European Union: EFSA Issues Guidance for the Risk Assessment of Genetically Modified Plants and Derived Food and Feed

Last Updated: 19 May 2005
Article by Jackie Smith and Katrina Lajunen

Originally published March 2005

The European Food Safety Authority ("EFSA") has published guidance1 to assist with the preparation and presentation of applications for authorisation of GM food and/or feed under Regulation 1829/2003 on GM food and feed and applications to authorise the placing on the market of genetically modified organisms ("GMOs") under Directive 2001/18 on the deliberate release into the environment of genetically modified organisms.

The guidance was prepared by the Scientific Panel on Genetically Modified Organisms ("GMO Panel") of the EFSA at the request of the European Commission. It was finalised and published in November 2004, following extensive stakeholder consultation that began in April 2004. It updates and replaces guidance issued by the Joint Working Group on Novel Foods and GMOs in March 2003 on the risk assessment of genetically modified plants and derived food and feed. However it does not replace a number of Council and Commission Decisions made within the framework of Directive 2001/18 which remain applicable.2

BACKGROUND

Under Regulation 1829/2003, only GM food and feed that has been authorised may be placed on the market in the EU. Authorisation requires a scientific assessment of any risks which they may present to human and/or animal health or to the environment. GM food and feed means: GMOs for food/feed use; food/feed containing or consisting of GMOs; food/feed produced from GMOs; and food containing ingredients produced from GMOs. Among others, Regulation 1829/2003, which has applied as of 18 April 2004, requires that in order to be authorised GM food/feed must not:

  • Have adverse effect on human health, animal health or the environment
  • Mislead the consumer/user
  • Differ from the food/feed which it is intended to replace to such an extent that its normal consumption would be nutritionally disadvantageous for the consumer/animal.

Directive 2001/18 sets out the principles and conditions regulating the deliberate release into the environment of GMOs. It set out a step-by-step approval procedure for risk assessment in respect of human health and the environment prior to the approval and release into the environment of GMOs.

Regulation 1829/2003 and Directive 2001/18 are closely linked. In particular, in the case of food and/or feed containing or consisting of GMOs, the applicant has the choice of either supplying an authorisation of the deliberate release into the environment already obtained under part C of Directive 2001/18 (without prejudice to the conditions set out by that authorisation) or of applying for the environmental risk assessment carried out at the same time as the safety assessment under Regulation 1829/2003. The interplay between this legislation, and between these measures and other related Directives or Regulations, is discussed in detail in Part I of the guidance document.

SCOPE

The scope of the guidance is set out in Part I of the guidance document. The guidance covers applications for the authorisation of GM food and feed, including feed for animals not intended to be used for food production. Food additives, flavourings and feed additives containing, consisting of or produced from GM plants also fall within the scope of the guidance.

However the guidance does not cover:

  • risk management issues such as traceability, labelling and co-existence
  • socio-economic and ethical issues
  • the deliberate release of GMOs into the environment for experimental purposes (under Part B of Directive 2001/18/EC)
  • the contained use of genetically modified microorganisms ("GMMs") (under Directive 90/219/EEC)
  • the placing of food and/or feed consisting of, containing or produced from GMMs (under Regulation 1829/2003)
  • the deliberate release into the environment of genetically modified animals or
  • the placing on the market of food and/or feed consisting of, containing or produced from genetically modified animals (under Regulation 1829/2003).

Separate guidance is being prepared by the EFSA's GMO Panel for food and feed containing, consisting of or produced from GMMs.

Part I of the guidance also sets out the legal background for the risk assessment of GMOS and GM food and feed at Community level. It summaries the main principles of the relevant EU Regulations, Directives and Decisions and explains how they interplay. In particular, in addition to Regulation 1829/2003 and Directive 2001/18, the key text is Regulation 178/2002 laying down the general principles of food law and procedures in food safety including the tasks of the EFSA3. Among others Regulation 178/2002 defines "hazard", "risk", "risk analysis", "risk assessment", "risk management" and "risk communication", all of which terms are used in the guidance document.

RISK ASSESSMENT4

Part II of the guidance sets out the risk assessment strategy for GMOs. Risk assessment is defined in Regulation 178/2002 as "a scientifically based process consisting of four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation." In respect of GMOs, the guidance suggests that the sequential steps in risk assessment identify characteristics which may cause adverse effects, evaluate their potential consequences, assess the likelihood of occurrence and estimate the risk posed by each identified characteristic of the GMOs.

The risk assessment strategy envisaged in the guidance is essentially a comparative approach in which, using appropriate methods and tools, the GMO and its derived product(s) are compared with its non-GM counterpart(s). The underlying assumption is that traditionally cultivated plants have gained a history of safe use for the normal consumer or animal and the environment and therefore may serve as a baseline for the environmental and food/feed safety assessment of GMOs. This approach relies upon the concepts of "familiarity" and "substantial equivalence", both of which were developed originally by the OECD in 19935 and elaborated further by the WHO/FAO in 2000.6 In summary, familiarity refers to the fact that most GM plants are developed from organisms or crop plants whose biology is well researched. Substantial equivalence, meanwhile, is based on the fact that an existing organism with a safe history of use as food or feed can serve as a comparator when assessing safety of GM food or feed.

On a case-by-case basis, data on composition, toxicity, allergenicity, nutritional value and environmental impact provide the cornerstones of the Community's risk assessment process. In particular, it describes the issues to be taken into account when carrying out a comprehensive risk assessment. These include:

  • molecular characterisation of the inserts
  • assessment of the modification to the agronomic characteristics of the GM plant, and
  • evaluation of food/feed safety aspects of the GM plant and/or derived food and feed.

The risk assessment of GMOs and their derived products described in the guidance is a two step process. First, the differences (both intentional and non-intentional) between the GMO (and the derived products) and their non-GM counterparts are identified. Second, an assessment is made of the effect that these identified differences have on the environment and on food/feed safety and nutrition.

When a product is likely to be used both for food and feed purposes an application must fulfil the relevant requirements of both food and feed.

INFORMATION REQUIRED FOR APPLICATIONS

Part III considers in detail the type of information that is required in applications for authorisation of GM plants and/or derived food and feed. This includes, for example, general information requirements, such as those regarding the applicant, the title of the project and a description of the method of production and manufacturing and/or the conditions for placing on the market the food(s) or feed(s) produced from it, including specific conditions for use and handling.

In addition, detailed guidance is given in respect of the requirements for the provision of data and information in respect of, among others:

  • molecular data
  • the trait and the changes that the GM makes to the plant phenotype and related information
  • the expression of the insert, on how the GM plant differs from the recipient plant in reproduction, dissemination and survivability
  • genetic stability of the insert and phenotypic stability of the GM plant
  • any change to the ability of the GM plant to transfer genetic material to other organisms
  • any toxic, allergenic or other harmful effects on human or animal health arising from the GM food/feed
  • the anticipated intake and/or extent of use
  • nutritional assessment of GM food/feed.

RISK CHARACTERISATION

Part IV of the guidance summarises the overall risk characterisation of GM plants in respect of food/feed safety and environmental impact. It describes how a risk characterisation should be carried out in a holistic manner and on a case-by-case basis, depending on the type of genetic modification, and what factors should be considered in doing so. Risk characterisation for these purposes is defined as "the quantitative or semi-quantitative estimate including attendant uncertainties, of the probability of occurrence and severity of adverse effect(s)/event(s) in a given population under defined conditions based on hazard identification, hazard characterisation and exposure assessment."7

The document notes that an extensive overview of risk assessment procedures is provided by the EU's Scientific Steering Committee ("SSC") in opinions issued in 20008 and in 20039. In addition, it highlights detailed strategies for risk assessment and risk characterisation of foods derived from GM plants described recently by the European Network on Safety Assessment of Genetically Modified Food Crops10 11, for chemicals in food and diet by Food Safety in Europe12, and for environmental risk assessment by the European Community13.

According to the guidance, the final risk characterisation should result in informed qualitative, and where possible quantitative, guidance to risk managers. It should state clearly what assumptions have been made during the risk assessment in order to predict the probability of occurrence and severity of adverse effect(s)/event(s) in a given population and/or on the environment, together with the nature and magnitude of uncertainties associated with establishing these risks.

To this end, it should, according to the guidance, include:

  • whether the cultivation of GM plants is as safe for the environment as the cultivation as non- GM plants
  • whether the consumption of foods/feed derived from GM plants is as safe for humans/animals as the conventional counterparts
  • specific conditions for GM crop cultivation, if required
  • the scientific basis for different options to be considered for risk management.

The guidance notes that the characterisation of risk may give rise to the need for further specific activities including, for example, post-market monitoring of the GM food/feed and/or for the environmental monitoring of GM plants.

APPLICATIONS

The guidance also provides in Annex information and model formats for the presentation of applications and related data, including the format of technical dossiers, of the summary applications and the submission of samples to the European Commission's Joint Research Centre.

The guidance is available on the EFSA's website at: http://www.efsa.eu.int

Footnotes

1 EFSA 2004. guidance document of the Scientific Panel on Genetically Modified Organisms for the Risk Assessment of Genetically Modified Plants and Derived Food and Feed (Question No EFSA-Q-2003-005), The EFSA Journal (2004) 99, 1-94. Final, edited version of 8 November 2004.

2 Decisions 2002/623/EC (Official Journal ("OJ") L200 of 2002 pp22-33), 2002/811/EC (OJ L280 of 2002 pp 27-36), 2002/812/EC (OJ L280 of 2002 pp37-61), and 2003/701/EC (OJ L254 of 2003 pp21-28).

3 Official Journal L 31 of 2002, pp1-24.

4 Risk assessment is defined in Regulation 178/2002 as: "a scientifically based process consisting of four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation."

5 OECD 1993. Safety considerations for Biotechnology: scale-up of crop plants; and OECD 1993. Safety evaluation of foods derived by modern biotechnology: concept and principles.

6 WHO/FAO 2000. Safety aspects of genetically modified foods of plant origin. Report of a joint FAO/WHO expert consultation on foods derived from biotechnology.

7 As defined by the EU's Scientific Steering Committee ("SSC") in 2000.

8 SSC 2000; First report of the Scientific Steering Committee on the harmonisation of risk assessment procedures. European Commission, Health & Consumer Protection Directorate- General.

9 SSC 2003; Second report of the Scientific Steering Committee on the harmonisation of risk assessment procedures. European Commission, Health & Consumer Protection Directorate- General.

10 ENTRANSFOOD, 2004 European Network on Safety Assessment of Genetically Modified Food Crops. Food and Chemical Toxicology 42, 7, Safety assessment, detection and traceability, and societal aspects of genetically modified foods.

11 FOSIE, 2002; Food Safety in Europe. Food and Chemical Toxicology 40, 2/3, 137-427. Risk assessment of chemicals in food and diet.

12 FOSIE, 2003; Food Safety in Europe. Food and Chemical Toxicology 41, 9, 1211-1271. Risk characterisation of chemicals in food and diet.

13 European Community, 2002; Report of the SSC's working group on harmonisation of risk assessment procedures in the Scientific Committees advising the European Commission in the area of human health and environmental health, 26-27 October 2000.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
 
In association with
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.

Disclaimer

Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.

Registration

Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.

Cookies

A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.

Links

This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.

Mail-A-Friend

If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.

Security

This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.