Ministry of Food and Drug Safety promotes designation of one new ingredient for UV filter

·?????? Tris-Biphenyltriazine’s safety and effectiveness recognized as appropriate for use

·?????? ‘Lawson-dihydroxyacetone mixture’ was excluded due to difficulty in ensuring safety.

·?????? Establishment and strengthening of standards for use of 6 types, including ‘benzophenone-3 and cyclopentasiloxane’

The Ministry of Food and Drug Safety (Minister Oh Yoo-kyung) issued an administrative notice on August 2nd of the revised ‘Regulations on Cosmetic Safety Standards, etc.’, which mainly includes new designation and deletion of ultraviolet ray blocking filters and establishment and strengthening of usage standards for cosmetic ingredients. They announced that they would receive comments until October 3rd.

The revised bill can be checked at the Ministry of Food and Drug Safety representative website (mfds.go.kr) → Laws/Data → Legal Information → Legislative/Administrative Notice.

New designation of UV blocking filter (1 type) = Only ingredients designated by the Ministry of Food and Drug Safety can be used for the purpose of ‘blocking UV rays.’ If cosmetics manufacturers want to use new raw materials for ‘UV ray protection’, they must ‘apply for UV filter designation’ to the Ministry of Food and Drug Safety.

As a result of reviewing the submitted data for ‘Tris-Biphenyltriazine’, the feasibility of use, including safety and effectiveness, was recognized. This application is the second one received since the legal basis for designating ingredients was established (2018). The first new ingredient, methoxypropylaminocyclohexynylideneethoxyethylcyanoacetate, was designated in November 2023.

The Ministry of Food and Drug Safety plans to implement the revision simultaneously with the notice so that the industry can quickly use the new ingredient in products.

The Ministry of Food and Drug Safety conducts a risk assessment on raw materials that cannot be used in cosmetics or whose use needs to be restricted, and according to the results, necessary action is being taken.

In this revision, based on the results of the risk assessment, the use standards for one type of UV protection ingredient, 'Lawson-dihydroxyacetone mixture', was deleted as there are no products used in Korea and it is difficult to ensure safety under the current standards. ?6 types of cosmetic raw materials (benzophenone-3, 2,6-dihydroxyethylaminotoluene, nonoxynol-9, butylphenylmethylpropional (Lillial), cyclotetrasiloxane (D4), cyclotetrasiloxane (D4), Pentasiloxane (D5)) have been listed for need of strengthening scientific standards for use.

The Ministry of Food and Drug Safety plans to collect opinions through administrative notice and complete the revision of the notice through follow-up procedures such as regulatory review. When the notice is revised, the raw materials must be used within the scope of the revised standards starting 6 months after the notice revision date, and products manufactured or imported according to the standards before the notice revision can only be sold for up to 2 years from the effective date.

However, in the case of cyclopentasiloxane (D5), considering the opinions of experts and industry that a sufficient grace period is needed for the development of alternative raw materials, and considering the European cases, the revised standards will be applied three years after the date of revision of the notification. In Europe, when the standards for use of cyclopentasiloxane (D5) are strengthened, a three-year grace period is granted.

For more information, please visit THE K BEAUTY SCIENCE website.

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