Upload
others
View
2
Download
0
Embed Size (px)
Citation preview
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
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
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
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).
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]
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
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
7
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
8
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
9
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
10
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
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
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
13
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
14
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
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
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
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
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
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]
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
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
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
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
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