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Chapter 4 Information Dissemination and Protection of Business Secrets
Article 19
Information on chemical substances registered and approved by the central competent authority shall be disseminated to the public. The information items which shall be disseminated are as follows:
I.Registrant information
II.Names of chemical substances
III.Manufacture or import conditions
IV.Classification and labelling
V.Guidance on safe use
VI.Physical and chemical properties
VII.Toxicological and ecotoxicological information
VIII.Hazard assessment
IX.Exposure assessment
The content pursuant to the previous paragraph shall be publicly disseminated through the Internet by the central competent authority.
Article 20
Information on chemical substances that is registered, which involves confidential matters on national defense or business secrets, shall be kept confidential.
The aforementioned business secrets shall conform to the following conditions:
I.They are not known to persons generally involved in information of this type;
II.They have economic value, actual or potential, due to their secretive nature; and
III.The owners have taken reasonable measures to maintain their secrecy.
For registered information determined to be business secrets pursuant to paragraph 1, the following shall be protected and kept confidential:
I.Registrant information
II.Substance identification
III.Information on manufacturing and importing
IV.Life cycle description
A registrant may apply for protection of confidential information with supporting documentation conforming to paragraph 2, on any of the following occasions:
I.Application for the registration of a new chemical substance,
II.Application for the phase 1 registration of an existing chemical substance,
III.Application for the standard registration of an existing chemical substance, or
IV.Application for the inclusion in the inventory of existing chemical substances pursuant to Article 14.
A registrant who does not apply for protection of confidential information regarding a chemical substance that is registered and approved pursuant to the previous paragraph may state the reasons for confidentiality, provide supporting documentation conforming to paragraph 2, and apply to the central competent authority for protection of confidential information when filing an extension application for a registered new chemical substance, or after the registration is approved for an existing chemical substance.
Article 21
The confidential period of the information on chemical substances approved by the central competent authority is valid for 5 years.
Except for the existing chemical substances, the confidential period pursuant to Article 20, paragraph 5 expires as the valid period for the corresponding registration expires.
A registrant may apply for extension of a confidential period specified in paragraph 1 three to six months prior to expiry of the period.
The maximum confidential period for a new chemical substance is 15 years; for an existing chemical substance, the maximum confidential period is 10 years. For a new chemical substance that has been included in the inventory of existing chemical substances, the maximum confidential period is 15 years.
Article 22
The central competent authority shall notify the registrants when information on chemical substances is publicly disseminated in accordance with Article 69, paragraph 2 of this Act.