Législation | Confidentiel Page 1

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

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

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

2007 2010 2013 2018

Preliminary registrationPre registration (june to december)

2008

« EINECS Substances » Timetable

Substance information exchange forum: SIEF

Deadline of registration :1000t/yearCMR 1&2 > 1t/yearR50/53 > 100t/year

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…

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…

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

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

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

What is the situation? If no data available on the substance If all tests are necessary

Hypothesis on Consortium20 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

Tonage band 1 to 10 10 to 100 100 to 1000 >1000

Total Cost K€ 60 200 500 1000Nb of Co. In the TB 10 4 4 2

Nb Co. Sharing cost 20 10 6 2

Cost / Co. In each TB 3 20 83 500

Co. In 1 to 10 3

Co. in 10 to 100 23Co in 100 to 1000 106Co. >1000 606

* 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

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

European UnionEuropean Union

Non EU Non EU countriescountries

D.U.

O.R.

MANE BSL

Prod. Article non EU.

P non EU

MANE AFFILIATES

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….