1. The proposed legislation
2/24/2019
REACH
The proposed legislation
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2. The Current EU Chemicals Policy
2/24/2019
The Current EU Chemicals Policy
Problems
Existing substances can be used without testing
Burden of proof on public authorities
No efficient instrument to deal with problematic substances
Lack of incentives for innovation, in particular of less hazardous substitutes
Burden of the Past
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3. A New EU Chemicals Policy
2/24/2019
A New EU Chemicals Policy
Objectives
Sustainable Development
Protection of human health and the environment
Maintain/enhance innovation/competitiveness
Maintain the Internal Market
Increased transparency and consumer awareness
Integration with international efforts
Promotion of non-animal testing
Guiding Principles - substitution and precaution
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4. The REACH System One System
2/24/2019
The REACH System
One System
Single, coherent system for new/existing chemicals
Three new elements:
Registration
Evaluation
Authorisation
Focus on substances:
high volumes
of greatest concern.
A Tiered Approach
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5. > 100 tonnes. (+ priority)
2/24/2019
REACH - White Paper
Registration
Evaluation
Authorisation
> 100 tonnes. (+ priority)
> 1 tonne
CMR (cat 1&2)
POPS
plus
Restrictions
Central Entity
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6. Reversed Burden of Proof
2/24/2019
And in practice?
New Responsibilities
Industry responsible for generating the knowledge
Downstream users - assess the safety of their products
Member State Authorities responsible for evaluating data submitted under Registration
New Agency - technical, scientific and administrative framework  
Reversed Burden of Proof
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7. REACH - since the White Paper?
2/24/2019
REACH - since the White Paper?
Duty of care
Pre-registration
Registration
intermediates
polymers
Authorisation
PBTs, vPvBs, ‘Other substances’
Agency
Council Conclusions
European Parliament
Working groups
Studies
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8. Manufacturers/Importers/Downstream users:
Duty of care
Manufacturers/Importers/Downstream users:
manufacture/use of substance
reasonably foreseeable conditions
health/environment not adversely affected.
Chemical Safety Assessment (Downstream user assessment)
Chemical Safety Report
Updated
Transmitted through supply chain

9. Registration Substances produced/imported > 1 tonne/year
2/24/2019
Registration
Industry demonstrate chemicals managed safely
Substances produced/imported > 1 tonne/year
Phased approach
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10. Registration of Chemicals: A Phased Approach
2/24/2019
Registration of Chemicals: A Phased Approach t
>1000 t + CMR t t
Yr 0
Yr 0 +3
Yr 0 + 6 Yr
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11. Registration Substances produced/imported > 1 tonne/year
2/24/2019
Registration
Industry demonstrate chemicals managed safely
Substances produced/imported > 1 tonne/year
Phased approach
Central data base run by an independent agency
Information requirements increase with volume
> 100 tonnes testing proposals
Intermediates/polymers - reduced requirements
Updated - new information
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12. Evaluation Data examined by Competent authorities.
2/24/2019
Evaluation
Confidence that industry is meeting obligations
Prevent unnecessary testing
Data examined by Competent authorities.
Standard (>100 tonnes) - testing proposals
Priority (concern about risks)
Additional information/testing can be required.
“Mutual recognition” system
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13. Control uses of very high concern substances
2/24/2019
Authorisation (1)
Control uses of very high concern substances
Very high concern?
CMR, PBT, vPvB, ‘Substances of equivalent concern’
produced/sold for specific uses/under certain conditions – for supply chain.
may include a review period.
Applicant to show:
adequate control of risks, or
social and economic benefits outweigh the risks.
Substitution considered
Prioritised.
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14. How does the Water Framework Directive fit in? Current draft:
Authorisation (2)
How does the Water Framework Directive fit in?
Current draft:
risks to health and environment from emission to aquatic compartment not considered if binding emission limit or eqs in a permit granted in accordance with 2000/60/EC.
Still under discussion

15. Restrictions Community concern For manufacture/marketing/use
2/24/2019
Restrictions
Safety net
Community concern
For manufacture/marketing/use
MS (or Com) initiate
Dossier (MS) to justify
RA and SEA produced – Committee opinion
Transparency via website
Commission proposal – commitology.
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16. 2/24/2019
Who does what?
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17. Increased animal testing Impact on downstream users
2/24/2019
Stakeholder concerns
High costs
Increased animal testing
Impact on downstream users
Production moving outside the EU
EU industry disadvantaged internationally
Loss of marketed substances
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18. Costs Business Impact Assessment study 2002:
2/24/2019
Costs
Business Impact Assessment study 2002:
Direct costs: €1.4—7 billion; most likely € 3.6 billion.
less than 0.1 % of yearly turnover over 11 years.
Proposal adapted
e.g. less data on intermediates, greater scope to waive testing
will now revise the study
Indirect costs: under assessment
90 % of costs from testing
Industry has very little information about its chemicals?
The knowledge gap REACH is designed to fill
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19. Benefits (1) For new and existing substances, equivalent:
2/24/2019
Benefits (1)
For new and existing substances, equivalent:
levels of protection
competitive advantages (Ex:hazardous v Nw: non-hazardous)
> 30,000 existing substances investigated
Acute (and long-term) toxicity
Improved innovation
more R&D flexibility
no significant loss of protection
Testing requirements: tonnes generally in-vitro
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20. Conclusion: benefits significantly outweigh costs
2/24/2019
Benefits (2)
Benefits: occupational health, public health & environment
Occupational Health Study
Commission will publish a study today
benefits estimated at between €18 and 54 billion
Public health study underway
initial results suggest substantial benefits
Environmental benefits hard to express in cash terms
reduced pollution of air, water, soil, reduced pressure on biodiversity
Conclusion: benefits significantly outweigh costs
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21. REACH = large-scale information collection, = large-scale testing.
2/24/2019
Limit animal testing
REACH = large-scale information collection, = large-scale testing.
Information requirements - smart/targeted:
exposure often taken into account.
not always necessarily to do new testing (eg (Q)SAR).
Low volume production/import chemicals (1-10 tonnes/year):
as far as possible no animal testing.
For higher volumes:
testing only if existing information/validated alternative methods not sufficient.
Testing programmes - decided by the competent authorities
Data sharing encouraged, but eventually compulsory; fair cost sharing.
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22. Internet consultation
2/24/2019
Timing
Internet consultation
May - July 2003
Focused on workability
Adoption
Planned - autumn 2003
Council and Parliament
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23. Benefits significantly outweigh costs
2/24/2019
Conclusions - REACH
High level of protection
Changing burden of proof
Improved knowledge
Encourage innovation
Substitution of most dangerous substances
Better:
tracking of chemicals
use of resources
reaction to emerging risks
information for downstream users
better consumer confidence
Benefits significantly outweigh costs
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