Food Contact Materials: The View From the European Union
By Keller and Heckman LLP’s Packaging Practice Group
Since 1976, the European Community has been working on the approximation of the laws of the European Union Member States regarding materials and articles intended to come into contact with food. In 1989, a new Framework Directive, calling for the adoption of specific Commission directives on 10 different categories of food contact materials, was promulgated.
Today, only two main categories of materials (regenerated cellulose and ceramics) are subject to fully harmonized Community legislation, and the harmonization of the next category of materials (plastics) is still to be completed despite the fact that the first directive on plastics materials was adopted over 10 years ago. In the meantime, to determine the requirements applicable to those materials that are not subject to fully harmonized regulation at the EU level requires reference to the legislation in place in each of the individual European Union Member States.
In the absence of fully harmonized EU legislation, the principle of "mutual recognition" may be relied upon to ensure that materials and articles that comply with the regulation in place in one Member State may freely circulate in the other parts of the EU. There is still some resistance to the application of the "mutual recognition" principle in the food-contact area, however, and this resistance, the slow progress toward harmonization in this area, and the continued use of different regulatory approaches by Member States have maintained barriers to trade in food-contact materials that are not justified for the protection of public health. Consequently, it is evident that a new approach toward harmonization in this area—one that prevents unnecessary barriers to trade while adequately safeguarding public health—is urgently needed.
One possible approach, which is used in the United States, would be to bring about a food contact notification (FCN) system in lieu of the "positive list" system currently being pursued in the EU. A FCN system would be designed to allow the marketing of food contact materials after a defined review period, provided that the notifier has submitted to the authorities sufficient information to demonstrate that the intended use of the material is safe. The data required to be submitted to the authorities could be equivalent to the data requirements currently in place for petitions to the European Commission's Scientific Committee on Foods (SCF) (or, once the proper procedures are in place, the European Food Safety Authority (EFSA)) to add materials to the directive governing plastic materials used in contact with food (the so-called "Plastics Directive"); the improvement would be that the submitter would not be forced to wait for an indefinite amount of time for an amendment to a directive to permit the intended use of its material but, rather, would be able to go to market at a fixed time (e.g., 120 days) after the submission, unless the authorities were to object on safety grounds in the interim. Of course, adoption of an FCN system in the EU is simply one suggestion for helping to resolve the current difficulty in navigating the sea of EU and national requirements relating to food contact substances, and is not the focus of this article. Our focus for the remainder of this article is as follows: We will first provide background information on the current legislative and other provisions that relate to the regulation of food contact substances in the EU. Next, we will discuss the principle of mutual recognition, its legal basis, and its applicability to food-contact materials. We will follow this discussion with some practical examples of the way in which the existing food contact legislation and the principle of mutual recognition may be applied in specific situations. We will then complete our discussion with a look at the current trends in developing harmonized food contact legislation throughout the EU.
I. EU Legislation on Food-Contact Materials and Articles
The EU currently is in the process of "harmonizing" legislation on food contact substances, principally by adopting directives that are designed to replace the existing national provisions of the Member States. This work, however, is far from being complete.
The EU began the process by adopting a "Framework Directive" governing all food contact materials (Directive 89/109/EEC), which provides the general safety criteria applicable to all food contact materials. The Framework Directive also provides for the adoption of specific directives covering 10 individual categories of food contact materials. To date, only some of these specific directives have been adopted.
If a directive applicable to a particular product is in place at the EU level and has been implemented in the Member States' national legislation, then the use of that product must comply with the directive. If an EU directive covering a particular product or application has not yet been promulgated, finalized, or implemented into national law, then the use of the product must comply with the appropriate national laws of each of the EU Member States, subject to the principle of "mutual recognition," as described below.
A. EU Legislation Applicable to All Food Contact Materials
As indicated above, the EU Framework Directive 89/109/EEC provides the general safety criteria applicable to all food contact materials. More specifically, Article 2 of this directive states that all food-contact materials: (1) must be manufactured in accordance with good manufacturing practices (GMPs), and (2) must not transfer their constituents to foodstuffs in quantities that could "endanger human health" or bring about an unacceptable change in the composition of the food or its "organoleptic" characteristics, i.e., they must not adulterate food. This directive has been implemented and is in place in all of the Member States.
Article 3 of the Framework Directive provides for the adoption of more specific directives covering the following categories of food contact materials:
- plastics, including varnishes and coatings,
- regenerated cellulose,
- elastomers and rubber,
- paper and board,
- metal and alloys,
- wood, including cork,
- textile products, and
- paraffin waxes and micro-crystalline waxes.
These specific directives may contain "positive lists" of the substances that may be used in contact with food, purity criteria, specific conditions of use, and specific and overall migration limits. They also may contain provisions permitting sampling and checking for compliance with established requirements, and other rules for the protection of public health. Based on the broad scope of the provisions these directives may contain, the Commission enjoys a fair degree of flexibility in determining the rules to be applied to specific food contact materials.
The Framework Directive also contains provisions relating to supplying information on food-contact materials to consumers and professional users. In particular, it requires materials that are not already in contact with food to bear a "fork and glass symbol," which is specified in Directive 80/590/EEC.
The European Commission currently is preparing an amendment to the Framework Directive, which would specify that the Commission is to adopt "measures" instead of using the specific term "directives" for specific food contact materials. This modification is intended to facilitate the application of new EU legislation in the Member States. In particular, while directives must be implemented into the national laws of each individual Member State, "regulations" need not go through this additional procedural step. The Commission's current thinking is that the more specific directives promulgated pursuant to the Framework Directive often are so detailed that they are more like regulations than directives and, thus, should become effective in the Member States under the doctrine of "direct effect" even in cases in which the Member States do not promulgate implementing legislation before the mandated deadlines. The use of the term "measure" in place of "directive" in this regard is thus considered by the Commission to be more accurate. The first amendment to the Framework Directive also would clarify and expand, to some extent, some of the labeling and traceability requirements of the directive, and would clarify that the scope of the directive explicitly covers "active and intelligent" food contact material systems, ion-exchange resins, adhesives, and printing inks. As discussed more fully below, however, the Commission is not yet ready to adopt general language on a "Threshold of Regulatory Concern" within the directive, as sponsored by industry, which would be a key concept for the streamlining of legislation currently in place.
B. Legislation in Place in the EU on Specific Food Contact Materials
While the current version of the Framework Directive requires the European Commission to adopt specific directives covering 10 specific categories of food contact materials, to date only a few of these specific directives have been promulgated. Namely, directives on plastic materials, regenerated cellulose, ceramics and, to a limited extent, elastomers and rubber currently are the subject of specific directives addressing their food contact use. Further, the directive on plastic materials is not yet complete with respect to the additives used in the production of plastics; currently the directive is considered to be "fully harmonized" only with respect to the list of monomers that are permitted in the production of food contact plastics.
In the meantime, one must refer to the legislation in place in the Member States to determine the requirements applicable to those materials that are not fully regulated at the EU level. Also, the principle of "mutual recognition" may be used to ensure that materials and articles that comply with the regulation in place in one Member State can freely circulate in the other parts of the EU, as discussed below.
We discuss in detail below the requirements applicable to food contact plastics in the EU, since the EU directive on plastics (the Plastics Directive) is the most comprehensive of the directives on food contact materials adopted thus far. We note, however, that the Plastics Directive is limited in its scope and is not yet complete with respect to its "positive list" of permitted plastics additives. Thus, plastic materials are still, to a great extent, regulated at the national level. This situation results in the need for expert analysis of the regulatory status of materials in many instances. The requirements applicable to other categories of food-contact materials also are discussed below in a more general way.
1. Plastics Materials and Articles
The 'Plastics Directive,' 2002/72/EC.
The so-called "Plastics Directive," Commission Directive 2002/72/EC, published in August 2002, replaces the directive previously referred to as the "Monomers Directive" (Commission Directive 90/128/EC). Due to frequent and substantial amendments to the Monomers Directive, the Commission consolidated the Monomers Directive and its seven amendments into a single text, now known as the Plastics Directive. The provisions of the Plastics Directive are essentially identical to those of the previous Monomers Directive. Namely, the Plastics Directive provides a complete positive list of permissible monomers for use in food contact plastic materials and an overall migration limitation (OML) that must be met for all plastics in contact with food, unless the use is subject to an exemption. For most food contact materials, the overall migration must not exceed 10 milligrams per square decimeter of the article. Specific migration limits (SML) and quantitative limitations (QM) (i.e., residual level limitations) also have been established for certain specific substances. Accordingly, all monomers intended for use in the production of food contact plastics must be listed on the Plastics Directive, and the final food contact article must meet the OML and any SMLs or QMs that have been established for substances used as components of the article.
The Plastics Directive also contains a list of substances that may be used as additives in the manufacture of plastic materials. These substances have been reviewed and considered safe by the European Communities Scientific Committee on Foods (SCF). The additives list, however, is not yet complete, and unlisted additives may still be used, provided that their use is demonstrated to be safe and meets any relevant requirements under applicable national laws.
It is important to note that the Plastics Directive does not apply to materials and articles composed of two or more layers, one or more of which does not consist exclusively of plastics, regardless of whether the layer in direct contact with food is exclusively plastic. (See Commission Directive 2002/72/EC, Article 1, paragraph 4.) Thus, there currently is no legal requirement that each monomer or starting material used to produce a multi-layer article having one or more non-plastic layers be listed on the Plastics Directive. The regulatory requirements applicable to such products are limited to compliance with the general safety criteria of the Framework Directive and compliance with the applicable national legislation in place in the individual Member States of interest. In this regard, however, a positive listing in the Plastics Directive for components of multi-layer materials having one or more non-plastic layers is relevant in that it indicates that such components have been evaluated by the SCF and determined to be "safe" for use in contact with food, subject to any noted limitations.
In addition, the positive lists of monomers and additives that are included in the Annexes to the Plastics Directive currently are not intended to include polymerization aids, nor are they intended to include substances used only in the production of surface coatings, epoxy resins, adhesives and adhesion promoters, or printing inks. Thus, these materials also are subject to the national laws of individual EU Member States.
Other Directives on Food Contact Plastics.
For reference only, we note that the only other EU directives related to food contact plastics are those concerning the testing of migration of the constituents of plastic materials and articles, those related to vinyl chloride monomer, and a directive on the use of certain epoxy derivatives in food-contact materials.
For substances that are not covered by a listing in the Plastics Directive, and in situations wherein the Plastics Directive does not represent fully harmonized legislation for the application of interest (i.e., if, for example, the unlisted material is an additive or an epoxy resin), then the national legislation in place in each of the individual Member States also must be consulted to establish the status and confirm the safety of the substance for its intended use in food contact plastic applications. Eight of the 15 EU Member States (the United Kingdom, Germany, Austria, France, the Netherlands, Belgium, Italy, and Spain) have some form of national "positive list" of permissible substances for use in manufacturing food contact plastics beyond the required implementation of the EU directives. In Germany and the United Kingdom, however, these positive lists are not legally binding and other factors can be used to demonstrate that a given compound is safe. The remaining EU countries (Denmark, Finland, Greece, Ireland, Luxembourg, Portugal, and Sweden) do not have any specific compositional requirements for plastic food contact materials other than those promulgated at the EU level, including the safety criteria established by the Framework Directive.
The laws of the Member States that have "positive lists" of permitted plastics additives are discussed briefly below:
Austria regulates food contact materials pursuant to its Lebensmittelgesetz (LMG) of 1975; some provisions of this law mirror those of the EU Framework Directive. Austria also has implemented provisions of the EU Plastics Directive through a series of Ordinances on Plastics (Kunststoffverordnung), the first of which is Ordinance No. 775 of 23 September 1994. Section 28 of the Austrian LMG of 1975 prohibits the marketing of food contact substances that are not approved or do not comply with the Austrian conditions of approval, or food contact materials and articles containing any such substances. "Approved substances" include both substances that have been approved in Austria following petitions filed under the framework of the Austrian Food Act of 1951 and the LMG of 1975, and substances listed in the EU Plastics Directive (and, accordingly, the Austrian Plastics Ordinances). Once a substance is "authorized" in Austria, it may be used by any subsequent manufacturer, without any additional request or procedure, provided that such use complies with any specific conditions of use that may be prescribed.
Belgium regulates food contact materials under the Royal Arrêté of 11 May 1992 on Materials and Objects Intended for Contact with Foodstuffs (the "1992 Decree"), as amended. This decree governs the composition of food contact materials by means of "positive lists" for various types of food contact materials, including the monomers, additives, and aids to polymerization authorized for use in food contact plastics. The provisions of the Plastics Directive have been implemented into Belgian law. For some materials that are not covered by the Plastics Directive (e.g., additives and aids to polymerization), Belgian law also contains a "positive" list of the substances that may be used to the exclusion of all others.
Food contact materials in France are regulated under a series of laws, decrees, arrêtés, and circulars. Decree 73-128 of 12 February 1973 (the "1973 Decree") and a series of subsequent arrêtés and circulars, as reproduced in the Recueil 1227 of the French Official Journal, provide, among other things, several positive lists of those starting substances and additives that are permitted for specified uses in food contact materials. These circulars, decrees, and arrêtes are not organized according to type of product, so they all must be reviewed to determine whether a given substance is listed. As construed by French officials, the applicable French regulations constitute a "positive list" so that the use of unlisted substances would require prior approval by French officials.
Germany regulates food contact materials pursuant to its Law of 15 August 1974 on Trade with Foodstuffs, Tobacco Products, Cosmetic Agents and Other Articles ("Lebensmittel und Bedarfsgegenständegesetz" or "LMBG"). Sections 30 and 31 of this law generally mirror the basic safety requirement set forth in the EU Framework Directive for food contact materials. In addition, Germany's Regulation of 10 April 1992 on Food-Contact Materials implements provisions of the Plastics Directive. One way for a manufacturer to assure that products that are not covered by the Regulation of 10 April 1992 meet the LMBG's general safety requirements is to consider guidance contained in Kunststoffe im Lebensmittelverkehr of the Bundesinstitut für gesundheitlichen Verbraucherschutz und Veterinärmedizin (BgVV), currently known as the "BgVV Recommendations." We note here that the BgVV has been dissolved in conjunction with the restructuring of Germany's institutions covering consumer health protection and food safety and, at this writing, it appears that BgVV's function of evaluating food contact materials will be transferred to the new Federal Agency for Consumer Protection and Food Safety. Nevertheless, the BgVV Recommendations remain in existence. These recommendations define specific positive lists of starting substances and additives, including reaction control agents, that are permitted for use in individual food packaging applications. Although they are not legally binding, the BgVV Recommendations are widely respected in Germany, and German manufacturers often insist that materials meet existing BgVV recommendations. However, products whose safety can be demonstrated by other means are also equally compliant with German law.
Food contact materials in Italy are regulated under the Decree of 21 March 1973 on Hygienic Requirements for Packaging, Containers, and Utensils Intended To Be Used in Direct Contact with Food and Substances for Personal Use ("the 1973 Decree"), as amended. This decree establishes rules for the authorization and control of objects intended to come into contact with food substances. Article 3, Title I of the 1973 Decree stipulates that food contact materials must be prepared exclusively from components specifically listed in an attachment to the law for different categories of materials (such as plastic, rubber, regenerated cellulose, paper and cardboard, glass, and stainless steel) and must otherwise comply with any conditions or limitations prescribed therein. The Ministerial Decree No. 220 of 26 April 1993 (the "1993 Decree") amends the 1973 Decree to implement the provisions of the Plastics Directive into the laws of Italy.
Spain has implemented the EU directives on food contact materials into its own national law. Specifically, Spain has implemented the Framework Directive, 89/109/EEC, by its Royal Decree 397/90 on materials and articles intended to be in contact with food, and the Plastics Directive by its Royal Decree 2207/94 on plastic materials and articles in contact with food (the "1994 Decree"). Spain's Resolution of 4 November 1982 contains a "positive list" of the additives that may be used in food-contact materials; however, this list has not been updated and it is understood that the Spanish authorities, in practice, take the position that Spain's implementation of the Plastics Directive supersedes this law with respect to plastic materials.
Food packaging materials are regulated in the Netherlands pursuant to a Decree of 1 October 1979 on Packaging and Articles of Daily Use ("Verpakkingen-en Gebruiksartikelen-besluit (Warenwet)"). This decree is implemented by the Ministerial Regulation of 25 January 1980 (the "Regeling verpakkingen en gebruiksartikelen (Warenwet)," as amended). These regulations are essentially a compilation of "positive lists" for different types of substances, including plastics, that are permitted in the Netherlands for use in manufacturing food packaging materials. The Warenwet Regulations are structured in 10 chapters that regulate plastics, paper and board, rubber, metals, glass, ceramics, textiles, regenerated cellulose, wood and cork, and coatings, respectively. As an example, Chapter I on plastics applies to monomers, additives, and aids to polymerization used in the production of food-contact plastics.
Finally, the UK has adopted into its own laws the EU Framework Directive via The Materials and Articles in Contact with Food Regulations 1987 (SI 1987/1523), as amended, and the Plastics Directive via The Plastic Materials and Articles in Contact with Food Regulations 1998, as amended. Thus, monomers must be appropriately listed in the UK while, for additives, only the general safety criteria apply (i.e., additives that are not listed on the UK additives list may be used provided that they are safe). As a means of ensuring the safety of additives used in plastic food contact materials, the UK recognizes and relies upon the determinations and recommendations of the British Industrial Biological Research Association (BIBRA) and the British Plastics Federation (BPF) as listed in the BIBRA/BPF Code of Practice. The BIBRA Recommendations, however, are not legally binding, are no longer being updated, and, thus, are of limited value. Consequently, other means, such as clearances in other countries, often are used to establish safety.
2. Other Categories of Food Contact Materials
The only other directives concerning materials and articles intended to contact food that have been adopted thus far at the EU level are those on regenerated cellulose film, and on N-nitrosamines and N-nitrosatable substances from elastomer or rubber teats and soothers. For other categories of materials, which are not yet the subject of specific directives, work toward the elaboration of common rules is being made in the forum of the Council of Europe (CoE). The CoE is a political organization that organizes cooperation between the governments of its member countries in a wide range of areas, including public health. (Currently, 44 European countries are members.) The CoE's Committee of Experts on Materials Coming into Contact with Food has the necessary expertise to develop guidelines, in the form of resolutions, applicable to the use of food contact materials. It has already developed resolutions on:
- colorants for plastics,
- aids to polymerization for plastics,
- ion-exchange and adsorbent resins,
- surface coatings, and
The CoE currently is updating its coatings resolution, and is working on resolutions on food contact paper and paperboard, packaging inks, and rubber, as well as guidelines on food contact metals and alloys, wood and cork, and good manufacturing practices for surface coatings.
CoE resolutions are not legally binding; however, they are widely respected by governments and industry alike. Furthermore, there are groups that would like to have the CoE work on food contact materials translated into the national legislation in place in the EU Member States. This approach would help to relieve some of the pressure on the Commission to promptly move forward with EU legislation on specific categories of food contact materials beyond plastics. This proposed path forward has created some controversy, however, as there is some concern that the procedures followed by the CoE are not as rigorous as those followed by the Commission with respect to completing scientific evaluations of materials and obtaining sufficient input from Member States and from industry groups. Thus, progress on CoE resolutions may, for a time, be slowed.
C. The Principle of Mutual Recognition
As mentioned above, if a directive applicable to a particular product is in place at the EU level and has been implemented in each of the Member States' national legislation, then the use of the product must comply with the directive. Very few areas of food contact legislation have been fully harmonized, however, and progress toward this goal is extremely slow. In the meantime, in situations in which an EU directive covering a particular product or application has not yet been promulgated, finalized, or implemented into national law, then the use of the product must comply with the appropriate national laws of each of the EU Member States, subject to the principle of "mutual recognition."
The principle of mutual recognition allows for the legal importation and sale in a Member State of products that are legally marketed in another Member State even if the products do not comply with the specific regulatory requirements of the country of import. As interpreted by the European Court of Justice, this means that Member States should allow products that are eligible for mutual recognition to freely circulate within their territory unless the Member States are able to demonstrate, following an appropriate authorization procedure, that the product presents a danger to public health.
We note, however, that, when relying on mutual recognition as a basis for accepting a substance, national authorities generally are more likely to accept the marketing of substances with a positive listing in another Member State, i.e., a substance that is explicitly included in a Member State's positive list or one that has been the subject of a favorable evaluation by the SCF, the body currently responsible for evaluating food contact substances in the EU (to be replaced at some point by a body within EFSA), as compared to a substance that has been marketed in another Member State solely on the basis of a manufacturer's independent safety conclusion.
While the principle of mutual recognition as applied in other areas, such as the regulation of direct food additives, has been the subject of important case law by the European Court of Justice (ECJ), so far, there has been no ruling by the Court in a case specifically involving food-contact materials. Unfortunately, while there was a chance that this would occur in 1999 following an action filed by the European Commission against France in connection with France's Order of 9 November 1994 on rubber products in contact with foodstuffs, the case was dropped by the Court of Justice due to a procedural issue unrelated to the substantive issues raised in the case.
By way of a brief bit of background, in August 1999, the European Commission decided to refer France's rubber decree to the Court of Justice on the grounds that this legislation fails to allow the importation of rubber products authorized for use in another Member State unless detailed rules on rubber products are applied by that State. Because detailed rules on rubber exist only in France, the Netherlands, and Germany, the French rubber decree would, in essence, preclude companies marketing rubber products in other countries—on the basis of determination of "safety" instead of an explicit positive listing—from marketing these products in France. The Commission, in its role of defending the free movement of goods principle enshrined in the EU Treaty, brought the case before the European Court of Justice in an effort to obtain a mandate for France to insert a "mutual recognition" clause in its legislation. This case would have provided the Court with the opportunity to confirm, with respect to food packaging materials, its existing case law on direct food additives and other products. Unfortunately, however, the ECJ has dismissed the case on procedural grounds and, therefore, the substance of this case will not be argued in court.
Additional support for the use of the principle of mutual recognition for food contact materials can, however, be found in the European Council resolution on mutual recognition of 28 October 1999. In this resolution, the Council encourages economic operators and citizens to make full use of the mutual recognition principle and invites the Commission to take measures to improve its application through information campaigns, guidebooks, and brochures.
II. Determining Compliance With EU Food Contact Legislation: Some Practical Examples
Having set the stage by discussing the applicable EU and national legislation governing food contact materials, we turn now to some practical examples of the way in which the relevant directives, national laws and regulations, and other useful concepts may be applied to specific products. Since, as discussed above, the most comprehensive EU-wide legislation applies to materials composed entirely of plastics, we will begin with this type of package.
A. Materials and Articles Made Entirely of Plastic
The first step in establishing a suitable status in the EU for a food package composed entirely of plastic is to ensure that each monomer used in the production of the package is listed on the Plastics Directive. As mentioned above, the Plastics Directive's positive list of monomers is considered to be exhaustive; thus, this part of the legislation is considered to be "fully harmonized" in the EU. Unlisted monomers simply are not permitted for use in the production of food-contact articles made entirely of plastic. Once a positive listing for each monomer has been identified, the next step is to ensure that any limitations on the use of those monomers, such as specific migration limits, are met.
Turning then to additives, the simplest way to establish a suitable status for each additive used in a plastic formulation is to identify a listing in the Plastics Directive's positive list of permitted plastic additives and to establish that any listed limitations are met. (Note that the Plastics Directive's additives list is divided into two parts: additives listed in Section A must meet any noted limitations such as specific migration limits (SML), while additives listed in Section B are subject to the noted SMLs only after Jan. 1, 2004, when verification is carried out using a fatty food simulating solvent.) Since the Plastics Directive and its amendments must be implemented into the national laws of each EU Member State, a positive listing on the Plastics Directive ensures that the use of the additive is permitted in every EU country. If one or more additives is not listed, however, there may still be a basis upon which to establish a suitable status for the use of the substance. This is because, as discussed previously, the Plastics Directive's additives list is considered to be "incomplete." The additives list is still being developed; thus, this part of the legislation is not yet "fully harmonized." Consequently, with respect to additives, the national laws of the individual EU Member States also apply.
For Member States that do not have a legally binding list of permitted plastic additives beyond the list that appears in the Plastics Directive, unlisted additives may continue to be used in food contact plastics, provided that such use is determined to be "safe." For countries that have national positive lists of permitted additives that go beyond the Plastics Directive listings, these positive lists must be considered. If each additive of interest is listed in each national positive list and meets any listed limitations, then the material may be used throughout the EU. The analysis does not stop there, however, in the (rather frequent) cases in which one or more additives is not listed. In such cases, it may be possible to rely upon the principle of mutual recognition as a legal basis upon which to market the material in Member States wherein legally binding national additives lists do not include one or more of the additives of interest. To rely on the principle of mutual recognition, however, the additive must be safe for the intended use, and the product must first be lawfully marketed in another EU Member State.
Finally, once a suitable status has been established for each component of a plastic food contact article, it is important to ensure that the article meets the overall migration limits set forth in the Plastics Directive.
Before turning to other types of food contact articles, it is worth noting that the regulatory situation in Germany with respect to plastic additives is unique. In particular, although Germany's BgVV Recommendations are not legally binding, they are widely respected and relied upon. Thus, although Germany may be considered to be a Member State that does not have a "legally binding" positive list of permitted additives beyond the list contained in the Plastics Directive, positive listings in the BgVV Recommendations frequently are desired to assure customers of the suitable regulatory status of an additive.
B. Complex Plastic Materials and Articles
Plastics that are used in multi-layer articles that also contain non-plastic layers, such as multi-layer films that contain both plastic and foil layers, or laminated paper and plastic articles, are not subject to the positive list requirements of the Plastics Directive. These articles are subject only to the general safety requirements in place in all EU Member States and the positive list requirements of those Member States that specifically address these types of multi-layer materials. Thus, in many ways, the analysis one must undertake to establish a suitable status for these multi-layer products is similar to the analysis that applies to plastic additives.
For most Member States, such articles may be marketed for use in food contact applications if it can be demonstrated that they are safe for the intended use and will not give rise to any taste or odor problems in the packaged food. For a few Member States (namely Austria, France, and the Netherlands), specific positive list requirements (and other requirements, depending upon the nature of the various layers) apply. Consequently, for these Member States, the specific national requirements must be consulted. If a component of a multi-layer material is not listed on the relevant national list, then the principle of mutual recognition would need to be relied upon as legal support for marketing the material in the Member State of interest. In this situation, the product would first need to be lawfully marketed in another EU Member State.
Plastic articles that contain recycled content present unique regulatory issues. At the EU level, the directives governing food contact materials do not explicitly address the use of recycled materials in contact with food. Thus, food contact articles containing recycled materials are regulated at the national level.
We note that, while the Plastics Directive does not explicitly addresses the use of recycled materials in contact with food, the EU's "Practical Guide for Users of European Directives" states as follows:
Recently, new procedures for obtaining monomers have been introduced, e.g., by depolymerization of the finished articles already used. The Commission considers that these monomers can be used as starting substances for the manufacture of plastics intended to come into contact with foodstuffs, if they comply with the applicable EEC Directives. As regards of the purity criteria of the mentioned monomers, see Directive 2002/72/EC, the Plastics Directive.
The Practical Guide is simply a guidance document and does not have the force of law. Nevertheless, the above-referenced provision makes clear that the Commission accepts the use of post-consumer recycled resins that are processed by depolymerization, provided that the finished monomers comply with the Plastics Directive and are of a suitable purity for the intended use.
As for EU Member State requirements, most Member States permit the use of recycled materials in contact with food, provided that the materials are demonstrated to be safe and suitable for the intended use. In this regard, although there currently is no EU directive that specifically addresses the use of recycled plastics in contact with food, the European Commission has sponsored a study on the criteria that should be considered for ensuring that recycled plastics are safe for such use. The study (referred to as the "AIR Study"), which was conducted by the Agro-Industrial Research Programme and coordinated by the United Kingdom's Ministry of Agriculture, Fisheries, and Food (MAFF), was accepted by the Commission in January of 1998. The AIR study recommendations currently are relied upon by at least some Member States as authoritative guidance on demonstrating the safety of recycled materials for use in contact with food.
Some countries, such as Belgium and France, require that data establishing the safety of particular recycled plastics must be submitted to and approved by government authorities. However, most Member States do not require such submissions. Currently, the language of legislation in two Member States, Italy and Spain, expressly prohibits the use of recycled materials in contact with food.
C. Other Materials and Articles
As for non-plastic articles, as detailed above, few materials are the subject of specific EU directives—most non-plastic articles currently are regulated solely at the Member State level. Regenerated cellulose films are a notable exception. Council Directive 83/229/EEC, as amended, sets out detailed requirements relating to cellulose films, including a positive list of materials that are permitted for use in the production of coated and uncoated cellulose films. As this directive is considered to fully harmonize the legislation in this area, cellulose films marketed for use in food contact materials in any Member State must comply with the requirements of this directive.
Rubber articles and ceramics are other types of packaging materials that are the subject of at least some legislation at the EU level. For ceramics, the EU legislation provides for lead limits and, for elastomers and rubber articles, the EU legislation provides for limits on the release of N-nitrosamines and N-nitrosable substances. As for compositional requirements for elastomers and rubber articles, in particular, national legislation still applies. Several Member States, including Italy, France, Germany, Spain, and The Netherlands, have specific positive lists of materials that may be used in the production of food contact rubber articles. (Again, Germany's list is a highly respected "recommendation.") In cases in which the use of an unlisted material is desired, the principle of mutual recognition again may be used as the legal basis for marketing the product in the "positive list" country of interest. In this case, it is important to first determine that the product is safe for the intended use, then to lawfully market the product in another EU Member State before marketing in the "positive list" country. We note that, were such a situation to be brought to the attention of the authorities in France, the authorities may well not agree to the application of mutual recognition. This situation exists despite the action that the Commission has taken against France in connection with the French Order of 9 November 1994 on rubber products, discussed in Section C above.
As for materials such as metal, glass, and paper and paperboard, as well as products such as catalysts, coatings, and adhesives used in the production of food contact articles, national laws still govern, subject to the general safety requirements of the Framework Directive. Although, as indicated above, the Council of Europe has prepared (or, in some cases, currently is preparing) resolutions to assist in establishing the safety and suitability of several of these types of products for use in food contact applications, the resolutions are not legally binding and, in some cases, progress on these resolutions is moving forward quite slowly. Thus, companies are in the unfortunate position of having to wade through the national legislation of every EU Member State to determine which requirements apply to their products.
III. Recent and Future Trends
While supporting the application of the mutual recognition principle to food contact materials that are not yet covered by harmonized directives, the Commission is continuing to develop and refine harmonized food contact legislation, still focusing mainly on plastics. In this regard, the Commission currently is preparing a first amendment to the Plastics Directive.
This amendment would provide for some significant changes to the Directive. Most importantly, the amendment would establish a Dec. 31, 2004, deadline for submitting petitions to include additives on the positive list of permitted plastic additives before the list becomes fully harmonized. There have been several deadlines for "completion" of the additives list, most recently the end of 2004. Under the proposed amendment, the additives list would not be considered as "fully harmonized" until all petitions for substances submitted before Dec. 31, 2004, are evaluated. Once those evaluations are complete, any additive not included on the positive list would not be permitted for use in the EU until a petition demonstrating its safety has been evaluated by the authorities and it is added to the positive list. In an attempt to place a more tangible time limit on completing the additives list, the amendment proposes that the Commission should prepare a draft directive to complete the positive list within six months of receiving from the European Food Safety Authority (EFSA) opinions on all of the additives petitioned prior to the Dec. 31, 2004, deadline.
In addition, colorants and solvents would expressly be added to the list of material types that are not yet required to be included on the additives list. Furthermore, the amendment would address "active packaging" materials, by explicitly stating that EU Member States may continue to regulate these types of packaging materials according to national legislation until harmonized rules are adopted. In keeping with this proposed amendment, a concurrent proposed amendment to the Framework Directive would define "active and intelligent" food contact materials systems, and would add these types of materials to the list of material types that should be the subject of specific directives. Under the proposed amendment, "active food contact materials systems" would contain "active" components that are "deliberately incorporated with the intention that either they or their reaction products would be released into the food or would absorb substances from the food." "Intelligent food contact materials systems" would be defined as those that "monitor the condition of the food."
The proposed amendment to the Plastics Directive also would clarify the status for use in food contact plastics of substances that are already permitted for use in the production of direct food additives and flavors. In this regard, the amendment would state that, if a listed monomer or plastic additive also is permitted for direct addition to certain foods as a food additive or flavoring agent, that substance must not migrate from food contact materials into those foods at levels that would exceed the permitted direct additive level or the level specified in the clearance under the Plastics Directive, whichever is lower. In addition, the amendment would state that, for foods in which the use of a substance as a direct additive or flavoring agent is not separately permitted, the substance must not migrate at levels that would have a technological function in the food.
Finally, the proposed amendment to the Plastics Directive would provide for the inclusion, in some cases, of more detailed information in written declarations of compliance. The current version of the Plastics Directive requires that written declarations must accompany plastic materials and articles at marketing stages, other than the retail stage, confirming that the materials comply with the rules applicable to them. Such declarations are not required for materials and articles that, by their nature, clearly are intended for food contact use. The amendment to the Directive would expand this requirement to include all plastic materials and articles, and would add the requirement that such declarations also should include, "where appropriate," information on the presence of substances that are subject to a restriction in food so that the end user may ensure compliance with the restriction.
These proposed changes to the Plastics Directive are consistent with some of the following trends in the Commission's thinking with respect to food contact regulation for the future.
First, the EU has been focusing on "active and intelligent" packaging systems in recent years and, more specifically, appropriate ways in which to regulate these types of materials. Recognizing that the traditional "positive list" system shows some important deficiencies when extended to active and intelligent packaging materials, the Commission sponsored, in part, a research project known as the "Actipak" project, to study these types of materials and to propose changes to the current system for regulating them. The report of this study suggests extending the scope of the Framework Directive explicitly to cover active and intelligent packaging and listing active and intelligent packaging materials among the packaging material types that should be the subject of specific directives (a proposal that has already been incorporated into the proposed draft first amendment to the Framework Directive).
The Actipak report also suggests modifying the Plastics Directive to provide for a separate annex dedicated exclusively to active and intelligent packaging materials. Furthermore, the report recommends modifying the Plastics Directive to allow for a higher overall migration limit (OML) for active and intelligent packaging, above the 60mg/kg limit currently in effect for more traditional packaging materials. Finally, the Actipak study concludes that dedicated migration test protocols for active and intelligent packaging systems should be developed and standardized.
Second, the Commission has indicated that it would like to rely more heavily on the Council of Europe to proceed with harmonization efforts for products not covered by the Plastics Directive. As discussed above, the Council of Europe has already developed resolutions on colorants for plastics, aids to polymerization for plastics, ion-exchange and adsorbent resins, surface coatings, and silicones. Further, it is working on draft resolutions on food contact paper and paperboard, packaging inks, and rubber, as well as guidelines on food contact metals and alloys, and wood and cork. The Commission hopes to be able to use these resolutions as the basis for directives on these categories of food contact materials. There have, however, been some concerns expressed in moving forward along these lines. In particular, some have cautioned that the CoE procedures for developing resolutions are not as inclusive of Member State and industry input, and do not employ scientific evaluations that are as rigorous as those employed by the Commission. Thus, progress on CoE resolutions and their possible use by the Commission as the basis for directives could be slowed considerably.
Third, the use of "worst case" calculations in lieu of migration test data has gained more widespread support in Europe both for demonstrating compliance with SML restrictions and for preparing dossiers requesting listings for new monomers and additives. The Commission recognizes the expense and difficulty manufacturers and enforcement agencies face in attempting to analyze food or food simulating solvents for the presence of plastic constituents and, as a result, has clarified the Plastics Directive to explicitly permit one to analyze a plastic material itself for a substance of interest (i.e., a monomer or additive) and use the results to calculate the potential level of migration of the substance to contacted food. Furthermore, the "Practical Guide for Users of European Directives" (updated to March 1, 2002) now contains a chapter devoted to the use of mathematical models to predict migration.
Fourth, progress is being made (albeit very slowly) in promoting the idea of using "food type" and "material type" consumption factors to more accurately estimate potential exposures to food-contact materials. Agreement on relevant consumption factors will be critical to the application of other useful concepts that are emerging in Europe, such as the concept of a "threshold of regulatory concern" and the "functional barrier" doctrine.
The EU system currently does not apply any material-type consumption factors or food-type distribution factors to estimate potential dietary exposures to food contact materials. Instead, the SCF considers only the amount of a material that may migrate to food in determining how much toxicology data it must evaluate to support a determination of safety. In so doing, the SCF does not allow for the idea that only a fraction of all packaged food is packaged using a given material (a concept acknowledged by the U.S. Food and Drug Administration via its use of "consumption factors"), nor does it allow for the idea that the typical human diet consists of a predictable combination of different food types (a concept acknowledged by FDA via its use of "food type distribution factors").
A significant amount of work has been done in Europe to promote the use of a "fatty food consumption factor" in evaluating migration test results using fatty food simulating solvents so that SML restrictions and required data packages for petitions may be more accurately assessed in situations involving contact with fatty foods.
As a result of this work, the SCF published, in December 2002, an "Opinion on the introduction of a fat (consumption) reduction factor (FRF) in the estimation of the exposure to a migrant from food contact materials." This opinion analyzes proposals from industry that support the introduction into EU legislation of an FRF that could be used in evaluating potential exposures to substances based on migration testing using fatty food simulating solvents, and fatty foods themselves, and concludes that the use of an FRF would be acceptable based on the SCF's evaluation if the Commission introduces such a system, but suggests the application of several limitations to ensure that the use of the FRF would not result in exposure estimates that vary too drastically from those calculated using the current system. While the SCF opinion gives some credence to the use of an FRF and, in that respect, is a step in the right direction, its limitations and qualifications have the result of watering it down to the extent that its value in impacting EU legislation is quite limited.
Work on developing data to support the use of other food type consumption factors, and on what is being referred to in Europe as "materials use consumption factors," has not progressed to any great extent as yet. Nevertheless, as evidenced by the SCF opinion on an FRF, the EU has indicated an interest in using consumption factors, and also has shown great interest in adding to its legislation concepts that relate to the use of such factors.
Further, the EU still appears to be working toward developing a "threshold of toxicological concern," akin to the "threshold of regulation concept" used by FDA, to place a limit on the extent of toxicology data needed to support the safety of food contact substances that result in very low dietary exposures. Setting a "threshold of toxicological concern" for food contact substances in the EU would help to simplify the regulatory process; however, to move forward with implementing this concept in a practical way, the Commission will need to resolve the consumption factor issue. By assuming that each material is used in contact with all types of food, and by neglecting to consider that the human diet consists of a distribution of different types of food, potential dietary exposures to individual food contact materials cannot be estimated with any reasonable degree of accuracy.
Work in developing a harmonized system for regulating food packaging in the EU previously has focused on formulating detailed positive lists of permitted materials. The Commission has now had more opportunities to focus its attention on the regulation of complex packaging systems and appears to recognize some of the shortcomings of the current system in this regard. Furthermore, the Commission seems to have a renewed realization of the extent of time and resources that will be involved in moving forward with regulating food contact materials using the current system. Thus, the trend seems to be moving toward finding ways to adopt legislation and implement requirements in a more efficient and practical manner to lessen the time and financial burden associated with regulating these materials while continuing to ensure a high level of protection of public health.
At the same time, however, the Commission appears to be considering extending its "positive list" system to additional types of substances, such as solvents used in the production of food-contact plastics. This dual approach signals to some extent that the Commission is unsure of the most effective path forward, and warns that inconsistent or unworkable systems could evolve.
Perhaps now is the time to move toward the use in Europe of a premarket notification system for regulating food contact materials similar to that adopted by FDA.
Directive 89/109/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs.
Article 1 of the Framework Directive makes clear that the directive applies not only to food contact materials and articles, but also to materials and articles that contact water intended for human consumption.
Directive 2002/72/EC of 6 August 2002 relating to plastic materials and articles intended to come into contact with foodstuffs.
Directive 90/128/EEC of 23 February 1990 concerning plastic materials and articles intended to come into contact with foodstuffs (OJ), as amended by Directive 92/39/EEC of 14 May 1992, Directive 93/9/EEC of 15 March 1993, Directive 95/3/EC of 14 February 1995, Directive 96/11/EC of 5 March 1996, Directive 1999/91/EC of 23 November 1999, Directive 2001/62/EC of 9 August 2001, and Directive 2002/17/EC of 21 February 2002.
These exemptions apply to containers of certain volumes, sealing applications, and articles that can be filled and where it is impracticable to estimate the surface area in contact with food.
Directive 82/711/EEC of 18 October 1982, as amended, laying down the basic rules for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs and Directive 85/572/EEC of 19 December 1985, as amended, laying down the list of simulants to be used for testing migration of plastic materials and articles intended to come into contact with foodstuffs.
Directive 78/142/EEC of 30 January 1978 on the approximation of the laws of the Member States relating to materials and articles which contain vinyl chloride monomer and are intended to come into contact with foodstuffs; Directive 80/766/EEC of 8 July 1980 laying down the Community method of analysis for the official control of the vinyl chloride monomer level in materials and articles which are intended to come into contact with foodstuffs; and Directive 81/432/EEC of 29 April 1981 laying down the Community method of analysis for the official control of vinyl chloride monomer released by materials and articles into foodstuffs.
Directive 2002/16/EC of 20 February 2002 on the use of certain epoxy derivatives in materials and articles intended to come into contact with foodstuffs.
Directive 83/229/EEC of 25 April 1983 on the approximation of the laws of the Member States relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs, as amended by Directive 93/10/EEC (OJ) and Directive 93/10/EEC of 15 March 1993 relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs, as amended (OJ).
Directive 93/11/EEC of 15 March 1993 concerning the release of the N-nitrosamines and N-nitrosatable substances from elastomer or rubber teats and soothers.
Council Resolution of 28 October 1999 on mutual recognition (2000/C 141/02), OJ C 141/5 of 19 May 2000.
If a company wishes to produce a food-contact material using a monomer that is not listed on the Plastics Directive, then a petition must be filed with the European Commission's Scientific Committee on Foods (SCF) (or, in the future, the European Food Safety Authority (EFSA)) to request a listing for the monomer of interest in the directive. This process, which involves a detailed review by the SCF of the data submitted and a subsequent amendment to the Plastics Directive, can take years, considering in particular the time needed for the legislative process of adopting an amendment to the directive.
Similar to the situation for monomers, to include a new additive in the Plastics Directive's positive list, a petition must be filed with the Commission, and the directive must eventually be amended to include the new additive. Although the additives list is not considered to be "fully harmonized," as discussed in Section III, below, it is expected to be considered complete within the next several years. Therefore, it is advisable for companies to go forward with petitions to list new additives of interest on the Plastics Directive, advisably before Dec. 31, 2004, even though such a listing is not yet considered mandatory.
References * This article was originally prepared for publication in EU Food Law: A Practical Guide, published by Woodhead Publishing Ltd. Jean-Philippe Montfort, "The Article 30 Solution": An Alternative to Market Food Contact Materials in the European Union, FOOD AND DRUG LAW JOURNAL, Volume 51 Number 1, 1996. Commission's Practical Guide for users of EEC Directives on materials and articles intended to come into contact with foodstuffs. Synoptic Document "Draft of Provisional List of Monomers and Additives Used in the Manufacture of Plastics and Coatings Intended to Come into Contact with Foodstuffs"