Transcript Beyond registration: what happens next

Managing the risk of
industrial chemicals and
biocides
TOWARDS A NON-TOXIC
FUTURE
Handling chemical risks across
consumer products, environment
and food
24 November 2016
Sørup Herregård, Ringsted
Jack de Bruijn
European Chemicals Agency
7th environment action plan
……….Horizontal chemicals legislation (REACH and
the Classification, Labelling and Packaging
Regulations), as well as legislation on biocidal
products and plant protection products, provides
baseline protection for human health and the
environment…..
Basic pillars of Chemicals legislation
Knowledge
Regulatory
action
Supply chain
communication
Safe use
3
9 years of REACH and CLP; The
journey so far
• ECHA published in May 2016 its
second report on the progress
with REACH and CLP
• Overall REACH is working
• Good progress made!
• There’s still a lot of work to do !
• 56 Recommendations and 18
ECHA commitments
4
Do we know more on chemicals?
169
460
1 500
Substances of Very High Concern
Risk management proposals
Dossiers for HPV chemicals checked for
compliance
14 000
Substances registered under REACH
130 000
Substances classified with GHS
>2million
Study summaries on properties
and effects of chemicals
Options used to meet the
information requirements
~75% of registrations contain read-across
Developmental
toxicity
Toxicity to
reproduction
Genetic toxicity in vivo
Repeated Dose
Toxicity
Toxicokinetics
Skin sensitisation
Eye irritation
Skin
irritation/corrosion
Acute Toxicity (all
routes)
0%
10%
20%
30%
Reliable experimental guideline studies
Testing proposals
(Q)SAR
Flags to ommit the study
40%
50%
60%
70%
80%
90%
100%
Experimental data from other sources
Read-across
Weight of evidence
Not reported
6
Good quality registration dossiers
• Quality is improved, but more needs to be done!
• Industry to update:
• Annual and total volumes that change
• New identified uses, uses advised against
• New knowledge on hazard (including C&L) and risks
leading to changes in the CSR
• Improved justifications for data-waiving
ofisregistration
dossiers
• 64
But%
this
not being done
consistently
submitted since 2008 were
never updated!
Chemical and DU industry should
improve supply chain communication
Upstream
Registrant (CSR)
Manufacturer/ Importer
Downstream
Formulator
Formulator
Communication
on uses and use
conditions to
the registrant
with
use maps
DU
DU
End user
DU
Communication on
safe use to
downstream users:
exposure
scenarios
8
Substitution of hazardous
substances is happening
 Authorisation provides incentive to substitute.
Innovation is taking place.
 Retailers demand supply of ‘SVHC-free’ products
 Consumers use the art 33 ‘right to ask’ info on
SVHC content of products (helped by easy
scanning tools)
9
Substances in
articles/products
• Awareness on obligations is limited (imported
articles)
• Need cooperation with, action in third countries
• Step up enforcement (imported articles)
• Support development/implementation of
consumers right to know tools?
→ Ultimately we need to understand in which
material streams and articles substances end up in!
10
Some food for thought
How to deal with combination effects?
(in a legislative context)
• Science is sufficiently clear (for many
decades!)
• Effects of exposure to mixtures generally
well described by concentration addition
• Actors cannot be held responsible for the
use of other substances by other actors
→ Assessing all possible exposure
combinations is a dead end route
12
Reduce the probability that effects
through combined exposure occur by
reducing the overall toxic pressure
Exposure
No-effect level
Divide by 10
or 100 ?
<1
Reduce to
0.1 or 0.01
13
Thank you
[email protected]
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