Regulations in Asia from China

to Japan, Korea, ASEAN

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Alain Khaiat, Ph. D.
President Seers Consulting
Lifetime Achievement Award in-cosmetics, Paris 2010

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2 ASEAN
 The ASEAN Cosmetic Directive (ACD) is in force in all 10
ASEAN member countries;
 The ACD is modeled after the EU Directive (6th amendment);
 Definition is same as EU, only one category of products;
 Ingredients are regulated by the annexes:
 Annex II: banned ingredients;
 Annex III: restricted ingredients;
 Annex IV: positive list of colors;
 Annex VI: positive list of preservatives;
 Annex VII: positive list of UV filters;
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3 Company’s responsibilities
The company or person responsible for placing the
cosmetic products in the market shall:
 ensure that the product will not cause damage to human health when
applied under normal or reasonably foreseeable conditions of use (safety
assessment);
 notify the regulatory authority before the product is placed on the market;
 keep the product’s technical and safety information readily accessible to the
regulatory authority (PIF: Product Information File, article 8);

GMP is a mandatory requirement for the manufacturing as well as the distributing

(GDP) facilities;

Companies must have adequate knowledge/experience of the requirements of the

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Directive
Where are we?

 All countries except Thailand have transposed the ACD

into local regulations;
 All countries are implementing the principles of ACD:
 Product notification;
 PIF requirement;
 Annexes to control ingredients;
 GMP – GDP requirements;
 Post market surveillance;

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But…

 Indonesia:
 Notification with quantitative formula;
 Mandatory expiry date;
 Name of licensor if product made under license;
 Name of primary manufacturer if product final pack is made by
a different company;
 Certificate of Free Sale;
 Letter of representation legalized;

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But…

Thailand:
Has not transposed the ACD into local
regulation;
Notification number to be printed;
Product picture and artwork need to be
uploaded for some products;

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But…

Vietnam:
Certificate of Free Sale;
Letter of representation legalized;

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8 Institutions
 ACC: ASEAN Cosmetic Committee tasked with
coordination, review and monitoring of the implementation
of the Directive. Composed by representatives of each
Member State, ASEAN Secretariat and ASEAN Cosmetic
Association (ACA);

 ACSB: ASEAN Cosmetic Scientific Body tasked with making

recommendations to ACC on safety, technical and
scientific matters (e.g. modification of annexes II to VII,
borderline products);

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9 China

 China regulation defines two categories:

 “Normal cosmetics”;
 “Special cosmetics”;

9 categories of special cosmetic based on the

claim and formula:
1.Sunscreen
2.Spot corrector/Anti-pigmentation/ Whitening
(claim related with anti-pigmentation, spot,
melanin, etc)
3.Slimming,
4.Breast care
5.Hair growth
6.Hair colors
7.Perms
8.Deodorant
9.Depilatories © Seers Consulting
10 China

 Additionally the requirements are slightly different for

imported products vs. locally made products:
 Locally made “normal cosmetics”: file to be submitted to
Provincial bureau, manufacturing can start before license
approval;
 Imported products as well as locally made “special cosmetics”:
a full dossier has to be submitted to CFDA for review by the
technical review expert committee. Samples have to be
submitted as well: CFDA will have them tested for “hygienic-
chemical” properties (i.e. Pb, As, Hg, methanol), toxicology (on
animals) and sometimes efficacy (Sunscreen);
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China: SFDA Tests for Registration

Local Testing are mandatory for product registration:

 Hygienic chemical tests – i.e. Mercury, Lead, Methanol, pH, etc.
 Microbiological tests – i.e. bacterial count, fecal coliforms, etc.
 Toxicological tests – i.e. eye irritation, skin irritation on rabbits, etc.

Selective Testing based on claims and formula:

 Human patch test;
 SPF/PA test;
 Human use test for safety;
 Impurity test i.e. asbestos in talc;
 Ingredients tests for “sunscreen, anti-spot, anti-acne” claim products;
12 China

 Registration lead time is about 3 months for locally made

“normal cosmetics” (2 months for testing + 5 days for
notification) up to 12 months for imported “special
cosmetics”;

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13 China
 CFDA has issued the list of ingredients that can be used in
cosmetics: 8,783 ingredients are on the list vs. over 20,000 in
INCI!
 If your product formula uses only ingredients from the list,
you can submit it for registration;
 If you want to use an ingredient which is not on the list, you
first have to register the ingredient;
 In the last 4 years only 3 ingredients have been approved!
 China positive list is a major blockage to innovation and
consumers travel to other countries, to buy the latest
product they want!
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14 Hong Kong

 Definitely the easiest! There is no regulation on

cosmetics;
 Customs requires the products to meet the regulations in
one of the “developed countries” e.g. EU, USA, China;

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15 India

 All products are in one category; list of banned,

restricted ingredients, positive list of preservatives, colors
and UV filters;
 All products must be registered at the local FDA where
the product is manufactured or where the product is
imported;
 Requirements and lead time may vary depending on
the State;

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16 India

 Products have to meet both the cosmetic regulations

and the Bureau of Indian Standards (BIS);
 Standards are often outdated, takes time to change;
 No coordination: sometimes regulation and standard
are requiring opposite things…

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17 India: animal testing regulation

 Rule 145-C states bluntly “no person shall use any animal
for cosmetic testing”;
 Draft rule 135-B reinforces: “no cosmetic tested on
animal shall be imported”;
 Both rules do not give information on ingredients
(included or not); no information on the date of
application of the ban; no grace period; etc.

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18 India Registration Requirements:
Locally made products

1. Collate all documents from respective departments;

2. Preparation and submission of dossiers;
3. Defending queries if any and follow up;
4. Obtain license to manufacture;

Total 3-6 months

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19 India Registration Requirements: Export
registration
1. Collation of data;
2. Obtain the CFS;
3. Submission to the country of destination;
4. Obtaining import license;
5. Preparing for export;

Total 3-6 months

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20 India Registration Requirements:
Imported products
1. Obtain required documents e.g. LOA, COA, FSC, etc.
2. Preparation and submission of dossier;
3. Defending queries if any and follow up;
4. Obtaining registration certificate (RC) number;
5. Prepare for importation;

Total: 6-9 months

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21 India

 GSR 137 related to metrology of packaged goods

requires cosmetics to bear on the top of the main display
panel a:
 Red or brown dot for non-vegetarian products;
 Green dot for vegetarian products;

The rule was published on 17 June 2014, with a date of

application of 1st July 2014!
There is no definition of “vegetarian cosmetics”, there is no
grace period. The industry associations are fighting the rule;
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22 Japan

 No change in the regulation;

 Two categories: Cosmetics – Quasi Drug
 Cosmetics: simple: all ingredients allowed except those
on the negative list, positive list for preservatives, organic
UV filters, Tar colors. Notification of foreign manufacturer
(1 day), notification of product (1 day), notification of
importation (2 weeks);

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23 Japan: Quasi Drug

 Whitening, acne, dandruff, skin chapping, sterilizing the

skin, “medicated product”;
 Active ingredients must be in the positive list;
 Non active ingredients must be in the positive list;
 Registration: foreign manufacturer (4-6 months); Product
registration (6 months or more); Importation license (2
weeks);
 New ingredients: tests to be done take up to 3 years and
cost is ~3MMUS$;

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24 Japan: Quasi Drug

 The recent problem on a whitening product using a

newly approved ingredient highlights, yet again, that
regulating products as “Quasi-Drug” or long approval
processes for registrations are not a guaranty for safety;

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25 Korea

 3 categories: Cosmetics, Functional Cosmetics, Quasi-Drugs;

 Cosmetics: no registration required, but need FSC, notarized
formula and BSE certificate to import products. Lists of banned
ingredients, positive lists for preservatives, colors, UV filters;
 Functional Cosmetics: Whitening, Sunscreen, anti-wrinkles.
Positive list of active ingredients. Registration takes about 6
months;
 Quasi-Drug: acne, mouthwash, hair dyes, etc. registration
takes about 10 months;
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26 Taiwan

 2 categories: cosmetics or medicated cosmetics.

Negative list, positive list for sunscreens, preservatives,
colors, hair dyes, whitening actives, antibacterial,
antiperspirant;
 Cosmetics: notification;
 Medicated cosmetics: e.g. acne, whitening, sunscreen:
registration (~ 4/6 months);

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27 THANK YOU

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