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The Deliberate Release into the Environment of Genetically Modified Organisms (Amendment) Regulations, 2019

​CLOSED CONSULTATION - CONSULTATION CONCLUDED

 
From: Ministry for the Environment, Sustainable Development and Climate Change
(
Environment & Resources Authority)
​Published: 22 February 2019
Running till: 11 March 2019
​Last Updated: 4 April 2019
Consultation Outcome: Final Report


ORIGINAL CONSULTATION

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 increases court penalties to render them commensurate to the application fees.

The amendments brought about by Commission Directive (EU) 2015/412 give 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).

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

Directive (EU) 2018/350 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 strengthens 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.​



2.       
Consultation Questions

In line with article 55 of the Environment Protection Act (Cap. 549) the public is invited to make submissions to ERA with their comments as to why and how these regulations could be amended.


3.
       
Documents

The Deliberate Release into the Environment of Genetically Modified Organisms (Amendment) Regulations
, are available from the following link: https://era.org.mt/en/Pages/Draft-Policies.aspx


Please be informed that submissions will be published on the webpage of this consultation at the end of the scoping phase. The lead Ministry has sole discretion upon the publication of comments.
Received contributions, together with the identity of the contributor, will be published on the Internet, unless the contributor objects to the publication of his/her personal data on the grounds that such publication would harm his/her legitimate interests. In this case the contribution may be published in anonymous form. Otherwise the contribution will not be published nor will, in principle, its content be taken into account.  Any objections concerning the publication of personal data should be sent to the service responsible for the consultation on the following email address: onlineconsultations@gov.mt.

Data Protection Statement the General Data Protection Regulation and the Data Protection Act (Chapter 586)

The General Data Protection Regulation and the Data Protection Act Chapter 586 regulate the processing of personal data whether held electronically or in manual form. The Ministry for European Affairs and Equality collects only information which is necessary for it to perform its intended functions and is set to fully comply with the Data Protection Principles as set out in the Data Protection Legislation.  Verification of the ID number provided will take place as deemed necessary. All personal data provided will be processed according to the General Data Protection Regulation and the Data Protection Act (Cap 586).

 

In addition, please be aware of:
 
·         Disclosure under the Freedom of Information Act (Chapter 496)
As we are a public authority all documents we hold, including documents related to this public consultation process, may be released following a request to us under the Freedom of Information Act (Chap. 496), unless such request may be subject of an exemption arising from the same Act.

​​www.konsultazzjoni.gov.mt

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