Legislative issues relating to active and intelligent packaging 479 2.6.1 Framework Directive 89/107/EEC as amended by Directive 94/34/ eEcI Directive 89/107/EEC specifies the definition for food additives and the scope of the directive. In simple terms, it states that food additives are not food ingredients or characteristic ingredients. Food additives are intentionally added to attain a technological effect during manufacturing, storage and distribution of the food Various categories of food additives have been identified each with its typical properties. Food additives are allowed only if there is a technological need, if there is no hazard to human health and if they do not mislead the consumer. Consumers should be informed about the presence of additives in foodstuffs by means of proper labelling of the food or the food additives. At a national level specific requirements on listing the ingredients as well as their traceability may exist. Relevance to active and intelligent packaging systems The directive on food additives is relevant only to systems that intentionally release substances into the food. The substance intentionally released from an active system should in the first place be an allowed food additive covered by one of the categories listed in Annex I of Directive 89/107/EEC. In addition there should be a technological need that cannot be met by other means. Validity of this clause may be difficult to demonstrate but active systems fulfil a technological function in the food when food is already packed. In addition, the requirement to add the lowest level possible to achieve a desired effect may support the use of active systems. Active systems usually will be active at the surface of the packed food, whereas a food additive is often mixed into the food As a result, the total amount of a substance may be significantly reduced when using an active system Foods may contain a substance that is also released from an active packagin system. In those cases, the final concentration in the food should be taken for a proper judgement of compliance with regulatory requirements. The food packer will carry that responsibility in first instance. The proper labelling of the active releasing system concerning the maximum amount of substance released from an active system avoids the possibility of that maximum limit being exceeded Active releasing systems may release the food additive via the headspace of the packed food to obtain a distribution as uniform as possible. In other cases the transfer of substances may be caused by intense contact with the active system In both cases the concentration at the surface may be higher than the maximum allowed concentration. However. measured on the basis of the bulk of the food the amount of food additive should be significantly below the allowed concentration limit. Taking into account that the whole bulk of the packed food is consumed this should not be a problem. In analysis of the foodstuff a proper homogenization of the food should be ensured Directive 89/107/eec does not form any hurdle to the use of active and
22.6.1 Framework Directive 89/107/EEC18 as amended by Directive 94/34/ EEC19 Directive 89/107/EEC specifies the definition for food additives and the scope of the directive. In simple terms, it states that food additives are not food ingredients or characteristic ingredients. Food additives are intentionally added to attain a technological effect during manufacturing, storage and distribution of the food. Various categories of food additives have been identified, each with its typical properties. Food additives are allowed only if there is a technological need, if there is no hazard to human health and if they do not mislead the consumer. Consumers should be informed about the presence of additives in foodstuffs by means of proper labelling of the food or the food additives. At a national level specific requirements on listing the ingredients as well as their traceability may exist. Relevance to active and intelligent packaging systems The directive on food additives is relevant only to systems that intentionally release substances into the food. The substance intentionally released from an active system should in the first place be an allowed food additive covered by one of the categories listed in Annex I of Directive 89/107/EEC. In addition, there should be a technological need that cannot be met by other means. Validity of this clause may be difficult to demonstrate but active systems fulfil a technological function in the food when food is already packed. In addition, the requirement to add the lowest level possible to achieve a desired effect may support the use of active systems. Active systems usually will be active at the surface of the packed food, whereas a food additive is often mixed into the food. As a result, the total amount of a substance may be significantly reduced when using an active system. Foods may contain a substance that is also released from an active packaging system. In those cases, the final concentration in the food should be taken for a proper judgement of compliance with regulatory requirements. The food packer will carry that responsibility in first instance. The proper labelling of the active releasing system concerning the maximum amount of substance released from an active system avoids the possibility of that maximum limit being exceeded. Active releasing systems may release the food additive via the headspace of the packed food to obtain a distribution as uniform as possible. In other cases the transfer of substances may be caused by intense contact with the active system. In both cases the concentration at the surface may be higher than the maximum allowed concentration. However, measured on the basis of the bulk of the food the amount of food additive should be significantly below the allowed concentration limit. Taking into account that the whole bulk of the packed food is consumed this should not be a problem. In analysis of the foodstuff a proper homogenization of the food should be ensured. Recommendations • Directive 89/107/EEC does not form any hurdle to the use of active and Legislative issues relating to active and intelligent packaging 479
480 Novel food packaging intelligent packaging systems. The substances released from active packaging ystems shall comply with the requirements of this directive Foods in contact with a releasing system should be homogenized before analyzing the food on the total amount of the relevant food additive 22.6.2 Specific directives on colours, sweeteners and food additives other than colours and sweeteners In addition to the framework directive, specific directives on food additives have been published. Directive 95/2/EC20(last amended by 2001/5/EC provides a glossary of the various categories of food additives covered by the directive. Also substances not included in the directive are indicated. for example substances for the treatment of drinking water. The directive is based on the positive list principle. The substances, provided with a so-called E number, are listed in five separate annexes. The annexes list substances for general use or for use in specified foods or concentrations A relevant issue is the packaging gases that are allowed in all foodstuffs. In nis respect, the Directive defines packaging gases as gases other than air, introduced into a container before, during or after placing a foodstuff in that Packaging gases provided with an E number are carbon dioxide, argon, helium, nitrogen, dinitrogen oxide and oxygen. The additives are subject to purity requirements, which are laid down in specific directives. Requirements for colours used in foodstuffs are laid down in Directive 94/36/EC.-- Colours allowed to add or restore colour in foodstuffs include colours of natural sources In five annexes the permitted colours and the conditions of their use are laid down. The annexes include a positive list, a list of foodstuffs that may not be coloured and colours with restricted uses Directive 94/35/EC2(as amended by Directive 96/83/EC+)concerns the use of sweeteners added to foodstuffs. Only the sweeteners listed may be used in the foodstuffs listed at a level fulfilling the intended purpose and shall not mislead consumer Relevance to active and intelligent packaging systems The specific directives of the framework Directive 89/107/EEC are relevant only to releasing systems. The specific directives are detailed and do not allow deviations. Therefore, the releasing systems should comply with qualitative and quantitative requirements on food additives. Manufacturers and food packers should realize that a releasing system may not be generally applicable to all foodstuffs but only to specified ones. Therefore, it seems obvious that the manufacturer of releasing systems should give proper instructions and define conditions of use, although the final user or food packer has his own esponsibility as well None of the specific directives mentions the removal of substances from the packed foodstuffs. This may be logical as the directives are dealing with
intelligent packaging systems. The substances released from active packaging systems shall comply with the requirements of this directive. • Foods in contact with a releasing system should be homogenized before analyzing the food on the total amount of the relevant food additive. 22.6.2 Specific directives on colours, sweeteners and food additives other than colours and sweeteners In addition to the Framework directive, specific directives on food additives have been published. Directive 95/2/EC20 (last amended by 2001/5/EC21) provides a glossary of the various categories of food additives covered by the directive. Also substances not included in the directive are indicated, for example substances for the treatment of drinking water. The directive is based on the positive list principle. The substances, provided with a so-called E number, are listed in five separate annexes. The annexes list substances for general use or for use in specified foods or concentrations. A relevant issue is the packaging gases that are allowed in all foodstuffs. In this respect, the Directive defines packaging gases as gases other than air, introduced into a container before, during or after placing a foodstuff in that container. Packaging gases provided with an E number are carbon dioxide, argon, helium, nitrogen, dinitrogen oxide and oxygen. The additives are subject to purity requirements, which are laid down in specific directives. Requirements for colours used in foodstuffs are laid down in Directive 94/36/EC.22 Colours allowed to add or restore colour in foodstuffs include colours of natural sources. In five annexes the permitted colours and the conditions of their use are laid down. The annexes include a positive list, a list of foodstuffs that may not be coloured, and colours with restricted uses. Directive 94/35/EC23 (as amended by Directive 96/83/EC24) concerns the use of sweeteners added to foodstuffs. Only the sweeteners listed may be used in the foodstuffs listed at a level fulfilling the intended purpose and shall not mislead consumers. Relevance to active and intelligent packaging systems The specific directives of the framework Directive 89/107/EEC are relevant only to releasing systems. The specific directives are detailed and do not allow deviations. Therefore, the releasing systems should comply with qualitative and quantitative requirements on food additives. Manufacturers and food packers should realize that a releasing system may not be generally applicable to all foodstuffs but only to specified ones. Therefore, it seems obvious that the manufacturer of releasing systems should give proper instructions and define conditions of use, although the final user or food packer has his own responsibility as well. None of the specific directives mentions the removal of substances from the packed foodstuffs. This may be logical as the directives are dealing with 480 Novel food packaging techniques
Legislative issues relating to active and intelligent packaging 481 additives. The use of an oxygen absorber, which removes oxygen from the headspace of the packed food, is excluded from the directive whereas flushing ith nitrogen is included. The resultant packaging gas is, however, similar. The application of gas absorbers is not covered by any directive and remains the responsibility of the food packer. As the application of oxygen absorbers is very similar to the use of packaging gases, it seems logical that labelling and food safety are handled in the same way Labelling of packed food Packaging gases used for packaging certain foodstuffs should not be regarded as ingredients and therefore should not be included in the list of ingredients on the label. However, consumers should be informed of the use of such gases inasmuch as this information enables them to understand why the foodstuff they have purchased has a longer shelf-life than similar products packaged differently. Therefore, the following text should be used on the label in the national language: packed under a protective atmosphere, as is required for modified-atmosphere packaging Food safety When the atmosphere inside a package is altered, the limiting factor for shelf- life may also change. For example, in an oxygen-free atmosphere the growth of aerobic micro-organisms is inhibited, but this atmosphere may promote the growth of anaerobic micro-organisms. The limiting factor for shelf-life may then become the growth of anaerobic micro-organisms. A similar reasoning may be valid for preservative-releasing systems. Shelf-life studies should reveal the poilage mechanism and the actual shelf-life of the food should be established Food additives released from active packaging systems shall comply with the requirements laid down in the framework directive and its subsequent specific directives. Limits and requirements on the total quantity of additives in foods and the purity of the additives shall be obeyed. Also the limitation of addition of substances to specified foods must be taken into account. Oxygen absorbers should be included in the section about modified- mosphere packaging by amending Article 1(3 r) of Directive 95/2/EC as packaging gases' are gases other than air, introduced into a container before, during or after placing of the foodstuff in that container, or by elective removal of oxygen after placing of the foodstuff in that Substances released into food shall be labelled according to requirements on belling
additives. The use of an oxygen absorber, which removes oxygen from the headspace of the packed food, is excluded from the directive whereas flushing with nitrogen is included. The resultant packaging gas is, however, similar. The application of gas absorbers is not covered by any directive and remains the responsibility of the food packer. As the application of oxygen absorbers is very similar to the use of packaging gases, it seems logical that labelling and food safety are handled in the same way. Labelling of packed food Packaging gases used for packaging certain foodstuffs should not be regarded as ingredients and therefore should not be included in the list of ingredients on the label. However, consumers should be informed of the use of such gases inasmuch as this information enables them to understand why the foodstuff they have purchased has a longer shelf-life than similar products packaged differently. Therefore, the following text should be used on the label in the national language: ‘packed under a protective atmosphere’, as is required for modified-atmosphere packaging Food safety When the atmosphere inside a package is altered, the limiting factor for shelflife may also change. For example, in an oxygen-free atmosphere the growth of aerobic micro-organisms is inhibited, but this atmosphere may promote the growth of anaerobic micro-organisms. The limiting factor for shelf-life may then become the growth of anaerobic micro-organisms. A similar reasoning may be valid for preservative-releasing systems. Shelf-life studies should reveal the spoilage mechanism and the actual shelf-life of the food should be established. Recommendations • Food additives released from active packaging systems shall comply with the requirements laid down in the framework directive and its subsequent specific directives. Limits and requirements on the total quantity of additives in foods and the purity of the additives shall be obeyed. Also the limitation of addition of substances to specified foods must be taken into account. • Oxygen absorbers should be included in the section about modifiedatmosphere packaging by amending Article 1(3 r) of Directive 95/2/EC as follows: ‘packaging gases’ are gases other than air, introduced into a container before, during or after placing of the foodstuff in that container, or by selective removal of oxygen after placing of the foodstuff in that container’ • Substances released into food shall be labelled according to requirements on labelling. Legislative issues relating to active and intelligent packaging 481
482 Novel food packaging techniques 22.7 Food flavouring Framework Directive 88/388/EEC2(as amended by 91/71/EEC26)concerns flavouring substances for use in or on foodstuffs to impart odour and/or taste The flavouring substances should be obtained from materials of vegetable or animal origin or by chemical synthesis. Flavourings should not imply addition of any element or substance in a toxicologically dangerous quantity. Maximum els for arsenic lead cadmium and chromium have been set. Also the content of 3, 4-benzopyrene is limited in all foods. There is a short list of substances that may be used at certain maximum concentrations in foodstuffs Labelling requirements concerning the description, quantity, suitability for food use and traceability have been laid down In Council regulation EC 2232/ 9627 a procedure is laid down which includes the listing of all flavouring ubstances in use in the eu member states. The substances will be evaluated to establish their conditions of use. Commission decision 1999/217.28 as amended by Commission decision 2000/489, lists more than 2800 substances The registration is a first step to a harmonized positive list of flavouring substances The Nordic countries have some specific rules for the use of flavourings in certain food products levance to active and intelligent packaging systems Active packaging systems releasing flavourings are by definition an attractive way of flavouring food. A flavour added to the packed foodstuff will generate an attractive or characteristic smell when consumers open the packed food Sausage casing may be flavoured to release the smoke flavour to the sausage in order to obtain a flavour taste and to preserve the sausage. a classic example is the use of wine barrels. which are used to store the wine but at the same time release their flavour to the wine, which may be characteristic of the wine. In modern wine making wood chips may be used to obtain the same effect. Although a wine barrel is clearly an active packaging material in the definition of active packaging systems, for historical reasons and because of the natural origin,wine barrels could be excluded from classification as an active packaging material Application of flavour-releasing systems will not be hindered by the existing regulations on flavouring, provided the rules laid down for flavouring of foodstuffs are taken into account Release of flavour, can however, also be used to hide some negative aspects of the foodstuff. Directive 88/388/EEC clearly indicates that flavouring must not be allowed to mislead consumers. The use of flavouring to hide spoilage is not acceptable; it would mislead consumers and may cause serious food poisoning. But, when the flavour is added in order to overwhelm an off-flavour of the food and the use of flavouring does not cause any toxic harm it may be found acceptable. Active flavour-releasing systems are also strong tools to avoid so-called scalping of flavour of packed foods. By supplementing the flavours through the packaging material this effect could be avoided
22.7 Food flavouring Framework Directive 88/388/EEC25 (as amended by 91/71/EEC26) concerns flavouring substances for use in or on foodstuffs to impart odour and/or taste. The flavouring substances should be obtained from materials of vegetable or animal origin or by chemical synthesis. Flavourings should not imply addition of any element or substance in a toxicologically dangerous quantity. Maximum levels for arsenic, lead, cadmium and chromium have been set. Also the content of 3,4-benzopyrene is limited in all foods. There is a short list of substances that may be used at certain maximum concentrations in foodstuffs. Labelling requirements concerning the description, quantity, suitability for food use and traceability have been laid down. In Council regulation EC 2232/ 9627 a procedure is laid down which includes the listing of all flavouring substances in use in the EU member states. The substances will be evaluated to establish their conditions of use. Commission decision 1999/217,28 as amended by Commission decision 2000/489,29 lists more than 2800 substances The registration is a first step to a harmonized positive list of flavouring substances. The Nordic countries have some specific rules for the use of flavourings in certain food products. 3 Relevance to active and intelligent packaging systems Active packaging systems releasing flavourings are by definition an attractive way of flavouring food. A flavour added to the packed foodstuff will generate an attractive or characteristic smell when consumers open the packed food. Sausage casing may be flavoured to release the smoke flavour to the sausage in order to obtain a flavour taste and to preserve the sausage. A classic example is the use of wine barrels, which are used to store the wine but at the same time release their flavour to the wine, which may be characteristic of the wine. In modern wine making wood chips may be used to obtain the same effect. Although a wine barrel is clearly an active packaging material in the definition of active packaging systems, for historical reasons and because of the natural origin, wine barrels could be excluded from classification as an active packaging material. Application of flavour-releasing systems will not be hindered by the existing regulations on flavouring, provided the rules laid down for flavouring of foodstuffs are taken into account. Release of flavour, can however, also be used to hide some negative aspects of the foodstuff. Directive 88/388/EEC clearly indicates that flavouring must not be allowed to mislead consumers. The use of flavouring to hide spoilage is not acceptable; it would mislead consumers and may cause serious food poisoning. But, when the flavour is added in order to overwhelm an off-flavour of the food and the use of flavouring does not cause any toxic harm it may be found acceptable. Active flavour-releasing systems are also strong tools to avoid so-called scalping of flavour of packed foods. By supplementing the flavours through the packaging material this effect could be avoided. 482 Novel food packaging techniques
Legislative issues relating to active and intelligent packaging 483 Another category of active packaging systems that may mislead consumers re absorbers For instance an absorber could be used to remove the amine smell of fish and, as a consequence, consumers will be deprived of a sensory indicator for spoilage. These types of active systems are not covered by the flavouring regulations but are actually comparable to hiding effects or, in the worst case misleading consumers Recommendations There are no fundamental objections to the use of an active system that releases flavouring substances, provided the regulations on flavouring are Allowed total quantities of flavourings in foods shall not be exceeded Flavouring to hide spoilage is not allowed Flavouring to mask natural or synthetic off-flavours should be further studied. Conditions of acceptability should be drafted Removal of substances is not an issue of the flavouring regulation but needs legal attention. Appropriate provisions could be included in the specific directive on active and intelligent food contact materials 22.8 Biocides and pesticides action of or otherwise exert a controlling Yeffect render harmless, prevent the on any harmful organism by chemical or biological means, as defined in Directive 98/8/EC. Several areas are excluded from the directive. Among others, food additives subject to Directive 89/107/EEC and food contact materials subject to Directive 89/109/ EEC are excluded from the biocide regulations 22.8.1 Relevance to active and intelligent packaging systems The biocide regulation excludes food additives and food contact materials. Thus, any substance with a biocidal effect should be listed in these regulations. Active systems intended to release a biocidally active substance into foods are limited to the use of substances allowed as food additives. All requirements and restrictions laid down in the regulations on food additives must be taken into account. Only in bulk transport is the use of biocides as well as pesticides allowed. A ship cargo space may be gassed with biocides or pesticides to protect the food. This may also be feasible with active systems of sufficient capacity This is considered a special category of application that should comply with the rules presently valid Often confusion is brought about with regard to the use of biocidal substances in food contact materials. There are two reasons to add biocidal products to food contact materials. First, it may be necessary to stabilize a polymer emulsion before manufacturing the final article. This application is indispensable to allow
Another category of active packaging systems that may mislead consumers are absorbers. For instance, an absorber could be used to remove the amine smell of fish and, as a consequence, consumers will be deprived of a sensory indicator for spoilage. These types of active systems are not covered by the flavouring regulations but are actually comparable to hiding effects or, in the worst case, misleading consumers. Recommendations • There are no fundamental objections to the use of an active system that releases flavouring substances, provided the regulations on flavouring are followed. • Allowed total quantities of flavourings in foods shall not be exceeded. • Flavouring to hide spoilage is not allowed. • Flavouring to mask natural or synthetic off-flavours should be further studied. Conditions of acceptability should be drafted. • Removal of substances is not an issue of the flavouring regulation but needs legal attention. Appropriate provisions could be included in the specific directive on active and intelligent food contact materials. 22.8 Biocides and pesticides Biocides are substances intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological means, as defined in Directive 98/8/EC. 30 Several areas are excluded from the directive. Among others, food additives subject to Directive 89/107/EEC and food contact materials subject to Directive 89/109/ EEC are excluded from the biocide regulations. 22.8.1 Relevance to active and intelligent packaging systems The biocide regulation excludes food additives and food contact materials. Thus, any substance with a biocidal effect should be listed in these regulations. Active systems intended to release a biocidally active substance into foods are limited to the use of substances allowed as food additives. All requirements and restrictions laid down in the regulations on food additives must be taken into account. Only in bulk transport is the use of biocides as well as pesticides allowed. A ship cargo space may be gassed with biocides or pesticides to protect the food. This may also be feasible with active systems of sufficient capacity. This is considered a special category of application that should comply with the rules presently valid. Often confusion is brought about with regard to the use of biocidal substances in food contact materials. There are two reasons to add biocidal products to food contact materials. First, it may be necessary to stabilize a polymer emulsion before manufacturing the final article. This application is indispensable to allow Legislative issues relating to active and intelligent packaging 483