Sanitary Registration of Cosmetics in Colombia

To manufacture, market, import or spend cosmetic products in Colombia, as a member country of the Andean Community, a mandatory health notification is required, which is an alphanumeric code issued by INVIMA. It is pertinent to clarify that the
obligatory sanitary notification
is equivalent to sanitary registration, according to the final provision of Decision 516 of 2002. This regulation is part of the block of harmonization of legislation on Cosmetic Products of the Commission of the Andean Community of National of which Colombia is part and whose regulations are fully applicable in its territory.

The regulation of the mandatory sanitary notification is found in Decision 516 of 2002, which was amended and complemented by Decision 833 of 2018.

What is meant by cosmetics?

Article 1 of Decision 516 of 2002 defines them as:

Any substance or formulation of local application to be used on the various superficial parts of the human body: epidermis, hair and capillary system, nails, lips and external genital organs or on the teeth and oral mucous membranes, in order to clean, perfume, modify their appearance and protect or maintain them in good condition and prevent or correct body odors.

How are cosmetics classified?

Annex 1 of Decision 516 of 2002 establishes an indicative list of categories of products that are considered cosmetics, such as:

a) Children’s cosmetics. b) Cosmetics for the eye area. c) Skin cosmetics. d) Lip cosmetics. e) Cosmetics for body grooming and hygiene. f) Deodorants and antiperspirants. g) Hair cosmetics. h) Nail cosmetics. i) Perfumery cosmetics. j) Oral and dental hygiene products. k) Products for and after shaving. l) Tanning products, sunscreen and self-tanning products. ll) Depilatories. m) Skin bleaching products.

Additionally, CAN Resolution 1906 of 2017 incorporates the following harmonized list of cosmetic forms:

1. Oil: Substance immiscible with water, greasy, viscous and liquid at room temperature.
2. Aerosol: Pressurized form containing ingredients that are released under activation of the valve system to disperse liquids, solids or gases.
3. Bar: solid mixture that is applied by sliding.
4. Compact solid: solid mixture that needs to be dissolved for its application.
5. Wax: mixture of fatty nature; natural or synthetic; solid or semi-solid.
6. Emulsion: heterogeneous system of two or more phrases, of semisolid or fluid consistency, stabilized with an emulsifier.
7. Cream gel: colloidal system where the continuous phase is solid and the dispersed phase is liquid to which small amounts of fat are added and are at the limit of emulsions.
8. Enamel: solvent-based mixture which, when applied to a dry surface, forms a covering film.
9. Gel: colloidal system, where the continuous phase is solid and the dispersed phase is liquid.
10. Granules: small particles that are usually dissolved or dispersed in aqueous or heterogeneous media.
11. Pencil: solid paste compacted into a cylinder that imitates the shape of a common pencil, which is applied to the skin.
12. Lotion: mixture or combination of two or more phases of fluid consistency with water as the main component, which may also contain alcohol and glycols, containing the dispersed or diluted solute.
13. Impregnated Support: base that acts as a support on which the cosmetic mixture or substance is impregnated.
14. Paste: semi-solid form with a high content of finally dispersed solids, with a firm consistency.
15. Pearls: soft gelatin or polymer containers containing oily or aqueous solutions.
16. Powder: a mixture of loose or compacted solids, finally divided. A mixture of finally divided, loose or compacted solid particles.
17. Ointment: substance of a greasy nature for application to the skin. The fundamental difference with emulsions is the absence of water.
18. Solution: mixture of one or more solutes in one or more solvents.
19. Suspension: dispersed system consisting of an insoluble solid phase in a liquid or semi-liquid phase.

Which products require mandatory health notification?

Article 5 of Decision 516 of 2002 affirms the mandatory nature of the sanitary notification for the commercialization of a cosmetic product, as follows:

The cosmetic products referred to in this Decision require, in order to be marketed or sold in the Subregion, the Mandatory Health Notification submitted to the Competent National Authority of the first Member Country of commercialization. Products manufactured in the Subregion must undergo the Mandatory Health Notification in the Member Country of manufacture prior to their commercialization.

What are the requirements to apply for a health notification?

On the official INVIMA website in the section on procedures and requirements to carry out a sanitary notification, some general, legal and technical requirements that must be met in order to proceed with the notification are indicated. However, the procedure can be done in person at the INVIMA offices or, virtually, online.
virtually
.

General Requirements:

1. Consignment (Consignment slips should be pasted completely on a sheet of paper with glue or bound as a sheet. Do not staple)
2. Basic information forms, application or, if applicable, letter of request.
3. Legal information.
4. Technical information.

Legal requirements for domestic products:

The manufacture of cosmetic products in the national territory must be carried out in an establishment authorized with production capacity by INVIMA, through a visit to the establishment’s facilities where the sanitary regulatory requirements are verified and a sanitary concept is issued in order for the establishment to start manufacturing activities. The following documents are also required:

1. Completely filled out and signed form. (Must be signed by a pharmaceutical chemist with professional card, based in Colombia).
2. Payment of the established fee.
3. Product name and brand name if applicable. (It may cover several trademarks for the same Sanitary Notification, but keeping the name of the product).
4. Cosmetic group, if applicable. (Read article 10 of Decision 516 of 2002) In this case you must take into account that you can group, in the case of cosmetic creams, only products with different scents or colors, but identical product name, uses and benefits.
5. Cosmetic form. (gel, liquid, cream, emulsion, liquid, etc.).
6. Manufacturing contract with the manufacturer, or conditioner; if applicable.