(1)

The Protocol to the Euro-Mediterranean Agreement establishing an Association between the European Communities and their Member States, of the one part, and the Hashemite Kingdom of Jordan, of the other part, to take account of the accession of the Republic of Bulgaria and Romania to the European Union (hereinafter ‘the Protocol’) was signed on behalf of the European Community and its Member States on 30 November 2009 subject to its conclusion.

(2)

In accordance with Article 8(2) of the Protocol, the Protocol has been applied on a provisional basis since 1 January 2007.

(3)

As a consequence of the entry into force of the Treaty of Lisbon on 1 December 2009, the European Union has replaced and succeeded the European Community.

(4)

The Protocol should be approved,

(1)

Regulation (EU) 2017/625 establishes the framework for official controls and other official activities to verify the correct application of Union food and feed law. That framework includes official controls performed on animals and goods entering the Union from third countries.

(2)

Regulation (EU) 2017/625 requires for certain categories of animals and goods that each consignment is made subject to official controls at designated border control posts of first arrival into the Union, because of the risk those categories of animals and goods may pose to public and animal health.

(3)

In addition to the categories of consignments already listed in Regulation (EU) 2017/625, foodstuffs containing both products of plant origin and processed products of animal origin (composite products), as well as hay and straw should undergo official controls at border control posts as they too may pose a risk to public and animal health.

(4)

Regulation (EU) 2017/625 should therefore be amended accordingly.

(5)

Since Regulation (EU) 2017/625 applies from 14 December 2019, this Regulation should also apply from that date,

(1)

Fishing quotas for the year 2017 have been established by:

(2)

Fishing quotas for the year 2018 have been established by:

(3)

Pursuant to Article 105(1) of Regulation (EC) No 1224/2009, when the Commission has established that a Member State has exceeded the fishing quotas which have been allocated to it, the Commission is to operate deductions from future fishing quotas of that Member State.

(4)

Commission Implementing Regulation (EU) 2018/1969 (9) has established deductions from fishing quotas for certain stocks in 2018 on account of overfishing in the previous years.

(5)

However, for certain Member States no deductions could be operated by Implementing Regulation (EU) 2018/1969 from quotas allocated for the overfished stocks because such quotas are not available for those Member States in the year 2018.

(6)

Article 105(5) of Regulation (EC) No 1224/2009 provides that, if it is not possible to operate deductions on the overfished stock in the year following the overfishing because the Member State concerned has no available quota, deductions may be operated on other stocks in the same geographical area or with the same commercial value. According to Commission Communication 2012/C 72/07 containing Guidelines for deduction of quotas under Article 105(1), (2) and (5) of Regulation (EC) No 1224/2009 (10) such deductions should be preferably operated from quotas allocated for stocks fished by the same fleet as the fleet that overfished the quota, taking into account the need to avoid discards in mixed fisheries.

(7)

The Member States concerned have been consulted with regard to the proposed deductions from quotas allocated for stocks other than those which have been overfished.

(8)

In certain cases, exchanges of fishing opportunities concluded in accordance with Article 16(8) of Regulation (EU) No 1380/2013 of the European Parliament and of the Council (11) enable deductions from the same stocks in the framework of Implementing Regulation (EU) 2018/1969.

(9)

On 17 October 2018, Spain informed the Commission that the catches in 2017 of swordfish in the Atlantic Ocean, South of 5° N (SWO/AS05N) had been erroneously reported. Following corrections submitted on 3 December 2018 by Spain in the aggregated catch data reporting system, it appears that the catch uptake for swordfish in the Atlantic Ocean, South of 5° N remains below the allocated quota for 2017. Therefore, the corresponding deductions should be deleted from the Annex to Implementing Regulation (EU) 2018/1969.

(10)

On 23 November 2018, Spain requested to update its catch declarations regarding yellowfin tuna in IOTC area of competence (YFT/IOTC). On the basis of the last updated data transmitted by Spain on 13 December 2018, it appears that the Spanish 2017 quota was exceeded for yellowfin tuna in IOTC area of competence (YFT/IOTC). The corresponding deduction should consequently be added to the Annex to Implementing Regulation (EU) 2018/1969.

(11)

Moreover, certain deductions required by Implementing Regulation (EU) 2018/1969 appear to be larger than the adapted quota available in the year 2018 and, as a consequence, cannot be entirely operated in that year. According to Communication 2012/C 72/07, the remaining amounts should be deducted from the adapted quotas available in subsequent years until the full overfished amount is paid back.

(12)

Implementing Regulation (EU) 2018/1969 should therefore be amended accordingly.

(13)

This Regulation should apply retroactively from the day on which Implementing Regulation (EU) 2018/1969 establishing the deductions from fishing quotas for the same stocks in 2018 entered into force,

(1)

In accordance with Article 67(3) of Regulation (EC) No 726/2004 of the European Parliament and of the Council (2), the revenue of the European Medicines Agency consists of a contribution from the Union and fees paid by undertakings to that Agency. Regulation (EC) No 297/95 lays down the categories and levels of such fees.

(2)

Those fees should be updated by reference to the inflation rate of 2018. The inflation rate in the Union, as published by the Statistical Office of the European Union (3), was 1,7 % in 2018.

(3)

For the sake of simplicity, the adjusted levels of the fees should be rounded to the nearest EUR 100.

(4)

Regulation (EC) No 297/95 should therefore be amended accordingly.

(5)

For reasons of legal certainty, this Regulation should not apply to valid applications which are pending on 1 April 2019.

(6)

In accordance with Article 12 of Regulation (EC) No 297/95, the update is to be made with effect from 1 April 2019. It is therefore appropriate that this Regulation enters into force as a matter of urgency and applies from that date,

(1)

In accordance with Article 7(1) of Regulation (EC) No 1107/2009, the United Kingdom received on 23 February 2011 an application from Otsuka AgriTechno Co., Ltd for the approval of the active substance flutianil.

(2)

In accordance with Article 9(3) of that Regulation, the United Kingdom, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (‘the Authority’) on 21 October 2011 of the admissibility of the application.

(3)

On 19 June 2013, the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority, assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

(4)

The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009. In accordance with Article 12(3) of Regulation (EC) No 1107/2009, it requested that the applicant supply additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the format of an updated draft assessment report on 2 June 2014.

(5)

On 29 July 2014, the Authority communicated to the applicant, the Member States and the Commission its conclusion (2) on whether the active substance flutianil can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority made its conclusion available to the public.

(6)

The Authority concluded that flutianil should be classified as carcinogen category 2 and reproductive toxicant (for the development) category 2. The active substance was therefore deemed not to fulfil the approval criteria referred to in Article 4(1) of Regulation (EC) No 1107/2009.

(7)

On 4 December 2014, the rapporteur Member State notified its intention to launch a request for harmonised classification under the provisions of Regulation (EC) No 1272/2008 of the European Parliament and of the Council (3). According to that proposal, it was not appropriate to classify flutianil as carcinogen or reproductive toxicant and therefore flutianil was deemed to fulfil the approval criteria referred to in Article 4(1) of Regulation (EC) No 1107/2009. The application was submitted by the United Kingdom to the European Chemicals Agency on 23 February 2015.

(8)

On 10 December 2015, the Commission presented a draft review report for non-approval of flutianil to the Standing Committee on Plants, Animals, Food and Feed. Given the potential implication for decision-making, the Commission decided to await the outcome of the classification process under Regulation (EC) No 1272/2008 before presenting a draft Regulation to the Standing Committee on Plants, Animals, Food and Feed.

(9)

In March 2016, the Risk Assessment Committee of the European Chemicals Agency proposed no classification as carcinogenic or toxic to reproduction for the active substance flutianil (4). On request of the European Commission, the Authority published on 5 July 2018 a ‘Statement on the impact of the harmonised classification on the conclusion on the peer review of the pesticide risk assessment of the active substance flutianil’ (5). In that statement, the Authority acknowledged that the harmonised classification proposed by the Risk Assessment Committee of the European Chemicals Agency was, based on new additional information, different from the provisional classification used in the Authority's conclusion. On 4 October 2018, the active substance flutianil was included in Part 3 of Annex VI to Regulation (EC) No 1272/2008 with no classification as carcinogenic or toxic to reproduction (6).

(10)

The Commission revised the draft review report in order to align it with the outcome of the classification process and submitted it for comments to the applicant together with a draft Regulation on 20 March 2018. The documents were presented to the Standing Committee on Plants, Animals, Food and Feed on 21 March 2018.

(11)

Following the publication of the Authority's statement, on 24 October 2018 the Commission presented to the Standing Committee on Plants, Animals, Food and Feed a revised review report and a draft Regulation providing that flutianil is approved.

(12)

The applicant was given the possibility to submit comments on the revised review report and on the Authority's statement.

(13)

As regards the new criteria to identify endocrine disrupting properties set in Commission Regulation (EU) 2018/605 (7), which became applicable on 10 November 2018, and the Joint guidance document to identify endocrine disrupting substances (8), the information contained in the conclusions of the Authority allow to infer that it is highly unlikely that flutianil is an endocrine disruptor via the estrogenic, androgenic, thyroidogenic and steroidogenic modalities. Although effects on the thyroid (weight increase) were observed, these occurred only at the top doses exceeding the maximum recommended doses for the type of study where the effects were observed. Testicular, prostate and uterus effects observed (histopathological changes) were within the historical control values or they were not replicated in the two-generation reproductive toxicity study, nor affected fertility parameters. The two-generation reproductive toxicity study was performed following the test protocol according to the latest OECD Guidelines (9), as prescribed by the Joint guidance document to identify endocrine disrupting substances and did not detect any endocrine sensitive reproductive and developmental parameters such as oestrous cycle length, mating index, mean number of implantation sites, preputial separation and vaginal opening.

(14)

It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance, and in particular the uses which were examined and detailed in the review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

(15)

It is therefore appropriate to approve flutianil.

(16)

In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions. It is, in particular, appropriate to require further confirmatory information, amongst others to confirm that flutianil is not an endocrine disruptor in accordance with Points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, in order to increase the confidence, in accordance with Point 2(2)(b) of Annex II to Regulation (EC) No 1107/2009, in the conclusion drawn by the Commission in recital 13.

(17)

In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (10) should be amended accordingly.

(18)

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

(1)

Benchmarks play an important role in the determination of the price of many financial instruments and financial contracts and in the measurement of performance for many investment funds. The contribution to and administration of benchmarks are in many cases vulnerable to manipulation and persons involved often face conflicts of interest.

(2)

In order to fulfil their economic role, benchmarks need to be representative of the underlying market or economic reality they intend to measure. Should a benchmark no longer be representative of an underlying market, such as interbank offered rates, there is a risk of negative effects on, inter alia, market integrity, the financing of households (loans and mortgages) and businesses in the Union.

(3)

Risks to users, markets and the economy of the Union generally increase where the total value of financial instruments, financial contracts and investment funds referencing a specific benchmark is high. Regulation (EU) 2016/1011 therefore establishes different categories of benchmarks and provides for additional requirements ensuring the integrity and robustness of certain benchmarks considered as being critical, including the power of competent authorities to mandate, under certain conditions, contributions to or the administration of a critical benchmark.

(4)

Pursuant to Article 20(1) of Regulation (EU) 2016/1011, the Commission is empowered to adopt implementing acts to establish and review at least every two years a list of critical benchmarks.

(5)

Commission Implementing Regulation (EU) 2016/1368 (2) established a list of critical benchmarks used in financial markets pursuant to Regulation (EU) 2016/1011.

(6)

According to point (b) of Article 20(1) of Regulation (EU) 2016/1011, benchmarks may be included in the list of critical benchmarks where those benchmarks are based on input data submitted by contributors the majority of which are located in one Member State and are recognised as being critical in that Member State.

(7)

On 10 October 2018, the Polish competent authority, Komisja Nadzoru Finansowego (‘KNF’), notified the European Securities and Markets Authority (‘ESMA’) of its proposal to recognise the Warsaw Interbank Offered Rate (‘WIBOR’) as a critical benchmark, under point (b) of Article 20(1) of Regulation (EU) 2016/1011, because it is critical in Poland and it is based on submissions of contributors, all of which are located in Poland.

(8)

WIBOR is a reference rate based on an average of the interest rates at which banks operating in the Polish money market are willing to lend unsecured funds to each other at different maturities. As of 10 October 2018, eleven banks participate in the WIBOR panel, all of which are located in Poland.

(9)

In its assessment submitted to ESMA, the KNF concluded that the cessation of WIBOR, or its provision on the basis of input data or of a panel of contributors no longer representative of the underlying market or economic reality, could have a significant adverse impact on the functioning of financial markets in Poland.

(10)

The assessment by the KNF illustrates that WIBOR is used as a reference in 60 % of total loans to households in Poland, and in 70,1 % of outstanding mortgages. In mortgages subscribed since 2013, WIBOR's prevalence has increased to 98,5 %. In addition, WIBOR serves as a reference for the coupon payments for nearly 26 % of the total nominal value of Polish bonds. KNF also presented data showing that WIBOR is used as a reference in OTC interest rate derivatives for an outstanding notional amount of EUR 366 billion. Finally, KNF concluded on the basis of a survey that WIBOR is referenced in investment funds with a total net asset value of EUR 2,6 billion. The total value of financial instruments and financial contracts referencing WIBOR is therefore larger than the gross national product of Poland. The assessment concludes that WIBOR is of vital importance for financial stability and market integrity in Poland, and that WIBOR's discontinuity or unreliability could have a significant adverse impact on the functioning of financial markets in Poland and on companies and consumers as it is used in loans, consumer credit products and investment funds.

(11)

On 8 November 2018, ESMA sent the Commission its opinion setting out that the KNF had taken into consideration all the elements and criteria included in Article 20(3) of Regulation (EU) 2016/1011 and that it had provided quantitative data to support the case for the recognition of WIBOR as a critical benchmark, as well as analytical reasoning highlighting the crucial role of WIBOR in the Polish economy.

(12)

Implementing Regulation (EU) 2016/1368 should therefore be amended accordingly.

(13)

In light of the crucial importance of WIBOR, its widespread use and its role in the allocation of capital in Poland, this Regulation should enter into force as a matter of urgency.

(14)

The measures provided for in this Regulation are in accordance with the opinion of the European Securities Committee,

(1)

The Agreement on the European Economic Area (2) (‘the EEA Agreement’) entered into force on 1 January 1994.

(2)

Pursuant to Article 98 of the EEA Agreement, the EEA Joint Committee may decide to amend, inter alia, Annex IX to that Agreement, which contains provisions on financial services.

(3)

Regulation (EU) No 575/2013 of the European Parliament and of the Council (3) and Directive 2013/36/EU of the European Parliament and of the Council (4) are to be incorporated into the EEA Agreement.

(4)

Annex IX to the EEA Agreement should therefore be amended accordingly.

(5)

The position of the Union within the EEA Joint Committee should therefore be based on the attached draft decision,

(1)

Directive 2002/60/EC lays down the minimum Union measures to be taken for the control of African swine fever, including those to be applied in the event of confirmation of a case of African swine fever in feral pigs.

(2)

In addition, Commission Implementing Decision 2014/709/EU (2) lays down animal health control measures in relation to African swine fever in the Member States or areas thereof as listed in the Annex thereto (the Member States concerned), and in all Member States as regards movements of feral pigs and information obligations. The Annex to Implementing Decision 2014/709/EU demarcates and lists certain areas of the Member States concerned, differentiated by the level of risk based on the epidemiological situation as regards that disease, including a list of high risk areas. That Annex has been amended several times to take account of changes in the epidemiological situation in the Union as regards African swine fever that needed to be reflected in that Annex.

(3)

In 2018 Bulgaria notified the Commission of cases of African swine fever in feral pigs and has duly taken the disease control measures required by Directive 2002/60/EC.

(4)

In light of the current epidemiological situation and in accordance with Article 16 of Directive 2002/60/EC, Bulgaria has submitted to the Commission a plan for the eradication of African swine fever (the eradication plan).

(5)

The Annex to Implementing Decision 2014/709/EU was amended by Commission Implementing Decision (EU) 2018/1635 (3) to take account, inter alia, of the cases of African swine fever in feral pigs in Bulgaria and Parts I and II of that Annex now include the infected areas in Bulgaria.

(6)

The eradication plan submitted by Bulgaria has been examined by the Commission and found to comply with the requirements set out in Article 16 of Directive 2002/60/EC. The plan should therefore be approved accordingly.

(7)

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