2001/59/EC: Commission Decision of 5 January 2001 authorising the Kingdom of the Netherlands to have a temporary exemption to allow the use of chlorofluorocarbons (CFCs) until 31 December 2002 in delivery mechanisms for hermetically sealed devices designed for implantation in the human body for delivery of measured doses of medication in accordance with Article 4(1) of Regulation (EC) No 2037/2000 of the European Parliament and of the Council on substances that deplete the ozone layer (Text with EEA relevance) (notified under document number C(2000) 4416)
Date: 2001-01-15
Institutions: European Commission
Subjects: Netherlands, dangerous substance, derogation from EU law, medical device, medicinal product, ozone

23.1.2001

EN

Official Journal of the European Communities

L 21/15

COMMISSION DECISION

of 5 January 2001

authorising the Kingdom of the Netherlands to have a temporary exemption to allow the use of
chlorofluorocarbons (CFCs) until 31 December 2002 in delivery mechanisms for hermetically
sealed devices designed for implantation in the human body for delivery of measured doses of
medication in accordance with Article 4(1) of Regulation (EC) No 2037/2000 of the European
Parliament and of the Council on substances that deplete the ozone layer

(notified under document number C(2000) 4416)

(Only the Dutch text is authentic)

(Text with EEA relevance)

(2001/59/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Regulation (EC) No 2037/2000 of the Euro-
pean Parliament and of the Council on substances that deplete
the ozone layer (1), and in particular Articles 4(1), 11(1)(f) and
18 thereof,

Whereas:

(1)

(2)

(3)

(4)

Article 4(1) of Regulation (EC) No 2037/2000 prohibits
the use and the placing on the market of chlorofluoro-
carbons.

Article 4(1) of Regulation (EC) No 2037/2000 states
that,
following a request of a Member State and in
accordance with the procedure referred to in Article
18(2), the Commission may authorise the use of chloro-
fluorocarbons until 31 December 2004 in delivery
mechanisms for hermetically sealed devices designed for
implantation in the human body for delivery of meas-
ured doses of medication.

Medtronic is a producer of the Isomed infusion system,
an implantable drug delivery system that is used for the
treatment of cancer pain, non-malignant pain, spasticity
and cancer chemotherapy. The Isomed device utilises a
minute quantity of CFC-114 to create the pressure to
deliver the medication. To date there is no alternative to
the CFC but Medtronic is seeking an alternative. As the
pump is implanted in the body there is no escape of
CFC into the environment during the use of this device.

aspects of

The Commission has examined the technical and
Isomed infusion system
economic
produced by Medtronic and accepts that currently there
is no technical and economically feasible alternative
substance or technology and that the temporary use of

the

(1) OJ L 244, 29.9.2000, p. 1.

(5)

(6)

CFCs in these drug pumps for medical uses remains
essential.

The competent authority in the Netherlands has given its
agreement
for a temporary exemption up to 31
December 2002 for the use of CFCs for the production
and export of medical drug pumps by Medtronic BV.

The Committee established by Article 18 of Regulation
(EC) No 2037/2000 examined this request at its meeting
of 5 October 2000 and agreed to an exemption up to
31 December 2002 with a maximum use of
75 ODP kg of CFCs and the possibility of this exemp-
tion being renewed for a further two years up to 31
December 2004 following a review of the technical and
economic availability of alternative substances or tech-
nologies by the Commission.

(7)

The measures provided for in this Decision are in
accordance with the opinion of the Committee,

HAS ADOPTED THIS DECISION:

Article 1

In accordance with Article 4(1) of Regulation (EC) No 2037/
2000, Medtronic BV (NL) is allowed to use chlorofluorocar-
bons in delivery mechanisms for hermetically sealed devices
designed for implantation in the human body for delivery of
measured doses of medication until 31 December 2002 and for
a maximum quantity of 75 ODP kg.

Article 2

The Commission will review this exemption in 2002 to
examine whether its extension to 31 December 2004 can be
authorised in the light of the development of technical and
economic alternative substances or technologies.

L 21/16

EN

Official Journal of the European Communities

23.1.2001

This Decision is addressed to the Government of the Kingdom of the Netherlands.

Article 3

Done at Brussels, 5 January 2001.

For the Commission

Margot WALLSTRÖM

Member of the Commission