Substance evaluation

The information generated through registration is, as mentioned previously, primarily intended to be used by manufacturers and importers to manage the risks related to their substances, but it may also be used to initiate the authorisation or restrictions procedures under REACH or other EU legislation.

In cooperation with the Member States, ECHA develops criteria for prioritising substances with a view to further evaluation after registration. Prioritisation shall be on a risk-based approach. The criteria shall consider, inter alia, structural similarity of the substance with known substances of concern, exposure information, and aggregated tonnage from the registrations submitted by several registrants. Based on these criteria, ECHA shall compile a draft rolling action plan specifying substances to be evaluated each year. Substances shall be included if there are grounds [1]

for considering that a given substance constitutes a risk to human health or the environment. ECHA adopts a final action plan on the basis of an opinion from the Member State Committee.

A Member State may choose one or more substances from the draft rolling action plan, with the aim of becoming a competent authority. As a competent authority it may carry out an evaluation of a substance itself or appoint another body to act on its behalf. If no Member State chooses a particular substance on the list it falls on ECHA to ensure that it is evaluated.

A Member State may notify ECHA at any time of a substance not on the rolling action plan, whenever it is in possession of information which suggests that the substance is a priority for evaluation.

Specific rules apply to the evaluation of intermediates (Art 49).

  • [1] For a critique of the rules on what information must be provided to the general public see Scott,‘REACH: Combining Harmonization and Dynamism’ (n 8) 86.
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