1 / 12

Cefic template to convert REACH dossier into GPS Safety Summary GPS / REACH workshop 04 Oct

This workshop on 4th October in Athens, Greece will cover the conversion of REACH dossiers into GPS Safety Summaries. It will provide a template, examples, and guidance on creating these summaries.

fgonzales
Download Presentation

Cefic template to convert REACH dossier into GPS Safety Summary GPS / REACH workshop 04 Oct

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Cefic template to convert REACH dossier into GPS Safety Summary GPS / REACH workshop 04 Oct Athens, Greece By: L. Heezen

  2. Content Introduction Conversion template Examples Cefic sponsored pilot

  3. GPS Safety Summary • GPS Safety Summary – Generic Template • The summary should be fairly basic and understood by a layman • In EU the content can be based on REACH registration dossier • The content is no fixed format. It is up to companies to decide what is in it. • Conversion template can be used for referencing • SIEF / Consortium could be asked to draft main body GPS Safety Summary. Member companies can complete with own information.

  4. Cefic template

  5. Template • Substance name • Company to decide: brand name, popular well known name, IUPAC name etc • General Statement Optional for companies to complete High level description of substance use and application, its hazards and recommendations on safe use • Sourced: M&S department, product manager, product steward • Chemical identity • Identifiers like CAS#, Einecs, IUPAC etc • Source IUCLID section 1, CSR part B (1)

  6. Template • Uses and Applications • Product uses, consistent with REACH dossier.. Focus on benefits for consumers and society. Address consumer use, even if no consumer use. Indicate sector of use or article category • Source: CSR part B (2) and (9), IUCLID section 3.5 • Physical/chemical propertiesGeneral info on state, odor, appearance, melting point etc. • Focus on properties affecting exposure and environmental health. • Source: IUCLID section 4, CSR part B (1), eSDS section 9 • Health EffectsHigh level statement on safe use for consumers and workers. • Summarize conclusions on health effects based on the toxicity testing results or structural activity relationship based findings. List result of key studies important for conclusion. • Source; IUCLID section 7, CSR 5,6 and 10, section 4 exposure scenario

  7. Template • Environmental EffectsHigh level statement on environmental effects. • Summarize conclusions on environmental effects e.g. aquatic and/or terrestrial toxicity, environmental fate, biodegradation. List result of key studies important for conclusion. • Source: IUCLID section 5 and 6, CSR chapters 4,7,8 and 10, scetion 4 of ES • ExposureExposure potential. Describe nature and level (expected concentration) of industrial, consumer and environmental use and describe practices that limit exposure • Source: section 1 of ES, Chapter 9 of CSR

  8. Template • Risk Management RecommendationsDescribe practices for use and exposure at workplace, consumer and the environment. Exposure and Risk Management Recommendations can be combined into a “Potential Exposures” section with subheadings for Workers, Consumers, and Environment. • Add generic text on normal hygiene measures, and environmental recommendations. • Source: Section 2 of ES, Chapters 9 and 10 CSR, • State Agency ReviewList whether the chemical has been or is currently under review by a regulatory agency . REACH, OECD, ICCA portal etc • Source: OECD portal, ICCA portal, internet • Regulatory information / Classification and labelling • Classification as notified, H-statements consistent to CSR • Source: CSR section B, chapter 3, eSDS section 2

  9. Template • Conclusion • Company own text • Contact Information within company • Functional e-mail address • Reference to ICCA IT portal • Glossary • Explanationterms used in the summary • Date of issue • Additional information • Disclaimer • Company is responsible for content. Standard disclaimer

  10. Examples DSM Rhodia DOW http://www.cefic.org/Industry-support/Implementing-reach/Documents-and-Tools1/

  11. Cefic sponsored pilot Cefic initiated example summary project with NA In total 15 summaries under preparation Specific chemicals provided by NA Commodity chemical that can be used by all registrants Can be used for translation in national language Available Q4 2011

  12. ICCA website: • www.icca-chem.org • ICCA GPS Guidance on Risk Assessment: • http://asp.zone-secure.net/v2/index.jsp?id=598/765/8216&lng=en • ICCA IT portal • http://www.icca-chem.org/en/Home/ICCA-initiatives/global-product-strategy/chemical-information-search/ • Cefic website: • http://www.cefic.eu/ Thank you lhe@cefic.be

More Related