Changes from plenary report to adopted text

RemovedSHORT JUSTIFICATION

AddedArticle 12 Official supervision by the competent authorities

RemovedThe sustainability and resilience of agriculture and of the entire food chain are largely based on the diversity and quality of seeds and other plant reproductive material (PRM). The main aim of this legislative proposal is to draw up a single regulation with a coherent framework encompassing the provisions hitherto included in 10 separate Directives.

Added1. For the purposes of the certification under official supervision, the competent authorities shall conduct regular audits, at least once per year, conduct audits every 18 months, to ensure that the professional operator fulfils the requirements referred to in Article 10(1). [Am. 98]

RemovedIn 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.

AddedThey shall also organise training and examinations of the personnel carrying out field inspections, sampling and testing provided for in this Regulation.

RemovedDerogations 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.

Added2. For the purposes of the certification under official supervision, the competent authorities shall carry out official inspections, sampling and testing on a portion of the crops on the site of production and on lots of the PRM in order to confirm compliance of that material with the requirements referred to in Article 7.

RemovedIn 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.

AddedThat portion shall be determined on the basis of the assessment of the potential risk of non-compliance of the PRM with those requirements.

RemovedFinally, 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.

Added3. The Commission may, by means of implementing acts, specify is empowered to adopt delegated acts in accordance with Article 75, supplementing this Regulation by specifying the requirements for the audits, training, examinations, inspections, sampling and testing, as referred to in paragraphs 1 and 2, with regard to particular genera or species. [Am. 99]

RemovedAMENDMENTS

AddedThose implementing delegated acts may specify one or more of the following elements: [Am. 100]

RemovedThe 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:

Added(a) the risk criteria as referred to in paragraph 2 and minimum portion of the crops and the lots of PRM, to be subject to inspections, sampling and testing, as referred to in paragraph 2;

RemovedRecital 5: (5) In order to achieve this transition to sustainable food systems, the Union legislation should therefore take account of the need to ensure the adaptability and diversity of PRM to the changing agricultural, horticultural and environmental conditions, to face the challenges of climate change, to protect and restore biodiversity and to meet increasing farmers’ and consumers’ expectations related to quality, resilience and sustainability of PRM.

Added(b) monitoring activities to be carried out by the competent authorities;

RemovedRecital 36 a (new): (36 a) The Regulation should strive for the 'One Health Approach’ as an integrated, unifying approach that aims to sustainably balance and optimise the health of people, animals, plants and ecosystems. It recognises that the health of humans, domestic and wild animals, plants, and the wider environment including ecosystems are closely interlinked and inter-dependent;

Added(c) use of particular accreditation schemes by the professional operator, and the possibility for the competent authorities to reduce the inspections, sampling and testing, and monitoring activities referred to in this Article due to the use of those schemes, as referred to in paragraph 2. [Am. 101]

RemovedRecital 38 a (new): (38 a) Heterogeneous material should not consist of a GMO or a category 1 or category 2 NGT plant as defined in Regulation (EU).../...

AddedThose implementing acts shall be adopted in accordance with the examination procedure referred to in Article 76(2). [Am. 102]

RemovedRecital 49: (49) In order to contribute to the sustainability of agricultural production and food systems while recognising that sustainability cannot be reduced to a single trait or variety but can only apply to a cultivated system as a whole, and in order to serve economic, environmental and broader societal needs, new varieties of all genera or species should show an improvement compared to the other varieties of the same genera or species registered in the same national variety register, concerning certain aspects. Among those aspects are their yield, including yield stability and yield under low input conditions; tolerance/resistance to biotic stresses, including plant diseases caused by nematodes, fungi, bacteria, viruses, insects and other pests; tolerance/resistance to abiotic stresses, including adaptation to climate change conditions; more efficient use of natural resources, such as water and nutrients; reduced need for external inputs, such as plant protection products and fertilisers; characteristics that enhance the sustainability of storage, processing and distribution; and quality or nutritional characteristics (‘value for sustainable cultivation and use’). For the purpose of deciding on the variety registration and in order to provide sufficient flexibility to register varieties with the most desirable characteristics, those aspects should be considered for a given variety as a whole.

AddedSECTION 4 Handling requirements

RemovedRecital 64: deleted

AddedArticle 13 Lots

RemovedArticle 1 – paragraph 1: This Regulation lays down rules for the production of plant reproductive material (‘PRM’) with a view to its marketing as PRM in the Union, and in particular requirements for the production of PRM in the field and other sites, categories of material, identity and quality requirements, certification, labelling, packaging, imports, professional operators and the registration of varieties.

Added1. PRM shall be marketed in lots. The content of the varieties and species of each lot shall be sufficiently homogeneous regarding homogeneously mixed and identifiable by its users as distinct from other lots of PRM. [Am. 103]

RemovedArticle 2 – paragraph 1 – subparagraph 3: The requirements concerning production of PRM shall apply only to production with a view to its marketing as PRM in the EU.

Added2. During processing, packaging, storage, or at delivery, lots of PRM may be merged into a new lot only if they belong to the same variety and harvest year. [Am. 104]

RemovedArticle 2 – paragraph 2 – point a: (a) to ensure quality and diversity of choice for PRM, and its availability for professional operators, farmers and final users;

AddedWhere lots consisting of different certification categories are merged, the new lot shall belong to the category of the component of the lowest category. The merging operation may only be undertaken in a facility and by persons authorised by the competent authority for this specific purpose.

RemovedArticle 2 – paragraph 2 – point b: (b) to ensure appropriate conditions for the competition of the professional operators across the Union and the functioning of the internal market in PRM;

Added3. During processing, packaging, storage, or at delivery, lots of PRM may be split into two or more lots.

RemovedArticle 2 – paragraph 2 – point d: (d) to contribute to the dynamic conservation and sustainable use of plant genetic resources and agro-biodiversity;

Added4. In cases of merging or splitting of the lots of PRM, as referred to in paragraphs 2 and 3, the professional operator shall keep records concerning the origin of the new lots.

RemovedArticle 2 – paragraph 2 – point e: (e) to contribute to sustainable and productive food systems, adapted to diverse climatic and soil conditions, for current and future projected climatic conditions;

Added5. The Commission may, by means of implementing acts, adopt specific requirements for all or certain species of PRM, concerning the maximum size of lots, their identification and labelling, the merging or splitting of lots in relation to the origin of the PRM lots, recording of those operations and labelling following the merging or splitting. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 76(2).

RemovedArticle 2 – paragraph 2 – point f: (f) to contribute to food security and food sovereignty.

AddedArticle 14 Packages, bundles and containers

RemovedArticle 2 – paragraph 4 – point e: (e) PRM sold or transferred in any other way, whether free of charge or not, for official testing, breeding, inspections, exhibitions or scientific purposes, including for on-farm research and for activities carried out in the framework of the dynamic conservation of genetic resources;

Added1. PRM shall be marketed in fastened packages, bundles or containers, bearing a sealing device and marking. In the case of PRM other than seeds and seed potatoes, it may also be marketed in the form of individual plants. [Am. 105]

RemovedArticle 2 – paragraph 4 – point e a (new): (e a) PRM produced by farmers for their own use;

Added2. The packages, bundles and containers referred to in paragraph 1 shall be fastened in such a way, that they cannot be opened without destroying that fastening or leaving traces demonstrating that the package, bundle or container has been opened. The effectiveness of the fastening device shall be ensured, either by incorporating the labels provided for in Articles 15 and 16 in the device or by use of a seal. Packages and containers shall be exempted from this requirement if the fastening cannot be reused.

RemovedArticle 3 – paragraph 1 – point 29 – point a: (a) traditionally grown or locally newly bred or developed under specific local conditions, and adapted to those conditions or the utilisation in a marginal environment or production system; and

Added3. In the case of pre-basic, basic or certified PRM, those packages, bundles and containers shall be fastened by the competent authority, or by the professional operator under the official supervision of the competent authority. Those packages and containers shall not be refastened unless this is done by the competent authority or by the professional operator under the official supervision of the competent authority. If a package, bundle or a container is refastened, the date of refastening and the details of the responsible competent authority shall be stated on the label referred to in Article 15.

RemovedArticle 3 – paragraph 1 – point 29 – point a a (new): (aa) not an F1 hybrid; and

Added4. Lots of pre-basic, basic or certified PRM may be repackaged, re-labelled, and re-sealed only under official control or by the competent authority, or by the professional operator under the official supervision of the competent authority. [Am. 106]

RemovedArticle 3 – paragraph 1 – point 29 – point b: (b) in the case of seeds, can be characterised by a certain level of genetic and phenotypical diversity between individual reproductive units

Added5. By way of derogation from paragraph 1, seeds and seed potatoes may be marketed from a professional operator directly to a farmer in bulk. [Am. 107]

RemovedArticle 3 – paragraph 1 – point 35 a (new): (35 a) Plant breeding means activities and practices involved in developing new plant varieties and their selection prior to application for registration;

AddedThat professional operator shall be authorized for that purpose by the competent authority. It shall inform the competent authority in advance of such activity and of the lot from which such seed and seed potato comes. [Am. 108]

RemovedArticle 3 – paragraph 1 – point 35 b (new): (35 b) ‘dynamic conservation of plant genetic resources’ means activities carried out by gene banks, community seed banks and other organisations and networks, as well as their members and individual seed savers, implying transfers of PRM in both formal and informal ways, whether or not for consideration and seeking to contribute to the long-term conservation and enrichment of plant genetic diversity.

AddedWhere seed and seed potato is loaded directly into the farmer’s machinery or trailer, the professional operator and the farmer concerned shall ensure traceability of that seed and seed potato by issuing and retaining documents indicating the species and variety, quantity, the time of transfer and lot identification. [Am. 109]

RemovedArticle 5 – paragraph 1 – point e: (e) as PRM exchanged between farmers in accordance with Article 30;

Added5a. The competent authority or the professional operator shall keep a record of the following:

RemovedArticle 6 – paragraph 2 – point d: (d) as PRM exchanged between farmers in accordance with Article 30;

Added(a) authorisation, purchase, load and transport of the PRM; and

RemovedArticle 22 – paragraph 1 – subparagraph 1 – point c a (new): (c a) it is not covered by an intellectual property right limiting its use for conservation purposes.

Added(b) quality, identification and traceability of the PRM. [Am. 110]