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About the author Francesca Torriani is the Head of the Technical Department at General Packing Italy SpA and Chairwoman of the ESA Flange Gaskets Division. She holds a degree in Energy Engineering from the Polytechnic
University of Turin.
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Food safety is a central concern for both regulatory authorities and consumers across the European Union( EU). For this reason, with the publication of Regulation( EC) No. 1935 / 2004, the EU sought to establish a common Framework Regulation for materials and articles intended to come into contact with food, overcoming the differences that at the time existed between the national legislations of the various Member States. Despite the progress made and the introduction of several specific regulations linked to this Framework Regulation, a harmonised EU legislative framework covering all materials on the market has yet to be achieved. It is therefore useful to examine Regulation( EC) 1935 / 2004 and its related measures, in order to understand their implications for gasket materials. Regulation 1935 / 2004
The principle underlying Regulation( EC) No. 1935 / 2004 is that any material or article intended to come into contact, directly or indirectly, with food must be sufficiently inert to prevent substances from being transferred to food in quantities large enough to endanger human health, or to cause an unacceptable change in the composition of the food, or a deterioration in its organoleptic properties. This principle is set out in Article 3, which also introduces the concept of good manufacturing practice( GMP). Further provisions are included
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in Articles 15, 16 and 17, addressing labelling, declarations of compliance and traceability requirements. Products that are not yet in contact with food when placed on the market must have labelling that includes: the words“ for food contact”, the name or trade name and the address or registered office of the manufacturer, processor or seller responsible for placing the product on the market, an identification number to ensure traceability and, if necessary, special instructions to be observed for safe and appropriate use. The traceability of materials and articles, by means of labelling or relevant documentation, must be ensured at all stages in order to facilitate control, the recall of defective products, consumer information and the attribution of responsibility. Such information must be made available to the competent authorities on demand.
Written declaration
It is also required that materials be accompanied by a written declaration stating that they comply with applicable rules relating to food contact materials. Appropriate documentation must be available to demonstrate such compliance and made available to the competent authorities on request. The declaration of compliance typically contains information on the identity of the producer or importer and of the recipient company, a description of the product and its composition( with particular attention to substances subject to
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