Chile Cosmetic Regulation

Chile regulates cosmetic products under a comprehensive regulatory framework, with oversight and implementation carried out by the Institute of Public Health (Instituto de Salud Pública, ISP). The regulatory system covers key aspects across the product lifecycle, including market authorization, safety control, labeling, advertising, and post-market surveillance. A clear understanding of this framework is essential for companies to navigate regulatory requirements and ensure compliant placement of cosmetic products on the Chilean market.

Part 1 Regulatory Framework and the Competent Authority

1.1 Main Regulations

Chile's Decree with Force of Law No. 725 (Health Code) constitutes the overarching legal framework for public health in Chile, and underpins cosmetic market access requirements. It entrusts the ISP with responsibility for market authorization and ongoing supervision, while establishing mandatory regimes for product sanitary registration and facility licensing. The Health Code also sets out fundamental safety requirements, providing the statutory foundation for more detailed technical and administrative provisions.

Supreme Decree No. 239/2002 serves as the implementing regulation of the Health Code, setting out detailed technical requirements across the cosmetic product lifecycle. It translates the Health Code's general principles into operational provisions, covering sanitary registration procedures, ingredient safety, and product quality control. It also establishes clear compliance thresholds for labeling, claims, and post-market oversight, ensuring that products placed on the market meet national safety and quality standards.

1.2 Competent Authority

ISP acts as the primary authority overseeing cosmetic regulation in Chile, with responsibilities covering product sanitary registration, technical assessment, and supervision of manufacturing facilities. In the post-market phase, it conducts surveillance through product testing, adverse reaction monitoring, and risk control measures. It also publishes technical standards and guidance documents to complement statutory requirements and provide clarity on compliance, contributing to the overall safety and quality of cosmetic products.

Part 2 Cosmetic Compliance Requirements

2.1 Definition

The Health Code defines cosmetic products as any preparations intended for external application to the human body (including the skin, hair, nails, lips, external genital organs, teeth, and oral mucosa), with the purpose of cleaning, perfuming, beautifying, or modifying its appearance, or maintaining the normal physicochemical condition of the skin and its appendages. Such products exert only local effects and, even if absorbed, must not produce systemic effects.

2.2 Classification

Under Chile's cosmetic regulatory framework, cosmetics are classified according to a combination of functional characteristics and risk factors, as illustrated in the table below.

2.3 Sanitary Registration

2.3.1 Standard Registration Procedure

In Chile, cosmetic products—whether imported or domestically manufactured—shall obtain sanitary registration prior to being commercialized or distributed within the national territory. This requirement establishes a mandatory pre-market authorization system administered by the ISP.

The registration process begins with the submission of an application to the ISP using official forms approved by the authority, provided in the form of a sworn declaration. The application form typically includes information on the applicant, responsible technical personnel, product identity and intended cosmetic purpose, as well as the manufacturer(s). These forms must be duly signed by the applicant or its legal representative, as well as by the individual responsible for technical oversight.

In addition to the application form, the following supporting documentation shall be submitted, signed by the applicant:

• Complete qualitative formula and quantitative expression of ingredients with cosmetic activity or subject to concentration restrictions;

• Product technical file, in Spanish;

• Certification of safety for use, issued by a qualified professional;

• Legal documentation evidencing the applicant's legal status and the product's regulatory status in the country of origin;

• Proof of payment.

The ISP evaluates registration applications primarily on the basis of the product name, cosmetic purpose, formulation, and the applicant's legal capacity. Where the assessment is deemed satisfactory, the ISP shall grant sanitary registration, which shall be valid for a period of five years from the date of approval.

2.3.2 Simplified Procedure for HBO Products

Under Chile's regulatory framework, HBO products are subject to a simplified regulatory pathway. These products are deemed to be registered once the manufacturer or importer has obtained sanitary authorization, thereby linking product compliance to the authorization status of the establishment rather than to an individual product-level registration.

To operate under this simplified regime, manufacturers and importers must submit a declaration to the ISP within thirty days of commencing activities. This declaration must include information identifying the owner, the establishment's location, its line of activity, as well as the formulation and characteristics of each product. Once the required information is submitted, the establishment is formally registered under the declared line of activity.

In addition, each new HBO product must be notified to the ISP prior to its commercialization in Chile. Although registration is generally deemed to occur through establishment authorization, manufacturers and importers may voluntarily apply for full product registration under the standard registration procedure.

2.4 Ingredients

Marketing authorization holders or importers responsible for placing cosmetic products on the Chilean market bear responsibility for ensuring formulation compliance with applicable ingredient restrictions and prohibitions. Formulations shall be promptly updated whenever ingredient restrictions are revised or new prohibitions enter into force.

At present, Chile does not maintain an independent cosmetic ingredient listing system. Article 31 of Supreme Decree No. 239/2002 provides that, the competent authority shall assess cosmetic ingredients based on the lists of permitted, restricted, and prohibited substances issued by the authority. In the absence of such national lists, reference shall be made to the ingredient lists of Regulation (EC) No 1223/2009 (Cosmetics Regulation) and its subsequent amendments, while relevant information from the United States Food and Drug Administration (FDA) may be used as supplementary guidance.

In regulatory practice, ISP integrates EU cosmetic ingredient lists into its Gicona database, and may supplement them with other internationally recognized sources where appropriate, in support of ingredient evaluation and regulatory enforcement. For substances newly prohibited or further restricted in the EU prior to 2026, products containing such substances must cease importation or manufacturing, although product authorization may be retained for a limited transitional period to enable formulation adjustments for compliance purposes. This transitional period is generally about one year, and does not apply to substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMR). For future EU updates, the implementation timelines for new or revised restrictions are generally aligned with the effective dates established under EU legislation.

2.5 Labelling

Cosmetic labelling functions as both an essential brand communication tool and a legal requirement to ensure consumer safety. In Chile, cosmetic product labels must be presented in Spanish and contain accurate information, including at a minimum the following mandatory elements:

1) Product name;

2) Cosmetic purpose;

3) Full ingredient list;

4) Minimum shelf life or expiry date (where applicable);

5) Batch or lot number;

6) Net content;

7) Name and address of the product sanitary registration holder; and (where applicable) the name and address of the manufacturer or importer, as well as the country of origin;

8) Use instructions and safety warnings;

9) Product sanitary registration number;

10) Storage conditions (where applicable).

Beyond the general requirements, Chile mandates additional labelling requirements for specific product categories:

• Children's cosmetics: Must prominently display the statement "Allowed for use in children under 6 years of age";

• Sunscreen products: Must indicate the sun protection factor in line with the regulatory scale and corresponding protection category, provide guidance on reapplication intervals, and include appropriate safety warnings.

2.6 Advertising

In Chile, the advertising and promotion of cosmetic products shall be consistent with the nature of the product, and aligned with the cosmetic purpose declared in its sanitary registration. All promotional content shall be truthful, supported by scientific evidence, and must not include any terms, expressions, images, or representations that may mislead or deceive consumers. In particular, cosmetic products shall not be attributed, either directly or indirectly, with therapeutic properties, or with effects and characteristics that the product does not possess or cannot be substantiated.

In addition, cosmetic products that do not hold a valid sanitary registration may not be distributed, donated, or otherwise provided to the public for advertising or promotional purposes. The competent authority may suspend or prohibit any advertising or promotion that does not comply with these requirements.

2.7 Post-market Surveillance

Even when a cosmetic product has secured sanitary registration from the ISP and is used as intended or under reasonably foreseeable conditions, adverse reactions may still occur. Such reactions are defined as any adverse and unintended effects on human health, ranging from mild allergic reactions to life-threatening outcomes. An adverse reaction is considered serious if it leads to temporary or permanent functional impairment, hospitalization, or an immediate threat to life, or if it causes or contributes to death.

Cosmetic sanitary registration holders are required to record and manage potential adverse reactions associated with products placed on the market. Although the regulations do not mandate reporting such events to the ISP, registration holders are generally expected to proactively notify the competent authority of any known adverse reactions. Reports must be submitted using the official designated form and sent to [email protected]. To be considered valid, a report should typically include at least information on the affected individual, product details, a description of the adverse reaction and relevant time-related information, as well as reporter information.

Reported adverse reactions are reviewed and assessed by the ISP. In this process, the ISP will follow up on the relevant product, evaluate the causal relationship between the adverse reaction and the product, and, where necessary, implement appropriate control measures to prevent similar adverse reactions from occurring in other consumers.