PURPOSE: to amend Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, by introducing a reference to the new regulatory procedure with scrutiny (comitology).

LEGISLATIVE ACT: Directive 2008/27/EC of the European Parliament and of the Council 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.

CONTENT: to recall, Council Decision 1999/468/EC laying down the procedures for the exercise of implementing powers conferred on the Commission has been amended by Council Decision 2006/512/EC ( CNS/2002/0298 ).

The amended Decision introduces a new regulatory procedure with scrutiny to be used for measures of general scope which seek to amend non-essential elements of a basic instrument, adopted under co-decision. This may include deleting some of those elements or supplementing the instrument, by the addition of new non-essential elements.

This procedure allows the legislator to oppose the adoption of "quasi-legislative" measures implementing a codecision-based instrument in cases where:

the draft may exceed the implementing powers provided for in the basic instrument; the draft is incompatible with the aim or the content of that instrument; or the draft fails to respect the principles of subsidiarity or proportionality.

In a joint statement, the three institutions agreed on a list of 26 basic instruments already in force to be adjusted without delay in accordance with the new regulatory procedure with scrutiny (see ACI/2006/2152 ). Each case has been assessed on the nature of the implementing powers conferred on the Commission and the specificity of each sector.

The purpose of this act, therefore, is to amend EU legislation concerning the deliberate release into the environment of genetically modified organisms, by introducing the new regulatory procedure with scrutiny .

ENTRY INTO FORCE: 21 March 2008.

The European Parliament adopted a resolution drafted by the report drafted by Gyula HEGYI (PES, HU) and made some amendments to the Commission’s proposal to amend Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms by introducing a reference to the new regulatory procedure with scrutiny. These were designed to expand the list of areas where implementing measures would be adopted in accordance with the regulatory procedure with scrutiny. These areas include the following:

- the establishment of threshold levels for the presence of GMOs in products above which labelling is mandatory (Article 21(3));

- conditions for the implementation of labelling provisions (Article 26(2)).

With regard to safeguard measures, Article 23(2) will now state that, within 60 days of the date of receipt of the information transmitted by the Member State, a decision shall be taken on the measure taken by that Member State. For the purpose of calculating the 60 day period, any period of time during which the Commission is awaiting further information or is seeking the opinion of the Scientific Committee which has been consulted shall not be taken into account. The period of time during which the Commission is awaiting the opinion of the Scientific Committee consulted shall not exceed 60 days. Similarly, the period of time that Council takes to act in accordance with the regulatory procedure shall not be taken into account.

Lastly, the text establishes that technical guidance notes will not be subject to the regulatory procedure with scrutiny.

The Committee on the Environment, Public Health and Food Safety adopted the report drafted by Gyula HEGYI (PES, HU) and made some amendments to the Commission’s proposal to amend Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms by introducing a reference to the new regulatory procedure with scrutiny. These were designed to expand the list of areas where implementing measures would be adopted in accordance with the regulatory procedure with scrutiny. These areas include the following:

decisions on applications for differentiated procedure regarding the deliberate release of GMOs for a purpose other than placing on the market; Community procedure in case of objections regarding the placing on the market of GMOs as or in products. The Committee amendment also involves a change in the applicable time limits; Member States’ ability to invoke safeguard clauses; certain labelling provisions and parts of the Annexes.

The Committee added that for products intended for direct processing, certain provisions on labelling will not apply to traces of authorised GMOs in a proportion no higher than 0.9 % or lower thresholds, provided that these traces are adventitious or technically unavoidable. The Commission shall establish the threshold levels in accordance with regulatory procedure with scrutiny.

PURPOSE: to amend Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms by introducing a reference to the new regulatory procedure with scrutiny (comitology).

PROPOSED ACT: Directive of the European Parliament and of the Council.

CONTENT: Council Decision 1999/468/EC laying down the procedures for the exercise of implementing powers conferred on the Commission has been amended by Council Decision 2006/512/EC ( CNS/2002/0298 ).

The amended Decision introduces a new regulatory procedure with scrutiny to be used for measures of general scope which seek to amend non-essential elements of a basic instrument, adopted under co-decision, including by deleting some of those elements or by supplementing the instrument by the addition of new non-essential elements.

This procedure allows the legislator to oppose the adoption of "quasi-legislative" measures implementing a codecision-based instrument when it considers that the draft exceeds the implementing powers provided for in the basic instrument, or that the draft is incompatible with the aim or the content of that instrument or fails to respect the principles of subsidiarity or proportionality.

In a joint statement, the three institutions agreed on a list of 26 basic instruments already in force to be adjusted without delay in accordance with the new regulatory procedure with scrutiny (see ACI/2006/2152 ). Each case has been assessed on its own merits, notably in view of the nature of the implementing powers conferred on the Commission and the specificity of each sector.

Lastly, in accordance with the abovementioned statement, the Commission is proposing to repeal any provisions of these instruments that provide for a time-limit on the delegation of implementing powers to the Commission.

PURPOSE: to amend Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms by introducing a reference to the new regulatory procedure with scrutiny (comitology).

PROPOSED ACT: Directive of the European Parliament and of the Council.

CONTENT: Council Decision 1999/468/EC laying down the procedures for the exercise of implementing powers conferred on the Commission has been amended by Council Decision 2006/512/EC ( CNS/2002/0298 ).

The amended Decision introduces a new regulatory procedure with scrutiny to be used for measures of general scope which seek to amend non-essential elements of a basic instrument, adopted under co-decision, including by deleting some of those elements or by supplementing the instrument by the addition of new non-essential elements.

This procedure allows the legislator to oppose the adoption of "quasi-legislative" measures implementing a codecision-based instrument when it considers that the draft exceeds the implementing powers provided for in the basic instrument, or that the draft is incompatible with the aim or the content of that instrument or fails to respect the principles of subsidiarity or proportionality.

In a joint statement, the three institutions agreed on a list of 26 basic instruments already in force to be adjusted without delay in accordance with the new regulatory procedure with scrutiny (see ACI/2006/2152 ). Each case has been assessed on its own merits, notably in view of the nature of the implementing powers conferred on the Commission and the specificity of each sector.

Lastly, in accordance with the abovementioned statement, the Commission is proposing to repeal any provisions of these instruments that provide for a time-limit on the delegation of implementing powers to the Commission.