Cosmetics · Skin trials
KTR has been designated as a "cosmetics inspection agency" by the Ministry of Food and Drug Safety and conducts testing and inspection for the quality control of cosmetics in order to develop the domestic cosmetics industry. KTR has a history of 40 years. Based on its experience as an internationally recognized testing laboratory representing Korea, it provides technical services through testing and analysis on quality control of cosmetic products and hazardous substances in raw materials and technical difficulties of cosmetics companies.
Overview
"Cosmestics" is defined as a product applied to the body to add attractiveness by cleaning/beautifying, brighten one's complexion, and to maintain or enhance the skin or hair, and has minor effect on the human body. However, products described under Article 2 Item 4 of the Pharmaceutical Laws are exempt.
Definition of Functional Cosmetics
1. Cosmetic products that help whiten the skin by preventing melanin pigmentation and hence suppressing freckles from forming
2. Cosmetic products that help whiten the skin by reducing the melanin pigmentation in skin
3. Cosmetic products that treat and improve wrinkles by giving the skin resilience
4. Cosmetic products that enable thorough tanning by blocking strong sunlight
5. Cosmetic products with a skin protecting function against UV rays by blocking or distracting them
6. Cosmetic products that can cause the alteration of hair color (including bleaching); temporary products are excluded
7. Cosmetic products that remove body hair; physical removal is excluded
8. Cosmetic products that help with hair loss; physical products that make hair look thicker (eg. coating) are excluded
9. Cosmetic products that help relieve acne-prone skin; limited to bodily cleaning products only
10. Cosmetic products that help relieve dryness due to atopic skin
11. Cosmetic products that help reduce stretch marks
Skin trials
Guideline of quality inspection in reference to the relevant laws
Laws, regulations and guideline regarding cosmetics
- If a cosmetics manufacturer or someone who intends to distribute or sell cosmetics that have been manufactured by himself/herself(including a consignment production) or imported, or someone who intends to sell cosmetics as an import agency((hereinafter referred to as "manufacturer/distributor") consigns the quality inspection of the manufactured or imported cosmetics to the inspection agency designated by the Ministry of Food and Drug Safety, the laboratories, facilities and equipments necessary for quality control may be omitted.
[Enforcement regulation of the Cosmetic Act, Article 6 and Clause 2]
- Cosmetics manufacturers or distributors must comply with the management standards for quality control of cosmetics, safety management after manufacturing and after sales, and other manufacturing and sales. In addition, quality control records must be prepared and kept. If the manufacturer or distributor does not have its own test facility, the product must be inspected by the cosmetic inspection agency after manufacture, or after the importer has clearance of the import. The cosmetic can then be sold to consumers if the results are found to be OK.
[Article 5 of the Cosmetic Act(the obligation of manufacturers and sellers, etc.) and Article 7 of enforcement regulation of the same Act(quality control standards for cosmetics, etc.)]
- Manufacturers and sellers of functional cosmetics who want to manufacture or import those products must be examined by the Ministry of Food and Drug Safety regarding the safety and efficacy of each item. Cosmetics without examination shall not be manufactured, imported, stored or displayed for the purpose of selling.
[Article 4(Examination of functional cosmetics and others), Article 15(Prohibition of manufacture and sale)
Quality inspection guide for distributed cosmetics
Safety management items and standards for distributed cosmetics
Although a certain substance has not been artificially added to cosmetics manufactured, imported or distributed domestically, it may be objectively confirmed that it has not been intentionally included in the packaging or manufacturing process. Also, it may be impossible to completely eliminate the substance technically. In this case, the detection limit of the substance is as follows.
| Item | Reference value | Amount required for inspection | Remarks |
|---|---|---|---|
| Internal capacity | 97% or more | Three finished products. Five products less than 10g(mL) | - |
| 100% or more | |||
| pH | 3~9 | At least 100 g (mL) | Products that do not contain water and products that become washed away shall be excluded |
| Lead | 20 μg/g or less | Powder products using clay as a raw material should contain not more than 50 μg/g | |
| Arsenic | 10 μg/g or less | - | |
| Mercury | 10 μg/g or less | ||
| Antimony | 10 μg/g or less | ||
| Cadmium | 5 μg/g or less | ||
| Dioxane | 100 μg/g or less | ||
| Methanol | 0.2 (v/v)% less | Wet wipes contain less than 0.002 (v/v)% | |
| Formaldehyde | 2000 μg/g 이하 | Wet wipes contain less than 2000 μg/g | |
| Phthalates | Not more than 100 μg/g as total | DBP, BBP, DEHP | |
| Total aerobic bacteria | Young and infant products and eye make-up products: 500 pieces / g (mL) or less | At least 50 g (mL) | For wet paper, the number of bacteria and fungi must not he more than 100 pieces/g(mL) |
| Other cosmetics: 1000 pieces / g (mL) or less | |||
| Escherichia coli | Not detected | - | |
| P. aeruginosa | Not detected | - | |
| Staphylococcus aureus | Not detected | - |
* Depending on the characteristics of each formulation, consigned inspection is possible for each test item
Guide for general test
Guidelines for the analysis of hazardous substances in cosmetics Test items and standards
| Item | Reference value | Remarks |
|---|---|---|
| Benzoylperoxide | Not allowed | - |
| Benzene | Not allowed | Applies to: Nail enamel |
| Steroide | Not allowed | - |
| N-Nitrosodiethanolamine | Not allowed | - |
| 39 types of steroid | |
|---|---|
| 1 | Beclomethasone |
| 2 | Beclomethasone 17-propionate |
| 3 | Beclomethasone 17, 21-dipropionate |
| 4 | Beclomethasone 21-acetate |
| 5 | Beclomethasone 21-hemisuccinate |
| 6 | Beclomethasone 21-propionate |
| 7 | Bethamethasone |
| 8 | Bethamethasone 17-valerate |
| 9 | Bethamethasone 17, 21-dipropionate |
| 10 | Bethamethasone 21-acetate |
| 11 | Bethamethasone 21-hemisuccinate |
| 12 | Bethamethasone 21-valerate |
| 13 | Budesonide |
| 14 | Clobetasol 17-propionate |
| 15 | Hydrocortisone 17-acetate |
| 16 | Hydrocortisone 21-acetate |
| 17 | Hydrocortisone 21-valerate |
| 18 | Cortisone 21-acetate |
| 19 | Dexamethasone |
| 20 | Dexamethasone 21-acetate |
| 21 | Dexamethasone 21-hemisuccinate |
| 22 | Hydrocortisone |
| 23 | Hydrocortisone 17-valerate |
| 24 | Prednisolone |
| 25 | Prednisolone 21-acetate |
| 26 | Prednisone 21-acetate |
| 27 | Triamcinolone acetonide |
| 28 | Triamcinolone diacetate |
| 29 | Hydrocortisone 21-hemisuccinate |
| 30 | Flurandrenolide |
| 31 | Fluocinolone acetonide |
| 32 | Fludrocortisone acetate |
| 33 | Hydrocortisone 17-butyrate |
| 34 | Dichlorisone acetate |
| 35 | Diflorasone diacetate |
| 36 | Amcinolide |
| 37 | Mometasone furoate |
| 38 | Fluticasone propionate |
| 39 | Clobetasone butyrate |
* This is to be carried out according to the characteristics of each formulation in terms of quality control.
| Allergy-inducing substances(24 types) | |
|---|---|
| α-Amyl cinnamic aldehyde | Benzyl alcohol |
| Cinnamyl alcohol | Citral |
| Eugenol | Hydroxycitronnellal |
| Isoeugenol | 2-Pentyl-3-phenylprop-2-en-1-ol; 2-Benzylidene-1-heptanol |
| Benzyl salicylate | 3-Phenyl-2-propenal; Cinnamic alde |
| 2H-1-Benzopyran-2-one; 1,2-Benzopyrone, Benzo-α-pyrone |
Geraniol |
| 4-(4-Hydroxy-4-methylpentyl)-3-cyclohexene-1-carboxaldehyde: Lyral | Anisic alcohol |
| Benzyl Cinnamate | Farnesol |
| 2-(4-tert-Butylbenzyl) Propionaldehyde | Linalool |
| Benzyl benzoate | Citronellol |
| Hexylcinnamaldehyde | Limonene |
| Methyl 2-octynoate | Alpha-isomethyl ionone |
Guideline test for the ingredient composition analysis of mixture limit
| Item | Reference value | Remarks |
|---|---|---|
| Paraben | For single use: less than 0.4% For mixed use : less than 0.8% |
Methyl paraben, Ethyl paraben, Propyl paraben, Butyl paraben, Isopropyl paraben, Isobutyl paraben |
| Benzyl alcohol | Less than 1.0% | Hair products are excluded from this |
| Phenoxy ethanol | Less than 1.0% | |
| Sorbic acid | Less than 0.6 % | |
| Benzoic acid | Less than 0.5 % | |
| Dehydroacetic Acid | Less than 0.6 % | |
| Salicylic Acid | Less than 0.5 % | |
| Methylisothiazolinone | Less than 0.01 % | |
| Iodopropynyl Butylcarbamate | Less than 0.05 % | Do not use on lip products |
| Imidazolidinyl urea | Less than 0.6 % | |
| Diazolidinyl urea | Less than 0.5 % | |
| Sodium Lauroyl Sarcosinate | Only allowed to products cleaned after use | |
| Chlorphenesin | Less than 0.3 % | |
| 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3, 3-dimethylbutan-2-one |
Less than 0.5 % | |
| DMDM Hydantoin | Less than 0.6% | |
| MDM Hydantoin | Less than 0.2% | |
| Dichlorophen(e)> | Less than 0.5% | |
| Methylisothiazolinone Methylchlotoisothiazolinone Mixture |
Less than 0.05% | (3: 1 mixture) |
* This is an item to check the amount used in terms of quality control.
Content and identification test of functional cosmetics
Content and identifying test of main ingredients according to "Standards and test methods for functional cosmetics" (Notification by the Ministry of Food and Drug Safety No. 2013-28, 2013.04.05) or "Manufacturers' standards and test methods"(approved by the Ministry of Food and Drug Safety)
Inspection/test application procedure and required documents
1) Inspection of cosmetics : Cosmetics manufacturers or sellers who do not have self-test facilities shall notify the cosmetics inspection agency after manufacturing or after the importer finished the customs clearance . They can start selling the products after checking that there is nothing wrong with the test result.
2) General requested test: You can request a test for quality control after manufacturing or before and after importing.
Reception procedure
| Written request for inspection of cosmetics |
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| When requesting a general test |
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