Scientific research and development normally takes place in quantities below 1 tonne
per year. There is no need to exempt such research and development because substances in
those quantities do not have to be registered in any case. However, in order to encourage
innovation, product and process oriented research and development should be exempted
from the obligation to register for a certain time period where a substance is not yet
intended to be placed on the market to an indefinite number of customers because its
application in preparations or articles still requires further research and development
performed by the potential registrant himself or in cooperation with a limited number of
known customers. In addition, it is appropriate to provide for a similar exemption to
downstream users using the substance for the purposes of product and process oriented
research and development, provided that the risks to human health and the environment are
adequately controlled in accordance with the requirements of legislation for the protection
of workers and the environment.
(29) Since producers and importers of articles should be responsible for their articles, it is
appropriate to impose a registration requirement on substances which are intended to be
released from articles and have not been registered for that use. In the case of substances of
very high concern which are present in articles above tonnage and concentration
thresholds, where exposure to the substance cannot be excluded and where the substance
has not been registered by any person for this use, the Agency should be notified. The
Agency should also be empowered to request that a registration be submitted if it has
grounds for suspecting that the release of a substance from the article may present a risk to
human health or the environment and the substance is present in those articles in quantities
totalling over 1 tonne per producer or importer per year. The Agency should consider the
need for a proposal for a restriction where it considers that the use of such substances in
articles poses a risk to human health or the environment that is not adequately controlled.