Diario Oficial de la Unión Europea del 31/5/2023 - Sección Legislación
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Fuente: Diario Oficial de la Unión Europea - Sección Legislación
L 141/2
EN
Official Journal of the European Union
31.5.2023
6
For pendimethalin and spirotetramat, the Authority concluded that all requirements with respect to completeness of data submission were met and that the modifications to the MRLs requested by the applicants were acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. In so concluding, the Authority took into account the most recent data on the toxicological properties of the substances. Neither the long-term exposure to these substances via consumption of all food products that may contain them, nor the short-term exposure due to high consumption of the relevant products showed a risk that the acceptable daily intake or the acute reference dose is exceeded.
7
Based on the reasoned opinions of the Authority and taking into account the relevant factors listed in Article 142
of Regulation EC No 396/2005, it is appropriate to conclude that the proposed modifications to the MRLs fulfil the requirements of that article.
8
Fish oil and sheep fat were temporarily included in Annex IV to Regulation EC No 396/2005 pending the finalisation of their evaluation either under Council Directive 91/414/EEC 4 or under Regulation EC
No 1107/2009 of the European Parliament and of the Council 5, and pending the review of MRLs on those active substances in accordance with Article 12 of Regulation EC No 396/2005. In the context of applications for renewal of the approval of those active substances under Regulation EC No 1107/2009, the Authority issued conclusions on the peer review of the pesticide risk assessment of fish oil and sheep fat 6. Based on those conclusions, no MRLs are required for fish oil and sheep fat. Therefore, it is appropriate for those substances to remain in Annex IV to Regulation EC No 396/2005.
9
Regulation EC No 396/2005 should therefore be amended accordingly.
10
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1
Annexes II and IV to Regulation EC No 396/2005 are amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 30 May 2023.
For the Commission The President Ursula VON DER LEYEN
4 Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market OJ L 230, 19.8.1991, p. 1.
5 Regulation EC No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC OJ L 309, 24.11.2009, p. 1.
6 Conclusion on the peer review of the pesticide risk assessment of the active substance fish oil. EFSA Journal 2022;201:7079.
Conclusion on the peer review of the pesticide risk assessment of the active substance sheep fat. EFSA Journal 2022;201:7073.
