Creating a transparent regulatory system for Taiwanese consumers to enjoy high quality and safe cosmetic products.
The Cosmetics Hygiene and Safety Act, which passed three legislative readings in May 2018 but has not yet gone into effect, authorizes the central health authority to formulate at least 26 regulations to accommodate implementation of the new law. This Committee appreciates the transparency shown by the authorities, such as holding additional communication meetings with industry prior to the pre-announcement. In addition, all draft regulations followed the administrative procedure for a 60-day notice and comment period to facilitate alignment with international standards and promote open communication with stakeholders and the general public.
However, this Committee agrees with the Retail Committee that when the formal announcement of a new regulation takes place, there is rarely any mention of the opinions raised by members of society, or any explanation of whether those opinions were accepted or rejected. As a result, the value of the public comment process has been greatly diminished.
Suggestion 1: Harmonize the product safety standards applied to PIF review with international practice in order to avoid technical barriers to trade.
One of the important changes under the new Cosmetics Hygiene and Safety Act is the requirement that product safety dossiers be presented as part of the Product Information File (PIF). Assessment of product safety is complicated because it is based on a number of different elements, including the raw materials, level and frequency of use, formulation composition, type of product, age of the consumer, skin type, application area, and exposure areas. Because of that complexity, plus the wide variety of cosmetics products, it takes a high degree of professional knowledge and skill to be able to judge whether a product is safe. There is no simple rule that can be applied in all cases.
The Committee urges the health authority to build up a professional safety-dossier review capability by adopting international best practices for conducting post-market audits. For the sake of Taiwan’s international trade relations and reputation, it is important to avoid misinterpretations that could lead to accusations of technical barriers to trade. The Committee will be happy to assist by leveraging member companies’ resources to help build professionalism through regulatory transparency and harmonization.
2.1 The latest version of the draft “List of Restricted Substances Used in Cosmetics Products” recently issued by the Taiwan Food and Drug Administration (TFDA) restricts the use of some ingredients because of their functions, but it allows others as long as the PIF contains proof of the claim. This is an unfair and unique-to-Taiwan regulation. The EU Cosmetics Directive Annex III, for example, is typical of the approach in major jurisdictions in that it regulates restricted substances only in terms of the level of use, type of product, and parts of the body affected. No function is restricted. The health authority’s focus in setting restrictions on such substances should be safety consideration only.
Since the parameters of the restricted list are unclear to industry, confusion will be unavoidable when companies seek to evaluate whether their formulations comply with the requirements. The Committee therefore urges the TFDA to delete all mention of “function” in the “Restriction” column of the draft list and also ensure that all other requirements imposing limitations on ingredients are harmonized with global regulatory trends.
2.2 The TFDA’s draft “Preservative List” allows a substance if it is used in the U.S., EU, and Japan. However, if there is any variance in the regulation among the three jurisdictions, the TFDA will accept only the most rigorous one – that is, the one calling for the lowest use level. This methodology will create Taiwan-unique regulations that may result in accusations of technical barriers to trade. The Committee therefore urges the TFDA to accept an ingredient or substance allowed in cosmetics products by any one of Taiwan’s major trade partners (such as the U.S., EU, and Japan) and to adopt the highest use level or a flexible standard if regulatory variances exist among the U.S., EU, and Japan.
2.3 The Taiwan Environmental Protection Administration has notified the WTO of its intention to ban non-natural polymers, such as synthetic waxes, under Taiwan’s 2017 law restricting the use of microbeads in rinse-off cosmetic products. This ban would be inconsistent with the practice in other countries, such as the U.S. Microbeads-Free Waters Act of 2015. Rather than adopt another unique-to-Taiwan regulation, we urge the TEPA to delay a decision on expanding the scope of the regulation until it can engage more fully with industry and scientific experts on the particular properties of these polymers, the appropriate methods for detecting plastics used in cosmetics formulations, and the impact that proposed changes would have on industry and consumers.
Suggestion 3: Collaborate with industry in setting the qualifications for foreign safety assessors assigned to checking imported cosmetics products.
The framework created by the new Cosmetics Act requires each cosmetics product to have a PIF that includes product safety data signed by a Safety Assessor (SA). According to the recently published draft “Regulation for Governing the Management of Product Information Files of Cosmetics Products,” an SA’s qualifications must include a degree from a specified university department. In addition, the SA must complete a specialized training course that lasts a prescribed number of hours and go through annual retraining.
These regulations are unique to Taiwan. The EU Cosmetics Directive has no provisions requiring SAs to accept additional training courses or to be retrained within a certain period. Although an article in the draft exempts foreign SAs from these requirements on a reciprocal basis, the three countries that have entered into cooperation agreements with Taiwan related to SAs are not among this country’s major trading partners. Thus, those agreements have no bearing on the foreign SA issue encountered by most cosmetics products imported into Taiwan. If training courses are deemed necessary, the Committee urges TFDA to simultaneously hold physical and on-line courses in both Mandarin and internationally commonly used languages so as to avoid creating a technical barrier to trade. The Committee will be more than willing to collaborate with TFDA in making arrangements with facilitating universities, organizations, platforms and/or facilitators to implement the training courses.
Suggestion 4: Include risk management in the Cosmetics Recall Guidance to balance consumer protection and industry feasibility.
The Cosmetics Recall Guidance is a newly established element of Taiwan’s cosmetics regulatory reform. It is classified into two levels. Level 1 entails products with banned ingredients that raise concerns about product safety and hygiene. A one-month lead time, shortened to 14 days when necessary, is stipulated for the recall. Level 2 involves failure to engage in pre-market notification or to have a PIF in place, or non-compliance regarding product claims or labeling. The lead time is two months.
Cosmetics pose far less of a safety concern for consumers than do medications. However, the current Cosmetics Recall Guidance and allotted lead times are not based on objective risk-assessment levels – and in fact are more restrictive than the recall guidelines for pharmaceuticals. Although the country-wide distribution for cosmetics is much broader than for medicine, the lead time given for cosmetics recall is shorter, making it impractical for the cosmetics industry to carry out.
We urge the TFDA to refer to its own Drug Recall Management guidelines, which classify risk for pharmaceuticals according to three levels. Level 1 provides a one-month lead time for products where there is concern about serious impact to human health. Level 2 gives a two-month lead time for products with defects or quality concerns. And Level 3 allows six months for cases where there is no product safety or quality concern and no artwork or insert changes. In other words, even though pharmaceuticals is an industry with more limited distribution channels than cosmetics, the timeframe is not as tight.
The new Cosmetics Recall Guidance should be aligned with international best practice for cosmetics recall. It should also use the Taiwan Drug Recall Management guidelines as a reference point. The result would be to provide the cosmetics industry in Taiwan with a reasonable risk-based classification system and feasible lead time for implementation.
Suggestion 5: Exempt the packaging of imported cosmetics from GMP labeling requirements when there are no sanitation or safety concerns.
Article 8 of the Cosmetics Hygiene and Safety Act requires manufacturing facilities to follow GMP standards to “ensure consistent production and management of products to meet their expected purposes and the quality standards required by market approvals or product specifications.” In addition, Article 4, Paragraph 1 of the draft “Enforcement Rules of the Cosmetics Hygiene and Safety Act” defines “cosmetics production premises” as the location “in which the production and packaging operations of cosmetics products are carried out.” Paragraph 2 of the same article narrows that definition by excluding premises in which otherwise complete packaging and labeling for cosmetics products undergo further processing such as combining packaging elements or conducting additional labeling.
A majority of imported products need the addition of stickers or a secondary outer package with Chinese labeling in order to comply with local regulations. Since the Chinese labeling operation does not impact the packaging from the original manufacturer, it should not raise any concern that product quality or safety has been compromised. In addition, the facilities and processes used for Chinese labeling are not as complicated as those for other production and packaging operations (such as filling), which require comprehensive quality control. It therefore makes sense to exclude such operations from the GMP standard since they do not undermine the quality or sanitation and safety levels of the cosmetics.