23.10.2013   

EN

Official Journal of the European Union

L 281/1

(1)

Pfizer Ltd has submitted an application in accordance with Article 13(3) of Regulation (EC) No 1831/2003 proposing to change the name of the holder of the authorisations as regards Commission Regulations (EC) No 2380/2001 (2), (EC) No 1289/2004 (3), (EC) No 1455/2004 (4), (EC) No 1800/2004 (5), (EC) No 600/2005 (6), (EU) No 874/2010 (7), Commission Implementing Regulations (EU) No 388/2011 (8), (EU) No 532/2011 (9) and (EU) No 900/2011 (10).

(2)

The applicant claims that, as a result of Pfizer Ltd’s decision to make its Animal Health Division a stand-alone company under the name of Zoetis Belgium SA and transfer all the marketing authorisations for coccidiostats from Pfizer Ltd to Zoetis Belgium SA, the latter owns the marketing rights for the additives decoquinate, lasalocid A sodium, maduramicin ammonium alpha, robenidine hydrochloride and salinomycin.

(3)

The proposed change of the terms of the authorisations is purely administrative in nature and does not entail a new assessment of the additives concerned. The European Food Safety Authority was informed of the application.

(4)

To allow the applicant to exploit its marketing rights under the name of Zoetis Belgium SA it is necessary to change the terms of the respective authorisations.

(5)

Regulations (EC) No 2380/2001, (EC) No 1289/2004, (EC) No 1455/2004, (EC) No 1800/2004, (EC) No 600/2005, (EU) No 874/2010, and Implementing Regulations (EU) No 388/2011, (EU) No 532/2011 and (EU) No 900/2011 should therefore be amended accordingly.

(6)

Since the modifications to the terms of the authorisations are not related to safety reasons, it is appropriate to provide for a transitional period during which existing stocks may be used up.

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

(a)

in the title, the words ‘Alpharma (Belgium) BVBA’ are replaced by ‘Zoetis Belgium SA’;

(b)

in the second column of the Annex, the words ‘Pfizer Ltd’ are replaced by ‘Zoetis Belgium SA’.

(a)

in the title, the words ‘Alpharma (Belgium) BVBA’ are replaced by ‘Zoetis Belgium SA’;

(b)

in the second column of the Annex, the words ‘Pfizer Ltd’ are replaced by ‘Zoetis Belgium SA’.

(a)

in the title, the words ‘Alpharma Belgium BVBA’ are replaced by ‘Zoetis Belgium SA’;

(b)

in the second column of Annex I, the words ‘Pfizer Ltd’ are replaced by ‘Zoetis Belgium SA’;

(a)

in the title, the words ‘Alpharma (Belgium) BVBA’ are replaced by ‘Zoetis Belgium SA’;

(b)

in the second column of the Annex to Regulation (EU) No 900/2011, the words ‘Pfizer Ltd’ are replaced by ‘Zoetis Belgium SA’.

23.10.2013   

EN

Official Journal of the European Union

L 281/4

(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,

23.10.2013   

EN

Official Journal of the European Union

L 281/6

(1)

On 12 December 2003, the European Council adopted the EU Strategy against Proliferation of Weapons of Mass Destruction (‘the Strategy’), Chapter III of which contains a list of measures that need to be taken both within the Union and in third countries to combat such proliferation.

(2)

The Union is actively implementing the Strategy and is giving effect to the measures listed in Chapter III thereof, in particular by releasing financial resources to support specific projects conducted by multilateral institutions, such as the International Atomic Energy Agency (IAEA).

(3)

On 17 November 2003, the Council adopted Common Position 2003/805/CFSP on the universalisation and reinforcement of multilateral agreements in the field of non-proliferation of weapons of mass destruction and means of delivery (1). That Common Position calls, inter alia, for the promotion of the conclusion of the IAEA Comprehensive Safeguards Agreements and Additional Protocols and commits the Union to working towards making the IAEA Comprehensive Safeguards Agreements and Additional Protocols the standard for the IAEA verification system.

(4)

On 17 May 2004, the Council adopted Joint Action 2004/495/CFSP on support for IAEA activities under its Nuclear Security Programme and in the framework of the implementation of the EU Strategy against Proliferation of Weapons of Mass Destruction (2).

(5)

On 18 July 2005, the Council adopted Joint Action 2005/574/CFSP on support for IAEA activities in the areas of nuclear security and verification and in the framework of the implementation of the EU Strategy against Proliferation of Weapons of Mass Destruction (3).

(6)

On 12 June 2006, the Council adopted Joint Action 2006/418/CFSP on support for IAEA activities in the areas of nuclear security and verification and in the framework of the implementation of the EU Strategy against Proliferation of Weapons of Mass Destruction (4).

(7)

On 14 April 2008, the Council adopted Joint Action 2008/314/CFSP on support for IAEA activities in the areas of nuclear security and verification and in the framework of the implementation of the EU Strategy against Proliferation of Weapons of Mass Destruction (5).

(8)

On 27 September 2010, the Council adopted Decision 2010/585/CFSP on support for IAEA activities in the areas of nuclear security and verification and in the framework of the implementation of the EU Strategy against Proliferation of Weapons of Mass Destruction (6).

(9)

The strengthening of the control of high-activity radioactive sources in accordance with the G-8 statement and Action Plan on securing radioactive sources, adopted at the 2003 Evian Summit, remains an important objective for the Union, which will be pursued through outreach to third countries.

(10)

On 8 July 2005, the States Parties and the European Atomic Energy Community agreed by consensus to amend the Convention on the Physical Protection of Nuclear Material (CPPNM) with a view to expanding its scope to encompass nuclear material and facilities in peaceful domestic use and storage, as well as in transport, and to oblige States Parties to make violations subject to criminal sanctions.

(11)

On 7 July 2007, the International Convention for the Suppression of Acts of Nuclear Terrorism entered into force. It requires States Parties to enact legislation to criminalise the offences set out in the Convention.

(12)

The IAEA pursues the same objectives as those set out in recitals 3 to 11 of this Decision. This is done through the implementation of its Nuclear Security Plan which is financed entirely through voluntary contributions to the IAEA Nuclear Security Fund.

(13)

The Union participates in the Nuclear Security Summit process and is committed to further enhancing its efforts which aim to strengthen nuclear security and to assist third countries in that regard. The Union welcomes recent steps to strengthen the IAEA Nuclear Security Programme as well as the International Conference on Nuclear Security hosted by the IAEA on 1-5 July 2013. The Union aims to maintain the sustainability and effectiveness of the implementation of previous Joint Actions and Council Decisions in support of the IAEA Nuclear Security Plans and is committed to providing further support in view of the adoption of the IAEA Nuclear Security Plan 2014-2017. Close coordination with the EU Chemical, Biological, Radiological and Nuclear (CBRN) Centres of Excellence Initiative, as well as other initiatives and programmes, will be undertaken to avoid duplication and maximise cost-effectiveness and continued risk reduction.

(14)

The technical implementation of this Decision should be entrusted to the IAEA which, on the basis of its longstanding and broadly-recognised expertise in the area of nuclear security, could significantly strengthen relevant capabilities in the target countries. The projects as supported by the Union can only be financed through voluntary contributions to the IAEA Nuclear Security Fund. Such contributions to be provided by the Union will be instrumental in enabling the IAEA to play a key role in the area of nuclear security by supporting the efforts of countries to fulfil their nuclear security responsibilities, as also recognised in the framework of the Nuclear Security Summit process,

(a)

to achieve progress towards the universalisation of international non-proliferation and nuclear security instruments, including IAEA Comprehensive Safeguards Agreements and Additional Protocols;

(b)

to enhance the protection of proliferation-sensitive materials and equipment and the relevant technology, providing legislative and regulatory assistance in the area of nuclear security and safeguards;

(c)

to strengthen the detection of, and response to, illicit trafficking of nuclear and other radioactive materials.

—

ensure the sustainability and effectiveness of support provided through previous Joint Actions and Council Decisions,

—

strengthen States’ indigenous nuclear security support infrastructures,

—

strengthen States’ legislative and regulatory frameworks,

—

strengthen nuclear security systems and measures for nuclear and other radioactive materials,

—

strengthen States’ institutional infrastructures and capabilities to deal with nuclear and radioactive materials out of regulatory control,

—

support awareness of and strengthen States’ response and resilience to cyber-crime impacting nuclear security,

—

develop additional laboratory capacity to support evaluation of industrial control and electronic system level technologies used to identify vulnerabilities to nuclear-related cyber-crime, and exploit and increase awareness of such issues, including through participation in regional exchanges, and the utilisation of compensatory or remediation measures.

23.10.2013   

EN

Official Journal of the European Union

L 281/14

(1)

Article 10 of Directive 92/65/EEC lays down the animal health requirements which are to be complied with in order for dogs, cats and ferrets to be the subject of trade in the Union. It provides, inter alia, that those animals must satisfy the conditions set out in Article 6 and, where applicable, in Article 7 of Regulation (EU) No 576/2013 of the European Parliament and of the Council of 12 June 2013 on the non-commercial movement of pet animals and repealing Regulation (EC) No 998/2003 (2).

(2)

Article 6 of Regulation (EU) No 576/2013 provides, inter alia, that those animals are to be accompanied by an identification document in the format of a passport in accordance with a model to be adopted by the Commission. The model for that passport is set out in Annex III to Commission Implementing Regulation (EU) No 577/2013 of 28 June 2013 on the model identification documents for the non-commercial movement of dogs, cats and ferrets, the establishment of lists of territories and third countries and the format, layout and language requirements of the declarations attesting compliance with certain conditions provided for in Regulation (EU) No 576/2013 of the European Parliament and of the Council (3).

(3)

Article 7 of Regulation (EU) No 576/2013 provides that Member States may authorise under certain conditions the non-commercial movement into their territory from other Member States of young dogs, cats and ferrets that have not been vaccinated against rabies, or that have been vaccinated but have not yet acquired protective immunity against this disease. Where they authorise such movement, Member States should inform the public by means of internet-based pages to which the Commission provides a link on its internet page that can be used for trade purpose.

(4)

In addition, Article 10 of Directive 92/65/EEC provides that dogs, cats and ferrets are to be accompanied by a health certificate which corresponds to the specimen in Part 1 of Annex E thereto.

(5)

Following the repeal of Regulation (EC) No 998/2003 of the European Parliament and of the Council of 26 May 2003 on the animal health requirements applicable to the non-commercial movement of pet animals and amending Council Directive 92/65/EEC (4) by Regulation (EU) No 576/2013, it is necessary to amend the specimen of that health certificate in order to replace the references to Regulation (EC) No 998/2003 by references to Regulation (EU) No 576/2013.

(6)

The health certificate set out in Part 1 of Annex E to Directive 92/65/EEC takes into account Commission Regulation (EU) No 388/2010 of 6 May 2010 implementing Regulation (EC) No 998/2003 of the European Parliament and of the Council as regards the maximum number of pet animals of certain species that may be the subject of non-commercial movement (5) which provides that the requirements and checks laid down in Directive 92/65/EEC are to apply to the movement of more than five pet animals where the animals are moved into a Member State from another Member State or a third country listed in Section 2 of Part B of Annex II to Regulation (EC) No 998/2003.

(7)

The rules laid down in Regulation (EU) No 388/2010 have been reviewed and included in Regulation (EU) No 576/2013. References to Regulation (EU) No 388/2010 in the specimen of the health certificate set out in Part 1 of Annex E to Directive 92/65/EEC should therefore be deleted.

(8)

Directive 92/65/EEC should therefore be amended accordingly.

(9)

To avoid any disruption of trade, the use of health certificates issued in accordance with Part 1 of Annex E to Directive 92/65/EEC before the date of application of this Decision, should be authorised during a transitional period subject to certain conditions.

(10)

This Decision should apply from the date of application of Regulation (EU) No 576/2013.

(11)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

23.10.2013   

EN

Official Journal of the European Union

L 281/20

(1)

Directive 92/65/EEC lays down the animal health requirements governing trade in and imports into the Union of certain animals. It provides that the import conditions for dogs, cats and ferrets are to be at least equivalent to the relevant conditions provided for in Regulation (EU) No 576/2013 of the European Parliament and of the Council of 12 June 2013 on the non-commercial movement of pet animals and repealing Regulation (EC) No 998/2003 (2).

(2)

Regulation (EU) No 576/2013 provides that where the number of dogs, cats or ferrets moved for non-commercial purposes during a single movement exceeds five, those pet animals are to comply with the animal health requirements laid down in Directive 92/65/EEC for the species concerned, except for certain categories of animals for which a derogation is provided for by Regulation (EU) No 576/2013 under certain conditions.

(3)

Directive 92/65/EEC provides that dogs, cats and ferrets are to be imported into the Union only from a third country which is on a list drawn up in accordance with the procedure referred to in that Directive. In addition, such animals are to be accompanied by a health certificate corresponding to a specimen drawn up in accordance with the procedure referred to therein.

(4)

Commission Implementing Decision 2011/874/EU of 15 December 2011 laying down the list of third countries and territories authorised for imports of dogs, cats and ferrets and for non-commercial movements of more than five dogs, cats and ferrets into the Union and the model certificates for imports and non-commercial movements of those animals into the Union (3) establishes the model health certificate for imports into the Union of dogs, cats and ferrets and provides that the territories or third countries they come from and any territories or third countries they transit must be either listed in Section 2 of Part B or in Part C of Annex II to Regulation (EC) No 998/2003 of the European Parliament and of the Council of 26 May 2003 on the animal health requirements applicable to the non-commercial movement of pet animals and amending Council Directive 92/65/EEC (4) or listed in Part 1 of Annex II to Commission Regulation (EU) No 206/2010 of 12 March 2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements (5).

(5)

In the interest of consistency of Union legislation, it is appropriate to include in that list of authorised territories and third countries the list of third countries that are approved for the importation of equidae into the Union, because those third countries have equally provided sufficient guarantees as to the existence and implementation of rules and principles of certification to be observed by third-country certifying officers in issuing the certificates required by veterinary legislation to prevent misleading or fraudulent certification. The list of third countries from which Member States authorise the import of live equidae is currently set out in Annex I to Commission Decision 2004/211/EC of 6 January 2004 establishing the list of third countries and parts of territory thereof from which Member States authorise imports of live equidae and semen, ova and embryos of the equine species, and amending Decisions 93/195/EEC and 94/63/EC (6).

(6)

Regulation (EC) No 998/2003 has been repealed by Regulation (EU) No 576/2013. Consequently, the list of territories and third countries previously listed in Section 2 of Part B or in Part C of Annex II to Regulation (EC) No 998/2003 is now set out in Annex II to Commission Implementing Regulation (EU) No 577/2013 of 28 June 2013 on the model identification documents for the non-commercial movement of dogs, cats and ferrets, the establishment of lists of territories and third countries and the format, layout and language requirements of the declarations attesting compliance with certain conditions provided for in Regulation (EU) No 576/2013 of the European Parliament and of the Council (7).

(7)

This Decision should therefore provide that imports of dogs, cats or ferrets into the Union are authorised only from territories and third countries listed in Annex I to Decision 2004/211/EC, in Part 1 of Annex II to Regulation (EU) No 206/2010 or in Annex II to Implementing Regulation (EU) No 577/2013.

(8)

Regulation (EU) No 576/2013 provides that dogs, cats and ferrets are not to be moved into a Member State from a territory or a third country other than those listed in Annex II to Implementing Regulation (EU) No 577/2013 unless they have undergone a rabies antibody titration test that complies with the validity requirements set out in Annex IV to Regulation (EU) No 576/2013.

(9)

Those requirements include the obligation to perform that test in a laboratory approved in accordance with Council Decision 2000/258/EC of 20 March 2000 designating a specific institute responsible for establishing the criteria necessary for standardising the serological tests to monitor the effectiveness of rabies vaccines (8) which provides that the Agence française de sécurité sanitaire des aliments (AFSSA) in Nancy, France (integrated since 1 July 2010 into the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail, ANSES) is to appraise the laboratories in Member States and third countries for the purposes of their authorisation to carry out serological tests to monitor the effectiveness of rabies vaccines in dogs, cats and ferrets.

(10)

Commission Decision 2005/64/EC of 26 January 2005 implementing Council Directive 92/65/EEC as regards import conditions for cats, dogs and ferrets for approved bodies, institutes and centres (9) establishes a model veterinary certificate for the imports into the Union of such animals destined for bodies, institutes and centres approved in accordance with Directive 92/65/EEC and provides that imports of those animals are to be authorised from territories or third countries listed in Section 2 of Part B or in Part C of Annex II to Regulation (EC) No 998/2003.

(11)

This Decision should therefore provide that imports into the Union of dogs, cats or ferrets destined for bodies, institutes and centres approved in accordance with Directive 92/65/EEC are authorised only from territories and third countries listed in Annex II to Implementing Regulation (EU) No 577/2013.

(12)

This Decision should therefore establish the new list of territories and third countries authorised for imports of dogs, cats or ferrets into the Union and a common model health certificate for imports into the Union of such animals. Decision 2005/64/EC should therefore be repealed.

(13)

In addition, Commission Decision 94/274/EC of 18 April 1994 laying down the system of identification for dogs and cats that are placed on the market in the United Kingdom and Ireland and not originating in those countries (10) and Commission Decision 94/275/EC of 18 April 1994 on recognising rabies vaccines (11), adopted on the basis of Directive 92/65/EEC before the amendments introduced by Regulation (EC) No 998/2003, have become obsolete and should therefore be repealed.

(14)

Council Directive 96/93/EC of 17 December 1996 on the certification of animals and animal products (12) lays down the rules to be observed in issuing the certificates required by veterinary legislation to prevent misleading or fraudulent certification. It is appropriate to ensure that rules and principles at least equivalent to those laid down in that Directive are applied by official veterinarians of third countries.

(15)

Commission Delegated Regulation (EU) No 1152/2011 of 14 July 2011 supplementing Regulation (EC) No 998/2003 of the European Parliament and of the Council as regards preventive health measures for the control of Echinococcus multilocularis infection in dogs (13) provides that from 1 January 2012, dogs entering Member States or parts thereof listed in Annex I thereto are to be treated against the parasite Echinococcus multilocularis in accordance with the requirements set out in that Regulation.

(16)

It is necessary to provide for a transitional period in order to give Member States time to adjust to the new rules laid down in this Decision and in particular to allow, subject to certain conditions, for the use of animal health certificates issued in accordance with Union rules applicable before the date of application of this Decision.

(17)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

(a)

Annex I to Decision 2004/211/EC;

(b)

Part 1 of Annex II to Regulation (EU) No 206/2010;

(c)

Annex II to Implementing Regulation (EU) No 577/2013.

(a)

they are accompanied by an animal health certificate drawn up in accordance with the model set out in Part 1 of the Annex and completed and signed by an official veterinarian in accordance with the explanatory notes set out in Part 2 of the Annex;

(b)

they comply with the requirements of the animal health certificate referred to in point (a) in respect of the territories or third countries that they come from and any territories or third countries they transit, as referred to in paragraphs 1(a), (b) and (c) of Article 1.

23.10.2013   

EN

Official Journal of the European Union

L 281/27

(1)

Regulation (EU) No 576/2013 of the European Parliament and of the Council of 12 June 2013 on the non-commercial movement of pet animals and repealing Regulation (EC) No 998/2003 (3) lays down the conditions relating to movements of pet animals from third countries and to the model certificate for such movements. That Regulation repeals and replaces Regulation (EC) No 998/2003 with effect from 29 December 2014. Regulation (EU) No 576/2013 provides that where the number of dogs, cats or ferrets moved for non-commercial purposes during a single movement exceeds five, those pet animals are to comply with the animal health requirements laid down in Directive 92/65/EEC.

(2)

Commission Implementing Decision 2011/874/EU of 15 December 2011 laying down the list of third countries and territories authorised for imports of dogs, cats and ferrets and for non-commercial movements of more than five dogs, cats and ferrets into the Union and the model certificates for imports and non-commercial movements of those animals into the Union (4) establishes the list of third countries and territories authorised for imports of dogs, cats and ferrets and for non-commercial movements into the Union of more than five dogs, cats or ferrets, in accordance with Directive 92/65/EEC, and the health certificate for such imports and non-commercial movements and the health certificate for non-commercial movements into the Union of five or less dogs, cats or ferrets, in accordance with Regulation (EC) No 998/2003.

(3)

Following the entry into force of Regulation (EU) No 576/2013, Commission Implementing Regulation (EU) No 577/2013 of 28 June 2013 on the model identification documents for the non-commercial movement of dogs, cats and ferrets, the establishment of lists of territories and third countries and the format, layout and language requirements of the declarations attesting compliance with certain conditions provided for in Regulation (EU) No 576/2013 of the European Parliament and of the Council (5) and Commission Implementing Decision 2013/519/EU of 21 October 2013 laying down the list of territories and third countries authorised for imports of dogs, cats and ferrets and the model health certificates for such imports (6) were adopted.

(4)

On the date of application of Implementing Regulation (EU) No 577/2013 and Implementing Decision 2013/519/EU, the provisions of Implementing Decision 2011/874/EU become obsolete.

(5)

Implementing Regulation (EU) No 577/2013 and Implementing Decision 2013/519/EU apply from 29 December 2014. In the interest of clarity of Union legislation, Implementing Decision 2011/874/EU should be repealed with effect from the same date.

(6)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,