Changes from plenary report to adopted text

Added(b) the examination is carried out under the official supervision and guidance of the competent authority concerned; and

Added(c) the examination is carried out in the premises dedicated to that purpose;

Added(ca) the examination does not replace the risk assessment required to apply for marketing authorisation under Directive 2001/18/EC on genetically modified organisms. [Am. 247]

Added2. Prior to granting the authorisation to carry out the technical examination on breeders’ premises, the competent authority shall audit the premises, the resources and the organisational capacities of the applicant. That audit shall verify whether the premises, the laboratory facilities, the organisation and the carrying out of the growing trials are suitable for realising the technical examination on breeders’ premises as regards compliance with the requirements of a value for sustainable cultivation and use referred to in Article 52.

Added3. The Commission is empowered to adopt delegated acts in accordance with Article 75, supplementing this Regulation by setting out the rules concerning the audit referred to in paragraph 2.

Added4. On the basis of the audit referred to in paragraph 2, the competent authority may recommend to the applicant, if appropriate, actions to ensure the suitability of the applicant’s premises and organisation of the examination.

Added5. The competent authority may carry out additional audits to the one referred to in paragraph 2 and, where applicable, recommend to the applicant to perform, within a specific period of time, corrective actions concerning the its premises and the working arrangements. In case the competent authority concludes, following that period, that the applicant’s premises and working arrangements are not suitable, it may withdraw or modify the authorisation referred to in paragraph 1.

AddedArticle 62 Additional rules on technical examination

Added1. The Commission is empowered to adopt delegated acts in accordance with Article 75, supplementing the requirements on the technical examination laid down in Article 59. Those delegated acts may concern:

Added(a) qualification, training and activities of staff of the competent authority or of the applicant, for the purposes of the technical examination referred to in Article 61;

Added(b) the necessary equipment, including laboratories for testing, necessary to carry out the technical examination;

Added(c) the establishment of a variety reference collection to compare the examined variety with other varieties to assess distinctness, and the storage management of such reference collection;

Added(d) the establishment of quality management systems, including record of activities and protocols or guidelines, to be used for the technical examination;

Added(e) the carrying out of growing trials and laboratory tests for particular genera or species, including bio-molecular techniques.

AddedThose delegated acts adapt to the available international technical and scientific protocols.

Added2. Where no requirements have been adopted pursuant to paragraph 1, technical examinations shall be carried out in accordance with national protocols as regards the elements referred in paragraph 1, points (a) - (e).

AddedArticle 63 Confidentiality

Added1. Where, during the technical examination provided for in Article 59, an examination of the genealogical components appears to be necessary, the results of that examination and the description of the genealogical components shall be treated as confidential, if the applicant requests so.

Added2. In the case of varieties of PRM intended exclusively for the production of agricultural raw materials for industrial purposes, certain elements of the technical examination and the intended uses of those varieties, whose public disclosure may affect the competitive position of the applicant, shall be treated as confidential, if that applicant requests so.

Added3. This Article shall apply without prejudice to Article 8 of Regulation (EU) 2017/625. The competent authorities shall take due account of the respect of confidentiality of commercial or industrial information where such confidentiality is provided for by Union or national law to protect a legitimate economic interest. [Am. 248]

AddedArticle 64 Provisional examination report and provisional official description

Added1. Following the technical examination provided for in Article 59, the competent authority shall produce a provisional examination report, as to the compliance with the distinctness, uniformity and stability requirements, and the characteristics of value for sustainable cultivation and use, as applicable, as referred to in Articles 48, 49, 50 and 52, and shall issue a provisional official description of the variety on the basis of that report.

Added2. The provisional examination report may refer to findings of other examination reports, produced on the relevant variety, by the competent authority concerned, other competent authorities or the CPVO.

Added3. The competent authority shall communicate the provisional examination report and the provisional official description of the variety to the applicant. The applicant may comment on these documents within 15 calendar days.

Added4. Where the competent authority does not consider that the provisional examination report constitutes a sufficient basis for a decision on the registration of the variety, it shall request from the applicant additional information, examinations or other actions, as appropriate, to ensure compliance of the variety with the requirements concerning distinctness, uniformity, stability and value for sustainable cultivation and/or use, as set out respectively in Articles 48, 49, 50 and 52.

AddedArticle 65 Examination report and final official description

AddedAfter taking into account any comments on the provisional examination report and the provisional official description provided by the applicant, the competent authority shall issue a final examination report and a final official description on the distinctness, uniformity and stability of the variety and including a summary of the examination results on value for sustainable cultivation and use.

AddedCompetent authorities shall, on reasoned request, make available the examination reports and the official description to third parties, subject to national or Union law on data protection and to rules on confidentiality.

AddedArticle 66 Examination of the denomination of a variety

AddedAfter the formal examination of the application provided for in Article 57, and prior to the registration of a variety in a national variety register pursuant to Article 67, the competent authority shall consult the CPVO on the variety denomination proposed by the applicant.

AddedThe CPVO shall submit to the competent authority a recommendation on the suitability of the variety denomination proposed by the applicant, in accordance with Article 54. The competent authority shall inform the applicant on that recommendation.

AddedArticle 67 Decision on the registration of a variety in the national variety register

Added1. If, on the basis of the procedure set out in Articles 55 to 66, it is concluded that the variety complies with the requirements set out in Article 47(1), the competent authority of the respective Member State shall decide to register the variety in the national variety register.

Added2. The competent authority shall adopt a decision refusing registration in the national variety register, if:

Added(a) it establishes that the respective requirements set out in Article 47(1) and Article 48 are not fulfilled; or [Am. 249]

Added(b) the applicant has failed to comply with any of the obligations set out for it in Articles 55 to 64.

Added3. Decisions refusing the registration of a variety in the national variety register shall state the reasons justifying such refusal.

Added4. The competent authority shall communicate to the applicant the decision referred to in paragraphs 1 and 2.

Added5. The decisions referred to in paragraph 1 and 2 may be appealed, in accordance with the administrative rules of the Member State concerned. Any appeal against a decision referred to in paragraph 1 shall have a suspensory effect on the registration of the respective variety.

Added6. The adoption of the decision referred to in paragraph 1 may be subject to a fee paid by the applicant, as established by the competent authority.

AddedArticle 68 Varieties registered pursuant to Directives 68/193/EEC, 2002/53/EC, 2002/55/EC and 2008/90/EC

Added1. By way of derogation from Articles 54 to 67, the competent authorities shall immediately register in their national variety registers all varieties officially accepted or registered before … [the date of the entry into force of this Regulation], in the catalogues, lists or registers established by their Member States pursuant to Article 5 of Directive 68/193/EEC, Article 3 of Directive 2002/53/EC, Article 3(2) of Directive 2002/55/EC and varieties with an official description pursuant to Article 7(4)7 of Directive 2008/90/EC, without applying the registration procedure set out by those Articles. [Am. 250]

Added2. By way of derogation from Article 53, varieties accepted in accordance with Article 3 of Directive 2008/62/EC and Article 3(1) and Article 21(1) of Directive 2009/145/EC, and varieties with an officially recognised description pursuant to Article 7 of Directive 2008/90/EC before… [OJ, please, insert the date of the entry into force of this Regulation] shall be immediately registered in the national variety registers as conservation varieties provided with an officially recognised description without applying the registration procedure set out by that Article. [Am. 251]

AddedSECTION 4 Registration period and variety maintenance

AddedArticle 69 Period of registration

Added1. The period of registration of a variety in a national variety register (‘period of registration’) shall be 10 years.

AddedHowever, that period of registration shall be 30 years for conservation varieties and varieties of species of fruit plants and vine propagating material, as listed respectively in Parts C and D of Annex I. [Am. 252]

AddedIn the case of varieties consisting of, or containing, a genetically modified organism, the period of registration shall be limited to the period for which that genetically modified organism is authorised for cultivation pursuant to Directive 2001/18/EC or Regulation (EC) No 1829/2003.

AddedIn the case of varieties consisting of, or containing, a category 2 NGT plant as defined in Article 3(8), of Regulation (EU) …/… (Office of Publications, please insert reference to NGT Regulation ...), the period of registration shall be limited to the period for which that plant is authorised pursuant to that Regulation.

Added2. The period of registration of a variety in a national variety register may be renewed for a further period of 10 years, or respectively 30 years, in accordance with the procedure and the conditions laid down in Article 70.

AddedIn the case of a variety consisting of or containing a genetically modified organism, the renewal of the period of registration shall be limited to the period for which that genetically modified organism is authorised for cultivation pursuant to Directive 2001/18/EC or Regulation (EC) No 1829/2003.

Added3. The registration of a variety may be subject to an annual fee paid by the applicant, as established by the competent authority.

AddedArticle 70 Procedure and conditions for registration renewal

Added1. Any person intending to renew the registration of a variety shall submit an application, no earlier than 12 months, and no later than 6 months, before the expiration of the period of registration as referred to in Article 69(1).

Added2. The application shall be submitted electronically. It shall be accompanied by evidence showing that the conditions set out in paragraph 3 are fulfilled.

Added3. The renewal of the registration of a variety in a national variety register may only be granted, if:

Added(a) the applicant has submitted sufficient evidence that the variety continues to comply with the respective requirements of Article 47(1); and

Added(b) the competent authority of the respective Member State has established that there is a person responsible for the variety maintenance in accordance with Article 72.

Added4. The competent authority may, on its own initiative, renew the registration of a variety, if it is still in large demand by the professional operators and farmers concerned, or it should be retained in the interest of conserving plant genetic resources, provided that the variety is no longer protected by a plant breeders’ right title in accordance with Regulation (EC) No 2100/94, and provided that the variety is off the list for a minimum of two years. [Am. 253]

AddedArticle 71 Removal from national variety registers