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REPUBLIC OF BULGARIA NATIONAL MARKET SURVEILLANCE PROGRAMME 2012

REPUBLIC OF BULGARIA · specific for some goods (for example Christmas decoration). The authorities are legally authorized to impose sanctions for noncompliance with the legal requirements,

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Page 1: REPUBLIC OF BULGARIA · specific for some goods (for example Christmas decoration). The authorities are legally authorized to impose sanctions for noncompliance with the legal requirements,

REPUBLIC OF BULGARIA

NATIONAL MARKET SURVEILLANCE PROGRAMME

2012

Page 2: REPUBLIC OF BULGARIA · specific for some goods (for example Christmas decoration). The authorities are legally authorized to impose sanctions for noncompliance with the legal requirements,

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

Regulation (EC) № 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 Regulation (EC) № 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 documents, 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

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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 vice-

chairman 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 Testing,

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

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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 Directive 2009/125/EC on ecodesign requirements for

energy-related products, Directive 2002/95/EC on the restriction of the use of certain hazardous

substances in electrical and electronic equipment (RoHS) and Directive 2002/96/EC on waste

electrical and electronic equipment (WEEE).

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5

SECTORAL NATIONAL MARKET SURVEILLANCE PROGRAMMES

Member State: REPUBLIC OF BULGARIA Planning for: 2012

Surveillance Authority: COMMISSION FOR CONSUMER PROTECTION

http://www.kzp.bg/

Person responsible for the Sectoral NMSP: Emilia Elchinova – Chief Director “Market Surveillance”

Rumyana Pekanova – Head of Department „Coordination of Control and Safety Product”

e-mail: [email protected]

[email protected]

r.pekanova @kzp.bg

No of EU legislation

applicable Sector

Description of the product

category

Type of

monitoring

Monitoring

motivation Monitoring activity Priority

Directive 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

Reactive/

Proactive/

Border control

Planned annual

monitoring

(“normal”

surveillance,

thematic checks-

up, etc.)/

Complaints/

Tests results/

New products/

During border

control/

RAPEX

notifications

Inspection of documents/

Visual inspection/

Product testing/

Inspection of companies/

Random checks

High

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6

No of EU legislation

applicable Sector

Description of the product

category

Type of

monitoring

Monitoring

motivation Monitoring activity Priority

Directive 2001/95/EC;

Decision 2006/502/EC

Lighters Lighters Reactive/

Border control

Planned annual

monitoring/

Complaints/

Tests results/

New products/

During border

control/

RAPEX

notifications

Inspection of documents/

Visual inspection/

Product testing /

Inspection of companies/

Random checks

High

Directive

2008/121/EC;

Regulation (EU) №

1007/2011;

Decision 2009/251/EC

Textile Children’s garments Reactive/

Border control

Planned annual

monitoring

(“normal”

surveillance,

thematic checks-

up, etc.)/

Complaints/

Tests results/

New products/

During border

control/

RAPEX

notifications

Inspection of documents/

Visual inspection/

Product testing/

Inspection of companies/

Random checks

High

Directive 94/11/EC;

Decision 2009/251/EC

Leather leather products;

shoes;

gloves;

furniture

Reactive/

Border control

Planned annual

monitoring

(“normal”

surveillance,

thematic checks-

up, etc.)/

Complaints/

Tests results/

New products/

During border

control/

RAPEX

notifications

Inspection of documents/

Visual inspection/

Product testing/

Inspection of companies/

Random checks

High

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No of EU legislation

applicable Sector

Description of the product

category

Type of

monitoring

Monitoring

motivation Monitoring activity Priority

Directive 69/493/ЕЕС Crystal glass crystal glass Reactive/

Proactive

Planned annual

monitoring/

Complaints/

New products

Information campaign/

Inspection of document/

Visual inspection/

Inspection of companies/

Random checks

Medium

Directive 87/357/EEC Food imitating

products

food imitating products Reactive/

Border control

Planned annual

monitoring

(“normal”

surveillance,

thematic checks-

up, etc.)/

Complaints/

Tests results/

New products/

During border

control/

RAPEX

notifications

Inspection of documents/

Visual inspection/

Product testing/

Inspection of companies/

Random checks

High

Directive 94/62/EC Packaging packaging and packaging

waste

Reactive

Planned annual

monitoring/

Complaints/

New products

Inspection of documents/

Visual inspection

Medium

Directive 2006/66/EC Equipment batteries and accumulators

and waste batteries

Proactive/

Reactive

Planned annual

monitoring/

Complaints/

New products/

RAPEX

notifications

Inspection of documents/

Visual inspection/

Inspection of companies/

Random checks

Medium

Directive 75/324/ЕС Equipment/

chemicals

aerosol dispensers Proactive/

Reactive

Planned annual

monitoring/

Complaints/

New products

Information campaign/

Inspection of documents/

Visual inspection/

Inspection of companies/

Random checks

Medium

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No of EU legislation

applicable Sector

Description of the product

category

Type of

monitoring

Monitoring

motivation Monitoring activity Priority

Directive 1999/94/EC;

Directive 2000/53/EC;

Directive 2007/46/EC

Motor vehicles motor vehicles Proactive/

Reactive

Planned annual

monitoring/

Complaints/

New products/

RAPEX

notifications

Inspection of documents/

Visual inspection

Medium

Directive 2007/46/EC Motor vehicle systems, components and

separate technical units

intended for motor

vehicles and their trailers

Proactive/

Reactive

Planned annual

monitoring/

Complaints/

New products

Inspection of documents/

Visual inspection

Medium

Directive 92/23/EEC;

Regulation (EC) №

1222/2009

Motor vehicle tyres for motor vehicles Proactive/

Reactive

Planned annual

monitoring/

Complaints/

New products

Inspection of documents/

Visual inspection

Medium

Directive 2010/30/EU Electrical equipment household appliances Proactive/

Reactive

Planned annual

monitoring/

Complaints/

New products

Inspection of documents/

Visual inspection

Medium

Directive 95/13/EC Electrical equipment household electric tumble

driers

Proactive/

Reactive

Planned annual

monitoring/

Complaints/

New products

Inspection of documents/

Visual inspection

Medium

Directive 96/60/EC Electrical equipment household combined

washer-driers

Proactive/

Reactive

Planned annual

monitoring/

Complaints/

New products

Inspection of documents/

Visual inspection

Medium

Directive 98/11/EC Electrical equipment household lamps Proactive/

Reactive

Planned annual

monitoring/

Complaints/

New products

Inspection of documents/

Visual inspection

Medium

Directive 2002/31/EC Electrical equipment household air-conditioners Proactive/

Reactive

Planned annual

monitoring/

Complaints/

New products

Inspection of documents/

Visual inspection

Medium

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No of EU legislation

applicable Sector

Description of the product

category

Type of

monitoring

Monitoring

motivation Monitoring activity Priority

Directive 2002/40/EC Electrical equipment household electric ovens Proactive/

Reactive

Planned annual

monitoring/

Complaints/

New products

Inspection of documents/

Visual inspection

Medium

Regulation (EU) №

1059/2010

Electrical equipment household dishwashers Proactive/

Reactive

Planned annual

monitoring/

Complaints/

New products

Inspection of documents/

Visual inspection

Medium

Regulation (EU) №

1060/2010

Electrical equipment household electric

refrigerators, freezers and

their combinations

Proactive/

Reactive

Planned annual

monitoring/

Complaints/

New products

Inspection of documents/

Visual inspection

Medium

Regulation (EU) №

1061/2010

Electrical equipment household washing

machines

Proactive/

Reactive

Planned annual

monitoring/

Complaints/

New products

Inspection of documents/

Visual inspection

Medium

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Surveillance Authority: STATE AGENCY FOR METROLOGICAL AND TECHNICAL SURVEILLANCE

http://www.damtn.government.bg/

Person responsible for the Sectoral NMSP: Maria Kancheva

e-mail: [email protected]

No of EU legislation

applicable Sector

Description of the product

category

Type of

monitoring

Monitoring

motivation Monitoring activity Priority

Directive 88/378/EEC;

Directive 2009/48/ЕС

Toys Toys by category with the

same kind of risk referred to

RAPEX notifications

Proactive/

On the national

territory/

Reactive

Notifications/

RAPEX

Visual inspections/

Inspection of

documents/

Testing

High

Toys packed in food Proactive/

On the national

territory/

Reactive

New products in the

scope of Directive

Visual inspections/

Inspection of

documents/

Testing

High

Toys that shoot objects Proactive/

On the national

territory/

Reactive

Complaints Visual inspections/

Inspection of

documents/

Testing

High

Toys bear the weight of a

child

Proactive/

On the national

territory/

Reactive

Complaints Visual inspections/

Inspection of

documents/

Testing

High

Electric toys supplied with

chemical source of electrical

energy (battery)

Proactive/

On the national

territory/

Reactive

Complaints Visual inspections/

Inspection of

documents/

Testing

High

Directive 2007/23/EC Pyrotechnic articles Pyrotechnic articles

Category 1, 2 and 3

Proactive/

Reactive/

On the national

territory

Re-inspection/

Complaints

Visual inspections/

Inspection of

documents

High

Directive 93/15/ЕЕС Explosives for civil

uses

Products falling under the

scope of the Directive

Reactive/

On the national

territory

Complaints Visual inspections/

Inspection of

documents

Medium

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11

No of EU legislation

applicable Sector

Description of the product

category

Type of

monitoring

Monitoring

motivation Monitoring activity Priority

Directive 94/9/EC Equipment intended

for use in potentially

explosive

atmospheres

Fluorescent lighting,

emergency lighting, portable

lighting, switches

Reactive/

On the national

territory

Complaints Visual inspections/

Inspection of

documents

High

Directive 89/686/EC Personal protective

equipment

Ear muffs Proactive/

On the national

territory/

Reactive

New products/

Lack of knowledge

Visual inspections/

Inspection of

documents/

Testing

Medium

Directive 2006/42/EC;

Directive 2000/14/EC

as amended by

Directive 2005/88/EC

Machinery Mobile or movable jacks –

mechanical/hydraulic

Proactive/

On the national

territory/

Reactive

Complaints/

Re-inspection

Visual inspections/

Inspection of

documents/

Testing

High

Winches and hoists Proactive/

On the national

territory/

Reactive

Lack of knowledge Visual inspections/

Inspection of

documents/

Testing

High

Garden equipment - Garden

blowers, vacuums and

blower/vacuums

Proactive/

On the national

territory

Complaints/

Inspection

Visual inspection/

Inspection of

documents/

Testing

High

Machinery intended for use

in woodworking industry

Proactive/

On the national

territory

Re-inspection Visual inspection/

Inspection of

documents

Medium

Cranes Proactive/

On the national

territory/

Reactive/

Border control

Re-inspection/

Complaints

Visual inspection/

Inspection of

documents

High

Directive 2009/142/ЕС Gas appliances Low-pressure, non

adjustable regulators having

a maximum outlet pressure

of less than or equal to 200

mbar

Proactive/

On the national

territory/

Reactive

Complaints/

Re-inspection

Visual inspections/

Inspection of

documents/

Testing

High

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12

No of EU legislation

applicable Sector

Description of the product

category

Type of

monitoring

Monitoring

motivation Monitoring activity Priority

Directive 2009/105/EC Simple pressure

vessels

Products falling under the

scope of the Directive

Reactive/

On the national

territory

Complaints Visual inspections/

Inspection of

documents

Medium

Directive 97/23/EC Pressure equipment Pressure vessels, Steam and

hot water boilers, Gas

appliances and installations

Reactive/

On the national

territory

Complaints Visual inspections/

Inspection of

documents/

High

Directive 2010/35/EС Transportable

pressure equipment

Transportable refillable

welded steel cylinders for

LPG

Proactive/

On the national

territory

Lack of knowledge Visual inspections/

Inspection of

documents/

Testing

High

Directive 1999/5/EC Radio and

telecommunication

equipment

Wireless routers

Wireless access point-WAP

Proactive/

On the national

territory

Re-inspection/

Lack of knowledge

Visual inspection/

Inspection of

documents

Medium

Directive

2009/125/EC;

Regulation (EC)

№ 106/2008;

Regulation (EC) №

1275/2008

Electrical equipment Desktops, notebooks,

monitors

Proactive/

On the national

territory

Lack of knowledge Monitoring Medium

Directive

2009/125/EC;

Regulation (EC) №

107/2009

Electrical equipment Products falling under the

scope of the Directive

Reactive/

On the national

territory

Complaints Visual inspections/

Inspection of

documents

Low

Directive

2009/125/EC;

Regulation (EC) №

244/2009

Electrical equipment Products falling under the

scope of the Directive

Reactive/

On the national

territory

Complaints Visual inspections/

Inspection of

documents

Low

Directive

2009/125/EC;

Regulation (EC) №

245/2009

Electrical equipment Products falling under the

scope of the Directive

Reactive/

On the national

territory

Complaints Visual inspections/

Inspection of

documents

Low

Directive

2009/125/EC;

Regulation (EC) №

278/2009

Electrical equipment Products falling under the

scope of the Directive

Reactive/

On the national

territory

Complaints Visual inspections/

Inspection of

documents

Low

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No of EU legislation

applicable Sector

Description of the product

category

Type of

monitoring

Monitoring

motivation Monitoring activity Priority

Directive

2009/125/EC;

Regulation (EC) №

640/2009

Electrical equipment Products falling under the

scope of the Directive

Reactive/

On the national

territory

Complaints Visual inspections/

Inspection of

documents

Low

Directive

2009/125/EC;

Regulation (EC) №

641/2009

Electrical equipment Products falling under the

scope of the Directive

Reactive/

On the national

territory

Complaints Visual inspections/

Inspection of

documents

Low

Directive

2009/125/EC;

Regulation (EC) №

642/2009

Electrical equipment Products falling under the

scope of the Directive

Reactive/

On the national

territory

Complaints Visual inspections/

Inspection of

documents

Low

Directive

2009/125/EC;

Regulation (EC) №

643/2009

Electrical equipment Products falling under the

scope of the Directive

Reactive/

On the national

territory

Complaints Visual inspections/

Inspection of

documents

Low

Directive

2009/125/EC;

Regulation (EC) №

1015/2010

Electrical equipment Products falling under the

scope of the Directive

Reactive/

On the national

territory

Complaints Visual inspections/

Inspection of

documents

Low

Directive

2009/125/EC;

Regulation (EC) №

1016/2010

Electrical equipment Products falling under the

scope of the Directive

Reactive/

On the national

territory

Complaints Visual inspections/

Inspection of

documents

Low

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No of EU legislation

applicable Sector

Description of the product

category

Type of

monitoring

Monitoring

motivation Monitoring activity Priority

Directive

2004/108/ЕС;

Directive 2006/95/EC

Electrical equipment Mixers and blenders Proactive/

On the national

territory/

Reactive

Complaints/

Re-inspection

Visual inspections/

Inspection of

documents/

Testing

High

Fans Proactive/

On the national

territory/

Reactive

Complaints/

Re-inspection

Visual inspections/

Inspection of

documents/

Testing

High

Conditioners Proactive/

On the national

territory/

Reactive

Complaints/

Re-inspection

Visual inspections/

Inspection of

documents/

Testing

High

Directive 2002/96/ЕС;

Directive 2002/95/EС

Electrical equipment

in relation to the

treatment of waste

electrical and

electronic equipment

Kettles for hot water Proactive/

On the national

territory

Re-inspection/

Complaints

Visual inspections/

Inspection of

documents

Medium

Printers Proactive/

On the national

territory

Re-inspection/

Complaints

Visual inspections/

Inspection of

documents

Medium

Directive 2009/23/EC Measuring

instruments

Non-automatic weighing

instruments:

- for direct sales;

- truck weighbridges.

Proactive/

Reactive/

Border control

Complaints/

Re-inspection/

Risk assessment

Inspection of

documents/

Visual inspection/

Target group –

installation site

High

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15

No of EU legislation

applicable Sector

Description of the product

category

Type of

monitoring

Monitoring

motivation Monitoring activity Priority

Directive 2004/22/EC Measuring

instruments

Measuring systems for

liquids other than water

Proactive/

Reactive/

Border control

Complaints/

Re-inspection/

Risk assessment

Inspection of

documents/

Visual inspection/

Target group –

installation site

High

Gas meters Proactive/

Reactive

Complaints/

Re-inspection/

Risk Assessment

Inspection of

documents/

Visual inspection

High

Water meters,

Active electrical energy

meters,

Heat meters

Automatic weighing

instruments,

Taximeters,

Material measures,

Exhaust gas analysers

Reactive Complaints/

Information from

other market

surveillance

authorities

Inspection of

documents/

Visual inspection

Low

Directive 95/16/EC Lifts Lifts for residential and

public accessible building

Proactive/

On the national

territory/

Reactive/

Border control

Re-inspection/

Complaints

Visual inspection/

Inspection of

documents

High

Directive 2000/9/EC Cableway

installations

subsystems of cableway Proactive/

On the national

territory/

Reactive

Complaints/

Inspection

Visual inspection/

Inspection of

documents

Medium

Directive 94/25/EC as

amended by

Directive

2003/44/EC

Recreational craft Products falling under the

scope of the Directive

Reactive/

On the national

territory

Complaints Visual inspection/

Inspection of

documents

Medium

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16

No of EU legislation

applicable Sector

Description of the product

category

Type of

monitoring

Monitoring

motivation Monitoring activity Priority

Directive 89/106/ЕС Construction

products

Concrete kerb units;

Concrete paving flags;

Proactive/

On the national

territory

Lack of knowledge Visual inspection/

Inspection of

documents/

Testing

Medium

Resilient,

textile and floor coverings

Proactive/

On the national

territory

Lack of knowledge Visual inspection/

Inspection of

documents

Medium

Directive 98/70/ЕС

and Directive

1999/32/ЕС as

amended by Directive

2009/30/EC;

Directive 2009/28/EC

Liquid fuels Biofuels,

Petrol,

Diesel fuel,

Heating fuels

Reactive/

Proactive

Complaints Product testing High

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17

Surveillance Authority: TECHNICAL CONTROL INSPECTORATE

http://www.tcibg.eu/

Person responsible for the Sectoral NMSP: Dipl. Eng. Georgi Georgiev

e-mail: [email protected]

No of EU legislation

applicable Sector

Description of the

product category Type of monitoring Monitoring motivation Monitoring activity Priority

Directive 2003/37/EC Motor Vehicles

Sub-sector

“Tractors”

New Agricultural and

Forestry Tractors

Proactive/

Inside the national

territory/

Checks on supply

chain, shops,

exhibitions/

Border control

Notification from

Customs Agency/

Complaints/

Technical reports/

Joint actions outcomes/

New products

Inspection of documents/

Visual inspection/

Inspection of companies

High

Directive 2003/37/EC

(separate directives

for components/

separate technical

units under the

Framework Directive

2003/37/EC)

Motor Vehicles

Sub-sector

“Tractors”

Components/

separate technical

units

Proactive/

Inside the national

territory/

Checks on supply

chain, shops,

exhibitions

Complaints/

Technical reports/

Joint actions outcomes/

New products

Inspection of documents/

Visual inspection/

Inspection of companies

High

Directive 97/68/EC Machinery –

emissions

Engines for non-road

mobile machinery

Proactive/

Inside the national

territory/

Checks on supply

chain, shops,

exhibitions/

Border control

Notification from

Customs Agency/

Complaints/

Technical reports/

Joint actions outcomes/

New products

Inspection of documents/

Visual inspection/

Inspection of companies

High

Directive 2006/42/EC Machinery Earth-moving

machinery, coupling

machinery

Passive control Registration control Inspection of documents High

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18

Surveillance Authority: PHARMACEUTICAL AGENCY

http://www.bda.bg/

Person responsible for the Sectoral NMSP: Lyubomir Dimitrov

e-mail: [email protected]

No of EU

legislation

applicable

Sector Description of the product

category Type of monitoring Monitoring motivation Monitoring activity Priority

Directive

93/42/EEC;

Directive

90/385/EEC;

Directive

98/79/EC

Medical

devices

Medical devices Reactive/

Proactive/

Border control

Complaints/

Tests results/

Joint actions/

During border control

Inspection of

documents/

Visual inspection/

Product testing/

Target groups/

Inspection of

companies/

Random checks

High

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19

Surveillance Authority: REGIONAL INSPECTORATE OF ENVIRONMENT AND WATERS

http://www.moew.government.bg/

Person responsible for the Sectoral NMSP: Ivan Angelov

Stefan Stefanov

e-mail: [email protected]

[email protected]

No of EU

legislation

applicable

Sector Description of the product

category

Type of

monitoring Monitoring motivation Monitoring activity Priority

Regulation (EC)

№ 842/2006,

Regulation (EC)

№ 1494/2007

Electrical

equipment,

chemicals

refrigeration products and

equipment and fire

protection systems which

contain fluorinated

greenhouse gases or

preparations containing

greenhouse gases

Reactive/

Border control

Complaints/

Technical reports/

Joint actions/

New products/

Lack of knowledge/

Re-inspection/

During border control

Information campaign/

Inspection of

documents/

Visual inspection/

Target groups/

Inspection of

companies/

Random checks

Medium

Regulation (EC)

№ 1005/2009

Electrical

equipment,

Chemicals

refrigeration products and

equipment and fire

protection systems which

contain or rely on substances

that deplete the ozone layer

Reactive/

Border control

Complaints/

Technical reports/

Joint actions/

New products/

Lack of knowledge/

Re-inspection/

During border control

Information campaign/

Inspection of

documents/

Visual inspection/

Target groups/

Inspection of

companies/

Random checks

High

Directive

2008/98/EC

Waste waste Reactive/

Border control

Complaints/

Technical reports/

Joint actions/

Re-inspection/

Border control

Control on type and

quantity of waste

generation and

permissions of waste

treatment

High

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20

No of EU

legislation

applicable

Sector Description of the product

category

Type of

monitoring Monitoring motivation Monitoring activity Priority

Directive

2004/42/EC

Products

containing volatile

organic

compounds

certain paints and varnishes

and vehicle refinishing

products in respect of

emissions of volatile organic

compounds due to organic

solvents

Reactive/

Proactive

Complaints/

Tests results/

Joint actions/

New products/

Lack of knowledge/

Re-inspection/

Re-sampling

Information campaign/

Inspection of

documents/

Visual inspection/

Product testing/

Target groups/

Inspection of

companies/

Random checks

Medium

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21

Surveillance Authority: MINISTRY OF HEALTH /28 REGIONAL NEALTH INSPECTORATES/

http://www.mh.government.bg/

Person responsible for the Sectoral NMSP: Dr. Dimitar Dimitrov

e-mail: [email protected]

No of EU

legislation

applicable

Sector Description of the

product category

Type of

monitoring Monitoring motivation Monitoring activity Priority

Directive

76/768/EEC

Cosmetics Cosmetic products Proactive/

Reactive/

Border control

Planned annual

monitoring (“normal”

surveillance, thematic

checks-up, etc.)/

Complaints/

Tests results/

New products/

Lack of knowledge/

Re-inspection/

Re-sampling/

During border control/

RAPEX notifications

Inspection of documents/

Visual inspection/

Product testing/

Target groups/

Inspection of companies/

Random checks/

Thematic checks-up

High

Regulation (EC)

№ 1272/2008;

Regulation (EC)

№ 1907/2006

Chemical

substances,

mixtures and

articles

Chemical substances,

mixtures and articles

(classification,

packaging, labelling and

providing information

through the chain)

Proactive/

Reactive/

Border control

Planned annual

monitoring (“normal”

surveillance, thematic

checks-up, etc.)/

Complaints/

Tests results/

New products/

Lack of knowledge/

Re-inspection/

Re-sampling/

During border control/

RAPEX notifications

Inspection of documents/

Visual inspection/

Product testing/

Random checks/

Thematic checks-up

High

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22

No of EU

legislation

applicable

Sector Description of the

product category

Type of

monitoring Monitoring motivation Monitoring activity Priority

Directive

98/8/EC

Biocidal products Biocidal products Proactive/

Reactive/

Border control

Planned annual

monitoring (“normal”

surveillance, thematic

checks-up, etc.)/

Complaints/

Tests results/

New products/

Lack of knowledge/

Re-inspection/

Re-sampling/

During border control/

RAPEX notifications

Inspection of documents/

Visual inspection/

Product testing/

Random checks/

Thematic checks-up

High

Regulation (EC)

№ 648/2004

Detergents Detergents and

surfactants intended for

detergents (labeling,

packaging and

providing information

about the constituents)

Proactive/

Reactive/

Border control

Planned annual

monitoring (“normal”

surveillance, thematic

checks-up, etc.)/

Complaints/

Tests results/

New products/

Lack of knowledge/

Re-inspection/

Re-sampling/

During border control/

RAPEX notifications

Inspection of documents/

Visual inspection/

Product testing/

Random checks/

Thematic checks-up

High

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23

Surveillance Authority: BULGARIAN FOOD SAFETY AGENCY

http://www.babh.government.bg/

Person responsible for the Sectoral NMSP: Dobrinka Pavlova

Head of Control of Plant Protection Products and Fertilizers Department

Bulgarian Food Safety Agency

e-mail: [email protected]

No of EU

legislation

applicable

Sector Description of the

product category Type of monitoring Monitoring motivation Monitoring activity Priority

Regulation (EC) №

1107/2009

Chemicals Plant protection products Inside the territory/

Preventive/

Reactive

Annual planning/

Complaints/

Test results/

Re-inspection/

Re-sampling/

Control for compliance

Inspection of

documents/

Visual inspection/

Product testing/

Inspection of

companies/

Random checks

High

Regulation (EC) №

2003/2003

Chemicals Fertilizers Inside the territory/

Preventive/Reactive

Annual planning/

Complaints/

Tests results/

Re-inspection/

Re-sampling/

Control for compliance

Inspection of

documents/

Visual inspection/

Product testing/

Inspection of

companies/

Random checks

High