If companies want to use an SVHCSubstance of Very High Concern: substances classified as CMR substances or as PBT/vPvB substances listed in REACH annex XIV (authorisation list), they have to apply for authorisation granted by the European Commission for each single use. The authorisation procedure is complex.
ACA can provide you with strategic advice and technical support covering the whole authorisation process comprising of
Analysis of Alternatives (AoA) and Substitution Plan (SP)
Support in checking the availability and technical and economic feasibility of possible alternative substances or methods, preparation of the AoA report.
Establishment of a strategy (incl. timeline) for the substitution of Annex XIV substances.
Socio-economic Analysis (SEA)
Advice on determining the cost/benefit calculation of a rejected authorisation for society or human health
Chemical Safety Report (CSR)
Compilation of operational conditions and risk management measures, exposure scenario building, health and environmental exposure assessment based on workplace and exposure measurements, human and environmental exposure modelling, risk characterisation.
Authorisation Dossier
Consolidation of documents in the authorisation dossier (with IUCLID software); preparation of the authorisation dossier comprising of AoA, SP and SEA as well as CSR.
Review Period
Support during the “Review Period” in ECHA consultations, telephone conferences (TIS, Trialogue), commenting on the RAC/SEAC opinion-making process in close colaboration with the applicant.
8 substances to be included in annex XIV REACH
