Detailing Korean functional cosmetic registration

Defining a Functional cosmetic in Korea

Before May 30th 2017 functional cosmetics in Korea only referred to whitening products, anti-wrinkle products and sunscreen products. However, afterwards, MFDS expanded the scope of functional cosmetics and newly designated 5 types of quasi-drug as functional cosmetics.

Currently, 9 types of cosmetics are defined as functional cosmetics as follows:

1. Whitening products;

2. Anti-wrinkle products;

3. Sunscreen products;

4. Hair Dyeing, Hair-decolorant products;

5. Products to remove body hair from skin (products that physically remove body hair are excluded);

6. Hair loss prevention products (coatings and other products that physically make hair appear thicker are excluded);

7. Acne (pimple) products (Rinse-off products only);

8. Atopy relieving products;

9. Cosmetics to help thinning red lines caused by stretch marks.

Functional cosmetic registration procedure

1. General procedure (document required) and time required for registration

*MAH: Market Authorized Holder

**MFDS: Ministry of Food and Drug Safety

***KPTA: Korean Korea Pharmaceutical Traders Association

2. Documentation requirements

The files required for review should be in the format required by MFDS.

1) Formula / BSE free certificate / FSC;

2) Product specification;

3) Fragrance spec (if the fragrance ingredient is in the formula);

4) Data on the details about the origin and development;

5) Data on safety:

• Data on toxicity test with single dose;

• Data on primary dermal irritation study;

• Data on ocular and other membranes irritation studies;

• Data on skin sensitization test;

• Data on phototoxicity and photo sensitization test;

• Data on patch test on a human body.

• Data on Cumulative human patch test (Only when it is judged that a safety problem such as occurrence of skin adverse reaction is worried in the human body test data)

6) Data on efficacy and functions (hair dye and hair discoloring products shall submit only the data of c):

        a. Data on efficacy test;

        b. Data on application to a human body;

        c. Data on hair efficacy test (cosmetics of Article 2 (6) of the Enforcement Rule of the Cosmetic Act).

7) Evidence data about establishing the sun protection factor (SPF) and the protection factor of UV-A (PA) (applicable only to cosmetics aiding in protecting skin from ultraviolet rays by blocking or scattering the ultraviolet rays).

8) Data on the standards and test methods (including the clinical specimen).

9) Assay and identification test of active ingredient in the finished product

10) PH test result (3 batches with 3 pieces)

11) Actual product

Procedural simplification through use of approved ingredients

The files required during MFDS review are quite extensive and complicated. Are there any simplifications available during registration? The answer is yes. Fortunately, there are some ingredients that have been approved by MFDS, and if the product only uses these ingredients as functional components, safety, clinical and efficacy data could be omitted. This also speeds up the whole process. This simplified process is called the "reporting process" while full registration process is called "approval process".

Each type of functional cosmetics has its list of specific ingredients that have been formerly reviewed and regarded as safe substances. The list is called “approved ingredients”. By using approved ingredients within limited concentration, the procedure can be simplified as above and will be shortened from 4-6 months to approximately 7 days(in case of whitening products and anti-wrinkles products).

1. UV filters

2. Whitening ingredients

3. Anti-wrinkle ingredients

4. Hair dye

* These ingredients are only allowed to be used in hair dye product, and prohibited in other products(except Resorcinol, Gallic acid).

** When two or more active ingredients listed in column1 are compounded, the total concentration (%) of each ingredient should not exceed 5.0%.

5. Hair removal

Note:

1. When the product contains only one of MFDS-approved active ingredients (i.e, anti-wrinkle or whitening), it will go through the "reporting process". But when the product contains combination of MFDS-approved active ingredients (i.e, anti-wrinkle + whitening), it should undergo full registration ---the "approval process".

2. The concentration of the approved ingredients used in functional cosmetics must be exactly within the ranges listed above. If the concentrations of approved ingredients are lower than the standard, the products will be regarded as general cosmetics.

6. Other exemptions

1) If one product has already been screened, functional cosmetics manufactured by the same manufacturer with identical efficacy of the screened cosmetic (the efficacy has been proved through a comparative experiment against a control group without active ingredients that resulting efficacy) and identical specification, concentration of the active ingredients, usage and dosage are exempt from safety, efficacy and clinical data. (while ingredients used as coloring agents, flavoring agents, suspending agents, emulsifiers, solubilizers, stabilizers, isotonic agents, pH adjusters, viscosity modifiers and solvents can be different);

2) For above condition, Atopy relieving products and thinning red lines caused by stretch marks products only allow exemptions for ingredients used differently in flavoring agent or preservatives;

3) Products with an SPF less than 10, do not require efficacy data relating to SPF and UV level;

4) If physical sunscreen products (products to protect the skin from UV light by blocking or scattering) that have already been screened, those products manufactured by the same manufacturer and have the same efficacy and active ingredients with the same type, usage, specification and concentration do not require submission of safety, efficacy and clinical data.

7. Other functional products

For newly designated functional cosmetics such as hair loss prevention products, acne relief products, atopy relief products, stretch marks relief products, there is no approved ingredients list, thus, they have to provide full data reports. These 4 types of functional cosmetics have special requirements for clinical test data.

Functional cosmetic to prevent hair loss

1) Human clinical data that must be included

• Double-blind

• Placebo control

• Random assignment

2) Clinical test period: more than 24 weeks

3) Subject selection conditions:

• Men and women with alopecia aged 18-54;

• Men with 3 or more by Norwood-Hamilton classification;

• Women with 1 or more by Ludwig classification.

4) Obtain more than 20 valid data for actual test group and control group, respectively.

Functional cosmetics to relieve Acne

1) Human clinical data that must be included:

• Double-blind

• Placebo control

• Random assignment

2) Clinical test period: The number of lesions is to be measured every 2 weeks and more than 8 weeks.

3) Subject selection conditions:

• IGA 2-3 grade acne factor from 20 to 40 years of age

• Obtain more than 30 valid data for actual test group and control group

Helps relieve dryness caused by atopy skin

① Human clinical data that must be included:

• Comparison test before and after using general cosmetic as control group;

• Active ingredient setting: One or more of the active ingredients should be selected the main ingredients for quality control.

② Clinical test period: 2 weeks to 4 weeks

③ Subject selection condition:

• Patients with mild atopy (more than 20 valid data per group)

• Limited to those who do not use drugs

④ Condition of clinical testing institution => GCP(Good Clinical Practice) designated by MFDS

Functional cosmetics to help thin red lines caused by stretch marks

1) Human clinical test data

• Comparison test before and after using general cosmetics as control group;

• Active ingredient setting: One or more of the active ingredients should be selected the main ingredients for quality control.

2) Clinical test period: more than 8 weeks

Technical review emphasis: safety data provision

Regulatory compliance burden is greatly reduced by the use of approved ingredients. But if you have to use ingredients out of list or are involved with cosmetic categories such as hair loss prevention, acne relief products which don't have approved ingredients, MFDS will conduct extensive technical review of all data generated by the accredited testing institution. Safety data is a priority concern. Korea used to use animal testing to generate safety data. After Feb 4th 2017, Korea MFDS followed world trends and banned animal testing of cosmetics and cosmetic ingredients from both domestic and overseas and now accepts alternative tests for animal testing.

MFDS has issued several alternative tests for animal testing:

Key Points

• Registration of functional cosmetics is a complicated procedure which requires submission of documents and approval from 2 authorities. MFDS itself will take approximately 3-5 months for technical review. MFDS spends the most time reviewing data from testing institutions, including safety, efficacy, and clinical data.

• Use of approved ingredients which have confirmed efficacy and safety, will markedly simplify the registration procedure. Use of ingredients outside of this inventory is subject to standard registration and requires generation of safety and efficacy data unless specific exemptions apply. Korea has banned animal testing to substantiate safety, but it has accepted alternatives. These methods are quicker.

• Products using multiple functional claims/effects always require full approval and no exemptions apply for use of approved ingredients.

• If one product has approval, other products from the same manufacture with a similar formula (based on specific qualifying criteria) are subject to a simplified registration process. This is preferential rule for stakeholders but one should still read the instructions carefully and pay attention to specifications, dosage etc.

• The newly designated functional cosmetic categories haven't got approved ingredients yet, so registration cannot be simplified. It is assumed that approved ingredients for these new categories will be issued when post market analysis provides safety and efficacy verification.

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South Korea Functional Cosmetic Regulation