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
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Subject matter and scope
This Regulation lays down procedures for risk assessment foreseen under Article 42(4) of Regulation (EU) 2016/2031 with a view to ensuring that such assessment is conducted within a reasonable period of time and on the basis of a demand for import accompanied by a comprehensive technical dossier and subject to a defined procedure.
Submission of technical dossiers
A technical dossier for carrying out the risk assessment referred to in Article 42(4) of Regulation (EU) 2016/2031 may only be submitted to the Commission by a National Plant Protection Organisation of a third country. The technical dossier shall be accompanied by elements indicating that demand for import exists within the meaning of Article 42(5) of Regulation (EU) 2016/2031.
Content of the technical dossier
The technical dossier shall contain for each plant, plant product or other objects all of the following elements: (a) information on the commodity, including treatments and processing of the commodity; (b) information on the identification of pests potentially associated with the commodity in the exporting country; (c) information on phytosanitary mitigation measures and inspections; (d) the contact details of the National Plant Protection Organisation contact point of the third country responsible for liaising with the Commission and the European Food Safety Authority (EFSA). The technical dossier shall also contain all the elements referred to 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) 2016/2031’. The applicant may indicate the information, the disclosure of which might harm the competitive position of a certain third party and which should therefore be treated as confidential in accordance with Article 6 of this Regulation. Verifiable justification shall be given in such cases. The dossier shall be submitted in one of the official languages of the Union.
Reception and examination of the technical dossier by the Commission
The Commission shall acknowledge receipt of the technical dossier. It shall examine whether the technical dossier contains the information described in points (a) to (d) of the first paragraph of Article 3, and may ask the applicant for additional information or clarifications, as required by the content and the subject of that technical dossier. Where the Commission concludes that those requirements are fulfilled, it shall transmit the technical dossier to EFSA and inform Member States accordingly.
Conduct and completion of the risk assessment
EFSA shall verify that the technical dossier complies with its document referred to in the second paragraph of Article 3, and may ask the applicant for additional information or clarifications, as required by the content and the subject of the technical dossier. Following that verification, EFSA shall proceed with the risk assessment. During the conduct of the risk assessment, EFSA may communicate directly with the applicant to ask for additional information or clarifications. EFSA shall inform the Commission of every communication with the applicant. EFSA shall complete the risk assessment within a reasonable period of time and submit it to the Commission. EFSA shall publish the risk assessment in the EFSA Journal . On the basis of that risk assessment, the Commission shall, as necessary, modify the list of high risk plants, plant products or other objects referred to in Article 42(3) of Regulation (EU) 2016/2031 in accordance with Article 42(4) of that Regulation.
Confidentiality
For the purpose of this Regulation, the provisions laid down in Article 39 of Regulation (EC) No 178/2002 concerning the confidentiality of information submitted by the applicant shall apply accordingly.
Entry into force and application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union . It shall apply from 14 December 2019.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.