EMC Directive
2004/108/EC
Alignment
with NLF
Belgrade, Serbia
November 2010
Jan Coenraads,
Secretary ECANB
[email protected]
Abbreviations used in this presentation
EO
MS
NA
NB
NAB
CAB
LVD
MSA
MSP
NLF
HS
= Economic Operator
= EU Member States (27 Countries)
= New Approach
= Notified Body
= National Accreditation Body
= Conformity Assessment Body
= Low Voltage Directive
= Market Surveillance Authority
= Market Surveillance Programme
= New Legal Framework
= Harmonised Standard
2
Old situation of
horizontal
Framework is
given in the New
Approach Blue
Guide
Note: A new Guide is
not yet available!
New Approach figures
Regulation covers 75% of internal market of
goods in EU:
• 22 industrial sectors
• representing a market volume of around
€ 1 500 billion a year
• 25 NA Directives (EMCD, LVD, R&TTED &
others)
• 1800 (NB), many cover several Directives.
"New Approach", was


successful in enabling manufacturers to sell
their products throughout the EU.
However, experience showed that its efficiency
and implementation could be improved.
Lets look at the
New Legal
Framework
-NLF-
13.8.2008

OJ L 218, pp. 21, 30, 82
The 3 EU documents

Regulation (EC) No 764/2008 laying down procedures relating to the
application of certain national technical rules to products lawfully
marketed in another MS.

Regulation (EC) No 765/2008 setting out the
requirements for accreditation and market
surveillance relating to the marketing of products.

Decision No 768/2008/EC on a common framework
for the marketing of products
EU Law is adopted, its
implementation has started...
Elements of the EU legislation

European Treaty (Treaty of Lisbon 2009)
•
•
defining the aims, principles and fields of European integration.
highest position in EU law and supersedes all other EU legislation as
well as the Member States (MS) national legislation.

Regulation
• direct legal force. MS are obligated to enforce the aspects
solved by the Regulation, without necessity to implement
it into national law.

Directive
•

is not directly effective. To become effective, MS must implement the
directives into their national legislation. Different MS may choose
different ways of implementation into their law.
Decision
•

is an executive tool solving a concrete specific
problem. It is obligatory only for subjects, to which it
is addressed.
Recommendations, Opinions, Resolutions
•
are not enforceable, they are giving recommendation to common
approach
7
Objectives of the NLF
• Facilitate the functioning of the internal
market:
• modernise the conditions for placing of industrial
products on the EU market.
• To introduce better rules on market
surveillance
• protect consumers & professionals from unsafe
products, including imports from third countries.
• Increases the confidence in and quality of
conformity assessments
• reinforced and clearer rules on the requirements for
notification of conformity assessment bodies
(testing, certification and inspection laboratories) 8
Objectives of the NLF (2)
• Enhances the credibility and clarifies the meaning
of CE marking.
• The CE marking will be protected as a community
collective trade mark, which will give authorities and
competitors additional means to take legal action against
manufacturers who abuse it;
• Provide a common legal framework for industrial
products in the form of a toolbox of measures for
use in future legislation.
• Provisions to support market surveillance and
application of CE marking, amongst other things and it
sets out simple common definitions (of terms which are
sometimes used differently) and procedures which will
allow future sectoral legislation to become more
consistent and easier to implement.
Regulation No
765/2008/EC
Accreditation and market
surveillance
Main aspects
Regulation (EC) No 765/2008
Overview of topics
Definitions (terminology of marketing and economic operators/operations)
making available on the market, placing on the market, manufacturer,
authorised representative, importer, distributor
conformity assessment body, accreditation body, market surveillance authority,
release for the free circulation, withdrawal, recall
Accreditation of the NB
- organisation of accreditation bodies
- procedures of the accreditation for notification
Market surveillance protecting the public interest
- health and safety
- occupational health and safety (on workplaces)
- consumer protection
- environment protection
Control of the products from 3rd countries
General principles of the CE marking
Regulation (EC) No 765/2008
Relevant Accreditation issues
Accreditation is the primary tool for checking of NB
competence (qualification) for a specific conformity assessment activity
MS have a right not to use the accreditation – in such case the
MS shall provide the Commission and all MS with documentation of
alternative verification of NB competence
Complains of NB against accreditation decision shall be solved
by MS
No decision yet how to proceed with accreditation procedure in
cases of NBs asking for notification according to more Directives (e.g. EMCD,
R&TTED and LVD).
Two possibilities are available:
One accreditation process and NAB decision covers all Directives, that the NB applied
for.
 For each Directive to be included into NB scope, a separate accreditation process.

Expenses for accreditation:
It is expected that the new accreditation rules will increase accreditation
costs for NBs!!
Regulation (EC) No 765/2008
Market surveillance issues
MS shall conduct market surveillance
MS shall appoint one or more MSA (incl. their scopes)
MS shall establish procedures for complaints or reports relating to product joined
risk
- monitor accidents and harm to health
- verify that corrective actions have been taken
- follow up scientific and technical knowledge
(state of the art) concerning safety
MS shall establish and periodically update their Market Surveillance
Programmes
- information shall be available to Commission and public
- the first MSP programme shall be applied by 1 January 2010
Products presenting a serious risk shall be uploaded by MS into
RAPEX (a previous risk analysis is necessary step)
MS shall apply restrictive measures that:
- shall be proportional
- shall be applied after 10 days period (incl. opportunity of the guilty to be heard)
- shall be withdrawn or amended after corrective action
RAPEX: EU Rapid Alert System for all dangerous consumer
products. (not medical devices).
Rapid exchange of information between MS via “National
Contact Points” and the Commission of:
measures taken to prevent or restrict the marketing or use
of products posing a serious risk to the health and safety of
consumers.
Both measures ordered by national authorities and
measures taken voluntarily by producers and distributors
are covered by RAPEX.
Every Friday, the Commission publishes an overview of the
dangerous products reported by the national authorities.
This weekly overview gives you all information on the
product, the possible danger and the measures that were
taken by the reporting country.
ICSMS
Information and Communication
System for Market Surveillance
States, where ICSMS is used by market
surveillance authorities:
Austria, Belgium, Cyprus, Estonia, Germany,
Luxemburg, Malta, Slovenia, Sweden,
Switzerland, The Netherlands and United
Kingdom.
Regulation (EC) No 765/2008
Control of 3rd country (imported) products
MS authorities (e.g. customs) responsible for goods imported shall perform the same control
activities as the Market surveillance bodies.
Products shall not be released for free circulation, when
- the characteristics of the products indicate a risk to public interest
- obligatory documentation is missing
- CE-marking is missing, or affixed in false or misleading manner
In such case, the MSA shall be notified by the authorities protecting the
external border.
MSA shall decide on the product risk or non-conformity in 3 working days and inform the
authorities protecting the external border on the measures adopted. If they are not informed in that time, the
products shall be released to internal circulation.
MSA
3 days
Regulation (EC) No 765/2008
CE Marking
CE marking shall be affixed only by:
-
manufacturer
authorized representative
CE marking is the only marking confirming product conformity with the
requirements of the Directive(s)
The affixing of the CE marking on products not covered by the appropriate
Directive is prohibited
By affixing the CE marking, the manufacturer indicates his responsibility for
product conformity with all relevant legislative requirements, among others
- Compliance with essential requirements
- fulfilling of the administrative provisions (EU DoC)
- satisfactory results of properly chosen conformity assessment
procedure
- providing necessary information for users and for the MSA
Affixing of misleading marks/signs similar to CE is prohibited
MS shall provide for penalties in case of infringements of the CE marking
Decision No 768/2008/EC
Common framework
Main aspects
18
Decision No 768/2008/EC
General remarks
The Decision No 768/2008/EC is a kind of template, which shall be used by
creators of a new legislation – especially amended New Approach
Directives, such as the EMC Directive.
The most important provisions are formulated in three Annexes:
- Annex I
harmonisation
- Annex II
– Reference provisions for Community
legislation for products
– Conformity assessment procedures (Modular
system)
- Annex III
– EU Declaration of Conformity (a template)
19
Decision No 768/2008/EC – Annex I
Some Terms and Definitions
Making available on the market  any supply of a product for
distribution, consumption or use on the Community market.
Placing on the market  first making available the product on the market
Manufacturer  natural or legal person who manufactures a product or has
a product designed or manufactured, and markets that product under his
name or trademark (’’by affixing his logo on the product he become its
manufacturer !!’’)
Authorized representative  natural or legal person established within the
EU who has got a written manufacturer’s mandate to act on his behalf in
specified tasks
Importer  person established within the EU who places a product from a
3rd country on the market
Distributor  any person not being manufacturer nor importer, who makes a
product available on the market
Economic operators  subjects mentioned in items 3 to 6
Technical specification  document prescribing technical requirements for
a product, process or service
Decision No 768/2008/EC – Annex I
Some Terms and Definitions 2
Conformity assessment  process demonstrating fulfilling of specified
requirements relating to a product, process, service, system, person or body
Conformity assessment body (CAB/NB)  body performing conformity
assessment activities including calibration, testing, certification and inspection
Recall  any measure aimed at achieving the return of a product that has
already been made available to the end user (Recall means taking away of
the defective products from ultimate owner/user)
Withdrawal  any measure aimed at preventing a product in the supply chain
from being made available on the market (Withdrawal does not relates to
products already sold to end users)
CE marking  marking by which the manufacturer indicates that the product is
in conformity with the applicable requirements set out in Community
harmonisation legislation providing for its affixing
Decision No 768/2008/EC – Annex I
Obligations of manufacturers
•
design and manufacture products in conformity with R&TTED +
•
•
•
draw up technical documentation & keep available for specified period
•
indicate his name and contact address to product, packaging, or
have quality procedures to assure series conformity
identify product (type/model/batch/serialnr. affixed, or in leaflets,
accompanying docs
•
provide the instruction for use and safety information in language of
•
•
•
•
issue the EU DoC - Declaration of Conformity
destination MS
affix the CE marking on the (compliant) product
on demand provide MSA documents and cooperate on risk removal
identify any economic operator to whom he has supplied the
product (on demand)
Decision No 768/2008/EC – Annex I
Obligations of authorised representatives
•
have a written mandate that authorises him to
perform specific tasks. These tasks cannot include
design of the product nor assembling the technical
documentation.
•
•
•
keep the EU DoC - Declaration of Conformity
•
identify any economic operator who has supplied the
product (on demand)
•
identify any economic operator to whom he has
supplied the product (on demand)
keep the technical documentation for a specified time
on demand provide the MSA documents and cooperate
on product-associated risk removal
Decision No 768/2008/EC – Annex I
Obligations of importers
•
•
place only compliant products to the EU market
•
ensure that instruction for use and safety information in
language of destination MS are provided
•
indicate his name and contact address to product, packaging,
or accompanying docs
•
assure that storage condition and transport do not jeopardize
its compliance
•
•
keep the EU Declaration of Conformity for specified period
•
on demand identify any economic operator who has supplied
the product
•
on demand identify any economic operator to whom he has
supplied the product
ensure that appropriate conformity assessment procedures
have been carried out (Documentation exist, CE marking
applied, DoC issued)
on demand provide the MSA documents and cooperate on risk
removal
Decision No 768/2008/EC – Annex I
Obligations of distributors
•
•
place only compliant products to the EU market
•
ensure that instruction for use and safety information in
language of destination MS are provided
•
ensure that manufacturer and importer have indicated
their names and contact addresses to product, packaging,
or accompanying documents
•
assure that storage condition and transport do not
jeopardize its compliance
•
on demand provide the MSA by documents and cooperate
on risk removal
•
on demand identify any economic operator who has
supplied him the product
•
on demand identify any economic operator to whom he has
supplied the product
ensure that appropriate conformity assessment
procedures have been carried out (Documentation exist,
CE marking applied, EU DoC issued)
Decision No 768/2008/EC – Annex I
EU Declaration of Conformity (DoC)
•
Only 1 DoC shall be issued in case more Directives
relating to one product!! (now different for EMCD!)
•
A DoC shall have a structure according to the Annex
III of the Decision 768/2008/EC
•
The EMCD can and may prescribe further obligatory
elements of the DoC.
•
The DoC shall be translated in any official languages
in MS of destination
•
The DoC shall be continuously updated (due to
changes in design, technology, legislation, harmonised
standards)

By drawing up the EU DoC the manufacturer shall
assume responsibility for the compliance of the
product
Decision No 768/2008/EC – Annex I
Notified Bodies and notification procedure
Notified Bodies 
are designated by a MS Notifying (Designating) Authority based on national
procedures conveyed to the Commission

are established under national law and have legal personality

are third parties - independent of manufacturers and their customers
body belonging to a business association or professional federation representing undertakings
involved in the design, manufacturing, provision, assembly, use or maintenance of products
which it assesses, may be a Notified Body on condition that it demonstrates its independence
and absence of any conflict of interest

NB, its top management and personnel shall not be involved in design,
manufacture, marketing, installation, use or maintenance of the products
assessed (personal purpose allowed)

shall not offer consultancy

shall be capable perform the notified scope tasks themselves or on their behalf
Decision No 768/2008/EC – Annex I
Notified Bodies and notification procedure
Notified Bodies shall:

have appropriate personnel with






sound technical training
knowledge of technology and harmonized standards
understanding of the essential requirements and
necessary authority to carry out the assessment
ability to draw up records, reports, certificates
observance of professional secrecy and confidentiality (except to their MS
competent authorities)

guarantee impartiality of assessment

have insurance agreement covering liability for improper decision

participate in the relevant standardisation activities (or be
informed of such as is done in ECANB by its Secretariat)

shall participate (directly or by means of designated MS
representatives) in activities of relevant NB Coordination Group
(ECANB) and apply as general guidance their documents and
decisions.
no requirement for testing equipment is explicitly specified!
Decision No 768/2008/EC – Annex I
NB and notification procedure
Notification procedure 
CAB submits to the Notifying Authority an application jointly
with:
 scope, i.e. Directive, module(s), product(s) applied for
 accreditation certificate of NAB confirming the fulfilling of the
requirements to NB
 other documentary evidence, if accreditation has not been
done

Notifying authority decides on the application
( designation,  refusal)

Notification is electronic (NANDO), providing all details of
the approved scope
Decision No 768/2008/EC – Annex I
NB and notification procedure (2)

If a Notifying Authority does not utilize the accreditation, it
provides the Commission and MSs with documentary
evidence of the NB qualification

Standstill procedure terms for the objections of Commission
and MS’s: 2 weeks, if the notification is based on the
accreditation certificate
2 months, if the notification is not based on
accreditation

Commission assign to NB an identification number (only one
for all Directives covered)

Notifying Authority is responsible for surveillance (either by
NAB or by itself)
Experience:
All Italian EMC NB’s have been deleted from
NANDO due to misunderstanding of these rules.
ALIGNMENT
• The New Legislative Framework is a new set of
rules whose overall objective is to improve the
functioning of the internal market.




Reinforce market surveillance at European level
Improve transparency in the control of Notified Bodies
Reinforce the CE marking
Ensure more consistency and compatibility between
Directives
• It requires the modification of the existing
Directives: we call this exercise ALIGNMENT.
Directives for Alignment
1. Low Voltage Directive 2006/95/EEC
2. Simple Pressure Vessels Directive: 2009/105/EC
3. Non-automatic Weighing Instruments Directive: 2009/23/EC
4. Civil Explosives Directive: 93/15/EEC
5. ATEX Directive: Directive 94/9/EC
6. Lifts Directive: 95/16/EC
7. Pressure Equipment Directive: 97/23/EC
8. Measuring Instruments Directive: 2004/22/EC
9. Electromagnetic Compatibility Directive: 2004/108/EC
10. Pyrotechnic articles Directive: 2007/23/EC
Question: Why is the Toy Directive not mentioned?
On 30 June 2009 a new Toy Safety Directive was already published.
This Directive is already fully aligned to the NLF.
It gives good insight of what one can expect in an aligned Directive,
but each Directive has possibility to make different decisions (if
justified)
What does NOT change in the EMCD?






Essential requirements
Scope: Definitions of “equipment, apparatus and fixed
installation”
Role of harmonised standards
Role of notified bodies
Conformity assessment procedures
Documentation requirements
Foreseen modifications for the EMC Directive
 Some definitions, contained in Art. 2.
 Obligations of Economic Operators:
 Safeguard procedure
 Doc requirements
 Procedural Operation of the NB??
Timeline for the alignment of the EMCD






The Commission is currently drafting
the proposal.
An impact assessment must be done.
Final Commission proposal: end 2010.
Discussions in the Council and
European Parliament in 2011.
The new text will establish a
transposition deadline for Member
States.
The new EMC Directive will not be
implemented in the Member States
before 2012.
End of Presentation
Thank you for your attention
Any QUESTIONS ??