"Active and Intelligent" Packaging − A European Anomaly
In an interesting paper published in the October 2005 edition of Food Additives and Contaminants,1 A. R. De Jong and a group of co-authors presented information about new systems now being developed to make it possible to use packaging materials to actively preserve foods, or to indicate when foods are spoiled in some way. A proposition set forth in this paper, which is worthy of serious legal discussion, is the authors' assertion that "most active and intelligent concepts that are on the market in the USA and Australia cannot be introduced in Europe yet, due to more stringent EU legislation."2
It is the purpose of this article to question this assertion and the need for the special provisions now included in the latest Framework Regulation for Food Contact Materials of the European Community.3
As this observer has said previously in a European forum, in the year 2000,4 it is difficult, if not impossible, to understand why any special legislation is needed to clear active or intelligent packaging from the legal perspective, unless one assumes that the law demands some showing of functionality for some such systems.5 In the United States, when Congress was considering the 1958 Food Additives Amendment,6 there was a point in 1957 when the FDA's legislative proposal, H. R. 4014, included a provision that would have required proof of functionality as one of the requirements for obtaining a clearance. This proposal was opposed by industry and the then Secretary of Commerce, Sinclair Weeks, advised the relevant subcommittee of the House Committee on Interstate and Foreign Commerce that:
The Department considers highly undesirable any blanket requirement such as is contained in H. R. 4014 that a chemical additive be shown to serve a purpose which will be useful to the consuming public before its use is permitted. Such a restriction would be undesirable and it might impose a great burden upon industry without any countervailing benefit to the consuming public.7
This point was discussed even more thoroughly during the hearings on the legislation, with industry's position being that the marketplace could be relied upon to weed out useless additives and that government intrusion into the "usefulness" arena was completely unnecessary.8
The idea of requiring showings of functionality was dropped and has never been revived. It was, of course, ultimately agreed that no additive should be used that would give rise to consumer deception or adulteration of food, so there is a provision in the Food Additives Amendment that specifically precludes clearance of any additive that would bring about such deception or fraud.9
In the same vein, we are not aware of any provision in the European Union's various statutes or framework regulations relating to packaging materials that speak to the issue of functionality. Thus, as to packaging materials, there is no difference between Europe and the U.S. where functionality is concerned.
What Is the Real Issue?
If this is correct, it is submitted that the thesis of the DeJong paper is in error to the extent that it declares it impossible to bring active and intelligent packaging to market in Europe due to legal proscriptions. It is, however, possible that some legislative modification might be necessary to permit active packaging where a system results in additions of substances so significantly that they are, in fact, direct food additives.
Stated another way, where a substance will be added to food from packaging in concentrations that exceed the general migration limitation of 60 mg/kg of food or 10mg/dm2, it is conceivable that it could not be justified as technologically required and this might require some sort of special dispensation since the direct additive provisions in Europe do require showings of technological requirement.
It is here submitted that if a substance is designed to be added to foods in some amount that exceeds the general migration limitation, albeit via a package, it is a direct additive and should be dealt with as such. (In the U.S., this was the case with butylated hydroxytoluene (BHT), which was once incorporated into cereal packages, the intent being for it to migrate into cereals and, thereby, extend shelf life.) If it is simply designed to help protect the food from deterioration, contamination, or other adulteration, and does not add anything to food, it is a classic "food contact substance" or indirect additive, already required to be regulated by existing law.
Indeed, the authors of the DeJong paper state in various places that substances used to effect "active and intelligent" packaging do have to be cleared by appropriate food contact or direct additive legal requirements in accordance with existing law. Why then the notion of another type of special clearance?
Some proponents of the special treatment have been heard to point to the fact that the EU Framework Regulation, newly revised in 2004, 10 calls for packaging materials to be "inert" and theorize that active and intelligent packaging is not intended to be inert. In this connection the Framework Directive actually provides as follows:
(3) The principle underlying this Regulation is that any material or article intended to come into contact directly or indirectly with food must be sufficiently inert to preclude substances from being transferred to food in quantities large enough to endanger human health or to bring about an unacceptable change in the composition of the food or a deterioration in its organoleptic properties.
Thus, the term "inert" is not any more absolute in Europe than in the U.S. Its use simply requires that there be no transfer of any quantity of a substance that exceeds the 60 µg/kg of food criterion, or that will endanger human health or change the character of the food in some significant way. This definition aptly covers all packaging materials where there is no intent to add anything to food, i.e., to have a technical effect in food. Since essentially all packaging is also intended to protect food from contamination and to keep it wholesome, it is hard to see how so called "active packaging" is distinguishable from other packaging. Indeed, the drafters of the Framework Directive seem to have encountered this same problem because it took them the following several paragraphs to try to draw a distinction:
(4) New types of materials and articles designed to actively maintain or improve the condition of the food ("active food contact materials and articles") are not inert by their design, unlike traditional materials and articles intended to come into contact with food. Other types of new materials and articles are designed to monitor the condition of the food ("intelligent food contact materials and articles"). Both these types of materials and articles may be brought into contact with food. It is therefore necessary, for reasons of clarity and legal certainty, for active and intelligent food contact materials and articles to be included in the scope of this Regulation and the main requirements for their use to be established. Further requirements should be stated in specific measures, to include positive lists of authorised substances and/or materials and articles, which should be adopted as soon as possible.
(5) Active food contact materials and articles are designed to deliberately incorporate "active" components intended to be released into the food or to absorb substances from the food. They should be distinguished from materials and articles which are traditionally used to release their natural ingredients into specific types of food during the process of their manufacture, such as wooden barrels.
(6) Active food contact materials and articles may change the composition or the organoleptic properties of the food only if the changes comply with the Community provisions applicable to food, such as the provisions of Directive 89/107/EEC on food additives. In particular, substances such as food additives deliberately incorporated into certain active food contact materials and articles for release into packaged foods or the environment surrounding such foods, should be authorised under the relevant Community provisions applicable to food and also be subject to other rules which will be established in a specific measure. In addition, adequate labeling or information should support users in the safe and correct use of active materials and articles in compliance with the food legislation, including the provisions on food labeling.
(7) Active and intelligent food contact materials and articles should not change the composition or the organoleptic properties of food or give information about the condition of the food that could mislead consumers. For example, active food contact materials and articles should not release or absorb substances such as aldehydes or amines in order to mask an incipient spoilage of the food. Such changes which could manipulate signs of spoilage could mislead the consumer and they should therefore not be allowed. Similarly, active food contact materials and articles which produce colour changes to the food that give the wrong information concerning the condition of the food could mislead the consumer and therefore should not be allowed either.
In our view, this tortuous attempt to draw a distinction between ordinary packaging and "active" packaging is inapt. The fact is that the only thing that distinguishes one type of packaging as "active," from another type that simply protects the food from spoilage or contamination is an apparent desire to make a marketing claim that the substances "added" will somehow enhance the characteristics of the food. As long as a substance used in a package does not result in untoward migration into a foodstuff, does not give rise to taste or odor problems, and is not used to mislead the consumer in any way, it is simply a food contact substance and should be treated as such.11
A prime purpose of essentially all packaging is to protect food from contamination or undue exposure, so all of it is "active." The only possible distinction here between packaging, generally, and so-called "active" packaging is that, in the latter case, some substances may be intended to be added to food in amounts that exceed the overall migration limits. Where this is so, the substance is really a direct additive and should be cleared as such.
What is termed "intelligent packaging" could present a different case. It has not been the subject of such strained attempts to define the nature of the concept. It is merely presented as a class of materials "designed to monitor the condition of the food."
Thus, presumably, such materials would serve no ordinarily protective purpose in the food package (i.e., would not help protect against contamination or adulteration of the food) other than to provide notice if the food had spoiled or was otherwise adversely affected.
This does, perhaps, present a practical distinction, but not because of the "inertness" criterion since it would still not be tolerated if it added anything to foods that would make them unhealthy. Here, the distinction is that something would be permitted that, at least in theory, is not required to make the package a better package, per se, and that will not be a part of the food either.
To the extent that proponents of legislative change have some reason for wanting such materials specially cleared or classified, they could be considered unique and worthy of some special regulatory form. Perhaps one reason for such a classification could be that regulators might otherwise be bothered by the fact that the substance cannot be considered reasonably necessary or functional as to the integrity of the package.
In our view, a substance can be incorporated in a package if it is safe and the government has no statutory basis for examining or passing on its functionality, or the value thereof, it being very reasonably presumed that no one will want to add to the cost of a packaging material by using something that is unnecessary.
In sum, it would appear that those who seek to establish new classifications for certain types of packaging materials are doing so for commercial reasons and not to fill a regulatory gap.12 They can accomplish this purpose in the normal way by the use of marketing techniques, such as special labeling, public education, or advertising. It is suggested here that trying to do so by adding regulatory complications where there is no public interest requirement is of questionable value, and should be avoided.
When statutes are changed, one must be careful of what he wishes for lest he set up new complications, the ultimate thrust of which might be to grant governments the right to impose added responsibilities in areas where none are necessary.
4. See Heckman, "Why 'Active and Intelligent' Packaging Systems Present No Special Regulatory Concern in the United States," presented on April 18, 2000, at the TNO Nutrition and Food Research Institute and European Union sponsored Actipak Conference on Active and Intelligent Packagings, Zeist, The Netherlands.
5. Indeed, a careful review of the 79-page "Final Report on Task 5 of the 'Actipak' Project, Recommendations for Legislative Amendments," indicates to this author that this presentation, the basis for the new EU proposals, does not indicate the need for changes to the fundamental EU packaging law provisions, although it does indicate ways in which some sort of legislative imprimatur might enhance the marketing of such systems. FAIR-Project PL 98-4170.
9. Food Additives Amendment of 1958, Pub. L. No. 85-929, 72 Stat. 1784, 21 U.S.C. 301-395. Section 409(c)(3)(B) provides that the FDA shall deny the clearance of any additive if the evidence provided for it "shows that the additive would promote deception of the consumer . . . or would otherwise result in adulteration or misbranding of food . . ."
11. Of course, if the use of the additive were to result in overall migration exceeding the prescribed limit of 10mg per square decimeter (EC Directive 2002/72, Article 2), it should be classified as a "direct additive" requiring conventional food additive clearance.
12. In fact, the document urging the EU to adopt special language for active and intelligent packaging, "Final Report on Task 5 of the 'Actipak' Project, Recommendations for Legislative Amendments," cited above in note 5, contains an Appendix II that clearly shows no member of the EU has heretofore found it necessary to have such special language and several of the countries have indicated they see no need for it. See p. 39 et. seq. of the referenced report.