1. COORDINATION OF MARKET SURVEILLANCE IN SWEDEN Visit from Montenegro, January 17th 2013 Amina Makboul

2. Overview About Swedac Coordination of market surveillance -Legal system/national regulation on market surveillance -Swedacs’ role as a national coordinator - Collaboration with Customs Up-coming activities

3. 3 SWEDAC The national accreditation body and a public authority responsible to: Ministry for Foreign Affairs Ministry of Enterprise, Energy and Communications Mrs. Ewa Björling, Minister for Trade

4. Swedacs’ role as a public authority Performs accreditation in Sweden The central expert authority for technical conformity assesment Gives guidance to the Government offices, other authorities and investigations in issues regarding technical conformity assesment and market surveillance Collaborates with other authorities Active participant in work of the EU and in international development projects Works as a national coordinator for market surveillance 4

5. Legal metrology and precious metals Swedac is the prescriptive and supervisory authority for measure instruments, e.g. Water meters Active electrical energy meters Weighing instruments Taximeters Swedac is also responsible for market surveillance on precious metals 5

6. 6 International development Support associations, candidates and other countries who align their legislation to the EU or with the WTO by assisting in their building up of conformity assessment infrastructures

7. Swedac Works for Government and Parliament Authorities Enterprises Organisations For the benefit of the Citizen Office in Borås and Stockholm, 115 employees and 2500 customers “An authority for quality and safety” 7

8. 8 Coordination of Market Surveillance in Sweden

9. Overview of the legal system horizontal/sectorial European directives horizontal/sectorspecific A national horizontal Regulation National sectorspecific regulations and laws National regulation SFS 2005:893 (EU) Regulation 765/2008 National law on toys SFS 2011:579 EU Directive on toys 2009/48

10. National regulation on market surveillance SFS (2005:893) Into force since January 2006 General definition of market surveillance Guidelines for market surveillance activities Clarification of responsibilities Requirement on cooperation and coordination of sector authorities Market Surveillance Council

11. General definition of market surveillance ”Measures by public authorities to ensure that a product made available on the market comply with existing requirements”

12. Guidelines The need for market surveillance shall be assessed for each product category, taking into account characteristics of a product risks associated with the product results from previous market surveillance activities foreseeable use other authorities’ market surveillance activities Authorities shall coordinate their market surveillance activities when appropriate.

13. Swedacs’ role as a national coordinator for market surveillance To hold the secretariat and chairmanship of the national Market Surveillance Council To support the market surveillance authorities in their implementation and adoption of Regulation 765/2008 To represent Sweden in working groups regarding market surveillance on a European and International level (IMP-MSG, PROSAFE, UNECE/UNECE MARS) To administrate ICSMS 13

14. Market Surveillance Council Representatives from sector authorities, Customs and the National Board of Trade Charimanship and secretariat at Swedac The Ministry for Foreign Affairs is represented at the meetings Industry and consumer organisations are regularly invited Forum for cooperation and exchange of experiences Horisontal role of coordination Action plan and a follow up report to the Government Information to the public and industry 4-5 meetings/year

15. 15 MSAs The Swedish Work Environment Authority The National Board of Housing, Building and Planning The National Electrical Safety Board The National Chemicals Inspectorate The Swedish Energy Agency The National Consumer Agency The National Medical Products Agency The Swedish Transport Agency The National Post and Telecom Agency The Swedish Radio and TV Authority The Swedish Rescue Services Agency The Swedish Environmental Protection Agency SWEDAC machinery, PPE (professional use), pressure equipment construction products, lifts, hot water boilers electrical products, EMC chemicals, RoHS energy efficiency GPSD, toys, PPE (private use) medical devices, pharmaceuticals, cosmetics rail systems, marine equipment, motor vehicles radio and telecommunications terminal equipment electronic communications networks and services explosives, gas appliances, transportable pressure equipment waste electrical and electronic equipment (WEEE) measuring instruments, precious metals Market surveillance authorityProduct categories

16. National Action Plan on Market Surveillance for 2013 Clarify responsibilities for different product categories and draw attention to possible coordination- or cross border problems Monitor the work of the European Commission on new/modified product legislation, and in particular that relating to a new draft legal instrument for market surveillance. Study the need for a new structure and design of the national action plan if a new law and ordinance on products/market surveillance come into force Review the feasibility of launching a joint project relating to Internet sales of e- cigarettes among the relevant authorities. Invite a Swedish Notified Body to one of the meetings to exchange ideas and experiences about their role as well as any challenges they might face Follow up a study on CE-marking from 2004 Plan and arrange a seminar to the business sector about ”CE-marking, product safety and other product requirements”, April 25th 2013

17. Coordination tool – a system for exchange of information

18. A national website for market surveillance

19. 19 Collaboration between the MSA:s and Customs

20. 20 Which MSA is responsible ?

21. Background: obligations on Customs (article 27 in EC Regulation 765/2008) Customs shall suspend the release of a product for free circulation on the Community market when any of the following findings are made: 1.The product displays characteristics which give cause to believe that the product presents a serious risk to health, safety, the environment […] 2.The product is not accompanied by the written or electronic required documentation/not marked 3.The CE marking has been affixed to the products in a false or misleading manner. The customs shall immediately notify the market surveillance authorities of any such suspension.

22. 22 Our model for cooperation between MSAs and Swedish Customs The cooperation model needs to be updated with: -A description on routines if Customs take the initiative (Codex for Customs) -Routines for products from Turkey

23. Joint operations between Customs and 4 MSAs in 2012 In collaboration with the Swedish Consumer Agency, National Electrical Safety Board and Swedish Transport Agency and Swedish Energy Agency 10 operations were made in order to stop non compliant products at the border (water scooters, toys, lamps etc) In 3 of these cases the products were destroyed during customs control upon request from the MSAs Result: 9564 articles were stopped for free circulation! 1 case is still under investigation

24. Activities in our action plan for 2013 regarding cooperation with customs Apply the cooperation model to a greater extent, both nationally and in cross-border cooperative projects. Continue, and develop cooperation in the “Forum for customs related issues” with the aim of seeking and highlighting solutions to practical problems. Examine the continuing potential for cooperation between the market surveillance authorities and the Swedish Customs in various kinds of information campaigns.

25. 25 Upcoming activities Market Surveillance Council meets 1st February Adopt the follow up report on the action plan for 2012 Visit to Swedish Customs 18th February Report on the study on CE marking to be submitted in March IMP-MSG meeting 15th March PROSAFE GA meeting 24 th April Product safety seminar 25th April A new national Regulation on market surveillance is under consideration…

26. Thank you! More information? amina.makboul@swedac.se