Table 1 . Options for providing input on socio-economic aspects of regulatory risk management |
Regulation |
Process and |
Phase |
Activity |
Performed |
Socio-economic input possible |
|
phase |
|
|
by |
|
REACH |
Restriction |
Preparation of proposal |
|
Authorities |
|
BPR
PPPR
Information on alternatives ; Assessment of costs and benefits
No formal process ; socio-economic input can be sent to evaluating member state or ECHA
Restriction |
SEAC draft |
Public consultation |
Authorities |
Provide feedback on SEAC opinion |
|
opinion |
|
|
|
Authorisation |
Application |
Prepare application |
Industry applicants |
Provide analysis of alternatives and socio-economic analysis |
Candidates for |
Defining potential |
Public consultation |
Authorities |
Provide information on alternatives , |
substitution |
candidates |
|
|
technical feasibility , economic |
Exclusion criteria
Derogation in emergency Derogation in emergency
Derogation to exclusion criteria
|
|
feasibility |
Public consultation |
Authorities |
Indicate essential to control serious |
|
|
danger ; disproportionate negative |
|
|
impact on society of disapproval |
Application |
Prepare application |
Industry applicants |
Application |
Prepare application |
Industry |
|
|
applicants |
Justify the ( socio-economic ) need
Provide economic evidence that socioagronomic system cannot be changed within a year
CAD / CMD |
Setting of OEL |
Deriving limits |
Impact assessment |
Authorities |
Provide input on socio-economic |
|
|
|
|
|
impact of new OEL |
Table 1 – Options for providing input on socio-economic aspects of regulatory risk management
‣ of the Netherlands recommended in 2014 that a limit of 0.1 mg / m 3 was not feasible and that a 2 mg / m 3 limit be set instead . 1 While such a clear relation between input from industry and resulting authority positions is unfortunately not always visible , it does show that a good study can have an important impact on a regulatory decision .
Summary & conclusion
In the decision-making process on RRMs for chemicals , socio-economic aspects can play an important role . Several regulatory processes provide options for stakeholders to submit information on such aspects . The formats and processes can differ and , in some cases , a formal option to provide such information has not been foreseen . In all cases , if you are a stakeholder who expects to be impacted seriously by the proposed RRM , it is up to you to ensure that the authorities are aware of that ( unwanted ) impact . You should not miss the opportunity to make your points clear and the best way to do it is to provide convincing calculations and data , supporting your position . •
Hans Marquart
SENIOR RESEARCHER – REGULATORY SERVICES & RISK ASSESSMENT
TRISKELION k + 31 6 5000 7586 J hans . marquart @ triskelion . nl j www . triskelion . nl
Reference :
1 : SER . Grenswaarde voor 1,3-Butadieen . Advies 14 / 08 , September 2014 , ISBN 978-94-6134-066-5
44 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981