What changed

PA_Legam

ORDINARY LEGISLATIVE procedure

SHORT JUSTIFICATION

(First reading without prior interinstitutional negotiations)

TheFollow sustainabilityup andto resiliencethe ofEuropean agricultureParliament andlegislative resolution on the proposal for a regulation of the entireEuropean foodParliament chainand areof largelythe basedCouncil on the diversityproduction and qualitymarketing of seeds and other plant reproductive material (PRM).in Thethe mainUnion, aimamending Regulations (EU) 2016/2031, 2017/625 and 2018/848 of thisthe legislativeEuropean proposalParliament isand toof drawthe upCouncil, aand singlerepealing regulationCouncil withDirectives a66/401/EEC, coherent66/402/EEC, framework68/193/EEC, encompassing2002/53/EC, the2002/54/EC, provisions2002/55/EC, hitherto2002/56/EC, included2002/57/EC, in2008/72/EC 10and separate2008/90/EC Directives.(Regulation on plant reproductive material)

In order to ensure the quality of PRM and consumer confidence, the rules on PRM production and marketing must be based on categorisation and protocols drawn up and monitored by the relevant authorities. Over and above those basic principles, a number of delegated and implementing acts will be drawn up to clarify and adapt the implementation arrangements to the broad diversity of PRM. In line with the principle of proportionality and farmers’ right to use their own seeds and other PRM, farmers must not be required to follow the principles set out in this proposal that apply solely to the production of PRM to be placed on the market as PRM rather than for other purposes, such as food. Your rapporteur also believes that farmers should have a derogation for seed and PRM exchanges, including when they receive payment for costs incurred.

1. Rapporteur: Herbert DORFMANN (EPP / IT)

Derogations should also be included to facilitate the conservation of certain PRM, recognise the specific characteristics of heterogeneous PRM, adapt the restrictions for sales to non-professional buyers, and recognise the special nature of gene banks and other conservation organisations. Your rapporteur believes, in particular, that heterogeneous material provides crucial pools of genetic diversity for climate change mitigation and that this therefore justifies opening up this category to all species so that they might be included. However, it is necessary, more generally, to exclude from the various derogations PRM consisting of genetically modified organisms or NGT plants.

2. Reference numbers: 2023/0227 (COD) / A9-0149/2024 / P9_TA(2024)0341

In order to be registered as a variety, the distinctness, uniformity and stability of the PRM must be verified. In its proposal, the Commission proposes including a complementary technical test of the value for sustainable cultivation and use (VSCU), which should confirm that a variety offers a ‘clear improvement’ compared to other varieties that are already registered. Your rapporteur believes that the value of a variety depends, first and foremost, on the conditions in which it develops and has been bred: a variety cannot be considered to be sustainable in itself as everything depends on the agricultural production system using it. That is why VSCU should be tested in different production methods, notably where synthetic pesticides are not used, as in organic farming. Moreover, VSCU testing should not result in varieties being excluded if that reduces crop biodiversity. VSCU testing should also be optional for fruits and vegetables because of the costs involved for small and medium-sized seed producers.

3. Date of adoption of the resolution: 24 April 2024

Finally, your rapporteur believes that the legislative proposal on PRM requires an amendment of Directive 98/44/EC on the legal protection of biotechnological inventions in order to maintain free access to genetic resources. To avoid destabilising the system of plant variety rights, which ensures fair remuneration for breeders without curbing access to innovation, PRM obtained from new genomic techniques (NGT) should not be patentable. Patents should only be extended to include the organic material derived therefrom. Finally, the scope of compulsory licensing should be widened in the case of a proven environmental or economic benefit.

4. Legal basis: Article 43(2) of the Treaty on the Functioning of the European Union

AMENDMENTS

5. Competent Parliamentary Committee: Committee on Agriculture and Rural Development (AGRI)

The Committee on the Environment, Public Health and Food Safety calls on the Committee on Agriculture and Rural Development, as the committee responsible, to take into account the following amendments:

6. Commission's position: takes note of the amendments proposed by the European Parliament, while reserving its detailed position on these until the opening of interinstitutional negotiations

Amendment 1

Proposal for a regulation

Article 1 – paragraph 1

Text proposed by the Commission

Amendment

This Regulation lays down rules for the production and marketing in the Union of plant reproductive material (‘PRM’), and in particular requirements for the production of PRM in the field and other sites, categories of material, identy and quality requirements, certification, labelling, packaging, imports, professional operators and the registration of varieties.

This Regulation lays down rules for the production of plant reproductive material (‘PRM’) with a view to its marketing as PRM and the marketing of PRM in the Union, and in particular requirements for the production of PRM in the field and other sites, categories of material, identy and quality requirements, certification, labelling, packaging, imports, exports, professional operators and the registration of varieties. This Regulation shall not apply to the production and marketing of PRM intended for other purposes, such as food or feed.

Or. fr

Amendment 2

Proposal for a regulation

Article 2 – paragraph 1 – subparagraph 3

Text proposed by the Commission

Amendment

The requirements concerning production of PRM shall apply only to production with a view to its marketing.

The requirements concerning production of PRM shall apply only to production with a view to its marketing as PRM.

Or. fr

Amendment 3

Proposal for a regulation

Article 2 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) to ensure quality and diversity of choice for PRM, and its availability for professional operators and final users;

(a) to ensure quality and diversity of choice for PRM, and its availability for professional operators, farmers and final users;

Or. fr

Amendment 4

Proposal for a regulation

Article 2 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) to ensure a equal conditions for the competition of the professional operators across the Union and the functioning of the internal market in PRM;

(b) to ensure appropriate and proportionate conditions for the competition of the professional operators across the Union and the functioning of the internal market in PRM;

Or. fr

Amendment 5

Proposal for a regulation

Article 2 – paragraph 2 – point d

Text proposed by the Commission

Amendment

(d) to contribute to conservation and sustainable use of plant genetic resources and agro-biodiversity;

(d) to contribute to dynamic conservation and sustainable use of plant genetic resources and agro-biodiversity;

Or. fr

Amendment 6

Proposal for a regulation

Article 2 – paragraph 4 – point c

Text proposed by the Commission

Amendment

(c) PRM produced for export to third countries;

(c) PRM produced for export to third countries outside commercial activities and for private use only;

Or. fr

Amendment 7

Proposal for a regulation

Article 2 – paragraph 4 – point e

Text proposed by the Commission

Amendment

(e) PRM used solely for official testing, breeding, inspections, exhibitions or scientific purposes.

(e) PRM sold or transferred in any other way, whether free of charge or not, for official testing, breeding, inspections, exhibitions or scientific purposes, in particular for participatory research on farms and for activities carried out by gene banks;

Or. fr

Amendment 8

Proposal for a regulation

Article 2 – paragraph 4 – point e a (new)

Text proposed by the Commission

Amendment

(ea) PRM produced by farmers for their own use;

Or. fr

Amendment 9

Proposal for a regulation

Article 2 – paragraph 4 – point e b (new)

Text proposed by the Commission

Amendment

(eb) PRM traded free of charge or against payment of costs incurred, between farmers or between farmers and end-users for scientific purposes, breeding and/or dynamic management of crop biodiversity.

Or. fr

Amendment 10

Proposal for a regulation

Article 3 – paragraph 1 – point 2 – point a

Text proposed by the Commission

Amendment

(a) production;

(a) production for marketing purposes;

Or. fr

Amendment 11

Proposal for a regulation

Article 3 – paragraph 1 – point 3

Text proposed by the Commission

Amendment

(3) ‘marketing’ means the following actions conducted by a professional operator: sale, holding, transfer for free, or offering for sale or any other way of transferring or distribution within, or import into, the Union;

(3) ‘marketing’ means the following actions conducted by a professional operator: sale, holding or offering for sale within the Union, to the Union or from the Union;

Or. fr

Amendment 12

Proposal for a regulation

Article 3 – paragraph 1 – point 27 – point d a (new)

Text proposed by the Commission

Amendment

(da) does not consist of a genetically modified organism as defined in Article 2(2) of Directive 2001/18/EC of the European Parliament and of the Council or a category 1 or category 2 NGT plant as defined in Regulation (EU) .../... of the European Parliament and of the Council;

Or. fr

Amendment 13

Proposal for a regulation

Article 3 – paragraph 1 – point 29 – point a

Text proposed by the Commission

Amendment

(a) traditionally grown or locally newly bred under specific local conditions in the Union, and adapted to those conditions; and

(a) either traditionally grown or locally newly bred and developed to respond to specific local conditions in the production systems concerned, and adapted to those conditions; and

Or. fr

Amendment 14

Proposal for a regulation

Article 3 – paragraph 1 – point 29 – point b

Text proposed by the Commission

Amendment

(b) characterised by a high level of genetic and phenotypical diversity between individual reproductive units;

(b) characterised by a certain level of genetic and phenotypical diversity between individual reproductive units;

Or. fr

Amendment 15

Proposal for a regulation

Article 3 – paragraph 1 – point 29 – point b a (new)

Text proposed by the Commission

Amendment

(ba) does not consist of a genetically modified organism as defined in Article 2(2) of Directive 2001/18/EC of the European Parliament and of the Council or a category 1 or category 2 NGT plant as defined in Regulation (EU) .../... of the European Parliament and of the Council;

Or. fr

Amendment 16

Proposal for a regulation

Article 3 – paragraph 1 – point 35 a (new)

Text proposed by the Commission

Amendment

(35a) ‘dynamic conservation’ means the preservation of genetic diversity within and between cultivated plant species, within or outside their natural habitat areas, with a view to combating the long-term decline of biodiversity;

Or. fr

Amendment 17

Proposal for a regulation

Article 5 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) as seed exchanged in kind between farmers in accordance with Article 30;

(e) as PRM exchanged between farmers in accordance with Article 30;

Or. fr

Amendment 18

Proposal for a regulation

Article 6 – paragraph 2 – point d

Text proposed by the Commission

Amendment

(d) as seed exchanged in kind between farmers in accordance with Article 30;

(d) as PRM exchanged between farmers in accordance with Article 30;

Or. fr

Amendment 19

Proposal for a regulation

Article 15 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1a. The official label shall indicate clearly the intellectual property rights concerning the PRM.

Or. fr

Amendment 20

Proposal for a regulation

Article 22 – paragraph 1 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) it is naturally associated with a particular area (‘source area’) contributing to the conservation of genetic resources or the restoration of the natural environment;

(b) it is naturally associated with a particular area (‘region of origin’) contributing to the conservation of genetic resources or the restoration of the natural environment;

Or. fr

Amendment 21

Proposal for a regulation

Article 22 – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

Professional operators shall report to the respective competent authorities, for each production season, the amount of preservation mixtures produced and marketed by them.

Professional operators shall report to the respective competent authorities, for each production season, the amount of preservation mixtures marketed by them.

Or. fr

Amendment 22

Proposal for a regulation

Article 22 – paragraph 3 – subparagraph 2

Text proposed by the Commission

Amendment

The Member States shall report on request to the Commission and to the other Member States the amount of preservation mixtures produced and marketed in their territory and, where applicable, the names of competent authorities responsible for plant genetic resources or of organisations recognised for this purpose.

The Member States shall report on request to the Commission and to the other Member States the amount of preservation mixtures marketed in their territory and, where applicable, the names of competent authorities responsible for plant genetic resources or of organisations recognised for this purpose.

Or. fr

Amendment 23

Proposal for a regulation

Article 27 – paragraph 1

Text proposed by the Commission

Amendment

1. By way of derogation from Article 5, PRM of heterogeneous material may be produced and marketed within the Union without belonging to a variety. The heterogeneous material shall be notified to and register by the competent authority prior to its production and/or marketing, in accordance with the requirements set out in Annex VI.

1. By way of derogation from Article 5, PRM of heterogeneous material of all species may be produced and marketed within the Union without belonging to a variety. The heterogeneous material shall be notified to the competent authority three months prior to its marketing, in accordance with the requirements set out in Annex VI.

Or. fr

Amendment 24

Proposal for a regulation

Article 27 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. Heterogeneous material shall not consist of a GMO or a category 1 or category 2 NGT plant as defined in Regulation (EU).../...

Or. fr

Amendment 25

Proposal for a regulation

Article 27 – paragraph 3 – subparagraph 1 – point c

Text proposed by the Commission

Amendment

(c) improve the rules on maitenance of heterogenous PRM, on the basis of the emergence of best practices.

deleted

Or. fr

Amendment 26

Proposal for a regulation

Article 27 – paragraph 4

Text proposed by the Commission

Amendment

4. Any professional operator producing and/or intending to market PRM of heterogeneous material shall submit a notification to the competent authority prior to marketing. If no further information is requested by the national competent authority within a time determined by the competent authority, the PRM of heterogeneous material may be marketed.

4. Any professional operator producing and/or intending to market PRM of heterogeneous material shall submit a notification to the competent authority prior to marketing. If no further information is requested by the national competent authority within three months, the PRM of heterogeneous material may be marketed.

Or. fr

Amendment 27

Proposal for a regulation

Article 27 – paragraph 7 – subparagraph 1

Text proposed by the Commission

Amendment

Heterogeneous material as notified pursuant to paragraph 1, shall be registered by the competent authorities in a dedicated register (‘heterogeneous material register’).

Heterogeneous material as notified pursuant to paragraph 1, shall be registered by the competent authorities in a dedicated register (‘heterogeneous material register’). Registration shall be free of charge.

Or. fr

Amendment 28

Proposal for a regulation

Article 28 – paragraph 1 – subparagraph 1 – introductory part

Text proposed by the Commission

Amendment

By way of derogation from Articles 5 - 12, 14, 15 and 20, PRM may be marketed to final users, if it complies with all of the following requirements:

By way of derogation from Articles 5 - 15 and 20, PRM may be marketed to final users, if it complies with all of the following requirements:

Or. fr

Amendment 29

Proposal for a regulation

Article 28 – paragraph 1 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) to bear an operator’s label with the denomination of the PRM and the indication ‘Plant reproductive material for final users – not officially certified’ or, in the case of seeds, ‘Seeds for final users – not officially certified’;

(a) to bear an operator’s label with the denomination of the PRM and the indication ‘Plant reproductive material for final users’ or, in the case of seeds, ‘Seeds for final users’;

Or. fr

Amendment 30

Proposal for a regulation

Article 29 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

It can be marketed as well from those gene banks, organisations and networks to persons who carry out conservation of that PRM as final consumers, for non-profit purposes.

It can be marketed as well from those gene banks, organisations and networks to persons who contribute to the dynamic conservation of that PRM as final consumers or farmers.

Or. fr

Amendment 31

Proposal for a regulation

Article 29 – paragraph 1 – subparagraph 3 – point b a (new)

Text proposed by the Commission

Amendment

(ba) bear a label indicating ‘PRM for conservation’;

Or. fr

Amendment 32

Proposal for a regulation

Article 29 – paragraph 1 – subparagraph 3 – point c

Text proposed by the Commission

Amendment

(c) be practically free from quality pests and any defects likely to impair its quality as a reproductive material, and have satisfactory vigour and dimensions in respect of its usefulness as PRM, and, in the case of seeds, have satisfactory germination capacity.

(c) be practically free from quality pests.

Or. fr

Amendment 33

Proposal for a regulation

Article 29 – paragraph 2

Text proposed by the Commission

Amendment

2. The gene banks, organisations and networks shall notify the competent authority of the use of the derogation referred to in paragraph 1 and the species concerned.

2. Every year, the gene banks, organisations and networks shall notify the competent authority of the use of the derogation referred to in paragraph 1 and the species concerned.

Or. fr

Amendment 34

Proposal for a regulation

Article 30 – title

Text proposed by the Commission

Amendment

Seed exchanged in kind between farmers

PRM exchanged between farmers

Or. fr

Amendment 35

Proposal for a regulation

Article 30 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. By way of derogation from Articles 5 - 25, farmers may exchange seeds in kind, if such seeds fulfill all of the following conditions:

1. By way of derogation from Articles 5 - 25, farmers may exchange PRM, including where they are reimbursed for direct costs incurred or as part of a mutual support system, if such PRM fulfils all of the following conditions:

Or. fr

Amendment 36

Proposal for a regulation

Article 30 – paragraph 1 – point 3

Text proposed by the Commission

Amendment

(3) are not subject to a service contract conducted by the respective farmer with a professional operator performing seed production; and

(3) are not subject to a service contract conducted by the respective farmer with a professional operator performing PRM production; and

Or. fr

Amendment 37

Proposal for a regulation

Article 30 – paragraph 1 – point 4

Text proposed by the Commission

Amendment

(4) the seed is used for dynamic management of farmer’s own seed for the purpose of contributing to agro-diversity.

(4) the PRM is used for dynamic management of farmer’s own PRM for the purpose of contributing to agro-diversity.

Or. fr

Amendment 38

Proposal for a regulation

Article 30 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

2. Such seeds shall fulfil all of the following requirements:

2. Such PRM shall fulfil all of the following requirements:

Or. fr

Amendment 39

Proposal for a regulation

Article 30 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) to be limited to small quantities, defined by the competent authorities for specific species per year and per farmer, without using commercial intermediaries or public offer of marketing; and

(b) to be limited to quantities defined by the competent authorities to meet the needs considered to be normal for specific species per year and per farmer, without using commercial intermediaries or public offer of marketing; and

Or. fr

Amendment 40

Proposal for a regulation

Article 30 – paragraph 2 – point c

Text proposed by the Commission

Amendment

(c) to be practically free from quality pests and any defects likely to impact their quality as seeds, and shall have satisfactory germination capacity.

(c) to be practically free from quality pests and any defects likely to impact their quality as PRM.

Or. fr

Amendment 41

Proposal for a regulation

Article 31 – title

Text proposed by the Commission

Amendment

Breeder’s seed

Breeder’s PRM

Or. fr

Amendment 42

Proposal for a regulation

Article 31 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

By way of derogation from Articles 5 -25, a competent authority may authorise operators to market seed of generations preceeding the pre-basic category to another operator, for the purpose of breeding new varieties (breeders’ seed).

By way of derogation from Articles 5 -25, a competent authority shall, on reasoned request, authorise operators to market PRM of generations preceeding the pre-basic category to another operator, for the purpose of producing pre-basic PRM that will allow new varieties to be bred (breeders’ seed).

Or. fr

Amendment 43

Proposal for a regulation

Article 32 – paragraph 1 – subparagraph 2 a (new)

Text proposed by the Commission

Amendment

This derogation shall not apply to PRM consisting of a genetically modified organism within the meaning of Directive 2001/18/EC or PRM consisting of an NGT plant within the meaning of Regulation (EU).../...

Or. fr

Amendment 44

Proposal for a regulation

Article 33 – paragraph 1 – subparagraph 1 – introductory part

Text proposed by the Commission

Amendment

In order to remove temporary difficulties in the general supply of PRM that may occur in the Union due to adverse climatic conditions or other unforeseen circumstances, the Commission, by means of an implementing act, may authorise Member States for a maximum period of 1 year, to allow the marketing of the categories of pre-basic, basic or certified material or seed, which fulfils one of the following conditions:

In order to remove temporary difficulties in the general supply of PRM that may occur in the Union due to adverse climatic conditions or other unforeseen circumstances, the Commission is empowered to adopt delegated acts, in accordance with Article 75, supplementing this Regulation in order to authorise Member States for a maximum period of 1 year, to allow the marketing of the categories of pre-basic, basic or certified material or seed, which fulfils one of the following conditions:

Or. fr

Amendment 45

Proposal for a regulation

Article 33 – paragraph 1 – subparagraph 3

Text proposed by the Commission

Amendment

That implementing act may set out the maximum quantities, which may be marketed per genera or species.

That delegated act shall set out the maximum quantities, which may be marketed per genera or species.

Or. fr

Amendment 46

Proposal for a regulation

Article 33 – paragraph 1 – subparagraph 4

Text proposed by the Commission

Amendment

That implementing act shall be adopted in accordance with the examination procedure referred to in Article 76(2).

deleted

Or. fr

Amendment 47

Proposal for a regulation

Article 33 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission may decide, by means of an implementing act, that the authorisation concerned has to be repealed or amended, if it concludes that is no longer necessary or proportionate to the objective of removing the temporary difficulties in the general supply of the PRM concerned. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 76(2).

3. The Commission is empowered to adopt delegated acts, in accordance with Article 75, supplementing this Regulation to decide that the authorisation concerned has to be repealed or amended, if it concludes that is no longer necessary or proportionate to the objective of removing the temporary difficulties in the general supply of the PRM concerned. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 76(2).

Or. fr

Amendment 48

Proposal for a regulation

Article 33 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4a. This exceptional authorisation shall not apply to PRM consisting of a genetically modified organism within the meaning of Directive 2001/18/EC or PRM consisting of an NGT plant within the meaning of Regulation (EU).../...

Or. fr

Amendment 49

Proposal for a regulation

Article 34 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3a. This provisional derogation shall not apply to PRM consisting of a genetically modified organism within the meaning of Directive 2001/18/EC or PRM consisting of an NGT plant within the meaning of Regulation (EU).../...

Or. fr

Amendment 50

Proposal for a regulation

Article 35 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) the requirements set out in paragraphs 2 to 5 are fulfilled.

(c) the requirements set out in paragraphs 2 to 5a are fulfilled.

Or. fr

Amendment 51

Proposal for a regulation

Article 35 – paragraph 5 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) a decision on equivalence has been adopted pursuant to Article 39 concerning that third country;

(a) a decision on compliance has been adopted pursuant to Article 39 concerning that third country;

Or. fr

Amendment 52

Proposal for a regulation

Article 35 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5a. This derogation shall not apply to PRM consisting of a genetically modified organism within the meaning of Directive 2001/18/EC or PRM consisting of an NGT plant within the meaning of Regulation (EU).../...

Or. fr

Amendment 53

Proposal for a regulation

Article 37 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3a. These emergency measures shall not apply to PRM consisting of a genetically modified organism within the meaning of Directive 2001/18/EC or PRM consisting of an NGT plant within the meaning of Regulation (EU).../...

Or. fr

Amendment 54

Proposal for a regulation

Article 39 – title

Text proposed by the Commission

Amendment

Imports on the basis of Union equivalence

Imports on the basis of compliance with Union rules

Or. fr

Amendment 55

Proposal for a regulation

Article 39 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

PRM may only be imported from third countries, if it is established, pursuant to paragraph 2, that it fulfils requirements equivalent to those applicable to PRM produced and marketed in the Union.

PRM may only be imported from third countries, if it is established, pursuant to paragraph 2, that it complies with the requirements applicable to PRM produced and marketed in the Union.

Or. fr

Amendment 56

Proposal for a regulation

Article 39 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

However, no such import shall be allowed, and no such equivalence shall be recognised pursuant to paragraph 2, for the preservation mixtures such as those referred to in Article 22, and for PRM such as that subject to the derogations of Articles 26 - 30.

deleted

Or. fr

Amendment 57

Proposal for a regulation

Article 39 – paragraph 2 – subparagraph 1 – introductory part

Text proposed by the Commission

Amendment

The Commission may recognise, by means of implementing acts, that PRM of specific genera, species or categories produced in a third country, or particular areas of a third country, fulfils requirements equivalent to those applicable to PRM produced and marketed in the Union, on the basis of all of the following:

The Commission may recognise, by means of implementing acts, that PRM of specific genera, species or categories produced in a third country, or particular areas of a third country, fulfils requirements consistent with those applicable to PRM produced and marketed in the Union, on the basis of all of the following:

Or. fr

Amendment 58

Proposal for a regulation

Article 39 – paragraph 2 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) an audit carried out by the Commission in the third country concerned, showing that the PRM concerned fulfils requirements equivalent to those applicable to PRM produced and marketed in the Union, where that audit has been considered necessary by the Commission; and

(b) an audit carried out by the Commission in the third country concerned, showing that the PRM concerned fulfils requirements consistent with those applicable to PRM produced and marketed in the Union, where that audit has been considered necessary by the Commission; and

Or. fr

Amendment 59

Proposal for a regulation

Article 41 – title

Text proposed by the Commission

Amendment

Obligations of professional operators producing PRM

Obligations of professional operators producing PRM intended for marketing

Or. fr

Amendment 60

Proposal for a regulation

Article 41 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

The activities referred to in Articles 28, 29 and 30 shall not be subject to the provisions of this article.

Or. fr

Amendment 61

Proposal for a regulation

Article 42 – paragraph 1

Text proposed by the Commission

Amendment

1. Professional operators shall ensure that PRM is traceable at all stages of production and marketing.

1. Professional operators shall ensure that PRM intended for marketing is traceable at all stages of production and marketing.

Or. fr

Amendment 62

Proposal for a regulation

Article 42 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3a. The activities referred to in Articles 28, 29 and 30 shall not be subject to the provisions of this article.

Or. fr

Amendment 63

Proposal for a regulation

Article 47 – paragraph 1 – subparagraph 1 – point f

Text proposed by the Commission

Amendment

(f) where the varieties are tolerant to herbicides, they are subject to cultivation conditions for the production of PRM and for any other purpose, adopted pursuant to paragraph 3 or, in the case they have not been adopted, as adopted by the competent authorities responsible for registration, to avoid the development of herbicide resistance in weeds due to their use;

(f) where the varieties have become tolerant to herbicides as a result of genetic modification and consist of a genetically modified organism or a category 2 NGT plant, they are subject to cultivation conditions for production of PRM and for any other purpose, adopted pursuant to paragraph 3 or, in the case they have not been adopted, as adopted by the competent authorities responsible for registration, to avoid the development of herbicide resistance in weeds due to their use;

Or. fr

Amendment 64

Proposal for a regulation

Article 47 – paragraph 1 – subparagraph 1 – point g

Text proposed by the Commission

Amendment

(g) where the varieties have particular characteristics other than the ones referred to in point (f) that may lead to undesirable agronomic effects, they are subject to cultivation conditions for the production of PRM and any other purpose, adopted pursuant to paragraph 3 or, in the case they have not been adopted, as adopted by the competent authorities responsible for their registration, to avoid those particular undesirable agronomic effects, such as the development of resistance of pests to the respective varieties or undesirable effects on pollinators.

(g) where the varieties have particular characteristics other than the ones referred to in point (f) that may lead to undesirable agronomic effects but demonstrate a favourable agronomic and ecological balance, they are subject to cultivation conditions for the production of PRM and any other purpose, adopted pursuant to paragraph 3 or, in the case they have not been adopted, as adopted by the competent authorities responsible for their registration, to avoid those particular undesirable agronomic effects, such as the development of resistance of pests to the respective varieties or undesirable effects on pollinators.

Or. fr

Amendment 65

Proposal for a regulation

Article 52 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

For the purposes of Article 47(1), point (c), the value of a variety for sustainable cultivation and use of a variety shall be considered as satisfactory if, compared to other varieties of the same species registered in the national variety register of the respective Member State, its characteristics, taken as a whole, offer a clear improvement for the sustainable cultivation and the uses which can be made of the crops, other plants or the products derived therefrom.

For the purposes of Article 47(1), point (c), the value of a variety for sustainable cultivation and use of a variety shall be considered as satisfactory if, compared to other varieties of the same species registered in the national variety register of the respective Member State, its characteristics, taken as a whole, offer a clear improvement, in at least one of the existing agricultural production systems, for the sustainable cultivation and the uses which can be made of the crops, other plants or the products derived therefrom.

Or. fr

Amendment 66

Proposal for a regulation

Article 52 – paragraph 1 – subparagraph 2 – introductory part

Text proposed by the Commission

Amendment

The characteristics referred to in the first subparagraph are the following, as appropriate for the species, regions, agro-ecological conditions and uses concerned:

The characteristics referred to in the first subparagraph will be tested in different agricultural production systems (organic, agro-ecological, regenerative, conservation, integrated management using minimal fertilisers and irrigation, and no pesticides or seed processing). The characteristics in the following list shall be adapted to the species, regions, agro-ecological conditions and uses concerned:

Or. fr

Amendment 67

Proposal for a regulation

Article 52 – paragraph 1 – subparagraph 2 – point f

Text proposed by the Commission

Amendment

(f) characteristics that enhance the sustainability of storage, processing and distribution;

(f) characteristics that enhance the sustainability of storage, processing and distribution, alongside their contribution to the sustainability of the production system linked to that PRM;

Or. fr

Amendment 68

Proposal for a regulation

Article 52 – paragraph 1 – subparagraph 2 – point g a (new)

Text proposed by the Commission

Amendment

(ga) preservation of traditional and cultural heritage.

Or. fr

Amendment 69

Proposal for a regulation

Article 52 – paragraph 1 – subparagraph 2 – point g b (new)

Text proposed by the Commission

Amendment

(gb) more sustainable agricultural production systems, as part of an ecosystem-based approach that takes into account all interactions with the environment concerned.

Or. fr

Amendment 70

Proposal for a regulation

Article 52 – paragraph 1 – subparagraph 2 – point g c (new)

Text proposed by the Commission

Amendment

(gc) pre or post-harvest waste reduction.

Or. fr

Amendment 71

Proposal for a regulation

Article 52 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. The examination of the value for cultivation and sustainable use shall remain voluntary for species listed in Parts B and C of Annex I.

Or. fr

Amendment 72

Proposal for a regulation

Article 52 – paragraph 2 b (new)

Text proposed by the Commission

Amendment

2b. The examination of the value for cultivation and sustainable use must not lead to the exclusion of varieties that would reduce the diversity of the species cultivated.

Or. fr

Amendment 73

Proposal for a regulation

Article 52 – paragraph 3 – subparagraph 4

Text proposed by the Commission

Amendment

The Commission may adopt, by means of implementing acts, a decision requesting a Member State to repeal or modify those rules, if they are deemed, on the basis of the available scientific and technical evidence, to be inappropriate for the examination of value for sustainable cultivation and use of a variety. Such implementing acts shall be adopted in accordance with the examination procedure referred to in Article 76(2).

deleted

Or. fr

Amendment 74

Proposal for a regulation

Article 52 – paragraph 4 – subparagraph 2

Text proposed by the Commission

Amendment

Where competent authorities are not able to carry out an examination under organic conditions, or the examination of certain characteristics, including disease susceptibility, testing may be carried out under low-input conditions and with only the absolutely necessary for the completion of the testing treatments with pesticides and other external inputs.

Where competent authorities are not able to carry out an examination under organic conditions, or the examination of certain characteristics, including disease susceptibility, testing may be carried out by professional operators involved in organic farming or by organic farmers under the official supervision of the national authorities.

Or. fr

Amendment 75

Proposal for a regulation

Article 53 – paragraph 1 – subparagraph 1 (new)

Text proposed by the Commission

Amendment

The registration procedure shall be free of charge for applicants.

Or. fr

Amendment 76

Proposal for a regulation

Article 53 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

The competent authority shall accept or reject the registration of a conservation variety, after checking its compliance with paragraph 1.

The competent authority shall accept or reject the registration of a conservation variety, after checking its compliance with paragraph 1. It shall inform the applicant of its decision, stating, where applicable, the grounds for refusal.

Or. fr

Amendment 77

Proposal for a regulation

Article 54 – paragraph 1 – point c – paragraph 1 – point i

Text proposed by the Commission

Amendment

(i) under which another variety of the same or of a closely related species is entered in a national variety register or in the Union variety register; or

(i) under which another variety of the same or of a closely related species is entered in a national variety register or in the Union variety register, in a commercial catalogue of a professional operator, or in documentation that is publicly available or has been submitted to the competent authority by a natural or legal person involved in the dynamic conservation or sustainable use of plant genetic resources and crop biodiversity; or

Or. fr

Amendment 78

Proposal for a regulation

Article 54 – paragraph 1 – point c – paragraph 1 – point ii a (new)

Text proposed by the Commission

Amendment

(iia) under which another traditional or local variety or a product derived therefrom has been registered;

Or. fr

Amendment 79

Proposal for a regulation

Article 54 – paragraph 1 – point f a (new)

Text proposed by the Commission

Amendment

(fa) it is already used for non-registered traditional or local varieties or products derived therefrom;

Or. fr

Amendment 80

Proposal for a regulation

Article 54 – paragraph 1 – point f b (new)

Text proposed by the Commission

Amendment

(fb) it is similar to or is likely to cause confusion with the denomination of a product with a recognised geographical indication.

Or. fr

Amendment 81

Proposal for a regulation

Article 61 – paragraph 1 – point c a (new)

Text proposed by the Commission

Amendment

(ca) the examination does not replace the risk assessment required to apply for marketing authorisation under Directive 2001/18/EC on genetically modified organisms or under Regulation (EU) .../... on plants obtained by certain new genomic techniques.

Or. fr

Amendment 82

Proposal for a regulation

Article 69 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

However, that period of registration shall be 30 years for varieties of species of fruit plants and vine propagating material, as listed respectively in Parts C and D of Annex I.

However, that period of registration shall be 30 years for conservation varieties and varieties of species of fruit plants and vine propagating material, as listed respectively in Parts C and D of Annex I.

Or. fr

Amendment 83

Proposal for a regulation

Article 77 a (new)

Text proposed by the Commission

Amendment

Article 77a

Commission report

No later than the entry into force of this Regulation, the Commission shall submit a report to the European Parliament and to the European Council assessing the adequacy of the provisions introduced by this Regulation and the resources available to the competent authorities to implement them. In its assessment, the Commission shall pay particular attention to the VSCU technical test as the derogation provided for in Article 61 of this Regulation should be used with great care in order to ensure the credibility of VSCU testing. Where appropriate, the Commission shall put forward proposals, including budgetary proposals, to balance the needs and resources of the competent authorities.

Or. fr

Amendment 84

Proposal for a regulation

Article 81 – title

Text proposed by the Commission

Amendment

[ ... ]

deleted

Or. fr

Amendment 85

Proposal for a regulation

Article 81 a (new)

Text proposed by the Commission

Amendment

Article 81a

Amendment of Directive 98/44/EC

Directive 98/44/EC is amended as follows:

Or. fr

Amendment 86

Proposal for a regulation

Article 81 b (new)

Text proposed by the Commission

Amendment

(1) In Article 4, the following paragraphs 4 and 5 are inserted:

‘4. By way of derogation from paragraphs 1, 2 and 3, NGT plants, plant material and parts thereof, and the genetic information they contain, shall not be patentable.

5. By way of derogation from paragraphs 1, 2 and 3, plants, plant material and parts thereof, and the genetic information they contain, which have been obtained using techniques excluded from the scope of Directive 2001/18/EC as listed in Annex 1B thereto, shall not be patentable.’

Or. fr

Amendment 87

Proposal for a regulation

Article 81 c (new)

Text proposed by the Commission

Amendment

(2) In Article 8, the following paragraph 3 is inserted:

‘3. By way of derogation from paragraphs 1 and 2, the protection conferred by a patent on a biological material possessing specific characteristics as a result of the invention shall not extend to biological material possessing those same characteristics that is obtained independently of the patented biological material and from essentially biological processes, or to biological material obtained from such material through propagation or multiplication.’

Or. fr

Amendment 88

Proposal for a regulation

Article 81 d (new)

Article 81d

Present text

Article 12(3) is amended as follows:

‘3. Applicants for the licences referred to in paragraphs 1 and 2 must demonstrate that:

‘3. Applicants for the licences referred to in paragraphs 1 and 2 must demonstrate that:

(a) they have applied unsuccessfully to the holder of the patent or of the plant variety right to obtain a contractual licence;

(a) they have applied unsuccessfully to the holder of the patent or of the plant variety right to obtain a contractual licence subject to payment of an appropriate royalty;

(b) the plant variety or the invention constitutes significant technical progress of considerable economic interest compared with the invention claimed in the patent or the protected plant variety.’

(b) the plant variety or the invention constitutes technical progress of proven economic or environmental interest compared with the invention claimed in the patent or the protected plant variety.’

Or. fr

ANNEX: LIST OF ENTITIES OR PERSONS FROM WHOM THE RAPPORTEUR HAS RECEIVED INPUT

List of entities or persons from whom the rapporteur has received input

IFOAM

Copa-Cogeca

Via Campesina

Limagrain

Arche Noah

INRAE

Brot für die Welt

SEMAE

Euroseeds