Changes from plenary report to adopted text

Added(66) In order to adapt the rules on the production and marketing of PRM to the technical and scientific developments and the applicable international standards, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending the requirements of this Regulation concerning the production and marketing of pre-basic, basic, certified and standard material and seeds.

Change 2

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Change 3

RemovedArticle 8 – paragraph 5 – subparagraph 1 – introductory part: The Commission may adopt implementing acts specifying the production and marketing requirements referred to in Annex III for certain genera or species of standard seed or material. Those requirements shall concern one or more of the following elements:

Added(68) In order to adapt the content of variety registers to the technical developments and follow up to the experience gained from variety registration, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending the requirements concerning that content.

RemovedArticle 8 – paragraph 5 – subparagraph 1 – point f: (f) germination rates, purity and content of other PRM, moisture, presence of earth or extraneous matter;

Added(69) In order to adapt the cultivation of varieties to the development of technical and scientific knowledge, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of adopting conditions of cultivation of varieties that are herbicide-tolerant or have other characteristics that could lead to undesirable agronomic effects. Those conditions should include measures in the field, such as crop rotation; monitoring measures; the notification of those measures by Member States to the Commission and the other Member States; reporting by professional operators to the competent authorities concerning the application of those measures; and the indications of those conditions in the national variety registers.

RemovedArticle 8 – paragraph 5 – subparagraph 1 – point g: (g) the application of internationally recognised bio-molecular or other technical methods, as well as their approval and use, and the listing of approved methods in the Union;

Added(70) In order to adapt testing and requirements for the sustainable value of cultivation and use requirements to the potential technical and scientific developments, and the possible development of international standards, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of supplementing this Regulation with certain elements. Those consist of the necessary methodologies for the growing trials to be carried out with a view to assessing, and adopting further requirements for, sustainable value of cultivation and use for certain genera or species.

Change 4

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Change 5

RemovedArticle 9 – title: Requirements for the production and marketing of selected clones and polyclonal PRM

Added(72) In order to adapt the provisions of this Regulation concerning technical examinations of varieties to the technical and scientific developments and the practical needs of competent authorities and professional operators, and follow up on the experience gained from the application of the respective rules, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of supplementing this Regulation by setting out the rules concerning the audit of the premises of professional operators to carry out technical examinations for the satisfactory value for sustainable cultivation and use.

RemovedArticle 9 – paragraph 1: 1. Pre-basic, basic and certified material of selected clones and standard material of polyclonal PRM shall be produced and marketed in accordance with paragraphs 2 and 3 and the requirements set out respectively in Annex II, Part C, and Annex III, Part C.

Added(73) In order to adapt the provisions of this Regulation concerning the examination for sustainable cultivation and use to the technical or scientific developments, and to any new Union policies or rules on sustainable agriculture, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of supplementing this Regulation by establishing the minimum requirements for carrying out this examination, establishing the methodologies for assessing the characteristics examined, establishing the standards for the evaluation and the reporting of the results of this examination and amending the characteristics examined.

RemovedArticle 9 – paragraph 2 – subparagraph 1: Selected clones and polyclonal PRM may only be produced and marketed if they are registered by a competent authority in at least one official register for selected clones and polyclonal PRM established by a Member State.

Added(74) It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

RemovedArticle 9 – paragraph 2 – subparagraph 2: That register shall include all elements referred to in the application for the registration of a selected clone and polyclonal PRM, as set out in Article 53a.

Added(75) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council.

RemovedArticle 9 – paragraph 3: 3. Selected clones and polyclonal PRM shall be maintained for the purpose of preserving their identity. The persons responsible for maintenance of selected clones and polyclonal PRM shall take all measures to be able to make them verifiable by the competent authorities or any other person, on the basis of kept records.

Added(76) In order to ensure uniform conditions for the implementation of this Regulation, and to improve the performance of professional operators and the identity and quality of PRM produced and marketed by them, implementing powers should be conferred to the Commission with respect to specifying the requirements for the audits, training, examinations, inspections, sampling and testing, with regard to particular genera or species, for the official supervision of the professional operators by the competent authorities.

RemovedArticle 9 – paragraph 3 a (new): 3a. Polyclonal PRM, registered in the register referred to in paragraph 2 of this Article, shall be produced and marketed only if it complies with all the requirements concerning standard material as referred to in Part C of Annex III. Polyclonal PRM shall be accompanied by a professional operator’s label with the indication ‘Polyclonal material’, in accordance with Article 17.

Added(77) In order to ensure uniform conditions for the implementation of this Regulation concerning handling and marketing of PRM, and adapt the respective rules to the experience gained from the application of the provisions of this Regulation, implementing powers should be conferred to the Commission for adopting specific requirements for all or certain species of PRM, concerning the merging or splitting of lots in relation to the origin of PRM lots, their identification, records on that operation and labelling following the merging or splitting of PRM lots.

RemovedArticle 10 – paragraph 1 – subparagraph 1: A professional operator may, upon application, be authorised by the competent authority to perform all or certain activities required for certification of PRM under official supervision of the competent authority for pre-basic, basic and certified material or seeds, and to print an official label for them.

Added(78) In order to ensure uniform conditions for the implementation of this Regulation, follow up on the practical experience gained by the application of its provisions, and improve the integrity of the marketed PRM, implementing powers should be conferred to the Commission for adopting specific requirements concerning the sealing, fastening, size and form of packages, bundles and containers of specific species of PRM.

RemovedArticle 10 – paragraph 1 – subparagraph 2 – point c: (c) employ qualified personnel for carrying out the sampling referred to in Annex II, or conclude contracts with companies or associations of professional operators employing qualified personnel for those activities;

Added(79) In order to ensure uniform conditions for the implementation of this Regulation, and in particular concerning the legibility, recognisability and security of labels, implementing powers should be conferred to the Commission for adopting specific provisions concerning the official labels, labels used for certain derogations and, labels used for some specific types of PRM, and set out the content, size, colour and form of those labels for the respective categories or types of PRM.

RemovedArticle 10 – paragraph 1 – subparagraph 2 – point d: (d) employ specialised personnel and equipment to carry out the testing referred to in Annex II, or use PRM testing laboratories employing qualified personnel for those activities;

Added(80) In order to ensure uniform conditions for the implementation of this Regulation and follow up on any practical experience gained by the application of the respective rules, implementing powers should be conferred to the Commission for adopting specific provisions concerning mixtures of seeds.

RemovedArticle 10 – paragraph 2 – introductory part: 2. The Commission is empowered to adopt delegated acts in accordance with Article 75, supplementing paragraph 1 as regards

Added(81) In order to ensure uniform conditions for the implementation of this Regulation with respect to retail marketing of PRM, and make the marketing of PRM as practical and suitable for each species as possible, implementing powers should be conferred to the Commission for adopting rules concerning the size, form, sealing and handling requirements of the small packages for seeds and the packages and bundles for other PRM marketed to final users.

RemovedArticle 10 – paragraph 2 – point a: deleted

Added(82) In order to ensure uniform conditions for the implementation of this Regulation and to address urgent supply difficulties of PRM, implementing powers should be conferred to the Commission for authorising, in the case of temporary difficulties in the supply of PRM, for a maximum period of 1 year, the marketing of PRM of the categories of pre-basic, basic or certified material or seed subject to less stringent requirements, or to derogate from the requirement to belong to a variety, and with respect to repealing and amending that authorisation.

RemovedArticle 10 – paragraph 2 – point b: specific actions to be taken by the competent authority, in order to confirm the compliance with paragraph 1, points (a) to (g).

Added(83) In order to ensure uniform conditions for the implementation of this Regulation, and ensure some flexibility to Member States to adopt national measures adapted to their agro-climatic conditions and higher quality standards, implementing powers should be conferred to the Commission for authorising the Member States to adopt, with regards to production and marketing of PRM, more stringent production or marketing requirements, in all or part of the territory of the Member State concerned, and with respect to repealing or amending such measures adopted pursuant to the PRM marketing Directives.

RemovedArticle 12 – paragraph 1 – subparagraph 1: For the purposes of the certification under official supervision, the competent authorities shall conduct regular audits, at least once every 18 months, to ensure that the professional operator fulfils the requirements referred to in Article 10(1).

Added(84) In order to ensure uniform conditions for the implementation of this Regulation, and ensure a swift response to sudden risks, implementing powers should be conferred to the Commission for taking emergency measures, where the production or marketing of PRM is likely to constitute a serious risk to human, animal or plant health, the environment or cultivation of other species, and such risk cannot be contained satisfactorily by measures taken by the Member State concerned, and with respect to repealing or amending any such measure taken by a Member State.

Change 6

ChangedArticle(85) 12In –order paragraphto 3ensure –uniform subparagraphconditions 1:for Thethe Commissionimplementation isof empoweredthis Regulation, implementing powers The power to adopt delegated acts in accordance with Article 75,290 supplementingTFEU thisshould Regulationbe byconferred specifyingdelegated to the requirementsCommission for thedeciding audits,in training,respect examinations,of inspections,supplementing samplingthis andRegulation testing,by asspecific referredrules toon inthe paragraphsorganisation 1of andtemporary 2,experiments withto regardseek improved alternatives to particularthe generascope orand species.certain provisions of this Regulation. [Am. 20]

Change 7

RemovedArticle 12 – paragraph 3 – subparagraph 2 – introductory part: Those delegated acts may specify one or more of the following elements:

Added(86) In order to ensure uniform conditions for the implementation of this Regulation with regard to the import of PRM, and ensure compliance of the third country requirements with the equivalent Union requirements, implementing powers should be conferred to the Commission with respect to recognising whether PRM of specific genera, species οr 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, in order to be imported.

RemovedArticle 12 – paragraph 3 – subparagraph 2 – point c: (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.

Added(87) In order to ensure uniform conditions for the implementation of this Regulation and to ensure appropriate maintenance of the registered varieties in third countries too, implementing powers should be conferred to the Commission with respect to recognising that the controls on variety maintenance carried out in the third country afford the same guarantees as those set out in the Union.

RemovedArticle 12 – paragraph 3 – subparagraph 3: deleted

Added(88) In order to ensure uniform conditions for the implementation of this Regulation, and to adapt its provisions to the evolving applicable protocols of the International Union for the Protection of new Varieties of Plants (UPOV) or protocols established by the CPVO, and the relevant technical and scientific developments, implementing powers should be conferred to the Commission for adopting specific requirements concerning distinctness, uniformity and stability per genera or species of varieties.

RemovedArticle 13 – paragraph 1: 1. PRM shall be marketed in lots. The content of the varieties and species of each lot shall be homogeneously mixed and identifiable by its users as distinct from other lots of PRM.

Added(89) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred to the Commission for adopting specific rules as regards the size of the standard sample of registered varieties used for the official post controls of PRM, the rules for the renewal of those samples and the provision of those samples to other Member States.

RemovedArticle 13 – paragraph 2 – subparagraph 1: 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.

Added(90) Since the objective of this Regulation, namely to ensure a harmonised approach with regard to the production and marketing of PRM, cannot be sufficiently achieved by the Member States but can rather, by reason of its effects, complexity and international character, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not exceed what is necessary in order to achieve that objective. In this view, and as necessary, it introduces derogations or specific requirements for certain types of PRM and professional operators.

RemovedArticle 14 – paragraph 1: 1. 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.

Added(91) This Regulation should apply from 3 years after its entry into force, in order to allow the competent authorities and the professional operators to adapt to its provisions and also to provide the necessary time for the adoption of the respective delegated and implementing acts. The rules concerning the satisfactory value for sustainable cultivation and use of varieties of vegetables and fruit plants should however apply from 5 years after its entry into force. That additional time period is needed for the competent authorities and professional operators to make the necessary preparations and carry out the first tests in the fields complying with those new rules.

RemovedArticle 14 – paragraph 4: 4. Lots of pre-basic, basic or certified PRM may be repackaged, re-labelled, and re-sealed only by the competent authority, or by the professional operator under the official supervision of the competent authority.

AddedHAVE ADOPTED THIS REGULATION:

RemovedArticle 14 – paragraph 5 – subparagraph 1: By way of derogation from paragraph 1, seeds and seed potatoes may be marketed from a professional operator directly to a farmer in bulk.

AddedCHAPTER I GENERAL PROVISIONS

RemovedArticle 14 – paragraph 5 – subparagraph 2: That 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.

AddedArticle 1 Subject matter

RemovedArticle 14 – paragraph 5 – subparagraph 3: Where 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.

AddedThis Regulation lays down rules for the production and with a view to marketing in the Union of plant reproductive material (‘PRM’), and for the marketing in the Union of PRM, and in particular requirements for the production of PRM in the field and other sites, categories of material, identy identity and quality requirements, certification, labelling, packaging, imports, professional operators and the registration of varieties. [Am. 21]

RemovedArticle 14 – paragraph 5 a (new): 5a. The competent authority or the professional operator shall keep a record of the following: / (a) authorisation, purchase, load and transport of the PRM; and / (b) quality, identification and traceability of the PRM.

AddedThis Regulation also lays down rules concerning the conditions of cultivation of certain varieties that are tolerant to herbicides or could have undesirable agronomic effects, including the cultivation for purposes beyond the production and marketing of PRM, for the production of food, feed and other products. [Am. 22]

RemovedArticle 14 – paragraph 6: 6. The Commission may, by means of implementing acts, adopt specific requirements concerning sealing, fastening, size and form of packages, bundles and containers of specific species of PRM, and specify conditions for the marketing of seeds and seed potato in bulk. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 76(2).

AddedArticle 2 Scope and objectives