Keywords

Summary



Keywords

1. Approximation of laws – Approximation measures – Genetically modified foodstuffs and animal feed – Products authorised pursuant to Directive 90/220, notified as existing products and having been the subject of an application for renewal of authorisation

(European Parliament and Council Regulation No 1829/2003, Arts 20 and 34; European Parliament and Council Directive 2001/18, Art. 23; Council Directive 90/220)

2. Approximation of laws – Approximation measures – Genetically modified foodstuffs and animal feed – Emergency measures which may be adopted by the Member States in order to confront a serious risk to human health, animal health or the environment

(European Parliament and Council Regulations No 178/2002, Art. 54, and No 1829/2003, Art. 34)

3. Approximation of laws – Approximation measures – Genetically modified foodstuffs and animal feed – Emergency measures which may be adopted by the Member States in order to confront a serious risk to human health, animal health or the environment

(European Parliament and Council Regulation No 1829/2003, Art. 34)

4. Approximation of laws – Approximation measures – Genetically modified foodstuffs and animal feed – Treatment of a serious risk to human health, animal health or the environment – Assessment and management coming under the responsibility of the Commission and the Council, subject to review by the Union judicature – Adoption and implementation by the Member States of emergency measures in the absence of a decision at Union level

(Art. 267, second para. and third para., TFEU and Art. 288 TFEU; European Parliament and Council Regulations No 178/2002, Art. 54, and No 1829/2003)

Summary

1. Genetically modified organisms such as MON 810 maize, which were authorised as, inter alia, seeds for the purpose of planting under Directive 90/220 on the deliberate release into the environment of genetically modified organisms and which were notified as existing products in accordance with the conditions set out in Article 20 of Regulation No 1829/2003 on genetically modified food and feed, and were subsequently the subject of a pending application for renewal of authorisation, may not have their use or sale provisionally suspended or prohibited, by a Member State, under Article 23 of Directive 2001/18 on the deliberate release into the environment of genetically modified organisms and repealing Directive 90/220; such measures may, however, be adopted pursuant to Article 34 of Regulation No 1829/2003.

(see para. 63, operative part 1)

2. Article 34 of Regulation No 1829/2003 on genetically modified food and feed authorises a Member State to adopt emergency measures only in accordance with the procedural conditions set out in Article 54 of Regulation No 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, compliance with which it is for the national court to ascertain.

(see para. 74, operative part 2)

3. With a view to the adoption of emergency measures, Article 34 of Regulation No 1829/2003 on genetically modified food and feed requires Member States to establish, in addition to urgency, the existence of a situation which is likely to constitute a clear and serious risk to human health, animal health or the environment. That risk must be established on the basis of new evidence based on reliable scientific data.

Protective measures adopted under Article 34 of Regulation No 1829/2003 cannot validly be based on a purely hypothetical approach to the risk, founded on mere assumptions which have not yet been scientifically verified. On the contrary, such protective measures, notwithstanding their temporary character and even if they are preventive in nature, may be adopted only if they are based on a risk assessment as complete as possible in the particular circumstances of an individual case, which indicate that those measures are necessary.

(see paras 76-77, 81, operative part 3)

4. In the light of the overall scheme provided for by Regulation No 1829/2003 on genetically modified food and feed and its objective of avoiding artificial disparities in the treatment of a serious risk, the assessment and management of a serious and evident risk to human health, animal health or the environment ultimately come under the sole responsibility of the Commission and the Council, subject to review by the Union judicature.

It follows that, at the stage of adoption and implementation by the Member States of the emergency measures referred to in Article 34 of that regulation, as long as no decision has been adopted in that regard at Union level, the national courts before which actions have been brought to test the lawfulness of such measures have jurisdiction to assess the lawfulness of those measures having regard to the substantive conditions provided for in Article 34 of Regulation No 1829/2003 and the procedural conditions laid down in Article 54 of Regulation No 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, whilst the uniformity of Union law may be ensured by the Court of Justice under the preliminary-ruling procedure since, if a national court has doubts as to the interpretation of a provision of Union law, it may, or must, in accordance with the second and third paragraphs of Article 267 TFEU, refer a question to the Court of Justice for a preliminary ruling.

However, when, in a case, the Commission has referred a matter to the Standing Committee on the Food Chain and Animal Health and a decision has been adopted at Union level, the factual and legal assessments relating to that case and contained in such a decision are binding on all bodies of the Member State which is the addressee of such a decision, in accordance with Article 288 TFEU, including its courts which are called on to assess the lawfulness of measures adopted at national level.

(see paras 78-80)