aim of reach to give « identity card » and « passport » for all substances origin of...
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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 - PowerPoint PPT PresentationTRANSCRIPT
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….