The person who manufactures or imports cosmetics for sale must manufacture or import only specially controlled cosmetics as registered.
The person who manufactures specially controlled cosmetics for sale must manufacture and have a place of manufacture and instruments and tools for use in manufacture in accordance with the criteria and procedure prescribed in the ministerial regulation.
Every time specially controlled cosmetics are imported, documents supporting importation in accordance with the criteria and procedure prescribed in the ministerial regulation must be made available and, upon release by the customs authorities or competent official concerned, shall be forwarded to the Food and Drug Administration without delay.
Section 23.
Any person who has registered specially controlled cosmetics and wishes to begin to manufacture or import such cosmetics must notify the Secretary General of the intention.
Upon notification pursuant to paragraph one, such person shall pay the annual fee at the rate stated in the ministerial regulation but not exceeding the rate annexed hereto, however, until a suspension of such manufacture or importation is notified.
If the annual fee is not paid within the given period, an additional payment at a rate of five percent per month shall be made and the Secretary-General shall issue a notice demanding payment of the annual fee and additional amount be made within thirty days from the date of receipt of such notice. If the payment is still not made fully, the Secretary-General shall revoke the register of such specially controlled cosmetics.
Section 24.
In the event it appears that a person who manufactures or imports specially controlled cosmetics for sale violated or failed to comply with Section 22 or the ministerial regulation issued under Section 22, the Secretary-General shall be empowered to order cessation of such violation or remedy or compliance and to make public known of said violation or non-complicance for the purpose of protection of the consumers as required case by case.
Section 25.
No person shall sell specially controlled cosmetics not duly registered or the register of which having been revoked except sold in a duty-free shop by an operator having fully complied with the criteria and procedure as prescribed and announced by the Minister under Section 13 paragraph two.
Section 26.
In the event, it is necessary for control purpose, the Secretary-General shall be empowered to issue orders as follows:
(1)that a person who manufactures or imports specially controlled cosmetics for sale is required to make detailed reports on his manufacture or importation operation;
(2)that a person who manufactures or imports specially controlled cosmetics for sale is required to submit simples of cosmetics manufacture or imported.
Section 27.
For the purpose of protection of public health, the Minister shall have power to make an announcement in the Royal Government Gazette specifying the quantity of the major components of the controlled cosmetics pursuant to Section 5(2) and prescribing forms of the container, criteria, and means of the manufacture, importation, and storage to be observed by persons manufacturing or importing controlled cosmetics for sale.
Section 28.
Any person who wishes to manufacture or import controlled cosmetics must act as follows:
(1)to inform the name and location of office and place of manufacture or storage of the cosmetics, as the case may be;
(2)to inform the name, category, or kind of cosmetics to be manufactured or imported;
(3)to inform the contents of active ingredients of such cosmetics.
Information pursuant to paragraph one shall be in accordance with the criteria and procedure prescribed in the ministerial regulation.
The manufacturer or importer of controlled cosmetics for sale must comply with the announcement of the Minister pursuant to Section 27.
The provisions in Section 23 paragraphs two and three, Section 24, and Section 26 shall be applied to manufacture or importation of controlled cosmetics for sale mutatis mutandis.
Section 29.
Any substance allowable as cosmetic component under Section 5(5) may be lawfully used in cosmetics withoutbeing subjectto any otherrelated law.
If any substance allowable as a cosmetic component under Section 5(5) is later on annourfced as a substance forbidden to be used as a cosmetic component under Section 5(4), such announcement shall come into force upon the expiration of a one hundred eighty days'period from the date of announcement, except in case it is seriously dangerous to users, the announcement may be made effective immediately or sooner.
Section 30.
A controlled label pursuant to Section 5(6) must bear texts as follows:
(1)a text that is factual and not one that may cause misunderstanding about the essence of the cosmetics;
(2)an indispensable text that if is not mentioned, the consumers may misunderstand about the essence of the cosmetics.
The text pursuant to paragraph one (2) shall be in accordance with the criteria, conditions, and specifications prescribed by the Committee in the Royal Government Gazette.
Section 31.
When seeing that any label is not in accordance with Section 30, the Committee shall order the manufacturer or importer of cosmetics for sale to stop using or correct such label.
Section 32.
Any person wishing to manufacture or import for sale cosmetics of which the label is controlled may request an opinion of the Secretary-General on the label to be used.
A request for opinion, fee, and time length taken in giving an opinion shall be in accordance with the regulation issued by the Minister.
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This legislation was the unofficial authorized translation by Food and Drug Administration. |