European Parliament Urges Further Regulatory Action on Food Contact Materials
Kelley Drye Client Advisory
December 30, 2016

The European Parliament is demanding significant changes to rules on Food Contact Materials (FCM) applicable to both packaged foods and processing of foods to be placed on the European Union (EU) market.   The current EU regulation governs materials intended to contact food as well as those that can reasonably be expected to be brought into contact with food or to transfer their constituents to food under normal or foreseeable conditions of use such as machinery used for the processing of food as well as cutlery and tableware.  The regulation prohibits the release of FCM constituents into food at levels harmful to human health or that change food composition, taste or odor in an unacceptable way and prescribes labeling requirements.  The regulation also applies to “active” or “intelligent” materials that maintain or improve the condition of packaged food or monitor the condition of packaged food or its environment. 

On 6 October 2016, the European Parliament adopted a resolution in which it calls upon the European Commission to take action to rectify trade barriers created by divergent Member State implementation of the regulation, increased costs for consumers, and the deterrent effect on innovation.  Noting that the Commission has adopted safety requirements that effectively harmonize the regulation only with respect to plastics, ceramics, regenerated cellulose, and active or intelligent materials, the Parliament demands specific regulatory requirements for the remaining 13 FCM categories including cork, paper and board, printing inks, etc.  In addition, the Parliament sees the need for improved traceability along the supply chain and urges the Commission to create a system requiring all FCM to be accompanied by a Declaration of Compliance and appropriate documentation.

In addition, the Parliament seeks increased funding of the European Food Safety Authority to support risk assessment for new safety requirements, including both multiple exposure scenarios and the so-called “cocktail effects” of substances with similar toxicological endpoints combined.  The Parliament also recommends that risk assessments should take into account “non-intentionally added substances” described as “impurities” resulting from chemical reactions.

The European Commission is required to respond to the Parliament by early January 2017. Early involvement by affected companies in the dialogue among the European Commission, the Parliament, and Member State regulatory authorities will be important to ensure that future regulation is both science-based and workable in order to achieve the Parliament’s stated objectives of eliminating trade barriers, disincentives on innovation, and unnecessarily high regulatory costs passed on to consumers.

Located in the heart of the European Quarter, the Brussels office of Kelley Drye, together with our Food and Drug Law Practice Group, is well positioned to advise and assist clients with any inquiries or concerns regarding  European Union changes to rules on Food Contact Materials (FCM).  Our team brings a unique, wide-angled legal perspective to help clients achieve their business objectives for foods, functional foods, medical foods, dietary supplements, foods/feeds for pets and livestock, cosmetics, nonprescription drugs and devices, and other health products.

For more information about this and related issues, please contact

Laura van der Meer
+32.2.899.2931
lvandermeer@kelleydrye.com