CONSULTATION BRIEF ON THE DELIBERATE RELEASE INTO THE ENVIRONMENT OF GENETICALLY MODIFIED ORGANISMS (AMENDMENT) REGULATIONS, 2019

1. BACKGROUND

The Deliberate Release into the Environment of Genetically Modified Organisms (Amendment) Regulations, 2019, seek to amend the Deliberate Release into the Environment of Genetically Modified Organisms Regulations (S.L 549.60, i.e. the principal regulations). The objectives of the amendment are outlined hereunder:

  1. To transpose Directive (EU) 2015/412 amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory;
  2. To transpose Directive (EU) 2018/350 amending Directive 2001/18/EC as regards the environmental risk assessment of genetically modified organisms;
  3. To address minor inconsistencies between the principal regulations and Directive 2001/18/EC;
  4. To designate the Food Safety Commission as the entity responsible for genetically modified food and feed as per the provisions of the Food Safety Act (Cap 449); and
  5. To increase court penalties to render them commensurate to the application fees.

2. IMPLICATIONS

The amendments brought about by Commission Directive (EU) 2015/412 are reflected in regulations 6(b), 7(b), 8(d), 8(f), 9, 10, and 16 of the Deliberate Release into the Environment of Genetically Modified Organisms (Amendment) Regulations, 2019. This amending Directive gives EU Member States the possibility to restrict or prohibit GMO cultivation in their territory through two methods:

  1. Demands made by Member States for the geographical scope of an application to exclude part or all of its territory from cultivation (during the authorisation phase);
  2. Adoption of measures restricting or prohibiting the cultivation of a genetically modified crop (during the post-authorization phase).

Measures adopted under the latter procedure are to be reasoned, roportional, nondiscriminatory and based on named compelling grounds such as those related to environmental policy objectives, land-use, agricultural policy objectives, etc.

Member States in which GMOs are cultivated must also take appropriate measures to avoid crossborder contamination into neighbouring states in which the cultivation of those GMOs is prohibited, unless such measures are unnecessary in light of particular geographical conditions.

The amendments brought about by Directive (EU) 2018/350 are reflected in regulations 17-20 of the Deliberate Release into the Environment of Genetically Modified Organisms (Amendment) Regulations, 2019. This Directive amends annexes II, III, IIIB and IV of Directive 2001/18/EC, corresponding to Schedules II, III, IIIB and IV of the principal regulations. The changes made to the schedules reflect technical progress in the field and take into account the essential elements of the guidance on environmental risk assessment of genetically modified plants. The amendments also strengthen the risk assessment that is to be undertaken for the deliberate release or the placing on the market of GMOs, and amends the content and level of detail required in notifications particularly, for the placing on the market of GMOs.

Other amendments proposed in the regulations relate to the correction of minor inconsistencies found between the principal regulations and Directive 2001/18/EC relating mainly to timeframes and cross-referencing.

Regulation 23(2)-(4) of the principal regulations are also being amended such that the penalties for non-compliance will be as follows:

Any person who commits an offence against the provisions concerning the deliberate release of GMOs, for any other purpose than for placing on the market shall, on conviction, be liable to a fine of not less than €50,000 and not more than €75,000 for a first conviction; and to a fine of not less than €65,000 and not more than €100,000, and/or to imprisonment for up to two years, for a subsequent conviction.

Any person who commits an offence against the provisions concerning the placing on the market of GMOs shall, on conviction, be liable to a fine of not less than €60,000 and not more than €90,000; and to a fine of €75,000 up to €120,000 and/or to imprisonment for up to 2 years for a subsequent conviction.

3. COMMENTS

In line with article 55 of the Environment Protection Act (Cap 549), the Deliberate Release into the Environment of Genetically Modified Organisms (Amendment) Regulations, 2019, the public is invited to make submissions to ERA with their comments as to why and how these regulations could be amended.

The Deliberate Release into the Environment of Genetically Modified Organisms (Amendment) Regulations, are available from the following link

Comments will be received by email on [email protected], for a period of 4 weeks commencing on 11th February 2019, until 11th March 2019.

Deliberate Release into the Environment of Genetically Modified Organisms (Amendment) Regulations, 2019 – English version
Deliberate Release into the Environment of Genetically Modified Organisms (Amendment) Regulations, 2019 – Maltese version​​
Post Consultation Brief on the Deliberate Release into the Environment of Genetically Modified Organisms (Amendment) Regulations, 2019​