The Statute for Control of Cosmetic Hygiene, first enacted in 1976, has since been revised many times to keep up with market demands. The Committee appreciates the hard work that the Taiwan Food and Drug Administration (TFDA) and Legislative Yuan have put into completing the new Act Governing Cosmetic Sanitation and Safety (for short, the new Cosmetics Act), which was enacted into law in May 2018. The enforcement date of the new Cosmetics Act to replace the current Statute for Control of Cosmetic Hygiene will be announced by the Executive Yuan later this year.
Although the cosmetics industry welcomes the new act in hope that it will better serve Taiwan consumers, the Committee has noticed several areas in the legislation that may have a negative impact on Taiwan’s business environment and hinder consumers’ access to innovative products. The cause of such concern derives from the law’s ambiguous wording and its deviation from standard international practice. As a member of the World Trade Organization (WTO), Taiwan is fundamentally obligated to draft and promulgate new regulations and policies in a transparent manner. The Committee urges the Taiwan government to make vigorous efforts to address industry concerns and take the following recommendations into serious consideration:
Suggestion 1: Clarify the definition of cosmetics to avoid creating technical barriers to trade.
Using the latest technology, leading countries are supplying cosmetics products with new functions to fulfill the desires of consumers. However, the current definition of “cosmetics” in Taiwan’s relevant regulations departs from prevailing international trends in terms of its impact on product type, claims, and functions, raising questions about the future market status for innovative cosmetics products.
In their regulations, the leading cosmetics-supplying countries and territories, such as the European Union, make a point of including the “protection” and “maintenance of good condition” of skin and oral care within the scope of their definitions of cosmetics. For example, the purpose of sunscreen lotion is for the “protection of skin” against UV light, while antioxidation against free radicals in skin cream is for “maintaining skin in good condition.”
According to TFDA officials, the newly enacted Cosmetics Act fails to include these two important phrases in the definition of cosmetics because of difficulty translating these terms into Chinese. The Committee finds it hard to understand why that translation task should be so challenging. In the absence of inclusion of that terminology in the definition, we are concerned about the potential limitation on product claims. In order not to inadvertently create technical barriers to trade that could open Taiwan to trade disputes before the WTO, the Committee urges the government to clarify the problems created by discrepancies in cosmetics definitions and incorporate a proper interpretation of Taiwan’s cosmetics definition in the enforcement rules or in the advertisement guidelines that are scheduled to be drafted soon.
Suggestion 2: Clearly define the meaning and interpretation of the unique clause on “Corrective Advertisements” in the new Cosmetics Act.
The Committee consistently supports the protection of consumers, and strongly opposes any use of misleading advertisements. At the same time, we urge the government to foster a business environment based on freedom of speech and the right to inform consumers about legitimate claims of product features and benefits.
Article 20 of the new Cosmetics Act stipulates that if advertisements are deemed to have led to undefined “serious incidents,” the cosmetics suppliers may be penalized by being required to issue a public apology through the media – a so-called “Corrective Advertisement.” Such a regulation, which threatens the freedom of suppliers to communicate to consumers, can be found in no other country in the world. Considering the vagueness of the term “serious incidents,” it is quite uncertain how this clause will be enforced and what the ramifications will be for industry.
Moreover, the penalty of public apology is so severe as to potentially cause substantial and irreversible damage to the supplier’s reputation. Since this unprecedented measure subjects suppliers to hidden and unpredictable regulatory exposure, the Committee strongly urges the government to ensure that this requirement is not abused through arbitrary interpretation. We request the opportunity for dialogue with the appropriate authorities to resolve the above-mentioned concerns before the new Cosmetics Act goes into effect.
Suggestion 3: Ensure a smooth transition for toothpaste and mouth wash under the new Cosmetics Act, considering their different nature from other cosmetics.
Toothpaste and mouthwash are a newly added category of cosmetics under the amended Cosmetics Act. Since the relevant cosmetics regulations were developed without considering the unique characteristics of toothpaste and mouthwash (particularly the fact that they are immediately rinsed off after use) and because considerable effort and resources are needed from both TFDA and the oral care industry to build up a good regulatory and implementation framework for the new category, the Committee urges the TFDA to adopt the following measures to assure a smooth transition and minimize the impact on both industry and consumers.
Provide a sufficient transition period after all the relevant enforcement rules are established. The new Cosmetics Act reclassifies non-medical toothpaste and mouthwash from the general commodity category to cosmetics and applies a different level of regulatory requirements. It is important to provide a sufficient grace period to the toothpaste and mouthwash companies to enable them to prepare for compliance with the new law. According to the TFDA’s current plans, it will release the draft enforcement rules within six months from passage of the legislation and finalize the rules within 12 months of passage. The plan calls for allowing another 12 months before the start of implementation.
That timeframe is far too short. Only after the final rules have been announced will it be possible for companies to fully assess the impact and begin to revise their artwork, labeling, and advertisements. As a rule, about four to six months are needed to update the artwork for a one-pack size of stock keeping unit (SKU), and each company on average has some 60-80 SKUs. In addition, companies may even have to reformulate their products to comply with the new rules. Generally three to four years are needed to conduct formulation studies and stability testing.
The problem is especially challenging for multinational companies, who share product labeling and formulations across borders and need to coordinate with entities in other countries for all changes. As a result, the Committee urges the TFDA to provide a sufficiently long grace period, which should start when all the relevant regulations are settled, to assure a smooth transition and minimize the impact on both industry and consumers.
Harmonize technical requirements and ingredient standards for toothpaste and mouthwash with those of major trading partners. Current cosmetics regulations governing prohibitions or restrictions on ingredients or substances related to anti-bacterial agents, preservatives, colorants, heavy metals, whitening agents, etc. were established without taking toothpaste and mouthwash into consideration. The Committee urges the TFDA to review and make appropriate modifications to these regulations by accepting the ingredients and substances allowed in oral care products by any one of Taiwan’s major trade partners (such as the United States, EU, and Japan) for the sake of harmonization with international regulations and to avoid adopting unique-to-Taiwan standards or restrictions.
Continue to use TFDA’s approved toothpaste claim list under the new Cosmetics Act. The TFDA announced a claim list for general toothpaste in 2005. The industry has been following the list for more than a decade, and consumers are very familiar with it. To minimize the impact on both industry and consumers, the Committee urges the TFDA to maintain these approved claims as a reference list after toothpaste is included in the new Cosmetics Act.
Suggestion 4: Ensure that any restrictions on the use of ingredients are based on scientific evidence and adopted in a transparent manner.
Certain ingredients, such as active ingredients for Special Use Cosmetics and cosmetic colorants, are subject to limits on usage and dosage. We urge the Taiwan government to ensure that the adoption of any ingredient restrictions and/or sanitation standards for cosmetics is based on sound science and objective assessments. Scientific references regarding conditions for ingredient safety and use can be found from governmental regulatory bodies in major markets, industrial consultation organizations, and such expert sources as the Cosmetics Ingredient Review (CIR) in the United States and the EU’s Scientific Committee on Consumer Safety (SCCS).
The ingredient restrictions and sanitation standards should also be aligned with those of major trading partners such as the United States, the EU, and Japan. Furthermore, we urge Taiwan to build a regulatory environment that fosters industry self-regulation to help spur industry advancement rather than impose burdensome constraints. Taiwan should refrain from setting unique regulatory requirements that may result in technical barriers to trade.