Regulation framework

The Community legislation comprises general mles applicable to all materials and articles laid down in the Framework Regulation and specific rules only applying to certain materials or certain substances. The two general principles on which legislation on food contact materials is based are the principles of inermess and safety of the material. A general overview is presented in Fig. 3.1. 

The Framework Regulation is adopted by the European Parliament and the Council while specific Directives and Regulations are adopted by the Commission after consultation with Member States in the Standing Committee of the food chain and animal health. The Commission can adopt only those proposals that gain a qualified majority of Member States in the Standing Committee. 

Basic requirements are set to ensure safe food and protect consumer interests. Three basic requirements are set to ensure safe food food contact materials 

Paper and Glass Active and Wood board intelligent materials 

All authorisations granted are general authorisations. This means everybody may use a substance authorised. There exists also the possibility to authorise the use of substances, materials or processes only for the individual petitioner. Authorised substances are listed in specific Community legislation. The Framework Regulation contains a list of materials for which specific legislation may be adopted. This list comprises 17 different materials. Only a few are yet covered by specific Community legislation (see sections 3.4 and 3.5). 

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The cytoskeleton The molecular framework regulating cell shape and the traffic of intracellular components... 

The basic rule in the Community food legislation specifies that only safe food shall be placed on the market (General Food Law Art. 14). Consequently food contact materials shall not transfer their substance into the food in concentrations that can endanger human health (Art. 3 Framework Regulation). The main players to ensure safety as regards food contact materials are the packaging industry, the food industry, competent authorities in the Member States, and the European Commission. 

Basic requirements for active and intelligent materials have been set in the Framework Regulation. However, some issues need further clarification. The main issues are the applicability of the requirements of the plastics directive to active and intelligent plastic materials, especially compliance with overall and specific migration limits, rules for non-plastic active and intelligent materials, risk assessment of active ingredients and if necessary conditions/restriction of their use, and mles on the efficacy of the materials in relation to instructions for their use and protection of the consumer. 

Framework Regulation 1935/2004/EC covers all materials and articles that (a) are intended to be brought into contact with food or (b) are already in contact with food and were intended for that purpose or (c) can reasonably be expected to be brought into contact with food or to transfer their constituents to food under normal or foreseeable conditions of use (Article 1.2). In Aimex I of the Regulation are listed the materials and articles that shall be covered by specific measures, i.e.,... 

In principle all the ingredients used must be on the EU positive list in the relevant legislation. Although some of the EU positive lists are not complete (like the additive list of the 2002/72/EC at this moment) or exclude some components like catalysts, all the materials must be safe and must comply with the framework Regulation (EC) 1935/2004 Article 3. How to deal with this is again described in section 5.2. 

The reason for determining overall migration is that the food contact material may bring about an unacceptable change in the composition of the food (Article 3 of the framework Regulation (EC) 1935/2004). The methods of determining the overall migration into the aqueous simulants (A, B and C) are as follows ... 

For the NIAS, there is a more urgent need due to Article 3 of the Framework Regulation (EC 1935/2004) and new upcoming legislation and the same approach to exposure should be used. The only drawback to the NIAS is the fact that these substances are often unknown and thus the toxicity of these substances cannot be used, and therefore it is almost impossible to apply the acceptable or tolerable intake of these NIAS. The combination of actual exposure and toxicology will help to determine the acceptable level of a specific migrant in the migration extract. 

EU legislation covering plastics food contact materials is well advanced with a positive list for monomers complete and a positive list for additives near completion. Decisions on how other substances used in plastics, such as aids to polymerisation and colourants are to be regulated, if at all, have yet to be made. Plastics used in contact with food must comply with the Framework Regulation, which lays down the basic rules ... 

Framework Regulation (EC) 1935/2004, Official Journal of the European Union, Vol. 47, 13 November 2004 (L338/4). 

It will be clear from the above sections that the current lack of harmonised EU legislation means that there is no single straightforward way to show compliance for most components of metal foodstuff packaging. The main measure which must be complied with is the Framework Regulation 1935/ 2004, Article 3 of which states that materials and articles should not transfer their constituents to food at levels which could (i) endanger human health ... 

In Europe the essential paragraph in Regulation (EC) No 1935/2004, commonly referred to as the framework regulation , applies to all materials intended for food contact and must consequently be observed by manufacturers of printing inks as well as by printers. It states that materials and articles intended for food contact... 

As regards responsibility, the resolution on packaging inks, in accordance with the above-mentioned framework regulation, states that the ink supplier... 

EU Regulation 1935/2004 - Regulation on materials and articles intended to come into contact with food ( Framework regulation ). 

No specific legislation exists in the EU for adhesives but all food contact materials must comply with the Framework Regulation (EC) 1935/2004 (see Chapter 3). Adhesives are described in Commission Directive 2002/16/ EC on the use of certain epoxy derivatives. In the absence of specific harmonised rules then the Practical Guide states that National Legislation should be considered. National legislation exists in Germany (BfR Empfehlungen XXVIII Components of adhesives) and in Slovenia. ... 

Multi-layer packaging which includes materials other than plastics, e.g., metals and paper, even if the food contact layer or part of the food contact layer consists of plastic, is currently not covered by any specific legislation. These multi-layer materials are regulated either by national legislation or by Article 3 of the Framework Regulation (EC 2004). Article 3 states that... 

In 2004 a new framework Regulation (EC) No 1935/2004 applicable to all materials intended to come into contact with foods was accepted. In this regulation, general requirements applicable to all food contact materials (FCM) are established. Specific provisions are included to allow the use of active and intelligent materials and articles, and a specific measure on active and intelligent materials was announced. In order to define the scope of... 

If required in a specific measure, then relevant food contact materials (FCM) shall be accompanied with a declaration of compliance, while appropriate documents shall be provided to relevant authorities to demonstrate such compliance. As most of the requirements in the framework regulation are applicable to all FCM, active and intelligent materials are subject to these rules as they can be considered FCM. In some cases there may be no direct contact with the food, e.g., intelligent packaging positioned on the outside of the primary package, but they are subject to the framework regulation for the reliability of the information provided to the consumer. 

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