South Korea Releases 2020 Cosmetics Manufacture and Distribution Management Plan

South Korea released the 2020 cosmetics manufacture and distribution management plan. The key management focus will include functional cosmetics, baby and children cosmetics and cosmetics frequently used by women. The key inspection items are ingredients, labeling, and advertising compliance.

On February 18, 2020, South Korean MFDS released the 2020 manufacture and distribution management plan for cosmetics, biomedicine, drug, and quasi-drug. The management plan for cosmetics manufacture and distribution is as follows.

1. Management Directions

1) Intensive inspection of cosmetics in circulation

Check functional cosmetics labels and claims compliance
Check whether the ingredients used comply with Regulation on Safety Standards, etc. for Cosmetics

2) Intensive collection and inspect key management products

Check whether baby and children cosmetics comply with Regulation on Safety Standards, etc. for Cosmetics
Check whether cosmetics frequently used by women comply with Regulation on Safety Standards, etc. for Cosmetics and quality control standard

2. Inspection Targets and Measures

Target	Measure	Estimated Number
Cosmetics in circulation	Collect and inspect cosmetics with safety risks	2300
South Korean cosmetic manufacturing enterprises	On-site inspection for manufacturers who obtained CGMP certificate	45
Oversea cosmetic manufacturing enterprises	On-site inspection for oversea enterprises manufacturing imported cosmetics exempted from quality inspection	13

3. Cosmetics Inspection Plan

1) Routine Inspection

South Korean manufacturing and responsible distribution enterprises: self-inspection

- For more than 300 enterprises subject to routine inspection, if the results of self-inspection are not submitted, the required inspection data is not completed, or the required materials are not submitted, an on-site inspection is required.

- To ensure the effectiveness of self-inspection, enterprises need to submit inspection items (determined by enterprises) and report through e-mail, paper document, or internet.

- Cosmetics manufacturing and responsible distribution enterprises shall make their self-inspection plans every three years according to local FDA’s requirements.

Oversea manufacturing enterprises

Conduct on-site inspection on oversea enterprises manufacturing imported cosmetics exempted from quality inspection to check whether they meet South Korean GMP standards.

2) Quality Inspection

Priority collection and inspection of cosmetics with safety risks
Collection and inspection standard

- To avoid duplicate collections, local FDAs should specify product types and inspection items

- Inspect heavy metals and microorganisms in baby and children cosmetics

- Inspect preservatives in cosmetics frequently used by women (such as women's cleaners, nail products, eye makeup, pigmented cosmetics)

- Inspect the enterprises with unqualified products

- Inspect products that may violate safety standards

3) Advertisement and Labeling Inspection

- Operate monitoring system for cosmetics false and exaggerated advertising and check illegal advertising

- Focus on the inspection of labels and advertisements of products with great social concern (functional cosmetics, cosmetics frequently used by women, baby and children cosmetics, etc.)

- Inspection of products illegally distributed online (SNS, etc.)

When the monitoring system for false and exaggerated advertising is running, it will meanwhile monitor cosmetics illegally distributed through SNS, such as cosmetics containing prohibited ingredients, unregistered cosmetics, etc.

4) Consumer Cosmetics Safety Management Supervisors

MFDS or local FDA can assign a person recommended by the cosmetic association or consumer group with expertise about cosmetic safety management or have completed the educational content designated by the MFDS as a supervisor. Their major duties include supporting inspection, questioning etc.