Governing Rules for Cosmetics Import Registration
The Drugs and Cosmetics Act and the new Indian Cosmetic Rules, 2020 have specific rules which govern the Import Registration of any Cosmetic product before it is imported and sold in India. A brief of the specific rules that matter to the Foreign Cosmetics manufacturer is as under :
Rule 129: Registration of Cosmetic Products Imported into the country
Registration of Cosmetic Products Imported into the country.
Rule 129 A: Form and manner of application for Registration Certificate.
An application for issuance of Registration certificate in Form 43 must be submitted on SUGAM Portal online in Form 42. The Checklist of all documents must be followed as per Guidance document issued by CDSCO along with the Fees of USD 2000 per category and USD 50 per variant of a product. Government fees of USD 2000 per category are defined as per Guidance document Page 3-4, column 3. Category fees of USD 2000 per category are as per Column 3 only.
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Rule 129 B: Registration certificate for the import of cosmetics
Single application or registration certificate in form 43 may be issued in respect of import of one or more cosmetics manufactured by the same manufacturer. Provided that the cosmetics are manufactured at one factory or more than one factory functioning co jointly as a single manufacturing unit.
Rule 129 C: Grant of RegistrationCertificate
Once the application is submitted on SUGAM in Form 42 and if licensing authority is satisfied according to rule 129 A and with respect to Schedule D III then it may issue registration certificate in form 43 within 6 months from date of receipt of an application. If an applicant does not receive a registration certificate within the expected period may appeal to the Central Government.
Rule 129 D: Duration of Registration Certificate
Validity of Registration certificate in Form 43 is 3 Years from the issue date. Applications need to apply 6 months before expiry for renewal.
Rule 129 E: Suspension and Cancellation of Registration Certificate.
Registration certificate once Issues lists the Conditions mentioned in the Certificate which must be followed. If the manufacturer or his authorized agent fails to comply with any of the conditions of the Registration Certificate, the licensing authority may after giving him an opportunity to show cause why such an order should not be passed, by an order in writing, stating the reasons therefor, suspend or cancel the Registration Certificate for such period as it thinks fit either wholly or in respect of some of the cosmetics to which it relates: Provided that a person who is aggrieved by the order passed by the licensing authority under this rule may, within thirty days of the receipt of the order, appeal to the Central Government and the Central Government may after such enquiry into the matter as it considers necessary and after giving the said appellant an opportunity of being heard pass orders as it thinks fit.
Rule 129 F: Prohibition of import of certain cosmetics.
No cosmetic, the manufacture, sale or distribution of which is prohibited in the country of origin,shall be imported under the same name or any other name except for the purpose of examination, test or analysis
Rule 129 G :Standard for imported cosmetics
Cosmetic Products have to comply with the specifications prescribed under Schedule S and Schedule Q or any other standard of quality and safety of CDSCO & BIS from time to time . No cosmetic shall be imported unless it complies with the specifications prescribed under Schedule S and Schedule Q or any other standards of quality and safety applicable to it, and other provisions under the rules.
Finished products specific standards as per Bureau of Indian Standards. The following cosmetics in finished form shall conform to the Indian Standards specifications laid down from time to time by BIS (+30) Skin Powders. / Skin Powder for infants./ Tooth Powder./ Toothpaste./ Skin Creams. / Hair Oils. /Shampoo, Soap-based. / Shampoo, Synthetic-Detergent based. / Hair Creams. / Oxidation hair dyes, Liquid. / Cologne./ Nail Polish (Nail Enamel). / After Shave Lotion. / Pomades and Brilliantines. / Depilatories Chemical. / Shaving Creams. / Cosmetic Pencils. / Lipstick. / Toilet Soap. / Liquid Toilet Soap./ Baby Toilet Soap. / Shaving Soap. / Transparent Toilet Soap./ Lipsalve / Powder Hair Dye / Bindi (Liquid). / Kum Kum Powder / Henna Powder …etc.
Contains a list of permitted dyes and pigments in soap and cosmetics as below:
IS 4707 (Part 1) Ingredients Generally recognized as Safe (GRAS) given in dyes, colors and pigments
IS 4707 (Part 2) Ingredients Generally not recognized as safe (GNRAS)
a) Annex A – List of substance which must not form part of the composition of cosmetic products.
b)Annex B – List of substances which cosmetic products must not contain except subject to the restrictions and conditions laid down.
c) Annex C – List of preservatives which cosmetic products may contain.
d) Annex D – List of U.V. filters which cosmetic sunscreen products may contain.
RULE 129H: Labeling and Packing of Cosmetics
No cosmetic shall be imported unless it is packed and labeled in conformity with the rules in Parts XV and as per RULE 148 , RULE 148 A , RULE 148 B and RULE 149, rule 149 A.
RULE 133: Import through points of entry
No cosmetic shall be imported into India except through the points of entry specified in rule 43A by CDSCO.
RULE 134: Cosmetic to contain Dyes, Colours and Pigments
No Cosmetic shall contain Dyes, Colours and Pigments other than those specified by the Bureau of Indian Standards (IS:4707 Part 1 and Part 2 as amended) and Schedule Q. The permitted Synthetic Organic Colours and Natural Organic Colours used in the Cosmetic shall not contain more than:
(i) 2 parts per million of arsenic calculated as arsenic trioxide.
(ii) 20 parts per million of lead calculated as lead.
(iii) 100 parts per million
RULE 134-A: Prohibition of import of cosmetic containing Hexachlorophene
CDSCO Mandates that No cosmetic containing hexachlorophene shall be imported in India and a Declaration for the same must be submitted to CDSCO along with Application in Form 42 for the same as well.
RULE 135. Import of cosmetic containing Lead or Arsenic compound prohibited
The approved Limits as per BIS and CDSCO for lead is less than 2p ppm and Arsenic is less than 2 ppm
RULE 135-A: Import of cosmetics containing mercury
Cosmetics imported into India shall contain mercury in the following proportion, namely;
(a) in cosmetics intended for use only in the area of eye, the level of mercury not exceeding seventy parts per million (0.007 per cent.) of mercury, calculated as the metal, as a preservative;
(b) in other finished cosmetic products, unintentional mercury shall not exceed one part per million (1 ppm)
RULE 135-B: Prohibition of import of cosmetics tested on animals
No cosmetic that has been tested on animals must be imported in india. CDSCO expects us to submit a undertaking along with our application in Form42 issued from the Legal or Actual manufacturer stating that the cosmetics products intended to be imported in India has not been tested on animals on or after the date 12.11.2014 as per circular, file no. 18- 12/2013-DC/part file dated 03.02.2015
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