REACH NOTOX B'V'

1
REACH _at_ NOTOX B.V.
1983 2008 25 year Services to Industrial
Chemical Companies www.notox.nl reach_at_notox.nl dan
ny.haacke_at_notox.nl
2
REACH the real challenge

• Do I want to continue running my business
  successfully, also in Europe?
• Do I want to be a regulatory affairs specialist?
• Whom can I trust my business to?

3
Dedicated people

• More than 300 specialists
• gt 70 M.Sc. / PhD degree
• 12,000 m2 of modern purpose built
• laboratories and offices
• Full scale GLP compliant since 1987
• Compulsory educational in-house
• training program
• All programs follow EU/OECD
• guidelines, and/or EPA or METI
• regulations
• Offices in Japan, USA and Switzerland

4
REACH task force at NOTOX

• 20 Regulatory Affairs managers (M.Sc./PhD level)
• Experience with Existing chemicals (gt 200)
• Evaluated over 200 existing chemicals (HPV)
• literature search, evaluation of data (GLP/non-
• GLP), QSAR, read-across, in vitro testing
• Experience with New chemicals (gt750)
• Completion and submission of 7C, 7B, 7A
  dossiers,
• PBT- and risk assessment, level 1-2 discussions
  with CA
• Notification and Sole Representative (gt40)
• In EU, USA, Japan, Canada,
  Switzerland, Australia and
• Korea

5
NOTOX standard procedure REACH (10 steps
approach)
1. Inventarisation
2. Pre-registration
3. Refinement of inventarisation
4. Data evaluation
5. Determination of data gaps
6. Set-up of testing strategy
7. Perform a substance assessment
8. Prepare a test proposal
9. Prepare the dossier
10. Submit the dossier to the Agency
6
Support in detail

• Evaluation available data
• IUCLID 5 completion
• Robust summaries
• QSAR, read-across, grouping
• Literature search
• CSA/CSR / test proposal
• Perform or waive necessary tests
• Support for SIEF meetings

7
Current status800 SIEFs - 90 legal entities

• Geographic

• Volume

8
General time frame REACH
Registration Phase
-
in substances
Phase
-
in
substances
1

10 t/y
10

100 t/y
Phase
-
in
Entry into force (EC 1907/2006)
substances
100

1000 t/y
Phase
-
in substances
gt 1000 t/y
gt 100 t/y R50/53
gt 1 t/y CMR
Set
-
up Agency
Pre
-
registration
1 June
1 June
1 Dec.
1 Dec.
1June
1June
2007
2008
2008
2010
2013
2018
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Urgent time frame

• Deadline first tier 30 November 2010
• Completion lead dossier July 2010
• Completion all Annex VII/VIII end points
• May 2010
• Start studies (28-d reprotox screen) September
  2009 (capacity available now)
• Outcome evaluation available data
• Summer 2009

10
Threats - Challenges

• Substance sameness
• SIEF facilitator Lead registrant
• SIEF communication
• Consortium agreement
• Exchange of data
• Cost sharing (data and consortium management)
• SDS deadline 2010

11
Benefits of NOTOX

• Comprehensive services portfolio
• Strong regulatory support group
• Global coverage of study requirements
• High level of Quality and Science
• Fast track model minimizing both turn around
  times and costs
• State of the art facilities equipment
• Extensive capital expenditure in 2008
• Dedicated people, open communication
• Partnership business model
• Dedicated study directors and program managers
  (single point of control)
• Reporting in sponsor specific format
• Global organization and top 10 CRO
• 25 years experience in regulatory affairs
  guaranties full support for the entire REACH
  process and beyond

12
Any Questions ??
Thank you

• Come to booth F30

• Contact
• The Netherlands
• NOTOX B.V.
• Danny Haacke,
• Sales Marketing Manager
• Tel [phone]
• E-mail danny.haacke_at_notox.nl
• Website www.notox.nl