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)
Date: 2008-01-16
Institutions: European Economic and Social Committee
Subjects: EC Directive, approximation of laws, electrical equipment, quality label, repeal, technical regulations, veterinary medicine

17.6.2008

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 approxima-
tion 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 Salva-
tore.

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

3. The Commission proposal

The EESC endorses the proposal

1.1
to repeal Directive
84/539/EEC relating to electro-medical equipment used in veter-
inary 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 The Directive concerned has for some time been
replaced by other current Community laws and would appear to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.

The EESC holds

1.3
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force at national level are repealed so that they do not create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.

the Commission responsible

2. Background

In its Communication of 16 March 2005 (COM(2005)
2.1
the Commission highlighted the need to simplify
97 final),
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.

Brussels, 16 January 2008.

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 neces-
sary 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.

The Commission notes that this legislation no longer
3.2
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

The EESC approves of the proposal to repeal Directive

4.1
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.

The EESC calls on the Commission to carry out the
4.3
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.

The President
of the European Economic and Social Committee
Dimitris DIMITRIADIS