REPUBLIC OF BULGARIA NATIONAL MARKET SURVEILLANCE PROGRAMME

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1 REPUBLIC OF BULGARIA NATIONAL MARKET SURVEILLANCE PROGRAMME 2012

2 Introduction To ensure the effective functioning of the Single European market and executing its obligations to guarantee the free movement of goods, since 2010 Bulgaria applies the requirements of 765/2008 of the European Parliament and the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing 339/33. The National market surveillance programme for 2012 is prepared on the basis of the Regulation and in accordance with the provision of article 18 (5) thereof. The National programme consists of seven sectoral programmes. Their realization meets the set up general objectives. I. General objectives To ensure unhindered and effective functioning of the internal market, Bulgaria has established, in the field of free movement of goods, a legislative framework and an infrastructure which is necessary for its implementation. The process of development of the technical legislation in the country is carried out in accordance with some basic principles: Timeliness The harmonized legal acts are transposed into the national legislation in the shortest time in order to guarantee a period which will be sufficient for the business to be in compliance; Information The opinion of the business is sought during the participation in the development of the European technical legislation in order to form national positions; All proposals for legal acts are publicly available for opinions and comments; Competent institutions publish actual information concerning the new requirements and forthcoming amendments; Accuracy The most precise and accurate reproduction of the requirements of the harmonized legislation is kept (is followed) in the process of transposition of the European legislation. The general and sectoral legislation in the field of free movement of goods as well as the principles of the old and new approach are transposed into Bulgarian legislation by various legal acts ministerial decrees and regulations. These acts lay down requirements for producers, importers, distributors and retailers. The observation of the requirements ensures production and placing on the market of safe and complying with the harmonized requirements products. In Bulgaria there is a system of authorities carrying out surveillance activities in order to guarantee strict compliance with the legally set up requirements. According to Regulation (EC) 765/2008 these authorities are called market surveillance authorities. They apply control and surveillance procedures and methods (prevention, inspection of, physical inspections, withdrawal, etc.) in order to place on the market only safe and complying with the legal requirements products. Within the frameworks of the prevention activities, the market surveillance authorities pursue an active policy to increase the information of the business and public. Within the frameworks of the initiatives to increase the information, the requirements of the European legislative framework concerning the safety of goods and procedures for conformity assessment are subject to explanation (clarification). Within the frameworks of the prevention activities, the market surveillance authorities provide information to their web sites and develop columns questions and answers, advises for the consumer, etc.; organize explanatory campaigns; participate in various forums and seminars; prepare and distribute printed materials. Within the frameworks of their information activities, the authorities provide data concerning dangerous products determined as such in consequence of their surveillance activity or for which they have received data in RAPEX system or as a result from the 2

3 cooperation with competent authorities of other member states. Specific surveillance activities are also carried out in case of signals and complaints from consumers and competitive economic operators. When planning and executing their surveillance activities, the authorities take into account great number of elements of the risk assessment: danger degree, particular consumer group, results from previous inspections, seasonal increase of the consumer interest for some goods, etc. The latter requires organization of specialized campaigns because the seasonal supply and demand is specific for some goods (for example Christmas decoration). The authorities are legally authorized to impose sanctions for noncompliance with the legal requirements, including imposing measures as prohibition or limitation of the realization of the product on the market. Most of the surveillance activities are carried out on site of retailers and wholesale dealers in view of the significant part of the import of the products compared to the part of the product produced in the country. In Bulgaria there is established infrastructure suitable to carry out testing of most of the products which are subject to surveillance. In case of lack of capacity for testing specific parameters, the competent authorities use the services of accredited laboratories of other member states. The administrative capacity and financial insurance of the surveillance activities are limited within the frameworks of the number of the specialized units in the relevant administrative structures and their annual budgets. II. Organization at national level Market surveillance activities in Bulgaria are performed by a system of competent authorities which functions are established in different sectoral laws. The surveillance functions are assigned to different institutions by different legal acts depending on the particulars of the product group. Bulgaria is among the member states which use the approach for organization of the market surveillance mainly at sectoral level. The seven sectoral market surveillance programmes for 2012 which will be realized by the competent authorities are presented as Annex to the present document. Within the meaning of Regulation (ЕC) 765/2008 market surveillance authorities are the following institutions: Commission for consumer protection, State agency for metrological and technical surveillance, Directorate for National Construction Supervision, Regional health inspectorates, Bulgarian food safety agency, Pharmaceutical agency, Technical control inspectorate and Regional inspectorates of environment and waters. The system of market surveillance authorities functions by way of distribution of the competences among five ministries, namely Ministry of economy, energy and tourism, Ministry of health, Ministry of agriculture and foods and Ministry of environment and water. A Council for coordination and exchange of information between competent authorities within the meaning of Regulation (ЕC) 765/2008 has been established by a governmental act Decree of Council of ministers 180/2005. Since 1 August 2011 the deputy ministers of economy, energy and tourism, assigned by their minister, are respectively chairman and vicechairman of the Council. The organizational and technical service of the Council s activity is realized by a Directorate within the Ministry of economy, energy and tourism. The Council for coordination consists of representatives of Ministry of environment and water, Ministry of health, Pharmaceutical agency, Commission for consumer protection, Bulgarian food safety agency, Directorate for National Construction Supervision, National Customs Agency, State agency for metrological and technical surveillance, Executive Agency on Vine and Wine, Executive Agency Fisheries and Aquacultures, Executive Agency Plant Variety, Approbation and Seed Control, General Directorate Criminal Police, Technical Control Inspectorate to the Minister of Agriculture and Food. These institutions within the arias of their 3

4 competences have control and surveillance functions for the products covered by Community harmonization legislation. They perform joint inspections, too. Institutions performing surveillance of products excluded from the scope of the Regulation (e.g. foodstuffs, medicinal products, etc.) also participate in the Council. The Council for coordination is in practice a coordination point within the meaning of the Regulation and has a key role for ensuring the effective implementation of Chapter III of Regulation (ЕC) 765/2008. The Commission for consumer protection is the specialized state authority in Bulgaria dealing with the problems of the consumers protection. The Commission is also one of the main internal market surveillance authorities. Among the main directions of activities are: surveillance of the general products and services safety at the Bulgarian market, protection of the main consumer rights, trade practices and methods of sale, etc. In addition the Commission for consumer protection is the Bulgarian contact point for RAPEX system. The State agency for metrological and technical surveillance (SAMTS) carries out market surveillance activities for products covered by the New approach directives except for medical devices, where the market surveillance activities are assigned to the Pharmaceutical agency to the Minister of health. Further the State Agency for Metrological and Technical Surveillance carries out market surveillance for products in the scopes of 2009/125/EC on ecodesign requirements for energy-related products, 2002/95/EC on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS) and 2002/96/EC on waste electrical and electronic equipment (WEEE). 4

5 SECTORAL NATIONAL MARKET SURVEILLANCE PROGRAMMES Member State: REPUBLIC OF BULGARIA Planning for: 2012 Surveillance Authority: COMMISSION FOR CONSUMER PROTECTION Person responsible for the al NMSP: Emilia Elchinova Chief Director Market Surveillance Rumyana Pekanova Head of Department Coordination of Control and Safety Product Description of the product 2001/95/EC Consumer products -Goods for children /bicycles, walkers, strollers, beds, chairs, cots, children clothing and etc./; -Equipment for camping and recreation /draft and oil lamps, folding chairs and tables, chairs, etc. / -Laser-products; -Ladders; -Cigarettes; -Equipment playgrounds; - electrical equipment Type of ( normal surveillance, thematic checksup, etc.)/ During border control/ RAPEX notifications activity companies/ 5

6 2001/95/EC; Decision 2006/502/EC 2008/121/EC; Regulation (EU) 1007/2011; Decision 2009/251/EC 94/11/EC; Decision 2009/251/EC Description of the product Type of Lighters Lighters Textile Children s garments Leather leather products; shoes; gloves; furniture / During border control/ RAPEX notifications ( normal surveillance, thematic checksup, etc.)/ During border control/ RAPEX notifications ( normal surveillance, thematic checksup, etc.)/ During border control/ RAPEX notifications activity Product testing / companies/ companies/ companies/ 6

7 Description of the product Type of 69/493/ЕЕС Crystal glass crystal glass Proactive 87/357/EEC Food imitating products food imitating products 94/62/EC Packaging packaging and packaging waste 2006/66/EC Equipment batteries and accumulators and waste batteries 75/324/ЕС Equipment/ chemicals aerosol dispensers / ( normal surveillance, thematic checksup, etc.)/ During border control/ RAPEX notifications / / RAPEX notifications / activity Information campaign/ document/ companies/ companies/ companies/ Information campaign/ companies/ 7

8 1999/94/EC; 2000/53/EC; 2007/46/EC Description of the product Type of Motor vehicles motor vehicles 2007/46/EC Motor vehicle systems, components and separate technical units intended for motor vehicles and their trailers 92/23/EEC; 1222/2009 Motor vehicle tyres for motor vehicles 2010/30/EU household appliances 95/13/EC household electric tumble driers 96/60/EC household combined washer-driers 98/11/EC household lamps 2002/31/EC household air-conditioners / RAPEX notifications / / / / / / / activity 8

9 Description of the product Type of 2002/40/EC household electric ovens Regulation (EU) 1059/2010 Regulation (EU) 1060/2010 Regulation (EU) 1061/2010 household dishwashers household electric refrigerators, freezers and their combinations household washing machines / / / / activity 9

10 Surveillance Authority: STATE AGENCY FOR METROLOGICAL AND TECHNICAL SURVEILLANCE Person responsible for the al NMSP: Maria Kancheva 88/378/EEC; 2009/48/ЕС Toys Description of the product Toys by with the same kind of risk referred to RAPEX notifications Toys packed in food Toys that shoot objects Toys bear the weight of a child Electric toys supplied with chemical source of electrical energy (battery) 2007/23/EC Pyrotechnic articles Pyrotechnic articles Category 1, 2 and 3 93/15/ЕЕС Explosives for civil uses scope of the Type of Notifications/ RAPEX in the scope of activity s/ s/ s/ s/ s/ s/ s/ 10

11 94/9/EC 89/686/EC 2006/42/EC; 2000/14/EC as amended by 2005/88/EC Equipment intended for use in potentially explosive atmospheres Personal protective equipment Description of the product Fluorescent lighting, emergency lighting, portable lighting, switches Ear muffs Machinery Mobile or movable jacks mechanical/hydraulic Winches and hoists Garden equipment - Garden blowers, vacuums and blower/vacuums Machinery intended for use in woodworking industry Cranes 2009/142/ЕС Gas appliances Low-pressure, non adjustable regulators having a maximum outlet pressure of less than or equal to 200 mbar Type of Lack of knowledge Re-inspection Lack of knowledge Inspection Re-inspection Re-inspection activity s/ s/ s/ s/ s/ 11

12 2009/105/EC Simple pressure vessels Description of the product scope of the 97/23/EC Pressure equipment Pressure vessels, Steam and hot water boilers, Gas appliances and installations 2010/35/EС 1999/5/EC 2009/125/EC; Regulation (EC) 106/2008; 1275/ /125/EC; 107/ /125/EC; 244/ /125/EC; 245/ /125/EC; 278/2009 Transportable pressure equipment Radio and telecommunication equipment Transportable refillable welded steel cylinders for LPG Wireless routers Wireless access point-wap Desktops, notebooks, monitors scope of the scope of the scope of the scope of the Type of Lack of knowledge Lack of knowledge activity s/ s/ s/ Lack of knowledge s/ s/ s/ s/ Low Low Low Low 12

13 2009/125/EC; 640/ /125/EC; 641/ /125/EC; 642/ /125/EC; 643/ /125/EC; 1015/ /125/EC; 1016/2010 Description of the product scope of the scope of the scope of the scope of the scope of the scope of the Type of activity s/ s/ s/ s/ s/ s/ Low Low Low Low Low Low 13

14 2004/108/ЕС; 2006/95/EC 2002/96/ЕС; 2002/95/EС 2009/23/EC Description of the product Type of Mixers and blenders Fans Conditioners Kettles for hot water in relation to the treatment of waste electrical and Printers electronic equipment Measuring instruments Non-automatic weighing instruments: - for direct sales; - truck weighbridges. Re-inspection Re-inspection Re-inspection Risk assessment activity s/ s/ s/ s/ s/ Target group installation site 14

15 2004/22/EC Measuring instruments Description of the product Measuring systems for liquids other than water Gas meters Water meters, Active electrical energy meters, Heat meters Automatic weighing instruments, Taximeters, Material measures, Exhaust gas analysers 95/16/EC Lifts Lifts for residential and public accessible building 2000/9/EC 94/25/EC as amended by 2003/44/EC Cableway installations Recreational craft subsystems of cableway scope of the Type of Risk assessment Risk Assessment Information from other market surveillance authorities Inspection activity Target group installation site Low 15

16 89/106/ЕС 98/70/ЕС and 1999/32/ЕС as amended by 2009/30/EC; 2009/28/EC Construction products Liquid fuels Description of the product Concrete kerb units; Concrete paving flags; Resilient, textile and floor coverings Biofuels, Petrol, Diesel fuel, Heating fuels Type of Proactive Lack of knowledge Lack of knowledge activity Product testing 16

17 Surveillance Authority: TECHNICAL CONTROL INSPECTORATE Person responsible for the al NMSP: Dipl. Eng. Georgi Georgiev /37/EC 2003/37/EC (separate directives for components/ separate technical units under the Framework 2003/37/EC) Motor Vehicles Sub-sector Tractors Motor Vehicles Sub-sector Tractors 97/68/EC Machinery emissions Description of the product New Agricultural and Forestry Tractors Components/ separate technical units Engines for non-road mobile machinery 2006/42/EC Machinery Earth-moving machinery, coupling machinery Type of activity Inside the national Checks on supply chain, shops, exhibitions/ Inside the national Checks on supply chain, shops, exhibitions Inside the national Checks on supply chain, shops, exhibitions/ Notification from Customs Agency/ Technical reports/ Joint actions outcomes/ Technical reports/ Joint actions outcomes/ Notification from Customs Agency/ Technical reports/ Joint actions outcomes/ companies companies companies Passive control Registration control 17

18 Surveillance Authority: PHARMACEUTICAL AGENCY Person responsible for the al NMSP: Lyubomir Dimitrov No of EU legislation 93/42/EEC; 90/385/EEC; 98/79/EC Medical devices Description of the product Medical devices Type of activity Joint actions/ During border control Target groups/ companies/ 18

19 Surveillance Authority: REGIONAL INSPECTORATE OF ENVIRONMENT AND WATERS Person responsible for the al NMSP: Ivan Angelov Stefan Stefanov No of EU legislation Regulation (EC) 842/2006, Regulation (EC) 1494/2007 Regulation (EC) 1005/ /98/EC Electrical equipment, chemicals Electrical equipment, Chemicals Description of the product refrigeration products and equipment and fire protection systems which contain fluorinated greenhouse gases or preparations containing greenhouse gases refrigeration products and equipment and fire protection systems which contain or rely on substances that deplete the ozone layer Type of Waste waste activity Technical reports/ Joint actions/ Lack of knowledge/ During border control Technical reports/ Joint actions/ Lack of knowledge/ During border control Technical reports/ Joint actions/ Information campaign/ Target groups/ companies/ Information campaign/ Target groups/ companies/ Control on type and quantity of waste generation and permissions of waste treatment 19

20 No of EU legislation 2004/42/EC Products containing volatile organic compounds Description of the product certain paints and varnishes and vehicle refinishing products in respect of emissions of volatile organic compounds due to organic solvents Type of Proactive activity Joint actions/ Lack of knowledge/ Re-sampling Information campaign/ Target groups/ companies/ 20

21 Surveillance Authority: MINISTRY OF HEALTH /28 REGIONAL NEALTH INSPECTORATES/ Person responsible for the al NMSP: Dr. Dimitar Dimitrov No of EU legislation 76/768/EEC Regulation (EC) 1272/2008; Regulation (EC) 1907/2006 Description of the product Type of Cosmetics Cosmetic products Chemical substances, mixtures and articles Chemical substances, mixtures and articles (classification, packaging, labelling and providing information through the chain) activity ( normal surveillance, thematic checks-up, etc.)/ Lack of knowledge/ Re-sampling/ During border control/ RAPEX notifications ( normal surveillance, thematic checks-up, etc.)/ Lack of knowledge/ Re-sampling/ During border control/ RAPEX notifications Target groups/ companies/ / Thematic checks-up / Thematic checks-up 21

22 No of EU legislation 98/8/EC Regulation (EC) 648/2004 Description of the product Type of Biocidal products Biocidal products Detergents Detergents and surfactants intended for detergents (labeling, packaging and providing information about the constituents) activity ( normal surveillance, thematic checks-up, etc.)/ Lack of knowledge/ Re-sampling/ During border control/ RAPEX notifications ( normal surveillance, thematic checks-up, etc.)/ Lack of knowledge/ Re-sampling/ During border control/ RAPEX notifications / Thematic checks-up / Thematic checks-up 22

23 Surveillance Authority: BULGARIAN FOOD SAFETY AGENCY Person responsible for the al NMSP: Dobrinka Pavlova Head of Control of Plant Protection Products and Fertilizers Department Bulgarian Food Safety Agency No of EU legislation 1107/ /2003 Description of the product Chemicals Plant protection products Inside the Preventive/ Chemicals Fertilizers Inside the Preventive/ Type of activity Annual planning/ Test results/ Re-sampling/ Control for compliance Annual planning/ Re-sampling/ Control for compliance companies/ companies/ 23