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Draft Code of Hygienic Practice for Packaged/Bottled Drinking Waters (Other Than Natural Mineral Waters) (Agenda Item 3)[6]

21. The Delegation of the United States presented the revised version of the Draft Code, which had been redrafted in the light of the discussions of the last session and the comments received. The Committee considered the Draft Code section by section and made the following amendments.

22. The Committee recalled that the Committee on Natural Mineral Waters while considering the Proposed Draft Standard for Packaged (Bottled) Waters other than natural Mineral Waters could not come to a conclusion on the need for a definition of commercial sterility and had forwarded it to the CCFH for consideration in the framework of the Code. The Committee discussed the opportunity of including a definition of commercial sterility in the Code. The Delegation of Uruguay expressed the opinion that the definition of commercial sterility should not be included in the Code since bottled waters when they meet stringent microbiological criteria were suitable for all consumers. Several delegations pointed out that the definition referred to a term which was not used in the text of the code and therefore no definition was needed.

23. The Observer from CSPI expressed the view that the definition should be included to address the specific use of bottled waters for infant formula. The Delegation of Brazil supported this view and stressed the importance of other high risk groups such as the immunocompromised. The Committee agreed not to include the definition in the Code.

Section 1. Introduction

24. The Committee recalled that the labelling section had been deleted and that some provisions related to consumer information had been included in the Introduction. After an exchange of views on the need to transfer some parts of the text to Section 5. Control of Operations, the Committee agreed to retain the current structure of the section and to clarify some of its provisions. A reference to contamination by viruses was added in the sentence on parasitic protozoa. The Observer from Consumers International stressed the importance of providing information on the public health significance of protozoa and the Committee agreed to specify that “these pathogens are difficult to detect and bacterial indicators of their potential presence are not always reliable” and therefore information on control measures the water has received can be useful to consumers.

25. The Committee recognized the need to provide information, when necessary, on the use of bottled waters to reconstitute infant formula and reworded the last sentence accordingly for clarification purposes.

Section 2.1 Scope

26. Some delegations considered it inappropriate to include a specific reference to “mineral waters” (other than natural mineral waters) since these had not yet been defined by the CCNMW. After an exchange of views, the Committee agreed to refer to “all bottled/packaged drinking waters other than natural mineral waters” as this clearly reflected the scope of the Code.

Section 2.3 Definitions

27. The Committee agreed to delete the definition of “food hygiene” as it was already defined in the General Principles of Food Hygiene. The Committee also noted that the definition of bottled waters was different from the Proposed Draft Standard.

Section 3. Primary Production

28. The Committee agreed that reference should be made to microbiological safety, as it was more appropriate than “quality”. In section 3.1.1 the first sentence was slightly reworded for clarification purposes.

Section 3.1 Environmental Hygiene

29. The Committee agreed that testing for radiological characteristics should be carried out where necessary, and that the frequency of testing was also determined by the amount of water collected.

Section 3.2 Hygienic Production of Water Supplies

Section 3.2.1.1 Consideration for Ground Water Supplies

30. The Committee agreed that when contamination was detected, production should cease until the characteristics of the water returned to established parameters. The Delegation of India proposed to delete the reference to approval of the underground supply by an official authority or a third party as this should be left to member countries and the Code should focus on the measures intended to ensure the safety of bottled waters. The Committee agreed to retain the current wording.

Section 3.3 Handling, Storage and Transport of Water

31. The Committee agreed to the following amendments: 1) in Section 3.3.1.3, to specify that wells should be properly disinfected; and 2) in Section 3.3.2 to delete the reference to piping as a “preferred” means of avoiding contamination from bulk transport

32. In section 3.3.2.2 Use and Maintenance, the Delegation of Uruguay proposed that dedicated transport should be required, and that the use of other food containers should not be allowed for other transport. The Committee had an exchange of views on this question and agreed to retain the provisions of the current text. Some editorial amendments were made to the section for clarification purposes.

Section 4.4 Facilities

Section 4.4.1 Water supply not intended for bottling

33. The Committee agreed that water not intended for bottling should be potable if it was expected to come into direct or indirect contact with water intended for bottling, especially if used for cleaning and disinfection of surfaces which came in contact with bottled water; and otherwise it might be non-potable. The section was rearranged accordingly for clarification purposes.

Section 5. Establishment: Control of Operation

34. The reference to Section 5.1 Control of Food Hazards was deleted as this was already covered in the General Principles of Food Hygiene. The Committee recognized the need to address specific issues related to contaminants and agreed to include an introductory paragraph concerning the need for control measures to ensure the safety and suitability of waters, to be included in a new Section 5.2 (replacing Section 5.1.1 Control measures for waters intended for bottling).

Section 5.2 Key Aspects of Hygiene Control

35. The Committee agreed to delete the reference to “quality” where applicable and to indicate that water should be “safe and suitable for consumption” after treatment. After an extensive exchange of views the Committee agreed to retain the sentence on the relationship between water quality and the treatment required to obtain safe bottled water.

36. The Committee agreed to reword the paragraph on hazard analysis as proposed by the Observer from the EC and to retain the sentence concerning the need for treatment of waters from different supplies.

37. The Committee discussed a proposal from the Delegation of Denmark concerning the use of water treatment agents at levels which would have the technological function of a preservative rather than a disinfectant. The Committee recalled that the levels of food additives such as preservatives were defined in commodity standards or in the General Standard for Food Additives. The Committee agreed to add a reference to “residues of chemical treatment” in the last sentence of the section, which stressed the need to avoid any type of contamination in relation to water treatment. The Delegation of Thailand expressed the view that no reference should be made to preservatives as this might encourage their use in bottled waters.

Section 5.4 Packaging

38. The Committee agreed that for general packaging requirements, reference should be made to the General Principles of Food Hygiene, and that the sections should be renumbered to reflect that the issues addressed were distinct.

Section 5.4.1 Washing and Disinfecting of Containers

39. The reference to “sanitizing” was replaced with “disinfection” for consistency with the corresponding sections of the General Principles. It was agreed that “reused and when necessary other containers” were covered in the section, and that washing should take place in an “appropriate system” as it was not necessary to require a closed system.

Section 5.4.2 Filling and Sealing of Containers

40. The Committee agreed that the requirement for “positive air pressure” in an enclosed area was not necessary and replaced the reference to “excessive moisture” with condensation for clarification purposes, as proposed by the Delegation of Thailand.

Section 5.4.3 Product Containers and Closures

41. The Committee agreed to take out the first sentence on non-toxic containers as this general requirement was covered by the General Principles of Food Hygiene. It was also agreed that new containers should be cleaned and disinfected if necessary after inspection.

Section 5.4.4 Use of Closures

42. The Committee agreed that closures should be tamper-resistant, as proposed by the Delegation of Uruguay.

Section 9. Product Information and Consumer Awareness

43. The Committee added a reference to the text in the Introduction on consumer information.

Appendix 1 HACCP System and Guidelines for its Application

44. The Committee agreed to delete this Appendix as reference should be made to the Annex to the General Principles of Food Hygiene.

Appendix 2 Microbiological, Chemical and Physical Criteria

45. The Delegation of India expressed the view that end-product specifications should not be included in codes of practice but in standards. The Committee however recalled that the General Principles included a reference to microbiological and other specifications (Section 5.2.3) and that some of the current codes included such specifications.

46. The Observer from the EC, referring to its written comments, proposed to include microbiological criteria for Enterococci, P.aeruginosa and colony count at 22° and 37° and to refer to E.coli in 250 ml (instead of 100ml) as bottled water and tap water were different. The Delegation of Austria strongly supported the proposal of the EC and pointed out the importance of reference to indicator bacteria. The Delegation of Uruguay, supported by other delegations, proposed to include the criteria which were specified in the Code of Hygienic Practice for Natural Mineral Waters. The Delegation of the United States stressed the need to review the additional criteria on the basis of Codex Principles and Guidelines for the Establishment and Application of Microbiological Criteria for Foods, and expressed the view that while E.coli was a safety indicator, the other criteria proposed were more related to quality than to safety.

47. The Committee could not come to a conclusion on the inclusion of other criteria and agreed to retain only the reference to Principles and Guidelines for the Establishment and Application of Microbiological Criteria for Foods (CAC/GL 21-1997) and to the WHO Guidelines (which included the reference to E.coli in 100 ml), with the understanding that the inclusion of additional criteria would be considered further in the future.

48. The Observer from Consumers International pointed out that the current limit for lead in the WHO Guidelines was too high and did not adequately protect children. The Committee agreed that the criteria for chemical and physical safety included in the WHO Guidelines should be followed and included the relevant reference in the Appendix.

49. The reference to the Proposed Draft Standard for Bottled/Packaged Waters other than Natural Mineral Waters was deleted as quality criteria were not within the scope of the Code.

Status of the Draft Code of Hygienic Practice for Bottled/Packaged Drinking Waters (other than Natural Mineral Waters)

50. The Committee agreed to advance the Draft Code to Step 8 for adoption by the 24th Session of the Commission (see Appendix II of this report).


[6] CL 1999/9-FH, CX/FH 99/3 (Comments of Belgium, Brazil, Costa Rica, Denmark, Finland, Indonesia, Mexico, Japan, Paraguay, Peru, Poland, South Africa, United Kingdom, United States, ISDC, Consumers International, UNESEM-GISEMES), CRD 4 (Comments of Italy, Spain) CRD 9 (Comments of European Community)

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