Market Surveillance
Europe
Jan Deconinck, M.Sc.
Prosafe Chairman
4th International Workshop on Conformity Assessment - Rio De Janeiro - 8 / 9 December 2008
Overview
1. Legal framework - "New Approach"
2. Overview of national organisation
1. Belgium
2. France
3. Spain
4. Portugal
3. Market surveillance (case study Belgium)
1. Tasks
2. Powers
3. Organisation
4. Conclusions
4th International Workshop on Conformity Assessment - Rio De Janeiro - 8 / 9 December 2008
•
Product Safety Enforcement Forum of
Europe
•
Established in 1990 by market surveillance
officers
•
Over 20 EU and EFTA member states
regularly represented at meetings
4th International Workshop on Conformity Assessment - Rio De Janeiro - 8 / 9 December 2008
•
Goal to improve market surveillance by
promoting closer co-operation and
collaboration amongst national authorities
•
Partner with European Commission on
EMARS Project and Lighters Project,...
•
www.prosafe.org
4th International Workshop on Conformity Assessment - Rio De Janeiro - 8 / 9 December 2008
4th International Workshop on Conformity Assessment - Rio De Janeiro - 8 / 9 December 2008
1. Legal Framework
"New Approach"
GPSD
Producers shall be obliged to place only safe
products on the market.
1. Legal Framework
GPSD
Producers shall be obliged to place only safe
products on the market.
A product shall be presumed safe as far as the risks
and risk categories covered by relevant national
standards are concerned when it conforms to
voluntary national standards transposing European
standards, …
1. Legal Framework
New approach
The directives establish only the essential requirements which the
products must satisfy. Products which do satisfy these requirements
must be authorised by the various Member States on their respective
markets. Manufacturers may of course place on the market products
which satisfy higher quality and safety levels. But Member States
cannot require this (except in certain specific cases).
Products which do not meet these requirements may not be placed on
the market.
The essential requirements imposed in the directives specifically relate
to the risks linked to use of the products. The requirements are imposed
on the designers, producers and importers and bear on the design,
manufacture and sale.
1. Legal Framework
These Directives have a dual purpose:
- ensuring the free movement of goods through
technical harmonisation of entire product sectors,
and of
- guaranteeing a high level of protection of public
interest
1. Legal Framework
Key principles :
- the definition of mandatory essential
requirements,
- the setting up of appropriate conformity
assessment procedures
- the introduction of CE marking.
- Business and industry are given a wide choice
of how to meet their obligations.
- The European standards bodies have the task
of drawing up technical specifications.
1. Legal Framework
•Products manufactured in conformity with
harmonised standards are presumed to be
conformant to the essential requirements
•Standards are not mandatory, they remain
voluntary (Alternate paths are possible but the producer
has an obligation to prove his products are conformant to the
essential requirements)
•Standards must offer a guarantee of quality
with regard to the essential requirements of
the directives
1. Legal framework
Europe
Belgium
General Product Safety
Directive 2001/95/EC of 3
DEC 2001
Law on Safety of Products
and Services of 9 FEB 1994
(modified 18 December
2002)
effective: 15 JAN 2004
effective: 16 FEB 2003
Consumer Products for
those aspects and risks
which are not covered by
specific Community law
with the same objective
+ professional products
+ services
1. Legal framework
Belgium
Professional products
Integration of the regulations concerning the safety of
•machinery
•personal protective equipment
•pressure equipment
•lifts
•...
into the law on safety of products and services
1. Legal framework
Belgium
Services
The fact to make a product (or installation) available to
a consumer
Each use that might endanger the consumer
•playgrounds
•fair grounds
•active leisure (karting, bungee, in-door climbing,...)
•renting of products (DIY, ice skating, ...)
•...
1. Legal framework
Belgium
The law is the horizontal legal base for :
- the transposition of several new approach directives
- Belgian ‘New Approach Type’ royal decrees
Renting
...
Active leisure
Fair grounds
Playgrounds
Lifts
...
PED
PPE
Toys
Machinery
Law on the safety of products and services
2. Overview of national organisation
Population
Surface
Belgium
10 million
30,500 km²
France
61 million
552,000 km²
Spain
45 million
506,000 km²
Portugal
10 million
92,000 km²
2.1 Overview of national organisation
BELGIUM
Geographic-Administrative structure
Belgium is a federal country which comprises
• 3 Regions :
Flanders
Wallonia
Brussels-Capital
• 3 Languages (Dutch, French and German)
2.2 Overview of national organisation
BELGIUM
Market Surveillance Organisation
Federal Public Service (FPS) Economy, S.M.E.'s, Selfemployed and Energy
•3 regional services
•Other authorities include:
•FPS Labour
•FPS Mobility and transport
•FPS Health
•FPS Finance
2.1 Overview of national organisation
BELGIUM
Market Surveillance Organisation
General coordination: Central Contact Point for Consumer
Products
Consumer Safety Commission (CSC)
The CSC is an independent assembly
•To issue recommendations and suggest any measure to better the
prevention of risks as regards the safety of products and services
•To make evaluations of risks concerning consumer products
• To co-ordinate all federal goverment campaigns concerning product
safety
2.2 Overview of national organisation
FRANCE
Geographic-Administrative structure
France is a republic divided into
26 Regions
100 Departments
2.2 Overview of national organisation
FRANCE
Market Surveillance Organisation
•The general Directorat for Competition, Consumption and
Fraud Repression is the General authority for market
surveillance. (DGCCRF):
• All consumer products, food, feed and industrial products on all
levels (production, import, distribution)
• Safety of services
•23 regional directorates (regions)
•Use of own laboratories (DGCCRF + DGDDI (Customs),
total of 9 labs 470 workers)
2.2 Overview of national organisation
FRANCE
Market Surveillance Organisation
•Other authorities include:
•The general directorate on customs (DGDDI)
•General directorate on regional action, quality and
industrial safety
•General directorate on housing and construction
•Directorate on working relations
General coordination: The Interministerial Committee on
Consumer Affairs
2.2 Overview of national organisation
FRANCE
Consumer Safety Commission (CSC)
•The CSC is an independant public authority
Missions:
•To issue recommendations (> 350) and suggest any measure
to better the prevention of risks as regards the safety of
products and services
•To bring to the public’s knowledge all the information the
Commission thinks necessary
•To search and make a list of all data on the dangers
presented by products or services
2.3 Overview of national organisation
SPAIN
Geographic-Administrative structure
Spain is, what is called a State of Autonomies, formally
unitary but, in fact, functioning as a highly decentralized
Federation of Autonomous Communities
• 50 provinces
• 17 autonomous communities
It is regarded as the most
decentralized nation in Europe
2.3 Overview of national organisation
SPAIN
Market Surveillance Organisation
The Autonomous Communities are each completely
responsible for all consumer issues.
The practice of market surveillance is the responsibility of the
autonomous communities.
General coordination: The Spanish
National Consumer Institute
•Link with European Commission
•RAPEX
2.4 Overview of national organisation
PORTUGAL
Geographic-Administrative structure
Portugal consists of 308 municipalities, witch are organised
in a very complex manner.
The main structures are:
18 districts
5 NUTS II Regions (Comissões de Coordenação
e Desenvolvimento Regional - Nomenclature of
Territorial Units for Statistics)
2.4 Overview of national organisation
PORTUGAL
Market Surveillance Organisation
Instituto do Consumidor (Institute of the Consumer)
The Institute is in charge of the control of compliance:
•advertising code,
•direct marketing
•consumer safety
2.4 Overview of national organisation
PORTUGAL
Consumer (Services and Products) Safety Commission (CSC)
The CSC is an independant
public authority
Missions:
•To issue recommendations and suggest any measure to
better the prevention of risks as regards the safety of
products and services
•To bring to the public’s knowledge all the information the
Commission thinks necessary
•To search and make a list of all data on the dangers
presented by products or services
3. Market Surveillance
Tasks - Powers - Organisation
Europe
Competent Authorities
Nominate the authorities competent to monitor the
compliance of products
and define their:
• tasks
• powers
• organisation
3.1 Market Surveillance – Tasks
Market Surveillance
Ensure that producers and distributors comply with their
obligations
3.1 Market Surveillance – Tasks
Market Surveillance
Ensure that producers and distributors comply with their
obligations
Producers shall only place safe products on the market
• Introduction of ‘harmonised’ standards which give presumption of
conformity
• Producers shall provide relevant information to enable
consumers to assess the risks inherent in a product
• Producers shall adopt measures to enable them to be
informed of risks an take appropriate actions
Traceability
---
RAPEX
3.1 Market Surveillance – Tasks
Market Surveillance
Ensure that producers and distributors comply with their
obligations
Distributors shall not supply products of which they
(should) know that they don’t comply with the applicable
safety requirements
Distributors shall participate in monitoring the safety of
products
3.1 Market Surveillance – Tasks
Market Surveillance
Ensure that producers and distributors comply with their
obligations
• Give the opportunity to consumers and other interested parties to
submit complaints and follow op these complaints
•Establish sectoral surveillance programmes
•Follow-up of scientific and technical knowledge concerning
product safety
•Periodical review and assessment of the surveillance activities
and approach
3.2 Market Surveillance - Powers
Europe
Powers
Give the authorities the necessary powers to take
appropriate action and measures
3.2 Market Surveillance - Powers
Belgium
Powers (1)
•By royal decree rules can be established for the
manufacturing, the import, the export, the
modification, the marketing, the renting, the
distribution for free, the labelling, the use ... of
products or types of products
•Advice is needed from the Consumer Safety Commission
3.2 Market Surveillance - Powers
•By royal decree rules can be established for the manufacturing, the
import, the export, the modification, the marketing, the renting, the
distribution for free, the labelling, the use ... of products or types of
products
3.2 Market Surveillance - Powers
Belgium
Powers (2)
•The Minister can order:
•to stop the selling of the product
•to withdraw the products of the market
•to inform the public
•to recall very dangerous products
•to destroy products if needed
•to publish the results of tests and decisions
•a warning to the manufacturer
•the manufacturer to have the product tested by an independent
laboratory
3.2 Market Surveillance - Powers
•The Minister can order:
•to withdraw the products of the market
foto eclipsbril
3.2 Market Surveillance - Powers
•The Minister can order:
•to publish the results of tests and decisions
3.2 Market Surveillance - Powers
•The Minister can order:
•to recall very dangerous products
3.2 Market Surveillance - Powers
•The Minister can order:
•to inform the public
3.2 Market Surveillance - Powers
•The Minister can order:
•to inform the public
3.2 Market Surveillance - Powers
•The Minister can order:
•to inform the public
3.2 Market Surveillance - Powers
•The Minister can order:
•to destroy products if needed
3.2 Market Surveillance - Powers
•The Minister can order:
•to stop the selling of the product
3.2 Market Surveillance - Powers
•The Minister can order:
•the manufacturer to have the
product tested by an
independent laboratory
3.2 Market Surveillance - Powers
Belgium
Powers (3)
•The competent authorities can:
•enter every storage shed, shop, plant
•take samples free of charge and examine them
•take every document they need
•hear producers and employees
•use the finding of other competent authorities
•block stocks
3.2 Market Surveillance - Powers
•The competent authorities can:
•take samples free of charge and examine them
3.2 Market Surveillance - Powers
•The competent authorities can:
•take samples free of charge and examine them
3.2 Market Surveillance - Powers
•The competent authorities can:
•take samples free of charge and examine them
3.2 Market Surveillance - Powers
•The competent authorities can:
•take every document they need
3.2 Market Surveillance - Powers
Europe
Penalties
Provide for effective, proportionate and dissuasive
penalties
3.2 Market Surveillance - Powers
Belgium
Penalties
•In case of non-respect of the law, penalties can go
up to € 20.000 for each infringement
•Penalties are doubled when the infringement is
repeated within 5 years
•Excessive/unauthorised profits can be confiscated
•Publication of the judgement by any means can be
ordered
3.3 Market Surveillance - Organisation
Belgian Competent Authorities
FPS Economy, SMEs,
Self-employed and
Energy
3.3 Market Surveillance - Organisation
Belgian Competent Authorities
FPS Economy, SMEs,
Self-employed and
Energy
FPS Employment,
Labour and Social
dialogue
3.3 Market Surveillance - Organisation
Belgian Competent Authorities
FPS Economy, SMEs,
Self-employed and
Energy
FPS Health, Food
Chain Safety and
Environment
FPS Employment,
Labour and Social
dialogue
3.3 Market Surveillance - Organisation
Belgian Competent Authorities
FPS Economy, SMEs,
Self-employed and
Energy
FPS Employment,
Labour and Social
dialogue
FPS Mobility
and Transport
FPS Health, Food
Chain Safety and
Environment
3.3 Market Surveillance - Organisation
Belgian Competent Authorities
FPS Economy, SMEs,
Self-employed and
Energy
FPS Employment,
Labour and Social
dialogue
FPS Mobility
and Transport
FPS Health, Food
Chain Safety and
Environment
FPS Finance
3.3 Market Surveillance - Organisation
Belgian Competent Authorities
FPS Employment,
Labour and Social
dialogue
FPS Economy, SMEs,
Self-employed and
Central Contact
Energy
Point
FPS Mobility
and Transport
FPS Health, Food
Chain Safety and
Environment
FPS Finance
3.3 Market Surveillance - Organisation
Belgian Competent Authorities
FPS Employment,
Labour and Social
dialogue
FPS Economy, SMEs,
Self-employed and
Central Contact
Energy
Point
FPS Health, Food
Chain Safety and
Environment
Consumer Safety
Commission
FPS Finance
FPS Mobility
and Transport
3.3 Market Surveillance - Organisation
Belgian Competent Authorities
FPS ECONOMY
FPS Economy
DG Energy
DG Quality and Safety
DG Control and Mediation
Central Laboratory
Safety Division
Product Safety Service
Installation Safety Service
Decentralised services
3.3 Market Surveillance - Organisation
Belgian Competent Authorities
CENTRAL CONTACT POINT
• Consumers, producers and distributors report
products and services that don’t fulfill the safety
requirements
• Belgian contact point for the European Exchange
systems (RAPEX, CIRCA, ...)
•Statiscal evaluations of risks concerning consumer
products
• Co-ordinate all federal goverment campaigns
concerning product safety
3.3 Market Surveillance - Organisation
Belgian Competent Authorities
CENTRAL CONTACT POINT
Central Contact Point
3.3 Market Surveillance - Organisation
Consumers
Industry
Authorities
Central Contact Point
3.3 Market Surveillance - Organisation
Consumers
Industry
Authorities
Central Contact Point
RAPEX
3.3 Market Surveillance - Organisation
Consumers
Industry
Authorities
Central Contact Point
RAPEX
Advisory
commissions
Ext. experts
and
mediation
3.3 Market Surveillance - Organisation
Consumers
Market
surveillance
Consumers,
industry, notified
bodies ...
Industry
Authorities
Central Contact Point
RAPEX
Advisory
commissions
Ext. experts
and
mediation
Product
Follow up
control
Market surveillance by the authorities
4. Conclusions
4.1 Organisation
The organisation of the Market Surveillance Authorities is
closely linked to the geographic administrative structure of
the country.
In highly decentralised countries a coordination authority is
needed:
• Belgium: Central Contact Point for Consumer Products
• France: Interministerial Committee on Consumer Affairs
• Spain: the National Consumer Institute
4. Conclusions
4.2 Enforcement <> Information
In most countries a distinction is made between:
• the Market Surveillance Authority
surveillance
enforcement
•
an (independent) Commission (outside authority)
to give independent advice
to inform the public
to gather statistical information
4. Conclusions
5.3 Effectiveness
In order to be effective, a MSA needs:
•
the necessary powers to take appropriate action and
measures
•
to participate in networking (information exchange)
- nationally
- European-wide
- internationally
5. Questions ?
4th International Workshop on Conformity Assessment - Rio De Janeiro - 8 / 9 December 2008