Korea Implements Amendments to Three Major Cosmetic Regulations

Korea’s Ministry of Food and Drug Safety (MFDS) recently implemented a series of amendments to three major regulations, namely “Requirements for Exemption from Quality Inspection of Imported Cosmetics”, “Standards for Manufacture and Quality Control of Excellent Cosmetics” and “Enforcement Rules of the Cosmetic Act”. All manufacturers and importers in Korea are required to comply with these new amendments.

Rectification Notice Replaces Direct Disqualification

Originally overseas manufacturers of cosmetics exempt from quality inspection were subject to disqualification if products were shown to be incompliant during subsequent regulatory supervision activities (see CL news on 26 August 2014). In practical application outright disqualification was found inappropriate. In an effort to improve this situation the MFDS now stipulates that a rectification notice is instead sent to the overseas manufacturers as specified in the amendments to “Requirements for Exemption from Quality Inspection of Imported cosmetics”.

Evaluation Method of Excellent Cosmetics Changed

The regulatory stipulations on recycling and manufacture of hazardous cosmetics in Korea as outlined in the “Standards for Manufacture and Quality Control for Excellent Cosmetics” do not conform to requirements as outlined in the newly revised Cosmetic Act. To avoid any confusion the MFDS amended the standard to align it with the Korean Cosmetics Act. The amendments stipulate that some manufacturers are permitted to apply for evaluation under “Standards for Manufacture and Quality Control for Excellent Cosmetics”. The evaluation method has also changed from assessment based on product category to assessment based on manufacturer’s type. What’s more, the certification logo is also changed for the purpose of unified management.

Wet Wipes Are Categorized as Cosmetics

For the purpose of protecting people's interests and safeguarding consumer safety, the MDFS amended the requirements for the training of manufacturers, registration of modifications of manufacturing's type and classification of wet wipes in the “Enforcement Rules of the Cosmetic Act”. From January 6 2015, when manufacturers cannot attend compulsory training courses because of natural disasters, physical illnesses or accidents, the person in charge can designate another person to attend the course instead. With respect to manufacturers who don’t register with the competent department when the manufacturing's type changes, punitive measures will be accordingly imposed. Furthermore, from July 1 2015 wet wipes for body cleansing are categorized as cosmetics, excluding wet wipes for special use in restaurants and hospitals.

 Overview of South Korea Cosmetics Regulation