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CONSIDERATION OF PROPOSED DRAFT GENERAL STANDARD FOR BOTTLED/PACKAGED WATERS OTHER THAN NATURAL MINERAL WATERS AT STEP 4 (Agenda Item 3)[3]

5. The Committee recalled that during the consideration of the Draft Standard for Natural Mineral Waters at its Fifth Session in October 1996, the Committee had recognized that bottled or otherwise packaged waters were internationally traded in volumes and therefore these products should be covered by an international standard. The Swiss Secretariat, after having several informal working group meetings, had prepared the Proposed Draft General Standard for consideration by the current Session of the Committee.

6. The Delegation of Canada emphasized that the objectives of the Codex Alimentarius Commission be kept in mind; namely, to protect the health of consumers and to ensure fair practices in food trade; and that the elaboration of health and safety aspects of Codex standards should be based on science-based objective criteria. Potential difficulties were recognized in the development of a standard that needed to reflect consumers expectations and perceptions and traditions that are different in various countries or regions. The Delegation proposed that in order to facilitate discussion and to avoid premature argumentation, the Committee should agree on the structure and hierarchy of the Standard and start with general broad aspects of the products covered and then proceed toward the more detailed aspects. The proposed approach was supported by the Committee. Several delegations also stated that the Proposed Draft Standard as currently drafted was overly prescriptive and required more flexibility and simplification.

SCOPE

7. The Committee generally agreed that the Scope of the Standard should be broadened to allow for flexibility. The Delegation of Canada offered a new text for discussion. The Committee agreed to amend the proposed text by making a specific reference to “natural mineral waters” for clarification. The Committee had a brief discussion on the need for a reference to the use of packaged waters as ingredients. It was noted that the Standard under discussion was being elaborated for packaged waters but not for “water as an ingredient” or “potable water”. The Committee decided not to include any reference to the use as ingredients as it was felt unnecessary. The Committee agreed to replace the original text of the Scope with the following:

This Standard applies to all waters other than natural mineral waters defined in Codex Standard 108-1981 (Rev 1-1997), that are filled into containers and are suitable for human consumption.
DESCRIPTION

8. The Committee had an extensive discussion on the structure and hierarchy of the Standard, especially on the categories of packaged waters to be included in it. The Committee supported the idea of establishing hierarchy of the products covered by the Standard. It generally agreed that there should be a generic definition that would cover all packaged waters on the market. However, the Committee had a lengthy discussions on whether the number of categories should be three, ground waters, surface waters and processed/treated waters; or two, ground waters and surface waters with subcategories, processed and non-processed waters. An informal working group, formed specifically to consider this issue, proposed to the plenary to develop two categories of waters under the generic definition of Packaged Waters, namely, Waters defined by origin which includes Ground waters and Surface waters, and Prepared waters. The Committee accepted this proposal and decided to place “Waters defined by origin” in square bracket for comments on an appropriate term and development of its definition.

9. Several delegations stated that the original Proposed Draft Standard included too many definitions and some definitions were too detailed. While it was requested that simplification and flexibility of the definitions were necessary, it was stated that they should be clear enough for consumers to distinguish between various types of packaged waters.

Packaged Waters

10. The Committee considered a generic definition for packaged waters based on a proposal by the Delegation of Canada. The Committee agreed to insert the term “other than natural mineral waters” after “packaged waters” for clarify that natural mineral waters covered under the Codex Standard were outside of the scope of this Standard (see also para. 7).

11. The Committee also had an exchange of views on the addition of minerals for the purpose of changing the flavour. It was stated that it could be understood that if the addition of flavours was not permitted, minerals added to change the flavour of the water were not allowed either. It was noted that in certain developing countries, minerals were added as nutritional supplements and this possibility should not be excluded. It was pointed out that flavouring substances had been well defined within the Codex and they did not include minerals and therefore addition of minerals for flavouring would not be excluded.

12. With an editorial amendment, the Committee agreed to include the following wording as the generic definition of “Packaged waters”:

Packaged waters, other than natural mineral waters, are waters for human consumption and may contain minerals, naturally occurring or intentionally added; may contain carbon dioxide, naturally occurring or intentionally added; but shall not contain added sugars, sweeteners, flavourings or other foods.
The Committee noted that other than packaged waters terms could be addressed in the labelling section.

Ground Waters

Artesian Water

13. The Committee decided to delete the Artesian well water from the heading of the definition in section 2.1.1.1 (a) Artesian water in view of difficulties of interpretation especially in Portuguese speaking countries. The designation of this type of products should be considered for different languages and countries under the labelling provision. For example, the following sentence was proposed for future consideration for inclusion in the labelling provision:

Artesian water may also be labelled with other names, such as artesian well water, as allowed by national legislation.
14. The Committee also agreed to delete the second sentence from this definition as the first sentence sufficiently defined the product.

Spring water

15. The Committee had an extensive debate on the definition of spring water. Many delegations were opposed to the current text of the definition as being too restrictive and based on geological emergence and did not correspond to the definition currently used in other parts of the world. It was pointed out that the current definition covered only waters which flow naturally to the surface of the earth only by a natural force but in addition to natural force for emergence, collection of water by boring should also be permitted. The Delegation of the USA stated that the definition should be scientifically justified. In view of controversial opinions on this issue, especially on the geological definition vs. cultural and commercial definition, the Committee decided to include in the Standard the proposal of Canada, as an alternative, and to place both texts in square brackets for comments.

16. The Committee decided to delete the word “only” after the word “collected in the second sentence of the first paragraph of the original definition.

Surface Waters

Glacial Waters

17. The Committee first decided to retain the definition since packaged glacial waters were being traded internationally. Then, the Committee agreed to replace the current definition with the following text, based on the proposal of the United States, to ensure that glacial water was derived from glacier ice and would not contain any non-glacial waters:

Glacial (glacier) water is (1) the runoff directly from the natural melting of ice of a glacier; or (2) water obtained from the melting of glacier ice at a bottled water operation.
The above text was placed in square brackets.

Prepared Waters

18. The Committee considered the wording of the definition of prepared waters on the basis of the proposal of the Delegation of Canada. The Committee agreed to clarify the outcome of the alteration by replacing the term “they have lost connection with the defined origin” with “their composition is no longer characteristics of the defined origins”. The Delegation of the United States proposed to delete the second sentence as the scope of the Standard already referred to waters suitable for human consumption; the passing through community water supply would not necessarily change the composition of the water; and there were waters fit for human consumption before treatments. The Committee agreed to place the following generic definition for Prepared Waters in square brackets:

Prepared waters are waters that have been substantially altered so that their composition is no longer characteristics of the defined origins. They have been rendered fit for human consumption or have passed through community water supply or have had the composition significantly changed.
19. The Committee had some discussions on the need for the definitions of Purified/Demineralized water (including deionized water, distilled water and reverse osmosis water) and Sterile/Sterilized water. Some delegations expressed the concern that the use of terms such as Purified water would mislead the consumer. A number of delegations stated that these waters were not intended for human consumption and therefore questioned the usefulness and legitimacy of their inclusion in the Standard. However, it was stated that these products were sold for human consumption in many countries. The Committee agreed to delete these definitions as these products would be covered by the definition of prepared waters; designation of these products could be addressed in the labelling provision; and these product names were self-explanatory.

Water with added minerals, mineralized water or mineralized table water

20. The Committee discussed on the appropriate term(s) to be used as the name of the products. Although it was generally agreed that the name should be selected so as not to cause confusions among consumers, several delegations stated that the term “mineralized water” or “mineralized table water” more properly reflected the characteristics of the products while a number of others preferred “water with added minerals” as less confusing. Many delegations stated that the matter was rather on the designation than definition of the product and therefore could possibly dealt with in the labelling provision. The Committee agreed to maintain the definition in this section as it includes a reference to the Codex General Standard for Food Additives and to clarify it as follows:

Water with added minerals, mineralized water or mineralized table water is prepared water with minerals added according to the provisions in the Codex General Standard for Food Additives (CODEX STAN 192-1995, Rev. 1-1997).
The Committee also decided to amend the heading of the definition by adding Mineralized water or mineralized table water and place it in square brackets.

21. The Committee noted that the concern of the Delegation of United Arab Emirates as regards desalination and subsequent salts addition to the seawater was already addressed in Section 2.1.2 “Prepared waters”.

Mineral Water

22. The Committee had an extensive debate on a possibility of including of a new definition of Mineral Water in the Proposed Draft Standard. Several delegations stressed the need and strongly asserted the inclusion of this definition stating that there were waters with similar characteristics as those of natural mineral waters but they did not fall under “natural mineral waters” as defined in the Standard for Natural Mineral Waters due to the practice of disinfection and/or transportation, and therefore excluded from marketing as “natural mineral water”. The Delegation of Japan stated that mineral content was the most important criterion for quality of water and therefore the Proposed Draft Standard should include the definition for Mineral Waters. The Delegation of Japan supported by several delegations proposed the wording for the definition of Mineral Water as follows:

Mineral water is water derived from an approved water supply, tapped at one or more bore holes or springs, protected from contamination and containing the total dissolved solids (TDS) of such contents as are recognized satisfactory as mineral water in each country. The level and relative proportions of minerals and trace elements contained in mineral water have the consistency, though there are a certain range of natural fluctuations, which is specific to the source.
23. The Delegation of France supported by many other delegations and the Observer from EC argued that the inclusion of this term would lead to the confusion of consumers as the term “Mineral Water” was very similar to the term Natural Mineral Water and strongly opposed to the inclusion of this new definition in the Proposed Draft Standard. It was stated that either this type of water was named as Spring Water or the proposed definition could be added to that of Spring Water.

24. Due to divergent opinions, the Committee did not reach consensus on the inclusion of a definition in the Proposed Draft Standard. As a compromise, the Committee agreed to include the term Mineral water in square brackets in the Proposed Draft Standard without the text on definition. It was further agreed that by way of a Codex Circular Letter, comments would be invited from governments and international organizations on a need for such a definition and on the text of the above definition.

Supplementary definitions

25. Committee decided to delete the definitions of Approved water supply, Water distribution system and Establishment as they were either unnecessary or already addressed in the Draft Code of Hygienic practice for Bottled/Packaged Drinking Waters (Other Than Natural Mineral Waters).

26. On the request to include the definition on Commercial sterility, the Committee agreed that it would more properly developed by the Codex Committee on Food Hygiene within the framework of the Code of Hygienic Practice and therefore decided to forward the following text to that Committee for consideration for inclusion in the Code.

“Commercial Sterility means the condition achieved by the application of appropriate treatment to render the bottled water free from microorganisms capable of growing in the product at normal non-refrigerated conditions at which the product is likely to be held during distribution and storage and free of viable microorganisms (including spores) of public health significance. The absence of viable microorganisms shall be determined with appropriate microbiological tests.”
ESSENTIAL COMPOSITION AND QUALITY FACTORS

Treatment and Handling

Collection of Ground Waters

27. The Committee agreed to replace the term “underground” with “ground” to be consistent with the heading of section 2.1.1.1, Ground water. The Committee also agreed to (1) keep the term “well water” as it is one of the defined terms in Section 2; and (2) insert the term “such” after “ground water” to indicate that the products followed were examples and it was not meant to contain an exhaustive list of products.

Transportation

28. The Committee recognized that the provision, except for the first sentence, referred to hygiene. As hygienic aspects of the products covered under the standard would be dealt with in the Code of Hygienic Practice for Bottled/Packaged Drinking Waters (Other than Natural Mineral Water), the Committee agreed to delete the second sentence and to retain the first and third sentence, that refers to the above Code.

Forms of Treatment

29. The Committee noted that these treatments specified in this provision were optional but not mandatory. On the need for detailed description of the types of treatments and waters that could be treated, the Committee generally agreed that it was premature to get in detail pending decisions on Section 2.1 Definitions. In response to the concerns that a treatment which alters significantly the characteristics of water defined by origin should not be applied to this kind of water, the Committee agreed to add the following sentence at the end of the first paragraph for clarification:

“Any anti-microbial treatments applied to waters defined by origin (Section 2.1.1) shall not significantly alter the composition of the water in so far as this relates to the characteristics of its origin.”
30. The Committee replaced the term “underground” with “ground” as in the provision for collection of ground waters.

Health related limits for certain substances

31. The Committee agreed to change the current maximum value for lead from 0.005mg/l to 0.01mg/l, that is in line with the current WHO Guideline value and the maximum level for natural mineral water.

32. The Committee agreed that the Health-Related limits be referred to the Codex Committee on Food Additives and Contaminants for consideration. It was noted that several delegations favored alignment of the levels to those being considered for Natural Mineral Waters.

33. The WHO Representative noted that the Draft Code of Hygienic Practice for Bottled (Packaged) Drinking Waters (other than Natural Mineral Waters) proposed that the chemical and physical safety criteria to be used for packaged water be those issued by WHO in its Guidelines for Drinking Water Quality[4] and pointed out that the proposed levels for arsenic, borate manganese and selenium presented in the Proposed Draft Standard substantially exceeded WHO guideline values and may present a public health concern. On the other hand the proposed value for nitrate was lower than WHO guideline value. Consistent with WHO’s precautionary policy regarding human exposure to food additives and contaminants, WHO would support the establishment of lower levels which would be feasible by the industry.

34. The WHO Representative emphasized that the primary aim of the WHO guidelines was the protection of public health and to serve as a basis for the development of national regulations that, if properly implemented, would ensure the safety of drinking water supplies through elimination or reduction to a minimum concentration, of constituents of water that was shown to be hazardous to health. The WHO Representative emphasized that the guideline values recommended were not mandatory limits. In order to define such limits it was necessary to consider the guideline values in the context of national conditions.

35. The Committee recognized that the WHO guidelines were intended to apply primarily to public drinking water supply.

HYGIENE

36. The Committee agreed to align the wording of Subsections 4.1-4.2 to the new standard text[5] recommended by the Codex Committee on Food Hygiene to the Codex Alimentarius Commission for adoption.

37. In relation to the request to include microbiological requirements, the Committee was informed that microbiological criteria had been elaborated by the Codex Committee on Food Hygiene to be included in Appendix II of the Draft Code of Hygienic Practice for Bottled/Packaged Drinking Waters (Other than Natural Mineral Water) and that after the completion of the Code, that Committee would review the current Code of Hygienic Practice for the Collecting, Processing and Marketing of Natural Mineral Waters. It was also noted that microbiological criteria normally were included in Codes of Hygienic Practice rather than in standards. The Committee decided that microbiological criteria be developed by the Committee on Food Hygiene and in the future the standard and the code for natural mineral waters should be consistent with other standards on this subject.

Approval of the waters defined by origin

38. The Committee discussed whether this section was necessary because of the Draft Code of Hygienic Practice for Bottled/Packaged Drinking Waters (Other Than Natural Mineral Waters) being developed by the Codex Committee on Food Hygiene. Several delegations pointed out that because some waters were defined by origin therefore an approval of water origin was needed. The Delegation of France stated that the approval of the water’s origin should include all the elements to guarantee the identity and safety of the waters defined according to their origin. The Committee agreed to amend the heading of the section to read Approval of the waters defined by origin and that the safety matters would be dealt with by the Codex Committee on Food Hygiene. However, the Committee decided to put section 4.3 within square brackets as it was felt premature to make a decision pending a conclusion on a definition of “Waters defined by origin”.

39. The Representative of WHO noted that the WHO microbiological guideline levels apply to bottled water intended for human consumption but not to natural mineral waters and were being revised to include process specifications, such as treatment and protection of source. He also noted that, at the request of the Codex Alimentarius Commission, WHO and FAO were in the process of convening an expert consultation on the microbiological risk assessment.

Packaging

40. The Committee decided to delete the second paragraph of the Section as it felt that the first paragraph sufficiently covered the necessary requirements and as the Codex Standard for Natural Mineral Waters did not contain this paragraph.

LABELLING

41. The Committee agreed to place Sections 6.1-6.3 in square brackets in view of the new structure of Section 2 Description and many product definitions placed in square brackets. The Committee confirmed that it would consider at its next Session a number of issues, such as the designation of “artesian well water”, “deionized water”, “demineralized water”, etc., which the Committee decided to discuss under the section of labelling (see paras 13 and 19).

METHODS OF ANALYSIS AND SAMPLING

42. The Committee noted that at the last session it could not review the methods of analysis and sampling provision of the Standard for Natural Mineral Waters and that one ISO Standard[6] endorsed for determination of Pseudomonas aeruginosa had been revoked by ISO. It might be necessary to consider for updating the provision in that standard at the same time as the development of the provision of methods of analysis and sampling in the Standard for Packaged (Bottled) Waters Other Than Natural Mineral Waters.

Status of the Proposed Draft General Standard for Packaged (Bottled) Waters Other Than Natural Mineral Waters

43. As many important issues in the text required further consideration, the Committee agreed to return the Proposed Draft Standard to Step 3 of the Procedure for comments. The amended text is attached to this Report as Appendix II.


[3] CX/NMW 98/2, CX/NMW 98/2-Add.1 (Comments from Australia, Czech Republic, Canada, Denmark, France, Hungary, Italy, Japan, Norway, USA, International Bottled Water Council (IBWA), International Soft Drink Council (ISDC), Groupement International des Sources d’Eaux Minerales Naturelles et des Eaux de Source (UNESEM-GISEMES), CRD 1 (Comments from Republic of South Africa), CRD 2 (Comments from Thailand), CRD 3 (Comments from Switzerland), CRD 4 (Comments from Canada), CRD 5 (Comments from Spain), CRD 6 (Comments from Cuba).
[4] Guidelines for Drinking Water Quality-Recommendations, Volume 1 (1993), and Addendum to vol. 1 (1998), World Health Organization, Geneva.
[5] ALINORM 99/13, Appendix VI.
[6] ISO 8360-2:1988.

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