EU and GB approval changes (May-August 2024)

NEWS

EU and GB approval changes (May-August 2024)

EU and GB approval changes

COLEAD’s Regulation Monitoring covers both European Union (EU) and Great Britain (GB) approval changes. Note that EU approvals still apply in Northern Ireland. Great Britain is the mainland comprising England, Scotland and Wales.

The European Commission (EC) has recently published changes to 14 plant protection product (PPP) approvals within the EU, some of which are important for ACP horticulture. These include:

  • Extension of the approval period for amisulbrom and valifenalate
  • Withdrawal of approval of acibenzolar-S-methyl
  • Renewal of approval of active substance metconazole as candidate for substitution
  • Expiration of the approval for dodemorph and Trichoderma atroviride (formerly harzianum) strain IMI 206040

In addition, the EC has recently notified the WTO of its intention to withdraw the approval of the active substance metribuzin and the expiration of tritosulfuron.

The Health and Safety Executive (HSE) has recently published changes to 36 PPP approvals within GB, of which 12 are of importance for ACP horticulture and whose approvals in GB are being withdrawn.

 

How will ACP producers/exporters be affected?

Non-approval, withdrawal of approval or expiration of approval mean that EU/GB maximum residue levels (MRLs) are likely to be maintained or reduced to the limit of determination (LoD) which, in most cases, will mean that they cannot be used on crops for export to the EU/GB.

  • COLEAD now compiles a dashboard of ACP countries impacted by the recent changes of approvals in the EU and GB. Check it out here.

 

What should ACP producers/exporters do now?

If you currently use dodemorph,Trichoderma atroviride strain IMI 206040, or acibenzolar-S-methyl on crops destined for the EU market, or one of the withdrawn substances from GB on crops for the GB market, you need to look for alternatives, or ensure that current uses allow you to comply with the new MRLs (most likely at LoD), as soon as the change is communicated. If this is likely to cause you significant problems, and you fear being left without effective and available alternatives, please contact COLEAD at: network@colead.link.

We will keep you informed as more information becomes available.

Our news is a quarterly update designed to inform you of any changes introduced during the preceding three months. If you require more frequent updates on EU approval changes changes, we recommend that you visit our AGRINFO website and subscribe to the bi-monthly newsletter on EU regulations.

 

ACP countries potentially impacted by changes of EU and GB PPP approvals during the period May-August 2024

COLEAD has compiled a dashboard presenting registered products containing the active substances for which the approval is not renewed or withdrawn in the EU and in GB and their respective conditions of use in ACP countries. This aims to outline the ACP countries where these approval changes might have repercussions for export. It is based on information extracted from the latest national lists of registered plant protection products made available by 34 ACP countries (list available here).

Figure 1: Map of the potentially impacted ACP countries following the changes of approvals in the EU and GB

COLEAD is making all effort to provide you with relevant and updated information. If your country is not included in the 34 countries included in our review, we highly recommend reaching out to your national authorities to check which products might be affected by these changes.

 

Key changes of approval in the EU during the period May-August 2024

The EC has recently published changes to 14 plant protection product (PPP) approvals within the EU. In this News, ‘key active substances’ refers to those used/registered in one or more ACP countries on horticultural crops that are frequently exported regionally or internationally. While COLEAD makes every effort to provide comprehensive information about EU and GB PPP regulatory changes, it is possible that some PPPs or crops relevant to you are not included in our list of key substances/crops. We recommend that you review the following section, which gives details on all approval changes since the beginning of 2024, to check for any others that could affect you. If you see any PPP that you use on crops for export to the EU or GB in the lists below, we recommend that you check the regulation using the link provided.

 

Approval periods have been extended for the following key substances (new expiry dates):

  • Amisulbrom (Expiry date: 15 September 2026)
  • Valifenalate (Expiry date: 01 March 2027)

 

Withdrawal of the active substances acibenzolar-S-methyl

Acibenzolar-S-methyl is a preventative fungicide effective against various fungal pathogens, such as downy mildew and white rust, and is commonly used on leafy vegetables, tomatoes, and tobacco crops.

The European Commission (EC) has published Commission Implementing Regulation (EU) 2024/1696 concerning the withdrawal of approval of acibenzolar-S-methyl for use in the EU. This is due to concerns about the active substance’s endocrine-disrupting properties. Furthermore, the manufacturer submitting the application for renewal of the approval ceased to support the dossier and self-classified the substance as toxic for reproduction. Any grace period granted for use in the EU will expire by 10 July 2025. The withdrawal of approval is expected to lead to a reduction in the acibenzolar-S-methyl maximum residue levels (MRLs) to 0.01–0.05 mg/kg on all products in 2025.

 

Expiration of the approval of the active substance dodemorph and Trichoderma atroviride strain IMI 206040

The EC has published Commission Implementing Regulation (EU) 2024/1280 concerning the expiration of approval of various active substances for use in the EU, due to the absence of application for renewal and support from the manufacturer. Among these, two are key to ACP horticulture: dodemorph and Trichoderma atroviride strain IMI 206040, both expiring on 31 August 2024.

 

All PPP approval changes in the EU introduced in 2024

Table 1 shows all changes to PPP approvals introduced in the EU since the beginning of 2024.

If you require additional information or face particular problems as a result of these changes, please contact COLEAD at: network@colead.link .

 

Key changes of approval in GB during the period May-August 2024

Since the beginning of 2024, approval status have been updated for 36 plant protection product (PPP) approvals within GB, of which 12 are considered key for ACP horticulture.

 

Withdrawal of the approvals for the following12 key active substances:

  • Carboxin (withdrawn on 31 May 2024)
  • Cyproconazole (withdrawn on 31 May 2024)
  • Diethofencarb (withdrawn on 31 May 2024)
  • Mancozeb (withdrawn on 31 May 2024)
  • Myclobutanil (withdrawn on 31 May 2024)
  • Famoxadone (withdrawn on 30 June 2024)
  • Milbemectin (withdrawn on 31 July 2024)
  • Profoxydim (withdrawn on 31 July 2024)
  • Indoxacarb (withdrawn on 31 August 2024)
  • Aluminium sulphate (withdrawn on 31 August 2024)
  • Flutriafol (withdrawn on 31 August 2024)
  • Hydrolysed proteins (withdrawn on 31 August 2024)

 

All PPP approval changes in GB since the beginning of 2024

Table 2 shows all changes to PPP approvals introduced in GB since the beginning of 2024.

 

Proposed future approval changes

All draft regulations must be notified either to the WTO Sanitary and Phytosanitary Committee (SPS) or Technical Barriers Committee (TBT) for a commenting period of 60 days before they are adopted. This provides an important opportunity for countries to comment on the proposed changes, and to seek an amendment if a change is likely to have a significant impact on exports. To provide feedback stakeholders should contact their national WTO contact point .

Table 3 shows recent WTO notifications of draft regulations that propose further changes to EU active substance approvals.

 

References

Lewis, K.A., Tzilivakis, J., Warner, D. and Green, A. (2016). An international database for pesticide risk assessments and management. Human and Ecological Risk Assessment: An International Journal, 22(4): 1050-1064. DOI: 10.1080/10807039.2015.1133242

 

This publication has been developped by the Fit For Market Plus programme, implemented by COLEAD within the framework of Development cooperation between the Organisation of African, Caribbean and Pacific States (OACPS), and the European Union (EU).

This publication has been produced with the financial support of the EU and the OACPS. Its contents are the sole responsibility of COLEAD and can under no circumstances be regarded as reflecting the position of the EU or the OACPS.