5.8.2014

Official Journal of the European Union

L 232/3

COMMISSION REGULATION (EU) No 845/2014

of 31 July 2014

establishing a prohibition of fishing for sandeel in Union waters of IIa, IIIa and IV — Management areas 1, 2, 3 and 4 by vessels flying the flag of Germany

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules of the common fisheries policy (1), and in particular Article 36(2) thereof,

Whereas:

(1)	Council Regulation (EU) No 43/2014 (2) lays down quotas for 2014.

(2)	According to the information received by the Commission, catches of the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein have exhausted the quota allocated for 2014.

(3)	It is therefore necessary to prohibit fishing activities for that stock,

HAS ADOPTED THIS REGULATION:

Article 1

Quota exhaustion

The fishing quota allocated to the Member State referred to in the Annex to this Regulation for the stock referred to therein for 2014 shall be deemed to be exhausted from the date set out in that Annex.

Article 2

Prohibitions

Fishing activities for the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein shall be prohibited from the date set out in that Annex. In particular it shall be prohibited to retain on board, relocate, tranship or land fish from that stock caught by those vessels after that date.

Article 3

Entry into force

This Regulation shall enter into force on the 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 July 2014.

For the Commission,

On behalf of the President,

Lowri EVANS

Director-General for Maritime Affairs and Fisheries

(1) OJ L 343, 22.12.2009, p. 1.

(2) Council Regulation (EU) No 43/2014 of 20 January 2014 fixing for 2014 the fishing opportunities for certain fish stocks and groups of fish stocks, applicable in Union waters and, to Union vessels, in certain non-Union waters (OJ L 24, 28.1.2014, p. 1).

ANNEX

No	19/TQ43
Member State	Germany
Stock	SAN/2A3A4., SAN/234_1, SAN/234_2, SAN/234_3, SAN/234_4
Species	Sandeel (Ammodytes spp.)
Zone	Union waters of IIa, IIIa and IV — Management areas 1, 2, 3 and 4
Closing date	15.7.2014

5.8.2014

Official Journal of the European Union

L 232/5

COMMISSION IMPLEMENTING REGULATION (EU) No 846/2014

of 4 August 2014

amending Annex D to Council Directive 92/65/EEC as regards the conditions for donor animals of the equine species

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A(I) to Directive 90/425/EEC (1), and in particular the first subparagraph of Article 22 thereof,

Whereas:

(1)	Directive 92/65/EEC lays down the animal health requirements governing trade in and imports into the European Union of animals, semen, ova and embryos not subject to the animal health requirements laid down in the specific acts of the European Union referred to in that Directive.

(2)

Chapter I of Annex D to Directive 92/65/EEC lays down the conditions governing the approval and supervision of centres for the collection of semen of animals of, amongst others, the equine species. Since the collection of semen of animals of the equine species is largely seasonal, the required permanence of the supervision by a centre veterinarian, frequently being contracted by the semen collection centre, appeared to be disproportionate compared to the limited added level of confidence in the animal health guarantees. As long as supervision is guaranteed during the activities of the semen collection centre in respect of semen of animals of the equine species intended for trade the competent authorities should be allowed to establish details of that supervision during the approval process.

(3)

Directive 92/65/EEC also provides that semen of donor animals of the equine species must have been collected from animals meeting the conditions laid down in Chapter II(I) of Annex D to that Directive. Those conditions should be reviewed as regards donor stallions taking into account international standards for health testing set up in the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals (2), and the capacity development in laboratories in the Member States.

(4)

In accordance with Article 12 of Regulation (EC) No 882/2004 of the European Parliament and of the Council (3), the competent authorities may only designate laboratories to carry out the analysis of samples taken during official controls that operate and are assessed and accredited in accordance with EN ISO/IEC 17025.

(5)

In Chapter III of Annex D to Directive 92/65/EEC requirements applicable to, amongst others, processing of embryos are laid down. Those requirements should be reviewed taking into account international standards for processing of embryos set out in Chapter 4.7 of the Terrestrial Animal Health Code (4).

(6)

The recent update of Annex D to Directive 92/65/EEC by Commission Regulation (EU) No 176/2010 (5) did not sufficiently take into account the discontinuous nature of collection of semen, ova and embryos of the equine species for trade and thus frequent testing of donor stallions is unnecessarily required. Additionally, since its adoption laboratory capacities to carry out advanced, highly sensitive, but less laborious tests for contagious equine metritis and equine viral arteritis have developed.

(7)	Annex D to Directive 92/65/EEC should be therefore amended accordingly.

(8)	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

Annex D to Directive 92/65/EEC is amended in accordance with the Annex to this Regulation.

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.

It shall apply from 1 October 2014.

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

Done at Brussels, 4 August 2014.

For the Commission

The President

José Manuel BARROSO

(1) OJ L 268, 14.9.1992, p. 54.

(2) Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, Edition 2013, World Organisation for Animal Health.

(3) Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (OJ L 165, 30.4.2004, p. 1).

(4) Terrestrial Animal Health Code, Edition 2013, World Organisation for Animal Health.

(5) Commission Regulation (EU) No 176/2010 of 2 March 2010 amending Annex D to Council Directive 92/65/EEC as regards semen collection and storage centres, embryo collection and production teams, and conditions for donor animals of the equine, ovine and caprine species and for handling semen, ova and embryos of those species (OJ L 52, 3.3.2010, p. 14).

ANNEX

Annex D to Directive 92/65/EEC is amended as follows:

(1)

In Chapter I(I), point 1.1 is replaced by the following:

‘1.1.

be placed under the supervision of a centre veterinarian authorised by the competent authority;’

;

(2)

Chapter II(I) is amended as follows:

(a)

point 1.5 is replaced by the following:

‘1.5.

it shall be subjected to the following tests, carried out and certified in a laboratory which is recognised by the competent authority and has the tests referred to hereinafter included in its accreditation in accordance with Article 12 of Regulation (EC) No 882/2004 of the European Parliament and of the Council (*1), according to the programme provided for in point 1.6:

(a)	an agar-gel immuno-diffusion test (Coggins test) or an ELISA for equine infectious anaemia with negative result;

(b)

a test for the isolation of the equine arteritis virus or the detection of its genome by polymerase chain reaction (PCR) or real-time PCR carried out with negative result on an aliquot of the entire semen of the donor stallion, unless the donor stallion has reacted with negative result at a serum dilution of one in four in a serum neutralisation test for equine viral arteritis;

(c)

an agent identification test for contagious equine metritis, carried out with negative result in each case on three specimens (swabs) taken from the donor stallion on two occasions with an interval of not less than seven days, and in no case earlier than seven days (systemic treatment) or 21 days (local treatment) after possible antimicrobial treatment of the donor stallion, from at least the following sites:

—	the penile sheath (prepuce),

—	the urethra,

—	the fossa glandis.

The specimens shall be placed in transport medium with activated charcoal, such as Amies medium, before dispatch to the laboratory.

The specimens shall be subjected to at least one of the following tests:

(i)	culture under microaerophilic conditions for at least 7 days for the isolation of Taylorella equigenitalis, set up within 24 hours after taking the specimens from the donor animal, or 48 hours where the specimens are kept cool during transport; or

(ii)	polymerase chain reaction (PCR) or real-time PCR for the detection of genome of Taylorella equigenitalis, carried out within 48 hours after taking the specimens from the donor animal.

(*1) Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (OJ L 165, 30.4.2004, p. 1).’ "

(b)

in point 1.6, the points (a), (b) and (c) are replaced by the following:

‘(a)

if the donor stallion is continuously resident on the semen collection centre for at least 30 days prior to the date of the first semen collection and during the collection period, and no equidae on the semen collection centre come into direct contact with equidae of lower health status than the donor stallion, the tests required in point 1.5 shall be carried out on samples taken from the donor stallion at least once a year at the beginning of the breeding season or prior to the first collection of semen intended for trade in fresh, chilled or frozen semen and not less than 14 days following the date of the commencement of the residence period of at least 30 days prior to the date of first semen collection;

(b)

if the donor stallion is resident on the semen collection centre for at least 30 days prior to the date of the first semen collection and during the collection period, but may leave the centre occasionally under the responsibility of the centre veterinarian for a continuous period of less than 14 days, and/or other equidae on the collection centre come into direct contact with equidae of lower health status, the tests required in point 1.5 shall be carried out as follows:

(i)

at least once a year on samples taken from the donor stallion at the beginning of the breeding season or prior to the first collection of semen intended for trade in fresh, chilled or frozen semen and not less than 14 days following the date of the commencement of the residence period of at least 30 days prior to the date of first semen collection; and

(ii)

during the period of collection of semen intended for trade in fresh, chilled or frozen semen as follows:

—	the test required in point 1.5(a) on samples taken not more than 90 days prior to the collection of semen for trade,

—

the test required in point 1.5(b) on samples taken not more than 30 days prior to the collection of semen for trade, unless the non-shedder state of a donor stallion is confirmed by virus isolation test, PCR or real-time PCR carried out on samples of an aliquot of the entire semen taken not more than 6 months prior to the collection of semen for trade and the donor stallion has reacted with positive result at a serum dilution of at least one in four in a serum neutralisation test for equine viral arteritis,

—	the test required in point 1.5(c) on samples taken not more than 60 days prior to the collection of semen for trade, which in the case of PCR or real-time PCR may be carried out on three specimens (swabs) taken on a single occasion;

(c)

if the donor stallion does not meet the conditions in points (a) and (b) and the semen is collected for trade in frozen semen, the tests required in point 1.5 shall be carried out on samples collected from the donor stallion as follows:

(i)	at least once a year at the beginning of the breeding season;

(ii)	during the storage period provided for in point 1.3(b) of Section I of Chapter III and before the semen is removed from the centre or used, on samples taken not earlier than 14 days and not later than 90 days following the date of collection of the semen.

By way of derogation from point (ii) of the first subparagraph, post-collection sampling and testing for equine viral arteritis as described in 1.5(b) is not required in case the non-shedder state of a seropositive donor stallion is confirmed by virus isolation test, PCR or real-time PCR carried out with negative result on samples of an aliquot of the entire semen of the donor stallion taken twice a year at an interval of at least four months and the donor stallion has reacted with positive result at a serum dilution of at least one in four in a serum neutralisation test for equine viral arteritis.’

(3)

Chapter III(II) is amended as follows:

(a)

point 1.8 is replaced by the following:

‘1.8.

The embryos shall be washed and have an intact zona pellucida, or the embryonic capsule in case of equine embryos, before and immediately after washing. In accordance with the IETS Manual, the standard washing procedure shall be modified to include additional washes with the enzyme trypsin where recommended for the inactivation or removal of certain pathogens.’

;

(b)

point 1.10 is replaced by the following:

‘1.10.

The zona pellucida of each embryo, or the embryonic capsule in case of equine embryos, shall be examined over its entire surface area at not less than 50 × magnification and certified to be intact and free of adherent material.’

(4)

In Chapter IV, point 4 is replaced by the following:

‘4.

In addition to the requirements laid down in Directive 90/426/EEC, donor mares shall:

4.1.	not be used for natural breeding during at least 30 days prior to the date of collection of ova or embryos and between the date of the first sample referred to in points 4.2 and 4.3 and the date of the collection of ova and embryos;

4.2.

be subjected with negative result to an agar-gel immuno-diffusion test (Coggins test) or an ELISA for equine infectious anaemia carried out on a blood sample taken not less than 14 days following the date of the commencement of the period of at least 30 days referred to in point 4.1 and not more than 90 days prior to the collection of ova or embryos for trade;

4.3.

be subjected to an agent identification test for contagious equine metritis, carried out with negative result in each case in a laboratory referred to in point 1.5 of Chapter (II)(I) on at least two specimens (swabs) taken from the donor mare in no case earlier than seven days (systemic treatment) or 21 days (local treatment) after possible antimicrobial treatment of the donor mare, from at least the following sites:

—	the mucosal surfaces of the clitoral fossa,

—	the clitoral sinuses.

The specimens shall be taken during the period referred to in point 4.1 on two occasions with an interval of not less than seven days in the case of the test referred to in point (i), or on one occasion in the case of the test referred to in point (ii).

The specimens shall be placed in transport medium with activated charcoal, such as Amies medium, before dispatch to the laboratory.

The specimens shall be subjected to at least one of the following tests:

(i)	culture under microaerophilic conditions for at least seven days for the isolation of Taylorella equigenitalis, set up within 24 hours after taking the specimens from the donor animal, or 48 hours where the specimens are kept cool during transport; or

(ii)	polymerase chain reaction (PCR) or real-time PCR for the detection of genome of Taylorella equigenitalis, carried out within 48 hours after taking the specimens from the donor animal.’

5.8.2014

Official Journal of the European Union

L 232/10

COMMISSION IMPLEMENTING REGULATION (EU) No 847/2014

of 4 August 2014

concerning the authorisation of DL-selenomethionine 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 authorisation.

(2)	In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of DL-selenomethionine. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(3)	That application concerns the authorisation of DL-selenomethionine, an organic compound of selenium, as a feed additive for all animal species, to be classified in the additive category ‘nutritional additives’.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 30 January 2014 (2) that, under the proposed conditions of use, DL-selenomethionine does not have an adverse effect on animal health, human health or the environment and that its use may be considered as an efficient source of selenium for all animal species. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

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

(6)

The Authority concluded that the limitation of the supplementation with organic selenium established for other organic compounds of selenium should also apply to DL-selenomethionine. Furthermore, in case different compounds of selenium are added to the feed, the supplementation with organic selenium should not exceed 0,2 mg per kg complete feed.

(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

The preparation specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, 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, 4 August 2014.

For the Commission

The President

José Manuel BARROSO

(1) OJ L 268, 18.10.2003, p. 29.

(2) EFSA Journal 2014; 12(2):3567.

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

Selenium in mg/kg of complete feed with a moisture content of 12 %

Category of nutritional additives. Functional group: compounds of trace elements

3b816

—

DL-selenomethionine

Characterisation of the additive

Solid preparation of DL-selenomethionine with a selenium content of 1 800 mg/kg to 2 200 mg/kg

Characterisation of the active substance

Organic selenium in form of DL-selenomethionine ((RS2)-2-amino-4-methylselenylbutanoic acid) from chemical synthesis

Chemical formula: C5H11NO2Se

CAS number: 2578-28-1

Powder with minimum 97 % DL-selenomethionine

Analytical method (1)

For the determination of DL-selenomethionine in the feed additive: high performance liquid chromatography with UV detection (HPLC-UV).

For the determination of total selenium in the feed additive: inductively coupled plasma mass spectrometry (ICP-MS), or inductively coupled plasma atomic emission spectrometry (ICP-AES).

For the determination of total selenium in premixtures, compound feed and feed materials: hydride generation atomic absorption spectrometry (HGAAS) after microwave digestion (EN 16159:2012).

All species

—

0,50 (total)

1.	The additive shall be incorporated into feed in the form of a premixture.

2.	For user safety: breathing protection, safety glasses and gloves should be worn during handling.

3.	Technological additives or feed materials included in the preparation of the additive shall ensure a dusting potential < 0,2 mg selenium/m3 air.

4.	In the directions for use of the additive and premixtures, indicate the storage and stability conditions.

5.	If the preparation contains a technological additive or feed materials for which a maximum content is set or which is subject to other restrictions, the feed additive manufacturer shall provide this information to the customers.

6.	Maximum supplementation with organic selenium: 0,20 mg Se/kg of complete feed with a moisture content of 12 %.

25 August 2024

(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

5.8.2014

Official Journal of the European Union

L 232/13

COMMISSION IMPLEMENTING REGULATION (EU) No 848/2014

of 4 August 2014

concerning the authorisation of L-valine produced by Corynebacterium glutamicum as a feed additive for all animal species and amending Regulation (EC) No 403/2009 as regards the labelling of the feed additive L-valine

(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) and Article 13(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 and modifying such authorisation.

(2)	In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of L-valine. 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 L-valine produced by Corynebacterium glutamicum (KCCM 80058) as a feed additive for all animal species, to be classified in the additive category ‘nutritional additives’.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 8 October 2013 (2) that, under the proposed conditions of use, the L-valine produced by Corynebacterium glutamicum (KCCM 80058) does not have an adverse effect on animal health, human health or the environment and that it is considered an efficacious source of the essential amino acid L-valine for animal nutrition. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(5)	The assessment of that substance 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 as specified in the Annex to this Regulation.

(6)	Commission Regulation (EC) No 403/2009 (3) authorised L-valine produced by Escherichia coli. In order to ensure the differentiation of the additives in the final feed, their identification number should be labelled on feed materials and compound feed together with their name and added amount.

(7)	Regulation (EC) No 403/2009 should therefore be amended accordingly. Since the modifications to the conditions of authorisation are not related to safety reasons, it is appropriate to provide for a transitional period during which existing stocks may be used up.

(8)	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 substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘amino acids, their salts and analogues’, is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.

Article 2

Amendment to Regulation (EC) No 403/2009

In the ninth column of the Annex to Regulation (EC) No 403/2009, the following paragraph is added:

‘Where voluntary declaration of the additive is made on the labelling of feed materials and compound feed, the following shall be included:

—	name and identification number of the additive,

—	added amount of the additive.’

Article 3

Transitional measures

Feed materials and compound feed as referred to in Article 2 which are produced and labelled before 25 February 2015 in accordance with the rules applicable before 25 August 2014 may continue to be placed on the market and used until the existing stocks are exhausted. As regards feed intended for pet animals, the time period for production and labelling referred to in the first sentence shall end 25 August 2016.

Article 4

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, 4 August 2014.

For the Commission

The President

José Manuel BARROSO

(1) OJ L 268, 18.10.2003, p. 29.

(2) EFSA Journal 2013; 11(10):3429.

(3) Commission Regulation (EC) No 403/2009 of 14 May 2009 concerning the authorisation of a preparation of L-valine as a feed additive (OJ L 120, 15.5.2009, p. 3).

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/kg of complete feed with a moisture content of 12 %

Category of nutritional additives. Functional group: amino acids, their salts and analogues.

3c370

—

L-valine

Additive composition

L-valine minimum 98 % (on dry matter basis)

Characterisation of the active substance

L-valine ((2S)-2-amino-3-methylbutanoic acid) produced by Corynebacterium glutamicum (KCCM 80058)

Chemical formula: C5H11NO2

CAS number: 72-18-4

Analytical method (1)

For the determination of L-valine in the feed additive: Food Chemical Codex ‘L-valine monograph’.

For the determination of valine in premixtures, compound feed and feed materials: ion exchange chromatography coupled with post-column derivatisation and spectrophotometric detection (HPLC/VIS) — Commission Regulation (EC) No 152/2009 (OJ L 54, 26.2.2009, p.1).

All species

—

Declarations to be made on the labelling of the additive:

—	moisture content.

Where voluntary declaration of the additive is made on the labelling of feed materials and compound feed, the following shall be included:

—	name and identification number of the additive,

—	added amount of the additive.

25 August 2024

(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

5.8.2014

Official Journal of the European Union

L 232/16

COMMISSION IMPLEMENTING REGULATION (EU) No 849/2014

of 4 August 2014

concerning the authorisation of the preparations of Pediococcus acidilactici NCIMB 30005, Lactobacillus paracasei NCIMB 30151 and Lactobacillus plantarum DSMZ 16627 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 authorisation. Article 10(7) of Regulation (EC) No 1831/2003 in conjunction with Article 10(1) to (4) thereof sets out specific provisions for the evaluation of products used in the Union as silage additives.

(2)

In accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003, the preparations of Pediococcus acidilactici NCIMB 30005, Lactobacillus paracasei NCIMB 30151 and Lactobacillus plantarum DSMZ 16627 were entered in the Register of Feed Additives as existing products belonging to the functional group of silage additives, for all animal species.

(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, applications were submitted for the authorisation of those preparations as feed additives for all animal species, requesting those additives to be classified in the category ‘technological additives’ and in the functional group ‘silage additives’. Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinions of 6 March 2014 (2) that, under the proposed conditions of use, the preparations concerned do not have an adverse effect on animal health, human health or the environment.The Authority also concluded that the preparations of Pediococcus acidilactici NCIMB 30005, Lactobacillus paracasei NCIMB 30151 and Lactobacillus plantarum DSMZ 16627 have the potential to improve the production of silage by increasing the lactic acid concentration and reduce dry matter losses. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the methods of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(5)

The assessment of the preparations of Pediococcus acidilactici NCIMB 30005, Lactobacillus paracasei NCIMB 30151 and Lactobacillus plantarum DSMZ 16627 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 as specified in the Annex to this Regulation.

(6)	Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow 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

The preparations specified in the Annex and feed containing them, which are produced and labelled before 25 February 2015 in accordance with the rules applicable before 25 August 2014 may continue to be placed on the market and used until the existing stocks are exhausted.

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, 4 August 2014.

For the Commission

The President

José Manuel BARROSO

(1) OJ L 268, 18.10.2003, p. 29.

(2) EFSA Journal 2014; 12(3):3613; EFSA Journal 2014; 12(3):3611; EFSA Journal 2014; 12(3):3612.

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

CFU/kg of fresh material

Category of technological additives. Functional group: silage additives

1k21013

—

Pediococcus acidilactici

NCIMB 30005

Additive composition

Preparation of Pediococcus acidilactici NCIMB 30005 containing a minimum of 1 × 107 CFU/g of additive.

Characterisation of the active substance

Viable cells of Pediococcus acidilactici NCIMB 30005.

Analytical method (1)

Enumeration in the feed additive: spread plate method using MRS agar (EN 15786).

Identification: Pulsed Field Gel Electrophoresis (PFGE).

All animal species

—

1.	In the directions for use of the additive and premixture, indicate the storage conditions.

2.	Recommended minimum content of the additive when used without combination with other micro-organisms as silage additives: 5 × 107 CFU/Kg fresh material.

3.	For safety: it is recommended to use breathing protection, eye protection and gloves during handling.

25 August 2024

1k20748

—

Lactobacillus paracasei

NCIMB 30151

Additive composition

Preparation of Lactobacillus paracasei NCIMB 30151 containing a minimum of 1 × 107 CFU/g of additive.

Characterisation of the active substance

Viable cells of Lactobacillus paracasei NCIMB 30151.

Analytical method (1)

Enumeration in the feed additive: spread plate method using MRS agar (EN 15787).

Identification: Pulsed Field Gel Electrophoresis (PFGE).

All animal species

1.	In the directions for use of the additive and premixture, indicate the storage conditions.

2.	Recommended minimum content of the additive when used without combination with other micro-organisms as silage additives: 5 × 107 CFU/Kg fresh material.

3.	For safety: it is recommended to use breathing protection, eye protection and gloves during handling.

1k20749

—

Lactobacillus plantarum

DSMZ 16627

Additive composition

Preparation of Lactobacillus plantarum DSMZ 16627 containing a minimum of 1 × 107 CFU/g of additive.

Characterisation of the active substance

Viable cells of Lactobacillus plantarum DSMZ 16627

Analytical method (1)

Enumeration in the feed additive: spread plate method using MRS agar (EN 15787).

Identification: Pulsed Field Gel Electrophoresis (PFGE).

All animal species

—

1.	In the directions for use of the additive and premixture, indicate the storage conditions.

2.	Recommended minimum content of the additive when used without combination with other micro-organisms as silage additives: 5 × 107 CFU/Kg fresh material.

3.	For Safety: it is recommended to use breathing protection, eye protection and gloves during handling.

25 August 2024

(1) Details of the analytical methods are available at the following address of the Reference Laboratory: www.irmm.jrc.be/eurl-feed-additives

5.8.2014

Official Journal of the European Union

L 232/20

COMMISSION IMPLEMENTING REGULATION (EU) No 850/2014

of 4 August 2014

establishing the standard import values for determining the entry price of certain fruit and vegetables

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1),

Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors (2), and in particular Article 136(1) thereof,

Whereas:

(1)

Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.

(2)

The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,

HAS ADOPTED THIS REGULATION:

Article 1

The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the day 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, 4 August 2014.

For the Commission,

On behalf of the President,

Jerzy PLEWA

Director-General for Agriculture and Rural Development

(1) OJ L 299, 16.11.2007, p. 1.

(2) OJ L 157, 15.6.2011, p. 1.

ANNEX

Standard import values for determining the entry price of certain fruit and vegetables

(EUR/100 kg)
CN code	Third country code (1)	Standard import value
0702 00 00	TR	41,5
0702 00 00	ZZ	41,5
0707 00 05	TR	81,4
0707 00 05	ZZ	81,4
0709 93 10	TR	98,5
0709 93 10	ZZ	98,5
0805 50 10	AR	148,7
	CL	123,3
	UY	134,5
	ZA	157,9
	ZZ	141,1
0806 10 10	BR	177,3
	CL	73,3
	EG	176,8
	MA	155,8
	TR	162,7
	ZZ	149,2
0808 10 80	AR	160,0
	BR	95,1
	CL	106,4
	NZ	121,7
	US	156,0
	ZA	98,6
	ZZ	123,0
0808 30 90	AR	69,4
	CL	102,8
	TR	191,6
	ZA	78,4
	ZZ	110,6
0809 29 00	CA	324,1
	TR	396,5
	US	408,0
	ZZ	376,2
0809 30	MK	58,0
	TR	141,8
	ZZ	99,9
0809 40 05	BA	45,5
	MK	88,1
	ZZ	66,8

(1) Nomenclature of countries laid down by Commission Regulation (EC) No 1833/2006 (OJ L 354, 14.12.2006, p. 19). Code ‘ZZ’ stands for ‘of other origin’.

5.8.2014

Official Journal of the European Union

L 232/22

COUNCIL DECISION

of 30 July 2014

appointing four Irish members and four Irish alternate members of the Committee of the Regions

(2014/515/EU)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 305 thereof,

Having regard to the proposal of the Irish Government,

Whereas:

(1)

On 22 December 2009 and on 18 January 2010, the Council adopted Decisions 2009/1014/EU (1) and 2010/29/EU (2) appointing the members and alternate members of the Committee of the Regions for the period from 26 January 2010 to 25 January 2015. On 20 September 2011, by Council Decision 2011/649/EU (3), Mr Des HURLEY was appointed as member and Ms Catherine YORE was appointed as alternate member until 25 January 2015.

(2)	Four members' seats on the Committee of the Regions have become vacant following the end of the terms of office of Mr Gerry BREEN, Ms Constance HANNIFFY, Mr Des HURLEY and Mr Brian MEANEY.

(3)	Two alternate members' seats have become vacant following the end of the terms of office of Mr Barney STEELE and Ms Catherine YORE.

(4)	Two alternate members' seats will become vacant following the appointment of Ms Maria BYRNE and Ms Mary FREEHILL as members of the Committee of the Regions,

HAS ADOPTED THIS DECISION:

Article 1

The following are hereby appointed to the Committee of the Regions for the remainder of the current term of office, which runs until 25 January 2015:

(a)

as members:

—	Ms Maria BYRNE, Councillor, Limerick City and County Council

—	Mr Eamon DOOLEY, Councillor, Offaly County Council

—	Ms Mary FREEHILL, Councillor, Dublin City Council

—	Mr Neale RICHMOND, Councillor, Dun Laoghaire Rathdown County Council;

and

(b)

as alternate members:

—	Ms Deirdre FORDE, Councillor, Cork County Council

—	Mr Clifford KELLY, Councillor, Cavan County Council

—	Mr Michael MURPHY, Councillor, Tipperary County Council

—	Mr William PATON, Councillor, Carlow County Council.

Article 2

This Decision shall enter into force on the day of its adoption.

Done at Brussels, 30 July 2014.

For the Council

The President

S. GOZI

(1) OJ L 348, 29.12.2009, p. 22.

(2) OJ L 12, 19.1.2010, p. 11.

(3) OJ L 261, 6.10.2011, p. 25.

		ISSN 1977-0677
Official Journal of the European Union		L 232

English edition	Legislation	Volume 57 5 August 2014

Contents		II Non-legislative acts	page
		REGULATIONS
	*	Commission Implementing Regulation (EU) No 843/2014 of 23 July 2014 entering a name in the register of protected designations of origin and protected geographical indications (Upplandskubb (PDO))	1
	*	Commission Implementing Regulation (EU) No 844/2014 of 23 July 2014 entering a name in the register of protected designations of origin and protected geographical indications (Cebularz lubelski (PGI))	2
	*	Commission Regulation (EU) No 845/2014 of 31 July 2014 establishing a prohibition of fishing for sandeel in Union waters of IIa, IIIa and IV — Management areas 1, 2, 3 and 4 by vessels flying the flag of Germany	3
	*	Commission Implementing Regulation (EU) No 846/2014 of 4 August 2014 amending Annex D to Council Directive 92/65/EEC as regards the conditions for donor animals of the equine species ( 1 )	5
	*	Commission Implementing Regulation (EU) No 847/2014 of 4 August 2014 concerning the authorisation of DL-selenomethionine as a feed additive for all animal species ( 1 )	10
	*	Commission Implementing Regulation (EU) No 848/2014 of 4 August 2014 concerning the authorisation of L-valine produced by Corynebacterium glutamicum as a feed additive for all animal species and amending Regulation (EC) No 403/2009 as regards the labelling of the feed additive L-valine ( 1 )	13
	*	Commission Implementing Regulation (EU) No 849/2014 of 4 August 2014 concerning the authorisation of the preparations of Pediococcus acidilactici NCIMB 30005, Lactobacillus paracasei NCIMB 30151 and Lactobacillus plantarum DSMZ 16627 as feed additives for all animal species ( 1 )	16
		Commission Implementing Regulation (EU) No 850/2014 of 4 August 2014 establishing the standard import values for determining the entry price of certain fruit and vegetables	20
		DECISIONS
		2014/515/EU
	*	Council Decision of 30 July 2014 appointing four Irish members and four Irish alternate members of the Committee of the Regions	22
		2014/516/EU
	*	Council Decision of 30 July 2014 appointing three Italian members and an Italian alternate member of the Committee of the Regions	24