Changes from plenary report to adopted text

RemovedArticle 22 – paragraph 1 – subparagraph 1 – point c b (new): (cb) it does 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) …/… (Office of Publications, please insert reference to NGT Regulation ...).

Added6. 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). [Am. 111]

RemovedArticle 26 – paragraph 1: 1. By way of derogation from Article 20, PRM of all genera or species listed in Annex I 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.

AddedSECTION 5 labelling requirements

RemovedArticle 26 – paragraph 2 a (new): 2 a. A variety of conservation, its parts and/or its genetic components may not be covered by an intellectual property right limiting its use for conservation, research, breeding and/or training, including on-farm participatory research and breeding.

AddedArticle 15 Official label

RemovedArticle 27 – paragraph 3 – subparagraph 2: Those amendments shall be developed in consultation with respective multi actor stakeholders involved in heterogeneous material in order to adapt to the development of the respective technical and scientific evidence, and the international standards, and to follow up on the experience gained by the application of this Article concerning all species.

Added1. Pre-basic, basic and certified material and seeds shall be identified, and their compliance with this Regulation shall be attested, through an official label, issued after the conclusion by the competent authority that the requirements referred to in Article 7 have been fulfilled.

RemovedArticle 27 – paragraph 4: 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.

Added2. The official label shall be issued by the competent authority and bear a serial number given by the competent authority.

RemovedArticle 27 – paragraph 7 – subparagraph 1: 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.

AddedIt shall be printed by:

RemovedArticle 29 – title: PRM marketed by, to, within and between organisations and networks dedicated to the dynamic conservation and sustainable use of plant genetic resources

Added(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 [Am. 112]

RemovedArticle 29 – paragraph 1 – subparagraph 1: By way of derogation from Articles 5 to 25, PRM may be marketed by, to, within, or between organisations and networks, including farmers, dedicated to the dynamic conservation and sustainable use of plant genetic resources whereby any of the activities are carried out for non-profit purposes.

Added(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. [Am. 113]

RemovedArticle 29 – paragraph 1 – subparagraph 2: It can be marketed as well from those conservation organisations and networks or their members to persons who carry out dynamic conservation of that PRM as final consumers, or for professional farming purposes.

Added3. The official label shall be affixed to the outside of the bundle, package or container by the professional operator under the official supervision of the competent authority, or by a person acting under the responsibility of the professional operator.

RemovedArticle 29 – paragraph 1 – subparagraph 3 – introductory part: In the cases provided for in the first and the second subparagraphs, conservation organisations and networks shall not fulfil the obligations under Article 41 to 43, and PRM shall be listed in a register kept by those conservation organisations and networks with a basic description of that PRM.

Added4. The official label shall be newly issued. Adhesive official labels may be used, if so authorised by the competent authority where there is no risk that they can be re-used.

RemovedArticle 29 – paragraph 1 – subparagraph 3 – point a: deleted

Added5. The Commission is empowered to adopt delegated acts in accordance with Article 75, supplementing this Article by establishing the following rules on:

RemovedArticle 29 – paragraph 1 – subparagraph 3 – point b: deleted

Added(a) the digital recording of all actions taken by the professional operators and the competent authorities in order to issue the official label;

RemovedArticle 29 – paragraph 1 – subparagraph 3 – point c: deleted

Added(b) the establishment of a centralised platform that connects the Member States and the Commission to facilitate the processing of, access to, and use of those records;

RemovedArticle 29 – paragraph 2: deleted

Added(c) the technical arrangements for the issuance of electronic official labels.

RemovedArticle 30 – title: PRM exchanged between farmers

AddedFollowing the adoption of such delegated act, the official label may also be issued in an electronic form (‘electronic official label’).

RemovedArticle 30 – paragraph 1 – introductory part: 1. By way of derogation from Articles 5 - 25, farmers may exchange PRM in kind or for monetary compensation covering direct costs incurred, if such PRM fulfils all of the following conditions:

Added6. By way of derogation from paragraphs 1 to 5 of this Article, pre-basic, basic material and seed basic material and seed and certified material and 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. [Am. 114]

RemovedArticle 30 – paragraph 1 – point 3: (3) are not subject to a service contract for multiplication conducted by the respective farmer with a professional operator performing PRM production; and

AddedArticle 16 Operator’s label

RemovedArticle 30 – paragraph 1 – point 4: (4) the PRM is used for dynamic management of farmer’s own PRM for the purpose of contributing to agro-diversity.

AddedStandard material and standard seed shall be identified through an operator’s label. That label shall attest that standard material or standard seed complies with the relevant production and marketing requirements, referred to in Article 8, on the basis of inspections, sampling and testing carried out by the professional operator.

RemovedArticle 30 – paragraph 2 – introductory part: 2. Such PRM shall fulfil all of the following requirements:

AddedThe 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 opeartor, operator. The information to be included on the outside of a 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. [Am. 115]

RemovedArticle 30 – paragraph 2 – point a: (a) not to belong to a to variety for which plant variety rights have been granted in accordance with Regulation (EU) 2100/94 and where the right is still in force;

AddedArticle 17 Content of labels

RemovedArticle 30 – paragraph 2 – point b: (b) to be limited to small quantities defined by the competent authorities sufficient to meet the own needs of a farmer for specific species per year, without using commercial intermediaries or public offer of marketing; and

Added1. The official label and the operator’s label, shall be written in at least one of the official Union languages.

RemovedArticle 30 – paragraph 2 – point c: (c) to be practically free from quality pests and any defects likely to impact their quality as PRM.

Added2. 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. [Am. 116]

RemovedArticle 30 – paragraph 3: deleted

Added3. Any space of the official label or the operator’s label apart from the elements mentioned in paragraph 4, may 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 ...). [Am. 117]

RemovedArticle 32 – paragraph 1 – subparagraph 2 a (new): 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).../...

Added4. The Commission shall, by means of implementing acts, specify the content, size, colour and form of the official or operator’s label, as applicable, in relation to the respective categories or types of PRM, for:

RemovedArticle 33 – paragraph 4 a (new): 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).../...

Added(a) the official label referred to in Article 15(1);

RemovedArticle 35 – paragraph 1 – point c: (c) the requirements set out in paragraphs 2 to 5a are fulfilled.

Added(b) the operator’s label referred to in Article 16;

RemovedArticle 35 – paragraph 5 a (new): 5 a. 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).../...

Added(c) the label for mixtures referred to in Article 21(1);

RemovedArticle 37 – paragraph 1 – subparagraph 1: Where there are reasonable grounds to suspect that the production or marketing of PRM could constitute a serious risk to human, animal or plant health, environment or cultivation of other species, and such risk cannot be contained satisfactorily by means of measures taken by the Member State concerned, the Commission shall take, without delay, by means of implementing acts, any appropriate interim emergency measures. Such measures shall be limited in time. They may include provisions restricting or prohibiting the marketing of the PRM concerned or laying down appropriate conditions for its production or marketing, depending on the gravity of the situation.

Added(d) the label for preservation mixtures referred to in Article 22(1);

RemovedArticle 37 – paragraph 1 – subparagraph 1 a (new): By means of derogation from the first subparagraph, in case of lack of compliance with refuge requirements or with other requirements imposed on cultivation of varieties containing or consisting of genetically modified organisms , the measures restricting or prohibiting the marketing of the PRM concerned shall be put in place until full compliance is restored.

Added(e) the label for repackaged and relabelled seeds referred to in Article 23(5);

RemovedArticle 41 – paragraph 1 a (new): The activities referred to in Articles 28, 29 and 30 shall not be subject to the provisions of this article.

Added(f) the label for PRM belonging to conservation varieties referred to in Article 26(2);