1. Minimizing regulatory burden for SMEs Marianne Klingbeil Deputy Secretary General, European Commission Meeting of the HLG, 19 September 2013

2. The tool box Think Small First principle: the impact on SMEs should be taken into account as early as possible in the policy-making process. SME test: the application of the Think Small First principle in the impact assessment process. Defined in the impact assessment guidelines. Reversed burden of proof: a strengthened SME test which includes 'a micro-enterprise exemption'.

3. Reversed burden of proof Since 2012 micro-enterprises should a priori be excluded from the scope of the proposed legislation unless the necessity/proportionality of their being covered can be demonstrated. Where an exception is impossible/disproportional, adapted solutions and lighter regimes should be considered. The analysis of whether to cover micros and of possible adapted solutions should be included in the impact assessment report.

4. Applied at every step Roadmaps should explain whether the planned initiative will have an impact on micro-enterprises/SMEs and if so, how the reversed burden of proof will be addressed. Public consultation should consult micro-enterprises on their preferred option: exemption, special provisions or full inclusion. Impact assessments should analyse whether micro- enterprises need to be included in the scope of an option. When an exemption is not feasible, the IA should identify possible alternatives.The IAB checks whether the reversed burden of proof has been carried out where applicable.

5. Practical application In 2013, 69 IA reports were presented to the IAB (up to September), 16 have been adopted so far. In none of these 16 cases micros have been exempted a priori from the scope of the initiative. The main justifications for their non-exemption were: SMEs/micros are not affected/present (e.g. Single Sky authorities, Public prosecutor's office, investment/money funds) SMEs/micros are among the beneficieries (e.g RTD spending programmes, Regional state aid guidelines, port services) The proposal concerns safety aspects (e.g. drug precursors)

6. Examples 1.Fees for European Medical Agency (no exemption from scope, mitigating measures) 2.E-Invoicing in Public Procurement (no exemption from scope) 3.Monitoring of Trade of Drug Precursors (no exemption from scope, mitigating measures) 4.Revision of Package Travel Directive (no exemption from scope) 5.Road Vehicles Weight Restrictions (no exemption from scope)

7. 1. Fees for European Medical Agency About 30% of companies in this field are micro- enterprises. As costs are important for smaller companies, fee reductions for SMEs and fee waivers for micro- enterprise were suggested, in line with feedback of consultation. Final proposal: Reductions of fees for SMEs and micro-enterprises fully exempted from fees.

8. 2. E-Invoicing in Public Procurement The IA contains an explicit analysis of impacts on SMEs/micro-enterprises for all options. Justification for their inclusion: micros should be able to benefit from e-invoicing and there are no negative impacts if they do not wish to do so. Final proposal: "This Directive does not place any additional costs or burden on enterprises, including micro, small and medium-sized enterprises."

9. 3. Monitoring of Trade of Drug Precursors No general exclusion of micros, as this would make it possible to circumvent controls. Traffickers could establish themselves as micro-entities in order to evade controls by the authorities. Mitigating measures for micros analysed (e.g. reduced or no fees). Micros exempted from fees in the proposal.

10. 4. Revision of Package Travel Directive SMEs constitute 99% tour operators and travel agencies in the EU, out of which 92% are micros. All operators suffer from the absence of fair competition and costs stemming from unclear rules. An exclusion of micro and small businesses from the scope would therefore not be a viable option. Impacts on SMEs/micros explicitly analysed for all options in the impact assessment. SMEs/micros will overall benefit from clearer rules and fair competition.

11. 5. Road Vehicles Weight Restrictions More than 80% are micro-companies. Any change to the legislation must apply to the micro enterprises in order to be effective. Mitigating measures not discussed because cost savings will outweigh investment costs in the longer term.

12. Background information Communication "Minimizing regulatory burden for SMEs - Adapting EU regulation to the needs of micro-enterprises" (COM (2011) 803 final). http://eur- lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2011:0803:FIN:EN:PDF Operational guidance on assessing impacts on micro- enterprises in Commission Impact Assessments: http://ec.europa.eu/governance/impact/key_docs/docs/meg_guidelines.pdf

13. The steps of the SME-test 1.Consultation with SME representatives 2.Preliminary assessment of businesses likely to be affected 3.Measurement of the impact on SMEs 4.Assess alternative options and use of mitigating measures, if appropriate For details see: http://ec.europa.eu/enterprise/policies/sme/small-business-act/sme- test/index_en.htm http://ec.europa.eu/enterprise/policies/sme/files/docs/sba/iag_2009_annex_en.pdf