EU Approval Status Update of 56 Substances
In June, the approval status of active pesticide substances in the European Union was updated frequently. The detailed approval status is as follow:
1. Isopyrazam
2. Bispyribac
3. Heptamaloxyloglucan
4. Paraffin oils
5. Sulfoxaflor
6. Prothioconazole, Propamocarb, Captan, Boscalid, SCLP, etc.
7. Bifenazate
1. Isopyrazam
According to Commission Implementing Regulation (EU) 2022/782, withdrawing the approval of the active substance Isopyrazam, amending the Annex to Commission Implementing Regulation (EU) No 540/2011. The announcement came into effect on June 8.
Reason for withdraw:
Commission Delegated Regulation (EU) 2022/692 consequently amended Annex VI to Regulation (EC) No 1272/2008 and classified Isopyrazam as toxic for reproduction category 1B.
The applicant neither provided any information to demonstrate negligible exposure nor any evidence that the conditions of Article 4(7) of Regulation (EC) No 1107/2009, concerning substances which are needed to control a serious danger to plant health that cannot be contained by other available means, are fulfilled.
Consequently, it is appropriate to withdraw the approval of Isopyrazam.
Transitional measures:
Member States shall withdraw authorisations for plant protection products containing Isopyrazam as active substance by September 8, 2022.
Grace period:
Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall expire by December 8, 2022.
2. Bispyribac
According to Commission Implementing Regulation (EU) 2022/808, amending the expiration of approval to July 31, 2022 of the active substance Bispyribac, amending the Annex to Commission Implementing Regulation (EU) No 540/2011. The announcement came into effect on June 13.
Reasons for revision:
In 2018, the re-evaluation of Bispyribac was not expected to be completed on schedule. The approval period of the active substance Bispyribac was extended from July 31, 2021 until July 31, 2023 by Commission Implementing Regulation (EU) 2018/1916.
However, on October 22, 2020, the applicant confirmed that it no longer supports the application for renewal of approval.
As the application for renewal was withdrawn, the extension of the approval period of this active substance, provided for by Implementing Regulation (EU) 2018/1916, is no longer justified. Therefore, a new expiry date should be set at the earliest date possible, while giving Member States sufficient time to withdraw authorisations for plant protection products containing that substance.
Therefore, the expiration of approval of Bispyribac is revised to July 31, 2022.
Influence:
As there is no further support for the re-evaluation of Bispyribac, the plant protection products will be banned by the EU after the expiration of Bispyribac, with a sales and distribution buffer period of not more than 6 months and an additional stock depletion period of not more than 1 year.
3. Heptamaloxyloglucan
According to Commission Implementing Regulation (EU) 2022/814, amending the expiration of approval to May 31, 2023 of the active substance Heptamaloxyloglucan, amending the Annex to Commission Implementing Regulation (EU) No 540/2011. The announcement came into effect on May 26.
Reasons for extend:
Due to the fact that the assessment of the active substance Heptamaloxyloglucan has been delayed for reasons beyond the control of the applicant, the approval of that active substance is likely to expire before a decision has been taken on its renewal. It is therefore necessary to extend its approval period to provide the time necessary to complete the assessment.
4. Paraffin oils
According to Commission Implementing Regulation (EU) 2022/800, amending the conditions of approval of the active substances Paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3, include the use as a fungicide in addition to the uses as an insecticide and acaricide, amending the Annex to Commission Implementing Regulation (EU) No 540/2011. The announcement came into effect on June 12.
Reasons for revision:
In accordance with Article 7(1) of Regulation (EC) No 1107/2009, on September 30, 2014, Total Fluids submitted an application to Greece, the rapporteur Member State, seeking an amendment to the conditions of approval of Paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3 in order to allow for their use as a fungicide. The application was found to be admissible by the rapporteur Member State.
It has been established with respect to one or more representative uses of at least one plant protection product containing paraffin oils CAS No 64742-46-7, CAS-No-72623-86-0 and CAS No 97862-82-3 that, when used as a fungicide, the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate to amend the specific provisions as laid down in the approval of paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS-No-97862-82-3 to include the use as a fungicide in addition to the uses as an insecticide and acaricide.
5. Sulfoxaflor
According to Commission Implementing Regulation (EU) 2022/686, amending the conditions of approval of the active substances Sulfoxaflor, uses in permanent greenhouses only, amending the Annex to Commission Implementing Regulation (EU) No 540/2011. The announcement came into effect on May 19.
Reasons for revision:
When Sulfoxaflor was approved for the first time, the applicant was required to submit information confirming a series of risks to bees from the use of the substance before August 18, 2017, and the applicant submitted the relevant confirmation information on time.
According to the assessment results of the confirmation information provided by the applicant, EFSA believes that the risk to bees caused by the use in permanent greenhouses is acceptable, but the risk assessment of honey for outdoor use has not been finalized.
Therefore, it cannot be concluded that the risk to bees from outdoor use is low, and the risk to bees from outdoor use of plant protection products containing Sulfoxaflor cannot be ruled out. Therefore, the approval conditions for Sulfoxaflor were revised to be limited to use in greenhouses.
Transitional measures:
Member States shall, where necessary, withdraw or amend authorisations for plant protection products containing sulfoxaflor as active substance by November 19, 2022 at the latest.
Grace period:
Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall expire by May 19, 2023 at the latest.
Active substance background:
Sulfoxaflor is a systemic insecticide which acts as an insect neurotoxin and is a member of a class of chemicals called sulfoximines which act on the central nervous system of insects.
Sulfoxaflor is a systemic insecticide, acts as a neurotoxin to affected insects, and kills through contact or ingestion.
Suitable for control of aphids, whiteflies, planthoppers, thrips, scale insects, etc.
It can effectively prevent pests that are resistant to neonicotinoid, pyrethroid, organophosphorus and carbamate pesticides. Once considered an alternative to high toxic to bee neonicotinoid insecticides, their use has also been limited due to uncertainty about the risks to bees.
6. Prothioconazole, Propamocarb, Captan, Boscalid, SCLP, etc.
According to Commission Implementing Regulation (EU) 2022/708, amending extension of the approval periods of the active substances Prothioconazole, Propamocarb, Captan, Boscalid, SCLP, etc., amending the Annex to Commission Implementing Regulation (EU) No 540/2011. The announcement came into effect on May 30.
These substances include:
Substances | Approval period will be extended until |
Flurochloridone | 31st May, 2023 |
Metam | 30th June, 2023 |
Aclonifen, Beflubutamid, Benthiavalicarb, Boscalid, Captan, Dimethomorph, Ethephon, Fluoxastrobin, Folpet, Formetanate, Metazachlor, Metribuzin, Milbemectin, Phenmedipham, Pirimiphos-methyl, Propamocarb, Prothioconazole, Proquinazid, S-metolachlor | 31st July, 2023 |
Acetic acid, Aluminium ammonium sulphate, Aluminium phosphide, Aluminium silicate, Calcium carbide, Cymoxanil, Dodemorph, 2,5-Dichlorobenzoic acid methylester, Ethylene, Extract from tea tree, Fat distillation residues, Fatty acids C7 to C20, Fish oil, Gibberellic acid, Gibberellins, Hydrolysed proteins, Iron sulphate, Magnesium phosphide, Metamitron, Plant oils/clove oil, Plant oils/rape seed oil, Plant oils/spear mint oil, Pyrethrins, Quartz sand, Repellents by smell of animal or plant origin/sheep fat, Straight Chain Lepidopteran Pheromones, Sulcotrione, Tebuconazole, Urea | 31st August, 2023 |
7. Bifenazate
According to Commission Implementing Regulation (EU) 2022/698, amending renewing the approval of the active substance Bifenazate, the restriction to use only in greenhouses, amending the Annex to Commission Implementing Regulation (EU) No 540/2011. The announcement came into effect on May 19.
Changes after re-evaluation:
Active substance content increased from ≥ 950 g/kg to ≥ 980 g/kg
Add related impurities toluene, set the limit ≤ 0.7 g/kg
Only uses on non-edible crops in permanent greenhouses shall be authorised.
Reasons for revision:
The restriction to use on non-edible crops will exclude dietary exposure of consumers and is required since the consumer risk assessment could not be finalised. As a high risk was identified to birds via long term exposure to Bifenazate, a restriction to use in greenhouses as defined in Article 3 of Regulation (EC) No 1107/2009 will ensure that birds are not exposed to Bifenazate. In addition, as the Authority identified a high risk to mammals for some representative uses and a high chronic risk to bees based on the available data, the restriction to use only in greenhouses will also prevent exposure to those non-target organisms as well as in drinking water.
The above information is excerpted from the Official Journal of the European Union.
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