Costa Rica leads regulatory changes on food additives and synthetic dyes

As Pro Tempore President of the Council of Ministers for Economic Integration (COMIECO) during the first half of 2025, Costa Rica convened a meeting of the Central American Commission on Food Additives (CCAA) on March 18 to evaluate the removal of the synthetic dye Erythrosine (Red No. 3) from the Central American Technical Regulation (RTCA). A final decision is pending confirmation from one Member State. If consensus is reached, the removal will become effective on July 15, 2025, pursuant to Article 8.2 of the RTCA, which provides a 12-month period for reformulation and relabeling, with an optional 6-month extension upon industry request. Although Erythrosine remains allowed under the Codex Alimentarius, its use will be restricted in the categories and amounts based on FDA criteria.

In parallel, the Costa Rican Ministry of Health announced it is assessing the use of certain petroleum-based synthetic dyes in food products, in line with recent FDA decisions due to potential health effects in children. As part of this review, the Ministry:

  • Urges the food industry to review formulas and consider natural alternatives.
  • Will conduct a technical review of currently permitted dyes in the country, aligned with international recommendations.
  • Commits to adopting regulatory measures to protect public health, in coordination with the industry and international standards.

Free Sale Certificates from Japan accepted for medical device registration

The Ministry of Health now accepts Free Sale Certificates issued by the following Japanese entities for the registration of Biomedical Equipment and Materials (EMB):

  • Japan Association of Clinical Reagents Industries (JACRI)
  • Ministry of Health, Labour and Welfare (MHLW)
  • Overseas Medical Equipment Technical Assistants (OMETA)

Apostille requirements vary depending on the issuing entity. Private organizations (e.g., JACRI and OMETA, in some cases) must obtain prior notarization, either certifying the document’s authenticity or confirming it is a true copy. Official government issuers (e.g., MHLW) do not require notarization and can proceed directly to apostille via the Japanese Ministry of Foreign Affairs. For more information, visit MOFA Japan.

Extension of registration validity for pharmaceuticals and medical devices

On February 20, 2025, the Ministry of Health enacted Resolution MS-DM-1054-2025, extending for six months the validity of health registrations for pharmaceuticals and EMBs that expired between September 1 and December 31, 2024. This measure is part of an emergency response strategy that applies the precautionary principle. However, such registrations will not qualify for expedited renewal procedures.

Food technologist requirement removed for direct-to-consumer establishments

Resolution MS-DM-RC-1012-2025, issued on February 19, 2025, removes the requirement for food technologists in direct-to-consumer establishments such as cafeterias, restaurants, and bakeries. The Ministry of Health clarifies that “Risk B” classification, which applies to facilities serving more than 100 people, is limited to restaurants and mobile food services. As such, these businesses are not considered part of the food industry for the purpose of requiring a food technologist, provided they comply with applicable sanitary regulations.

At BLP, our Health and Regulatory Law experts are ready to assist you in navigating these changes.
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