Report of the OTO Advisory Council (April 12, 1993)

1-(5) Relaxing regulations concerning the requirement for a technical director and for related facilities relating to the import and sale of cosmetics

1. Complainant: Korean Trade Association (Kankoku Boueki kyokai)

2. Ministry concerned: Ministry of Health and Welfare

3. Complaint:

Companies importing and selling cosmetics resemble manufacturers in that they supply cosmetics to the public. Since problems with sanitation must be avoided, businesses importing and selling cosmetics are regulated under the Pharmaceutical Affairs Law and must obtain a license, again like manufacturers. Conditions for licensing require that each sales office has a technical director who has the requisite knowledge and experience and that it has related facilities (storage facilities, testing facilities).

The complainant states that the requirement to employ pharmacists and have related facilities greatly increases the costs of companies importing and selling cosmetics, and believes that when very safe cosmetics are involved the requirements to hire pharmacists and have the required facilities not be applied.

4. Results of deliberation:

The requirements to hire chief technicians and have the required facilities are the minimum necessary to ensure appropriate quality control. Even if cosmetics are very safe, defective products can be produced if quality control is neglected. Accordingly, it is inappropriate not to apply these requirements. However, chief technicians do not necessarily have to be qualified as pharmacists. Persons having completed specialized courses in pharmacology or chemistry in high school or other institutions, or with equivalent knowledge and experience also qualify, and knowledge and experience gained abroad are valid. Regarding testing facilities, which are mentioned in the related facilities required, testing may be carried out at testing facilities specified by the minister of Health and Welfare, and thus the complainant should have no difficulty meeting this requirement.

The ministry or agency concerned and the complainant have agreed to examine the qualifications of specific chief technician candidates to determine whether they meet qualification requirements.

Government decision (May 27, 1993)

With regard to the technical director necessary for cosmetic importers, the ministry or agency concerned and the claimant will study whether the specific chief technician candidates meet the qualification requirements.