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Document L:2023:005:FULL

Official Journal of the European Union, L 005, 6 January 2023


Display all documents published in this Official Journal
 

ISSN 1977-0677

Official Journal

of the European Union

L 5

European flag  

English edition

Legislation

Volume 66
6 January 2023


Contents

 

II   Non-legislative acts

page

 

 

REGULATIONS

 

*

Commission Delegated Regulation (EU) 2023/56 of 19 July 2022 amending Regulation (EU) 2019/1241 of the European Parliament and of the Council as regards specific technical measures for red seabream (Pagellus bogaraveo) in ICES subareas 6 to 8

1

 

*

Commission Delegated Regulation (EU) 2023/57 of 31 October 2022 amending and correcting Delegated Regulation (EU) 2022/127 supplementing Regulation (EU) 2021/2116 of the European Parliament and of the Council

7

 

*

Commission Implementing Regulation (EU) 2023/58 of 5 January 2023 authorising the placing on the market of the frozen, paste, dried and powder forms of Alphitobius diaperinus larvae (lesser mealworm) as a novel food and amending Implementing Regulation (EU) 2017/2470 ( 1 )

10

 

*

Commission Implementing Regulation (EU) 2023/59 of 5 January 2023 concerning the authorisation of a preparation of Pediococcus pentosaceus DSM 32292 as a feed additive for all animal species ( 1 )

16

 

*

Commission Implementing Regulation (EU) 2023/60 of 5 January 2023 concerning the authorisation of conjugated linoleic acid (t10, c12)-methylester as a feed additive for pigs for fattening and dairy cows (holder of authorisation: BASF SE) ( 1 )

19

 

*

Commission Implementing Regulation (EU) 2023/61 of 5 January 2023 concerning the authorisation of a preparation of endo-1,4-beta-glucanase from Aspergillus niger CBS 120604, a preparation of endo-1,3(4)-beta-glucanase from Aspergillus neoniger MUCL 39199, a preparation of endo-1,4-beta-xylanase from Trichoderma citrinoviride MUCL 39203 and a preparation of endo-1,4-beta-xylanase from Trichoderma citrinoviride CBS 614.94 as feed additives for all animal species ( 1 )

24

 

*

Commission Implementing Regulation (EU) 2023/62 of 5 January 2023 correcting the Polish language version of Regulation (EU) No 1300/2014 on the technical specifications for interoperability relating to accessibility of the Union’s rail system for persons with disabilities and persons with reduced mobility ( 1 )

31

 

 

DECISIONS

 

*

Decision No 1/2022 of the Joint Committee on Agriculture of 17 November 2022 amending Annexes 1 and 2 to the Agreement between the European Community and the Swiss Confederation on trade in agricultural products [2023/63]

32

 


 

(1)   Text with EEA relevance.

EN

Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.

The titles of all other Acts are printed in bold type and preceded by an asterisk.


II Non-legislative acts

REGULATIONS

6.1.2023   

EN

Official Journal of the European Union

L 5/1


COMMISSION DELEGATED REGULATION (EU) 2023/56

of 19 July 2022

amending Regulation (EU) 2019/1241 of the European Parliament and of the Council as regards specific technical measures for red seabream (Pagellus bogaraveo) in ICES subareas 6 to 8

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2019/1241 of the European Parliament and of the Council of 20 June 2019 on the conservation of fisheries resources and the protection of marine ecosystems through technical measures, amending Council Regulations (EC) No 1967/2006, (EC) No 1224/2009 and Regulations (EU) No 1380/2013, (EU) No 2016/1139, (EU) 2018/973, (EU) 2019/472 and (EU) 2019/1022 of the European Parliament and of the Council, and repealing Council Regulations (EC) No 894/97, (EC) No 850/98, (EC) No 2549/2000, (EC) No 254/2002, (EC) No 812/2004 and (EC) No 2187/2005 (1), and in particular Article 2(2) and Article 15(2) thereof,

Whereas:

(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,

HAS ADOPTED THIS REGULATION:

Article 1

Annexes VI and VII to Regulation (EU) 2019/1241 are amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

It shall apply until 31 December 2023.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 19 July 2022.

For the Commission

The President

Ursula VON DER LEYEN


(1)  OJ L 198, 25.7.2019, p. 105.

(2)  https://www.ices.dk/sites/pub/Publication%20Reports/Advice/2020/2020/sbr.27.6-8.pdf

(3)  https://stecf.jrc.ec.europa.eu/documents/43805/2874177/STECF+21-05+-+Eval+JRs+LO+and+TM+Reg.pdf

(4)  https://stecf.jrc.ec.europa.eu/documents/43805/2485362/STECF+PLEN+19-01.pdf

(5)  https://stecf.jrc.ec.europa.eu/documents/43805/2620849/STECF+PLEN+19-03.pdf

(6)  https://stecf.jrc.ec.europa.eu/documents/43805/2874177/STECF+21-05+-+Eval+JRs+LO+and+TM+Reg.pdf

(7)  https://stecf.jrc.ec.europa.eu/documents/43805/2874177/STECF+21-05+-+Eval+JRs+LO+and+TM+Reg.pdf

(8)  Commission Delegated Regulation (EU) 2020/2013 of 21 August 2020 amending Regulation (EU) 2019/1241 of the European Parliament and of the Council as regards technical measures for certain demersal and pelagic fisheries in the North Sea and in the South Western Waters (OJ L 415, 10.12.2020, p. 3).

(9)  https://stecf.jrc.ec.europa.eu/documents/43805/2874177/STECF+21-05+-+Eval+JRs+LO+and+TM+Reg.pdf

(10)  https://stecf.jrc.ec.europa.eu/documents/43805/2874177/STECF+21-05+-+Eval+JRs+LO+and+TM+Reg.pdf

(11)  OJ L 149, 30.4.2021, p. 10.


ANNEX

Annexes VI and VII to Regulation (EU) 2019/1241 are amended as follows:

(1)

In Annex VI, Part A is amended as follows:

(a)

The nineteenth entry of table is replaced as follows:

‘Red seabream (Pagellus bogaraveo)

36 cm (1)  (2)  (3)

(b)

The text in point 1 below the table is replaced as follows:

‘1.

The minimum conservation reference sizes specified in this Part for cod (Gadus morhua), haddock (Melanogrammus aeglefinus), saithe (Pollachius virens), pollack (Pollachius pollachius), hake (Merluccius merluccius), megrim (Lepidorhombus spp.), sole (Solea spp.), plaice (Pleuronectes platessa), whiting (Merlangius merlangus), ling (Molva molva), blue ling (Molva dypterygia), mackerel (Scomber spp.), herring (Clupea harengus), horse mackerel (Trachurus spp.), anchovy (Engraulis encrasicolus), bass (Dicentrarchus labrax) and sardine (Sardina pilchardus) shall apply to recreational fisheries in the North Western Waters, except for red seabream (Pagellus bogaraveo), for which a minimum conservation reference size (MCRS) of 40 cm shall apply in ICES sub-areas 6 and 7 until 31 December 2023(1).

(1)

In the absence of new rules adopted before 31 December 2023, as of 1 January 2024 the applicable MCRS for red seabream shall be 33 cm.’

(2)

In Annex VI, the following point is added to Part C:

‘11.

Closed areas for the conservation of red seabream in ICES sub-areas 6 and 7

11.1.

From 1 January to 30 June 2023, all fishing for red seabream in ICES sub-areas 6 and 7 shall be prohibited to vessels flying the French flag.’

(3)

In Annex VII, Part A, the twentieth entry of the table is replaced as follows:

‘Red sea-bream (Pagellus bogaraveo)

36 cm (4)  (5)

(4)

In Annex VII, the following point is added to Part C:

‘5.

Closed areas for the conservation of red seabream in ICES sub-area 8

5.1.

From 1 February to 30 September each year, fishing with bottom set longlines (LLS) and bottom trawls (OTB) in the western area of the Cantabrian Sea, opposite to Asturias and Galicia, shall be prohibited within the geographical areas enclosed by sequentially joining with rhumb lines the following coordinates, which shall be measured according to the WGS84 system:

43°47'00'' N, 005°15'00'' W

43°47'00'' N, 005°12'00'' W

43°43'00'' N, 005°12'00'' W

43°43'00'' N, 005°15'00'' W

43°55'00'' N, 006°46'00'' W

43°55'00'' N, 006°37'00'' W

43°53'00'' N, 006°46'00'' W

43°53'00'' N, 006°37'00'' W

44°00'49'' N, 007°01'12'' W

44°00'49'' N, 006°57'26'' W

43°58'32'' N, 006°57'26'' W

43°58'32'' N, 007°01'12'' W

44°02'48'' N, 007°13'49'' W

44°00'15'' N, 007°10'03'' W

44°00'15'' N, 007°10'03'' W

44°00'15'' N, 007°13'49'' W.

44°10'00'' N, 008°18'00'' W

44°10'00'' N, 008°14'00'' W

44°07'00'' N, 008°14'00'' W

44°07'00'' N, 008°18'00'' W

43°34'00'' N, 004°44'00'' W

43°34'00'' N, 004°39'00'' W

43°32'00'' N, 004°39'00'' W

43°32'00'' N, 004°44'00'' W

44°07'00'' N, 007°50'00'' W

44°07'00'' N, 007°45'00'' W

44°05'00'' N, 007°45'00'' W

44°05'00'' N, 007°50'00'' W

5.2.

From 1 January to 30 June each year, fishing for red seabream in ICES subarea 8 shall be prohibited to vessels flying the French flag.

5.3.

For recreational fisheries, fishing for red seabream shall be prohibited within the geographical areas enclosed by sequentially joining with rhumb lines the following coordinates, which shall be measured according to the WGS84 system:

Area RF 1 (Cariño/Celeiro)

43°46'23'' N, 007°52'04'' W

43°48'30'' N, 007°52'04'' W

43°49'26'' N, 007°41'17'' W

43°45'44'' N, 007°33'21'' W

43°43'49'' N, 007°33'21'' W

Area RF 2 (Ribadeo)

43°33'26'' N, 007°02'58'' W

43°35'27'' N, 007°02'58'' W

43°35'29'' N, 007°01'20'' W

43°33'33'' N, 007°01'20'' W

Area RF 3 (Navia):

43°33'51'' N, 006°44'02'' W

43°35'52'' N, 006°44'02'' W

43°35'52'' N, 006°42'32'' W

43°33'52'' N, 006°42'32'' W

Area RF 4 (Ensenada Canero)

43°33'10'' N, 006°28'55'' W

43°34'53'' N, 006°30'17'' W

43°36'14'' N, 006°28'13'' W

43°34'18'' N, 006°28'13'' W

Area RF 5 (Ensenada de Cabrera/Ría San Martín de la Arena)

43°26'18'' N, 004°04'51'' W

43°28'22'' N, 004°04'51'' W

43°28'55'' N, 004°01'17'' W

43°26'56'' N, 004°01'17'' W

Area RF 6 (Ría de Treto)

43°27'49'' N, 003°25'58'' W

43°28'59'' N, 003°23'36'' W

43°26'16'' N, 003°22'27'' W

43°25'09'' N, 003°24'41'' W

Area RF 7 (Bilbao/Plentzia)

43°21'18'' N, 003°07'47'' W

43°23'18'' N, 003°07'47'' W

43°28'13'' N, 002°56'42'' W

43°26'08'' N, 002°56'42'' W

Area RF 8 (Bermeo/Mundaka)

43°25'36'' N, 002°43'23'' W

43°27'35'' N, 002°43'23'' W

43°26'57'' N, 002°38'45'' W

43°24'57'' N, 002°38'45'' W

5.4.

The measures listed in points 5.1 to 5.3 shall apply until 31 December 2023.’


(1)  This minimum conservation reference size shall apply until 31 December 2023.

(2)  In ICES sub-areas 6 and 7 a minimum conservation reference size of 40 cm shall apply for the catches of red sea-bream in recreational fisheries.

(3)  In the absence of new rules adopted before 31 December 2023, as of 1 January 2024 the applicable MCRS shall be 33 cm.’

(4)  This minimum conservation reference size shall apply until 31 December 2023.

(5)  In the absence of new rules adopted before 31 December 2023, as of 1 January 2024 the applicable MCRS shall be 33 cm.’


6.1.2023   

EN

Official Journal of the European Union

L 5/7


COMMISSION DELEGATED REGULATION (EU) 2023/57

of 31 October 2022

amending and correcting Delegated Regulation (EU) 2022/127 supplementing Regulation (EU) 2021/2116 of the European Parliament and of the Council

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2021/2116 of the European Parliament and of the Council of 2 December 2021 on the financing, management and monitoring of the common agricultural policy and repealing Regulation (EU) No 1306/2013 (1), and in particular Article 44(5), Article 64(3), point (d), and Article 94(5) thereof,

Whereas:

(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,

HAS ADOPTED THIS REGULATION:

Article 1

Amendments to Delegated Regulation (EU) 2022/127

Delegated Regulation (EU) 2022/127 is amended as follows:

(1)

the following Chapter IIIa is inserted:

‘CHAPTER IIIa

Specific conditions for the payment of advances

Article 15a

Specific conditions for the payment of advances referred to in Article 44(3a) of Regulation (EU) 2021/2116

1.   The payment of advances referred to in Article 44(3a) of Regulation (EU) 2021/2116 shall not exceed 80 % of the forecasted expenditure of the approved operational programme or, where relevant, of the interventions referred to in Articles 55 and 58 of Regulation (EU) 2021/2115.

2.   The payment of advances referred to in paragraph 1 shall be subject to the lodging of a security at least equivalent to the amount of the advance.’

;

(2)

Article 27 is replaced by the following:

‘Article 27

Scope

This Section shall apply in cases where specific Union rules provide that a sum may be advanced before the obligation established to obtain any aid or advantage has been met.’

;

(3)

in Article 28, the following paragraph 1a is inserted:

‘1a.   Applications for the release of the security relating to advance payments shall be accompanied by supporting documents proving final entitlement to the sum granted or that the sum granted, plus any addition provided for in the specific Union rules, has been repaid.’

;

(4)

the following Article 31a is inserted:

‘Article 31a

Apiculture programmes

For amounts paid as aid under apiculture programmes pursuant to Article 55 of Regulation (EU) No 1308/2013, the operative event for the exchange rate shall be 1 January of the year when the payment is made.’

.

Article 2

Correction to Delegated Regulation (EU) 2022/127

In Article 24 of Delegated Regulation (EU) 2022/127, the first subparagraph of paragraph 4 is replaced by the following:

‘4.   If an obligation is fulfilled timely, and the presentation of the proof of fulfilment is subject to a fixed time limit, the security covering that obligation shall be forfeited for each calendar day exceeding that time limit according to the formula 0,2/time limit in days set and taking account of Article 26.’

.

Article 3

Entry into force

This Regulation shall enter into force on the seventh day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 31 October 2022.

For the Commission

The President

Ursula VON DER LEYEN


(1)  OJ L 435, 6.12.2021, p. 187.

(2)  Commission Delegated Regulation (EU) 2022/127 of 7 December 2021 supplementing Regulation (EU) 2021/2116 of the European Parliament and of the Council with rules on paying agencies and other bodies, financial management, clearance of accounts, securities and use of euro (OJ L 20, 31.1.2022, p. 95).

(3)  Regulation (EU) 2021/2115 of the European Parliament and of the Council of 2 December 2021 establishing rules on support for strategic plans to be drawn up by Member States under the common agricultural policy (CAP Strategic Plans) and financed by the European Agricultural Guarantee Fund (EAGF) and by the European Agricultural Fund for Rural Development (EAFRD) and repealing Regulations (EU) No 1305/2013 and (EU) No 1307/2013 (OJ L 435, 6.12.2021, p. 1).

(4)  Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (OJ L 347, 20.12.2013, p. 671).


6.1.2023   

EN

Official Journal of the European Union

L 5/10


COMMISSION IMPLEMENTING REGULATION (EU) 2023/58

of 5 January 2023

authorising the placing on the market of the frozen, paste, dried and powder forms of Alphitobius diaperinus larvae (lesser mealworm) as a novel food and amending Implementing Regulation (EU) 2017/2470

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12(1) thereof,

Whereas:

(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,

HAS ADOPTED THIS REGULATION:

Article 1

1.   The frozen, paste, dried and powder forms of Alphitobius diaperinus larvae (lesser mealworm) are authorised to be placed on the market within the Union.

The frozen, paste, dried and powder forms of Alphitobius diaperinus larvae shall be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470.

2.   The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

Article 2

Only the company Ynsect NL B.V. (9) is authorised to place on the market within the Union the novel food referred to in Article 1, for a period of 5 years from the date of entry into force of this Regulation, unless a subsequent applicant obtains an authorisation for that novel food without reference to the scientific data protected pursuant to Article 3 or with the agreement of Ynsect NL B.V.

Article 3

The scientific data contained in the application file and fulfilling the conditions laid down in Article 26(2) of Regulation (EU) 2015/2283 shall not be used for the benefit of a subsequent applicant for a period of 5 years from the date of entry into force of this Regulation without the agreement of Ynsect NL B.V.

Article 4

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 5 January 2023.

For the Commission

The President

Ursula VON DER LEYEN


(1)  OJ L 327, 11.12.2015, p. 1.

(2)  Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72).

(3)  Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).

(4)  Ynsect NL B.V. 2018, 2019, 2020 and 2021 (unpublished).

(5)  Ynsect NL B.V. 2019 and 2020 (unpublished).

(6)  Ynsect NL B.V. 2018 and 2019 (unpublished).

(7)  Ynsect NL B.V. 2021 (unpublished).

(8)  EFSA Journal 2022; 20(7):7325.

(9)  Address: Harderwijkerweg 141B, 3852 AB Ermelo, the Netherlands.


ANNEX

The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

(1)

in Table 1 (Authorised novel foods), the following entry is inserted:

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

Data protection

Frozen, paste, dried and powder forms of Alphitobius diaperinus larvae (lesser mealworm)

Specified food category

Maximum levels (g/100g)

1.

The designation of the novel food on the labelling of the foodstuffs containing it shall be “Frozen/paste Alphitobius diaperinus larvae (lesser mealworm)” or “Dried/powder Alphitobius diaperinus larvae (lesser mealworm)” depending on the form used.

2.

The labelling of food supplements containing the novel food shall bear a statement that those food supplements should not be consumed by persons under 18 years of age.

3.

The labelling of the foodstuffs containing frozen, paste, dried or powder forms of Alphitobius diaperinus larvae (lesser mealworm) shall bear a statement that this ingredient may cause allergic reactions to consumers with known allergies to crustaceans, and products thereof, and to dust mites.

This statement shall appear in close proximity to the list of ingredients.

 

Authorised on 26.1.2023. This inclusion is based on proprietary scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: Ynsect NL B.V, Harderwijkerweg 141B, 3852 AB Ermelo, the Netherlands.

During the period of data protection, the novel food is authorised for placing on the market within the Union only by Ynsect NL B.V., unless a subsequent applicant obtains authorisation for that novel food without reference to the proprietary scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283, or with the agreement of Ynsect NL B.V.

End date of the data protection: 26.1.2028.’

Cereal bars

25 (Dried form)

25 (Powder form)

Bread and rolls

20 (Powder form)

Processed and breakfast cereals

10 (Dried form)

10 (Powder form)

Porridge

15 (Powder form)

Pre-mixes (dry) for baked products

10 (Powder form)

Dried pasta-based products

10 (Powder form)

Stuffed pasta-based products

28 (Frozen or paste form)

10 (Powder form)

Whey powder

35 (Powder form)

Soups

15 (Powder form)

Cereal-, pasta-based dishes

5 (Powder form)

Pizza-based dishes

5 (Dried form)

5 (Powder form)

Noodles

10 (Powder form)

Snacks other than chips

10 (Dried form)

10 (Powder form)

Chips/crisps

10 (Powder form)

Crackers and bread sticks

10 (Powder form)

Peanut butter

15 (Powder form)

Ready-to-eat savoury based sandwich

20 (Powder form)

Meat preparations

14 (Frozen or paste form)

5 (Powder form)

Meat analogues

40 (Frozen or paste form)

15 (Powder form)

Milk and dairy analogues

10 (Powder form)

Chocolate confectionary

5 (Powder form)

Food supplements as defined in Directive 2002/46/EC for the adult population

4 g/day (Powder form)

(2)

in Table 2 (Specifications), the following entry is inserted:

Authorised novel food

Specification

Frozen, paste, dried and powder forms of Alphitobius diaperinus larvae (lesser mealworm)

Description/Definition:

The novel food consists of the frozen, paste, dried, and powder forms of the whole lesser mealworm. The term “lesser mealworm” refers to the larval form of Alphitobius diaperinus, an insect species that belongs to the family of Tenebrionidae (darkling beetles).

The entire lesser mealworms are meant for human consumption, no parts are removed.

The novel food is intended to be marketed in 4 different forms, namely: (i) whole blanched and frozen A. diaperinus larvae (ADL frozen), (ii) paste from whole blanched, ground, and frozen A. diaperinus larvae (ADL paste), (iii) whole blanched, and freeze-dried A. diaperinus larvae (ADL dried), and (iv) powder from whole blanched, freeze-dried and ground A. diaperinus larvae (ADL powder).

A minimum 24 hours fasting period is required to allow the larvae to discard their bowel content before killing the insects by a thermal treatment.

Characteristics/Composition (ADL frozen or paste):

 

Ash (% w/w): ≤ 1,5

 

Moisture (% w/w): 65-80

 

Crude protein (N × 6,25) (% w/w): 12-25

 

Digestible Carbohydrates (% w/w): 0,4-2

 

Fat (% w/w): 5-12

 

Peroxide value (Meq O2/kg fat): ≤ 0,2

 

Dietary fibre (% w/w): 1-4

 

 (*1)Chitin (% w/w): 1,0-2,6

Heavy metals:

 

Lead: ≤ 0,1 mg/kg

 

Cadmium: ≤ 0,05 mg/kg

Mycotoxins:

 

Aflatoxins (Sum of B1, B2, G1, G2): ≤ 4 μg/kg

 

Aflatoxin B1 (μg/kg): ≤ 2

 

Deoxynivalenol: ≤ 200 μg/kg

 

Ochratoxin A: ≤ 1 μg/kg

Microbiological criteria:

 

Total aerobic colony count: ≤ 105  (*2)CFU/g

 

Yeasts and moulds: ≤ 100 CFU/g

 

Escherichia coli: ≤ 50 CFU/g

 

Salmonella spp.: Absence in 25 g

 

Listeria monocytogenes: Absence in 25 g

 

Sulphite-reducing Anaerobes: ≤ 30 CFU/g

 

Bacillus cereus: ≤ 100 CFU/g

 

Enterobacteriaceae: ≤ 100 CFU/g

 

Coagulase-positive staphylococci: ≤ 100 CFU/g

Characteristics/Composition (ADL dried or powder):

 

Ash (% w/w): ≤ 5

 

Moisture (% w/w): 1-5

 

Crude protein (N × 6,25) (% w/w): 50-70

 

Digestible Carbohydrates (% w/w): 1,5-3,5

 

Fat (% w/w): 20-35

 

Peroxide value (Meq O2/kg fat): ≤ 5

 

Dietary fibre (% w/w): 3-6

 

 (*1)Chitin (% w/w): 3,0-9,1

Heavy metals:

 

Lead: ≤ 0,1 mg/kg

 

Cadmium: ≤ 0,05 mg/kg

Mycotoxins:

 

Aflatoxins (Sum of B1, B2, G1, G2): ≤ 4 μg/kg

 

Aflatoxin B1 (μg/kg): ≤ 2

 

Deoxynivalenol: ≤ 200 μg/kg

 

Ochratoxin A: ≤ 1 μg/kg

Microbiological criteria:

 

Total aerobic colony count: ≤ 105 CFU/g

 

Yeasts and moulds: ≤ 100 CFU/g

 

Escherichia coli: ≤ 50 CFU/g

 

Salmonella spp.: Absence in 25 g

 

Listeria monocytogenes: Absence in 25 g

 

Sulfite-reducing Anaerobes: ≤ 30 CFU/g

 

Bacillus cereus: ≤ 100 CFU/g

 

Enterobacteriaceae: ≤ 100 CFU/g

 

Coagulase-positive staphylococci: ≤ 100 CFU/g


(*1)  Chitin calculated as Acid Detergent Fibre.

(*2)  CFU: Colony Forming Units.’


6.1.2023   

EN

Official Journal of the European Union

L 5/16


COMMISSION IMPLEMENTING REGULATION (EU) 2023/59

of 5 January 2023

concerning the authorisation of a preparation of Pediococcus pentosaceus DSM 32292 as a feed additive for all animal species

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

(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,

HAS ADOPTED THIS REGULATION:

Article 1

The preparation specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 5 January 2023.

For the Commission

The President

Ursula VON DER LEYEN


(1)  OJ L 268, 18.10.2003, p. 29.

(2)  EFSA Journal 2022;20(7):7426.


ANNEX

Identification number of the additive

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

CFU/kg of fresh material

Category of technological additives. Functional group: silage additives

1k1018

Pediococcus pentosaceus DSM 32292

Additive composition:

Preparation of Pediococcus pentosaceus DSM 32292 containing a minimum of 1 × 1010 CFU/g additive

Characterisation of the active substance:

Viable cells of Pediococcus pentosaceus DSM 32292

Analytical method  (1):

Enumeration in the feed additive: Spread plate method on MRS agar (EN 15786)

Identification: Pulsed-Field Gel Electrophoresis (PFGE) or DNA sequencing methods

All animal species

-

-

-

1.

In the directions for use of the additive and premixtures, the storage conditions shall be indicated.

2.

Minimum content of the additive when used without combination with other micro-organisms as silage additives: 5×107 CFU/kg of easy and moderately difficult to ensile fresh material (2).

3.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection.

26.1.2033


(1)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en.

(2)  Easy to ensile forage: > 3 % soluble carbohydrates in fresh material; moderately difficult to ensile forage: 1,5-3,0 % soluble carbohydrates in the fresh material, in accordance with Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (OJ L 133, 22.5.2008, p. 1).


6.1.2023   

EN

Official Journal of the European Union

L 5/19


COMMISSION IMPLEMENTING REGULATION (EU) 2023/60

of 5 January 2023

concerning the authorisation of conjugated linoleic acid (t10, c12)-methylester as a feed additive for pigs for fattening and dairy cows (holder of authorisation: BASF SE)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

(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,

HAS ADOPTED THIS REGULATION:

Article 1

The substance specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, is authorised as a feed additive for fattening pigs and dairy cows, in accordance with the conditions laid down in that Annex.

Article 2

1.   The substance specified in the Annex and premixtures containing that substance, which are intended for pigs for fattening and dairy cows and are produced and labelled before 26 July 2023 in accordance with the rules applicable before 26 January 2023 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Feed materials and compound feed containing the substance specified in the Annex, which are intended for pigs for fattening and dairy cows and are produced and labelled before 26 January 2024 in accordance with the rules applicable before 26 January 2023 may continue to be placed on the market and used until the existing stocks are exhausted.

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 5 January 2023.

For the Commission

The President

Ursula VON DER LEYEN


(1)  OJ L 268, 18.10.2003, p. 29.

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

(3)  EFSA Journal 2016;14(1):4348.

(4)  EFSA Journal 2019;17(3):5614.


ANNEX

Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of active substance/kg of complete feedingstuff with a moisture content of 12 %

Category of Zootechnical additives. Functional group: Other zootechnical additives (improvement of zootechnical parameters/performance)

4d895

BASF SE

Conjugated linoleic acid (t10, c12)-methylester

Additive composition:

Preparation of omega-6-fatty acid as t10,c12- octadecadienoic acid (conjugated linoleic acid)-methylester (CLA(t10,c12)-ME).

Liquid formulation:

CLA (t10,c12)-ME ≥ 28 %

CLA (c9,t11)-ME ≥ 28 %

CLA (t10,c12) < 2 %

CLA (c9,t11) < 2 %

Fatty acids of sunflower oil: 38-42 % free or as methylesters and less than 1 % as trans trans isomers.

Solid formulation:

CLA (t10,c12)-ME: ≥ 9 %

CLA (c9,t11)-ME: ≥ 9 %

CLA (t10,c12): < 1 %

CLA (c9,t11): < 1 %

Fatty acids of sunflower oil:13-15 % (free or as methylesters).

Vegetable oils (hydrogenated triglycerides, predominantly stearic acid and to a minor extent palmitic

acid): 44,5 %.

Colloidal silica: 15 %.

Calcium sulphate: 5 %.

Characterisation of the active substance:

Conjugated linoleic acid (t10,c12)-methylester.

Chemical formula: C19 H34O2

CAS number: 21870-97-3

Analytical method :  (1)

For the determination of Omega-6-fatty acid as octadecadienoic acid (trans-10, cis-12- isomer) in feed additive: gas Chromatography coupled to Flame Ionization Detector (GC-FID)

For the quantification of CLA (t10,c12)-methylester in premixtures and feedingstuffs:

high performance liquid chromatography coupled to spectrophotometric detection (HPLC-UV)

Pigs for fattening

-

400

5 000

1.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

2.

For dairy cows, the level of CLA (t10,c12)-ME in the daily ration shall not exceed 10 g/head/day.

3.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential health risks resulting from their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including eye and skin protection.

26.1.2033

Dairy cows

 

175

350

 

 

-

-

 


(1)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports.


6.1.2023   

EN

Official Journal of the European Union

L 5/24


COMMISSION IMPLEMENTING REGULATION (EU) 2023/61

of 5 January 2023

concerning the authorisation of a preparation of endo-1,4-beta-glucanase from Aspergillus niger CBS 120604, a preparation of endo-1,3(4)-beta-glucanase from Aspergillus neoniger MUCL 39199, a preparation of endo-1,4-beta-xylanase from Trichoderma citrinoviride MUCL 39203 and a preparation of endo-1,4-beta-xylanase from Trichoderma citrinoviride CBS 614.94 as feed additives for all animal species

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

(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,

HAS ADOPTED THIS REGULATION:

Article 1

Authorisation

The preparations specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, are authorised as additives in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

Transitional measures

1.   The preparations specified in the Annex and premixtures containing these preparations, which are produced and labelled before 26 July 2023 in accordance with the rules applicable before 26 January 2023 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Compound feed and feed materials containing the preparations specified in the Annex which are produced and labelled before 26 January 2024 in accordance with the rules applicable before 26 January 2023 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.

3.   Compound feed and feed materials containing the preparations specified in the Annex which are produced and labelled before 26 January 2025 in accordance with the rules applicable before 26 January 2023 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food producing animals.

Article 3

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 5 January 2023.

For the Commission

The President

Ursula VON DER LEYEN


(1)  OJ L 268, 18.10.2003, p. 29.

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

(3)  In the Register of feed additives: endo-1,4-beta-glucanase from Aspergillus niger CBS 120604 was identified as cellulase from Aspergillus niger CBS 120604; endo-1,3(4)-beta-glucanase from Aspergillus neoniger MUCL 39199 was identified as beta-glucanase from Aspergillus niger MUCL 39199 or Aspergillus tubingensis MUCL 39199; endo-1,4-beta-xylanase from Trichoderma citrinoviride MUCL 39203 was identified as xylanase from Trichoderma longibrachiatum MUCL 39203 or Trichoderma koningii MUCL 39203; endo-1,4-beta-xylanase from Trichoderma citrinoviride CBS 614.94 was identified as xylanase from Trichoderma longibrachiatum CBS 614.94.

(4)  EFSA Journal 2018;16(4):5224.

(5)  EFSA Journal 2022;20(7):7425.


ANNEX

Identification number of the additive

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

Units of activity of additive/kg of fresh material

Category: technological additives. Functional group: silage additives.

1k105

Endo-1,4-beta-glucanase (EC 3.2.1.4)

Additive composition

Preparation of endo-1,4-beta-glucanase produced by:

Aspergillus niger CBS 120604, having a minimum activity of 25 650 DNS (1)/g additive

Solid form

Characterisation of the active substance

Endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger CBS 120604

Analytical method  (2)

For the determination of endo-1,4-beta-glucanase in the feed additive:

colorimetric (DNS) method based on the enzymatic hydrolysis of the carboxymethyl cellulose (CMC) at pH 4,5 and 37 °C

All animal species

-

-

-

1.

In the directions for use of the additive and premixtures, the storage conditions shall be indicated.

2.

Minimum content of the additive when used without combination with other enzymes or micro-organisms as silage additives: 3 DNS/kg of fresh material.

3.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye, and breathing protection.

26 January 2033


Identification number of the additive

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

Units of activity of additive/kg of fresh material

Category: technological additives. Functional group: silage additives.

1k106

Endo-1,3(4)-beta-glucanase

(EC 3.2.1.6)

Additive composition

Preparation of endo-1,3(4)-β-glucanase produced by:

Aspergillus neoniger MUCL 39199, having a minimum activity of 10 000 DNS (3)/g additive

Solid form

Characterisation of the active substance

Endo-1,3(4)-beta-glucanase (EC 3.2.1.6) produced by Aspergillus neoniger MUCL 39199

Analytical method  (4)

For the determination of endo-1,3(4)-beta-glucanase in the feed additive:

colorimetric (DNS) method based on the enzymatic hydrolysis of the carboxymethyl cellulose (CMC) at pH 4,5 and 37 °C

All animal species

-

-

-

1.

In the directions for use of the additive and premixtures, the storage conditions shall be indicated.

2.

Minimum content of the additive when used without combination with other enzymes or micro-organisms as silage additives: 3,4 DNS/kg of fresh material.

3.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection.

26 January 2033


Identification number of the additive

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

Units of activity of additive/kg of fresh material

Category: technological additives. Functional group: silage additives.

1k107

Endo-1,4-beta-xylanase

(EC 3.2.1.8)

Additive composition

Preparation of endo-1,4-beta-xylanase produced by:

Trichoderma citrinoviride MUCL

39203, having a minimum activity of 51 600 DNS (5)/g additive

Solid form

Characterisation of the active substance

Endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma citrinoviride MUCL 39203

Analytical method  (6)

For the determination of endo-1,4-beta-xylanase in the feed additive:

colorimetric (DNS) method based on the enzymatic hydrolysis of the xylan at pH 4,5 and 37 °C

All animal species

-

-

-

1.

In the directions for use of the additive and premixtures, the storage conditions shall be indicated.

2.

Minimum content of the additive when used without combination with other enzymes or micro-organisms as silage additives: 3,2 DNS/kg of fresh material.

3.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection.

26 January 2033


Identification number of the additive

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

Units of activity of additive/kg of fresh material

Category: technological additives. Functional group: silage additives.

1k108

Endo-1,4-beta-xylanase

(EC 3.2.1.8)

Additive composition

Preparation of endo-1,4-beta-xylanase produced by:

Trichoderma citrinoviride CBS 614.94, having a minimum activity of 70 000 DNS (7)/g additive

Solid form

Characterisation of the active substance

Endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma citrinoviride CBS 614.94

Analytical method  (8)

For the determination of endo-1,4-beta-xylanase in the feed additive:

colorimetric (DNS) method based on the enzymatic hydrolysis of the xylan at pH 4,5 and 37 °C

All animal species

-

-

-

1.

In the directions for use of the additive and premixtures, the storage conditions shall be indicated.

2.

Minimum content of the additive when used without combination with other enzymes or micro-organisms as silage additives: 15 DNS/kg of fresh material.

3.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection.

26 January 2033


(1)  1 DNS (3,5-dinitrosalicylic acid) unit is the amount of reducing sugar released as glucose equivalents in μmol per g per min at pH 4,5 and 37 °C from starch.

(2)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(3)  1 DNS (3,5-dinitrosalicylic acid) unit is the amount of reducing sugar released as glucose equivalents in μmol per g per min at pH 4,5 and 37 °C from starch.

(4)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(5)  1 DNS (3,5-dinitrosalicylic acid) unit is the amount of reducing sugar released as xylose equivalents in μmol per g per min at pH 4,5 and 37 °C from birchwood xylan.

(6)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(7)  1 DNS (3,5-dinitrosalicylic acid) unit is the amount of reducing sugar released as xylose equivalents in μmol per g per min at pH 4,5 and 37 °C from birchwood xylan.

(8)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en


6.1.2023   

EN

Official Journal of the European Union

L 5/31


COMMISSION IMPLEMENTING REGULATION (EU) 2023/62

of 5 January 2023

correcting the Polish language version of Regulation (EU) No 1300/2014 on the technical specifications for interoperability relating to accessibility of the Union’s rail system for persons with disabilities and persons with reduced mobility

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 on the interoperability of the rail system within the European Union (1), and in particular Article 5(11) thereof,

Whereas:

(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,

HAS ADOPTED THIS REGULATION:

Article 1

(does not concern the English language)

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 5 January 2023.

For the Commission

The President

Ursula VON DER LEYEN


(1)  OJ L 138, 26.5.2016, p. 44.

(2)  Commission Regulation (EU) No 1300/2014 of 18 November 2014 on the technical specifications for interoperability relating to accessibility of the Union’s rail system for persons with disabilities and persons with reduced mobility (OJ L 356, 12.12.2014, p. 110).


DECISIONS

6.1.2023   

EN

Official Journal of the European Union

L 5/32


DECISION No 1/2022 OF THE JOINT COMMITTEE ON AGRICULTURE

of 17 November 2022

amending Annexes 1 and 2 to the Agreement between the European Community and the Swiss Confederation on trade in agricultural products [2023/63]

THE JOINT COMMITTEE ON AGRICULTURE,

Having regard to the Agreement between the European Community and the Swiss Confederation on trade in agricultural products, and in particular Article 11 thereof,

Whereas:

(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,

HAS DECIDED AS FOLLOWS:

Article 1

Annexes 1 and 2 to the Agreement between the European Community and the Swiss Confederation on trade in agricultural products are replaced, respectively, by the texts contained in the annexes to this Decision.

Article 2

This Decision shall enter into force on 1 January 2023.

Done at Brussels, 17 November 2022.

For the Joint Committee on Agriculture

The Chair, and the Head of the European Union Delegation

Frank BOLLEN

The Head of the Swiss Delegation

Michèle DRÄPPEN

The Committee Secretary

Luis QUEVEDO LEY


ANNEX 1

CONCESSIONS GRANTED BY SWITZERLAND

The tariff concessions set out below are granted by Switzerland for the following products originating in the European Union and are, where applicable, subject to an annual quantity:

Swiss tariff heading

Description

Customs duty applicable (CHF/100 kg gross weight)

Annual quantity (tonnes net weight)

0101 2991

Live horses (excluding pure-bred horses for breeding and horses for slaughter) (in number of head)

0.00

100 head

0204.5010

Goat meat, fresh, chilled or frozen

40.00

100

0207.1481

Breasts of fowls of domestic species, frozen

15.00

2 100

0207.1491

Cuts and edible offal of fowls of domestic species, including livers (excluding breasts), frozen

15.00

1 200

0207.2781

Breasts of turkeys of domestic species, frozen

15.00

800

0207.2791

Cuts and edible offal of turkeys of domestic species, including livers (excluding breasts), frozen

15.00

600

0207.4210

Ducks of domestic species, not cut in pieces, frozen

15.00

700

 

Fatty livers of ducks or geese of domestic species, fresh or chilled

 

 

0207.4300

of ducks

 

 

0207.5300

of geese

9.50

20

 

Cuts and edible offal of ducks, geese or guinea fowls of domestic species, frozen (excluding fatty livers)

 

 

0207.4591

of ducks

 

 

0207.5591

of geese

 

 

0207.6091

of guinea fowls

15.00

100

0208.1000

Fresh, chilled or frozen meat and edible offal of rabbits or hares

11.00

1 700

0208.9010

Meat and edible offal of game, fresh, chilled or frozen (other than of hares or wild boar)

0.00

100

ex 0210 1191

Hams and cuts thereof, with bone in, of swine (other than wild boar), salted or in brine, dried or smoked

 

 

ex 0210 1991

Hams and cuts thereof, boneless, of swine (other than wild boar), salted or in brine, dried or smoked

0.00

1 000  (1)

0210.2010

Dried meat of bovine animals

0.00

200  (2)

 

Edible birds’ eggs, in shell

 

 

ex 0407 2110

of fowls of the species Gallus domesticus, fresh

 

 

ex 0407 2910

other, fresh

 

 

ex 0407 9010

other, preserved or cooked

47.00

150

ex 0409 0000

Natural acacia honey

8.00

200

ex 0409 0000

Natural honey, other (excluding acacia)

26.00

50

0602.1000

Unrooted cuttings and slips

0.00

unlimited

 

Plants in the form of pomaceous fruit rootstock (of seedling origin or produced by vegetative propagation):

 

 

0602.2011

grafted, bare-rooted

 

 

0602.2019

grafted, with root ball

 

 

0602.2021

not grafted, bare-rooted

 

 

0602.2029

not grafted, with root ball

0.00

 (3)

 

Plants in the form of stone fruit rootstock (of seedling origin or produced by vegetative propagation):

 

 

0602.2031

grafted, bare-rooted

 

 

0602.2039

grafted, with root ball

 

 

0602.2041

not grafted, bare-rooted

 

 

0602.2049

not grafted, with root ball

0.00

 (3)

 

Plants other than in the form of pomaceous or stone fruit rootstock (of seedling origin or produced by vegetative propagation), of kinds which bear edible fruit:

 

 

0602.2051

with bare roots

 

 

0602.2059

other than bare-rooted

0.00

unlimited

 

Trees, shrubs and bushes, of kinds which bear edible fruit, bare-rooted:

 

 

0602.2071

of kinds which bear pomaceous fruit

 

 

0602.2072

of kinds which bear stone fruit

0.00

 (3)

0602.2079

other than of kinds which bear pomaceous or stone fruit

0.00

unlimited

 

Trees, shrubs and bushes, of kinds which bear edible fruit, with root ball:

 

 

0602.2081

of kinds which bear pomaceous fruit

 

 

0602.2082

of kinds which bear stone fruit

0.00

 (3)

0602.2089

other than of kinds which bear pomaceous or stone fruit

0.00

unlimited

0602.3000

Rhododendrons and azaleas, grafted or not

0.00

unlimited

 

Roses, grafted or not:

 

 

0602.4010

wild roses and wild rose stems

 

 

 

other than wild roses or wild rose stems:

 

 

0602.4091

with bare roots

 

 

0602.4099

other than bare-rooted, with root ball

0.00

unlimited

 

Plants (of seedling origin or produced by vegetative propagation), of useful species; mushroom spawn:

 

 

0602.9011

seedling vegetables and turf rolls

 

 

0602.9012

mushroom spawn

 

 

0602.9019

other than seedling vegetables, turf rolls or mushroom spawn

0.00

unlimited

 

Other live plants (including their roots):

 

 

0602.9091

with bare roots

 

 

0602.9099

other than bare-rooted, with root ball

0.00

unlimited

0603.1110

Cut roses of a kind suitable for bouquets or for ornamental purposes, fresh, from 1 May to 25 October

 

 

0603.1210

Cut carnations of a kind suitable for bouquets or for ornamental purposes, fresh, from 1 May to 25 October

 

 

0603.1310

Cut orchids of a kind suitable for bouquets or for ornamental purposes, fresh, from 1 May to 25 October

 

 

0603.1410

Cut chrysanthemums of a kind suitable for bouquets or for ornamental purposes, fresh, from 1 May to 25 October

 

 

0603.1510

Cut lilies (Lilium spp.) of a kind suitable for bouquets or for ornamental purposes, fresh, from 1 May to 25 October

 

 

 

Other cut flowers and flower buds, of a kind suitable for bouquets or for ornamental purposes, fresh, from 1 May to 25 October:

 

 

0603.1911

woody

 

 

0603.1918

other than woody

0.00

1 000

0603.1230

Cut carnations of a kind suitable for bouquets or for ornamental purposes, fresh, from 26 October to 30 April

0.00

unlimited

0603.1330

Cut orchids of a kind suitable for bouquets or for ornamental purposes, fresh, from 26 October to 30 April

 

 

0603.1430

Cut chrysanthemums of a kind suitable for bouquets or for ornamental purposes, fresh, from 26 October to 30 April

 

 

0603.1530

Cut lilies (Lilium spp.) of a kind suitable for bouquets or for ornamental purposes, fresh, from 26 October to 30 April

 

 

0603.1930

Cut tulips of a kind suitable for bouquets or for ornamental purposes, fresh, from 26 October to 30 April

 

 

 

Other cut flowers and flower buds, of a kind suitable for bouquets or for ornamental purposes, fresh, from 26 October to 30 April:

 

 

0603.1931

woody

 

 

0603.1938

other than woody

0.00

unlimited

 

Tomatoes, fresh or chilled:

 

 

0702.0010

cherry tomatoes:

from 21 October to 30 April

 

 

0702.0020

Peretti tomatoes (elongated):

from 21 October to 30 April

 

 

0702.0030

other tomatoes, of a diameter of 80 mm or more (beef tomatoes):

from 21 October to 30 April

 

 

0702.0090

other:

from 21 October to 30 April

0.00

10 000

 

Iceberg lettuce, without outer leaf:

 

 

0705.1111

from 1 January to the end of February

0.00

2 000

 

Witloof chicory, fresh or chilled:

 

 

0705.2110

from 21 May to 30 September

0.00

2 000

0707.0010

Cucumbers for salad, 21 October to 14 April

5.00

200

0707.0030

Pickling cucumbers, > 6 cm but ≤ 12 cm in length, fresh or chilled, from 21 October to 14 April

5.00

100

0707.0031

Pickling cucumbers, > 6 cm but ≤ 12 cm in length, fresh or chilled, from 15 April to 20 October

5.00

2 100

0707.0050

Gherkins, fresh or chilled

3.50

800

 

Aubergines (eggplants), fresh or chilled:

 

 

0709.3010

from 16 October to 31 May

0.00

1 000

0709.5100

0709.5900

Mushrooms, fresh or chilled, of the genus Agaricus or other, with the exception of truffles

0.00

unlimited

 

Sweet peppers, fresh or chilled:

 

 

0709.6011

from 1 November to 31 March

2.50

unlimited

0709.6012

Sweet peppers, fresh or chilled, from 1 April to 31 October

5.00

1 300

 

Courgettes (including courgette flowers), fresh or chilled:

 

 

0709.9950

from 31 October to 19 April

0.00

2 000

ex 0710 8090

Mushrooms (uncooked or cooked by steaming or boiling in water), frozen

0.00

unlimited

0711.9090

Vegetables and mixtures of vegetables, provisionally preserved (for example, by sulphur dioxide gas, in brine, in sulphur water or in other preservative solutions), but unsuitable in that state for immediate consumption

0.00

150

0712.2000

Dried onions, whole, cut, sliced, broken or in powder, but not further prepared:

0.00

100

0713.1011

Peas (Pisum sativum), dried, shelled, whole, unprocessed, for use as animal feed

Rebate of CHF 0.90 on the duty applied

1 000

0713.1019

Peas (Pisum sativum), dried, shelled, whole, unprocessed (excluding those for use as animal feed, for technical purposes or for brewing)

0.00

1 000

 

Hazelnuts or filberts (Corylus spp.), fresh or dried:

 

 

0802.2190

in shell, other than for use as animal feed or for oil extraction

 

 

0802.2290

shelled, other than for use as animal feed or for oil extraction

0.00

unlimited

0802.3290

Tree nuts

0.00

100

ex 0802 9090

Pine nuts, fresh or dried

0.00

unlimited

0805.1000

Fresh or dried oranges

0.00

unlimited

 

Mandarins (including tangerines and satsumas); clementines, wilkings and similar citrus hybrids, fresh or dried

 

 

0805.2100

mandarins (including tangerines and satsumas)

0.00

unlimited

0805.2200

clementines

0.00

unlimited

0805.2900

other

0.00

unlimited

0807.1100

Watermelons, fresh

0.00

unlimited

0807.1900

Melons, fresh, other than watermelons

0.00

unlimited

 

Apricots, fresh, in open packings:

 

 

0809.1011

from 1 September to 30 June

 

 

0809.1091

in other packings:

from 1 September to 30 June

0.00

2 100

0809.4013

Fresh plums, in open packings, from 1 July to 30 September

0.00

600

0810.1010

Strawberries, fresh, from 1 September to 14 May

0.00

10 000

0810.1011

Strawberries, fresh, from 15 May to 31 August

0.00

200

0810.2011

Raspberries, fresh, from 1 June to 14 September

0.00

250

0810.5000

Fresh kiwi fruit

0.00

unlimited

ex 0811 1000

Strawberries, uncooked or cooked by steaming or boiling in water, frozen, not containing added sugar or other sweetening matter, not put up in packings for retail sale, intended for industrial use

10.00

1 000

ex 0811 2090

Raspberries, blackberries, mulberries, loganberries and black, white or red currants, gooseberries, uncooked or cooked by steaming or boiling in water, frozen, not containing added sugar or other sweetening matter, not put up in packings for retail sale, intended for industrial use

10.00

1 200

0811.9010

Bilberries, uncooked or cooked by steaming or boiling in water, frozen, whether or not containing added sugar or other sweetening matter

0.00

200

0811.9090

Edible fruit, uncooked or cooked by steaming or boiling in water, frozen, whether or not containing added sugar or other sweetening matter (excluding strawberries, raspberries, blackberries, mulberries, loganberries and black, white or red currants, gooseberries, bilberries and tropical fruit)

0.00

1 000

0904.2200

Fruits of genus Capsicum or Pimenta, dried, crushed or ground

0.00

150

0910.2000

Saffron

0.00

unlimited

 

Wheat and meslin (except durum wheat), for use as animal feed

 

 

1001.9931

containing other cereals of Chapter 10

 

 

1001.9939

other

Rebate of CHF 0.60 on the duty applied

50 000

 

Maize (corn) for use as animal feed

 

 

1005.9031

containing other cereals of Chapter 10

 

 

1005.9039

other

Rebate of CHF 0.50 on the duty applied

13 000

 

Virgin olive oil, other than for use as animal feed:

 

 

1509.1091

in glass containers holding 2 litres or less

60.60 (4)

unlimited

1509.1099

in glass containers holding more than 2 litres or in other containers

86.70 (4)

unlimited

 

Olive oil and its fractions, whether or not refined, but not chemically modified, other than for use as animal feed:

 

 

1509.9091

in glass containers holding 2 litres or less

60.60 (4)

unlimited

1509.9099

in glass containers holding more than 2 litres or in other containers

86.70 (4)

unlimited

ex 0210 1991

Hams, in brine, boneless, enclosed in a bladder or in an artificial gut (jambon en vessie)

 

 

ex 0210 1991

Piece of boneless chop, smoked (jambon saumoné)

 

 

ex 0210 1991

ex 1602 4910

Pork neck, dried in air, seasoned or not, whole, in pieces or thinly sliced (Coppa)

 

 

1601.0011

1601.0021

Sausages and similar products, of meat, meat offal or blood; food preparations based on these products of animals of headings 0101 to 0104 , excluding wild boar

0.00

3 715

 

Tomatoes, whole or in pieces, prepared or preserved other than by vinegar or acetic acid:

 

 

2002.1010

2002.1020

in containers holding more than 5 kg

in containers holding 5 kg or less

2.50

4.50

unlimited

 

Tomatoes, prepared or preserved other than by vinegar or acetic acid, other than whole or in pieces:

 

 

2002.9010

in containers holding more than 5 kg

0.00

unlimited

2002.9021

Tomato pulp, puree and concentrate, in hermetically sealed containers, with a dry matter content of 25 % or more by weight, consisting of tomatoes and water and possibly salt or other seasoning, in containers holding 5 kg or less

0.00

unlimited

2002.9029

Tomatoes, prepared or preserved other than by vinegar or acetic acid, other than whole or in pieces, and other than tomato pulp, puree or concentrate:

 

 

 

in containers holding 5 kg or less

0.00

unlimited

2003.1000

Mushrooms of the genus Agaricus prepared or preserved other than by vinegar or acetic acid

0.00

1 700

 

Artichokes, prepared or preserved other than by vinegar or acetic acid, frozen, other than products of heading No 2006:

 

 

ex 2004 9018

in containers holding more than 5 kg

17.50

unlimited

ex 2004 9049

in containers holding 5 kg or less

24.50

unlimited

 

Asparagus, prepared or preserved other than by vinegar or acetic acid, not frozen, other than products of heading No 2006:

 

 

2005.6010

in containers holding more than 5 kg

 

 

2005.6090

in containers holding 5 kg or less

0.00

unlimited

 

Olives, prepared or preserved other than by vinegar or acetic acid, not frozen, other than products of heading No 2006:

 

 

2005.7010

in containers holding more than 5 kg

 

 

2005.7090

in containers holding 5 kg or less

0.00

unlimited

 

Capers and artichokes, prepared or preserved other than by vinegar or acetic acid, not frozen, other than products of heading No 2006:

 

 

ex 2005 9911

in containers holding more than 5 kg

17.50

unlimited

ex 2005 9941

in containers holding 5 kg or less

24.50

unlimited

2008.3090

Citrus fruit, otherwise prepared or preserved, whether or not containing added sugar or other sweetening matter or spirit, not elsewhere specified or included

0.00

unlimited

2008.5010

Apricot pulp, otherwise prepared or preserved, not containing added sugar or other sweetening matter or spirit, not elsewhere specified or included

10.00

unlimited

2008.5090

Apricots, otherwise prepared or preserved, whether or not containing added sugar or other sweetening matter or spirit, not elsewhere specified or included

15.00

unlimited

2008.7010

Peach pulp, otherwise prepared or preserved, not containing added sugar or other sweetening matter or spirit, not elsewhere specified or included

0.00

unlimited

2008.7090

Peaches, otherwise prepared or preserved, whether or not containing added sugar or other sweetening matter or spirit, not elsewhere specified or included

0.00

unlimited

 

Juice of any single citrus fruit other than orange, grapefruit or pomelo, unfermented, not containing added spirit:

 

 

ex 2009 3919

not containing added sugar or other sweetening matter, concentrated

6.00

unlimited

ex 2009 3920

containing added sugar or other sweetening matter, concentrated

14.00

unlimited

 

Dessert wines, specialities and mistelles in containers:

 

 

2204.2150

holding 2 litres or less (5)

8.50

unlimited

2204.2250

holding more than 2 litres but not more than 10 litres (5)

8.50

unlimited

2204.2960

holding more than 10 litres (5)

8.50

unlimited

ex 2204 2150

Port, in containers holding 2 litres or less, as described (6)

0.00

1 000  hl

 

Retsina (a Greek white wine), as described (7)

 

 

ex 2204 2121

in containers holding 2 litres or less

 

 

 

in containers holding more than 2 litres but not more than 10 litres, of a total alcoholic strength by volume:

 

 

ex 2204 2221

of more than 13 % vol.

 

 

ex 2204 2222

of 13 % vol. or less

 

 

 

in containers holding more than 10 litres, of a total alcoholic strength by volume:

 

 

ex 2204 2923

of more than 13 % vol.

 

 

ex 2204 2924

of 13 % vol. or less

0.00

500  hl

 

Dog and cat food intended for retail sale in hermetically sealed containers;

 

 

2309.1021

containing milk powder or whey

 

 

2309.1029

other

0.00

6 000  (8)


(1)  Including 480 tonnes of Parma and San Daniele ham under the terms of the exchange of letters of 25 January 1972 between the Community and Switzerland.

(2)  Including 170 tonnes of Bresaola under the terms of the exchange of letters of 25 January 1972 between the Community and Switzerland.

(3)  Subject to an overall annual quota of 60 000 plants.

(4)  Including the contribution to the guarantee fund for compulsory storage.

(5)  Covers only products specified in Annex 7 to the Agreement.

(6)  Description: ‘Port’ means a quality wine produced in a specified region (Oporto in Portugal) in accordance with Regulation (EC) No 1493/1999.

(7)  Description: ‘Retsina’ means a table wine within the meaning of the Community provisions referred to in point A.2 of Annex VII to Regulation (EC) No 1493/1999.

(8)  Concession granted by Switzerland to the European Community under the exchange of letters of 30 June 1996.


ANNEX 2

EUROPEAN UNION CONCESSIONS

The tariff concessions set out below are granted by the European Union for the following products originating in Switzerland and are, where applicable, subject to an annual quantity:

CN code

Description

Customs duty applicable (EUR/100 kg net weight)

Annual quantity (tonnes net weight)

0102 29 41

0102 29 49

0102 29 51

0102 29 59

0102 29 61

0102 29 69

0102 29 91

0102 29 99

ex 0102 39 10

ex 0102 90 91

Live bovine animals of a live weight exceeding 160 kg

0.00

4 600 head

ex 0210 20 90

Meat of bovine animals, boneless, dried

0.00

1 200

ex 0401 40 10

0401 40 90

0401 50 11

0401 50 19

0401 50 31

0401 50 39

0401 50 91

0401 50 99

Cream, of a fat content, by weight, exceeding 6 %

0.00

2 000

0403 10

Yoghurt

0402 29 11

ex 0404 90 83

Special milk, for infants, in hermetically sealed containers of a net content not exceeding 500 g, of a fat content, by weight, exceeding 10 % (1)

43.80

unlimited

0602

Other live plants (including their roots), cuttings and slips; mushroom spawn

0.00

unlimited

0603 11 00

0603 12 00

0603 13 00

0603 14 00

0603 15 00

0603 19

Cut flowers and flower buds of a kind suitable for bouquets or for ornamental purposes, fresh

0.00

unlimited

0701 10 00

Seed potatoes, fresh or chilled

0.00

4 000

0702 00 00

Tomatoes, fresh or chilled

0.00 (2)

1 000

0703 10 19

0703 90 00

Onions (other than seed)

Leeks and other alliaceous vegetables, fresh or chilled

0.00

5 000

0704 10 00

0704 90

Cabbages, cauliflowers, kohlrabi, kale and other similar edible brassicas with the exception of Brussels sprouts, fresh or chilled

0.00

5 500

0705

Lettuce (Lactuca sativa) and chicory (Cichorium spp.), fresh or chilled:

0.00

3 000

0706 10 00

Fresh or chilled carrots and turnips

0.00

5 000

0706 90 10

0706 90 90

Salad beetroot, salsify, celeriac, radishes and similar edible roots, with the exception of horseradish (Cochlearia armoracia), fresh or chilled

0.00

3 000

0707 00 05

Cucumbers, fresh or chilled

0.00 (2)

1 000

0708 20 00

Beans (Vigna spp., Phaseolus spp.), fresh or chilled

0.00

1 000

0709 30 00

Aubergines (eggplants), fresh or chilled

0.00

500

0709 40 00

Celery other than celeriac, fresh or chilled

0.00

500

0709 51 00

0709 59

Mushrooms and truffles, fresh or chilled

0.00

unlimited

0709 70 00

Fresh or chilled spinach, New Zealand spinach and orache spinach

0.00

1 000

0709 99 10

Salad vegetables, other than lettuce (Lactuca sativa) and chicory (Cichorium spp.), fresh or chilled

0.00

1 000

0709 99 20

Fresh or chilled chard (white beet) and cardoons

0.00

300

0709 99 50

Fresh or chilled fennel

0.00

1 000

0709 93 10

Fresh or chilled courgettes

0.00 (2)

1 000

0709 93 90

0709 99 90

Other vegetables, fresh or chilled

0.00

1 000

0710 80 61

0710 80 69

Mushrooms (uncooked or cooked by steaming or boiling in water), frozen

0.00

unlimited

0712 90

Dried vegetables, whole, cut, sliced, broken or in powder, whether or not obtained from cooked vegetables, but not further prepared, with the exception of onions, mushrooms and truffles

0.00

unlimited

ex 0808 10 80

Apples, other than cider apples, fresh

0.00 (2)

3 000

0808 30

0808 40

Pears and quinces, fresh

0.00 (2)

3 000

0809 10 00

Fresh apricots

0.00 (2)

500

0809 29 00

Cherries, other than sour cherries (Prunus cerasus), fresh

0.00 (2)

1 500  (3)

0809 40

Plums and sloes, fresh

0.00 (2)

1 000

0810 10 00

Strawberries

0.00

200

0810 20 10

Raspberries, fresh

0.00

100

0810 20 90

Blackberries, mulberries and loganberries, fresh

0.00

100

1106 30 10

Flour, meal and powder of bananas

0.00

5

1106 30 90

Flour, meal and powder of other fruits of Chapter 8

0.00

unlimited

ex 0210 19 50

Hams, in brine, boneless, enclosed in a bladder or in an artificial gut

0.00

1 900

ex 0210 19 81

Piece of boneless chop, smoked

ex 0210 19 81

ex 1602 49 19

Pork neck, dried in air, seasoned or not, whole, in pieces or thinly sliced

ex 1601 00

Sausages and similar products, of meat, meat offal or blood; food preparations based on these products of animals of headings 0101 to 0104 , excluding wild boar

ex 2002 90 91

ex 2002 90 99

Powdered tomatoes, whether or not containing added sugar, other sweetening matter or starch (4)

0.00

unlimited

2003 90 90

Mushrooms, other of the genus Agaricus, prepared or preserved other than by vinegar or acetic acid

0.00

unlimited

0710 10 00

Potatoes, uncooked or cooked by steaming or by boiling in water, frozen

 

 

2004 10 10

2004 10 99

Potatoes, prepared or preserved other than by vinegar or acetic acid, frozen, other than products of heading No 2006, with the exception of flour, meal or flakes

 

 

2005 20 80

Potatoes, prepared or preserved other than by vinegar or acetic acid, not frozen, other than products of heading No 2006, with the exception of flour, meal or flakes and preparations that are thinly sliced, fried or baked, whether or not salted or flavoured, in airtight packings, suitable for immediate consumption

0.00

3 000

ex 2005 91 00

ex 2005 99

Powdered preparations of vegetables and mixtures of vegetables, whether or not containing added sugar, other sweetening matter or starch (4)

0.00

unlimited

ex 2008 30

Flaked or powdered citrus fruit, whether or not containing added sugar, other sweetening matter or starch (4)

0.00

unlimited

ex 2008 40

Flaked or powdered pears, whether or not containing added sugar, other sweetening matter or starch (4)

0.00

unlimited

ex 2008 50

Flaked or powdered apricots, whether or not containing added sugar, other sweetening matter or starch (4)

0.00

unlimited

2008 60

Cherries, otherwise prepared or preserved, whether or not containing added sugar or other sweetening matter or spirit, not elsewhere specified or included

0.00

500

ex 0811 90 19

ex 0811 90 39

Cherries, uncooked or cooked by steaming or boiling in water, frozen, containing added sugar or other sweetening matter

0811 90 80

Cherries, other than sour cherries (Prunus cerasus), uncooked or cooked by steaming or boiling in water, frozen, not containing added sugar or other sweetening matter

ex 2008 70

Flaked or powdered peaches, whether or not containing added sugar, other sweetening matter or starch (4)

0.00

unlimited

ex 2008 80

Flaked or powdered strawberries, whether or not containing added sugar, other sweetening matter or starch (4)

0.00

unlimited

ex 2008 99

Other flaked or powdered fruits, whether or not containing added sugar, other sweetening matter or starch (4)

0.00

unlimited

ex 2009 19

Powdered orange juice, whether or not containing added sugar or other sweetening matter

0.00

unlimited

ex 2009 21 00

ex 2009 29

Powdered grapefruit juice, whether or not containing added sugar or other sweetening matter

0.00

unlimited

ex 2009 31

ex 2009 39

Powdered juices of any other citrus fruits, whether or not containing added sugar or other sweetening matter

0.00

unlimited

ex 2009 41

ex 2009 49

Powdered pineapple juice, whether or not containing added sugar or other sweetening matter

0.00

unlimited

ex 2009 71

ex 2009 79

Powdered apple juice, whether or not containing added sugar or other sweetening matter

0.00

unlimited

ex 2009 81

ex 2009 89

Powdered juice of any other single fruit or vegetable, whether or not containing added sugar or other sweetening matter

0.00

unlimited


(1)  For the products of this subheading, ‘special milk for infants’ means products that are free of pathogenic and toxicogenic germs and which contain less than 10 000 revivifiable aerobic bacteria and less than two coliform bacteria per gram.

(2)  Where relevant, a specific duty and not the minimum duty should apply.

(3)  Including 1 000 tonnes under the terms of the exchange of letters of 14 July 1986.

(4)  See Joint Declaration on the tariff classification of powdered vegetables and powdered fruit.


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