(1)

Regulation (EU) 2019/1241 (the ‘Technical Measures Regulation’) on the conservation measures of fisheries resources and the protection of marine ecosystems through technical measures entered into force on 14 August 2019. Annex VI and VII of that Regulation lay down specific regional technical measures for the North Western Waters and the South Western Waters of Union waters.

(2)

Belgium, Spain, France, Ireland and the Netherlands (the ‘North Western Waters Member States’) have a direct fisheries management interest in the North Western Waters; Belgium, Spain, France, the Netherlands and Portugal (the ‘South Western Waters Member States’) have a direct fisheries management interest in the South Western Waters. On 5 March 2021, the two regional groups submitted two joint recommendations proposing measures to improve the conservation status of red seabream (Pagellus bogaraveo) that the International Council for the Exploration of the Sea (ICES) assessed with a zero-catch advice in ICES subareas 6 to 8 for the period 2021-2022 (2). In March 2022, Member States submitted updated versions of these joint recommendations suggesting an extension of the proposed end date of certain measures.

(3)

The North Western Waters Advisory Council and the South Western Waters Advisory Council were consulted on these joint recommendations in March 2021 and in February 2021, respectively.

(4)

The Scientific, Technical and Economic Committee for Fisheries (STECF) assessed the joint recommendations and the evidence provided by the North Western Waters Member States and the South Western Waters Member States in the Plenary of May 2021 (3). These joint recommendations propose to extend the type of the technical measures that were previously taken by France and Spain at national level, and were assessed by the STECF in the Plenaries of April 2019 (4) and June 2019 (5) to make them applicable in the NWW and SWW sea basins.

(5)

The Fisheries and Aquaculture Expert Group (EGFA) was consulted on the joint recommendations by written procedure in May 2022.

(6)

The North Western Waters Member States’ joint recommendation proposes a spatio-temporal closure for vessels flying the French flag to fish for red seabream in ICES subareas 6 and 7. The STECF (6) concluded that the management measure has the potential to reduce catches of red seabream and that the spatio-temporal closure for commercial fisheries coincides with the spawning period for this species. The proposed measure should therefore be included in Regulation (EU) 2019/1241.

(7)

The South Western Waters Member States’ joint recommendation proposes a seasonal spatio-temporal closure for commercial fisheries and a year-round closure for recreational fisheries in several areas. The joint recommendation also includes an additional seasonal closure for vessels flying the French flag to fish for red seabream in ICES subarea 8. The STECF (7) concluded that the closures for commercial fisheries are in the area where spawning is likely to take place and that the closure for recreational fisheries appears to be in areas where juvenile red seabream aggregate. The proposed measures should therefore be included in Regulation (EU) 2019/1241.

(8)

Both joint recommendations propose in addition setting minimum conservation reference sizes (MCRS) of 36 cm and 40 cm for the catches of red seabream in commercial and recreational fisheries, respectively. In the North Western Waters, this Regulation proposes amending Annex VI to increase the Minimum Conservation Reference Sizes (MCRS) to 36 cm for commercial fisheries and to 40 cm for recreational fisheries. In the South Western Waters, this Regulation proposes amending Annex VII to include the MCRS of 36 cm for commercial fisheries. The MCRS of 40 cm for recreational fisheries is already a legal obligation in accordance with Commission Delegated Regulation (EU) 2020/2013 (8).

(9)

The STECF (9) concluded that the joint recommendation contains positive elements that will improve the management of the stocks, but due to lack of supporting data it is not possible to fully assess the impact of these measures on the respective stocks. Member States will review these measures by 31 December 2023 in light of the ongoing scientific studies and pending the new advice on red seabream to be released by ICES in 2023. Given that both commercial and recreational fisheries contribute to the overall fishing mortality of a stock for which data is scarce and with a zero-catch advice, the proposed MCRS should be included in Annexes VI and VII of Regulation (EU) 2019/1241, except for recreational fisheries in Annex VII, which is already a legal obligation.

(10)

Overall, although the STECF (10) cannot assess whether the catches of red seabream will be reduced, these management measures represent an improvement as compared to those presented in 2019 and have the potential to reduce catches of red seabream as compared to the baseline measures provided in Regulation (EU) 2019/1241. Therefore, Annexes VI and VII of Regulation (EU) 2019/1241 should be amended to include these measures.

(11)

As the measures provided for in this Regulation have a direct impact on the planning of the fishing season of Union vessels and on related economic activities, this Regulation should enter into force on the day following that of its publication.

(12)

The measures in this Regulation applicable to Union waters are in pursuit of the objectives set out in Article 494(1) and (2) of the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part (11), and have regard to the principles referred to in Article 494(3) of that agreement. They are without prejudice to any measures applicable in waters of the United Kingdom of Great Britain and Northern Ireland,

(1)

Commission Delegated Regulation (EU) 2022/127 (2) supplements Regulation (EU) 2021/2116 with rules on paying agencies and other bodies, financial management, clearance of accounts, securities and use of euro.

(2)

In accordance with Article 44(3a) of Regulation (EU) 2021/2116, Member States may decide to pay advances to beneficiaries as regards the interventions referred to in Title III, Chapter III, of Regulation (EU) 2021/2115 of the European Parliament and of the Council (3) and as regards measures regulating or supporting agricultural markets. In order to ensure a coherent and non-discriminatory payment of advances and to guarantee the protection of Union funds, it is appropriate to set out specific conditions for the payment of advances in the form of maximum percentages of forecast expenditure and the requirement for beneficiaries to lodge a security.

(3)

In addition, the provisions on securities laid down in Chapter IV of Delegated Regulation (EU) 2022/127 should be adapted to take into account those specific conditions.

(4)

In Article 24(4) of Delegated Regulation (EU) 2022/127, the reference to Article 27 is incorrect and should be replaced by a reference to Article 26 of that Regulation.

(5)

For aid payments under apiculture programmes made pursuant to Article 55 of Regulation (EU) No 1308/2013 of the European Parliament and of the Council (4), it is appropriate to ensure continuity by maintaining the currently applicable operative event for the exchange rate.

(6)

Delegated Regulation (EU) 2022/127 should therefore be amended and corrected accordingly,

(1)

Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list of novel foods may be placed on the market within the Union.

(2)

Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) has established a Union list of novel foods.

(3)

On 7 January 2018, the company Ynsect NL B.V. (formerly known as Proti-Farm Holding NV) (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place frozen, paste, dried and powder forms of Alphitobius diaperinus larvae (lesser mealworm) on the Union market as a novel food. The applicant requested for Alphitobius diaperinus larvae in frozen, paste (ground), dried, and powder (ground) forms to be used as a food ingredient in a number of food products for the general population, and in powder form in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (3) for the adult population.

(4)

The applicant also made a request to the Commission for the protection of proprietary scientific data for a number of studies submitted in support of the application, namely analytical data on the composition of the novel food (4), the stability studies on the novel food (5), an in vitro protein digestibility study (6), and a sub-chronic 90-day toxicity study (7).

(5)

On 17 July 2018, the Commission requested the European Food Safety Authority (‘the Authority’) to carry out an assessment of frozen and freeze-dried forms of the Alphitobius diaperinus larvae as a novel food.

(6)

On 26 April 2022, the Authority adopted its scientific opinion on the ‘Safety of frozen and freeze-dried formulations of the lesser mealworm (Alphitobius diaperinus larvae) as a novel food pursuant to Regulation (EU) 2015/2283’ (8) in accordance with Article 11 of Regulation (EU) 2015/2283.

(7)

In its scientific opinion, the Authority concluded that the frozen, paste, dried and powder forms of Alphitobius diaperinus larvae are safe under the proposed conditions of use at the proposed use levels. Therefore, the opinion of the Authority gives sufficient grounds to establish that frozen, paste, dried and powder forms of Alphitobius diaperinus larvae under the assessed conditions of use fulfil the conditions for their placing on the market in accordance with Article 12(1) of Regulation (EU) 2015/2283.

(8)

In that scientific opinion, the Authority also concluded, based on limited published evidence on food allergy related to insects, that the consumption of the novel food may induce primary sensitisation and allergic reactions to lesser mealworm proteins. The Authority recommended carrying out further research on the allergenicity of Alphitobius diaperinus larvae.

(9)

In order to address the Authority’s recommendation, the Commission is currently exploring the ways to carry out the necessary research on the allergenicity of Alphitobius diaperinus larvae. Until the data generated by the research is assessed by the Authority, and considering that, to date, evidence directly linking the consumption of Alphitobius diaperinus larvae to cases of primary sensitisation and allergies is inconclusive, the Commission considers that no specific labelling requirements concerning the potential of Alphitobius diaperinus larvae to cause primary sensitization should be included in the Union list of authorised novel foods.

(10)

In its scientific opinion, the Authority also considered that the consumption of Alphitobius diaperinus larvae may cause allergic reactions in persons that are allergic to crustaceans and dust mites. Furthermore, the Authority noted that additional allergens may end up in the novel food, if these allergens are present in the substrate fed to insects. Therefore, it is appropriate that frozen, paste, dried and powder forms of Alphitobius diaperinus larvae as such and foods containing them are appropriately labelled in accordance with Article 9 of Regulation (EU) 2015/2283.

(11)

Food supplements containing the powder form of Alphitobius diaperinus larvae should not be consumed by persons under 18 years of age and therefore, a labelling requirement should be provided in order to properly inform the consumers about that.

(12)

In its scientific opinion, the Authority noted that its conclusion on the safety of the novel food was based on the analytical data on the composition of the novel food, the stability studies on the novel food, the in vitro protein digestibility study, and the sub-chronic 90-day toxicity study submitted by the applicant, without which it could not have assessed the novel food and reached its conclusion.

(13)

The Commission requested the applicant to further clarify the justification provided with regard to their proprietary claim over those studies and to clarify their claim to an exclusive right of reference to them in accordance with Article 26(2)(b) of Regulation (EU) 2015/2283.

(14)

The applicant declared that they held proprietary and exclusive right of reference to the scientific data from those studies at the time they submitted the application.

(15)

The Commission assessed all the information provided by the applicant and considered that they have sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, the scientific data on the composition of the novel food, the stability studies on the novel food, the in vitro protein digestibility study, and the sub-chronic 90-day toxicity study should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place frozen, paste, dried and powder forms of Alphitobius diaperinus larvae on the market within the Union during a period of 5 years from the entry into force of this Regulation.

(16)

However, restricting the authorisation of frozen, paste, dried and powder forms of Alphitobius diaperinus larvae and the reference to the scientific data contained in the applicant’s file to the sole use by them does not prevent subsequent applicants from applying for an authorisation to place on the market the same novel food, provided that their application is based on legally obtained information supporting such authorisation.

(17)

It is appropriate that the inclusion of frozen, paste, dried and powder forms of Alphitobius diaperinus larvae as a novel food in the Union list of novel foods contains the information referred to in Article 9(3) of Regulation (EU) 2015/2283.

(18)

Frozen, paste, dried and powder forms of Alphitobius diaperinus larvae should be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470. The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.

(19)

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(1) of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of Pediococcus pentosaceus DSM 32292. 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 Pediococcus pentosaceus DSM 32292 as a feed additive for all animal species, to be classified in the additive category ‘technological additives’ and in the functional group ‘silage additives’.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 29 June 2022 (2) that, under the proposed conditions of use, the preparation of Pediococcus pentosaceus DSM 32292 does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that it should be considered a respiratory sensitiser and noted that no conclusions could be drawn on its eye and skin irritancy or skin sensitisation potential. The Authority further concluded that the additive, at the proposed concentration, has the potential to improve the preservation of nutrients in silage prepared with moderately difficult to ensile material. 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 the preparation of Pediococcus pentosaceus DSM 32292 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 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)

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)

The substance conjugated linoleic acid (t10, c12)-methylester was authorised without a time limit in accordance with Council Directive 70/524/EEC (2) as a feed additive for all animal species, and was included in the category ‘nutritional additives’ and functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’. That substance was subsequently entered into the Register of feed additives as an existing product, in accordance with Article 10(1), point (b), of Regulation (EC) No 1831/2003.

(3)

The inclusion of conjugated linoleic acid (t10, c12)-methylester in the group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’ was based on a report of 18 March 1994 of the Scientific Committee for Animal Nutrition on the classification of vitamins in the Annex to Directive 70/524/EEC. This report considered that this substance had a similar effect to that of a vitamin.

(4)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003, in conjunction with Article 7 thereof, an application was submitted on 13 October 2010 for the authorisation of conjugated linoleic acid (t10, c12)-methylester as a feed additive for pigs for fattening and dairy cows. The applicant requested the additive to be classified in the additive category ‘nutritional additives’ and in the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’. 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 opinion of 3 December 2015 (3) that, under the proposed conditions of use, conjugated linoleic acid (t10, c12)-methylester used in the nutrition of pigs for fattening and dairy cows does not have adverse effects on animal health, consumer safety or the environment. Concerning pigs for fattening, the Authority concluded that conjugated linoleic acid (t10, c12)-methylester might have a potential for an improvement of the feed to gain ratio. It effectively increases fat firmness due to an increased amount of saturated fatty acids in the subcutaneous fat. There is also an increase in intramuscular fat, its degree of saturation and in marbling score. Conjugated linoleic acid (t10, c12)-methylester might also have a potential to improve the proportion of lean meat to subcutaneous fat in the carcass. For dairy cows, the Authority concluded that conjugated linoleic acid (t10, c12)-methylester reduces milk fat content and has the potential to reduce milk fat yield and milk energy output. In a further opinion of 24 January 2019 (4), the Authority stated that the allocation of this additive to the category ‘nutritional additives’ did not seem to be justified. The Commission, taking into account the considerations from the Authority and the effects of the additive on the zootechnical performance of pigs for fattening and dairy cows, has decided to classify this additive under the category ‘zootechnical additives’ and under the functional group ‘other zootechnical additives’.

(6)

The Authority concluded that the exposure of users by inhalation of the solid product is likely to be minimal. As regards the liquid product, no data on potential mist formation were provided. A beadlet formulation of the liquid product elicited mild but persistent dermal irritation, whereas it was not an eye irritant. The skin sensitisation potential was masked by the effect of the placebo. Neither the liquid nor the solid product was tested as such for skin and eye irritation and skin sensitisation. The Authority further concluded that the additive was effective. The Authority does not consider that there is a need for specific requirements of post-market monitoring. The initial method of analysis provided by the applicant was validated by the Reference Laboratory set up by Regulation (EC) No 1831/2003 and verified by EFSA. Due to the fact that maximum/minimum contents are established in the EFSA opinion, the first method of analysis was not considered sufficient for the purpose of Regulation (EC) No 1831/2003 as the method applied only to feed additives but not to premixtures and feedingstuffs and did not quantify the level of incorporation of the additive in those premixtures and feedingstuffs. The applicant submitted a second method for the quantification in premixtures and feedingstuffs that was validated by the Reference Laboratory.

(7)

The assessment of conjugated linoleic acid (t10, c12)-methylester 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. 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 conjugated linoleic acid (t10, c12)-methylester to the use of that substance in the nutrition of pigs for fattening and dairy cows, 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 such an authorisation. Article 10(2) of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2). Article 10(7) of Regulation (EC) No 1831/2003 sets out specific provisions for the placing on the market and use of products used in the Union as silage additives.

(2)

The preparations of endo-1,4-beta-glucanase from Aspergillus niger CBS 120604, endo-1,3(4)-beta-glucanase from Aspergillus neoniger MUCL 39199, endo-1,4-beta-xylanase from Trichoderma citrinoviride MUCL 39203 and endo-1,4-beta-xylanase from Trichoderma citrinoviride CBS 614.94 were entered in the Register of feed additives as existing products (3) for all animal species belonging to the functional group of silage additives, in accordance with Article 10(1), point (b), of Regulation (EC) No 1831/2003.

(3)

In accordance with Article 10(7) of Regulation (EC) No 1831/2003 in conjunction with Article 10(2) and Article 7 thereof, an application was submitted for the authorisation of the preparations of endo-1,4-beta-glucanase from Aspergillus niger CBS 120604, endo-1,3(4)-beta-glucanase from Aspergillus neoniger MUCL 39199, endo-1,4-beta-xylanase from Trichoderma citrinoviride MUCL 39203 and endo-1,4-beta-xylanase from Trichoderma citrinoviride CBS 614.94 as feed additives for all animal species. The applicant requested the preparations to be classified in the additive category ‘technological additives’ and the functional group ‘silage additives’. 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 7 March 2018 (4) and 29 June 2022 (5), that, under the proposed conditions of use, the preparations concerned do not have adverse effects on animal health, consumer health or the environment. The Authority also concluded that in the absence of data, no conclusion could be drawn on the skin and eye irritancy of the additives and on their skin sensitisation potential. Owing to the proteinaceous nature of the active substances, these preparations should be considered to be potential respiratory sensitisers. The Authority further concluded in its opinion of 29 June 2022 that the preparations concerned have the potential to improve the production of silage from easy, moderate and difficult to ensile forage materials. 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.

(5)

The assessment of the preparations of endo-1,4-beta-glucanase from Aspergillus niger CBS 120604, endo-1,3(4)-beta-glucanase from Aspergillus neoniger MUCL 39199, endo-1,4-beta-xylanase from Trichoderma citrinoviride MUCL 39203 and endo-1,4-beta-xylanase from Trichoderma citrinoviride CBS 614.94 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those preparations 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)

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

(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)

The Polish language version of the Annex to Commission Regulation (EU) No 1300/2014 (2) contains an error in point 4.2.1.4 subpoint (2) that broadens the scope of the requirement set out in that provision.

(2)

The Polish language version of the Annex to Regulation (EU) No 1300/2014 should therefore be corrected accordingly. The other language versions are not affected.

(3)

The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 51(1) of Directive (EU) 2016/797, delivered on 30 January 2014,

(1)

The Agreement between the European Community and the Swiss Confederation on trade in agricultural products (‘the Agreement’) entered into force on 1 June 2002.

(2)

Annexes 1 and 2 to the Agreement list the tariff concessions granted by the Swiss Confederation and the European Union (‘the Parties’), respectively.

(3)

The Parties have agreed to amend Annexes 1 and 2 to the Agreement following the latest review of the Harmonised System and an error made in the latest adaptation of Annex 1 concerning the tariff concession for boneless hams. It has also been decided to incorporate into Annex 1 to the Agreement the tariff concessions granted by Switzerland in 1996 for dog and cat food intended for sale,