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 )

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 contact their colleagues in other Member States

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: For more information please visit:

Thank you For your attention!