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COUNCIL DIRECTIVE 93/68/EEC of 22
July 1993

amending Directives 87/404/EEC
(simple pressure vessels), 88/378/EEC (safety of toys), 89/106/EEC
(construction products), 89/336/EEC (electromagnetic compatibility), 89/392/EEC
(machinery), 89/686/EEC (personal protective equipment), 90/384/EEC
(non-automatic weighing instruments), 90/385/EEC (active implantable medicinal
devices), 90/396/EEC (appliances burning gaseous fuels), 91/263/EEC
(telecommunications terminal equipment), 92/42/EEC (new hot-water boilers fired
with liquid or gaseous fuels) and 73/23/EEC (electrical equipment designed for
use within certain voltage limits)

 

THE COUNCIL OF THE EUROPEAN
COMMUNITIES,

 

Having regard to the Treaty
establishing the European Economic Community, and in particular Article 100a
thereof,

Having regard to the proposal from
the Commission (1),

In cooperation with the European
Parliament (2),

Having regard to the opinion of the
Economic and Social Committee (3),

Whereas the Council has already
adopted a series of Directives designed to remove technical barriers to trade
in accordance with the principles established in its Resolution of 7 May 1985
on a new approach to technical harmonization and standards (4); whereas each of
these Directives provides for the affixing of the 'CE' marking; whereas,
therefore, in the interests of simplifying Community legislation and making it
more consistent, these various provisions need to be replaced by uniform
prescriptions; whereas it is therefore necessary to harmonize these provisions,
particularly with regard to products which may fall within the scope of several
of these Directives;

Whereas, in its communication of 15
June 1989 on a global approach to certification and testing (5), the Commission
proposed that common rules be drawn up concerning a 'CE' conformity marking
with a single design; whereas, in its Resolution of 21 December 1989 on a
global approach to conformity assessment (6), the Council approved as a guiding
principle the adoption of a consistent approach such as this with regard to the
use of the 'CE' marking;

Whereas the two basic elements of
the new approach which must be applied are therefore the essential requirements
and the conformity assessment procedures;

Whereas this harmonization of the
provisions concerning the affixing and use of the 'CE' marking requires that
existing Directives undergo detailed amendment to bring them into line with the
new arrangements,

HAS ADOPTED THIS DIRECTIVE:

 

Article 1

The following Directives are hereby
amended:

1. Council Directive 87/404/EEC of
25 June 1987 on the harmonization of the laws of the Member States relating to
simple pressure vessels (7);

2. Council Directive 88/378/EEC of 3
May 1988 on the approximation of the laws of the Member States concerning the
safety of toys (8);

3. Council Directive 89/106/EEC of
21 December 1988 on the approximation of the laws, regulations and
administrative provisions of the Member States relating to construction
products (9);

4. Council Directive 89/336/EEC of 3
May 1989 on the approximation of the laws of the Member States relating to
electromagnetic compatibility (10);

5. Council Directive 89/392/EEC of
14 June 1989 on the approximation of the laws of the Member States relating to
machinery (11);

6. Council Directive 89/686/EEC of
21 December 1989 on the approximation of the laws of the Member States relating
to personal protective equipment (12);

7. Council Directive 90/384/EEC of
20 June 1990 on the harmonization of the laws of the Member States relating to
non-automatic weighing instruments (13);

8. Council Directive 90/385/EEC of
20 June 1990 on the approximation of the laws of the Member States relating to
active implantable medical devices (14);

9. Council Directive 90/396/EEC of
29 June 1990 on the approximation of the laws of the Member States relating to
appliances burning gaseous fuels (15);

10. Council Directive 91/263/EEC of
29 April 1991 on the approximation of the laws of the Member States concerning
telecommunications terminal equipment, including the mutual recognition of
their conformity (16);

11. Council Directive 92/42/EEC of
21 May 1992 on efficiency requirements for new hot-water boilers fired with
liquid or gaseous fuels (17);

12. Council Directive 73/23/EEC of
19 February 1973 on the harmonization of the laws of the Member States relating
to electrical equipment designed for use within certain voltage limits (18).

 

Article 2

Directive 87/404/EEC is hereby
amended as follows:

1. throughout the text, the term 'EC
mark' is replaced by 'CE marking';

2. in Article 5 the first paragraph
is replaced by the following text:

'1. Member States shall presume that
vessels bearing the CE marking comply with all the provisions of this
Directive, including the conformity assessment procedures referred to in
Chapter II.

Conformity of vessels with the
national standards which transpose the harmonized standards the reference
numbers of which have been published in the Official Journal of the European
Communities shall result in a presumption of conformity to the essential safety
requirements referred to in Article 3. Member States shall publish the
reference numbers of such national standards.';

3. the following paragraph is added
to Article 5:

'3. (a) Where the vessels are
subject to other Directives covering other aspects and which also provide for
the affixing of the CE marking, the latter shall indicate that the vessels in
question are also presumed to conform to the provisions of those other
Directives.

(b) However, where one or more of
those Directives allow the manufacturer, during a transitional period, to
choose which arrangements to apply, the CE marking shall indicate conformity only
to the Directives applied by the manufacturer. In this case, particulars of the
Directives applied, as published in the Official Journal of the European
Communities, must be given in the documents, notices or instructions required
by the Directives and accompanying such vessels.';

4. In Article 9 the first paragraph
is replaced by the following text:

'1. Member States shall notify the
Commission and the other Member States of the approved bodies which they have
appointed to carry out the procedures referred to in Article 8 (1) and (2)
together with the specific tasks which these bodies have been appointed to
carry out and the identification numbers assigned to them beforehand by the
Commission.

The Commission shall publish in the
Official Journal of the European Communities a list of the notified bodies with
their identification numbers and the tasks for which they have been notified.
The Commission shall ensure that this list is kept up to date.';

5. Article 11 is replaced by the
following text:

'EC verification

 

Article 11

1. EC verification is the procedure
whereby a manufacturer or his authorized representative established within the
Community ensures and declares that the vessels which have been checked in
accordance with paragraph 3 are in conformity to the type described in the EC
type-examination certificate or with the design and manufacturing schedule
referred to in Annex II section 3 having received a certificate of adequacy.

2. The manufacturer shall take all
the necessary measures for the manufacturing process to ensure that the vessels
conform to the type described in the EC type-examination certificate or to the
design and manufacturing schedule referred to in Annex II section 3. The
manufacturer or his authorized representative established within the Community
shall affix the CE marking to each vessel and draw up a declaration of
conformity.

3. The approved body shall carry out
the appropriate examinations and tests in order to check the conformity of the
vessels with the requirements of this Directive by examination and testing of
vessels in accordance with the following paragraphs:

3.1. The manufacturer shall present
his vessels in the form of uniform batches and shall take all necessary
measures in order that the manufacturing process ensures the uniformity of each
batch produced.

3.2. These batches shall be
accompanied by the EC type-examination certificate referred to in Article 10,
or, where the vessels are not manufactured in accordance with an approved
prototype, by the design and manufacturing schedule referred to in Annex II
section 3. In this case the approved body shall, prior to EC verification,
examine the schedule in order to certify its conformity.

3.3. When a batch is examined, the
inspection body shall ensure that the vessels have been manufactured and
checked in accordance with the design and manufacturing schedule and perform a
hydrostatic test or a pneumatic test of equivalent effect on each vessel in the
batch at a pressure Ph equal to 1,5 times the vessel's design pressure in order
to check its soundness. The pneumatic test shall be subject to acceptance of
the test safety procedures by the Member State in which the test is performed.

Moreover, the inspection body shall
carry out tests on test-pieces taken from a representative production
test-piece or from a vessel, as the manufacturer chooses, in order to examine
the weld quality. The tests shall be carried out on longitudinal welds.
However, where differing weld techniques are used for longitudinal and circular
welds, the tests shall be repeated on the circular welds.

For the vessels referred to in Annex
I, section 2.1.2 these tests on test-pieces shall be replaced by a hydrostatic
test on five vessels taken at random from each batch in order to check that
they conform to the requirements of Annex I, section 2.1.2.

3.4. In the case of accepted
batches, the approved body shall affix, or cause to be affixed, its
identification number to each recipient and draw up a written certificate of
conformity relating to the tests carried out. All recipients in the batch may
be placed on the market except for those which have not successfully undergone
a hydrostatic test or a pneumatic test.

If a batch is rejected, the notified
body or the competent authority shall take appropriate measures to prevent the
putting on the market of that batch. In the event of frequent rejection of
batches, the notified body may suspend the statistical verification.

The manufacturer may, under the
responsibility of the notified body, affix the latter's identification number
during the manufacturing process.

3.5. The manufacturer or his
authorized representative must be able to supply on request the approved body's
certificates of conformity referred to in subparagraph 3.4.';

6. in Article 12 (1) the first
sentence is replaced by the following text:

'1. A manufacturer fulfilling the
obligations arising out of Article 13 shall affix the CE marking provided for
in Article 16 to vessels which he declares to be in conformity:

- to the design and manufacturing
schedule referred to in Annex II section 3, and on which a certificate of
adequacy has been drawn up, or

- an approved prototype.';

7. Article 15 is replaced by the
following text:

'Article 15

Without prejudice to Article 7:

(a) where a Member State establishes
that the CE marking has been affixed unduly, the manufacturer or his authorized
representative established within the Community shall be obliged to make the
product conform as regards the provisions concerning the CE marking and to end
the infringement under the conditions imposed by the Member State;

(b) where non-conformity continues,
the Member State must take all appropriate measures to restrict or prohibit the
placing on the market of the product in question or to ensure that it is
withdrawn from the market in accordance with the procedures laid down in
Article 7.';

8. in Article 16 (1) the second
subparagraph is replaced by the following text:

'The CE conformity marking shall
consist of the initials "CE " in the form shown in the specimen in
Annex II. The CE marking shall be followed by the distinguishing number
referred to in Article 9 (1) of the approved inspection body responsible for EC
verifications or EC surveillance.';

9. in Article 16 the second paragraph
is replaced by the following text:

'2. The affixing of markings on the
vessels which are likely to deceive third parties as to the meaning and form of
the CE marking shall be prohibited. Any other marking may be affixed

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