Cosmetics

OBJECTIVE OF REGISTRATION

• To ensure that cosmetic products in Sri Lanka are safe and not injurious and harm to health.
• To prohibit the use of certain toxic substances as ingredients in cosmetic products.
• To ensure that cosmetic products are properly labelled with batch markings and listing of ingredients used.
• To protect from whitening products.

‍How to register your product 

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 1 .For Imported cosmetics

A.   Documents for Obtaining Sample Import License

• Fulfilled application form [12 KB]
• Business Registration Certificate
• Valid Original Letter of authorization(as a Sole Agent LOA or Tabulated LOA)
• Declaration from the manufacturer stated no more Importers registered in Sri Lanka.
• Filled and signed declaration form.
• Product label (Art work/Scanned commercial label)

B.   Data Requirement for Preparation of Cosmetic Application for Registration

1. For Imported cosmetics

1. Fulfilled “Schedule I form A & B” application [75 KB]
2. Copy of sample import license.
3. Valid and original free sale certificate or certificate issued by the cosmetic regulatory body/chamber of commerce (It should be attested by the Sri Lankan embassy in the respective country).
4. Original Letter of authorization issued by the product (Brand) owner within a three year period, clearly indicating the product/Brand owner, product with brand name, manufacturer, and the local authorized agent in Sri Lanka.
5. Copy of business registration certificate.
6. Certificate of analysis report for finished product with specifications and results.
7. Composition:the ingredient list by their chemical name with CAS number, function and include their exact quantities (w/w%).
8. Declaration confirming the finished product is free from steroids issued by the manufacturer (for leave-on skin care products).
9. Original art work of the product labels.
10. Cosmetic product safety report for the finished product signed by a qualified person.
11. Material Safety data
12. Valid ISO 22716:2007 Certification/ GMP Certificate issued by the cosmetic regulatory body of the country of origin for the cosmetic manufacturing plant.
13. Fully packed samples (two) of cosmetics in the form that is intended to be marketed(including Lot no., Manufacturing  Date,Expiry date, Manufacturer’s & Importers details)
    • Documents should be in English, in a legible font size, printed in one side A4 and submitted in a hard file cover, and all pages should be numbered from top to bottom and vice versa with an index.
    • Separate applications should be made in respect of each cosmetic to be registered. [i.e.different brands etc.]. Products of foreign manufacturers should be submitted through a Marketing authorization Holder.
    • Up to ten (10) colour variant within the same cosmetic product series can be submitted under a single application file. This applies to cosmetic products such as: Nail Polish, Hair Dye, Hair colour, Lipstick, Lip liner, Eye Shadow, Eye Liner, Eye pencil, Mascara, Concealer, Colour corrector, Contour, Foundation, Face Powder
      • Please note: For this type of submission,the formula, packaging, product features, and all other parameters must be identical, except for the colour of the cosmetic product. Applicants must submit the formula, label, and test reports for all ten colour variants as part of the single file. The applicable fee for this single file submission will be equivalent to the total fee for ten separate files, as previously charged.

2. For Locally manufactured cosmetics

First step: Obtain the acknowledgment letter from the Manufacturing Division of the NMRA by visiting on Thursday. This letter is required for the ISO inspection by the SLSI (Sri Lanka Standards Institution) for the manufacturing facility’s compliance with ISO 22716:2007 certification.

Once got the ISO22716:2007 Certification for the facility can proceed with the product registration.

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1. Fulfilled “Schedule I form A & B” application [75 KB]
2. Copy of business registration certificate.
3. Certificate of analysis report for finished product with specifications and results issued by SLAB accredited laboratory or as per the SLSI standards Note: Heavy metal test results (for Pb, Hg, As, Cd) are mandatory for the skin care products.
4. Composition:the ingredient list by their chemical name with CAS number, function and include their exact quantities (w/w%).
5. Environmental protection License issued by Central Environmental Authority of Sri Lanka.
6. Declaration confirming the finished product is free from steroids issued by the manufacturer (for leave-on skincare products).
7. Original art work of the product label.(Label should be in three languages including Sinhala, Tamil and English)
8. Material Safety data
9. Valid ISO 22716:2007 Certification/ GMP Certificate issued by the cosmetic regulatory body of the country of origin for the cosmetic manufacturing plant.
10. Fully packed samples (two) of cosmetics in the form that is intended to be marketed (including Lot no.,Manufacturing  Date, Expiry date,Manufacturer’s  details)
    • Documents should be in English, in a legible font size, printed in one side A4 and submitted in a hard file cover, and all pages should be numbered from top to bottom and vice versa with an index.
    • Separate applications should be made in respect of each cosmetic to be registered. [i.e,different brands etc.]. Product owner should submit the files to NMRA.
    • Up to ten (10) colour variant within the same cosmetic product series can be submitted under a single application file. This applies to cosmetic products such as: Nail Polish, Hair Dye, Hair colour, Lipstick, Lip liner, Eye Shadow,Eye Liner, Eye pencil, Mascara, Concealer, Colour corrector, Contour,Foundation, Face Powder
      • Please note: For this type of submission,the formula, packaging, product features, and all other parameters must be identical, except for the colour of the cosmetic product. Applicants must submit the formula, label, and test reports for all ten colour variants as part of the single file. The applicable fee for this single file submission will be equivalent to the total fee for ten separate files, as previously charged.

Validity Period of Registration

• The Provisional Registration for a period of two year (or one) will be issued for first time registration and is specified in the certificate.
• The Full Registration of a product is valid for a period of five years and is specified in the certificate.
• When additional data are requested, the applicant will have to furnish additional information requested by the authority within 3 months to facilitate further evaluation.
• If the product is rejected, the market authorization holder will be able to appeal for registration within a one month. If not it will not be considered.

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Renewal of Registration

• Application for renewal should be made before six months from the date of expiry of registration.

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Flow Chart of Registration Process of Cosmetic is as Follows

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Steps involved for registration of cosmetic

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