The Ministry of Health of Guatemala has recently implemented changes in the regulatory framework governing cosmetics, following the entry into force of the RTCA SANITARY REGISTRATION REGULATIONS FOR COSMETICS, RTCA 71.03.35:21, on February 5, 2024.
This regulation includes modifications to technical requirements for the registration and updating of sanitary registrations of cosmetics, and expands the requirements for the legal documentation necessary for their registration.
Expanded documentation requirements:
- Distribution or Manufacturing Agreement: A signed contract detailing the distribution or manufacturing agreement between the parties, or an excerpt from the same.
- Notarized Power of Attorney: A document issued by the manufacturer authorizing a third party to appear as the holder of the sanitary registrations.
- Clarification Letter: A letter signed by the manufacturer explaining the commercial relationship between the manufacturer and the holder of the sanitary registration.
Purpose of the Changes: These changes are to ensure transparency and accountability in the cosmetics industry. By requiring documentation to verify the relationship between manufacturers and holders of sanitary registrations, the Ministry of Health aims to strengthen regulatory compliance and consumer safety in Guatemala.
Cosmetic companies operating in Guatemala must be aware of these regulatory changes.
If you are interested in the sanitary registration of products that are not manufactured by your company directly, you should keep in mind that you will require your manufacturer to provide this type of legal documentation so that your company can retain ownership of the sanitary registrations.
For more information or assistance on how to comply with these updated regulations, please feel free to contact [email protected] or [email protected].
For more information or assistance on how to comply with these updated regulations, please feel free to contact [email protected]or[email protected]