(1)

Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Spain’s application to register the name ‘Pebre bord de Mallorca’/‘Pimentón de Mallorca’ 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 ‘Pebre bord de Mallorca’/‘Pimentón de Mallorca’ should therefore be entered in the register,

(1)

Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Croatia’s application to register the name ‘Varaždinski klipič’ 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 ‘Varaždinski klipič’ 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 and renewing such authorisation.

(2)

Bacillus amyloliquefaciens CECT 5940 was authorised for 10 years as a feed additive for chickens for fattening by Commission Regulation (EC) No 1292/2008 (2).

(3)

In accordance with Article 14 of Regulation (EC) No 1831/2003, in conjunction with Article 7 thereof, an application was submitted by the holder of the authorisation of Bacillus amyloliquefaciens CECT 5940 as a feed additive for the renewal of the authorisation for chickens for fattening, and for a new authorisation for chickens reared for laying, requesting that additive to be classified in the additive category ‘zootechnical additives’. That application was accompanied by the particulars and documents required under Articles 7(3) and 14(2) of that Regulation.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 28 January 2020 (3) that the applicant has provided data demonstrating that the additive complies with the conditions of authorisation. The Authority confirmed its previous conclusions that Bacillus amyloliquefaciens CECT 5940 does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that it is not an irritant to skin/eye or a skin sensitiser but should be considered a potential respiratory sensitiser. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards to users of the additive. The Authority also concluded that the additive has the potential to be efficacious in chickens reared for laying.

(5)

The assessment of Bacillus amyloliquefaciens CECT 5940 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the authorisation of that additive should be renewed as specified in the Annex to this Regulation.

(6)

As a consequence of the renewal of the authorisation of Bacillus amyloliquefaciens CECT 5940 as a feed additive under the conditions laid down in the Annex to this Regulation, Regulation (EC) No 1292/2008 should be repealed.

(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 substances geraniol, citral, 3,7,11-trimethyldodeca-2,6,10-trien-1-ol, (Z)-nerol, geranyl acetate, geranyl butyrate, geranyl formate, geranyl propionate, neryl propionate, neryl formate, neryl acetate, neryl isobutyrate, geranyl isobutyrate and prenyl acetate (‘the substances concerned’) were authorised without a time limit by Directive 70/524/EEC as feed additives for all animal species. Those additives substances were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1)(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 re-evaluation of the substances concerned as feed additives for all animal species. The applicant requested those additives to be classified in the additive category ‘sensory additives’ and in the functional group ‘flavouring compounds’. The application was 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 opinion of 25 May 2016 (3) that, under the proposed conditions of use the substances concerned do not have adverse effects on animal health, human health or the environment. The Authority concluded that for the marine environment, the safe use level is estimated to be 0,05 mg/kg feed. The levels of use proposed for the substances concerned exceeds the safe level for the marine environment, therefore, the use for marine animals is not authorised. The Authority also concluded in the opinion that, since the substances concerned are efficacious when used as flavourings in food and their function in feed is essentially the same as in food, no further demonstration of efficacy was necessary. Therefore, that conclusion could be extrapolated to feed. Although the applicant withdrew the application for water for drinking, it should be possible to use the substances concerned within compound feeds which are subsequently administered via water.

(5)

The Authority concluded that in the absence of data the substances concerned should be considered hazardous for the skin, and eye contact and for respiratory exposure. Geraniol, citral and 3,7,11-trimethyldodeca-2,6,10-trien-1-ol, are also reported to be skin sensitisers. Consequently, appropriate protective measures should be taken. The Authority does 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 additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(6)

The assessment of the substances concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of the substances concerned should be authorised as specified in the Annex to this Regulation.

(7)

Restrictions and conditions should be provided for to allow better control. Since safety reasons do not require the setting of a maximum content and taking into account the re-evaluation performed by the Authority, a recommended content should be indicated on the label of the feed additive. Where such content is exceeded, certain information should be indicated on the label of premixtures.

(8)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the substances concerned, it is appropriate to allow a transitional period for 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)

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

(2)

L-isoleucine produced by Escherichia coli FERM ABP-10641 was authorised for 10 years as a feed additive for all animal species by Commission Regulation (EU) No 348/2010 (2).

(3)

In accordance with Article 14 of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of L-isoleucine produced by Escherichia coli FERM ABP-10641 as a feed additive for all animal species, requesting this additive to be classified in the additive category ‘nutritional additives’, functional group ‘amino acids, their salts and analogues’. This application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003. Moreover, the application requested, in accordance with Article 7 of Regulation (EC) No 1831/2003, L-isoleucine produced by Escherichia coli FERM ABP-10641 to be authorised for use in water for drinking in the additive category ‘nutritional additives’, functional group ‘amino acids, their salts and analogues’ for all animal species, and for use in feed to be classified in the additive category ‘sensory additives’, functional group ‘flavouring compounds’. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of L-isoleucine produced by Corynebacterium glutamicum KCCM 80 189 as a feed additive for use in feed and in water for drinking for all animal species. The application concerns the authorisation of L-isoleucine produced by Corynebacterium glutamicum KCCM 80 189 as a feed additive for all animal species to be classified in the additive category ‘nutritional additives’, functional group ‘amino acids, their salts and analogues’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(5)

The European Food Safety Authority (‘the Authority’) concluded in its opinions of 28 January 2020 (3) (4) that, under the proposed conditions of use, L-isoleucine produced by Escherichia coli FERM ABP-10641 or Corynebacterium glutamicum KCCM 80 189 does not have an adverse effect on animal health, consumer health or the environment. It also stated that L-isoleucine produced by Escherichia coli FERM ABP-10641 was hazardous by inhalation for persons handling the additive. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of this additive. No adverse effects on user safety were stated for L-isoleucine produced by Corynebacterium glutamicum KCCM 80 189. The Authority also concluded that the additive is an efficacious source of the essential amino acid isoleucine for non-ruminant animals and that for the supplemental L-isoleucine to be fully efficacious in ruminants, it should be protected against degradation in the rumen. The Authority expressed concerns on the simultaneous oral administration of the amino acid via water for drinking and feed. However, the Authority did not propose a maximum content for L-isoleucine. Thus, in the case of supplementation with L-isoleucine via water for drinking, it is appropriate to alert the user to take into account the dietary supply with all the essential and conditionally essential amino acids.

(6)

Restrictions and conditions should be provided for to allow for a better control for L-isoleucine when used as flavouring. For L-isoleucine used as flavouring, the recommended content should be indicated on the label. Where such content is exceeded, certain information should be indicated on the label of the additive and premixtures. As regards the use of L-isoleucine as a flavouring, the Authority states that no further demonstration of efficacy is necessary when the substance is used at the recommended dose level. The use of L-isoleucine as a flavouring compound is not authorised in water for drinking. The fact that the use of the L-isoleucine is not authorised for use as a flavouring in water for drinking, does not preclude its use in compound feed, which is administered via water.

(7)

The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the reports on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(8)

The assessment of L-isoleucine produced by Escherichia coli FERM ABP-10641 and by Corynebacterium glutamicum KCCM 80 189 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this additive should be authorised as specified in the Annex to this Regulation.

(9)

As a consequence of the renewal of the authorisation of L-isoleucine produced by Escherichia coli FERM ABP-10641 as a feed additive under the conditions laid down in the Annex to this Regulation, Regulation (EU) No 348/2010 should be repealed.

(10)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for L-isoleucine produced by Escherichia coli FERM ABP-10641, it is appropriate to provide a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal of the authorisation.

(11)

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 and renewing such authorisation.

(2)

The preparation of Saccharomyces cerevisiae CBS 493.94 was authorised for 10 years as a feed additive for horses by Commission Regulation (EC) No 886/2009 (2).

(3)

In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted by the holder of that authorisation for the renewal of the authorisation of Saccharomyces cerevisiae CBS 493.94 as a feed additive for horses requesting that additive to be classified in the additive category ‘zootechnical additives’. That application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 12 November 2019 (3) that, Saccharomyces cerevisiae CBS 493.94 does not have an adverse effect under the authorised conditions of use for the animal health, consumer health or the environment. It also concluded that the additive should be considered as a moderate eye irritant and a potential skin and respiratory sensitiser. Therefore, 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. Since the Authority was unable to conclude on the new proposed minimum dose, the previous doses should be maintained.

(5)

The assessment of Saccharomyces cerevisiae CBS 493.94 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the authorisation of that additive should be renewed as specified in the Annex to this Regulation.

(6)

As a consequence of the renewal of the authorisation of Saccharomyces cerevisiae CBS 493.94 as a feed additive under the conditions laid down in the Annex to this Regulation, Regulation (EC) No 886/2009 should be repealed.

(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 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

(2)

Butylated hydroxyanisole was authorised without a time limit as a feed additive for all animal species in accordance with Council Directive 70/524/EEC. This additive was subsequently entered in the Register of feed additives as an existing product, 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 re-evaluation of butylated hydroxyanisole as a feed additive for all animal species. The applicant has later withdrawn the application with regard to cats.

(4)

The applicant requested the additive to be classified in the additive category ‘technological additives’ and in the functional group ‘antioxidants’. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(5)

The European Food Safety Authority (‘the Authority’) concluded in its opinions of 6 March 2018 (3) and 12 November 2019 (4) that, under the proposed conditions of use, butylated hydroxyanisole does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that the additive should be considered a skin, eye irritant and a potential skin sensitiser. Therefore, 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. The Authority also concluded that since butylated hydroxyanisole is authorised as an antioxidant for use in food at comparable use levels, no studies are required to demonstrate the efficacy of butylated hydroxyanisole as an antioxidant in feedingstuffs for all animal species. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the methods of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(6)

The assessment of butylated hydroxyanisole shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of butylated hydroxyanisole should be authorised as specified in the Annex to this Regulation.

(7)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of butylated hydroxyanisole, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

(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)

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 Regulation (EC) No 1831/2003 provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2) and Article 4 of the same Regulation for the authorisation of a new use of an additive.

(2)

Ethyl ester of β-apo-8’-carotenoic acid was authorised without a time limit in accordance with Directive 70/524/EEC as feed additive for poultry belonging to the functional group ‘colourants, including pigments’, under the heading ‘carotenoids and xanthophylls’. The additive was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003.

(3)

In accordance with Articles 4 and 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the authorisation of ethyl ester of β-apo-8’-carotenoic acid in water for drinking and the re-evaluation of ethyl ester of β-apo-8’-carotenoic acid as feed additive for chickens for fattening, laying hens and minor poultry species for laying and for fattening. The applicant requested the additive to be classified in the additive category ‘sensory additives’ and in the functional group ‘colourants’. The application was 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 8 March 2016 (3) and of 12 November 2019 (4) that, under the proposed conditions of use, ethyl ester of β-apo-8’-carotenoic acid does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that ethyl ester of β-apo-8'-carotenoic acid is not an irritant to skin and eyes, and not a dermal sensitiser. On the inhalation toxicity of ethyl ester of β-apo-8’-carotenoic acid, the Authority cannot conclude on the risk of users by inhalation. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health. The Authority further concluded that the additive concerned is effective in adding colour to food of animal origin. The Authority does 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 European Union Reference Laboratory set up by Regulation (EC) No 1831/2003.

(5)

As regards the use in water for drinking, the Commission considers that the simultaneous use of the additive in water for drinking and feed is difficult to manage, as there are maximum levels established for safety reasons and there are also other additives containing xanthophylls and carotenoids that may be used in feed. The simultaneous use of ethyl ester of β-apo-8’-carotenoic acid in water for drinking and feed increases the ways of administration and the risk to exceed the maximum levels authorised for additives containing carotenoids and xanthophylls. Consequently, the use in water for drinking should be denied.

(6)

The assessment shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of ethyl ester of β-apo-8’-carotenoic acid should be authorised as specified in the Annex to this Regulation.

(7)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the substance concerned, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

(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)

It appears from the information provided to the Commission by Slovenia that, due to the unfavourable weather conditions, during the growing season 2018/2019, the seed crop of the species crimson clover (Trifolium incarnatum L.) intended for the production of basic seed was severely affected. As a consequence, there was not enough basic seed available in Slovenia for the production of certified seed of the first generation for the 2020 harvest.

(2)

Other Member States, partly facing harvesting problems, have not been able to cover the need of Slovenia for the category of basic seed.

(3)

In the light of these circumstances, temporary difficulties in the general supply of certified seed of crimson clover occur. These difficulties cannot be overcome otherwise than by allowing, for a specific period and subject to an appropriate maximum quantity, the marketing in the Union of certified seed of the second generation of crimson clover produced in Slovenia.

(4)

Therefore, this Decision should authorise the marketing in the Union of certified seed of crimson clover of the second generation produced in Slovenia from certified seed of the first generation, subject to certain conditions and limitations.

(5)

It also appears from the information provided to the Commission by Slovenia that, in total, a quantity of 30 tonnes of crimson clover seed are needed to resolve these supply difficulties for the period expiring on 30 June 2021.

(6)

The derogation does not prevent the application of the other conditions for the marketing of certified seed of crimson clover, as laid down in Directive 66/401/EEC.

(7)

The Member States should immediately notify the Commission and the other Member States of the quantities in respect of which they have granted authorisation for marketing pursuant to this Decision, in order to ensure its coordinated implementation.

(8)

It is appropriate that Slovenia acts as coordinator in order to ensure that the total quantities of marketed seed authorised pursuant to this Decision does not exceed the maximum quantity whose marketing it allows.

(9)

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

(1)

Commission Implementing Decision 2014/709/EU (4) lays down animal health control measures in relation to African swine fever in certain Member States, where there have been confirmed cases of that disease in domestic or feral pigs (the Member States concerned). The Annex to that Implementing Decision demarcates and lists certain areas of the Member States concerned in Parts I to IV thereof, differentiated by the level of risk based on the epidemiological situation as regards that disease. The Annex to Implementing Decision 2014/709/EU has been amended several times to take account of changes in the epidemiological situation in the Union as regards African swine fever that need to be reflected in that Annex. The Annex to Implementing Decision 2014/709/EU was last amended by Commission Implementing Decision (EU) 2020/1330 (5), following changes in the epidemiological situation as regards that disease in Poland.

(2)

Since the date of adoption of Implementing Decision (EU) 2020/1330, there have been new occurrences of African swine fever in feral pigs in Poland, and in Germany close to the border with Poland.

(3)

In late September 2020, one case of African swine fever in a feral pig was observed in the district of obornicki in Poland in an area currently not listed in the Annex to Implementing Decision 2014/709/EU. This case of African swine fever in a feral pig constitutes an increased level of risk, which should be reflected in that Annex. Accordingly, this area of Poland not listed in that Annex affected by this recent case of African swine fever, should now be listed in Parts I and II thereof.

(4)

Also in late September 2020, one case of African swine fever in a feral pig was observed in the district of sokołowski in Poland in an area currently listed in Part II of the Annex to Implementing Decision 2014/709/EU, located in close proximity to an area currently listed in Part I thereof. This case of African swine fever in a feral pig constitutes an increased level of risk, which should be reflected in that Annex. Accordingly, this area of Poland listed in Part I of that Annex, that is in close proximity to an area listed in Part II affected by this recent case of African swine fever, should now be listed in Part II of that Annex instead of in Part I thereof.

(5)

In addition, in late September 2020, one case of African swine fever in a feral pig was observed the municipality of Bleyen-Genschmar in Germany and Commission Implementing Decision (EU) 2020/1391 (6) was adopted following the establishment of an infected area in Germany, in accordance with Article 15 of Directive 2002/60/EC. This case of African swine fever in a feral pig in Germany is located in close proximity to an area in Poland currently not listed in the Annex to Implementing Decision 2014/709/EU. This case of African swine fever in a feral pig constitutes an increased level of risk, which should be reflected in that Annex. Accordingly, this area of Poland not listed in the Annex to Implementing Decision 2014/709/EU, that is in close proximity to the area in Germany affected by this recent case of African swine fever, should now be listed in Part I of that Annex.

(6)

Following the recent cases of African swine fever in feral pigs in Poland and in Bleyen-Genschmar in Germany close to the border with Poland, and taking into account the current epidemiological situation in the Union, regionalisation in Poland has been reassessed and updated. In addition, the risk management measures in place have also been reassessed and updated. These changes need to be reflected in the Annex to Implementing Decision 2014/709/EU.

(7)

In order to take account of recent developments in the epidemiological situation of African swine fever in the Union, and in order to combat the risks associated with the spread of that disease in a proactive manner, new high-risk areas of a sufficient size should be demarcated for Poland and duly listed in Parts I and II of the Annex to Implementing Decision 2014/709/EU.

(8)

Given the urgency of the epidemiological situation in the Union as regards the spread of African swine fever, it is important that the amendments made to the Annex to Implementing Decision 2014/709/EU by this Decision take effect as soon as possible.

(9)

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