Normpack Legislation

All materials that come into contact with food must be risk assessed for the intended use and must meet the requirements set out in the legislation

What are the requirements and the scope

European legislation for materials and products intended for food contact (Food Contact Materials, FCM) is based on:

a Framework regulation that applies to all materials
a Good Manufacturing Practice (GMP) regulation that applies to all materials
material specific rules

The legislation covers all materials that are expected to come into contact with food. This includes, for example, packaging, process equipment such as hoses, conveyor belts and disposable gloves in the food industry, and household utensils.

All harmonized rules can be found on the Commission's pages on food contact materials.

The framework regulation

The Framework Regulation (EC) No 1935/2004 is the overall law that place requirements on all materials that come into contact with food. The requirements apply to both food companies and manufacturers of materials and products.

The regulation states that the material, under intended conditions of use, must not transfer substances to the food in such quantities that it:

can pose a risk to human health
entails an unacceptable change in the composition of the food
deteriorate the smell and taste of the food

It also states that the manufacturing should take place in accordance with good manufacturing practice. And consumers should not be misled by the labeling of the material.

The framework regulation also specifies labeling rules and how the symbol "glass and fork" is to be used.

Furthermore, it is stated that suppliers must show that the requirements are met by issuing a document, Declaration of Compliance (DoC). However, the framework regulation does not specify what the document should contain. Such descriptions can be specified in material specific rules. The content description in the Plastic Regulation (EC) No 10/2011 is usually applied.

GMP Regulation

To meet the requirements for FCM manufacture, the GMP Regulation (EC) No 2023/2006 should be applied. GMP stands for Good Manufacturing Practice. It states that entrepreneurs must have a quality system (which includes quality assurance, quality control and documentation) as well as to have a good structure in their documentation. The requirements apply to all stages of the manufacture, refining and distribution of materials and products. The quality system must be adapted to the size of the company and its placement in the value chain.

Material specific rules

For many material types there are common EU rules, so called harmonized rules.

For types of materials that do not have harmonized rules, national rules or recommendations are generally applied to evaluate the material. Normpack applies either:

the German BfR (Bundesinstitut für Risikobewertung)
the Dutch Warenwet or
the American FDA (Food and Drug Administration)

Plastic

The Plastic Regulation (EC) No 10/2011 states that plastics for food contact use may only be manufactured from chemical substances listed in the positive list, in the Regulation's Annex I (Art. 6 indicates exemptions).

For many of the substances there are limits, so called Specific Migration Limits (SML) for how much of the substance is allowed to migrate to the food. In addition, many substances have requirements for the maximum permissible total content that the material may contain, as well as other specific restrictions.

The plastic regulation is updated continuously, at least twice a year.

Paper and Cardboard

For paper and cardboard, there are no harmonized EU rules. Manufacturers usually use the German BfR recommendation No. XXXVI for paper. There are also detailed requirements for baking paper (baking sheets), filter paper and absorbents.

Other materials

The framework regulation lists 17 materials / usage areas that are specifically regulated. Materials not mentioned here, are still covered by the basic requirements set out in the framework regulation.

Requirements differ for different areas of use

Different foods effect materials differently, depending on the acidity of the food, fat content, etcetera. Contact times and temperatures also influence how the material behaves. When evaluating a material, it is done based on knowledge of the type of food that will be in contact with the material and under which conditions.