+ Agenda Items 2, 3 and 4 CRD 14 JOINT FAO/WHO FOOD STANDARDS PROGRAMME CODEX COMMITTEE ON FOOD HYGIENE Thirty-Nine Session New Delhi, India, October 30 November 4, 2007 EC comments on the Matters referred by the Codex Alimentarius Commission and/or other Codex Committees to the Food Hygiene Committee (Agenda item 2, CX/FH 07/39/2) Strategic Plan 2008-2013 of the Codex Alimentarius Commission Member States competence Member States vote The Member States of the European Community (MSEC) are pleased to submit their comments on the relevant parts of the Strategic Plan 2008-2013 of the Codex Alimentarius Commission. Action 2.2: Review risk analysis principles developed by relevant Codex Committees The MSEC note that CCFH has still to consider the development of its document on the application of risk analysis policies for its own work. Among the documents already developed by other committees, the MSEC are of the opinion that consistency should be improved between all relevant texts on risk analysis policies applied by Codex Committees as a whole, and therefore welcome the global review of all these texts by the Codex Committee on General Principles. Action 2.3: Enhance communication among relevant Codex subsidiary bodies and the FAO/WHO scientific expert bodies The MSEC note that the Document titled "Process by which the Codex Committee on Food Hygiene will undertake its work" had originally an Annex dealing with interaction between CCFH and JEMRA but that this Annex has been deleted and would be considered in the future when developing a document on the application of risk analysis policies applied by CCFH. Action 3.3: Develop committee-specific decision making and priority setting criteria The MSEC note that CCFH has established a mechanism to prioritise the list of proposals for new work through a physical working group meeting prior each plenary session of CCFH..
CX/FH 07/39-CRD 14 2 Review of Codex Committee Structure and Mandates of Codex Committees and Task Forces The MSEC support the extension of the CCFH meeting interval with recourse when appropriate to an efficient intersession working mechanism based on electronic or physical working groups in line with the relevant guidelines included in the Procedural Manual in particular as regards working languages. Guidelines for the Control of Campylobacter and Salmonella spp. In Broiler (young bird) Chicken Meat European Community Competence. European Community Vote. Although this would complicate the work and probably extend its duration, the EC could support the extension of the scope of the new work to cover chicken meat in general subject to the availability of data. The Use of the Lactoperoxidase System for Milk and Milk Products in International Trade Mixed Competence. European Community Vote. The ECMS consider that milk and milk products are a very important and safe food source. This safety is ensured through a reliable and well-documented series of controls which include, in particular, the cold chain. It is recognised, however, that in some developing and least developed countries there are substantial practical barriers to the safe availability of milk and milk products, notably the absence of a secure cold chain system. The report of the FAO/WHO Technical Meeting on benefits and potential risks of the LPS of raw milk preservation provides important and valuable insight into this technology, especially the food safety dimension. On the basis of this report, the ECMS agree that this technology has the potential to improve safe access to milk and milk products in such countries, thus providing important nutrition and health benefits. The ECMS are also reassured by the findings of the report that the LPS should not be used to disguise milk of poor microbiological quality. Similarly, the ECMS see potential for the LPS in facilitating trade in milk and milk products within and between countries which are currently faced with problems in ensuring milk hygiene because of inadequate cold chain systems. The ECMS, however, would caution against any suggestion that the LPS is an acceptable alternative to maintaining milk hygiene through a secure cold chain. Instead, as recommended in the FAO/WHO paper, it must be made clear that LPS should be used only in situations where technical, economical and/or practical reasons do not allow the use of cooling facilities. It is also important that use of LPS should be applied only as part of an integrated programme to improve milk production and quality. In these circumstances, the ECMS would question whether milk processed using this technology should be considered as equivalent to milk produced in the absence of the logistic difficulties that limit the efficiency of the cold chain. In summary, therefore, the ECMS see the LPS as an important and potentially effective instrument in promoting safe milk in (some) developing and least developed countries. It could also serve to promote trade regionally between such countries. Importantly, the ECMS would not want to see it
CX/FH 07/39-CRD 14 3 presented as an equivalent or alternative technology to milk hygiene control systems where the chill chain operates satisfactorily. It appears that new scientific data have been provided by several delegations. It is not up to CCFH in charge of risk management aspects to analyse these data. The ECMS believe these data should be evaluated by the FAO/WHO expert group with a view to possibly amend its report, to be then considered again.
CX/FH 07/39-CRD 14 4 Progress Report on the Joint FAO/WHO Expert Meetings on Microbiological Risk Assessment (JEMRA) and Related Matters (Agenda item 3, CX/FH 07/39/3) Viruses in Food Mixed Competence Member States Vote The ECMS note that the FAO/WHO expert meeting on Viruses in Food took place in the period 21-24 May 2007. This prevented the proposal for new work presented by the Netherlands to be submitted on time in respect of the appropriate procedure (CL 2007/7-FH). The ECMS regret that this procedural hindrance would prevent CCFH to immediately start new work on this issue despite the importance of the subject. Global Initiative for Food-related Scientific Advice The ECMS expressed at several occasions in the recent past concerns related to the resources allocated to the provision of scientific advice by FAO and WHO. The ECMS are therefore pleased to see that initiatives are being taken to ensure sustainable funding of the programmes of FAO and WHO on the provision of scientific advice to the Codex Alimentarius Commission and member countries.
CX/FH 07/39-CRD 14 5 Proposed Draft Code of Hygienic Practice for Powdered Formulae for Infants and Young Children (Agenda item 4, CX/FH 07/39/4) Mixed Competence European Community Vote The European Community and its Member States (ECMS) would like to congratulate Canada and its drafting partners on the significant progress they achieved during the session of the physical working group which took place in Ottawa in the period 4-7 June 2007. From a general point of view, the ECMS support the general content of this revised draft Code but have strong concerns regarding the division of products between the annexes on microbiological criteria and wish to propose a series of comments based on the scientific opinions provided by the European Food Safety Authority (EFSA). Infants are known to be particularly vulnerable to food borne infections. The microbiological safety of products that are specifically manufactured to satisfy their nutritional needs is therefore of the utmost importance. It is in this framework that the EFSA the scientific body of the EC, was asked to provide scientific opinions 1,2 on the microbiological risks of infant formula, their significance to public health and the best control options to reduce these risks along the food chain. The ECMS would like to report two of the main conclusions of these risk assessments: - Salmonella and Enterobacter sakazakii are the microorganisms of greatest concern in infant formula. Contamination of powdered infant formula with E. sakazakii and with Salmonella has been the cause of infection in infants, sometimes with serious after effects or death. Although E. sakazakii has caused illness in all age groups of neonates (up to ca 4-6 weeks of age), preterm or low birth weight infants and those immunocompromised are at greatest risk. The widespread distribution of E. sakazakii suggests that consumption of low numbers in infant formula and followon formula by healthy infants and children does not lead to illness. - Dry foods such as dry soups, dried dairy products, infant formulae, spices, herbs and seasonings are frequently contaminated with Bacillus cereus and other Bacillus species although at different levels. Dehydrated foods (soup, purées, infant formulae) in which presence of spores of pathogenic Bacillus is frequent, might permit growth of B. cereus once re-hydrated in warm water. Some dehydrated foods are consumed by potentially fragile consumers, such as neonates. Fatal cases linked to infant formulae were reported. Therefore, in addition to good practices designed to reduce delay between preparation and consumption, it might be advisable to recommend that numbers of B. cereus spores in such dehydrated foods should be as low as possible. 1 Opinion of the Scientific Panel on Biological Hazards on a request from the Commission related to the microbiological risks in infant formulae and follow-on formulae. The EFSA Journal (2004)113, 1-35 2 Opinion of the Scientific Panel on Biological Hazards on the request from the Commission for review of the opinion on microbiological risks in infant formulae and follow-on formulae with regard to Enterobacteriaceae as indicators, The EFSA Journal (2007) 444, 1-2
CX/FH 07/39-CRD 14 6 Microbiological criteria The ECMS note that the Committee agreed during its last session that "two separate Annexes would be developed that would focus on the specific hygienic practices and microbial criteria for infant formula, formula for special medical purposes for infants, and human milk fortifiers and one on follow-up formula, respectively. 3 " The ECMS note that after lengthy discussion, the mandate of last session of CCFH was not met due to lack of consensus as the proposed Annex I now covers all products intended to infants of less than 12 months including follow-up formula. The ECMS note that several members of the Working Group did not support the decision to include follow-up formulae for infants up to 12 months of age in Annex I. The ECMS do not support the proposed approach as it implies the application of the microbiological criteria of E. sakazakii to follow-up formula which are not intended to be the sole source of nutrition when they are used (i.e. contamination can occur from many different sources). In addition follow-up formula are intended for infants older than 6 months which are not part of the most vulnerable age group. The ECMS are of the opinion that the establishment of a microbiological criterion for E. sakazakii has no strong scientific basis for follow-up formula. The ECMS therefore recommend the deletion of follow-up formula from the scope of Annex I. This category of products should be included in the scope of Annex II The ECMS would like to propose presumptive Bacillus cereus as a process hygiene criterion in addition to Mesophilic Aerobic Bacteria to be included in the microbiological criteria both in Annexes I and II. Product information and consumer awareness (Section IX) The ECMS would like to recall that the present proposed draft Code applies to hygienic practice while specific labelling conditions have already been laid down in the specific Codex standards elaborated by CCNFSDU: - The Codex Standard for Infant Formula and Formulas for Special Medical Purposes intended for infants (adopted by the Codex Alimentarius Commission in July 2007); - The Codex Standard for follow-up formula (Codex STAN 156-1987). This proposed draft code applies to powdered formulae for infants and young children which include infant formulae and follow-up formulae. Statements which should only apply to infant formula are often made in this proposed draft code for both infant formulae and follow-up formulae. The ECMS believe that this Code is not the correct place to specify labelling requirements, which are within the scope of the labelling provisions in the specific Codex standards. In particular, negative statements such as "may contain pathogenic microorganisms", "powdered formulae are not sterile", "failure to follow manufacturers' instructions may cause serious illness", were extensively discussed at CCNFSDU level and were not supported. The rationale is that a 3 ALINORM 07/30/13 paragraph 156
CX/FH 07/39-CRD 14 7 negative labelling on infant formula and follow-up formula could be misinterpreted by consumers and encourage the use of other products without this warning that are not specially adapted instead of using the specially manufactured powdered formula. The ECMS consider that the recommendation "industry and national governments should be encouraged to validate the label to ensure that the intended messages are understood" has no place in a hygiene code. Labelling issues are already covered under the specific Codex standards as mentioned above. Some specifications are going beyond the Codex Standard for infant formula and follow-up formula by mentioning specific details which might not always be appropriate depending on the product. The ECMS suggest using the same wording as in the specific Codex Standards such as "the label shall carry clear graphic instructions illustrating the method of preparation" or "the directions shall carry clear graphic instructions illustrating the method of preparation of the product".
CX/FH 07/39-CRD 14 8 Annex: Proposed amendments to the text Amendments Justification 2.2 USE Where applicable, this document should be used in combination with the International Code of Marketing of Breast Milk Substitutes, relevant WHA resolutions and the WHO Global Strategy for Infants and Young Child Feeding. SECTION IX PRODUCT INFORMATION AND CONSUMER AWARENESS All health care professionals and caregivers should be informed that and that the use of it is important to follow Good Hygienic Practices during reconstitution, handling, and feeding, including appropriate storage is essential.this is to minimize the risk of foodborne illness, primarily due to E. sakazakii and Salmonella. Clear instructions for the appropriate preparation, handling and use of PF should be conveyed to the final user. This statement is already present in the Codex Standard for Infant Formulae and is not relevant for all the products covered by this Code, e.g. follow-up formulae. The ECMS believe that negative statements such as "powdered formulae are not sterile" may lead to misinterpretation and encourage the use of other products without this warning. Text is missing in the proposed draft. 9.3 LABELLING Where applicable, labelling provisions should also take into account the recommendations of the International Code of Marketing of Breast-Milk Substitutes (1981). Where literacy is low, pictograms may be useful. The label should carry clear graphic instructions illustrating the method of preparation. The label should include information to make clear the potential risks of inappropriate preparation, handling and use because powdered formula is not sterile, e.g., that PF is not sterile and because that This statement is already present in the Codex Standard for infant formula but is not applicable to all products covered by this Code. The ECMS therefore suggest to delete it. The ECMS recommend using the same wording as in the specific existing Codex standards. The ECMS do not support negative warning labelling statements which might mislead the consumers, a high level of
CX/FH 07/39-CRD 14 9 failure to follow manufacturers instructions may cause serious illness. Industry and national governments should be encouraged to validate the label cooperate in order to ensure that the intended messages are understood by all potential users. When considering the wording of such information, consideration should also be given to any potential risk of caregivers being inadvertently encouraged to use inappropriate alternatives to powdered infant formulae (e.g., milk powder). ANNEX I MICROBIOLOGICAL CRITERIA FOR POWDERED INFANT FORMULA, FOLLOW- UP FORMULA UP TO 12 MONTHS, INFANT FORMULA FOR SPECIAL MEDICAL PURPOSES AND HUMAN MILK FORTIFIERS confusion and might lead to panic responses. Respect of legislation regarding the information put on the labelling should be the primary responsibility of the industry. The ECMS do not support the implementation of a validation process for every label which would lead to administrative burden ("pre-market approval"). Follow-up formulae should be excluded from the scope of Annex I as there is no scientific justification to apply a criterion on E. sakazakii for this type of products. Presumptive Bacillus cereus n=5, c=1, m=50 cfu/g, M=500cfu/g, class plan=3 The methods to be employed for Presumptive Bacillus cereus should be the most recent editions of ISO 7932. ANNEX II MICROBIOLOGICAL CRITERIA FOR POWDERED FOLLOW-UP FORMULA FOR INFANTS AND YOUNG CHILDREN AND FORMULA FOR SPECIAL MEDICAL PURPOSES FOR YOUNG CHILDREN The ECMS suggest to exclude follow-up formula intended for infants from the scope of Annex I, and therefore these products should be added in the scope of Annex II, where this should be clearly stated. Presumptive Bacillus cereus n=5, c=1, m=50 cfu/g, M=500cfu/g, class plan=3 The methods to be employed for Presumptive Bacillus cereus should be the most recent editions of ISO 7932.