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REACH - set fra et downstream perspektiv

REACH - set fra et downstream perspektiv. Begrænsning og Godkendelse. MANUFACTURER/ IMPORTER. DOWNSTREAM USER. Chemical Safety Assessment (CSA)  Chemical Safety Report (CSR). Identified use. Conditions for safe use. Exposure scenario. Exposure assessment. SDS. Supply chain.

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REACH - set fra et downstream perspektiv

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  1. REACH- set fra et downstream perspektiv Begrænsning og Godkendelse

  2. MANUFACTURER/ IMPORTER DOWNSTREAM USER Chemical Safety Assessment (CSA)  Chemical Safety Report (CSR) Identified use Conditions for safe use Exposure scenario Exposure assessment SDS Supply chain Risk characterisation Extended SDS REACH keywords Authorisation Registration Evaluation Restriction Inventory

  3. POP POOL 76/769/EEC Annex XVI Annex XVII Annex XIII Formal process International agreement Formal process Substance is banned / restricted Substance is approved for a specific use Restrictions and AuthorisationsLimiting the use of specific substances Restriction Authorisation

  4. CMR 1+2 AuthorisationPool of substances – predefined criterias CMR CarcinogeneMutagene Reproduktionstoksiske PBT/vPvB Persistente BioakkumulerendeToksiske Endocrine Disruptors = Hormonforstyrrende stoffer

  5. POOL CMR 1-2 Direct Authorisation Substance A Applicant 1 Specific use A Specific use B Specific use C Authorisation Substance A Applicant 2 Specific use B Substance Application date Sunset date PBT / vPvB Endocrine Dis. Formal process Substance A XX.XX.XX XX.XX.XX Independent of tonnage Phase 2: Application for authorisation for specific use Phase 1: Inclusion of Substance on Annex XIII. Authorisation Annex XIII – a “living” list Annex XIII Substance B XX.XX.XX XX.XX.XX Substance C XX.XX.XX XX.XX.XX Substance D XX.XX.XX XX.XX.XX • “Annex XIII date” ? • Criterias for prioritisation: • -PBT,vPvB • Wide dispersive use • High volume • Dependent on • Agency capacity

  6. Articles Professionel Preparations Importer Substances • APPLICATION FOR AUTHORISATION • Identity of substance • Name and contact details of the person • Request of authorisation, specifying use • Chemical Safety Report • May include: • Socio-economic analysis • Analysis of the alternatives,incl. substitution plan EU “Annex XIII date” Application date Minimum 18 months ? ? Authorisation Generel process Authorisation is needed before use Normal use Time Sunset date

  7. Details of authorisation SDS (1-16) SDS (1-16) DS or or Annex Un-classifed substance Authorisation Communication downstream Substance on Annex XIII Contains substance from Annex XIII (above concentration limit) Substance Rawmaterial Product Professionel

  8. Has specific use been authorised? Production Application for Authorisation Mixer No Mixer Rawmaterials No Agency Notification Yes Application of Product Yes MS Database No Action No further Action Action Authorisation Actions by “formulators” downstream PBT/vPvB Endocrine dis. CMR 1+2 - Reformulation possible? or - Should product be cancelled? Classification limit 0,1 wt %

  9. Authorisationareas where it is not applicable • Substances used for PPORD < 1ton/year(Product and Process Oriented Research and Development) • On-site isolated or transported isolated intermediate Covered by independent legislation: • Waste material • Biocidal products • Other areas not relevant for our sector, eg.: • Medical products • Pesticide products • Food additives

  10. THE END of this part

  11. RestrictionInclusion of substances on Annex XVI Time EU COM AGENCY WWW Dossier NGO 0 MS 30 days 3rd parties + 30 days Draft Decision WWW Draft Decision + 12 m (or 15 m) SEA RA MS EU COM + 3 m Final Decision Total estimated time approx. 15 - 18 months XVI

  12. Authorisation Inclusion of substances on Annex XIII Time EU COM AGENCY Dossier MS 0 WWW Dossier MS NGO + 30 days 90 days 3rd parties + 90 days Draft Decision MS EU COM + 3 m’s Final Decision Total estimated time approx. 15 - 18 months XIII Title VII: Article 54-56

  13. Importer EU Authorisation - granting WWW Time Application Applicant(s) AGENCY NGO 0 X days 3rd parties Opinion + 10 m (or 5 m) Substances Draft Decision Preparations WWW + 2 m Article Draft Decision + 2m SEA RA MS EU COM + 3m Final Decision Total estimated time approx. 18 months WWW Title VII: Article 61

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