Rules in SIAA's Articles of Association 10
Confidentiality Level D

Provisions for Voluntary Registration of Quality and Safety Data etc.
1. Objective
These detailed rules stipulate the rules concerning “Data, etc. Concerning Quality and Safety”
that are voluntarily registered with this society by its members to demonstrate that theirantibacterial products, antifungal products, antiviral products, industrial sterilization coating
materials, or antibacterial agents satisfy the requirements of the “Voluntary Specifications forQuality and Safety” by voluntary management.
2. Definitions of Terms
Term 3 of the “Provisions Concerning Labeling, Terminology etc.” shall apply.
3. Data for Submission(1) For antibacterial agent manufacturers etc. (generic designation for manufacturers,vendors, and importers of antibacterial agents):“Admission/Voluntary Registration Data Sheet Concerning Quality and Safety I(Antibacterial Agents),” filled in with necessary matters, shall be submitted to theSecretariat.
(2) For antibacterial product manufacturers etc. (generic designation for manufacturers,
vendors, and importers of antibacterial products):
For each set of equivalent antibacterial products, “Admission/Voluntary Registration
Data Sheet Concerning Quality and Safety II (Antibacterial Products),” filled in withnecessary matters, shall be submitted to the Secretariat.
(3) For antifungal product manufacturers etc. (generic designation for manufacturers,vendors, and importers of antifungal products)
For each set of equivalent antifungal products, "Admission/Voluntary Registration
Data Sheet Concerning Quality and Safety III (Antifungal Products)," filled in withnecessary matters, shall be submitted to the Secretariat.
(4) For antiviral product manufacturers, etc. (generic designation for manufacturers,vendors, and importers of antiviral products)
For each set of equivalent antiviral products, “Admission/Voluntary Registration Data
Sheet Concerning Quality and Safety V (Antiviral Products),” filled in with necessarymatters, shall be submitted to the Secretariat.
(5) For industrial sterilization coating material manufacturers, etc. (generic designation formanufacturers, vendors, and importers of antiviral products)
For each set of the equivalent sterilization coating material, “Admission/VoluntaryRegistration Data Sheet Concerning Quality and Safety VI (Sterilization CoatingMaterials),” filled in with the necessary matters, shall be submitted to the Secretariat.
(6) A copy of test result certificate for an antibacterial productFor an antibacterial product, a copy of the JNLA logo-bearing test result certificate
according to Term 4 of the "Voluntary Specifications for Quality and Safety" shall besubmitted to the Secretariat. If the determination is made using a test method other thanthat specified in Term 5 of JIS Z 2801(2000), a test result certificate not bearing theJNLA logo shall be submitted to the Secretariat.
(7) A copy of test result certificate for an antiviral productFor an antiviral product, a copy of the test report issued by a test institution, asdescribed in Term 6 of the "Voluntary Specifications for Quality and Safety", shall besubmitted to the Secretariat.
(8) A copy of test result certificate for an industrial sterilization coating material
For an industrial sterilization coating material, a copy of the test report issued by a test

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Rules in SIAA's Articles of Association 10
Confidentiality Level D

institution, as described in Term 7 of the "Voluntary Specifications for Quality andSafety", shall be submitted to the Secretariat.
(9) Material safety data sheet (SDS)
An antibacterial agent manufacturer etc. shall submit a SDS providing information on
the physicochemical properties and handling instructions etc. of the antibacterial agent
to the Secretariat.
(10) A case where the agents are designated as priority assessment chemical substanceFor the products which contain chemical substances designated as priority assessment
chemical substances (Article 2-5 of Chemical Substances Examination Law) by the
New Chemical Substances Examination Law amended on May 20, 2009, the failure
information on the products using such agents must be submitted every six months
after registration.
4. Acceptance of Voluntary Registration
The Secretariat shall accept the application for voluntary registration, provided that the"Admission/Voluntary Registration Data Sheet Concerning Quality and Safety I (AntibacterialAgents), II (Antibacterial Products), III (Antifungal Products), V (Antiviral Products), or VI(Industrial Sterilization Coating Materials)" provides the necessary matters, and that a document
according to Term 3 is submitted, and the Secretariat shall notify this fact to the voluntary
registration applicant (member).
5. Indication of the SIAA Brand MarkFor an antibacterial product (and a set of the equivalent antibacterial products), antibacterial
agent, antifungal product (and a set of equivalent antifungal products), antiviral product (and aset of equivalent antiviral products), and industrial sterilization coating material (and equivalentindustrial sterilization coating materials) described in the “Notification of Voluntary Registration
Acceptance,” the SIAA brand mark may be indicated with the application for its use. For
details, see the “Labeling and Terminology Provisions” and “SIAA Brand Mark Management andOperation Provisions.”
6. Information DisclosureThis society shall disclose information on the voluntarily registered “Admission/VoluntaryRegistration Data Sheet Concerning Quality and Safety I (Antibacterial Agents), II (AntibacterialProducts), III (Antifungal Products), V (Antiviral Products), and VI (Industrial Sterilization
Coating Materials).” Concerning the method of information disclosure, etc., provisions shallfollow those established by the “Website Management and Operation Provisions.”
7. Storage of Documents Relating to Voluntary Registration
Each member shall store all documents relating to the voluntary registration (including electronicmedia etc.) for its product for 10 years after termination of the sale of the product.

Formulated : June 24, 1998
Amended : June 02, 1999
Amended : June 22, 2000
Amended: June 22, 2001
Tentatively amended : July 24, 2001
Amended : May 15, 2003
Amended : February , 2007
Amended : December 21, 2007
Amended : December 20 , 2011

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Rules in SIAA's Articles of Association 10
Confidentiality Level D

Amended : May 10, 2013
Amended: December 14, 2021
(The registration of industrial sterilization coating
materials shall be operated on or after April 1, 2022)

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