Changes from report parliamentary committee draft to plenary report

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

AddedArticle 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;

AddedArticle 8 – paragraph 5 – subparagraph 2: Those implementing acts shall be adopted in accordance with the examination procedure set out in Article 76(2), in order to adapt to the developments of the relevant international technical and scientific standards and taking into account the possible implications for PRM production and availability and for small operators. Those implementing acts shall be proportionate to the category of PRM.

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

AddedArticle 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.

AddedArticle 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.

AddedArticle 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.

AddedArticle 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.

AddedArticle 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.

AddedArticle 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.

AddedArticle 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;

AddedArticle 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;

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

AddedArticle 10 – paragraph 2 – point a: deleted

AddedArticle 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).

Article 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).

Change 3

RemovedThe competent authority should ha a certain flexibility in the scheduling of the control, the year frequencies may not follow the real production steps during the year.

AddedArticle 12 – paragraph 3 – subparagraph 1: The Commission 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.

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

AddedArticle 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.

AddedArticle 12 – paragraph 3 – subparagraph 3: deleted

AddedArticle 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.

Article 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.

Change 4

RemovedThis limitation do not represent a quality’s standard for seeds and it will increase the waste production.

AddedArticle 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.

Change 5

ChangedArticle 14 – paragraph 5 a (new): 5a. The4: competent4. authorityLots andof thepre-basic, professionalbasic operatoror shallcertified keepPRM amay recordbe ofrepackaged, there-labelled, following:and /re-sealed (a)only authorisation,by buy,the loadcompetent andauthority, transportor ofby the PRM; and /professional (b)operator quality,under identificationthe andofficial traceabilitysupervision of the PRM.competent authority.

Change 6

RemovedThis represent a specific derogation, however it should be possible only with a complete traceability.

AddedArticle 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.

Change 7

ChangedArticle 1514 – paragraph 6: 6. By way5 of– derogationsubparagraph from2: paragraphsThat 1professional tooperator 5,shall pre-basic,be basicauthorized andfor certifiedthat seedpurpose andby material,the importedcompetent fromauthority. thirdIt countriesshall pursuantinform tothe Articlecompetent 39,authority shallin beadvance marketedof insuch theactivity Unionand withof the respectivelot OECDfrom labelwhich thatsuch wasseed accompanyingand themseed atpotato import.comes.

Change 8

RemovedWording

AddedArticle 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.

RemovedArticle 19 – paragraph 1 – point c: (c) with the exception of standard seed or standard material, the PRM concerned is marketed under a lower category, in accordance with the requirements applicable for that category;

AddedArticle 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.

RemovedIn this regulation, the focus is on the marketing standard and not the production. Regarding the category, it is important that the final labeling on the market correspond to the real standards.

AddedArticle 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).

RemovedArticle 20 – paragraph 2 – subparagraph 2 – point b – point i: (i) to the purpose of ensuring food and feed security, or ensuring high value of industrial processing; or

AddedArticle 15 – paragraph 2 – subparagraph 2 – point a: (a) the competent authority, that issued the official label, if so requested by the professional operator, or if the professional operator is not authorised to carry out certification under official supervision, by the competent authority in accordance with Article 10; or

RemovedThis amendments gives more flexibility for the certification.

AddedArticle 15 – paragraph 2 – subparagraph 2 – point b: (b) the professional operator or associations of professional operators, under the official supervision of the competent authority, where the professional operator is authorised to carry out certification under official supervision in accordance with Article 10.

Change 9

ChangedArticle 2115 – paragraph 1 –6: subparagraph6. 1:By Mixturesway of certified seedderogation orfrom mixturesparagraphs of1 standardto seed5 of various genera or species listed in Parts A and Bthis ofArticle, Annexpre-basic, Ibasic and complyingcertified withseed theimported requirementsfrom ofthird Articlescountries 5pursuant to 8, as well as of different varieties of those genera orArticle species,39, mayshall be produced and marketed in the Union,Union ifwith theythe fulfilrespective theOECD requirementslabel ofthat thiswas Article.accompanying them at import.

Change 10

RemovedAlso the seed listed in the Part B (Genera and species to be used for the production of vegetables) should be mentioned.

AddedArticle 16 – paragraph 2: The operator's label shall be issued, printed and affixed on the outside of a plant bundle, package or container by the professional operator, or by a person acting under the responsibility of the professional operator. The information to be included on the professional operator’s label may also be printed directly on the plant bundle, package or container by the professional operator, or by a person acting under the responsibility of the professional operator.

RemovedArticle 21 - paragraph 4 a (new): 4a. Μixtures of seeds referred to in paragraph 1 may contain seeds of various genera or species which are, or are not, listed in Annex I, Parts A and B.

AddedArticle 17 – paragraph 2: 2. The official label and the operator’s label shall be legible, indelible, not modifiable if tampered with, printed on one side, made of untearable material unless it is an adhesive label, not having been used previously, and easily visible. It shall include, where applicable, a reference to the plant variety right and a reference to the register referred to in Article 46 in the case of further intellectual property rights.

RemovedFlowering mixtures and mixtures for greening currently contain many species that are not listed. This is important because these species are used as part of nature conservation measures. These mixtures are currently used on a large scale.

AddedArticle 17 – paragraph 3: 3. Any space of the official label or the operator’s label apart from the elements mentioned in paragraph 4, shall, where relevant, be used for additional information by the competent authority. Such information shall be presented in letters not larger than those used for the content of the official label or the operator’s label as referred to in paragraph 4. That additional information shall be strictly factual, it shall not represent advertising material, and shall be related only to the production and marketing requirements or to labelling requirements for genetically modified organisms or category 1 NGT plants as defined in Article 3(7) of Regulation (EU) …/… (Office of Publications, please insert reference to NGT Regulation ...). .

RemovedArticle 22 – paragraph 1 – subparagraph 1 – point b: (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;

AddedArticle 17 – paragraph 4 – subparagraph 1 – point h: deleted

RemovedThis definition of "source area" is the the same definition of "region of origin" in the in Article 3 of EU Directive 2010/60, which currently regulates the marketing of preservation mixtures. This amendments it to avoid misunderstandings.

AddedArticle 17 – paragraph 4 – subparagraph 1 – point i: deleted

AddedArticle 17 – paragraph 4 – subparagraph 1 – point n a (new): (na) the label for polyclonal material referred to in Article 9(4).

AddedArticle 19 – paragraph 1 – introductory part: In the case where official controls carried out during the marketing of PRM show that it has not been produced or marketed within the Union in compliance with the respective requirements applicable to that PRM, the competent authorities shall ensure that the professional operator concerned takes the necessary corrective actions concerning the PRM, its premises and production methods, as appropriate. Those actions shall aim at achieving one or more of the following elements:

AddedArticle 19 – paragraph 1 – point c: (c) with the exception of standard seed or standard material, heterogeneous seed or heterogeneous material and PRM marketed under the derogations provided for in Articles 27 to 30, the PRM concerned is marketed under a lower category, in accordance with the requirements applicable for that category;

AddedArticle 19 – paragraph 1 – point d: (d) where applicable, the professional operator may be sanctioned by additional means to the withdrawal or modification of the authorisation referred to in Article 11.

AddedArticle 20 – paragraph 2 a (new): 2a. Upon application by a Member State, the Commission may, by means of implementing acts, authorise a Member State to be released from the obligation to apply the provisions laid down in this Article for the production and marketing of PRM within its territory, specifically pertaining to a genus or species listed in Annex IV, which is not normally reproduced or marketed within its territory. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 76(2). / The authorisation referred to in the first subparagraph of this paragraph shall be based on an assessment of the conditions laid down in paragraph 2, second subparagraph, points (a) and (b). / The authorisation referred to in the first subparagraph of this paragraph shall be subject to regular review. The Commission may decide, by means of implementing acts, that the authorisation is to be repealed, if it considers that it is no longer justified in view of the conditions referred to in paragraph 2, second subparagraph, points (a) and (b). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 76(2).

AddedArticle 21 – paragraph 1 – subparagraph 1: Mixtures of certified seed or mixtures of standard seed of various genera or species listed in Parts A and B of Annex I and complying with the requirements of Articles 5 to 8, whether or not in combination with commercial seed, as well as of different varieties of those genera or species, may be produced and marketed in the Union, if they fulfil the requirements of this Article.

AddedArticle 21 – paragraph 1 – subparagraph 2 – point b: (b) an operator’s label, in all other cases.

AddedArticle 21 – paragraph 1 – subparagraph 3: For the purposes of the second subparagraph, point (a), the professional operators shall submit to the competent authority the list of constituent varieties and commercial seed components of the mixture and their ratios, for verification of eligibility of those varieties.

AddedArticle 22 – paragraph 1 – subparagraph 1 – introductory part: By way of derogation from Articles 5 to 8 and Article 21(1), Member States may authorise the production and marketing of a mixture of seeds of various genera or species listed in Parts A, B and C of Annex I, and genera or species of other Parts of that Annex, or of genera or species not listed in that Annex, if such mixtures fulfil all of the following conditions:

AddedArticle 22 – paragraph 1 – subparagraph 1 – point a: (a) they contribute to the conservation of genetic resources, or the restoration of the natural environment; and