Regulations for materials in contact with foodstuffs
Regulatory texts :
The basic text regulating the suitability of materials and articles intended to come into contact with foodstuffs, products and beverages is Decree No. 92-631 of 8 July 1992.
Commission Directive 2002/72/EC of 6 August 2002 relating to plastic materials and articles intended to come into contact with foodstuffs
https://eur-lex.europa.eu/legal-content/FR/TXT/PDF/?uri=CELEX:32002L0072&from=IT
Order of 2/01/2003 on plastic materials and objects placed or intended to be placed in contact with foodstuffs, products and beverages (Directive 2002/72/EC of 6 August 2002) ;
https://www.admi.net/jo/20030129/ECOC0200138A.html
Application :
The text applies to materials and articles
- intended to be brought into contact with foodstuffs;
- or brought into contact with food in accordance with their intended use. The foodstuffs concerned are foods and beverages (including water intended for human or animal consumption and natural mineral waters)
- both as finished products and as intermediate products, intended for human or animal consumption.
Criteria for suitability for food contact :
Materials and articles must be inert with respect to food. In particular, they must not: release constituents in an amount dangerous to health (human and animal); bring about an unacceptable change in the composition of the food; alter the organoleptic properties of the food. For plastic materials and articles (made exclusively of plastic) which in their finished state are intended to come into direct contact with foodstuffs, the inertness criteria to be met are the following (Directive 2002/72/EC): - compliance with the positive list (the monomers and additives used must appear in the lists in Annexes II and III of Directive 2002/72/EC) and the restrictions on use
- attestation of conformity by suppliers;
- overall migration limits according to the decree of 2/01/2003;
- specific migration limits of monomers and/or residual quantity of monomers in the material or object according to the order of 2/01/2003
- specific migration limits of additives and/or quantity in the material or object
- the various constituents used appear on the positive lists of authorised constituents;
Migration, limits of acceptability :
- Overall migration limit set by the Order of 2 January 2003 (art. 2), i.e. 10 mg/dm², or 60 mg per kg of foodstuffs depending on the geometry of the material or object. A material or object whose migration level exceeds the overall migration limit by an amount not exceeding the analytical tolerance defined below must be considered to be in compliance with the order (art. 8 and chapter VI of the annex to the order):- 20 mg/kg or 3 mg/dm² in migration tests using rectified olive oil or its substitutes;
- 12 mg/kg or 2 mg/dm² in migration tests using the other simulants referred to in Directives 82/711/EEC and 85/572/EEC. Specific migration limits of monomers and/or maximum residual quantities of monomers in the material or object (article 7 and chapter I of the annex of the decree of 2/01/2003) - Specific migration limits of additives and/or maximum quantities in the material or object if applicable, specified in the above texts (in particular article 7 and chapter II of the annex of the decree of 2/01/2003) - Specific migration limits of epoxy derivatives, the limits are specified in the decree of 2 April 2003
Rules for checking suitability criteria :In order to check the migration criteria, the following information should be provided to the laboratory
- Material references ;
- Nature of the monomers and additives subject to specific migration limits or maximum residual quantities, without revealing confidential information;
- Contact conditions (time and temperature);
- Test conditions according to directive 82/711/EEC modified by directives 93/8/EEC and 97/48/EEC, and directive 85/572/EEC (Order of 2/01/2003, article 8):
- Temperature and contact time ;
- Methods to be used for the overall migration according to the standards of the NF EN 1186 series.Methods to be used for the specific migration according to the experimental standards for the measurement of specific migrations, of the prEN 13130-1 to 28 series or the CEN/TS technical specifications of the 13130 series part 1 to 28 and the ongoing work of CEN/TC 194 SC1 concerning the determination of BADGE, BFDGE and their derivatives as well as NOGE and their derivatives.