COUNCIL DIRECTIVE of
25 June 1987 on the harmonization of the laws of the Member States relating
to simple pressure vessels (87/404/EEC)
THE COUNCIL OF THE
EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community,
and in particular Article 100 thereof, Having regard to the proposal from
the Commission(1),
Having regard to the opinion of the European Parliament(2),
Having regard to the opinion of the Economic and Social Committee(3),
Whereas Member states have the responsibility of ensuring the safety on their
territory of persons, domestic animals and property with regard to the hazards
resulting from the leakage or bursting of simple pressure vessels;
Whereas, in each Member State, mandatory provisions define in particular the
safety level required of simple pressure vessels by specifying design and
operating characteristics, conditions of installation and use and inspection
procedures before and after placing on the market; whereas these mandatory
provisions do not necessarily lead to different safety levels from one Member
State to another but do, by their disparity, hinder trade within the Community;
Whereas the national provisions ensuring such safety must be harmonized in
order to guarantee the free movement of simple pressure vessels without lowering
existing and justified levels of protection in the Member States;
Whereas Community legislation as it stands at present provides that, notwithstanding
one of the fundamental rules of the Community, namely the free movement of
goods, barriers to intra-Community movement resulting from disparities in
national laws on the marketing of products have to be accepted in so far as
those provisions may be recognized as necessary to satisfy essential requirements;
whereas the harmonization of laws in the present case must therefore be confined
to those provisions needed to satisfy the essential safety requirements for
simple pressure vessels; whereas, because they are essential, these requirements
must replace the corresponding national provisions;
Whereas this Directive therefore contains only mandatory and essential requirements;
whereas, to facilitate proof of conformity with the essential requirements,
it is necessary to have harmonized standards at European level in particular
as to the design, operation and installation of simple pressure vessels so
that products complying with them may be assumed to conform to the safety
requirements; whereas these standards harmonized at European level are drawn
up by private bodies and must remain non-mandatory texts; whereas for that
purpose the European Committee for Standardization (CEN) and the European
Committee for Electrotechnical Standardization (CENELEC) are recognized as
the competent bodies for the adoption of harmonized standards in accordance
with the general guidelines for cooperation between the Commission and those
two bodies signed on 13 November 1984; whereas, for the purposes of this Directive,
a harmonized standard is a technical specification (European standard or harmonization
document) adopted by one or both of those bodies upon a remit from the Commission
in Accordance with the provisions of Council Directive 83/189/EEC of 28 March
1983 laying down a procedure for the provision of information in the field
of technical standards and regulations(4) and the abovementioned general guidelines;
Whereas a check on compliance with the relevant technical requirements is
necessary to provide effective protection for users and third parties; whereas
the existing inspection procedures differ from one Member State to another;
whereas, in order to avoid multiple inspections, which are in effect barriers
to the free movement of vessels, arrangements should be made for the mutual
recognition of inspection procedures by the Member States; whereas, in order
to facilitate the mutual recognition of inspection procedures, harmonized
Community procedures should be set up and the criteria for appointing the
bodies responsible for carrying out tests, surveillance and verification should
be harmonized;
Whereas the presence on a simple pressure vessel of the EC mark indicates
that it satisfies the provisions of this Directive and therefore makes it
unnecessary, on import and placing into service of the vessel, to repeat the
inspections already carried out; whereas nevertheless simple pressure vessels
might represent a safety hazard; whereas provision should therefore be made
for a procedure to reduce this hazard, HAS ADOPTED THIS DIRECTIVE:
CHAPTER I
Scope, placing on the market and free movement
Article 1
1. This Directive applies to simple pressure vessels manufactured in series.
2. For the purposes of this Directive, 'simple pressure vessel' means any
welded vessel subjected to an internal gauge pressure greater than 0,5 bar
which is intended to contain air or nitrogen and which is not intended to
be fired. Moreover, -the parts and assemblies contributing to the strength
of the vessel under pressure shall be made either of non-alloy quality steel
or of non-alloy aluminum or non-age hardening aluminum alloys, -the vessel
shall be made of: -either a cylindrical part of circular cross-section closed
by outwardly dished and/or flat ends which revolve around the same axis as
the cylindrical part, -or two dished ends revolving around the same axis,
-the maximum working pressure of the vessel shall not exceed 30 bar and the
product of that pressure and the capacity of the vessel (PS.V) shall not exceed
10 000 bar/litre, -the minimum working temperature must be no lower than minus
50 °C and the maximum working temperature shall not be higher than 300 °C
for steel and 100 °C for aluminum or aluminum alloy vessels.
3. The following vessels shall be excluded from the scope of the Directive:
-vessels specifically designed for nuclear use, failure of which may cause
an emission of radioactivity, -vessels specifically intended for installation
in or the propulsion of ships and aircraft, -fire extinguishers.
Article 2
1. Member States shall take all necessary steps to ensure that the vessels
referred to in Article 1, hereinafter referred to as 'vessels', may be placed
on the market and taken into service only if they do not compromise the safety
of persons, domestic animals or property when properly installed and maintained
and when used for the purposes for which they are intended.
2. The provisions of this Directive do not affect the right of Member States
to specify - with due observance of the Treaty - the requirements they deem
necessary to ensure that workers are protected when using vessels, provided
it does not mean the vessels are modified in a way unspecified in this Directive.
Article 3
1. Vessels in respect of which the product of PS and V exceeds 50 bar/litre
must satisfy the essential safety requirements set out in Annex I.
2. Vessels in respect of which the product of PS and V is 50 bar/litre or
less must be manufactured in accordance with sound engineering practice in
one of the Member States and bear markings as laid down in section 1 of Annex
II, with the exception of the EC mark referred to in Article 16.
Article 4
Member States shall not impede the placing on the market and the taking into
service in their territory of vessels which satisfy the requirements of this
Directive.
Article 5
1. Member States shall presume compliance with the essential safety requirements
referred to in Article 3 in respect of vessels bearing the EC mark denoting
conformity with the relevant national standards incorporating the harmonized
standards whose reference numbers have been published in the Official Journal
of the European Communities. Member States shall publish the reference numbers
of such national standards.
2. Member States shall presume that vessels in respect of which the manufacturer
has not applied, or has applied only in part, the standards referred to in
paragraph 1, or for which no such standards exist, comply with the essential
requirements referred to in Article 3 where, after receipt of an EEC type-examination
certificate, their conformity with the approved model has been certified by
the affixation of the EC mark.
Article 6
1. Where a Member State or the Commission, considers that the harmonized standards
referred to in Article 5 (1) do not entirely meet the essential requirements
referred to in Article 3, the Commission or the Member State concerned shall
bring the matter before the Standing Committee set up under Directive 83/189/EEC,
hereinafter referred to as 'the committee', giving the reasons therefor. The
committee shall deliver an opinion without delay. In the light of the committee's
opinion, the Commission shall inform the Member States whether or not it is
necessary to withdraw those standards from the publications referred to in
Article 5 (1).
Article 7
1. Where a Member State finds that vessels bearing the EC mark and used in
accordance with their intended purpose might compromise the safety of persons,
domestic animals or property, it shall take all appropriate measures to withdraw
those products from the market or to prohibit or restrict their being placed
on the market. The Member State concerned shall immediately inform the Commission
of any such measure, indicating the reasons for its decision, and in particular
whether non-conformity is due to:
(a)failure to meet the essential requirements referred to in Article 3, where
the vessel does not meet the standards referred to in Article 5 (1);
(b)incorrect application of the standards referred to in Article 5 (1);
(c)shortcomings in the standards referred to in Article 5 (1) themselves.
2. The Commission shall enter into consultation with the parties concerned
as soon as possible. Where, after such consultation, the Commission finds
that any measure as referred to in paragraph 1 is justified, it shall immediately
so inform the Member State that took the action and the other Member States.
Where the decision referred to in paragraph 1 is attributed to shortcomings
in the standards, the Commission, after consulting the parties concerned,
shall bring the matter before the Committee within two months if the Member
State which has taken the measures intends to maintain them and shall initiate
the procedures referred to in Article 6.
3. Where a vessel which does not comply bears the EC mark, the competent Member
State shall take appropriate action against whomsoever has affixed the mark
and shall inform the Commission and the other Member States thereof.
4. The Commission shall ensure that the Member States are kept informed of
the progress and outcome of this procedure.
CHAPTER II
Certification procedures
Article 8
1. Prior to production of pressure vessels of which the product of PS and
V exceeds 50 bar/litre, manufactured:
(a)in accordance with the standards referred to in Article 5 (1), the manufacturer,
or his authorized representative established within the Community, shall at
his own choice: -either inform an approved inspection body as referred to
in Article 9, which after examining the design and manufacturing schedule
referred to in Annex II 3, shall draw up a certificate of adequacy attesting
that the schedule is satisfactory, or -submit a prototype vessel for the EC
type- examination referred to in Article 10;
(b)not, or only partly, in accordance with the standards referred to in Article
5 (1), the manufacturer, or his authorized representative established within
the Community, must submit a prototype vessel for the EC type-examination
referred to in Article 10.
2. Vessels manufactured in accordance with the standards referred to in Article
5 (1) or with the approved prototype shall, prior to their being placed on
the market, be subject:
(a)to the EC verification referred to in Article 11 where the product of PS
and V exceeds 3 000 bar/litre:
(b)at the choice of the manufacturer, where the product of PS and V does not
exceed 3 000 bar litre but exceeds 50 bar/litre: -either to the EC declaration
of conformity referred to in Article 12, or -to the EC verification referred
to in Article 11.
3. The records, and correspondence relating to the certification procedures
referred to in paragraphs 1 and 2 shall be drafted in an official language
of the Member State in which the approved body is established or in a language
accepted by that body.
Article 9
1. Each Member State shall notify the Commission and the other Member States
of the approved bodies responsible for carrying out the certification procedures
referred to in Article 8 (1) and (2). The Commission shall publish a list
of these bodies and the distinguishing number it has allotted them, for information
purposes, in the Official Journal of the European Communities and shall ensure
that the list is kept up to date.
2. Annex III sets out the minimum criteria which Member States must meet as
regards approval of these bodies.
3. A Member State which has approved a body must withdraw approval if it finds
that the body no longer meets the criteria listed in Annex III. It shall immediately
inform the Commission and the other Member States accordingly. EC type-examination
Article 10
1. EC type-examination is the procedure by which an approved inspection body
ascertains and certifies that a prototype vessel satisfies the provisions
of this Directive which apply to it.
2. The application for EC type-examination shall be lodged by the manufacturer
or by his authorized representative with a single approved inspection body
in respect of a prototype vessel or of a prototype representing a family of
vessels. That authorized representative must be established in the Community.
The application shall include: -the name and address of the manufacturer or
of his authorized representative and the place of manufacture of the vessels,
-the design and manufacturing schedule referred to in Annex II 3. It shall
be accompanied by a vessel which is representative of the production envisaged.
3. The approved body shall carry out the EC type-examination in the manner
described below. It shall examine not only the design and manufacturing schedule
in order to check its conformity, but also the vessel submitted. When examining
the vessel, the body shall:
(a)verify that the vessel has been manufactured in conformity with the design
and manufacturing schedule and may safely be used under its intended working
conditions;
(b)perform appropriate examinations and tests to check that the vessel complies
with the essential requirements applicable to it.
4. If the prototype complies with the provisions applicable to it the body
shall draw up an EC type-examination certificate which shall be forwarded
to the applicant. That certificate shall state the conclusions of the examination,
indicate any conditions to which its issue may be subject and be accompanied
by the descriptions and drawings necessary for identification of the approved
prototype. The Commission, the other approved bodies and the other Member
States may obtain a copy of the certificate and, on a reasoned request, a
copy of the design and manufacturing schedule and the reports on the examinations
and tests carried out.
5. A body which refuses to issue an EC type-examination certificate shall
so inform the other approved bodies. A body which withdraws an EC type-examination
certificate shall so inform the Member State which approved it. The latter
shall inform the other Member States and the Commission thereof, giving the
reasons for the decision. EC verification
Article 11
1. The purpose of EC verification is to check a certify that series-manufactured
vessels comply with the standards referred to in Article 5 (1) or with the
approved prototype. It shall be performed by an approved inspection body in
accordance with the provisions set out below. That body shall issue an EC
verification certificate and affix the mark of conformity provided for in
Article 16.
2. Verification shall be performed on the batches of vessels submitted by
their manufacturer or by his authorized representative established within
the Community. Batches shall be accompanied by the EC type-examination certificate
referred to in Article 10, or, if 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 the latter case the approved body shall, prior
to EC verification, examine the schedule in order to certify its conformity.
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 shall 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 premature test
shall be subject to acceptance of the test safety procedures by the Member
States 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 weld quality.
The tests shall be carried out on longitudinal welds. However, where differing
welding techniques are used for longitudinal and circular welds, the tests
shall be repeated on the circular welds.
4. For the vessels referred to in section 2.1.2 of Annex I, 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 section 2.1.2 of Annex I. EC declaration of conformity
Article 12
1. A manufacturer fulfilling the obligations arising out of Article 13 shall
affix the EC mark provided for in Article 16 to vessels which he declares
to be in conformity with the standards, referred to in Article 5 (1) or with
an approved prototype. By this EC declaration of conformity procedure the
manufacturer becomes subject to EC surveillance, in cases where the product
of PS and V exceeds 200 bar/litre.
2. The purpose of EC surveillance is to ensure, as required by Article 14
(2), that the manufacturer duly fulfils the obligations arising out of Article
13 (2). Surveillance shall be performed by the approved body which issued
the EC type-examination certificate referred to in Article 10 where the vessels
have been manufactured in accordance with an approved prototype or, if this
is not the case, by the approved body to which the design and manufacturing
schedule was sent in accordance with Article 8 (1) (a), first indent.
Article 13
1. Where a manufacturer makes use of the procedure referred to in Article
12, he must, before commencing manufacture, send the approved body which issued
the EC type-examination certificate or the certificate of adequacy a document
describing the manufacturing processes and all of the pre-determined systematic
measures taken to ensure conformity of the pressure vessels to the standards
referred to in Article 5 (1) or the approved prototype. This document shall
include:
(a)a description of the means of manufacture and checking appropriate to the
construction of the vessels:
(b)an inspection document describing the appropriate examinations and tests
to be carried out during manufacture, together with the procedures therefor
and the frequency with which they are to be performed;
(c)an undertaking to carry out the examinations and tests in accordance with
the inspection document referred to above and to have a hydrostatic test or,
subject to the agreement of the Member State, a pneumatic test carried out
on each vessel manufactured at a test pressure equal to 1,5 times the design
pressure. These examinations and tests shall be carried out under the responsibility
of qualified staff who are sufficiently independent from production personnel,
and shall be covered by a report;
(d)the addresses of the places of manufacture and storage and the date on
which manufacture is to commence.
2. In addition, when the product of PS and V exceeds 200 bar/litre, manufacturers
shall authorize access to the said places of manufacture and storage by the
body responsible for EC surveillance, for inspection purposes, and shall allow
that body to select sample vessels and shall provide it with all necessary
information, and in particular: -the design and manufacturing schedule, -the
inspection report, -the EC type-examination certificate or certificate of
adequacy, where appropriate, -a report on the examinations and tests carried
out.
Article 14
1. The approved body which issued the EC type- examination certificate or
certificate of adequacy must, before the date on which any manufacture begins,
examine both the document referred to in Article 13 (1) and the design and
manufacturing schedule referred to in Annex II, section 3, in order to certify
their conformity where vessels are not manufactured in accordance with an
approved prototype.
2. In addition, where the product of PS and V exceeds 200 bar/litre, that
body must during manufacture: -ensure that the manufacturer actually checks
series-produced vessels in accordance with Article 13 (1) (c), -take random
samples at the places of manufacture or at the place of storage of vessels
for inspection purposes. The body shall supply the Member State which approved
it, and, on request, the other approved bodies, the other Member States and
the Commission, with a copy of the inspection report.
CHAPTER III
EC mark
Article 15
Where it is established that the EC mark has been wrongly affixed to vessels
because: -they do not conform to the approved prototype, -they conform to
an approved prototype which does not meet the essential requirements referred
to in Article 3, -they do not conform, in respect of the vessels referred
to in Article 8 (1) (a), to the relevant standards referred to in Article
5 (1). -the manufacturer has failed to fulfil his obligations under Article
13, the body responsible for EC surveillance must report to the Member State
concerned and, where appropriate, withdraw the EC type-examination certificate.
Article 16
1. The EC mark and the inscriptions provided for in Annex II, section 1, shall
be affixed in a visible, easily legible and indelible form to the vessel or
to a data plate attached to the vessel in such a way that it cannot be removed.
The EC mark shall consist of the symbol CE, the last two digits of the year
in which the mark was affixed, and the distinguishing number referred to in
Article 9 (1) of the approved inspection body responsible for EC verification
or EC surveillance.
2. The affixing to vessels of marks or inscriptions which are likely to be
confused with the EC mark shall be prohibited.
CHAPTER IV
Final provisions
Article 17
Any decision taken pursuant to this Directive and resulting in restrictions
on the placing on the market and/or taking into service of a vessel shall
state the exact grounds on which it is based. Such a decision shall be notified
without delay to the party concerned, who shall at the same time be informed
of the judicial remedies available to him under the laws in force in the Member
State in question and of the time limits to which such remedies are subject.
Article 18
1. Before 1 January 1990, Member States shall adopt and publish the laws,
regulations and administrative provisions necessary in order to comply with
this Directive. They shall forthwith inform the Commission thereof. They shall
apply such provisions from 1 July 1990.
2. Member States shall communicate to the Commission the texts of the provisions
of national law which they adopt in the field covered by this Directive. Article
19 This Directive is addressed to the Member States. Done at Luxembourg, 25
June 1987. For the Council The President H. DE CROO (1)OJ N° C 89, 15. 4. 1986,
p. 2. (2)Opinion delivered on 19 June 1987 (not yet published in the Official
Journal). (3)OJ N° C 328, 22. 12. 1986, p. 20. (4)OJ N° L 109, 26. 4. 1983,
p. 8.
ANNEX I
The essential safety requirements for the vessels are set out below:
1.MATERIALS Materials must be selected according to the intended use of the
vessels and in accordance with 1.1 to 1.4.
1.1.Pressurized parts The materials referred to in Article 1 used for manufacturing
the pressurized parts must be: -capable of being welded, -ductile and-tough,
so that a rupture at minimum working temperature does not give rise to either
fragmentation or brittle-type fracture, -not adversely affected bagging.
For steel vessels, the materials must in addition meet the requirements set
out in section 1.1.1 and, for aluminum or aluminum alloy vessels, those
set out in section 1.1.2. They must be accompanied by an inspection slip drawn
up by the producer of the materials as described in Annex II
1.1.1.Steel vessels N°n-alloy quality steels meet the following requirements:
(a)they must be non-effervescent and be supplied after normalization treatment,
or in an equivalent state;
(b)the content per product of carbon must be less than 0,25 % and that of
ssulfurand phosphorus must each be less than 0,05 %.
(c)they must have the following mechanical properties per product: -the maximum
tensile strength Rm,max must be less than 580 N/mm2, -the elongation after
rupture must be: -if test pieces are taken parallel to the direction of rolling:
thickness 73 mm: A80 mm 722 %, thickness
ANNEX II
1.EC MARK AND INSCRIPTIONS
The vessel or data plate must bear the EC mark provided for in Article 16,
together with at least the following information: -the maximum working pressurePS
in bar -the maximum working temperature Tmax in °C -the minimum working temperature Tmin
in °C -the capacity of the vesselV in l -the name or mark of the manufacturer
-the type and serial or batch identification of the vessel. Where a data plate
is used, it must be so designed that it cannot be re-used and must include
a vacant space to enable other information to be provided.
2.INSTRUCTIONS
The instructions must provide the following information: -the particulars
given in 1 above except for the vessel's serial identification, -the intended
use of the vessel, -the maintenance and installation requirements for vessel
safety. They must be in the official language or languages of the country
of destination.
3.DESIGN AND MANUFACTURING SCHEDULES
The design and manufacturing schedules must contain a description of the techniques
and operations employed in order to meet the essential requirements referred
to in Article 3 or the standards referred to in article 5 (1) and in particular:
(a)a detailed manufacturing drawing of the vessel type;
(b)the instructions;
(c)a document describing: -the materials selected, -the welding processes
selected, -the checks selected, -any pertinent details as to the vessel design.
When the procedures laid down in Articles 11 to 14 are used, the schedule
must also include:
ii(i)the certificates relating to the suitable qualification of the welding
operations and of the welders or operators;
i(ii)the inspection slip for the materials used in the manufacture of parts
and assemblies contributing to the strength of the pressure vessel;
(iii)a report on the examinations and tests performed or a description of
the proposed checks.
4.DEFINITIONS AND SYMBOLS
4.1.Definitions
(a)The design pressure 'P' is the gauge pressure chosen by the manufacturer
and used to determine the thickness of the pressurized parts.
(b)The maximum working pressure 'P' is the maximum gauge pressure which may
be exerted under normal conditions of use.
(c)The minimum working temperature Tmin is the lowest stabilized temperature
in the wall of the vessel under normal conditions of use.
(d)The maximum working temperature Tmax is the highest stabilized temperature
which the wall of the vessel may attain under normal conditions of use.
(e)The yield strength 'RET' is the value at the maximum working temperature
Tmax -of the upper yield point ReH, for a material with both a lower and an
upper yield point, -or of the proof stress Rp0,2, -or of the proof stress
Rp1,0 in the case of non-alloy aluminum.
(f)Families of vessels: Vessels form part of the same family if they differ
from the prototype only in diameter, provided that the permissible requirements
referred to in sections 2.1.1 or 2.1.2 of Annex I are complied with and/or
in the length of their cylindrical portion within the following limits: -where
a prototype has one or more shell rings in addition to the ends, variants
in the family must have at least one shell ring, -where a prototype has just
two dished ends, variants in the family must have no shell rings. Variations
in length causing the apertures and/or penetrations to be modified must be
shown in the drawing for each variant.
(g)A batch of vessels consists at the most of 3 000 vessels of the model of
the same type.
(h)There is series manufacture within the meaning of this Directive if more
than one vessel of the same type is manufactured during a given period by
a continuous manufacturing process, in accordance with a common design and
using the same manufacturing processes.
(i)Inspection slip: document by which the producer certifies that the products
delivered meet the requirements of the order and in which he sets out the
results of the routine in-plant inspection test, in particular chemical composition
and mechanical characteristics performed on products made by the same production
process as the supply, but not necessarily on the products delivered.
4.2.Symbols >TABLE POSITION>
ANNEX III
MINIMUM CRITERIA TO BE TAKEN INTO ACCOUNT BY MEMBER STATES WHEN APPOINTING
INSPECTION BODIES
1.The inspection body, its director and the staff responsible for carrying
out the verification tests shall not be the designer, manufacturer, supplier
or installer of vessels which they inspect, nor the authorized representative
of any of those parties. They shall not become directly involved in the design,
construction, marketing or maintenance of the vessels, nor represent the parties
engaged in these activities. This does not preclude the possibility of exchanges
of technical information between the manufacturer and the inspection body.
2.The inspection body and its staff must carry out the verification tests
with the highest degree of professional integrity and technical competence
and must be free from all pressures and inducements, particularly financial,
which might influence their judgment or the results of the inspection, especially
from persons or groups of persons with an interest in the result of verifications.
3.The inspection body must have at its disposal the necessary staff and possess
the necessary facilities to enable it to perform properly the administrative
and technical tasks connected with verification; it must also have access
to the equipment required for special verification.
4.The staff responsible for inspection must have: -sound technical and professional
training, -satisfactory knowledge of the requirements of the tests they carry
out and adequate experience of such tests. -the ability to draw up the certificates,
records and reports required to authenticate the performance of the tests.
5.The impartiality of inspection staff must be guaranteed. Their remuneration
must not depend on the number of tests carried out nor on the results of such
tests.
6.The inspection body must take out liability insurance unless its liability
is assumed by the State in accordance with national law, or the Member State
itself is directly responsible for the tests.
7.The staff of the inspection body is bound to observe professional secrecy
with regard to all information gained in carrying out its tasks (except vis-à-vis
the competent administrative authorities of the State in which its activities
are carried out) under this Directive or any provision of national law giving
effect to it.