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The European Union (EU) has in place a comprehensive and strict legal regime on genetically modified organisms (GMOs), food and feed made from GMOs, and food/feed consisting or containing GMOs.  The EU’s legislation and policy on GMOs, based on the precautionary principle enshrined in EU and international legislation, is designed to prevent any adverse effects on the environment and the health and safety of humans and animals, and it reflects concerns expressed by skeptical consumers, farmers, and environmentalists.

GMOs and food or feed made from GMOs can be marketed in or imported into the EU, provided that they are authorized after passing strict evaluation and safety assessment requirements that are imposed on a case-by-case basis.  Authorizations are granted for a ten-year period by the European Commission through a centralized procedure, as provided for in Regulation No. 1829/2003, or by national competent authorities under Directive 2001/18/EC, which regulates the intentional release of GMOs into the environment.  At the EU level, the European Food and Safety Authority (EFSA) conducts the required risk assessments.  GMOs, or food and feed consisting of or containing GMOs, are assigned a unique identifier and are labeled as such to ensure traceability and enable consumers to make informed choices.

Since 2001 the EU has had a de facto moratorium on GMO approvals.  However, a September 2013 decision of the General Court of the EU, which requires the Commission to push forward a pending (since 2001) authorization proposal for marketing maize 1507, may put an end to the moratorium.

While marketing and importing GMOs and food and feed produced with GMOs are regulated at the EU level, the cultivation of GMOs is an area left to the EU Members.  EU Members have the right to prohibit or restrict the sale or cultivation of approved GMOs based on adverse effects on health and the environment.  A pending Commission proposal, as amended by the European Parliament, will give EU Members more flexibility to invoke socioeconomic grounds and impacts on local or regional environments when imposing such measures. 

Liability issues and compensation schemes for individuals fall primarily within the domain of the EU Member States.  In general, the EU espouses the principle that the polluter pays.  The EU court system is used mainly for preliminary rulings regarding the interpretation of EU legislation on GMOs.

I.  Introduction

European Union (EU) legislation defines a genetically modified organism (GMO) as “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.”[1]  The EU was prompted to adopt legislation on GMOs for two key reasons: (1) to protect human and animal health and welfare, consumer interests, and the environment, as required by articles 168 (public health), 169 (consumer protection), and 191 (environment) of the Treaty on the Functioning of the European Union (TFEU);[2] and (2) to ensure that authorized GMOs, or genetically modified (GM) products derived from a GMO may circulate freely within the EU and the European Economic Area to ensure their effective functioning.[3]  Based on the precautionary principle, which is embodied in EU legislation,[4] the Cartagena Protocol on Biosafety to the Convention on Biological Diversity,[5] and other international instruments,[6] the EU and its Members are required to take measures to prevent adverse effects on human health and the environment that may occur owing to the intentional release of GMOs into the environment or the marketing of and import into the EU of GMOs or products made from GMOs. 

Since 2001, the EU has placed a de facto moratorium on approvals of GMOs.[7]  An official list of authorized GM plants is available at the EU public register of GM food and feed.[8]  The United States, Canada, and Argentina have in the past challenged before the World Trade Organization (WTO) the moratorium itself; the lack of action with respect to certain products; and the practice by EU Members of resorting to a safeguard clause, which allows them to restrict or ban the cultivation of GMOs in their territories.  In 2006, the EC-Biotech Panel of the WTO found against the EU for violating the Sanitary and Phytosanitary Agreement.[9]  Following the September 2013 decision of the General Court, which held that the Commission failed to act on a GM cultivation request for maize 1507, the Commission complied with the Court’s ruling in November 2013 by forwarding a proposal for approval of maize 1507 to the Council.[10]  The application for cultivation for maize 1507 was submitted initially in 2001 by Pioneer Hi-Bred International, Inc. under Directive 2001/18/EC on the Deliberate Release of GMOs into the Environment.  Maize 1507 is currently approved in the EU only for food and feed uses.  A number of EU Members, such as France, Austria, and Poland are expected to oppose the proposal, while Britain, Spain, and Sweden are expected to vote in favor.[11]

GMO cultivation in the EU is limited because of concerns expressed by stakeholders about adverse effects on the environment, farmlands, and biodiversity.[12]  Under the current legal regime, EU Members may restrict or totally ban cultivation in their territories of those GMOs already authorized in the EU by resorting to the safeguard clause of Directive 2001/18/EC, or by using the notification procedures under the rules on internal markets.[13]

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II. Public and Scholarly Opinion

At the request of the European Commission, a 217-page report was commissioned to evaluate the effectiveness of the legal framework on authorization of GMOs in the EU,[14] as provided for in Regulation (EC) Nos. 1829/2003[15] and 1830/2003.[16]  The report was based on a questionnaire, interviews, and surveys sent to stakeholders and competent authorities.[17]

The report found that the EU authorization procedure is generally considered to achieve the objectives of the protection of human and animal health through the use of science-based risk assessment, and that there were no cases of animal or human health problems resulting from GMOs to date.  Concerns were expressed that the authorization procedure may not facilitate the effective functioning of the internal market as well as it could, because of different interpretations of the tolerance level for the adventitious and technically unavoidable presence of GMOs in food and feed.[18]

On the question of whether EU GMO legislation promotes or inhibits the development of the agricultural biotechnology sector, given the fact that the main objective is to protect the environment and human health, 50% of respondents stated that the legislation is not adequate because potential benefits are not taken into account.[19]

With regard to existing labeling rules, in general farmers and retailers were satisfied.  In addition, nongovernmental organizations (NGOs) and consumer organizations were in favor of the rules, which allow the general public to make an informed choice.  They stated that the mandatory labeling rules should also be expanded to include livestock products and products from microorganism fermentation, which are currently excluded.  NGOs expressed the need to clarify even further that the 0.9% labeling threshold is not a tolerance level but applies only to the adventitious and technically unavoidable presence of GMOs.[20]

The study also noted that, due to the lack of availability of GM-labeled products in the EU markets, it was not easy to evaluate public acceptance of GMOs.[21]  However, many respondents cited the general negative public attitude and suggested that consumers should be made more aware of the scientific risk assessment that GMOs undergo under the authorization procedure.[22]

A US Council on Foreign Relations paper, The Regulation of GMOs in Europe and the United States: A Case-Study of Contemporary European Regulatory Politics, provides a comparison of the EU and US approaches to GMOs.[23]  The authors opine that the EU’s current regulatory approach on GMOs is more restrictive than that of the US, which in general was more stringent until the mid-1980s.  The authors examine the divergent approaches between the two partners from the perspective of the cultural approach to GMOs and on economic grounds.  They cite the case of Monsanto’s introduction of nonlabeled GM food in the EU and its purchase of a large number of seeds as an influential factor that to a large extent shaped the negative attitude of EU consumers and farmers against GMOs.  The authors conclude that the EU’s adoption of strict rules on GMOs have less to do with culture or economic reasons and more with a different overall approach to risk management during the last decade and more reliance on the precautionary principle.[24]

Finally, a study prepared for the European Commission by the Swiss Federal Institute of Technology and the University of Reading, titled Assessment of the Economic Performance of GM Crops Worldwide, provides an overview of financial and other benefits from growing GMOs.[25]  The study provides an overview of the economic performance of GM crops worldwide based on the current state of knowledge; it also examines the direct economic and other effects of growing GM crops that influence farmers’ income, as represented by the following economic parameters: crop yields, seed costs, pesticide and herbicide costs, labor costs, and gross margins.[26]

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III.  Structure of Pertinent Legislation

The EU and its twenty-eight Members share competence in the areas related or affected by the use of GMOs—that is, the environment, consumer protection, and public health matters.[27]

At the EU level, two basic and comprehensive pieces of legislation regulate various aspects of GMOs: Regulation No. 1829/2003 on Genetically Modified Food and Feed,[28] and Directive 2001/18/EC on the Deliberate Release into the Environment of Genetically Modified Organisms and Repealing Council Directive 90/220/EEC.[29]  Directive 2001/18/EC was amended by Directive 2008/27/EC.[30]  Implementation of Directive 2001/18/EC is also closely linked with Directive 91/414/EEC on the Placing of Plant Protection Products on the Market, as amended.[31]  In addition, Regulation (EC) No 1830/2003 governs traceability and labeling requirements of GMOs and amends Directive 2001/18/EC[32] concerning the traceability and labeling of GMOs and the traceability of food and feed products produced from GMOs and amending Directive 2001/18/EC.

Both Regulations No. 1829/2003 and 1830/2003 are directly applicable in the legal systems of the twenty-eight EU Member States.  Concerning Directive 2001/18/EC, EU Members are required to comply with the requirements contained therein, but are free to choose the method of implementation.  Exports of GMOs in general are governed by Regulation (EC) No. 1946/2003 on Transboundary Movements of Genetically Modified Organisms.[33]

Moreover, in 2010, the Commission prepared its Guidelines for the Development of National Co-existence Measures to Avoid the Unintended Presence of GMOs in Conventional and Organic Crops.[34]  The guidelines urge EU Members to develop their own national measures based on their specific local and regional conditions in order to avoid the unintended presence of GMOs in conventional and organic crops.[35]  Another recommendation is the possibility for EU Members to exclude GMO cultivation from large areas of their territory (GM-free areas) to avoid the unintended presence of GMOs in conventional and organic crops.  In such a case, EU Members should show that purity from GMO contamination cannot be achieved through other methods.[36]

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IV.  Restrictions on Research, Production, and Marketing

A.  Research

Directive 2001/18/EC requires EU Members and the Commission to ensure that research on GMOs is conducted prior to their being released into the environment or placed on the market.[37]  Each EU Member must allocate appropriate funding for such research, in compliance with budgetary procedures.  Researchers must be granted access to all pertinent materials, provided that intellectual property rights are fully respected.[38]

At the EU level, in 2010 the Commission published a compendium titled A Decade of EU-Funded GMO Research, which summarizes the results of fifty research projects assessing the safety of GMOs for the environment and for animal and human health between 2001 and 2010.  The projects were funded to the amount of €200 million (approximately US$ 273 million) from the EU.[39]

B.  Cultivation 

Member States have the right to invoke the safeguard clause, as provided for in article 23 of Directive 2001/18/EC, and to temporarily ban the cultivation or use of a GMO in their territory.[40]  Members have to substantiate their actions with new or additional information that an authorized GMO can pose a threat to the environment or human health.  The Commission may ask EFSA to provide a scientific opinion on the information provided by Member States.  In these cases, the GMO Panel of EFSA assesses the new evidence provided by the Member State in the form of a scientific opinion.  A number of EU Members have prohibited individual authorized GMOs or GM seeds, including Austria, Hungary, France, Greece, Germany, and Luxembourg, all of which ban the cultivation of the GM maize MON810.  Poland has enacted legislation that prohibits the marketing of all GM seeds.  Since 2002 the Commission has repeatedly proposed that national safeguard measures on GMO cultivation be repealed, with no success.

 In addition, Austria, Hungary, and Luxembourg have notified the Commission of their ban on the cultivation of the approved Amflora potato.[41]  The company BASF Plant Science GmbH had submitted two authorization procedures for the Amflora potato that were subsequently adopted by the Commission in March 2010: (a) a procedure based on Directive 2001/18/EC for cultivation and use for industrial purposes, and (b) a procedure based on Regulation 1829/2003 for the production of animal feed.  On December 13, 2013, the General Court (GC)—based on a legal action instituted by Hungary in 2010 and assisted by Austria, France, Luxembourg, and Poland—annulled the Amflora authorization decisions adopted by the Commission.  The GC held that the Commission had failed to comply with the authorization procedures by not requesting the opinion of the competent committees composed of representatives of the Member States.[42]  In this regard, the GC concluded that “if the Commission had complied with those rules, the result of the procedure or the content of the contested decisions could have been substantially different.”[43]

In July 2010, at the request of a number of EU Members, the Commission introduced a proposal for a Regulation to amend the safeguard clause of Directive 2001/18/EC and to expand the legal grounds on GMO cultivation.  When adopted, EU Member States will be able to restrict or prohibit GMO cultivation in part or all of their territory without recourse to the safeguard clause.  While this proposal was approved by the Parliament in 2011, no agreement could be reached in the Council.  The Parliament’s amendment includes grounds related to local and regional environments, such as the prevention of the development of pesticide resistance among weeds and pests, the prevention of negative impacts on the local environment due to changes in agricultural practices connected with the cultivation of GMOs, and the maintenance of local biodiversity.  It also includes grounds relating to socioeconomic impacts, such as the need to preserve seed purity and to protect the diversity of agricultural production.  These measures will stay in force for a period of five years.[44]

C.  Authorization Under Directive 2001/18/EC

The general objective of Directive 2001/18/EC is to harmonize the national legislation on GMOs in the twenty-eight EU Member States in compliance with the precautionary principle and to ensure that individuals and companies take necessary measures to safeguard the environment and human health prior to intentionally releasing into the environment a GMO or placing in the EU market a GMO or GM products. 

The procedure for authorization for a GMO to be placed on the market is similar to that provided under Regulation No. 1829/2003.  An individual or a company must notify the competent authority of a Member State where the GMO will be marketed for the first time.  In turn, the competent authority will send the dossier with necessary documentation to the competent authorities of the EU Members and the Commission.[45]  The notification will contain (a) the information required in Annexes III and IV and results obtained from research on the potential impact on the environment and human health; (b) an environmental risk assessment pursuant to Annex II, section D, which must take into account the direct and indirect effects and immediate and delayed effects on human health and the environment, as prescribed in Annex II; (c) conditions for placing the item on the market; (d) consent for a period of up to ten years; (e) a monitoring plan; and (f) a proposal for labeling and packaging, and a summary of the dossier.[46]

The Directive requires that the EU Members designate the competent authority or authorities to be in charge of monitoring the implementation of its provisions.[47]  The role of the national authorities is to examine notifications and carry out control and other measures.[48]  The competent authority is required to prepare an assessment report within ninety days after receiving the notification, which will indicate whether or not the GMO is to be placed on the market and the conditions thereof.[49]

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V.  Restrictions on Releasing GMOs into the Environment

Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the Deliberate Release into the Environment of Genetically Modified Organisms and Repealing Council Directive 90/220/EEC requires EU Members to ensure that the intentional release of GMOs into the environment is possible only if it is in compliance with part B of Directive 2001/18/EC. “Deliberate release” is defined as “any intentional introduction into the environment of a GMO or a combination of GMOs for which no specific containment measures are used to limit their contact with and to provide a high level of safety for the general population and the environment.”[50]  In 2012, the Court of Justice held that the “location of release” of genetically modified organisms is determined by all the information relating to the location of the release submitted by the notifier to the competent authorities of the Member State on whose territory the release will occur.[51]

Intentional release into the environment may occur, provided that prior to the release of a GMO or GMOs an individual in charge submits a notification to the national competent authority of the Member State where the release will take place.  In addition, the following items must be prepared or obtained:

  • A dossier containing information, as provided for in Annex III of the Directive
  • An environmental risk assessment consistent with the requirements of Annex II of the Directive
  • Explicit consent prior to release
  • A monitoring plan pursuant to the requirements of Annex III designed to detect the adverse effects of the GMO(s) on human health and the environment [52]
  • Disclosure of information to the public on the release and results of the release and provide a reasonable time frame for the public to respond.[53]

If there are modifications or unintended changes to the release of a GMO into the environment, or additional information emerges on new risks that could potentially affect human health after the competent authority has granted its consent, the individual in charge must take measures to avert such risks and must notify the competent national authorities.[54]

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VI. Restrictions on GMOs in Foodstuffs

Regulation No. 1829/2003 prohibits placing on the EU market a GMO for food use, or a food containing or consisting of GMOs or food products produced “from” GMOs, unless an authorization is granted.  Food and feed produced “with” a GMO are excluded from the scope of this Regulation.  The critical determining factor is whether material derived from a GMO is present in the food or feed; thus, if a GMO is not present in the food or feed, then such food or feed does not fall within the purview of Regulation 1829/2003.[55]

To be marketed in or imported into the EU, any food or feed produced from a GMO, or food or feed that contains or consists of GMOs, must be previously authorized and must not cause any adverse effects on human and animal health and the environment, mislead consumers, or differ from the food it intends to replace to the extent that nutritionally it does not offer any advantage to consumers.[56]

A.  Authorization Under Regulation No. 1829/2003

An application for authorization, which is sent to the national competent authority, must include the name and address of the applicant, designate the food and its specifications, and meet inter alia the following requirements:

  • Comply with Annex II to the Cartagena Protocol on Biosafety, if applicable
  • Describe in detail the method of production and manufacturing
  • Include a copy of independent peer-reviewed studies
  • State that the food will not raise ethical or religious concerns of consumers
  • Indicate conditions for placing the GMO food or feed on the market
  • Provide for post-market monitoring, if the food is intended for human consumption[57]

The application must also include the required technical dossiers in compliance with Annexes III and IV of Directive 2001/18/EC, a copy of the authorization decision if the GMO was approved under Part C of Directive 2001/18/EC, and a monitoring plan to evaluate environmental effects in compliance with this Directive.[58]

Within fourteen days the national competent authority must inform the applicant that it received the application and forward all information to the EFSA.  It must also inform the Commission and the EU Members of the application.  The EFSA must then provide its opinion within a six-month deadline.  The Commission, within three months after receiving the opinion, must submit to the Standing Committee on the Food Chain and Animal Health a draft of its decision.  The draft must include all the appropriate and relevant information, including the name of the authorization holder and the unique identifier that is given to each GMO approved in the EU.

The Commission’s decision is published in the Official Journal of the European Union

B.  Labeling and Traceability Requirements

The right of consumers to information is recognized in article 169 of the TFEU.  Based on this article, the EU is obliged to promote this right in legislation affecting consumers.[59]

Labeling requirements apply to foods delivered to the final consumers or mass caterers in the EU that either contain or consist of GMOs, or are produced from or contain ingredients produced from GMOs.  Regulation No. 1829/2003 requires that the phrase “genetically modified” or “produced from genetically modified [name of the organism]” must appear clearly next to the ingredient list.[60]  When there is no list of ingredients the same phrase must appear on the label.  In the case of nonpackaged food, the same labeling must appear on the food display or next to it.[61]  When GMOs are found in minute amounts in conventional food due to their adventitious or technically unavoidable presence during cultivation, harvest, or transport, the food is not subject to labeling provided that the amount present is less than 0.9%.[62]  Similar labeling requirements are contained in Directive 2001/18/EC.[63]

The traceability and labeling of GMOs and the traceability of food and feed products produced from GMOs are governed by Regulation (EC) No. 1830/2003.[64]  Directive 2001/18/EC introduced a general traceability requirement, which obliges EU Members to ensure traceability at all stages of marketing for GMOs.

When placing on the market a product consisting of or containing GMOs, operators (individuals or legal entities) are required to provide in writing two important items: (a) a statement that the product contains or consists of GMOs, and (b) the unique identifier assigned to each GMO (a numeric or alphanumeric code) in order to facilitate the identification of the GMO.  This type of information must be forwarded from one operator to the next.[65]

When placing on the market a product for food and feed produced from GMOs, operators must forward to those who will receive them, the following:

  • Each food ingredient produced from GMOs
  • Each of the feed materials or additives produced from GMOs
  • If there is no list of ingredients, an indication that the product is produced from GMOs[66]

Operators must ensure that prepackaged products consisting of or containing GMOs carry a label with the words, “[t]his product contains genetically modified organisms” or “this product contains genetically modified [name of the organism].”[67]  For non-prepackaged products offered to consumers, the same phrase must appear on the product or where the product is displayed.[68]

The traceability or labeling requirements do not apply when there are traces of GMOs of no higher than 0.9%, and the traces of GMOs are “adventitious or technically unavoidable.”[69]

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VII. Liability Issues

In general, liability issues arising from the use of food or feed produced from GMOs or consisting of or containing GMOs fall within the legal systems of the EU Member States, where producers and importers of GMOs may be subject to the general rules of civil liability.[70]  The specific question of liability and compensation schemes for damage due to the presence of GMOs in non-GM crops is the subject of a lengthy study by the European Centre of Tort and Insurance Law, which provides information on the individual EU Member States.[71] 

At the EU level, the scope of Directive 2004/35/EC on Environmental Liability with Regard to the Prevention and Remedying of Environmental Damage[72] may be relevant to this discussion.  The general EU principle is that the polluter pays for environmental damage.  Directive 2004/35/EC extends the damage or imminent threats of damage to the environment––including protected species and their natural habitats, water, and land––due to a number of activities, including any deliberate release into the environment, transport, or placing on the market of GMOs, as defined by Directive 2001/18/EC.[73]  The scope appears to be limited, however, since biodiversity found in farmlands appears to fall outside its scope, unless such farmland is located within a protected area.[74] 

In 2011, the Court of Justice of the EU rendered a preliminary ruling in a case that could be influential in paving the way for biotech companies to be held accountable for GMOs released into the environment that cause damage to individuals.  In this case, the Court upheld the right to compensation of a German beekeeper who instituted legal proceedings against the State of Bavaria when Monsanto’s GM corn (MON810), which was cultivated for research purposes in plots owned by the State of Bavaria, contaminated his honey.  The Court found that the beekeeper suffered an economic loss by not being able to sell his product and that he ought to be compensated.[75]

In 2013, the Parliament, in amending the Commission’s proposal on restrictions to the cultivation of GMOs, added a new article 26c related to liability requirements.  This new article requires EU Members to establish a general mandatory system of financial liability and financial guarantees, such as through insurance.  Such a liability and insurance scheme will be applicable to all operators and will ensure that the polluter pays for the unintended effects of damage that may occur due to the deliberate release or marketing of GMOs.[76]

At the international level, the purpose of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity is to ensure protection during the transfer, handling, and use of living modified organisms that may adversely affect the conservation of natural habitats or species.  However, its application is limited to the transboundary movement of GMOs.[77]  In the implementation of article 27 of the Cartagena Protocol, the Nagoya‑Kuala Lumpur Supplementary Protocol was adopted.  It establishes international rules and procedures for liability and a means of redress in case of damage to biological diversity as a result of living modified organisms.[78]  The Supplementary Protocol applies to damage resulting from living modified organisms that originate in transboundary movement and extends to the following:

  • Direct use as food or feed, or for processing
  • Contained use
  • Intentional release into the environment[79]
  • Damage resulting from any authorized use of the living modified organisms[80]

The EU ratified the Supplementary Protocol on March 21, 2013, by depositing the instruments of approval.[81]

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VIII.  Judicial Decisions / Prominent Cases

The EU court system has played a significant role in the area of GMOs, by interpreting provisions of EU legislation on GMOs and by ensuring effective implementation when the Commission initiates action against certain EU Members for failing to comply with its requirements.  The most recent judgment delivered in September 2013 terminates the EU’s de facto moratorium by requiring the Commission to take further action in a long-pending application for authorization.

A.  Case T-164/10: Pioneer Hi-Bred International, Inc.

On September 26, 2013, the General Court issued a judgment in Case T-164/10 and found against the Commission for failing to act under Directive 2001/18/EC by not submitting to the Council a proposal under article 5(4) of the Comitology Decision 1999/468/EC.[82]  The facts of this case involve the 2001 application for authorization of maize 1507 for cultivation by Pioneer Hi-Bred International, Inc. under Directive 2001/18/EC on the deliberate release of GMOs into the environment. 

In 2007, Pioneer Hi-Bred International initiated a first action before the General Court of the European Union against the Commission for its failure to present a decision of authorization of that maize for vote to the Regulatory Committee.  The General Court closed the case when the Commission presented a proposal for a draft authorization decision to the Regulatory Committee in February 2009.  The Committee, however, failed to deliver an opinion.  In 2010, following the absence of an opinion by the Regulatory Committee, Pioneer Hi-Bred International launched a second action for failure to act (Case T-164/10) against the Commission for not having referred to the Council a proposal for an authorization decision, in compliance with the comitology procedure applicable at the time.  In November 2013 the Commission complied with the General Court’s decision.[83]

B.  Judgment in Case C-442/09: Karl Heinz Bablok and Others v. Freistaat Bayern

In 1998 Monsanto received authorization for marketing the genetically modified MON810 maize.  As noted in Part VII, above, a beekeeper in the State of Bavaria, Germany, claimed that his honey and the pollen that he produced for sale as a food supplement on land close to public land where MON810 maize was being cultivated for research purposes became contaminated by MON810 and therefore he could not sell his honey and pollen.  He instituted a legal action before the Bavarian Higher Administrative Court.  The latter requested that the EU Court of Justice issue a preliminary ruling as to whether the mere presence of genetically modified maize pollen that has lost its ability to reproduce prohibited the beekeeper from placing his products on the market without authorization.[84]

The EU Court determined that products such as honey and food supplements containing GMO pollen constitute foodstuffs containing ingredients produced from GMOs within the meaning of the regulation.  Therefore, it concluded that the pollen in question was “produced from GMOs” and that it constituted an “ingredient” of the honey and pollen-based food supplements.  The Court also noted that foodstuffs containing ingredients produced from GMOs are subject to the authorization procedure, irrespective of whether the GMO is introduced intentionally or adventitiously.[85]

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Theresa Papademetriou
Senior Foreign Law Specialist
March 2014

 


[1] Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the Deliberate Release into the Environment of Genetically Modified Organisms and Repealing Council Directive 90/220/EEC, art. 2(2), 2001 O.J. (L 106) 1, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:106:0001:0038:EN:PDF.  Directive 2001/18/EC was amended by Directive 2008/27/EC, 2008 O.J. (L 81) 45/EC, http://eur-lex.europa.eu/ LexUriServ/LexUriServ.do?uri=OJ:L:2008:081:0045:0047:EN:PDF.

[2] Treaty on the Functioning of the European Union (TFEU), 2012 O.J. (C 326) 47, http://eur-lex.europa.eu/LexUri Serv/LexUriServ.do?uri=OJ:C:2012:326:0047:0200:EN:PDF.

[3] Regulation (EC) No. 1829/2003 of the European Parliament and of the Council of 22 September 2003 on Genetically Modified Food and Feed, art. 1, 2003 O.J. (L 268) 1, http://eur-lex.europa.eu/LexUriServ/LexUri Serv.do?uri=OJ:L:2003:268:0001:0023:EN:PDF.

[4] Article 191 of the TFEU, supra note 2, which  refers to the precautionary principle without defining it, aims to safeguard the environment.  The principle also applies to areas related to food, human and animal health, and consumer interests.  A 2000 Communication from the Commission provides common guidelines on the precautionary principle’s application, stating that it applies “where scientific evidence is insufficient, inconclusive or uncertain and there are indications through preliminary objective scientific evaluation that there are reasonable grounds for concern that the potentially dangerous effects on the environment, human, animal or plant health may be inconsistent with the chosen level of protection.”  Communication from the Commission on the Precautionary Principle, COM (2000) 0001 final, para. 3 (Feb. 2, 2000), http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?ur i=CELEX:52000DC0001:EN:NOT

[5] Cartagena Protocol on Biosafety to the Convention on Biological Diversity Concerning the Safe Transfer, Handling and Use of Living Modified Organisms Resulting from Modern Biotechnology, art. 10, Jan. 29, 2000, http://www.cbd.int/doc/legal/cartagena-protocol-en.pdf.  The Cartagena Protocol on Biosafety to the Convention on Biological Diversity was signed by the Community and its Member States in 2000.  The Council concluded the Protocol on behalf of the Community through the adoption of  Decision 2002/628/EC: Council Decision of 25 June 2002 Concerning the Conclusion, on behalf of the European Community, of the Cartagena Protocol on Biosafety, 2002 O.J. (L 201) 48, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32002D0628:EN:HTML.

[6] The precautionary principle has been consolidated in international law and the EU and its Members are bound by it.  It was first recognized in Principle No. 15 of the Rio Declaration adopted at the 1992 UN Conference on the Human Environment and Development.  Rio Declaration on Environment and Development, Annex I, princ. 15, UN Doc. A/CONF.151/5/Rev.1, June 3–14, 1992, 31 I.L.M. 874, http://www.unep.org/Documents.Multilingual/Default. asp? documentid=78&articleid=1163.  In addition, article 3 of the 1992 UN Framework Convention on Climate Change refers to the precautionary principle.  United Nations Framework Convention on Climate Change, May 9, 1992, 1771 U.N.T.S. 107, http://treaties.un.org/pages/ViewDetailsIII.aspx?&src=TREATY&mtdsg_no=XXVII~7& chapter=27&Temp=mtdsg3&lang=en.  It was also referenced in the Preamble to the 1992 Convention of Biological Diversity.  UN Convention on Biological Diversity, June 5, 1992, 1760 U.N.T.S. 79, http://treaties.un.org/pages/ ViewDetails.aspx?src=TREATY&mtdsg_no=XXVII-8&chapter=27&lang=en.  The precautionary principle is also indirectly recognized in article 5.7 of the WTO Sanitary and Phytosanitary Agreement.  WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement), Apr. 15, 1994, http://www.wto.org/english/ tratop_e/sps_e/spsagr_e.htm.

[7] Maria Lee, EU Regulation of GMOs: Law and Decision Making for a New Technology 3 (2006).

[8] As of today, the list of forty-nine authorized GMOs for food and feed use includes twenty-seven maizes, eight cottons, seven soybeans, three oilseed rapes, one sugar beet, one potato, and two microorganisms.  Press Release, European Commission, Memo, Questions and Answers on EU’s Policies on Cultivation and Imports of GMOs (Nov. 6, 2013), http://europa.eu/rapid/press-release_MEMO-13-952_en.htm (citing EU Register of Authorized GMOs, European Commission, Health and Consumers, http://ec.europa.eu/food/dyna/gm_register/ index_en.cfm (last visited Dec. 11, 2013).

[9] Lee, supra note 7, at 189.

[10] Charlie Dunmore, EU Prepares New GMO Maize Cultivation Approval: Draft, Reuters (Oct. 31, 2013), http://www.reuters.com/article/2013/10/31/us-eu-gmo-cultivation-idUSBRE99U0W820131031.

[11] Id.

[12] Within the EU, a number of countries—the Czech Republic, Germany, Poland, Portugal, Romania, Slovakia, and Spain—planted MON810, a genetically modified maize variety sold by Monsanto, on a commercial basis in 2008.  The total acreage for the seven countries increased from 88,673 hectares in 2007 to 107,719 hectares in 2008.  Spain planted more than others.  However, in 2009, the EU acreage decreased by 9% compared to 2008 because of Germany’s prohibition on MON810.  Timo Kaphengst et al., Assessment of the Economic Performance of GM Crops Worldwide 1 (Ecologic Institute Mar. 2011), http://ec.europa.eu/food/plant/gmo/reports_studies/ docs/economic_performance_report_en.pdf.

[13] Proposal for a Regulation of the European Parliament and of the Council Amending Directive 2001/18/EC as Regards the Possibility for the Member States to Restrict or Prohibit the Cultivation of GMOs in Their Territory, at 3, COM (2010) 375 final (July 13, 2010), http://ec.europa.eu/food/food/biotechnology/docs/proposal_en.pdf.

[14] European Commission Directorate General for Health and Consumers, Evaluation of the EU Legislative Framework in the Field of GM Food and Feed (Final Report) (July 12, 2010), http://ec.europa. eu/food/food/biotechnology/evaluation/docs/evaluation_gm_report_en.pdf.

[15] Regulation (EC) No 1829/2003, supra note 3.

[16] Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 Concerning the Traceability and Labeling of Genetically Modified Organisms and the Traceability of Food and Feed Products Produced from Genetically Modified Organisms and Amending Directive 2001/18/EC, 2003, O.J. (L 268) 24, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:268:0024:0028:EN:PDF.

[17] European Commission Directorate General for Health and Consumers, supra note 14, at XIV.

[18] Id. at XV.

[19] Id. at 76.

[20] Id. at 105.

[21] Id. at 144.

[22] Id. at 52.

[23] Diahanna Lynch & David Vogel, The Regulation of GMOs in Europe and the United States: A Case-Study of Contemporary European Regulatory Politics (Council on Foreign Relations Apr. 5, 2001), http://www.cfr.org/ agricultural-policy/regulation-gmos-europe-united-states-case-study-contemporary-european-regulatory-politics/p8688.

[24] Id.

[25] Kaphengst et al., supra note 12, at II.

[26] Id.

[27] TFEU, supra note 2, art. 4.

[28] Regulation (EC) No. 1829/2003, supra note 3, art. 1.

[29] Directive 2001/18/EC, supra note 1.

[30] Directive 2008/27/EC of the European Parliament and of the Council of 11 March 2008 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, 2008 O.J. (L 81) 45, http://eur-lex.europa.eu/LexUriServ/Lex UriServ.do?uri=OJ:L:2008:081:0045:0047:EN:PDF.

[31] Directive 91/414/EEC on the Placing of Plant Protection Products on the Market, 1991 O.J. (L 230) 1, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:1991:230:0001:0032:EN:PDF, as amended by Commission Directive 1999/80/EC, O.J. (L 210) 13, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:1999:210: 0013:0015:EN:PDF.

[32] Regulation (EC) No. 1830/2003, supra note 16.

[33] Regulation (EC) No. 1946/2003 of the European Parliament and of the Council of 15 July 2003 on Transboundary Movements of Genetically Modified Organisms, 2003 O.J. (L 287) 1, http://eur-lex.europa.eu/LexUriServ/LexUri Serv.do?uri=OJ:L:2003:287:0001:0010:EN:PDF.

[34] Commission Recommendation of 13 July 2010 on Guidelines for the Development of National Co-existence Measures to Avoid the Unintended Presence of GMOs in Conventional and Organic Crops, 2010 O.J. (C 200) 1, http://ecob.jrc.ec.europa.eu/documents/CoexRecommendation.pdf.

[35] Id. at 4.

[36] Id. at 5.

[37] Directive 2001/18/EC, supra note 1, Recital 21.

[38] Id.

[39] European Commission, European Research Area, Food, Agriculture & Fisheries & Biotechnology, A Decade of EU-funded GMO Research (2001–2010), http://ec.europa.eu/research/biosociety/pdf/a_decade_of_eu-funded_gmo_research.pdf.

[40] Directive 2001/18/EC, supra note 1, art. 23, para. 1.

[41] Press Release, European Commission, supra note 8.

[42] Press Release No. 160/13 of the General Court, The General Court Has Annulled the Commission’s Decisions Concerning Authorisation to Place on the Market the Genetically Modified Potato Amflora (Dec. 13, 2013), http://europa.eu/rapid/press-release_CJE-13-160_en.htm.

[43] Id.

[44] See Article 26b added by the European Parliament to the Proposal for a Regulation of the European Parliament and of the Council Amending Directive 2001/18/EC as Regards the Possibility of the Member States to Restrict or Prohibit the Cultivation of GMOs in Their Territory, 2013 O.J. (C 33) E/350.

[45] Directive No. 2001/18/EC, supra note 1, art. 13, para. 1.

[46] Id. art. 13, para. 2.

[47] Id. art. 4, para. 4.

[48] Id. art. 4, paras. 4 & 5.

[49] Id. art. 14, paras. 1–3.

[50] Directive 2001/18/EC, supra note 1, art. 2(3).

[51] Case C-552/07, 2001/18 Judgment of the Court (Fourth Chamber) of 17 February 2009 (reference for a preliminary ruling from the Conseil d’État (France))—Commune de Sausheim v. Pierre Azelvandre, http://curia. europa.eu/juris/document/document.jsf;jsessionid=9ea7d2dc30dbc3b29977a1134bcfb724c51ba52915a8.e34KaxiLc3qMb40Rch0S
axuMaNb0?text=&docid=72933&pageIndex=0&doclang=en&mode=lst&dir=&occ=first&part=1&cid=929369
.

[52] Directive 2001/18/EC, supra note 1, art. 6.

[53] Id. art. 9.

[54] Id. art. 8, para. 1.

[55] Reg. (EC) No. 1829/2003, supra note 3, Recital 16.

[56] Id. art. 4, para. 1.

[57] Id. art. 5, paras. 1–3.

[58] Id. art. 5, para. 5(a), (b).

[59] TFEU, supra note 2.

[60] Reg. No. 1829/2003, supra note 3, art. 13, para. 1(a).

[61] Id. art. 13, para. 1(c).

[62] Id. art. 12, para. 2. 

[63] Directive 2001/18/EC, supra note 1, arts. 21 & 26.

[64] Regulation (EC) No. 1830/2003, supra note 16.

[65] Id. arts. 1, 6, 8.

[66] Id. art. 6, para. 1.

[67] Id. art. 4, para. 6(a).

[68] Id. art. 4, para. 6(b).

[69] Id. art. 7 (amending Directive 2001/18/EC art. 21).

[70] See also para. 2.5 of Commission Recommendation of 13 July 2010 on Guidelines for the Development of National Co-existence Measures to Avoid the Unintended Presence of GMOs in Conventional and Organic Crops, 2010 O.J. (C 200) 1, at 5, http://ecob.jrc.ec.europa.eu/documents/CoexRecommendation.pdf.

[71] European Centre of Tort and Insurance Law, Liability and Compensation Schemes for Damage Resulting from the Presence of Genetically Modified Organisms in Non-GM Crops Reports (Bernhard A. Koch ed., Apr. 2007).

[72] Directive 2004/35/CE of the European Parliament and of the Council of 21 April 2004 on Environmental Liability with Regard to the Prevention and Remedying of Environmental Damage, 2004 O.J. (L 143) 56, http://eur-lex. europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:143:0056:0075:EN:PDF.

[73] Id. Annex III(11).

[74] Canadian Institute for Environmental Law and Policy, GMO Statutory Liability Regimes: An International Review 11 (2004).

[75] Rady Ananda, EU High Court Rules on GMO Contamination; Opens Door to Biotech Liability, Food Freedom (Sept. 6, 2011), http://foodfreedom.wordpress.com/2011/09/06/eu-court-rules-on-gmo-contamination/.

[76] Article 26c, Position of the European Parliament Adopted at First Reading on July 5, 2011, with a View to the Adoption of Regulation (EU) No. …/2011 of the European Parliament and of the Council Amending Directive 2001/18/EC as Regards the Possibility for the Member States to Restrict or Prohibit the Cultivation of GMOs in Their Territory, 2013 O.J. (C 33) E/350.

[77] Cartagena Protocol, supra note 5.

[78] Nagoya–Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety, Oct. 15, 2010, http://bch.cbd.int/protocol/NKL_text.shtml.

[79] 1999/468/EC: Council Decision of 28 June 1999 laying down the Procedures for the Exercise of Implementing Powers Conferred on the Commission, 1999 O.J. (L 184) 23, http://eur-lex.europa.eu/Notice.do?val=329852: cs&lang=en&list=335859:cs,329853:cs,329852:cs,&pos=3&page=1&nbl=3&pgs=10&hwords=&checktexte=checkbox&visu=#texte.  Article 2, para. (b) and article 5 of this decision specify that when the Commission adopts implementing legislation concerning the health and safety of humans, animals, and plants it has to do so with the assistance of a regulatory committee, composed of representatives of the EU Members and chaired by a representative of the Commission.  The representative prepares a draft, which is voted on by the representatives of the Member States. 

[80] Id. art. 3(1) & (2). 

[81] Press Release, United Nations Decade on Biodiversity, Convention on Biological Diversity Communique, European Union Approves Nagoya‑Kuala Lumpur Supplementary Protocol on Liability and Redress Montreal (Mar. 26, 2013), http://www.cbd.int/doc/press/2013/pr-2013-03-26-eu-en.pdf.

[82] Case T164/10, Pioneer Hi-Bred International, Inc., Judgment of the General Court (Seventh Chamber), Sept. 26, 2013, http://curia.europa.eu/juris/document/document_print.jsf?doclang=EN&text=&pageIndex=0&part=1&mode= lst&docid=142241&occ=first&dir=&cid=127901.

[83] See Dunmore, supra note 10.

[84] Case C-442/09, Karl Heinz Bablok and Others v. Freistaat Bayern, Judgment of the Court (Grand Chamber), Sept. 6, 2011, http://curia.europa.eu/juris/document/document.jsf?text=&docid=109143&pageIndex=0&doclang=en& mode=lst&dir=&occ=first&part=1&cid=780715.

[85] Id. para. 109.

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Last Updated: 04/28/2014