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REACH Consequences for Downstream Industries: A Danish Perspective

sawyer-summers avatar
sawyer-summers
27 diapositives · 400 Views · Nov 13, 2014

This presentation discusses the implications of the REACH regulation on downstream companies in Denmark, focusing on the extensive documentation requirements and challenges associated with high- and low-volume substances. Key issues include substance reformulation due to regulatory changes, limited reaction times for compliance, and the effects on competitiveness and innovation in the industry. The session highlights the importance of effective communication in the supply chain while addressing the complexities of registration and authorisation processes for manufacturers and distributors.

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  1. Session 2: View by the industry REACH Consequences for the Downstream industry- a Danish perspective Helle Simon Elbro DK-REACH project group/hse consult

  2. Manufacturer DU Company DU Company DU Company DU Company DU Company DU Company External complexity 30,000 substances Nail Varnish remover Acetone Distributor Soap & Detergents Professional Application of paint Distributor

  3. Purchase of raw materials (x100) BUT Regulation is on chemical Substance level (x100) Sale of Products (x100) Internal complexity PRODUCT

  4. Amount of High Volume substancesFor a typical DU-Company Substances Approx. 40% High volume substances Approx. 70% of raw materials contains min. one high volume substance Raw material 100% of products contain min. one high volume substance Products

  5. Amount of Low Volume substancesFor a typical DU-Company Substances Approx. 10% Low volume substances Approx. 20% of raw materials contains min. one low volume substance Raw material Products Approx. 80% of products contains min. one low volume substance

  6. REACH Consequences • Extensive documentation work • Substances “disappear” →Reformulation of raw materials/products • Limited reaction time • Other issues 1. Importer role 2. DU role

  7. Manufacturer Substance Raw material Product SDS SDS SDS DU Company Supplier Registration Authorisation € € EU EU Agency Documentation acting as Importer Customer

  8. 2009 40 Collection of own and customer use 2012 Product > 35 2017 SDS SDS DU company Supplier 350 300 (75) (150) 220 (40) 2009 2012 65 (35) 2017 Documentation in DU role300 raw materials Communication of identified use Raw material Customer Check own and customer use with exposure scenario

  9. Product SDS SDS DU company Supplier 350 300 (75) (150) 350 (150) Combination of exposure Scenarios from several raw materials 270 (60) Documentation in DU-role350 products Raw material Customer 2009 2012 2017

  10. REACH Consequences • Extensive documentation work • Substances “disappear” →Reformulation of raw materials/products • Limited reaction time • Other issues

  11. Substances “disappear” EU Commission: 1-2% CEFIC 20-40% (1-100 tonnage) Commercial reasons Health & Environment reasons Mainly the “speciality chemicals (20/80 rule)

  12. Problematic Classified Defined Unknown Products contain many substances *) Defined substances either have a CAS-no or are classified

  13. Options if substances disappear • Dialogue with supplier • Establish more documentation • Together with supplier • Alone or in a consortia • Re-formulation of raw material>> Validation of product • Re-formulation of product Increasing resource and time requirements

  14. Problematic Defined Unknown Consider our options Substances may disappear - when prices are increasing Classified

  15. Problematic Defined Different use Unknown Consider our options Substances may disappear - when not registered - or not for our use No registration Classified

  16. Problematic Defined Different use Unknown Consider our options Substances may disappear - when not applied for authorisation or not for our use Not applied for authorisation Classified

  17. Problematic Defined Unknown Consider our options Substances may disappear- when classified stronger Classified

  18. “Worst case” is re-formulation! • Price increase of raw material • Substance in raw material is not registered – or not for our use • Substance in raw material does not get authorisation - or not for our use • New and stronger classification for one of the substances in a raw material And we don’t know how many and when substances/raw materials may disappear.

  19. REACH Consequences • Extensive documentation work • Substances “disappear” →Reformulation of raw materials/products • Limited reaction time • Other issues

  20. Collection of own and customer use Communication on identified use SDS SDS DU Company Supplier 350 300 (70) (150) 2009 2012 2017 Limited reaction time Repetitive work – lack of control Raw material Product Customer

  21. NEW INFORMATION 1st extended SDS (Intended use) Pre(Registration) Limited reaction time Communication in Supply chain can be complex GOODS Decision on Registration Manufacturer Supplier Supplier Distributor DU Company

  22. Time Years Validation at (industrial) customer Approval at Authorities External documentation Field evaluation Lab-testing Few days Limited reaction time if complicated re-formulation is needed New additive in functional product (wood-stain) Change of solvent based on Certificate of Analysis

  23. REACH Consequences • Extensive documentation work • Substances “disappear” →Reformulation of raw materials/products • Limited reaction time • Other issues

  24. Other issues • Loss of competitiveness. • Example: Import of ready-made articles from outside EU • Loss of innovation. • Example: No exemption for R&D on new uses in preparations (unlike PPORD on new substances) • Loss of confidentiality. • Example: Registration number on SDS

  25. REACH Consequences • Extensive documentation work • Substances “disappear” →Reformulation of raw materials/products • Limited reaction time • Other issues

  26. THE END

  27. Raw materials • To be reformulated • Or disappear Substances “disappear”  Products to be reformulated