SME Issues. webinar, 02 July 2013, 2pm BST

Transcription

1 SME Issues webinar, 02 July 2013, 2pm BST

2 Today s webinar aims Learn practical ways to ensure SMEs can meet REACH deadlines; Hear first hand from an SME with experience of REACH compliance both as a manufacturer and distributor; Hear more from ECHA's Director of Cooperation on what training, support and guidance the agency offers.

3 Q&A session If you have any unanswered questions please submit them to the Chemical Watch Forum, after the webinar.

4 Speakers John Mugford, Regulatory Affairs manager, Whyte Group; Paul Thomas, Senior Ecotoxicologist, CEHTRA; Charles Alarcon, Senior Industrial Hygenist, CEHTRA; Andreas Herdina, Director of Co-operation, ECHA; Chair: Mamta Patel, Editorial Director, Chemical Watch

5 REACH so far and the road ahead; a SME s view

6 Whyte Group Although Whyte Group as a Whole does not meet the criteria for an SME its individual companies do. Whyte Chemicals Ltd. Whyte Chemicals have exclusive distribution distribution agreements with major Asian and transatlantic manufacturers ensuring our supply is always secure. Whyte Chemicals SARL Grosvenor Chemicals Ltd. Prime Formulations Ltd.

7 The Regulatory Affairs Department Only exists at Whyte Chemicals Ltd Just two people involved in Reach functions Ensure compliance for all companies within the group. REACH only forms part of their work Whyte Chemicals have exclusive distribution distribution agreements with major Asian and transatlantic manufacturers ensuring our supply is always secure. Most SME s will not have this level of cover. Problems for Importers.

8 Access to Consultants Limited by volume/margin Availability of competent consultants. Whyte Chemicals have exclusive distribution distribution agreements with major Asian and transatlantic manufacturers ensuring our supply is always secure.

9 SIEF Participation Pre-registration Invitation to join the SIEF overload. Downstream Users Whyte Chemicals have exclusive distribution distribution agreements with major Asian and transatlantic manufacturers ensuring our supply is always secure.

10 Documentation Safety Data Sheets CLP Notifications Exposure Scenarios IUCLID Whyte Chemicals have exclusive distribution distribution agreements with major Asian and transatlantic manufacturers ensuring our supply is always secure.

11 Downstream Users Uses Transportable Isolated intermediates. Whyte Chemicals have exclusive distribution distribution agreements with major Asian and transatlantic manufacturers ensuring our supply is always secure.

12 Keeping On Top Non EU Suppliers Only Representatives European Suppliers Lead Registrants Whyte Chemicals have exclusive distribution distribution agreements with major Asian and transatlantic manufacturers ensuring our supply Polymers is always secure. Monomers in

13 Costs Reduction in registration fees High cost of Letters of Access. Stage Payments Whyte Chemicals have exclusive distribution distribution agreements with major Asian and transatlantic manufacturers ensuring our supply is always secure. Are the costs fair Anti-Competition External Authority

14 Issues outside of the SMEs Control Late registration ECHA unwilling to be involved Whyte Chemicals have exclusive distribution distribution agreements with major Asian and transatlantic manufacturers ensuring our supply is always secure.

15 2018 Lead Registrant unavailable SME Picking up the role No learned or developed competencies Mixtures & Impurities Whyte Chemicals have exclusive distribution distribution agreements with major Asian and transatlantic manufacturers ensuring our supply is always secure. Reduction of product lines The prospect of closure

16 Conclusion Personal Perspective Other SMEs Just scratching the surface. Whyte Chemicals have exclusive distribution distribution agreements with major Asian and transatlantic manufacturers ensuring our supply is always secure.

17 Questions will be taken at the end of the Webinar Whyte Chemicals have exclusive distribution distribution agreements with major Asian and transatlantic manufacturers ensuring our supply is always secure.

18 Consultancy for Environmental and Human Toxicology and Risk Assessment Science Beyond Regulatory Compliance 2018: the Challenge for SMEs 28 June

19 Brief overview Paul Thomas Costs of REACH dossiers Techniques to reduce cost Charles Alarcon Practical problems in getting on site compliance Ways to achive compliance

20 REACH 2018 dossier cost Total cost for a REACH dossier: 320 K Annexes VII et VIII ( TPA) 75 K Annex VII (1-10 TPA) Registration cost corresponds to: Studies: >80% of the total price Technical dossier: RS and compilation of study results & risk assessment Submission costs at ECHA (depends on tonnage and SME status) Replacing studies using alternative techniques will dramatically reduce your overall costs 3

21 Alternative techniques to reduce Several options available: studies Column 2 waivers under the REACH regulation e.g. hydrolysis: no need if readily biodegradable Beware red herrings! e.g. fish no need if substance is highly insoluble Other waivers Read-across from other similar structures (if proven) Category approaches (for entire groups of chemicals) Weight of Evidence approaches (based on scientific judgement) Alternatives to in vivo experiments 4

22 Alternatives to in vivo experiments Animal replacement using in vitro methods ECHA put considerable emphasis on use of 3 Rs to replace in vivo studies on vertebrate animals Advantage: new methods accepted by ECVAM to reduce number of animals used: Skin corrosivity: OCDE 430, 431, 435 Skin irritation: OCDE 439 Eye irritation: OCDE 437, 438 Dermal absorption: OCDE 428 Mutagenicity /genotoxicity: OCDE 471, 473, 476, 479, 480, etc. Others in the pipeline (e.g. fish embryo or cell lines; sensitisation) Disadvantage: often these in vitro methods are more expensive than the in vivo studies they replace 5

23 Alternatives to in vivo experiments Experimental replacement using in Silico methods Quantitative Structure Activity Relationships ((Q)SARs). Different types available: SAR based structural alerts may be used to support read across or Weight of evidence approach (e.g. Derek; OECD Toolbox) QSARs a mathematical model relating structural parameters to a property of interest (provides an endpoint value) (Q)SARs) are low cost and much quicker to perform than laboratory studies A quality QSAR costs less than 1/5 th the price of a lab study 6

24 Issues with existing QSAR tools Quality of training set is essential For many QSARs huge disagreement between: Predicted values Experimental and predicted values Example: LogKow experimental and predictions for Myrcene Beta (CAS: ) Impacts potential C&L and RA of substances Which is right? KOWWIN Exp. Database Exp value KOWWIN pred. MOLINSPIRATION ALogPS SPARC MLogP isaferat

25 Methods for determining validity Initial data quality (training set) Test set Follows OECD 5 principals Defined endpoint, Unambiguous algorithm, Clear applicability domain, Goodness of fit, Mechanistic interpretation QMRF & QPRF Poor experimental fit R² = Figure 4: isaferat QSAR for Alkane + alcohol vapour pressure (log Pa 25 C) 8

26 Conclusion REACH registration can be expensive even for low tonnage bands Most cost is due to laboratory studies Some ways to reduce the number of studies have been explored greatly reducing the cost of REACH dossier production (>50%) 9

27 REACH and SMEs REACH Exposure Scenarios are documents containing a high level of technical information. Not easy for SMEs to understand their REACH obligations. Major difficulties finding appropriate methods to archive and ensure traceability of actions. 10

28 REACH and SMEs SMEs will need technical support to achieve ES compliance (for both 2018 registrations and DU esds compliance) Technical support: Internal support, from internal employees EHS not easy, need for training, internal employees often not available for this compliance work. External support, from consultants fundamental for the consultant to have concrete experience from past cases. 11

29 Practical case with SMEs esds compliance on site (1 production site, 80 employees) 12

30 Practical case with SMEs Example of training plan: 1 d Training HSE team Overview of terminology in esds Understanding of model inputs Practical case with relevant esds 1 d Activity process mapping and risk assessment in the plant 0,5 d on-site check list compliance with OC and RMM from esds supplier. 13

31 Practical case with SMEs Conclusion: Immediate gain: SME responsibility covered Optimization of technical cost with best risk management measures on plant Achieved within a limited time frame and known budget 14

32 Two day low cost SME colloquium Colloquium at the Royal Society in London to be planned: Practical hands-on workshops covering SME issues in-depth proposed in Q (<300 per attendee) «1 minute» survey to be sent round after the Webinar 15

33 Science Beyond Regulatory Compliance Thank you for your attention For more info contact : Paul.Thomas@cehtra.fr Bordeaux Lyon Paris Nottingham Brussels Toronto New Delhi Trivandrum

34 ECHA paying attention to SMEs Chemical Watch SME webinar 2 July 2013 Andreas Herdina Director of Cooperation ECHA SME Ambassador European Chemicals Agency

35 REACH Review SME Annex General Report on REACH of 5 February 2013 SME Annex with eight recommendations ECHA is following up on the recommendations, but is not a sole player on any of them Cooperative effort needed with Commission, (sectoral) industry associations and national helpdesks/mscas Implementation of REACH depends also on SMEs adequately fulfilling their obligations ECHA can provide assistance to SMEs / advisors 2

36 SMEs who are they? More inexperienced registrants (SMEs, near SMEs ) expected for 2018 registration deadline; assumptions on numbers still open; only partly manufacturers, also importers/ors SMEs not only registrants; mainly DUs with obligations to communicate in the supply chain Country-specific differences Large variety: medium to micro Many SMEs still unaware of REACH duties 3

37 SMEs (2013 REACH registration) Company size % Registered by a large company 80% Registered by an SME (based on the numbers of dossiers) * 20% Medium company 11% Small company 6% Micro company 3% * The number of SMEs based on the company sizes was 35%; there were 575 SME newcomers (of which 81 LRs) 4

38 SMEs (2010 REACH registration) Company size % Registered by a large company 87 % Registered by an SME (based on the numbers of dossiers) 13 % Medium company 8 % Small company 4 % Micro company 1 % 5

39 SME verification statistics (ECHA verified all claimants) % of the companies that had registered as SMEs were not able to demonstrate their eligibility for the claimed fee reductions (76% not SMEs at all) % of the companies were unable to demonstrate their eligibility for the claimed fee reductions (58% not SMEs at all) 6

40 ECHA s ongoing benefits for SMEs Training of national helpdesks (through HelpNet) Frontline public actors supporting SMEs Supportive services for duty holders ECHA Helpdesk User manuals for ECHA s IT tools in all official EU languages, IUCLID pop-ups ECHA-term, Chesar link to Escom Webinars, video tutorials Simplification for DUs ENES (clarifying, exemplifying and standardising ES) 7

41 Initiatives ahead Reviewing SME needs for 2018 Questionnaire to SMEs having registered 2013 Costs for preparing registration dossiers Recommendations on cost and data sharing (LoA) together with Commission and industry associations Making Guidance more user-friendly More guidance in a nutshell, simpler language Accessibility via re-designed guidance / Q&A webpages Clarify reduced info requirements (Annexes III / VI) Revised SME pages on ECHA website Explore simplification of IT-tools 8

42 Further help to be explored Training, certification of consultants Funding from EU financial institutions to overcome liquidity problems linked to REACH Loans, instalments Validation on demand of consistency of industry associations sector-specific guidance with REACH and ECHA Guidance An open ear for creative suggestions (feedback from associations and individual SMEs helpful) 9

43 Communication with SMEs Cooperation of ECHA with partners Access to heterogeneous SME groups needs platforms provided by stakeholders at sector and national levels Reaching the unreachables means to address those who think that REACH does not apply to them Innovative communication tools and media platforms SMEs to subscribe to ECHA Newsletter (currently ~16000 subscribers) and e-news ECHA seeks orientation by analysing feedback from national helpdesks, enforcement authorities, SME associations and registrants 10

44 Solidarity between industry actors? Is industry willing to provide rebates on LoA for SMEs as ECHA is doing for its fees? Can LoA be charged on a tonnage basis? Is industry ready to intervene to stop certain abusive practices of consortia leaders? Is industry willing to provide rebates on their IT platforms for SMEs when creating new SIEFs? Is industry willing to apply systems of parenting REACH coordinators of SMEs by large companies? 11

45 Final remarks: - No change to REACH by 2018; SMEs have duties - Can industry self-regulate its own problems? - Should DCG recommend solutions? - What further support should ECHA provide? - Who can be our partners? andreas.herdina@echa.europa.eu

46 Q&A session If you have any unanswered questions please submit them to the Chemical Watch Forum, after the webinar.

47 Thank you for attending A downloadable recording of this presentation (with slides) will be available shortly. If you have any questions, please contact Lorna (lorna@chemicalwatch.com) NEXT New Chemicals Regulations in Malaysia - 18 July

48 WE WILL RESUME SHORTLY Thank-you for your patience