Research and analysis

Annual report on GMO inspection and enforcement activities in England 2017

Updated 7 July 2023

Applies to England

Executive summary

Genetic Modification Inspectorate activities 2016 to 2017

1. The APHA Genetic Modification Inspectorate (GMI) is responsible for the enforcement of legislation relating to the deliberate release ^{[footnote 1]} and marketing of genetically modified organisms (GMOs) in England. The legislative regime stems from 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 (OJ 2001 L 106, p. 1). This Directive is adopted in English law through the Genetically Modified Organisms (Deliberate Release) Regulations 2002 and enforced through the Environmental Protection Act 1990. Currently there is just one GM event, for insect-resistant maize, authorised for commercial cultivation in the European Union; this crop is not suitable for UK conditions and no commercial growing of GM crops occurred in the UK in 2016 to 2017.

2. The GMI’s work covers three main areas: 1) inspection of experimental GMO deliberate release sites and auditing of deliberate release consent holders to ensure that they comply with conditions laid down in each consent; 2) auditing of producers and importers of seed of at-risk species to assist those companies in appropriately managing the risk of adventitious (accidental or technically unavoidable) GM presence (AGMP) in their seed; and 3) investigation of suspected releases or marketing of unauthorised GMOs.

3. There was one consent for an experimental release of GMOs authorised for planting in 2016 to 2017, for Camelina sativa (camelina), and a further three consents (one for GM camelina and two for GM potatoes) were in the post-trial monitoring phase, following previously authorised releases. Consent holders for all four consents were subjected to management audits and all were deemed to be acting responsibly in managing the releases and post-trial consent conditions. Additionally, a management audit of Rothamsted Research was undertaken in spring 2017 in anticipation of their trial of GM wheat modified for improved agronomic performance.

4. In total there were two growing season inspections of the GM camelina crop and four post-trial inspections for three consents on sites formerly used for GM potato and GM camelina releases. One consent, for GM potatoes (consent code 06/R42/01) held by BASF, was confirmed as satisfying all post-trial monitoring requirements and the trial was formally terminated at the end of the year.

5. The GMI undertook three management audits of consent holders for current and planned releases and four for post-trial monitoring and management. All consent holders were found to be discharging their duties responsibly.

6. During the reporting period the GMI submitted 45 reports to Defra relating to audits of seed companies for their risk management of AGMP. All the companies that participated in the GMI audit programme were considered to have acted responsibly in managing the risk of AGMP in their seed.

7. Following on from the 2015 case of AGMP in UK National List trials seed, and recognising the potential for increased risk of AGMP in trials material compared to commercial seed, particularly with winter oilseed rape where trial application deadlines and sowings times are very tight, the GMI reviewed the audit approach. A new protocol was agreed with Defra’s Varieties and Seeds Policy team and APHA’s Plant Variety and Seeds Team to ensure timely consideration of the risk of AGMP in National List trials material and prioritising trial applicants who do not usually participate in the GMI’s seed audit programme.

8. During the reporting period the GMI investigated four incidents involving the importation, release and/or marketing of suspected unauthorised GMOs, including: four cases of suspect GM ornamental fish and one case of suspected AGMP in sweet corn seed.

9. The three suspect GM fish cases were through interceptions at a border inspection post and were confirmed to have GM presence; the fish in question were all prevented from further distribution/sale in the UK.

10. The case involving suspected GM sweet corn was elicited through positive GM test results during a routine seed audit. Following further investigation the GMI was content that the imported seed did not contain AGMP.

11. The GMI provided expert representation at one EU Coexistence Bureau committee meeting on the coexistence of GM and non-GM potato and provided contributions to the Bureau’s final report. The GMI also contributed to the Bureau’s final report on the coexistence of GM and non-GM cotton.

The work of the Genetic Modification Inspectorate

The role of the GM Inspectorate

The European Union (EU) has strict rules in place governing the release of genetically modified organisms (GMOs) ^{[footnote 2]} to the environment, and any organisation wishing to carry out a release must go through a formal process to obtain official consent. The Genetic Modification Inspectorate for England is part of the Animal and Plant Health Agency, and has designated responsibility for ensuring compliance with legislation concerning the deliberate release to the environment of GMOs ^{[footnote 3]}. This legislation is designed to ensure that experimental field trials of GMOs are carried out in such a way as to minimise any risk to human health or the environment.

The GMI has statutory responsibility to:

• inspect all deliberate release trials of GMOs, conducted in England, to ensure they are carried out in accordance with the limitations and conditions of their respective consents
• investigate any potential breaches of the GM deliberate release legislation, such as the unauthorised release of GMOs
• provide impartial, evidence-based, advice on GMO issues to policy makers and stakeholders

The GMI undertakes this work on behalf of the Department for Environment, Food and Rural Affairs (Defra) Genetic Resources and GMO Team (Defra GMO Team)

In addition to carrying out its statutory duties, the GMI is responsible for assisting seed companies in their obligation to minimise the risk of AGMP in conventional and organic seed they produce in England and/or import into England. This work is carried out on behalf of the Defra Variety and Seeds Policy team.

The GM Inspectorate field inspection programme

The GMI’s field inspection programme is designed to ensure that GMO deliberate release trials remain consistent with the limitations and conditions of their respective consents, and to make sure any potential risks to human health or the environment are kept to a minimum. To achieve this the GMI undertakes ‘management audits’ of the systems consent holders have in place to manage their releases, and also conducts field inspection visits to ensure these systems are properly implemented in situ. GMI management audits and field inspections are described in more detail overleaf.

During the 2016 to 2017 reporting year, one GMO was released in experimental research trials in England. This was the oil-bearing plant Camelina sativa, modified to produce omega-3 long-chain polyunsaturated fatty acids and astaxanthin. In addition there were a number of GM trials in the post-trial phase of release and applications for new consents for release (see Box 1).

Box 1 - part B GM trials 2016 to 2017:

One Part B (experimental) release of a GMO was carried out in England:

• Camelina (Camelina sativa), modified for the production of omega-3 long-chain polyunsaturated fatty acids and astaxanthin - release carried out in spring 2016 by Rothamsted Research (consent 16/R8/01)

The following releases were in the post-trial monitoring phase:

• Camelina, modified for the production of omega-3 long-chain polyunsaturated fatty acids - releases carried out in 2014 and 2015 by Rothamsted Research (consent 14/R8/01)
• potato, modified to resist late blight - releases carried out in 2010, 2011 and 2012 by The Sainsbury Laboratory (consent 10/R29/01)
• potato, modified to resist late blight - releases carried out in 2007 and 2008 by BASF (consent 06/R42/01)

For further information on consents granted to release genetically modified organisms available at genetically modified organisms: applications, decisions and notifications.

Additionally, the GMI undertook the following actions on consent applications/new consents:

• commented on the draft consent for release of GM potato modified for late-blight resistance by The Sainsbury Laboratory (consent 16/R29/01; note that although scheduled for 2016 sowing, ultimately this trial did not go ahead)
• commented on the application and draft consent for release of GM wheat modified for improved agronomic performance by Rothamsted Research (consent 16/R8/02)
• commented on the application for release of GM potato modified for late-blight resistance, nematode resistance and improved tuber quality by The Sainsbury Laboratory (consent 17/R29/01)

Consent holder management audits undertaken in 2016 to 2017

Before a GMO is released GM Inspectors undertake an audit of the systems the consent holder will use to manage the release, in order to determine whether they have appropriate arrangements in place to ensure the safe and effective operation of the trial. Such pre-release audits include comprehensive checks on the relevant aspects of administration and infrastructure, details of the management chain, the systems in place for receipt, storage and transport of plant material, plans for planting and safe disposal of material at harvest. The audit also looks at growing-season monitoring plans and how the consent holder would respond if the integrity of the trial were compromised.

Additionally, pre-release management audits look at the safeguards the consent holder has in place to ensure that only those transformation events covered by the consent are released. As such, consent holders must provide suitable evidence that the GMO for release matches the description set out in the application for release, and in the consent conditions, and that no adventitious GMOs are present. Evidence may be in the form of the results of analysis (for example, from PCR testing) and/or in the form of documentation relating to the production of the GMO, including maintaining genetic isolation during initial production, bulking, storage and transport.

In the case of consents that are in the post-trial phase of the release, management audits are carried out prior to the commencement of post-trial monitoring by the consent holder. Such audits are aimed at ensuring consent holders have appropriate policies and procedures in place for managing volunteers and/or groundkeepers, are adhering to subsequent cropping restrictions (as appropriate), and ensuring the limitations and conditions of the consent continue to be met.

Management audits continue to be carried out whilst the consent remains active. Once the GMI is satisfied that the monitoring and control requirements have been fulfilled in accordance with the consent conditions, the consent holder can apply to the Defra GMO Team for termination of the release, which, if granted, means the release site can revert to normal use.

In 2016 to 2017 the GMI conducted management audits of:

Rothamsted Research

Spring 2016 post-trial monitoring audits for GM camelina consent 14/R8/01 (2014 and 2015 releases); growing season audit GM camelina consent 16/R8/01 (2016 release).

Spring 2017 post-trial monitoring audits for GM camelina consent 14/R8/01 (2014 and 2015 releases); post-trial monitoring audit GM camelina consent 16/R8/01 (2016 release); growing season audit GM camelina consent 16/R8/01 (2017 release); growing season audit GM wheat consent 16/R8/02 (2017 release).

The Sainsbury Laboratory

Spring 2017 post-trial monitoring audit of GM potato consent 10/R29/01 (2010, 2011 and 2012 releases).

Growing season field inspections undertaken in 2016 to 2017

The GMI is contracted to inspect each new Part B experimental release at least once during the growing season to ensure compliance with the limitations and conditions of the consent for release. Depending on the type of GMO and the individual consent conditions and limitations, inspections may include checks on the location, layout and dimensions of each trial, the isolation distance from related crops/species, the width of the pollen barrier (where applicable), consent holder monitoring plans, and details of planned agronomic operations (including protocols for sowing, harvest, and crop disposal). Key times for carrying out inspections are at planting, prior to or during flowering, at harvest and at crop disposal. Additional inspection visits may be carried out depending on the findings of earlier inspections and whether there are any-identified or potential risks.

The GMI carried out two field inspections of the GM camelina release under consent 16/R8/01. The visits, undertaken soon after sowing and just before flowering, confirmed that the release was being conducted according to the conditions of the consent, and there were no risks to human health or environment. Following the inspections reports were sent to the Defra GMO Team detailing the findings of the visit. All growing season field inspection reports are placed on the GMI website.

Post-trial monitoring inspections undertaken in 2016 to 2017

As well as stipulating conditions relating to the growing crop, experimental release consents often have requirements that apply after the GMO has been harvested. These post-trial specifications generally include a period of monitoring by the consent holder (for example, checking for and controlling volunteers and/or groundkeepers), and usually include cropping restrictions (for example, leaving the site fallow for a specified period and/or not growing specific crops). The purpose of such conditions is to ensure that, as far as reasonably possible, no GMOs remain in the environment once the trial has been completed. The GMI carries out regular visits each year to all former deliberate-release sites that are subject to post-trial conditions.

In 2016 to 2017 the GMI conducted four post-trial monitoring inspections relating to three consents. These were comprised of two visits to the site of a former GM camelina release undertaken by Rothamsted Research (consent 14/R801), one to the site of a former GM potato release undertaken by The Sainsbury Laboratory (10/R29/01; 2010, 2011 and 2012 releases) and one to the site of a former GM potato release undertaken by BASF (06/R42/01; 2007 release).

Consent holder monitoring reports

At the end of the growing season consent holders are required to submit a report to the Secretary of State for Environment, Food and Rural Affairs giving details of the monitoring they have carried out, the findings of this monitoring, and any risk-management measures applied. These reports facilitate an assessment of the release, and determine whether the measures informed by the risk assessment were adequate, or whether any amended or additional measures are needed in future to prevent or mitigate risk. In the case of releases authorised to take place over more than one year, consent holder growing-season reports help Defra determine whether it is appropriate for the trial to continue; post-trial monitoring reports provide Defra with information on the effectiveness of the measures in place to control any GM volunteers or groundkeepers.

Following the post-trial inspection of the BASF GM potato consent 06/R42/01, and taking into account the consent holder’s monitoring report, it was concluded by the Defra GMO Team that the release met the final post-trial criteria for volunteer/groundkeeper control and the trial was officially terminated.

Consent holder reports are assessed by the GMI to ensure they are in accordance with the requirements of the relevant EC Decision ^{[footnote 4]}, before being sent to the Defra GM Team for its consideration. Final trial reports are forwarded on to the European Commission.

Overall findings of the 2016 to 2017 field inspection programme

Management audits confirmed that all consent holders had suitable procedures in place to manage their releases appropriately. All deliberate release trials of GMOs carried out in 2016 to 2017 were inspected and found to be consistent with the conditions set out in their respective consents; none of the releases were found to pose a risk to human health or the environment. Post-trial monitoring inspections confirmed that all consent holders were effectively managing the post-trial phases of their releases, and the GMI and the Defra GMO Team were content with all end-of-year reports submitted by consent holders.

In conclusion, all consent holders were found to be managing their GMO releases and trials sites in accordance with the conditions of their respective consents.

The GM Inspectorate seed audit programme

Background to the GMI seed audit programme

In the EU there are strict rules ^{[footnote 5]} governing the release and marketing of GMOs, which specify that before any new GM line can be sold it must be rigorously assessed and shown to be safe to human health and the environment. Only then is the GMO approved for sale. Currently the UK does not grow any GM crops commercially, but there are large areas of the world where such crops are cultivated on a commercial basis, and because of this there is the potential for non-GM seed to acquire the accidental (adventitious) presence of GMOs, either by cross-pollination or due to seed admixture. These GMOs may not have been approved in the EU, therefore UK companies importing and/or marketing seed of at-risk species, for planting, must have appropriate controls in place to minimise the risk of adventitious GM Presence (AGMP) in their seed.

To help these companies comply with this legislation the GMI undertakes, on behalf of Defra, a programme of audits of companies that handle and market non-GM seed (for example, conventional and organic seed) for cultivation in England.

What do seed audits involve?

Each audit visit to a seed company involves looking in detail at the various stages of seed production, including variety development, sowing, growing, harvest, transport, storage, and processing. At each of these stages the risk of adventitious GM presence is explored, as are the controls in place to manage this risk. Where appropriate the GMI recommends actions that companies can take reduce the risk of AGMP. This work is carried out on behalf of the Defra Variety and Seeds Policy team, which is responsible for the Seed Marketing Regulations, and the Defra GM Team, which is responsible for upholding GM legislation.

By focusing resources towards the beginning of the seed production/marketing chain the GMI aims to achieve the widest coverage in terms of proportion of eligible seed marketed, whilst minimising the burden on the seeds industry as a whole, in accordance with principles of better regulation. The GMI therefore invites for audit only those seed companies in England that produce and/or import seed, rather than visiting every seed merchant.

What species do the audits cover?

Seed of crop species that are at risk of AGMP are determined using quantitative risk assessment modelling. For 2016 to 2017 the most at-risk species were identified as:

• Brassica napus (winter and spring oilseed rape, swede, etc.)
• Brassica rapa (turnip, turnip fodder rape, stubble turnips, pak choi, etc.)
• Glycine max (soya)
• Zea mays (maize, including sweetcorn)

GMI audits include seed intended for agricultural and horticultural use, official trials and private company trials.

As there are currently no thresholds for unauthorised GMOs in conventional seed and there are no statutory rules on how AGMP risk in seed should be managed, participation in the GMI seed audit programme is voluntary. Seed companies are invited to participate in the audit programme as a way of ensuring they are effectively managing the risks of AGMP in their seed. Box 2, below, outlines the three types of audit the GMI undertakes.

Reports resulting from Detailed and Targeted audits are sent to the company to alert them of any vulnerabilities in terms of AGMP in seed, to inform them of the suitability of their controls, and to give them notice of any recommendations to enhance these controls. Basic audit reports are more formulaic and are not sent to the company. A copy of each report is sent to the Defra Variety and Seeds Policy team.

Box 2 - GMI seed audits fall into three categories, as follows:

Detailed audits: these are scheduled to take place once every three years, and involve a visit to the company by a GM Inspector who carries out a thorough assessment of the risk of AGMP to the company’s seed, and the controls in place to minimise this risk. The Inspector then produces a detailed report, which includes recommendations on how the company can further improve its controls, where applicable. In cases where a significant risk of AGMP is identified, the company may be requested to participate in a Targeted audit, which would normally take place before the next growing season (see below);

Basic audits: these take place in the intervening two years (between detailed audits) and usually involve a telephone-based assessment of the company’s practices to determine whether there has been any significant change in risk since the last detailed audit. Change in risk is evaluated in terms of species marketed, countries of origin, and company controls such as GMO testing. Following the audit a short report is produced detailing the findings. If the risk of AGMP is deemed to have increased significantly the GMI may request that the company participates in a Targeted audit;

Targeted audits: these are carried out when there is considered to be a requirement for further clarification/investigation regarding AGMP risk in a company’s seed, but the company is not scheduled for a detailed audit. Targeted audits can arise due to the findings of detailed and basic audits, and generally focus on specific risk elements, including whether any previous recommendations relating to these risks have been implemented.

Seed audits carried out during 2016 to 2017

During the 2016 to 2017 audit period there were 45 seed companies in England that were considered eligible for inclusion in GMI’s audit programme. No companies were considered to need a Targeted audit. Table 1, below, shows the number and type of seed audits undertaken in 2016 to 2017.

Table 1 - summary of seed audit programme for the 2016 to 2017 financial year

Audit type	Summary details
Detailed audits	Audits undertaken and detailed reports completed: 12
Basic audits	Audits undertaken and reports completed: 16
Targeted audits	No targeted audits were required
Non-participants	Companies declining to participate: 6
No crops of interest	Companies not marketing any crops of interest: 11

Summary reports are published annually on the GMI website. These show the seed companies that the GMI has audited, the species of the seed they marketed, the countries of origin of this material, and the overall findings of the audits.

Revised approach to seed for official trials ^{[footnote 6]}

Following an incident of AGMP in seed sown in National List trials in 2015 (see GMI annual report 2015 to 2016) Defra’s Varieties and Seeds Policy team commissioned the GMI to review the auditing of companies submitting material for such trials. As the breeders of varieties are often based overseas, and may have no UK base, access to their AGMP risk-control measures has been variable given the voluntary nature of the audits. Following the review the GMI, Varieties and Seeds Policy team and APHA’s Plant Variety and Seeds Team agreed a protocol for dealing with overseas applicants for National List trials where the applicant is not otherwise audited by the GMI. This protocol includes an audit of the applicant’s measures to reduce the likelihood of AGMP similar to the approach taken for detailed audits of commercial seed, the difference being that the questions are particularly targeted towards risks associated with trials seed. Whilst these audits are voluntary, in the event that an applicant cannot or does not provide sufficient assurance that their trials material is free from unauthorised GMOs, Defra reserves the right to deny the applicant entry into the UK National List trials process.

The new approach will be implemented in the 2017 to 2018 season.

Incidents involving unauthorised GMOs

Unauthorised release of GMOs

In addition to auditing seed companies and ensuring experimental field trials comply with their respective consent conditions, the GMI has statutory responsibility to investigate any incidents, in England, where there has been a suspected or confirmed infringement of GM deliberate release legislation. GM Inspectors have a number of powers, conferred under Section 125(1) of Part VI of the Environmental Protection Act 1990, which (for example) grant rights of entry and inspection, enables inspectors to take samples and collect evidence in relation to suspect GMOs, and deal with the cause of any imminent risk to the environment. Breaches or potential breaches of GM deliberate release legislation are investigated on a case-by-case basis and action is taken as appropriate. Incidents that were investigated in the 2016 to 2017 reporting period are detailed below.

Update on AGMP in oilseed rape seed entered in 2015 UK National List trials

As reported in the GMI Annual Report 2015 to 16, in October 2015 the GMI was contacted by a UK seed company to report that it had received a positive GM test result for a candidate winter oilseed rape variety that it had entered into UK National List and private trials in England and Scotland. An investigation by the GMI, in cooperation with the company and the Scottish Inspectorate, determined that 25 trial sites were affected in the UK.

The company put forward a management and monitoring plan which included destroying the affected plots and carrying out regular monitoring for oilseed rape regrowth and volunteers. The English and Scottish GM Inspectorates confirmed that the company’s plan was appropriate and proportionate, and monitored progress by liaising with the company and trials officers, and by undertaking targeted inspections to ensure compliance. The plan required that monitoring continue up to spring 2017, and that appropriate subsequent crops were planted that allowed the use of herbicides designed to kill broad-leaved weeds. The GMI continued to monitor the actions taken by the company throughout 2016, including visiting a proportion of the affected sites to confirm compliance with the agreed protocol.

The GMI was content with the actions taken by the company during 2016 to 2017. Monitoring is scheduled to continue until after 1 April 2017 and a further update will be given in the GMI 2017 to 2018 Annual Report.

Suspected GM presence in sweet corn for marketing in the UK

During a routine detailed seed audit undertaken in August 2016 the GMI identified a positive test certificate for GM testing of sweet corn marketed by the audited company. The subsequent investigation revealed that the positive test certificate had erroneously been sent with the shipment. The US producer of the seed was able to demonstrate that the positive result had been returned for the seed before cleaning and that subsequent tests, following cleaning, were negative. The cleaning process removes maize seeds, which are quite physically different from sweet corn seed. As GM maize is commonly grown in the USA and GM maize/sweet corn hybrid seeds are to be expected on sweet corn cobs through cross-pollination it was concluded that no GMOs had been marketed or released to the environment. However, the oversight on the part of the UK company in not realising they had received a positive test result on their seed was flagged as a major concern in the audit report. It was recommended to the UK seed company that they improve their data-checking protocols to ensure that seed with a positive test result cannot be placed on the market and the company was scheduled for a targeted audit (see Box 2 above) in the next audit round to check compliance with the recommendation.

Potential marketing of GM fish

During the year the GMI received three alerts from APHA staff at Manchester Airport Border Inspection Post that they had intercepted suspect GM ornamental fish. Two of the alerts related to zebra Danios (Danio rerio) and one related to giant Danios (Danio malabaricus); the first time this latter species has been reported in the UK as being genetically modified. In all three cases the fish were destined for aquarist retail outlets and the fish were surrendered and further marketing was prevented.

The GMI discussed each case with the relevant importers and reminded them of their legal duty not to market unauthorised GM fish. In all cases there was no indication that the importer intended to import GM fish. The GMI continues to support importers in reminding their suppliers that GM fish are not authorised for sale in the EU.

Expert representation

European Coexistence Bureau expert representation

The European Coexistence Bureau ^{[footnote 7]} (ECoB) organises the exchange of technical and scientific information on best agricultural practice for the coexistence of GM, conventional and organic crops, with the goal of developing EU consensus agreement on crop-specific guidelines for coexistence measures.

In May 2016 the GMI attended the second meeting of the Technical Working Group on the coexistence of GM potatoes, and subsequently contributed to the Best practice document for the coexistence of genetically modified potato with conventional and organic farming).

During the year the GMI also contributed to the final version of the best practice document for the coexistence of genetically modified cotton with conventional and organic farming.

European Enforcement Project on contained use and deliberate release of genetically modified organisms (EEP)

In 1997, based on a Dutch initiative and initially funded by the European Commission, governmental inspectors under Directive 90/219/EEC ^{[footnote 8]} set up a Europe-wide network. In 1999 Germany initiated a parallel network dealing with all technical aspects relevant to inspectors responsible for the deliberate release of GMOs. Subsequently, these networks joined to form the EEP group, which is comprised of inspectors and representatives of competent authorities from all 28 EU Member States, plus representatives from Canada, Norway, Switzerland, Iceland and Ukraine.

On 26 and 27 May 2016, the GMI attended the 19th Annual Meeting of the EEP. The GMI presented papers on the 2015 National List AGMP incident and contingency planning and led an interactive session on risk assessment for AGMP in seeds.

Contact and information

The GMI is located at the National Agri-food Innovation Campus, near York.

Further information on the GM Inspectorate and its activities.

Or you can contact us at:

GM Inspectorate

Animal and Plant Health Agency (APHA)

Room 11G03

Sand Hutton

York

YO41 1LZ

Telephone: 020 8026 2466 or 020 8026 2515

Email: gm-inspec@apha.gov.uk

More information about APHA.

More information about the release of GMOs for research purposes, including the application and consent process.

More information on Seed Certification matters.

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1. This applies to the release to the environment of GMOs other than those in clinical trials. Responsibility for enforcing legislation controlling the deliberate release of GMOs in clinical trials (for example, GM vaccines) is the responsibility of the Health and Safety Executive. ↩

2. Organisms as defined in European Directive 2001/18/EC. ↩

3. Experimental GMO trials other than clinical trials of GM vaccines, which are the responsibility of the Health and Safety Executive. ↩

4. 2003/701/EC: Commission Decision of 29 September 2003 establishing pursuant to Directive 2001/18/EC of the European Parliament and of the Council a format for presenting the results of the deliberate release into the environment of genetically modified higher plants for purposes other than placing on the market. ↩

5. GM crops may only be grown within the EU if they are authorised for cultivation and the varieties offered for sale have been placed on the Common Catalogue of Varieties. Currently only one GM line is authorising cultivation in the EU: MON810 maize modified with a cry1A (b) gene which confers resistance to lepidopteran pests. ↩

6. Seed of species deemed at risk of AGMP are also subject to separate regulations on seed marketing. These regulations require that all varieties of certain species are subject to field trials to ensure they adhere to a number of criteria on the stability, distinctness and uniformity of the variety before they are allowed to be marketed. Once a variety is confirmed to have complied with the required criteria it is added to the National List of plant varieties. Defra administers these National List trials through the Plant Variety Rights and Seeds Office in APHA. For more information available at add a new plant variety to the national lists. ↩

7. Further information on the European Coexistence Bureau. ↩

8. Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms, this Directive has now been superseded. ↩