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Interpretation of the latest requirements for food contact materials and products in Chile
Time：
2025-09-09
The Chilean Ministry of Health has launched a public consultation on the revision of regulations on food contact materials and products, with plans to replace the current Food Hygiene Regulations with general and specific requirements for food contact materials.
1、 Core revision content
1. General requirements for food contact materials and products
(1) Exemption scope: Exemption for coating/lining materials on cheese skins, meat products, or fruit surfaces (such materials are part of food and can be consumed with food).
(2) New term definitions: Clarify 11 key terms, including Good Manufacturing Practices (GMP), sales of food contact materials and products, packaging, active/smart materials and products, traceability, utensils, etc.
(3) Basic compliance requirements: Food contact materials and products must comply with GMP and must not transfer substances that are harmful to health, alter food ingredients, or affect sensory characteristics to food.
(4) Metal raw material restrictions: The total content of antimony, chromium, copper, iron, lead, tin, and zinc in metals and their raw materials is ≤ 1%; The content of arsenic and other harmful metal/metal pollutants is ≤ 0.01% (refer to Article 125 of Decree No. 977/96).
(5) Traceability and declaration: It is necessary to establish a traceability system (for product control, recall of non-conforming products, and responsibility tracing); Compliant products in the supply chain (excluding products aimed at end consumers) are required to provide a Declaration of Conformity (DoC).
(6) Labeling requirements: Food contact materials and products that have not come into contact with food at the time of listing must be labeled with the symbol "for food contact", purpose statement, or "knife and fork glass"; Tableware, salt jars, and other products specifically designed for food contact are exempt from this label.
(7) Ink requirements: Printing ink for non food contact surfaces must avoid the migration of substances to the contact surface, which may affect safety; Prohibit direct contact of printed surfaces with food.
2. Special requirements for food contact plastics
(1) Terminology and scope: Define terms such as additives, total migration limit (OML), specific migration limit (SML), unintentional addition of substances (NIAS), etc; Exemption from adhesives and inks (subject to general safety requirements), excluding the use of ion exchange resins, rubber, and silicone.
(2) Migration limit: For substances outside the positive list without SML, the specific migration amount (SM) is ≤ 0.01mg/kg; The total migration amount (OM) of special dietary foods for infants and young children is ≤ 60mg/kg, and in other cases, OM is ≤ 10mg/dm2; The SM of substances/substance groups outside the positive list is ≤ 0.01mg/kg.
(3) Compliance certification and recycled plastics: Compliance certification can be provided through overseas accredited laboratory reports, accreditation bodies, or written statements from manufacturers/importers; Recycled plastics must comply with this regulation, and the production factory must obtain a health report from the local health department.
In addition, the Chilean Ministry of Health will clarify the following through technical standards:
The "Positive List of Food Contact Plastic Substances" containing over 1000 substances, including phthalates such as DBP, BBP, DEHP, DINP, DIDP, etc., all have specific specification restrictions; Detailed specifications of substances, restrictions on substance groups, and compliance verification instructions; Specific migration limits for BADGE and its derivatives (prohibiting BFDGE and other phenolic glycidyl ethers (NOGE)); 24 elemental restrictions on plastic materials and products (19 with SML and containing primary aromatic amines (PAA) restrictions); Distribution rules for food simulants (including the correspondence between simulants used for migration testing and food).
2、 Effective time
After the regulations are published in the official gazette, requirements related to total migration volumes (OMs) take effect 24 months, while requirements related to specific migration volumes (SMs) and total specific migration volumes (TSMs) take effect 48 months; After the release, food contact materials and products can comply with the new regulations in advance. The deadline for public feedback on the revised proposal is September 23, 2025.
In the face of increasingly strict global control over food contact materials, Jiayu Testing has a professional testing technology team, equipped with advanced instruments and equipment, proficient in various regulatory standards, and specializes in providing FCM food contact material testing services for various food contact materials (such as plastics, coatings, metals, silicone, glass ceramic enamel, bamboo, paper, cardboard, etc.) in China, the United States, the European Union and its member states (France, Italy, Germany, etc.), Japan, South Korea and other countries to ensure that your products meet the regulatory requirements of various countries. Welcome to contact us at 400-9269-886!
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