Regulation of food contact materials in the EU

National provisions on specific materials still exist in areas where Community legislation is not adopted. The rule of mutual recognition applies to this national legislation. Any product lawfully produced and marketed in one Member State must, in principle, be admitted to the market of any other Member State. The only reason a Member State can reject a product is on the basis of protection of human health. Even under mutual recognition, national legislation may foresee that the use of a substance lawfully manufactured and/or marketed in another Member State is subject to prior authorisation provided certain requirements are fulfilled such as a simplified procedure for having the substance included on a national list. In non-harmonised areas 

Member States may even adopt new national legislation. This has to be notified to the Commission and must not introduce a new unjustified barrier to trade. 

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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. ... 

There arespecificenvironmental and safety regulationsin each country or continentthat are mandatory for all food-contact materials and articles. The materials and articles used in the Nordic countries (and in the EU) must comply with certain regulations, e.g. EU directives, or, in the US, EDA regulations. One of the requirements is that food-contact materials should not endanger human health. Adhesives in food-contact materials must also comply with this requirement, including those in multilayer materials. 

Regulation 10/2011/EU of the Commission concerning plastic materials and objects that will come in contact with food products, OJEU, no. L 12/2011, pp. 1-89. A unique substance in the nanometric form is currently featured in the union lisf on line 807. It involves titanium nitride nanoparticles. It indicates that they can be used in PET bottles (for Polyethylene terephthalate) at a maximum of 20 mg/kg . 

The EU Directive 2002/72/EC regulates plastics intended to come in contact with food, where the principle of regulation is the establishment of a positive list, which presently is restricted to monomers and start substances. Directive 2002/72/EC (and its amendment 2004/19/EC) contain in their Annexes I-IV, lists of evaluated monomers and additives and the corresponding specific migration limit (SML) values. SML is expressed as the amount of a substance (mg) allowed to migrate from the plastic into 1 kg of food. The law requires compliance with the SML for the end-use material, in addition to the requirement of compliance with the overall migration limit (60 mg/kg food). 

According to regulations of the European Union (EU), cellulose is available in the list of allowed monomers and other starting substances, which shall be used for the manufacture of plastic materials, intended to be exposed to foodstuffs. In addition, according to Great Britain, cellulose is certified without time limit for use in the production of polymeric materials in contact with food or drinks or intended for such contact [14]. 

The compatibility of the plasticizer in the PLA matrix, the morphological stability of the plasticized material and the prevention of the plasticizer migration from the material bulk should be optimized as leaching out of additives from materials could impact the media in contact. This is of particular importance where food packaging applications are concerned, because food safety has to be ensured and contamination risks should be minimized. As with all substances intentionally added to the packaging polymer, the choice of plasticizer must comply with the European Commission regulation EU 10/2011 on plastic materials intended to come into... 

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