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Takehome:
In H1 2017, Korean cosmetic authorities newly designated 4 quasi-drug categories as functional cosmetics (see news on CL). Now Korea Cosmetic Association released more instructions on how to register these new functional cosmetics in a Q&A format.
On Technical review
Q1：If I want to use new ingredients in a hair dye product, what special documents should I submit?
A: The product should first comply with cosmetic distribution standard, and if ingredients are listed the International Cosmetics Ingredients Dictionary (ICID) (published by Cosmetic, Toiletry, and Fragrance Association), the safety data can be exempted. Otherwise the product requires submission of safety data and hair dye efficacy data.
Q2: For hair loss products which are undergoing re-evaluation, can product name be changed? How long will it take for re-evaluation if product information is changed?
A: Because hair loss products have been changed from quasi drug to functional cosmetics, the data submitted should be re-evaluated. Before the re-evaluation is complete, product information can be changed. The length of re-evaluation depends on what information has been changed:
1. Change name of the product -- 15 days for re-evaluation process;
2. Change ingredients or proportion of each component in the formula. Amendment of additives should comply with cosmetic rules. Product form should remain unchanged – 2 weeks;
3. Change other information– 60 days.
Q3: For product to relieve acne and product to relieve hair loss, does Korea provide guidelines for related human body testing methods?
A: Yes, Korea provides guidelines for human body testing methods relating to acne relieving product and hair loss relieving product. These guidelines can be found on MFDS official website, and Chemlinked also sorted them out on our portal (see Doc. on CL).
Q4: Do functional cosmetics that help to relieve dryness due to atopic skin have to be evaluated by a designated agency?
A: Yes, the testing must be conducted by designated testing institutions (see Korean approved testing institutions). If conducting tests abroad, the foreign testing agencies must be managed at the equivalent or higher level, and must provide clinical data of human body testing.
Q5: When conducting human body testing for dryness caused by irritation relieving product, can the testing subject take antihistamines?
A: No. To test any ingredients including additives in dryness caused by irritation relieving product, the subjects can't take antihistamines. Therefore it is recommended to not choose sensitive individuals.
On Safety Standard
Q1: Since these 4 restricted ingredient:1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3, 3-Methylbutanone ,1,3-Bis(hydroxymethyl)imidazolidine-2-thione,(1-Hydroxyethylidene)diphosphonic acid and its salts, and Oxalic acid, its esters and alkaline salts can be applied to hair products, can they be applied to hair dye products as well?
A: These ingredients can be applied to hair products but are still prohibited for hair dye products. The newly designated functional cosmetics can still be manufactured and imported in accordance with original quasi-drug requirements for one year and can be displayed or marketed for two years until the new regulations for these products in “Safety Standard for Cosmetics” are finalized.
Q2: Can "inorganic sulphites and hydrogensulphites" be used as sterilization preservatives in the same way as before in newly designated functional cosmetics?
A: Yes, "inorganic sulphites and hydrogensulphites" can be used in new functional cosmetics as sterilization preservatives in the same way and in the same condition (as SO2 within 0.2%).
One exception: when used in oxidative hair dye products, the SO2 in "inorganic sulphites and hydrogensulphites" can have a maximum concentration of 0.67%.
On claims and advertisement
Q1: When should new functional cosmetics such as hair dye, desalting, bleach agent products, epilating agent products start to use updated cosmetic precautions on the label?
A: Currently provisions relating to precautions on the label of new functional cosmetics in the "Enforcement Regulations of the Cosmetic Act" are under revision. Therefore these products can be manufactured or imported with previous precautions on the label.
- We will update the news once the amendment is finished.
Q2: Can anti-hair loss product be displayed and advertised as functional cosmetics after re-evaluation?
A: Anti-hair loss products can be sold as functional cosmetics until all efficacy data is reviewed and the re-evaluation process is complete. But if the efficacy data can't prove the product is capable of anti-hair loss, the product won't be approved as functional cosmetics.
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