1. Législation | Confidentiel

2. Aim of REACh Origin of REACh:
To give « identity card » and « passport » for all substances
Origin of REACh:
February 2001: presentation of the « White Book » by European Commission
May 2003: Internet consultation
October 2003: First Commitee’s proposition
November 005: first read
December 2006: Vote by the European Parliament & adoption by the council
June 2007: entry into force of the REACH regulation
1998: authority wanted to know more about chemical substances and to have an homogeneous system

3. What is REACh? Aims: Scope:
COMMISSION REGULATION (EC) N° 1907/2006 of 18 December 2006
Registration Evaluation Authorization of Chemicals
Substances manufactured and/or imported
Up to one ton/year
For every legal entity
Aims:
Human Health protection and Environment protection
Scope:
Chemical substances MANUFACTURED AND/OR IMPORTED without specific regulation

4. « EINECS Substances » Timetable
Deadline of registration :
1-100t/year
Deadline of registration :
>100t/year
Deadline of registration :
1000t/year
CMR 1&2 > 1t/year
R50/53 > 100t/year
Preliminary registration
Pre registration
(june to december)
Substance information exchange forum: SIEF
2007
2008
2010
2013
2018
1er june: REACH enters
Into force
After 6 years and a half
After 11 years
After 3 years and a half

5. Publication of the pre-registration list by ECHA
about EINECS pre-registered
But… we can find this EINECS number : (cocaïne) and the registration will be made in 2010!!
Bug ?: about 40% of pre-registered substances have to be registered before december 2010…

6. Required tests are in accordance with the tonnage of the substance…
To establish a file for each substance manufactured and/or imported up to 1 ton/year
What does the file say?
Physico-chemical requirements
Toxicological requirements
Ecotoxicological requirements
Required tests are in accordance with the tonnage of the substance…

7. Physico-chemical Requirements
Sub >1000t/year (annexe X)
Sub >100t/year (annexe IX)
Sub >10t/year (annexe VIII)
Sub >1t/year (annexe VII)
Physico-chemical requirements
- State of substance at 20°C, Melting/freezing point
- Boiling point
- Relative density
- Vapour pressure
- Surface tension
- Water solubility
- Partition coefficient (logP)
- Flash point
- Flammability
- Explosive properties
- Selfignition temperature
- Oxidizing properties
- Granulometry
- Stability in organic solvents, identity of degradation
relevant products
- Dissociation constant, viscosity

8. Toxicological Requirements
Sub >1000t/year (annexe X)
Sub >100t/year (annexe IX)
Sub >10t/year (annexe VIII)
Sub >1t/year (annexe VII)
Toxicological requirements
- Skin irritation/corrosion
- Eye irritation
- Skin sensitisation
- In vitro gene mutation in bacteria
- Acute oral toxicity
- Repeated dose toxicity
- In vitro cytogenicity study in mammalian cell
- Cell or in vitro micronucleus test (mutagenicity)
- In vitro gene mutation in mammalian cells
- Acute inhalation toxicity
- Acute dermal toxicity
- Short term reapeated dose toxicity study (28d)
- Screening for reproductive/developmental toxicity
- Prenatal developmental toxicity study
- Assessment of toxicokinetic behaviour
- Two generation reproduction toxicity study (rat, rabbits)
- Sub-chronic toxicity study (90d)
- Carcinogenicity toxicity study (2 years)
- Long term effect on reproductive toxicity (>12months)
- Further toxicity tests

9. Ecotoxicological Requirements
Sub >1000t/year (annexe X)
Sub >100t/year (annexe IX)
Sub >10t/year (annexe VIII)
Sub >1t/year (annexe VII)
Ecotoxicological requirements
- Short term toxicity Daphnia
- Growth inhibition study aquatic plant (on algae)
- Biodegradability
- Short term toxicity on fish
- Activated sludge respiration inhibition
- Abiotic degradation
- Absorption/desorption sceening study
- 21d daphnia study
- Fish early life stage toxicity test
- Stimulation testing on ultimate degradation in surface water
- Soil and sediment simulation testing
- Identification of degradation products
- Bioconcentration in aquatic species
- Short term effects on fish, invertebrates and on plants (14d)
- Effects on soil micoorganisms
- Long term effects on invertebrates,sediment organism, birds and on plant
- Long term reproductive toxicity

10. Hypothesis on Consortium
What is the situation?
If no data available on the substance
If all tests are necessary
Hypothesis on Consortium
20 members in the consortuim
10 members for 1 to 10 ton/year
4 members for 10 to 100 ton/year
4 members for 100 to 1000 ton/year
2 members for up to 1000 ton/year

11. * Manfred Fleischer, Testing Costs and Testing Capacity According to the REACH Requirements – Results of a Survey of Independent and Corporate GLP Laboratories in the EU and Switzerland, Journal of Business Chemistry, Vol. 4, Issue 3 September 2007

12. Scope of REACh
Substances concerned by REACh

13. Pre-registration of substances concerned by REACh
For example: : TOBACCO EXTRACT
Participation of Key pre-SIEF
Strategic MANE specialities
R50/53 substances
Pre consortia participation
EFFA consortia (since October 2007)
EFEO consortia (since March/april 2008)
Why?
To avoid superfluous testing
To exchange data on substances and define the cost of data sharing
to build a common registration file

14. Consortia participation
SIEF participation
To define our role in different SIEF
1) leader
2) involved
3) passive
4) dormant
Consortia participation
Discussion & data evaluation
In the future…
Participation of the testing launch (if necessary…)
…etc
MANE’s Official Position

15. REACH: a world-wide concern… For Non European Manufacturers :
Appointed an « Only Representative » (OR)
What are the possibilities to appointed an OR for non European manufacturer?
To reference with the Technical Guidance Document (TGD) on registration from September 24th, 2008:
possibility to appointed an OR within the supply chain

16. Non EU countries Prod. Article non EU. O.R. MANE BSL European Union
P non EU
MANE AFFILIATES
O.R.
MANE BSL
D.U.

17. Flavors for Tobacco are in the scope of REACh
Pre-registration and registration are necessary
SIEF’s activities/participants remain vague
At this time, the cost is not well known but…
Consortia’s approach should reduce the cost
MANE GROUP is very active and try to help their customers with the « OR strategy »…

18. Thank you for your attention….