Although the Netherlands was the first European Union Member State to have legal coexistence guidelines on genetically engineered (GE) crops, commercial production of genetically modified (GM) crops has not yet taken place there, and there are no GE livestock. While the government and the agriculture sector take a pragmatic approach toward the import and use of GM products, public opinion is divided as to whether GM foods pose health risks, and the complex regulatory environment and effective pressure from environmental groups have worked to hamper the commercial manufacture of genetically modified organisms (GMOs).

Activities involving GMOs are for research purposes in laboratories or field trials, and are tightly regulated, in particular through EU Directives made applicable in the Netherlands. The Ministry of Infrastructure and Environment oversees the GMO-related activities in the Netherlands; its Bureau for Genetically Modified Organisms carries out licensing. Prior risk assessment and subsequent monitoring and reporting are necessary for all GMO-related activities. Criminal penalties and administrative sanctions may be applied to violations of licensing requirements.

The Netherlands Food and Consumer Product Safety Authority and the Institute of Food Safety are responsible for determining the safety of GMO food and feed, respectively. Labeling of pre-packaged food products for sale in the Netherlands requires conformity with the Food Labeling (Commodities Act) Decree and the relevant EU Regulation on food and feed.Contained-use license holders must ensure, if making GMOs available to another party, that the GMO packaging label or the document accompanying the GMOs clearly indicates the presence of GMOs.

I. Introduction

Commercial production of genetically modified (GM) crops has not yet occurred in the Netherlands.[1] According to a report on biotechnology in the Netherlands issued by the US Department of Agriculture (USDA) in June 2013, “there are no genetically engineered (GE) crops under development that will be on the market in the next five years.”[2] However, the Netherlands does import large quantities of GE crops and derived products.[3] It also transships such imported crops and products to other European Union (EU) countries, or exports them to non-EU countries, using the requisite documentation and labeling required under EU law.[4] Because cultivation of GE crops is not permitted, GE seed is not imported.[5] Additionally, because GE products for consumers must be labeled, imported quantities of the products are small.[6] The main imported GE crops and derived products are soybeans from Brazil and the United States and soybean meal from Brazil and Argentina.[7] In accordance with EU legislation, the Netherlands has a Low Level Presence policy for unapproved GE varieties in feed.[8] According to the USDA report, “the Dutch livestock sector depends on feed imports from third countries [that consist] mainly of GE soybean meal. The livestock sector does not include any GE animals nor do Dutch agricultural research institutes have them for research purposes.”[9]

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II. Public and Scholarly Opinion

The Dutch government and parliament view GM crop varieties as “a very important field of development for the economy and civil society at large.”[10] While the government and the agricultural sector have been characterized as taking a pragmatic approach towards the import and use of GE agricultural products, because of “cumbersome regulations” and the specter of protests from environmental groups, crop trials and the cultivation of biotech crops for commercial purposes are viewed as being effectively blocked.[11] There are other considerations as well. According to a 2008 report published by the Commission on Genetic Modification (Commissie Genetische Modificatie, COGEM), an independent scientific advisory committee[12] on the environmental and economic impact of GM crops on Dutch agriculture,[13] “given the small area of land used for agriculture in the Netherlands, the GM crops currently available are not particularly attractive for Dutch farming,” and properties added thus far “offer few advantages to [a Dutch farmer of arable land].”[14]

Awareness of GM foods and of animal cloning is relatively high in the Netherlands; it was reported in 2010 that some 93% of the Dutch public had heard of the GM foods and 87% were aware of animal cloning.[15] Public opinion is divided as to whether GM foods are good for people, with 43% of persons surveyed of the view that such foods are not good, 44% disagreeing with that view, and 13% not sure.[16] Although the majority of respondents believed that GMO foods were not safe for future generations, a higher proportion of the Dutch (34%) compared to other Europeans held that the products would be safe.[17] On the whole, in the view of one study, the Dutch general public’s perceptions on conventional crop and food safety “are grounded more in culture and tradition than in scientific safety testing.”[18]

Among political parties, it appears that the Party for the Animals has recently been active against the use of GMOs. In January 2013, it put forward a proposal to make Amsterdam a GMO-free zone.[19]Some of the other organizations and institutions active on GMO issues (chiefly against GMOs) in the Netherlands are Gentech-NL – ASEED (which called for a march against MonsantoS on October 30, 2013);[20] Milieudefensie (Friends of the Earth Netherlands); Greenpeace Netherlands; Nederlands Platform Genetechnologie; De Gentechvrije Burgers; GoedeWaar.nl; and Burgers voor gentechvrij voedsel.[21]

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III. Structure of Pertinent Legislation

A. Definition of GMOs

Under the Decree on Genetically Modified Organisms in the Environment (hereinafter GMO Decree),[22] “genetically modified organisms” (genetisch gemodificeerde organismen) are defined as organisms, with the exception of human beings, in which the genetic material has been altered in a way that is not possible in nature through mating or through natural recombination.[23] Genetic material is defined as DNA and RNA; genetic modification, as the alteration of genetic material in a way that is not possible in nature through reproduction or recombination; and organisms, as microorganisms and other biological entities with the capacity for multiplication or transmission of genetic material.[24]

B. Regulation of GMOs

GMOs in the Netherlands are regulated at the international, European Union, national, and local levels. The Netherlands is a party to the Convention on Biological Diversity,[25] the Cartagena (Biosafety) Protocol,[26] and the Aarhus Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters.[27]The Netherlands signed The Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety on March 7, 2011.[28]

In the case of EU regulation, Directive 90/219/EEC on the contained use of GM microorganisms as amended by Directive 98/81/EC (the Contained Use Directive)[29] and Directive 2001/18 on the deliberate release of GMOs into the environment (the Deliberate Release Directive)[30] have been implemented in Dutch law by the GMO Decree. Other key EU legislation includes Directive 2009/41/EC on the framework for laboratory experiments using GM microorganisms,[31] Regulation EC No. 178/2002 on general principles and requirements of food law and procedures for food safety,[32] Regulation EC No. 258/97 on novel foods and novel food ingredients,[33] Regulation EC No. 1829/2003 on GM food and feed,[34] and Regulation EC No. 1830/2003 on the traceability and labeling of GMOs and traceability of GMO derived food products.[35] Regulation 1946/2003 applies to transboundary movements of GMOs.[36]

The basic purpose of current Dutch legislation on GMOs is to implement European Union directives on the subject, which seek to balance the promotion of scientific progress with protection of the environment and consumer safety. This is mainly accomplished in the GMO Decree. The overarching national law on which the GMO Decree is based is the Environmentally Hazardous Substances Act.[37] In addition to the GMO Decree, key items of legislation implementing the EU law in the Netherlands are the Regulation on GMOs,[38] the Environmental Management Act,[39] the Food and Commodities Act,[40] and the Decree on Novel Foods.[41]

At the local level, cities and provinces have taken action against GMOs. For example, on January 26, 2011, Friesland Province became the first GMO-free region in the Netherlands, and in July of that year the Community Council of Nijmegen declared the city to be GMO-free.[42]

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IV. Restrictions on Research, Production, and Marketing

A. Licenses and Risk Assessments

Prior risk assessment and authorization is required in order to engage in activities involving GMOs. The Dutch Environment Management Act provides that anyone who by virtue of his profession manufactures a substance, preparation, or genetically modified organism; imports it into or administers, prepares, processes, or makes it available to others in the Netherlands; and who knows or reasonably could have guessed that by his actions the substance, preparation, or organism may pose a threat to human health or the environment, must take all measures that can reasonably be demanded of him to avoid or reduce the risks as far as possible.[43] Under Dutch law, as part of the permit process for such activities, COGEM is responsible for assessing the risks they might pose to health and the environment[44] and reporting its findings to the Minister of Infrastructure and the Environment.[45]

GMOs are classified into three groups under Dutch law. Group I comprises GM microorganisms that meet the rules for GMO classification laid down by the Minister of Infrastructure and Environment, as well as such microorganisms manufactured using organisms and vectors not designated as suitable for the production of Group I organisms but that, upon application to the Minister, are found to meet the classification criteria. Group II is other GM microorganisms, and Group III is GMOs other than microorganisms.[46]

The GMO Decree requires that a license be obtained for the genetic modification of plants and microorganisms.[47] The Decree allows for various types of licenses, which may be roughly divided into the three categories of contained use, market introduction, and other purposes such as field trials.[48] In general, the GMO permit is to include the following information: the purpose of the genetic modification; the name of the host(s), vector(s), and insert(s); the safety level; and the exact place of the work.[49] The specific kinds of information required for each type of permit are set forth in Annex 4 of the GMO Decree.

The Bureau for Genetically Modified Organisms (Bureau Genetisch Gemodificeerde Organismen, or Bureau GGO), on behalf of the Ministry of Infrastructure and the Environment, handles the granting of licenses (vergunningverlening) to work with GMOs.[50] The government maintains a database of licenses that have been granted as well as those that are pending. In addition, the database website includes information from 2008 on the locations of field trials in the Netherlands and the registration of GM crops.[51]

B. Contained Use (Ingeperkt Gebruik)

Anyone who intends to engage in the contained use of GMOs must conduct an analysis beforehand of possible risks to humans or the environment and keep available a summary report for the Minister of Infrastructure and the Environment, and for the authority that has jurisdiction over the establishment where the activities in question take place.[52] It is prohibited to carry out contained use of GMOs without a permit issued in response to an application for a license.[53]

For purposes of standard laboratory research or manufacturing involving procedures on a small scale (generally up to ten liters of culture fluid per unit), a Group I Class A permit is required.[54] Class A covers laboratories, animal housing, storage rooms, or greenhouses intended for (1) genetic modification of organisms or (2) education, research, development or the non-industrial-purpose reproduction, storage, use, possession, transport, disposal, or destruction of GMOs.[55] Group I Class A permit holders must prepare a report before June 1 every year on the previous year’s activities and keep it for five years, at the disposal of the Minister.[56] There is also a Group I Class B permit, for “other operations” involving Group I organisms.[57] Such permits might involve procedures on a large scale (use of more than ten liters)[58] or work not covered by small-scale or large-scale operations.[59]

All work carried out under a contained use license is to be monitored by a Biological Safety Officer (Biologische-veiligheidsfunctionaris, BVF). The BVF must be authorized by the State Secretary of Infrastructure and the Environment.[60] The license holder charges the BVF with such tasks as drafting and modifying detailed internal procedures and rules for the safe handling of GMOs, and conducting internal monitoring of compliance with the relevant legal provisions as well as those procedures and rules.[61]

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V. Restrictions on Releasing Organisms into the Environment

A. Conditions for Deliberate Release into the Environment

For activities involving the release of GMOs into the environment, adherence to procedures set forth under EU Directive 2001/18/EC (the Deliberate Release Directive) is required.[62] An application for a license to place GMOs on the market must contain, among other material, information required by the Directive, an environmental risk assessment, the desired duration of the license, and a monitoring plan.[63] In general, a marketing license is granted for up to ten years.[64] An application for a permit for deliberate release of GMOs into the environment for other purposes(e.g., for field trials) must include information needed to carry out an

environmental risk assessment, in accordance with Annex III of the Directive as well as the environmental risk assessment itself.[65]

It is prohibited without a license to produce GMOs to use, hold, or be made available to another party, to introduce or discard them in the Netherlands, or to transport GMOs that are not microorganisms.[66] Exceptions to this ban include, for example, GMOs for contained use;[67] the transport of GMOs, other than microorganisms, for other purposes in accordance with ministerial rules;[68] operations for other purposes involving medicinal substances and preparations for human use that consist of or contain GMOs, if certain conditions are met;[69] GMOs as or in products or marketed products, or insofar as they meet certain conditions;[70] GMOs as or in marketed products if the competent authority of another Member State has provided for their market placement or otherwise been granted prior written permission;[71] and traces of a GMO in products marketed and intended for direct use as food or feed, or for processing.[72]

Material derived from GMOs for which a permit or written permission has been granted by a competent authority of another EU Member state is prohibited from placement on the market unless a license or written consent has been granted for such a purpose.[73]

Violation of the GMO Decree’s licensing requirements is deemed a criminal offense in conformity with article 1a of the Dutch Act on Economic Offenses, with maximum penalties ranging from imprisonment for six years for intentional acts and fines up to €78,000 (approximately US$106,018).[74] The Minister for Infrastructure and the Environment may also apply certain “standard” administrative sanctions, such as revocation of the license.[75]

B. Reporting and Transparency

Licensees are responsible for providing various types of reports. Before a licensee begins work, he or she should provide a description of the proposed work (Beschrijving van Voorgenomen Werkzaamheden) for the coming year.[76] The report must be approved, with written confirmation, by the Bureau GGO.[77] As was noted above in connection with contained use licensees, at the end of the work year, a report of work performed (Verslag van Verrichte Werkzaamheden) must be submitted.[78] Once a field trial is terminated, a final report must be prepared, in conformity with the fixed format required by the European Commission.[79]

If the applicant or the holder of a license for placing GMOs on the market or for other purposes becomes aware of new information on the risks that the GMO or the operations involving it may pose to humans or the environment, or if there is a modification or unintended change in the deliberate release of GMOs into the environment, the person must immediately notify the Minister of Infrastructure and the Environment, take any measures needed to protect humans and the environment from the risks, and revise the relevant information in the authorization application and submit it to the Minister.[80] If a significant potential risk is involved, the Minister must publicize the new information,[81] as is also required if the Minister becomes aware of the release without a license of GMOs into the environment.[82]

An authorization that has been obtained for GMO-related activities also applies when there is a change in the location of those activities, if the change does not lead to different or greater risks to humans or the environment than those posed by the licensed activities.[83] Among other conditions for granting such authorization, the Minister of Infrastructure and the Environment, in concert with the Minister of Agriculture, Nature Management and Fisheries, must state in writing to the licensee that the proposed change meets the necessary criteria and there is no reason to amend the license.[84] The Minister of Infrastructure and Environment is to issue a notice, containing all the key relevant information, in one or more daily newspapers, or at least the Government Gazette(Staatscourant).[85]

C. Monitoring

All work carried out under a permit for GMO release into the environment must be monitored by an Environmental Safety Officer (Milieuveiligheidsfunctionaris), who must be authorized by the Minister of Infrastructure and the Environment.[86] In conformity with the GMO Decree, a register of the location of GMOs must be maintained.[87]

D. Coexistence

The Netherlands was the first country in the EU to have legal coexistence guidelines, the stakeholders having reached a consensus in 2005.[88] In agriculture, coexistence “refers to the possibility of cultivating GM crops alongside conventional and organic farming without one excluding the other.”[89] On July 13, 2010, the European Commission decided on new rules for coexistence that now permit Member States to enforce their own conception of the term.[90] In the past, the Member States could only arrange for gene technology-free zones on the basis of voluntary agreements; under the new rules, they can prohibit the cultivation of certain GM plants.[91] Previously, a Member State’s mandatory measures were required to be “appropriate” to maintain the admixture of GMOs in conventional crops under the EU-wide threshold value of 0.9%. With the adoption of the new guidelines, “national cultivation regulations can be so constructed to prevent much lower GMO proportions.”[92]

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VI. Restrictions on GMOs in Foodstuffs

A. Regulatory Agencies and Risk Assessments

EC Regulations 1829/2003 on GM food and feed, 1830/2003 on the traceability and labeling of GMOs, and 1946/2003 on the transboundary movement of GMOs set rules at the EU level for the use of GMOs in foodstuffs. The European Food Safety Agency (EFSA) is responsible for providing “objective scientific advice on all matters with a direct or indirect impact on food and feed safety in the EU,”[93] and it has issued guidance documents for risk assessment of GM plants and derived food and feed.[94] The Ministry of Health, Welfare and Sports and the Ministry of Economic Affairs, Agriculture and Innovation are responsible for the implementation of Directives 1829/2003 and 1830/2004 in the Netherlands.

In addition, Regulation 882/2004[95] provides for institutes within EU Member States to serve as National Reference Laboratories for purposes of GMO analysis. In the Netherlands, there are two Routine Field Laboratories that conduct GMO sample analysis for the government: the Netherlands Food and Consumer Product Safety Authority (Nederlandse Voedsel-en Warenautoriteit, NVWA) for food, and the Institute of Food Safety (RIKILT) for feed.[96] The NVWA is “an independent agency in the Ministry of Economic Affairs and a delivery agency for the Ministry of Health, Welfare and Sport.”[97] The NVWA’s Office for Risk Assessment “identifies early warning signs of troubling aspects of innovations in GM agriculture, screens potential threats to human and animal health, evaluates public perceptions, and commissions necessary research.”[98] The Office is said to have become the “front office” for GMO regulation, even though it “confines its duties to weighing the risks and benefits of a particular GM crop and does not engage in policy enactment, decision making, or food law enforcement.”[99]

B. Labeling

In general, labeling of prepackaged food products for sale in the Netherlands requires conformity with the Food Labeling (Commodities Act) Decree (Warenwetbesluit Etikettering van levensmiddelen). It is obligatory under the Decree to provide, among other information, the product name; the net quantity; the minimum best-before date or latest consumption date; and information on the manufacturer, packager, or seller.[100] If a foodstuff product makes any claims as to its nutritional value, benefit to health, or medical advantages, the producer must comply with certain rules that differ according to the claim and the product.[101] The Decree on Novel Foods (Warenwetbesluit Nieuwe Voedingsmiddelen)[102] may also apply to GMOs.

For GM foods, Dutch labeling requirements are also based on articles 12–13 of EU Regulation 1829/2003. The requirements are applicable to foods that are “to be delivered as such to the final consumer or mass caterers” and that contain or consist of GMOs or that are “produced from or contain ingredients produced from GMOs.”[103] They are not applicable to foods with material that “contains, consists of or is produced from GMOs in a proportion no higher than 0,9 per cent of the food ingredients considered individually or food consisting of a single ingredient, provided that this presence is adventitious or technically unavoidable.”[104] In addition, the labeling must mention any characteristic or property where (a) a food differs from its conventional counterpart in terms of its composition, nutritional value or effects, intended use, or health implications for certain population groups, and/or (b) ethical or religious concerns may arise from the food.[105] For those foods that lack a conventional counterpart, the labeling must contain appropriate information about their nature and characteristics.[106] There are also labeling requirements for contained-use license holders that make GMOs available to another party.[107] According to a USDA report, “since the Netherlands follows EU legislation, standard U.S. labels fail to comply with Netherlands labeling requirements.”[108]

The Decree on Novel Foods states that the reference “made without genetic engineering” is used only for food or drink that (1) does not consist of or is not derived from GMOs; (2) is not prepared with the aid of substances that consist of or are derived from GMOs or produced using technical processing aids derived from GMOs; and (3) is not derived from animals that are fed with GM feed or feed with GM additives; produced using modern biotechnology, with certain exceptions; or that contain traces of GM DNA, except when unintentional and unavoidable.[109]

It may be noted that new EU food labeling rules will generally apply from December 13, 2014, but with some requirements to apply from January 1, 2014, or December 13, 2016.[110] The new

EU Regulation 1169/2011[111] will repeal Directive 2000/13/EC,[112] article 3 of which sets forth general requirements for the labeling of foodstuffs.[113]

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VII. Liability Regime

The Netherlands apparently has no special regime for liability or compensation for damage in connection with GMO crops.[114] Under Dutch law, there is a distinction between strict liability and fault-based liability for wrong acts.[115] Strict liability falls into the two main categories of strict liability for unlawful acts of other individuals and strict liability for defective objects and substances, with possibility two relevant sources: vicarious liability (Civil Code art. 6:170, on tortious acts by employees) and strict liability for hazardous substances (Civil Code art. 6:175).[116] The Civil Code covers fault-based liability in article 6:162.[117]

To establish a causal link between alleged damage and the presence of a GM crop, Dutch law is said to rely on a two-stage test: the condition sine qua non (“but for”) test, whereby the GMO’s presence is a necessary condition for the existence of the damage, and the imputation test.[118] This test is basedon the Civil Code, Book 6, article 98, which states that compensation can only be claimed insofar as the damage related to the event creating liability can be imputed to the debtor as a result of the event.[119] Dutch case law had further developed the imputation test to include the requirement of “reasonable imputability” now codified in article 98.[120]

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VIII. Judicial Decisions / Prominent Cases

No key judicial decisions or prominent cases were found.

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Wendy Zeldin
Senior Legal Research Analyst*
March 2014

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