European Authorization of Genetically Modified Maize for Animal Feed Use

Historically, Europe has been reluctant to authorize genetically modified crops for use in feed. However, some forms of genetically modified maize were recently approved for use in animal feed in Europe. Some of the procedures that were followed to obtain approvals for these products are outlined in this article.

In the past, genetically modified organisms (GMOs) were considered novel foods and had to comply with European Regulation 258/97 of 27 January 1997 on novel foods and novel ingredients. Novel foods are foods without a history of human consumption in Europe in significant amounts prior to 15 May 1997. [1]

In 2003, a new regulatory framework dedicated to GMOs was established by the European Union in order to ensure that the developments of modern biotechnology and of GMOs are safe (Regulation EC 1829/2003)[2]. In general, this regulation introduced a centralized procedure of authorization by the European Commission based on an independent risk assessment carried out by the European Food Safety Authority (EFSA). The marketing authorization request must be submitted to the competent authority at the national level (e.g., the DGCCRF[3] for France and the Food Standards Agency for the UK) which must then send it to EFSA[4] without delay. As per this centralized procedure, EFSA publishes summaries of the GMO application on the EFSA website and sends the application to the European Commission and the Member states, who are then consulted on the application over a three month period. EFSA must give its conclusions within six months of receiving the marketing authorization request. The overall EFSA opinion that includes the GMO panel conclusions (EFSA’s panel specialized in evaluation of GMOs) is sent to the European Commission which submits a draft Decision to the Standing Committee of Food Chain and Animal Health (SCoFCAH with the representatives of the 27 Member States) within three months of receiving EFSA conclusions. The decision is adopted according to comitology procedure.[5]

On October 24, 2007, the European Commission authorized the marketing of products containing, consisting of, or produced from maize DAS1507xNK603 from Pioneer and Dow AgroSciences.[6] This regulation covered placement of products containing or consisting of this maize for the same uses as any other maize, with the exception of cultivation. The regulation stated that the application included information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of GMOs and a risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC.  Implementation of a monitoring plan for environmental effects and yearly reporting of the results was required by the ruling. As specified in the regulation, products that include the genetically modified maize should list “maize” as the ingredient, should not include reference to genetic modification, and should include the words “not for cultivation”.

Applications for genetically modified feed ingredients (such as maize DAS1507xNK603) should meet requirements laid down in guidance documents published by EFSA[7], such as:

1. Guidance Document for the risk assessment of genetically modified microorganisms and their derived products intended for food and feed use by the Scientific Panel on Genetically Modified Organisms (2006)

2. Guidance Document for the risk assessment of genetically modified plants and derived food and feed by the Scientific Panel on Genetically Modified Organisms (2006)

3. Guidance Document of the Scientific Panel on Genetically Modified Organisms for the risk assessment of genetically modified plants containing stacked transformation events (2007)

4. Guidance on the environmental risk assessment of genetically modified plants (2010)

The application to the United Kingdom for maize DAS1507xNK603 (EFSA-GMO-UK-2004-2005) that was reviewed by EFSA included molecular characterization of the inserted DNA and expression of the newly expressed proteins.[8] A comparative analysis of agronomic traits and composition was undertaken and the safety of the newly expressed proteins and the whole food/feed was evaluated with respect to potential toxicity, allergenicity and nutritional quality. As mentioned above, an environmental assessment and a monitoring plan for environmental effects was required for maize DAS1507xNK603, even though it was approved for uses other than cultivation. However, this environmental assessment was general in nature and did not include tests that would be required if maize DAS1507xNK603 was a cultivated crop (i.e., testing on non-target organisms such as bees and soil-dwelling animals).

A key point of an authorization request for genetically modified (GM) food and feed is verification of the detection method. This is part of the centralized authorization procedure which is conducted by the European Commission’s Joint Research Centre (JRC) in its capacity as the Community Reference Laboratory for GM food and feed. The JRC is assisted by the European Network of GMO Laboratories. In the case of maize DAS1507xNK603, the JRC carried out an in-house verification study to assess the performance of two quantitative, event-specific methods (previously validated on the parental lines) to detect and quantify the TC1507 and the NK603 maize transformation events on flour produced from maize DAS1507xNK603 (unique identifiers DAS-01507-1 and MON-00603-6). The study was conducted according to internationally accepted guidelines. Pioneer Hi-Bred International provided the method-specific samples (semi-ground seeds 1507xNK603 and null), whereas the JRC prepared the verification samples (calibration samples and blind samples at an unknown GM percentage). The results of the in-house verification study were evaluated with reference to the European Network of GMO Laboratories (ENGL) method performance requirements. The report indicated that the methods validated on the parental GM lines could be used to detect the two different genetic manipulations in the crossed line.[9]

Once approval is gained, GMOs are authorized for use in Europe for 10 years. A renewal procedure has to be applied to extend the initial approval before the expiration date. The authorization expiration date of maize DAS1507xNK603 is 23 October 2017. Because maize DAS1507xNK603 is considered to be maize, it is authorized for the same uses as conventional maize.

Overall, genetically modified crops for use in feed are not regulated as novel foods. They are subject to Regulation EC 1829/2003, which provides a harmonized procedure for the assessment and authorization of GM food and feed by EFSA. EFSA has provided a considerable amount of guidance on requirements for successful approvals. Submissions must demonstrate that the GM crop is similar to the non-GM crop in terms of nutrition and safety. Crops that contain more than one genetic modification must demonstrate that all modifications are present, stable and expressed at levels comparable to crops containing the individual genetic modifications.  As demonstrated by maize DAS1507xNK603, applications for GM crops that are only to be used in feed should also include an environmental assessment and a monitoring plan, even though products containing the GM crops are required to be labeled “

References

[1]Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients –  OJ L 43, 14.2.1997, p. 1–6.

[2] Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed.

[3] Direction Générale de la Concurrence, de la Consommation et de la Répression des Fraudes.

[4] In Europe, Member states are responsible for forwarding all European marketing authorization requests to EFSA. Companies are not allowed to send their dossier directly to EFSA.

[5] Comitology in the European Union refers to the committee system which oversees the delegated acts implemented by the European Commission, as defined at http://europa.eu/scadplus/glossary/comitology_en.htm, site accessed December 10, 2010.

[6] Commission of the European Communities. COMMISSION DECISION of 24   2007 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize 1507xNK603 (DAS-Ø15Ø7-1xMON-ØØ6Ø3-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:285:0047:0051:EN:PDF,

[7] EFSA. GMO guidance documents. http://www.efsa.europa.eu/en/gmo/gmoguidance.htm

[8] EFSA. Opinion of the Scientific Panel on Genetically Modified Organisms on an application (Reference EFSA-GMO-UK-2004-05) for the placing on the market of insect-protected and glufosinate and glyphosate-tolerant genetically modified maize 1507 x NK603, for food and feed uses, and import and processing under Regulation (EC) No 1829/2003 from Pioneer Hi-Bred and Mycogen Seeds. http://www.efsa.europa.eu/en/scdocs/doc/355.pdf, site accessed December 10, 2010.

[9] European Commission (2005). Event-specific method for the quantitation of maize 1507xNK603 using real-time PCR. Validation Report. http://gmo-crl.jrc.ec.europa.eu/summaries/DAS1507xNK603%20val_report.pdf, site accessed December 10, 2010.

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