Use of Mutual Recognition to Market Food Contact Materials in the Enlarged Europe
By Keller and Heckman LLP’s Packaging Practice Group
Many food contact materials, whether plastics or non-plastics, remain subject to national rules of Member State in non-harmonized areas. This means that, for virtually any food-contact materials, companies potentially are faced with 25 sets of different national requirements applicable to their products, and keeping up with these requirements would simply represent an impossible task for any company.
This points to the need for EU authorities to make increased efforts to complete the harmonization in the food-contact area as soon as possible. However, it also shows the need for companies, with the support of EU authorities, to look at the principle of mutual recognition to effectively market their food-contact materials in the enlarged Europe and therefore actually to benefit from the single enlarged EU market.
This article reviews the principle of mutual recognition in the context of the food contact laws in place in the new Member States.
The Principle of Mutual Recognition
The principle of mutual recognition allows for the legal importation and sale into one Member State of products that are legally produced or marketed in another Member State, even if the products do not comply with the specific regulatory requirements of the country of import, unless the Member State of destination can demonstrate, following an appropriate procedure, that the product presents a danger to the public health. "Mutual recognition" is based on the idea that once a product has been lawfully manufactured and/or placed on the market of a Member State, it is presumed to guarantee an adequate level of protection to the health of consumers and to the environment, and that all other Member States must accept its placement in their markets.
Mutual recognition is based on the fundamental principle of the free movement of goods between EU Member States embodied in the EU Treaty, particularly in Articles 28 and 30 thereof. Since the famous case "Cassis de Dijon" in 19791, the Court has had many occasions to refine the concept of mutual recognition and in particular to set up the conditions under which Member States may invoke Article 30. In recent decisions against Denmark and France2 , the Court clarified the conditions under which a Member State may rebut the presumption that because the product has been lawfully manufactured and/or placed on the market in a Member State it guarantees an adequate degree of safety.
To summarize this case law:
- Member States may restrict the importation and marketing of such products only when such measures are necessary to satisfy a legitimate objective listed in Article 30 and proportionate to the objective pursued.
- The burden of proof is with that Member State seeking the restrictive measures: It must conduct a case-by-case risk assessment of the products at stake, precisely identify the alleged risk, assess the probability of its occurrence, and assess the severity of the consequences.
- Only then, in the case of real risk posed by a product, may a Member State impose a restrictive measure that must be proportionate to the legitimate objective pursued. The Member State must also show that the measure is suitable to achieve the goal, and that no alternative measure(less restrictive on intra-community trade) would achieve it.
Also, from a procedural standpoint, the Court has recognized that under certain strict conditions and provided it is justified under legitimate objectives and proportionate to achieve the desired objectives, the Member State of destination may verify, through a prior authorization procedure, the degree of safety achieved by the product. The analysis of the proportionality of a given procedure is decided on a case-by-case basis.
Authorization Procedures in the New Member States under Articles 28 and 30 of the EU Treaty
The question then is whether the pre-market authorization procedures in place in the Member States, including the new Member States, can be imposed on companies wishing to sell throughout Europe products that have been lawfully marketed in one or more Member States.
To determine that, one needs to verify whether these procedures comply with the principles set by the European Court of Justice (ECJ) and commented upon by the EU Commission. These procedures must not discriminate against products legally produced and marketed in another Member State in favor of domestic products. A Member State that applies an authorization procedure to such products must demonstrate the necessity for this restriction and that the restriction is proportionate in relation to the protection of human health.
In addition, and more specifically in cases dealing with (direct) food additives, which are also relevant to food contact substances, the ECJ has consistently stated that a procedure, which requires prior authorization in the interest of public health for products lawfully produced and/or marketed in another Member State, complies with Community law only3:
(1) If it is readily accessible to traders,
(2) If it can be completed within a reasonable time (which the Commission evaluates to be 90 days),
(3) If, when it is refused, the refusal can be challenged before the courts, and
(4) If the authorization granted leads to a measure of general application (i.e., a measure allowing the use of the newly approved additive by all interested parties).
The procedures in place in each Member State, new and old, should therefore be reviewed to verify whether they meet the criteria specified by the ECJ.
While a detailed analysis of each procedure would be necessary to determine justification and the compliance of each such procedure with Articles 28 and 30 of the EU Treaty, these procedures on several counts appear not to meet the criteria set forth by the ECJ and could therefore not be successfully opposed to food contact materials and articles lawfully marketed in other Member States.
In particular, concerning accessibility, for instance, the Member States' obligation to provide for such a procedure cannot be fulfilled if that procedure is not expressly stated in binding legislation. As far as we could determine, the existing procedures are not spelled out in an accessible way. Also, while authorities in the new Member States claim that they will not object to the marketing of products originating from other Member States on the basis of the principle of mutual recognition, there are no "mutual recognition clauses" that specifically refer to products lawfully manufactured and marketed in other Member States.
Also, the laws of the new Member States have not established a simplified authorization procedure for specific ingredients of products lawfully marketed in other Member States, as required by the Court of Justice when the national law is based on a positive listing of authorized ingredients. Indeed, in line with their historical practices, most of the new Member States have maintained specific pre-market authorization procedures for products that do not comply with the existing legislation, including food contact materials and articles made with substances that are not listed in the positive lists. However, these procedures lead to the granting of an authorization that is specific to the product of the applicant and valid only to that applicant and does not lead to the inclusion of the authorized substance in the positive list.
To illustrate the problem, let's assume that Producer P produces additive A and sells it to 20 companies that are using A in making food contact materials. There is no procedure in place in the new Member States allowing P to get approval for the use of A in contact with food. Rather, the only way for A to be used in these countries would be for each of the 20 companies using A to get an individual authorization for their own products containing A.
If confirmed, this regulatory situation would be more restrictive to trade than necessary and therefore not justified nor proportionate to the objective pursued in a sector where the Community legislator has decided to regulate food-contact materials by means of positive lists, applicable to all parties concerned. However, only a detailed review of each procedure would support confirmation that the legislation in these countries does not provide a suitable authorization procedure for unlisted substances and is therefore illegal under Community law and cannot be successfully opposed to products eligible for mutual recognition.
A review of the food contact legislation in the new Member States shows that several new Member States have specific national requirements on food contact materials, thereby increasing the number of Member States with specific requirements. This increasingly complex picture makes it virtually impossible for companies to know what the requirements are in every EU Member State.
Pending completion of the harmonization process, the principle of mutual recognition allows companies to benefit from the EU single market. In the spirit of the EU Treaty, it should be possible for companies to (1) determine that their products are safe and can be lawfully marketed in at least one Member State, (2) market their products in at least that State and (3) market the same product in all other Member States on the basis of the principle of mutual recognition. The burden is on the Member States to determine that products so marketed are not safe.
In the countries where prior authorization procedures exist, however, these would have to be followed, but only to the extent that they comply with the principles set up by the ECJ. Our initial investigation of the procedures in the new Member States reveals important discrepancies that could disqualify most of these procedures. If the local procedures are shown not to conform with EU law, then companies could simply proceed to market their products in the EU.