Guidelines for Antimicrobial Products Activities for establishing new rules English Version Contents: Chapter 1 Guidelines for activities to establish voluntary rules for products with new functions 1. Purpose of the guidelines 2. Consumers' needs and the necessity for new functions 3. Definition of "antimicrobial" 4. Information to be provided 5. Marking on antimicrobial products 6. Testing methods of antimicrobial products 7. Activities of companies dealing with antimicrobial products 8. Activities for helping consumers to have a proper understanding of antimicrobial products 9. Relationship with general consumer legislation and fair business rules Chapter 2 Measures to make the guidelines effective 1. Prompt establishment of voluntary rules by industry groups concerned 2. Necessity of standardizing testing method 3. System of third-party testing bodies Conference members * The guidelines for antimicrobial products were established as the first report of the Meeting on Life-Related Processed Products with New Functions of the Consumer Goods and Service Industries Bureau, the Ministry of International Trade and Industry in March 1999. This is the English version of the guidelines. Compiled by the Manufacturing Industries Bureau, the Ministry of Economy, Trade and Industry (October 28, 2002)
Chapter 1 Guidelines for activities to establish voluntary rules for products with new functions 1. Purpose of the guidelines These guidelines provide basic principles for voluntary activities of the parties concerned with a view to fostering sound markets for products with new function, by helping consumers to have a correct understanding through the appropriate provision of information by companies. These guidelines provide basic general guiding principles for voluntary activities required for the parties concerned in order to foster sound markets for products with new functions, which are expected to emerge successively, by helping consumers to correctly understand the new functions of the products and select them with confidence through the proper provision of information by companies under transparent and objective standards. 2. Consumers' needs and the necessity for new functions In order to foster and develop sound markets for products with new functions, it is necessary that, in consideration of consumers' needs and environmental effects, circumstances should be created whereby consumers can select products with confidence and with a proper understanding of the new functions. Products with new functions should be developed and supplied through free competitive markets based on creative and voluntary activity by each company, provided, however that they not violate laws or regulations. In order to foster and develop markets for such products, however, it is necessary that they provide new utilities based on consumers' needs. Also, each company should produce and sell such products giving due consideration to their environmental effects and to consumers who have no need for such functions. In addition, consumers should judge correctly whether such new functions are actually necessary for their lives, considering the environmental effects, before they decide to buy such products. In the following sections, guidelines are proposed for "antimicrobial products", whose markets have recently been expanding at an especially rapid pace among products with new 1
functions for domestic use, to suggest voluntary activities required for the parties concerned. 3. Definition of "antimicrobial" 3.1 Necessity to clarify the term "antimicrobial" and its content In order to establish sound markets for "antimicrobial products," as described above, it is essential that consumers should properly understand the term "antimicrobial" and its usage. It is necessary, therefore, that companies should clarify the term and the content. There is no consistent terminology and usage for "antimicrobial products" and related products now on the market. This inconsistency tends to prevent consumers from properly understanding the meaning of the term. Some consumers, for instance, falsely identify it with "sterilized" or "aseptic." Therefore, definition of the term "antimicrobial" and its content helps consumers correctly understand "antimicrobial products". 3.2 Definition of "antimicrobial" in the case of "antimicrobial products" "Antimicrobial" in "antimicrobial products" shall be defined as "inhibiting the growth of bacteria * on the surface of products." In the case of "antimicrobial products" being products with new functions, "antimicrobial" shall be defined as "inhibiting the growth of bacteria * on the surface of products." This definition is associated only with bacteria and "the surface of the products" so that it can lead to accurate marking of functions of antimicrobial products and develop an environment where consumers can properly select the products. 2
"Fungi" such as molds are not included in bacteria covered by the term "antimicrobial" used in the case of "antimicrobial products." * The kinds of bacteria should be specified separately using testing methods of antimicrobial efficacy referred to in Section 6.1 i). 3.3 Definition of secondary effects of "antimicrobial" Secondary effects accompanying antimicrobial efficacy shall not be included in the category of "antimicrobial," because different "antimicrobial products" or different usages have different kinds of secondary effects, which makes it difficult to give a general definition. When such secondary effects are marked, it is necessary that the content should be separately defined and announced. The category of "antimicrobial" shall not include secondary effects accompanying antimicrobial efficacy referred to below as "secondary effects", such as preventive or deterrent against dirt, smell and slime, etc. or preventive or deterrent effects against mold. When such secondary effects are marked, it is necessary that companies and groups which use the marking should separately define the effects and announce the content. However, it is desirable that the marking method, and contents, which are to be defined separately, should conform to these guidelines. 3
4. Information to be provided Consumers shall be provided with information concerning antimicrobial products necessary to select such goods with confidence. In addition, it is necessary that information should be provided for consumers in conformity with the definition of "antimicrobial" to prevent consumers from overestimating the effects. Information to be provided for consumers should include the following items: i the fact that the product is treated with antimicrobial finish including information about the treated part in the case of partial treatment ii antimicrobial efficacy desirable to include information concerning the duration of the efficacy in the case of products under continuing use iii) the type of antimicrobial agent used * classified into inorganic / organic / natural organic, and others iv) safety of antimicrobial products Though the necessary safety information depends on the kind of products or different usages, essential items as acute oral toxicity, skin sensitization, and skin irritation should be confirmed and information should be provide on these items. v usage and cautions required to obtain and maintain the antimicrobial efficacy * antimicrobial agent, herein, shall be matter that is kneaded or applied in order to generate antimicrobial material. However, when the materials that the articles are made from are themselves antimicrobial materials without any such treatment as kneading or application, for example, metal that has antimicrobial efficacy with surface reaction, such materials themselves shall be "antimicrobial agents." It is necessary that information should be provided in conformity with the definition of "antimicrobial" to prevent consumers from overestimating the effects of antimicrobial products. 4
5. Marking on antimicrobial products 5.1 Marking methods for information to be provided From the viewpoint of providing concise information for consumers, appropriate marking methods are character marking, notes certifying that the products meet the voluntary standards of the industry groups, or emblems established by the industry groups. Information to be provided in product marking shall be the following five items: i the fact that the product is treated with antimicrobial finish, ii antimicrobial efficacy, iii type of antimicrobial agent, iv safety of antimicrobial products, v usage and cautions required to obtain and maintain the antimicrobial efficacy. It is necessary that these items should be marked clearly on the products or in instruction manuals. However, i shall be marked on the products, and iii shall be marked on the products as far as possible. In addition, it is appropriate that marking methods for information to be provided should be character marking, notes certifying that the products meets the voluntary standards of the industry groups, or emblems established by the industry groups However, it is necessary that v should be marked in characters in any marking method. When emblems are applied as marking, it is necessary that the products should conform to voluntary rules concerning the items described above, set by industry groups or others that have established the marks. 5. 2 Marking methods for secondary effects of "antimicrobial" When secondary effects of "antimicrobial" are marked, it is necessary that they should have been verified and disclosed to consumers. When secondary effects of "antimicrobial," are marked, it is necessary that they should have been verified through testing methods that could guarantee presumable validity in accordance with usage of the antimicrobial products. It is also necessary that the companies or groups using such marking should establish rules for such marking methods, and that they should be disclosed to consumers. 5
However, it is desirable that when such companies or groups establish rules for such marking methods, they should conform to these guidelines. 6. Testing methods of antimicrobial products 6.1 Confirmation of antimicrobial efficacy of antimicrobial products It is appropriate that the testing method should be selected, depending on the types of antimicrobial products, from among testing methods established as Japanese Industrial Standards referred to below as "JIS" concerning the method for evaluating antimicrobial efficacy. As for the method for evaluating duration of antimicrobial efficacy, it is appropriate that the deterioration-acceleration process should be applied, depending on the usage of the antimicrobial products before the evaluation tests of antimicrobial efficacy are conducted. i Testing methods of antimicrobial efficacy It is desirable that methods for evaluating antimicrobial efficacy should be established as JIS, and that testing methods of antimicrobial efficacy should conform to them. It is appropriate that the relevant JIS should allow such methods to be selected depending on the types of antimicrobial products, for example shakeflask method, bacteria counting method, dropping method and film covering method. Bacteria to be used for the tests should be selected from among Staphylococcus aureus, Klebsiella pneumoniae, Escherichia coli, etc., depending on the types and usages of antimicrobial products. ii Method for evaluating duration of antimicrobial efficacy As for duration, it is appropriate that the deterioration-acceleration process with detergent, chemicals, etc. should be applied, depending on the usage of antimicrobial products, before the evaluation tests of antimicrobial efficacy are conducted. 6
6.2 Confirmation of safety of antimicrobial products Makers that produce antimicrobial products shall confirm their safety through either of the following methods. i) By obtaining the data provided by antimicrobial agent makers or antimicrobial material makers excluding cases where such data is not sufficient in itself to confirm safety ii By examining the antimicrobial products. Makers that produce antimicrobial products shall confirm their safety through either of the following methods. i) By obtaining Material Safety Data Sheet (referred to below as "MSDS") or other data provided by antimicrobial agent makers or antimicrobial material makers. However, this method of confirmation should not be adopted if safety could not be sufficiently confirmed, in view of antimicrobial finish treatment methods and usage of the products or other matters, where such data in itself is insufficient because of unexpected chemical reactions, etc. ii By examining antimicrobial products. 6.3 The relationship between tests in laboratories and those under actual conditions of use Tests should be conducted to evaluate efficacy and safety in laboratories under test conditions set to cover the temperature, humidity and nutrition density expected in ordinary use. However, it is desirable that test conditions and testing methods should be improved to have greater conformity to actual conditions of use. Tests for efficacy and safety of antimicrobial products should be conducted to judge whether sufficient efficacy and safety can be ensured under actual conditions of use. In order to evaluate such efficacy and safety, these tests should be conducted in laboratories 7
using standard strains of target bacteria through testing methods described in Section 6.1, under test conditions set to cover the temperature, humidity and nutrition density expected in ordinary use. It is desirable that groups and others that establish testing methods should endeavor to improve testing conditions and methods to provide greater conformity to actual conditions of use. 6.4 Combination of product inspections and received raw material inspections "Product inspection" data obtained through the inspections of the product's antimicrobial efficacy shall be collated with "received raw material inspection" data provided by antimicrobial material makers, in order to confirm whether the products are equipped with the expected efficacy throughout the production process. It is appropriate that "product inspection" data should be collated with "received raw material inspection" data in order to confirm whether the products are equipped with the expected efficacy throughout the production process. "Product inspection" is conducted throughout the production process to examine antimicrobial efficacy of such products by some means, for instance, inspection after a specific time. "Received raw material inspection" is conducted to confirm antimicrobial efficacy by use of information provided by antimicrobial material makers. Such inspections shall be conducted at the most appropriate time in terms of the production process management and quality control of the makers. 6.5 Testing system for antimicrobial products The tests of antimicrobial efficacy, etc. shall be either conducted by each company itself or entrusted to third-party testing bodies. In either case, in addition, it is important for organizations that conduct the tests to endeavor to improve the system of test execution and management. In such cases, furthermore, it is appropriate that testing procedures and systems should be officially accredited for technical competence. 8
The tests of antimicrobial efficacy shall be conducted either as: i tests of antimicrobial efficacy, etc. conducted at laboratories affiliated to each company, or ii tests entrusted to third-party testing bodies. In either case, it is important for organizations which conduct the tests to endeavor to improve the system of test execution and management. In such cases, furthermore, each company and third-party organization that conducts tests referred to below as "third-party testing bodies" should be officially accredited for technical competence of execution procedures and systems. 7. Activities of companies dealing with antimicrobial products 7.1 Necessity of voluntary rules established by industry groups concerned It is necessary that industry groups related to antimicrobial product makers referred to below as "industry groups concerned" should establish and announce voluntary rules based on these guidelines. In such cases, voluntary rules established by other groups may be applied. On the company side, it is necessary that the industry groups concerned should establish and announce voluntary rules based on these guidelines. In such cases, voluntary rules established by other groups may be applied, if necessary. However, it is necessary that before applying the voluntary rules, groups whose rules are applied and groups that apply those rules should agree and announce specific applicable items, etc. 7.2 Necessity to include consumers, etc. in establishment In setting voluntary rules, it is necessary that a committee should be established with consumers and others involved, in order to incorporate a wide range of opinions. In establishing voluntary rules, it is necessary that i a committee should be established with consumers and academic experts involved to discuss the rules, and that ii such rules should contain products which clearly define references and information services, to ensure appropriate, quick and reliable responses for consumers. 9
7.3 Necessity of administrative activities in establishing and enforcing voluntary rules It is necessary that administrative agencies should follow up on the establishment and enforcement of the voluntary rules based on these guidelines to assure their effectiveness. When industry groups concerned establish and enforce voluntary rules based on these guidelines, it is necessary that administrative agencies should follow up on the process of establishing voluntary rules, the procedure of establishing JIS and other matters to enhance enforcement measures, content of the rules, and so on. 7.4 Importance of establishing information provision system for consumers It is necessary that industry groups concerned should provide sufficient information for consumers. And it is important that a system to provide such information should be established. It is also important, that distributors should cooperate to this end. It is necessary that industry groups should provide sufficient information to consumers about the content of voluntary rules and other matters. And it is important that a system to provide such information be established. It is also important that distributors, who have broad contact with consumers, should cooperate to this end. 8. Activities for helping consumers to have a proper understanding of antimicrobial products 8.1 Information exchange between consumers and industry groups concerned It is desirable that industry groups concerned should allow consumers and consumer groups to actively use information services as frequently as necessary, to develop proper understanding on the part of consumers. It is desirable that industry groups and consumers groups concerned should exchange information regularly through an information service system established by discussion of concrete ways of providing information to develop proper understanding of antimicrobial products on the part of consumers. 10
For this purpose, it is desirable that industry groups concerned should allow consumers and consumer groups to actively use information services as frequently as necessary. 8.2 Matters to be considered in establishing voluntary rules It is important that, in the process of establishing voluntary rules, industry groups concerned should endeavor to maintain close contact with consumers and consumer groups by establishing conferences where opinions can be exchanged, or by other measures. In order to help consumers properly understand antimicrobial products, it is important that, in the process of establishing voluntary rules, industry groups concerned should endeavor to maintain close contact with consumers and consumer groups by establishing conferences where opinions can be exchanged, or by other measures. One of the possible ways that industry groups concerned can maintain contact with consumers and their groups is to invite their involvement as part of a newly established committee. 8.3 Monitoring of application of voluntary rules It is necessary that industry groups concerned should regularly monitor application of the voluntary rules after they are established. At the same time, it is desirable that they should actively collect information about product tests and inspections conducted by consumer groups. It is necessary that industry groups concerned should regularly monitor application of the voluntary rules concerning antimicrobial products after they are established. At the same time, it is desirable that they should actively collect information about product tests and inspections conducted by consumer groups. It is also appropriate that administrative agencies should provide the necessary advice to support the cooperation of consumer groups. 11
8.4 Importance of activities of consumer groups for providing better information Consumer groups play an important role in conducting inspections and providing information in order to help consumers build a proper understanding of antimicrobial products. Consumer groups have an important role in conducting inspections, providing information and handling publicity activities in order to help consumers build a proper understanding of effects and cautions relating to antimicrobial products. 9. Relationship with general consumer legislation and fair business rules It is important that each company should endeavor to enhance quality control and markings, and establish and apply voluntary rules in adherence with the spirit of the Household Goods Quality Labeling Law, the Act against Unjustifiable Premiums and Misleading Representations, the Product Liability Law, the Act concerning Prohibition of Private Monopolization and Maintenance of Fair Trade, etc. It is important that each company should endeavor to develop quality control and clear markings that help consumers to have a proper understanding of a variety of antimicrobial products in adherence with the spirit of the Household Goods Quality Labeling Law, the Act against Unjustifiable Premiums and Misleading Representations, the Product Liability Law, etc., in addition to observing such laws. It is also important that each company should endeavor to establish fair business in adherence with the Act concerning Prohibition of Private Monopolization and Maintenance of Fair Trade and the Act against Unjustifiable Premiums and Misleading Representations, in addition to observing such laws. 12
Chapter 2 Measures to make the guidelines effective In order to make effective the guidelines proposed in Chapter 1, it is necessary to actively develop voluntary rules, testing methods, and third-party testing bodies. Concrete measures for such issues are described below. 1. Prompt establishment of voluntary rules by industry groups concerned As for the "voluntary rules of industry groups concerned" proposed in Section 7 of these guidelines, it is desirable that issues such as the following be discussed promptly: composition of the committee, creation of contact point for consumer consultation, and establishment of measures to provide information. Also, it is desirable that voluntary rules should be established by means of new or existing rules, for instance, fair competition rules, and that they should be announced by about the end of 1999. It is desirable that testing methods should be based on quantitative measures generally adopted by inspection bodies until JIS are established. Third-party testing bodies shall not be officially accredited before JIS are established. 2. Necessity of standardizing testing method * As for the "testing method of antimicrobial products" proposed in Section 6 of these guidelines, JIS * should be established by about the end of 2000, since fair and neutral concrete technical standards are expected to be established immediately. * It is desirable that those who prepare the draft standards have an overall knowledge of antimicrobial products and have a neutral, fair attitude. * When the draft standards are prepared, a committee should be established comprising industry groups concerned, consumers, and academic experts to discuss it. * It is desirable that such standards should be established as overall testing method standards applicable to all antimicrobial products rather than complicated standards established for each industry or product, because they are expected to be easy for industry groups concerned to apply and for consumers to understand. * It is also desirable that such standards should not involve numerical standards of antimicrobial efficacy applied to each industry or product. 13
* This was established as "JIS Z 2801" in 2000. (JIS Z 2801: Antimicrobial products Test for antimicrobial activity and efficacy (2000)) 3. System of third-party testing bodies * It is desirable that the "third-party testing bodies" referred to in Section 6.5 of these guidelines be officially accredited to ensure the capabilities required to provide fair services, such as testing and investigating ability, and warranted neutrality. * As for accreditation, it is appropriate that "third-party testing bodies" should be officially accredited whenever they are recognized to have such capabilities as are required to provide fair services, such as testing and investigating ability, and warranted neutrality, even if they are joint-stock corporations or foreign testing bodies. * As for concrete procedures, it is desirable that "third-party testing bodies" should acquire official accreditation as testing establishments from the Minister of International Trade and Industry in accordance with Article 57 of the Industrial Standardization Law, while taking into account trends in ISO/IEC Guides 58 and 25, which are standards, as soon as possible after JIS are established. 14
Members of the Meeting on Life-Related Processed Products with New Functions Members at the time of establishing the guidelines Bunichi Ito: Chief of Commodity Test Office, Japan Consumers' Association incorporated foundation Kinya Kimoto: Professor, Meiji University Hiroki Korai: Professor, The University of Tokushima Yoshiko Konishi: Chief Training Commissioner of East Japan Branch, Nippon Association of Consumer Specialists aggregate corporation Sumio Saito: Chief Commissioner of Public Relations Committee, Society of Industrial Technology for Antimicrobial Articles Masaru Sakuma: Administration Officer, Japan Plastic Houseware Manufacturers Industry Union Akira Shinbo: Chief of Living Environment Section, Consumer and Environmental Protection Division Bureau of Citizens and Cultural Affairs, Tokyo Metropolitan Government Tadashi Takenaka: Deputy Director of Secretariat, Home Electric Appliances Fair Trade Conference aggregate corporation Michiko Tooyama: Researcher of Commodity Test Division, The National Consumer Affairs Center of Japan Noboru Nakajo: Chairperson of Committee for Antimicrobial Standardization, Japan Housing Equipment & System Association aggregate corporation Tooru Nagakubo: Chief of Product Safety Planning Section, Consumer Product Safety Association 15
Yoji Nishimoto: Chief Investigator of Antimicrobial Articles Workshop, All Japan Stationery Association aggregated corporation Katsumi Hayakawa: Professor, Kawamura Gakuen Women's University Shoji Yoshimura: Director of Secretariat, Japanese Association for the Function Evaluation of Textiles Naoe Wada: Expert Commissioner, Japan Housewives' Association 16