EU approval not renewed for three key PPPs and other changes notified to WTO

The European Commission (EC) has recently issued notifications of changes to plant protection product (PPP) approvals within the European Union (EU). Approval was not renewed for three PPPs that are important to African, Caribbean and Pacific (ACP) horticulture: alpha-cypermethrin, mancozeb and pencycuron. The EU also notified the World Trade Organization (WTO) of its intention not to renew three key PPPs: indoxacarb, famoxadone and abamectin.

In this news, ‘key active substances’ refers to those used/registered in one or more ACP countryies on horticultural crops that are frequently exported regionally or internationally.

COLEACP makes every effort to digest the information issued from the EC, but it is possible that some of your PPPs are not included in our list of key substances. This news also summarises all EU PPP approval changes introduced to date in 2021 and in 2020. If you see a relevant PPP for your activity within the lists below, we invite you to check the complete regulation using the link provided.

Alpha-cypermethrin

Alpha-cypermethrin is an insecticide for control of chewing and sucking insects in a wide range of crops.

On 18 May 2021 the EC published Implementing Regulation (EU) 2021/795. The authorisation was withdrawn in the EU on 7 June 2021 and the use of this insecticide in the different EU Member States will be withdrawn on 7 December 2021 after a transition (grace) period.

Following the end of the grace period, the EC is expected to take actions to reduce the maximum residue levels (MRLs) to the limit of determination (LoD), which in most cases means that the PPP can no longer be used on crops for export to the EU. The timeline for the lowering of the MRLs has not yet been communicated. Updated information will be issued as soon as it becomes available.

Mancozeb

Mancozeb is a commonly used fungicide for control of a wide range of pathogens including blights, leaf spots, scabs and rusts on crops.

The EC published Implementing Regulation (EU) 2020/2087 in December 2020. As of 5 January 2021, mancozeb is no longer approved as an active substance in the EU (see news from November 2020). The grace period for farmers to use up stocks of products with mancozeb in the EU ends on 4 January 2022.

Normally the MRLs would be lowered to the LoD at the end of this grace period. However, because the MRLs for mancozeb are grouped with those for all dithiocarbamates, which are currently under review, the MRLs cannot be lowered specifically for mancozeb without affecting other substances in the dithiocarbamate group (maneb, metiram, propineb, thiram and ziram).

The European Food Safety Authority (EFSA) started an independent MRL review for the dithiocarbamate group (including mancozeb) on 15 December 2020. The ‘Overview of the MRL review progress under Article 12 of Regulation (EC) No 396/2005’ was updated in July 2021 and indicates a delay in the release of the reasoned opinion, which (initially expected in December 2021) is now expected on 2 March 2022.

After the reasoned opinion is issued, the procedure to reach publication on lowering an MRL generally takes approximately 3–4 months. The MRL is then usually applied 20 days later, followed by a grace period of (normally) 6 months. Under this scenario, the MRL would come into force at the end of November 2022.

Based on these estimations, COLEACP predicts that mancozeb MRLs are not likely to be lowered before mid-2022. However, this is not definite, and the situation may change, particularly as the grace period can be shortened, and nothing has yet been published by the EC regarding the timeline.

Updated information will be issued as soon as it becomes available.

Pencycuron

Pencycuron is a fungicide used mainly to control diseases caused by Rhizoctonia solani and Pellicularia spp. on a range of crops.

The EC had extended the approval periods for a range of substances, including pencycuron to allow sufficient time for their reassessment. However, the PPP manufacturers involved have confirmed that they no longer support the renewal of approval for these active substances. As a result, the extensions of the approval periods are no longer justified.

On 6 November 2020 the EC published Implementing Regulation (EU) 2020/1643, setting the date for the expiration of approval of pencycuron in the EU to 31 May 2021 (see news from November 2020).

It is expected that the EC will lower the MRLs of this substance at the end of the maximum grace period (18 months). However, this is not definite as no information has been published by the EC, and the situation may change. Updated information will be issued as soon as it becomes available.

All PPP approval changes introduced in 2021

Table 1 shows all changes to PPP approvals introduced in Commission Implementing Regulations since the start of 2021.

In addition to the changes presented above, please note in particular the following changes to the list of candidates for substitution (CfS):

• etoxazole was renewed from 1 February 2021;
• propoxycarbazone was deleted from the list of CfS since 9 August 2021; and
• cypermethrine renewal was notified to the WTO on 30 July 2021.

If you require additional information, or face particular problems as a result of these changes, please contact COLEACP at: network@coleacp.org.

All PPP status changes introduced in 2020

Table 2 presents a review of PPP status changes introduced in 2020. If you require additional information, or face particular problems as a result of these changes, please contact COLEACP at: network@coleacp.org.

Early notification of approval change

The World Trade Organization (WTO) Technical Barrier to Trade (TBT) notifications advise that an active ingredient is subject to a proposed non-renewal or modification of condition of approval for use in the EU (usually linked to human or environmental risks). This is not necessarily indicative of the final EU decision, as further Committee work is done by the EC and EU Member States after notification, which can change the proposal.

The draft regulation should be notified to the WTO Technical Barriers to Trade- Information Management System (TBT IMS) for a commenting period of 60 days.

The publication of the definitive regulation may take a significant period of time after the WTO consultation has been completed. However, this is an opportunity to become informed in advance on foreseen regulation changes and ensure a smooth transition when the new text comes into force (early preparation). It is also the opportunity to submit concerns on potential difficulties (trade barriers) related to the proposed changes. For WTO member countries, comments can be submitted via their National Notification Authority.

Table 3 presents WTO notifications of Draft Commission Regulation with regard to active substance approval, potentially affecting horticulture products.

Note that the EU has notified its intention not to renew three key PPPs:

• indoxacarb (notification: 2 August 2021; open for comments until 1 October 2021);
• famoxadone (notification: 19 March 2021); and
• abamectin (notification: 15 March 2021).