(1)

On 6 April 2022, the European Parliament and Council adopted Decision (EU) 2022/563 (2) providing the Union’s macro-financial assistance to the Republic of Moldova (Moldova) for an amount of EUR 150 000 000, in medium term-loans and in grants. The Memorandum of Understanding (MOU) setting out the Union’s macro-financial assistance entered into force on 18 July 2022 and that assistance will be available for a period of two and a half years. On 1 August 2022, following the successful fulfilment by Moldova of all policy actions agreed with the Union in the MOU, the first instalment of EUR 50 000 000 was disbursed.

(2)

Decision (EU) 2022/563 providing the Union’s macro-financial assistance was adopted in parallel with the International Monetary Fund (IMF) programme for Moldova of 20 December 2021 under the Extended Credit Facility/Extended Fund Facility arrangement for the amount of USD 564 000 000. On 11 May 2022, as a result of the growing financing needs stemming largely from the effects of the war in Ukraine on the Moldovan economy, the IMF adopted a decision to increase the arrangement by USD 267 000 000. On 9 January 2023, the IMF announced that Moldova had successfully undergone the second programme review, and provided for the immediate disbursement of a further USD 27 000 000 to Moldova under the arrangement.

(3)

The Union’s indicative allocation for Moldova under the European Neighbourhood Instrument was EUR 518 150 000 for the 2014-2020 period, including budgetary support and technical assistance. The single support frameworks for the 2014-2017 and 2017-2020 periods identified the priority sector for cooperation with Moldova funded by the European Neighbourhood Instrument for the previous budgetary period. The priorities for the 2021-2027 period are set out in the new multiannual indicative programme, which has been prepared in close consultation with all relevant stakeholders.

(4)

Given that there is still a significant residual external financing gap in Moldova’s balance of payments for 2023, over and above the resources provided by the IMF and other multilateral institutions, it is necessary to increase the Union’s macro-financial assistance provided to Moldova in accordance with Decision (EU) 2022/563. That increase is, under the current exceptional circumstances, considered to be an appropriate response to Moldova’s request for support to its economic stabilisation, in conjunction with the IMF programme. The Union’s macro-financial assistance would support the economic stabilisation and the structural reform agenda of Moldova, supplementing resources made available under the IMF’s financial arrangement.

(5)

The determination of the amount of the Union’s increased macro-financial assistance is based on an updated quantitative assessment of Moldova’s residual external financing needs, and takes into account its capacity to finance itself with its own resources, in particular the international reserves at its disposal. The determination of the amount of the assistance also takes into account expected financial contributions from multilateral donors, including the IMF and the World Bank, and the need to ensure fair burden sharing between the Union and other donors, as well as the pre-existing deployment of the Union’s other external financing instruments in Moldova and the added value of the overall Union involvement.

(6)

The increase of the Union’s macro-financial assistance should be subject to additional economic policy conditions, to be added to the existing MOU which should, as a consequence, be amended accordingly. In addition, it is necessary to lay down the detailed financial terms of the Union’s macro-financial assistance in an addendum to the loan agreement and to the grant agreement that were signed on 22 June 2022 by the Commission and Moldova.

(7)

Decision (EU) 2022/563 should therefore be amended accordingly,

(1)

in Article 1, paragraph 1 is replaced by the following:

(2)

Article 4 is amended as follows:

(1)

Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Türkiye’s application to register the name ‘Gemlik Zeytini’ was published in the Official Journal of the European Union (2).

(2)

As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Gemlik Zeytini’ should therefore be entered in the register,

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such an authorisation.

(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of 6-phytase produced by Trichoderma reesei CBS 146250. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(3)

The application concerns the authorisation of the preparation of 6-phytase produced by Trichoderma reesei CBS 146250 as a feed additive for all poultry species and all pigs, to be classified in the category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 27 September 2022 (2) that the genetic modification of the production strain Trichoderma reesei CBS 146250 does not give rise to safety concerns, that the preparation of 6-phytase is safe for all poultry species and all pigs at the proposed conditions of use, and that its use as a feed additive does not give rise to concerns for consumer health and the environment. It also concluded that the preparation is considered a respiratory sensitiser, due to the proteinaceous nature of the active substance, and stated that in the absence of data it could not conclude on the potential of the additive to be irritant to eyes or skin. The Authority further concluded that the preparation is efficacious in increasing the phosphorus utilisation at the proposed conditions of use. It did not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(5)

The assessment of the preparation of 6-phytase produced by Trichoderma reesei CBS 146250 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised. The Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive.

(6)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(1)

The use of a preparation of carvacrol, thymol, D-carvone, methyl salicylate and L-menthol as a feed additive for chickens for fattening, chickens reared for laying and minor poultry species reared for laying was authorised by Commission Implementing Regulation (EU) 2020/996 (2).

(2)

The Annex to Implementing Regulation (EU) 2020/996 erroneously provides for the description of the functional group “other zootechnical additives (improvement of zootechnical parameters)”. The opinion of the European Food Safety Authority (“the Authority”) of 15 May 2019 (3) stated that the additive has the potential to increase growth performance in chickens for fattening, chickens reared for laying and minor poultry species reared for laying. The term “zootechnical” is too generic and may encompass different functions, while not expressing the specific effects of the additive. Therefore, in order to be in line with the opinion of the Authority, the functional group of the feed additive should refer to the improvement of performance parameters.

(3)

Implementing Regulations (EU) 2020/996 should therefore be corrected accordingly.

(4)

Considering that the functional group should appear on the label of the feed additive, of the premixtures and compound feed containing it, it is necessary to provide for a transitional period allowing feed business operators to make the necessary adaptations to the labels.

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such an authorisation.

(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of endo-1,4-beta-xylanase, endo-1,4-beta-glucanase and xyloglucan-specific endo-beta-1,4-glucanase produced by Trichoderma citrinoviride DSM 33578. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(3)

That application concerns the authorisation of the preparation of endo-1,4-beta-xylanase, endo-1,4-beta-glucanase and xyloglucan-specific endo-beta-1,4-glucanase produced by Trichoderma citrinoviride DSM 33578 as a feed additive for all poultry species, ornamental birds and piglets, to be classified in the category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 23 November 2022 (2) that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase, endo-1,4-beta-glucanase and xyloglucan-specific endo-beta-1,4-glucanase produced by Trichoderma citrinoviride DSM 33578 does not have adverse effects on animal health, consumer safety or the environment. The Authority also concluded that the preparation should be considered a respiratory sensitiser but, in the absence of data, could not conclude on the irritancy potential of the preparation to skin. The Authority also concluded that the preparation of endo-1,4-beta-xylanase, endo-1,4-beta-glucanase and xyloglucan-specific endo-beta-1,4-glucanase produced by Trichoderma citrinoviride DSM 33578 has the potential to be efficacious in poultry for fattening, poultry reared for laying and reared for breeding, and ornamental birds. However, owing to the lack of sufficient data, the Authority could not conclude on the efficacy of the preparation for laying hens and weaned piglets. The Authority considered that there was no need for specific requirements of post-market monitoring. It also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(5)

The assessment of the preparation of endo-1,4-beta-xylanase, endo-1,4-beta-glucanase and xyloglucan-specific endo-beta-1,4-glucanase produced by Trichoderma citrinoviride DSM 33578 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied for poultry for fattening, poultry reared for laying and reared for breeding, and ornamental birds. Accordingly, the use of that preparation should be authorised for those animal species and categories. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive.

(6)

It has been proposed to, and accepted by, the applicant to submit supplementary information addressing the shortcomings identified in the Authority’s opinion concerning the efficacy of the preparation for laying hens and weaned piglets.

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10(2) of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

(2)

The preparation of Saccharomyces cerevisiae CNCM I-1077 was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for dairy cows and cattle for fattening by Commission Regulation (EC) No 1200/2005 (3). That preparation was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1), point (b), of Regulation (EC) No 1831/2003.

(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003, in conjunction with Article 7 thereof, an application was submitted for the authorisation of the preparation of Saccharomyces cerevisiae CNCM I-1077 as a feed additive for dairy cows and cattle for fattening. In accordance with Article 7 of Regulation (EC) No 1831/2003, another application was submitted for the authorisation of a new use of that preparation as a feed additive for minor ruminant species and camelids. Those applications requested that additive to be classified in the additive category ‘zootechnical additives’ and in the functional groups ‘digestibility enhancers’ and ‘gut flora stabilisers’ and were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinions of 4 July 2017 (4) and 29 June 2022 (5) that, under the proposed conditions of use, the preparation of Saccharomyces cerevisiae CNCM I-1077 is safe for the target animals, the consumers and the environment. It also concluded that the preparation is not a skin irritant or sensitiser but is an eye irritant, and that inhalation exposure is unlikely. The Authority concluded that the preparation has a potential to improve the performance of cattle for fattening when supplied at a minimum dose approximating to 6 × 108 CFU/kg complete feed, while also noting that two in vivo studies showed a positive effect on the growth performance of the cattle supplied with the additive at a minimum dose of 5 × 108 CFU/kg complete feed. It extended this conclusion to minor ruminant species and camelids reared for meat production. The Authority could not conclude, based on the data provided by the applicant, on the efficacy of that additive for dairy cows, but noted that the preparation showed a positive effect on performance in dairy cows in three studies. The Authority also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(5)

The applicant withdrew the application on 24 February 2023 for the authorisation of the preparation under the functional group ‘digestibility enhancers’ and for its use for minor dairy ruminant species and dairy camelids.

(6)

Considering the overall data provided, the already demonstrated capacity of the additive to improve the performance parameters in other dairy ruminants, namely dairy goats and dairy sheep, and the long-standing history of marketing and use of that preparation, the Commission considers that the conditions for the demonstration of the efficacy are met for cattle for fattening, minor ruminant species and camelids reared for meat production supplied with the additive at a minimum dose of 5 × 108 CFU/kg complete feed, and for dairy cows supplied with the additive at a minimum dose of 4 × 108 CFU/kg complete feed.

(7)

The assessment of the additive shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised. The Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive.

(8)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the preparation concerned which are intended for dairy cows and cattle for fattening, it is appropriate to provide for a transitional period for the interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(1)

Commission Implementing Regulations (EU) 2018/982 (2) and (EU) 2021/2097 (3) authorised the use of a preparation of benzoic acid, calcium formate and fumaric acid as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding for a 10-year period.

(2)

The Annexes to Implementing Regulations (EU) 2018/982 and (EU) 2021/2097 provide, in their respective column ‘other provisions’, that the additive is not to be used with other sources of benzoic acid or benzoates, calcium formate, formates and fumaric acid. This is to prevent exceeding the maximum dose by using other additives that contain those substances or sources thereof.

(3)

That restriction is justified for benzoic acid and benzoates as the additive contains a high level of benzoic acid in its composition, but it is not justified for the other substances, calcium formate, formates and fumaric acid, as the additive contains very low levels of calcium formate and fumaric acid. In order to ensure proportionality, the prohibition to combine with other additives should apply only to other additives containing benzoic acid and benzoates. The combination of this additive with other additives containing formic acid, formates, fumaric acid and fumarates should be allowed provided that in complete feedingstuffs the levels of 10 000 mg/kg for formic acid and 20 000 mg/kg for fumaric acid are not exceed for chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding. When the additive contains salts of formic and fumaric acids, those levels should not be exceeded either.

(4)

Formates (salts of formic acid) are sources of formic acid and fumarates (salts of fumaric acid) are sources of fumaric acid. It is necessary to harmonise the existing authorisations to ensure that the maximum levels of those acids and of all possible sources of those acids (salts of those acids) are not exceeded. In Implementing Regulation (EU) 2018/982 the restriction in the column ‘other provisions’ refers to the use of the preparation with other additives containing sources of calcium formate, formate and fumaric acid. As the calcium formate is already included in the term formate (salt of formic acid) and there may be other formates that can be a source of formic acid, the new restriction should apply to formates in general. In addition, the restriction should apply to fumaric acid and to fumarates as fumarates may be also a source of fumaric acid. In Implementing Regulation (EU) 2021/2097 in the column ‘other provisions’ the restriction refers to the use of the preparation with other additives containing sources of calcium formate or formic acid and fumaric acid. In order to be coherent, it is necessary to extend the new proposed restriction to formates and fumarates and eliminate the reference to calcium formate as this substance is already covered by the reference to formates.

(5)

Implementing Regulations (EU) 2018/982 and (EU) 2021/2097 should therefore be amended accordingly.

(6)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting or denying such authorisation. Article 10(2) of that Regulation provides rules for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

(2)

The preparations of lasalocid A sodium (Avatec 15 % cc) and lasalocid A sodium (Avatec 150 G) were authorised by Commission Regulation (EC) No 1455/2004 (3) for 10 years as feed additives belonging to the group ‘coccidiostats and other medicinal substances’ for use for chickens for fattening and chickens reared for laying. Those feed additives were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the authorisation of the preparation of lasalocid A sodium (Avatec 150 G) as a feed additive for chickens for fattening and chickens reared for laying, requesting the additive to be classified in the additive category ‘coccidiostats and histomonostats’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. No such application was submitted for the authorisation of the preparation of lasalocid A sodium (Avatec 15 % cc).

(4)

The European Food Safety Authority (‘the Authority’) stated in its opinions of 16 May 2017 (4) and 1 July 2020 (5) that it could not conclude on the safety and efficacy of the preparation of lasalocid A sodium (Avatec 150 G) for chickens for fattening and chickens reared for laying, indicating that no safe level of the active substance lasalocid A sodium, when added to feed, could be identified for those target species. The Authority concluded that the coccidiostatic efficacy of the preparation was insufficiently demonstrated at the lowest proposed dose level of 75 mg lasalocid A sodium per kg of complete feed. Consequently, it had not been established that the preparation of lasalocid A sodium (Avatec 150 G) does not have an adverse effect on animal health and that it has a coccidiostatic effect on the target species, when used under the proposed conditions. Therefore, the existing authorisation of the preparation of lasalocid A sodium (Avatec 150 G) was suspended by Commission Implementing Regulation (EU) 2021/932 (6).

(5)

The authorisation of the preparation of lasalocid A sodium (Avatec 150 G) was suspended pending the submission and assessment of supplementary data to be produced by the applicant according to a time schedule listing the necessary studies to be carried out, consisting of tolerance and ‘floor pen’ efficacy studies for chickens for fattening and chickens reared for laying.

(6)

In accordance with Implementing Regulation (EU) 2021/932, the suspension measure is to be reviewed by 31 December 2023 and in any event after the adoption by the Authority of a non-favourable opinion on the safety and efficacy of the preparation of lasalocid A sodium (Avatec 150 G) for use for chickens for fattening and chickens reared for laying.

(7)

Since the adoption of the Authority’s opinion of 1 July 2020, the applicant submitted to the Commission supplementary data on 29 June 2022, which were forwarded to the Authority.

(8)

On 23 November 2022, the Authority adopted an opinion (7) following the assessment of the supplementary data submitted by the applicant and concluded that the preparation of lasalocid A sodium (Avatec 150 G) is safe and efficacious for chickens for fattening at the maximum and minimum dose level of 90 mg lasalocid A sodium per kg of complete feed. However, it also considered that an extrapolation of the results of the tolerance studies, all in chickens for fattening, to the chickens reared for laying is not possible, considering that, while zootechnical performance seems to be the most sensitive endpoint to evaluate the tolerance to lasalocid A sodium, negative effects were observed on performances of animals with low growth rate and a potential negative effect was noted on the breeding period with lasalocid A sodium when fed to chickens reared for breeding. The Authority could therefore still not conclude on the safety of that additive for chickens reared for laying.

(9)

In its opinion of 16 May 2017, the Authority also concluded that the preparation of lasalocid A sodium (Avatec 150 G) is safe for the user, for the environment and for the consumer provided a withdrawal period of three days is applied for compliance with the maximum residue limits (‘MRL’). In particular, the Authority stated that its previous conclusions that there is no likely risk to the user handling the additive, laid down in its opinion of 7 April 2010 (8), did not need to be reconsidered. The Authority further stated that the concurrent administration of lasalocid A sodium with tiamulin and certain other medicinal substances should be avoided, and recommended that a post-market monitoring of Eimeria spp. resistance to lasalocid A sodium be undertaken.

(10)

In addition, the Authority verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003, including the addendum produced on 23 January 2023, recommending the addition of a new multi-analyte method based on liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) for the determination of lasalocid A sodium in compound feed.

(11)

The assessment of the preparation of lasalocid A sodium (Avatec 150 G) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied as regards the use for chickens for fattening. Accordingly, the use of that additive should be authorised for that use. It is appropriate to provide for post-market monitoring on the resistance of Eimeria spp. to lasalocid A sodium. The MRL established for lasalocid A sodium in Commission Regulation (EU) No 37/2010 (9) should apply to residues of that substance or its metabolites originating from the use thereof as a feed additive, in the relevant foodstuffs of animal origin.

(12)

However, the Authority’s opinions of 16 May 2017, 1 July 2020 and 23 November 2022 show that it has not been established that the preparation of lasalocid A sodium (Avatec 150 G) does not have an adverse effect on animal health, when used for chickens reared for laying. The assessment of that additive thus shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are not satisfied as regards the use for chickens reared for laying and accordingly, the authorisation of the preparation of lasalocid A sodium (Avatec 150 G) as a feed additive belonging to the category ‘coccidiostats and histomonostats’ should be denied for chickens reared for laying.

(13)

Article 10(5) of Regulation (EC) No 1831/2003 imposes an obligation on the Commission to adopt a Regulation withdrawing from the market feed additives for which no applications as required by Article 10(2) of that Regulation were submitted before the deadline provided for in that provision. Therefore, the preparation of lasalocid A sodium (Avatec 15 % cc) should be withdrawn from the market. As Article 10(5) of Regulation (EC) No 1831/2003 does not differentiate between authorisations issued with a time limit and authorisations without a time limit, for clarity reasons it is appropriate to provide for the withdrawal from the market of feed additives whose limited authorisation periods pursuant to Directive 70/524/EEC have already expired.

(14)

As a consequence of the above review and of the authorisation of the preparation of lasalocid A sodium (Avatec 150 G) for chickens for fattening, the denial of its authorisation for chickens reared for laying, and the withdrawal from the market of the preparation of lasalocid A sodium (Avatec 15 % cc), Regulation (EC) No 1455/2004 and Implementing Regulation (EU) 2021/932 should be repealed.

(15)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. In particular, Article 10(2) of that Regulation, provides rules for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

(2)

Article 10(5) of Regulation (EC) No 1831/2003 imposes an obligation on the Commission to adopt a Regulation withdrawing from the market feed additives for which no applications as required by Article 10, paragraphs 2 and 7 of Regulation (EC) No 1831/2003 were submitted before the deadline provided for in those provisions, or for which an application was submitted but subsequently withdrawn.

(3)

Therefore, the feed additives as listed in the Annex should be withdrawn from the market.

(4)

In the case of feed additives for which applications have been submitted only for certain animal species or categories of animals, or applications have been withdrawn only for certain animal species or categories of animals, the withdrawal from the market should only concern the animal species and categories of animals for which no application has been submitted or for which the application has been withdrawn.

(5)

As a consequence of the withdrawal from the market of the listed feed additives, it is appropriate to repeal the provisions authorising them. Consequently, Commission Regulation (EC) No 1810/2005 (3) should be amended accordingly and Commission Regulations (EC) No 1453/2004 (4), (EC) No 2148/2004 (5) and (EC) No 943/2005 (6) should be repealed.

(6)

It is appropriate to allow a transitional period within which existing stocks of the additives concerned, premixtures, feed materials and compound feed which have been produced with those additives may be used up, in order to allow interested parties to adapt to the withdrawal of those products from the market.

(7)

The withdrawal from the market of the products listed in the Annex does not prevent them from being authorised or from being subject to a measure concerning their status in accordance with Regulation (EC) No 1831/2003.

(8)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(1)

Article 3 is deleted;

(2)

Annex III is deleted.

(1)

Commission Implementing Regulation (EU) 2018/2019 (2) establishes, on the basis of a preliminary risk assessment, a list of high risk plants, plant products and other objects.

(2)

Following a preliminary assessment, 34 genera and one species of plants for planting originating from third countries were provisionally listed in Implementing Regulation (EU) 2018/2019 as high risk plants. That list includes the genus Crataegus L.

(3)

On 3 May 2022, the United Kingdom (3) submitted to the Commission, a request for export to the Union of dormant, bare-rooted, free of leaves plants for planting of Crataegus monogyna that are up to 7 years old and have a maximum diameter of 6,5 cm at the base of the stem, and of plants for planting of Crataegus monogyna in growing medium that are up to 15 years old and have a maximum diameter of 13 cm at the base of the stem (‘the relevant plants’). That request was supported by the relevant technical dossier.

(4)

On 30 March 2023, the European Food Safety Authority (‘the Authority’) adopted a scientific opinion regarding the risk assessment of the relevant plants, originating in the United Kingdom (4). It identified Erwinia amylovora as the pest relevant for those plants.

(5)

The Authority evaluated whether, regarding Erwinia amylovora, the special requirements for the introduction into and movement within the specified protected zones, listed in point 9 of Annex X to Commission Implementing Regulation (EU) 2019/2072 (5), of plants of Crataegus L., other than fruits and seeds, are fulfilled.

(6)

On the basis of that opinion, the phytosanitary risk arising from the introduction into the Union territory of the relevant plants from the United Kingdom is considered to be reduced to an acceptable level.

(7)

The relevant plants which are up to 7 years old and bare-rooted, as included in the dossier submitted by the United Kingdom, present a lower phytosanitary risk due to their characteristics. Consequently, all relevant plants that are up to 15 years old and with a maximum diameter of 13 cm at the base of the stem, originating in the United Kingdom, should no longer be considered high risk plants.

(8)

Therefore, all relevant plants that are up to 15 years old and with a maximum diameter of 13 cm at the base of the stem, originating in the United Kingdom should be removed from the list of high risk plants, plant products and other objects in the Annex to Implementing Regulation (EU) 2018/2019.

(9)

Implementing Regulation (EU) 2018/2019 should therefore be amended accordingly.

(10)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee for Plants, Animals, Food and Feed,

(1)

Highly pathogenic avian influenza (HPAI) is an infectious viral disease in birds and may have a severe impact on the profitability of poultry farming causing disturbance to trade within the Union and exports to third countries. HPAI viruses can infect migratory birds, which can then spread these viruses over long distances during their autumn and spring migrations. Therefore, the presence of HPAI viruses in wild birds poses a continuous threat for the direct and indirect introduction of these viruses into establishments where poultry or captive birds are kept. In the event of an outbreak of HPAI, there is a risk that the disease agent may spread to other establishments where poultry or captive birds are kept.

(2)

Regulation (EU) 2016/429 establishes a new legislative framework for the prevention and control of diseases that are transmissible to animals or humans. HPAI falls within the definition of a listed disease in that Regulation, and it is subject to the disease prevention and control rules laid down therein. In addition, Commission Delegated Regulation (EU) 2020/687 (2) supplements Regulation (EU) 2016/429 as regards the rules for the prevention and control of certain listed diseases, including disease control measures for HPAI.

(3)

Commission Implementing Decision (EU) 2021/641 (3) was adopted within the framework of Regulation (EU) 2016/429 and it lays down emergency measures at Union level in relation to outbreaks of HPAI.

(4)

More particularly, Implementing Decision (EU) 2021/641 provides that the protection, surveillance and further restricted zones established by the Member States following outbreaks of HPAI, in accordance with Delegated Regulation (EU) 2020/687, are to comprise at least the areas listed as protection, surveillance and further restricted zones in the Annex to that Implementing Decision.

(5)

The Annex to Implementing Decision (EU) 2021/641 was recently amended by Commission Implementing Decision (EU) 2023/1083 (4) following outbreaks of HPAI in poultry or captive birds in Germany, France and Poland that needed to be reflected in that Annex.

(6)

Since the date of adoption of Implementing Decision (EU) 2023/1083, France has notified the Commission of new outbreaks of HPAI in establishments where poultry or captive birds were kept, located in Nouvelle-Aquitaine and Occitania administrative regions.

(7)

The competent authority of France has taken the necessary disease control measures required in accordance with Delegated Regulation (EU) 2020/687, including the establishment of protection and surveillance zones around those outbreaks.

(8)

In addition, the competent authority of France decided to establish further restricted zones in addition to the protection and surveillance zones established for certain outbreaks located in that Member State.

(9)

The Commission has examined the disease control measures taken by France in collaboration with that Member State, and it is satisfied that the boundaries of the protection and surveillances zones in France established by the competent authority of that Member State are at a sufficient distance from the establishments where the outbreaks of HPAI have been confirmed.

(10)

In order to prevent any unnecessary disturbance to trade within the Union and to avoid unjustified barriers to trade being imposed by third countries, it is necessary to rapidly describe at Union level, in collaboration with France, the protection, surveillance zones and further restricted zones duly established by that Member State in accordance with Delegated Regulation (EU) 2020/687.

(11)

Therefore, the areas listed as protection, surveillance and further restricted zones for France in the Annex to Implementing Decision (EU) 2021/641 should be amended.

(12)

Accordingly, the Annex to Implementing Decision (EU) 2021/641 should be amended to update regionalisation at Union level to take account of the protection, surveillance and further restricted zones duly established by France in accordance with Delegated Regulation (EU) 2020/687, and the duration of the measures applicable therein.

(13)

Implementing Decision (EU) 2021/641 should therefore be amended accordingly.

(14)

Given the urgency of the epidemiological situation in the Union as regards the spread of HPAI, it is important that the amendments to be made to Implementing Decision (EU) 2021/641 by this Decision take effect as soon as possible.

(15)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,