New Era for Cosmetics Regulation

The revised cosmetics law shows promise, but implementation issues remain.

Of the eight issues raised the previous year that AmCham Taipei’s 2019 Taiwan White Paper deemed to have been fully resolved, half related to a single industry – cosmetics:

  • Clarifying the definition of cosmetics under the law to avoid creating technical barriers to trade.
  • Clearly defining the workings of a prospective requirement for “corrective advertising” following findings of serious cases of misleading ads.
  • Ensuring a smooth transition for the regulation of toothpaste and mouthwash as cosmetics for the first time.
  • Ensuring that any restriction on the use of ingredients is based on scientific evidence and adopted in a transparent manner.  

Most of the progress results from the May 2018 passage of an amended Cosmetics Hygiene and Safety Act, the first portions of which came into effect from July this year. Although it regards the revised law as a generally positive measure, the Chamber’s Cosmetics Committee continues to draw the government’s attention to several areas needing consideration. 

An example is the new law’s requirement that product information files (PIFs) include safety dossiers, which are used to determine whether products are safe to be sold. “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,” the Committee noted in its 2019 White Paper submission. “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.”   

“A company like Procter & Gamble has sufficient resources like doctors and toxicologists who can conduct such complicated assessments,” says Abigail Lin, in charge of Global Product Stewardship for P&G Taiwan. “But for small distributors, they’ll have a difficult time getting such confidential product information from the original companies and manufacturers.”

The Committee therefore urges the Taiwan Food and Drug Administration (TFDA) to build up a professional safety-dossier review capability by referencing international best practices for conducting post-market audits.

In addition, the Committee is concerned about certain Taiwan-unique regulations under the new law. One such provision requires that companies’ Safety Assessors (SA) – those responsible for signing off on PIFs – complete a specialized training course with annual retraining. There is no such stipulation in international best practice. The Committee suggests that English-language training courses be developed and offered online so that foreign SAs can achieve certification. Otherwise, products made overseas and certified by foreign SAs could face serious barriers when imported into Taiwan. 

A final issue involves Good Manufacturing Practice (GMP) certification. To achieve GMP status, the enforcement rules for the new law require that packaging and labeling functions be carried out at the same site as production. For most imported cosmetics, however, Chinese-language labeling is usually added in Taiwan in a simple operation.

Since the Chinese labeling process does not impact the quality, sanitation, or safety levels of the cosmetics, the Committee argues that it “makes sense to exclude such operations from the GMP standard.”

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