 340) Potassium selenate Substance
Regulation amending Annex of
Regulation 2377/90
Regs 748/97; 1076/98; 997/99 Pregnant Mare Serum Gonadotrophin Annex III (01.01.2001) – Propylene glycol Propyleneglycol alginate (Propane-1,2- Annex II (E-number 405) diol alginate) Propyl-p-hydroxybenzoate Annex II (E-number 216) Prunus laurocerasus Pulsatilla pratensis No recommendation Pyrantel embonate Pyrethrum extract Pyrrolidone [2-Pyrrolidone] Quercus cortex Quillaia saponins Regs 2728/99; 1478/2001 No recommendation Rhamni purshiani cortex No Rhei radix Ricini oleum Rifaximin (bovine milk) Regs 2034/96; 1191/98 Rifaximin (meat) Regs 2034/96; 2560/98 Regs 675/92; 3426/93 Rosmarini aetheroleum Rosmarini folium Ruscus aculeatus Ruta graveolens Salviae folium Sambuci flos Regs 1441/95; 1850/97; 1568/98 Secalis cornuti extractum No recommendation Selenicerus grandiflorus Serenoa repens Annex II (E-number 551) Silybum marianum Sinapis semen Sodium 2-methyl-2-phenoxypropanoate Annex II Annex II (E-number 262) Substance
Regulation amending Annex of
Regulation 2377/90
Sodium acetylsalicylate Annex II (E-number 401) Sodium benzyl 4-hydroxybenzoate Sodium bicarbonate Annex II (E-number 500) Sodium boroformiate Sodium butyl 4-hydroxybenzoate Sodium cetostearyl sulphate Sodium chromoglycate Annex II (E-number 331) Sodium cyclamate Annex II (E-number 952) Sodium dichloroisocyanurate Sodium dioctylsulfosuccinate Sodium ethyl-p-hydroxybenzoate Annex II (E-number 215) Sodium formaldehydesulphoxylate Sodium gluconate Annex II (E-number 576) Sodium glycerophosphate Sodium hypophosphite Annex II (E-number 325) Sodium laurylsulphate Sodium methyl-p-hydroxybenzoate Annex II (E-number 219) Sodium phosphates Annex II (E-number 339) Sodium propionate Sodium propyl-p-hydroxybenzoate Annex II (E-number 217) Sodium pyrosulphite Sodium salicylate Regs 1286/2000; 1875/2004 Sodium thiosulphate Solidago virgaurea Annex II (E-number 200) Sorbitan monolaurate Annex II (E-number 493) Sorbitan monooleate Annex II (E-number 494) Sorbitan monopalmitate Annex II (E-number 495) Sorbitan monostearate Annex II (E-number 491) Sorbitan sesquioleate Sorbitan tristearate Annex II (E-number 492) Spectinomycin (bovine, porcine, Regs 3059/94; 1568/98; 2728/99; 1960/2000; 869/2002; 1181/2002 Regs 675/92; 1442/95 Regs 1140/96; 1530/2002 Strychni semen [Nux vomica] Regs 2385/99; 1960/2000 Strychnine Annex Sulfonamide group Regs 675/92; 3426/93; 281/96 Regs 895/93; 544/2003 Substance
Regulation amending Annex of
Regulation 2377/90
Symphyti radix Syzygium cumini Tartaric acid [L-tartaric acid] and mono- and di-basic salt of sodium, potassium and calcium Tau-fluvalinate Regs 426/98; 1931/99 Terebinthinae aetheroleum rectificatum Annex II Terebinthinae laricina Regs . 3426/93; 281/96 Regs 3093/92; 1311/96; 1000/98; 1646/2004 Thiamphenicol (bovine, chicken) Regs 895/93; 1798/96; 1000/98; 804/99 Thiamphenicol (pigs) Annex III (01.01.2007) Thiopental sodium Thuja occidentalis Thymi aetheroleum Regs 2728/99; 2338/2000; 807/2001 Tiliae flos Regs 955/94; 1102/95; 1917/98; 2338/2000; 2391/2000; 1274/2001; 1181/2002 Tiludronic acid, disodium salt Regs 1916/98; 2593/99; 2908/2000; 2232/2004; 205/2006 Tosylchloramide sodium Regs 2393/99; 1680/2001 ; 6/2006 Tricaine methane sulphonate Trichlormethiazide Regs 1942/99; 61/2003 Regs 895/93; 1441/95; 426/98 Regs 675/92; 281/96; 121/98; 1181/2002 Trimethylphloroglucinol Substance
Regulation amending Annex of
Regulation 2377/90
Regs 1937/2002; 1101/2004 Turnera diffusa Regs 3093/92; 1442/95; 1838/97; 1960/2000; 1181/2002 Urginea maritima Urticae herba Regs 1147/96; 749/97 Vegetable carbon Annex II (E-number 153) Vetrabutine hydrochloride Viburnum opulus No recommendation Viburnum prunifolium No recommendation Virola sebifera (1:100) Viscum album Xylazine hydrochloride Regs 2593/99; 1752/2002

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