AFBV and WGG summary comments on Commission regulatory proposal on plants obtained by certain new genomic techniques and their food and feed
French Plant Biotechnologies Association (AFBV) and its German partner, the Wissenschaftskreis Genomik und Gentechnik (WGG) are pleased with the important step represented by the European Commission's proposal to adapt the regulation of genetically modified plants dating from 2001. This proposal should facilitate the introduction of long-awaited plant innovations derived from new genomic techniques (NGTs) (targeted mutagenesis and cisgenesis).
In the interest of a more sustainable agriculture that can adapt more quickly to the challenges of climate change, it is urgent that the Commission, the Council of Ministers and the European Parliament adopt this proposal, if possible, during the current mandate.
Our collective comments are summarised below with reference (Comment Xy) to the enclosed documents.
A. Annex I criteria.
It is important that these criteria be simple, precise and clear. Developers and authorities involved in the verification process must be able to determine unambiguously whether the declared NGT plant meets one or more of these criteria. To this end, clarifications are needed on the following points:
1. Modifications limited to 20: With regard to the proposed ceiling of 20 modifications per plant, we
believe that only modifications that are different should be taken into account so as not to penalise
polyploid crops such as wheat (Comment A1).
2. Off-target: It appears that off-targets are included in the number of modifications. Rather than
counting them as part of the plant modifications, we suggest that specific modalities should be put in
place to ensure that they are limited or avoided (Comment A2).
3. Criterion 1 on the limit of 20 nucleotides: It should be clarified that the limit of 20 nucleotides
corresponds to what is obtained when using one guide RNA and that these 20 nucleotides are either
in a contiguous sequence or distributed over the modified area (Comment A3).
4. Criterion 3a: Random cisgenesis: We believe that random cisgenesis should be added to criterion
3a. This is the example used by the JRC in its report on the economic impact of NGT plants
(doi:10.2760/715646) – (Comment A4).
5. Criteria 3a and 3b: "contiguous DNA sequence": A definition of this term should be given
(Comment A5).
6. Criterion 3b: substitutions: Criterion 3b allows substitutions to be made. Information should be
provided on the relationships that should or should not exist between substituted sequences
(Comment A6).
B. Modalities of use in breeding.
Article 3 of the proposal indicates that an NGT-1 plant may correspond to the progeny of verified NGT-1 plants, including progeny resulting from the crossing of these plants. It is important to clarify the types of crosses that can be carried out and, in particular, to confirm that verified NGT-1 plants can be used in conventional breeding programs. If this is the case, certain aspects need clarification: in the course of breeding, modifications carried by these plants will segregate. Do they need to be tracked? When multiple NGT-1 plants are bred, can progeny containing more than 20 modifications be used and marketed, provided compliance with traceability and labelling requirements? Should the labelling of reproductive material of such progeny provide the identification numbers of each of the NGT-1 parents? (Comment R2).
C. Organic farming and markets - Article 5 (2) and Recital 23:
We believe that organic farmers and markets should have the freedom to choose whether or not to use NGT-1 plants and products in the same way as certain modified plants and products that are currently excluded from Directive 2001/18/EC (Comment R3).
D. Entry into force:
The use of NGT plants must be made possible quickly. Therefore, we believe that it would be appropriate to shorten, in particular for NGT-1 plants, the two-year period, and to achieve this purpose to make public for consultation the items listed in Article 27 (a) and (b) as soon as possible.
► Summary comments on the Commision`s poposal forNGT plants
► Detailed comments on the Commission's proposal for NGT plants
Texts of Regulation and Annexes with additional comments.
► Project of regulation for NGT-plants - AFBV-WGG comments
► Project of regulations for NGT-plants - Annexes AFBV-WGG comments
AFBV and WGG summary comments on Commission regulatory proposal on plants obtained by certain new genomic techniques and their food and feed
French Plant Biotechnologies Association (AFBV) and its German partner, the Wissenschaftskreis Genomik und Gentechnik (WGG) are pleased with the important step represented by the European Commission's proposal to adapt the regulation of genetically modified plants dating from 2001. This proposal should facilitate the introduction of long-awaited plant innovations derived from new genomic techniques (NGTs) (targeted mutagenesis and cisgenesis).
In the interest of a more sustainable agriculture that can adapt more quickly to the challenges of climate change, it is urgent that the Commission, the Council of Ministers and the European Parliament adopt this proposal, if possible, during the current mandate.
Our collective comments are summarised below with reference (Comment Xy) to the enclosed documents.
A. Annex I criteria.
It is important that these criteria be simple, precise and clear. Developers and authorities involved in the verification process must be able to determine unambiguously whether the declared NGT plant meets one or more of these criteria. To this end, clarifications are needed on the following points:
1. Modifications limited to 20: With regard to the proposed ceiling of 20 modifications per plant, we
believe that only modifications that are different should be taken into account so as not to penalise
polyploid crops such as wheat (Comment A1).
2. Off-target: It appears that off-targets are included in the number of modifications. Rather than
counting them as part of the plant modifications, we suggest that specific modalities should be put in
place to ensure that they are limited or avoided (Comment A2).
3. Criterion 1 on the limit of 20 nucleotides: It should be clarified that the limit of 20 nucleotides
corresponds to what is obtained when using one guide RNA and that these 20 nucleotides are either
in a contiguous sequence or distributed over the modified area (Comment A3).
4. Criterion 3a: Random cisgenesis: We believe that random cisgenesis should be added to criterion
3a. This is the example used by the JRC in its report on the economic impact of NGT plants
(doi:10.2760/715646) – (Comment A4).
5. Criteria 3a and 3b: "contiguous DNA sequence": A definition of this term should be given
(Comment A5).
6. Criterion 3b: substitutions: Criterion 3b allows substitutions to be made. Information should be
provided on the relationships that should or should not exist between substituted sequences
(Comment A6).
B. Modalities of use in breeding.
Article 3 of the proposal indicates that an NGT-1 plant may correspond to the progeny of verified NGT-1 plants, including progeny resulting from the crossing of these plants. It is important to clarify the types of crosses that can be carried out and, in particular, to confirm that verified NGT-1 plants can be used in conventional breeding programs. If this is the case, certain aspects need clarification: in the course of breeding, modifications carried by these plants will segregate. Do they need to be tracked? When multiple NGT-1 plants are bred, can progeny containing more than 20 modifications be used and marketed, provided compliance with traceability and labelling requirements? Should the labelling of reproductive material of such progeny provide the identification numbers of each of the NGT-1 parents? (Comment R2).
C. Organic farming and markets - Article 5 (2) and Recital 23:
We believe that organic farmers and markets should have the freedom to choose whether or not to use NGT-1 plants and products in the same way as certain modified plants and products that are currently excluded from Directive 2001/18/EC (Comment R3).
D. Entry into force:
The use of NGT plants must be made possible quickly. Therefore, we believe that it would be appropriate to shorten, in particular for NGT-1 plants, the two-year period, and to achieve this purpose to make public for consultation the items listed in Article 27 (a) and (b) as soon as possible.
► Summary comments on the Commision`s poposal forNGT plants
► Detailed comments on the Commission's proposal for NGT plants
Texts of Regulation and Annexes with additional comments.
► Project of regulation for NGT-plants - AFBV-WGG comments
► Project of regulations for NGT-plants - Annexes AFBV-WGG comments