Chile Cosmetics Regulations

The beauty and personal care market in Chile have experienced remarkable growth, reaching a staggering $3.3 billion in sales in 2021. Among the various segments, colour cosmetics have emerged as the trendsetters, captivating consumers with innovative products and vibrant shades. Chile stands out as the most competitive country in Latin America and the Caribbean, thanks to its stable macro-economic environment and investment-friendly policies, attracting both domestic and international players to its burgeoning cosmetics market. With a projected compound annual growth rate (CAGR) of 2.65% during the forecast period from 2020 to 2025, the Chilean cosmetics product market continues to show promising prospects, offering ample opportunities for growth and innovation within the industry.

Cosmetic products play a significant role in our daily lives, helping us maintain personal hygiene and enhance our appearance. However, behind the scenes, there are stringent regulations in place to ensure the safety and efficacy of these products. In Chile, the regulation of cosmetics is overseen by the Ministry of Health, which continuously updates and enforces laws to protect consumers and the environment.

Definition Of Cosmetics According To Chile Cosmetic Regulations

Preparations ordained for external application on human body for beauty purposes, physical aspect modification, and conservation of the normal, physical or chemical condition of the skin, hair, mucous membrane, nails, outer genital region and teeth.

The Legislation Distributes Cosmetics In Two Categories

High Risk Cosmetics

These include colored makeup, sanitizers, body lotions/treatments, insect repellent, anti-ageing treatments etc.

Low Risk Cosmetics

These include-Nail cosmetics such as nail removers, nail enamel; hair cosmetics such as body hair remover wax, shampoos, sprays, conditioners; sanitary pads(disposable) and tissues; perfumes and toiletries such as deodorants, eau de toilettes, perfumes; mouthwash and shaving products.

Chile Regulatory Authorities

INSTITUTE OF PUBLIC HEALTH (ISP)-Cosmetics in Chile are registered at National Regulatory Agency INSTITUTE OF PUBLIC HEALTH (ISP).
AGENCIA NACIONAL DE MEDICAMENTOS (ANAMED) - Under ISP the cosmetics registration and notification process is done by ANAMED.

Chile Regulatory Process By ISP And ANAMED

The registration process is carried out by Chilean regulatory entity (ISP) so that products can be marketed and distributed in the country. The validity of registration is of 5 YEARS. At the end of this period the company must re-register the product. Only legally established local companies can carryout the registration or notification of cosmetic products in Chile.

For cosmetic registration- The name, cosmetic purpose, formula of product and legal status of the applicant must be verified.

If the evaluation request is positive the registration resolution can be issued which include the detailed about the conditions under which the product can be marketed but on the other hand if the registration by ISP is denied the product cannot be marketed.

If foreign company want to import and register then their products should be manufactured in independent lab, should have pharmaceutical consulting company, law firm or they should appoint a representative to operate the registration process. Also, the company should have pharmacist in their staff.

Registration Fee Structure

For High Risk Cosmetics (Approx):

US $835 (valid for 5 years); US $350 (renewal fee for additional 5 years)

For Low Risk Cosmetics (Approx)

US $55

Items Given To ISP For Registration Are-

Sample Of The Product To Be Marketed,
Complete Ingredient List And Formula Used For Manufacturing Product,
Quality Specifications,
QC and QA Tests Reports,
Labels Written In Spanish,
Certificate of Free Sale Given By State Or Federal Authority In US

Stages For Cosmetics Registration in Chile

Stage 1 – Registration and Notification With The ISP

After the completion of making stable formula by QF or cosmetic lab pharmacist (here stable formula represents that the product is free from microbes, has standard pH, accepted viscosity and solubility, etc. company has to make agreement with cosmetic laboratory, ware house rental agreement.

Further company has to cancel the tariff in the ISP of the notification and registration.

Stage 2- Process of Purchasing The Elements Necessary For Elaboration Of Cosmetic Product

After obtaining the notification from ISP company will buy raw materials from the cosmetic suppliers and containers exactly same which were sent to the agreement laboratory.

Later the labelling should be done with the registration number which was provided by the ISP.

Stage 3- Start Manufacturing The Product To Be Distributed And Marketed In The Country

The lab delivers the product already filled and labelled which is to be dispatched to the warehouse as indicated by the client. The remaining raw materials and containers and cosmetic formula will be used to manufacture further batches of cosmetic.

Cosmetics Labelling Regulations In Chile

Cosmetics products are mandatory to have all the labelling of containers and packaging in Spanish language only. Information to be given on the product is given below:

Name of the product
Cosmetic formula given according to INCI nomenclature of cosmetic ingredients. Order should be in descending concentration.
Duration of the product to be used or expiration date.
Any warnings, indications or instructions to be given for use storage or conservation.
Quantity of the product in metric units.
Production or batch number code or key.
Name and address of the registration holder and producer or importer.
The phrase to be written in children cosmetics stating that product is permitted only for children younger than 6 years of age (“permitido su uso en niños menores de 6 años”).
In sun screening products, SPF factor to be written in accordance with certain parameters and other information.

Cosmetic soaps which contain ingredients like triclosan or triclocarbon should not make any direct or indirect therapeutic claims on their labels by using the terms such as antiseptic, disinfecting or any claims on personal hygiene.

Animal Testing per Cosmetic Regulations In Chile

Chile is second South American country to prohibit animal testing for finished cosmetics as well as their ingredients by following federal bill. On 26 January 2024, a significant stride in animal welfare and cosmetic safety was achieved in Chile with the enactment of Law No. 21646, as published in the Diario Oficial de la Republica de Chile. This law prohibits the use of animals for testing the safety and efficacy of cosmetics, personal hygiene, and odorization products, as well as their individual ingredients or formulations. In line with this mandate, manufacturers are now required to employ alternative testing methods that do not involve animal subjects to demonstrate product safety and effectiveness, as per the standards outlined in the Sanitary Code. Amendments to Law No. 20.380 on the protection of animals underscore this prohibition, with strict penalties established for any infringements. However, exceptions to the ban on animal testing are permitted under certain conditions, such as when no alternative testing method is recognized, or when widely used ingredients are subject to specific restrictions. This legislation marks a pivotal step towards promoting cruelty-free practices in the cosmetic industry while upholding public health and safety standards in Chile.

For any assistance with cosmetic regulatory affairs, import in Chile, please reach out to info@artixio.com

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