Introduction

GMO approval process

Consistent with the WTO?

Comment



Introduction

On March 2 2015 the Council of the European Union (consisting of representatives of all 28 member states) adopted new rules with respect to the approval of genetically modified organisms (GMOs)(1) that allow member states to ban or restrict the cultivation of GMOs in their territory, even if such cultivation has been approved at EU level.(2)

The European Union expects that most prohibitions or restrictions under the new rules will be implemented at EU level. However, member states will have the flexibility to adopt national cultivation restrictions on the basis of environmental or agricultural policy objectives or other compelling grounds (eg, town and country planning, land use, socio-economic affects, coexistence and public policy). Whether the new rules comply with relevant obligations of the European Union and its member states under the World Trade Organisation (WTO) remains an open question.

GMO approval process

Before a GMO can be cultivated in the European Union it must undergo an approval process taking into account the direct, indirect, immediate and delayed effects on human health and the environment, in line with rules established in 2001. In addition to this risk assessment, the GMO must also comply with EU requirements on the marketing of seed and plant propagating material.

Under the old rules, a member state could ban or restrict the use of a GMO in its territory if it had evidence that the crop created a risk to human health or the environment. The opposition of certain member states meant that the EU-wide approval process has proved particularly difficult and few GMOs have ever been approved.

In this respect, it is worth recalling that the European Union's approval process for GMOs and certain related member state 'safeguard measures' preventing the marketing and import of GMOs and GMO-containing products were successfully challenged before the WTO by Argentina, Canada and the United States in 2006. In EC – Biotech, the WTO found first that the European Union applied a general de facto moratorium on the approval of GMO products that caused undue delays in violation of its obligations under the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement). Secondly, the WTO found that the member state 'safeguard measures' violated the SPS Agreement because they were not based on a risk assessment. Since the GMO crops in question had already been approved at EU level – which included individual risk assessments finding no evidence that the crops presented greater risk to human health or the environment than their non-biotech counterparts – the subsequent member state prohibitions could not be justified on the basis of the crops' alleged risks.

Under the new rules, a member state has the flexibility to restrict or ban GMO cultivation in its territory without affecting the risk assessment for EU-wide authorisations:

by seeking to amend the geographical scope of the authorisation during the EU level approval procedure; or

after the GMO has been approved at EU level, by seeking to restrict it on the basis of environmental or agricultural policy objectives or other compelling grounds, including land use, local agricultural structures, protection of eco-system and public policy.

Consistent with the WTO?

Under the relevant WTO rules, in particular the SPS Agreement, the European Union and its member states have committed to certain obligations in respect of sanitary and phytosanitary (SPS) measures, which are laws and requirements applied to protect human, animal or plant life or health. SPS measures can be imposed only if they are:

necessary to protect human, animal or plant life or health;

based on scientific principles; and

not maintained without sufficient scientific evidence.

These measures must also be based on an appropriate assessment of the alleged risks, taking into account assessment techniques developed by the relevant international organisations. They cannot be more trade-restrictive than necessary to achieve the appropriate level of protection.

If the European Union's new rules qualify as an SPS measure, they must comply with all of the above WTO obligations. It is questionable whether the non-scientific public policy grounds relating to "town and country planning, land use, socio-economic impacts, coexistence and public policy" are permissible under the WTO rules for justifying a measure taken to prevent the spreading of disease and to protect human, animal or plant life or health. The specific language of the SPS Agreement and the well-established jurisprudence in respect of the need for a scientific justification of SPS measures seems to suggest otherwise.

Comment

Although the new GMO rules seek to disconnect the EU-wide approval process from individual member state consent – thereby limiting the risk of delays for implementation in at least some member states – they seem to have replaced one problematic situation with another. In situations where a GMO crop is authorised at EU level, after having passed an individual risk assessment, a member state would nevertheless be allowed to restrict or prohibit cultivation in its territory for reasons unrelated to the protection of human, animal or plant life or health. Allowing member states to ban GMOs from their territory for reasons other than health protection, without scientific evidence or a proper risk assessment, or even in direct contradiction of the risk assessment conducted at EU level demonstrating an absence of risk, appears to be problematic under relevant WTO law.

For further information on this topic please contact Jasper M Wauters or Marcus Sohlberg at King & Spalding LLP by telephone (+41 22 591 0800) or email (jwauters@kslaw.com or msohlberg@kslaw.com). The King & Spalding LLP website can be accessed at www.kslaw.com.

Endnotes

(1) The term 'genetically modified organism' is defined in EU Directive 2001/18/EC, as amended, in two parts:

'organism' means any biological entity capable of replication or of transferring genetic material; and

'genetically modified organism' means an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination.

(2) The new rules will enter into force 20 days following their publication in the Official Journal, which is expected in Spring 2015.