Transcript The Mutual Recognition Regulation (EC) 764/2008 Rita L’ABBATE 6th MARS Group meeting Bratislava, 2 October 2008

The Mutual Recognition Regulation
(EC) 764/2008
Rita L’ABBATE
6th MARS Group meeting
Bratislava, 2 October 2008
Index
• Problems with Mutual Recognition
• The Mutual Recognition Regulation 764/2008 (JO
L218 of 13.08.2008)
Problems with Mutual Recognition in
the non-harmonised area of products
1. Lack of awareness of the principle (businesses
and administrations)
2. Legal uncertainty about:
a) the scope of the principle and
b) the burden of proof
(businesses and administrations)
3. Risk of not getting access to market in
another Member State (businesses)
4. The absence of a dialogue between
authorities (administrations)
The Mutual recognition- problems
1. Lack of awareness
•
National rules give the impression that they
always prevail
⇒ Businesses and administrations take the national
rule for granted
•
Mutual recognition is a concept developed in
the jurisprudence of the Court of justice on
Articles 28 and 30 EC Treaty
⇒Few people are familiar with mutual recognition
The Mutual recognition- problems
2. Legal uncertainty about scope and
burden of proof
•
Scope: which products are covered?
•
Widespread legal uncertainty about the burden
of proof: abundant jurisprudence of the Court of
Justice requires specialised legal knowledge
⇒ National administrations and businesses take a very
cautious attitude
The Mutual recognition- problems
3. The risk for businesses in another Member
State
Difficult for businesses to know if, how and when
mutual recognition will be applied
⇒Risk avoidance through dialogue (negotiations?)
with administration of Member State of destination
The Mutual recognition- problems
4. The absence of dialogue between
competent authorities
Lack of common address book for authorities that
wish to contact their colleagues in another Member
State where the product is lawfully marketed
⇒Difficult for competent authorities to identify and
their colleagues in other Member States
contact
The Mutual Recognition Regulation
(EC) N° 764/2008
Summary of the Regulation
• Denial of mutual recognition becomes the
exception.
• Definition of rights and obligations:
 Burden of proof on receiving Member State
 Tight deadlines for receiving Member State
• Product Contact Points in Member States will
provide information to enterprises and
competent authorities
• Repeal Decision 3052/95/EC
• Indicative list of products
The Mutual Recognition Regulation
(EC) N° 764/2008
 Administrative decisions:
1.Addressed to economic operator
2.Directly or indirectly denying access to the
market
3.Based on a « technical rule »
 Denial of market access - effect of the decision:
• Prohibition
• Modification (1 or + characteristics)
• Additional Testing
• Withdrawal of a product
The Mutual Recognition Regulation
(EC) N° 764/2008
Regulation does not apply to:
 Most railway equipment
 Withdrawal of dangerous products under GPSD
 Withdrawal of food and feed in order to protect
human health and requiring rapid action
 Emergency measures for food and feed
 Measures regarding non-compliance with EU food
and feed law
The Mutual Recognition Regulation
(EC) N° 764/2008
• Mutual recognition = basic rule (EC Treaty)
• Both actual and possible denial of mutual
recognition governed by Regulation
• Possible denial of mutual recognition?
⇒Obligation for national authorities to start dialogue with
the economic operator and to follow the procedural
requirements established by the Regulation
The Mutual Recognition Regulation
(EC) N° 764/2008
Possible denial of mutual recognition
• Step 1: MS intends to adopt decision to deny MR
 Written notice to economic operator
 Specifying the technical rule
 Setting out technical or scientific evidence:
• that the intended decision is justified by overriding reason of
public interest;
• that no less trade-restrictive measure can be taken
 Intended decision must be based on the characteristics
or type of product
The Mutual Recognition Regulation
(EC) N° 764/2008
Possible denial of mutual recognition
• Step 2: economic operator can submit
comments within time limit set out in written notice
• Step 3: assessment of comments (if any)
• Step 4: decision by public authorities
The Mutual Recognition Regulation
(EC) N° 764/2008
Possible denial of mutual recognition
Competent authorities must:
 Immediately inform economic operator and
 Provide technical or scientific justification for
their decision on the grounds of Article 30 or
mandatory requirements recognised by ECJ
The Mutual Recognition Regulation
(EC) N° 764/2008
Product Contact Points
• Member States must designate at least one Product
Contact Point and inform EC & MS
• Member States are free to entrust the role of Product
Contact Point to new or existing private or public
bodies
• Tasks: to be performed upon request and free of
charge within 15 working days
The Mutual Recognition Regulation
(EC) N° 764/2008
Product Contact Points
Tasks:
 Provide technical rules applicable to a specific
type of product in that Member State
 Advise whether the product is subject to prior
authorisation
 Give contact details of the competent authorities
 Describe remedies generally available in the
national territory in the event of a dispute between
competent authorities and economic operators
The Mutual Recognition Regulation
(EC) N° 764/2008
Regulation will apply from 13 May 2009
Find the text of the Regulation on:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:218:0021:0029:EN:PDF
For more information please visit:
http://ec.europa.eu/enterprise/regulation/goods/mutrec_en.htm
Thank you
For your attention!