I refer to the European Union Commission proposal for a Regulation on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625[1] (hereinafter, proposal for a Regulation) to put in evidence the following critical profile.
1 – The precautionary principle and its consequence on the proposal for a Regulation
In the European Union law is in force the precautionary principle set out in article 191 of the Treaty on the Functioning of the European Union (TFEU).[2]
“The precautionary principle is an approach to risk management, where, if it is possible that a given policy or action might cause harm to the public or the environment and if there is still no scientific agreement on the issue, the policy or action in question should not be carried out.”.[3]
In an interconnected system of things and people – such as the context in which we live – the spread of animal and/or plant organisms with modified genetic material entails a potential risk for human health and the environment because the consequences of the interactions of the aforementioned organisms with humans and the environment are not known.
Consequently, article 4 of the proposal for a Regulation must be changed as follows (changes are in bold):
“Article 4
Deliberate release of NGT plants for any other purpose than placing on the market and
placing on the market of NGT products
In implementation of the precautionary principle enshrined in article 191 of the Treaty on the Functioning of the European Union (TFEU), no plant – whatever its type, category, legal or botanical definition – with genetic modifications will be able to leave the perimeter of the laboratory where it was created or in which it is studied until it is achieved with proven scientific evidence:
– that the plant in question does not harm human health,
– that the plant in question does not damage the environment.
Violation of what is established in the previous period entails, in addition to liability for damages and for any infringement of the law, the perpetual closure of the laboratory and the perpetual ban of those responsible for the violation from the industry, art, commerce, profession they exercise.
Without prejudice to full compliance with what is stated in the two previous sentences and without prejudice to other requirements of Union law, a NGT plant may only be deliberately
released into the environment for any other purpose than placing on the market, and a NGT
product may only be placed on the market, if:
(1) the plant is a category 1 NGT plant and
(a) has obtained a decision declaring that status in accordance with Article 6 or 7;
or
(b) is progeny of plant(s) referred to in point (a); or
(2) the plant is a category 2 NGT plant and has been authorised in accordance with
Chapter III.”
I thank you for your time and attention.
FOOTNOTES
[1] Brussels, 5.7.2023
COM(2023) 411 final
2023/0226 (COD)
Proposal for a
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
on plants obtained by certain new genomic techniques and their food and feed, and
amending Regulation (EU) 2017/625
(Text with EEA relevance)
{SEC(2023) 411 final} – {SWD(2023) 411 final} – {SWD(2023) 412 final} –
{SWD(2023) 413 final}
Here you are the pdf file with the proposal for a Regulation 090166e5fe3067be
[2] The precautionary principle
I quote from Precautionary principle available at the following address:
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=LEGISSUM%3Aprecautionary_principle
The underlined is mine.
“The precautionary principle is an approach to risk management, where, if it is possible that a given policy or action might cause harm to the public or the environment and if there is still no scientific agreement on the issue, the policy or action in question should not be carried out.
However, the policy or action may be reviewed when more scientific information becomes available.
The principle is set out in Article 191 of the Treaty on the Functioning of the European Union (TFEU).
The concept of the precautionary principle was first set out in a European Commission communication adopted in February 2000, which defined the concept and envisaged how it would be applied.
The precautionary principle may only be invoked if there is a potential risk and may not be used to justify arbitrary decisions.
Examples of where the EU has applied the precautionary principle include its regulatory framework for chemicals (Regulation (EC) No 1907/2006 — known as REACH) and the general regulation on food law (Regulation (EC) No 178/2002).”
[3] See footnote 2.
Quotations and footnotes were verified on the date of publication of this article on the site www.giorgiocannella.com