A FRESH COAT OF PAINT ON THE ANALYSIS OF ALTERNATIVES

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The report analyzes a March 2019 General Court ruling (Case T-837/16) to clarify the legal requirements for granting authorisations under the REACH Regulation, specifically regarding the availability of safer alternatives. It emphasizes that the burden of proof rests solely with the applicant to provide 'cogent' and 'reliable' evidence that no suitable alternatives exist. The document argues that the European Commission cannot rely blindly on SEAC's opinions if they lack 'full, consistent and relevant' reasoning. It further asserts that substitution plans are mandatory if alternatives exist but are not currently feasible for the applicant, and that uncertainties regarding alternatives cannot be deferred to future review reports. To implement these findings, the report proposes a detailed checklist for SEAC, updates to the opinion template to shift the focus toward the applicant's burden of proof, and revisions to third-party consultation instructions to clarify that third parties are not required to provide a full analysis of alternatives to raise valid doubts.

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  • The General Court established that the burden of proof for demonstrating the absence of suitable alternatives lies entirely with the applicant, and the applicant 'bears the risk' if a conclusion cannot be reached due to insufficient information.
  • The European Commission is responsible for authorisation decisions and may depart from SEAC's scientific opinion; however, SEAC's reasoning must be 'full, consistent and relevant' to be sufficient.
  • Evidence provided by applicants to prove the absence of alternatives must be 'substantial', 'reliable', and 'cogent', covering all applied-for uses; 'mere hypothesis' is insufficient for granting authorisation.
  • A substitution plan is mandatory if an alternative is available in general but is not technically or economically feasible for the specific applicant; this plan must include a calendar of actions and R&D information.
  • It is legally impermissible to grant an authorisation while leaving uncertainties about the availability of alternatives open or to require the applicant to resolve these uncertainties in a later review report.
  • Third parties participating in public consultations are not required to provide a full analysis of alternatives or prove that suitable alternatives exist for their comments to be considered valid.

Cite the original document

APA
ClientEarth (2019). A FRESH COAT OF PAINT ON THE ANALYSIS OF ALTERNATIVES. https://www.clientearth.org/media/w1blwp3i/recommendation-seac_190529_final.pdf
Chicago
ClientEarth. A FRESH COAT OF PAINT ON THE ANALYSIS OF ALTERNATIVES. 2019. https://www.clientearth.org/media/w1blwp3i/recommendation-seac_190529_final.pdf.
Wikipedia
{{cite report |author=ClientEarth |title=A FRESH COAT OF PAINT ON THE ANALYSIS OF ALTERNATIVES |date=May 2019 |url=https://www.clientearth.org/media/w1blwp3i/recommendation-seac_190529_final.pdf |access-date=23 October 2026 |via=Climate Insights Directory}}
BibTeX
@techreport{clientearth2019fresh, author = {{ClientEarth}}, title = {{A FRESH COAT OF PAINT ON THE ANALYSIS OF ALTERNATIVES}}, institution = {ClientEarth}, year = {2019}, month = may, url = {https://www.clientearth.org/media/w1blwp3i/recommendation-seac_190529_final.pdf}, urldate = {2026-10-23}, note = {Indexed by Climate Insights Directory} }

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