Prsentation PowerPoint

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The Mutual Recognition Regulation (EC) 764/2008
Rita LABBATE 6th MARS Group
meeting Bratislava, 2 October 2008
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Index

• Problems with Mutual Recognition
• The Mutual Recognition Regulation 764/2008 (JO
  L218 of 13.08.2008)

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Problems with Mutual Recognition in the
non-harmonised area of products

• Lack of awareness of the principle (businesses
  and administrations)
• Legal uncertainty about
• a) the scope of the principle and
• b) the burden of proof
• (businesses and administrations)
• Risk of not getting access to market in another
  Member State (businesses)
• The absence of a dialogue between authorities
  (administrations)

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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

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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

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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

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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 contact their colleagues in other Member
  States

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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

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The Mutual Recognition Regulation(EC) N 764/2008

• Administrative decisions
• Addressed to economic operator
• Directly or indirectly denying access to the
  market
• Based on a  technical rule 
• Denial of market access - effect of the decision
• Prohibition
• Modification (1 or characteristics)
• Additional Testing
• Withdrawal of a product

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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

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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

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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

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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

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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

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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

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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

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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?
  uriOJL200821800210029ENPDF
• For more information please visit
• http//ec.europa.eu/enterprise/regulation/goods/mu
  trec_en.htm

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• Thank you
• For your attention!