Commission Recommendation of 16 August 2005 concerning the measures to be taken by the consent holder to prevent any damage to health and the environment in the event of the accidental spillage of an oilseed rape (Brassica napus L., GT73 line — MON-00073-7) genetically modified for tolerance to the herbicide glyphosate (notified under document number C(2005) 3073)
Date: 2005-08-16
Institutions: European Commission
Subjects: environmental protection, oil seed rape, transgenic plant

3.9.2005

EN

Official Journal of the European Union

L 228/19

COMMISSION RECOMMENDATION

of 16 August 2005

concerning the measures to be taken by the consent holder to prevent any damage to health and
the environment in the event of the accidental spillage of an oilseed rape (Brassica napus L., GT73
line — MON-00073-7) genetically modified for tolerance to the herbicide glyphosate
(notified under document number C(2005) 3073)

(Only the Dutch text is authentic)

(2005/637/EC)

damage to health and the environment in the event of
accidental spillage of
the oilseed rape MON-00073-7
during transportation, storage, handling in the envir-
onment and processing into derived products.

(5)

(6)

In this framework the consent holder is best placed to
inform operators and users directly about the safety and
general characteristics of the product and the monitoring
conditions,
in particular the appropriate management
measures to be taken in the event of accidental grain
spillage.

The Commission therefore considers it preferable for
specific technical guidelines to be added to the decision
to place the oilseed rape MON-00073-7 on the market
to prevent any damage to health and the environment in
case of accidental spillage of this product,

HEREBY RECOMMENDS:

Article 1

When applying the provisions of Article 4(2) of the decision to
place on the market an oilseed rape (Brassica napus L., GT73
line — MON-00073-7) genetically modified for tolerance to the
herbicide glyphosate, the measures listed in the Annex shall be
taken into account.

Article 2

This Recommendation is addressed to the Kingdom of
Netherlands.

the

Done at Brussels, 16 August 2005.

For the Commission

Stavros DIMAS
Member of the Commission

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
establishing the European
Community, and in particular the second indent of Article
211 thereof,

Whereas:

(1)

(2)

(3)

On 16 January 2003, the Commission received a dossier,
in accordance with the third subparagraph of Article
second indent of Article 14(2) of
13(1) and the
Directive 2001/18/EC of the European Parliament and
the Council of 12 March 2001 on the deliberate
of
environment of genetically modi-
release
fied
Council Directive
and
90/220/EEC (1) requesting authorisation to place on the
market a product based on a genetically modified oilseed
rape (Brassica napus L., GT73 line — MON-00073-7),
together with a favourable assessment report from the
competent authority of the Kingdom of the Netherlands.

into the
organisms

repealing

The Commission has sent the assessment report to all the
other Member States and some of them have expressed
and maintained objections to the said report concerning
the molecular characterisation, allergenic potential, moni-
toring, labelling and detection of the product. In such a
case,
in accordance with the first
subparagraph of Article 18(1) of Directive 2001/18/EC,
must take a decision pursuant to the procedure provided
for in Article 30(2) of the Directive, to which Articles 5
and 7 of Council Decision 1999/468/EC (2) apply, having
regard to the provisions of Article 8 thereof.

the Commission,

In February 2005, the Japanese Environmental Studies
Institute published a report referring to the accidental
genetically modified for
presence of oilseed rape
tolerance to a herbicide around five of
the six port
facilities where sampling had been carried out.

(4)

It seems necessary to prevent the same situation arising
in the European Union, and in particular to prevent any

(1) OJ L 106, 17.4.2001, p. 1. Directive as last amended by Regulation

(EC) No 1830/2003 (OJ L 268, 18.10.2003, p. 24).

(2) OJ L 184, 17.7.1999, p. 23.

L 228/20

EN

Official Journal of the European Union

3.9.2005

ANNEX

1. The consent holder must inform operators in the Community who handle and process bulk mixtures of imported

oilseed rape grains which may contain MON-00073-7 oilseed rape that:

(a) MON-00073-7 oilseed rape has received consent for import and use, in accordance with the definition given in

Article 3 of the Decision, in the Community;

(b) the establishment of a general surveillance plan for any unanticipated adverse effects arising from the placing on

the market of MON-00073-7 oilseed rape for the above uses is a condition of consent.

2. The consent holder must provide operators with a national contact person for the reporting of any unanticipated

adverse effects.

3. The consent holder must inform operators that the possibility of and consequences arising from accidental spillage of
MON-00073-7 oilseed rape have been evaluated by the European Food Safety Authority (EFSA) in the context of its
intended uses. The consent holder must maintain regular contact with operators to ensure that they are informed of
any changes to current practice which may change the conclusions of the environmental risk assessment.

4. The consent holder must ensure that operators are alert to the possibility that accidental spillage of imported oilseed
rape grains in ports and crushing facilities may result in the germination and establishment of volunteer plants,
including MON-00073-7 oilseed rape.

5. In the event that volunteer oilseed rape plants include MON-00073-7 oilseed rape, the consent holder must:

(a)

inform operators that these plants should be eradicated to minimise the potential for unanticipated adverse effects
arising from the MON-00073-7 oilseed rape;

(b) provide operators with appropriate plans for eradicating volunteer oilseed rape plants that include MON-00073-7

oilseed rape.

6. Under Article 4(5) of Directive 2001/18/EC and section C.1.6 of Council Decision 2002/811/EC (1), Member States
may carry out checks and/or additional monitoring with respect to accidental spillage of MON-00073-7 oilseed rape
grains and identification of potential unanticipated adverse effects arising from such spillage.

(1) OJ L 280, 18.10.2002, p. 27.