The concept of "duty of care" is novel to European chemicals legislation, and includes a general safety requirement and specific requirements to perform chemical safety assessments. The chemical safety assessment requirements differ from actor to actor, i.e., depending on whether they are conducted by manufacturers or importers of chemical substances as such or in preparations, or by downstream users. The duty of care also applies to the placing on the market of "articles".
Issues of concern
The "duty of care" applies irrespective of tonnage, and to all substances, including those that are otherwise exempted from registration, evaluation or authorization requirements.
It is not clear to what extent compliance with the other requirements in the REACH Regulation ensures compliance with the duty of care, or to what extent this requirement overlaps the requirements laid down in other Community legislation (such as legislation on general products safety, product liability, or environmental liability).
Key terms used to define the duty of care - e.g., "reasonably foreseeable use and conditions" and "human health and the environment are not adversely affected" - are themselves not defined, are highly subjective and, accordingly, may be interpreted in any number of ways.
The "duty of care" also includes the obligation for all actors in the supply chain to "identify and apply and, where suitable, recommend appropriate measures to reduce the risks identified in the chemical safety assessment." There is no indication as to what would constitute "appropriate measures", or to what level risks must be "reduced".
(The provisions related to the "duty of care" are included in Points 3 to 5 of the Regulation, and Point 63 of the Regulation for "articles".)
Last Updated: May 2003