Food Packaging Regulation in the Enlarged Europe
By Keller and Heckman LLP’s Packaging Practice Group
On May 1, 2004, ten new Member States joined the European Union (EU). These countries are Poland, Hungary, the Czech Republic, Slovakia, Slovenia, Estonia, Lithuania, Latvia, Malta, and Cyprus. The accession of these new countries into the EU brings the total number of Member States to 25.
This article reviews the food packaging legislation in the "Enlarged" EU. More specifically, it reviews how the new Member States have adopted the EU legislation on food contact materials, whether they have maintained national requirements in addition to the Community-wide legislation, and what companies should do to market food contact materials in the newly enlarged EU.
Food Contact Legislation in New Member States
This article reviews the food contact legislation in place in the new Member States that joined the EU on May 1, 2004. It reviews the status of the implementation of the EU food contact Directives in the enlarged EU, as well as the legislation in place in each of the new Member States on issues that are not yet harmonized at the EU level.
Adoption of the "Acquis Communautaire"
As a prerequisite to joining the EU, the new Member States had to adopt the full body of legislation in place in the EU (the so-called "acquis communautaire"), including all EU Directives on food contact materials. The Framework Directive 89/109/EEC (which has been replaced by the Framework Regulation, effective Dec. 3, 2004) and the Plastics Directive 2002/72/EC, as amended, are therefore in place in all the Member States.
Importantly, no transition periods were granted to any of the "new" Member States that would enable any such countries to deviate from the EU food-contact legislation for a temporary length of time. Thus, for materials that are subject to EU legislation, the regulatory status in these countries is the same as it was in the "old" Member States prior to enlargement (and still is today).
Companies often question whether they should review the implementation of the EU Directives in each Member State and the answer to that question becomes even more relevant in the enlarged Europe as the review of 25 sets of implementation provisions would obviously represent a considerable task. In our opinion, this work is largely unnecessary. Indeed, although the EU food contact legislation has been adopted in the form of Directives that require implementation in national law to be effective, these Directives in practice are so detailed and prescriptive that they leave little room for the Member States to do anything other than to fully adopt the EU text verbatim.
Even if a country implemented a given Directive incorrectly, the doctrine of "direct effect" would still allow a company to rely on the provisions of the Directive to market its products in that country, regardless of the exact status of the local text.
Finally, because the laws in place in the new Member States have been reviewed, and sometimes amended as part of the Enlargement process, one could even expect that they are probably more consistent with the Acquis than the corresponding regulations of some of the "old" Member States.
Therefore, while a detailed review of national implementation rules may reveal some gaps that a company could possibly use to its advantage in a given country, for practical reasons, most companies wishing to market their products throughout the EU can simply consider that all the EU food contact Directives are fully in place in all 25 Member States and that they must be relied upon fully.
Regulations in the Non-Harmonized Areas
In adapting their national law to EU food contact legislation, some of the new Member States have maintained some national provisions in areas that are not fully harmonized, i.e., in areas for which EU legislation does not regulate all of the provisions involved.
Here again, the situation is no different between the "new" and "old" EU, because all Member States may and do maintain or adopt national laws in non-harmonized areas. However, the novelty of the Enlargement process and the necessary legislative changes made in the new Member States to adapt to it, make it likely that few, if any, persons or companies know exactly what are the national requirements for food contact materials in the new Member States.
While general safety principles and labeling provisions applicable to all food contact materials have been adopted under the Framework Regulation, EU food contact legislation remains largely un-harmonized. In particular, there is no specific EU legislation in place for materials such as paper and board, metals and alloys, can coatings, elastomers, rubber, etc.
Even with plastic materials—by far the most regulated area in the food-contact field—there is much room for national legislation regarding additives, colorants, catalysts, and other substances. Also, EU regulation still does not regulate multilayer and composite materials made of plastics and other materials, such as recycled materials, for food-contact use.
In the old EU, only about half of the Member States have in place legislation adopting the EU Directives (Denmark, Ireland, Portugal, Luxembourg, Sweden, and the United Kingdom), while the other half have maintained or adopted specific legislation covering plastic additives, paper and board, rubbers and other materials, either by means of binding legislation (in Austria, Belgium, France, Italy, Spain, and the Netherlands, and to a lesser extent in Finland and Greece), or non-binding legislation (as in Germany).
A review of the legislation in the new Member States shows a comparable situation. Indeed, as summarized in the table included in this Special Focus article, some of these countries have maintained national lists of plastic additives, colorants, and the like, as well as legislation in other areas, such as can coatings, paper and board (the Czech Republic, Slovakia, and Slovenia), while other have not (Estonia, Hungary, Latvia, Lithuania, and Poland).
Following is a summary of the main features of the legislation in the new Member States as they relate to plastics and other food contact materials.
Plastics Legislation in the New Member States
Two main features emerge from a review of the plastic legislation in the new Member States:
First, most of the countries reviewed (i.e., all new countries except Malta and Cyprus) have transformed the incomplete EU list of additives of Plastics Directive 2002/72/EC into a strict positive list of the additives that can be used in these countries, to the exclusion of all others. This is the case in all the countries reviewed, except Hungary. In doing so, they have anticipated the future adoption by the EU of a positive list of additives sometime after 2007.
Of course, the positive lists of additives in these countries are not "final." As the European Commission adopts new Directives amending the Plastics Directive to list new food contact additives, these new Directives will be implemented in these countries as well by means of an amendment to the positive list and permitting the use of the new additives there as well. Unlike traditional positive list countries (like France or The Netherlands) that have their own positive list in addition to the EU list of additives, in the new countries, only the EU-listed additives can be used even if that list, at the EU level, is considered incomplete. This also means that none of the many additives that are listed in the specific national lists in the old EU are listed on the new Member States' positive lists and can, therefore, not be used in these countries.
Second, these same countries have in place approval processes for food contact materials containing unlisted plastic additives (and other substances). As described more fully below, the nature of these procedures is different from the procedures in the "old" Member States, in particular, because they lead to the individual approval of the product or material of the applicant, and not to an amendment of the legislation that would allow the use of the substance at stake by all interested parties.
The contrast is even greater with respect to colors and coatings. About half of the countries reviewed have positive lists or other requirements for colors and plastic coatings (the Czech Republic, Slovakia, and Slovenia), while the others have no such requirements. The situation in Hungary is slightly different. Although no non-harmonized provisions are enacted in a legal instrument, the National Institute for Food Safety and Hygiene (OETI) insists that German recommendations on non-harmonized food contact materials be followed, while for colorants in plastics, that the French positive list is followed. The question then is whether, like in Germany, industry's behavior will make these recommendations into quasi-legal requirements.
Finally, as far as could be determined, there are no specific requirements in the new Member States on catalysts, polymerization production aids, and other categories of substances not (yet) specifically regulated at the EU level. No specific provisions on multilayer materials have been found in any of these countries.
Regulations on Other Food Contact Materials
In addition to adopting the EU food contact legislation, as summarized in the attached table, the Czech Republic, Slovakia, Slovenia, and, to a limited extent, Lithuania has enacted specific rules on materials that are not harmonized at the EU level. In the Czech Republic, Slovakia, and Slovenia, there are specific provisions for metal articles, paper and paperboard, rubber and silicones, glass, and cork. Additionally, Slovakia and Slovenia have specific requirements for wooden materials and textiles. Lithuania imposed certain analytical criteria applicable to rubber, paper, and paperboard. Interestingly, Slovenia also has comprehensive legislation on cookware.
While the Acquis Communautaire on food contact materials is now in place throughout the 25 Member States, there remain large areas of that legislation that are still not subject to EU harmonized rules. This also means that, for virtually any food contact materials, companies potentially are faced with 25 sets of different national requirements applicable to their products. Even if the actual list of countries with specific national requirements is about half that figure, the situation may change as countries adopt new rules, thereby requiring companies to follow the development of the national rules in all 25 EU Member States. This would be very difficult, if not impossible, for many companies.
This requires EU authorities to make increased efforts to complete the harmonization in the food contact area as soon as possible and to ensure that the principle of mutual recognition effectively serves to allow food contact materials to benefit from the single enlarged EU market.
 It has been recognized on several occasions by the European Court of Justice that Directives, although in principle not directly applicable in the Member States unless adopted into their national legal order, can be relied upon by private individuals or companies should that Member State fail to implement (correctly) the provisions at stake, provided that the provisions of the Directive are (1) unconditional, (2) sufficiently precise, and (3) contain rights which individuals are able to assert against the state. However, the direct effect doctrine does not function in the reverse order, i.e., the provisions of a non-implemented directive cannot be enforced by the failing state against private individuals and companies.