agenda item 11 (b) cx/rvdf 06/16/13 (part 1) october 2005 ... · cx/rvdf 06/16/13, part 1 2 3. the...

* To be confirmed

Agenda Item 11 (b) CX/RVDF 06/16/13 (Part 1) October 2005

JOINT FAO/WHO FOOD STANDARDS PROGRAMME

CODEX COMMITTEE ON RESIDUES OF VETERINARY DRUGS IN FOODS Sixteenth Session

Cancun, Quintana Roo*, Mexico, 8 -12 May 2006

REPORT OF THE WORKING GROUP ON RESIDUES OF VETERINARY DRUGS WITHOUT ADI/MRL

Document prepared by the European Community, with the assistance of Australia, Canada, Denmark, France, Germany, the Netherlands, New Zealand, Sweden, Thailand,

United States and IFAH

1. The 15th CCRVDF agreed to establish a Working Group to develop recommendations on how to deal with compounds without an ADI or MRL. To this end CL 2004/50-RVDF part C requested the following information from Codex members (reply by 28 February 2005):

a. all compounds with no Codex MRLs used at the national level for food producing animals, and compounds in use that raise health concerns,

b. compounds in use that create trade problems,

c. compounds recommended for inclusion in a prohibited use (negative) list, and the reason for the inclusion in that list, and

d. other tolerances or applications of an analytical limit of detection or determination.

Description and purpose of the task of the working group

2. The purpose of the working group was to address two issues which had been raised in earlier CCRVDF meetings:

- The trade difficulties arising from the residues of substances whose residues raise consumer health concerns due to their toxicity and which should therefore not be used as veterinary drugs (see e.g. ALINORM 03/31 para. 70, ALINORM 05/15).

- The availability of veterinary drugs for the treatment of food producing animals in those member countries that largely rely on the Codex safety evaluation (see e.g. ALINORM 03/31 para. 84) and to increase the number of veterinary drugs recommended as safe for use by the Codex Alimentarius Commission.

Moreover the working group was asked to consider the recommendations of the Joint FAO/WHO Technical Workshop on Residues of Veterinary Drugs without ADI/MRL (Bangkok, 24 – 26 August 2004) addressed to the Codex Alimentarius Commission.

CX/RVDF 06/16/13, Part 1

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3. The 15th CCRVDF asked the Working Group to carry out the following tasks1:

- Establish two lists of compounds:

- all compounds used at the national level for which no Codex MRLs exist and

- all compounds of concern for health protection or trade issues;

- Establish criteria for prioritizing all listed compounds;

- Prioritise the listed compounds for future consideration;

- Develop recommendations on how to proceed with consideration of the priority list;

- Discuss the proposed recommendations with the JECFA Secretariat and consider how these relate to the outcomes of the JECFA consideration of the recommendations of the Bangkok FAO/WHO Technical Workshop;

- As necessary, consider other risk management options to address compounds for which an ADI cannot be set due to lack of data or where JECFA has concerns for the compound; and

- Develop a timetable for action on prioritized compound.

4. The goal is to prepare a paper for consideration of the 16th Session of the Committee through the ad hoc Working Group on Priorities.

Working Group Activities

5. Comments on CL 2004/50-RVDF were received from Australia, Canada, Costa Rica, the European Community, Sweden and the United States2. Additionally, the working group obtained the SPS notifications of Costa Rica and El Salvador as well as the information on prohibited compounds on the homepage of the New Zealand Food Safety Authority3.

6. The draft was revised based on comments received and a new document sent out on 13 May 2005 with a request for comments by 15 July 2005. This mailing was updated twice in order to include additional contributions from Australia and Costa Rica on 3 and 17 June 2005 respectively. The mailing contained a discussion document, asking 10 specific questions, and two annexes (a list of all veterinary drugs in use and a list of veterinary drugs prohibited in at least one Codex member).

7. Comments on the mailing of 13 May 2005 were received from Australia, Denmark, the Netherlands, Korea, Sweden, Thailand, the United Kingdom, the United States and IFAH.

8. The majority of working group members also wished to hold a physical meeting. Therefore, an informal meeting was convened on 15 September 2005 in Brussels.

9. The comments received on the 13 May 2005 mailing were included in a revised document that was circulated to working group members on 22 August 2005 for comments by 7 September 2005.

10. The working group also considered an SPS notification by Japan4 describing a national procedure to establish MRLs on the basis of evaluations performed outside of the national regulatory authority.

11. The comments received were considered in the 15 September 2005 informal meeting of the working group and the document was revised accordingly in the meeting. The revised document was circulated to working group members participating in the meeting on 16 September 2005 for comments by 23 September 2005. The updated document was circulated to all working group members on 29 September 2005 for comments by 19 October 2005. A revised document was sent to the Codex secretariat on 21 October 2005.

1 see report 15th CCRVDF/ALINORM 05/31 para. 175 2 See CX/RVDF 06/16/13, Part 2 (for information) 3 available at: http://www.nzfsa.govt.nz/acvm/subject/vet/prohibited.htm 4 G/SPS/N/JPN/145 available at: http://docsonline.wto.org/


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Issues for consideration by the ad hoc Working Group on Priorities and the 16th CCRVDF

Veterinary drugs used at the national level for which no Codex MRLs exist

12. To identify the veterinary drugs used in food producing animals, it appears necessary to consider all substances (compounds) addressed in national/regional legislation.

13. It is reiterated that “veterinary drug” is defined in the 14th Codex Procedural Manual (p. 44) as “any substance applied or administered to any food producing animal, such as meat or milk producing animals, poultry, fish or bees, whether used for therapeutic, prophylactic or diagnostic purposes or for modification of physiological functions or behaviour”. For this reason the term ‘veterinary drug’ has been used in most cases, even though the terms ‘veterinary drug’, ‘substance’ or ‘compound’ may in this context be used synonymously.

14. The attached “List of veterinary drugs used in food producing animals” (Annex I) has been assembled from the information mentioned above. The list is an attempt to identify those veterinary drugs used or likely to be used in food producing animals.

15. In compiling the list, it was postulated that veterinary drugs can be used for at least one purpose/species legally if they have been evaluated for use in food producing animals with the result that

- an MRL was set, or

- a decision was made that an MRL was not necessary.

In contrast if a compound is expressly prohibited in a member country or has been assigned an analytical performance limit (APL) only, it was presumed that there may be concern regarding the safety and/or misuse of the compound.

16. Moreover for completeness and transparency, veterinary drugs for which Codex MRLs exist have been included in Annex I.

Veterinary drugs of concern as regards consumer health protection or trade issues

17. The attached “List of Veterinary drugs of concern as regards consumer health protection or trade” (Annex II) has been assembled from the information mentioned above.

18. It lists those veterinary drugs that are either:

- entirely prohibited or not tolerated by at least one Codex member due to health concerns as they have a potential to create trade problems, or

- considered by working group members to present health concerns, and

- considered by working group members to present trade problems.

Where possible, the concern connected to the veterinary drug has been indicated.

19. It needs to be reiterated in relation to the last indent in para. 18 above that trade issues arise if legislation on the use of approved or permitted veterinary drugs differs between importing and exporting countries and, in particular, if the detection of residues of a veterinary drug leads to rejection of consignments at import that would be compliant in the country of origin. Differences in the legislation on the use of veterinary drugs may be linked to differences in:

- appreciation of the toxicity or other risks (e.g. pharmacological effects or development of antimicrobial resistance) of veterinary drugs,

- use patterns,

- rules on extra label/off label use,

- levels of consumer protection,

- societal values,

- enforcement rules,

- approaches to prevent unauthorised use,


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or combinations of the above.

20. Trade problems have also occurred where national MRLs are not identical to Codex MRLs, or to those of other Codex members.

21. In summary it needs to be stressed that it is only possible to assemble an indicative list of veterinary drugs creating trade problems. The list should be updated regularly.

Criteria for prioritizing all listed compounds/veterinary drugs for JECFA evaluation/re-evaluation

22. Bearing in mind that the protection of human health and ensuring fair practices in trade are major objectives of Codex, the prioritisation of veterinary drugs for further JCFA/re-evaluation should consider the following aspects: necessity for the treatment and prevention of disease in animals, agronomic impact, and data/evaluation availability. It is in this respect reiterated that protection of consumer health and ensuring fair practices in trade are main Codex objectives.

Consumer health protection

23. Veterinary drugs used in food producing animals, but completely prohibited by at least one Codex member for reasons related to consumer health, should be given priority using a risk based approach. Public health concerns may relate not only to the inherent toxicity of the drug and its effects on human gut flora, but also to the potential for misuse.

Trade concerns

24. Trade disruptions may occur when food safety decisions differ between countries leading to a number of problems including rejection of consignments due to the detection of residues, added compliance costs in the exporting country to meet the different requirements or complete cessation of trade. Priority should be given to evaluation of those veterinary drugs that have led to the rejection of consignments in the past.

Necessity for the treatment of animals

25. Priority should be given to the evaluation of veterinary drugs that are needed to avoid unnecessary suffering or disease in animals (i.e. morbidity and mortality). Moreover those veterinary drugs that are needed by Codex member that rely on the Codex safety evaluation should be given priority. Additionally the extent to which the substances are used for the treatment of animals should be considered.

Agronomic impact

26. The availability of veterinary drugs can have a profound impact on the agricultural economy of Codex members. In consequence, consideration should be given to the economic impact of the use or non-use of a veterinary drug and the extent of its use when weighing the risks against the benefits in risk management decisions, including the prioritisation of these drugs for further consideration.

Availability of data and/or evaluation

27. Priority should be given to the evaluation of veterinary drugs for which sufficient data are available to support a decision on their use in food producing animals. Annex I provides indications as to what substances have been evaluated in which country/region. Hence veterinary drugs already evaluated according to procedures similar to those employed by JECFA/CCRVDF at national/regional level should be given priority. Veterinary drugs can only be evaluated for use in food producing animals if sufficient data is available. Therefore, subject to the previous criteria being satisfied, priority should be given to the evaluations of drugs which have already been evaluated at national/regional level employing procedures similar to those used by JECFA/CCRVDF. However, where there is insufficient data to support the safe use of a particular substance in food producing animals, consideration could be given to a recommendation to not use the substance and the establishment of an appropriate analytical performance limit (APL) for the substance.


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Priority list of veterinary drugs for future consideration

28. On the basis of the criteria provided in paragraphs 24 through 27 above, veterinary drugs should be included in a priority list for future evaluation or re-evaluation by the JECFA. The list should present information on the respective veterinary drugs’ characteristics in relation to the above mentioned criteria. A first list of veterinary drugs that were suggested for such a priority list has been assembled (Annex III). The finalised priority list should identify:

- substances proposed to JECFA to consider whether it can be concluded that they should not be used in food producing animals due to concerns linked to their human health risk and

- substances proposed for JECFA evaluation/re-evaluation with the aim of enhancing the availability of veterinary drugs for the treatment of food producing animals.

29. The veterinary drugs listed in the current Annex III are a starting point for a Priority List of Veterinary Drugs Requiring Evaluation or Re-evaluation by JECFA at the 16th CCRVDF. Annex III should be futher developed before and during the 16th CCRVDF meeting by all Codex members.

30. Veterinary drugs recommended for use on the draft priority list are proposed for inclusion into the existing list of veterinary drugs that have been evaluated by Codex (Status of Maximum Residue Limits for Veterinary Drugs in Food5) on a temporary basis and indicating the different basis for their inclusion.

31. Concerning veterinary drugs that should not be used in food producing animals, the fact that a substance is prohibited for use by one or more Codex members due to consumer health concerns can be used as a starting point for the identification of candidates for such a list. These veterinary drugs have been included in Annex III. However, this criterion alone is insufficient and unsatisfactory for a final Codex list. Additional considerations should be made for each veterinary drug in order to identify the criteria for recommending a ban.

32. It is evident that these criteria should be based on scientific considerations that address both toxicology (hazard) and residue (exposure) issues. They should nevertheless also allow for some flexibility in order allow the risk and the benefit evaluation of the use of a veterinary drug. Therefore, for those veterinary drugs for which an ADI or MRL cannot be established it is recommended that JECFA considers approaches that will provide an estimate of the risk posed to the human consumer through the use of each of these drugs in food producing animals. Such an approach will assist the CCRVDF in risk management decisions regarding the use of these veterinary drugs.

Discussion of the proposed recommendations with the JECFA Secretariat and consideration of the recommendations of the Bangkok FAO/WHO Technical Workshop

33. The Bangkok FAO/WHO Technical Workshop recommendations may be re-ordered and summarised as follows:

a. Veterinary drugs whose residues are generally recognized as highly toxic and which should not be used as veterinary drugs must be addressed by the Codex Alimentarius. CCRVDF should identify those veterinary drugs and develop a policy that aims to ensure that they are not used in food animal production. Such a policy should include the recommendation of analytical performance limits for the determination of residues of those veterinary drugs.

b. Codex should develop an approach and timetable to allow completion of the work on MRLs within 10 years for those substances which have been evaluated by national governments and are legally used in many countries but which have no Codex MRL.

c. As one approach to address the work on MRLs, Codex should consider temporary MRLs that are based on national/regional MRLs and their accompanying assessment reports that have been adopted using a procedure that applies risk assessment principles. Codex will need to address how to reconcile differences for veterinary drugs with more than one national/regional MRL. This list of temporary MRLs should be valid for a certain time period (to be determined by Codex). A temporary MRL on this list should subsequently be made permanent if

− no comments have been received that put the original risk assessment into question, or

5 provided as handout at the 15th CCRVDF and also available in database format at: http://faostat.fao.org/faostat/


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− JECFA was able to establish an ADI based on review of the underlying data and to propose an MRL.

Substances that do not meet either of these conditions should be moved to a list of veterinary drugs not to be used in food animals. If comments have been received that put the original risk assessment into question, the veterinary drug may be referred to JECFA for further evaluation.

d. For those substances for which it is not possible or practical to establish an ADI or MRL, Codex should work in conjunction with JECFA6 to consider alternative risk assessment tools such as :

− margin of exposure,

− threshold of toxicological concern,

− statistical approaches.

Using tools such as these, JECFA should develop an estimate of the risks associated with the anticipated exposure of consumers to residues of the veterinary drug in food. This procedure should, if possible, result in risk assessment that may be used by the CCRVDF in order to assist in risk management decisions by the CCRVDF and national regulatory authorities.

34. The recommendations above can be translated into the following project elements:

a. Identification of a priority list of veterinary drugs to be evaluated or re-evaluated by JECFA (proposal see above and Annex III).

− Agreement at the 16th CCRDVF approach to and on format of Priority List of Veterinary Drugs Requiring Evaluation or Re-evaluation by JECFA.

− Agreement at the 17th CCRDVF (and as appropriate at later CCRDVF sessions) on the priority of veterinary drugs to be proposed to JECFA for evaluation or re-evaluation until all veterinary drugs in Annex I have been addressed.

− Agreement at the 17th CCRDVF (and as appropriate re-consideration at later CCRDVF sessions) on a procedure for the identification and provision of the necessary data as well as on an alternative risk assessment policy. This policy would have to describe how to proceed with veterinary drugs:

i. to be recommended for prohibition and to set criteria and agree on a procedure to establish control limits (possibly linked to other risk management options – see also para. 45 below) that facilitate international trade and

ii. that may acceptably be used in food producing animals. This would include a procedure to accept evaluations performed outside the Codex system as a temporary measure.

35. The detailed elaboration of an alternative risk assessment policy would fall under the scope of the Discussion Paper on Risk Management Methodologies, Including Risk Assessment Policies in the Codex Committee on Residues of Veterinary Drugs in Foods developed under the chairmanship of France7. The recommendations of the 2005 Bangkok FAO/WHO Technical Workshop regarding alternative approaches to risk assessment for veterinary drugs other than the establishment of an ADI and MRL should be considered by this working group.

36. One recommendation of the Bangkok meeting was that JECFA may be asked whether MRLs could be set for all food producing species in order to increase the availability of veterinary drugs for food producing animals. If this is not possible, JECFA could be asked for suggestions on how the scope of MRLs can be enlarged by extrapolation.

6 JECFA intends elaborate on these points at its next meeting in February 2006 in order to provide

recommendations to CCRVF on what is needed to implement such proposals 7 JECFA will consider this issue from a scientific perspective at its next meeting (personal communication from

the JECFA Secretariat to chairperson this working group)


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37. It was however noted that in addition to residue and metabolism data the setting of MRLs requires consideration of Good Practice in the Use of Veterinary Drugs8 that may not be available in all food producing species. JECFA can according to its current risk assessment policy only propose MRLs when relevant data are submitted because MRLs are derived from residue studies in the specific species and tissue in question. Extrapolations need to be based on some data. Hence JECFA can only respond to such a request if relevant data are publicly available or are submitted. Extrapolation to species other than those for which data are provided would have to follow an alternative risk assessment policy agreed by the CCRVDF.

38. Concerning the procedure to consider evaluations performed outside the Codex system as a temporary measure, it is proposed to implement a procedure suggested by the Joint FAO/WHO Technical Workshop on Residues of Substances without ADI/MRL in Food and similar to that suggested for implementation in Japan9: For veterinary drugs without Codex status (JECFA evaluation) results from outside the Codex system (i.e. of member countries) will be proposed for adoption. Codex will consider how to resolve differences when veterinary drugs have multiple ADIs or MRLs from national/regional authorities. The procedure would be based on the presumption that:

- Codex members apply their standards not only to domestic products but also to imports,

- the standards have been based on scientific considerations,

- the MRLs would be provisional.

39. A similar procedure could be applied for control limits (i.e. analytical performance limits -APL). They would also have to be linked to a basic toxicological evaluation and the agreement on parameters of appropriate analytical methods (agreed analytical performance limits). The latter may be further developed by the Ad hoc Working Group on Methods of Analysis and Sampling.

40. It may have to be clarified with the Codex Alimentarius Commission or the Executive Committee whether this is in line with the Working Principles for Risk Analysis for Application in the Framework of Codex Alimentarius10 and in particular para. 10 thereof which reads: “When there is evidence that a risk to human health exists but scientific data are insufficient or incomplete, the Codex Alimentarius Commission should not proceed to elaborate a standard but should consider elaborating a related text, such as a code of practice, provided that such a text would be supported by the available scientific evidence.”

41. A process following a similar approach as suggested by the present document has been initiated by CCPR as regards interim MRLs based on national legislation as a pilot project aimed at replacing more hazardous compounds with newer safer pesticides11.

42. The initial list of temporary/operative MRLs adopted in application of the alternative risk assessment procedure is to be valid for a certain time period only [e.g. 15 years]. Thereafter MRLs/Codex status should be adopted without time limitation, if either of the following conditions are met:

- no comments have been received from Codex members that put the original risk assessment into question, or

- JECFA considered the veterinary drug and was able to establish an ADI and to propose an MRL.

43. Veterinary drugs which do not fulfil either of these conditions should be moved to a list of veterinary drugs recommended as not to be used in food animals.

44. If JECFA considered the veterinary drug and was not able to establish an ADI and propose an MRL, JECFA should clearly identify the knowledge/data gaps including the risk associated with them and provide a risk assessment that estimates the risk to the consumer posed by residues of the veterinary drug in food.

8 GPVD is the official recommended or authorized usage including withdrawal periods, approved by national

authorities, of veterinary drugs under practical conditions (14th Codex Procedural Manual p. 45) 9 see SPS notification G/SPS/N/JPN/145 available at: http://docsonline.wto.org/ or

http://www.mhlw.go.jp/english/topics/mrls/final/index.html) 10 see Codex Procedural Manual, page 101-107 at: ftp://ftp.fao.org/codex/ProcManuals/Manual14e.pdf 11 see ALINORM 05/28/24 paras 189 - 203 available at: http://www.codexalimentarius.net/web/reports


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Other risk management options

45. Risk management options other than setting MRLs fall under the scope of national regulatory programmes. They should be taken up in the revision of the Codex Guidelines for the Establishment of a Regulatory Programme for Control of Veterinary Drugs Residues12. They may consist of, e.g., the following measures:

- Recommendation of complete prohibition of the use of veterinary drugs that have been shown as not being suitable for use in food producing animals by Codex members.

- Recommendation of restriction of the use of the veterinary drug to specific indications and/or production groups and/or species, including, e.g., prohibition of extra label/off label use by Codex members. Here it may also be considered whether the option chosen in the Codex MRL list for Clenbuterol is a viable solution: “Due to the potential abuse of this drug, the MRLs are recommended only when associated with a nationally approved therapeutic use, such as tocolysis or as an adjunct therapy in respiratory disease”.

Timetable for action on prioritized veterinary drugs

46. On the basis of the discussion above, the following proposal for a timetable is made:

16th CCRDVF

- agree on format of draft Priority List of Veterinary Drugs Requiring Evaluation or Re-evaluation by JECFA

- identify issues that have to be addressed by:

- JECFA

- in new Risk Management Methodologies, Including Risk Assessment Policies in the Codex Committee on Residues of Veterinary Drugs in Foods (WG chaired by France)

- in the Codex Guidelines for the Establishment of a Regulatory Programme for Control of Veterinary Drugs Residues

17th CCRDVF

- adopt first priority list of veterinary drugs

- agree on outlines of an alternative risk assessment policy

- agree on approach based on APLs

JECFA meeting

- evaluate veterinary drugs on first priority list

- make proposals for further definition of the alternative risk assessment policy

18th CCRDVF

- adopt second priority list of veterinary drugs

- agree on an alternative risk assessment policy including criteria for veterinary drugs for whom the prohibition of use in food producing animals is recommended to Codex members

- adopt proposal for CAC for temporary MRLs/APLs on the basis of JECFA’s evaluation of the first priority list and set time limit for their validity

- adopt proposal for CAC for a list of veterinary drugs not to be used in food animals

JECFA meeting

- evaluate veterinary drugs on priority list

- make, if considered necessary by 17th CCRDVF, further proposals for futher definition of the alternative risk assessment policy

[X]th CCRDVF

- agree on MRLs/Codex status without time limitation and veterinary drug to be moved to the list of veterinary drugs recommended not to be not to be used in food animals.

12 (see report of 15th CCRVDF/ALINORM 05/28/31Paras 117-122)

CX/RVDF 06/16/13, Part 1 Annex I List of veterinary drugs used in food producing animals

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Annex I to CCRVDF Working Group document to develop recommendations on veterinary drugs without MRL or ADI

List of veterinary drugs used in food producing animals

Explanations:

This list has been assembled using information provided by working group members, available on the Internet and through SPS notifications.

MRLs have generally not been distinguished according to species. This has been done firstly, because this would have rendered the table incredibly complex and secondly because Codex members allow extra label/off label use of substances that have been evaluated for other species.

In Australia and New Zealand veterinary drugs and pesticides are covered by the same legislation.

In Canada ‘no MRL’ means no detectable residue by the recommended analtytical method or no MRL is required (e.g. endogenous substances).

Costa Rica allows use of compounds with Codex MRLs if not in Codex list accepts US MRLs, if no US, EU MRLs

In the European Union, veterinary drugs fall under two legal categories: veterinary medicinal products and feed additives. The use of antimicrobials as feed additives will be generally prohibited from 2006 onwards. The use of hormones for growth promotion is generally prohibited. ‘Restricted’ on other substances means no off-label use permitted for the substance.

The substance listing for Japan needs verification as the information has been taken from SPS notifications. Japan considers disinfectants veterinary drugs (these have however not been considered in this list)

In the United States ‘prohibited’ means prohibited from extra label use. ‘Permitted tolerance’ means a tolerance level other than an MRL or APL has been set for endogenous substances. Enrofloxacin is prohibited for use in poultry only.

Abbreviations APL = analytical performance limit MRL = maximum residue limit ADI = acceptable daily intake SPS = Agreement on the application of sanitary and phytosanitary measures


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Veterinary drug Major application

Codex/ JECFA

Australia Canada Costa Rica

EU Japan Korea New Zealand

US Other Other Other

Abamectin

anthelminthic, antiprotozoan, insecticide

yes, MRL permitted, MRL

permitted permitted, MRL

permitted permitted, no MRL

permitted, no MRL

Absinthium extract

herbal remedy permitted, no MRL

Acacia catechu permitted, no MRL

Acepromazine tranquilizer permitted, no MRL


permitted, no MRL

Acetyl cysteine mucolytic permitted, no MRL

permitted, no MRL

Acetaminophen permitted, no MRL

Acetanilide permitted,no MRL

permitted, no MRL

Acetylamino-5-nitrothiazole (2-)

permitted, MRL

Acetylisovaleryl-tylosin,

antibiotic permitted, MRL

permitted

Acetylmethionine permitted, no MRL

permitted, no MRL

Acetylsalicylic acid

vitamine permitted,no MRL

permitted, no MRL

permitted, no MRL

Acetylsalicylic acid DL-lysine

permitted, no MRL

Adenosine permitted, no MRL

permitted, no MRL

Adonis vernalis permitted, no MRL

Adrenocortical extract

permitted, no MRL

Aesculus hippocastanum

permitted, no MRL

Agnus castus permitted, no MRL

Ailanthus altissima

permitted, no MRL


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Codex/ JECFA




Aklomide anthelminthic, antiprotozoan


Alanine alfacalcidol

permitted, no MRL

permitted, no MRL

Albendazole (oxide)

anthelminthic antiprotozoan


permitted, MRL



permitted, MRL

Alfaprostol permitted, no MRL

Allantoin permitted, no MRL

permitted, no MRL

Allium cepa permitted, no MRL

Aloes, Aloe vera gel and whole leaf extract of Aloe vera, Aloes Barbados and Capae

permitted, no MRL

permitted, no MRL

Alpha-cypermethrin

insecticide yes, MRL + JECFA, CCRVDF Step 6

permitted, MRL


permitted no MRL

permitted, no MRL

Alphamethrin insecticide permitted, no MRL

Altrenogest hormone permitted, MRL

permitted.MRL

permitted, MRL


permitted, MRL

Aluminium distearate

permitted, no MRL

Aluminium hydroxide

permitted, no MRL

permitted, no MRL

Aluminium hydroxide acetate

permitted, no MRL

Aluminium monostearate

permitted, no MRL

permitted, no MRL

Aluminium phosphate

permitted, no MRL

Aluminium salicylate

permitted, no MRL

permitted, no MRL


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Codex/ JECFA




Aluminium silicate

permitted, no MRL

Aluminium tristearate

permitted, no MRL

Amikacin sulfate permitted, no MRL

Aminoethanol [2-aminoethanol] (ethanolamine)

permitted, no MRL

Aminoethanol glucoronate (2-Aminoethanol glucoronate)

permitted, no MRL

Aminoethyl dihydro-genphosphate [2-Aminoethyl dihydrogenphosphate]

permitted, no MRL

Amitraz insecticide

permitted, MRL


permitted, no MRL

Ammonium chloride

permitted, no MRL

permitted, no MRL

Ammonium lauryl sulphate

permitted, no MRL

permitted, no MRL

Ammonium sulfate

permitted, no MRL

Amoxicillin antibiotic permitted, MRL



permitted, MRL

Ampicillin antibiotic permitted, MRL

permitted, MRL



permitted, MRL

Amprolium antimicrobial, anthelminthic, antiprotozoan

permitted, MRL

permitted,MRL



permitted, MRL

Anacolin permitted, no MRL

Androstone hormone permitted, no MRL


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Codex/ JECFA




Angelicae radix aetheroleum

permitted, no MRL

Anisi aetheroleum

permitted, no MRL

Anisi stellati fructus standardised extracts and preparations thereof

permitted, no MRL

Antipyrine permitted, no MRL

Apocynum cannabinum

permitted, no MRL

Apramycin antibiotic permitted, MRL

permitted, MRL

permitted permitted, MRL, ovine, porcine, chicken, rabbits:, permitted, no MRL


permitted, MRL

Apricot fragrance permitted, no MRL

Aqua levici permitted, no MRL

Arecoline hydrobrimide

permitted, no MRL

Arginine permitted, no MRL

permitted, no MRL

Aristrolochia spp and preparations thereof

prohibited

permitted, no MRL

Arnicae montana permitted, no MRL

Arnicae radix permitted, no MRL


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Codex/ JECFA




Arsanilic acid/arsenic

permitted,MRL


prohibited

permitted, MRL

Artemisia abrotanum

permitted, no MRL

Asparginine permitted, no MRL

Aspartic acid permitted, no MRL

permitted, no MRL

Aspergillus oryzae

permitted, no MRL

Aspoxicillin antibiotic permitted Atherol permitted,

no MRL

Atipamezol permitted, no MRL

Atropa belladonna

permitted, no MRL

Atropine muscarinic blocking agent

permitted,no MRL


permitted, no MRL

Azagly-nafarelin permitted, no MRL

Avilamycin antimicrobial permitted, MRL

permitted permitted permitted, no MRL

Avoparcin antimicrobial permitted, MRL

prohibited

permitted, no MRL

Azamethiphos permitted, no MRL

permitted, no MRL

Azaparone/azaperone

tranquilizer yes, MRL permitted, MRL

permitted,no MRL



permitted, no MRL

Azaperol APL Bacitracin antimicrobial permitted,

MRL permitted,no MRL

permitted permitted, MRL(milk), no MRL (meat)


permitted, MRL

Balsamum peruvianum

permitted, no MRL


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Codex/ JECFA




Baquiloprim antimicrobial permitted, MRL

permitted

Barium selenate permitted, no MRL

Beclomethasone dipropionate

permitted, no MRL

Bellis perennis permitted, no MRL

Benzalkonium chloride

permitted,no MRL

permitted, no MRL

permitted, no MRL

Benzocaine permitted, MRL

permitted, no MRL

permitted, no MRL

Benzyl alcohol permitted, no MRL

permitted, no MRL

Benzyl benzoate permitted, no MRL

permitted, no MRL

Benzylpenicillin (see also Procain-Benzylp.)

antibiotic yes, MRL permitted, MRL

permitted,MRL



Benzyl-p-hydroxybenzoate

permitted, no MRL

Beta sympathomimetic agents (β-agonists) other than clenbuterol

β-agonist prohibited

NZ: prohibited

Betaine permitted, no MRL

permitted, no MRL

Betaine glucoronat

permitted, no MRL

Betamethasone steroidal anti-inflammatory drug


permitted

Bicozamycin antibiotic permitted Biotin permitted,

no MRL permitted,

no MRL permitted,

no MRL

Bithionol anthelminthic antiprotozoan

permitted


16


Codex/ JECFA




Bismuth subcarbonate

permitted, no MRL

Bismuth subgallate

permitted, no MRL

Bismuth subnitrate

permitted, no MRL

permitted, no MRL

Bismuth subsalicylate

permitted, no MRL

Bituminosulfonates ammonium and sodium salts

permitted, no MRL

Boldo folium permitted, no MRL

Boric acid and borates

permitted, no MRL

permitted, no MRL

Bovine somatotropin

hormone yes, MRL not specified

permitted prohibited for animals welfare reasons

permitted, no MRL

permitted, no MRL

Brombuterol APL Bromhexine permitted,

no MRL permitted,

no MRL

Bromide sodium salt

permitted, no MRL

Bromofenofos anthelminthic, antiprotozoan

permitted

Bronopol antimicrobial permitted, no MRL

permitted, no MRL

Brotizolam sedative, hypnotic

permitted, no MRL


Buquinolate antimicrobial permitted, MRL


Buserelin hormone (lhrh)-agonist

permitted, no MRL

permitted, no MRL

Butafosfan phosphorus replacement

permitted, no MRL

permitted, no MRL

Butane [n- permitted,


17


Codex/ JECFA




Butane] no MRL Butanol [n-Butanol]

permitted, no MRL

Butorphanol tartrate

permitted, no MRL

Butyl 4-hydroxybenzoate

permitted, no MRL

permitted, no MRL

Butylscopolaminium bromide

permitted, no MRL

Caffeine permitted, no MRL

permitted, no MRL

Calcium acetate permitted, no MRL

permitted, no MRL

Calcium aspartate permitted, no MRL

Calcium benzoate permitted, no MRL

Calcium borogluconate

permitted, no MRL

permitted, no MRL

Calcium carbonate

permitted, no MRL

permitted, no MRL

Calcium chloride permitted, no MRL

permitted, no MRL

Calcium citrate permitted, no MRL

Calcium glucoheptonate

permitted, no MRL

permitted, no MRL

Calcium glucolactate

permitted, no MRL

Calcium gluconate

permitted, no MRL

permitted, no MRL

Calcium gluconogluco-heptonate

permitted, no MRL

Calcium glutamate

permitted, no MRL

Calcium glycerophosphate

permitted, no MRL


18


Codex/ JECFA




Calcium hydroxide

permitted, no MRL

permitted, no MRL

Calcium hypophosphite

permitted, no MRL

permitted, no MRL

Calcium maleate permitted, no MRL

Calcium oxide permitted, no MRL

permitted, no MRL

Calcium pantothenate

permitted, no MRL

permitted, no MRL

Calcium phosphate

permitted, no MRL

permitted, no MRL

Calcium polyphosphates

permitted, no MRL

Calcium propionate alcium silicate

permitted, no MRL

Calcium stearate permitted, no MRL

permitted, no MRL

Calcium sulphate permitted, no MRL

Calendula officinalis

permitted, no MRL

Calendulae flos permitted, no MRL

Camphor permitted, no MRL

permitted, no MRL

Camphora permitted, no MRL

Capsici fructus permitted, no MRL

Carazolol production aid yes, MRL APL permitted permitted, MRL


Carbadox yes, but JECFA recommended withdrawa

proposing regulatory amendment to ban

permitted prohibited

permitted, MRL

permitted, MRL


19


Codex/ JECFA




l Carbasalate calcium

permitted, no MRL

Carbendazim APL Carbetamide permitted,

MRL

Carbetocin hormone permitted permitted, no MRL


Carbomycin antibiotic permitted, tolerance zero

Cardamom extract

permitted, no MRL

Cardiospermum halicacabum

permitted, no MRL

Carlinae radix permitted, no MRL

Carnitine permitted, no MRL

permitted, no MRL

Carprofen nonsteroidal anti-inflammatory drug

permitted, MRL

permitted

Carvi aetheroleum

permitted, no MRL

Caryophylli aetheroleum

permitted, no MRL

Cefacetrile antibiotic permitted permitted, MRL (milk), permitted, no MRL (meat)

permitted, no MRL

Cefalexin antibiotic permitted permitted, MRL



20


Codex/ JECFA




Cefalonium antibiotic permitted, milk, MRL(milk), permitted, no MRL (meat)


Cefapirin antibiotic permitted,MRL



Cefazolin antibiotic permitted, milk, MRL(milk), permitted, no MRL(meat)


Cefoperazone antibiotic permitted permitted, MRL (milk), permitted, no MRL (meat)


Cefquinome antibiotic permitted permitted, MRL


Ceftiofur antibiotic yes, MRL permitted, MRL

permitted,MRL



permitted, MRL pigs, poultry sheep: permitted, no MRL

Cefuroxime antibiotic yes, MRL, JECFA milk

permitted, MRL


Centellae asiaticae extractum

permitted, no MRL


21


Codex/ JECFA




Cephalonium antibiotic permitted, MRL

permitted, no MRL

Cephapirin antibiotic permitted, MRL

permitted, MRL

permitted, no MRL

permitted, MRL

Cetostearyl alcohol

permitted, no MRL

permitted, no MRL

Cetrimide permitted permitted, no MRL

permitted, no MRL

Chloramphenicol JECFA could no safe limit

prohibited APL

prohibited

prohibited APL

prohibited

prohibited

prohibited

Chlorhexidine disinfectant permitted, MRL

permitted,no MRL

permitted, no MRL


permitted, tolerance zero

Chlormadinone/ Chlormadinone acetate

hormone APL permitted, MRL

permitted

Chlorobutanol permitted,no MRL

permitted, no MRL


Chlorocresol permitted, no MRL

permitted, no MRL

permitted, no MRL

Chloroform prohibited

permitted, no MRL

prohibited

Chlorphenamine permitted, no MRL

Chlorpirifos: permitted permitted, MRL

Chlorpromazine JECFA APL prohibited

prohibited

Chlortetracycline yes, MRL permitted, MRL

permitted,MRL


permitted, MRL

permitted, MRL

Choline permitted, no MRL

permitted, no MRL

Chrysanthemi cinerarifolii flos

permitted, no MRL

Chymotrypsin permitted, no MRL

permitted, no MRL


22


Codex/ JECFA




Cimaterol APL Cimicifugae racemosae rhizoma

permitted, no MRL

permitted, no MRL

Cinchonae cortex standardised extracts and preparations thereof

permitted, no MRL

Cinnamomi cassiae aetheroleum

permitted, no MRL

Cinnamomi cassiae cortex standardised extracts and preparations thereof

permitted, no MRL

Cinnamomi ceylanici aetheroleum

permitted, no MRL

Cinnamomi ceylanici cortex standardised extracts and preparations thereof

permitted, no MRL

Ciprofloxacin antimicrobial prohibited

permitted, no MRL

Citri aetheroleum permitted, no MRL

Citronellae aetheroleum

permitted, no MRL

Citrulline permitted, no MRL

Clavulanic acid antimicrobial permitted, MRL


permitted


23


Codex/ JECFA




Clazuril antiprotozoan permitted, no MRL

Clenbuterol, Clenbuterol hydrochloride/ Hydroxymethylclenbuterol

tocolytic, adjunct therapeutic in respiratory disease, production aid

yes, MRL prohibited APL Hydroxymethylclenbuterol


permitted

Clenpenterol APL Clopidol antimicrobial,

anthelminthic,antiprotozoan

permitted, MRL


permitted, MRL

Cloprostenol [r rs-cloprostenol]

permitted,no MRL


permitted, no MRL

Clorsulon anthelminthic, antiprotozoan

permitted, MRL

permitted, MRL


permitted, MRL

Closan permitted, MRL

Closantel anthelminthic, antiprotozoan




Cloxacillin antibiotic permitted, MRL

permitted, no MRL



permitted, MRL

Cobalt carbonate permitted, no MRL

permitted, no MRL

Cobalt dichloride permitted, no MRL

permitted, no MRL

Cobalt gluconate permitted, no MRL

permitted, no MRL

Cobalt oxide permitted, no MRL

permitted, no MRL

Cobalt sulphate permitted, no MRL

permitted, no MRL

Cobalt trioxide permitted, no MRL

Coco alkyl dimethyl betaines

permitted, no MRL

Colchicine prohibited

prohibited


24


Codex/ JECFA




Colistimethate sodium (colistin sodium methane sulfonate)

antimicrobial permitted, no MRL

Colistin antimicrobial permitted permitted, MRL

permitted, no MRL

Condurango cortex standardised extracts and preparations thereof

permitted, no MRL

permitted, no MRL

Convallaria majalis

permitted, no MRL

Copper chloride permitted, no MRL

permitted, no MRL

Copper gluconate permitted, no MRL

permitted, no MRL

Copper heptanoate

permitted, no MRL

Copper methionate

permitted, no MRL

Copper oxide permitted, no MRL

permitted, no MRL

Copper sulphate permitted, no MRL

permitted, no MRL

Coriandri aetheroleum

permitted, no MRL

Corticotrophin permitted, no MRL

Coumafos insecticide permitted, MRL

permitted, MRL


permitted

Crataegus permitted, no MRL

Crostebol (Clostebol?)

hormone permitted

Cupressi aetheroleums

permitted, no MRL


25


Codex/ JECFA




Cyfluthrin yes, MRL permitted, MRL

permitted, MRL


permitted, no MRL

Cyhalothrin yes, MRL permitted, MRL

permitted, MRL


Cypermethrin (see also alpha cypermethrin)

insecticide yes, MRL JECFA, CCRVDF Step 6

permitted, MRL


permitted, no MRL

Cyromazine permitted permitted, MRL

permitted, no MRL

Cysteine permitted, no MRL

Cytidine permitted, no MRL

Danofloxacin antimicrobial yes, MRL permitted, MRL



permitted, MRL

Dapsone prohibited

permitted, no MRL

prohibited

Decoquinate antimicrobial, anthelminthic,antiprotozoan

permitted, MRL



permitted, MRL

Deltamethrin (Thalomethrin)

insecticide yes, MRL permitted, MRL

APL permitted permitted, MRL


Dembrexine permitted, no MRL

Denaverine hydrochloride

permitted, no MRL

Deslorelin acetate permitted, no MRL

Destomycin A antibiotic permitted Detomidine permitted,

no MRL permitted,

no MRL

Dexamethasone steroidal anti-inflammatory drug

JECFA permitted, MRL

permitted, no MRL

permitted, MRL


Dexpanthenol permitted, no MRL

permitted, no MRL


26


Codex/ JECFA




Diazinon permitted permitted, MRL

permitted, no MRL

Dibutylsuccinate insect repellent

permitted

Dichlorvos permitted, no MRL


permitted, MRL

Diclazuril anthelminthic,antiprotozoan

yes, MRL, (JECFA recommended modifications)

permitted, MRL

permitted, MRL



permitted, MRL

Diclofenac permitted permitted, MRL

Dicloxacillin antibiotic permitted, MRL


Dicopper oxide permitted, no MRL

Dicyclanil insect growth regulator



permitted

Dienestrol APL Diethyl phthalate permitted,

no MRL

Diethyl sebacate permitted, no MRL

Diethylene glycol monoethyl ether

permitted, no MRL

Diethylstilbestrol (DES)

JECFA prohibited


prohibited

prohibited

Difloxacin anitmicrobial permitted, MRL

permitted

Diflubenzuron permitted, MRL

Digitalis purpurea

permitted, no MRL

Dihydro-streptomycin


permitted, MRL



permitted, MRL


27


Codex/ JECFA




Diiodo-L-thyrosine [3 5-Diiodo-L-thyrosine]

permitted, no MRL

Dimanganese trioxide

permitted, no MRL

Dimethicone permitted, no MRL

permitted, no MRL

Dimethyl acetamide

permitted, no MRL

permitted, no MRL

Dimethyl phthalate

permitted, no MRL

permitted, no MRL

Dimethyl sulfoxyde

permitted, no MRL

permitted, no MRL

Dimetridazole (5-nitroimadazole)

permitted, MRL

prohibited

prohibited

prohibited

prohibited

prohibited

Diminazene anthelminthic, antiprotozoan


permitted permitted permitted, MRL

Dinitolmide antimicrobial, anthelminthic, antiprotozoan

permitted

Dinitro-benzamide (3,5-)

permitted, no MRL

permitted, no MRL

Dinoprost hormone permitted permitted, no MRL


Dinoprost tromethamine

permitted, no MRL

permitted, no MRL

Diprophylline permitted, no MRL

permitted, no MRL

Dipyrone APL permitted Dipyrone metabolites

APL

Doramectin anthelminthic, antiprotozoan, insecticide

yes, MRL + JECFA, CCRVDF Step 6

permitted, MRL

permitted, MRL



permitted, MRL


28


Codex/ JECFA




Doxapram permitted, no MRL

permitted, no MRL

Doxycycline antibiotic permitted, no MRL



D-Phe6-luteinizing hormone releasing hormone

permitted, no MRL

Echinacea permitted, no MRL

Echinacea purpurea

permitted, no MRL

Efrotomycin antibiotic permitted Emamectin anthelminthic,

antiprotozoan, insecticide

permitted, MRL

Enilconazole permitted, no MRL

Enramacycin antibiotic permitted Enrofloxacin antimicrobial JECFA permitted,

MRL permitted,

MRL permitted,

no MRL permitted,

MRL prohibited for poultry

Epinephrine permitted, no MRL

permitted, no MRL

Eprinomectin anthelminthic, antiprotozoan

permitted, MRL

permitted, MRL



permitted, MRL

Ergometrine maleate


Erythromycin antibiotic JECFA permitted, MRL

permitted, MRL



permitted, MRL

Estradiol (17β-), Estradiol and related esters


permitted, no MRL


permitted, no MRL

permitted, tolerance

Etamiphylline camsylate

permitted, no MRL

permitted, no MRL


29


Codex/ JECFA




Etamsylate permitted, no MRL

Ethanol permitted, no MRL

permitted, no MRL

Ethion permitted Ethopabate antimicrobial,

anthelminthic, antprotozoa

permitted, no MRL


permitted, MRL

Ethyl lactate permitted, no MRL

permitted, no MRL

Ethyl oleate permitted, no MRL

permitted, no MRL

Ethylenediamine permitted, no MRL


Ethylenediamine-tetraacetic acid and salts (EDTA)

permitted, no MRL

permitted, no MRL

Etiproston tromethamine

permitted, no MRL

permitted, no MRL

Etyprostontromethiamine

hormone permitted

Eucalypti aetheroleum

permitted, no MRL

Eucalyptol permitted, no MRL

permitted, no MRL

Eucalyptus globulus

permitted, no MRL

Euphrasia officinalis

permitted, no MRL

Famphur insecticide permitted permitted, MRL

Febantel (see also fenbendazole, oxfendazole)




Fenbendazole (see also febantel, oxfendazole)


permitted, MRL



permitted, MRL


30


Codex/ JECFA




Fenchlorphos insecticide permitted Fenpipramide hydrochloride

permitted, no MRL

Fenprostalene hormone permitted, no MRL

permitted, MRL


Fenvalerate insecticide permitted Fertirelin acetate permitted,

no MRL permitted,

no MRL permitted,

no MRL

Flavophospholipol

permitted, MRL


Florfenicol anitmicrobial permitted, MRL

permitted, MRL



Fluazuron yes, MRL permitted, MRL

permitted MRL

Flubendazole anthelminthic, antiprotozoan




Flugestone acetate

hormone permitted, MRL

Flumequine anitmicrobial yes, MRL, JECFA, CCRVDF Step 6

permitted, MRL



Flumethrin insecticide permitted, MRL

permitted, MRL honey: permitted, no MRL


Flunixin, Flunixin meglumine

anitmicrobial permitted, MRL

permitted, MRL



permitted, MRL

Fluvalinate insecticide, acaricide

permitted

Foeniculi aetheroleum

permitted, no MRL

Folic acid permitted, no MRL

Follicle Stimulating

hormone permitted, no MRL


31


Codex/ JECFA




Hormone (natural FSH from all species and their synthetic analogues) Formaldehyde permitted,

no MRL permitted,

no MRL permitted,

no MRL

Formic acid permitted, no MRL

permitted, no MRL

Fosfomycin antibiotic permitted Frangulae cortex standardised extracts and preparations thereof

permitted, no MRL

Furaltadone bound metabolite (AMOZ)

APL APL

Furazolidone JECFA prohibited

prohibited, APL

prohibited

prohibited

Furazolidone bound metabolite (AOZ)

APL APL

Furosemide permitted, no MRL


permitted, no MRL

Gentamicin, Gentamicin sulfate

antibiotic




permitted, MRL

Gentianae radix standardised extracts and preparations thereof

permitted, no MRL

Ginkgo biloba permitted, no MRL

Ginseng permitted, no MRL

permitted, no MRL


32


Codex/ JECFA




Glutamic acid permitted, no MRL

permitted, no MRL

Glutamine permitted, no MRL

Glutaraldehyde permitted, no MRL

permitted, no MRL

Glycalpyramide anthelminthic, antiprotozoan

permitted

Glycerol formal permitted, no MRL

permitted, no MRL

Glycine permitted, no MRL

permitted, no MRL

Glycopeptides prohibited

Gonadotrophin releasing hormone

permitted, no MRL

permitted, no MRL

Gonadotropin, Gonadorelin hydrochloride or diacetate tetrahydrate [Gonadotrophins (LH, FSH) releasing hormone, GnRH]

permitted, no MRL


permitted, no MRL

Guaiacol permitted, no MRL

permitted, no MRL

Guanosine permitted, no MRL

Halofuginone, Halofuginone hydrobromide

anthelminthic, antiprotozoan

permitted, MRL

permitted, MRL


permitted, MRL

Haloperidol APL Haloxon anthelminthic,

antiprotozoan permitted permitted,

MRL

Hamamelis virginiana

permitted, no MRL


33


Codex/ JECFA




Harpagophytum procumbens

permitted, no MRL

Harunga madagascariens (1:100)

permitted, no MRL

Heparin and salts permitted, no MRL

Heptaminol permitted, no MRL

permitted, no MRL

Hesperidin permitted, no MRL

Hesperidin methyl chalcone

permitted, no MRL

Hexestrol APL Hexetidin permitted,

no MRL

Hippocastini semen

permitted, no MRL

Histidine permitted, no MRL

permitted, no MRL

Human Chorionic Gonadotrophin (natural HCG and its synthetic analogues)

permitted, no MRL

permitted, no MRL

Human menopausal urinary gonadotrophin

permitted, no MRL

Humic acid and its sodium salt

permitted, no MRL

permitted, no MRL

Hyaluronic acid permitted, no MRL

Hydrochloric acid

permitted, no MRL

permitted, no MRL

Hydrochlorothiazide

permitted, no MRL

permitted, no MRL


34


Codex/ JECFA




Hydrocortisone steroidal anti-inflammatory drug

permitted, MRL



permitted, MRL

Hydrogen peroxide

permitted, no MRL

permitted, no MRL

permitted, no MRL

Hydroxyethylsalicylat

permitted, no MRL

Hydroxyquinoline [8-hydroxyquinoline]

permitted, no MRL

permitted, no MRL

Hygromycin, Hygromycin B

antibiotic

permitted, no MRL



Hyperici oleum permitted, no MRL

Hypericum perforatum

permitted, no MRL

Imidocarb anthelminthic, antiprotozoan




Inosine permitted, no MRL

Inositol permitted, no MRL

permitted, no MRL

Iodine and iodine inorganic compounds including: Sodium and potassium – iodide Sodium and potassium – iodat

permitted, no MRL

permitted, no MRL

Iodine organic compounds

permitted, no MRL

Iodoform permitted, no MRL

permitted, no MRL


35


Codex/ JECFA




Iodophor antiprotozoan permitted, no MRL

Ipronidazole (5-nitroimadazole)

antiprotozoan prohibited

prohibited

prohibited

Iron ammonium citrate

permitted, no MRL

Iron dextran permitted, no MRL

permitted, no MRL

permitted, no MRL

Iron dichloride permitted, no MRL

Iron glucoheptonate

permitted, no MRL

Iron sulphate permitted, no MRL

permitted, no MRL

Isobutane permitted, no MRL

permitted, no MRL

Isoeugenol anaesthetic

permitted

Isoflurane permitted, no MRL

Isoleucine permitted, no MRL

permitted, no MRL

Isometamidium anthelminthic, antiprotozoan


permitted permitted MRL

Isopropanol permitted, no MRL

permitted, no MRL

Isoxsuprine APL permitted, no MRL

permitted, no MRL

Ivermectin anthelminthic, antiprotozoan, insecticide


permitted, MRL



permitted, MRL

Jecoris oleum permitted, no MRL

Josamycin antibiotic permitted permitted permitted, no MRL

Juniperi fructus permitted, no MRL


36


Codex/ JECFA




Kanamycin antibiotic JECFA permitted permitted, MRL


Ketamine permitted permitted, no MRL

permitted, no MRL

Ketanserin tartrate

permitted, no MRL

Ketoprofen permitted, MRL

permitted,MRL


permitted, no MRL

Kitasamycin antibiotic permitted, MRL

permitted, no MRL

Lachnanthes tinctoria

permitted, no MRL

Lactic acid permitted, no MRL

permitted, no MRL

permitted, no MRL

Laidlomycin antibiotic permitted, MRL

Lanolin permitted, no MRL

permitted, no MRL

Lasalocid (sodium)

permitted, MRL

permitted, MRL


permitted, no MRL

permitted, MRL

Lauri folium aetheroleum

permitted, no MRL

Lauri fructus permitted, no MRL

Lavandola aetheroleum

permitted, no MRL

Lecirelin permitted, no MRL

Lespedeza capita permitted, no MRL

Leucine permitted, no MRL

permitted, no MRL

Levamisole, Levamisole hydrochloride


permitted, MRL


permitted, MRL

Levomethadon permitted, no MRL


37


Codex/ JECFA




Levothyroxine permitted, no MRL

Lidocaine hydrochloride

permitted, no MRL

permitted, no MRL

permitted, no MRL

Lincomycin antibiotic yes, MRL permitted, MRL

permitted, MRL



permitted, MRL chicken: permitted, no MRL

Linear alkyl benzene sulphonic acids

permitted, no MRL

Lini oleum permitted, no MRL

Lobaria pulmonaria

permitted, no MRL

Lobeline permitted, no MRL

Luprostiol permitted, no MRL

permitted, no MRL

Luteinizing Hormone (natural LH from all species and their synthetic analogues)

pemitted, no MRL

permitted, no MRL

Lysine permitted, no MRL

permitted, no MRL

Lysozyme anthelminthic, antiprotozoan

permitted

Mabuterol APL Maduramicin, Maduramicin ammonium


permitted, MRL


permitted, MRL

Magnesium permitted, no MRL

permitted, no MRL

Magnesium acetate

permitted, no MRL

permitted, no MRL


38


Codex/ JECFA




Magnesium aluminium silicate

permitted, no MRL

permitted, no MRL

Magnesium asparate

permitted, no MRL

permitted, no MRL

Magnesium carbonate

permitted, no MRL

permitted, no MRL

Magnesium chloride

permitted, no MRL

permitted, no MRL

Magnesium citrate

permitted, no MRL

permitted, no MRL

Magnesium gluconate

permitted, no MRL

permitted, no MRL

Magnesium glutamate

permitted, no MRL

Magnesium glycerophosphate

permitted, no MRL

permitted, no MRL

Magnesium hydroxide

permitted, no MRL

permitted, no MRL

Magnesium hypophosphite

permitted, no MRL

permitted, no MRL

Magnesium orotate

permitted, no MRL

Magnesium oxide permitted, no MRL

permitted, no MRL

Magnesium phosphate

permitted, no MRL

permitted, no MRL

Magnesium stearate

permitted, no MRL

permitted, no MRL

Magnesium sulphate

permitted, no MRL

permitted, no MRL

Magnesium trisilicate

permitted, no MRL

Majorana herba permitted, no MRL

Malachite green (leucomalachite green)

APL permitted, no MRL


39


Codex/ JECFA




Malic acid permitted, no MRL

permitted, no MRL

Manganese carbonate

permitted, no MRL

permitted, no MRL

Manganese chloride

permitted, no MRL

permitted, no MRL

Manganese gluconate

permitted, no MRL

Manganese glycerophosphate

permitted, no MRL

permitted, no MRL

Manganese oxide permitted, no MRL

permitted, no MRL

Manganese pidolate

permitted, no MRL

Manganese ribonucleate

permitted, no MRL

Manganese sulphate

permitted, no MRL

permitted, no MRL

Mannitol permitted, no MRL

permitted, no MRL

Marbofloxacin antimicrobial permitted, MRL


Matricaria recutita

permitted, no MRL

Matricariae flos [Chamomilla]

permitted, no MRL

Mebendazole anthelminthic, antiprotozoan

permitted, MRL

APL permitted, MRL


Mecillinam (Mecillinum?)

antibiotic permitted, no MRL

permitted

Medicago sativa permitted, no MRL

Medroxyprogesterone acetate

permitted, no MRL

permitted, no MRL APL

permitted, no MRL

Megestrol acetate APL Melatonin permitted,

no MRL


40


Codex/ JECFA




Melengestrol acetate

hormone JECFA CCRVDF Step 6

permitted, MRL


permitted, MRL

Melissae aetheroleum

permitted, no MRL

Melissae folium permitted, no MRL

Meloxicam non-steroidal anti-inflammatory drug

permitted, MRL

permitted, MRL


Menadione [vitamin K 3]

permitted, no MRL

Menbutone antidiarrheal permitted, no MRL


Menthae arventis aetheroleum

permitted, no MRL

Menthae piperitae aetheroleum

permitted, no MRL

Menthol permitted, no MRL

permitted, no MRL

Mepivacaine permitted, no MRL

Mercaptamine hydrochloride

permitted, no MRL

Mercaptobenzimidazole (2-)

antiprotozoan APL

Metamizole permitted, MRL

permitted, no MRL

Methionine permitted, no MRL

permitted, no MRL

Methyl-benzoquate


permitted

Methyl-nicotinate permitted, no MRL

Methyl-salicylate permitted, no MRL

permitted, no MRL


41


Codex/ JECFA




Methyl-2-thiouracil (4(6)-)

APL

Methy-lbenzoate permitted, no MRL

Methyl-paraben permitted, no MRL


Methyl-prednisolone

steroidal anti-inflammatory drug

permitted, MRL


permitted, MRL

Methyl-pyrrolidone [1-Methyl-pyrrolidone]

permitted, no MRL

permitted, no MRL

Metoclorpramide antiemetic

permitted

Metoserpate hydrochloride

tranquilizer permitted permitted, MRL

Metronidazole (5-nitroimadazole)

antiprotozoan JECFA prohibited2

prohibited

permitted, no MRL

prohibited prohibited1

Millefolii herba permitted, no MRL

Miloxacin antimicrobial permitted Mineral hydrocarbons low to high viscosity including microcrystalline waxes approximately C10-C60; aliphatic branched aliphatic and salicyclic compounds

permitted, no MRL


42


Codex/ JECFA




Mirosamycin antibiotic permitted Monensin, Monesin sodium


permitted, MRL


permitted, MRL Chicken, goat: permitted, no MRL

Monothioglycerol permitted, no MRL

permitted, no MRL

Montanide permitted, no MRL

Morantel, Morantel tartrate


permitted, MRL

permitted, MRL

permitted, MRL


milk: permitted, no MRL

Moxidectin anthelminthic, antiprotozoan


permitted, MRL



permitted, MRL

Myglyol permitted, no MRL

permitted, no MRL

Myristicae aetheroleum

permitted, no MRL

Nafcillin antibiotic permitted, MRL


Nalidixic acid antimicrobial permitted Nanaforcin antibiotic permitted Naphthalophos permitted,

MRL

Narasin antibiotic, anthelminthic, antiprotozoan

permitted, MRL

permitted, MRL



permitted, MRL

Natamycin antibiotic permitted, no MRL

Neomycin (including framycetin)


permitted, MRL



permitted, MRL

Neostigmine permitted, no MRL

permitted, no MRL

permitted, no MRL

Nequinate anthelminthic, antiprotozoan



43


Codex/ JECFA




Netobimin permitted, MRL

Nicarbazin antimicrobial, anthelminthic, antiprotozoan


permitted, MRL


permitted, MRL

Nickel gluconate permitted, no MRL

permitted, no MRL

Nickel sulphate permitted, no MRL

permitted, no MRL

Nicoboxil permitted, no MRL

Nitarsone anthelminthic, antiprotozoan

permitted, MRL

permitted

Nitrobin, panazon permitted, MRL

Nitrofurans prohibited

prohibited

prohibited

prohibited

Nitrofurantoin bound metabolite (AHD)

APL APL

Nitrofurazone (see also nitofurans)

JECFA prohibited

prohibited (see Nitrofurans)

permitted, no MRL

prohibited

Nitrofurazone bound metabolite (SEM)

APL APL

Nitroimadazoles (Other than dimetridazole Ipronidazole)

antiprotozoan prohibited

Metronidazole = prohibited

prohibited prohibited

Nitroxinil anthelminthic, antiprotozoan

permitted, MRL

permitted, MRL


Nonivamide permitted, no MRL

Norfloxacin antimicrobial permitted permitted, no MRL


44


Codex/ JECFA




Norgestomet hormone permitted, MRL

permitted, MRL


Nortestosterone (19-), Nortestosterone (19-epi-)

hormone APL prohibited (hormone)

Nosiheptide antibiotic permitted Novobiocin antibiotic JECFA permitted,

MRL permitted, MRL

permitted, MRL meat: permitted, no MRL


permitted, MRL

Nystatin JECFA permitted, no MRL


Ofloxacin antimicrobial permitted Okoubaka aubrevillei

permitted, no MRL

Olaquindox permitted, MRL

APL (measured as m-QCA)

prohibited

permitted, MRL

Oleandomycin antibiotic JECFA permitted, MRL


permitted, MRL

Oleyloleat permitted, no MRL

Omeprazole permitted, no MRL

Orbifloxacin antimicrobial permitted Organochlorines prohibite

d

Orgotein permitted, no MRL

Ormetoprim antimicrobial, anthelminthic, antiprotozoan

permitted, no MRL


permitted, MRL

Ornitine permitted, no MRL


45


Codex/ JECFA




Orotic acid permitted, no MRL

permitted, no MRL

Oxacillin antibiotic permitted, MRL


Oxalic acid permitted, no MRL

Oxfendazole (see also febantel, fenbendazole)



permitted, no MRL



permitted, MRL

Oxibendazole anthelminthic, antiprotozoan

permitted, MRL

permitted

Oxidation products of terebinthinae oleum

permitted, no MRL

Oxolinic acid JECFA permitted, MRL

permitted, MRL

permitted, MRL

Oxyclozanide anthelminthic, antiprotozoan

permitted, MRL


Oxytetracycline antibiotic


permitted, MRL



permitted, MRL

Oxytocin permitted, no MRL


permitted, no MRL

Pancreatin permitted, no MRL

permitted, no MRL

Papain permitted, no MRL

permitted, no MRL

Papaverine permitted, no MRL

permitted, no MRL

Paracetamol permitted, no MRL

permitted, no MRL

Parconazole permitted, no MRL

Paromomycin antibiotic, anthelminthic, antiprotozoan

permitted, MRL

permitted

Penethamate antibiotic permitted, MRL

permitted


46


Codex/ JECFA




Penicillin G antibiotic

yes, MRL benzylpenicillin, procaine

permitted, MRL


permitted, MRL

permitted, MRL partly tolerance zero (pig, poultry)

Pepsin permitted, no MRL

permitted, no MRL

Peracetic acid permitted, no MRL

permitted, no MRL

Permethrin insecticide JECFA permitted, MRL

permitted, MRL

permitted, no MRL

Phenol permitted, no MRL

permitted, no MRL

Phenoxymethyl-penicillin


permitted

Phenyl-2-thiouracil (4(6)-

APL

Phenylalanine permitted, no MRL

permitted, no MRL

Phenylbutazone APL permitted permitted, no MRL

prohibited

Phloroglucinol permitted, no MRL

Phoxim yes, MRL permitted permitted, MRL chicken: permitted, no MRL

permitted, no MRL

Phytolacca americana

permitted, no MRL

Phytomenadione [vitamin K1]

permitted, no MRL

Piperazine permitted, no MRL

permitted, MRL

permitted, no MRL

permitted, MRL

Piperazine dihydrochloride (chicken meat)


permitted, no MRL



47


Codex/ JECFA




Piperonyl butoxide

insecticide synergist

permitted, no MRL


Pyrimethamin permitted prohibited

Pirlimycin antibiotic

JECFA, CCRVDF Step 6

permitted, MRL



permitted, MRL

Polaxalene permitted, no MRL

permitted, no MRL

Policresulene permitted, no MRL

Poloxamer permitted, no MRL

permitted, no MRL

Polyethylene glycol stearates with 8-40 oxyethylene units

permitted, no MRL

Polyethylene glycol-15-hydroxystearate

permitted, no MRL

Polyethylene glycol-7-glyceryl-cocoate

permitted, no MRL

Polyethylene glycols (molecular weight 200 to 10.000)

permitted, no MRL

permitted, no MRL

Polymyxin B antibiotic JECFA permitted, MRL

permitted

Polyoxyl castor oil with 30 to 40 oxyethylene units

permitted, no MRL


48


Codex/ JECFA




Polyoxyl hydrogenated castor oil with 40 to 60 oxyethylene units (fatty acid polyethylene glycol ester)

permitted, no MRL

Polysorbate 80 permitted, no MRL

permitted, no MRL

Polysulphated glycosaminoglycan

permitted, no MRL

Polyvinylpyrrolidine – iodine

permitted, no MRL

permitted, no MRL

Porcine somatotropins

JECFA CCRVDF Step 6

permitted, no MRL

Potassium bromide

permitted, no MRL

permitted, no MRL

Potassium DL-aspartate

permitted, no MRL

Potassium glucuronate

permitted, no MRL

Potassium glycerophosphate

permitted, no MRL

permitted, no MRL

Potassium nitrate permitted, no MRL

permitted, no MRL

Potassium selenate

permitted, no MRL

Praziquantel anthelminthic, antiprotozoan

permitted, MRL

permitted, no MRL


Prednisolone steroidal anti-inflammatory drug

permitted, no MRL




Pregnant mare serum gonadotrophin

permitted, no MRL

permitted, no MRL


49


Codex/ JECFA




Prethcamide permitted, no MRL

Prifinium anticholonergic drug

permitted

Procain-(Benzyl)penicillin

antibiotic


permitted

Procaine permitted, no MRL

permitted, no MRL

permitted, no MRL

Progesterone hormone yes, MRL not specified

permitted, no MRL

permitted permitted, no MRL restricted (hormone)

permitted, no MRL

permitted, MRL

Proline permitted, no MRL

permitted, no MRL

Promacyl insecticide permitted Propane permitted,

no MRL permitted,

no MRL

Propetamphos insecticide permitted Propionylpromazine

JECFA APL

Propoxur nsecticide permitted permitted permitted, no MRL

Propyl-2-thiouracil (4(6)-n-)

APL

Propylene glycol permitted, no MRL

permitted, no MRL

Propylparaben permitted, no MRL


Prunus laurocerasus

permitted, no MRL

Pyrantel embonate

permitted, no MRL

permitted, no MRL

Pyrantel tartrate permitted, MRL



50


Codex/ JECFA




Pyrethrum extract permitted, no MRL

permitted, no MRL

Pyrimethamine antimicrobial, anthelminthic, antiprotozoan

permitted, no MRL

permitted

Pyrrolidone [2-pyrrolidone]

permitted, no MRL

Quatresin permitted, no MRL

Quercus cortex permitted, no MRL

Quillaia saponins permitted, no MRL

Ractopamine β-agonist (JECFA CCRVDF Step 6

permitted, MRL

permitted, MRL

prohibited (beta-agonist)


permitted, MRL

Rafoxanide anthelminthic, antiprotozoan

permitted, MRL

permitted

R-cloprostenol permitted, no MRL

Rhei radix permitted, no MRL

Ricini oleum permitted, no MRL

Rifaximin antibiotic permitted, milk, MRL, meat no MRL

permitted

Ritodrine APL Robenidine (hydrochloride)

antimicrobial, anthelminthic, antiprotozoan

permitted,MRL



permitted, MRL

Romifidine permitted, no MRL

Ronidazole (5-nitroimadazole)

antiprotozoan JECFA prohibited

prohibited

permitted, no MRL

prohibited

prohibited1


51


Codex/ JECFA




Rosmarini aetheroleum

permitted, no MRL

permitted, no MRL

Rosmarini folium permitted, no MRL

permitted, no MRL

Roxarsone production aid permitted, MRL


permitted, MRL

Ruscus aculeatus permitted, no MRL

Ruta graveolens permitted, no MRL

Salbutamol β-agonist

APL

Salicylic acid permitted, no MRL

permitted, no MRL

permitted, no MRL


Salinomycin (sodium)

antibiotic, anthelminthic, antiprotozoan

permitted, MRL

permitted, MRL



Salviae folium permitted, no MRL

Sambuci flos permitted, no MRL

Sarafloxacin antimicrobial yes, MRL APL permitted, MRL


Selenicerus grandiflorus


Selenium permitted, no MRL


Semduramycin, Semduramicin (sodium)


permitted, no MRL



permitted, MRL

Serenoa repens permitted, no MRL

Serine permitted, no MRL

permitted, no MRL

Serotonin permitted, no MRL

permitted, no MRL


52


Codex/ JECFA




Silybum marianum

permitted, no MRL

Sinapis semen permitted, no MRL

Sodium 2-methyl-2-phenoxypropanoate

permitted, no MRL

Sodium acetylsalicylate

permitted, no MRL

Sodium benzyl 4-hydroxybenzoate

permitted, no MRL

Sodium boroformiate

permitted, no MRL

Sodium butyl 4-hydroxybenzoate

permitted, no MRL

Sodium cetostearyl sulphate

permitted, no MRL

Sodium chloride permitted, no MRL

permitted, no MRL

Sodium chlorite pemitted,no MRL

permitted, no MRL

Sodium chromoglycate

permitted, no MRL

Sodium cacodylate

permitted

Sodium dichloroisocyanu-rate

permitted, no MRL

permitted, no MRL

Sodium dioctylsulfosuccinate

permitted, no MRL

permitted, no MRL

Sodium formaldehydesul-phoxylate

permitted, no MRL

permitted, no MRL

Sodium glycerophosphate

permitted, no MRL

permitted, no MRL


53


Codex/ JECFA




Sodium hypophosphite

permitted, no MRL

permitted, no MRL

Sodium laurylsulphate

permitted, no MRL

permitted, no MRL

Sodium nifrustyrenate

antimicrobial permitted

Sodium propionate

permitted, no MRL

permitted, no MRL

Sodium pyrosulphite

permitted, no MRL

permitted, no MRL

Sodium salicylate permitted, no MRL

permitted, no MRL

Sodium selenate permitted, no MRL

Sodium selenite permitted, no MRL

permitted, no MRL

permitted, no MRL

Sodium stearate permitted, no MRL

permitted, no MRL

Sodium sulfabromo-methazine

permitted, MRL

Sodium sulfa-chloropyrazine monohydrate

permitted, MRL

Sodium thiosulphate

permitted, no MRL

permitted, no MRL

Solidago virgaurea Somatosalm

permitted, no MRL

Sorbitan sesquioleate

permitted, no MRL

permitted, no MRL

Sorbitan trioleate permitted, no MRL

Spectinomycin antibiotic


permitted, MRL


permitted, MRL

permitted, MRL

Spiramycin antibiotic yes, MRL permitted, MRL

permitted, MRL



54


Codex/ JECFA




Stilbenes diethylstilbestrol (DES)

JECFA prohibited

prohibited

prohibited

prohibited

prohibited

prohibited

Streptomycin (see also Dihydrostreptom.)


permitted, MRL

prohibited

permitted, MRL

permitted, MRL

permitted, MRL

Strychni semen [Nux vomica]

permitted, no MRL

Strychnine permitted, no MRL

prohibited

permitted, no MRL

permitted, no MRL

Sulfabenzamide antimicrobial permitted, MRL

permitted

Sulfabromomethazine sodium


Sulfacetamide antimicrobial permitted, MRL


Sulfachloro-pyrazine sodium monohydrate

antimicrobial permitted, MRL

Sulfachloropyridazine


prohibited



Sulfadiazine, Sulphadiazine


permitted, MRL


Sulfadimethoxine antimicrobial permitted, MRL


permitted, MRL

Sulfadimidine antimicrobial yes, MRL permitted, MRL

permited, MRL


Sulfadoxine antimicrobial permitted, MRL

permitted, MRL


Sulfaethoxypyridazine



Sulfaguanidine antimicrobial permitted, MRL



55


Codex/ JECFA




Sulfamerazine antimicrobial permitted, MRL


permitted trout, tolerance zero

Sulfamethazine (sulfadimidine)


permitted, MRL

permitted, MRL

Sulfamet(h)oxazol(e)

antimicrobial permitted permitted permitted, no MRL

Sulfamethoxyoyridazine


Sulfamoildapsone antimicrobial permitted Sulfamonomethoxine

antimicrobial permitted permitted, MRL

Sulfanilamide antimicrobial permitted, MRL


Sulfanitran antimicrobial permitted, MRL

permitted permitted, tolerance zero

Sulfapyridine antimicrobial permitted,MRL

permitted

Sulfaquinoxaline antimicrobial permitted, MRL

permitted, MRL


permitted, MRL

Sulfathiazole antimicrobial permitted, MRL

prohibited


permitted, MRL

Sulfatroxazole, Sulphatroxazole


permitted

Sulfisozole antimicrobial permitted Sulfoguaiacol antimicrobial permitted,

no MRL

Sulfomyxin antimicrobial permitted, tolerance zero

Sulfonamide group all substances (’sulfas’)

antimicrobial permitted permitted, MRL

permitted

Sulphur permitted, no MRL

permitted, no MRL


56


Codex/ JECFA




Symphyti radix permitted, no MRL

Syzygium cumini permitted, no MRL

Tanninum permitted, no MRL

Tapazole APL Tartaric acid [L-tartaric acid] and mono- and di-basic salt of sodium potassium and calcium

permitted, no MRL

permitted, no MRL

Taufluvalinate permitted, no MRL

Teflubenzuron insecticide permitted, MRL

permitted, MRL

permitted

Temephos insecticide permitted Terdecamycin antibiotic permitted Terebinthinae aetheroleum rectificatum

permitted, no MRL

Terebinthinae laricina

permitted, no MRL

Terpin hydrate permitted, no MRL

permitted, no MRL

Testosterone (epi-), Testosterone and its esters


permitted, no MRL specified

permitted prohibited (hormone)

permitted, no MRL

permitted, MRL

Tetracaine permitted, no MRL

permitted, no MRL

Tetrachlorvinphos



57


Codex/ JECFA




Tetracycline, (see also chlortetracyclien,oxytetracyline)

antibiotic yes, MRL singly or in combination

permitted, MRL

permitted, MRL



permitted, MRL sum

Theobromine permitted, no MRL

Theophylline permitted, no MRL

permitted, no MRL

Thiabendazole anthelminthic, fungicide


permitted, MRL



permitted, MRL

Thiamphenicol antimicrobial yes, MRL JECFA

permitted, MRL

APL permitted permitted, MRL


Thiamylal permitted, no MRL

Thiomersal permitted, no MRL

permitted, no MRL

Thiopental sodium

permitted, no MRL

Thiotic acid permitted, no MRL

Thiouracil (2-) APL Threonine permitted,

no MRL permitted,

no MRL

Thuja occidentalis

permitted, no MRL

Thymi etheroleum

permitted, no MRL

Thymidine permitted, no MRL

Thymol permitted, no MRL

permitted, no MRL

Thyrostatic substances

prohibited

prohibited

Tiamulin antibiotic

permitted, MRL



permitted, MRL

Tiaprost permitted, no MRL

permitted, no MRL


58


Codex/ JECFA




Tiliae flos permitted, no MRL

Tilmicosin antibiotic yes, MRL permitted, MRL



permitted, MRL

Tiludronic acid disodium salt

permitted, no MRL

Timerfonate permitted, no MRL

Tiopronin hepatotonic permitted Toldimphos permitted,

no MRL permitted,

no MRL

Tolfenamic acid non-steroidal anti-inflammatory drug

permitted, MRL

permitted

Toltrazuril anthelminthic, antiprotozoan

permitted, MRL, bovine, permitted, no MRL


Tolubuterol APL Tosylchloramide sodium

permitted, no MRL

Tragacanth permitted, no MRL

Trenbolone (acetate), Trenbolone (ß-)

hormone yes, MRL permitted, no MRL


permitted, no MRL

Tribromsalan anthelminthic, antiprotozoan

permitted

Triamcinolon permitted permitted, no MRL

Trichlormethiazide

permitted, no MRL

permitted, no MRL

permitted, no MRL

Tricaine methane sulphonate

permitted, MRL

permitted, no MRL

Trichlorfon yes, MRL permitted, MRL



59


Codex/ JECFA




Triclabendazole anthelminthic, antiprotozoan




Tricopyr (herbicide?)

permitted, MRL

Trimethoprim antimicrobial permitted, MRL



Trimethylphloroglucinol

permitted, no MRL

Tripelennamine (hydrochloride)

antihistamine permitted, no MRL


permitted, MRL

Trypsin permitted, no MRL

permitted, no MRL

Tryptophan permitted, no MRL

permitted, no MRL

Tulathromycin antibiotic

permitted, MRL

Turnera diffusa permitted, no MRL

Tylosin antibiotic

JECFA permitted, MRL

permitted permitted, MRL)


Tyrosin amino acid permitted, no MRL

Urea permitted, no MRL

permitted, no MRL

Urginea maritima permitted, no MRL

Uridine permitted, no MRL

Urticae herba permitted, no MRL

Valine permitted, no MRL

permitted, no MRL

Valnemulin antibiotic permitted, MRL

permitted

Vancomycin antibiotic prohibited


60


Codex/ JECFA




Vedaprofen non-steroidal anti-inflammatory drug

permitted, MRL

permitted

Vetrabutine hydrochloride

permitted, no MRL

permitted, no MRL

Vincamine permitted, no MRL

Virginiamycin antibiotic permitted, no MRL


permitted, MRL

permitted, MRL

Virola sebifera (1:100)

permitted, no MRL

Viscum album permitted, no MRL

Vitamin A vitamine permitted, no MRL

permitted, no MRL

Vitamin B1 vitamine permitted, no MRL

permitted, no MRL


permitted, no MRL


permitted, no MRL


permitted, no MRL


permitted, no MRL


permitted, no MRL

Vitamin D vitamine permitted, no MRL

permitted, no MRL

Vitamin E vitamine permitted, no MRL

permitted, no MRL

Wool alcohols permitted, no MRL

Xylazine, Xylazine hydrochloride

tranquilizer JECFA permitted, no MRL

permitted, no MRL


Zearalanone APL


61


Codex/ JECFA




Zeranol yes, MRL permitted, MRL

permitted, no MRL

permitted prohibited hormone


permitted, no MRL

Zinc acetate permitted, no MRL

Zinc aspartate permitted, no MRL

Zinc chloride permitted, no MRL

permitted, no MRL

Zinc gluconate permitted, no MRL

permitted, no MRL

Zinc oleate permitted, no MRL

Zinc oxide permitted, no MRL

permitted, no MRL

Zinc stearate permitted, no MRL

Zinc sulphate permitted, no MRL

permitted, no MRL

Zinc-bacitracin antimicrobial permitted, MRL

Zoalene (dinitoluamide)

permitted, MRL

MRL permitted, MRL

CX/RVDF 06/16/13, Part 1 Annex II List of Veterinary drugs of concern as regards consumer health protection or trade

62

Annex II to CCRVDF Working Group document to develop recommendations on veterinary drugs without MRL or ADI

List of Veterinary drugs of concern as regards consumer health protection or trade Explanations:

This list has been assembled using information provided by working group members, available on the Internet and through SPS notifications.

Concern means that the substances have not been expressly prohibited but are not authorised and there is a concern for misuse and residues of these substances in food will be legally pursued.

Canada bans the use of 5-nitroimadazoles in general.

In the European Union, veterinary drugs fall under two legal categories: veterinary medicinal products and feed additives. The use of antimicrobials as feed additives will be generally prohibited from 2006 onwards. The use of hormones for growth promotion is generally prohibited. Antimicrobials and hormones may however been authorised for other purposes.

In the United States ‘prohibited’ means prohibited from extra label use.


63

prohibited in Veterinary drug Concern

Canada European Community

United States

Costa Rica/ El Salvador

New Zealand

Aristrolochia spp and preparations thereof

concern for nephrotoxicity, mutagenicity, carcinogenicity

prohibited

Arsanilic acid cumulative poison prohibited Beta sympathomimetic agents (beta-agonists) other than ractopamine

concern

Beta sympathomimetic agents (beta-agonists) other than clenbuterol (and in the EU Isoxsuprine)

acute food poisoning tachycardia prohibited prohibited

Carbadox concern for genotoxicity and carcinogenicity

concern proposing a regulatory amendment to ban

prohibited (former authorisation as feed additive withdrawn)

Chloramphenicol concern for aplastic anaemia, carcinogenicity

prohibited prohibited prohibited prohibited prohibited

Chloroform concern for mutagenicity and carcinogenicity in connection with lack of data


Chlorpromazine concern for behavioural changes even due to small dose in connection with lack of data

concern prohibited prohibited

Clenbuterol acute food poisoning tachycardia prohibited Colchicine concern for genotoxicity and mutagenicity

in connection with lack of data prohibited prohibited

Dapsone concern for reproductive and teratogenic effects in connection with lack of data


Dimetridazole (5-nitroimadazole)

concern for systemic toxicity and carcinogenicity

prohibited prohibited prohibited prohibited

Furazolidone (5-nitrofuran) concern for carcinogenicity prohibited prohibited prohibited


64

prohibited in Veterinary drug Concern Canada European

Community United States

Costa Rica/ El Salvador

New Zealand

Glycopeptides concern for induction of antimicrobial resistance subsequent to the veterinary use and transfer of the resistance characteristics to the human consumer, resulting in an inability to treat a resistant disease in the human consumer

concern prohibited

Hormonal growth promoters endocrine, developmental, immunological, neurobiological, immunotoxic, genotoxic and carcinogenic effects

prohibited

Ipronidazole (5-nitroimadazole)

concern for systemic toxicity and carcinogenicity

prohibited prohibited prohibited

Malachite green concern for carcinogenicity concern Metronidazole (5-nitroimadazole)

concern for mutagenicity in connection with lack of data


Nitrofurans/ Nitrofurazone concern for carcinogenicity. prohibited prohibited prohibited prohibited Olaquindox concern for genotoxicity and

carcinogenicity prohibited

(former authorisation as feed additive withdrawn)

Organoclorines prohibited Other nitroimadazoles (than Dimetridazole Ipronidazole)

concern for systemic toxicity, carcinogenicity.

prohibited Metronidazole prohibited prohibited

Phenylbutazone Concern for carcinogenicity, blood dyscrasias and hypersensitivity reactions.

concern prohibited

Ronidazole (5-nitroimadazole)

concern for mutagenicity in connection with lack of data


Stilbenes, diethylstilbestrol (DES) concern for developmental toxicity and carcinogenicity

prohibited prohibited prohibited prohibited prohibited

Strychnine strong poison prohibited Sulfathiazole prohibited Thyrostatic substances concern for carcinogenicity concern prohibited prohibited Vancomycine concern for induction of antimicrobial

resistance concern prohibited

CX/RVDF 06/16/13, Part 1 Annex III: Starting point for a Priority List of Veterinary Drugs Requiring Evaluation or Re-evaluation by JECFA at the 16th CCRVDF

65

Annex III: Starting point for a Priority List of Veterinary Drugs Requiring Evaluation or Re-evaluation by JECFA at the 16th CCRVDF

Explanations: Substances marked in yellow/grey shade have already been evaluated by JECFA The contry code indicates who suggested the veterinary drug

indicates that this evaluation did not result in an MRL recommendation

The following veterinary drugs have been suggested for the priority list, but not considered for the reasons cited below:

Avermectins: several avermectins have already evaluated by Codex (i.e. ivermectin, doramectin, moxidectin, abamectin, eprinomectin) Benzimidazoles: several benzimidazoles have already evaluated by Codex (i.e. fenbendazole, albendazole, oxfendazole, flubenadzole, thiabendazole, triclabendazole) Clenbuterol: has already been evaluated by JECFA/CCRDVF and has a recently reviewed Codex status Hormonal growth promoters: Trenbolone acetate, Zeranol, Progesterone, Esterdiol-17ß and Testosterone have a Codex status, Progesterone, Esterdiol-17ß, Testosterone have moreover been recently been evaluated by JECFA/CCRDVF; Melengestrol acetate is currently at step 5 of the Codex step procedure. Pirlimycin: is at step 5 of the Codex procedure Sulfadimidine: Codex MRLs exist Tetracycline: Codex MRLs exist Tilmicosin: Codex MRLs exist Abbriviations ADI = acceptable daily intake Country Codes AU = Australia CAN = Canada CR = Costa Rica DE = Germany KR = Korea NL = The Netherland SE = Sweden TH = Thailand UK = United Kingdom US = United States


2

veterinary drug

status consumer health protection concerns

trade concerns necessity for the treatment/prevention of disease in animals

agronomic impact

data/evaluation availability

other risk management considerations

Altrenogest (AU) use widely used Amitraz (CR) use trade problems Amoxicillin (CR) use trade problems Ampicillin (SE) use important

antimicrobial

Avilamicin (CR) use trade problems Bacitracin (CR) use trade problems Carbadox (SE) ban Cefoperazon (CR) use trade problems Cefuroxime (CAN)

Evaluated: 62nd JECFA use insufficient toxicity data on

unidentified residues in milk, metabolism in milk, inadequate depletion study (cows)

Cephalosporins (KR) use widely used Chloramphenicol (NL, DE, US, KR)

Evaluated: 42nd and 62nd JECFA)

ban concern for aplastic anaemia, carcinogenicity, and inability to establish an ADI or MRL

numerous rejected consignments worldwide

Chlorpromazine (CAN) Evaluated: 38th JECFA

use long persistence of substance in humans, small doses may cause behavioural change

insufficient toxicity data

Cloxacillin (KR) use widely used Colistin (KR) use Dexamethasone (CAN)

Evaluated: 50th JECFA use ADI (0.015 µg/kg), no MRLs

inadequate analytical method

Dinitolmide (AU) use widely used Danofloxacin (KR) use induction of

antimicrobial resistance

widely used


3

veterinary drug



agronomic impact



Enrofloxacin (TH, KR, CR) Evaluated: 48th JECFA

use induction of antimicrobial resistance

trade problems wide range of use in poultry and pigs

important data missing

Erythromycin (TH) Evaluated: 12th JECFA


Ethion (AU) use widely used Flavofosfolipol (CR) use trade problems Flunixin (SE) use important anti-

inflammatory and analgesic drug

Flunixin Meglumin (CR) use trade problems Fosfomycin (CR) use trade problems Glycopeptides (KR) - vancomycin, - teicoplanin

ban induction of antimicrobial resistance

Iso-eugenol (AU) use widely used Josamycin (CR) use trade problems Kanamycin (KR)

Evaluated: 12th JECFA use widely used important data on toxicology

missing

Kitasamycin (CR) (AU) use trade problems widely used Maduramycin (CR) use trade problems Malachite green (NL, DE, SE) ban concern for

carcinogenicity numerous rejected consignments worldwide

Malathion (AU) use widely used Mebendazol (CR) use trade problems Metamizol (SE) use important for the

treatment of severe pain in pig, cattle and equidae

Monensin (CR) use trade problems Narasin (CR) use trade problems


4

veterinary drug



agronomic impact



Nitrofurans (NL, UK, DE, US, KR) - furazolidone - nitrofurazone - Evaluated: 40th JECFA

ban concern for carcinogenicity

numerous rejected consignments worldwide

insufficient residue data

Nitroimidazoles (e.g. Ronidazole, Evaluated: 34th, 42th JECFA Ipronidazole, Dimetridazole, Evaluated: 34th JECFA Metronidazole (UK, D, US, SE)) Evaluated: 34th JECFA

ban concern for systemic toxicity and carcinogenicity

important data on toxicology missing

Novobiocin (CAN) Evaluated: 12th JECFA

use no detectable residues in food by recommended methods?

MRLs

Nystatin (CAN) Evaluated: 12th JECFA

use no detectable residues in food by recommended methods ?

MRLs

Olaquindox (KR, AU) ? concern for genotoxicity and carcinogenicity

Oleandomycin (CAN) Evaluated: 38th JECFA


no detectable residues in food by recommended methods

MRLs

Oxitocin (CR) use trade problems Oxolinic Acid (SE)

Evaluated: 43th JECFA use important

antimicrobial for fish farming

toxicology studies did not meet requirements

Penicillins (UK) - Benzyl penicillin - procaine penicillin (Penicillin

G)

use

Permethrin (SE) Evaluated: 54 th JECFA

use important for the treatment of ectoparasites

important data on toxicology missing


5

veterinary drug



agronomic impact



Phenylbutazone (SE) ban Concern for carcinogenicity, blood dyscrasias and hypersensitivity reactions.

Polymyxcin B (CAN) Evaluated: 12th JECFA


no detectable residues in food by recommended methods

MRLs

Propionylpromazine (CAN) Evaluated: 12th JECFA

use concern on high level of residues at injection site

insufficient toxicity data, insufficient residue data

measures concerning injections site residues

Pyrimethamin (KR) ban Robenidin (CR) use trade problems Roxarsone (SE) ban Salinomycin (CR) use trade problems Semiduramyin (CR) use trade problems Spinosad (AU) use widely used Stilbenes, Diethylstilbestrol (DES) (NL, UK, US)

Evaluated: 5th JECFA

ban concern for developmental toxicity and carcinogenicity

Sulphonamides other than Sulfadimidine (UK, SE, KR, AU)

use used extensively in many countries for treatment of bacterial infections

Temephos (AU) use widely used Thiamphenicol (CAN)

Evaluated: 52nd, 58th JECFA

use ADI = 5µg/kg insufficient depletion studies inadequate methods of analysis

Thyrostatic substances use concern for carcinogenicity

Tiamulin (CR) use trade problems Triflumuron. (AU) use widely used Trimethoprim (KR) use widely used


6

veterinary drug



agronomic impact



Tylosin (TH, SE) Evaluated: 38th JECFA

use used extensively for treatment of bacterial infections cattle and pigs

insufficient toxicity and microbiological data

Xylazine (CAN) Evaluated: 38th JECFA

use insufficient toxicity data, inadequate data on metabolism, residue date not sufficient to identify marker residue, inadequate depletion studies

agenda item 11 (b) cx/rvdf 06/16/13 (part 1) october 2005 ... · cx/rvdf 06/16/13, part 1 2 3. the...

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