In Chile, cosmetic products are regulated by the Instituto de Salud Pública de Chile (ISP). Within ISP, ANAMED manages the main regulatory work for cosmetics, including registration, authorizations, inspections and post-market oversight.
The regulatory route is not the same for every product. Most cosmetics require sanitary registration before they can be marketed, while certain hygiene, odorizing and low-risk products follow a simplified notification-based route under the conditions established by ISP.
This article explains the current Chile cosmetic regulations, including the role of ISP, product classification, cosmetic registration requirements, labelling, import requirements and the post-market obligations that companies should consider before selling cosmetics in Chile.
Cosmetic Regulatory Authority and Legal Framework in Chile
The Instituto de Salud Pública de Chile (ISP) is responsible for cosmetic registration and sanitary control in Chile. Under Supreme Decree No. 239, ISP also checks whether cosmetic products meet the applicable regulatory and quality requirements.
Cosmetic-related work is handled within ISP through the Agencia Nacional de Medicamentos (ANAMED). Its current cosmetic pages cover registration, notifications, establishment authorizations, safety alerts and cosmetovigilance.
Cosmetic products that need registration must receive sanitary authorization from ISP before they are sold in Chile. ISP also keeps a separate notification system for hygiene, odorizing and low-risk cosmetic products that use the simplified route.
Main Cosmetic Regulation – Supreme Decree No. 239
Chile’s main cosmetic regulation is Supreme Decree No. 239/2002, known as the Reglamento del Sistema Nacional de Control de Productos Cosméticos. It sets the rules for areas such as registration, import, manufacture, storage, distribution, sale, advertising and promotion of cosmetics.
The regulation is still in force, with later amendments incorporated into the current consolidated legal text.
What Is Considered a Cosmetic Product in Chile?
Under Chilean law, a cosmetic product is a preparation intended for external application to the human body for purposes such as beautifying, changing physical appearance, or maintaining the normal physicochemical condition of the skin and its appendages. The Health Code also makes clear that a cosmetic should have only a local action or, if absorbed, should not produce a systemic effect.
Supreme Decree No. 239 groups cosmetics into different categories. These include low-risk products, hygiene products, special cosmetics, and products meant for children under six.
The category affects the route the product follows in Chile. So, before applying, companies need to check how the product is classified and which ISP process applies.
Cosmetic Product Categories and Regulatory Routes
Chile does not use one single route for every cosmetic product. The regulatory path depends on how the product is classified under the Health Code, Supreme Decree No. 239, and the current ISP procedures.
Cosmetics Requiring Sanitary Registration
Cosmetics that are going to be sold in Chile usually need to be registered with ISP first. This applies to both locally made products and imported cosmetics.
Hygiene, Odorizing and Low-Risk Products
Certain products follow a simplified route instead of the standard cosmetic registration process. ISP currently provides a notification and simplified registration procedure for products classified as hygiene, odorizing or low risk, often referred to as HBO products.
Personal hygiene products in this group can include liquid soaps, shampoos, conditioners, toothpastes, mouthwashes, deodorants and shaving products. Solid soaps are one example of products treated as low risk by ISP.
Special Cosmetics and Cosmetics for Children
Chile also identifies special cosmetics as products that may involve additional risk because of their formulation, concentration of active ingredients or intended purpose and therefore require specific directions for use. The regulation also separately defines cosmetics intended for children under six years of age and sets age-related requirements for those products.
Cosmetic Registration in Chile
Cosmetic products that fall under the standard registration route must obtain sanitary registration from the Instituto de Salud Pública (ISP) before they can be marketed in Chile. The registration process covers the product dossier, supporting documents, applicable fees, validity, renewal and any later changes made to the registration.
Cosmetic Registration Requirements
For cosmetics that require sanitary registration, the application is submitted to the Instituto de Salud Pública (ISP). Under Supreme Decree No. 239, the filing must identify the applicant and technical director, state the product name and cosmetic purpose, indicate whether the product is manufactured locally or imported, and identify the manufacturer.
The dossier must also include the complete qualitative formula and the quantitative amount of ingredients that have cosmetic activity or are subject to concentration limits. Ingredients may be identified using the ISP cosmetic ingredient register or INCI nomenclature. A technical declaration is also required, covering items such as finished-product specifications, the analytical method used for relevant ingredients, the proposed shelf life and its technical basis, and the type of packaging.
For imported cosmetics, the legal documentation may include a Certificate of Free Sale, an official cosmetic product certificate, or another document from the health authority in the country of origin, depending on the case. The regulation also requires certification of product safety by a qualified professional.
Cosmetic Registration Process
Cosmetic registration applications are handled electronically through ISP. GICONA has traditionally been used for cosmetic registrations, but ISP is now progressively moving regulatory services to the SAFIS platform. Applicants should therefore confirm the current filing system before submitting a new application.
The current ISP process broadly follows these steps:
- Gather the technical and legal documents required for the product.
- Access the current ISP electronic filing platform using the registered holder credentials.
- Select the cosmetic registration service and complete the electronic application form.
- Upload the supporting documents in the requested digital format.
- Pay the applicable ISP fee.
- Submit the application for ISP review.
- Respond to any observations or additional requests raised during the evaluation.
- Once the review is completed, ISP issues the corresponding resolution approving or rejecting the registration request.
ISP currently lists cosmetic product registration under service code 4112001, covering products manufactured in Chile as well as imported cosmetics that require sanitary registration before they can be marketed or distributed in the country.
Registration Fees
ISP currently lists the fee for cosmetic product registration under service code 4112001 at CLP 828,750 + VAT per product. This is the current tariff shown in the official ISP service catalogue.
For hygiene, odorizing and low-risk cosmetic products that use the simplified route, ISP lists service code 4112055 at CLP 52,449 + VAT per product.
Because ISP tariffs can change, applicants should check the latest value in the official service catalogue before filing.
Registration Validity and Renewal
A cosmetic registration in Chile is valid for five years from the date of approval. Under Supreme Decree No. 239, the registration can be renewed for further five-year periods by paying the applicable renewal fee, unless the registration has been expressly cancelled.
ISP currently lists a separate renewal service for cosmetic registrations under code 4112043. The current official service catalogue shows the renewal fee as CLP 348,098 + VAT per product.
The simplified registrations or declarations used for hygiene, odorizing and low-risk products are excluded from this renewal procedure.
Changes to an Existing Cosmetic Registration
Changes made after a cosmetic has been registered in Chile may require a separate modification request to the Instituto de Salud Pública (ISP).
ISP currently lists individual procedures for changes such as:
- product name;
- product formula;
- packaging type or material;
- registration holder, licensor, importer or distributor;
- product specifications;
- analytical methods;
- shelf-life period; and
- approved product varieties.
These are handled through separate ISP services, and the applicable fee depends on the type of change requested.
Formula changes are especially important where an ingredient becomes prohibited or newly restricted. ISP’s current ingredient guidance states that registration holders and importers must review their formulations and make the required adjustments when ingredient restrictions change.
Cancellation of Cosmetic Registration
A cosmetic registration in Chile can be cancelled in certain situations. Under Supreme Decree No. 239, this may happen at the request of the registration holder or when ISP identifies serious problems with the information or product covered by the registration.
Cancellation may also be considered if there are significant undeclared changes to the product formula, serious breaches of sanitary requirements, or if an ingredient becomes prohibited, restricted or subject to a lower permitted concentration.
Requirements for Foreign Cosmetic Companies and Importers
Foreign cosmetic companies cannot treat registration and import as the same step. The product must first meet the applicable Chilean registration requirements, while the company handling the import must also comply with the establishment and import controls administered by ISP.
Local Applicant and Establishment Requirements
For cosmetic registration, ISP assigns an inscription number to the registration holder that acts directly or contracts a third party to import or manufacture cosmetics. The applicant information submitted to ISP includes the company or individual’s legal identity, representation details, Chilean tax ID (RUT), address and related corporate information.
If imported finished cosmetics are stored and distributed in Chile, the storage facility must be authorized for that activity. ISP maintains a specific authorization process for warehouses storing imported finished cosmetic products, and such facilities may store, clear and distribute those products once authorized.
Importer Authorization
For hygiene, odorizing and low-risk cosmetic products, ISP has a separate authorization procedure for establishments that manufacture or import these products. The current ISP service catalogue lists this under code 4111051.
For standard imported cosmetics, the importer must also comply with the requirements that apply to the relevant storage and distribution establishment before the products can be released for commercial use.
Import Documentation and Product Entry
Imported cosmetics are subject to ISP control when they enter Chile. ISP currently issues the Certificado de Destinación Aduanera (CDA) for products under sanitary control, while the National Customs Service handles the corresponding customs entry declaration.
After customs processing and transfer to the authorized storage location, the consignee cannot sell, distribute, use or otherwise dispose of the imported cosmetics until ISP grants the Authorization for Use and Disposal. For cosmetics, the application must include the relevant batch analysis report issued either by the foreign manufacturer or by a Chilean quality-control laboratory.
Cosmetic Labelling Requirements in Chile
Cosmetic products sold in Chile must be labelled in Spanish. Under Article 40 of Supreme Decree No. 239, the label must include at least the following information:
- Product name
- Cosmetic purpose, unless this is obvious from the product name
- Full ingredient list using INCI nomenclature, generally in descending order of concentration
- Minimum durability period or expiry date, where required
- Batch or manufacturing code
- Net content in metric units
- Name and address of the registration holder. If the manufacturer or importer is different, their details and the country of manufacture should also be shown.
- Directions for use, warnings and precautions, when these are needed.
- ISP registration number
- Storage and conservation precautions, where necessary
Some cosmetic categories have additional labelling requirements. Cosmetics intended for children under six years of age must carry the statement “Permitido su uso en niños menores de 6 años.” Sunscreen products must also display the applicable sun protection factor and related protection category according to the requirements set out in Article 40 bis of Supreme Decree No. 239.
ISP also confirms that the way the authorization number appears on the label depends on whether the product is registered or notified. Registered cosmetics and hygiene, odorizing and low-risk products therefore do not use exactly the same registration-number format.
Animal Testing Rules for Cosmetics in Chile
Chile prohibits the use of animals for safety and efficacy testing of cosmetics, personal hygiene products and odorizing products, including their ingredients, ingredient combinations and final formulations. The rule comes from Law No. 21,646, which amended the Chilean Health Code and took effect in January 2025.
Manufacturers must use alternative testing methods that do not involve animals when those methods are recognized by the Instituto de Salud Pública (ISP) or the OECD. Chile also prohibits the sale, commercialization, import and introduction into the national market of covered products that were tested on animals for safety or efficacy after the law entered into force.
The law allows limited exceptions for certain ingredient-related testing. These exceptions are subject to specific conditions, including the absence of an accepted alternative method and other criteria set out in the Health Code.
Products may use claims such as “cruelty free” or “not tested on animals” only when the conditions in the law are met. Such claims cannot be used if the product, its ingredients, ingredient combinations or final formulation were tested on animals after the law took effect, or if the manufacturer relied on those test results to demonstrate safety or efficacy.
Post-Market Requirements and Cosmetovigilance
Cosmetic oversight in Chile continues after a product reaches the market. ISP operates a cosmetovigilance system to collect, assess and follow reports of unwanted effects linked to the normal or reasonably foreseeable use of cosmetic products. The aim is to identify safety concerns and take measures when needed.
Adverse Reaction Monitoring
Consumers, healthcare professionals and other reporters can notify ISP about adverse reactions to cosmetics (RAC). Reports can cover reactions ranging from irritation and itching to more serious events that may require medical care. ISP reviews these reports together with other safety information to identify possible risks associated with cosmetic use.
Responsibilities of Registration Holders
Companies responsible for cosmetic products should continue to monitor product safety after commercialization and maintain the information needed to respond to safety concerns. Where a risk is identified, ISP may issue safety communications or take regulatory action depending on the nature of the problem.
Market Surveillance and Non-Compliant Cosmetics
ISP also monitors cosmetics that may be sold without the required sanitary authorization or that otherwise fail to comply with Chilean requirements. It provides a reporting channel for suspected illegal or non-compliant cosmetics and publishes alerts and market-withdrawal notices when necessary.
Key Considerations Before Selling Cosmetics in Chile
Before placing a cosmetic product on the Chilean market, companies should first confirm which regulatory route applies. Standard cosmetic products require sanitary registration with the Instituto de Salud Pública (ISP), while hygiene, odorizing and low-risk products follow the simplified notification route.
Imported cosmetics also need to meet the applicable local requirements before sale. ISP states that products must have the required sanitary authorization before they can be sold or distributed, and imported products must have the relevant importer declared in the registration.
Companies should also check whether the manufacturing or importing establishment requires separate ISP authorization. This is particularly important for hygiene, odorizing and low-risk products, for which ISP maintains a specific establishment-authorization procedure.
Natural or handmade positioning does not create a separate exemption from Chilean cosmetic rules. ISP specifically states that there is no special “artisanal cosmetics” category under the current regulation; products must still be manufactured in an authorized cosmetic-production facility and have the required sanitary authorization, unless they qualify for the lower-risk route.
Conclusion
Selling cosmetics in Chile requires companies to first identify the correct regulatory route for the product and then meet the requirements set by the Instituto de Salud Pública (ISP). Standard cosmetics generally require sanitary registration, while hygiene, odorizing and low-risk products may follow the simplified notification route where the applicable conditions are met.
Companies should also consider the full compliance cycle, including product classification, registration or notification, labelling, importer and establishment requirements, renewal, post-registration changes and cosmetovigilance. The exact requirements depend on the product type and the route used under Chile’s current cosmetic regulatory framework.
Need support with cosmetic registration and compliance in Chile? Explore Artixio’s cosmetic regulatory compliance services for support with product registration, labelling, ingredient compliance and market-entry requirements.
FAQs
1. Who regulates cosmetic products in Chile?
The Instituto de Salud Pública de Chile (ISP) is the authority responsible for sanitary control and registration of cosmetics in Chile. Cosmetic-related activities are handled within ISP through ANAMED.
2. Do all cosmetics need ISP registration in Chile?
No. Standard cosmetic products generally require sanitary registration, while products classified as hygiene, odorizing or low-risk cosmetics can use the simplified authorization route provided by ISP.
3. How long is a cosmetic registration valid in Chile?
A cosmetic sanitary registration is valid for five years from the date of approval. It can be renewed for further five-year periods by paying the applicable fee, provided the registration has not been cancelled.
4. How much does cosmetic registration cost in Chile?
ISP currently lists the standard cosmetic registration fee at CLP 828,750 + VAT per product. The simplified authorization for hygiene, odorizing and low-risk cosmetics is currently CLP 52,449 + VAT per product. Applicants should verify the current ISP tariff before filing because fees can change.
5. Can foreign companies import cosmetics into Chile?
Imported cosmetics must meet the applicable ISP registration and import requirements. The local holder/importer and the relevant storage or importing establishment may also need to meet separate authorization requirements before the products can be commercially released in Chile.
6. Do natural or handmade cosmetics need authorization in Chile?
Yes. ISP does not provide a separate exemption simply because a product is described as natural or artisanal. The applicable registration or simplified authorization route still depends on how the product is classified under Chilean cosmetic rules.
7. How can companies check whether a cosmetic is authorized in Chile?
ISP provides separate online databases for registered cosmetic products and notified low-risk products, allowing users to verify whether a product has been authorized in Chile.
8. Do cosmetics intended only for export need registration in Chile?
Cosmetic products manufactured exclusively for export do not need Chilean sanitary registration, but the authorized manufacturing laboratory must notify ISP. If those products are later distributed or sold within Chile, sanitary registration is required before commercialization.
