The Americas

Chile – Proposal to amend Exempt Resolution 393/02 of the Ministry of Health, establishing nutritional guidelines on the use of vitamins, minerals, and dietary fiber in foods

/ infoAlimentario

The Ministry of Health has published a proposed amendment to Exempt Resolution 393/02 of the Ministry of Health, which establishes nutritional guidelines on the use of vitamins, minerals, and dietary fiber in foods.

Currently, various types of sugar—both traditional and non-traditional—are used to sweeten foods, as are additives that, as a secondary effect, impart sweetness, none of which are expressly included in the fortification exclusion list of Exempt Resolution No. 393/02 issued by the Ministry of Health.

The problem that arises is that, since they are not included in this exclusion list, they can be used as vehicles for substances or elements with a physiological effect on the body, such as vitamins, minerals, pre- and probiotics, beta-glucans, EPA, and DHA, posing an interpretive challenge under the regulations and affecting enforcement.

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Chile – Proposal to amend Exempt Resolution 394/02 of the Ministry of Health, establishing nutritional guidelines on food supplements and their vitamin and mineral content

/ infoAlimentario

The Ministry of Health has published a proposed amendment to Exempt Resolution 394/02 of the Ministry of Health, which establishes nutritional guidelines for dietary supplements and their vitamin and mineral content.

Currently, various types of sugar—both traditional and non-traditional—are used to sweeten foods, as are additives that, as a secondary effect, impart sweetness, none of which are expressly included in the fortification exclusion list of Exempt Resolution No. 393/02 issued by the Ministry of Health. The problem that arises is that, since they are not included in this exclusion list, they can be used as vehicles for substances or elements with a physiological effect on the body, such as vitamins, minerals, prebiotics, probiotics, beta-glucans, EPA, and DHA, posing an interpretive challenge to the regulation and its enforcement.

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Chile – Proposal to amend the Food Sanitary Regulations (Decree No. 977/96) introducing requirements for the entry and control of foods

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The Ministry of Health has published a proposed amendment to the Food Sanitary Regulations (D.S. 977/96) that introduces requirements for the entry and control of food.

The food import procedure has been analyzed, and it has been identified that the current document does not clearly set out, for both importers and staff of the Regional Ministerial Health Secretariats (SEREMI in Spanish) and other public services, matters such as the required documentation and the procedures to be followed in the food control process for products entering the country. In this regard, the Regional Ministerial Health Secretariats (SEREMIs), the National Customs Service, and the private sector, thru the Executive Productivity Roundtables led by the Production Development Corporation, have submitted observations and requests to improve the Manual for the Import of Foods Intended for Human Consumption. However, after analyzing the provisions of the Food Sanitary Regulations and the requirements set forth in the manual, the decision has been made to incorporate the requirements into the Regulations, in accordance with the principle of transparency established by the Codex Alimentarius and the recommendations of FAO/WHO.

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Chile – Proposal to Modify the Manual for the Import of Foods Intended for Human Consumption

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The Ministry of Health has published a proposed amendment to the Manual for the Importation of Food Intended for Human Consumption.

The current version of the manual has been reviewed and the food entry procedure analyzed, identifying that the document does not clearly set out, either for stakeholders or for the inspection personnel of the Regional Ministerial Secretariats (SEREMI in Spanish) of Health, matters such as the required documentation and the procedures to be followed in the control process for foods entering the country. In this regard, the Regional Ministerial Secretariats (SEREMIs) of Health, the National Customs Service, and the private sector, thru the Executive Productivity Roundtables led by the Production Development Corporation, have submitted observations and requests to improve the Manual for the Import of Foods Intended for Human Consumption. It has been detected that the deadline established for filing the reconsideration appeal does not comply with Law 19.880. Likewise, it is necessary to modify the wording of section 11, entitled “Importation of Food Products for Processing and Export,” to clarify the procedure applicable to this intended use. In consideration of the National Customs Service’s request to review Section 10.2 of the manual regarding travel baggage, as well as the need to have a procedure in place for donations during emergency situations as soon as possible, the decision was made to partially update the document.

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Brazil – Anvisa promotes sectoral meetings to discuss the revision of regulations on good manufacturing practices for food production

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The National Health Surveillance Agency (ANVISA in Portuguese) will hold two virtual meetings with representatives from the food production chain to present the draft revisions to the Good Manufacturing Practices standard and encourage participation in the open public consultations.
This is an opportunity for stakeholders to address their questions and submit contributions on the topic. Two events will be held: the first on February 4, from 10:00 a.m. to 12:00 p.m., open to all sectors; the second on February 5, also from 10:00 a.m. to 12:00 p.m., specifically for the nutritional formula and dietary supplement manufacturing sector.

Consult the public consultations that will be presented:

Public Consultation No. 1362, dated November 12, 2025 – Proposal for a regulatory act on the draft Resolution of the Collegiate Board of Anvisa establishing the Good Practices requirements, the principles of the Hazard Analysis and Critical Control Points (HACCP) system, and the Standard Operating Procedures (SOPs) to be implemented in the food production chain (revokes).

  • Public Consultation No. 1363, dated November 12, 2025 – Proposal for a Normative Instruction (IN) establishing Good Manufacturing Practices for nutritional formulas and food supplements.
  • Public Consultation No. 1364, dated November 11, 2025 – Proposal for a Normative Instruction (IN) establishing the specific requirements for Good Manufacturing Practices for salt.
  • Public Consultation No. 1365, dated November 11, 2025 – Proposal for a Normative Instruction (IN) establishing specific requirements for good manufacturing practices for bottled water.
  • Public Consultation No. 1366, dated November 11, 2025 – Proposal for a Normative Instruction (IN) establishing specific requirements for good manufacturing practices for processed peanuts and their derivatives.
  • Public Consultation No. 1367, dated November 11, 2025 – Proposal for a Normative Instruction (IN) establishing the basic procedures for Good Manufacturing Practices in establishments that produce edible ice cream.
  • Public Consultation No. 1368, dated November 11, 2025 – Proposal for a Normative Instruction (IN) establishing the basic procedures for Good Manufacturing Practices in establishments that produce and/or process canned fruits and/or vegetables.