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Draft Commission Implementing Regulation concerning the non-renewal of approval of the active substance indoxacarb, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Implementing Regulation (EU) No 540/2011 (Text with EEA relevance): (...)

In order for an active substance to be approved in accordance with Regulation (EC) No 1107/2009 (concerning the placing of plant protection products on the market), it must be demonstrated that the substance is not harmful to human health, animal health or the environment. (...)

The EFSA identified a critical concern in relation to the high long-term risk to wild mammals for all representative uses and, additionally, a high risk to consumers and workers for the representative use in lettuce and a high risk to bees for the representative use in maize, sweet corn and lettuce for seed production. Furthermore, there are several areas of the risk assessment not finalised due to lack of data in the dossier. These concerns mean that indoxacarb does not meet the approval criteria as outlined in Regulation (EC) No 1107/2009 and cannot be approved currently. (...)

Commission Implementing Regulation (EU) 2021/1409 of 27 August 2021 concerning the authorisation of phytomenadione as a feed additive for horses (Text with EEA relevance): (...)
The European Food Safety Authority ('the Authority') concluded in its opinion of 17 March 2021 that, under the proposed conditions of use, phytomenadione does not have adverse effects on animal health, consumer safety or the environment. (...)

Commission Implementing Regulation (EU) 2021/1425 of 31 August 2021 concerning the authorisation of manganese chelate of lysine and glutamic acid as feed additive for all animal species (Text with EEA relevance): (...)
The European Food Safety Authority ('the Authority') concluded in its opinions of 10 January 2020 and 27 January 2021 that, under the proposed conditions of use, manganese chelate of lysine and glutamic acid does not have an adverse effect on animal health, consumer safety or the environment. (...)

Draft Commission Implementing Regulation amending Implementing Regulation (EU) 2016/1141 to update the list of invasive alien species of Union concern: The proposed draft Regulation is a new legislative act which updates the list of invasive alien species of Union concern in implementation of the Regulation (EU) No 1143/2014 of the European Parliament and of the Council on the prevention and management of the introduction and spread of invasive alien species. The list was established by Commission Implementing Regulation (EU) No 2016/1141, and was updated by Commission Implementing Regulation (EU) No 2017/1263 and by Commission Implementing Regulation (EU) No 2019/1262. The notified proposal for a draft Regulation adds further species to the list.

Draft Commission Implementing Regulation withdrawing the approval of the active substance isopyrazam in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, amending Commission Implementing Regulation (EU) No 540/2011 and repealing Implementing Regulation (EU) No 1037/2012: (...)

In order for an active substance to be approved in accordance with Regulation (EC) No 1107/2009 (concerning the placing of plant protection products on the market), it must be demonstrated that the substance is not harmful to human health, animal health or the environment. (...)

Commission Implementing Regulation (EU) 2021/2092 concerning the authorisation of potassium diformate as a feed additive for pigs for fattening and weaned piglets (Text with EEA relevance): (...) The European Food Safety Authority ('the Authority') concluded in its opinion of 5 May 2021 that, under the proposed conditions of use, potassium diformate does not have adverse effects on animal health, consumer safety or the environment. (...)

Commission Implementing Regulation (EU) 2021/2090 of 25 November 2021 concerning the denial of authorisation of titanium dioxide as a feed additive for all animal species (Text with EEA relevance): (...)
The European Food Safety Authority ('the Authority') noted in its opinion of 5 May 2021 that it could not conclude on the safety of titanium dioxide for the target species, consumers and environment, given the absence of specific data related to its use as a feed additive and considering that the genotoxicity of particles of titanium dioxide could not be ruled out, raising potential concerns on the safety of the additive for the target species (especially for long-living animals and reproductive animals), consumers and users. (...)

Commission Implementing Regulation (EU) 2021/2093 of 29 November 2021 concerning the authorisation of disodium 5'-guanylate as a feed additive for all animal species (Text with EEA relevance): (...)
The European Food Safety Authority ('the Authority') concluded in its opinion of 5 May 2021 that, under the proposed conditions of use, disodium 5'-guanylate does not have adverse effects on animal health, human health or the environment. The Authority further concluded that disodium 5'-guanylate is efficacious to contribute to the flavour of feed. (...)

Commission Implementing Regulation (EU) 2021/2080 of 26 November 2021 concerning the authorisation of L-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli NITE SD 00268 as a feed additive for all animal species except finfish (Text with EEA relevance): (...)
The European Food Safety Authority ('the Authority') concluded in its opinion of 5 May 2021 that, under the proposed conditions of use, L-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli NITE SD 00268 does not have an adverse effect on animal health, consumers safety or the environment. (...)

Commission Implementing Regulation (EU) 2021/2076 of 26 November 2021 concerning the authorisation of L-tryptophan produced by Escherichia coli KCCM 80210 as a feed additive for all animal species: (...) The European Food Safety Authority ('the Authority') concluded in its opinion of 27 January 2021 that, under the proposed conditions of use, L-tryptophan produced by Escherichia coli KCCM 80210 does not have an adverse effect on the health of non-ruminant animals, consumer safety or the environment. To be safe for ruminants, the L-tryptophan should be protected against degradation in the rumen. (...)