Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Law Summary Any food or food additive for which compositional specifications or standards are established and specified in the Ministry of Health, Labour and Welfare Notification (Ministry of Health and Welfare Notification No. 370, 1959; hereinafter referred as “the Notification”) based on Article 11 of the Food Sanitation Act of Japan shall not be used or marketed unless it meets the standards or specifications. In the Notification, non-alcoholic beverages are classified into four categories as follows: 1) mineral waters (non-alcoholic beverages consisting of only water), 2) frozen fruit beverages, 3) fruit juices for ingredients, and 4) beverages other than those mentioned from 1) to 3) above. Compositional specifications and standards are established for each individual category. The existing standards for raw water for mineral waters were established based on the Codex standards for natural mineral waters (European Regional Standards) at the time in 1994. These standards are demonstrated as standards for manufacturing of non-alcoholic beverages under the title of “Non-alcoholic Beverages” in “D Monographs” of “Part 1 Food” stipulated in the Notification. On the other hand, the existing standards for raw water for beverages falling under 4) above—beverages other than mineral waters, frozen fruit juices, and fruit juices for ingredients—were established based on the “water quality standards” under the Waterworks Act of Japan at the time in 1993. These standards also are shown as standards for manufacturing of non-alcoholic beverages under the same title in the same Notification. In response to the latest Codex standards for natural mineral waters and the revision of water quality standards based on the Waterworks Act, Japan decided to divide the group of “mineral waters” into the following two categories: A) mineral waters for which the spring source is hygienically controlled and the source water does not require sterilization or bacteria elimination and B) mineral waters for which the source water requires sterilization or bacteria elimination. The category A is based on Codex standards for natural mineral waters and B is based on the water quality standards based on the present Waterworks Act. The section below outlines the amendment. Outline of the Amendment 1. The existing standards for the raw water for mineral waters will be deleted. The category “mineral waters” is to be divided into two categories: “mineral waters (non-sterilized or non-bacteria elimination)” and “mineral waters (sterilized or bacteria elimination)”. For each category, compositional specifications for finished product will be newly established (see Attachments 1 and 2). In addition, for the category “mineral waters (non-sterilized or non-bacteria elimination),” standards on hygiene management of spring sources will be newly established as standards for manufacturing (see Attachment 3). 2. The existing standards for raw water (potable water) for beverages falling under the category 4) mentioned in the summery above will be revised. More specifically, new requirements for water used as an ingredient will be set as “water used as an ingredient shall meet the compositional standards for one of the following three water categories: i) tap water as stipulated in the Waterworks Act, ii) mineral waters (non-sterilized or non-bacteria elimination), and iii) mineral waters (sterilized or bacteria elimination).” 3. The existing compositional specifications for cadmium for both non-alcoholic beverages and powdered non-alcoholic beverages will be deleted. 4. The existing compositional specifications for tin for both non-alcoholic beverages and powdered non-alcoholic beverages will be applied only to canned products. Note: When used as an ingredient of other non-alcoholic beverages, the existing specifications for iron and hardness will be continuously applied even after the amendment becomes effective. Iron: Not more than 0.3 mg/L Hardness (minerals including calcium and magnesium): Not more than 300 mg(as Ca and Mg)/L Note: When used as an ingredient of other non-alcoholic beverages, the existing specifications for iron and hardness will be continuously applied even after the amendment becomes effective. Iron: Not more than 0.3 mg/L Hardness (minerals including calcium and magnesium): Not more than 300 mg(as Ca and Mg)/L Attachment 3 Standards for manufacturing of mineral waters (non-sterilized or non-filter sterilized) —Standards concerning hygiene management of spring sources — a. Source water shall be only mineral water that is collected directly from natural or drilled sources from underground water bearing strata for which all possible precautions should be taken to ensure its hygiene, including the protection of the environment of the spring source and the place of water collection. b. Source water shall be constant in its composition and stable of its discharge and its temperature. c. Source water shall not contain any anthropogenic environmental pollutant. This requirement, however, does not apply to cases in which compositional specifications for the water are established. d. Source water shall be free from pathogenic microorganisms and shall not contain organisms or substances that cause a suspicion that it was contaminated by pathogenic microorganisms. e. Source water shall test negative for spore-forming sulphite-reducing anaerobes, fecal streptococci, pseudomonas aeruginosa, and coliform bacteria, and its bacterial count shall be not more than 5/ml. f. Source water shall be directly collected from sources, automatically filled in airtight containersor tightly sealed containers. g. Source water shall not be treated by any treatment other than precipitation, filtration, aeration, carbonation, or deaeration. h. The facilities and equipment used in the process from the collection of the source water through packing shall be kept clean and hygienic so as to exclude any possibility of the contamination of source water. i. The whole operation from collection of the source water through filling shall be done in a clean and hygienic manner. j. The bacterial count of the finished product immediately after filling shall be not more than 20/ml. k. The records on the matters related to microorganisms stated in e. and j. above shall be retained for six months. .