Materials that can be reasonably expected to come into contact with food are subject to regulations and guidelines, both at the European Union and national (member state) level Framework Regulation 1935/2004 lays out the foundation for general safety requirements, labeling, certification, and record-keeping, while providing for the establishment of specific measures for groups of materials. The gist is that any material or article intended to come into contact with food must not endanger human health, change the composition of the food, or change its taste properties. Compliance with EU food contact legislation may require prior approval of raw material and testing and certification of finished products to ensure safety.
This report provides an overview of EU contact material legislation. Where EU legislation does not cover certain types of material or substances, manufacturers and exporters are advised to check national legislation.
Regulation 1935/2004 entered into force on 3 December 2004 and applies to all food contact materials, both direct (e.g. drinking glass) and indirect (e.g. layered plastic material). The regulation provides the following definition of food contact materials. In their finished state, they are either:
(a) Intended to be brought into contact with food, or
(b) Already brought into contact with food and are intended for that purpose, or
(c) Can reasonably be expected to be brought into contact or to transfer their components to foods.
The scope of products potentially impacted by EU food contact legislation is broad, ranging from raw material, packaging and packaging materials to food processing machinery, and even lining of refrigerators. Please note that this Regulation does not apply to antiques, edible covering and coating materials, and fixed public or private water supplies.
• General Safety Requirements (Article 3)
Production of food contact materials and articles should be undertaken in a manner so as to avoid the transfer of constituents to food in harmful amounts. Specifically, these amounts cannot be such that they:
o Endanger human health, or
o Bring about an unacceptable change in the composition of the food, or
o Bring about deterioration in taste characteristics.
As part of the compliance process, manufacturers are required to implement Good Manufacturing Practices (GMPs), in accordance with Regulation EC 2023/2006, as discussed in this report.
• Application for authorization of new substance (Article 9 and following)
Manufacturers have to ensure that the substances used in food contact material are approved. Approval is subject to a procedure whereby the applicant introduces a technical dossier to a competent authority in a member state (e.g. a local government regulatory agency) that in turn submits it to the European Food Safety Authority (EFSA). EFSA is in charge of informing other member states and the European Commission (EC) about the received application and is responsible for issuing an opinion. By adopting a specific measure, the Commission authorizes the use of the substance based on the favorable opinion of EFSA. Other than specific measures on substances, the Commission may adopt purity standards for substances, limits on the migration of certain constituents into food, provisions protecting human health against hazards arising from oral contact with materials and articles, special conditions of use for substances and/or the materials and articles in which they are used. In the absence of EU specific measures, national legislation prevails.
• Labeling (Article 15)
Materials and articles that are not in contact with food at the time of placement on the market, but are intended to be in contact (e.g. microwaveable containers, cutlery, etc.) have the following labeling requirements:
• The words “for food contact”, or the symbol below, must be present; for example on plastic bags for groceries, unless it is clear to the user that the product is intended for food contact use.
• Special safety instructions are to be included if they are necessary, for example if product has to be handled with special care.
• The product name and the name and address of the manufacturer, processor, or seller responsible for placing the product on the EU market should be displayed.
• Product traceability information must be adequate.
• Relevant information about active ingredient materials and articles should also comply with appropriate EU or national provisions, applicable to food, including labeling.
• This information must be noticeable, clearly legible, indelible, and in a language easily understood by consumers. The location of the information at the retail level must be on the materials and articles or their packaging or shown on a notice in the vicinity of the materials and articles. Other than at the retail stage, the information must be on accompanying documents, the labels or packaging, or the materials and articles themselves.
• Declaration of Compliance (Article 16)
All materials and articles must be accompanied by a “written declaration” of compliance. Manufacturers can demonstrate compliance using “appropriate documentation” that should be available to authorities upon demand.
• Traceability (Article 17)
Traceability is the ability to identify suppliers and recipients of materials, articles, substances, and products throughout the supply chain. Traceability is intended to facilitate control, conduct recalls of defective products, provide information to consumers, and attribute responsibility. The implementation of this process is left to industry.
• Annex I
Based on the list in the Regulation’s Annex I, the Commission intends to consider the following list of materials and substances for specific future measures: adhesives, cork, rubbers, glass, ion-exchange resins, metals and alloys, paper and board, printing inks, silicones, textiles, varnishes and coatings, waxes, and wood.
GOOD MANUFACTURING PRACTICES REGULATION
Other than the Framework Regulation, manufacturers should refer to Regulation EC 2023/2006 which sets out Good Manufacturing Practices (GMPs). GMPs apply to all stages of manufacture and distribution, excluding production of starting substances. Such starting substances, however, should be chosen to ensure compliance of the end product with relevant rules. GMPs include aspects of quality assurance, consistency of production, and conformity with applicable rules of the materials and articles. Such quality assurance systems are established by business operators, and should account for the following:
• Knowledge and skills of the personnel
• Organization of the premises and equipment
• Business size
Guidance about Good Manufacturing Practices applicable to certain products is outlined in the Annex to this GMP regulation.