Confidentiality Level D

Labeling and Terminology Provisions
1. Objective
These detailed rules define the terms related to antibacterial products, antifungal products, antiviralproducts, industrial sterilization coating materials, antibacterial agents, antifungal agents, antiviral
agents, and industrial sterilization coating agents (hereinafter, these eight items are collectively
referred to as “products, etc.”), as well as stipulate the standards for labeling for such products toprovide their users with necessary information.
2. Scope
The “Voluntary Specifications for Quality and Safety” shall apply.
3. Definitions of Terms(1) Antibacterial
Refers to suppression of the proliferation of bacteria on the surface of a product.
(2) Antifungal
Refers to suppression of the growth of fungi such as molds.
(3) Antiviral
Refers to decrease of the number of specific viruses on a product.
(4) Sterilization (Definition in JIS Z 2811)
Refers to a decrease of the viable count of an object.
(5) Industrial sterilization coating
Refers to the name of a category used for coating liquids and paints applied to decrease theviable count of an object.
(6) Antibacterial agent
Refers to an agent (or material) having an antibacterial function.
Distinguishing between agents and materials
All antibacterial agents sold by manufacturers of antibacterial agents shall be handled as“agents,” whereas antibacterial master batches, antibacterial stainless steel, etc. forsecondary products shall be handled as “materials.” In addition, antibacterial (and/or
antiviral) coating liquids using antibacterial and/or antiviral agents shall be handled as“coating materials.” Under these provisions, the term agents is used to represent bothtypes.
(7) Antifungal agent
Refers to an agent having an antifungal function.
(8) Antivirus agent
Refers to an agent (substance) that brings out an antiviral function.
(9) Industrial sterilization coating agent
Refers to an agent (substance) that brings out the function of an industrial sterilization
coating.
(10) Inorganic antibacterial agent containing silver, etc.
Refers to an antibacterial agent prepared by impregnating a metal such as silver, copper, orzinc, an inorganic compound thereof, or a mixture thereof, in an inorganic compound.
(11) Organic antibacterial agent
Refers to a synthetic organic antibacterial agent and natural organic antibacterial agent.
(12) Inorganic antifungal agent
Refers to an antifungal agent made by impregnating an inorganic compound with metals suchas silver, copper, and zinc, inorganic compounds of such metals, and their mixtures.
(13) Organic antifungal agent
Refers to a synthetic organic antifungal agent and natural organic antifungal agent.
(14) Inorganic antiviral agent

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Refers to an antiviral agent made by impregnating an inorganic compound with metals suchas silver, copper, and zinc, inorganic compounds of such metals, and their mixtures.
(15) Organic antiviral agent
Refers to a synthetic organic antiviral agent and natural organic antiviral agent.
(16) Inorganic industrial sterilization coating agent
Refers to an industrial sterilization coating agent made by impregnating an inorganic
compound with metals such as silver, copper, and zinc, inorganic compounds of such metals,
and their mixtures.
(17) Organic industrial sterilization coating agent
Refers to a synthetic organic industrial sterilization coating agent and natural organic
industrial sterilization coating agent.
(18) Organic-inorganic mixed antibacterial agent
Refers to a synthetic organic antibacterial agent, natural organic antibacterial agent, and a
mixture of these antibacterial agents and inorganic bacterial agent(19) Organic-inorganic mixed antifungal agent
Refers to a synthetic organic antifungal agent, natural organic antifungal agent, and a mixtureof these antifungal agents and inorganic antifungal agent(20) Organic-inorganic mixed antiviral agent
Refers to a synthetic organic antiviral agent, natural organic antiviral agent, and a mixture ofthese antiviral agents and inorganic antiviral agent(21) Organic-inorganic mixed industrial sterilization coating agent
Refers to a synthetic organic industrial sterilization coating agent, natural organic industrial
sterilization coating agent, and a mixture of a synthetic or natural organic industrial
sterilization coating agent and an inorganic industrial sterilization coating agent.
(22) Antibacterial metal
Refers to a metal material having an antibacterial function.
(23) Antiviral metal
Refers to a metal material having an antiviral function.
(24) Antibacterial product
Refers to a product undergoing antibacterial treatment by the use of antibacterial agents withthe objective of providing antibacterial function, whether it is a finished product or anintermediate product. However, antibacterial metals shall be handled as antibacterial products.
(25) Antifungal product
Refers to a product undergoing antifungal treatment, whether it is a finished product or anintermediate product.
(26) Antiviral product
Refers to a product undergoing antiviral treatment, whether it is a finished product or anintermediate product.
(27) Industrial sterilization coating material
Refers to a coating liquid and paint applied to decrease the bacterial count of an object, whichforms a film on the object by applying them. Objects coated with this material are notincluded in this product.
(28) Equivalent antibacterial products
Refers to antibacterial products, etc. that share the same material, manufacturing process, andantibacterial agent specifications (antibacterial agent used, treatment method, range of amountadded, etc.) but differ only in terms of secondary factors such as shape.
(29) Equivalent antifungal products
Refers to antifungal products, etc. that share the same material, manufacturing process, andantifungal agent specifications (antifungal agent used, treatment method, range of amountadded, etc.), but differ only in terms of secondary factors such as shape.
(30) Equivalent antiviral products
Refers to antiviral products, etc. that share the same material, manufacturing process, andantiviral agent specifications (antiviral agent used, treatment method, range of amount added,etc.) but differ only in terms of secondary factors such as shape.
(31) Equivalent industrial sterilization coating material

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Refers to an industrial sterilization coating material that shares the same material,
manufacturing process, and industrial sterilization coating agent specifications (industrial
sterilization coating agent used, range of amount added, manufacturing process, etc.), butdiffers only in terms of other components that do not affect the industrial sterilization coating
function.
(32) Chemical substance
Article 2-1 of the Act on the Evaluation of Chemical Substances and Regulation of Their
Manufacture, etc. (hereinafter referred to as “Chemical Substances Control Act”) as shown
below shall be observed.
Refers to a compound obtained by causing a chemical reaction on an element or compound(excluding radioactive substances and the products listed below).
(i)Radioactive substances defined in Article 20 of the Atomic Energy Basic Law(ii)
Designated substances defined in Article 2-3 of the Poisonous and Deleterious
Substances Control Law (1950 Law No. 303)
(iii)
Stimulant drugs defined in Article 2-1 of the Stimulant Drug Control Law (1951 Law
No. 252) and raw materials for stimulant drugs specified in Article 2-5(iv)
Narcotics defined in Article 2-1 of the Narcotic Control Law (1953 Law No. 14)(33) General chemical substance
The following chemical substances defined in Article 2-7 of Chemical Substances Control Act(excluding priority assessment chemical substances, monitoring chemical substances,class I specified chemical substances, and class II specified chemical substances):(i)
Chemical substances listed in the list of existing chemical substances(ii)
Newly announced chemical substances(iii)
Previous class II and III monitoring chemical substances* 1 – 3 exclude the substances designated as priority assessment chemical substances, etc.
(iv)
Chemical substances whose designation as priority assessment chemical substance has
been canceled(34) Safety test concentration
Refers to the “concentration of an antibacterial, antifungal, antiviral, or industrial sterilization
coating agent” used in the safety test, which is calculated with such product (active
ingredient) as the base value (based on 100% by weight).
(35) Fungal resistance test
Refers to a test for evaluating the resistance of an antifungal product to fungi.
(36) Durability-tested product
Refers to a product that underwent durability testing under the conditions specified for eachproduct category.
(37) Label, etc.
Refers to a package box, label, instruction manual, etc. attached to products, etc.
(38) Pamphlet, etc.
Refers to all media stating the information on products, etc., including technical documents,
catalogues, pamphlets, newspaper/magazine advertisements, TV commercial messages
concerning products, etc.
(39) Antibacterial activity value
A value indicating the difference in the common logarithms of viable cell count after
inoculation culture between the surface of non-antibacterial products and antibacterial
products.
(40) Antiviral activity
A value indicating the difference in the common logarithms of viral infectivity after a
specified virus inoculation time period, between the surface of non-antiviral products andantiviral products.
(41) Repetitive reduction value (Evaluation of an industrial sterilization coating material)
JS Z 2811 shall apply (A value indicating the difference in the common logarithms of viablecount, between an uncoated test piece immediately after bacterial inoculation and a coated test
piece that has undergone repetitive operation after four hours of inoculation).
(42) Comparative repetitive reduction value (Evaluation of an industrial sterilization coating
material)

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A value indicating the difference in the common logarithms of viable count after four hours of
inoculation, between an uncoated test piece that has undergone repetitive operation and acoated test piece that has undergone repetitive operation.
4. On Labeling and Terminology for Products, etc.
For voluntarily registered product, etc., the following matters shall, as a rule, be indicated at an
easily noticeable portion by the users on the label, etc. of the product, etc. For JIS-specified
commodities, relevant provisions of the Industrial Standardization Act shall apply.
(1) Name of the manufacturer or vendor of the product, etc.
(2) Name and code number of the product, etc.
(3) To the manners of description and label application for the type of the antibacterial agent
used, information on the antifungal agent used, and the information, treatment method, andtreatment portion of the antiviral agent used, the separately formulated “SIAA Brand MarkManagement and Operation Provisions” shall be applied.
(4) Mode of use for assuring the onset and persistence of the desired antibacterial, antifungal, or
antiviral effectThis item shall be described in handling instructions, cautions, etc.
(5) Antibacterial SIAA brand markThe antibacterial SIAA brand mark shall be accompanied by a statement of necessary mattersselected out of the type, antibacterial treatment method, and treatment portion of theantibacterial agent, etc. used. The statement shall be given in a way that conforms to theseparately formulated “SIAA Brand Mark Management and Operation Provisions.”(6) Antifungal SIAA brand markThe antifungal SIAA brand mark shall be accompanied by a statement of necessary mattersselected out of listing number of the Antifungal Agent Positive List, the method of antifungal
treatment, antifungal treatment portion of the antifungal agent used. The statement shall begiven in a way that conforms to the separately formulated “SIAA Brand Mark Management
and Operation Provisions.”(7) Antibacterial and antifungal SIAA brand markThe antibacterial and antifungal SIAA brand mark shall be accompanied by a statement ofnecessary matters selected out of SIAA antibacterial product number、SIAA antifungal productnumber, listing number of the Antifungal Agent Positive List, the method of antifungal
treatment, antifungal treatment portion of the antifungal agent used. The statement shall begiven in a way that conforms to the separately formulated “SIAA Brand Mark Management
and Operation Provisions.”(8) Antiviral SIAA brand markThe antiviral SIAA brand mark shall be accompanied by a statement of the necessary mattersselected out of the type of the antiviral agent used, antiviral treatment method, and treatment
portion. The statement shall be given in a way that conforms to the separately formulated“SIAA Brand Mark Management and Operation Provisions.”(9) Sterilization coating SIAA brand markThe sterilization coating SIAA brand mark shall be accompanied by a statement of thenecessary matters, such as the type of the industrial sterilization coating agent used. The
statement shall be given in a way that conforms to the separately formulated “SIAA Brand
Mark Management and Operation Provisions.”
5. On Labeling and Terminology for Pamphlets, etc. for Products, etc.
(1) The labeling and terminology shall conform to the labeling and terminology manual
formulated by this society.
(2) The labeling and terminology, etc. that are used in Japan shall not be subject to legal
regulations by the Pharmaceutical Affairs Law, Food Sanitation Law, Agricultural Chemicals
Regulation Law, Poisonous and Deleterious Substances Control Law, Act against
Unjustifiable Premiums and Misleading Representations and others. Additionally, ones thatare used abroad shall not be subject to regulations by the relevant laws of the countries andK8-4

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regions where products which are voluntarily registered with this society are manufactured
and sold.
(3) For JIS-specified commodities, the provisions of the Japanese Industrial Standardization Act
shall apply.
6. On the Indication of the Substance Name(s) of Antibacterial Agent(s), Antiviral Agent(s), or
Industrial Sterilization Coating Agent(s) Contained in Antibacterial Products, Antiviral Products,
or Industrial Sterilization Coating Materials
Described below are provisions concerning how to indicate the substance name(s) andconcentration(s) of the antibacterial agent(s), antiviral agent(s), or industrial sterilization coating
agent(s) used in the antibacterial product, antiviral product, or industrial sterilization coating
material, on sales promotion materials, etc. (*1).
(1) Indication of substance name(s)1) The substance name of the antibacterial agent, antiviral agent, or industrial sterilization
coating agent used in the antibacterial product, antiviral product, or industrial sterilization
coating material shall be indicated by its major classification name and middle classification
name (system) according to “Table 1.” (*2)2) When more than one antibacterial agent, antiviral agent, or industrial sterilization coating
agent is contained, the substance names of all the antibacterial, antiviral, or sterilizing
ingredients used shall be indicated by their major classification name and middle
classification name (system). (*3)3) In addition to the major classification name and middle classification name, chemical name,nonproprietary name, abbreviated name, etc. may be indicated as required.

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Confidentiality Level D(2) Indication of concentrations used
1) The concentration(s) of antibacterial, antiviral, or industrial sterilization coating agent(s) usedin the antibacterial product, antiviral product, or industrial sterilization coating material shallnot be indicated. (*4)
(3) Time of enforcement
1) These rules concerning antibacterial products shall go into force for sales promotion
materials, etc. generated on and after July 24, 2001. These rules concerning antiviral products
shall go into force for sales promotion materials, etc. generated on and after April 1, 2019.
These rules concerning industrial sterilization coating materials shall go into force for sales
promotion materials, etc. generated on and after April 1, 2022.
2) For already prepared materials concerning antibacterial products, their use will be permitted
until September 2003, but will be no longer acceptable thereafter.
[Notes] *1: Sales promotion materials, etc. are documents that are not attached to the body of the
product, generated for the sake of an explanation of the product, such as catalogues,
handbills, pamphlets, and SDS, and do not include labels, product instruction
manuals, containers, etc. that are integral parts of the body of the product.
*2: Labeling example; Synthetic organic antibacterial agent (alcohol-containing)
Synthetic organic antiviral agent (alcohol-containing)*3: Labeling examples; Synthetic organic antibacterial agents (alcohol-containing,
phenol-containing)
Inorganic antibacterial agent (silver-containing)
Synthetic organic antibacterial agent (alcohol-containing)
Natural organic antibacterial agent (terpene-containing)
Inorganic antiviral agent (silver-containing)*4: The antibacterial agents, antiviral agents, or industrial sterilization coating agents
contained in the antibacterial product, antiviral product, or industrial sterilization
coating material occur at various portions in the product depending on the intended
use or treatment method for the product, accordingly, concentration labeling issometimes inappropriate. Additionally, there is not always a correlation between
the concentration and potency of antibacterial agents, antiviral agents, or industrial
sterilization coating agents. Hence, when this occurs, a temporary rule is made not toindicate the concentration(s) of antibacterial agent(s), antiviral agent(s), andindustrial sterilization coating agent(s) used in the product. A survey will takeplace on general concentration ranges by type of product, and the findings will be
posted as reference information on the website of the society and elsewhere.
7. On the Indication of the Active Ingredient Name(s) of Antifungal Agent(s) Contained in
Antifungal Products
Described below are provisions concerning how to indicate the active ingredient name(s) andblending concentration(s) of the antifungal agent(s) used in the antifungal product on sales
promotion materials, etc. (*1).
(1) Indication of active ingredient name(s)1) The active ingredient name of the antifungal agent used in the antifungal product shall be
indicated by its nonproprietary name if one is used or by its major classification name selectedaccording to “Classification of Antibacterial and Antifungal Agents.” (*2)2) If the chemical name of the active ingredient is used, the active ingredient name of theantifungal agent used in the antifungal product shall be indicated by its middle classification
name selected according to “Table 1” or shall not be disclosed. (*3)(2) Management of usage restrictions
All the antifungal agents contained in antifungal products shall be “selected for use fromamong the antifungal agents included in the Antifungal Agent Positive List and satisfy the

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conditions included in the information on the usage restriction of each antifungal agent,” andthe maximum possible blending amount is specified as a safety requirement.
[Notes] *1: Sales promotion materials, etc. are documents that are not attached to the body of the
product, generated for the sake of an explanation of the product, such as catalogues,
handbills, pamphlets, and SDS, and do not include labels, product instruction
manuals, containers, etc. that are integral parts of the body of the product.
*2: Labeling example;
Synthetic organic antifungal agent*3: Labeling examples;
Alcohol-containing,
Terpene-containing
Not disclosed
Table 1: Classification of Antibacterial, Antifungal, Antiviral, and Industrial Sterilization Coating
Agents[Major classification][Middle classification]
Inorganic antibacterial agents
Silver-containing antibacterial agents
Inorganic antifungal agents
Zinc-containing antibacterial agents
Inorganic antiviral agents
Copper-containing antibacterial agents
Inorganic industrial sterilization Other inorganic antibacterial agents (*1)
coating agents
Synthetic organic antibacterial
Alcohol-containing synthetic organic antibacterial agentsagentsPhenol-containing synthetic organic antibacterial agents
Synthetic organic antifungal
Aldehyde-containing synthetic organic antibacterial agentsagentsCarboxylic acid-containing synthetic organic antibacterial agents
Synthetic organic antiviral
Ester-containing synthetic organic antibacterial agentsagentsEther-containing synthetic organic antibacterial agents
Synthetic organic industrial
Nitrile-containing synthetic organic antibacterial agentssterilization coating agents
Peroxide-containing synthetic organic antibacterial agents
Halogen-containing synthetic organic antibacterial agents
Pyridine/quinoline-containing synthetic organic antibacterial agents
Triazine-containing synthetic organic antibacterial agents
Isothiazolone-containing synthetic organic antibacterial agents
Imidazole/thiazole-containing synthetic organic antibacterial agents
Anilide-containing synthetic organic antibacterial agents
Biguanide-containing synthetic organic antibacterial agents
Disulfide-containing synthetic organic antibacterial agents
Thiocarbamate-containing synthetic organic antibacterial agents
Surfactant-containing synthetic organic antibacterial agents
Organic metal-containing synthetic organic antibacterial agents
Other synthetic organic antibacterial agents (*1)
Natural organic antibacterial
Terpene-containing natural organic antibacterial agentsagentsCarbohydrate-containing natural organic antibacterial agents
Natural organic antifungal
Tropolone-containing natural organic antibacterial agentsagents
Ester-containing natural organic antibacterial agents
Natural organic antiviral agents Other natural organic antibacterial agents (*1)
Natural organic industrial
sterilization coating agents
Organic-inorganic mixed
antibacterial agents
Organic-inorganic mixed
antifungal agents⎯ (*2)
Organic-inorganic mixed
antiviral agents
Organic-inorganic mixed
industrial sterilization coating

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agentsPhotocatalytic antibacterial
agentsAntibacterial metals
Antiviral metals

Titanium oxide-containing photocatalytic antibacterial agents
Other photocatalytic antibacterial agents (*1)
Antibacterial stainless steel
Antibacterial alumite
Antiviral stainless steel
Antiviral alumite
Other metals (* 1)(Notes) *1: If falling under the category of any other substance, the chemical name or
nonproprietary name, etc. of the antibacterial or antiviral substance shall be specified inparentheses.
*2: For antibacterial, antiviral, or industrial sterilization coating agents, the middle
classification names of the organic and inorganic antibacterial agents, the organic andinorganic antiviral agents, and the organic and inorganic industrial sterilization coating
agents contained shall be indicated.
Antifungal agents shall be indicated according to the active ingredient name describedin Term 7-(1).
Formulated: June 24, 1998
Amended: June 2, 1999
Amended: June 22, 2001
Tentatively amended: July 24, 2001
Tentatively amended: August 22, 2001
Tentatively amended: September 21, 2007
Amended: May 19, 2008
Amended: May 10, 2013
Tentatively amended:
September 18, 2014
Amended: March 26, 2019
(Antiviral products shall be
operated after ISO 21702 is issued)
Amended: December 14, 2021
(The registration of industrial sterilization coating
materials shall be operated on or after April 1, 2022)

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