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Chile Cosmetic Product Registration

COSMETIC REGISTRATION IN CHILE

Regulatory Authority

  • Institute of Public Health, ISP

Link for Regulatory Authority

N/A

Local Regulation

N/A

Who can Register?

a. Chilean legislation requires that cosmetics products be registered at the Institute of Public Health.
b. The health authority also mandates that only companies -local or foreign – legally established in Chile may file for registration.

Data to be Communicated

Product Information File:

a. Product samples
b. Complete qualitative and quantitative formula
c. Quality specification
d. Label written in Spanish.
e. Stability tests and quality control
f.  A free sale certificate granted by a state or federal authority in the United States is notarized and legalized at a Chilean Consulate.
g. Name
h. Cosmetic purpose
i.  Qualitative formula with ingredients in INCI nomenclature
j. Information on the expiration date, storage precautions, and indications ISP registration approval number

Process to Register Cosmetic Product

Registration Fees

The registration fee for high-risk cosmetics amounts to around US $835 per product, which remains valid for a duration of five years. For renewal, extending validity for another five years, an approximate fee of US $350 is required. Conversely, the registration fee for low-risk cosmetics is approximately US $55.

Additional Information

Labelling Information

Labelling must be in Spanish and contain the following:

  • Product name
  • Purpose of the cosmetics
  • Qualitative formula with ingredients listed according to INCI nomenclature.
  • Details regarding expiration date, storage precautions, and usage indications
  • Approval number from ISP registration

Animal Testing

Chile has implemented stringent measures, severely limiting the sale or importation of products developed through reliance on animal testing conducted globally. Under these regulations, any items subject to animal testing, regardless of where the testing occurred, face significant restrictions in their availability within the Chilean market. 

This policy reflects Chile’s commitment to animal welfare and aligns with global trends towards ethical and cruelty-free practices in product development and testing. By enforcing such restrictions, Chile aims to encourage the use of alternative methods for product testing, promoting innovation while minimizing harm to animals. 

These regulations underscore Chile’s proactive stance in addressing ethical considerations surrounding animal testing and signify its dedication to fostering a more humane and responsible approach to product development and trade.