1. 1 MS-activities in Bulgaria Svetlozar TOLEV DG”Market surveillance”- SAMTS UNECE “MARS” Group meeting 24 – 26 September 2006 Bratislava, Slovakia

2. 2 MARKET SURVEILLANCE AUTHORITIES FOODSTAFFS FOODSTAFFS Ministry of Health Ministry of Agriculture and Forestry PHARMACEUTICALS PHARMACEUTICALS Ministry of Health NEW APPROACH DIRECTIVES NEW APPROACH DIRECTIVES State Agency for Metrological and Technical Surveillance (SAMTS) Ministry of Regional Development and Public Works (MRDPW) GENERAL PRODUCT SAFETY - 2001/95/EC GENERAL PRODUCT SAFETY - 2001/95/EC Commission on Consumer Protection

3. 3 MARKET SURVEILLANCE (New Approach) LEGISLATIVE FRAMEWORK Law on Technical Requirements to Products (LTRP): adopted in 1999; amendments : first - October 2002 last - May 2005; Ordinance on Market Surveillance: adopted in June 2003 amendment: October 2005

4. 4 New Approach market surveillance authorities According to the LTRP market surveillance is carried out for products under New Approach Directives as follows: by SAMTS: 1. DG ”Market surveillance” (LVD, EMC, CPD, TOYS, MD, PPE, RTTE, GAD, PED – end consumers products) 2. DG ”High Risk Equipment Inspection” (high risk equipment – non end consumers product) 3. DG ”Metrological Supervision”(NAWI, MID) by SAMTS and MRDPW - for construction products The law on medical devices (adopted in August 2006) will regulate the market surveillance on medical devices

5. 5 activities DG ”Market surveillance” activities Checks and monitoring according to the Annual plan Checks and monitoring according to the Annual plan Proactive checks of products (Thematically, Big Chains, Cheap products, etc.) Proactive checks of products (Thematically, Big Chains, Cheap products, etc.) Monitoring – for new products Monitoring – for new products Campaigns (Instruction for use in Bulgarian language, S Campaigns (Instruction for use in Bulgarian language, Season products, etc.) Non-scheduled checks Non-scheduled checks Notifications and complaints from citizens and institutions Notifications and complaints from citizens and institutions Notifications received under the RAPEX Notifications received under the RAPEX first notifications – November 2005 first notifications – November 2005 Testing of samples of products

6. 6 activities 2005 - 2006 (I and II quarter) DG ”Market surveillance” activities 2005 - 2006 (I and II quarter)

7. 7 Total number of: 2005 2006 till July Checked and monitored products 2 750 4 193 non – compliant products 1 137 1 366 Non-scheduled checks 770 560 Tested products 12 48 confirmed as non – compliant 11 30 (+10?) Annual plan RAPEXComplaints Toys1017- LVD399

8. 8 The number products: checked and monitored /non – compliant Year: 2005 2006 till July Year: 2005 2006 till July 958 /254 822/268 LVD & EMC 958 /254 822/268 262 /108 628/184 Machinery 262 /108 628/184 498 /283 543/198 Toys 498 /283 543/198 Construction products 544 /189 570/280 Construction products 544 /189 570/280 Gas appliances 114 / 29 459/124 Gas appliances 114 / 29 459/124 R&TTE 48 / 9 352/111 R&TTE 48 / 9 352/111 Preassure equipment & vessels 246 /245 103/ 55 Preassure equipment & vessels 246 /245 103/ 55 Personal protective equipment 56 / 20 156/ 40 Personal protective equipment 56 / 20 156/ 40

9. 9 2005 - 2006 (I and II quarter) Administrative and penal actions 2005 - 2006 (I and II quarter) 2005 2006 till July Acts for administrative infringements 297 4 51 in respect of traders 198 336 ( 682 prod.) in respect of importers/producers 99 115 ( 183 prod.) Penal acts issued 147 246 Orders for temporary suspension of the distribution/use 42 63 Orders for prohibition of the distribution/use of the product & withdrawal from the market 9 26

10. 10 MARKET SURVEILLANCE COOPERATION Agreement for joint activities with the Commission on Trade and Consumer Protection Agreement for cooperation and joint activities in the field of construction products with the Directorate for National Construction Control from the MRDPW Common Instruction covering the regulations and procedures of interaction between the Customs authorities and SAMTS   Council for cooperation and exchange of information between market surveillance authorities

11. 11 Efficient and effective market surveillance Problems   “Working” documents   Cooperation   Optimal structure (institutions)   Competent personnel (experts, inspectors, lawyers)   Appropriate Annual plan   Efficient non-scheduled checks (on the basis of notifications received)   Experts and inspectors with sound experience (max specific knowledge under particular directives)   Operative managers   Principle of ”proportionality”   Team working!   Finance   Samples/specimens testing   Standards (BDS)   IT equipment/data base/information exchange system – RAPEX   Travel expenditures   Training   ADCO, seminars, workshops   Joint activities and projects

12. 12 Thank you!