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MS-activities in BulgariaSvetlozar TOLEV

DG”Market surveillance”- SAMTS

UNECE “MARS” Group meeting

24 – 26 September 2006

Bratislava, Slovakia

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MARKET SURVEILLANCE AUTHORITIES

FOODSTAFFS FOODSTAFFS Ministry of Health Ministry of Health Ministry of Agriculture and ForestryMinistry of Agriculture and Forestry

PHARMACEUTICALSPHARMACEUTICALSMinistry of HealthMinistry of Health

NEW APPROACH DIRECTIVESNEW APPROACH DIRECTIVES State Agency for Metrological and Technical State Agency for Metrological and Technical

SurveillanceSurveillance (SAMTS)(SAMTS)Ministry of Regional Development and Public Ministry of Regional Development and Public

Works Works (MRDPW)(MRDPW)

GENERAL PRODUCT SAFETYGENERAL PRODUCT SAFETY - - 2001/95/EC 2001/95/EC Commission on Consumer ProtectionCommission on Consumer Protection

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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

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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

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DG ”Market surveillance” aactivitiesctivities

CChecks and monitoring according to thehecks and monitoring according to the Annual planAnnual plan Proactive checks of productsProactive checks of products (Thematically, Big Chains, Cheap (Thematically, Big Chains, Cheap

products, etc.)products, etc.) MMonitoringonitoring – for new products – for new products CCampaigns (ampaigns (IInstruction for use in Bnstruction for use in Bulgarian language, Sulgarian language, Season

products, etc.)

Non-scheduled checks Non-scheduled checks Notifications and complaints from citizens and Notifications and complaints from citizens and

institutionsinstitutions Notifications received under the Notifications received under the RAPEXRAPEX

first notifications – November 2005first notifications – November 2005 Testing of samples of products

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DG ”Market surveillance” aactivitiesctivities 20052005 - 2006 (I and II quarter) - 2006 (I and II quarter)

Construction PRODUCTS 16 -20 %

GAS APPLIANCES

4- 15 %

R&TTE2 - 12 %

PPE2 -6 %

PRESSURE EQUIPMENT &

S P V

3 - 9 %

LVD&EMC18 %

MACHINERY10- 20 %

TOYS 18%

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DG ”Market surveillance” aactivitiesctivities 20052005 - 2006 (I and II quarter) - 2006 (I and II quarter)

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 planAnnual plan RAPEXRAPEX Complaints Complaints

Toys Toys 1010 1717 --

LVD LVD 33 99 99

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The number products: checked and monitored /non – compliant

YearYear: : 2005 2005 2006 2006 till Julytill July

LVD & EMC 9 95858 /254/254 822/822/268268 Machinery 262 262 /108/108 628/628/184184 Toys 498 498 /283/283 543/543/198198 Construction productsConstruction products 544 544 /189/189 570/570/280280 Gas appliancesGas appliances 114 114 // 2929 459/459/124124 R&TTE R&TTE 48 48 // 99 352/352/111111 PPreassure equipment reassure equipment & & vesselsvessels 246 246 /245/245 103/ 103/ 5555 Personal protective equipmentPersonal protective equipment 56 56 // 2020 156/ 156/ 4040

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Administrative and penal actions 20052005 - 2006 (I and II quarter) - 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

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MARKET SURVEILLANCE MARKET SURVEILLANCE COOPERATIONCOOPERATION

•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

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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

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Thank you!