packaging materials 7. metal packaging for foodstuffs - Europa

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Pa c k a g i n g ma t e r i a l s: 7. m e t a l pa c k a g i n g f o r f o o d s t u f f sREGULATORY ASPECTSThe regulatory status for can coatings in contact with food is far from clear today.The USA has a well-known and universally accepted system, which has been inuse since the mid-1950s. In Europe, the situation is evolving and differs betweencountries from non-existent to specific legislation such as in The Netherlands.Today (2007) there is no specific harmonised European regulation for can coatings, with the exception ofthe use of certain epoxy derivatives under Commission Regulation (EC) No 1895/2005. Instead, nationalregulations are relevant. In addition, compliance with the Framework Regulation (EC) No 1935/2004,applicable to all food contact materials and articles is essential. This Regulation sets the basis for safe foodcontact materials. The Council of Europe developed Resolutions for several food contact materials notalready covered by harmonised EU legislation. Resolution AP(2004)1 for coatings in contact with foodsets a good standard for bringing safe metal coatings to the market.FDA requirements for direct food contact lacquersMost food companies require that any product intended as a coating on metals for direct food contactmust comply with 21 CFR 175.300 (resinous and polymeric coatings) of the US FDA Regulations. 21 CFR175.300 consists of a list of permitted substances and materials with any relevant restrictions. This is inaddition to any local regulations that may also apply.The FDA defines several categories of foodstuffs, with different requirements. The respective CFRs needto be carefully consulted to understand possible compositional requirements for the respective food types.For compliance testing, a list of test conditions required for each type of foodstuff to measure extractionwith food simulants (ether, water, heptane or 8% ethanol) is given. Maximum limits for extractives (globalmigration) in relevant simulants have been established and refer to the chloroform-soluble part of thedry residue of the extract.European Community regulationsCoatings are listed in Annex I of the Framework Regulation (EC) No 1935/2004 as a category of foodcontact materials for which a specific regulation may be established. As a result of the highly specificprocess technology applied to make a final metal coating it was understood both by industry as well asthe European Commission that coatings should be regulated separately from plastics. A specific Europeanharmonised legislation for this category of food contact materials still needs to be developed.Toxicological acceptance of used substances (Regulation (EC) No 1935/2004)Like any other food contact material, metal packaging intended to come into contact with foodstuff hasto be in compliance with the overall requirements of the EU Framework Regulation (EC) No 1935/2004.According to Article 3 of this Regulation, the following essential requirements must be met:• No transfer of packaging constituents to food in quantities that might endanger human health• No unacceptable change in the composition of the food• No deterioration of the organoleptic characteristics of the food.24
It is within the responsibility of the manufacture to demonstrate compliance with Article 3 of the FrameworkRegulation. In order to do so, the following approaches should be considered.In the absence of any specific Community legislation for coated food contact materials, the nationallegislation of EU Member States applies, where it exists. To ensure that coatings comply with Article 3 ofthe Framework Regulation, Member States often apply restrictions by the European Food Safety Authority(EFSA) on substances toxicologically evaluated in the context of plastics intended to come into contactwith foods. Only a small proportion of the substances used for plastics are also used in the rather complexworld of coatings chemistry. Therefore, only a restricted number of substances, needed to manufacture foodcontact coatings, have been toxicologically evaluated by EFSA or in the past by the Scientific Committee onFood (SCF). Some Member States have their own legal requirements on substances used for food contactand have applied their own toxicological assessment to these substances.Migration limits (Commission Directive 2002/72/EC)In the absence of national legislation on coated metal packaging, Member States apply, where suitable,provisions on plastic food contact materials according to Commission Directive 2002/72/EC (PlasticsDirective) and its amendments. Substances used in metal coatings, but regulated by the Plastics Directive,or by national legislation in certain Member States, have to meet the applicable specific migration limits(SML) mentioned in this legislation.Overall migration (OM) tests on metal packaging are usually carried out according to the protocols ofCouncil Directives 82/711/EEC, 85/572/EEC and 93/8/EEC, which have been established specifically forplastics. The overall migration limit of 10 mg/dm 2 or 60 mg/kg specified for plastics in Commission Directive2002/72/EC is usually applied to surface coatings as well. CEN has published guidelines on testing OM onpolymeric coatings on metal substrates (CEN/TS 14235:2002), which suggests that for overall migrationthere is no need to test with 3% acetic acid, but only 10% ethanol or distilled water. In addition, alternativesimulants for fatty foods can be used in place of olive oil.Pa c k a g i n g ma t e r i a l s: 7. m e t a l pa c k a g i n g f o r f o o d s t u f f sRegulation gap: laminated metal packagingCurrently the legal situation in the EU for laminated metal packaging is almost similar to the one forcoated metal packaging. However, laminated structures containing at least one layer that is not plasticare expressly not covered by Commission Directive 2002/72/EC and its amendments to date. Althoughthe Plastics Directive is suitable for most of the plastic layers of laminated metal packaging, there are stillgaps in the current legislation, for example with regard to adhesives used for the manufacture of this typeof food contact materials. Where it exists, national legislation should be applied to demonstrate the legalcompliance of components for adhesives.Epoxy Derivative Regulation (EC) No 1895/2005In 1996, migration levels above those permitted in the Plastics Directive 90/128/EEC for bisphenol Adiglycidyl ether (BADGE) were detected in some canned foodstuffs, especially in fatty foodstuffs suchas sardines in vegetable oil. The can coating industry successfully improved their epoxy-based productsin the following years in order to reduce the concentration of low molecular weight epoxy componentsmigrating from the final lacquer film. Epoxy derivatives, in particular BADGE, its hydrolysis products andhydrochlorine adducts, have been examined with respect to their toxicological profiles.25
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packaging materials 7. metal packaging for foodstuffs - Europa

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