Directive 2008/27/EC of the European Parliament and of the Council of 11 March 2008 amending Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, as regards the implementing powers conferred on the Commission
Date: 2008-03-11
Institutions: Council of the European Union, European Parliament
Subjects: European Commission, approximation of laws, environmental protection, genetically modified organism, health policy, marketing, powers of the institutions (EU)

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Official Journal of the European Union

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DIRECTIVE 2008/27/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 11 March 2008

amending Directive 2001/18/EC on the deliberate release into the environment of genetically
modified organisms, as regards the implementing powers conferred on the Commission

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

(4)

Having regard to the Treaty
Community, and in particular Article 95 thereof,

establishing the European

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and
Social Committee (1),

After consulting the Committee of the Regions,

Acting in accordance with the procedure
Article 251 of the Treaty (2),

laid down in

(5)

(6)

Whereas:

The Commission should be empowered to adopt the
measures necessary for the implementation of Directive
2001/18/EC. Those measures are designed to adapt
certain annexes, establish criteria for the notification
and fix minimum thresholds. Since those measures are
of general scope and are designed to amend non-essential
elements of Directive 2001/18/EC, inter alia, by supple-
menting it with new non-essential elements, they must
be adopted in accordance with the regulatory procedure
with scrutiny provided for in Article 5a of Decision
1999/468/EC.

Directive 2001/18/EC should therefore be amended
accordingly.

Since the amendments made to Directive 2001/18/EC by
this Directive are technical
in nature and concern
they do not need to be
committee procedure only,
is therefore not
transposed by the Member States.
necessary to lay down provisions to that effect,

It

(1)

(2)

(3)

Directive 2001/18/EC of the European Parliament and of
the Council (3) provides that certain measures are to be
Council Decision
adopted
1999/468/EC of 28 June 1999 laying down the
procedures for
implementing powers
the exercise of
conferred on the Commission (4).

accordance with

in

the

introduced

Decision 1999/468/EC has been amended by Decision
2006/512/EC, which
regulatory
procedure with scrutiny for the adoption of measures
of general scope and designed to amend non-essential
elements of a basic instrument adopted in accordance
with the procedure referred to in Article 251 of the
Treaty, inter alia, by deleting some of those elements or
by supplementing the instrument with new non-essential
elements.

and

the Council

In accordance with the statement by the European
the Commission (5)
Parliament,
for the regulatory
concerning Decision 2006/512/EC,
procedure with scrutiny to be applicable to instruments
adopted in accordance with the procedure referred to in
Article 251 of the Treaty which are already in force,
those instruments must be adjusted in accordance with
the applicable procedures.

(1) OJ C 161, 13.7.2007, p. 45.
(2) Opinion of the European Parliament of 14 November 2007 (not yet
published in the Official Journal) and Council Decision of 3 March
2008.

(3) 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).

(4) OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision

2006/512/EC (OJ L 200, 22.7.2006, p. 11).

(5) OJ C 255, 21.10.2006, p. 1.

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Amendments

Directive 2001/18/EC is hereby amended as follows:

1. Article 16(2) and (3) shall be replaced by the following:

‘2.
The criteria and information requirements referred to
in paragraph 1, as well as any appropriate requirements for
a summary of
the dossier, shall be established. Those
measures, designed to amend non-essential elements of
this Directive by supplementing it, shall be adopted, after
consultation of
in
accordance with the regulatory procedure with scrutiny
referred to in Article 30(3). The criteria and information
requirements shall be such as to ensure a high level of
safety of human health and the environment and shall be
based on the available scientific evidence concerning such
safety and on experience gained from the release of
comparable GMOs.

relevant Scientific Committee,

the

The requirements set out in Article 13(2) shall be replaced
by those adopted in accordance with the first subparagraph,
and the procedure set out in Article 13(3), (4), (5) and (6)
and Articles 14 and 15 shall apply.

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and information requirements

Before the regulatory procedure with scrutiny referred
3.
to in Article 30(3) is initiated with a view to a decision on
criteria
referred to in
paragraph 1,
the Commission shall make the proposal
available to the public. The public may make comments
to the Commission within 60 days. The Commission shall
forward any such comments, together with an analysis, to
the Committee established pursuant to Article 30.’;

2. Article 21(2) shall be replaced by the following:

traces of

For products where

‘2.
technically
cannot be
unavoidable
excluded, a minimum threshold may be established below
which these products shall not have to be labelled in
accordance with paragraph 1.

adventitious or
authorised GMOs

Threshold levels
shall be established according to the
product concerned. Those measures, designed to amend
non-essential elements of this Directive by supplementing
it, shall be adopted in accordance with the regulatory
procedure with scrutiny referred to in Article 30(3).’;

3. Article 21(3) shall be replaced by the following:

‘2.
Conditions for the implementation of paragraph 1
shall be established, without duplicating or creating incon-
sistencies with labelling provisions laid down in existing
Community
legislation. Those measures, designed to
amend non-essential elements of this Directive by supple-
menting it, shall be adopted in accordance with the regu-
latory procedure with scrutiny referred to in Article 30(3).
In so doing, account should be taken, as appropriate, of
labelling provisions
in
accordance with Community legislation.’;

established by Member States

6. Article 27 shall be replaced by the following:

‘Article 27

Adaptation of annexes to technical progress

The adaptation to technical progress of Sections C and D of
Annex II, Annexes III to VI, and Section C of Annex VII,
designed to amend non-essential elements of this Directive,
shall be adopted in accordance with the
regulatory
procedure with scrutiny referred to in Article 30(3).’;

7. Article 30(3) shall be replaced by the following:

For

intended

products

‘3.
processing,
paragraph 1 shall not apply to traces of authorised
GMOs in proportions no higher than 0,9 % or lower
thresholds, provided that these traces are adventitious or
technically unavoidable.

direct

for

The threshold levels referred to in the first subparagraph
may be established. Those measures, designed to amend
non-essential elements of this Directive by supplementing
it, shall be adopted in accordance with the regulatory
procedure with scrutiny referred to in Article 30(3).’;

4. Article 23(2) shall be replaced by the following:

‘2. Within 60 days of the date of receipt of the infor-
mation transmitted by the Member State, a decision shall
be taken on the measure taken by that Member State in
accordance with the regulatory procedure referred to in
Article 30(2). For the purpose of calculating the 60-day
period, any period of time during which the Commission
information which it may have
is
requested from the notifier or is seeking the opinion of
the Scientific Committee or Committees which has or
have been consulted shall not be taken into account. The
period of time during which the Commission is awaiting
the opinion of the Scientific Committee or Committees
consulted shall not exceed 60 days.

awaiting further

Likewise, the period of time the Council takes to act in
accordance with the regulatory procedure referred to in
Article 30(2) shall not be taken into account.’;

5. Article 26(2) shall be replaced by the following:

‘3. Where
to this paragraph,
is made
Article 5a(1)
and Article 7 of Decision
1999/468/EC shall apply, having regard to the provisions
of Article 8 thereof.’;

reference
(4)

to

8. the first paragraph of Annex II shall be replaced by the

following:

‘This Annex describes in general terms the objective to be
achieved, the elements to be considered and the general
principles and methodology to be followed to perform
the environmental risk assessment
(e.r.a.) referred to in
Articles 4 and 13. Technical guidance notes may be
developed in accordance with the regulatory procedure
referred to in Article 30(2) in order to facilitate the imple-
mentation and explanation of this Annex.’;

9. the introductory wording to Annex IV shall be replaced by

the following:

‘This Annex describes in general terms the additional infor-
mation to be provided in the case of notification for
placing on the market and the information for labelling
requirements regarding GMOs as or in products to be
placed on the market and GMOs exempted under the
second subparagraph of Article 2(4). Technical guidance
inter alia, the description of how the
notes, as regards,
product
is intended to be used, may be developed in
accordance with the regulatory procedure referred to in
Article 30(2)
in order to facilitate the implementation
and explanation of this Annex. The labelling requirements
for exempted organisms set out in Article 26 shall be met
by providing
and
restrictions on, use.’;

recommendations

appropriate

for,

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10. the first and second paragraphs of Annex VII shall be

replaced by the following:

‘This Annex describes in general terms the objective to be
achieved and the general principles to be followed in the
design of the monitoring plan referred to in Article 13(2),
Article 19(3) and Article 20. Technical guidance notes may
be developed in accordance with the regulatory procedure
referred to in Article 30(2) in order to facilitate the imple-
mentation and explanation of this Annex.’

Article 2

Entry into force

This Directive shall enter into force on the day following its
publication in the Official Journal of the European Union.

Article 3

Addressees

This Directive is addressed to the Member States.

Done at Strasbourg, 11 March 2008.

For the European Parliament
The President

H.-G. PÖTTERING

For the Council
The President
J. LENARČIČ