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European Commission sets up regulation 450/2009 on active and intelligent packaging

European Commission sets up regulation 450/2009 on active and intelligent packaging

Changes in the way food products are produced, distributed, stored and retailed, reflect the continuing increase in consumer demand for improved quality and extended shelf life for packaged foods. Active Packaging actively changes the condition of the packaged food to extend life or to improve safety and sensory properties, while maintaining the quality of the packaged products, playing an important role in preservation of food. Active packaging is designed in a way so as to make the packages interact with food and the environment. It changes the condition of packed food to increase shelf-life, improve safety or expand sensory properties. Intelligent Packaging monitors the condition of packaged foods to give information about the quality of the packaged food during transport and storage, and is designed to sense the environment and convey information to the user. It helps to monitor and communicate information about food quality. These packaging concepts are being developed to actively prevent food spoilage, increase shelf life, enhance product attributes like appearance, taste, flavor, aroma etc.,
A new regulation 450/2009 has been introduced by the European Commission on active and intelligent packaging. All existing products must be approved by 21 January 2011 to stay on the market, with all new products subject to the same authorisation process. Some of the highlights of this regulation:
The Regulation should establish the specific rules for active and intelligent materials and articles to be applied in addition to the general requirements established in Regulation (EC) No 1935/2004 for their safe use. Many different types of active and intelligent materials and articles exist. The substances responsible for the active and/or intelligent function can be contained in a separate container, for example, inclusion in a small paper sachet or, the substances can be directly incorporated into the packaging material, for example, incorporation in the plastic of a plastic bottle. Those substances, responsible for creating the active and/or intelligent function of those materials and articles (the components) should be evaluated in accordance with this Regulation. The passive parts, such as the container, the packaging into which that container is placed and the packaging material in which the substance is incorporated, should be covered by the specific Community or national provisions applicable to those materials and articles.
The active and intelligent materials and articles may be composed of one or more layers, or parts of different types of materials, such as plastics, paper and cardboard or coatings and varnishes. Requirements for those materials may be either fully harmonised, or only partially harmonised, or not yet harmonised at Community level. The rules laid down in this Regulation should apply without prejudice to Community or national provisions that regulate such materials. The individual substance or, if relevant, the combination of substances which constitute the components should be evaluated to guarantee that they are safe and comply with the requirements laid down in Regulation (EC) No 1935/2004. In some cases, it may be necessary to evaluate and authorise the combination of substances, when the active or intelligent function implies interaction between different substances leading to an enhancement of the function or the generation of new substances responsible for the active and intelligent function.
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 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. 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.
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