COMMI SSION IMPLEMENTING REGUL ATION (EU) 2018/2018 
of 18 December 2018 
laying down specif ic rules concer ning 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 
THE EUR OPEAN COMMISSION, 
Having regar d 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 
prote ctive 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/EC (1), and in particular Article 42(6) 
thereof, 
Whereas: 
(1)  Rules should be established to ensure that the risk assessment refer red to in Article 42(4) of Regulation (EU) 
2016/2031 is conduct ed 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 conduct ed, an application should be submitted to the Commission only by 
the National Plant Protection Org anisation, within the meaning of the International Plant Protection Conv ention, 
of the third countr y. This is necessar y to ensure that all the necessar y 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 author ity of the third countr y. This would be necessar y for the credibility and justif ication of 
the risk assessment as a basis of measures taken pursuant to Article 42(4) of Regulation (EU) 2016/2031. Those 
provis ions 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 provid e scientific or 
technical assistance pursuant to Article 31 of Regulation (EC) No 178/2002 of the European Parliament and of 
the Council (2). 
(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 identif ication of pests poten tially associated with the commodity in the expor ting countr y, 
data on national phyt osanitar y mitig ation 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 whic h phytosa ­
nitar y mitig ation measures may be required. 
(4)  In order to provide EFSA with all the necessar y elements to conduct the risk assessment, the technical dossier 
should contain the information specifi ed in the EFSA document entitled ‘Information required for dossiers to 
suppor t demands for impor t of high risk plants, plant products and other objects as foreseen in Article 42 of 
Regulation (EU) 2016/2031 (3)’. 
(5)  It is appropr iate that, after ackno wledging receipt of the technical dossier , the Commission examine whether it 
contains the required information and may ask, where necessar y, for additional information or clarifications so 
that it is ensured that the application contains all the required and appropr iate elements for the risk assessment. 
(6)  Rules should be established concer ning 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 concer ning conf identiality of Regulation (EC) No 178/2002 should apply according ly. 19.12.2018 L 323/7 Official Jour nal of the European Union EN     
(1)OJ L 317, 23.11.2016, p. 4. 
(2)OJ L 31, 1.2.2002, p. 1. 
(3)European Food Safet y Autho rity (EFSA) , Dehnen-Schmutz K, Jaques Miret JA, Jeger M, Potting R, Corini A, Simone G, Kozelska S, Munoz 
Gua jardo I, Stancanelli G and Gardi C, 2018. Information required for dossiers to suppor t demands for impor t of high risk plants, plant 
products and other objects as foreseen in Article 42 of Regulation (EU) 2016/2031. EFSA suppor ting publication 2018:EN-1492, 
22pp. doi:10.2903/sp.efsa.2018.1492 (8)  For reasons of legal certainty , this Regulation should apply from the same date as Regulation (EU) 2016/2031. 
(9)  The measures provi ded for in this Regulation are in accordance with the opinion of the Standing Committee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
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 ensur ing that such assessment is conduct ed within a reasonable period of time and on the basis of 
a demand for impor t accompanied by a comprehensive technical dossier and subject to a defined procedure. 
Article 2 
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 Protect ion Org anisation of a third countr y. 
The technical dossier shall be accompan ied by elements indicating that demand for impor t exists within the meaning of 
Article 42(5) of Regulation (EU) 2016/2031. 
Article 3 
Content of the technical dossier 
The technical dossier shall contain for each plant, plant product or other objects all of the followi ng elements: 
(a)  information on the commodity , including treatments and processing of the commodity ; 
(b)  information on the identification of pests pote ntially associated with the commodity in the expor ting countr y; 
(c)  information on phytosan itary mitig ation measures and inspections; 
(d)  the contact details of the National Plant Protect ion Org anisation contact point of the third countr y responsible for 
liaising with the Commission and the European Food Safety Author ity (EFSA ). 
The technical dossier shall also contain all the elements refer red to in the EFSA document entitled ‘Information required 
for dossiers to suppor t 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 whic h might harm the competitive position of a certain 
third party and whic h should theref ore be treated as conf idential 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 offici al languages of the Union. 
Article 4 
Reception and exami nation of the technical dossier by the Commission 
The Commission shall ackn owledg e receip t of the technical dossier . 
It shall examine whether the technical dossier contains the information descr ibed 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 according ly. 
Article 5 
Conduct and completion of the risk assessment 
EFSA shall verify that the technical dossier compl ies with its document refer red 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 . 19.12.2018 L 323/8 Official Jour nal of the European Union EN     Following that verification, EFSA shall proceed with the risk assessment. 
Dur ing 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 ever y communication with the applicant. 
EFSA shall compl ete 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 necessar y, 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. 
Article 6 
Conf identiality 
For the purpose of this Regulation, the provisions laid down in Article 39 of Regulation (EC) No 178/2002 concer ning 
the conf identiality of information submitted by the applicant shall apply according ly. 
Article 7 
Entr y into force and application 
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union. 
It shall apply from 14 December 2019. 
This Regulation shall be binding in its entirety and directly applicable in all Member State s. 
Done at Brussels, 18 December 2018. 
For the Commission 
The President 
Jean-Claude JUNCK ER  19.12.2018 L 323/9 Official Jour nal of the European Union EN