(1)

Commission Regulation (EC) No 1881/2006 (2) sets maximum levels for certain contaminants, including tropane alkaloids, in foodstuffs.

(2)

Atropine is the racemic mixture of (-)-hyoscyamine and (+)-hyoscyamine of which only the (-)-hyoscyamine enantiomer exhibits anticholinergic activity. It is not always possible to distinguish between the enantiomers of hyoscyamine, for analytical reasons. However, as the synthesis of tropane alkaloids in plants leads to (-)-hyoscyamine and (-)-scopolamine and not to (+)-hyoscyamine and (+)-scopolamine, analytical results on atropine and scopolamine in food of plant origin reflects the occurrence of (-)-hyoscyamine and (-)-scopolamine respectively.

(3)

The European Food Safety Authority (‘the Authority’) adopted in 2013 an opinion on tropane alkaloids in food and feed (3). The Authority established a group acute reference dose (‘ARfD’) of 0.016 μg/kg per body weight (‘b.w.’) expressed as the sum of (-)-hyoscyamine and (-)-scopolamine, assuming equivalent potency. The Authority concluded that, based on the limited information available, the dietary exposure of toddlers could significantly exceed the group ARfD. It therefore highlighted the need for better characterisation of tropane alkaloids in food and feed, either naturally or as contaminants, and recommended compiling analytical data on the occurrence of tropane alkaloids in cereals and oilseeds.

(4)

Taking into account the conclusions of the opinion, maximum levels for atropine and scopolamine were established by Commission Regulation (EU) 2016/239 (4) in processed cereal based foods and baby foods for infants and young children, containing millet, sorghum, buckwheat or their derived products.

(5)

The Authority published a call for proposals to investigate the concentrations of tropane alkaloids in a wide range of plant-derived food products across different regions within the Union, following the recommendation in its opinion from 2013. The investigation’s findings were published on 8 December 2016 (5).

(6)

On 5 February 2018, the Authority published a scientific report on the assessment of acute dietary exposure to tropane alkaloids in the Union population, taking into account new occurrence data (6). For several acute exposure estimates, the ARfD was exceeded for several population groups. This makes the presence of tropane alkaloids, in particular atropine and scopolamine, a health concern.

(7)

Maximum levels of those tropane alkaloids should therefore be set for foodstuffs found to contain a high concentration of them and contributing significantly to the exposure of the population, namely certain cereals, products derived from them and herbal infusions. As regards, in particular, cereals and cereals products, good agricultural and harvesting practices minimise contamination of the crop by seeds of species containing tropane alkaloids, such as Datura stramonium. In case of contamination, those seeds can be removed for certain cereals by sorting and cleaning. However, they cannot easily be removed from sorghum, millet, maize and buckwheat. Given that the maximum levels for those foodstuffs are higher than the levels set out for foodstuffs for infants and young children, a maximum level for the sum of atropine and scopolamine may be set for each of those foods.

(8)

Furthermore, recent monitoring data indicate that processed cereal based foods and baby foods for infants and young children containing maize or maize derived products can also be contaminated with tropane alkaloids. It is therefore appropriate to extend to these foods the existing maximum levels for processed cereal based foods and baby foods for infants and young children.

(9)

Regulation (EC) No 1881/2006 should therefore be amended accordingly.

(10)

Given that good agricultural and harvesting practices have only recently been introduced or implemented and in order to allow the food business operators to adapt to the new requirements set out in this Regulation while ensuring the protection of vulnerable populations, it is appropriate to provide, as regard foods other than foods for infants and young children containing maize, a reasonable period until the maximum levels start applying and for a transitional period for all foodstuffs which have been lawfully placed on the market before the date of its application.

(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 such authorisation.

(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of phytomenadione. (2) 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 phytomenadione as a feed additive for horses. The applicant requested this additive to be classified in the additive category ‘nutritional additives’.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 17 March 2021 (3) that, under the proposed conditions of use, phytomenadione does not have adverse effects on animal health, consumer safety or the environment. The Authority concluded that users will not be exposed by inhalation when the additive is presented in solid form or viscous liquid. Data from the Scientific Committee on Consumer Safety indicates that vitamin K1 can be categorised as a dermal sensitiser. For preparations, the Authority could not conclude on their potential to be toxic by inhalation or on their potential as skin/eye irritant. 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 and its preparations. The Authority concluded that phytomenadione is considered as an efficacious source of vitamin K1 for horses, when added to feed. 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.

(5)

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

(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of a preparation of Bacillus licheniformis DSM 28710. 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 Bacillus licheniformis DSM 28710 as a feed additive for laying hens, minor poultry species for laying, poultry species for breeding and ornamental birds, to be classified in the category ‘zootechnical additives’.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 28 January 2021 (2) that, under the proposed conditions of use, the preparation of Bacillus licheniformis DSM 28710 does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that in the absence of data, no conclusions could be drawn on the skin/eye irritation or skin sensitisation potential of the additive, but that it is considered a 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. The Authority also concluded that the preparation of Bacillus licheniformis DSM 28710 has the potential to be efficacious as zootechnical additive in feedingstuffs. 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 additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(5)

The assessment of the preparation of Bacillus licheniformis DSM 28710 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 product should be authorised as specified in the Annex to this Regulation.

(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 and renewing such authorisation.

(2)

The preparation of Clostridium butyricum FERM BP-2789 was authorised for 10 years as a feed additive for minor avian species except laying birds, weaned piglets and minor porcine species (weaned) by Commission Implementing Regulation (EU) No 373/2011 (2), for chickens reared for laying by Commission Implementing Regulation (EU) No 374/2013 (3) and for turkeys for fattening and turkeys reared for breeding by Commission Implementing Regulation (EU) No 1108/2014 (4).

(3)

In accordance with Article 14(1) of Regulation (EC) No 1831/2003, in conjunction with Article 7 thereof, an application was submitted by the holder of the authorisation of the preparation of Clostridium butyricum FERM BP-2789 as a feed additive for the renewal of the authorisation for chickens reared for laying, turkeys for fattening, turkeys reared for breeding, minor avian species (excluding laying birds), weaned piglets and weaned minor porcine species, and for a new authorisation for chickens for fattening, suckling piglets and suckling minor porcine species, 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 27 January 2021 (5) that the applicant had provided evidence that the additive complies with the conditions of authorisation. The Authority further concluded that the preparation of Clostridium butyricum FERM BP-2789 does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that the preparation is not an irritant to skin and eyes and that sensitisation via respiratory route could not be excluded. 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 for fattening, suckling piglets and suckling minor porcine species.

(5)

The assessment of the preparation of Clostridium butyricum FERM BP-2789 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 the preparation of Clostridium butyricum FERM BP-2789 as a feed additive under the conditions laid down in the Annex to this Regulation, Implementing Regulations (EU) No 373/2011, (EU) No 374/2013 and (EU) No 1108/2014 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.

(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of ferric citrate chelate. 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 ferric citrate chelate as a feed additive for piglets and minor porcine species (suckling and weaned) to be classified in the additive category ‘zootechnical additives’ and functional group ‘other zootechnical additives’.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinions of 12 November 2019 (2) and 27 January 2021 (3) that, under the proposed conditions of use, ferric citrate chelate does not have an adverse effect on animal health, consumer safety or the environment. The Authority concluded that the additive should be considered a respiratory and skin sensitiser and a potential eye irritant. 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 concluded that the feed additive has the potential to improve zootechnical parameters of weaned piglets and that this conclusion can be extended to sucking piglets for the period in which solid feed is given and extrapolated to all minor porcine 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 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 ferric citrate chelate 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 substance should be authorised.

(6)

In order to align the name of this substance with other, already authorised iron containing additives, ‘ferric’ should be replaced with the synonym term ‘iron(III)’.

(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.

(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 produced by Bacillus subtilis LMG-S 15136. 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 (EC 3.2.1.8) produced by Bacillus subtilis LMG-S 15136 as a feed additive for lactating sows to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinions of 7 October 2019 (2) and 27 January 2021 (3) that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase produced by Bacillus subtilis LMG-S 15136 does not have an adverse effect on animal health, consumer safety or the environment. The Authority concluded that that additive should be considered a respiratory sensitiser and a potential dermal 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 concluded that the additive has a potential to be efficacious as a zootechnical additive in sows during the lactation period. 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 Reference Laboratory set up by Regulation (EC) No 1831/2003.

(5)

The assessment of the preparation of endo-1,4-beta-xylanase produced by Bacillus subtilis LMG-S 15136 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 as specified in the Annex to this Regulation.

(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 the preparation Enterococcus faecium DSM 7134 as a feed additive was authorised for laying hens by Commission Implementing Regulation (EU) 2021/422 (2) for a 10-year period.

(2)

In the Annex to Implementing Regulation (EU) 2021/422, the wrong identification number of the additive has been inserted in the column ‘Identification number of the additive’.

(3)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 30 September 2020 (3) that the additive may be used via water for drinking, as part of the conditions of use subject to the safety and efficacy assessment. The specification deriving from that conclusion was not included in the column ‘Other provisions’ of the Annex to Implementing Regulation (EU) 2021/422, and should therefore be added therein for reasons of legal certainty.

(4)

The Authority’s opinion also indicated that the additive is not a dermal or ocular irritant, but a potential dermal and respiratory sensitiser. The Annex to Implementing Regulation (EU) 2021/422, in the column ‘Other provisions’, erroneously refers to the use of breathing protection, glasses and gloves as personal protection equipment, while it should instead refer to the use of breathing and skin protection in order to take appropriate account of the Authority’s opinion concerning users’ safety.

(5)

In the Annex to Implementing Regulation (EU) 2021/422, a minor clerical error has been made as regards the name of the authorisation holder.

(6)

Implementing Regulation (EU) 2021/422 should therefore be corrected accordingly. For the sake of clarity, it is appropriate to replace the whole Annex to the said Implementing Regulation by the corrected version thereof.

(7)

In order to allow feed business operators to adapt the labelling of the additive and feed containing it to the corrected terms of authorisation, a transitional period should be provided for as regards the placing on the market of those products.

(8)

In order to preserve the legitimate expectations of the interested parties in relation to the terms of the authorisation of the additive, this Regulation should enter into force as a matter of urgency.

(9)

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