Confidentiality Level D

Judging Provisions for Listing of Antifungal Agent in the Positive List(Note) By establishing these provisions, the "Judging Provisions for Listing of Antifungal Agent inthe Positive List K22" shall be deleted and replaced to these provisions.
1. Objective
These provisions stipulate the procedures, judging criteria, etc. to determine whether it is listed
or not regarding the application for listing antifungal agents in the Antifungal Agent Positive List of
this society.

2. Procedures from the application for listing to the determination whether it is listed or not(1) Application for listing
The person who applies for listing antifungal agents in the Positive List shall submit thefollowing documents required to judge the listing to the Secretariat of this society.
(i) Application Form (Attached Form 1)(ii) Antifungal Agent Positive List Entry Sheet (Attached Form 2)(iii) Copy of the test report showing the safety data
(2) Checking and preparation of application documents
The Secretariat shall examine the submitted documents, confirm whether all the items arefilled in and whether it can judge the listing only with the submitted documents, etc., and informthe applicant of the requirement of adding to unfilled items, if any, or of submitting additional
documents, if necessary.
If it is too difficult for the Secretariat to judge the appropriateness of documents, theSecretariat may request the Antibacterial Technical Management Committee and the Antifungal
Committee to judge by submitting to those committees such documents in which the company
name, name of antifungal agent, etc. are deleted to make it impossible to identify the applicant.
According to the opinion and determination of the Secretariat itself, Antibacterial TechnicalCommittee, Management Committee and Antifungal Committee, the Secretariat shall prepare
the documents for the Judging Committee required for the judgment of listing by requesting theapplicant to correct, add, submit additional documents, etc.
(3) Judgement by the Judging Committee for Listing of the Positive List
The Secretariat shall summon the Judging Committee for Listing and, on the basis of thedocuments submitted by the applicant, shall request the judgement of the Judging Committee
regarding whether it is listed or not in the Antifungal Agent Positive List.
The Judging Committee shall be held with the attendance of members of the Judging
Committee, staffs of the Secretariat and the applicant of listing in the Positive List. However,
the applicant of listing in the Positive List may only attend the meeting in which the judgmentof antifungal agent applied by such applicant is discussed and, if the applicant does not wish toattend, the Judging Committee may be held with the absence of the applicant.
(4) Handling of the judgment result by the Judging Committee
When the Judging Committee has permitted the listing in the Positive List, the Secretariat
shall add such antifungal agent to the Antifungal Agent Positive List.
When the Judging Committee has determined that the listing in the Positive List isinappropriate, the Secretariat shall inform the applicant of the judgment result and the reason.
When the Judging Committee has requested to correct the documents or submit additional
documents and the applicant has submitted such documents to the Secretariat, the judgment
shall be discussed again in the Judging Committee which is held thereafter.

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3. Judgment criteria(1) The necessary matter shall be filled in the required items of the Antifungal Agent Positive
List Entry Sheet and there shall be no error.
(2) Information on restriction of product use I. Recommended amount to be added II. Maximum
blending amount according to each use condition III. Regarding the prohibited use
application, the reliability of its fundamental data shall be confirmed from the safety test
reports etc. that are the basis for such data, and the logical relation between such data and theinformation on restriction shall be considered as appropriate.
4. Operation of the Judging Committee for Listing of Antifungal Agent in the Positive List
(1) Members of the Judging Committee
The members are three, consisting of one expert in antifungal agents, one expert in safety andone representative of consumer institutions. The members of the Judging Committee shall be
paid remuneration and travelling costs according to the internal rules.
(2) Composition of the Judging Committee
The Judging Committee shall be held with the attendance of members of the Judging
Committee, staffs of the Secretariat and the applicant of listing in the Positive List. However,
the applicant of listing in the Positive List may only attend the meeting in which the judgmentof antifungal agent applied by such applicant is discussed and, if the applicant does not wish toattend, the Judging Committee may be held with the absence of the applicant.
(3) Judgement of listing
The determination whether it is listed or not in the Positive List shall be discussed using thejudgement criteria of Term 3, and the listing shall be permitted with a concurring vote of notless than half of the members of the Judging Committee.
(4) The meeting of the Judging Committee shall, as a rule, be held four times a year. However, if
there is any specific reason including in the case where the number of application for correction
is too large, which can not be processed in four meetings a year, or in the case where there has
been no application since the last meeting of the committee, the above-mentioned rule shall not
be applied.
5. Confidentiality(1) The documents submitted by the applicant for the listing of antifungal agent in the Positive List
shall be handled in accordance with the Society Document Management Provisions.
(2) The members of the Judging Committee, staffs of the Secretariat, members of the Antibacterial
Technical Management Committee and members of the Antifungal Committee must keep theconfidentiality of the information contained in the documents submitted by the applicant in thecertification review and the information inferable from the same.

Formulated: May 13, 2011
Amended: September 18, 2013
Amended: August 5, 2015

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Attachment
Form 1 (Application Form)Month/Day/Year
To: Society of Industrial Technology for Antimicrobial Articles
ApplicantAddress (In the case of corporate body, location of principal place of business )Name (in the case of corporate body, name of institution or company and name of representative)

In compliance with the "7. Voluntary Specifications for Quality and Safety", I apply the listing of
the following antifungal agents in the Positive List.

(The product name of antifungal agent shall be described.)

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Form 2 (Antifungal Agent Positive List Entry Sheet)
Antifungal agent
Product name/Tradename
Registration applicant (member) information
Applicant (company) name
Address
Name of responsible person* Department to which the person
belongs
Address
Contact
Telephoneaddressand Fax
Product content
Select and describe the chemical name or the middle
Chemical name of the effective classification name in the classification table ofingredient of the antifungal agent 1) antibacterial agents and antifungal agents in the
Labeling and Terminology Provisions, or not disclose.
- Select and describe the nonproprietary name or the* Nonproprietary name of the major classification name in the classification table ofeffective ingredient 1)
antibacterial agents and antifungal agents in theLabeling and Terminology Provisions.
Blending concentration of theeffective ingredient 3)
CAS No. 3)
JCSCL No. 3)
Applicable international andnational laws①②Regulation (substance for which
notification is specified or indication
is mandatory, etc.)
Registration (domestic and foreign
inventory, etc.)

Information such as usage results
inside and outside Japan
Effect of productMicrobial species*Bacterial
strain No.

Aspergillus niger
Penicillium funiculosum

Information on restriction of product use 4)

I*

Recommended amount tobeadded(highestacceptable compoundedamount)Supporting data:

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Test resultsConfidentiality Level D

Use condition

IIConditional amount to beadded (Conditional maximum
blending amount)

Maximum
blending
amount according to eachuse condition

Supporting data:

III

Prohibited use application

Supporting data:

Safety/environmental impact information
For the compounding antifungal agent consisting of more than one antifungal ingredient, the safety test
must, as a rule, be conducted using compounding ingredient. However, when the blending of each
effective ingredient is judged to be less likely to cause chemical change or increasing toxicity, the safety
test shall be permitted to be conducted using each effective ingredient. In this case, however, the basis of
the determination must be submitted. The method of determination shall be under the chemical structure,
biological test and the investigation results with literature etc. concerning cases of human beings.

***
*
*

Acute oral toxicity
Primary skin irritation
Mutagenicity 2)
Skin sensitization potential
Higher carcinogenicity test, genetic toxicity
Aquatic toxicity
Octanol/water partition coefficient and solubility to various
solvents
BOD/COD
other ( )Items specified by * are the required items and others are optional items.

Note 1) It is desirable that the name of effective ingredient is indicated using either the chemicalname or nonproprietary name.
2) When the result of the mutagenicity test is positive, the safety must be verified in its higher
carcinogenicity test.
3) Three items in the product content information (blending information of the effective
ingredient, CAS-No. and JCSCL number) may be specified as non-disclosure informationby the applicant after examination.
4) At least two items of the information on restriction of product use: Information on
restriction of use I (maximum blending amount), II (maximum blending amountappropriate to each condition or use), III (prohibited use application) must be indicated.
However, item III (prohibited use application) must be inevitably indicated.

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