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REACH Industry Update

REACH Industry Update. WERCS US User Group Meeting 2008. Dr. Erwin Annys Sr. Advisor Product & Innovation Policy. REACH: Polymers. WERCS User Group Meeting 2008. Dr. Erwin Annys Sr. Advisor Product & Innovation Policy. Definition.

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REACH Industry Update

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  1. REACH Industry Update WERCS US User Group Meeting 2008 Dr. Erwin Annys Sr. Advisor Product & Innovation Policy

  2. REACH: Polymers WERCS User Group Meeting 2008 Dr. Erwin Annys Sr. Advisor Product & Innovation Policy WERCS Users group 2008 Erwin Annys

  3. Definition • In accordance with REACH (Article 3(5)), a polymer is defined as a substance meeting the following criteria: • (a) Over 50 percent of the weight for that substance consists of polymer molecules (see definition below); and, • (b) The amount of polymer molecules presenting the same molecular weight must be less than 50 weight percent of the substance. WERCS Users group 2008 Erwin Annys

  4. Definition • In the context of this definition: • A "polymer molecule" is a molecule that contains a sequence of at least 3 monomer units, which are covalently bound to at least one other monomer unit or other reactant. • A "monomer unit" means the reacted form of a monomer substance in a polymer (for the identification of the monomeric unit(s) in the chemical structure of the polymer the mechanism of polymer formation may, for instance, be taken into consideration). WERCS Users group 2008 Erwin Annys

  5. Definition • A "sequence" is a continuous string of monomer units within the molecule that are covalently bonded to one another and are uninterrupted by units other than monomer units. This continuous string of monomer units can possibly follow any network within the polymer structure. • • "Other reactant" refers to a molecule that can be linked to one or more sequences of monomer units but which cannot be regarded as a monomer under the relevant reaction conditions used for the polymer formation process. WERCS Users group 2008 Erwin Annys

  6. Additives • A polymer, as any other substance defined in Article 3(1), can also contain additives necessary to preserve the stability of the polymer and impurities deriving from the manufacturing process. These stabilisers and impurities are considered to be part of the substance and do not have to be registered separately. Stabilisers include for example heat stabilisers, anti-oxidants (both useful during extrusion) and light stabilisers (e.g. for preservation during use). Impurities are unintended constituents of the polymer such as catalysts residues or unreacted monomers WERCS Users group 2008 Erwin Annys

  7. Polymers • Polysaccharides, polypeptides… polymers? • Monomers? • Polydispersity? • Examples • Inuline: yes constituted of different monomeric unities (sugars) and having a polydispersity • Enzymes: no, no polydispersity • Immunoglobulines: no, no polydispersity WERCS Users group 2008 Erwin Annys

  8. REACH: The Chemical Safety Report – a state of the art WERCS User Group Meeting 2008 Dr. Erwin Annys Sr. Advisor Product & Innovation Policy WERCS Users group 2008 Erwin Annys

  9. Chemical Safety Assesment • A chemical safety assessment consists of • Evaluation human health hazard • Evaluation physicochemical hazard impact on human health • Evaluation environmental hazard • PBT and vPvB evaluation WERCS Users group 2008 Erwin Annys

  10. Chemical Safety Assesment • If this ends up in a classification according to directive 67/548/EEG or 1999/45/EG or as PBT or vPvB • Exposure assessment • Risk characterisation WERCS Users group 2008 Erwin Annys

  11. Chemical Safety Assesment WERCS Users group 2008 Erwin Annys

  12. Use identification WERCS Users group 2008 Erwin Annys

  13. Use WERCS Users group 2008 Erwin Annys

  14. Environmental exposure assessment WERCS Users group 2008 Erwin Annys

  15. Environmental exposure assessment WERCS Users group 2008 Erwin Annys

  16. Secondary poisoning WERCS Users group 2008 Erwin Annys

  17. e-SDS WERCS Users group 2008 Erwin Annys

  18. e-SDS WERCS Users group 2008 Erwin Annys

  19. e-SDS WERCS Users group 2008 Erwin Annys

  20. REACH: Substance Identity – the most recent information WERCS User Group Meeting 2008 Dr. Erwin Annys Sr. Advisor Product & Innovation Policy WERCS Users group 2008 Erwin Annys

  21. Constituents • Individual chemical species (molecules) in a substance are called constituents • A substance consists of “constituents” • A preparation consists of “components” or “ingredients” • Constituent ≠ component or ingredient WERCS Users group 2008 Erwin Annys

  22. Types of substance • Well defined substances: • Mono-constituent substances • One main constituent ≥80% • Multi-constituent substances • Two or more main constituents between 10 - 80% • In both cases ca. 100% of the composition can be defined WERCS Users group 2008 Erwin Annys

  23. Types of substance • Poorly defined or variable substances: • Also known as UVCB-substances of Unknown or Variable composition, Complex reaction products or Biological materials • Cannot be sufficiently identified by their composition • Number of constituents is relatively large • Composition largely unknown, very variable or poorly predictable WERCS Users group 2008 Erwin Annys

  24. Mono-constituent substances Examples WERCS Users group 2008 Erwin Annys

  25. Multi-constituent substances Example WERCS Users group 2008 Erwin Annys

  26. UVCB Example • Chemical derivative of a plant extract: • Fatty acids, coco, compounds with diethanolamine • UVCB because • Complex mixture of amides formed from various fatty acids present in the coconut oil • Ratio of fatty acids can vary in the source WERCS Users group 2008 Erwin Annys

  27. UVCB Example • A refined product of a plant-derived substance: • Turpentine oil WERCS Users group 2008 Erwin Annys

  28. UVCB Example • A chemical derivative of a chemical • Reaction product of a di-carboxylic acid and amino-alcohol • UVCB because • Complicated mixture of amides and esters WERCS Users group 2008 Erwin Annys

  29. Enzymes WERCS Users group 2008 Erwin Annys

  30. REACH: The Authorisation Process WERCS User Group Meeting 2008 Dr. Erwin Annys Sr. Advisor Product & Innovation Policy WERCS Users group 2008 Erwin Annys

  31. MS or Agency makes Annex XV dossier Candidate list Inclusion in Annex XIV Applicat. authorisation Authorisation granted/not Review authorisations Authorisation WERCS Users group 2008 Erwin Annys

  32. MS or Agency makes Annex XV dossier Candidate list Inclusion in Annex XIV Applicat. authorisation Authorisation granted/not Review authorisations Authorisation RIP 4.4 RIP 4.3&4.5 RIP 3.7 WERCS Users group 2008 Erwin Annys

  33. WERCS Users group 2008 Erwin Annys

  34. Identification of SVHC WERCS Users group 2008 Erwin Annys

  35. Prioritisation WERCS Users group 2008 Erwin Annys

  36. Application for authorisation WERCS Users group 2008 Erwin Annys

  37. Thanks for your attention WERCS Users group 2008 Erwin Annys

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