Furthermore, an application for authorisation must be made for substances listed in Annex XIV of the REACH regulation [8].
In principle, every application for authorisation of a candidate product constitutes a case for comparative assessments, as required by the PPP Regulation.
With a view to the upcoming application for authorisation foreign producers have the opportunity to focus their expenditures on the specific relevant requirements.
In addition, the initial comparative assessments of substances available for a certain common use may be more demanding than a repeated assessment that is triggered by an application for authorisation of another product for the same use.
In the future, EU Member States shall perform a comparative assessment whenever they evaluate any application for authorisation of a PPP that contains a CFS, in the following shortly denoted as candidate product.
By implementation of quantitative and qualitative risk characterisation methods in the application for authorisation (Art. 62(4)(d) REACH in conjunction with Art. 14 and Annex I REACH) and its review by ECHA's committee for risk assessment (Art. 64(4) REACH), the authorisation scheme ensures the assessment of the risks in each application of SVHC in an article.
In addition, as put forward by first reactions to the legal appraisal, when preparing the application for authorisation, EEA based producers of articles can use the structured system of downstream and upstream information and communication concerning chemical substance risks, established by Title IV REACH ('Information in the Supply Chain') [23].
"This is to enable government to have the time and space to consider applications for emergency authorisations without having to provide interim comment or provoking representations from different interest groups whose views on the issue are well known".
In its review of applications for marketing authorisations (MAAs) for cell therapies, the CHMP is obliged to consult the Committee for Advanced Therapies (CAT), who conduct detailed scientific assessments of these applications, with assessment by staff from national regulatory authorities and specialist advisors to the regulators.
