Recital (8)

While some medicinal products are also chemicals and are relevant to the objectives of this Regulation, the application and use of hazard and risk assessments performed on chemicals under Union law on medicinal products is different from the application and use of hazard and risk assessments performed under the main Union legal acts on chemicals. It is thus appropriate to adopt a stepwise approach and to include, as a first step and taking due account of the administrative burden for the EMA, only the chemicals data which have the highest added value. Under that first step, the data with the highest assessed added value are data on relevant active substances, which are considered to be active substances covered by Union legal acts on medicinal products listed in Annex I, Part 2, and also subject to regulatory processes under other Union legal acts listed in Annex I, Part 1, as well as other active substances with particular persistent, bio-accumulative and toxic properties or with a known high level of residues in the environment. The specific chemicals data to be included for those relevant active substances should include chemicals data related to environmental risk assessments carried out under Union law on medicinal products for human and veterinary use, non-clinical studies carried out under Union law on medicinal products for human use and maximum residue limit values and the chemicals data underlying their derivation that the EMA holds, as well as specific reference values.