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Aim of REACh To give «  identity card  » and «  passport  » for all substances Origin of REACh:

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

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Aim of REACh To give «  identity card  » and «  passport  » for all substances Origin of REACh:

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  1. Législation | Confidentiel

  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 IMPORTEDwithoutspecificregulation

  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 11 years After 6 years and a half After 3 years and a half

  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. 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. 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

  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 AFFILIATES P non EU D.U. MANE BSL European Union

  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….

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