CAHIER SCIENTIFIQUE | REVUE TECHNIQUE LUXEMBOURGEOISE 2 | 2011 21
too much weight was given to these properties for ranking potential risks. Within the “inherent properties” criterion, a slightly higher score considers that according to Art. 58(3) priority shall normally be given to substances with PBT/vPvB properties. However, a higher weight for the ‘PBT/vPvB inherent properties’ would result in a hazard and not a risk driven ranking of PBT/vPvB substances leading to high total scores for substances with low volumes and low releases and hence low risk. The second tier of ECHA’s approach takes into account regulatory effectiveness. It was introduced because situations may occur where inclusion in Annex XIV will require regulatory efforts but most likely will not result in benefits for human health or the environment. There are also cases possible where authorisation may hamper the use of other risk management instruments while not contributing significantly to achieving the control of risk. In this step, all relevant available information from various sources is taken into account for deriving the final recommendation on Annex XIV inclusion. Once a substance has entered Annex XIV, producers and importers of the substance have to apply for an authorisation for each use of the SVHC within a set date. An authorisation is in principle possible via two routes. The adequate control route requires a quantitative risk assessment. This route can be applied if a chemical safety report including a quantitative risk assessment shows that the risk to human health and the environment is adequately controlled (Art. 60(2-3)). ECHA’s Committee for Risk Assessment (RAC) then prepares an opinion. For PBT, vPvB and non-threshold CMR substances, or if an adequate control of risk cannot be demonstrated, this route cannot be applied. Instead, the Socio-Economic assessment route (Art. 60(4)) is possible. Here, a socio-economic analysis (SEA) is obligatory and ECHA’s Committee for SEA (SEAC) prepares an opinion. For further details on the procedure for application for an authorisation please see Figure 1. An authorisation can be granted, if it is shown that socio-economic benefits outweigh the risk and if there are no suitable alternative substances or technologies. Exemptions from authorisation obligations are listed in Box 1.
Applicant: Application to ECHA - Art. 62(1-2) 2) A 62(1
Applicant: Pays fee aalone lo e oor iin a jo jjoint i t application pp - Art. Art 62(7) ( )
Committee for Risk Assessment (RAC) and Committee for Socio-Economic Analysis (SEAC) (max. (max 10 months after application application, 5 months if an authorisation already exists): C Completeness l t check h k + preparing i draft d ft Opinion(s) O i i ( ) - Art. A t 64(1 64(1,3,4,10) 3 4 10)
ECHA: Public P bli lt ti consultation Art 64(2) - Art.
Applicant (1 month after reception of draft Opinion(s)): Indicate if he intends to comment on draft Opinion(s) p ( ) - Art. 64(5) ( ) comments
no comments
Applicant (2 months after reception of the Opinion(s)): Written th draft d ft O pi i ( )) W itt argumentation - Art. g Art 64(5) ( )
ECHA s RAC + SEAC ((2 months after ECHA's the applicant's applicant s argumentation): months after the applicant's applicant s Final O i i ( ) - Art. Opinion(s) A Final 64(5) argumentation):
Opinion(s)): sent to )) O t Commission, C i i i Member Mb b ECHA (15 days d after ft the th final fi l Opinion): O i i )( Opinions O Opinions i i i i sent t to t t Commission, C M Member 64(5-6) States and applicant Decision publication - Art Art. ( - )Art 64(5) -+Art Art. on publication on ECHA website Art. pp ( ) +onDecision pon ECHA website
Commission Draftft authorisation, authorisation C i i (3 months th after ft receipt): i t) D th i ti fifinall ddecision i i granting ti or refusing authorisation (via comitology) - Art Art. 64(8)
Official Journal: Publication - Art. Art 64(9): summaries summaries, authorisation number Figure 1: Application procedure for an authorisation of a use of a substance listed in Annex XIV REACH.