(1)

In accordance with Council Decision (EU) 2016/1392 (2), the Amending Protocol to the Agreement between the European Community and the Principality of Monaco providing for measures equivalent to those laid down in Council Directive 2003/48/EC (‘the Amending Protocol’) was signed on 12 July 2016, subject to its conclusion at a later date.

(2)

The text of the Amending Protocol which is the result of the negotiations, duly reflects the negotiating directives issued by the Council as it aligns the Agreement between the European Community and the Principality of Monaco providing for measures equivalent to those laid down in Council Directive 2003/48/EC (3) (the ‘Agreement’) with the latest developments at international level concerning automatic exchange of information, namely, with the Global Standard for automatic exchange of financial account information in tax matters developed by the Organisation for Economic Cooperation and Development (OECD). The Union, the Member States and the Principality of Monaco have actively participated in the work of the Global Forum of the OECD to support the development and implementation of that Global Standard. The text of the Agreement, as amended by the Amending Protocol, is the legal basis for implementing the Global Standard in the relations between the Union and the Principality of Monaco.

(3)

The European Data Protection Supervisor was consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001 of the European Parliament and of the Council (4).

(4)

The Amending Protocol should be approved,

(1)

Regulation (EC) No 329/2007 gives effect to measures provided for in Council Decision (CFSP) 2016/849 (2).

(2)

On 2 March 2016, the United Nations Security Council adopted Resolution (UNSCR) 2270 (2016) providing for new measures against North Korea. In accordance with that Resolution, on 4 April 2016 the Sanctions Committee established pursuant to UNSCR 1718 (2006) published a list of additional goods to which prohibitions on the transfer, procurement and provision of technical assistance apply (the ‘sensitive goods’ list).

(3)

Following the adoption of Resolution (UNSCR) 2270 (2016), on 4 August 2016 the Council adopted Decision (CFSP) 2016/1341 (3). Council Regulation (EU) 2016/1333 (4) amended Regulation (EC) No 329/2007 accordingly, adding Annex Ig.

(4)

This proposal identifies the sensitive goods to be included in Annex Ig of Regulation (EC) No 329/2007 and allocates the reference numbers taken from the Combined Nomenclature as set out in Annex I to Council Regulation (EEC) No 2658/87 (5). Annex Ig of Regulation (EC) No 329/2007 should therefore be amended accordingly,

(1)

Commission Decision 2000/572/EC (3) lays down the animal and public health veterinary certification conditions for the importation into the Union of consignments of certain meat preparations from third countries. It provides that such consignments are to be accompanied by an animal and public health certificate complying with the model set out in Annex II thereto (‘the health certificate for meat preparations’).

(2)

Commission Decision 2007/777/EC (4) lays down the animal and public health conditions for imports into the Union of consignments of meat products and treated stomachs, bladders and intestines. It provides that only consignments complying with the requirements of the model animal health and public health certificate set out in Annex III thereto (‘the health certificate for meat products and treated commodities’) and accompanied by such a certificate are to be imported into the Union.

(3)

Commission Regulation (EU) No 206/2010 (5) lays down the veterinary certification requirements for imports into the Union of consignments of fresh meat of equidae intended for human consumption. It provides that such consignments are only to be imported, if they are accompanied by a veterinary certificate drawn up in accordance with the model veterinary certificate ‘EQU’ for fresh meat, excluding minced meat, of domestic solipeds (Equus caballus, Equus asinus and their cross-breeds) set out in Part 2 of Annex II (‘the EQU certificate’) thereto.

(4)

Council Directive 96/22/EC (6) prohibits, amongst others, the importation from third countries of meat or products intended for human consumption obtained from animals which have been administered certain substances, including beta-agonists. This Directive allows imports of animals intended for breeding, breeding animals at the end of their reproductive life, or meat therefrom, from third countries, which can afford guarantees at least equivalent to those laid down in that Directive, which have been established for the purpose of giving effect to Chapter V of Council Directive 96/23/EC (7) describing the measures to be taken in the event of infringement.

(5)

Directive 96/23/EC lays down measures for monitoring the presence of certain substances and groups of residues in live animals and animal products. It provides that imports of animals for slaughter and of products of animal origin intended for human consumption are only to be authorised from third countries whose monitoring plan has been approved by the Commission.

(6)

Domestic solipeds are usually not raised solely for the production of meat and are only sent for slaughter at the end of their productive life. In the Union, animals of the equidae family are considered to be food-producing animals, unless they are irreversibly excluded from slaughter for human consumption in accordance with Directive 2001/82/EC of the European Parliament and of the Council (8).

(7)

Following audit missions in certain third countries, where deficiencies had been detected, and in order to ensure compliance with the provisions of Directive 96/22/EC, it is necessary to reinforce the guarantees on imports of fresh meat of equidae intended for human consumption, meat preparations as well as meat products and treated stomachs, bladders and intestines produced therefrom as regards the monitoring of substances and groups of residues and substances referred to in Annex I to Directive 96/23/EC.

(8)

Therefore, the health certificate for meat preparations, the health certificate for meat products and treated commodities and the EQU certificate should be amended so that they provide the necessary guarantees that the commodities covered by them, when they are produced from or contain meat of domestic solipeds, were produced from meat which meets the requirements set out for the imports of fresh meat of domestic solipeds.

(9)

Decisions 2000/572/EC and 2007/777/EC and Regulation (EU) No 206/2010 should therefore be amended accordingly.

(10)

To avoid any disruption of trade, imports into the Union of consignments of commodities accompanied by the health certificate for meat preparations, the health certificate for meat products and treated commodities and the EQU certificate issued in accordance with Decisions 2000/572/EC and 2007/777/EC and Regulation (EU) No 206/2010 before the amendments made by this Regulation should continue to be authorised for a transitional period.

(11)

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

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.

(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of a preparation of kidney bean lectins (Phaseolus vulgaris lectins). 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 a preparation of kidney bean lectins (Phaseolus vulgaris lectins) as a feed additive for suckling piglets to be classified in the additive category ‘zootechnical additives’.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinions of 29 October 2014 (2) and 22 October 2015 (3) that, under the proposed conditions of use, the preparation of kidney bean lectins (Phaseolus vulgaris lectins) does not have an adverse effect on animal health, human health or the environment. It further concluded that the additive should be considered as a respiratory sensitizer and there is a potential hazard by inhalation exposure. The Authority has also concluded that it can have some potential to improve the performance of the piglets during the post-weaning period. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(5)

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

(6)

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

(1)

Article 17 of Regulation (EC) No 470/2009 requires that the maximum residue limit (MRL) for pharmacologically active substances intended for use in the Union in veterinary medicinal products for food-producing animals or in biocidal products used in animal husbandry is established in a Regulation.

(2)

Table 1 of the Annex to Commission Regulation (EU) No 37/2010 (2) sets out the pharmacologically active substances and their classification regarding maximum residue limits (MRLs) in foodstuffs of animal origin.

(3)

Monepantel is currently included in that table as an allowed substance, for ovine and caprine species, applicable to muscle, fat, liver, kidney and milk.

(4)

An application for the extension of the existing entry for monepantel to bovine species has been submitted to the European Medicines Agency (EMA).

(5)

The EMA, based on the opinion of the Committee for Medicinal Products for Veterinary Use, has recommended the establishment of an MRL for monepantel in bovine tissues, excluding animals producing milk for human consumption.

(6)

According to Article 5 of Regulation (EC) No 470/2009, the EMA is to consider using MRLs established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species, or MRLs established for a pharmacologically active substance in one or more species for other species.

(7)

The EMA has considered that the extrapolation of the MRL for monepantel from ovine and caprine milk to bovine milk is not appropriate at this time due to insufficient data.

(8)

Regulation (EU) No 37/2010 should therefore be amended accordingly.

(9)

It is appropriate to grant the stakeholders concerned a reasonable period of time to take measures that may be required to comply with the new MRL.

(10)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,

(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,

(1)

On 26 January 2015, 5 February 2015 and 23 June 2015, the Council adopted Decisions (EU) 2015/116 (1), (EU) 2015/190 (2) and (EU) 2015/994 (3) appointing the members and alternate members of the Committee of the Regions for the period from 26 January 2015 to 25 January 2020. On 13 May 2016, by Council Decision (EU) 2016/814 (4), Ms Elisabeth VITOUCH was replaced by Ms Muna DUZDAR as an alternate member.

(2)

An alternate member's seat on the Committee of the Regions has become vacant following the end of the term of office of Ms Muna DUZDAR,

—

Mr Peter FLORIANSCHÜTZ, Abgeordneter zum Wiener Landtag und Mitglied des Gemeinderats der Stadt Wien.

(1)

Article 168 of Directive 2006/112/EC establishes a taxable person's right to deduct value added tax (VAT) charged on supplies of goods and services received by him for the purposes of his taxed transactions. Point (a) of Article 26(1) of that Directive lays down a requirement to account for VAT when a business asset is put to use for the private purposes of the taxable person or his staff or, more generally, for purposes other than those of his business.

(2)

By virtue of Council Implementing Decision 2013/805/EU (2), Poland was authorised, until 31 December 2016, to limit to 50 % the right to deduct VAT on the purchase, intra-Community acquisition, importation, hire, or leasing of certain motorised road vehicles and expenditure related thereto where such vehicle is not entirely used for business purposes, and to relieve the taxable person from accounting for VAT on the non-business use of vehicles covered by the restriction (the ‘derogating measures’).

(3)

By letter registered with the Commission on 8 February 2016, Poland requested authorisation to continue to apply the derogating measures.

(4)

In accordance with the second subparagraph of Article 395(2) of Directive 2006/112/EC, the Commission informed the other Member States, by letter dated 6 June 2016, of the request made by Poland. By letter dated 8 June 2016, the Commission notified Poland that it had all the information necessary to consider the request.

(5)

In accordance with the Article 3(2) of Decision 2013/805/EU, Poland submitted, together with the extension request, a report to the Commission on the application of that Decision, including a review of the percentage limitation applied on the right of deduction. Based on currently available information, Poland believes that a rate of 50 % is still justifiable. At the same time, to avoid double taxation, the requirement for accounting for VAT on the non-business use of a motor vehicle should be suspended where it has been subject to that limitation. Those derogating measures can be justified by the need to simplify the procedure for charging VAT and to prevent evasion through incorrect record keeping and false tax declaration.

(6)

The extension of these derogating measures should be limited in time to allow for an evaluation of their effectiveness and of the appropriate percentage; Poland should therefore be authorised to continue to apply the derogating measures until 31 December 2019.

(7)

Where Poland considers that a further extension of the derogating measures beyond 2019 is necessary, a report on the application of the derogating measures, including a review of the percentage applied, should be submitted to the Commission, together with the extension request by no later than 1 April 2019.

(8)

The extension of the derogating measures will only have a negligible effect on the overall amount of tax collected at the stage of final consumption and will not adversely affect the Union's own resources accruing from VAT.

(9)

Implementing Decision 2013/805/EU should be therefore amended accordingly,

(1)

The Treaty on the Functioning of the European Union (TFEU) stipulates that Member States and the Union are to work towards developing a coordinated strategy for employment and particularly for promoting a skilled, trained and adaptable workforce as well as labour markets that are responsive to economic change with a view to achieving the objectives defined in Article 3 of the Treaty on European Union.

(2)

The Europe 2020 strategy for smart, sustainable and inclusive growth (‘Europe 2020 strategy’) proposed by the Commission enables the Union to turn its economy towards smart, sustainable and inclusive growth, accompanied by high level employment, productivity and social cohesion. Five headline targets constitute shared objectives which guide the action of the Member States, and take into account their relative starting positions and national circumstances as well as the positions and circumstances of the Union. On 14 July 2015, the Council adopted Recommendation (EU) 2015/1184 (4) on broad guidelines for the economic policies of the Member States and of the Union. Furthermore, on 5 October 2015, the Council adopted Decision (EU) 2015/1848 (5) on guidelines for the employment policies of the Member States for 2015 (‘employment guidelines’). Those two sets of guidelines form the integrated guidelines for implementing the Europe 2020 strategy (‘Europe 2020 integrated guidelines’). The European Employment Strategy has the leading role in the implementation of the employment and labour market objectives of the Europe 2020 strategy.

(3)

The Europe 2020 integrated guidelines are in line with the conclusions of the European Council of 17 and 18 March 2016 and with the Stability and Growth Pact. They give precise guidance to the Member States on defining their National Reform Programmes and on implementing reforms, while reflecting interdependence. The employment guidelines should form the basis for any country-specific recommendations the Council may address to the Member States under Article 148(4) TFEU, in parallel with the country-specific recommendations addressed to the Member States under Article 121(2) TFEU. The employment guidelines should also form the basis for the establishment of the Joint Employment Report sent annually by the Council and the Commission to the European Council.

(4)

The examination of Member States' National Reform Programmes contained in the Joint Employment Report shows that Member States should make every effort to boost demand for labour, enhance labour supply, skills and competences, enhance the functioning of labour market, foster social inclusion, combat poverty and promote equal opportunities.

(5)

Member States should explore the use of the European Social Fund when implementing the employment guidelines.

(6)

The employment guidelines should remain stable to ensure a focus on their implementation. Any updating of the employment guidelines should therefore remain strictly limited. In the light of an assessment of the developments of the labour markets and the social situation since the adoption of the employment guidelines in 2015, no update is necessary. The reasons for their adoption in 2015 remain valid, therefore those guidelines should be maintained,

(1)

On 25 October 2010, the Council adopted Decision 2010/638/CFSP (1) concerning restrictive measures against the Republic of Guinea.

(2)

On the basis of a review of Decision 2010/638/CFSP, those restrictive measures should be extended until 27 October 2017.

(3)

Decision 2010/638/CFSP should therefore be amended accordingly,

(1)

Annex IV to Directive 2009/156/EC sets out diagnostic methods for African horse sickness to be used, when necessary, for testing equidae prior to their movement within the Union or imports from non-EU countries.

(2)

Since the adoption of Directive 2009/156/EC, laboratory capacities to carry out advanced, highly sensitive and efficient tests for the diagnosis of African horse sickness have developed. In parallel, the Chapter related to the diagnosis of African horse sickness in the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the World Organisation for Animal Health (OIE) (2) has been amended to reflect that development.

(3)

As part of their 2014 work programme, the European Union Reference Laboratory for African horse sickness (3) produced a report on the technical assessment of the diagnostic methods described in Annex IV to Directive 2009/156/EC. The assessment, which was presented to the Commission in May 2015, concluded that the competitive enzyme-linked immunosorbent assay (ELISA) is no longer available, indirect ELISA is not in common use but could be provided in 4-6 months after the request and that the blocking ELISA is commercially available and commonly used for analysis of samples during the Proficiency Test exercises organised by the European Union Reference Laboratory for African horse sickness.

(4)

In addition, the report points out that the nucleic acid recognition by reverse-transcription polymerase chain reaction (RT-PCR) methods have advantages over serological diagnostic methods, because they allow for the detection of the disease at an early stage of infection. In addition, most of the national reference laboratories of the European Union Member States use real-time RT-PCR methods, including for the diagnosis of African horse sickness, which have proven to be fit for purpose in the annual Proficiency Test exercises performed from 2009 to 2014. The report also indicates that outside the Union there are a number of OIE reference laboratories and other laboratories with specific African horse sickness expertise that have implemented at least one of the real-time RT-PCR methods for the detection of African horse sickness genome.

(5)

On the 24-25 November 2015, the Joined Workshop of African Horse Sickness/Bluetongue European Union Reference Laboratories together with national reference laboratories held in Ascot, United Kingdom, recommended the inclusion in Annex IV to Directive 2009/156/EC of real time reverse transcription (RRT)-polymerase chain reaction (PCR) methods for the detection of the African horse sickness virus.

(6)

Although all available real-time RT-PCR methods for the African horse sickness genome detection are sufficiently sensitive, the procedure described by Agüero et al. (2008) (4) is the most widely used by laboratories. The method described by Guthrie et al. (2013) (5) was specifically designed to ensure that horses from areas at risk of African horse sickness can be transported safely after the minimum quarantine period required in accordance with the Terrestrial Animal Health Code (6) of the OIE.

(7)

It is therefore appropriate to incorporate in Annex IV to Directive 2009/156/EC methods for agent identification and for the detection of antibody as complementary methods for a rapid diagnosis of African horse sickness.

(8)

Annex IV to Directive 2009/156/EC should be therefore amended by deletion of the competitive ELISA test and by an updating the procedures for the indirect and blocking ELISA tests in accordance with Chapter 2.5.1. of the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the OIE, Edition 2016 based on the Version adopted by the World Assembly of Delegates of the OIE in May 2012 (7). At the same time, real-time RT-PCR procedures as described by Agüero et al. (2008) as well as by Guthrie et al. (2013) should be included in that Annex to make those agent identification tests available for the purpose of pre-movement testing.

(9)

Directive 2009/156/EC should therefore be amended accordingly.

(10)

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