EN Official Journal of the European Union C 151/11

Opinion of the European Economic and Social Committee on the Proposal for a Directive of the European Parliament and of the Council repealing Council Directive 84/539/EEC on the approximation of the laws of the Member States relating to electro-medical equipment used in veterinary medicine

COM(2007) 465 final — 2007/0168 (COD)

(2008/C 151/02)

On 26 September 2007 the Council decided to consult the European Economic and Social Committee, under Article 95 of the Treaty establishing the European Community, on the

Proposal for a Directive of the European Parliament and of the Council repealing Council Directive 84/539/EEC on the approximation of the laws of the Member States relating to electro-medical equipment used in veterinary medicine

The Section for the Single Market, Production and Consumption, which was responsible for preparing the Committee's work on the subject, adopted its opinion on 3 December 2007. The rapporteur was Mr Salvatore.

At its 441st plenary session, held on 16 and 17 January 2008 (meeting of 16 January), the European Economic and Social Committee adopted the following opinion by 151 votes with one abstention.

1. Conclusions and recommendations

1.1 The EESC endorses the proposal to repeal Directive 84/539/EEC relating to electro-medical equipment used in veterinary medicine. The Directive concerned has for some time been replaced by other current Community laws and would appear to serve no further purpose for the single market or for trade with third countries.

1.2 The EESC notes that the decision to repeal Directive 84/539/EEC has been approved by the Member States and the industry following wide consultation.

1.3 The EESC holds the Commission responsible for conducting checks to ensure that the corresponding laws in force at national level are repealed so that they do not create new technical barriers or undermine the expected benefits.

2. Background

2.1 In its Communication of 16 March 2005 (COM(2005) 97 final), the Commission highlighted the need to simplify national and European legislation when this would improve the competitiveness of companies and cut unnecessary costs.

2.2 This policy guideline was reinforced in 2006 with the working document entitled First progress report on the strategy for the simplification of the regulatory environment (COM(2006) 690 final), which identified initiatives ripe for simplification in the 2006-2009 period. Council Directive 84/539/EEC, on the approximation of the laws of the Member States relating to electro-medical equipment used in veterinary medicine, was among the 43 initiatives selected.

2.3 The European Parliament's IMCO committee, which has already examined the issue, has decided to lend complete support to the Commission's decision.

3. The Commission proposal

3.1 The consultation of interested parties (the industry and Member States) led to the conclusion that Directive 84/539/EEC was no longer used in practice as its objectives and the necessary guarantees in terms of health and safety were covered by other Community laws in force, including Directive 93/42/EEC on medical devices (for human use), and the directives on machinery and electromagnetic compatibility.

3.2 The Commission notes that this legislation no longer appears to serve any purpose for the single market or for trade with third countries. Applying the principle of ‘parallel forms’, the Commission therefore proposes the repeal of Directive 84/539/EEC as of 31 December 2008. Following that date, the Annex III mark of conformity should no longer be used.

3.3 The Commission also calls on the Member States to adopt all necessary provisions to conform to this Directive by 31 December 2008.

4. Comments

4.1 The EESC approves of the proposal to repeal Directive 84/539/EEC and agrees with the reasons for doing so.

4.2 The EESC would point out that the Bulgarian, Danish, Italian, Romanian and Swedish versions of the Directive's title include the word ‘human’: this should be deleted.

4.3 The EESC calls on the Commission to carry out the necessary checks to ensure that the benefits stemming from this decision, with regard to electro-medical equipment used in veterinary medicine, are not undermined by new national laws that might constitute unjustifiable barriers to trade.