EU and GB approval changes (April-June 2023)
- 28/07/2023
- Posted by: Gaetan Dermien
- Category: Uncategorized
| EU and GB approval changes Following the United Kingdom (UK) departure from the European Union (EU), COLEAD’s Regulation Monitoring now covers both EU and Great Britain (GB) approval changes, enabling us to keep COLEAD members and partner-beneficiaries up-to-date on both regulatory frameworks. 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 52 plant protection product (PPP) approvals within the EU, some of which are important for ACP horticulture. These include: – Extension of the approval period for 12 PPPs The EC has recently notified the WTO of its intention not to renew the approval of S-metolachlor. GB published its decision to withdraw the active substance alpha-cypermethrin.
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 can not be used on crops for export to the EU/GB.
What should ACP producers/exporters do now? If you currently use oxamyl or S-metalochlor on crops destined for the EU markets, or alpha-cypermethrin on crops for GB, 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. |
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 2023, 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 itself using the link provided.
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 MRL changes, we recommend that you visit our AGRINFO website and subscribe to the bi-monthly newsletter on EU regulations.
AGRINFO is a programme funded by the European Union and implemented by COLEAD (Committee Linking Entrepreneurship-Agriculture-Development). It provides an online information service that keeps you up-to-date on evolving EU policies, regulations and standards with potential impacts on agri-food value chains. It provides clear summaries for third-country partners about the “what, why and when” of recent and upcoming changes, and actions needed to adjust to new rules.
Key changes of approval in the EU during the period April-June 2023
The EC has recently published changes to 52 plant protection product (PPP) approvals within the EU, including changes to 12 actives substances that are of importance for ACP horticulture.
Extension of the approval periods for the following key substances:
- ametoctradin (Expiry date: 31 December 2025)
- boscalid (Expiry date: 15 April 2026)
- captan (Expiry date: 15 November 2025)
- dimetomorph (Expiry date: 15 February 2025)
- etephon (Expiry date: 15 November 2024)
- fluopicolide (Expiry date: 31 August 2026)
- fluoxastrobin (Expiry date: 15 June 2025)
- folpet (Expiry date: 15 February 2025)
- mandipropamid (Expiry date: 31 December 2025)
- metalaxyl (Expiry date: 30 September 2026)
- metaldehyde (Expiry date: 31 August 2026)
- pirimiphos-methyl (Expiry date: 15 June 2025)
Non-renewal of the active substance oxamyl
Oxamyl is a soil-applied nematicide and insecticide used to control chewing and sucking insects on a wide range of crops.
The European Commission (EC) has published Commission Implementing Regulation (EU) 2023/741 concerning the non-renewal of approval of the active substance oxamyl in the EU. Any grace period granted for use in the EU will expire by 30 September 2023. This relatively rapid withdrawal from the EU market might mean that a review of the MRLs is initiated before the end of 2023; we will provide an update on this as soon as the information becomes available. Any grace period granted for use in the EU will expire on 30 September 2023, resulting in a relatively rapid withdrawal of this substance from the EU market. As a consequence, a review of Maximum Residue Limits (MRLs) for oxamyl have been reviewed, and a draft regulation on the subject has been notified to the World Trade Organisation (WTO).
All PPP approval changes in the EU introduced in 2023
Table 1 shows all changes to PPP approvals introduced in the EU since the beginning of 2023.
If you require additional information, or face particular problems as a result of these changes, please contact COLEAD at: network@colead.link.
Changes of approval in GB
The Health and Safety Executive (HSE) has recently introduced changes to 180 plant protection product (PPP) approvals within GB, including 179 extensions of apporvals and the withdrawal of approval of alpha-cypermethrin.
For more information on GB approval changes, download the GB approvals register here.
Withdrawal of the active substance alpha-cypermethrin
Alpha-cypermethrin is an insecticide for control of chewing and sucking insects in a wide range of vegetables and cereals crops (asparagus, brassicas, cucurbits, leafy crops, barley, oats, and more).
On 06 April 2023, HSE published its decision to withdraw the approval of alpha-cypermethrin in GB. This decision enters into force on 06 April 2022. Grace periods are set for sale and suppy up to the 6 October 2023, and for storage, disposal and use until 6 October 2024.
Table 2 shows all changes to PPP approvals introduced in GB since the beginning of 2023.
Further proposed approval changes
Table 3 shows WTO notifications of draft regulations of active substance approval changes.
Table 3. World Trade Organization (WTO) notifications of EU decisions concerning active substance approvals potentially affecting horticulture exports, in accordance with Regulation (EC) 1107/2009 and amending Regulation (EU) 540/2011.
| Active substance | Key substance* | Active substance status | Publication | Deadline to submit comment | Link |
| S-Metolachlor | non-renewal | 24/05/2023 | 23/07/2023 | Link |
*Key active substances are those used/registered in one or more African, Caribbean and Pacific (ACP) country on horticultural crops that are frequently exported regionally or internationally.
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 notifying country or region (usually linked to human or environmental risks).
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 feed back into the regulatory process to seek an amendment if the change is likely to have a significant impact on exports. When this is the case, stakeholders should contact their national WTO contact point in order to provide their feedback.
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.
