European Union May Impose User Fees For Review Of Packaging Materials

Date: Dec 01, 2006

The battle over user fees may soon be joined on the other side of the Atlantic as it has been in the United States.

As is well known by now, the U.S. Food and Drug Administration (FDA) would like to see user fees for food contact notification (FCN) reviews.

Now the European Commission's Directorate General on Health and Consumer Protection (DG SANCO) has issued a "Consultation Document" on whether at least some types of submissions to the European Food Safety Authority (EFSA) should be charged a fee. The Consultation Document is intended to provide a basis for discussions among EU Member States, EFSA and other interested parties on the issue, but there is little doubt as to where this ship is headed.

The EFSA is the FDA-equivalent agency for food safety in the EU. Among other things, EFSA is responsible for providing scientific advice to the Commission, the Member States and the European Parliament, collecting and analyzing data on safety throughout the food chain, identifying emerging risks and communicating to the public on risks.

DG SANCO recognizes that these and other tasks are generally useful to the public by safeguarding the public health. However, it also notes that some tasks directly benefit firms applying for market authorizations for products or substances. EFSA evaluates these authorization files (also known as "dossiers") to determine compliance with applicable legislation and to assess the risks for a particular product or chemical substance under the conditions of its intended use. EFSA's review and clearance of packaging materials and their components under the Plastics Directive fits within this evaluative process.

In these latter cases, DG SANCO suggests that fees can be justified as public money is being used partly for private interests. This would also provide an additional source of revenue for EFSA, allowing the agency to do a better job. The document admits some disadvantages in allowing user fees, but just as quickly minimizes their potential impact, revealing the leanings of the authors.

Pick your poison

The Consultation Document presents two options for determining who would pay EFSA fees for processing dossiers.

Option 1 would require all applicants for an authorization to pay a fee, since presumably they have a monetary interest in anything that they would file.

Option 2 would draw a distinction between procedures in which the authorization is granted to a specific person or entity, and those in which the authorization is generic, allowing fees only in the latter case.

DG SANCO specifically asks interested parties to comment on whether a fees system should be imposed at all and if so: Are the factors listed in the Consultation Document the most important ones for identifying the advantages and disadvantages of the two options? If not, indicate other essential factors. Which option do you prefer and why?

Interested parties may submit comments to DG SANCO by Feb. 15, 2007. Those comments will be used in preparing a Commission report on the subject. If the report recommends fees, it will also specify the sectors in which authorizations will be affected. The full text of the Consultation Document is available at www.ec.europa.eu/food/consultations/index_en.htm.

Used with permission. Copyright FOOD & DRUG PACKAGING, December, 2006.

For further information about this article, please contact George G. Misko at 202-434-4170 or by email at misko@khlaw.com.