Defined in the Act, “Cosmetic” includes;

any substance or mixture of substances manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth and includes deodorants and perfumes.

Provisions Under The Act

All cosmetics, manufactured, imported, sold and distributed and offered for sale in Sri Lanka should be registered under the provisions of the Act.

Cosmetic manufacturers and importers within or outside Sri Lanka intending to market their products in Sri Lanka should register their products.

• The application for registration shall be made along with the required documents in Schedule IV Form A of Cosmetics, Devices and Drugs Regulations – (The gazette of the Democratic Socialist Republic of Sri Lanka (Extraordinary) No. 378/ of 1985.)
• The documents required for registration should be in English and submitted in a hard file cover.
• The documents for registration are processed only if they are complete.
• Separate applications should be made in respect of each cosmetic to be registered. [i.e. products containing the same ingredients but made to different formulations (in terms of strength/ content of ingredient(s), form, description, etc) or by a different manufacturer].
• Products of foreign manufacturers should be submitted through a local agent.

Pre-requisites for registration of a cosmetic

• Obtaining Sample Import Licence
  by submitting
  • a copy of business registration certificate of the applicant
  • letter of authorization from the manufacturer appointing the local agent
  • request of a local agent

Data Requirements

All the certificates for registration of cosmetic should be signed by an Authorized Officer.

General Documents/ Requirements

• Copy of sample import licence
• Original or Certified Free sale certificate
• Original Certificate of Analysis
• Master Formulation with the composition in percentages and the functions of all the ingredients certified by authorized officer.
• List of countries which the cosmetic is approved or registered for sale
• Fully packed samples and the labels of cosmetics in the form that is intended to be marketed
• Stability data

(i.e. THE APPLICANT FOR PRODUCT REGISTRATION/ LOCAL AGENT)

The applicant should be responsible for the product and all information supplied in support of his application for registration of the product.

He should be responsible for updating any information relevant to the product/ application. The CDDRA should be informed in a timely manner any change in product information during the course of evaluation, and after product registration, especially if the information pertains to rejection/ withdrawal, additional data on product safety or current Good Manufacturing Practice (cGMP) compliance of the manufacturers.

He should provide additional documents for renewal of registration (Provisional/ Full), six months before the expiry of certificate of registration.

The marketing authorization holder must assume responsibility for the quality and safety of his products.

The fee for registration of cosmetics is specified in Schedule II of the regulations and last amendment is the gazette notification no. 1601/15, May, 2009 and will be subjected to revision from time to time.

Processing Fee

• Processing fee for the registration of cosmetic is Rs.500 (five hundred) + VAT.

Certificate of Registration

The fee for the issue of a -

• Certificate of (for five years) Registration of a cosmetic for the first time is Rs.5000 (five thousand) + VAT.
• Certificate of (for five years) Registration of a cosmetic for the first time for Local Product is Rs.1000 (one thousand) + VAT.
• Provisional Certificate of registration for a cosmetic is Rs.2000 (two thousand) + VAT.
• Provisional Certificate of registration for a cosmetic local product is Rs.500 (five hundred) + VAT.
• Renewal of certificate of full registration is Rs.2500 (two thousand five hundred) + VAT.
• Duplicate copy of the certificate of registration if the original is damaged or lost which bears the words “Duplicate Copy”: Rs.1000 (one thousand) + VAT.
• Amended copy of certificate of registration is Rs.1000 (one thousand) + VAT.

Licence to import cosmetics:

The fees for the issue of a –

• licence to import registered cosmetic is Rs.2000 (two thousand) + VAT.
• licence to import cosmetic samples for test, examination fee is Rs.100 (one hundred) + VAT.
• Amended copy of certificate of import licence is Rs.1000 (one thousand) + VAT

If the market authorization holder fails to comply with the conditions of registration of that cosmetic, the authority may remove the name of the cosmetic from the register of cosmetics after seeking the opinion from the Cosmetics Evaluation Sub-Committee.

Mode of Payment

The payment should be made shroff counter of Ministry of Health.

Any application made is not refundable once a application has been submitted and payment confirmed. Applications without the correct fees will not be entertained.

Multiple Applications

A separate application is required for each product i.e. product containing the same ingredients but made to different specifications (in terms of strength/ content of ingredient(s), dosage form, description, etc.) or by a different manufacturer shall require a separate application for product registration.

Decisions of the Cosmetics Evaluation Sub-Committee (CESC)

A regulatory decision is made based on the outcome of the evaluation of the submitted documentation. The evaluation may be done by internal evaluators and sometimes both internal and external evaluators. The final decision will be notified to the applicant.

Product Identification Number

An identification number will be allocated by the authority when a product application is deemed to have satisfied the registration requirements. The identification number is specific for the product registered with the name, identity, composition, characteristics, origin (manufacturer) and market authorization holder. It may NOT be used for any other product.

The following prefix is used before the product identification number.

CR – Cosmetic Registration

Award of Registration Certificate

The registration certificate will be issued in the format given in Schedule III, Form A of regulation 5(2).

Validity Period of Registration

The Full Registration of a product is valid for a period of five years and is specified in the certificate.

The Provisional Registration of a product is valid for a period of one year and is specified in the certificate.

If the product is Temporarily Rejected, the market authorization holder will have to furnish additional information requested by the authority within 3 months to facilitate further evaluation.

If the requirement for registration is not fulfilled satisfactory the application will be rejected completely.

Renewal of Registration

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

A grace period will extend until the decision is given to the application for renewal.

Cancellation of Registration

The authority may cancel the registration of any product if:

• The composition of the product has been changed or
• Any of the conditions of registration of the product has been contravened or changed, or
• Any report on adverse reactions of serious nature have been received from national or any international sources, or
• The information which was furnished at the time of application is later found to be false or insufficient.
• For any other matters as specified by the authority at the time of cancellation.

Any applicant/ market authorization holder aggrieved by the decisions of the CDDA may make a written appeal to the CDDA/CESC. All notice of appeals must be made within thirty days from the date of the CDDA notification.

Change in Particulars of Registered Products

Any change in product name, packaging, contents of product label, package insert, or product literature, or any relevant particulars of the registered product should be made with prior to approval of the authority.

The registration of the product maybe cancelled if changes are made without the prior approval of the authority.

Criteria for Registration

A product will be registered only if it satisfies all requirements of the CDDA, especially with respect to safety and quality of the product.

Product Label

The following information should be present on the labeling of the product.

Outer label/ Secondary packaging material

• Name of product [Complete name with brand name (if any)]
• Formulation
• Name and address of the manufacturer and local agent
• List of ingredients
• Batch number of the product
• Storage conditions (If any to be mentioned)
• Manufacturing date and Expiry date
• Instructions to use
• Necessary warnings

Inner label/ Immediate packaging material/ Primary Packaging material

• Individual name for each product
• Individual Batch number for each product
• Name and Address of manufacturer
• Individual expiry date of each product

*Exempted for products which their weight is less than 15ml/ 15g and pencils