Items EUCCK's Proposal Comment

Functional cosmetics

  • It is needed to enlarge general cosmetic claims containing current functional cosmetic categories of whitening, anti-wrinkle and sun-screening.
  • However, if an early modification of the law is difficult, in addition to simplification of review period and process, a product that wishes to claim as functional cosmetics shall be reviewed after release in the market. In-market control system shall be introduced.
  • Forms of control on functional cosmetics differ across countries, and some operate a system similar to the Korea's.
  • Japan categorizes whitening products into quasi-drug (cosmeceutical), and China classifies whitening, sun-screening products into cosmetics for special purpose, with both governments involved in pre-market screening. Although the U.S. government does not screen products, it controls sunblocks as over-the-counter drug.
  • Korea is in the process of improving its screening system for functional cosmetics.

  • - Simplified process
  • Among the check items for screening, information not directly relevant to quality including manufacturing method, storage condition, use-by-date, color description is to be exempt from the screening requirement.

  • - Expanded exemption
  • So long as safety is ensured, more ingredients along with their content, standards and test methods will be notified. The exemption from screening for already approved products of the same company will be expanded to include anti-wrinkling, whitening products in addition to the previously waived sunscreens.
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    Quality management

  • Cosmetics manufacturers or importers should be allowed to take responsibility for all manufactured or imported products and to mange their quality on their own. To this end, cosmetics manufacturers or importers should be released the products to meet quality management criteria per product instead of batch numbers and KFDA shall be rigorously applied it in the market. Autonomous quality assurance system should be introduced.
  • Quality control system on cosmetics may be operated differently across countries taking into account the ability of the nation's industry to manage quality of its own products.
  • In KFDA's understanding, Korea does not have many businesses that have the capacity to control quality on their own and this is not the time to introduce autonomous quality assurance system.
  • However, the KFDA, as a long term plan, is giving full consideration to the shift to autonomous quality control with enhancement in the industry's ability of quality control.
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    Labeling and advertising of cosmetics

  • MIHWAF's plan to change the scope of labeling and advertising in cosmetics that allows various expression (incluindg comparative ad) is welcomed, and expect to see the scope of expansion very soon. Moreover,
  • the criteria of cosmetic advertisement data provided by internal or external institute shall be presented to achieve international harmonization. As long as the company can prove the results based on fact, it should be permitted to be claimed to provide information to consumers.
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  • Since approval of cosmetics labeling and advertising requires individual review and confirmation, whether or not to accept internationally-proven data must be decided in the labeling/advertising review process. However, MIHWAF(Ministry for Health, Welfare and Family Affairs) is considering for a revision of the Cosmetics Act to allow greater variety of labeling and advertising. In order to allow more scope for advertising and labeling.
  • Classification of Cosmetics

     

  • MIHWAF's plan to change regulations for some quasi-drug products having no safety problems and classification as cosmetics in foreign countries such as deodorants is very welcomed, and expects to classify them as cosmetics as soon as possible.
  • MIHWAF is currently trying to revise the enforcement rules of the Cosmetics Act in order to move deodorants, bath preparations, emollients and some other items currently classified as quasi-drugs to the cosmetics category.
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    BSE
    (Bovine Spongiform Encephalopathy) certificate

  • When the manufactures submit certificate proving that any derivatives from ruminants were not used, this should be accepted and shall not be required by product.
  • BSE-free certificate is required as a means to confirm that the product does not contain any extracts or derivatives of ruminants that contracted BSE.
  • BSE-free certificate is required by product because there is no way to certify in terms of changes in ingredient or manufacturing environment occurred after the point when manufacturers submit certificate proving that any derivatives from ruminants were not used.
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