15.07.2019

RAC/SEAC propose a 12-year review period for the first time in the case of a review report

If an applicant is unable to implement substitution of a substance subject to authorisation within the review period of a granted authorisation, the applicant may submit a review report to request another authorisation. In the present case, FoBiG and our long-term partners from RPA Ltd have supported the Czech company Spolana s.r.o. in the submission of such a review report. In this context, more than 500 occupational measurements (air and biomonitoring) as well as several thousand measurements related to releases to the environment were evaluated in detail, extensively discussed and exposure values for risk characterisation derived. The resulting Chemical Safety Report (CSR) was submitted as part of the review Report. The recently published ‚RAC/SEAC Opinion‘ (available here) proposed a review period of 12 years as requested by the applicant and it is now to the European Commission to decide on the review period granted.

For further questions please contact Klaus Schneider.