Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food

Overview

This Regulation establishes specific requirements for the manufacture and marketing of plastic materials and articles intended to come into contact with food, already in contact with food or which can reasonably be expected to come into contact with food. Furthermore, this Regulation shall apply to materials and articles which are placed on the EU market and fall under the following categories:

• materials and articles and parts thereof consisting exclusively of plastics;
• plastic multi-layer materials and articles held together by adhesives or by other means;
• materials and articles referred to in points (1) or (2) that are printed and/or covered by a coating;
• plastic layers or plastic coatings, forming gaskets in caps and closures, that together with those caps and closures compose a set of two or more layers of different types of materials; or
• plastic layers in multi-material multi-layer materials and articles.

It is important to note that the Regulation shall not apply to the following materials and articles which are placed on the EU market and are intended to be covered by other specific measures:

• ion exchange resins;
• rubber;
• silicones.

Background

Plastics are made of monomers and other starting substances which are chemically reacted to a macromolecular structure, the polymer, which forms the main structural component of the plastics. To the polymer additives are added to achieve defined technological effects. The polymer as such is an inert high molecular weight structure. As substances with a molecular weight above 1 000 Da usually cannot be absorbed in the body the potential health risk from the polymer itself is minimal.

Potential health risk may occur from non- or incompletely reacted monomers or other starting substances or from low molecular weight additives which are transferred into food via migration from the plastic food contact material. Therefore monomers, other starting substances and additives should be risk assessed and authorised before their use in the manufacture of plastic materials and articles.

The risk assessment of a substance to be performed by the European Food Safety Authority (hereinafter the Authority) should cover the substance itself, relevant impurities and foreseeable reaction and degradation products in the intended use. The risk assessment should cover the potential migration under worst foreseeable conditions of use and the toxicity. Based on the risk assessment the authorisation should if necessary set out specifications for the substance and restrictions of use, quantitative restrictions or migration limits to ensure the safety of the final material or article.