Understanding the European Union's R&D Regulations

Date: Feb 24, 1997

In contrast to the Toxic Substances Control Act (TSCA) R&D exception in the United States, R&D activities in Europe pursuant to the European Union's Dangerous Substances Directive can be rather confusing. This is particularly true because the procedures to be followed depend on the annual amount of the R&D substance that is manufactured or imported. Also, above a certain amount, the notification requirements vary from country to country and each competent authority in the countries in which R&D may take place must be notified in advance.

If the total amount of the R&D substance is less than 100 kg per year and R&D activity is carried out under controlled laboratory conditions, no notification to the competent authority in the Member State in which R&D is being conducted is required. Record keeping is required, however. In such a case, the importer of record of the R&D material must maintain records of the identity of the substance, labeling data, quantities, and a list of customers.

If total R&D shipments to the EU will exceed 100 kg per year, then notification is required to proceed. Companies may choose to qualify for the exemption for "process-oriented" R&D. There is no quantity limitation on this exemption; however, the notification requirements vary greatly and the exemption is for a period of one year, although renewals are possible. The amounts are calculated per manufacturer or per importer. The amount also applies to the total amount in the EU, not per Member State.

In some Member States, the process-oriented R&D submission requires only a simple list of information (e.g., Germany, United Kingdom) while other countries require a formal dossier, the requirements for which depend on the amount of R&D material to be imported (e.g., Netherlands, Italy). In addition, some countries charge fees (e.g., Germany), while many others do not (e.g., France, Italy, Luxembourg, United Kingdom). Further still, some countries accept or require applications in English (e.g., Italy, Netherlands, United Kingdom), while others require the use of their national language (e.g., Germany, France, Luxembourg).

In general, for European notification, information that can be claimed as confidential business information is limited and may not include: (1) trade name; (2) name of manufacturer and notifier; (3) physico-chemical data; (4) summary results of toxicological and ecotoxicological data; and (5) handling methods and emergency measures. A claim of confidentiality may be made for other information in these filings, but justification must be provided for the information that is declared confidential.

The twelve-month period for the process-oriented R&D exemption begins to run upon the date of first import in all countries. However, the date upon which a company will be able to first import R&D samples following a process-oriented R&D filing varies. For example, in France, import may begin upon approval of the filing, which usually takes two to three weeks. In Luxembourg, however, import may not begin until 30 days after the filing is submitted, although the notifier can submit a request to the competent authority for expedited review and authorization to import. In addition, if a filing is incomplete it will be returned in some cases which delays the review period for a process-oriented R&D filing. In some cases, the resubmission date is considered "day one."

It is unfortunate that the EU system puts the R&D company at a disadvantage. As a result, companies conducting large scale R&D may wish to consider the standard Annex VII dossier route to avoid a hodgepodge of requirements and deadlines. Once a standard dossier is submitted and approved by one Member State, it must be recognized by all.

For more information, please contact Thomas C. Berger at 202-434-4285 or berger@khlaw.com.