Regulation of active and intelligent packaging 1731 Regulation EC No 19352004

In 2004 a new framework Regulation (EC) No 1935/20043 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 active and intelligent packaging, the following definitions of active and intelligent materials are given:

'Active food contact materials and articles' (hereinafter referred to as 'active materials and articles') means materials and articles that are intended to extend the shelf-life or to maintain or improve the condition of packaged food. They are designed to deliberately incorporate components that would release or absorb substances into or from the packaged food or the environment surrounding the food. 'Intelligent food contact materials and articles' (hereinafter referred to as 'intelligent materials and articles') means materials and articles which monitor the condition of packaged food or the environment surrounding the food.

The definition of active packaging refers to 'deliberately' incorporated components with the intention to release or absorb substances. This distinguishes active materials from passive packaging materials which in a few cases may have an effect on the food, but which are added for other reasons, e.g., a monomer. The definition also excludes all packaging materials from natural sources. For instance, wooden barrels are therefore not subject to the provisions on active materials. The substances released from these are not deliberately added to food. But if a wood extract were to be incorporated into an active packaging system then this would fall under the general and specific measures on active materials and articles. The definition on intelligent materials is restrictive as it refers to packaged foods only. This means that an ordinary thermometer or recording equipment used in food production are not considered 'intelligent' articles.

Article 3 of the framework regulation requires that food contact materials shall not transfer their constituents to foods in quantities which could 'endanger human health, or bring about an unacceptable change in the composition of the food, or bring about a deterioration in the organoleptic characteristics'. In particular, releasing materials cannot meet these requirements as they are designed to change the composition or the organoleptic properties of the food. Absorbing materials may also change the composition or organoleptic properties of the food. Therefore a special Article 4 has been inserted which allows changes in the composition or organoleptic characteristics of the food, provided the changes comply with the provisions of Directive 89/107/ EEC10 on food additives and its related implementing measures. In the absence of Community measures national provisions shall be applicable. Inserting this provision took away the hurdle, in the old framework Directive 89/109/ EEC2, for the introduction of active packaging with a releasing function. Additional requirements on active and intelligent materials are related to misleading the consumer and to labelling. Active packaging used to change the composition of food or its organoleptic properties in order to mask spoilage of that food is not acceptable, whilst information provided by intelligent packaging shall be reliable and not mislead the consumer. The regulation introduces the European Food Safety Authority (EFSA) and its role, including procedures and time frames. These are in accordance with 'general food law'.11 The EFSA has to be consulted on issues affecting public health. This means also that the authorisation of active and intelligent materials will be subject to an EFSA evaluation.

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.

17.3.2 Draft regulation on active and intelligent materials and articles

A specific regulation12 on active and intelligent packaging is under preparation and approaching its final stage. In spite of the fact that this is still a draft regulation, it is most likely that the final regulation will not differ significantly from the document now available. Therefore the document can be taken as a starting point for requirements on active and intelligent packaging.

The draft regulation in particular deals with the authorisation procedure for active and intelligent 'components'. Active and intelligent components are defined as 'individual substances or a combination of substances which cause the active function or provide the intelligent information'. It should be taken into account that most active and intelligent packaging has a complex structure. In general, active and intelligent packaging can be divided into two types. One consists of the active or intelligent components, while the second part concerns the so-called carriers or passive parts that contain the component. Carriers may be interpreted to include a material on which a releasing component is adsorbed and the packaging of the components. In the example of an ethanol releaser, the ethanol is absorbed on a silica gel which in turn is packaged in a paper or plastic sachet. The ethanol is defined as the active component that is subject to authorisation. The silica gel and the sachet form the passive part and should comply with safety requirements as defined in the framework regulation and implemented EU or national measures.

Migration from food contact materials (FCM) is subject to EU or national regulations. Overall migration and specific migration limits are established in the various regulations.20'40 These limits are set to ensure inertness and safety of the FCM. Active releasing packaging is not designed to be inert. It will in many cases exceed the overall migration limit and in some cases the specific migration limits set for FCM. Therefore a substance released deliberately from an active packaging material should not be included in overall migration. Special protocols may be needed for the determination of overall migration. CEN methods EN 1186, Parts 1—1513 may not be suitable. Specific migration limits may be exceeded provided the final food complies with the rules and restrictions applicable to processed foods.

Finally the draft regulation requires that active and intelligent packagings 'are suitable and effective for the intended purpose' and that the active and intelligent components are authorised. Authorisation will be granted after a positive opinion of the EFSA and will be valid only to the applicant for an authorisation. The authorisation will be valid for a period of ten years and may be renewed for another period of ten years. The authorisation will be published in a Decision to the applicant. In addition the active and intelligent components will be inserted in a list of authorised components.

A requirement, in line with Regulation (EC) No 1935/2004,3 concerning a declaration of compliance and the availability of appropriate documentation, has been confirmed in the draft regulation. It means that for any active and intelligent material a statement shall be provided that certifies that the material is safe to be used in contact with food under specified conditions of contact. To support such a statement the certifier shall have documentation that can prove the validity of the certificated. These documents shall be available to relevant authorities for inspection. In many cases this will include analytical data on, e.g., migration, total release, and effectivity of the active and intelligent of active components.

17.3.3 Requirements for authorisation - EFSA guidelines

The EFSA has been appointed to advise the European Commission on the safety of substances to come into contact with foods. Opinions of EFSA are based on a risk assessment. In general the conclusions given in an opinion will be adopted by the Commission, although occasionally the Commission may decide to deviate from the EFSA opinion as a risk management issue. In Fig. 17.1 a flow scheme related to the authorisation procedure is depicted.

The Scientific Committee of Food (SCF), the predecessor of the European Food Safety Authority (EFSA), established guidelines for food contact materials14 and in particular for plastics. EFSA's working group on food contact materials provided detailed explanatory guidance15 in the Note for guidance. The guidelines are not generally applicable to active and intelligent packaging, and EFSA will publish additional guidelines and explanatory guidance that may support applicants when drafting an application and developing a testing protocol. This guidance should be available at the moment the regulation on active and intelligent packaging is ready for implementation. Only a rough and predictive overview of the guidelines is feasible at this stage. EFSA will require all data needed to make a proper safety assessment, and in spite of any guidelines they will always be authorised to ask for additional information. It is likely that an application should contain:

Fig. 17.1 Procedure for application, evaluation and authorisation of active and intelligent components.

• general information on the identity of the applicant

• summary document which summarises all the information provided

• technical dossier containing a description of the active or intelligent material, its function and the active or intelligent components. Additional information may be required but this could depend on the type of active or intelligent packaging.

For releasing materials it is likely that there will be a focus on the releasing component and its authorisation as a food additive, including any quantitative restriction or a restriction on the types of food. The information on efficacy may be important, e.g., in the case of a released preservative the final efficacy in the food should be demonstrated. A general rule may be considered that if the released component shows insufficient or no technical effect on the food, then the food additive does not comply with the requirements on food additives10'16'17 or any other relevant regulation on the composition of food and its additives, e.g., the requirements on food flavours.1819 As a consequence such a material may not obtain a favourable opinion. Some information may be requested on the carrier of the releasing substance, but as this will not be part of an authorisation the safety of the carrier is the responsibility of the producer and the final user. In many cases the carrier may be subject to other provision on food contact materials. In principle the carrier should be inert and should not migrate to the food at an unacceptable concentration.

For absorbing materials the focus will be on the toxicological properties and quantities of components that (unintentionally) migrate into the food. If the absorber consists of plastic then only the plastics Directive 2002/72/EC20 will be applied. Many active materials are composed of various types of materials, e.g., plastic, paper, metal and adhesive. No harmonised EU regulation exists on these materials and therefore they are subject to the framework regulation3 and relevant national provisions of EU Member States. As mentioned for releasing materials, the efficiency or capacity of the absorber will almost certainly be considered in the final evaluation. As an example, the use of an oxygen absorber which has insufficient capacity to decrease and maintain the oxygen content to a low concentration may at best mislead the consumer or create in the worst case an even more dangerous situation due to the overgrowth of specific microbes. Also the possible growth of anaerobic bacteria present on some foodstuffs may be a reason not to apply an oxygen scavenger. It could be questioned whether this can be covered in an authorisation. It may be better to maintain the responsibility for final food safety with the food packers, who are familiar with their food products and possible problems.

Intelligent materials will probably need a demonstration of the reliability of the information provided, to comply with the respective requirement in the draft regulation. In respect of unintended migration a distinction may be feasible for materials that are positioned inside or outside the primary packaging. In the latter case the actual migration of any intelligent component may be negligible and it would be logical to adapt the need for toxicological information to the 'no migration' or 'functional barrier' principle. This would mean that un-authorised substances can be used behind a barrier layer, provided the substances are not mutagenic, carcinogenic or toxic to reproduction according to Directive 67/548/EEC.21 If the intelligent material is or may come into contact with the food then the intelligent ingredients will need an evaluation based on migration level and toxicological properties as outlined in the Note for guidance.1415

17.3.4 General safety

Many EU directives and regulations related to food and food safety have been published. All relevant regulations have been extensively discussed before.22 Without being exhaustive, the following subjects could be subject to relevant European or Member States' regulations and might be taken into account in an evaluation procedure performed by EFSA:

• food contact materials

• food additives

• flavourings

• general product safety

• misleading claims

As a general rule all the regulations related to food have the requirement that the final food should be safe for consumption. This may relate to chemical composition or to microbiological deterioration. Chemical composition may refer to food additives,10 flavouring substances18,19 or sweeteners.23 If these substances are added via active packaging then the final food must comply with the relevant requirements for food production. The regulation on hygiene24 requires that all measures shall be taken to assure the wholesomeness of the food. Active packaging may be a useful tool to comply with this requirement as it is usually applied to extend the shelf life of the food or at least to maintain the quality of food during its shelf life. The regulation on biocides25 is actually not applicable as biocides are not allowed in processed food. Only substances that are authorised as preservatives in food may be applied. Food contact materials with antimicrobial surfaces (e.g. after incorporation of silver ions in food contact materials) are frequently, but incorrectly, referred to as active packaging. The anti-microbial surface has no effect on the food itself and therefore it is excluded from the definition of active packaging.

Products shall be safe as established in Directive 2001/95/EC.26 'Safe products' means that under normal or reasonably foreseeable conditions of use the product does not present any risk or only the minimal risks compatible with the product's use. In judging safety aspects, the characteristics of the product, presentation, labelling instructions and the category of consumers, especially children, should be considered. Also the shape and size of active or intelligent packaging in the form of, for example, a sachet that is packed together with the food may give reasons for concern. A sachet filled with active compounds may be misunderstood by consumers and pose a threat. In some cases a visually attractive object may be packed together with the food. In such instances extreme care should be taken to avoid confusing consumers. Equally, controls must stop possible dangers to human health, for example, from consumers trying to eat sachets filled with active compounds. Appropriate labelling will be essential.

Some active packaging is designed to absorb components from the packaged food, e.g., a moisture absorber. When using this type of absorber the final weight of the food available for consumption may change. Directives 75/ 106/EEC27 and 76/211/EEC28 include labelling of weight and tolerances. When part of the food is absorbed by an absorber then the final weight may no longer comply with the intended and declared food weight.

Besides the framework Regulation 1935/20043 and the specific Directive 2002/72/EC20 on food contact materials, other directives on food contact materials have been adopted and may be relevant in assuring the safety of active or intelligent packaging. This concerns directives on regenerated plastics,29'30'31 ceramics32 and a regulation on certain epoxy compounds.33 In the absence of harmonised EU regulations, existing national regulations may be applicable and may be useful to demonstrate safety of active or intelligent packaging.

17.3.5 Labelling

Labelling of foodstuffs is meant to give consumers information on the composition of the food and so protect their interests. Labelling appears to be a complex issue as there are many EU directives and regulations that include requirements on labelling. Food labelling may concern the food, food additives or food contact materials as well as active and intelligent packaging. Framework regulation 1935/20043 requires labelling of food contact materials that are not yet in contact with food. This labelling could be done by 'for food contact', or indicating use (e.g. 'soup spoon'), or by using the symbol in Fig. 17.2. Exceptions to this rule are articles that from their shape are clearly designed for food contact. In addition, food contact materials should be labelled with instructions for safe use. Identification should be added to allow food contact materials to be traced. Labelling of food contact materials should not mislead the ultimate consumer. For active packaging, information on the permitted use and the identity and quantity of the released substance has to be provided in order to allow a food packer to comply with any restriction. Materials that may be mistaken as a part of the food, such as loose sachets, must be labelled using the symbol for a non-edible item (Fig. 17.3).

Fig. 17.2 Symbol for food contact materials.


Fig. 17.3 Symbol proposed for labelling active materials.

Directive 2000/13/EC34 deals with labelling, presentation and advertising of foodstuffs and is applicable to all foodstuffs intended for sale to consumers or caterers. Also Directive 89/107/EEC10 sets requirements on labelling of food additives. In principle, all substances used in the manufacture or preparation of foodstuffs and still present in the finished product should be declared on the label in order to inform the consumer about the substances present. It is of no interest how or when the substances are added to the food and therefore substances released from an active packaging system should be declared.

A minimum durability date should be provided and for highly perishable foodstuffs a 'use by' date should be given. This latter requirement is a hindrance to the use of a time temperature indicator (TTI). A 'use by' date should also cover foreseeable incorrect storage conditions, e.g., during transport. Therefore 'use by' dates are set on a very safe (short) period. By use of appropriate TTIs the total safe consumption period could be used for the benefit of both the consumer and the manufacturer or retailer. It is assumed that further effort by TTI manufacturers may result in a legal recognition of TTI as a replacement for 'use by' dates.

Modified atmosphere gases are regulated as food additives (Directive 95/ 2/EEC35). Gases that may be added are listed. When modified gas packaging is applied this should be labelled. However there are no provisions for the removal of gases from the packed food. This means that a CO2 releasing system falls within the definition of food additive. But an oxygen scavenger does not comply with the definition as the oxygen is removed. The final gas composition in a modified atmosphere may be comparable to that in packaged food using an oxygen absorber, but it is not yet clear whether there is any regulation that would prevent the use of oxygen absorbers. On the other hand there is no prohibition on the removal of oxygen from packaged food and no labelling requirement for the modified atmosphere. Only Regulation 1935/2004 requires that the use or presence of an active device, extending the shelf life of the food, should be labelled.

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