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 firstname.lastname@example.org.