Existing chemicals legislation does not address in a direct manner, nor does it impose specific obligations or requirements on, producers and formulators of products containing chemicals (the so-called downstream users of chemicals). These products are regulated by other pieces of legislation, either of general applicability (such as Directive 2001/59/EC on general product safety*), or applicable to specific products, such as cosmetics,** electronic or electrical appliances*** or cars.****
This situation is likely to change under the future chemicals legislation, which is intended to cover the whole life cycle of a chemical, from its manufacture to its ultimate disposal, and including downstream uses of chemicals in specific products. Indeed, one of the objectives of the future legislation, as spelled out in the White Paper on a Strategy for a future Chemicals Policy, is to extend "the responsibility along the manufacturing chain", and to make users responsible for all aspects of the safety of their products. This is likely to entail a series of new obligations, as detailed below, that may significantly impact the relationships between manufacturers and their customers.
Testing Requirements
All substances manufactured or imported in yearly quantities above 1 ton must be registered within the so-called REACH (Registration, Evaluation and Authorization of Chemicals) system. For this purpose, manufacturers and importers of chemicals must submit information on the intended uses, and on estimated human and environmental exposure of their chemicals. Where a specific use is not covered by the registration, or differs from those uses originally identified by the registration, and as a consequence the resulting exposure patterns also will differ substantially from those previously evaluated, the downstream user will need to either perform its own testing on the chemical substance for that specific use, or participate in the registration consortia likely to be organized under the future legislation.
Risk Assessment Requirements
Similarly, manufacturers or importers must also submit, for purposes of registration, a preliminary risk assessment covering the intended uses. These manufacturers or importers are likely to call upon the downstream users to participate in the risk assessment, and to provide the necessary information. In addition, substances subject to authorization will be banned unless authorized in specific uses. Here again, the downstream users will have to participate in the request for authorization, and to submit data, including a risk assessment, on the use of specific interest that would justify the authorization.
Information Requirements
Downstream users may be required by the future legislation to inform the authorities about any downstream use that was not listed by a manufacturer/importer and has not been addressed by the initial risk assessment. Further, some Members of the European Parliament have expressed their intent to introduce substantial new public data provisions that would generally require manufacturers, importers and downstream users to make available to the public meaningful and relevant information on the content and properties of chemicals and their regulatory status, including with specific reference to human health and environmental protection.
In addition to the significant testing, risk assessment and information burden that will weigh on the downstream users, these future requirements also give rise to questions regarding the confidentiality of the uses of chemicals, which manufacturers usually seek to protect from their different customers and from their competitors, as well as questions regarding the extent and the practical legal consequences of imposing an additional legal responsibility on the downstream users for the safety of specific uses of chemical substances and preparations.
These concerns illustrate the need for industry as a whole to follow the adoption of the future provisions regarding downstream users closely, and intervene during the legislative process leading to the adoption of final legislation, as appropriate, and as warranted by its specific interests.
* Official Journal L 11/4, 15 January 2002.
** Directive 76/768/EEC on cosmetic products, Official Journal L 262/169 of 27 September 1976
*** Directive on the restrictions of the use of certain hazardous substances in electrical and electronic equipment, and Directive on waste electrical and electronic equipment, joint texts approved by the Conciliation Committee on 8 November 2002 (not yet published in the Official Journal).
**** Directive 2000/53/EC on end-of-life vehicles, Official Journal L 269/43 of 21 October 2000.
Last Updated: January 2003