AFBV-WGG-Statement zur Einordnung neuer Züchtungsmethoden

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Association Française des Biotechnologies Végétales                                                    Wissenschaftlerkreis Grüne Gentechnik e.V.
23-25 rue Jean-Jacques Rousseau                                                                                  Postfach 12 01 27,
75001 Paris, France                                                                                                        60114 Frankfurt/Main, Germany
https://www.biotechnologies-vegetales.com                                                                  http://www.wgg-ev.de
contact: secretariat@biotechnologies-vegetales.com   
                                            Kontakt: jany@wgg-ev.de

                                                                                                            Frankfurt am Main and Paris, 13 September 2019


Statement of AFBV and WGG proposing small changes to the GMO Directive to enable and accelerate smart breeding in European agriculture

Adoption of small amendments to EU Directive 2001/18/EC would permit plant and animal breeders to accelerate precision breeding programs, fostering innovation throughout European agriculture

Following the European Court of Justice (ECJ) decision of 25 July 2018 in case C-528/16, Scientists, several Member States, industrial organizations, trading partners and stakeholders have called for the EU to adapt its GMO legislation (Directive 2001/18/EC and associated regulations) to reflect scientific and technical progress made since its implementation. As updating the Directive may take several years, AFBV and WGG propose small changes to the Directive that can be enacted quickly permitting accelerated adoption of targeted genetic variation in crops and other organisms to achieve important sustainable development goals, including a clean environment, healthy diets, resilience to climate change, the protection of biodiversity, animal welfare and the satisfaction of consumer needs.

Specifically, AFBV and WGG propose to exclude the following techniques under Part 2 of Annex I A to the Directive:
  1. The removal by sexual crossing or by a molecular mechanism of excision of the recombinant nucleic acid molecules present in a parental GMO line, so that the offspring of such GMO parent does not retain any recombinant nucleic acid molecules, and
  2. editing nucleic acid sequences, up to complete allele replacements, in an organism to correspond to sequences known to occur in its natural gene pool.
In the case of both sets of techniques any recombinant nucleic acids that may have been used during the process are no longer present in the target organism. Before commercial release relevant information on the organism is made available to the relevant competent authority, e.g. the variety registration authority in the case of plant varieties.

Further, AFBV and WGG propose to add the following new categories of organisms1 to those already exempted under Annex I B:
  1. Organisms having nucleic acid sequences that have been edited, up to complete allele replacements, to correspond to sequences known to occur in their Kingdom (beyond their natural gene pool),
  2. Organisms having nucleic acid sequences that have been edited to correspond to new sequences which could have been obtained through random mutagenesis, and
  3. Organisms having undergone the insertion of one or more allele(s) known to occur in their natural gene pool. 
Categories (1) and (3) involve sequences known to exist in nature and category (2) involves new sequences that could have been obtained by random mutagenesis.  All three new categories imply the absence or elimination of recombinant nucleic acid molecules in the target organisms.  Competent authorities of member states will validate, upon request of a notifier and prior to deliberate release, the conformity of a target organism with the required criteria to meet the new exemptions.
                                                                                   Categories herein described are for plants; they can be adapted to animals and microorganisms.
Proposed changes to Annex I A, Part 2 and Annex I B

In this table, categories are described for plants. They can be adapted to animals and microorganisms taking into account their own specificities.

bgf-Jany 14.09.2019
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