The Cosmetics Hygiene and Safety Act (hereinafter, the “New Act”), previously known as the Statute for the Administration of Cosmetics Hygiene (hereinafter, the “Old Act”), was amended on a large scale on May 2, 2018. To enable relevant operators to accommodate the New Act and make adjustments, the provisions other than those cosmetics labeling issues, which will go into effect on July 1, 2021, came into effect on July 2020. Since these legal amendments introduce various new administration systems, the amendments also authorize the Ministry of Health and Welfare (hereinafter, the “MOHW”) to formulate relevant rules and standards, which will be successively introduced in phases depending on the type of product. This article is intended to introduce the future administration systems of cosmetic products, and concurrently introduce the future examination standards for the labeling and advertisement contents of cosmetics products as described below:
I. Definition of cosmetics and the highlights of these amendments
Pursuant to Article 3, Subparagraph 1 of the New Act, “Cosmetics” means “preparations applied to the exterior of the human body, teeth or mucous membranes of the mouth to moisturize the hair, stimulate the sense of smell, improve body odor, modify the appearance, or cleanse the body, provided that this does not apply to those which are recognized as drugs under other laws and regulations.” 」
These legal amendments are primarily highlighted below:
1. The definition of cosmetic products is expanded by including oral preparations such as “non-medicinal toothpaste” and non-medicinal mouthwash, which were previously general goods, in the scope of administration.
2. The original designation of “medicated cosmetics” is changed into “special purpose cosmetics.”
3. A product notification system is established.
4. Product information files (PIF) are added.
5. The Good Manufacturing Practice (GMP) guidelines for cosmetics are added.
6. Regulatory standards for the contents of cosmetics labels, promotions and advertisements are formulated.
7. Criminal punishment is abolished with administrative fines greatly increased.
8. Border control of cosmetics may be strengthened by prescribing the manners of random inspection and random testing, and importation shall be granted when passing the testing.
9. Whistle blowing provisions are stipulated in the Regulations on Cosmetics Hygiene and Safety Violation Report and Reward are formulated.
II. Post-marketing administration system for cosmetics
1. The original premarket approval system which the special purpose cosmetics products were subject to will be gradually replaced by the post-marketing administration system for cosmetics products under the New Act after it is successively put in place:
i. Special purpose cosmetics are “medicated cosmetics” under the Old Act and clearly defined as cosmetics with sun protection, hair coloring, perming, antiperspirant, deodorant, teeth whitening or any other purpose. The so-called special purpose ingredients should comply with the requirements under the List of Ingredient and Use Restrictions for Special Purpose Cosmetics:
ii. Cosmetic manufacturers are currently required to apply to the MOHW for registration if any of the ingredients listed in the List of Ingredient and Use Restrictions for Special Purpose Cosmetics is used in their products, and manufacture or importation is not permitted until the application is approved and a license is granted.
iii. However, with the successive establishment of control measures such as the “product notification system,” “product information files (PIF),” and the requirement that “manufacturing sites shall meet the Good Manufacturing Practice (GMP) guidelines,” neither the manufacture nor the importation of special purpose cosmetics products requires a license, beginning with July 1, 2024. Thus, the existing administration system will be replaced by the above post-marketing administration system.
2. Product notification system
i. Pursuant to Article 4, Paragraph 1 of the New Act, an operator that manufactures or imports the types of cosmetics products announced by the MOHW and a specific quantity of cosmetics products shall complete the notification of the products and create PIFs on the MOHW’s “cosmetics product notification platform” before supplying, selling, giving away, publicly displaying or consumer trial offer of cosmetics; and this shall also apply to any modifications of such products.
ii. Major notification items include:
iii. Implementation timeline: Except for operators of handmade soaps which are exempted from factory registration, all cosmetics products shall be notified beginning with July 1, 2021; and all special purpose cosmetics shall be notified beginning with July 1, 2024.
iv. Violators will be subject to a fine of NT$10,000 to NT$1,000,000 pursuant to Article 23 of the New Act and a fine may be imposed continuously for each instance of violation. In case of material violations, the violator may be subject to a suspension of business operations for one month to one year or be ordered to close down its business or all or part of the registration items of its company, business or factory may be revoked, or the notification or license of such cosmetic product may be revoked or canceled.
i. As stipulated in Article 4, Paragraph 1 of the New Law as mentioned above, a PIF shall be created before a cosmetic product may be supplied, sold, given away, publicly displayed or provided for evaluation by the consumers.
ii. PIFs shall include the following information: Basic product information, manufacturing methods and processes, information on adverse reactions, physical and chemical properties of the product, toxicological data of the ingredients, product stability test reports, microbiological test reports, anti-decay test reports, supporting data for functional evaluation, etc.
iii. The above information should be kept at the place where the product is manufactured or imported for verification and be retained for at least 5 years from the day after the last marketing day of the product.
iv. The relevant information must be signed by the safety assessor, and dated security assessment conclusions and recommendations must be issued.
v. The New Act also stipulates an ancillary regulation for the qualifications of safety assessors, who are required to be graduates from a department of medicine, pharmacy, toxicology, cosmetic science and related departments and institutions and have received the training courses provided by the domestic or foreign universities or the central competent authority on safety assessment of cosmetic products.
vi. Implementation timeline:
(1) Special purpose cosmetics: 2024.
(2) Cosmetics for babies, eyes and lips, non-medicinal toothpaste, mouthwash, etc.: 2025.
(3) All cosmetics: 2026.
As stipulated in Article 23 of the New Act, violators are also subject to a fine of NT$10,000 to NT$1,000,000 and a fine may be imposed continuously for each instance of violation. In case of material violations, the violator may be subject to penalties such as suspension, closedown, or revocation of registration.
4. GMP guidelines for cosmetics
i. Article 8, Paragraph 2 of the New Act provides: “The manufacturing sites of the types of cosmetics announced by the central competent authority shall meet the GMP guidelines for cosmetics products and may be inspected on site by the central competent authority.” This provision is made based on the ISO GMP for cosmetics.
ii. Implementation timeline: The timeline is the same as the PIFs set forth in Paragraph 3 above.
iii. Under Article 22 of the New Act, violators will be penalized with a fine of NT$20,000 to NT$5,000,000 and may be fined for each instance of violation. In case of material violation, the violator may be suspended or close down or the entirety or part of its registration items may be revoked or the notification or license of such cosmetics product may be revoked.
III. Cosmetics advertising
1. Judicial Constitutional Interpretation No. 744
i. Articles 24 and 30 of the old Act stipulate that obscene, indecent or exaggerated advertisements shall not be inserted or broadcast via all kinds of communication tools for cosmetic products. In addition, an application shall be filed, with respect to cosmetics, with the health authorities at the level of the central government or municipality under the direct jurisdiction of the Executive Yuan for the approval of all the language, pictures or wordings in advance, and documents supporting the approval shall be provided to the communication entities. Violators of this provision shall be subject to a fine of up to NT$50,000; and in case of material or repeated violations, the original license issuing authority may revoke the license for the business operation or factory establishment.
ii. The Grand Justices rendered Judicial Constitutional Interpretation No. 744 of January 1, 2017, holding that the above provisions of the Old Act pertain to ex post review on cosmetics advertising. Since the restrictions on the freedom of speech of cosmetic operators have exceeded the scope of necessity and violate the principle of proportionality under Article 23 of the Constitution and the gist of protecting the freedom of speech under Article 11 of the Constitution, they should be invalidated on the promulgation date of the interpretation.
2. The amendments to the New Act formulate the Regulations Governing the Criteria for Cosmetics Labeling, Promotions, Advertisements Involving Deception, Exaggeration, or Medical Efficacy (hereinafter, the “Criteria Regulations”) with respect to the wordings of relevant cosmetics labels, promotions or advertisements in order to provide a review basis for determining if a cosmetic product involves falsehood or exaggerations or medical efficacy claims. If any falsehood or exaggeration is concluded, a fine of NT$40,000 to NT$200,000 will be imposed; if expression involved medical efficacy is concluded, a fine of NT$600,000 to NT$5,000,000 will be imposed; and in case of material violation, the violator may be closed down, its registration items may be revoked, and the fine may be imposed continuously for each instance of violation. In case the provisions on advertising are violated, a correction advertisement shall be inserted, and failure to do so will result in a fine of NT$120,000 to NT$2,000,000.
The Criteria Regulations also contain examples of expressions that illustrate falsehood, exaggeration or medical efficacy as indicated in the following examples:
i. Expressions involving any effect on physiological functions or alteration of the body structure shall not be used:
Expressions that involve an alteration of physiological functions or body structure to the extent that they do not meet the definition of cosmetics such as “relaxing muscle traction,” “revitalizing hair follicles,” “improving microvascular circulation,” “enhancing (increasing) autoimmunity,” “increasing cell metabolism,” “preventing fat lines and stretch marks,” “removing fat, reducing fat, eliminating fat or burning fat,” “reducing allergy or combating allergy,” “promoting (stimulating) collagen synthesis,” etc.
ii. Examples of expressions which may normally be used or similar expressions :
“Recovering youthful radiance or illuminating radiance,” “removing excess oil, controlling oil or combating acne,”, “purifying (whitening) skin or skin whitening,” “tightening pores, purifying pores, shrinking pores,” “antibacterial,” etc. In addition, it is advisable to pay attention to the relevant notes. For example, if an anti-acne efficacy is claimed, objective and fair test data to support the claim should be prepared in advance.
iii. Expressions relating to medical efficacy shall not be used:
(1) “Smoothening skin scars,” “filling and removing wrinkles,” “removing scars”, “eliminating inflammation or reducing redness and swelling,” “sterilization,” “hair removal,” “hair growth,” “medicinal use, medicated soaps, potions, medicament,” etc.
(2) Regarding the labeling of medicinal use and medicated soaps, the Criteria Regulations separately indicate that if such products were imported and manufactured before the New Act came into effect, they may continue to be sold within the originally specified shelf life until a five-year period expired following the effective date of the New Act.