Sri Lanka Cosmetics Regulation

In Sri Lanka, cosmetic products are regulated by Cosmetics, Devices & Drugs Regulatory Authority (CDDRA) under the Cosmetics, Devices and Drugs Act No. 27 of 1980 and Cosmetics, Devices and Drugs Regulations. Defined in the Act, cosmetic refer to 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. For the purpose of supervision, cosmetic products are divided into controlled cosmetics and general cosmetics. Controlled cosmetics are those that have the potential to be absorbed through the skin or mucous membrane or contain substances that maybe harmful or are promoted for use in children and the products not listed under controlled cosmetics are general cosmetics. Controlled cosmetics are subject to more stringent control than general cosmetics.

All cosmetics, manufactured, imported, sold and distributed and offered for sale in Sri Lanka should be registered under the provisions of the Act. Manufacturers/importers are responsible for applying to the CDDRA to have their products registered. The registration holder either manufacturer or importer must in writing declare that they are responsible for ensuring safety quality and efficacy of the registered cosmetic product and that the product complies with all existing regulations. Full registration of a cosmetic will be valid for a period of 5 years. Under certain circumstances provisional registration may be granted for a period of one year. Provisional registration will be granted for a:

  • New cosmetic product
  • New manufacturer
  • New formulation of an existing product
  • Products which have been suspended due to quality problems will be given provisional registration on reapplication for registration

The industry maybe allowed manufacturing or importing unregistered products for the sole purpose of a selective test sampling or clinical studies before its registration. However, prior approval from the CDDRA must be obtained for such activities.

All properly submitted applications for registration as cosmetics will be reviewed by the Cosmetic Evaluation Subcommittee (CESC) appointed by the Cosmetics, Devices and Drugs Technical Advisory Committee (TAC). The evaluation may be done by internal evaluators and sometimes both internal and external evaluators. 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.

Labelling Requirements

The containers of all cosmetics imported, manufactured, processed or packed locally or sold or exposed for sale should have labels bearing the following information.

GENERAL COSMETICS

  • The brand name, type of product
  • Product category
  • The weight / volume of contents
  • The date of manufacture
  • If it is not stable for at least 36 months include “Best used before” / Expiry date
  • The batch number or lot number assigned by the manufacturer
  • The product registration number (optional)
  • Country of manufacture and the name and address of the manufacturer
  • The name and address of the company or person responsible for marketing the product locally
  • The function of the product unless it is clear from the presentation of the product
  • Instructions on use unless it is clear from the product type or presentation
  • Special precautions to be observed in its use
  • Warning statements

CONTROLLED COSMETICS

In addition to the labelling requirement stipulated above, controlled cosmetics” are required to bear an ingredient declaration.

All items should have their labeling at least in the English language, but preferably in all three languages (English, Sinhala, and Tamil).