Confidentiality Level D

Voluntary Specifications for Quality and Safety
1. Objective
These detailed rules stipulate the specifications for the quality and safety of antibacterial
products, antifungal products, antiviral products, or industrial sterilization coating materials(hereinafter referred to as “products”), as well as antibacterial agents, antifungal agents, antiviral
agents, or industrial sterilization coating agents used to bring out their functions (hereinafterreferred to as “agents”) registered with this society, in order to maintain the qualities of suchproducts and agents at constant levels.
2. Scope(Antibacterial agents, antiviral agents, and(Antibacterial products, antiviral products, andindustrial sterilization coating agents)
industrial sterilization coating materials)
These specifications shall apply to the
These specifications shall apply to theantibacterial agents, antiviral agents, or
antibacterial products, antiviral products, orindustrial sterilization coating agents thatindustrial sterilization coating materials thatare or are going to be commerciallyare or are going to be commerciallyavailable in Japan or the countries listed inavailable in Japan or the countries listed in
the Attached Table of the Admission
the Attached Table of the Admission
Provisions Operating Manual.
Provisions Operating Manual.
(Antifungal agents)
These specifications shall apply to theantifungal agents that are or are going to
be commercially available in Japan.

(Antifungal products)
These specifications shall apply toantifungal products that are or are going to
be commercially available in Japan.

3. Terminology
Term 3 of the “Provisions Concerning Labeling, Terminology, etc.” shall apply.
4. Antibacterial Performance Criteria(Antibacterial agents)(Antibacterial products)
The antimicrobial agent shall meet theAfter being treated by the “Durability Test
antimicrobial performance criteria based on
Method,” an antibacterial product shallthe minimum inhibitory concentration
conform to the antibacterial performance(MIC) shown in Table 1, depending on thecriteria shown in Table 21).
type of antimicrobial agent.
Note 1) Clearance of the antibacterial performance criteria for antibacterial products shall be
determined by a JNLA-certified test institution that is a member of this society andcertified by a logo-bearing test result certificate issued by JNLA. However, if thedetermination is made using a test method other than that specified in Term 5.2 of JIS
Z2801, a test result certificate shall be issued but shall not bear the JNLA logo. A
durability test shall also be performed at a JNLA-certified test institution that is amember of this society.

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Bacteria

Minimum inhibitory
concentration

Table 1. Antibacterial Performance Criteria for Antibacterial Agents
Test method
Antibacterial performance
Remarks(Competent institution)
criteria
Minimum inhibitory
concentration determination
method I1)
Applied to slightly soluble
Not more than 800 g/mL(Society of Industrial
antibacterial agents.
Technology for
Antimicrobial Articles)
Minimum inhibitory
concentration determination
Applied to freely soluble
method2)
or freely dispersible
Not more than 800 g/mL(Japan Society ofantibacterial agents.
Chemotherapy)
Note 1) The “minimum inhibitory concentration determination method I” specified by this society
shall be used.
2) One of the minimum inhibitory concentration (MIC) determination methods specified by
the Japan Society of Chemotherapy shall be used.

Bacteria

Table 2. Antibacterial Performance Criteria for Antibacterial Products
Test method
Antibacterial performance criteria
Remarks

Methods specified inTerm 5.2 of JIS Z
28011-1)-1-2)

Antibacterial activity value not lessthan 2.03)

JIS K 6400-9

Antibacterial activity value not lessthan 2.03)

Antibacterial power
test method II2)
(shaking method)

Antibacterial activity value not lessthan 2.03)

This test method shall, as a rule, be
used except for photocatalytic
antibacterial products. For
products having a shape such that
this method is inapplicable, the test
may be performed using a test piecein tabular form.
Shall be used only for products
having a shape such that none of the
JIS Z 2801 methods is applicable.
(Example: soft foam material)
Shall be used only for products
having a shape such that none of the
JIS Z 2801 methods is applicable.
(Example: soft foam material)

Antibacterial power
Shall be used only for products
test method IV4)
Antibacterial activity value not less having a shape such that none of the(Film contact methodthan 2.03)
JIS Z 2801 methods is applicable.
for liquid water(Example: sheets)
absorbent substances)
Note 1-1) For products that can undergo interference of the manifestation of their antibacterial
performance due to air blockade caused by the film placed thereon, products that allow thebacterial liquid to diffuse over the entire surface of the test piece even without the film
mounted thereon because of water absorption or any other reason, and the like, the filmmounting step may be omitted from this method. Note that according to the definition
established by this society, an untreated test piece refers to a test piece collected directlyfrom an untreated product.
1-2) Untreated sample pieces(i) In “JIS Method 5.2.6 (b) Preparation of Test Pieces”, the statement appears: “If no
untreated test pieces are available, the film defined in 5.2 may be used.” Regarding this,the following rule shall apply.“An untreated sample piece must be derived from a productthat has not undergone antibacterial treatment. An untreated test piece must be prepared

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using the same material and treatment method as for the test sample. However, if such an
untreated sample is unavailable, a sample prepared from a material of the same quality ofchemical composition and structure* having undergone the same treatment method may
be used. In this case, details of the untreated test piece shall be specified in thedescription of the test method.
Footnote*) As used herein, the term material of the same quality of refers to a material
having the same chemical ingredients and chemical structure.”(ii) If it is impossible to fulfill the requirements for test validity of JIS Z 2801(2010) 5.8a) 2)～3) because there is the decrease of the bacterial count in the untreated test piece per se,
the culture medium concentration of the test liquid inoculum may be increased above
1/500 NB, but the culture medium concentration of the treated test piece shall be the same
culture medium concentration of the untreated test piece. In this case, the testing method
shall be the "film contact method" and the diluted concentration shall be indicated. If thistesting method was used, the SIAA brand mark without ISO number shall be indicated.
2) The “antibacterial power test method II for antibacterial products (shaking method)” specified
by this society shall be used.
3) For all test microorganisms specified for each test method, the antibacterial activity value
must not be less than 2.0.
4) The “antibacterial power test method IV for antibacterial products (film contact method for
liquid-absorbing materials)” specified by this society shall be used.
5. Antifungal Performance Criteria(Antifungal agents)(Antifungal products)
An antifungal agent shall be an antifungal
After being treated by the "Durability Test
agent that meets the antifungal
Method," an antifungal product shall conformperformance criteria shown in Table 3,
to the antifungal performance criteria shown
which are based on the evaluation testin Table 4.1)
method for the antifungal effect for
antifungal agents.
Note 1) The report of Antifungal Test issued by supporting member or Antibacterial andAntifungal Test Manager of this society shall be used.

Minimum
inhibitory
concentration
Molds

Table 3. Antifungal Performance Criteria for Antifungal Agents
Test method
Antifungal performance(Competent institution)
criteria

Remarks

The evaluation test method forthe antifungal effect for
Not more than 800 g/mL
antifungal agents1)(SIAA)

Note 1) The "evaluation test method for the antifungal effect for antifungal agents, minimum inhibitory
concentration determination method and MIC determination method to fungi by the agar
plate dilution method" specified by this society shall be used.
Table 4. Antifungal Performance Criteria for Antifungal Products

Molds

Test method

JIS Z 2911-2000 methods1)
ASTM G21-96 method

Antifungal performance criteria

Remarks

For products having ashape such that thisShall be rated lesser by one grade or method is inapplicable,
the test may be performed
more than untreated products2), 3).
using a test piece intabular form.

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Note 1) The JIS Z 2911 (2010) methods include a variety of methods by material and intended use.
Choose the appropriate test method in accordance with the standard "antibacterial power.
If the rating criteria are 5 levels or more, the processed product is 0 to 2 and the unprocessed
product is 2 or more.
Note 2) In ASTM G21-96 method, the processed product is 0 to 2 and the unprocessed product is 2
or more.
Note 3) If the judgment results vary between test pieces of the same level, conformity with theantifungal performance standard shall be judged by the median.
6. Antiviral Performance Criteria(Antiviral agents)(The antiviral performance of an antiviral
agent shall be determined based on its
antiviral activity, and no performance
criteria is specified for antiviral agents.

(Antiviral products)
After being treated by the "Durability Test
Method," an antiviral product shall conformto the antiviral performance criteria shown in
Table 5.

Table 5. Antiviral Performance Criteria for Antiviral Products

Viruses

Test method

ISO 21702 methods

Antiviral performance criteria

Remarks

Antiviral activity: 2.0 or higher
For products having a shape such
Shall be tested using at least one type that this method is inapplicable,of influenza virus or feline
the test may be performed using a
calicivirus.
test piece in tabular form.

Note 1) The antiviral performance of antiviral products shall be tested by any of the following seventest institutions, and the antiviral test report issued by the relevant test institution shall be
submitted:
Japan Food Research Laboratories, KAKEN TEST CENTER General Incorporated
Foundation, Boken Quality Evaluation Institute, Japan Textile Products Quality andTechnology Center, Nissenken Quality Evaluation Center, Technical Evaluation Center,
DAIWA CHEMICAL INDUSTRY CO.,LTD., Kanagawa Institute of Industrial Science andTechnology.
7. Performance Criteria for Industrial Sterilization Coating Materials(Industrial sterilization coating agents)(Industrial sterilization coating materials)
The performance of an industrial
An industrial sterilization coating material
sterilization coating agent shall beshall conform to the performance criteria
determined based on the performance ofshown in Table 6, after being treated in a
the industrial sterilization coating
durability test performed using a test piecematerial, and no performance criteria arewhich is made of an appropriate material
specified for industrial sterilization
chosen from among the applications of thecoating agents.
registered product and is coated with thismaterial.
Table 6. Performance Criteria for Industrial Sterilization Coating Materials
Test method

Performance criteria for industrial
sterilization coating materials1)

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Remarks

Bacteria

Confidentiality Level D

JIS Z 2811

All of the following three criteria
shall be satisfied:- Initial reduction value: 2.0 or
higher- Repetitive reduction value: 2.0 or
higher- Comparative repetitive reduction
value: 2.0 or higher

A test piece2) that is coated under
the specified coating conditions
shall be used.

1) The effects on all test microorganisms specified by the test method shall satisfy the above
criteria.
2) The material of the test piece shall be indicated in a voluntary registration data sheet.
* The performance of industrial sterilization coating materials shall be tested by any of the following
test institutions that are the members of the committee drafting JIS Z 2811:2021, and a copy of thetest report issued by the relevant test institution shall be submitted:
Japan Food Research Laboratories, Boken Quality Evaluation Institute, Japan Textile Products
Quality and Technology Center
8. Safety Criteria
8.1 Basic Considerations
None of the chemical substances listed below shall be used intentionally as a component ofan antibacterial, antifungal, antiviral, or industrial sterilization coating agent.
Note) The chemical substances that must not be included as ingredients of antibacterial agentsand antifungal agents are as follows:(i) Chemical substances not listed in the Law Concerning the Examination andRegulation of Manufacture etc. of Chemical Substances (1973 Law No. 117)
(hereinafter referred to as Chemical Substances Examination Law) and relevant
regulations(ii) Specified chemical substances of 1st kind (Article 2-2 of Chemical Substances
Examination Law), specified chemical substances of 2nd kind (Article 2-3 of Chemical
Substances Examination Law), chemical substances designated as monitoringchemical substances (Article 2-4 of Chemical Substances Examination Law) by the
Enforcement Rules for the Chemical Substances Examination Law. Regarding the
products designated as priority assessment chemical substances (Article 2-5 ofChemical Substances Examination Law), Term 3-6 of the provisions for voluntary
registration of quality and safety data etc. shall apply.
(iii) The radioactive substances specified in Article 2, paragraph (2), of the Regulation on
the Prevention of Ionizing Radiation Hazards.
(iv) The substances regulated by the Restriction of Hazardous Substances (RoHS)
Directive.
(v) The poisonous or deleterious substances specified by the Poisonous and Deleterious
Substances Control Act or Cabinet Order for the Designation of the Poisonous andDeleterious Substances. (The exceptions to this control act or cabinet order specifying
substance names or concentrations shall apply, if set forth.)(vi) The chemical substances subject to control by the Law governing the Control ofHousehold Products Containing Harmful Substances (1973 Law No. 112) andrelevant regulations.
(vii) Other substances recognized by this society as being problematic regarding safety.
8.2 Safety Criteria for Antibacterial Agents, Antiviral Agents, or Industrial Sterilization Coating
Agents

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Antibacterial agents, antiviral agents, or industrial sterilization coating agents shall meet all
the safety criteria shown in Table 7 when evaluated by safety tests performed by a publicorganization or equivalent organization.
Table 7. Safety Criteria for Antibacterial Agents, Antiviral Agents, or Industrial Sterilization Coating
Agents1)
Example of official method
Safety test item Safety test method2)
Safety criteria4)
3)

Acute oral
toxicity

Primary skinirritation

Mutagenicity

Skin
sensitization
potential- OECD TG420 (Fixed dose
procedure)Single-dose toxicity- OECD TG423 (Toxic classtests using rodents
procedure)- OECD TG425 (Up-anddown procedure)- OECD TG404(Rabbit skin irritation
Primary skin irritation
test/corrosivity)
tests or in vitro- ASTM (F719-81)
alternative methods- Draise method
using rabbits- OECD TG439(in vitro skin irritancy)- Methods stipulated in the
notification of the Industrial
Safety and Health Act- Test methods related to
new chemical substances
listed in the Chemical
Reverse mutation test
Substances Examination(Ames test)
Law- OECD TG471(Preincubation method or
Plate method shall be used.
Five strains or more shall be
used.)- Guidance on Test Methods
for Biological Safety
Evaluation of Medical
Devices (Attachment to the
Notification No. 0106 1 of
the Ministry of Health,Labour and Welfare,
Pharmaceutical and Food
Safety Bureau, Evaluation
Sensitization test using and Licensing Division)6)(Adjuvant and Patch Test or
guinea pigs or local
Maximization Test)
lymph node assay- OEcD TG406(LLNA) using mice(Maximization Test or
Buehler method)- Guidance on Test Methods
for Biological Safety
Evaluation of Medical
Devices (Attachment to the
Notification No. 0106 1 of
the Ministry of Health,Labour and Welfare,

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The determined LD50 shallexceed 2,000 mg/kg
weight.
No irritable reactions shallbe observed, or theirritancy shall be weak if
any (primary irritancy
index P.I.I. < 2.00).
Non-irritant

The sample shall test
negative formutagenicity7).

The sample shall test
negative.

Confidentiality Level D

Pharmaceutical and Food
Safety Bureau, Evaluationand Licensing Division)6)(LLNA method)- OECD/TG429 (LLNA/RI)- OECD/TG442A(LLNA/DA)- OECD/TG442B(LLNA/Brdu-ELISA)
Note 1) Safety testing shall be performed on bulk material, and the criteria shall be fulfilled.
If the criteria are not met with bulk material, dilute the bulk material and perform the test to
confirm the fulfillment of the criteria. In this case, however, the concentration used in the
product, in view of data dispersion, shall not be more than half the maximum concentration
for confirmed safety.
2) As safety test data on agents, test results published in public evaluation documents may becited. For the reliability of such data, “Concerning reliability assessment of hazardousness
data on human health effects in the Act on the Evaluation of Chemical Substances andRegulation of Their Manufacture” shall be referred to, and such data shall be able towithstand the evaluation. However, safety tests shall be carried out separately fornanomaterials.
3) Other test methods, which are generally recognized as equivalent or more rigid, may also be
used.
4) Regarding primary skin irritation, mutagenicity and skin sensitization potential, fulfillmentof the safety criteria by the bulk material shall be deemed the clearance of the criteria by the
diluted material.
5) If a positive result is obtained in the Ames test, mutagenicity can be evaluatedcomprehensively by carrying out more than one advanced test [Example: any one of thechromosome aberration test using cultured mammalian cells (OECD/TG473), mouse
lymphoma TK test (OECD/TG476), or in vitro mammalian cell chromosomal aberration
test (OECD/TG473), as well as micronucleus test using rodents (OECD/TG474)].
6) Although the test methods are based on extraction, as a rule, because they are for medical
equipment, the tests shall be carried out using bulk material or dilutions according to thisstandard.
8.3 Safety Criteria for Antibacterial Products, Antiviral Products, or Industrial Sterilization Coating
Materials
1) The concentration of an antibacterial agent, antiviral agent, or industrial sterilization coating
agent1) contained in an antibacterial product, antiviral product, or industrial sterilization
coating material shall not be more than the maximum concentration (based on weight)
confirmed to be safe. If safety is evaluated using diluted bulk material, however, the diluted
concentration shall not be more than half the maximum concentration confirmed to be safe.
2) The antibacterial agents, antiviral agents, or industrial sterilization coating agents used in
antibacterial products, antiviral products, or industrial sterilization coating materials shallmeet all the safety criteria 2) shown in Table 7.
3) For products for which safety test data for antibacterial agents or antiviral agents areunavailable, such as antibacterial metals and antiviral metals, the safety criteria shown in
Table 8 shall be met2).
4) For products for which a safety test cannot be performed using the agents themselves, suchas products manufactured through ion exchange and coupling treatment, the safety test
may be performed using a sample collected from the surface of a product. In such a case,however, it is not allowed to perform the safety test using extract of the product.
Note 1) For surfaces such as painted surfaces which are formed by post-treatment such as
painting, the concentration shall be determined as the concentration (based on weight)of the antibacterial agent, antiviral agent, or industrial sterilization coating agent in thepaint film.

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Confidentiality Level D2) Other safety tests deemed appropriate are not precluded from being additionallyperformed.
Table 8. Safety Criteria for Antibacterial Metals or Antiviral Metals
Safety criteria for antibacterial products
Safety criteria
Category
Test method
Material test
Dissolution test

1959 Ministry of Health andWelfare Notification No. 3701)

Shall meet the specifications.

Shall test negative in closed
patch test or test negative orSkin patch test2)
semi-negative in Kawai’s
method.
Note 1) Standards and criteria for food and food additives, etc.No.3 Apparatus andContainers/ Packages
Specifications for 4. Metal can in A: "General Specifications for Instruments orContainers/Packages or Their Raw Materials" and D: "Specifications by Material for
Instruments or Containers/Packages or Their Raw Materials".
2) It is not required for applications where the product is not in constant contact with the skin(applications where the product is in constant contact: Ring, earrings, and so on). Although“skin patch test” is exempt from submission in the case of voluntary registration, adocument stating that the product is not used for application where it contacts the skinconstantly shall be submitted to the secretariat.
Closed patch test (48 hours) or
Kawai’s method (replica method)

8.4 Safety Criteria for Antifungal Agents
1) The antifungal agents which may be included in antifungal products shall be listed in
Attached Table 1 "Antifungal Agent Positive List" 1).
2) Antifungal agents listed in the "Antifungal Agent Positive List" shall meet all the safety
requirements shown in Table 9. Only the antifungal agents whose safety information,
environmental impact information and products use restriction information shall be listed
in such list 2).
Note 1) Attached Table 1 (Antifungal Agent Positive List) shall be disclosed on the website ofthis society.
2) Detailed procedures for the listing of antifungal agents in the Antifungal Agent Positive
List shall be separately stipulated by the "Judging Rules for Listing of Antifungal Agentin the Positive List".

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Table 9. Safety Requirement Necessary for Listing in the Antifungal Agent Positive List
1. The mutagenicity shall be negative.
However, even if the mutagenicity is positive, the case in which the mutagenicity is proven to
be negative in the high-level carcinogenicity test shall be acceptable.
2. The following information on antifungal agents shall be specified.
1) Chemical name of effective ingredients (nonproprietary name)2) Blending concentration of the effective ingredient3) Safety information 1)
Required items) Acute oral toxicity, primary skin irritation and skin sensitization potential
Optional items) Carcinogenicity
4) Environmental impact information
Required items) Toxicity of fish
Optional items) Octanol-water partition coefficient, solvent solubility and BOD/COD
value
5) Information on restriction of product use(1) Recommended amount to be added (highest acceptable compounded amount): Level I(2) Maximum blending amount according to each service condition (service conditions andthe conditional amount to be added): Level II(3) Prohibited intended use (specific intended use): Level III
Note 1) Regarding the testing method of safety, the standards stipulated in Table 7 shall be applied.
8.5 Safety Criteria for Antifungal Products
1) All the antifungal agents contained in antifungal products shall be selected for use only
from the antifungal agents shown in Attached Table 1 "Antifungal Agent Positive List"1)and shall not include any other antifungal power ingredients not included in such table.
2) In the use of all the antifungal agents contained in antifungal products, the conditions of
the products use restriction information of each antifungal agent stipulated in Attached
Table 1 shall be met.
Note 1) Attached Table 1 (Antifungal Agent Positive List) shall be disclosed on the website ofthis society.
9. Safety of Components other than Agents Contained in Products
The safety of components other than antibacterial agents, antifungal agents, antiviral agents, orindustrial sterilization coating agents contained in products or coating materials shall be subject toproduct safety control (voluntary control) by the companies registering the relevant products or
coating materials.
10. Material Safety Data Sheets (SDSs)(Antibacterial, antifungal, antiviral, and(Antibacterial, antifungal, and antiviral products
industrial sterilization coating agents)
as well as industrial sterilization coating
A SDS bearing information onmaterials)
physicochemical properties and handlingSDSs for the raw materials shall be available1).
instructions, etc. for the antibacterial agent,
antifungal agent, antiviral agent, and industrial
sterilization coating agent shall be available.
Note 1) For products that do not permit generation of SDS, such as regenerated feedstock, thesafety criteria for material test and dissolution test shown in Table 7 shall be met. In
addition, when the dissolution test of D "Standards for appliances or containers andpackaging or materials of these raw materials" is carried out, products made of materials
other than metals conform to the dissolution test according to the type of material in thestandard.

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11. Periodical Performance Check
Antibacterial product manufacturers which registered an antibacterial product for this societysatisfying the antibacterial performance criteria described in Term 4 shall undergo the performancecheck of the registered product every five year, with the details stipulated separately.

Formulated: June 24, 1998
Amended: June 2, 1999
Amended: June 22, 2000
Amended: June 22, 2001
Amended: June 22, 2002
Amended: May 15, 2003
Amended: February 2, 2007
Amended: May 21, 2007
Amended: December 21, 2007
Amended: February 6, 2008
Amended: February 4, 2011
Amended: December 20, 2011
Amended: May 11, 2012
Amended: May 10, 2013
Amended: September 18, 2013
Amended: May 14, 2014
Amended: May 16, 2016
Amended: September 13, 2016
Amended: February 7, 2017
Amended: May 18, 2017
Amended: September 15, 2017
Amended: March 26, 2019
(Antiviral products shall be operated
after ISO 21702 is issued)
Amended: May 18, 2020
Amended: December 1, 2020
Amended: March 16, 2021
Amended: August 1 , 2021
Amended: November 22, 2021
Amended: March 8, 2022
(The registration of industrial sterilization coating
materials shall be operated on or after April 1, 2022)

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