Changes from plenary report to adopted text

Added(a) prior to the harvesting, a field inspection has been carried out by the competent authority, or the professional operator under the official supervision of the competent authority, and that inspection has confirmed compliance of that PRM with the production requirements referred to in Article 7(1);

Added(b) it is in the process of being certified by the competent authority, or by the professional operator under the official supervision of the competent authority; and

Added(c) the requirements set out in paragraphs 2 to 55a are fulfilled. [Am. 185]

Added2. PRM referred to in paragraph 1 may be marketed only by the professional operator who has produced that PRM to the professional operator who is to carry out the certification. Such PRM may not be further transferred to any other person before its final certification.

Added3. PRM referred to in paragraph 1, shall be accompanied by a label, issued by the professional operator, with the indication ‘Seeds/Material not yet finally certified’.

Added4. If the competent authority, where the PRM has been harvested (‘competent authority of production’), and the competent authority where the PRM is certified pursuant to Article 7 (‘competent authority of certification’) are different, they shall exchange the relevant information concerning the production and marketing of that PRM.

Added5. PRM which has been harvested in a third country, but has not yet been certified as pre-basic, basic or certified material pursuant to Article 7, may be marketed in the Union by reference to any of those categories, if:

Added(a) a decision on equivalence has been adopted pursuant to Article 39 concerning that third country;

Added(b) the requirements set out in paragraph 1, points (a) and (b), paragraphs 2 and 3, are fulfilled, and the professional operators of the third county concerned have been subject to the official supervision of their competent authorities;

Added(c) the competent authorities of the Member State and the third country concerned exchange between themselves the relevant information concerning the marketing of that material; and

Added(d) on request, the competent authorities of the third country concerned provide all relevant production information to the competent authority of the Member State of certification.

AddedFor the purposes of this paragraph, references made in paragraphs 1 - 5 to the competent authority of production shall be construed as references made to the competent authority of the third country concerned, and references made therein to the requirements set out pursuant to Article 7(1) shall be construed as references made to equivalent requirements of the third country, as recognised pursuant to Article 39(2).

Added5a. This derogation shall not apply to PRM consisting of a genetically modified organism within the meaning of Directive 2001/18/EC. [Am. 186]

AddedArticle 36 More stringent production and requirements

Added1. The Commission, by means of implementing acts, may authorise the Member States to impose, with regards to production and marketing of PRM, more stringent production or marketing requirements than those referred to in Articles 7 and 8, in all or part of the territory of the Member State concerned, provided that those more stringent requirements correspond to specific production conditions in, and agro-climatic needs, of, that Member State in regard to the respective PRM and do not prohibit, impede or restrict the free movement of PRM that is in conformity with this Regulation. [Am. 187]

AddedThose implementing acts shall be adopted in accordance with the examination procedure referred to in Article 76(2).

Added2. In order to obtain the authorisation referred to in paragraph 1, Member States shall submit to the Commission a request setting out:

Added(a) the draft provisions containing the proposed requirements; and

Added(b) a justification on the necessity and proportionality of such requirements in light of possible additional costs of production and marketing. [Am. 188]

Added3. The authorisation referred to in paragraph 1 shall be granted only if the following conditions are fulfilled:

Added(a) the implementation of the draft provisions, as referred to in paragraph 2, point (a), ensures the improvement of the identity and quality of the PRM concerned, and it is justified by the specific agricultural or climatic conditions of the Member State concerned; and

Added(b) the draft provisions are necessary and proportionate to the objective of the measure referred to in paragraph 2, point (a).

Added4. Where applicable, each Member State shall, by … [one year after date of application of this Regulation], review the measures it has adopted pursuant to Article 5 of Directive 66/401/EEC, Article 5 of Directive 66/402/EEC, Article 7 of Directive 2002/54/EC, Article 24 of Directive 2002/55/EC, Article 5 of Directive 2002/56/EC and Article 7 of Directive 2002/57/EC, and either repeal those measures or amend them to comply with the production and marketing requirements set out in, and adopted pursuant to, Articles 7 and 8.

AddedThe Member State concerned shall inform the Commission and the other Member States of those actions.

AddedThe Commission may, by means of implementing acts, decide that the measures, as referred to in the first subparagraph, are to be repealed or amended, in case they are considered to be unnecessary and/or disproportionate to their objective. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 76(2).

AddedArticle 37 Emergency measures

Added1. Where the production or marketing of PRM is likely to 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.

AddedBy way of derogation from the first subparagraph, in the 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. [Am. 189]

AddedSuch measures may be taken on the Commission’s own initiative or at the request of a Member State. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 76(2).

AddedOn duly justified imperative grounds of urgency to address a serious risk to human health, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 76(3).

Added2. Where a Member State officially informs the Commission of the need to take emergency measures and the Commission has not acted in accordance with paragraph 1, that Member State may adopt the appropriate, proportionate and time-limited interim emergency measures. Those measures may include provisions restricting, prohibiting or laying down appropriate conditions for the production or marketing of PRM within the territory of that Member State, depending on the gravity of the situation. The Member State concerned shall immediately inform the other Member States and the Commission of the measures adopted and the time period they cover, stating the grounds for its decision. That approach permits a Member State to act quickly and effectively in emergency situations to protect health, the environment and economic interests. [Am. 190]

Added3. The Commission may decide, by means of implementing acts, that the national interim emergency measures referred to in paragraph 2 are to be repealed or amended, if it considers that those measures are not justified in view of the respective risk as referred to in paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 76(2). The Member State concerned may maintain its national interim emergency measures until the date of application of the implementing act(s) referred to in this paragraph.

AddedArticle 38 Temporary experiments to seek improved alternatives to provisions of this Regulation

Added1. By way of derogation from Articles 2, 5, 6, 7, 8 and, 9, 20, 26, 27 and 47 to 53, the Commission may, by means of implementing acts, decide on the organisation of is empowered to adopt delegated acts in accordance with Article 75 in order to supplement this Regulation by organising temporary experiments to seek improved alternatives to provisions of this Regulation concerning the genera and species it applies to, the requirements for belonging to a registered variety, PRM or the production and marketing requirements for pre-basic, basic, certified and standard material or seed, and the obligation to belong to pre-basic, basic and certified material or seed, production and marketing requirements for heterogeneous material, and the obligation to belong to pre-basic, basic and certified material or seed. [Am. 191]

AddedThose experiments may take the form of technical or scientific trials examining the feasibility and appropriateness of new requirements compared to the ones set out in Articles 2, 5, 6, 7, 8 and, 9, 20, 26, 27 and 47 to 53 of this Regulation. [Am. 192]

Added2. The implementing delegated acts referred to in paragraph 1 shall be adopted in accordance with the examination procedure referred to in Article 76(2) and shall specify one or more of the following elements: [Am. 193]

Added(a) the genera or species concerned;

Added(b) the conditions of the experiments per genera or species;

Added(c) the duration of the experiment;

Added(d) the monitoring and reporting obligations of the participating Member States.

AddedThose delegated acts shall adapt to the evolution of techniques for production of the PRM concerned, as and shall be based on any comparative trials carried out by the Member States. [Am. 194]

Added3. The Commission shall review the results of those experiments and summarise them in a report, indicating, if necessary, the need to amend Articles 2, 5, 6, 7, 8 or to 9, 20, 26, 27 and 47 to 53. [Am. 195]

AddedSECTION 8 Imports from third countries

AddedArticle 39 Imports on the basis of Union equivalence

Added1. PRM may only be imported from third countries, if it is established, pursuant to paragraph 2, that it fulfils requirements equivalent to those applicable to PRM produced and marketed in the Union.

AddedHowever, no such import shall be allowed, and no not be authorised, nor shall such equivalence shall be recognised pursuant to under paragraph 2, for the preservation mixtures such as those PRM referred to in Article 22, and for PRM such as that subject to the derogations of Articles 26 - 30 22 to 29, except where it originates in neighbouring countries. [Am. 196]

Added2. The Commission may recognise, by means of implementing acts, that 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, on the basis of all of the following:

Added(a) a thorough examination of the information and data provided by the third country concerned;

Added(b) an audit carried out by the Commission in the third country concerned, showing that the PRM concerned fulfils requirements equivalent to those applicable to PRM produced and marketed in the Union, where that audit has been considered necessary by the Commission; and

Added(c) in the case of seeds, the fact that this the country concerned participates in the OECD Schemes for the Varietal Certification of Seed moving in International Trade and implements the methods of the International Seed Testing Association (ISTA), or, where applicable, complies with the rules of the Association of Official Seed Analysts (AOSA).

AddedFor that purpose, the Commission shall examine:

Added(a) the third country’s legislation on the species concerned;

Added(b) the structure of the competent authorities of the third country and its control services, the powers available to them, the guarantees that can be provided with regard to the application and enforcement of the legislation of the third country applicable to the sector concerned, and the reliability of the official certification procedures;

Added(c) the performance by the competent authorities of the third country of adequate official controls concerning the identification and quality of the PRM of the species concerned;

Added(d) the guarantees given by the third country that:

Added(i) the conditions applied to the production sites from which PRM are exported to the Union comply with requirements that are equivalent to those referred to in this Article; and

Added(ii) those production sites are subject to regular and effective controls by the competent authorities of the third country.

AddedThe Commission may also carry out audits to verify the compliance with points (b) to (d) of the second subparagraph.

AddedThose implementing acts shall be adopted in accordance with the examination procedure referred to in Article 76(2).

Added3. The implementing act referred to in paragraph 2 may provide for one or more of the following elements, as appropriate for the respective PRM: