EC 1935/2004 is a European legislation whose full title is "Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food". It standardizes materials and articles intended to come into contact with food (Food Contact Materials, FCMs). Enacted in 2004, it replaced the previously implemented Directives 80/590/EEC and 89/109/EEC and was issued as a directly applicable Regulation rather than a Directive. This means it does not require transposition into national law by member states but is directly effective in all EU member states, giving it stronger and more immediate legal force.

1. Core Objectives:The Regulation's primary objectives are threefold:

•Ensuring Food Safety: Preventing the release of harmful substances from FCMs into food, thereby safeguarding food quality and human health.

•Harmonizing Regulatory Standards: Aligning potentially divergent regulations among EU member states to facilitate market circulation and fair competition.

•Ensuring Transparency: Mandating requirements such as labeling and Declarations of Conformity (DoC) to ensure product information transparency, enabling traceability and informed consumer choice.

•Plastics, Rubber, Paper and board, Ceramics, Metals, Glass, Glass ceramics,

•Printing inks, Regenerated cellulose, Textiles, Varnishes and coatings,

•Adhesives, Ion exchange resins, Silicones, Waxes, Wood, and Cork.

•Note:The Regulation does not apply to antiques, edible coatings (e.g., cheese rind), or fixed public or private water supply equipment.

•Plastics: Governed by Regulation (EU) No 10/2011 (and its amendments), including the "positive list" of authorized monomers and additives and Specific Migration Limits (SMLs).

•Ceramics: Governed by Directive 84/500/EEC, stipulating migration limits for lead and cadmium.

•Regenerated Cellulose: Governed by Directive 2007/42/EC.

•Active and Intelligent Materials: Governed by Regulation (EC) No 450/2009, requiring additional authorization.

•Overall Migration in Distilled Water

•Overall Migration in 3% Acetic Acid

•Overall Migration in 10% Ethanol

•Full Set of Overall Migration Tests

•Total Phthalates Content

•Specific Migration of Phthalates in 3% Acetic Acid

•Specific Migration of Phthalates in 10% Ethanol

•Specific Migration of Phthalates in Olive Oil Substitute (95% Ethanol and Isooctane)

•Specific Migration of Aromatic Amines in 3% Acetic Acid

•Lead and Cadmium Release (Heavy Metals), etc.

5. Key Requirements: Labeling, DoC, and TraceabilityEC 1935/2004 sets clear requirements for labeling, the Declaration of Conformity (DoC), and product traceability.

1) Labeling Requirements:

•The product or its packaging must be marked with the "food contact" symbol or statement (e.g., the glass-and-fork symbol, or the words "for food contact").

•Provide any necessary instructions for use (e.g., applicable temperature limits, suitability for microwave use, etc.).

•Active and intelligent materials must be clearly labeled, describing their function, and must not mislead consumers.

•This is a mandatory technical document, central to information transmission within the supply chain.

•The DoC must contain: manufacturer information, product identification, a statement of conformity with the relevant regulations, the specifications of the restrictions complied with (e.g., migration limits), and instructions for use.

•For materials like plastics, a DoC must accompany the product through all stages of distribution, up to but excluding the retail stage.

•To facilitate production control, recall of defective products, consumer information access, and liability allocation, traceability of materials and articles must be ensured at all stages.

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