Changes from plenary report to adopted text

RemovedArticle 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

Added1. This Regulation applies to the genera and species listed for the respective uses referred to in Parts A to E of Annex I.

RemovedArticle 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.

AddedIts requirements concern, respectively, all types of PRM, only seeds, or only material other than seeds.

RemovedArticle 15 – paragraph 6: 6. By way of derogation from paragraphs 1 to 5 of this Article, pre-basic, basic and certified seed imported from third countries pursuant to Article 39, shall be marketed in the Union with the respective OECD label that was accompanying them at import.

AddedThe requirements concerning production or imports of PRM shall apply only to production with a view to its marketing within the Union. [Am. 23]

RemovedArticle 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.

Added2. The objectives of this Regulation are the following:

RemovedArticle 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.

Added(a) to ensure quality, safety and diversity of choice for PRM, and its availability for professional operators, farmers and final users; [Am. 24]

RemovedArticle 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 ...). .

Added(b) to ensure a equal fair conditions for the competition of the professional operators across the Union and the functioning of the internal market in PRM; [Am. 25]

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

Added(c) to support innovation and competitiveness of the PRM sector in the Union;

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

Added(d) to contribute to the dynamic conservation and sustainable use of plant genetic resources and agro-biodiversity; [Am. 26]

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

Added(e) to contribute to sustainable agricultural production, adapted to current and future projected climatic and soil conditions; [Am. 27]

RemovedArticle 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:

Added(f) to contribute to food security and food sovereignty. [Am. 28]

RemovedArticle 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;

Added3. The Commission is empowered in accordance with Article 75 to adopt delegated acts, amend amending Annex I, in order to adapt it that Annex to the developments of technical and scientific knowledge, and the economic data concerning production and marketing of genera and species, by adding genera and species to or removing them from the list in that Annex. [Am. 29]

RemovedArticle 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.

AddedThe delegated act acts referred to in the first subparagraph shall add genera or species to the list in Annex I if they fulfil at least two of the following elements: [Am. 30]

RemovedArticle 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).

Added(a) represent a significant area of production of PRM and a significant value of marketed PRM in the Union

RemovedArticle 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.

Added(b) are of substantial importance for security of food and feed production in the Union, compared to other genera and species not listed in that Annex; and

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

Added(c) are marketed in at least two Member States;

RemovedArticle 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.

Added(ca) present an interest in terms of environmental sustainability. [Am. 31]

RemovedArticle 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:

AddedThe delegated act referred to in the first subparagraph shall remove genera or species from the list in Annex I if they no longer fulfil at least two of the elements set out in the second subparagraph.

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

Added4. This Regulation does not apply to:

RemovedArticle 22 – paragraph 1 – subparagraph 1 – point b: (b) they are naturally associated with a particular area (‘region of origin’) contributing to the conservation of genetic resources or the restoration of the natural environment;

Added(a) propagating material of ornamental plants as defined in Article 2 of Directive 98/56/EC, and propagating material of genera or species listed in Annex I to this Regulation which are exclusively used for ornamental purposes; [Am. 32]

RemovedArticle 22 – paragraph 1 – subparagraph 1 – point c: (c) they comply with the requirements of Annex V.

Added(b) forest reproductive material as defined in Article 3 of Regulation (EU) .../… of the European Parliament and of the Council+ and propagating material of genera or species listed in Annex I to this Regulation which are exclusively used for forestry purposes; [Am. 33]

RemovedArticle 22 – paragraph 1 – subparagraph 1 – point c a (new): (ca) they do not consist of a GMO or a category 1 NGT plant as defined in Article 3(7) of Regulation (EU) or of a category 1 or 2 NGT plant as defined in Article 3(8) of Regulation (EU) …/… OJNGT Regulation].

Added(c) PRM produced solely for export to third countries; [Am. 34]

RemovedArticle 22 – paragraph 1 – subparagraph 2: Such mixtures constitute ‘preservation mixtures’ and this shall be mentioned on their label.

Added(d) PRM sold or transferred in any way, whether free of charge or not, between final users for their own private use and outside their commercial activities;

RemovedArticle 22 – paragraph 2 – subparagraph 1 – point a: (a) authorisation requirements for mixtures of seeds collected directly from a natural place belonging to a defined region of origin, for the conservation and restoration of the natural environment (directly harvested preservation mixtures);

Added(e) PRM used solely sold or transferred in any way, whether free of charge or not, for official testing, breeding, inspections, exhibitions or scientific purposes., including on-farm research and activities carried out by gene banks; [Am. 35]

RemovedArticle 22 – paragraph 2 – subparagraph 2: Those delegated acts shall be based on the experience gathered by the implementation of this Article, and any technical and scientific developments and the improvement of the quality and identification of preservation mixtures. They may concern particular genera or species only.

Added(ea) the production and marketing of PRM by conservation organisations and networks referred to in Article 29 in small quantities as defined in Annex VIIa, whether free of charge or not, for the purpose of dynamic conservation; [Am. 353]

RemovedArticle 23 – title: Re-packaging and re-labelling of PRM lots

Added(eb) PRM produced by farmers for their own use. [Am. 37]

RemovedArticle 23 – paragraph 1: 1. PRM lots of pre-basic, basic and certified seed shall be repackaged and relabeled in accordance with this Article, Articles 14 and 15, where this is necessary for splitting or merging of lots.

AddedArticle 3 Definitions

RemovedArticle 23 – paragraph 2 – subparagraph 1 – introductory part: The re-packaging and re-labelling of a PRM lot shall be conducted by:

AddedFor the purposes of this Regulation, the following definitions apply:

RemovedArticle 25 – paragraph 1: 1. After the marketing of standard seeds, the competent authorities shall, if indicated by the risk analysis, carry out control plot tests to check whether the seeds comply with the requirements set out in Article 8 and in Annex III, as appropriate.

Added(1) ‘plant reproductive material’ (‘PRM’) means plants as defined in Article 2(1) of Regulation (EU) 2016/2031, capable of, and intended for, producing entire plants;

RemovedArticle 25 – paragraph 2: 2. The proportion of the control plot tests shall be determined on the basis of a risk analysis concerning possible non-compliance of the respective seeds with those requirements. Such a risk analysis shall be carried out by the competent authority on the basis of territorial characteristics, the existence of plant health risks in the region, and the track record of the professional operator.

Added(2) ‘professional operator’ means any natural or legal person, involved professionally in one or more of the following activities in the Union concerning the commercial exploitation of PRM: [Am. 38]

RemovedArticle 26 – paragraph 1: 1. By way of derogation from Article 20, PRM of genera and species listed in Annex IV and belonging to a conservation variety registered in a national variety register referred to in Article 44(1), point (b), may be produced and marketed in the Union as standard seed or material, if it complies with all the requirements concerning standard seed and material for the respective species, as referred to in Article 8.

Added(a) production;