116
including on whether the precautionary dimension that after all exists in REACH is
counteracted by complex and slow implementation procedures so that the regulatory speed is even slower today than under the previous EU risk assessment programme for existing substances. A corresponding question needs to be asked also
concerning HELCOM, which – despite more commonly than EU referring to the
precautionary principle – has been quite reluctant to act on decaBDE and PFOA ,
albeit not to the same extent as the EU.
All in all, this regulatory reluctance signals a weak tradition and capacity in both
institutions to cope with uncertainty, which may fuel sociopolitical controversy . For
example, in the case of decaBDE assessment and regulation in the EU, divergent
opinions on how to interpret available knowledge and remaining uncertainty opened
the way for politicisation of the issue and consequently controversial regulatory and
court processes. Without policy and regulatory reforms, which most importantly
need to move towards a more fully reversed burden of proof ,
18 substantial diffi culties will remain even in the future when managing hazardous chemicals and their
environmental and health risks, thereby jeopardising the agreed objectives in e.g.
BSAP .
19
Turning from the dominating risk-based and polluter-oriented chemical regulations to the more environment-oriented directives and plans, such as MSFD and
BSAP, they clearly stand for a more holistic perspective, being in line with EAM ,
often expressing precaution as important. From the aquatic starting point, these
tools aim at addressing a number of substances based on environmental monitoring
and stated limit values. Here as well, however, decaBDE and PFOA have been
included at quite a late stage. Moreover, even if identifi ed as being of concern,
MSFD and BSAP as such do not lead to phasing out or restrictions on substances
that are targeted. In addition, country-based implementation is far from effective.
Despite observed regulatory hurdles such as the high burden of proof in EU chemicals policy, it is therefore still not certain that environment-oriented policies such as
MSFD and BSAP are more effi cient in promoting the agreed objectives of, for
example, good environmental status.
Based on the reasoning above, it seems obvious that both policy orientations and
approaches are needed and that they need to be better linked than today. Our case
studies indicate that this coordination is required both in science (e.g. in terms of
information and knowledge exchange between REACH and MSFD /BSAP) and
management (e.g. by allowing fast-tracking in REACH of hazardous substances
that show up in the marine environment or by triggering upstream sanitation measures if prohibited hazardous substances continue to show up in the environment as
result of leakage from already introduced products in society). In addition, starting
from EAM, both MSFD and BSAP should reasonably be developed to include
mechanisms for addressing groups of similar hazardous substances and other types
18 For example, the reversed burden of proof in REACH concerns substance registration but not, for
example, restrictions (see further in Karlsson 2010 ).
19 See, e.g. Karlsson et al. ( 2011 ) and Karlsson ( 2010 ) for more detailed ideas on governance
reforms.
M. Karlsson and M. Gilek
including on whether the precautionary dimension that after all exists in REACH is
counteracted by complex and slow implementation procedures so that the regulatory speed is even slower today than under the previous EU risk assessment programme for existing substances. A corresponding question needs to be asked also
concerning HELCOM, which – despite more commonly than EU referring to the
precautionary principle – has been quite reluctant to act on decaBDE and PFOA ,
albeit not to the same extent as the EU.
All in all, this regulatory reluctance signals a weak tradition and capacity in both
institutions to cope with uncertainty, which may fuel sociopolitical controversy . For
example, in the case of decaBDE assessment and regulation in the EU, divergent
opinions on how to interpret available knowledge and remaining uncertainty opened
the way for politicisation of the issue and consequently controversial regulatory and
court processes. Without policy and regulatory reforms, which most importantly
need to move towards a more fully reversed burden of proof ,
18 substantial diffi culties will remain even in the future when managing hazardous chemicals and their
environmental and health risks, thereby jeopardising the agreed objectives in e.g.
BSAP .
19
Turning from the dominating risk-based and polluter-oriented chemical regulations to the more environment-oriented directives and plans, such as MSFD and
BSAP, they clearly stand for a more holistic perspective, being in line with EAM ,
often expressing precaution as important. From the aquatic starting point, these
tools aim at addressing a number of substances based on environmental monitoring
and stated limit values. Here as well, however, decaBDE and PFOA have been
included at quite a late stage. Moreover, even if identifi ed as being of concern,
MSFD and BSAP as such do not lead to phasing out or restrictions on substances
that are targeted. In addition, country-based implementation is far from effective.
Despite observed regulatory hurdles such as the high burden of proof in EU chemicals policy, it is therefore still not certain that environment-oriented policies such as
MSFD and BSAP are more effi cient in promoting the agreed objectives of, for
example, good environmental status.
Based on the reasoning above, it seems obvious that both policy orientations and
approaches are needed and that they need to be better linked than today. Our case
studies indicate that this coordination is required both in science (e.g. in terms of
information and knowledge exchange between REACH and MSFD /BSAP) and
management (e.g. by allowing fast-tracking in REACH of hazardous substances
that show up in the marine environment or by triggering upstream sanitation measures if prohibited hazardous substances continue to show up in the environment as
result of leakage from already introduced products in society). In addition, starting
from EAM, both MSFD and BSAP should reasonably be developed to include
mechanisms for addressing groups of similar hazardous substances and other types
18 For example, the reversed burden of proof in REACH concerns substance registration but not, for
example, restrictions (see further in Karlsson 2010 ).
19 See, e.g. Karlsson et al. ( 2011 ) and Karlsson ( 2010 ) for more detailed ideas on governance
reforms.
M. Karlsson and M. Gilek