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NOTOX B.V.

NOTOX B.V. REACH (Registration and Evaluation). SOCMA Corporate Excellence Conference 16 May 2008 Savannaha, Georgia. Core business of NOTOX B.V. Regulatory support for the notification of industrial, crop protection and biocidal products

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NOTOX B.V.

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  1. NOTOX B.V. REACH (Registration and Evaluation) SOCMA Corporate Excellence Conference 16 May 2008 Savannaha, Georgia

  2. Core business of NOTOX B.V. • Regulatory support for the notification of industrial, crop protection and biocidal products • Performance of studies for the registration of industrial and agrochemicals • Conduct of pre-clinical studies on APIs in support of new drug development

  3. Track Record Regulatory Support Industrial and specialty chemicals: • HPV OECD/ICCA • > 50 substances • HPV US-EPA Test plans and gap-filling • > 150 substances • Notification dossiers EU • > 1,000 substances • consortia experience

  4. REACH Provisions • REACH objectives: • Protection of human health and environment • Development of hazards, use conditions and exposure information for existing substances • Compulsory sharing of information to ensure competitiveness of EU chemical industries • Reduce animal testing (in vitro, QSAR, read-across) • Responsibility for hazard information shifts from the government to the industry • Sustain REACH-IT portal for communication among registrants

  5. REACH Regulation • Evaluate existing (EINECS) substances (30,000) 2010 - 2018 • Compile registration technical dossiers on EINECS substances – IUCLID 5 • Reduction of testing requirements for new chemicals 1 – 10 tons • QSAR and alternatives for animal studies accepted, also using read-across

  6. REACH: phase-in substances Tiered approach for registration • 2,600 substances > 1,000 MT + CMR • 2,900 substances 100 – 1,000 MT • 4,600 substances 10 – 100 MT 20,000 substances 1 – 10 MT There will be one pre-registration and consortia building opportunity (SIEF formation) before data collection starts.

  7. REACH: Exemptions • Substances under PPORD are exempted for 5 – 10 years • medicinal products including intermediates • waste • foodstuffs • pesticides • radioactive substances • substances in transit - customs supervision • cosmetics • Polymers are exempted (for the moment) .

  8. NEW chemical guideline (67/548/EEC) amended REACH: Time schedule Registration Phase - in substances Phase - in substances 1 – 10 t/y 10 – 100 t/y Phase - in substances Entry into force (EC 1907/2006) 100 – 1000 t/y Phase - in substances > 1000 t/y > 100 t/y + R50/53 > 1 t/y + CMR - Set up Agency Pre - registration 1 June 1 June 1 Dec. 1 Dec. 1June 1June 2007 2008 2008 2010 2013 2018

  9. Data requirements for phase-in substances * Requires a test plan submitted to ECHA for any additional studies from Annex IX or X CSR: Chemical Safety Report

  10. Who is responsible • Manufacturer of chemicals in the EU • Importers of chemicals, products and articles • Only representatives (OR) for non-EU manufacturers Other players: • Third party representatives • Downstream users

  11. 1- 10 MT/y (Annex VII) • Physico-chemical properties • Acute toxicity • Environmental toxicity and biodegradation • Rough costs: € 50,000 - € 65,000 or minimum $75,000

  12. 10 – 100 MT/y (Annex VIII) • Additional acute toxicity • Repeated dose toxicity • Reproductive toxicity • Additional environmental toxicity and behaviour • Rough costs: € 180,000 - € 220,000 or minimum $270,000

  13. 100 – 1,000 t/y (Annex IX) • Additional physico-chemical • Further repeated dose toxicity • Long-term aquatic toxicity • Degradation and e-fate behaviour • Terrestrial toxicity • Rough costs: € 550,000 – € 1,000,000 minimum $825,000

  14. > 1,000 MT/y (Annex X) Only after approval by authorities: • Additional long-term toxicity • Additional long-term aquatic toxicity • Additional terrestrial toxicity • Rough costs: € 1,300,000 mimimum $2,000,000

  15. Pre-registration Approaches To be done between 1 June and 1 December 2008

  16. What is needed to pre-register a substance: • Registration number (EINECS/CAS) • Chemical name (IUCLID or CAS) • Registrant/Contact information • Registration deadline and tonnage • Information on similar substances for QSAR and potential read-across • Must submit via REACH-IT portal

  17. Prepare for SIEF activities • Determine value of data you own • Decide on required role in consortia (lead, active or passive member) • Decide on sharing company confidential information (composition data, use information) • Advise downstream users of REACH conformance

  18. Test plan: • Data gaps based on volume needs (Annex VII + VIII) • Data needs based on scientific or use considerations for Annex IX + X end-points • Data needs based on the outcome of the CSA/CSR • What can be waived using Annex XI

  19. After Pre-registration • Companies who have pre-registered a substance will automatically become listed on the pre-SIEF page (REACH-IT) of this substance. • To initiate discussions after pre-registration, a pre-registrant can volunteer on the pre-SIEF page to become SIEF formation facilitator . • ECHA will publish by 1 January 2009, a list of pre-registered substances on its website. The list will comprise of all substances that have been pre-registered by 1 December 2008. For each substance the following information is displayed: • Substance identification: EINECS number, CAS number and names of the substance • Substance identification of the similar substances, if applicable • The first envisaged registration deadline

  20. Registration Technical Dossier: • Annex VII: ± € 3,500 • Annex VIII: ± € 15,000 • Annex IX: ± € 30,000 • Annex X: ± € 39,000 Based on setting the economic values and making robust summaries of one study per endpoint. The estimated time for a substance imported/produced in Europe above 100 MT, is a worst case estimate as only data from Annex VII and VIII are compulsory to report .

  21. Annex XI: what’s in it? • Testing does not appear scientifically necessary • Use existing (non-GLP) data • Use historical human data • Weight of evidence • (Q)SAR possibilities • In vitro methods • Grouping and read-across • Testing is technically not possible • Substance-tailored exposure-driven testing

  22. REACH and new chemicals(non-phase-in substances) • Changing of notification levels • < 1 ton: exempt • 1-10 tons: limited testing (Annex VII) • > 10 tons: full package (Annex VII + VIII) plus a test plan if > 100 tons • Introduction of in-vitro testing • Introduction of computer models • Introduction of read-across

  23. Important websites http://echa.europa.eu/pre-registration http:// echa.europa.eu/reachit http:// echa.europa.eu/iuclid

  24. Thank you Any Questions ?? Contact: Robert B. Foster, Senior Scientific Advisor NOTOX (USA) Tel: 508-830-6708 E-mail: notoxusa@aol.com Website: www.notox.nl

  25. Data packages for Annex VII-X Existing and New Substances

  26. Melting point Boiling point Relative density Vapour pressure Surface tension Water solubility Partition coefficient Flash point Flammability Explosive properties Self-ignition temperature Oxidising properties Granulometry Test Package 1 – 10 t/a (Annex VII)Physico-chemical properties

  27. Acute oral toxicity In vitro skin corrosion and/or in vitro skin irritation In vitro eye irritation Sensitisation (LLNA) In vitro mutagenicity (Ames test) Aquatic toxicity – Daphnia acute test Algae growth inhibition Biodegradation All other available data Test Package 1 – 10 t/a (Annex VII)Toxicological information

  28. Toxicity data: In vivo skin irritation * In vivo eye irritation * In vitro cytogenicity in mammalian cells and/or In vitro gene mutation in mammalian cells * Depending on Annex VII result Acute dermal or inhalation 28-day repeated dose Reproductive toxicity - Developmental screen (OECD 421 or 422) Toxicokinetic assessment Test Package 10 – 100 t/a (Annex VIII) This is in addition to Annex VII

  29. Test Package 10 – 100 t/a (Annex VIII) This is in addition to Annex VII Aquatic toxicology: • Acute toxicity with fish • Active sludge respiration inhibition test • Hydrolysis as function of pH (abiotic) • Adsorption/desorption screening study • Further degradation testing if needed

  30. Physico-chemical properties: Stability in organic solvents Dissociation constant Viscosity Toxicological Information: 90-day repeated dose Teratogenicity 2-generation study Test Package 100 – 1000 t/a (Annex IX) This in addition to Annex VII+VIII

  31. Aquatic toxicology: Long-term study on Daphnia Long-term study on fish One of the following: -Fish ELS or - Fish embryo and sac-fry stages - Fish juvenile growth Degradation: - further biotic studies - Soil or sediment simulation testing - identification of degradation products E-fate/behaviour: - fish bioconcentration - further adsorption / desorption studies Test Package 100 – 1000 t/a (Annex IX) This in addition to Annex VII+VIII

  32. Test Package 100 – 1000 t/a (Annex IX) This in addition to Annex VII+VIII Further e-fate testing: Effects on terrestrial organisms: • Acute toxicity on earthworms • Effects on soil micro-organisms • Acute toxicity to plants

  33. Test Package > 1000 t/a (Annex X) This in addition to Annex VII+VIII+IX Further toxicity testing only in agreement with authorities. Further aquatic testing only in agreement with authorities. Additional terrestrial studies: • Long-term testing on earthworms • Long-term testing on soil invertebrates • Long-term testing on plants • Long-term testing to sediment organisms (proposal) • Long-term or reproductive study on birds

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