Germany discourages the cultivation of genetically modified (GM) crops to the extent possible within the already stringent European Union (EU) legislation on genetically modified organisms (GMOs). Germany imposes strict liability for accidental contamination with GMOs, and has tough and methodically enforced controls over the release of GMOs. In 2009 Germany banned MON810 maize from cultivation for agricultural purposes, even though the EU has approved it for release into the environment. The only other GM plant that the EU has approved for release, the Amphora potato, is currently not being grown as a crop in Germany. Since 2013 the experimental planting of GM plants has also been abandoned owing to persistent vandalism.

German public opinion is averse to food that contains GMOs, and German scholarly councils have stressed the environmental risks emanating from the release of GMOs. German scientists, on the other hand, would like to continue researching GMOs. In 2010 the German Federal Constitutional Court held that the restrictive German legislation is compatible with German constitutional principles.

I. Introduction

German legislation on genetically modified organisms (GMOs) operates within the framework of European Union (EU) law. Germany transposed EU Directive 18/2001 on the release of GMOs into the environment[1] in 2004 by reforming the German Act on Genetic Engineering,[2] while EU Regulation 1829/2003 on GMOs in foodstuffs took effect in Germany with its enactment at the EU level in 2003.[3] Within the limits of EU law, the German laws and regulations on GMOs are characterized by restrictiveness, complexity, and rigorous requirements that allow for effective governmental oversight and enforcement and hold polluters responsible through civil liabilities. As a result of these stringencies and of the banning of MON810 maize in 2009,[4] no genetically modified (GM) plants have been cultivated in Germany in recent years as agricultural crops.[5] Even the number of plantings for research purposes has dwindled from about five hundred in the year 2000 to seventy-five in 2012.[6] In 2013 no experimental planting was carried out owing to persistent sabotage by anti-GMO activists.[7]

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II. Public and Scholarly Opinion

The German position on GMOs is characterized by a population that is averse to GM plants in foodstuffs and apprehensive of the release of GMOs into the environment on the one hand, and a scientific community that does not want to lose its ability to research GMOs[8] on the other. Some farmers also would find GM planting useful, in particular planting of the banned MON810 maize.[9] The German Farmer’s Association, on the other hand, advises against the cultivation of GM crops in response to the popular aversion to foods containing GMOs.[10]

The German debate on GMOs has been robust, with the adversaries of GMOs invoking the precautionary principle of protecting the environment against unforeseeable risks,[11] while proponents of GMO research and GM plant cultivation stress economic advantages, particularly for the third world,[12] and the lack of substantiated harm from GMOs[13] after decades of intensive research.[14] In 2008 a Council of Environmental Scholars weighed in on this debate, holding that a total avoidance of pollution from GM planting is technically not feasible.[15] The Council sees the risks of GMOs as a threat not so much to human health as to the environment, citing the risks of contaminating natural areas and non-GM crops, dissemination through vertical and horizontal gene transfers, toxic effects on nontargeted organisms, and effects possibly resulting from changes in agricultural practices.[16]

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III. Structure of Pertinent Legislation

In Germany the research, production, marketing, and release of GM plants are governed by the Genetic Engineering Act.[17] The Act deals with GMOs in both plants and animals but does not deal with food or feed containing GMOs. The latter are governed by directly applicable EU regulations, primarily Regulations 1829/2003 on GMOs in food or feed and 1830/2003 on the traceability and labeling of GMOs and foods containing them,[18] with German legislation limited to the implementation of the EU rules.[19] Nor does the German Genetic Engineering Act deal with GMOs in pharmaceutical products. The Act on Pharmaceutical Drugs[20] and various best-practice guidelines for producing pharmaceutical drugs apply to these.[21]

Germany first enacted the Genetic Engineering Act in 1990, yet with respect to GM plants the current version is based on a reform of 2005[22] that transposes EU law, particularly Directive 2001/18, which deals with the release of GMOs into the environment. Germany had delayed transposition until the European Court of Justice declared Germany to be tardy in the discharge of its obligation.[23] In compliance with the European mandate, the 2005 version of the Act became somewhat less restrictive than it formerly had been.[24] Yet after the 2005 reform, Germany had to reform the Act again in 2006 and 2008 to live up to EU requirements.[25]

The purposes of the Genetic Engineering Act are threefold. First, the Act aims to protect the environment and human and animal health from risks emanating from GMOs. Second, the Act aims to guarantee that genetically modified, conventionally produced, and organically grown products, particularly food and feed, can be grown, produced, and marketed in coexistence with each other. Third, the Act creates the legal framework for research on and the development and economic use of GMOs.[26]

Germany introduced the goal of coexistence between GM, non-GM, and organic plantings in 2005, in compliance with the common-market orientation of Directive 18/2001. At the same time, Germany changed the definition of a GMO to protect against environmental pollution through GM plants. Since then the German Act has defined a GMO not only as an organism whose genetic material has been altered in a way that does not occur naturally by mating or natural recombination, but also as one that has come into existence through mating or natural recombination between a GMO and a non-GM organism.[27] Accordingly, plants that were accidentally bred through recombination with GMOs also fall under the restrictions of the Genetic Engineering Act, such as requiring a permit to be marketed or released. [28] Rulings in German court cases based on this expanded definition have led to the destruction of many contaminated plantings.[29]

The Genetic Engineering Act has a chapter on working with GMOs in enclosed spaces and another on marketing GMOs and releasing them into the environment. In addition, administrative procedural rules are provided, as are a civil liability regime and penal provisions. Given the preeminence of EU law in authorizing GM plants for release and marketing, the German Law focuses primarily on safety rules that must be observed in lab work or individual releases, particularly plantings, both experimental and agricultural.[30] Yet in banning MON810 Germany has set aside the EU prerogative to approve GMOs[31] under the German justification that this GMO poses a risk to health and the environment.[32]

The Genetic Engineering Act is implemented by the German states[33] and, at the federal level, by the Federal Office of Consumer Protection and Food Safety.[34] The latter acts as an advisory and at times supervisory agency for the state agencies, and together they carry out the numerous approval processes that are required in researching, producing, and using GMOs. The Federal Office also acts as a liaison in consultations with and notification of EU authorities and the other EU member states, and thereby carries out the German part of these intertwined responsibilities.[35]

Germany also has a Central Committee for Biological Safety, which is composed of scientists from various disciplines. The Committee participates in approval proceedings, advises the government on policy, monitors safety, and issues annual reports.[36]

Even though genetic engineering law is federal in Germany, the states still have some possibilities of implementing their own policies, be it through strict enforcement of the federal laws, protection of state parks and forests, or state-wide quality labels of origin. The State of Baden-Württemberg, for instance, uses all these techniques to discourage GM planting and prides itself on being a GMO-free region.[37]

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IV. Restrictions on Research, Production, and Marketing

Germany has a dense regulatory regime for the research and production of GMOs in enclosed spaces. The operator of the installation is responsible for proper risk assessment and adequate containment measures, and there is tight governmental oversight. The rules for handling GMOs in laboratories or production facilities differ, depending on the riskiness of the activity. Compliance is ensured through numerous reporting duties and the appointment of an internal monitoring official.[38] In addition, permits are required for all installations and processes, and these are awarded only to properly qualified operators.[39] If GMOs are released into the environment in the course of experimental plantings, the general rules on the release of GMOs apply (see Part V, below).[40]

The rules for marketing GMOs fall largely into the domain of EU law, in that a GMO or a product containing GMOs must be approved at the EU level before being marketed throughout the EU. The approval process is governed by Directive 2001/18, and if the GMO or GMO product concerns food or feed, by Regulation 1829/2003. At times an applicant may ask for approval under both regimes if the GMO is to be used for crop cultivation as well as food or feed.[41] In compliance with the EU common-market principles, Germany permits the importation of the approximately fifty GMOs that the EU has approved as food or feed.[42] Of the two EU-approved GMOs for release into the environment, Germany allows the marketing of only the Amphora potato, having banned MON810 maize in 2009, as explained above (see Part I).

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V. Restrictions on Releasing Organisms into the Environment

Although the approval of GMOs for release into the environment is primarily governed by EU law, the Member States still have much discretion over fashioning the regulatory systems to protect the environment from undue risk when GM plants are cultivated, and Germany has made use of this discretionary power to create a very stringent system to control any GMO releases.

Releases are permitted only after governmental approval is obtained, and the permit criteria are as strict as those for the operator of a GMO-processing installation in that they insist on highly qualified operators and observance of state of the art techniques. Moreover, the law requires that approval be granted only after balancing and weighing the benefits of a release with any potential risks,[43] and this statutory criterion is subject to conflicting interpretations.[44]

The locations register for GM plantings is an important tool for transparency and governmental oversight, yet it also allows anti-GMO activists to locate plantings for the purpose of destroying them.[45] Growers of GMO crops must notify the authorities three months prior to seeding or planting, and again three days prior to each release. The information must include a description of the GMO and the exact location of its release.[46] Portions of the register are available to the public on the Internet, whereas personal data are released only if the requester has a justifiable interest. The published portion of the register specifies the exact location of each planting,[47] and researchers who conduct experimental plantings hold this publicity responsible for the destruction of virtually all research plantings since 2004.[48]

To avoid contamination of adjacent plantings or the environment at large, various best practices must be observed in the cultivation of GM plants, among them separation zones for GM maize. The distance of a field of GM maize from a planting of conventional maize must be at least one hundred fifty meters, and from an organic planting of maize, three hundred meters.[49] These are the only prescribed separation zones, yet there has been discussion on the need for a ten-kilometer zone to protect the beehives of beekeepers (see Part VIII, below, for the EU honey decision and its impact), and the State of Baden-Württemberg may be in the process of requiring a one-kilometer zone to protect nature preserves.[50]

The authorities of the states enforce the laws and regulations on the release of GMOs so as to avoid accidental contamination of adjacent fields and harvested crops.[51] For this purpose, the authorities may prohibit plantings[52] and destroy contaminated plantings (see Part VIII, below). Some states pride themselves on the thoroughness of their oversight. The State of Baden-Württemberg, for instance, tests crops methodically for contamination.[53]

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VI. Restrictions on GMOs in Foodstuffs

In compliance with the EU common-market principles, Germany permits the importation of the approximately fifty GMOs that the EU has approved for food or feed.[54] Currently, GMOs are mostly used in Germany in feed for livestock. Little food labeled as containing GMOs is marketed for human consumption in Germany, yet given the EU labeling rules, the ingredients of such foods may still contain GMOs below the threshold level of 0.9%. In addition, dietary supplements and additives in such foods may contain GMOs, since these are not subject to the requirements of Regulations 1829/2003 on GMOs in food or feed and Regulation 1830/2003 on the traceability and labeling of GMOs and foods containing them.[55]

To market food that is free of even traces of GMOs, Germany allows the use of a label indicating “No Genetic Engineering” (Ohne Gentechnik). Under the auspices of the German authorities, this label is administered by an association that supports GMO-free food.[56] In order to qualify for this label, a food must be free of traces of GMOs, and the additives and dietary supplements in such foods must also be free of GMOs. For meat and meat products to qualify for the label, the animals must have been fed a GMO-free diet for lengthy periods before slaughter.[57]

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VII. Liability Regime

The Act on Genetic Engineering contains a strict liability regime for damage caused by GMOs.[58] Damages are capped at €85 million (about US$117,050,000), and the operators of research or production facilities must obtain liability insurance or coverage through governmental guarantees. Injunctive relief is also available.

This liability regime also applies to the accidental pollution of adjacent properties. If a grower of GM plants contaminates a neighbor’s field and the neighbor’s planting must therefore be destroyed (owing to the unauthorized release of GMOs), then the grower of the GM plants is presumed to have caused this damage and is fully liable. Likewise, if food is produced from GMO-contaminated plants and therefore must be labeled as containing GMOs owing to the level of contamination, or can no longer qualify for the “No Genetic Engineering” label, then the grower presumed to have caused this contamination is fully liable for the reduction in marketability and value of the contaminated food.[59] Damages can be considerable, considering the German preference for foods without GMOs. In fact, this liability regime has proven to be the biggest deterrent to the cultivation of GM crops in Germany, and has caused the German Farmer’s Association to advise against the cultivation of GM plants.[60]

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VIII. Judicial Decisions / Prominent Cases

German judicial decisions have touched on many aspects of GMO legislation, both domestic and European. In 2009 the Administrative Court of Munich referred the Bablok case (honey case)[61] to the European Court of Justice (ECJ).[62] In 2010 the Federal Constitutional Court (FCC) upheld the Genetic Engineering Act.[63] In 2012 and 2013 administrative courts upheld destruction orders for GMO-contaminated plantings,[64] while at various times anti-GMO activists have been tried in the criminal courts.[65]

The FCC decision of 2010 balances and weighs the potential risks of GMO releases with the interests of researchers and users of GMOs. A constitutional challenge had been brought by the government of the German State of Sachsen Anhalt, which objected to the publication of location register data (see Part V, above) on the grounds that this could invite vandalism by anti-GMO activists. The State also objected to the strict liability regime for contamination of neighboring properties. The Court held that the Act on Genetic Engineering struck an appropriate balance between the purpose of protecting against GMO risks on the one hand, and the enhancement of research on and the development and proper use of GMOs on the other. The Court also pointed out that the data on the German locations of GM plantings could be viewed in Internet registers according to the Cartagena Protocol[66] and in the EU’s Register of Genetically Modified Foodstuff and Animal Feed.[67] With respect to the liability provisions contained in the Genetic Engineering Act regarding the contamination of neighboring properties, the Court held that the Act merely exemplified and clarified liabilities already existing in the German law of nuisance.

The Bablok decision of the ECJ continues to generate follow-up decisions and legislative proposals in Germany. In Bablok, the EJC had held that GMO-contaminated honey and pollen fell under the restrictions of Regulation 1829/2003. In March 2012 the Bavarian Higher Administrative Court rejected in part claims of a beekeeper for additional measures to protect his bees from the risk of contamination by GMO plantings.[68] In June 2012 a parliamentary minority party submitted a legislative draft calling for the introduction of ten-kilometer separation zones between GM plantings and the location of beehives.[69]

Acts of vandalism against GMO crops also generate court decisions that touch on various aspects of the law on GMOs. In May 2013 a Higher Regional Court rescinded and remanded a lower court’s conviction of destroyers of GM plantings because the lower court had failed to examine whether the permit for the planting had been given in violation of the law. The perpetrators had used the justification (defense) of necessity and had claimed that the permit had been in violation of the law.[70]

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Edith Palmer
Chief, Foreign, Comparative and International Law Division II
March 2014

 

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Last Updated: 12/30/2020