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The community legislation within the European Union

The European Commission is the main actor of the legal framework concerning GMO. However, the EU must take care about the international market, it GMO policy shall comply with the World Trade Organization (WTO) one. The building blocks of the GMO legislation are:

• Directive 2001/18/EC (12^th March 2001) on the deliberate release into the environment of GMO and repealing Council Directive 90/220/EEC (1990);
• Regulation 1830/2003/EC (22^nd September 2003) concerning traceability and labelling of GMO and the traceability of food and feed products produced from GMO.

The directive 2001/18/EC gives the legal definition of a genetically modified organism: “A GMO means an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination”. It also makes the distinction between techniques leading or not to genetic modifications. Are then considered as genetic modifications:

• “recombinant nucleic acid techniques involving the formation of new combinations of genetic material by the insertion of nucleic acid molecules produced by whatever means outside an organism, into any virus, bacterial plasmid or other vector system and their incorporation into a host organism in which they do not naturally occur but in which they are capable of continued propagation;
• techniques involving the direct introduction into an organism of heritable material prepared outside the organism including micro-injection, macro-injection and micro-encapsulation;
• cell fusion (including protoplast fusion) or hybridization techniques where live cells with new combinations of heritable genetic material are formed through the fusion of two or more cells by means of methods that do not occur naturally.”

However, on condition that they do not involve the use of recombinant nucleic acid molecules or GMO, techniques of in vitro fertilization, conjugation, transduction, transformation and polyploidy induction are not considered to result in genetic modification. Furthermore, several genetic modification techniques yielding organisms to be excluded from the Directive, on the condition that they do not involve the use of recombinant nucleic acid molecules or GMO:

• mutagenesis;
• cell fusion (including protoplast fusion) of plant cells of organisms which can exchange genetic material through traditional breeding methods.

The protection of human health and the environment requires that due attention be given to controlling risks from the deliberate release into the environment of GMOs. For that reason, the EU has adopted regulations and administrative provisions related to the deliberate release and placing on the market GMO in accordance with the precautionary principle. The precautionary principle, detailed in Article 191 of the Treaty on the Functioning of the EU, provides that “where scientific data do not permit a complete evaluation of the risk, recourse to this principle may, for example, be used to stop distribution or order withdrawal from the market of products likely to be hazardous”. This framework contributes to set up a common risks assessment method in the case of GMO use, from containment or trial. The measures set by this directive concerning the procedure for granting consent for the deliberate release and placing on the market of GMOs provide:

• authorization of release for 10 years and renewable;
• controls after placing on the market;
• common risks assessment method for the environment;
• common goals of monitoring;
• mechanism enabling the modification, the suspension or the termination of the release;
• public consultation by an information exchange system (directive 90/220/ESC).

The regulation 1830/2003/EC set the framework to ensure products containing GMO and food and animal feed derived from them can be traced at all stages of the production and distribution chain. The rules do not cover human and veterinary drugs, which are authorized by the regulation 2309/93/ESC. Final consumer packaging or pre-packaged products containing GMOs should be labelled, except if the GMO rate does not reach 0.9% and if the presence of GMO in the product is involuntary or technically inevitable. This traceability has to be effective for 5 years (EurLex, 2015).

A legislative flexibility for the Member States in the European Union

A new European directive, the Directive 2015/412/EU from the 11^th March 2015, allows a flexibility for the Member States. It sets that “the Member States may restrict or prohibit the cultivation of GMOs in all or part of their territory as from the date of entry into force of the Union authorization and for the whole duration of the consent/authorization, provided that an established standstill period, during which the Commission was given the opportunity to comment on the proposed measures, has elapsed”. This procedure is called the “opt-out” (EurLex, 2015).

Safety evaluation of GMO

The EU legal framework on GMOs provides that no GMO or genetically modified food and feed can be placed on the market before it has been granted an authorization in accordance with that legal framework. To this end, a scientific assessment is performed by the European Food Safety Authority (EFSA), in cooperation with the scientific bodies of the Member States. Where the results of the risk assessment show that the product does not pose a risk to health or to the environment under the proposed conditions of placing on the market/use, the Commission submits to the Member States, represented in the Standing Committee, a draft implementing decision of authorization, in accordance with the procedure set out in Regulation (EC) No 182/2011 (comitology procedure). Under this procedure, Member States vote under the “qualified majority” defined in the Treaty. In the Standing Committee, if Member States vote “Yes”, the Commission adopts the draft decision. If they vote “No”, or if the result of the vote is “No opinion” (no qualified majority either in favour or against is expressed), the Commission may submit the draft decision to another body representing the Member States at a higher level: the Appeal Committee. In the Appeal Committee, the Member States vote a second time on the draft decision tabled by the Commission. If the Member States vote “Yes”, the Commission adopts the draft decision. If they vote “No”, the Commission cannot adopt the draft decision. If the result of the vote is “No opinion”, the Commission is required by the GMO legal framework and by the Charter of Fundamental Rights to adopt a decision on the application so, in practice, has little choice but to give the authorization (European Commission, 2015).

Should organisms edited by CRISPR/Cas9 be considered as GMOs?

Genome editing with CRISPR/Cas9 represents a specific and efficient tool to generate useful novel phenotypes with an economic interest by base additions, deletions, gene replacement or transgene insertion. These techniques generate phenotypic variation that is indistinguishable from that obtained through natural means or conventional mutagenesis. The fast development of this new technique leads to several issues concerning the regulatory status of organismes edited by engineered nucleases regarding to GMO legislation in the European Union. The European Commission has been trying to answer this issue since 2007 without managing to decide on account of the scientific, ethic, economic and societal questions raised by this issue, when it has to present it conclusion by march 2016. It appears that organisms edited by engineered nuclease should only fit to the current GMO legislation in the case of transgene insertion, even if the best regulatory issue may be a product base approach.

References

European Commission. « Review of the decision-making process on GMOs in the EU », 2015. http://europa.eu/rapid/press-release_MEMO-15-4779_en.htm?locale=EN.

http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32001L0018

http://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32003R1830&from=FR

http://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32015L0412&from=FR