The European Union (EU) recently adopted new rules with respect to the approval of genetically modified organisms (GMOs)1 for cultivation that allow Member States to ban or restrict GMO cultivation in their territory, even if such cultivation has been approved at the EU level.2 In addition, the European Commission recently proposed new EU-wide rules for the use of food and animal feed products containing GMOs, which also give Member States more freedom to adopt national restrictions or prohibitions.3
The new rules on GMO cultivation entered into effect on April 2, 2015. The EU seeks to disconnect the EU-wide approval process from individual Member State consent by implementing any restriction or prohibition at the EU level, at the stage of authorization or renewal of GMO applications. However, Member States will have the flexibility to adopt national cultivation restrictions or prohibitions on the basis of grounds distinct from and complementary to the EU risk assessment. National restrictions may be adopted on grounds relating to environmental or agricultural policy objectives, or other non-scientific compelling grounds such as town and country planning, land use, socio-economic impacts, coexistence and public policy.
European Commission Proposal for New Rules on Use of GMO Products
In addition to the recently adopted rules on GMO cultivation, the European Commission has also recently proposed new rules allowing Member States to adopt measures restricting or prohibiting the use in all or part of their territory of a GMO or a GM food and feed, provided that such measures are reasoned, based on compelling grounds in accordance with Union law, and are in line with the principles of proportionality and non-discrimination between national and non-national products. Although the proposal states that the relevant restrictions or prohibitions “should refer to the use and not to the free circulation and imports of genetically modified food and feed,” the effect of this proposal would be to allow Member States to ban the sale and use of a GMO or a GM food and feed, thus rendering importation of these products pointless.
In line with the cultivation rules, the new proposal for the authorization to use GMO products maintains a single scientific risk-management system at the EU level and gives each Member State the power to ban the use of EU-approved GMO products on their territory on the basis of grounds other than risks to human and animal health and the environment, including for non-scientific reasons. In fact, the new proposal expressly states that to avoid any interference with the EU’s risk assessment related competences, “Member States should not be authorized to use grounds which are related to risks to health and to the environment which should be dealt with in accordance with the procedure already established in Regulation (EC) No 1829/2003.”4 Thus, once a GMO has been authorized for use as food or animal feed in the European Union, an individual Member State can still decide to opt out or restrict that particular GMO from being used in their territory provided such decision is based on compelling, non-health grounds and is proportionate and non-discriminatory.5
Under the existing rules, in place since 2003, Member States can only adopt national restrictions, so called emergency measures, to prevent the use in their territory of GMO products authorized at the EU level if there is scientific evidence demonstrating that the product is likely to pose a serious risk to human or animal health or to the environment.
If the European Commission proposal is adopted and the rules enter into force, the European Union would have a consistent set of rules regarding GMOs for both cultivation and for food and feed, which would allow Member States to regulate GMOs on the basis of individual concerns other than health protection.
Are the EU’s New Rules Consistent with its WTO Obligations?
While the EU believes the new rules on GMO cultivation will improve the process for authorizations, concerns have been raised over their consistency with the EU’s obligations as a Member of the WTO.
When announcing its new proposal, the European Commission stated that any measure adopted by Member States needs to be compatible with the internal market and “consistent with the EU’s international obligations—of which the EU’s WTO obligations are an integral part.”6 The European Commission did not provide details as to how this could be done given the authorization granted to Member States to ban, for non-health related reasons and on non-scientific grounds, GMO products that are found to be scientifically “safe” by the EU regulator.
Indeed, under the relevant rules of the WTO, in particular the SPS Agreement, the EU and its Member States have committed to certain obligations in respect of sanitary and phytosanitary measures (SPS measures), such as laws, regulations or requirements applied, among others, to protect human, animal or plant life or health from pests, diseases, or disease-causing organisms and to prevent or limit other damage to a country from the entry, establishment or spread of pests. Such SPS measures can only be imposed if they are necessary to protect human, animal or plant life or health, are based on scientific principles and are not maintained without sufficient scientific evidence. Furthermore, these measures must be based on an appropriate assessment of the risks to human, animal or plant life or health, taking into account risk assessment techniques developed by the relevant international organizations. They cannot be more trade restrictive than necessary to achieve the appropriate level of protection.
Allowing Member States to adopt individual bans on GMO products (as proposed by the European Commission) would likely qualify as an SPS measure, as evidenced by the WTO’s findings in the EC—Biotech case. The same is likely to be true for the already adopted rules allowing Member States to restrict or prohibit the cultivation of GMOs. Indeed, the findings of the WTO panel in EC—Biotech with respect to certain of the Member State’s safeguard measures, which also concerned cultivation, suggest that cultivation measures would also be considered covered by the disciplines in the SPS Agreement.
If the use and cultivation-related rules qualify as an SPS measure, they must comply with all of the WTO’s obligations requiring, among others, a scientific justification and a proper risk assessment. This scientific risk assessment continues to be conducted at the EU level by the relevant authorities. However, under the new rules, a positive risk assessment would not mean that the GMO product could be used or the GMO could be cultivated in every Member State. These products will be subject to a second, non-scientific layer of scrutiny at the Member State level. The broad range of “town and country planning, land use, socio-economic impacts, coexistence and public policy” grounds appears to effectively allow Member States to disregard their WTO obligations. It is highly questionable whether such non-scientific “public policy” grounds are permissible for a trade-restrictive measure that is justified as a measure taken to protect the spread of disease and to protect human, animal or plant health.
It seems that the EU is further developing the “public morals” argument it previously raised to justify a ban on seal products under the general rules of the WTO’s General Agreement on Tariffs and Trade and the Agreement on Technical Barriers to Trade. This ban was challenged by Norway and Canada in the WTO EC—Seals dispute. In that case, the WTO upheld the public morals defense, finding only a violation of the rules because of the discriminatory application of the EU seals ban. Whether a similar conclusion would be reached in the context of an SPS challenge of the GMO ban remains to be seen. The specific language of the SPS Agreement and the well-established jurisprudence with respect to the need for a scientific justification of SPS measures seems to suggest otherwise.
Although the new GMO-related rules seek to disconnect the EU-wide approval process from individual Member State consent, thus limiting the risk of delays for implementation in at least some Member States, it seems to have replaced one problematic situation with another. In situations where a GMO-crop is authorized at an EU level, after having passed an individual and scientific risk assessment, a Member State would nevertheless be allowed to restrict or prohibit cultivation and use 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 and absence of a proper risk assessment, or even in direct contradiction of the risk assessment conducted at the EU level demonstrating an absence of risk, appears to be highly problematic under relevant WTO law which imposes specific obligations for SPS measures that are even stricter than those imposed on technical regulations and standards.