Commission Implementing Regulation (EU) 2018/2018 of 18 December 2018 laying down specific rules concerning the procedure to be followed in order to carry out the risk assessment of high risk plants, plant products and other objects within the meaning of Article 42(1) of Regulation (EU) 2016/2031 of the European Parliament and of the Council
Commission Implementing Regulation (EU) 2018/2018of 18 December 2018laying down specific rules concerning the procedure to be followed in order to carry out the risk assessment of high risk plants, plant products and other objects within the meaning of Article 42(1) of Regulation (EU) 2016/2031 of the European Parliament and of the CouncilTHE 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/ECOJ L 317, 23.11.2016, p. 4., and in particular Article 42(6) thereof,Whereas:(1)Rules should be established to ensure that the risk assessment referred to in Article 42(4) of Regulation (EU) 2016/2031 is conducted within a reasonable period of time and on the basis of a timely processing of technical dossiers.(2)In order for that risk assessment to be conducted, an application should be submitted to the Commission only by the National Plant Protection Organisation, within the meaning of the International Plant Protection Convention, of the third country. This is necessary to ensure that all the necessary elements for the assessment of the risk associated with plants, plant products or other objects to be introduced in the Union territory are certified by the responsible public authority of the third country. This would be necessary for the credibility and justification of the risk assessment as a basis of measures taken pursuant to Article 42(4) of Regulation (EU) 2016/2031. Those provisions should apply without prejudice to the right of the Commission to submit requests to the European Food Safety Authority (EFSA) to issue scientific opinions pursuant to Article 29 and provide scientific or technical assistance pursuant to Article 31 of Regulation (EC) No 178/2002 of the European Parliament and of the CouncilOJ L 31, 1.2.2002, p. 1..(3)The technical dossier should contain data on the commodities to be introduced into the territory of the Union, as well as data on the identification of pests potentially associated with the commodity in the exporting country, data on national phytosanitary mitigation measures, inspections and treatments and processing of the commodity and contact details of the natural person responsible for liaising with the Commission and EFSA. Such data are essential in order to perform the commodity risk assessment and to identify the pest species for which phytosanitary mitigation measures may be required.(4)In order to provide EFSA with all the necessary elements to conduct the risk assessment, the technical dossier should contain the information specified in the EFSA document entitled "Information required for dossiers to support demands for import of high risk plants, plant products and other objects as foreseen in Article 42 of Regulation (EU) 2016/2031European Food Safety Authority (EFSA), Dehnen-Schmutz K, Jaques Miret JA, Jeger M, Potting R, Corini A, Simone G, Kozelska S, Munoz Guajardo I, Stancanelli G and Gardi C, 2018. Information required for dossiers to support demands for import of high risk plants, plant products and other objects as foreseen in Article 42 of Regulation (EU) 2016/2031. EFSA supporting publication 2018:EN-1492, 22pp. doi:10.2903/sp.efsa.2018.1492".(5)It is appropriate that, after acknowledging receipt of the technical dossier, the Commission examine whether it contains the required information and may ask, where necessary, for additional information or clarifications so that it is ensured that the application contains all the required and appropriate elements for the risk assessment.(6)Rules should be established concerning the conduct of risk assessment by EFSA, its communication with the applicant and the publication of that assessment, in order to ensure a transparent, efficient and timely risk assessment process.(7)In order to avoid that the disclosure of certain information harms the competitive position of certain third parties, the provisions concerning confidentiality of Regulation (EC) No 178/2002 should apply accordingly.(8)For reasons of legal certainty, this Regulation should apply from the same date as Regulation (EU) 2016/2031.(9)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,HAS ADOPTED THIS REGULATION: