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2nd Workshop on the Study supporting the Evaluation of the FCM legislation Thon Hotel EU, Brussels Monday 9 September 2019 1 WIFI Network Thon Hotels No password 2 Agenda Introduction Objectives and format Presentation


  1. 2nd Workshop on the Study supporting the Evaluation of the FCM legislation Thon Hotel EU, Brussels Monday 9 September 2019 1

  2. WIFI Network – Thon Hotels No password 2

  3. Agenda • Introduction • Objectives and format • Presentation approach and consultation strategy • Discussion on preliminary findings • Session 1 – Effectiveness • Session 2 – Efficiency • Session 3 – Relevance and Coherence • Session 4 – EU added value + concluding comments • Final remarks 3

  4. Agenda 11h00 – 11h30: Tea and coffee break 12h30 to 13h30: Lunch buffet 15h00 – 15h30: Tea and coffee break 17h30: End 4

  5. ..Where are we? 1 st workshop 2 nd workshop Data Structuring Analysis Reporting collection 5

  6. ..Why are we here? 1 st workshop 2 nd workshop Data Structuring Analysis Reporting collection 6

  7. Objectives and format 1) Objectives: collect feedback and further evidence • During the workshop • Also written contributions until 16 September 2) Format • 4 sessions • 3 steps per session  Presentation  Table discussion  Reporting 7

  8. Table discussions and reporting Table discussion • Different findings discussed per table • 1 rapporteur per table • Rapporteurs complete the feedback document Reporting • All feedback documents will be collected • Session 1 to 3: some rapporteurs speak • Session 4: all rapporteurs speak • Maximum 3 minutes per table 8

  9. Feedback documents Feedback Document – Session number Table number Evaluation Comments and supporting evidence question & key finding number 9

  10. EQ 7 (relevance) on evolving science and innovation 1. Regulation (EC) 1935/2004 does not provide sufficient flexibility when it comes to considering new scientific knowledge and technological developments 2. There is no mechanism in place to prioritise the handling of certain substances of health concern 3. It is unclear to what extent Regulation (EC) 1935/2004 stimulated research and innovation 10

  11. Feedback documents - example 3 14 Feedback Document – Session number Table number Evaluation Comments and supporting evidence question & key finding number C= Disagreement that the Reg does not foresee periodic EQ7 revision of specific measures Finding1 E= Reg 10/2011 has been modified 13 times in 8 years C= Innovation: the regulation stimulated industry research for the development of safer materials EQ7 E1= annual investment for the development of new FCM by Finding3 the plastic industry increased by 5% since the entry into force of the Regulation (from X Mln to X Mln per year) C= Innovation: the regulation does not stimulate industry investment in research in the EU EQ7 Finding3 E1= procedures in the EU are much longer and uncertain 11 than in the USA. For example …

  12. EQ 7 (relevance) on evolving science and innovation 1. Regulation (EC) 1935/2004 does not provide sufficient flexibility when it comes to considering new scientific knowledge and technological developments 2. There is no mechanism in place to prioritise the handling of certain substances of health concern 3. It is unclear to what extent Regulation (EC) 1935/2004 stimulated research and innovation 12

  13. Feedback documents - example 3 14 Feedback Document – Session number Table number Evaluation Comments and supporting evidence question & key finding number C= Disagreement that the Reg does not foresee periodic EQ7 revision of specific measures Finding1 E= Reg 10/2011 has been modified 13 times in 8 years C= Innovation: the regulation stimulated industry research for the development of safer materials EQ7 E1= annual investment for the development of new FCM by Finding3 the plastic industry increased by 5% since the entry into force of the Regulation (from X Mln to X Mln per year) C= Innovation: the regulation does not stimulate industry investment in research in the EU EQ7 Finding3 E1= procedures in the EU are much longer and uncertain 13 than in the USA. For example …

  14. Feedback documents - example 3 14 Feedback Document – Session number Table number Evaluation Comments and supporting evidence question & key finding number C= Disagreement that the Reg does not foresee periodic EQ7 revision of specific measures Finding1 E= Reg 10/2011 has been modified 13 times in 8 years C= Innovation: the regulation stimulated industry research for the development of safer materials EQ7 E1= annual investment for the development of new FCM by Finding3 the plastic industry increased by 5% since the entry into force of the Regulation (from X Mln to X Mln per year) C= Innovation: the regulation does not stimulate industry investment in research in the EU EQ7 Finding3 E1= procedures in the EU are much longer and uncertain 14 than in the USA. For example …

  15. Feedback documents - example 3 14 Feedback Document – Session number Table number Evaluation Comments and supporting evidence question & key finding number C= Disagreement that the Reg does not foresee periodic EQ7 revision of specific measures Finding1 E= Reg 10/2011 has been modified 13 times in 8 years C= Innovation: the regulation stimulated industry research for the development of safer materials EQ7 E1= annual investment for the development of new FCM by Finding3 the plastic industry increased by 5% since the entry into force of the Regulation (from X Mln to X Mln per year) C= Innovation: the regulation does not stimulate industry investment in research in the EU EQ7 Finding3 E1= procedures in the EU are much longer and uncertain 15 than in the USA. For example …

  16. Table discussions and reporting • 1 rapporteur complete the feedback document • All feedback documents will be collected • Reporting: maximum 3 minutes per table + written contribution until 16 October 16

  17. Agenda • Introduction • Objectives and format • Presentation approach and consultation strategy • Discussion on preliminary findings • Session 1 – Effectiveness • Session 2 – Efficiency • Session 3 – Relevance and Coherence • Session 4 – EU added value + concluding comments • Final remarks 17

  18. ..Where do we stand? 1 st workshop 2 nd workshop Data Structuring Analysis Reporting collection 18

  19. Sources of information Desk Consultation research Analysis 19

  20. Consultation strategy OPC and SME When? survey • October to June Why? • To complement desk research Case Studies • To collect perceptions and views on the Regulation Consultation Who? Tools Interviews • Member States Competent Authorities and third countries • Business Operators • NGOs • Scientific institutes, experts and Focus laboratories Groups • Regulatory support businesses Workshops 20

  21. Consultation strategy OPC and SME When? survey • 12 weeks, February –May 2019 Why? Case Studies • To give citizens and experts the opportunity to provide their views on the Regulation Consultation Tools Interviews Who? • 503 replies, among which 219 citizens • Responses from more than 28 countries Focus • No campaigns identified Groups Workshops 21

  22. Background of respondents Type Country of residence 153 5%4% EU citizen 7% Business 44% 74 67 66 Public authority 40 39 36 28 Other 41% BE FR DK HU IT PT UK Other

  23. Consultation strategy Why? SME survey • To explore the needs and challenges faced by EU SMEs in the context of the FCM Case Studies legislation Consultation Who? Tools Interviews • 701 replies from 21 MS • Distributed to the SME panel of the Enterprise Europe Network and managed by DG GROW Focus Groups Workshops 23

  24. Background of respondents Country Size 29% Medium (50 to 249 employees) Small (10 to 49 employees) 31% Micro (1 to 9 employees) Self-employed (no additional PL IT RO FR ES PT Other employees) 33% 7%

  25. Consultation strategy OPC and SME Why? survey • To gather first-hand data and facts on several aspects related to the FCM legislation Case Studies • To illustrate and exeplify complex issues Consultation What? Tools • 6 case studies covering: Interviews • The authorization process • Effects of the lack of harmonisation • Compliance along the supply Focus chain Groups • Challenges of SMEs • Enforcement and controls • Coherence of the FCM Workshops legislaiton 25

  26. Consultation strategy OPC and SME Why? survey • To investigate, clarify and substantiate the evidence obtained via desk research and Case Studies other consultation tools Who? Consultation • 40 interviews Tools • Relevant stakeholder groups: Interviews • Member States Competent Authorities and third countries • Business Operators Focus • NGOs Groups • FCM experts and consultants Workshops 26

  27. Consultation strategy OPC and SME Why? survey • To stimulate discussion and gather information on several aspects related to the FCM legislation Case Studies What? • 6 focus groups covering: Consultation • Official controls Tools • Effects of the lack of Interviews harmonisation • FCM and REACH • Risk assessment and management Focus • Enforcement and controls Groups • Coherence of the FCM legislation Workshops 27

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