Législation | Confidentiel

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

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

« 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

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…

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…

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

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

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

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

* 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

Scope of REACh Substances concerned by REACh

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

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

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

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

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 »…

Thank you for your attention….