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Southern Common Market releases technical regulations on food contact silicone, to be implemented on June 16, 2026

Time：

2026-01-21

The Southern Common Market (MERCOSUR) has officially released the "Technical Regulations on Silicones Used in the Manufacturing of Materials, Containers, Coatings, and Equipment in Contact with Food", which will come into effect on June 16, 2026. This regulation officially removes and integrates the silicone parts previously scattered in the list of plastics, elastomers, and adhesives, establishing general regulations and a positive list for silicone.

On December 18, 2025, the Southern Common Market (MERCOSUR) officially issued Resolution GMC/RES. No. 34/25 on the Technical Regulations of the Southern Common Market for Silicones Used in the Manufacturing of Materials, Containers, Coatings, and Equipment in Contact with Food. This regulation officially removes and integrates the silicone parts previously scattered in the list of plastics, elastomers, and adhesives, establishing general regulations and a positive list for silicone. This resolution will be incorporated into the legal systems of all member states before June 16, 2026.

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Main changes

（1） Scope of application

Silicone suitable for manufacturing materials, containers, coatings, and equipment in contact with food.

（2） General provisions

2.1 Basic Requirements

·Manufacturing according to good manufacturing practices and compatible with the food to be in contact with;

·Under foreseeable normal usage conditions, harmful substances or pollutants shall not be transferred into food, and their migration amount shall not reach a level that may alter the composition and/or sensory characteristics of the food, or pose a risk to human health;

·The purity and technical quality of the substances used in manufacturing must meet the requirements of their intended use;

·Manufacturers or importers should be aware of or able to provide ingredient information of their products to the competent health authorities and/or other responsible agencies upon request.

2.2 Raw material requirements

·Only use authorized substances listed in sections I to V of the formal list and comply with corresponding requirements;

·In addition to the authorized substances listed on the official inventory, the following substances can also be used:

① Plastic colorants that comply with the requirements of MERCOSUR/GMC/RES. No 15/10 for plastic packaging and equipment used in contact with food

② The following metal salts are allowed as additives: authorized ammonium, calcium, magnesium, potassium, and sodium salts of acids, phenols, or alcohols (including double salts and acid salts), aluminum salts, barium salts, cobalt salts, copper salts, iron salts, lithium salts, manganese salts, nickel salts, and zinc salts (including double salts and acid salts) should meet the corresponding metal element migration restriction requirements

③ A mixture of authorized substances, where no chemical reaction occurs between the components

④ Food additives authorized for use under the technical regulations of the Southern Common Market shall comply with the established restrictions on their food use, and the sum of the dosage of additives present in the food and the amount that may migrate from the container shall not exceed the limit specified for each type of food

2.3 Physical and chemical indicators

The following physical and chemical indicators are specified for silicone products:

Volatile organic compounds<0.5%;

Extractable organic compounds (distilled water, acetic acid, ethanol)<0.5%;

Peroxide test negative;

Primary aromatic amines ≤ 0.01 mg/kg.

2.4 Migration Test

The standards and methods for specific migration limits shall be implemented in accordance with the technical regulations of the Southern Common Market on plastic material migration (MERCOSUR/GMC/RES. No 32/10) and on plastic material additives in contact with food (MERCOSUR/GMC/RES. No 39/19 and subsequent revised resolutions).

（3） Positive List

When manufacturing silicone, only substances in parts I, II, III, IV, and V of this list are allowed.

The first three parts of the positive list in this resolution refer to the silicone section of BfR Proposal XV, and additional supplementary lists are attached. The main body includes the following content:

The list is divided into the following five parts, mainly specifying the substances authorized for use and their restrictive requirements:

Part I: Silicone oil (fluid) and its corresponding lotion (organic polysiloxane and related additives, which shall meet the kinematic viscosity requirements);

Part II: Silicone resin (including linear or branched organopolysiloxanes and processing aids);

Part III: Silicone elastomers (silicone rubber) (including licensed substances such as base polymers, crosslinking agents, catalysts, and additional licensed substances for coating applications);

Part IV: Additives, Fillers, and Additives for Fillers

Part V: Monomer

Compliance recommendations

The Southern Common Market Silicone Resolution stipulates the requirements for full process control from raw materials to final products. The relevant producers and operators exporting to the Southern Common Market should strictly control the raw material selection process in accordance with the requirements of the formal list, initiate supply chain component verification and update the compliance statement (DoC) synchronously, comply with good manufacturing practices (GMP) for production, and ensure that products meet specific migration limits and specification requirements under the new independent supervision system.

Jiayu Testing, as a professional third-party testing and certification service organization, has qualifications such as CMA, CNAS, CPSC, and has obtained laboratory accreditation from multiple authoritative certification agencies at home and abroad. It 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.) to ensure that your products meet the regulatory requirements of various countries. Welcome to contact us at 400-9269-886!