Contents
- (1) In accordance with Article 42(3) of Regulation (EU) 2016/2…
- (2) In accordance with Article 42(1a) of Regulation (EU) 2016/…
- (3) In order for the Commission to decide whether to list plan…
- (4) It is also appropriate to establish rules concerning the p…
- (5) Experience has shown that the following scientific and tec…
- (6) In order to ensure that the technical dossier submitted by…
- (7) A preliminary assessment group should be established in or…
- (8) Rules should be established concerning the procedure to co…
- (9) Rules should be established concerning the confidential tr…
THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EU) 2016/2031 of the European Parliament and of the Council of 26 October 2016 on protective measures against pests of plants, amending Regulations (EU) No 228/2013, (EU) No 652/2014 and (EU) No 1143/2014 of the European Parliament and of the Council and repealing Council Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/ECnote, and in particular Article 42(1a) thereof,Whereas:
(1)In accordance with Article 42(3) of Regulation (EU) 2016/2031 high-risk plants, plants products and other objects are provisionally listed in the Annex to Commission Implementing Regulation (EU) 2018/2019note. Their introduction into the Union is prohibited pending a risk assessment.
(2)In accordance with Article 42(1a) of Regulation (EU) 2016/2031, it is appropriate to establish rules setting out the procedure to conduct the listing of high-risk plants, plant products or other objects. Those rules should ensure that the listing is conducted on the basis of a timely, effective and transparent process.
(3)In order for the Commission to decide whether to list plants, plant products or other objects as high-risk plants, plant products or other objects, Member States should submit to the Commission a request indicating the plants, plant products or other objects that they wish to be listed as high-risk plants, plant products or other objects (‘the plants, plant products and other objects concerned’), accompanied by a technical dossier containing the relevant technical and scientific supporting evidence.
(4)It is also appropriate to establish rules concerning the procedure for the listing of high-risk plants, plant products or other objects on the basis of a Commission initiative, where the Commission considers that initiative necessary for addressing a phytosanitary risk. In those cases, the Commission should prepare a technical dossier containing the relevant technical and scientific supporting evidence.
(5)Experience has shown that the following scientific and technical evidence is essential: data on the import, or interest for the import, of the plants, plant products or other object concerned into the Union from third countries; data on the interceptions of plants, plant products or other objects due to the presence of pests associated with those plants, plant products or other objects; data on the production in the Union of the plants, plant products or other objects concerned and other host plants that may be affected by pests; information on the pests hosted by the plants, plant products or other objects concerned; and data demonstrating that the plants, plant products or other objects concerned may present a pest risk of an unacceptable level for the Union territory, when introduced from a third country.
(6)In order to ensure that the technical dossier submitted by a Member State contains the required elements for the preliminary assessment, it is appropriate that the Commission checks its completeness and asks, where necessary, for additional information or clarifications.
(7)A preliminary assessment group should be established in order to carry out the preliminary assessment of the plants, plant products or other objects concerned. The preliminary assessment group should consist of experts designated by the Member States, experts from the European Food Safety Authority, and from the Commission.
(8)Rules should be established concerning the procedure to conduct the preliminary assessment by the preliminary assessment group, its communication with the requesting Member State, if appropriate, and the publication of the assessment.
(9)Rules should be established concerning the confidential treatment of certain pieces of information, in particular, where that is requested by any person with a legitimate interest, in order to protect the interests of that person from the disclosure of that information. Those pieces of information should comprise the manufacturing or production process, including the method and innovative aspects thereof, as well as other technical and industrial specifications inherent to that process or method, except for information which is relevant to the assessment of safety; commercial links between a producer or importer and the requesting person, where applicable; and commercial information revealing sourcing, market shares or business strategy of the requesting person,
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