Keywords

Summary



Keywords

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1. Actions for failure to fulfil obligations ° Pre-litigation procedure ° Letter of formal notice ° Delimitation of the subject-matter of the dispute ° Reasoned opinion ° Detailed statement of complaints

(EC Treaty, Art. 169)

2. Actions for failure to fulfil obligations ° Examination by the Court as to whether the action is well founded ° Situation to be taken into consideration ° Situation at the expiry of the period laid down in the reasoned opinion

(EC Treaty, Art. 169)

3. Approximation of laws ° Procedure for the provision of information in the field of technical standards and regulations ° Member States' obligation to communicate all draft technical regulations to the Commission ° Concept of technical regulation ° Regulations concerning the quality of waters intended for molluscs ° Inclusion ° Conditions

(Council Directive 83/189, Art. 8)

4. Approximation of laws ° Procedure for the provision of information in the field of technical standards and regulations ° Member States' obligation to communicate all draft technical regulations to the Commission ° Concept of technical regulation ° Compulsory technical specifications concerning production methods and procedures for medicinal products ° Included

(Council Directive 83/189, Art. 1(1) and (5) and Art. 8)

Summary

1. At the pre-litigation stage of proceedings for failure of a State to fulfil its obligations, the purpose of the letter of formal notice is to delimit the subject-matter of the dispute and to indicate to the Member State, which is invited to submit its observations, the factors enabling it to prepare its defence.

Although the reasoned opinion provided for in Article 169 of the Treaty must contain a coherent and detailed statement of the reasons which led the Commission to conclude that the State in question failed to fulfil one of its obligations under the Treaty, the letter of formal notice is not subject to such strict requirements of precision, since, of necessity, it cannot contain anything more than an initial brief summary of the complaints.

2. In an action under Article 169 of the Treaty, the question whether a Member State has failed to fulfil its obligations must be determined by reference to the situation in the Member State as it stood at the end of the period laid down in the reasoned opinion, and the Court cannot take account of any subsequent changes.

3. Where national regulations concerning certain aspects of the quality of the waters intended for edible lamellibranch molluscs stipulate that only molluscs grown in waters complying with the technical specifications it lays down may be marketed, they must be regarded as technical regulations subject to the notification requirement under Article 8 of Directive 83/189 laying down a procedure for the provision of information in the field of technical standards and regulations.

4. It is plain from Article 1(1) of Directive 83/189 laying down a procedure for the provision of information in the field of technical standards and regulations, as amended by Directive 88/182, that the concept of technical specification includes production methods and procedures for medicinal products as defined in Article 1 of Directive 65/65 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products.

Accordingly, a national regulation introducing new compulsory technical specifications for the marketing of proprietary medicinal products made from cattle organs and tissues constitutes a technical regulation within the meaning of Article 1(5) of Directive 83/189, and should be notified to the Commission in accordance with Article 8 thereof.