Artem anyshchenko madelene eriksson kaja kaptu r ska evita stanga
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Artem Anyshchenko Madelene Eriksson Kaja Kaptu r ska Evita Stanga

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Artem anyshchenko madelene eriksson kaja kaptu r ska evita stanga

What lessons can we learn from the current reforms of the EU authorisation procedures under the regulation of GMOs (that hands back greater powers to the MSs) about attempts to develop ecological federalism as a constitutionalised approach to dealing with challenges of environmental regulation in a multi-level governance regime?

Artem Anyshchenko

Madelene Eriksson

Kaja Kapturska

Evita Stanga


Outline

Outline

  • The legislation on GMOs and the authorisation procedure

  • The current proposal for reforms

  • Cases, challenges, hiatus, opinions

  • Conclusions and suggestions

  • Discussion questions


The authorisation procedure

The authorisation procedure

  • Application to the national authority

  • National authority informs EFSA

  • EFSA informs other MSs national authorities and the Commission

  • EFSA gives scientific opinion (6 months)

  • Commission decides on the authorisation (3 months)


Requirements art 4 1 and art 16 1 reg 1829 2003

Requirements: art 4 (1) and art 16 (1) Reg1829/2003

  • The applicant must show that the food or feed does not have adverse effects on

    • human health

    • animal health

    • environment

  • The product should not mislead the consumer

  • It should not differ from the food or feed it is intended to replace to such extent that is it is nutritionally disadvantageous


Reforms

Reforms

13 MSs invited the Commission to leave the decision on GMO cultivation to them

Commissions Communication July 2010 presented

  • Commission Recommendation

  • Proposal for a Regulation

    • amending Directive 2001/18/EC

      • as regards the possibility for the MSs to restrict or prohibit the cultivation of GMOs in their territory


The new law

The new law

Attempt of politicians to develop

  • ecological federalism

  • diversity

  • multi-level governance

    Combining

  • EU authorisation system → based on science

  • with freedom for MSs → to decide if to cultivate GM crops


Advantages and lessons

Advantages and lessons

  • facilitate decision making

  • take into account all relevant factors

  • reduce the recourse of MSs to safeguard measures

  • reduce the institutional burdens on the Commission and EFSA

  • avoid the procedure of Art 114(5) TFEU

  • provide legal certainty to stakeholders


Lessons

Lessons

Multi level governance

Result of seeking more balance where interests of MSs are not taken into account enough

  • ecological federalism

  • local risk assessment

  • authorisation

    GMOs - a field where the MSs opinions differ

  • hard to govern at one level


  • Lessons1

    Lessons

    Impact assessment

    • done at the most appropriate level

      • to justify decisions at different levels

        Balancing

      • social benefits and the potential disadvantages of environment

        • local needs and EU economic policy


    Challenges

    Challenges

    • Dichotomy between an attempt to create a constitutionalised approach to the challenges of environmental protection in connection to scientific risk assessment and interests of health and safety on one hand,

      and endeavours to eliminate the critique of institutional failure and lack of democracy

    • Authorisation as a shift of burden of proof to an applicant


    Challenges1

    Challenges

    • The authorisation procedure requires EU regulators to strike a balance between scientific and political legitimacy


    Case i

    Case I

    • C-58/10 and C-68/10 Monsanto


    Artem anyshchenko madelene eriksson kaja kaptu r ska evita stanga

    • Hungary v EC [GC 2010]

    • authorisation of a GM potato for cultivation in EU


    Lessons2

    Lessons

    • GMO legislation creates precautionary governance structures that allow for a broad input into the authorisation process not only of scientific, but also of other (political, social) factors.

    • Authorisation practice has a danger to lead the EU institutions to the extremes of either purely science-based decision making or a highly politicised precautionary rhetoric (emotion discourse).


    Lessons3

    Lessons

    EU perspective

    • failure to apply the GMO risk assessment in a balanced way

      MS prospective

    • failure to adhere to a harmonised framework due to heated anti-GMO rhetoric and political aspiration at national level

      Peoples’ prospective:

    • “Why should we take a risk?”


    How to achieve a balance

    How to achieve a balance?

    • Careful consideration of the scientific uncertainties involved in health and environmental decision-making

    • Further elaborations to involve the discussion on democratic legitimacy of EU law

    • Need for regulatory solutions offering constitutional ideas


    Criticism of the proposal

    Criticism of the proposal

    • “The decision goes against the concept of a single European internal market” /C.Happach-Kasan, agriculture spokeswoman for Germany’s FDP party/

    • The new regulation will change the system greatly, however it is hard to predict the concequences of it /Prof. Joachim Schiemann, former scientist of EFSA GMO Panel/

    • Lack of unitary regulation within the EU will disturb competition /Marek Sawicki, Former minister for the agriculture in Poland/


    Question 1

    Question 1

    Ecological federalism or centralization?

    Doyou think that GMOs authorisation procedures should be regulated centrally by the EU institutions or that MSs should decide on their own if they want to cultivate GMOs?


    Question 2

    Question 2

    Is there any ideal legal solution for the authorisation of GMOs problem?


    Question 3

    Question 3

    How to protect existentially important public goods for the welfare of citizens by means of “unity in diversity” beyond nation states?


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