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EFSA Publishes Guidance on Active and Intelligent Packaging

Aug 20, 2009

The European Food Safety Authority's (EFSA) Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) has published new guidelines on the information needed to support a dossier for active and intelligent substances to be used in contact with food. See, "Guidelines on Submission of a Dossier for Safety Evaluation by the EFSA of Active or Intelligent Substances Present in Active and Intelligent Materials and Articles Intended to Come into Contact with Food."

The guidelines explain those factors the authority will consider when assessing the safety of active and intelligent substances used in contact with food. According to EFSA's Guidelines, the safety assessment will focus on three inter-related matters that include:

• The migration of active or intelligent substances;
• The migration of their degradation and/or reaction products; and
• The toxicological properties of the substances, per se, and their degradation or byproducts.

Applications must include a dossier outlining key information about the active or intelligent material. The dossier should consist of three sections: (1) a "summary document" containing a summary of all of the information provided in the technical dossier and safety assessment; (2) administrative information, including information on the applicant company on whose behalf the dossier is being submitted and the person responsible for communications with EFSA; and (3) a technical dossier containing all the technical data needed to ensure the safety of the substance for the intended use.

The guidelines follow-up on Regulation (EC) No 450/2009, which went into effect on June 18, 2009. The final regulation, published on May 29 in the Official Journal of the European Union, establishes specific requirements for the marketing of active and intelligent materials and articles intended to come into contact with food. These provisions build upon the general requirements established in 2004 in the Framework Regulation (Regulation (EC) No 1935/2004) for the safe use of active and intelligent packaging materials. The new regulation defines "active materials and articles" as "materials and articles that are intended to extend the shelf-life or to maintain or improve the condition of packaged food; they are designed to deliberately incorporate components that would release or absorb substances into or from the packaged food or the environment surrounding the food." Meanwhile, "intelligent materials and articles" are "materials and articles which monitor the condition of packaged food or the environment surrounding the food."

Only active and intelligent materials are covered by the regulation. The so-called "passive parts" of food contact materials, such as the container, the packaging into which that container is placed, and the packaging material into which the active or intelligent components are incorporated, continue to be governed by other European Union or national provisions.