Codex Alimentarius Commission (29 th Session)

Transcription

1 Codex Alimentarius Commission (29 th Session) Geneva 3-7 July 2006 European Community Positions 1

2 PART I INTRODUCTION Agenda item 1 Session Adoption of the Agenda and Arrangements for the Member States Competence.. 1 ALINORM 06/29/1 ALINORM 06/29/1A ALINORM 06/29/1B Agenda item 2 Report by the Chairperson on the 57th and 58th Sessions of the Executive Committee Member States Competence.. ALINORM 06/29/3 ALINORM 06/29/3A 1 This is without prejudice to the substantive competence that the Community has for individual items on the agenda. 2

3 PART II PROCEDURAL MATTERS Agenda item 3 Amendments to the Procedural Manual Member States Competence.. ALINORM 06/29/4 ALINORM 06/29/4A EC position: The Member States of the European Community (MSEC) fully support the proposed amendments to the rules of procedure regarding the duration of the terms of office of the members of the Executive Committee. The MSEC also agree that the newly created Codex Committee on Food Additives (CCFA) and the Codex Committee Contaminants in Food (CCCF) should discuss the substantive amendments to the texts tables in Annex 2 of ALINORM 06/29/4 Add. 1 for subsequent consideration by the Codex Alimentarius Commission, but that in the meantime the provisions of these texts remain in force in so far as they related to the work of CCFAC and CCCF. 3

4 PART III CODEX STANDARDS AND RELATED TEXTS Agenda item 4 Draft Standards and Related Texts at Step 8 of the Procedure (including those submitted at Step 5 with a recommendation to omit Steps 6 and 7 and those submitted at Step 5 of the Accelerated Procedure Agenda item 4 - Part 1 Standards and related Texts submitted for adoption at Step 8, at Step 5 of the Accelerated Procedure and Step 5/8 1) CCCPL: Draft Standard for Instant Noodles (except Sections 4 and 9) Annex to CL 2006/15-CPL EC position: in favour of adoption. 2) CCCPL: Proposed draft Standard for Instant Noodles (Sections 4 and 9) Annex to CL 2006/15-CPL EC position: The ECMS question the long list of anti-oxidants and the high maximum levels established in particular for BHA (321), BHQ (320) and TBHQ (319), but do not wish to block adoption of the standard. 3) CCFAC: Draft revision of the Preamble of the Codex General Standard for Food Additives ALINORM 06/29/12, Appendix V EC position: In favour of adoption. 4) CCFAC: Draft and proposed draft food additive provisions of the General Standard for Food Additives (GSFA) ALINORM 06/29/12, Appendix VII EC position: In favour of adoption. 4

5 5) CCFAC: Draft Maximum Level for Lead in Fish ALINORM 06/29/12, Appendix XXIV EC position: The Codex Committee on Food Additives and Contaminants (CCFAC) agreed to forward the draft maximum level of 0.3 mg/kg for lead in fish to the 29 th session of the Codex Alimentarius Commission for adoption at Step 8. The delegations of the European Community and the United States made reservations to this decision. The European Community (EC) reserved its position because the EC notes that it is recognised that analytical data on lead in fish show that most fish species could achieve a maximum level of 0.2mg/kg and that only a limited number of fish species required a higher level. Therefore the EC is of the opinion that it would have been more appropriate to propose a maximum level of 0.2 mg/kg for lead in fish with the additional provision that for the specific fish species for which it can be demonstrated with reliable data from at least various countries and sources, encompassing the main production areas/processes of those products and as far as they are engaged in international trade, that the level of 0.2 mg/kg is not reasonably achievable, a higher maximum level can be applied. Taking into account the comments made by other Member Countries in CCFAC on this issue, and in the interest of finding a common solution which meets to a large extent the concerns of the different Member Countries, the EC agrees to lift its reservation and accepts the adoption of the maximum level of 0.3 mg/kg for lead in fish.. 6) CCFAC: Draft Maximum Levels for Cadmium in marine bivalve molluscs (excluding oysters and scallops) and in cephalopods (without viscera) and in polished rice ALINORM 06/29/12, Appendix XXV EC position: Draft maximum level for Cadmium in marine bivalve molluscs (excluding oysters and scallops) and in cephalopods (without viscera) The Codex Committee on Food Additives and Contaminants (CCFAC) agreed to forward the draft maximum level of 2 mg/kg cadmium in marine bivalve molluscs (excluding oysters and scallops) and cephalopods (without viscera) to the 29 th session of the Codex Alimentarius Commission for adoption at Step 8. The delegation of the European Community expressed its reservation to this decision. The European Community (EC) wishes to remark that the Commission adopted at step 5 at its 28 th session the draft maximum level of 1 mg/kg for cadmium in marine bivalve molluscs (excluding oysters and scallops) and in cephalopods (without viscera). Concern as regards this 5

6 decision was expressed by the delegations of South Africa, Thailand and Chile supported by several other delegations as regards this level which was considered too low to be practicable, the need to better define the range of species to which the maximum levels were applicable in order to avoid trade barriers created by levels set by national legislations and the use of this level for processed products. These delegations suggested that these issues need to be further considered by the CCFAC (ALINORM 05/28/41 77 and Appendix VI) The EC notes that these issues have not been considered by the CCFAC at its 38 th session and that the originally proposed maximum level of 1 mg/kg has been increased to 2 mg/kg without considering these issues. In case the Codex wishes to pursue with the adoption of the level of 2 mg/kg for cadmium in marine bivalve molluscs (excluding oysters and scallops) and cephalopods (without viscera), the EC maintains, for the reasons outlined before, its reservation as regards the adoption by the Codex Commission of the maximum level of 2 mg/kg for cadmium in marine bivalve molluscs (excluding oysters and scallops) and cephalopods (without viscera) Draft maximum level for Cadmium in polished rice The Codex Committee on Food Additives and Contaminants (CCFAC) agreed to forward the draft maximum level of 0.4 mg/kg cadmium in polished rice to the 29 th session of the Codex Alimentarius Commission for adoption at Step 8. The delegations of the European Community, Egypt and Norway made reservations to this decision. The EC does not object to the adoption by the Codex Commission of the maximum level of 0.4 mg/kg cadmium in polished rice. Rice produced in specific regions can contain cadmium levels up to 0.4 mg/kg, being influenced by geological factors. As it is understood that such rice is only to a limited extent in international trade and not exported to the EU, the EC has no intention to change its current legislation. 7) CCFAC: Proposed draft food additive provisions of the General Standard for Food Additives (GSFA) ALINORM 06/29/12, Appendix XI EC position: In favour of adoption. 8) CCFAC: Proposed draft amendments to the International Numbering System for Food Additives 6

7 ALINORM 06/29/12, Appendix XVI EC position: In favour of adoption. 9) CCFAC: Specifications for the Identity and Purity of Food Additives arising from the 65 th JECFA meeting ALINORM 06/29/12, Appendix XVII EC position: In favour of adoption. 10) CCFAC:Proposed draft Appendix to the Codex Code of Practice for the Prevention and Reduction of Aflatoxins Contamination in Tree Nuts Additional Measures for the Prevention and Reduction of Aflatoxins Contamination in Brazil nuts (N ) ALINORM 06/29/12, Appendix XX EC position: In favour of adoption. 11) CCFAC:Proposed draft Code of Practice for the Prevention and Reduction of Dioxin and Dioxin-like OCB Contamination in Food and Feeds ALINORM 06/29/12, Appendix V EC position: In favour of adoption. 12) CCFAC:Proposed draft revised Guideline Levels for Radionuclides in Foods Contaminated Following a Nuclear or Radiological Emergency for Use in International Trade ALINORM 06/29/12, Appendix XXXI EC position: In favour of adoption. 13) CCFICS: Proposed draft Principles and Guidelines for Imported Food Inspection Based on Risk ALINORM 06/29/30, Appendix II EC position: In favour of adoption. New Zealand had a strong reservation but seems to be in a position to lift it taking into account on-going discussions at CCGP level on risk analysis terms. 14) CCFICS: Proposed draft Principles for Traceability/Product Tracing as a Tool within a Food Import and Export Inspection and Certification System 7

8 ALINORM 06/29/30, Appendix III EC position: In favour of adoption. We could accept the amendment proposed by Brazil in ALINORM 06/29/5A. 15) CCFL: Draft Amendment to the Guidelines for the Production, Processing, Labelling and Marketing of Organically Produced Foods: Annex 2 Permitted Substances: Table 3 ALINORM 06/29/22, Appendix II EC position: In favour of adoption. 16) CCFL: Proposed Draft Amendment to the Guidelines on Nutrition Labelling: Definition of Trans Fatty Acids ALINORM 06/29/22, Appendix V EC position: In favour of adoption. 17) CCFL: General Standard for Fruit Juices and Nectars: labelling provisions related to processing aids ALINORM 06/29/22 para. 4-5 EC position: In favour of adoption. Background: The Commission adopted the General Standard for Fruit Juices and Nectars at its 29 th Session (2005) and noted that three processing aids (isinglass and sodium/potassium caseinates) would be included in the Standard after endorsement of related labelling provisions by CCFL (ALINORM 05/28/41, para. 64). These labelling provisions were endorsed by the 37 th Session of the CCFL, thereby allowing the inclusion of the processing aids in the General Standard for Fruit Juices and Nectars. 18) CCMAS: Methods of analysis and sampling for inclusion in Codex standards and/or in CODEX STAN ALINORM 06/29/23, Appendix II EC position: In favour of adoption (Position on gluten method still to be agreed) Background: The CCMAS considered methods submitted for endorsement in Proposed Draft or Draft Standards and in standards that have already been adopted. This is mentioned in conjunction with the standards submitted at Step 8 or 5/8 insofar as it results in an amendment to the methods of analysis included in adopted standards, or to CODEX STAN Method for Gluten (AT does not agree to discuss this at CAC; UK not agree; IRL ok with Type II Methods; NL does not agree) The ECMS would propose to change the classification of this method for analysis of Gluten, which the 17th meeting of CCMAS has endorsed as a type I and instead adopt it as a type II method. 8

9 Background The 27th meeting of CCMAS in May 2006 endorsed as a type I method the Enzyme-Linked Immunoassay R5 Mendez (ELISA) method for determination of Gluten in the draft revised standard for Glutenfree foods. If a method is adopted as a type I method, it means that this is the only method which should be used in a possible dispute. Other methods are used today and much developement in the area of method of analysis is going on. Criteria approach In the Codex system, the criteria approach, has been adopted for type II and III methods. The consequence of this is that other methods could be used as long as they fulfil the same criteria as the adopted type II or III method. The criteria approach is described in the manual. Criteria approach could not be applied for type I methods. Since the R5 ELISA (Mendez) method is not the only existing method for analysis of gluten it is not appropriate to classify it as a type I method. The ECMS therefore would propose that CAC change the method classification and adopt it as a type II method instead. The complete description of the different Codex types of methods is shown below:. Codex Procedural Manual 15th ed. page PRINCIPLES FOR THE ESTABLISHMENT OF CODEX METHODS OF ANALYSIS PURPOSE OF CODEX METHODS OF ANALYSIS The methods are primarily intended as international methods for the verification of provisions in Codex standards. They should be used for reference, in calibration of methods in use or introduced for outine examination and control purposes. METHODS OF ANALYSIS Definition of types of methods of analysis (a) Defining Methods (Type I) Definition: A method which determines a value that can only be arrived at in terms of the method per se and serves by definition as the only method for establishing the accepted value of the item measured. Examples: Howard Mould Count, Reichert-Meissl value, loss on drying, salt in brine by density. (b) Reference Methods (Type II) Definition: A Type II method is the one designated Reference Method where Type I methods do not apply. It should be selected from Type III methods (as defined below). It should be recommended for use in cases of dispute and for calibration purposes. Example: Potentiometric method for halides. 9

10 (c) Alternative Approved Methods (Type III) Definition: A Type III Method is one which meets the criteria required by the Codex Committee on Methods of Analysis and Sampling for methods that may be used for control, inspection or regulatory purposes. Example: Volhard Method or Mohr Method for chlorides (d) Tentative Method (Type IV) Definition: A Type IV Method is a method which has been used traditionally or else has been recently introduced but for which the criteria required for acceptance by the Codex Committee on Methods of Analysis and Sampling have not yet been determined. Examples: chlorine by X-ray fluorescence, estimation of synthetic colours in foods. 19) CCMMP: Draft Amendment to Section 2 Description of the General Standard for Cheese ALINORM 06/29/11, Appendix II EC position: In favour of adoption. 20) CCMMP: Draft Standard for a Blend of Evaporated Skimmed Milk and Vegetable Fat ALINORM 06/29/11, Appendix III EC Position: In favour of adoption. The ECMS wish to underline the need to retain provisions dealing with the names of the products in its current state, as they prevent any confusion between the products covered by these standards and products exclusively made of milk and offer in addition a degree of flexibility for the use of names recognised in national legislation (however the mention of filled milk as an example in the standard is not acceptable). 21) CCMMP: Draft Standard for a Blend of Skimmed Milk and Vegetable Fat in Powdered Form ALINORM 06/29/11, Appendix IV EC position: Same as previous point 22) CCMMP: Draft Standard for a Blend of Sweetened Condensed Skimmed Milk and Vegetable Fat ALINORM 06/29/11, Appendix V EC position: Same as previous point 23) CCMMP: Draft Revised Standard for Cheddar (C-1) 10

11 ALINORM 06/29/11, Appendix VI EC position: The European Community and its Member States (ECMS) fully support the final adoption of all individual cheese standards as proposed by the CCMMP and welcome their finalization at the same time in accordance with the critical review carried out by the Executive Committee during its 55 th Session (CX/EXEC 05/55/3). However the ECMS note that CCFL was not in a situation to endorse the labelling provisions requiring mention of the country of origin despite the justification provided by CCMMP. The ECMS strongly support the declaration of the country of origin as required by section 7.2 as its omission for this particular type of foods could mislead or deceive the consumer; this approach is fully in line with section of the General Standard for the Labelling of Prepackaged Foods. As a compromise, the ECMS could accept that the provisions regarding country of origin labelling would not be applicable for Cream Cheese (C-31) and Cottage Cheese (C-16) if this concession would allow the lifting of the remaining reservations (United States, Canada, New Zealand, Australia). The ECMS do not believe that a partial adoption of the standards (i.e. without section 7.2.) could be an appropriate way forward as these standards were discussed as a package, the labelling requirements of which constitute an essential component. 24) CCMMP: Draft Revised Standard for Danbo (C-3) ALINORM 06/29/11, Appendix VII EC position: See Cheddar. 25) CCMMP: Draft Revised Standard for Whey Cheeses ALINORM 06/29/11, Appendix VIII EC position: in favour of adoption. 26) CCMMP: Proposed draft Revised Standard for Edam (C-4) ALINORM 06/29/11, Appendix IX EC position: See Cheddar. 27) CCMMP: Proposed draft Revised Standard for Gouda (C-5) ALINORM 06/29/11, Appendix X EC position: See Cheddar. 11

12 28) CCMMP: Proposed draft Revised Standard for Havarti (C-6) ALINORM 06/29/11, Appendix XI EC position: See Cheddar. 29) CCMMP: Proposed draft Revised Standard for Samso (C-4) ALINORM 06/29/11, Appendix XII EC position: See Cheddar. 30) CCMMP: Proposed draft Revised Standard for Emmental (C-9) ALINORM 06/29/11, Appendix XIII EC position: See Cheddar. Although the ECMS do not support at all the request of Switzerland to revoke the standard of Emmental, the proposed strategy on this issue is to keep a low profile and avoid being in the front row, should a discussion occur. 31) CCMMP Proposed draft Revised Standard for Tilsiter (C-11) ALINORM 06/29/11, Appendix XIV EC position: See Cheddar. 32) CCMMP: Proposed draft Revised Standard for Saint-Paulin (C-13) ALINORM 06/29/11, Appendix XV EC position: See Cheddar. 33) CCMMP: Proposed draft Revised Standard for Provolone (C-15) ALINORM 06/29/11, Appendix XVI EC position: See Cheddar. 34) CCMMP: Proposed draft Revised Standard for Cottage Cheese (C-16) ALINORM 06/29/11, Appendix XVII EC position: See Cheddar. COOL provisions could be dropped for compromise. 35) CCMMP: Proposed draft Revised Standard for Coulommiers (C-18) 12

13 ALINORM 06/29/11, Appendix XVIII EC position: See Cheddar. 36) CCMMP: Proposed draft Revised Standard for Cream Cheese (C-31) ALINORM 06/29/11, Appendix XIX EC position: See Cheddar. COOL provisions could be dropped for compromise. 37) CCMMP: Proposed draft Revised Standard for Camembert (C-33) ALINORM 06/29/11, Appendix XX EC position: See Cheddar. 38) CCMMP: Proposed draft Revised Standard for Brie (C-34) ALINORM 06/29/11, Appendix XXI EC position: See Cheddar. 39) CCMMP: Proposed draft Standard for Mozzarella ALINORM 06/29/11, Appendix XXII EC position: See Cheddar. 40) CCMMP: Proposed draft Standard for Dairy Fat Spreads ALINORM 06/29/11, Appendix XXIII EC position: In favour of adoption. Although there might be some divergences of approach compared to the Standard for Fat Spreads and Blended Spreads, it is considered that the current text could be acceptable as is. 41) CCNFSDU: Draft Revised Standard for Processed Cereal-Based Foods for Infants and Young Children ALINORM 06/29/26, Appendix II EC position: In favour of adoption. Extensive comments on this standard have been provided by Argentina, China, Peru, US, Venezuela, ENCA and ILCA. There is a risk that the text is sent back to CCNFSDU, what we would like to avoid. The European Community (EC) fully supports the adoption of the Draft Revised Standard on Processed Cereal-based Foods Intended for Infants and Young Children. The revision of the standard has been discussed extensively for a long period of time and it is important that the standard should be revised. 13

14 The EC notes that the Codex Committee on Food Additives and Contaminants (CCFAC) endorsed the food additives provisions of the draft revised standard with some modifications. CCFAC also endorsed additional provisions on flavours and recommended that they should be included in the section 4 Food Additives. The EC agrees to all the amendments proposed by CCFAC. Defensive points Modifications to paragraph second sub paragraph Comments by Argentina Argentina proposed to add a reference to paragraph of the Guidelines for the Use of Nutrition and Health Claims. Paragraph of the Guidelines refers specifically to health claims, which are not mentioned in the current wording of Therefore, the EC should not support this proposed amendment. USA USA considers that the wording of paragraph is confusing as it only refers to nutrition claims whereas paragraph 1.4 of the Guidelines for the Use of Nutrition and Health Claims mentions both nutrition and health claims. The EC considers that the provisions of the Guidelines for the Use of Nutrition and Health Claims would apply as is specifically mentioned in the first subparagraph of and therefore health claims could be made subject to national legislation. If this point is raised the EC would not support the reopening of this issue. Comments of ENCA and ILCA The two NGO observers, ENCA and ILCA, have submitted the same extensive comments on the draft revised standard. These comments have been presented in CCNFSDU during the discussions on the revision of the standard, however, they did not receive the support of the Committee. The EC should oppose the reopening of the discussion in CAC. It is possible that due to comments of ENCA and ILCA it may be suggested that there is not consensus on the standard and that the standard should be sent back to the CCNFSDU. If this happens, the EC position should be that such a decision would not be justified as the issues raised in the comments of the observers have already been considered by the CCNFSDU but they were not supported by the members of the Committee. 42) CCPR: Draft Maximum Residue Limits for Pesticides, including Dried Chili Pepper ALINORM 06/29/24, Appendix II EC position: The European Community (EC) maintains and confirms its reservations on the adoption of a maximum residue limit for METHIOCARB (132) of 2 mg/kg in Peppers, Sweet NB: To the concern expressed by the Delegation of Germany regarding the proposed MRL for pepper, the Delegation was asked to send their comments in concern form. DELTAMETHRIN (135) of 2 mg/kg in Leafy vegetables 14

15 The EC has established a lower ARfD than JMPR based on the same data and does not support the advancement of this MRL because of the dietary intake concerns. OXYDEMETON-METHYL (166) of 0.05 mg/kg in Pears The EC has a strong reservation against the advancement of the MRL for pear to Step 8 due to intake concerns. CHLORPROPHAM (201) of 30 mg/kg in Potato The EC is opposed to the advancement of the MRL for potato because of intake concerns related to micro-waved unpeeled potatoes for toddlers. 43) CCPR: Draft Guidelines on Estimation of Uncertainty of Results ALINORM 06/29/24, Appendix IV EC position: In favour of adoption. 44) CCPR: Proposed draft Maximum Residue Limits for Pesticides ALINORM 06/29/24, Appendix III EC position: In favour of adoption. 45) CCRVDF: Draft Maximum Residue Limits ALINORM 06/29/31, Appendix II EC position: In favour of adoption except for Trichlorfon in cattle milk. The European Community (EC) maintains and confirms its reservation on the adoption of a maximum residue limit for Trichlorfon (Metrifonate) at 50 µg/kg in cattle milk. Background (16 th CCRVDF report ALINORM 06/29/31) Trichlorfon (metrifonate) 45. The Committee recalled that at its 15th Session it had agreed to hold the MRL for Trichlorfon at Step 7 pending the submission of new data for JECFA re-evaluation. It further noted that the JECFA Secretariat had agreed to reschedule Trichlorfon as a priority substance and to specifically address the toxicological concerns raised by the Delegation of the European Community. 46. The JECFA Secretariat explained that based on the request of the 15th Session a detailed explanation of the scientific concerns raised by the European Community had been received by the JECFA Secretariat and these were considered at the 66th JECFA meeting. The full draft assessment report had been provided to the European Community after the JECFA meeting, and was also distributed as CRD 6 for the 16 th CCRVDF. JECFA had responded in detail to all the specific toxicological concerns raised, taking into account all available information, including some new data that had been submitted. In conclusion JECFA confirmed the ADI for Trichlorfon established at the 60th meeting since it did not find any basis for revising it. The previously recommended MRLs were not reconsidered. 15

16 47. The Delegation of the European Community acknowledged the submission of the draft JECFA report on the assessment of Trichlorfon and stated that due to the short interval between the 66th JECFA meeting and the 16th Session of CCRVDF, it had not been possible for them to review the JECFA assessment prior to the Session of CCRVDF. The Delegation confirmed the concerns previously expressed regarding the safety of Trichlorfon, in relation to genotoxicity, development toxicity, neurotoxicity and the assessment of pharmacokinetics data, which in their view did not allow the establishment of an ADI and subsequently MRLs for Trichlorfon. In addition, the Delegation had expressed concern that for the main metabolite, dichlorvos, no reliable ADI had been established. 48. Therefore the Delegation of the European Community proposed to defer the discussion on the MRLs until the next Session of the Committee in order to better examine the JECFA report. The position of the European Community was supported by two other delegations. 49. Other delegations were in favour of advancing the MRL because: all concerns as to the safety of Trichlorfon had been adequately addressed by JECFA; the conclusions of JECFA were clear and no new data are available to consider a further evaluation; the product was in use in many countries; and further delay in recommending a MRL in milk for this substance could have serious implication on trade. 50. The Committee agreed to advance the MRL for Trichlorfon to Step 8 and noted the reservation of the European Community and its Member States to this decision for the reasons mentioned above. 16

17 Agenda item 4 - Part 2 Standards and related Texts submitted for adoption 46) CCFAC: Codex General Standard for Contaminants and Toxins in Foods, including Schedule I ALINORM 06/29/12, Appendix XVIII EC position: In favour of adoption. 37 th CCFAC agreed to Append Schedule I to the GSCTF and to request the 28 th CAC to revoke the existing individual Codex standards for Maximum/Guideline Levels for contaminants and toxins. The 28 th CAC in noting that Schedule I had not officially been submitted for adoption, requested the CCFAC to submit it for adoption. 47) CCFAC: Amended Annex to Table 3 of the GSFA ALINORM 06/29/12, Appendix VIII EC position: In favour of adoption. This amendment is a consequential change to the inclusion of the food additives provisions of the commodity standards with a one-to-one relationship with a food category of the GSFA into the GSFA. 48) CCFAC: Revision of the Descriptor of Food Category 13.6 Food supplements of the GSFA ALINORM 06/29/12, Appendix XXXIII EC position: In favour of adoption. This amendment is related to the descriptor of the Food category 13.6 Food Supplement of the GSFA to align it with the Codex Guidelines for Vitamin and Mineral Food Supplements (CAC/GL 55/2005). 49) CCRVDF: Compendium of Methods of Analysis Identified as Suitable for Support to Codex MRLs ALINORM 06/29/31, Appendix IX EC position: The European Community and its Members States (ECMS) are rather surprised to the see that the Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF) s Compendium of Methods of Analysis Identified as Suitable for Support to Codex MRLs (ALINORM 06/29/31, Appendix IX) is proposed for adoption in Part 2 of Annex to ALINORM 06/29/05. In paragraph 16 of ALINORM 06/29/9C-Add.2 (Agenda item 11), this discussion is introduced in an open manner (emphasis added): The Commission may wish to recommend that the above Compendium be not given the status of Codex Standard, Guidelines or recommendation but be maintained and updated by the Committee for use by Codex members. As indicated in the notes of Part 2 of Annex to ALINORM 06/29/05 (Agenda item 4): 17

18 This Compendium lists methods of analysis identified by the CCRVDF as suitable for support to Codex MRLs. The Committee will regularly update and revise the Compendium on the basis of information submitted by Codex members and observers. According to paragraphs 119 and 120 of ALINORM 06/29/31 (emphasis added) on the Methods of analysis for residues of veterinary drugs in foods: 119. The Committee endorsed the recommendation of the ad hoc Working Group to ask the Codex Secretariat to issue a Circular Letter requesting that members and observers review the list of methods; review and update any addresses of contact points for information; advise of any methods for which they are no longer able to provide information; and provide information on substances and matrices for which validated methods are still required The Committee agreed to forward to the 29th Session of the Codex Alimentarius Commission the Compendium of Methods of Analysis Identified as Suitable to Support Codex MRLs (see Appendix X). There is no direct reference to possible adoption in the final report of the 16 th session of the Codex Committee on Residues of Veterinary Drugs in Foods. The ECMS recollection of discussion at the last CCRVDF meeting is that this list of methods of analysis should have no official status in the Codex step procedure. The rationale being that the Committee does not have the resources to check in details each method and to compare different methods on scientific grounds. The ECMS recognise that such a Compendium is extremely useful for developing countries. From an ECMS viewpoint, this Compendium is drafted for information purposes only, as a resource list, and it is meant for continuous revision at each session the CCRVDF. The formal adoption of this Compendium would prejudge the status of this Compendium which still has to be discussed within the CCRVDF. In addition it must be noted that if this Compendium were to be adopted, methods of analysis relating to compounds with no Codex MRL should be withdrawn form the list. Background information: It has to be noted that a similar situation can be found in the framework of the Codex Committee on Pesticide Residues (CCPR), in paragraphs 179 to 181 of ALINORM 06/29/24 (emphasis added) on the Proposed draft Revision of the List of Methods for Pesticides Residue Analysis : 179. The Chair of the Working Group provided an update of the collation of methods of analysis. The Representative of IAEA informed the Committee that the methods of analysis currently available on the IAEA website (CRD 19) had been provided by several countries and consist mostly of abstracts, methods principles and literature references, as well as links to relevant external web pages The Delegation of Australia stated that the list of methods should be considered as a resource list and was not a list of preferred or obligatory methods for Codex purposes. Some delegations indicated that they would provide relevant methods to the Committee or that their methods were available free of charge on the internet The Committee agreed that a Circular Letter would be sent requesting information on methods for the determination of pesticide residues, to be addressed to the Codex Secretariat and the IAEA, for further consideration at the next session. Conclusion: The ECMS are opposed to the adoption, at this stage of the relevant work of the CCRVDF, of the Compendium of Methods of Analysis Identified as Suitable for Support to Codex MRLs as proposed in Part 2 of Annex to ALINORM 06/29/05. 18

19 The ECMS are of the opinion that the Commission should recommend that the above Compendium be not given the status of Codex Standard, Guidelines or recommendation but be maintained and updated by the Committee for use by Codex members. Agenda item 4 - Part 3 Standards and related Texts held at the Commission at Step 8 50) Draft MRLs for Bovine Somatotropin (ALINORM 95/31; Appendix II) held at Step 8 by the 23 rd Session of the Commission (1999). EC position: Item not to be discussed as there is agreement to hold it at step 8. 19

20 Agenda Item 5 - Proposed Draft Standards and Related Texts Submitted at Step 5 1) CCFAC: Proposed draft revision of the Codex Class Names and the International Numbering System for Food Additives CAC/GL (NO7 2005) ALINORM 06/29/12, para 98 and Appendix XV EC position: In favour of advancement to step 5. Background: Extract of CCFAC 38 report: Extract of CCFL 34 report: 20

21 The classification of carriers and packaging gases as food additives depends on their technological function according to the definition of a food additive. Once it is decided these substances should be considered as food additives, then CCFL will have to consider the modification of the list of food additive classes to appear on the label as required by the General Standard for the Labelling of Prepackaged Foods. 2) CCFAC: Proposed draft Maximum Level for Total Aflatoxins Almonds, Hazelnuts and Pistachios ready to eat ALINORM 06/29/12, para 132 and Appendix XXII EC position: The Codex Committee on Food Additives and Contaminants (CCFAC) agreed to advance to Step 5 the proposed maximum level of 8 µg/kg for total aflatoxins in ready-to-eat almonds, hazelnuts and pistachios. The delegation of Iran expressed its reservation to this decision. (ALINORM 06/29/ and 132 and Appendix XXII) The European Community (EC) can accept the adoption of the level of 8 µg/kg for total aflatoxin in ready-to-eat almonds, hazelnuts and pistachios at Step 5 by the Codex Alimentarius Commission. 21

22 The EC wishes to indicate that a possible future acceptance of this level for ready-to-eat almonds hazelnuts and pistachios at Step 8 of the Codex uniform procedure will depend on the consideration of the different issues which will be addressed in the discussion paper on the aflatoxin level in ready-to-eat nuts (ALINORM 06/29/12, 129) in particular * the consumer health risk assessment of different levels of aflatoxins in ready-to-eat nuts * the sampling plan for aflatoxin contamination in almonds, Brazil nuts, hazelnuts and pistachios * the effects of codes of practice 3) CCFAC: Proposed draft Maximum Levels for Tin in Canned Foods (other than beverages) and in Canned Beverages ALINORM 06/29/12, para 183 and Appendix XXVIII EC position: The Codex Committee on Food Additives and Contaminants (CCFAC) agreed to forward the draft maximum level of 150 mg/kg in canned beverages and 250 mg/kg in canned foods other than beverages to the 29 th session of the Codex Alimentarius Commission for adoption at Step 5. The delegation of the European Community expressed its reservation to this decision The EC maintains its reservation for the following reasons: 1) Addendum to toxicological monograph on the assessment at the 64 th meeting of JECFA not yet available The JECFA was requested to assess the likelihood of the occurrence of effects at the proposed maximum levels (200 mg/kg in canned beverages and 250 mg/kg in canned foods other than beverages). In February 2005 at its 64 th meeting, the JECFA performed this assessment and reconsidered studies of the acute toxic effects seen in humans after consumption of foods containing high concentrations of inorganic compounds of tin, and considered also a new study on the comparative assessment of gastrointestinal potency in man of tin chloride and tin migrated from packaging. Only the summary conclusions of the 64 th meeting are yet available (WHO Technical Report Series 930) and the addendum to the toxicological monograph is still not yet published. 2) Lower levels can be achieved by applying good practices The European Community proposes a maximum level of 200 mg/kg in canned foods other than beverages and 100 mg/kg in canned beverages. Available data have shown that these levels are already readily achievable. In addition, The Codex Alimentarius Commission adopted at its 28 th Session in 2005 (ALINORM 05/28/42, Appendix V) the Code of Practice for the prevention and reduction of inorganic tin contamination in canned foods (CAC/RCP ) In the preamble to the Codex General Standard for Contaminants and Toxins in Foods (CODEX STAN rev ) one of the criteria mentioned to be applied for the 22

23 establishment of maximum levels for maintaining a consistent policy in the matter is the following: Maximum levels shall be set as low as reasonably achievable. Providing it is acceptable from the toxicological point of view, maximum levels shall be set at a level which is (slightly) higher than the normal range of variation in levels in foods that are produced with current adequate technological methods, in order to avoid undue disruptions of food production and trade. Where possible, maximum levels shall be based on GMP and/or GAP considerations in which the health concerns have been incorporated as guiding principle to achieve contaminant levels as low s reasonably achievable. Therefore the European Community is of the opinion that the availability of data on the presence of inorganic tin in canned beverages and canned foods other than beverages, obtained after the implementation of the recommended measures to prevent and reduce the presence of inorganic tin in canned foods as outlined in the Code of Practice for the prevention and reduction of inorganic tin contamination in canned foods (CAC/RCP ) should be awaited before proceeding with the discussions on a maximum level.. 3) High levels not needed for technological reasons Tin is used to protect the steel base both externally and internally in contact with foods. The lacquering of cans significantly reduces the risk of tinplate corrosion and avoid tin dissolution. The use of plain tinplate cans also serves a functional/technological purpose. The need for tin dissolution to maintain the desired colour and flavour attributes of products such as asparagus, light coloured fruits and tomato based products has long been established. The presence of tin creates a reducing atmosphere in the can and prevents undesirable oxidative changes in these products, which would otherwise develop brown discolorations and unacceptable flavours. However the level of tin needed for this functional/technological purpose are much lower than the levels discussed. In EU-legislation stannous chloride is authorised in canned and bottled white asparagus for this technological purpose at a maximum levels of 25 mg tin /kg canned or bottled food Therefore the functional / technological need of tin for some canned foods does not provide a justification for the levels currently proposed for adoption at Step 5. Background: The maintenance at this stage of the reservation of the EC as regards the proposed Codex levels for tin in canned food and beverages for adoption at step 5 is justified for the reasons outlined in the EC position focusing on the incomplete information currently available to enable EC and CCFAC to take an informed decision: - complete JECFA risk assessment not yet available (only summary conclusions) - positive effects on the reduction of the tin levels as the consequence of the application of the Codex Code of Practice - no concrete information provided on what levels of tin are needed for technological purposes (argument used in the discussions to justify the proposed levels) 23

24 If this information will be available and discussed in detail in the Codex Committee dealing with contaminants, then EC will be in the position to consider its position and to take an informed decision. 4) CCNFSDU: Draft Revised Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants (Section B) ALINORM 06/29/26, para 126 and Appendix IV B EC position: In favour of advancement to step 5. Extensive comments have been provided (Australia, Bolivia, Brazil, Costa Rica, Norway, Peru, US, Venezuela, ILCA, ISDI,WSRO). The European Community (EC) fully supports the adoption of the Section B of the Draft Revised Standard on Infant Formulae and Formulae for Special Medical Purposes Intended for Infants at Step 5 of the procedure. This would bring the two parts of the draft revised standard together at the same step in the procedural process. The EC fully supports the structure of Section B of the draft revised standard with cross references to the relevant Codex texts which should reduce the risk of discrepancies between the relevant standards. Due to the nature of the products covered by this section of the standard, provisions different from those that apply to Section A of the standard may need to be included, for example in relation to the essential composition and food additives. The specific details of such provisions will depend on the outcome of the discussions on Section A of the standard. 5) CCMAS: Proposed draft Guidelines for Settling Disputes over Analytical (Test) Results ALINORM 06/29/26, para 43 and Appendix III EC position: In favour of advancement to step 5. 6) CCMMP: Proposed draft Model Export Certificate for Milk and Milk Products ALINORM 06/29/11, para 142 and Appendix XXIV EC position: In favour of advancement to step 5. The ECMS have some concerns as regards the mention of the name and address of the producer on the certificate. 7) CCPR: Proposed draft MRLs 24

25 ALINORM 06/29/24 paras 93 94; and Appendix VI EC position: In favour of advancement to step 5. As regards Phorate, this substance has been on the agenda of last years JMPR. The JMPR concluded that there are short term intake concerns for potatoes only. That's why CCPR proposed to advance from Step 4 to Step 5 only. It is general policy of CCPR in this cases to go to Step 5, but the proposed MRL will not go beyond Step 6 if the intake problems are continuing to exist. And, according to the CCPR policy-document, if CCPR has returned for 3 times the MRL proposel back to Step 6, it will be discussed within JMPR (that has to look to a lower GAP).Therefore the EC does not oppose the advancement of the proposed MRL for Phorate to Step 5. 8) CCRVDF: Proposed draft MRLs for Colistin and Ractopamine ALINORM 06/29/31, para 77 and Appendix IV EC position: In favour of advancement to step 5. 9) CCRVDF: Proposed draft Guidelines for National Regulatory Food Safety Assurance Programmes Associated with the Use of Veterinary Drugs in Food Producing Animals ALINORM 06/29/31, para 86 and Appendix VII EC position: In favour of advancement to step 5. 10) Work by correspondence (ref ALINORM 04/27/41 para.172): Proposed draft revised Recommended International Code of Practice for the Processing and Handling of Quick Frozen Foods ALINORM 06/29/6 Add.1 EC position: In favour of advancement to step 5. Background: Developed by correspondence as per quality provisions (Codex and USA Secretariats). Finalization of hygienic/safety provisions by the Codex Committee on Food Hygiene after adoption at Step 5. 25

26 Agenda Item 6 Revocation of existing Codex Standards and Related Texts 1) CCPR: Maximum Residue Limits for Pesticides ALINORM 06/29/24; paras and Appendix VII EC position: In favour of revocation. 2) CCFAC: List of Individual Codex Maximum Levels and Guideline Levels for Contaminants and Toxins ALINORM 05/28/12, para 124 and Appendix XVIII EC position: In favour of revocation. 3) CCFAC: Food Additive Provisions of the GSFA ALINORM 06/29/12, paras 63 and 81 and Appendices VII, XII and the attached Annex EC position: In favour of revocation. 26

27 Agenda Item 7 Proposals for the Elaboration of new Standards and Related Texts and for the Discontinuation of Work Proposals for New Work 1) TFFBT: Proposed Draft Guideline for the Conduct of Food Safety Assessment of Foods derived from Recombinant-DNA Animals ALINORM 06/29/34, Paras. 19 and 23, Appendix II EC position: In favour of new work. 2) TFFBT: Proposed Draft Annex to the Codex Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants (CAC/GL ) regarding food safety assessment of foods derived from recombinant-dna plants modified for nutritional or health benefits ALINORM 06/29/34, Paras. 32 and 36, Appendix III. EC position: In favour of new work. 3) CCFAC: Guidelines for the Use of Flavourings ALINORM 06/29/12, Para.87 and Appendix XIV EC position: In favour of new work. 4) CCFAC: Revision of the Preamble of the Codex General Standard for Contaminants and Toxins in Foods ALINORM 06/29/12, Para.119 and Appendix XIX EC position: In favour of new work. 5) CCFAC: Code of Practice for the Prevention and Reduction of Ochratoxin A Contamination in Wine ALINORM 06/29/12, Para.140 and Appendix XXIII EC position: In favour of new work. 27

28 6) CCFAC: Code of Practice for the Reduction of Acrylamide in Food ALINORM 06/29/12, Para.185 and Appendix XXIX EC position: In favour of new work. 7) CCFAC: Code of Practice for the Reduction of Contamination of Food with PAH from Smoking and Direct Drying Processes ALINORM 06/29/12, Para. 188 and Appendix XXX EC position: In favour of new work. 8) CCMMP: Amendment to the List of Additives of the Code Standard for Creams and Prepared Creams ALINORM 06/29/1, Para.159 and Appendix XXVII EC position: In favour of new work. 9) CCPR: Priority List of Pesticides (New Pesticides and Pesticides under Periodic Review) ALINORM 06/29/24, Paras and Appendix X EC position: In favour of new work. 10) CCPR: Extension of the Work on the Revision of the Codex Classification of Foods and Animal Feeds ALINORM 06/29/24, Paras and Appendix IX EC position: In favour of new work. 11) CCRVDF: Priority List of Veterinary Drugs Requiring Evaluation of Re-evaluation ALINORM 06/29/31, Para.133 and Appendix XI EC position: In favour of new work. 12) CCFL: Proposed Draft Amendment to the Guidelines for Organically Produced Foods (Ethylene) 28

29 ALINORM 06/29/22, Para. 77 EC position: In favour of new work. 13) CCFL: Definition of advertising ALINORM 06/29/22, Para.146 EC position: In favour of new work. US, Philippines and Food Industry against. 14) CCMAS: Revision of Principles for the Establishment or Selection of Codex Sampling Procedures in the Procedural Manual ALINORM 06/29/23, para EC position: In favour of new work. 15) CCMAS: Review of Analytical Terminology for Codex Use approved as new work by the 26th Session of the Commission3 to be transferred from the Procedural Manual to a Proposed Draft Guideline on Analytical Terminology ALINORM 06/29/23, para.55 EC position: In favour of new work. Proposals for the Discontinuation of Work 1) CCFAC: Discontinuation of work on draft and proposed draft Food Additive Provisions of the GSFA ALINORM 06/29/12, Para. 81 and Appendix XIII EC position: In favour of discontinuation of work. 2) CCPR: Proposed Draft Amendment to the Codex MRL Elaboration Procedure (In Relation to the Establishment of Interim MRLs) ALINORM 06/29/24, paras EC position: In favour of discontinuation of work. 29

30 PART IV PROGRAMME AND BUDGETARY MATTERS Agenda item 8 Financial and Budgetary Matters Member States Competence.. ALINORM 06/29/9 - Point for information 9 Strategic Planning of the Codex Alimentarius Commission Member States Competence.. ALINORM 06/29/9A - In favour of the recommendations formulated by the Working Group comprising the Chairperson and three Vice-Chairpersons 30

31 PART V POLICY AND GENERAL MATTERS Agenda item 10 Implementation of the Joint FAO/WHO Evaluation of the Codex Alimentarius and other FAO and WHO Work on Food Standards Member States Competence.. a) General Implementation Status EC position: The Member States of the European Community (MSEC) highly appreciate the work that has been carried out until now on the implementation of proposals endorsed by the 26 th Session of the Codex Alimentarius Commission, reflected in Tables I and II of the document. The MSEC especially recognize the key supporting role of the Executive Committee as regards its contribution to the management tasks and the important supporting role of the Codex Committee on General Principles to take on a large number of the proposed actions, including revisions of the Procedural Manual. The MSEC are of the opinion that following directions for improvement should be pursued: - Strengthen the advisory role of the Executive Committee in keeping the Codex work tailored to the needs of its Members; - Strengthen the resources of the Codex Secretariat to provide to the Executive Committee with strategic proposals based on thorough analysis; - Continue modernising the Procedural Manual with the assistance of CCGP. In particular, the relations between the Commodity Committees and General Committees are described in the Procedural Manual but few guidance is given for the relations between General Committees. Consistency in guidance would strengthen the management of Codex. Scientific advice in Codex The MSEC wish to express their deep concerns regarding financial problems encountered by the joint FAO/WHO expert committees and consultations. In this regard, it seems that this problem mainly originates in the financial contribution from WHO. The MSEC therefore urge WHO to put in place the appropriate mechanisms to secure the financing of this essential activity at the basis of Codex work. 31

32 b) Review of Codex Committee Structure and Mandates of Codex Committees and Task Forces ALINORM 06/29/9B Part I ALINORM 06/29/9B Part II EC position The MSEC support proposal 1. The MSEC oppose proposal 2 The MSEC support proposal 3. Recent experiences (e.g. CCFICS working groups)have demonstrated that much progress can be achieved during the inter-session with appropriate mechanism. The MSEC support proposal 4, which allows organising physical working group sessions prior to the plenary. The MSEC support proposal 5. Taskforces have more focused terms of reference and are dissolved once the task is completed. Good results were achieved by taskforces in the recent past (e.g. TBBT, TFFJ, TFAF). 32