Bill 530.

First debate (committee stage)
  • TypeBill
  • 530
  • FiledSeptember 22, 2025

Summary.

The bill prohibits the manufacture, importation, sale, packaging, offering and distribution in Panama of food for human consumption containing the synthetic artificial colorants listed in its Annex A. It covers food and beverages produced, packaged, imported, distributed or sold in the country, including processed products, nonalcoholic beverages, confectionery, breakfast cereals, frozen products and infant foods. It excludes inputs intended exclusively for nonfood industrial uses. It defines synthetic artificial colorant, food and the competent health authority: MINSA, through the Food Safety Directorate (Dirección de Inocuidad de Alimentos) and, where applicable, the Pharmacy and Drugs Directorate (Dirección de Farmacias y Drogas).

MINSA could grant limited, temporary exceptions, through a reasoned and published resolution, for ingestible pharmaceutical products requiring more time for technical reformulation and for substantiated cases of force majeure. Replacement would remain mandatory within the maximum period it sets. Manufacturers, importers and sellers would have to prevent food containing prohibited colorants from entering the market, disclose information about formulations and labels, keep supplier records, withdraw affected products from the applicable date and inform consumers of the withdrawal. They would also have to ensure that labels and claims about the absence of synthetic artificial colorants are accurate. Natural colorants used would be identified in ingredient lists by their technical names or E numbers, where applicable; MINSA would issue supplementary labeling and verification rules.

The maximum period for eliminating synthetic colorants from food products would be 2 years from promulgation, with possible sector-specific extensions supported by reasons and technical justification. As a reference for the transition, the text mentions FOA and the deadline the FDA set through January 2027 for food in its revocation of Red No. 3. MINSA, through the Food Safety Directorate, would inspect facilities, take samples, conduct laboratory analyses and verify documents at plants and points of importation and sale. It could coordinate controls with the Ministry of Commerce and Industries (Ministerio de Comercio e Industrias, MICI), the National Customs Authority (Autoridad Nacional de Aduanas) and municipal authorities. The bill provides for a national monitoring program and certification of accredited public and private laboratories.

Noncompliance would result in fines scaled to volume and severity, withdrawal or detention of batches, seizure, suspension of sales or health permits, and closure in serious or repeat cases, without prejudice to other liabilities. The bill provides for criminal liability for fraud involving adulteration or deliberate false labeling. It creates a replacement program administered by MINSA, in cooperation with MICI, the University of Panama (Universidad de Panamá), the Technological University of Panama (Universidad Tecnológica de Panamá) and research centers, to offer assistance, temporary incentives, reformulation testing and training to food producers and micro, small and medium-sized enterprises. MINSA would promote natural alternatives, assess substances authorized by agencies such as the FDA, and could update Annex A and issue technical rules. The annexes list prohibited colorants and plant, floral, microbial and mineral alternatives. The proposal concerns the cited health and commerce authorities, laboratories, manufacturers, importers, distributors, food retailers, pharmaceutical producers and consumers.

What it proposes.

  • Prohibition of synthetic artificial colorants in food for human consumption.
  • Transition, labeling, health surveillance and penalties.
  • Support for replacement with alternatives of natural origin.

Who it would affect.

  • Food and beverage manufacturers and producers.
  • Food importers, packagers, distributors and sellers.
  • Producers of ingestible pharmaceuticals subject to temporary exceptions.
  • Laboratories participating in colorant monitoring.

Key points.

  1. Prohibits food containing the colorants listed in Annex A and applies to food and beverages for human consumption sold in Panama, excluding inputs for nonfood industrial uses.Arts. 1-4
  2. Allows reasoned, temporary exceptions for certain ingestible pharmaceuticals and cases of force majeure, without removing the replacement obligation.Art. 5
  3. Requires disclosure of information about formulations and labels, supplier records, withdrawal of affected products, notice of withdrawal and verification of labeling claims.Arts. 6-7
  4. Sets a maximum period of 2 years from promulgation to eliminate synthetic colorants, with possible reasoned sector-specific extensions.Art. 8
  5. Provides for inspections, sampling, analyses and document verification, as well as a national monitoring program and laboratory certification.Arts. 9-10
  6. Establishes fines, measures concerning batches and permits, closure, and criminal liability for fraud in the specified circumstances.Art. 11
  7. Creates a reformulation support program, promotes natural colorants and authorizes the Ministry of Health (Ministerio de Salud, MINSA) to update the list of prohibited colorants and issue supplementary technical rules.Arts. 12-14
  8. Lists prohibited synthetic colorants and alternatives, and requires a MINSA resolution on the final list, verification and penalties.Arts. 15-17