1. In order to ensure a harmonised approach, the
Agency shall in cooperation with the
Member States develop criteria for prioritising
substances with a view to further
evaluation. Prioritisation shall be on a risk-based approach. The criteria shall consider:
(a) hazard information, for instance structural similarity of the substance with known
substances of concern or with
substances which are
persistent and liable to bio-accumulate, suggesting that the substance or one or more of its transformation products has properties
of concern or is
persistent and liable to bio-accumulate;
(b) exposure information;
(c) tonnage, including aggregated tonnage from the
registrations submitted by several registrants.
2. The
Agency shall use the criteria in paragraph 1 for the purpose of compiling a draft Community rolling action plan which shall cover
a period of three years and shall specify
substances to be evaluated each year.
Substances shall be included if there are grounds for considering (either on the basis of a dossier
evaluation carried out by the
Agency or on the basis of any other appropriate source, including information in the
registration dossier) that a given substance constitutes a risk to human health or the environment. The
Agency shall submit the first draft rolling action plan to the
Member States by 1 December 2011. The
Agency shall submit draft annual updates to the rolling action plan to the
Member States by 28 February each year.
The
Agency shall adopt the final Community rolling action plan on the basis of an opinion from the Member State Committee set up under
Article
76(1)(e) (hereinafter referred to as the Member State Committee) and shall publish the plan on its website, identifying the
Member State who will carry out the
evaluation of the
substances listed therein as determined according to Article
45.