On 29th August, Taiwan released the amendment of Cosmetic Manufacturing Factory Standard. The main changes were the addition of three new articles and the deletion of one old article about colorant manufacturing.
The main reason to amend this regulation is the implementation of the new cosmetic overarching act, Cosmetic Hygiene and Safety Act. The main change in this regulation is to correct/update some terminology and adjust the order of some articles to align with the Cosmetic Hygiene and Safety Act. For example, the legal basis of this regulation is changed from Statue for Control of Cosmetic Hygiene to Cosmetic Hygiene and Safety Act. Besides this type of change, there are three articles added and one article deleted.
Three articles added
Article 22 The manufacturing site that performs the packaging operation shall have the following equipment:
First, the gauge and other necessary dispensing equipment (such as manual counters or automatic dispensing equipment, etc.).
Second, moisture-proof packaging equipment.
Third, the bottle plug or bottle capping equipment.
Fourth, semi-automatic or automatic printing equipment.
Fifth, rotary workbench or ordinary workbench.
ChemLinked Interpretation: This new added article regulates the equipment required in manufacturing sites that perform the packaging operation. It is the first time that the government makes specific equipment requirements for manufacturing sites that perform the packaging operation, which means TFDA is paying more attention to packaging manufacturing sites.
In the meantime, it is worth noting that according to Cosmetics Manufacturers that Are Exempted from Factory Registration (2019.7.1), this kind of manufacturing site is exempted from factory registration.
Article 23 The manufacturing sites for other types of cosmetics (besides types mentioned from Article 12 to the preceding article) should have necessary equipment complying with this regulation in accordance with the type, properties and production process of this product.
ChemLinked Interpretation: From Article 12 to article 22, the regulation regulates equipment requirements separately for manufacturing sites that producing powder cosmetics, liquid cosmetics, emulsion cosmetics, oil cosmetics, ointment cosmetic, solid cosmetics, eyebrow pencil cosmetics, spray cosmetics, non-manual soap manufacturing site, handmade soap manufacturing site, and manufacturing sites where packaging operations are performed. In case that there are other types of cosmetics manufacture sites left over, this article makes sure that all types of cosmetics manufacture factories also should comply with this regulation.
Hand-made soaps manufacturing sites whose kitchen area or power capacity and scale of thermal energy of its production equipment do not reach the standards in Factory Management Guidance is also exempted from factory registration.
Article 24 If a cosmetic manufacturing site fails to set up relevant equipment in accordance with Articles 5 and 11 to 22, it shall prepare the relevant supporting documents and materials and submit a statement to the competent authority of the municipality or county (city). Those who have obtained the consent of the competent authorities may be exempted from setting up.
ChemLinked Interpretation: Considering the rapid development of cosmetics manufacturing technology, and the manufacturer can manufacture products by themselves or commission to manufacture part of their products, the equipment that should be available in the site can be adjusted due to actual production needs. This article is added to support special circumstances.
One article deleted
Former Article 12 The cosmetic colorant manufacturing sites’ equipment should be set up according to the actual needs of products.
ChemLinked Interpretation: Because the registration of colorants has been abolished, the regulation about colorant manufacture is also deleted.
Besides articles mentioned above, this regulation is mainly about the specific requirements for cosmetic factories, such as the storage requirements for ingredients, half-finished products and finished products, hygienic requirements and printing requirements. If you would like a translated version of this regulation, please contact us by email@example.com.
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