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 Registration Evaluation Authorisation and restriction of Chemical substances

3. 3WERCS Users group 2008 Erwin Annys REACH Registration Evaluation Authorisation Restriction Classification index Sharing data Info in supply chain Down stream use Responsibility industry Agency

4. 4WERCS Users group 2008 Erwin Annys > 1 ton Registration 0 1 2 3 4 5 6 7 8 9 10 11 >100 ton 01/06/07 01/12/10 01/06/13 01/06/18 01/06/08 01/12/08 >1000 ton CMR >1 ton N, R50-53 > 100 ton Pre-registration Non phase-in substances

5. 5WERCS Users group 2008 Erwin Annys Possibilities for pre-registration on-line, created in REACH-IT single upload, created in IUCLID or other application bulk upload, created in IUCLID or other application a substance listed in the EC inventory or a multi-constituent substance of which all constituents are listed in the EC inventory xxx a substance not listed in the EC inventory or a multi-constituent substance of which one or more constituents are not listed the in EC inventory xx- as a newcomer, after 1 December 2008 xx-

6. 6WERCS Users group 2008 Erwin Annys Note About the screenshots shown: Text and help text is not finalised yet Look and feel is not finalised yet

7. 7WERCS Users group 2008 Erwin Annys Pre-registering on-line using REACH-IT before pre-registering you need to have created an account in REACH-IT for your company you need to be logged in you need to have the information on the substance you want to pre- register at hand select “pre-register a phase-in substance” in the functional menu

8. 8WERCS Users group 2008 Erwin Annys Pre-registering on-line using REACH-IT steps (are implemented as different tabs) 1.identification:mandatory 2.similar substances:optional 3.tonnage:mandatory 4.contact:optional 5.representative:optional 6.remarks:optional 7.validation:mandatory typically takes 2 – 40 minutes to go through all steps

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

31. 31WERCS Users group 2008 Erwin Annys The most simple situation M1 outside EU inside EU ImporterEU DU 2 The importer registers the substance A EU DU 1 EU DU 3 Substance A

32. 32WERCS Users group 2008 Erwin Annys Import from different suppliers M1 outside EU inside EU ImporterEU DU 2 The importer registers the substance A for the combined tonnages EU DU 1 EU DU 3 I keeps control and can import from every other M M2 M3 Substance A

33. 33WERCS Users group 2008 Erwin Annys Import by different importers M outside EU inside EU Importer 1EU DU 2 EU DU 1 EU DU 3 No registration costs for M but every new EU client has to do a registration Both importers have to register according to their tonnage Importer 2 Substance A

34. 34WERCS Users group 2008 Erwin Annys Import from a formulator M1 outside EU inside EU ImporterEU DU 2 The importer registers the substances A, B and C for their tonnage in the formulation EU DU 1 EU DU 3 I needs to know the composition before he can register! M2 M3 Substance A Substance B Substance C F

35. 35WERCS Users group 2008 Erwin Annys Solution The only representative (OR) Article 8 Only representative of a non-Community manufacturer 1. A natural or legal person established outside the Community who manufactures a substance on its own, in preparations or in articles, formulates a preparation or produces an article that is imported into the Community may by mutual agreement appoint a natural or legal person established in the Community to fulfil, as his only representative, the obligations on importers under this Title.

36. 36WERCS Users group 2008 Erwin Annys Solution 2. The representative shall also comply with all other obligations of importers under this Regulation. To this end, he shall have a sufficient background in the practical handling of substances and the information related to them and, without prejudice to Article 36, shall keep available and up-to-date information on quantities imported and customers sold to, as well as information on the supply of the latest update of the safety data sheet referred to in Article 31. 3. If a representative is appointed in accordance with paragraphs 1 and 2, the non-Community manufacturer shall inform the importer(s) within the same supply chain of the appointment. These importers shall be regarded as downstream users for the purposes of this Regulation.

37. 37WERCS Users group 2008 Erwin Annys Only Representative M outside EU inside EU (Importer) DU 1EU DU 2 OR : OR takes over the registration obligation from the importer who becomes a DU EU DU 1 EU DU 3 OR Costs are for M, but with one registration he can cover the whole EU market I/DU is dependent from the M and can’t buy from another unless this is covered by another registration (Importer) DU 2

38. 38WERCS Users group 2008 Erwin Annys Import from a formulator M1 outside EU inside EU (Importer) DUEU DU 2 The OR registers the substances A, B and C for their tonnage in the formulation EU DU 1 EU DU 3 I becomes DU and doesn’t have to register so he doesn’t need to know the exact composition M2 M3 Substance A Substance B Substance C F OR

39. 39WERCS Users group 2008 Erwin Annys Import from different suppliers M1 outside EU inside EU (Importer) DUEU DU 2 Each OR registers substance A for the tonnage of its M EU DU 1 EU DU 3 M2 M3 Substance A OR1 OR2 OR3 I can not buy A from M4 unless this is covered by a registration

40. 40WERCS Users group 2008 Erwin Annys Import from different suppliers M1 outside EU inside EU (Importer) DUEU DU 2 OR can represent more than one M but he has to do a registration for each of them according to their tonnage and pay a fee for each of them EU DU 1 EU DU 3 M2 M3 Substance A OR I can not buy A from M4 unless this is covered by a registration

41. 41WERCS Users group 2008 Erwin Annys Example from the guidance Outside EUinside EU Non-EU Manufacturer 1 Non-EU Manufacturer 3 Non-EU Manufacturer 2 Non-EU Distributor Role and Registration Obligations Importer 1 - Registers 3 tonnes - is a DU of the OR for the remaining 5 tonnes OR -Registers the tonnage exported by the not-EU manufacturer 2 and 3, i.e. 16 tonnes of substances The registration dossier should be made for 10-100 tonnes, including a CSR. - OR does two registrations, each for 1 – 10 tonnes Importer 2 -Does not need to register - Is a DU of the OR Importer 3 -Does not neetd to register -Is a DU of the OR Importer 1 Importer 2 Importer 3 Only Representative DU of 3 tonnes 5 tonnes 3 tonnes Appoint as OR

42. 42WERCS Users group 2008 Erwin Annys > 1 ton Don’t forget the timing 0 1 2 3 4 5 6 7 8 9 10 11 >100 ton 01/06/07 01/12/10 01/06/13 01/06/18 01/06/08 01/12/08 >1000 ton CMR >1 ton N, R50-53 > 100 ton Pre-registration Non phase-in substances

43. 43WERCS Users group 2008 Erwin Annys What to register?

44. 44WERCS Users group 2008 Erwin Annys REACH: The review of Annexes IV and V WERCS User Group Meeting 2008 Dr. Erwin Annys Sr. Advisor Product & Innovation Policy

45. 45WERCS Users group 2008 Erwin Annys Review of Annex IV

46. 46WERCS Users group 2008 Erwin Annys Surprise

47. 47WERCS Users group 2008 Erwin Annys Annex IV Noble gases The addition of the following substances from Annex V: –Helium He –Neon Ne –Xenon Xe The addition of another noble gas: Krypton Kr The Commission services are of the opinion that the noble gases fulfil the criteria for inclusion into Annex IV. Moreover, the existing annex already included one noble gas (Argon) and Annex V included 3 other noble gases (Helium, Neon, Xenon). For consistency reasons, it therefore seems appropriate to re-group all noble gases in Annex IV and to delete the corresponding entries in Annex V.

48. 48WERCS Users group 2008 Erwin Annys Annex IV (2) Sugars The addition of the following sugars that the Commission has accepted are of minimum risk: Fructose Galactose Lactose The Commission services consider that these three substances fulfil the criteria for inclusion into Annex IV.

49. 49WERCS Users group 2008 Erwin Annys Annex IV (3) Carbon and graphite The deletion of the following substances based on the analysis of the contractor: Graphite Carbon The concerned EINECS entries have in the past been used to identify nanoforms of carbon or graphite. For these nanoforms insufficient information is available to conclude that they present minimum risk because of their intrinsic properties. As Annex IV does not distinguish between different forms of one substance, carbon and graphite should be deleted and registration should be required for these substances.

50. 50WERCS Users group 2008 Erwin Annys Annex IV (5) Oils, fats, waxes, fatty acids and their salts The deletion of all the current vegetable oils’ entries, as the Commission is proposing a generic entry in Annex V to cover all vegetable oils: … The deletion of the all the current fatty acids’ entries, as the Commission is proposing a generic entry in Annex V to cover a number of these substances: …

51. 51WERCS Users group 2008 Erwin Annys Annex IV (4) Vitamin A The deletion of the following substance based on the analysis of the contractor: Vitamin A Deletion is proposed because Vitamin A may exhibit significant risks on the basis of its intrinsic properties (e.g. reproductive toxicity).

52. 52WERCS Users group 2008 Erwin Annys Annex V 1.Substances which result from a chemical reaction that occurs incidental to exposure of another substance or article to environmental factors such as air, moisture, microbial organisms or sunlight. 2. Substances which result from a chemical reaction that occurs incidental to storage of another substance, preparation or article. 3. Substances which result from a chemical reaction occurring upon end use of other substances, preparations or articles and which are not themselves manufactured, imported or placed on the market.

53. 53WERCS Users group 2008 Erwin Annys Proposal new guidance Examples of substances covered by this entry are the products produced from the use of adhesives and paints, combustion products of petrol during the use of cars, and the reaction products of bleaching agents during washing of textiles. This also covers substances present as ionic mixtures resulting from mixing salts, acids and bases. However, the toxicological and ecotoxicological properties of salts are determined by the properties of their acidic and alkaline constituents. In so far, registration would be inappropriate for substances produced in a solution through mixing acids, bases or salts, provided that all acids, bases and salts introduced into the mixture have already been registered by an actor up the supply chain and none of the produced substances is isolated from the mixture.

54. 54WERCS Users group 2008 Erwin Annys Annex V 4. Substances which are not themselves manufactured, imported or placed on the market and which result from a chemical reaction that occurs when: (a) a stabiliser, colorant, flavouring agent, antioxidant, filler, solvent, carrier, surfactant, plasticiser, corrosion inhibitor, antifoamer or defoamer, dispersant, precipitation inhibitor, desiccant, binder, emulsifier, de-emulsifier, dewatering agent, agglomerating agent, adhesion promoter, flow modifier, pH neutraliser, sequesterant, coagulant, flocculant, fire retardant, lubricant, chelating agent, or quality control reagent functions as intended; or (b) a substance solely intended to provide a specific physicochemical characteristic functions as intended.

55. 55WERCS Users group 2008 Erwin Annys Annex V 5. By-products, unless they are imported or placed on the market themselves 6. Hydrates of a substance or hydrated ions, formed by association of a substance with water, provided that the substance has been registered by the manufacturer or importer using this exemption. 7. The following substances which occur in nature, if they are not chemically modified: Minerals, ores, ore concentrates, raw and processed natural gas, crude oil, coal. 8. Substances which occur in nature other than those listed under paragraph 7, if they are not chemically modified, unless they meet the criteria for classification as dangerous according to Directive 67/548/EEC or PBT, vPvB or equivalent concern

56. 56WERCS Users group 2008 Erwin Annys Annex V 9. The following substances obtained from natural sources, if they are not chemically modified, unless they meet the criteria for classification as dangerous according to Directive 67/548/EEC or PB, vPvB or equivalent concern, with the exception of those only classified as flammable [R10], as a skin irritant [R38] or as an eye irritant [R36]: Vegetable fats, vegetable oils, vegetable waxes; animal fats, animal oils, animal waxes; fatty acids from C6 to C24 and their potassium, sodium, calcium and magnesium salts. Glycerol 10.The following substances if they are not chemically modified: Liquefied petroleum gas, natural gas condensate, process gases and components thereof, coke, cement clinker, magnesia.

57. 57WERCS Users group 2008 Erwin Annys Annex V 11. The following substances unless they meet the criteria for classification as dangerous according to Directive 67/548/EEC or PBT,vPvB or equivalent concern and provided that they do not contain constituents meeting the criteria as dangerous in accordance with Directive 67/548/EEC present in concentrations above the lowest of the applicable concentration limits set out in Directive 1999/45/EC or concentration limit set out in Annex I to Directive 67/548/EEC, unless conclusive scientific experimental data show that these constituents are not available throughout the life-cycle of the substance and those data have been ascertained to be adequate and reliable: Glass, ceramic frits

58. 58WERCS Users group 2008 Erwin Annys Annex V 12.Compost, biogas 13.Hydrogen and oxygen.

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