1. Législation | ConfidentielPage 1

2.  Aim 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

3.  What is REACh? 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. Deadline of registration : >100t/year Deadline of registration : 1-100t/year 1 er june: REACH enters Into force After 3 years and a half After 6 years and a half After 11 years 2007201020132018 Preliminary registration Pre registration (june to december) 2008 « EINECS Substances » Timetable Substance information exchange forum: SIEF Deadline of registration : 1000t/year CMR 1&2 > 1t/year R50/53 > 100t/year

5.  Publication of the pre-registration list by ECHA ◦ about 150 000 EINECS pre-registered  But… we can find this EINECS number : 200-032-7 (cocaïne) and the registration will be made in 2010!!  Bug ?: about 40% of pre-registered substances have to be registered before december 2010…

6.  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. Sub >1t/year (annexe VII) Sub >10t/year (annexe VIII) Sub >100t/year (annexe IX) Physico-chemical Requirements 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 Sub >1000t/year (annexe X) - Stability in organic solvents, identity of degradation relevant products - Dissociation constant, viscosity

8. Sub >1t/year (annexe VII) Sub >10t/year (annexe VIII) Sub >100t/year (annexe IX) Toxicological Requirements Toxicological requirements - Skin irritation/corrosion - Eye irritation - Skin sensitisation - In vitro gene mutation in bacteria - Acute oral toxicity Sub >1000t/year (annexe X) - 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. Sub >1t/year (annexe VII) Sub >10t/year (annexe VIII) Sub >100t/year (annexe IX) Ecotoxicological Requirements Ecotoxicological requirements - Short term toxicity Daphnia - Growth inhibition study aquatic plant (on algae) - Biodegradability Sub >1000t/year (annexe X) - 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.  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: 284-656-5: 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.  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 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 24 th, 2008: possibility to appointed an OR within the supply chain

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

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….