PowerPointPrsentation

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REACH The EU Regulation on Registration,
Evaluation, Authorisation and Restriction of
CHemicals
Prof. Dr. Bernd Delakowitz
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• Motivation
• Features
• 3. Positions and Concerns
• History and Current State (Feb 2007)
• How to Proceed

Prof. Dr. Bernd Delakowitz
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• Motivation
• and Causes

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• World Chemicals Production 2000
• Turnover totals up to 1 565 billion (approx.
  twice the amount of global telecom industry)
• 7 of global income (GDP)
• 9 of global trade
• EU 31 of worlds chemicals prod. (US 28 )
• EU Some 4,7 million people employed

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• Structure of EU Chemicals Industry
• Some 20 000 SMEs representing 96 of all chemical
  enterprises in the EU
• EUs third biggest employer
• Biggest contributor to EUs trade surplus
• 500 000 downstream users

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• HSE Problems
• EU distinguishes between so called old
  chemicals entering the market before 1981 (ca.
  102.000, listed in EINECS) and new chemicals (gt
  3.200) after 1981
• General lack of knowledge about the properties of
  old chemical substances because up to 1981 it was
  possible to market the chemicals without any
  formal authorisation (and insufficient
  evaluation)
• Vast majority of existing chemicals (around
  105.000) with unknown or not sufficiently known
  properties. So far, only about 9.000 ( 8)
  chemicals are sufficiently investigated with
  respect to the humans health and the natural
  environment

 
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• HSE Problems
• Various old installations for bulk chemicals with
  high energy and resource demand, significant
  emissions to the environment, old technologies
  (e. g. chlorine production in mercury cells,
  fertilizer production)
• A patchwork of too many and often not consistent
  regulations both on European and member states
  levels

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Environmental Water Problems Resulting from
Hazardous Chemicals

• Toxification with chemicals
• Eutrophication (nitrogen)
• Contamination due to oil discharges

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• HSE Problems
• Problematic chemicals not only pollute natural
  water resources but contaminate animals and men
• Brominated flame retardants, used in fabrics and
  TVs
• PFCs, from manufacture and use of non-stick
  coatings (e.g. PTFE/Teflon), anti-stain
  treatments (Scotchguard) and telomers (e.g.
  McDonalds food packaging)
• Anti-fouling additive TBT has decimated shellfish
  stocks
• Food cans continue to contain a proven hormone
  disrupter, bisphenol A

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• Regulatory Problems
• Current system for chemicals management in the EU
  is inefficient
• Difficult to identify and to address risks
• Lack of information about substances on the
  market produced before 1981
• Burden of proof on public authorities !
• No efficient instrument to deal with problematic
  substances

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2. Publication, Principles and Features of REACH
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Official Journal of the European Union ISSN
1725-2555 L 396, Volume 49, 30 December 2006 -
Acts whose publication is obligatory -
 
Regulation (EC) No 1907/2006 of the European
Parliament and of the Council of 18 December 2006
concerning the Registration, Evaluation,
Authorisation and Restriction of Chemicals
(REACH), estab-lishing a European Chemicals
Agency, ....
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• Objectives of REACH
• To develop an integrated and coherent chemicals
  policy reflecting the precautionary principle and
  the principle of sustainability
• To increase the safety of humans and the
  environment in the handling of chemicals and at
  the same time to improve the com-petitiveness of
  the chemicals industry in Europe (???)

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• What is REACH
• A single regulatory framework for registration,
  evaluation and authorisation of chemicals to
  replace the current dual system for assessing
  risks of "existing old" badly evaluated (placed
  on market before 1981) and new much better
  known substances.

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REACH Requirements The REACH draft originally
required (re-) assessment of ca. 30.000
chemicals currently used in EU chemicals industry
and its down-stream users based on quantities
produced (gt 1t/a) - volume-oriented approach -
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REACH Requirements Reversal of burden of proof
from authorities to industry (manufacturer,
importer, supplier, downstream user) for testing
and risk assessment of chemicals. In other
words Shift of responsibility from authorities
to industry
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REACH Registration
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• REACH Registration
• All substances (phase-in articles, EINECS) or
  newly produced (non-phase-in) or imported in
  quantities of
• gt 1.000 t/a
• gt 100 t/a for environmental hazardous
  substances (R50/53)
• gt 1 t/a for CMR-substances
• will have to be registered at the REACH Agency
  until 11/2010

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• REACH Registration
• Registration not required for
• - substances for use in research activities (!)
• - polymers
• - radioactive substances
• - substances in drugs or nutrient additives
• - REACH appendix IV (e.g. water, natural oils)
• - REACH appendix V (e.g. minerals, coal)
• - already registered or re-imported substances
• Information required will be proportional to
  production volumes and risk potentials

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• REACH Pre-Registration
• Old phase-in substances (EINECS) gt 1 t/a
• Without pre-registration no interim periods for
  registration of new non-phase-in substances can
  be claimed (Art. 23)
• Pre-registration period
• 01. June 2008 until 01. December 2008

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Registration Deadlines
REACH Notification and Registration Deadlines
(interim periods for registration)
100 - 1000 t
10 100 t
gt 1000 t / gt 1 t CMR gt 100 t R50-53
Start 06/2007
11/2010
05/2013
05/2018
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• REACH Evaluation
• Two types of evaluations dossiers (already
  existing information) and substances evaluation
  and testing, respectively.
• Member States' competent authorities can carry
  out evaluations of substances when they have
  justified reasons that there is a risk to human
  health or to the natural environment (such as
  rivers, animals, plants and groundwater).

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REACH Evaluation
Provide confidence that industry is meeting
obligations - Prevent unnecessary (animal) testing
Dossier evaluation
Substance evaluation
Examine any information on a substance
Check test proposals
Compliance

• Output (REACH database at Agency, SIEF -Substance
  Information Exchange Forum)
• Further information decisions
• Info to other parts of REACH/other legislation

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REACH Data Sharing
Avoidance of unnecessary animal testing to save
costs

• Information gt 10 years freely available
• At registration registrants indicate if share
  non-animal data
• Non-phase-in substances ( new, not in articles
  so far)
• Agency enables contact with previous or potential
  registrants
• Studies involving vertebrate animals not repeated
• Phase-in substances ( old, in articles and
  market)
• Potential registrants of similar substances have
  access to SIEF
• Share data (incl. new tests) and costs
• Sharing mandatory (vertebrate animals)

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REACH Authorisation Authorisation will be
required for highly problematic substances - CMRs
(carcinogenic, mutagenic or toxic to
reproduction), PBTs (persistent, bioaccumulative
and toxic) , vPvBs (very persistent and very
bioaccumulative) and other substances with
serious and irreversible effects on humans and
the environment
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REACH Authorisation Authorisation will be
granted to these substances if risks can be
adequately controlled or on valid socio-economic
grounds if there are no technological alternatives
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REACH Authorisation
Ensure risks from substances of very high concern
are properly controlled or that they are
substituted.

• Applicant to show
• adequate control of risks, or
• social and economic benefits outweigh the risks
• Socio-economic authorisation - time-limited
  (REACH, Appendix XIV)
• Supplier may sell authorisation down supply chain

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Downstream Users (DU)

• Manufacturer/importer registration to cover all
  uses identified by downstream users
• DU must
• implement suppliers risk reduction measures for
  identified uses
• DU need to
• enter into dialogue with their suppliers
• consider consortia building and/or cost sharing
• DU may need to apply for authorisation

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• REACH Agency
• New agency to manage the day-to-day running of
  the system Helsinki, Finland (EU Council 12 Dec
  2004)
• Responsibilities
• - Registration (reject or require completion of
  registration)
• - Evaluation (ensure a harmonised approach take
  decisions)
• - Authorisation/restrictions (facilitate
  process suggest priorities)
• - Secretariat for Forum and Committees
• - Deal with appeals (registration, RD,
  evaluation, confidentiality)

 
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Performance of REACH  taken from S.
Guether/SAXONIA, 2006
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REACH Helpdesks, Tools and Links
http//www.bdi-online.de/de/fachabteilungen/7240.h
tm
http//132.195.14.44/cgi-bin/komnet-f/asinfo.cgi?s
etcatRCH (Chatt-Room)
http//www.reach-info.de/01_aktuell/01_aktuelles.h
tm Official UBA-page on REACH
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3. Positions and Concerns
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Positions and Concerns A public hearing held on
19 January 2005 in the EU Parliament  gave the
opportunity to a wide variety of stakeholders to
express their views and concerns upon REACH
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Positions and Concerns Chemical Industry For
the chemicals industry and its down-stream users
(e.g. carmakers), the Commission's plans for
REACH conjure up fears of bureaucracy, lack of
flexibility and loss of competitiveness (...
stifling innovation, .. risk of
de-industrialisation, etc.)
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• Positions and Concerns
• Chemical Industry (2)
• Industry claims that the Commissions REACH
  system is too costly, unworkable and will result
  in up to 1,4 Mio job losses in the sector
• In 2004, the leaders of the 'big three' (UKs T.
  Blair, Germanys G. Schroeder and Frances J.
  Chirac) teamed up with their industries to
  condamn the "bureaucratic and unnecessarily
  complicated" draft legislation

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• Positions and Concerns
• Economic Impact
• Commission estimates the overall economic impact
  for chemicals industry and downstream users at
  between 2.3 - 5.4 billion over 11 years (less
  than 0.1 of the annual turnover of the sector or
  0,5 per person per year in the EU)

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Positions and Concerns Economic Impact These
figures are heavily disputed by industry studies
performed by the German BDI and the Mercer
study in France which calculates the costs caused
by REACH up to 54 billion. Industry, therefore,
insisted on an independent extensive impact
assessment of the Commission's proposal
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• Positions and Concerns
• Economic Impact
• The NGOs, on the other hand, compared the costs
  to industry with the financial gains from
  reductions in public health costs, less negative
  impacts on the environment and productivity
  savings.
• A study for WWF (UK, David Pearce, 2004)
  estimated the financial gains at around 230
  billion by 2020

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4. History and Current State (February 2007)
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REACH Agenda
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REACH Agenda
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REACH Finalisation
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5. How to proceed
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(No Transcript)
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REACH Improvements
 
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• REACH Deadlines (Short-term)
• Information exchange within supply chains
  (manufacturer, importer, supplier, user) and
  notification to Agency starts 01. June 2007
• Registration of new non-phase-in substances
  starts 01. June 2008 (June/2007 for gt 1 t/a CMR
  substances)
• Pre-registration of old phase-in substances
  starts 01. June 2008 and ends 01. Dec. 2008
• Notification and registration for high-volume and
  hazardous substances ends November 2010

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Thank you for your attention