Consumer-Oriented Safety Management of Cosmetics

1) Safety Control of Cosmetics
A) Preparing Regulation on Safety Standard of Cosmetics
After a full revision of the「Cosmetics Act」(effective on Feb. 5, 2012), the government reinforced the businesses' obligation for securing quality and safety of cosmetics and facilitated prompt release of products into the market by focusing on supervision and follow-up management of products in the market.
Regulation on safety standard of cosmetics was revised to specify standards on use of restricted or prohibited raw materials as well as standards on safety control of cosmetics. Also, by MFDS tried to improve the safety of cosmetics by revising material and product standards based on safety information at home and abroad and through hazard assessments.
Also, MFDS will take into account the hazard assessment results and adverse incidents and examples at home and abroad, to revise domestic standards on safety management of cosmetics that are being distributed and standards on the use of restricted or prohibited materials to be in harmony with international standards.

B) Qualifying Cosmetic Good Manufacturing Practice(CGMP),
MFDS recommends the cosmetic manufacturer to comply with the 'Good Manufacturing Practice for Cosmetics(cGMP)' and has been operating cGMP as the excellent cosmetic manufacturing management standards.
In March 2011, MFDS began to carry out assessment and evaluation and as of 2015 (as of June, 2015), a total of 65 businesses were recognized to comply with cGMP. Also, to promote the application of cGMP, MFDS allowed some process manufacturers to receive evaluation on their implementation status and, changed the evaluation by product group to evaluation by manufacturer.
To secure international competitiveness of cosmetic quality and to improve productivity, cGMP must be used widely in the country so to reduce the burden of applicant applying for an evaluation of cGMP implementation, the evaluation process will be shortened from 120 days to 90 days.

2) Strengthening of Industrial Power through Safety Management of Production
A) Strengthening of Toxic Substance Management in Cosmetics Products
It became necessary to establish a tolerance limit on content of prohibited raw material when such materials prohibited from use are unintentionally derived in the manufacturing and storage process without adding, and cannot be technically and completely removed.
A tolerance limit on content of unintentionally occurring, prohibited raw material, was established for the materials prohibited from use, and the individual standards of 'water tissue' which would change its status from industrial product to (Quasi-Drug)’ in July 2015, was established.
MFDS plans to revise relevant regulations by additionally setting tolerance limit of prohibited raw materials occurring unintentionally, based on based on safety information at home and abroad and through hazard assessments.

B) Preparing Manual of Cosmetic Good Manufacturing Practice
.MFDS recommends cosmetic manufacturers to comply with 'Cosmetic Good Manufacturing Practice for Cosmetics (cGMP)' and has been operating cGMP as the excellent cosmetic manufacturing management standards.
To enhance cosmetic manufacturers' understanding of cGMP, in July 2013, MFDS has prepared a manual on cGMP based on its experience up to now and scientific facts and has been distributing the manual.
Upon discovery of new technology or knowledge related to cGMP at home and abroad, MFDS will immediately reflect those information in the manual, and in「cGMP」, to contribute to improvement of cosmetic manufacturers' manufacture management level.

3) Reinforcing Safety Management of Cosmetics
A) Monitoring of Cosmetics
To create safe manufacture and distribution management foundations, MFDS set up a basic monitoring direction every year, established the 'Basic Plan on Manufacturing and Distribution Management' and has been carrying out follow-up management of cosmetics. With a full revision and enforcement of the「Cosmetics Act」 (revised on Aug. 4, 2011, and enforced on Feb. 3, 2012), MFDS carried out monitoring on cosmetic manufacturers and manufacturing sellers.
To establish cosmetic safety management system that consumers can feel safe and reassured, MFDS will further expand monitoring activities on manufacturing sellers and manufactures and analyze vulnerable areas for each cosmetic distribution channel.

B) Inspection of Ads·Labelling
While cosmetics are everyday items that are most frequently and widely used, due to lack of exclusive personnel to monitor and inspect ads and labelling, there was no effective measures to manage them until recently.
In 2014, MFDS carried out joint monitoring on suitability of cosmetic labeling and advertisement including those of organic cosmetics and cosmetics for baby and infants, and regular monitoring system was established with exclusive monitoring personnel dedicated to this task.
In 2015, MFDS plans to carry out planned joint monitoring on the labeling or advertisement of products that are socially controversial, organic cosmetics and seasonal cosmetics, and also carry out intensive monitoring on advertisements that can misguide people to see cosmetics as pharmaceuticals.

C) Sampling and Testing Cosmetic Products
To secure safety and quality of cosmetics, MFDS has been sampling and testing cosmetic products every year according to the 'Basic Plan of Quality Inspection' on ‘Basic Plan of Manufacturing and Distribution Control of Biopharmaceutical, Herbal Medicine, Cosmetics and Quasi-Drug'.
To expand the scope of items subject to special collection and inspection work, 260 million won of budget was secured for special collection and inspection work. In addition, over 800 items are regularly collected and inspected annually by determining the testing item per item, target number of items per local governments for regular quality inspection.
It is planned to introduce voluntary recall system of manufacturing sellers, etc. and to prepare detailed procedure for recall and discard in 「Legislation of Cosmetics Act」for prompt recall and discard of nonconforming products as a result of collection and inspection. To promptly recall and dispose those products that have been sampled, tested and found to be defective, MFDS will prepare detailed procedure for recall and disposal of such products in the 「Cosmetics Act」.