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Release of GMOs into the Environment

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Introduction
Why and how are releases regulated?
Who are the key stakeholders?
Legal requirements and obligations
Principles for the environmental risk assessment
Getting consent for an environmental release
Getting consent for placing on the market
GMOs authorised for experimental releases in Malta
GMOs authorised for placing on the EU market
National safeguard measures
Voting at Regulatory Committee Meetings


Introduction

The release of a GMO into the environment means an introduction of the GMO into the environment, without any precise confinement measure being taken to restrict the contact between this GMO and the population or the environment in general. There are two broad categories of release of GMOs into the environment:

  • the experimental release of GMOs into the environment - that is, the introduction of GMOs into the environment for experimental purposes, also commonly known as field or clinical trials. These types of releases are mainly carried out for the purposes of study, research, demonstration and development of novel varieties. The behaviour of the GMO in an open environment and its interactions with other organisms and the environment are studied. In legislation, these releases are referred to as Part B releases.
  • release of GMOs into the environment by placing on the market for commercial purposes - if the results of the experimental release are positive, the company may decide to place the GMO on the market, that is, make it available to third parties either free of charge or for a fee. The GMO may be placed on the market for purposes of cultivation, importation or transformation of GMOs into industrial products. In legislation, these releases are referred to as Part C releases.


Why and how are releases regulated? 

Although considerable work has been carried out in the field of GMOs and a large amount of data has been gathered, there are still concerns as regards the safety of human health and the environment.

Consequently, in the EU and Malta there are strict regulations controlling the release of GMOs into the environment. The Deliberate Release of GMOs into the Environment Regulations, 2002 (Legal Notice 170 of 2002)
give effect to Directive 2001/18/EC on the Deliberate Release of GMOs into the Environment. MEPA is the designated Competent Authority in Malta for the implementation of these regulations.

The regulations apply to all GMOs, although plants have been the subject of most interest in recent years. The legislation adopts a step-by-step approval process on a case-by-case assessment of the risks to human health and the environment before any GMO, such as maize, tomatoes, or microorganisms, can be released into the environment.

The entire regulatory process is underpinned by a detailed environmental risk assessment, prepared by the applicant, who examines and evaluates any possible harmful consequences of releasing a particular GMO. MEPA reviews this assessment with the help of its advisory committee, the Biosafety Co-ordinating Committee
.

Products derived from GMOs, such as paste or ketchup from a GMO tomato, are not covered by these regulations.


Who are the key stakeholders?

The key stakeholders who may be affected by these regulations include:
  • importers of seeds, grains and crops
  • importers of other organisms, such as animals and micro- organisms
  • farmers
  • research institutions including biotech companies.


Legal requirements and obligations

Any release of GMOs into the environment must comply with the provisions of Legal Notice 170 of 2002
. The legal requirements and obligations of this legislation include:

  • observing the laid down principles for the environmental risk assessment
  • mandatory post-market monitoring requirements, including long-term effects associated with the interaction with other GMOs and the environment,
  • mandatory information to the public
  • a requirement for Member States to ensure labelling and traceability at all stages of the placing on the market
  • first approvals for the release of GMOs to be limited to a maximum of ten years
  • phasing out the release of GMOs containing antibiotic resistance marker (ARM) genes, which may have adverse effects on human health and the environment
  • an obligation to consult the Scientific Committee(s) / European Food Safety Authority (EFSA)
  • the possibility for the Council of Ministers to adopt or reject a Commission proposal for authorisation of a GMO by qualified majority


Principles for the environmental risk assessment

The safety of GMOs depends on the inserted genetic material, the GMO that is produced, the receiving environment and the interaction between the GMO and the environment. The objective of the environmental risk assessment is to identify and evaluate potential adverse effects of the GMO(s), direct or indirect, immediate or delayed. The environmental risk assessment also requires evaluation in terms of how the GMO was developed and examines the potential risks associated with the new GMO (for example toxic or allergenic proteins), and the possibility of gene-transfer (for example of antibiotic resistance genes).

The risk assessment methodology is as follows:  

  • identification of any characteristics of the GMO(s) which may cause adverse effects
  • evaluation of the potential consequences of each adverse effect
  • evaluation of the likelihood of the occurrence of each identified potential adverse effect
  • estimation of the risk posed by each identified characteristic of the GMO(s) 
  • application of management strategies for risks resulting from the experimental release or placing on the market of GMO(s) 
  • determination of the overall risk of the GMO(s)


Getting approval for an experminetal release

Consents to release GMOs into the environment for research and experimental purposes, are only valid to releases in Malta, and are subject to the following procedure:

Procedural steps & timescales for the experimental release of GMOs


Flowchart depicting procedure

Submission:
The applicant should contact MEPA prior to submitting a notification, in order to advise that a notification is to be submitted and clarify any uncertainties before submission.
Applicants must then submit a detailed notification to MEPA. Amongst the information required in the notification, it should include: information on the nature of the GMO; how it has been modified; the precise nature of the research programme proposed; where it will be released and how will the release be monitored.
Once MEPA confirms that the notification is complete, the notification is considered as valid, and the review process commences.

Review:
MEPA has 90 days to review the notification. The information in the notification, which is duly marked for inclusion in the public register, would be made available to the public.
MEPA forwards the notification to its advisory committee, the Biosafety Co-ordinating Committee (BCC), to examine the application and put forward a recommendation.
The Summary Notification Information Format (SNIF) submitted with the notification is sent to the European Commission within 30 days after the review process has initiated.

Decision-making:
Following consideration of the recommendation by the BCC, MEPA will grant/reject consent. If a consent is granted it is likely to include a number of conditions, by which the applicant has to abide.


Getting approval for placing on the market

Consents for crops to be grown, processed or imported for commercial purposes are valid across the EU, and are subject to the following procedure:

Procedural steps & timescales for the placing on the market of GMOs

Flowchart depicting procedure

Submission:
The applicant submits a notification to a national competent authority of a Member State of his own choice.
The notifications must contain a full environmental risk assessment, including amongst others, a post-marketing monitoring plan and a proposal for labelling and packaging.

Review:
The Member State where the notification was submitted takes the lead and conducts a thorough review of the notification.
If a negative opinion is given, the applicant may wish to withdraw the notification, before it is circulated and hence becomes public. If a favourable opinion is given by the lead Member State, the full notification, the Member State's assessment report and the SNIF are forwarded to the European Commission.

Consultation:
The Commission circulates the notification to the other 24 Member States for further evaluation and comments by their competent authorities, as the final decision is then subject to a collective decision by all EU Member States.
MEPA can therefore be the competent authority which takes the lead, if the applicant submits the notification in Malta, or one of the competent authorities of the 24 Member States, which are consulted at this stage.
This first consultation period is of 60 days and as part of the review of any such application, MEPA seeks the recommendation of the Biosafety Co-ordinating Committee (BCC).
If there are no objections by the Member States, the competent authority that carried out the original assessment, grants the consent for the placing on the market of the GMO. This consent is valid throughout the EU.
If objections are raised, the applicant is allowed to respond to the Member States' objections and comments. The applicant's responses are circulated by the Commission to the Member States and a further 45 days are allowed for Member States to evaluate the information submitted by the applicant. If objections are maintained by any of the Member States during this second and final period of consultation, a decision has to be taken at Community level.

Decision-making:
The Commission first asks the opinion of its Scientific Committees. If the scientific opinion is favourable, the Commission then proposes a draft Decision to the Regulatory Committee composed of representatives of Member States, for opinion.
If the Regulatory Committee gives a favourable opinion by qualified majority, the Commission adopts the Decision and a consent is issued accordingly by the competent authority of the lead Member State. If not, the draft Decision is submitted to the Council of Ministers for adoption or rejection by qualified majority. If the Council does not act within 3 months, the Commission can adopt the decision.

Placing on the market:
The consent is valid for the whole of the EU and it is subject to any conditions or restrictions agreed by Member States. Consent is given for a maximum period of 10 years for the initial consent. After 10 years a renewed application has to be submitted.

Public Participation & Consultation:
During the regulatory process, the public is informed and has access to the publicly available data on the internet
. Such data includes the SNIF and assessment report of the lead Member State. Comments may also be submitted here.


GMOs authorised for experimental purposes in Malta

No releases of GMOs into the environment for experimental purposes, also known as Part B releases, have been authorised in Malta to this date.


GMOs authorised for placing on the EU market

Under Directive 2001/18/EC and previously, Directive 90/220/EC (which was repealed by Directive 2001/18/EC since 17 October 2002), numerous GMOs have been approved for placing on the EU market (also known as Part C releases). These authorisations cover a number of different intended uses. Several authorised GMOs have a scope which is restricted to import and processing, while some also include cultivation or food and feed as a requested use. Varieties of agricultural products include maize, oil seed rape, soybean and chicory. Numerous applications for the placing on the market of GMOs for authorisation under Directive 2001/18/EC are pending, e.g. maize, oil seed rape, cotton, rice. 

List of pending, authorised and withdrawn applications under EC Directive 2001/18/EC 


National safeguard measures 

A number of Member States have invoked the so-called 'safeguard clause' of the previous Directive 90/220/EEC. This clause is also included in Directive 2001/18/EC, which replaces Directive 90/220/EEC. This clause provides that where a Member State has justifiable reasons to consider that a GMO, which has received written consent for placing on the market, constitutes a risk to human health or the environment, it may provisionally restrict or prohibit the use and/or sale of that product on its territory.

This safeguard clause was invoked on nine separate occasions under Directive 90/220/EEC, three times by Austria, twice by France, and once each by Germany, Luxembourg, Greece and the United Kingdom. The scientific evidence provided by these Member States as justification for their measures was submitted to the Scientific Committees of the European Union for opinion.

In spite of the repeal of Directive 90/220/EEC, eight (8) of the nine (9) bans remain in place (UK has withdrawn its ban) and have now to be considered under the safeguard provision (Article 23) of Directive 2001/18/EC.

List of pending safeguard clauses under Directive 2001/18/EC


Voting at regulatory committee meetings 

The Regulatory Committee, which is composed of representatives from the Competent Authorities of the Member States, was set up under Directive 2001/18/EC to assist the Commission in the regulatory procedure of the decision-making on applications for the placing on the market of GMOs (Part C releases).

The Regulatory Committee is convened when no agreement is obtained amongst the Member States following the 45-day consultation period. A Commission Decision on the GMO in question would be put forward for voting by the Member States.

Voting takes place by qualified majority, which will be obtained if:

  • the decision receives at least 232 votes in favour or against the decision out of a total of 321 votes 
  • the decision is approved by a majority of Member States
  • the decision is approved by at least 62% of the EU's population (the check on this latter criterion must be requested by a Member State) 

If qualified majority in favour or against the decision is not reached at this meeting, the proposed decision would be forwarded to the Council of Environment Ministers for further voting, which has to take place within 3 months.

Votes available per Member State

 

 

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