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

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

3. 3WERCS Users group 2008 Erwin Annys 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.

4. 4WERCS Users group 2008 Erwin Annys 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).

5. 5WERCS Users group 2008 Erwin Annys 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.

6. 6WERCS Users group 2008 Erwin Annys 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

7. 7WERCS Users group 2008 Erwin Annys 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

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

9. 9WERCS Users group 2008 Erwin Annys 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

10. 10WERCS Users group 2008 Erwin Annys 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

11. 11WERCS Users group 2008 Erwin Annys Chemical Safety Assesment

12. 12WERCS Users group 2008 Erwin Annys Use identification

13. 13WERCS Users group 2008 Erwin Annys Use

14. 14WERCS Users group 2008 Erwin Annys Environmental exposure assessment

15. 15WERCS Users group 2008 Erwin Annys Environmental exposure assessment

16. 16WERCS Users group 2008 Erwin Annys Secondary poisoning

17. 17WERCS Users group 2008 Erwin Annys e-SDS

18. 18WERCS Users group 2008 Erwin Annys e-SDS

19. 19WERCS Users group 2008 Erwin Annys e-SDS

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

21. 21WERCS Users group 2008 Erwin Annys 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

22. 22WERCS Users group 2008 Erwin Annys 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

23. 23WERCS Users group 2008 Erwin Annys 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

24. 24WERCS Users group 2008 Erwin Annys Mono-constituent substances Main Constituent%Impurity%Name m-xylene91o-xylene5m-xylene o-xylene87m-xylene10o-xylene Examples

25. 25WERCS Users group 2008 Erwin Annys Multi-constituent substances Main Constituents%Impurity%Name m-xylene o-xylene 50 45 p-xylene5Mixture of: m-xylene and o-xylene Example

26. 26WERCS Users group 2008 Erwin Annys 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 EC 263-153-4CAS 61790-63-4Condensation products of coco fatty acids and diethanolamine

27. 27WERCS Users group 2008 Erwin Annys UVCB Example A refined product of a plant-derived substance: Turpentine oil EC: 232-350-7CAS: 8006-64-2 Any of the volatile predominately terpenic fractions or distillates resulting from the solvent extraction of; gum collection from, or pulping of softwoods. Composed primarily of the C10H16 terpene hydrocarbons: alpha-pinene, beta- pinene, limonene, 3-carene, camphene. May contain other acyclic, monocyclic or bicyclic terpenenes, oxygenated terpenes and anethole. Exact composition varies with refining methods and the age, location and species of the softwood source

28. 28WERCS Users group 2008 Erwin Annys 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 EC 294-006-2CAS: 91672-02-5Reaction products of nonanedioicacid and 2-amino-2- methyl-1-propanol

29. 29WERCS Users group 2008 Erwin Annys Enzymes

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

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

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

33. 33WERCS Users group 2008 Erwin Annys

34. 34WERCS Users group 2008 Erwin Annys Identification of SVHC

35. 35WERCS Users group 2008 Erwin Annys Prioritisation

36. 36WERCS Users group 2008 Erwin Annys Application for authorisation

37. 37WERCS Users group 2008 Erwin Annys