Questions under consideration in Codex and other international fora, and the need for guidelines of exchange of information and transparency concerning genetically modified foods (Agenda Item 6a)
Work on risk analysis including the precautionary principle and other legitimate factors. The precautionary principle in the European Region, as applied to internal and external trade (Agenda Item 6b)
Food Safety Objectives (Agenda Item 6c)
Recommendations of the Melbourne Conference. International system of rapid alert. Pan-European rapid alert system for food (Agenda Item 6d)
The presence of the parasite Anisakis spp. in fish: Sanitary and commercial implications (Agenda Item 6e)
Gluten-free foods for coeliacs. Analysis of the situation and future action (Agenda Item 6f)
Discussion Paper on Exchange of Information Between Governments Concerning Biotechnology-Derived Foods[10]
45) The Delegation of Switzerland presented the discussion paper (CX/EURO 00/6) and drew the attention of the Committee to the discussion in the Working Group of the Codex ad hoc Intergovernmental Task Force on Foods Derived from Biotechnology (TFBT) regarding the need for exchange of information between governmental authorities on issues related to such foods. The Delegation stressed the importance of strengthening information exchange mechanisms among countries, in particular among regulatory authorities responsible for standardization. These mechanisms would enable authorities to obtain first-hand information about the work of other bodies and would also improve transparency in decision making. The Delegation informed the Committee of its proposal to manage the list of contact points, should such a system be established by the Task Force.
46) Several delegations suggested the following points for further consideration; 1) exchange of information is important not only for biotechnology-related foods but also other foods in general; 2) the content of such information, as well as its quality needs to be clarified; 3) it is important to take into account existing information exchange mechanisms, including that through Codex Contact Points.
47) The Representative of WHO informed the Committee that in the case of Joint FAO/WHO Expert Consultations on Foods Derived from Biotechnology, relevant information such as the selection of experts and the report of the consultation was being distributed to Codex Contact Points through the Codex-L system. The Representative also indicated that the Inter-Agency Network for Safety in Biotechnology (IANB) composed of FAO, WHO, OECD, WTO, the Convention of Biological Diversity and other relevant international organizations working for safety in biotechnology had been established to improve information sharing and collaboration.
48) The Representative of FAO informed the Committee of a proposal under study by FAO to develop an international “clearinghouse” on food safety and plant/animal health that would provide a single access point, for relevant national and international information for use by governments, stakeholders, civil society organizations and media. The clearinghouse would include a Rapid Alert System on food safety, animal and plant health, and link with relevant existing national, regional and international systems. The Clearinghouse would allow effective searching and viewing of relevant existing Internet World-Wide Web sites and databases. The main sources would be official information/data issued and published by competent authorities in Member countries as well as regional and international organizations. It would be maintained as a collaborative effort between national and multilateral partners, each in their respective areas of expertise. The Representative of FAO informed the Committee that the proposal was still under consideration by FAO and several Member countries. Several countries expressed interest in the proposal and requested proper coordination of all these initiatives to avoid duplication.
49) The Committee noted the current and planned mechanisms of information exchange by FAO, WHO and Codex, and suggested that future mechanisms on biotechnology could be developed on the basis of those systems. The Committee expressed its appreciation to the Delegation of Switzerland for bringing this matter to the attention of the Committee and noted that the ad hoc Task Force was the most appropriate forum to discuss it further.
Matters Submitted to the Procedure in the Framework of Codex and in Other International Fora[11]
50) The Delegation of Spain introduced document CX/EURO 00/6 Add.1 and expressed concern over the duplication of work between FAO/WHO/Codex and other international fora, in particular in the area of foods derived from biotechnology and the application of the precautionary principle. The Delegation stated that this would lead to inefficient use of resources and creation of discrepancies of opinions and regulations.
51) Several delegations shared the view of the Delegation of Spain and emphasized the need for clear understanding of the respective role of each international forum, including that of the Codex Alimentarius Commission. Duplication of work should be avoided and more efforts should be made to ensure that the activities of international fora were more complementary in nature. It was suggested that coordination at national level was also important to streamline the work of various international fora.
52) The Committee agreed that the Codex Alimentarius Commission should be recognized as the primary body for discussion on food safety, in conformity with its status, and that complementarity of work among various international fora should be further improved.
The Precautionary Principle: Considerations for its Uniform Interpretation and Application in the European Region[12]
53) The Delegation of Spain recalled that the precautionary principle had been discussed in other fora, especially in relation to the environment, but it was essential for Codex to take the lead in the consideration of precaution for food safety matters, since it represented a reference in international trade. The Delegation stressed the need to consider this issue in the framework of risk analysis, and to take into account the cases when uncertainty or lack of data had been identified in one of the four steps of risk assessment. The Delegation indicated that clear points of convergence could be identified and recognized between the Communication of the EC on the precautionary principle and the work of the Committee on General Principles.
54) Some delegations, including the Delegation of France, speaking on behalf of the Member States of the European Union, stressed the need to clarify that the precautionary principle in Europe was a risk management tool but was not intended to create additional barriers to trade. For this purpose it would be useful to provide concrete examples of its application to food safety issues, in order to facilitate the debate with countries outside the Region.
55) The Delegation of the United Kingdom pointed out that the recommendations on the precautionary principle might be directed to governments for its application at the national level or within the Codex system. In view of current discussions on this issue, it appeared preferable to provide advice to governments on its application as a matter of priority.
56) The Committee expressed its support for the precautionary principle in the area of food safety and considered that:
Discussion paper on A) Risk Analysis, including the precautionary principle and food safety objectives, and b) the role of science and other legitimate factors in the Codex Decision-Making Process[13]
57) The Delegation of Sweden summarized current discussions on risk analysis in Codex and indicated that the Committee on Food Hygiene would consider the Proposed Draft Principles and Guidelines for the Conduct of Microbiological Risk Management (CX/FH 00/6), including a section on microbiological food safety objectives, which referred to the appropriate level of protection. The Delegation indicated that it would be useful to present specific examples of such objectives for specific pathogens for clarification purposes, and pointed out that food safety objectives were relevant not only for microbiological aspects but also for issues related to chemical contamination.
58) The Delegation of Sweden presented the relevant sections of the document under discussion in the Committee on General Principles (ALINORM 01/33, Appendix III) and suggested a flexible approach at the next session of the Committee: the second sentence of paragraph 34 in the first alternative could be moved to the end of the second proposal.
Other Legitimate Factors
59) The Delegation of the Netherlands expressed the view that Good Agricultural Practice (GAP), Good Practice in the Use of Veterinary Drugs and Good Manufacturing Practice (GMP) were based on science and should not be considered as other legitimate factors.
60) Other delegations pointed out that these practices were related to political decisions made at the national level and although partly based on scientific data, they should be considered as other legitimate factors, as compared with scientific evidence used in risk assessment.
61) The Committee noted that it was not intended to reach a decision on these issues, but only to identify questions to be addressed and encourage member countries in the region to contribute positively to the current debate. The Committee agreed that further clarification was needed on the nature of other legitimate factors, and especially whether the above-mentioned practices should be considered as such.
62) The Committee recalled that the FAO Conference on International Food Trade beyond 2000 had considered the need for an international food safety rapid alert system. The Delegation of the Netherlands presented the document which referred to the discussions of the Conference and described the EC Rapid Alert System for Food. The Delegation proposed to extend the current System to all countries in the region, broadening the Contact Point in the EC and limiting the system to an exchange of information as a first stage.
63) The Committee expressed its appreciation and interest for this proposal in view of the importance of rapid information and efficient action to ensure food safety, especially in cases of outbreaks of foodborne diseases.
64) The Observer from the EC indicated that a proposal for revision of the EC legislation was under consideration (Com 2000/139 Final-2), and that the Rapid Alert System included countries in the EU and the European Economic Area (EEA). Its extension would be considered in the future, especially for those countries which had applied for membership of the EU.
65) The Delegations of Hungary and the Czech Republic informed the Committee of their national system of alert. The Delegation of the Czech Republic also informed the Committee of its ongoing preparations in this area and of its readiness to join the EC system in the future. The Delegation of Finland indicated that the Nordic countries had established a system of information exchange with the Baltic countries with the contact point in Norway, and stressed the need for a practical system which could be used in case of crisis.
66) The Representative of WHO presented the WHO Outbreak Alert System for communicable diseases, including foodborne diseases, whereby the information on outbreaks is collected from different sources, including networks such as Pro-Med, national authorities and the media. This information is checked by a verification team in the Outbreak Verification System and forwarded to public health authorities after confirmation.
67) The Committee noted that the establishment of a Pan-European rapid alert system would be considered by the Pan-European Conference on Food Safety, to be organized in the second half of 2001 (see also Agenda Item 3).
68) The Delegation of Spain introduced a document which highlighted the adverse health effects associated with nematodes of the genus Anisakis, and the need to address this specific issue since current Codex standards only include references to parasites or nematodes in general. The Delegation proposed that the Committee on Fish and Fishery Products should consider the development of requirements addressing the presence of Anisakis spp. in fish, including appropriate control measures.
69) The Secretariat recalled that the food safety aspects of parasites in general and nematodes in particular were under consideration in the Committee on Fish and Fishery Products, as appeared in the following documents, advanced to Step 5 by the last session of the CCFFP (June 2000)[16]. The Proposed Draft Code of Practice for Fish and Fishery Products included a reference to Anisakis simplex, in the section on hazards associated with fresh fish and shellfish (section 4.1.1.1 Parasites) and recommendations for safe handling of fresh fish. The Proposed Draft Standard for Salted Atlantic Herring and Salted Sprats included provisions for the absence of live nematodes in the Hygiene Section, while the method for determining the viability of nematodes was still under development.
70) The Delegation of Spain indicated that it was aware of the existence and value of these references but considered that it was necessary to proceed with a more detailed debate on these questions.
71) Several delegations expressed the view that the regional Committee was not competent to decide on the relevance of a specific food safety issue in fish and fishery products, or to determine whether this represented an area of concern to the region. The Delegation of Spain indicated that its intention was not to initiate a technical discussion but to draw the attention of the CCFFP to the need for specific requirements and control measures related to Anisakis spp.
72) The Committee noted the concerns presented by the Delegation of Spain and agreed that it was more appropriate for this question to be raised and addressed in the Committee on Fish and Fishery Products.
73) The Delegation of Spain, while introducing the discussion paper, recalled that the Committee on Nutrition and Foods for Special Dietary Uses could not reach consensus on the maximum level and method of analysis to be included in the Draft Revised Standard for Gluten-Free Foods, and asked the advice of the Commission since no further progress on the revision was possible at this stage. The Delegation stressed the importance of this issue for the region and proposed to consider future action in the framework of Codex.
74) The Secretariat pointed out that the Committee on Food Labelling had never considered the definition of “gluten free”, neither had it been proposed at any stage that it should do so. The CCFL had established Guidelines for Use of Nutrition Claims including conditions for claims for specific nutrients, which had been defined by the CCNFSDU, and this was a different area of work. The level of gluten was not discussed as the condition for a claim, but as a product definition in the revision of the current Standard, which had been assigned to the CCNFSDU as the sole Committee responsible. As to the methods, the CCMAS was not responsible for coordination between laboratories, or the definition of methods for specific analytes, but for their endorsement, and the methods had to be proposed by the Committees responsible for the standards, as the CCNFSDU in the present case.
75) Some delegations suggested that although it had not been the case so far, this question might be considered by the CCFL. The Committee noted that member countries would have the opportunity to present their views when considering the Draft Standard at the next session of the Commission.
76) The Delegation of Sweden recalled that it had proposed to the Committee on Methods of Analysis and Sampling a proprietary method for the determination of gluten, which had not been accepted since the responsibility for proposing the method belonged to the CCNFSDU. The CCMAS had however agreed, in reply to a more general question, that proprietary methods could be used in Codex standards (ALINORM 99/23, para. 8).
77) The Committee noted that the Prolamin Working Group was working on the validation of methods for gluten detection, which should be completed in 2001, and agreed that the establishment of a new group was not necessary as it might duplicate work. The Committee also recognized the importance of coordination between laboratories working on gluten determination in the Region. The Committee recommended that all concerned Committees consider this issue as a matter of priority in order to establish a level and a method of analysis applicable to gluten-free foods.
78) The Regional Adviser for WHO/Europe reported on the initiatives taken by the WHO/EURO Regional Office in the attempt to organize a consultation of experts on the celiac disease. Contacts had been taken with the Ministry of Health of Israel (since the incidence of celiac disease seems to be very high in a particular population group in that country) and with the Prolamine Working Group in order to organize a scientific meeting on the clinical and food related aspects of celiac diseases. This could not be organized due to lack of funds. The Representative indicated that the interest of WHO in becoming active on the issue was however still present and the WHO Regional Office through its Food Safety Programme was ready to play a coordinating role among all stakeholders involved, especially on the matter of a suitable detection method for small amount of gliadins, provided that funds were made available. The Committee was also informed that JECFA had considered matters related to certain allergens at its last meeting and the possibility to address intolerance to gluten would be considered in the future.
