474 Novel food packaging that storage times are relatively short and temperatures are low. Taking this into account the probability of migration through the primary packaging into the food is negligible. These types of intelligent systems should not be considered as food contact materials with respect to migration testing. Nevertheless, it may be necessary to include intelligent substances in a positive list for which oxicological evaluation can be kept to a minimum eco Active and intelligent packaging systems manufactured from plastics only shall comply with the compositional and migration requirements(except for ntentionally released substances) Substances intentionally released from an active releasing system shall comply with relevant requirements for food and food additives. Provisions should be made for allowance of migration values higher than the overall igration of 60 mg/kg food It is proposed to draft a specific directive in which active and intelligent packaging systems are regulated. For regulation of composite materials reference to existing national regulations with regard to the base packaging materials and separate listing of the active and intelligent ingredients seems the best solution for the time being Active and intelligent packaging systems should be accompanied with a declaration of compliance provided the provisions proposed have been realized It will remain very difficult and laborious for enforcement laboratories to prove violation of Article 2 of Directive 89/109/EEC for complex systems For manufacturers it may be difficult to demonstrate compliance with the rules, as they are usually not aware of the composition of all parts of the final article. A proper certification system may provide a better guarantee of the safety of the packaging system. Proper rules and guidelines, as well as the appointment of recognized certification laboratories would be required for that purpose. The scheme given in Fig. 22.2 could be a starting point for drafting a certification procedure 22.5. 4 Basic rules for migration tests At the EU level, rules for testing plastic food contact materials are given in 82/ 711/EECo as amended by 93/8/EEC and 97/48/EEC. 2 Directive 85/572/ EEC provides a list of simulants that could replace real foodstuffs in migration testing. Simulants prescribed for compliance testing are water, 3% acetic acid 10% ethanol or olive oil. In some cases olive oil may be replaced with the substitute food simulants 95% ethanol and iso-octane In directive 85/572/EEC it is recognized that a fat simulant may be a stronger extractive than the food Depending on the food and its fat content reduction factors are included in the list. this means that the migration value obtained with a fat simulant should be divided by the value indicated for that particular food. The reduction factors from 2 to 5
that storage times are relatively short and temperatures are low. Taking this into account the probability of migration through the primary packaging into the food is negligible. These types of intelligent systems should not be considered as food contact materials with respect to migration testing. Nevertheless, it may be necessary to include ‘intelligent substances’ in a positive list for which toxicological evaluation can be kept to a minimum. Recommendations • Active and intelligent packaging systems manufactured from plastics only shall comply with the compositional and migration requirements (except for intentionally released substances). • Substances intentionally released from an active releasing system shall comply with relevant requirements for food and food additives. Provisions should be made for allowance of migration values higher than the overall migration of 60 mg/kg food. • It is proposed to draft a specific directive in which active and intelligent packaging systems are regulated. For regulation of composite materials reference to existing national regulations with regard to the base packaging materials and separate listing of the active and intelligent ingredients seems the best solution for the time being. • Active and intelligent packaging systems should be accompanied with a declaration of compliance provided the provisions proposed have been realized. • It will remain very difficult and laborious for enforcement laboratories to prove violation of Article 2 of Directive 89/109/EEC for complex systems. For manufacturers it may be difficult to demonstrate compliance with the rules, as they are usually not aware of the composition of all parts of the final article. A proper certification system may provide a better guarantee of the safety of the packaging system. Proper rules and guidelines, as well as the appointment of recognized certification laboratories would be required for that purpose. The scheme given in Fig. 22.2 could be a starting point for drafting a certification procedure. 22.5.4 Basic rules for migration tests At the EU level, rules for testing plastic food contact materials are given in 82/ 711/EEC10 as amended by 93/8/EEC11 and 97/48/EEC. 12 Directive 85/572/ EEC13 provides a list of simulants that could replace real foodstuffs in migration testing. Simulants prescribed for compliance testing are water, 3% acetic acid, 10% ethanol or olive oil. In some cases olive oil may be replaced with the substitute food simulants 95% ethanol and iso-octane. In Directive 85/572/EEC it is recognized that a fat simulant may be a stronger extractive than the food. Depending on the food and its fat content reduction factors are included in the list. This means that the migration value obtained with a fat simulant should be divided by the value indicated for that particular food. The reduction factors vary from 2 to 5. 474 Novel food packaging techniques
Legislative issues relating to active and intelligent packaging 475 Collection of information on systems active-antelligent ingn mmL时 Restrictions of use Dry D certifying HOmogeneous: F Administrativc vchificntior of complian Af ingredients food additive regulation s notified substance functional barier a for requred test ition of A/ ingredients ato of hra ximum release Returm to → CERTIFICATE Fig. 22.2 Scheme for certification procedure In Directive 9748/EC detailed conditions of time and temperature are given to demonstrate compliance with the limits set in Directive 2002/72/EC. The test conditions to be applied shall represent the worst foreseeable conditions of use in case of contact with foodstuffs. Food contact materials and articles should be ccompanied with a statement indicating the restrictions of use, if any, with respect to the types of food and the maximum contact conditions of time and temperature, according to Article 6 of Directive 89/109/EEC
In Directive 97/48/EC detailed conditions of time and temperature are given to demonstrate compliance with the limits set in Directive 2002/72/EC. The test conditions to be applied shall represent the worst foreseeable conditions of use in case of contact with foodstuffs. Food contact materials and articles should be accompanied with a statement indicating the restrictions of use, if any, with respect to the types of food and the maximum contact conditions of time and temperature, according to Article 6 of Directive 89/109/EEC. Fig. 22.2 Scheme for certification procedure. Legislative issues relating to active and intelligent packaging 475
476 Novel food packaging techniques Directive 97/48/EC explicitly mentions that, if the food contact material under specified contact conditions shows physical or other changes that do not occur under conditions of use, the migration test shall be carried out under the worst foreseeable contact conditions of use in which these physical or other hanges do not take place. This article allows for the use of specially developed testing protocols depending on the problems encountered in the standardized testing protocols. However, the test protocols are applicable only to materials made of plastic. This means that materials composed of one or more layers not made of plastic are not covered by the eu regulation. At a national level,for ample in the Netherlands, the testing protocols are used for most types of food contact materials. Detailed methods in which the requirements of these directives are taken into account have been drafted and validated by the European Standardisation Committee(CEN) in EN 1186 and EN 13130 Relevance to A&I packaging systems The appearance(size and shape)and the composition of active and intelligent packaging systems depend on their application. Systems used to wrap the food and made of plastics solely can be examined according to the requirements of Directive 82/711/EEC. If such a system intentionally releases substances to the food, then technically the system can be examined according to the requirements of Directive 82/711/EEC, but it may exceed the overall migration limit without endangering human health, changing the composition of the food in an unacceptable way or deteriorating sensory properties. Therefore these systems would require a special approach in interpretating migration values Most active and intelligent packaging systems are composed of various(non- plastic) materials. In principle, these materials are excluded from EU regulations. However, at a national level the same testing protocols are applied to most other non-plastic food contact materials. In contrast to conventional packaging materials and articles, active and intelligent packaging systems have often a very limited surface area compared to the food in contact with them Many of these systems are not intentionally in contact with the food but only by accident. For example, a sachet with an oxygen absorber may not be in contact with the food at all at the stage of packing. During transport or handling in a retail shop the food may make contact with the absorber, but only a relatively small area of the food will be in contact with the absorber sachet. Nevertheless, migration may occur and migration testing is required to guarantee food safety The test conditions of time and temperature can be selected from Directive 82/ 711/EEC, and the appropriate simulants from Directive 85/572/EEC. For active and intelligent packaging systems in contact with dry foodstuffs(without free fat on the surface)no migration tests with simulants are prescribed. If necessary, the specific migration of substances should be measured in the food itself. Systems in contact with aqueous or fatty foods require testing with simulants In principle, the protocols prescribe that food contact materials are brought into contact with a food simulant. This can be achieved by total immersion or by one- sided contact of the material with the food simulant. One-sided contact of plastic
Directive 97/48/EC explicitly mentions that, if the food contact material under specified contact conditions shows physical or other changes that do not occur under conditions of use, the migration test shall be carried out under the worst foreseeable contact conditions of use in which these physical or other changes do not take place. This article allows for the use of specially developed testing protocols depending on the problems encountered in the standardized testing protocols. However, the test protocols are applicable only to materials made of plastic. This means that materials composed of one or more layers not made of plastic are not covered by the EU regulation. At a national level, for example in the Netherlands, the testing protocols are used for most types of food contact materials. Detailed methods in which the requirements of these directives are taken into account have been drafted and validated by the European Standardisation Committee (CEN) in EN 1186 and EN 13130. Relevance to A&I packaging systems The appearance (size and shape) and the composition of active and intelligent packaging systems depend on their application. Systems used to wrap the food and made of plastics solely can be examined according to the requirements of Directive 82/711/EEC. If such a system intentionally releases substances to the food, then technically the system can be examined according to the requirements of Directive 82/711/EEC, but it may exceed the overall migration limit without endangering human health, changing the composition of the food in an unacceptable way or deteriorating sensory properties. Therefore these systems would require a special approach in interpretating migration values. Most active and intelligent packaging systems are composed of various (nonplastic) materials. In principle, these materials are excluded from EU regulations. However, at a national level the same testing protocols are applied to most other non-plastic food contact materials. In contrast to conventional packaging materials and articles, active and intelligent packaging systems have often a very limited surface area compared to the food in contact with them. Many of these systems are not intentionally in contact with the food but only by accident. For example, a sachet with an oxygen absorber may not be in contact with the food at all at the stage of packing. During transport or handling in a retail shop the food may make contact with the absorber, but only a relatively small area of the food will be in contact with the absorber sachet. Nevertheless, migration may occur and migration testing is required to guarantee food safety. The test conditions of time and temperature can be selected from Directive 82/ 711/EEC, and the appropriate simulants from Directive 85/572/EEC. For active and intelligent packaging systems in contact with dry foodstuffs (without free fat on the surface) no migration tests with simulants are prescribed. If necessary, the specific migration of substances should be measured in the food itself. Systems in contact with aqueous or fatty foods require testing with simulants. In principle, the protocols prescribe that food contact materials are brought into contact with a food simulant. This can be achieved by total immersion or by onesided contact of the material with the food simulant. One-sided contact of plastic 476 Novel food packaging techniques
Legislative issues relating to active and intelligent packaging 477 materials is achievable by filling an article such as a bottle or by using a migration cell for one-sided contact. Due to the construction of many active and intelligent packaging systems this approach is not feasible, and only submersion of the article is an option. The conditions of contact and, as a consequence, the migration of substances during submersion in food simulant may deviate severely from the conditions of contact occurring under real conditions of contact. For example, the conditions of contact of a small oxygen absorber with roasted nuts are not comparable to submersion in a fat simulant, not even when the allowed reduction factor is applied. When submersing the oxygen absorber in oil the whole article is soaked with oil, which does not happen when it is in contact with nuts. Comparable situations were observed when using systems in contact with meat, for which Directive 85/572/EEC requires testing with water and oil. The tests with water and, in case of processed meat products, with 3% acetic acid by total immersion results in excessive migration of iron ions into the food simulant. After the migration period the food simulant is usually brown- coloured by iron oxide. This phenomenon does not occur with foodstuffs therwise, the food contaminated with brown spots would not be acceptable from a sensory point of view In the case of moisture absorbers submersion of the absorber leads to contact conditions significantly different from those occurring in contact with food under real conditions as well. Active and intelligent packaging systems are in contact with the foodstuff under different conditions from conventional packaging materials. In addition, the composition(multi-layer) of the system as well as the presence of an active ingredient, are reasons for high migration when testing under conventional conditions. Therefore, there is a need for extending the existing test protocols with so-called dedicated test methods Within the Actipak project some experiments with dedicated tests have been performed. Oxygen-absorbing labels were tested by sandwiching the label between layers of filter paper immersed in iso-octane as the fatty food simulant After the migration period the paper was extracted and the overall migration was etermined. Migration from a paper fibre-based moisture absorber was determined with a block of agar. The agar immobilizes the water in a comparable way as water bound in meat, for example. To demonstrate potential migration the absorber was first partly saturated with water containing a fluorescent label. After the contact period the migration of the fluorescent label was measured. This test could be useful to demonstrate whether or not migration may occur. Similar tests were performed with a moisture regulator based on the hygroscopic properties of sugar solutions. Migration of iron and sodium chloride from an oxygen absorber in real food, food simulants and alternative simulants has been determined as well. The results are very promising, but need further standardization ar Intelligent systems placed on the outside of the primary packaging may form separate group. These intelligent systems are connected to the packaging material by means of an adhesive. Many intelligent systems are composed of plastic material that contains the intelligent ingredients as one of the layers of
materials is achievable by filling an article such as a bottle or by using a migration cell for one-sided contact. Due to the construction of many active and intelligent packaging systems this approach is not feasible, and only submersion of the article is an option. The conditions of contact and, as a consequence, the migration of substances during submersion in food simulant may deviate severely from the conditions of contact occurring under real conditions of contact. For example, the conditions of contact of a small oxygen absorber with roasted nuts are not comparable to submersion in a fat simulant, not even when the allowed reduction factor is applied. When submersing the oxygen absorber in oil the whole article is soaked with oil, which does not happen when it is in contact with nuts. Comparable situations were observed when using systems in contact with meat, for which Directive 85/572/EEC requires testing with water and oil. The tests with water and, in case of processed meat products, with 3% acetic acid by total immersion results in excessive migration of iron ions into the food simulant. After the migration period the food simulant is usually browncoloured by iron oxide. This phenomenon does not occur with foodstuffs; otherwise, the food contaminated with brown spots would not be acceptable from a sensory point of view. In the case of moisture absorbers, submersion of the absorber leads to contact conditions significantly different from those occurring in contact with food under real conditions as well. Active and intelligent packaging systems are in contact with the foodstuff under different conditions from conventional packaging materials. In addition, the composition (multi-layer) of the system, as well as the presence of an active ingredient, are reasons for high migration when testing under conventional conditions. Therefore, there is a need for extending the existing test protocols with so-called dedicated test methods. Within the Actipak project some experiments with dedicated tests have been performed. Oxygen-absorbing labels were tested by sandwiching the label between layers of filter paper immersed in iso-octane as the fatty food simulant. After the migration period the paper was extracted and the overall migration was determined. Migration from a paper fibre-based moisture absorber was determined with a block of agar. The agar immobilizes the water in a comparable way as water bound in meat, for example. To demonstrate potential migration the absorber was first partly saturated with water containing a fluorescent label. After the contact period the migration of the fluorescent label was measured. This test could be useful to demonstrate whether or not migration may occur. Similar tests were performed with a moisture regulator based on the hygroscopic properties of sugar solutions. Migration of iron and sodium chloride from an oxygen absorber in real food, food simulants and alternative simulants has been determined as well. The results are very promising, but need further standardization and validation. Intelligent systems placed on the outside of the primary packaging may form a separate group. These intelligent systems are connected to the packaging material by means of an adhesive. Many intelligent systems are composed of plastic material that contains the intelligent ingredients as one of the layers of Legislative issues relating to active and intelligent packaging 477
478 Novel food packaging techniques the system or in a plastic sachet. There is no direct contact with the food. In ddition, the shelf-life of foods with an intelligent system on the outside elatively short. Even if a polyolefin is used for the primary packaging the lag time will prevent any migration. There is no need yet to require migration testing of intelligent systems connected to the outside of the primary packaging commendations Active and intelligent packaging systems composed of only plastic shall be tested according to Directives 82/71 1/EEC and 85/572/EEC Substances intended to be released from an active system could be quantified by migration testing or by determination of the total amount present, while assuming that the total amount of substance present in the active system will be released to the packed food The annex of Directive 97/48/EC should be extended to allow testing with foodstuffs too Article 1(4)of Directive 82/711/EEC should be amended to allow application of the provisions of the Directive to active and intelligent packaging systems not composed of plastics only Intelligent systems placed on the outside of the primary packaging should be excluded from migration testing. Clause 4 of Chapter Il of the Annex of Directive 9748/EEC should be extended for that purpose An additional Chapter V in the Annex of Directive 97/48/EC should be inserted to allow for dedicated test protocols for some types of active and intelligent packaging systems Dedicated test protocols need further development and standardization 22.55 Other directives on food contact materials Other specific directives concerning food contact materials have been published However, these directives do not influence the use of active and intelligent packaging systems and are hence not discussed here in detail. For the sake of ompleteness, these directives are listed belot 93/10/EEC regenerated cellulose film 93/111/EC Ist amendment to Directive 93/10/EEC 84/500/EECI6 ceramic articles intended to come into contact with foodstuffs 2002/16/EC use of certain epoxy derivatives 22. 6 Food additives The requirements for food additives are formulated in general terms in Frame- work Directive 89/107/EEC. Specific directives have been published on colour sweeteners and food additives other than colours and sweeteners
the system or in a plastic sachet. There is no direct contact with the food. In addition, the shelf-life of foods with an intelligent system on the outside is relatively short. Even if a polyolefin is used for the primary packaging the lag time will prevent any migration. There is no need yet to require migration testing of intelligent systems connected to the outside of the primary packaging. Recommendations • Active and intelligent packaging systems composed of only plastic shall be tested according to Directives 82/711/EEC and 85/572/EEC. • Substances intended to be released from an active system could be quantified by migration testing or by determination of the total amount present, while assuming that the total amount of substance present in the active system will be released to the packed food. • The annex of Directive 97/48/EC should be extended to allow testing with foodstuffs too. • Article 1 (4) of Directive 82/711/EEC should be amended to allow application of the provisions of the Directive to active and intelligent packaging systems not composed of plastics only. • Intelligent systems placed on the outside of the primary packaging should be excluded from migration testing. Clause 4 of Chapter II of the Annex of Directive 97/48/EEC should be extended for that purpose. • An additional Chapter V in the Annex of Directive 97/48/EC should be inserted to allow for dedicated test protocols for some types of active and intelligent packaging systems. • Dedicated test protocols need further development and standardization. 22.5.5 Other directives on food contact materials Other specific directives concerning food contact materials have been published. However, these directives do not influence the use of active and intelligent packaging systems and are hence not discussed here in detail. For the sake of completeness, these directives are listed below. 93/10/EEC14 regenerated cellulose film 93/111/EC15 1st amendment to Directive 93/10/EEC 84/500/EEC16 ceramic articles intended to come into contact with foodstuffs 2002/16/EC17 use of certain epoxy derivatives 22.6 Food additives The requirements for food additives are formulated in general terms in Framework Directive 89/107/EEC. Specific directives have been published on colours, sweeteners and food additives other than colours and sweeteners. 478 Novel food packaging techniques