1. Link between Directive 98/34/EC and Regulation (EC) No 764/2008
Brussels, 7 December 2012
Lilia PETROVA – European Commission, DG Enterprise and Industry

2. 98/34 procedure – historical background
Cassis de Dijon judgment of the ECJ
New policy for the Internal Market
Adoption of Directive 83/189/EEC
Now Directive 98/34/EC (modified by Directive 98/48/EC)

3. What is Directive 98/34/EC ? A system of notification
of technical regulations
in draft form
applying standstill periods
during which the Commission
and all Member States
can react in a specific form

4. Objectives of Directive 98/34/EC
Smooth functioning of the Internal Market
Transparency
All participants in the notification procedure are informed
Prevention
Avoiding barriers to trade before they even appear
Subsidiarity
Detecting those cases where EU intervention appears most appropriate
+ Better Regulation
+ Instrument for industrial policy

5. Scope of Directive 98/34/EC
27 EU Member States, Liechtenstein, Norway and Iceland (EEA States), Switzerland, Turkey
The Directive applies to all industrial and agricultural products, including fish products as well as to Information Society services

6. Scope of Directive 98/34/EC
Technical regulations
A. Technical specifications
(products)
B. Other requirements
(products)
C. Laws/regulations/administrative provisions prohibiting the manufacture, importation, marketing/use of a product or prohibiting the provision/use of a service (ECJ)
D. Rules on Information Society services

7. Scope of Directive 98/34/EC De facto technical regulations
Fiscal or financial measures affecting the consumption of products or services
De facto
technical
Regulations
are…
Voluntary agreements
Laws/Regulations referring to some voluntary measures with presumption of conformity

8. Reactions from Commission and Member States
Blocking
Comments
Detailed opinion
Total standstill
period 3 months
Total standstill
period 6 months
Total standstill
period 12 months
4 months for V.A.
and IS services
Taking into account
+ Obligation to
respond
Taking into account
Possible extension to
18 month
Communication of the final text

9. Scope of Regulation (EC) No 764/2008
The Regulation applies to administrative decisions addressed to economic operators, on the basis of a technical rule, in respect of any product lawfully marketed in another Member State, where the direct or indirect effect of that decision is the prohibition, modification, additional testing or withdrawal of the product (Article 2.1)

10. Conditions for the application of the Mutual Recognition Regulation
The (intended) administrative decision must concern a product lawfully marketed in another Member State
The (intended) administrative decision must concern a product which is not subject to harmonised EU law
The (intended) administrative decision must be addressed to an economic operator

11. Conditions for the application of the Mutual Recognition Regulation
The (intended) administrative decision must be based on a technical rule which:
Prohibits the marketing of a Product lawfully placed on the market in another Member State
Lays down characteristics required of that product
Imposes on the product, for the purposes of protecting consumers or the environment, any other requirements which affect the life-cycle of the product after it has been placed on the market

12. Conditions for the application of the Mutual Recognition Regulation
The direct or indirect effects of the (intended) administrative decision must be any of the following:
prohibition of the placing on the market of that (type of) product;
modification or additional testing of that (type of) product before it can be
placed or kept on the market;
withdrawal of that (type of) product from the market

13. Relationship between Directive 98/34/EC and Regulation (EC) No 764/2008
The Directive and the Regulation have differing objectives and apply at different stages:
The Directive seeks to prevent trade barriers in the form of ‘technical regulations’ before they are adopted, by enabling the Commission and Member States to verify that the technical rule is compatible with EU law
The Regulation applies after a ‘technical rule’ has been adopted; it seeks to ensure that any authorities taking decisions based on such rules apply the principle of mutual recognition correctly in individual cases.

14. Relationship between Directive 98/34/EC and Regulation (EC) No 764/2008
Mutual recognition clauses for products lawfully manufactured and/or marketed in other EU Member States or in Turkey, or lawfully manufactured in an EFTA/EEA State still needed
The standard mutual recognition clause may be completed with an additional reference to the applicability of the Regulation:
"The application of this law is subject to Regulation (EC) No 764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State, and to subsequent amendments"

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