The proposed new EU chemicals legislation would significantly extend the scope of chemicals regulation in the EU. As currently conceived in the White Paper, the new legislation would substantially expand the list of chemical substances subject to environmental regulation. As a consequence, the proposed new legislation would regulate, for the first time, many thousands of chemical substances which previously were exempt.
A comparison of the regulatory thresholds under the current and proposed future chemicals legislation does not reveal this significant change. Under the existing Dangerous Substances Directive (Directive 67/548/EEC on the classification, labeling and packaging of dangerous substances, as amended)*, substances manufactured below ten kilograms are exempt from notification. Under the proposed new legislation, the threshold is one ton; substances manufactured or imported below that level would be exempt.
The proposed new chemicals legislation's significant departure from existing legislation is revealed in its treatment of so-called existing substances. Under the Dangerous Substances Directive, existing substances -- i.e. substances which were marketed in the EU prior to 1981 and which, therefore, are listed on the European Inventory of Existing Chemical Substances ("EINECS") -- are exempt from notification. Under the proposed new legislation, however, there is no such grandfathering of existing substances. The consequences of this change are readily calculated. Substances which are manufactured or imported above one ton in the EU and which have, to date, been exempted from notification because they were marketed in the EU prior to 1981 and, therefore, on the EINECS list, would now, for the first time, be subject to registration requirements. Beyond the fact that such substances would now be entered into the registration system, the impact of these new requirements will be particularly significant for those substances which must generate and submit costly new testing data.
Another important issue that is raised, but not fully resolved, by the White Paper is the extent to which substances which are subject to regulation under other legislation, and thereby exempt from existing notification requirements, will continue to be exempt under the new chemicals legislation. For example, food additives, which are subject to regulation under the Directive 89/107/EEC on food additives authorized for use in foodstuffs intended for human consumption** and its subsequent specific Directives, are not subject to other existing notification requirements (e.g., under the Dangerous Substances Directive). Likewise, pesticides and biocides, which are regulated by Directive 91/414/EEC*** and Directive 98/8/EC****, respectively, are not subject to other existing notification requirements. The White Paper would appear to reflect an intention to continue such exemptions. Current discussions, however, among European Commission members and others, focusing on food additives and pesticides and biocidal products, have generated concerns within industry that the final legislation may eliminate such exemptions.
In contrast, based on current discussions, it appears that the final legislation may further define, and limit, the scope of the regulation of intermediates. Specifically, the final legislation may clarify that exemptions for intermediates would include, by way of example, non-isolated intermediates, isolated intermediates distributed and transported within the same legal entity and isolated intermediates distributed under controlled conditions. In this respect, if the final new chemicals legislation were to specifically adopt, or at least clarify the existence of, such exemptions, the manufacturers of intermediates would realize a significant benefit. As a result, this issue is being closely watched by potentially affected industry members.
As these issues discussed above clearly indicate, the final scope and/or exemptions under the new chemicals legislation is by no means fully resolved. Specific language in the White Paper is subject to further clarification or modification. The threshold issue, discussed above, provides a good example of the potential significance of future clarification. As indicated, only substances manufactured or imported at levels in excess of one ton would be subject to the registration requirements. Current discussions have focused on whether that one ton registration threshold would expose substances manufactured and/or imported at levels less than one ton to regulation by Member States. Although this result does not appear to be intended by the White Paper, there is certainly room for argument, and such arguments are likely to be made by or on behalf of Member States inclined to take a more aggressive posture on this issue. Accordingly, for this and other reasons, industry must be vigilant and, as appropriate, opportunistic in tracking the further developments of the White Paper provisions.
Footnotes
* Official Journal L 196/1, 16 August 1967.
** Official Journal L40/27 of 11 February 1989
*** Official Journal L 230/1 of 19 August 1991
**** Official Journal L 123/1 of 24 April 1998
Last Updated: January 2003