EFSA News Story, 14 August 2009
The European Food Safety Authority (EFSA) has published guidelines for industry on how to submit applications for the safety assessment of active and intelligent substances in materials which are intended to come into contact with food.
In general terms, active food contact materials absorb or release substances in order to preserve or improve the condition of packaged food or extend its shelf life. Intelligent food contact materials monitor the condition of packaged food or the surrounding environment, providing information on the freshness of the food.
Regulation (EC) n° 450/2009 lays out an authorisation process for the use of new active or intelligent substances in food contact materials. The legislation foresees that manufacturers requesting such an authorisation must first submit an application for the assessment of the safety of the relevant substance(s) to EFSA.
The guidelines specify which aspects EFSA will take into account when assessing the safety of active or intelligent substances - for example, their toxicological properties and the extent to which they, or their breakdown products, may transfer into foods.
The document also sets out the types of data that EFSA needs to conduct its safety assessments such as information on the physical or chemical characteristics of the relevant substances, how they are manufactured and their intended uses.
The guidelines were adopted by EFSA’s expert panel on food contact materials, the CEF Panel, on 21 July following a public consultation.
A copy of the guidance can be found on the EFSA website at: efsa_guidelines_active_intelligent_packaging_en
Further details have been provided on a separate EFSA page:
Regulation (EC) No 450/2009 is a specific measure that lays down specific rules for active and intelligent materials and articles intended to be used in contact with foodstuffs to be applied in addition to the general requirements established in Regulation (EC) No 1935/2004 for their safe use. The substance(s) responsible for the active and/or intelligent function of the material should be evaluated under the regulation (EC) No 450/2009.
A community list of authorised substances, that can be used to manufacture an active or intelligent component of active and/or intelligent materials and articles, shall therefore be established after the European Food Safety Authority (EFSA) has performed a risk assessment and has issued an opinion on each substance. In some cases, restrictions may be proposed by the EFSA on a group of substances especially when the active or intelligent function implies interactions between different substances.
Substances deliberately incorporated into active materials and articles to be released into the food or the environment surrounding the food, do not need to be listed in the Community list. They shall be used in full compliance with the relevant Community and national provisions applicable to food, and shall comply with the provisions of Regulation (EC) No 1935/2004 and its implementing measures. The same shall apply to substances which are incorporated in active materials and articles by techniques such as grafting and immobilisation, in order to have a technological effect in the food. However, for these substances already approved in food legislation, their stability under the intended packaging manufacturing and processing conditions must be verified by the packaging manufacturer and a dossier for safety evaluation has to be submitted if chemical reaction, degradation or decomposition of these substances is likely to occur.
Passive parts should be covered by the specific community or national legislation applicable to those materials. These guidelines do not apply to substances used behind a functional barrier as defined by article 3 of Regulation (EC) No 450/2009. Substances behind such a barrier will not, by definition, migrate in amounts which could endanger human health or bring about unacceptable changes in the composition of the food or of its organoleptic properties. Consequently, these active and intelligent substances do not need a safety evaluation and are also outside the scope of Regulation (EC) No 450/2009. However, this functional barrier concept does not apply to substances in nanoparticulate form which should be assessed on a case by case basis (article 5(2)(c)ii of regulation No 450/2009).
The purpose of this document is to give guidance to applicants and other interested parties for the preparation and the submission of a dossier for the evaluation of the safety of active and/or intelligent substances responsible for active and/or intelligent functions of active and/or intelligent materials and articles intended to be used in contact with food. It gives guidance on the administrative and technical data required, and on the format of a submission (hereinafter referred to as “dossier”) for the evaluation by the EFSA.