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
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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.
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"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.
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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 agent s."
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.
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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.
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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.
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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
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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.
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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.
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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.
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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.
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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.
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<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.
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(*) 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.
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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:
Akira Shinbo:
Administration Officer, Japan Plastic Houseware Manufacturers
Industry Union
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
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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
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