do-me/EUR-LEX huggingface dataset:
Commission Communication in the framework of the implementation of Council Directive 93/42/EEC of 14 June 1993 in relation to medical devices and Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in-vitro diagnostic medical devices (Text with EEA relevance)
Date: 2002-07-31
Institutions: European Commission
Subjects: artificial reproduction, harmonisation of standards, medical device, medical diagnosis, radiobiology

CEN

CEN

CEN

C 182/8

EN

Official Journal of the European Communities

31.7.2002

Commission Communication in the framework of the implementation of Council Directive
93/42/EEC of 14 June 1993 in relation to medical devices (1) and Directive 98/79/EC of the
European Parliament and of the Council of 27 October 1998 on in-vitro diagnostic medical
devices (2)

(2002/C 182/05)

(Text with EEA relevance)

(Publication of titles and references of harmonized standards under the Directive)

OEN (1)

Reference and title of the standard

Reference document

EN ISO 13485
Quality systems — Medical devices — Particular
requirements for the application of EN ISO 9001
(revison
to
EN 13485:1996)
ISO 13485:1996)

(identical

of

Reference of the
superseded standard

Date of cessation
of presumption of conformity
of the superseded standard
Note 1

EN 46001

1.3.2004

EN ISO 13488
Quality systems — Medical devices — Particular
requirements
application of EN 46002:
the
1996), 9002 (identical to ISO 13488:1996)

for

EN ISO 14971
Medical devices — Application of risk management
to medical devices (ISO 14971:2000)

EN 46002

1.3.2004

EN 1441

1.4.2004

(1) ESO (European standardisation organisations):

— CEN: rue de Stassart 36, B-1050 Brussels; tel. (32-2) 550 08 11, fax (32-2) 550 08 19 (http://www.cenorm.be);
— Cenelec: rue de Stassart 35, B-1050 Brussels; tel. (32-2) 519 68 71, fax (32-2) 519 69 19 (http://www.cenelec.org);
— ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis Cedex, tel. (33-4) 92 94 42 00, fax (33-4) 93 65 47 16 (http://www.etsi.org).

Note 1: Generally the date of cessation of presumption of conformity will be the date of withdrawal (dow), set by the European
Standardisation Organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can
be otherwise.

(1) OJ L 169, 12.7.1993, p. 1.
(2) OJ L 331, 7.12.1998, p. 1.
Euro exchange rates
Date: 2002-07-31
Institutions: European Commission
Subjects: euro, exchange rate

31.7.2002

EN

Official Journal of the European Communities

C 182/1

I

(Information)

COMMISSION

Euro exchange rates (1)

30 July 2002

(2002/C 182/01)

1 euro =

USD

JPY

DKK

GBP

SEK

CHF

ISK

NOK

BGN

CYP

CZK

EEK

HUF

LTL

Currency

US dollar

Japanese yen

Danish krone

Pound sterling

Swedish krona

Swiss franc

Iceland króna

Norwegian krone

Bulgarian lev

Cyprus pound

Czech koruna

Estonian kroon

Hungarian forint

Lithuanian litas

Exchange
rate

0,9835

117,64

7,4315

0,6294

9,2235

1,4579

84,07

7,505

1,9464

LVL

MTL

PLN

ROL

SIT

SKK

TRL

AUD

CAD

Currency

Latvian lats

Maltese lira

Polish zloty

Romanian leu

Slovenian tolar

Slovak koruna

Turkish lira

Australian dollar

Canadian dollar

0,57504

HKD

Hong Kong dollar

30,243

NZD

New Zealand dollar

15,6466

SGD

Singapore dollar

Exchange
rate

0,5921

0,4138

4,0802

32335

226,9728

44,39

1662000

1,8055

1,5456

7,6712

2,0863

1,7341

244,4

KRW

South Korean won

1163,58

3,4522

ZAR

South African rand

10,0076

___________
(1) Source: reference exchange rate published by the ECB.
Corrigendum to Commission Regulation (EC) No 1359/2002 of 25 July 2002 fixing the export refunds on rice and broken rice and suspending the issue of export licences (OJ L 197 of 26.7.2002)
Date: 2002-07-31
Institutions: European Commission
Subjects: export licence, export refund, rice

L 201/66

EN

Official Journal of the European Communities

31.7.2002

CORRIGENDA

Corrigendum to Commission Regulation (EC) No 1359/2002 of 25 July 2002 fixing the export refunds on rice
and broken rice and suspending the issue of export licences

(Official Journal of the European Communities L 197 of 26 July 2002)

On page 43, footnote 1 beneath the table:

for:
read:

‘… 950 t.’,
‘… 289 t.’
Commission Regulation (EC) No 1403/2002 of 31 July 2002 determining the extent to which applications for import licences lodged in respect of subquota II for frozen meat of bovine animals, provided for in Regulation (EC) No 954/2002, can be accepted
Date: 2002-07-31
Institutions: European Commission
Subjects: beef, frozen product, import licence, quantitative restriction

1.8.2002

EN

Official Journal of the European Communities

L 203/47

COMMISSION REGULATION (EC) No 1403/2002

of 31 July 2002

determining the extent to which applications for import licences lodged in respect of subquota II
for frozen meat of bovine animals, provided for in Regulation (EC) No 954/2002, can be accepted

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Commission Regulation (EC) No 954/2002 of
4 June 2002 opening and providing for the administration of a
tariff quota for frozen meat of bovine animals covered by CN
code 0202 and products covered by CN code 0206 29 91 (1
July 2002 to 30 June (2003) (1), and in particular Article 12(4)
thereof,

Whereas:

Article 12(2) of Regulation (EC) No 954/2002 fixes at 13 250
tonnes the quantity of subquota II in respect of which approved
operators can lodge an application for an import licence based
on imports in the period 15 to 17 July 2002. As the import
licences applied for exceed the available quantity, a reduction

coefficient should be fixed in accordance with Article 12(4) of
Regulation (EC) No 954/2002,

HAS ADOPTED THIS REGULATION:

Article 1

Each application for an import licence lodged in accordance
with Article 12(2) of Regulation (EC) No 954/2002 in the
period 15 to 17 July 2002 shall be accepted at a rate of
2,8816 % of the quantities applied for.

Article 2

This Regulation shall enter into force on 1 August 2002.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 31 July 2002.

For the Commission

J. M. SILVA RODRÍGUEZ

Agriculture Director-General

(1) OJ L 147, 5.6.2002, p. 8.
Commission Regulation (EC) No 1392/2002 of 31 July 2002 establishing the standard import values for determining the entry price of certain fruit and vegetables
Date: 2002-07-31
Institutions: European Commission
Subjects: agri-monetary policy, citrus fruit, fruit vegetable, grape, import price, perennial vegetable, pip fruit, stone fruit

1.8.2002

EN

Official Journal of the European Communities

L 203/9

I

(Acts whose publication is obligatory)

COMMISSION REGULATION (EC) No 1392/2002

of 31 July 2002

establishing the standard import values for determining the entry price of certain fruit and
vegetables

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(2)

Having regard to the Treaty establishing the European
Community,

In compliance with the above criteria,
the standard
import values must be fixed at the levels set out in the
Annex to this Regulation,

Having regard to Commission Regulation (EC) No 3223/94 of
21 December 1994 on detailed rules for the application of the
last
import arrangements
amended by Regulation (EC) No 1498/98 (2), and in particular
Article 4(1) thereof,

fruit and vegetables (1), as

for

HAS ADOPTED THIS REGULATION:

Article 1

Whereas:

(1)

Regulation (EC) No 3223/94 lays down, pursuant to the
outcome of the Uruguay Round multilateral trade nego-
tiations, the criteria whereby the Commission fixes the
standard values for imports from third countries,
in
respect of the products and periods stipulated in the
Annex thereto.

The standard import values referred to in Article 4 of Regula-
tion (EC) No 3223/94 shall be fixed as indicated in the Annex
hereto.

Article 2

This Regulation shall enter into force on 1 August 2002.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 31 July 2002.

For the Commission

J. M. SILVA RODRÍGUEZ

Agriculture Director-General

(1) OJ L 337, 24.12.1994, p. 66.
(2) OJ L 198, 15.7.1998, p. 4.

L 203/10

EN

Official Journal of the European Communities

1.8.2002

to the Commission Regulation of 31 July 2002 establishing the standard import values for determining the entry
price of certain fruit and vegetables

ANNEX

CN code

0702 00 00

0709 90 70

0805 50 10

0806 10 10

0808 10 20, 0808 10 50, 0808 10 90

0808 20 50

0809 20 95

0809 30 10, 0809 30 90

0809 40 05

Third country
code (1)

Standard import
value

(EUR/100 kg)

096
999
052
999
388
524
528
999
052
064
220
508
600
624
999
388
400
508
512
528
720
804
999
052
388
512
528
804
999
052
400
404
999
052
064
999
064
999

30,6
30,6
78,8
78,8
59,8
55,7
52,0
55,8
157,8
114,9
121,5
75,3
142,2
190,3
133,7
92,4
119,0
75,5
94,8
69,4
143,5
107,1
100,2
89,6
93,5
79,1
92,6
66,9
84,3
453,9
289,9
251,2
331,7
110,3
88,7
99,5
62,3
62,3

(1) Country nomenclature as fixed by Commission Regulation (EC) No 2020/2001 (OJ L 273, 16.10.2001, p. 6). Code ‘999’ stands for ‘of

other origin’.
WRITTEN QUESTION P-2403/02 by Wolfgang Ilgenfritz (NI) to the Commission. Money laundering directive.
Date: 2002-07-31
Institutions: European Parliament, Provisional data
Subjects: Austria, EC Directive, money laundering, recycling of capital

C 137 E/82

Official Journal of the European Union

EN

12.6.2003

What action does the Council intend to take in order to make the truth known and to protect Ostia’s
image, given that the Italian public health authorities have categorically denied any risks and given
assurances that it is safe to bathe anywhere on the coast?

How does it intend to prevent the major efforts and investments being made by the public authorities and
the private sector with a view to enhancing the Rome coastline’s appeal to Italian and foreign tourists from
being undermined by false accusations?

Reply

(6 February 2003)

As a general rule, it is not for the Council to express a view on medias statements nor has it discussed this
particular subject. The Honourable Member should rather address his question to the Italian authorities
who can react in their own right through the proper channels.

(2003/C 137 E/092)

WRITTEN QUESTION P-2403/02

by Wolfgang Ilgenfritz (NI) to the Commission

(31 July 2002)

Subject: Money laundering directive

There is currently a debate going on in Austria concerning Directive 2001/97/EC (1) of the European
Parliament and of the Council of 4 December 2001 amending Council Directive 91/308/EEC (2) on
prevention of the use of the financial system for the purpose of money laundering, published in the
Official Journal of the European Communities on 28 December 2001.

In this connection the question arises as to whether the recitals of the Money Laundering Directive,
particularly Nos 16, 17 and 18, have the force of law, or whether they are merely explanatory in nature.

In our opinion the recitals of the Money Laundering Directive have the force of law and are binding on the
Austrian legislature.

Could the Commission inform me whether this is the case?

(1) OJ L 344, 28.12.2001, p. 76.
(2) OJ L 166, 28.6.1991, p. 77.

Answer given by Mr Bolkestein on behalf of the Commission

(4 September 2002)

Article 253 of the EC Treaty lays down that directives ‘shall state the reasons on which they are based’.

The purpose of the recitals to a directive is thus to explain the reasoning followed by the legislative
authority or authorities which adopted the measure in question.

The obligations imposed by a directive are set out in the articles, whereas the recitals to a directive do not
have, strictly speaking, the force of law.
Commission Regulation (EC) No 1405/2002 of 31 July 2002 determining the world market price for unginned cotton
Date: 2002-07-31
Institutions: European Commission
Subjects: cotton, world market price

1.8.2002

EN

Official Journal of the European Communities

L 203/51

COMMISSION REGULATION (EC) No 1405/2002

of 31 July 2002

determining the world market price for unginned cotton

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Protocol 4 on cotton, annexed to the Act of
Accession of Greece, as last amended by Council Regulation
(EC) No 1050/2001 (1),

Having regard to Council Regulation (EC) No 1051/2001 of 22
May 2001 on production aid for cotton (2), and in particular
Article 4 thereof,

Whereas:

(1)

(2)

In accordance with Article 4 of Regulation (EC) No
1051/2001, a world market price for unginned cotton is
to be determined periodically from the price for ginned
cotton recorded on the world market and by reference to
the historical relationship between the price recorded for
ginned cotton and that calculated for unginned cotton.
That historical
relationship has been established in
Article 2(2) of Commission Regulation (EC) No 1591/
2001 of 2 August 2001 (3). Where the world market
price cannot be determined in this way, it is to be based
on the most recent price determined.

In accordance with Article 5 of Regulation (EC) No
1051/2001, the world market price for unginned cotton
is to be determined in respect of a product of specific
characteristics and by reference to the most favourable
offers and quotations on the world market among those

considered representative of the real market trend. To
that end, an average is to be calculated of offers and
European
recorded on one or more
quotations
exchanges for a product delivered cif to a port in the
Community and coming from the various supplier coun-
tries considered the most representative in terms of inter-
national trade. However, there is provision for adjusting
the criteria for determining the world market price for
ginned cotton to reflect differences justified by the
quality of the product delivered and the offers and quota-
tions concerned. Those adjustments are specified in
Article 3(2) of Regulation (EC) No 1591/2001.

(3)

The application of the above criteria gives the world
market price for unginned cotton determined herein-
after,

HAS ADOPTED THIS REGULATION:

Article 1

The world price for unginned cotton as referred to in Article 4
of Regulation (EC) No 1051/2001 is hereby determined as
equalling EUR 24,238/100 kg.

Article 2

This Regulation shall enter into force on 1 August 2002.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 31 July 2002.

For the Commission

J. M. SILVA RODRÍGUEZ

Agriculture Director-General

(1) OJ L 148, 1.6.2001, p. 1.
(2) OJ L 148, 1.6.2001, p. 3.
(3) OJ L 210, 3.8.2001, p. 10.
2002/637/EC: Commission Decision of 31 July 2002 amending Decision 92/452/EEC establishing lists of embryo collection teams and embryo production teams approved in third countries for export of bovine embryos to the Community as regards Canada (Text with EEA relevance) (notified under document number C(2002) 2888)
Date: 2002-07-31
Institutions: European Commission
Subjects: Canada, animal breeding, cattle, health control, import, third country, veterinary inspection

3.8.2002

EN

Official Journal of the European Communities

L 206/29

COMMISSION DECISION

of 31 July 2002

amending Decision 92/452/EEC establishing lists of embryo collection teams and embryo
production teams approved in third countries for export of bovine embryos to the Community as
regards Canada

(notified under document number C(2002) 2888)

(Text with EEA relevance)

(2002/637/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 89/556/EEC of 25 September 1989 on animal health conditions
governing intra-Community trade in and importation from third countries of embryos of domestic animals
of the bovine species (1), as last amended by Commission Decision 94/113/EC (2), and in particular Article 8
thereof,

Whereas:

(1)

(2)

(3)

(4)

The competent veterinary services of Canada have forwarded a request for amendment to the list
established by Commission Decision 92/452/EEC (3), as last amended by Decision 2002/456/EC (4),
of teams officially approved in their territory for the export of embryos of domestic animals of the
bovine species to the Community.

Guarantees regarding compliance with the requirements specified in Article 8 of Directive 89/
556/EEC have been provided to the Commission by the competent veterinary services of the country
concerned, and the collection team concerned has been officially approved for exports to the
Community.

Decision 92/452/EEC should therefore be amended accordingly.

The measures provided for in this Decision are in accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:

Article 1

In the Annex to Decision 92/452/EEC the row for the Canadian team E 549 is replaced by the following:

‘CA

E 549

E 549 (IVF)

Abbotsford Veterinary Clinic
PO Box 524
Unit 200-33648 McDougall Avenue
Abbotsford
British Columbia V2S 5Z5

Dr R. Vanderval
Dr Martin Darrow’

This Decision shall apply as from the 20th day following that of its publication in the Official Journal of the
European Communities.

Article 2

(1) OJ L 302, 19.10.1989, p. 1.
(2) OJ L 53, 24.2.1994, p. 23.
(3) OJ L 250, 29.8.1992, p. 40.
(4) OJ L 155, 14.6.2002, p. 60.

L 206/30

EN

Official Journal of the European Communities

3.8.2002

This Decision is addressed to the Member States.

Article 3

Done at Brussels, 31 July 2002.

For the Commission

David BYRNE

Member of the Commission
Commission Regulation (EC) No 1402/2002 of 31 July 2002 on the issue of import licences for frozen thin skirt of bovine animals
Date: 2002-07-31
Institutions: European Commission
Subjects: beef, frozen product, import licence, quantitative restriction

L 203/46

EN

Official Journal of the European Communities

1.8.2002

COMMISSION REGULATION (EC) No 1402/2002

of 31 July 2002

on the issue of import licences for frozen thin skirt of bovine animals

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Commission Regulation (EC) No 996/97 of 3
June 1997 on the opening and administration of an import
tariff quota for frozen thin skirt of bovine animals falling within
CN code 0206 29 91 (1), as last amended by Regulation (EC)
No 1266/98 (2), and in particular Article 8(3) thereof,

Whereas:

(1)

(2)

Article 1(3)(b) of Regulation (EC) No 996/97 fixes the
amount of frozen thin skirt which may be imported on
special terms in 2002/2003 at 800 tonnes.

Article 8(3) of Regulation (EC) No 996/97 lays down
the quantities applied for may be reduced. The
that
lodged relate to total quantities which
applications

exceed the quantities available. Under these circum-
stances and taking care to ensure an equitable distribu-
tion of the available quantities, it is appropriate to reduce
proportionally the quantities applied for,

HAS ADOPTED THIS REGULATION:

Article 1

All applications for import licences made pursuant to Article 8
of Regulation (EC) No 996/97 are hereby met to the extent of
0,4940 % of the quantity requested.

Article 2

This Regulation shall enter into force on 1 August 2002.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 31 July 2002.

For the Commission

J. M. SILVA RODRÍGUEZ

Agriculture Director-General

(1) OJ L 144, 4.6.1997, p. 6.
(2) OJ L 175, 19.6.1998, p. 9.
Prior notification of a concentration (Case COMP/M.2881 — Koninklijke BAM NBM/HBG) (Text with EEA relevance)
Date: 2002-07-31
Institutions: European Commission
Subjects: building industry, economic concentration, exchange of information, industrial infrastructure, merger control, public works

31.7.2002

EN

Official Journal of the European Communities

C 182/7

Prior notification of a concentration

(Case COMP/M.2881 — Koninklijke BAM NBM/HBG)

(2002/C 182/04)

(Text with EEA relevance)

1.
On 5 July 2002 the Commission received notification of a proposed concentration pursuant to
Article 4 of Council Regulation (EEC) No 4064/89 (1), as last amended by Regulation (EC) No 1310/97 (2),
by which the Dutch undertaking Koninklijke BAM NBM (BAM NBM), acquires, within the meaning of
Article 3(1)(b) of the Regulation, control of the undertaking Hollandsche Beton Groep NV (HBG) by way of
purchase of shares.

This notification has been declared incomplete on 12 July 2002. The undertakings concerned have
2.
now provided the further information required. The notification became complete within the mearning of
Article 10(1) of Regulation (EEC) No 4064/89 on 19 July 2002. Accordingly the notification became
effective on 22 July 2002.

3.

The business activities of the undertakings concerned are:

— BAM NBM: homes and industrial construction (including maintenance, repair and renovation) instal-
lation, earth moving, construction of roads, viaducts, bridges and tunnels, project development, infra-
structural and rail construction, asphalt production,

— HBG: homes and industrial construction (including maintenance, repair and renovation) earth moving
infrastructural and rail

construction of roads, viaducts bridges and tunnels, project development,
construction, asphalt production, dredging, consultancy and engineering.

On preliminary examination, the Commission finds that the notified concentration could fall within

4.
the scope of Regulation (EEC) No 4064/89. However, the final decision on this point is reserved.

The Commission invites interested third parties to submit

5.
proposed operation.

their possible observations on the

Observations must reach the Commission not later than 10 days following the date of this publication.
Observations can be sent by fax (No (32-2) 296 43 01 or 296 72 44) or by post, under reference
COMP/M.2881 — Koninklijke BAM NBM/HBG, to:

European Commission,
Directorate-General for Competition,
Directorate B — Merger Task Force,
J-70,
B-1000 Brussels.

(1) OJ L 395, 30.12.1989, p. 1; corrigendum: OJ L 257, 21.9.1990, p. 13.
(2) OJ L 180, 9.7.1997, p. 1; corrigendum: OJ L 40, 13.2.1998, p. 17.