STC Number - 469

EU Regulation on high risk plants (Regulation (EU) 2016/2031)

Maintained by: European Union
Raised by: Israel
Supported by: Canada; Kenya; United States of America
First date raised: November 2019 G/SPS/R/97/Rev.1 paras. 3.14-3.19
Dates subsequently raised: June 2020 (G/SPS/R/99 paras. 3.296-2.305)
Number of times subsequently raised: 1
Relevant documents: G/SPS/N/EU/272 G/SPS/N/EU/272/Add.1 G/SPS/N/EU/272/Add.2 G/SPS/N/EU/272/Add.3 G/SPS/GEN/1748
Products covered: 06 Live trees and other plants; bulbs, roots and the like; cut flowers and ornamental foliage
Primary subject keyword: Plant Health
Keywords: Plant health; Sufficiency of scientific evidence; Risk assessment; Appropriate level of protection
Status: Not reported
Date reported as resolved:

Extracts from SPS Committee meeting summary reports

In November 2019, Israel raised a concern regarding EU Regulation 2016/2031 notified in G/SPS/N/EU/272, dealing with importation of high-risk plants, which would enter into force on 14 December 2019. The European Union had sent a clarification letter to all IPPC contact points in May 2019, which stated that introduction of plants listed as high-risk plants from non-EU countries would be allowed only if (1) that country had submitted a demand for the importation together with the technical dossier; (2) the dossier had been assessed; and (3) the European Union had decided whether and under which conditions the prohibition would be lifted.

Israel remarked that listing of the specific plant genera lacked scientific justification and imposition of the ban was disproportionate to actual risk, rendering the EU measure inconsistent with Articles 2.2, 5.4 and 5.8 of the SPS Agreement. Israel further regretted that the European Union was unable to carry out the risk analysis in an expedient manner. EFSA's information requirements increased the burden and necessitated multiple additional submissions of information, some of which did not appear relevant to assessment of risk emanating from Israel, in contradiction with Annex C(1)(c) of the SPS Agreement. Israel was exporting 12 of the plants on the high-risk plant list to the European Union, and information dossiers on five plant genera had been submitted, but the assessment had not been completed on any of the dossiers. The uncertainty imposed by the prospective ban had severely affected Israel's producers and disrupted ongoing trade. Israel urged the European Union to reconsider the letter sent to IPPC contact points and perform risk assessments on plants while continuing ongoing trade.

Canada expressed its concern about the approaching deadline of 14 December, when the EU Regulation would come into force. Canada had been working with the European Union to seek clarification on the process of continuing trade beyond the deadline, as well as information required by the European Union for development of a comprehensive dossier. Canada called for additional time to be allotted for further bilateral consultations with other Members before any trade-restrictive measures would be put into place. Canada suggested that the 14 December deadline be maintained only for submission of information; then a transition period of at least six months should allow for trade to continue, during which the European Union would undertake comprehensive dossier reviews, complete risk assessments and a collaborative consultation process.

The United States shared the concern. The US statement is contained in G/SPS/GEN/1748.

Kenya also invited the European Union to consider granting a longer transition period to complete pest risk analyses under the said EU measure, particularly in the case of developing countries.

The European Union remarked that Regulation 2016/2031 was necessary to ensure the appropriate level of protection in the European Union. The measure had been adopted after a preliminary assessment had revealed that some plant species posed high risks. The European Union highlighted the efforts made to disseminate information on the new plant health regime and minimize trade disruption. EFSA had published guidance in October 2018 and organised two webinars in 2019 to assist national authorities in preparation of dossiers. In response to Israel, the European Union clarified that the first two dossiers that had been submitted, in relation to Albizia julibrissin and Robinia pseudoacacia, were still under review.

In June 2020, Israel provided the following statement: In the previous SPS meeting in November, Israel raised its concerns as regards the EU regulation on so-called high-risk plants. This regulation, which has now come into force, has banned the import of 35 plant genera and two species into the European Union and has thus stopped on-going trade, without the European Union submitting any scientific evidence of the phytosanitary risks behind the selection of this list of plants. In September 2018, the European Union organized a meeting in Brussels with agricultural attach├ęs during which Members were urged to submit dossiers on these high-risk plants as soon as possible (but not before January 2019). It was clear to all the delegates that if they acted accordingly and EFSA concluded their analysis on time, a ban would be avoided. Unfortunately, this has not been the case. Israel was the first country to submit two dossiers in January 2019. EFSA assessments of these two dossiers concluded in November 2019 and February 2020 respectively. Although in one case over half a year has passed since the conclusion of EFSA's risk assessment, the lifting of the ban imposed on 14 December 2019 has yet to be raised. On a positive note, the European Union just a week ago, provided Israel with a draft legislation for the re-opening of trade on two of these commodities. This we very much appreciate. Unfortunately, these draft measures do not appear to take into account EFSA findings on the level of risk identified. As this is a new process for both the European Union and its trading parties, we beseech the European Union to provide further guidance on its appropriate level of protection and how new import measures relate to the levels of risk identified by EFSA. We would like to reiterate that trade of these plants with the European Union had been ongoing for many years without any phytosanitary problems. The ban, which is still in place, and the continued uncertainty of not knowing when trade may recommence and under what circumstances, severely affects our producers. It is also in direct conflict with Article 5.4 of the SPS Agreement which states that Members should, when determining the appropriate level of sanitary or phytosanitary protection, take into account the objective of minimizing negative trade effects. While we acknowledge the progress made, we continue to urge the European Union to reconsider its current policy with the aim of bringing it in line with the SPS Agreement. We believe that ongoing trade should not be banned, even temporarily, unless there is specific justification to do so. Where this is not the case, risk assessments should be performed while having minimal effects on ongoing trade i.e. by carrying out the risk assessments while trade continues and making appropriate changes in import requirements per risks identified thereafter. Failing this, we continue to urge the European Union to conclude the process without any further delays.

The European Union provided the following response: The European Union would like to take this opportunity to recall some previous statements in the WTO SPS Committee and provide Members with an update on the state of play of the implementation of its regulatory measures concerning high-risk plants. The new EU plant health regime, Regulation (EU) No. 2016/2031, which entered into force in December 2019, maintains a generally open system but increases the level of phytosanitary protection of the European Union. A preliminary assessment conducted by the European Union authorities revealed that a limited number of plants and plant products, listed in Regulation (EU) No. 2018/2019, posed unacceptable risks. As a result, the introduction of these high-risk plants into the European Union can only take place following a risk assessment carried out by the European Food Safety Authority (EFSA) based on a technical dossier submitted by the interested exporting countries. Once the risk assessment is completed, the European Commission adopts an implementing measure detailing the relevant import requirements. The European Union has made significant efforts to disseminate information on the new plant health regime and minimize trade disruption. The European Commission held meetings in Brussels with non-EU countries to provide explanations and address possible concerns. EFSA has published a technical report detailing the information necessary for technical dossiers and organised two webinars to assist national authorities in the preparation of dossiers. In addition, the European Union has notified every draft regulatory measure and provided detailed responses to all the comments received. As of today, the European Union has received 53 applications and EFSA has concluded six risk assessments. The system is now operational and processes all applications in accordance with the established rules and procedures. As regards the specific case of Israel, out of five applications, EFSA has concluded the assessment of the first two (Albizia julibrissin and Robinia pseudoacacia) and the third one is for adoption in the plenary meeting of the EFSA Panel in July 2020. The European Union has also concluded its internal consultation procedures and sent draft legal acts to Israel for a five-day consultation. The deadline for the consultation was 23 June 2020. The European Commission expects to adopt the corresponding legal acts very soon. Publication in the Official Journal of the European Union will take place a few days after adoption. The European Union would like to reassure Israel and all the other WTO Members that it is making every effort to speed up the implementation of these regulatory measures, which are necessary to ensure the appropriate level of phytosanitary protection in its territory.