Member States will review the testing proposals submitted by registrants during the "standard" evaluation. The "priority" evaluation provisions allow Member States to include in their review any information, whether or not already submitted by registrants, and to require the registrants to submit further information as they deem necessary. There are no clear criteria or provisions that will allow industry to anticipate or prepare for such further requirements.
Decisions of individual Competent Authorities (i.e., Member States) must be endorsed through a Community-wide mutual recognition procedure to ensure consistency. Disagreement between Competent Authorities can ultimately require a Commission decision. "Standard" evaluations for "phase-in" substances are allocated to Member States' Competent Authorities on the basis of their populations. Evaluations of non "phase-in" substances are carried out by the Competent Authorities of the Member State of manufacture or import.
Issues of concern
Standard evaluation provisions also apply to testing proposals made by downstream users through the chemical safety reports.
The Competent Authority who evaluates the first registration of a specific substance will also evaluate subsequent registrations of the same substance. It is unclear whether the decisions concerning the performance of testing taken with respect to the first registration will be binding during evaluations of subsequent registrations.
The priority evaluation provisions place significant, poorly defined, seemingly unlimited discretion in the hands of the Member States, which can be used to require further information from the registrants or downstream users. Based on any information in the registration as well as "any other relevant information," Member States may require registrants or downstream users to submit further information (even if not required in the Annexes to the Regulation) if, in the judgment of the Member State, the available information or the structural similarity with "known substances of concern" or with PBT substances "suggests" that the substance "or one or more of its transformation products" has "properties of concern." Further, Member States may "examine" any information previously submitted and "take any appropriate decisions." The absence of any clear definitions of these terms and concepts, and of any clearly defined criteria as to when or why such additional information should be required, creates significant risks to registrants and downstream users.
The Member States can also decide to aggregate the tonnage of a substance for which there are multiple registrants, and thereby require the submission of the substantial additional information requirements in Annexes VI, VII or VIII.
As an application of the right to be heard, the draft decision of the evaluating authority must be communicated for comments to the registrants and/or downstream users concerned, and the evaluating authority must take such comments into account. However, this does not apply if the right to be heard is already provided for in national legislation.
In absence of agreement between registrants on who will perform and submit the required tests, only one company shall be designated to perform the testing, taking into account proportionality. However, the costs have to be shared equally. If no payment is given, any of the actors shall have a claim, enforceable in national courts, to prohibit the other from manufacturing, importing or placing the substance on the market.
(The provisions related to evaluation are included in Points 35 to 43 of the Regulation.)
Last Updated: May 2003