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Regulatory framework
Food grade plastics
Regulatory framework
Applicable laws and regulations in the EU
In industrial processing, food inevitably comes into contact with machine parts made of different materials. Transport containers, slide rails, screw conveyors, scrapers or filling devices – these components are often made of plastic. Paper, glass, aluminium, composite material and above all plastics are used as packaging materials. There are various laws in the European Union and the United States governing the contact of materials and materials with foodstuffs that companies must observe when manufacturing the materials and substances.
Framework Regulation 1935/2004/EC
The most important overarching European legislation is EU Framework Regulation 1935/2004/EC: According to Article 3 of it, all materials and articles intended to come into contact directly or indirectly with food must be sufficiently inert. This means that constituents may only be transferred from the material to the food in such quantities that
- they will not endanger human health
- the change in the chemical composition of the food is acceptable
- the organoleptic properties – the smell, taste, appearance and colour – of the food are not changed
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govern the contact of plastics with food in the EU: Framework Regulation 1935/2004/EC, Regulation 2023/2006/EC and Regulation 10/2011/EU
Directive 2023/2006/EC
The Directive is based on Framework Regulation 1935/2004/EC and concerns Good Manufacturing Practice (GMP). Companies producing materials for contact with food have to establish and use a quality assurance system and quality control system and documentation in accordance with the guidelines of Good Manufacturing Practice.
Directive 10/2011/EC
To comply with the requirements of Framework Regulation 1935/2004/EC, companies must also comply with further material-related regulations known as "individual measures". For food-grade plastics, this is Directive 10/2011/EU, which has been in force since May 2011, often also referred to as the Plastic Implementation Measure (PIM), including its latest amendments.
Contents of Directive 10/2011/EC
Only the substances listed in the “Union list” of Regulation 10/2011/EU may be used to manufacture the plastic. This is a positive list of initially 885 substances which is updated on a regular basis. It is subdivided into the following sections:
- auxiliary materials excluding solvents
- monomers and other starting substances
- additives excluding dyes
The total quantity of non-volatile substances migrating from the material into the food is measured, regardless of their chemical nature. This value (10mg/dm2 contact surface or 60mg/kg food) is to ensure that the chemical composition of the food is not unacceptably altered. This global migration value applies equally to all plastics.
A maximum permissible quantity of certain substances which can migrate from the material into the food may not be exceeded. The values are intended to ensure that human health is not endangered. A plastic may contain one or more substances that have to be tested, or none at all.
The information required in the declarations of conformity for food grade materials is precisely defined. Among other things, precise information on the type of food in question, contact temperatures and contact times must be provided. This information is based on migration studies performed using various food simulants. The regulation distinguishes between five different food types (dry, aqueous, acidic, fatty, alcoholic) that are tested using the simulants. There is also a large number of contact times and temperatures to choose from. This can make migration tests very time-consuming and complicated.
Applicable laws in the USA
The Food and Drug Administration (FDA) is the regulatory authority for medicines and food additives in the United States.
All relevant regulations for drugs and food additives are published in the Code of Federal Regulations (CFR) in Title 21. In contrast to the EU, the exact requirements are very material-specific. It is generally assumed that all components of a material can migrate into food. Plastics, dyes and other contact materials are therefore referred to as “indirect food additives”.
Title 21 is divided into various chapters (parts). Information on plastics is provided in "Part 177 Indirect food additives: Polymers". A four-digit number is used to identify the type of plastic: for instance 1520 for polyolefins or 1500 for polyamides.
The relevant paragraph for polyamides is “21 CFR, Part 177, Paragraph 1500”. Dyes are regulated in “21 CFR, Part 178,3297” (Colourants for Polymers). These paragraphs regulate the requirements for the respective food-grade plastics, both in terms of ingredients and additional requirements such as extraction limits. In addition, substances from the Gras list (generally recognised as safe) can be used at any time as additives for materials intended to come into contact with food.
Applicable laws in Japan and China
A number of Röchling materials also comply with the legal requirements listed below:
- Japan: Food sanitation act: Positive list for materials and additives of apparatus, containers and packaging made by synthetic resins
- China: National food safety standard: GB 9685, GB4806.1, GB4806.6, GB4806.7
We would be happy to send you details and confirmations on request.
