19.5.2017

EN

Official Journal of the European Union

L 128/1

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AGREEMENT

under Regulation (EU) 2015/1017 of the European Parliament and of the Council of 25 June 2015 on the European Fund for Strategic Investments, the European Investment Advisory Hub and the European Investment Project Portal and amending Regulations (EU) No 1291/2013 and (EU) No 1316/2013 — the European Fund for Strategic Investments

THE EUROPEAN PARLIAMENT AND THE EUROPEAN INVESTMENT BANK (the ‘Parties’),

—	having regard to the Treaty on European Union, in particular Article 14 thereof,

—	having regard to the Treaty on the Functioning of the European Union, and in particular Articles 15, 16, 232, 308, 309 and 339 thereof,

—	having regard to the Statute of the European Investment Bank (EIB), and in particular Article 11(7) and Articles 16 and 18 thereof,

—

having regard to Regulation (EU) 2015/1017 of the European Parliament and of the Council of 25 June 2015 on the European Fund for Strategic Investments, the European Investment Advisory Hub and the European Investment Project Portal and amending Regulations (EU) No 1291/2013 and (EU) No 1316/2013 — the European Fund for Strategic Investments (1) (the ‘EFSI Regulation’), and in particular Article 17(5) thereof,

—	having regard to Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (2),

—	having regard to Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (3),

A.	whereas the EFSI Regulation establishes the European Fund for Strategic Investments (EFSI), an EU guarantee, an EU guarantee fund, a European investment advisory hub (EIAH) and a European investment project portal;

B.

whereas the purpose of the EFSI is to support, in the Union, through the supply of risk-bearing capacity to the EIB, the following: (a) investments; (b) increased access to financing for companies as well as other entities having up to 3 000 employees, with a particular focus on small and medium-sized enterprises (‘SMEs’) and small mid-cap companies;

C.	whereas the EFSI Regulation provides that the EFSI should be established as a distinct, clearly identifiable and transparent facility managed by the EIB, the operations of which should be clearly distinguished from other operations of the EIB;

D.

whereas in order to ensure accountability to European citizens, the EIB should regularly report to the European Parliament and to the Council on the progress, impact and operations of the EFSI, in particular as regards the additionality of operations conducted under the EFSI compared to normal EIB operations, including special activities, and appropriate arrangements should be adopted for this purpose;

E.

whereas, in accordance with Article 17(5) of the EFSI Regulation, the European Parliament and the EIB are to conclude an agreement on the detailed arrangements for the exchange of information between the European Parliament and the EIB under the EFSI Regulation, including on the selection procedure for the EFSI Managing Director and the EFSI Deputy Managing Director;

F.

whereas Article 7(6) of the EFSI Regulation provides that, following an open and transparent selection process in line with EIB procedures, the Steering Board is to select a candidate for each of the positions of Managing Director and Deputy Managing Director, and requires that the European Parliament and the Council be kept duly informed in a timely manner at all the stages of the selection procedure, subject to strict confidentiality requirements. Following a hearing with the candidate selected for each position and the approval from the European Parliament, the Managing Director and Deputy Managing Director are to be appointed by the President of the EIB for a fixed term of three years, renewable once;

G.

whereas Article 16(2) of the EFSI Regulation provides that the EIB, in cooperation with the European Investment Fund (EIF) where appropriate, is to submit an annual report to the European Parliament and to the Council on EIB financing and investment operations covered by the EFSI Regulation. That annual report, which is to include operational and financial information as further specified in Article 16(2) of the EFSI Regulation, is to be made public;

H.

whereas Article 17(1) of the EFSI Regulation provides that, at the request of the European Parliament or of the Council, the Chairperson of the Steering Board and the Managing Director are to report on the performance of the EFSI to the requesting institution, including by participating in a hearing before the European Parliament;

I.

whereas Article 17(2) of the EFSI Regulation further provides that the Chairperson of the Steering Board and the Managing Director are to reply orally or in writing to questions addressed to the EFSI by the European Parliament or the Council, in any event within five weeks of the date of receipt of a question;

J.

whereas Article 17(4) of the EFSI Regulation provides that, at the request of the European Parliament, the President of the EIB is to participate in a hearing of the European Parliament that concerns EIB financing and investment operations covered by the EFSI Regulation. The President of the EIB is to reply orally or in writing, within five weeks of the date of their receipt, to questions addressed to the EIB by the European Parliament or the Council concerning EIB financing and investment operations covered by the EFSI Regulation;

K.	whereas Article 18(1) of the EFSI Regulation requires the EIB to evaluate the functioning of the EFSI by 5 January 2017. The EIB is to submit its evaluation to the European Parliament, the Council and the Commission;

L.	whereas this Agreement is without prejudice to the Tripartite Agreement between the European Commission, the European Court of Auditors and the European Investment Bank of 27 October 2003,

AGREE AS FOLLOWS:

Article 1

Purpose and scope

This Agreement sets out the detailed arrangements for the exchange of information between the European Parliament and the EIB provided for in the EFSI Regulation, including on the selection procedure for the Managing Director and the Deputy Managing Director.

SECTION I

ACCESS TO INFORMATION

Article 2

Regular reports

2.1.   In accordance with Article 14(9) of the EFSI Regulation, the EIB shall submit an annual report to the European Parliament, to the Council, and to the Commission, with regard to the services provided by the EIAH and the execution of its budget, including information on the fees received and the use thereof (the ‘EIAH Report’).

The EIB shall prepare the EIAH Report by reference to the period ending on 31 December of each year, and shall submit it no later than by 1 September of the following year.

2.2.   In accordance with Article 16(2) of the EFSI Regulation, the EIB, in cooperation with the EIF where appropriate, shall submit an annual report to the European Parliament and to the Council on EIB financing and investment operations covered by the EFSI Regulation (the ‘EFSI Report’). The EFSI Report shall include:

(a)

an assessment of EIB financing and investment operations at operation, sector, country and regional levels and their compliance with the EFSI Regulation, in particular with the criterion of providing additionality, together with an assessment of the allocation of EIB financing and investment operations between the general objectives of the EFSI;

(b)	an assessment of the added value, the mobilisation of private sector resources, the estimated and actual outputs and the outcomes and impact of EIB financing and investment operations on an aggregated basis, including the impact on employment creation;

(c)

an assessment of the extent to which operations covered by the EFSI Regulation contribute to the achievement of the general objectives of the EFSI, including an assessment of the level of EFSI investments in the areas of research, development and innovation and transport (including TEN-T and urban mobility), telecommunications, energy infrastructure and energy efficiency;

(d)	an assessment of the compliance with the requirements concerning the use of the EU guarantee and with the key performance indicators;

(e)	an assessment of the leverage effect achieved by EFSI-supported projects;

(f)	a description of the projects where the support of the European Structural and Investment Funds is combined with the support of the EFSI, and the total amount of the contributions from each source;

(g)	the financial amount transferred to beneficiaries and an assessment of EIB financing and investment operations on an aggregated basis;

(h)	an assessment of the added value of EIB financing and investment operations, and of the aggregate risk associated with those operations;

(i)	detailed information on calls on the EU guarantee, losses, returns, amounts recovered and any other payments received;

(j)	the financial reports on EIB financing and investment operations covered by the EFSI Regulation audited by an independent external auditor.

The EIB shall prepare the EFSI Report by reference to the period ending on 31 December of each year, and shall submit it no later than by 31 May of the following year. Without prejudice to the provisions of the first subparagraph, raw data shall be provided by the EIB to the European Parliament in the same format and within the same timeframe (being no later than by 31 March of the year when the relevant EFSI Report is due) as it is provided to the Commission.

2.3.   The language of the EIAH Report and of the EFSI Report shall be English.

Article 3

EFSI evaluation reports

3.1.   In accordance with Article 18(1) of the EFSI Regulation, by 5 January 2017 the EIB shall evaluate the functioning of the EFSI and shall submit its evaluation to the European Parliament.

3.2.   In accordance with Article 18(3) of the EFSI Regulation, the EIB shall publish a comprehensive report on the functioning of the EFSI, which shall include an evaluation of the impact of the EFSI on investment in the Union, employment creation and access to financing for SMEs and mid-cap companies, by 30 June 2018 and every three years thereafter.

3.3.   In accordance with Article 18(5) of the EFSI Regulation, the EIB shall provide, and shall ensure that the EIF provides, in due time, the European Parliament with their respective independent evaluation reports, which assess the impact and practical results achieved by the specific activities of the EIB and the EIF respectively under the EFSI Regulation.

The assessment of the need for performing such independent evaluations, in addition to those specified in Articles 3.1 and 3.2, and the decision on the timing of such independent evaluations, rests entirely with the EIB or the EIF, as appropriate.

3.4.   The evaluation reports specified in this Article shall be provided to the European Parliament without delay after their approval by the EIB or the EIF, as appropriate.

3.5.   The language of the evaluation reports referred to in this Article shall be English.

Article 4

Reporting on amendments to the EFSI Agreement

In accordance with point (i) of Article 4(2) of the EFSI Regulation, the agreement concluded between the Commission and the EIB on the management of the EFSI and on the granting of the EU guarantee (the ‘EFSI Agreement’) shall include an obligation on those parties to report to the European Parliament on amendments to the EFSI Agreement.

Article 5

Decisions of the Investment Committee

5.1.   In accordance with the third subparagraph of Article 7(12) of the EFSI Regulation, the EIB shall submit to the European Parliament a list of all decisions of the Investment Committee of the EFSI rejecting the use of the EU guarantee.

5.2.   The EIB shall submit the list referred to in Article 5.1 to the European Parliament twice a year, by 31 March and by 30 September.

5.3.   The information provided by the EIB to the European Parliament in accordance with Article 5.1 shall be subject to strict confidentiality requirements and shall be handled by the European Parliament in accordance with Article 10.

5.4.   Without prejudice to Article 5.3, the EIB shall forward to the European Parliament all the decisions of the Investment Committee of the EFSI on the use of the guarantee as soon as those become available. Where applicable, the EIB shall include in the list of the decisions approving the use of the EU guarantee information on the operations, in particular their description, the identity of the promoter or financial intermediary, and the objectives of the project supported by the EIB under EFSI. In the case of commercially sensitive decisions, the EIB shall forward such decisions and information concerning promoters or financial intermediaries at the date of closing of the relevant financing or any earlier date when commercial sensitivity ends.

5.5.   In accordance with the second subparagraph of Article 7(12) of the EFSI Regulation, the decisions of the Investment Committee of the EFSI approving the use of the EU guarantee shall be public and accessible.

Article 6

Changes to sector or geographic concentration limits of EFSI portfolio

6.1.   In accordance with point 8 of Annex II to the EFSI Regulation, if the Steering Board of the EFSI decides to modify the indicative sector or geographical concentration limits set for the EFSI portfolio, it shall explain its decision in that respect to the European Parliament.

6.2.   In accordance with the second subparagraph of Article 7(3) of the EFSI Regulation, the minutes of the Steering Board shall be published as soon as the Steering Board has approved them. Those minutes, together with the Steering Board's written explanation concerning any modification referred to in Article 6.1, shall be forwarded to the European Parliament as soon as they become available and in any event at the latest simultaneously with the publication of the minutes.

SECTION II

AD HOC REPORTING AND RESPONDING TO QUESTIONS

Article 7

Ad hoc reporting, hearings and other meetings

7.1.   In accordance with Article 17(4) of the EFSI Regulation, at the request of the competent committees of the European Parliament, the President of the EIB shall participate in at least one hearing before the European Parliament on issues concerning EIB financing and investment operations covered by the EFSI Regulation. The competent committees of the European Parliament and the EIB shall agree on a date that falls in the course of the following year for the holding of such hearing.

7.2.   Pursuant to questions addressed by the European Parliament to the EIB on issues concerning EIB financing and investment operations covered by the EFSI Regulation, the competent committees of the European Parliament may invite the President of the EIB to additional ad hoc meetings on such issues.

The competent committees of the European Parliament and the EIB shall seek agreement on the date for such ad hoc meetings, which date shall be as soon as practicable and at the latest within five weeks from the date of the request of the competent committees of the European Parliament.

In accordance with the relevant provisions of the Rules of Procedure of the European Parliament, such hearings and ad hoc meetings may be confidential.

7.3.   At the request of the President of the EIB or of the Chair of the competent committee of the European Parliament and with mutual agreement, senior staff of the EIB and of the EIF may attend the hearings and ad hoc meetings, including any confidential meetings, referred to in Articles 7.1 and 7.2.

7.4.   At the request of the Chair of the competent committee of the European Parliament, pursuant to questions addressed by the European Parliament on issues concerning EIB financing and investment operations covered by the EFSI Regulation, the competent committees of the European Parliament may invite senior staff of the EIB to ad hoc exchanges of views on such issues, to be held on a mutually agreed date.

In accordance with the relevant provisions of the Rules of Procedure of the European Parliament, such ad hoc exchanges of views may be confidential.

7.5.   In accordance with Article 17(1) of the EFSI Regulation, at the request of the competent committees of the European Parliament, the Managing Director of the EFSI shall report on the performance of the EFSI, including by participating in hearings before the European Parliament.

The competent committees of the European Parliament and the Managing Director of the EFSI shall seek agreement on the date for such hearings, which date shall be as soon as practicable and in any event within five weeks from the date of the request of the competent committees of the European Parliament.

Such reporting to the European Parliament by the Managing Director of the EFSI on the performance of the EFSI may take the form of ad hoc meetings with the competent committees of the European Parliament, to be organised at the request of such competent committees, on a mutually agreed date.

In accordance with the relevant provisions of the Rules of Procedure of the European Parliament, such hearings and ad hoc meetings may be confidential.

7.6.   At the reasoned request of the Managing Director of the EFSI or of the Chair of the competent committee of the European Parliament, and with mutual agreement, senior staff of the EIB and of the EIF may attend the hearings and the ad hoc meetings, including any confidential meetings, referred to in Article 7.5.

Article 8

Responding to questions

8.1.   In accordance with Article 17(4) of the EFSI Regulation, at the request of the competent committees of the European Parliament, the President of the EIB shall reply orally or in writing to questions addressed to the EIB by the European Parliament on issues concerning EIB financing and investment operations covered by the EFSI Regulation.

8.2.   In accordance with Article 17(2) of the EFSI Regulation, the Managing Director of the EFSI shall reply, orally or in writing, to questions addressed to the EFSI by the European Parliament.

8.3.   The European Parliament shall address any questions to the President of the EIB pursuant to Article 8.1 through the Chair of the competent committee of the European Parliament. It shall address any questions to the Managing Director of the EFSI pursuant to Article 8.2 through the Chair of the competent committee of the European Parliament and the Secretariat of the EFSI.

8.4.   Any questions addressed by the European Parliament to the President of the EIB pursuant to Article 8.1, or to the Managing Director of the EFSI pursuant to Article 8.2, shall be answered as quickly as possible and in any event within five weeks of the date of receipt of a question.

Oral replies to questions addressed by the European Parliament to the President of the EIB pursuant to Article 8.1, or to the Managing Director of the EFSI pursuant to Article 8.2, may take the form of ad hoc meetings, as provided for in Article 7.2 and in the third subparagraph of Article 7.5, respectively.

SECTION III

SELECTION PROCEDURES

Article 9

Selection procedure for Managing Director and Deputy Managing Director

9.1.   The EIB shall draw up the criteria for selection of the Managing Director and Deputy Managing Director of the EFSI in accordance with the EFSI Regulation, including the required balance of skills, knowledge and experience, seeking to promote the highest standards and to ensure diversity, including gender diversity.

9.2.   The EIB shall inform the relevant committees of the European Parliament of a vacancy two weeks before the publication of that vacancy, giving details of the open selection procedure that the EIB will follow.

9.3.   The EIB shall inform the relevant committees of the European Parliament of the composition of the pool of applicants (number of applications, mix of professional skills, gender and nationality balance), as well as the method to be used to screen the pool. Such screening shall result in a shortlist of at least two potential candidates proposed by the EIB to the Steering Board.

9.4.   The EIB shall provide the relevant committees of the European Parliament with the shortlist of candidates. The EIB shall provide such shortlist at least three weeks before the Steering Board selects the final candidate.

9.5.   The relevant committees of the European Parliament may submit questions concerning the selection criteria or the shortlist, or both, within a week of receiving the shortlist of candidates. The EIB shall reply in writing within two weeks.

9.6.   The approval process shall comprise the following steps:

(a)	the EIB shall send the names of the proposed Managing Director and Deputy Managing Director to the European Parliament, together with written explanations of the reasons for that selection;

(b)	the European Parliament shall organise as rapidly as possible, and at the latest within four weeks, a hearing with the candidate for each position;

(c)	the European Parliament shall decide on the approval of the proposals through a vote in each of the relevant committees on a draft resolution followed by a vote for approval or rejection on that resolution, to be completed within six weeks of the proposals.

9.7.   Following approval by the European Parliament, the President of the EIB shall appoint the Managing Director and the Deputy Managing Director in accordance with the provisions of the EFSI Regulation.

9.8.   If the European Parliament does not approve a proposal of the EIB, the EIB may draw on the pool of existing candidates or relaunch the selection procedure.

9.9.   The EIB shall notify without undue delay any resignation, dismissal, temporary replacement or vacancy occurring in the governance structure of EFSI to the European Parliament.

SECTION IV

GENERAL PROVISIONS

Article 10

Confidentiality

10.1.   Having regard to the fact that some of the information exchanged in the context of this Agreement may be of a confidential character or commercially sensitive, the Parties undertake to abstain from disclosing without the prior written consent of the other any confidential information received by them in this context.

That undertaking, however, shall not affect any communication of information which is required by law, regulation, treaty, or by an order of a court having jurisdiction on the matter and shall be without prejudice to the relevant provisions of the EFSI Regulation on transparency and public disclosure of information.

For the purposes of this Agreement, ‘confidential information’ shall mean any information in written or other permanent (including electronic) form which is clearly identified as confidential.

In designating information as confidential information, the EIB shall comply with its Transparency Policy, as published on its website at the time such information is provided to the European Parliament.

10.2.   The European Parliament shall handle and protect any confidential information provided by the EIB pursuant to this Agreement in accordance with the relevant provisions of the Rules of Procedure of the European Parliament, and in particular Rule 210a (Procedure for the consultation by a committee of confidential information received by Parliament) thereof, and with the Decision of the Bureau of the European Parliament of 15 April 2013 concerning the rules governing the treatment of confidential information by the European Parliament (4), in respect of ‘other confidential information’ (as defined therein).

10.3.   In accordance with the relevant provisions of its Rules of Procedure, the European Parliament shall maintain a list of persons handling confidential information.

10.4.   The European Parliament and the EIB shall keep each other informed on the initiation and outcome of any judicial, administrative or other proceedings in which a third party seeks access to confidential information provided by the EIB to the European Parliament.

Article 11

Staff-level preparatory meetings

11.1.   In order to prepare exchanges of views, hearings or other forms of interaction foreseen in this Agreement, staff-level meetings shall be organised if so requested by the European Parliament or by the EIB.

11.2.   Staff-level meetings shall be held at least one week in advance of the exchange of views, hearing or other form of interaction to which they relate.

Article 12

Linguistic arrangements

Any request originating from the European Parliament under this Agreement may be transmitted to the EIB in any official language of the Union. The replies of the EIB shall be in English.

Article 13

Final provisions

13.1.   The Parties shall periodically assess the practical implementation of this Agreement and shall carry out a review as soon as the regulation extending the duration of EFSI enters into force and again by 30 June 2019, in the light of practical experience of implementation.

13.2.   This Agreement shall enter into force on the day following that of its signature.

13.3.   This Agreement shall be published in the Official Journal of the European Union.

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(1)  OJ L 169, 1.7.2015, p. 1.

(2)  OJ L 8, 12.1.2001, p. 1.

(3)  OJ L 145, 31.5.2001, p. 43.

(4)  OJ C 96, 1.4.2014, p. 1.

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19.5.2017

EN

Official Journal of the European Union

L 128/9

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/854

of 18 May 2017

conferring protection under Article 99 of Regulation (EU) No 1308/2013 of the European Parliament and of the Council on the name ‘Darnibole’ (PDO)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1), and in particular Article 99 thereof,

Whereas:

(1)	In accordance with Article 97(2) and (3) of Regulation (EU) No 1308/2013, the United Kingdom's application to register the name ‘Darnibole’ was examined by the Commission and subsequently published in the Official Journal of the European Union  (2).

(2)	No statement of objection has been received by the Commission under Article 98 of Regulation (EU) No 1308/2013.

(3)	In accordance with Article 99 of Regulation (EU) No 1308/2013, the name ‘Darnibole’ should be protected and entered in the register referred to in Article 104 of the Regulation.

(4)	The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of Agricultural Markets,

HAS ADOPTED THIS REGULATION:

Article 1

The name ‘Darnibole’ (PDO) is hereby protected.

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.

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(1)  OJ L 347, 20.12.2013, p. 671.

(2)  OJ C 457, 8.12.2016, p. 3.

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19.5.2017

EN

Official Journal of the European Union

L 128/10

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/855

of 18 May 2017

amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance diflubenzuron

(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 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular the first alternative of Article 21(3) and Article 78(2) thereof,

Whereas:

(1)	Commission Directive 2008/69/EC (2) included diflubenzuron as active substance in Annex I to Council Directive 91/414/EEC (3).

(2)	Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

(3)

In accordance with Commission Directive 2010/39/EU (5), the applicant, at whose request diflubenzuron was included in Annex I to Council Directive 91/414/EEC, was to provide confirmatory information as regards the potential toxicological relevance of the impurity and metabolite 4-chloroaniline (PCA).

(4)	The applicant submitted that information to the rapporteur Member State Sweden within the time period provided for its submission.

(5)	Sweden assessed the information submitted by the applicant. It submitted its assessment, in the form of an addendum to the draft assessment report, to the other Member States, the Commission and the European Food Safety Authority, hereinafter ‘the Authority’, on 20 December 2011.

(6)

The Commission consulted the Authority, which presented its conclusion on the risk assessment of confirmatory information for diflubenzuron on 7 September 2012 (6). The Authority communicated its views on diflubenzuron to the applicant, and the Commission invited the applicant to submit its comments on the review report. The draft assessment report, the addendum and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 16 July 2013 in the format of the Commission review report for diflubenzuron.

(7)

Although the results of genotoxicity studies indicated that PCA is an in vivo genotoxic agent, and PCA is a carcinogenic agent, a genotoxic and carcinogenic potential were not observed in studies with an appropriate animal model for human exposure to diflubenzuron, and hence to PCA as a metabolite and impurity. In light of the information submitted by the applicant, the Commission considered that the confirmatory information required had been provided.

(8)

In its conclusion, given the genotoxic properties of PCA identified on the basis of the confirmatory information, and given the carcinogenic properties of PCA and the absence of a threshold for acceptable exposure, the Authority however identified a new concern on potential exposure to PCA as a residue.

(9)

The Commission initiated a review of the approval of the active substance diflubenzuron. The Commission considered that, in the light of the new scientific and technical knowledge described above, there were indications that the approval of the active substance diflubenzuron no longer satisfied the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 with respect to its potential harmful effect on human health, through exposure to PCA as a residue. It invited the applicant to submit information as regards the potential exposure to PCA as a residue and, if exposure is confirmed, consideration of the potential toxicological relevance.

(10)	The applicant submitted that information to Sweden within the time period provided for its submission.

(11)	Sweden assessed the information submitted by the applicant. It submitted its assessment, in the form of an addendum to the draft assessment report, to the other Member States, the Commission and the Authority on 23 July 2014.

(12)	The Commission consulted the Authority, which presented its conclusion on the risk assessment of data submitted for the review of the approval of diflubenzuron on 11 December 2015 (7). The Authority communicated its views on diflubenzuron to the applicant.

(13)

The Commission considers that the information submitted in the review process did not demonstrate that the risk from the potential exposure of consumers to PCA as a residue is acceptable. In particular, the presence of PCA in the metabolic pathway has been demonstrated in some plants and livestock and could not be excluded in others. Moreover, studies indicated a significant transformation of diflubenzuron residues into PCA under conditions similar or equal to food sterilisation processes, and such transformation could not be excluded for household processing practices.

(14)

Given the genotoxic and carcinogenic properties of PCA and the absence of a threshold for acceptable exposure, it was not established that the exposure of consumers to PCA as a residue, consequent on application consistent with good plant protection practice, has no harmful effects. Since toxicological reference values for PCA cannot be set and as consequently no safe residue levels can be identified, any exposure of consumers to PCA should be prevented.

(15)	The Commission invited the applicant to submit its comments on the review report. The comments of the applicant did not alleviate the concerns on consumer safety through exposure to PCA.

(16)	The draft assessment report, the addendum and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on Plants, Animals, Food and Feed and finalised on 23 March 2017 in the format of the Commission review report for diflubenzuron.

(17)

The Commission concluded that exposure of consumers to PCA cannot be excluded except by imposing further restrictions. In particular, the use of diflubenzuron should be limited to non-edible crops only, and crops treated with diflubenzuron should not enter the food and feed chain. In order to minimise the exposure of consumers to PCA, it is therefore appropriate to amend the conditions of use of diflubenzuron.

(18)	The Annex to Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

(19)	Member States should be provided with time to amend or withdraw authorisations for plant protection products containing diflubenzuron.

(20)	For plant protection products containing diflubenzuron, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should expire at the latest 15 months after the entry into force of this Regulation.

(21)	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

Amendment to Implementing Regulation (EU) No 540/2011

In the seventh column, ‘specific provisions’, of entry 174 on diflubenzuron of Part A of the Annex to Implementing Regulation (EU) No 540/2011, the text is replaced by the following:

‘Only uses as insecticide in non-edible crops may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on diflubenzuron, and in particular Appendices I and II thereof, as amended in the Standing Committee on Plants, Animals, Food and Feed on 23 March 2017 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

—	the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers shall be compared and verified against this specification of the technical material;

—	the protection of aquatic organisms, terrestrial organisms and non-target arthropods including bees;

—	the potential unintended exposure of food and feed crops to diflubenzuron from uses on non-edible crops (e.g. through spray drift);

—	the protection of workers, residents and bystanders.

Member States shall ensure that crops treated with diflubenzuron do not enter the food and feed chain.

Conditions of use shall include adequate risk mitigation measures, where appropriate.’

Article 2

Transitional measures

Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing diflubenzuron as active substance by 8 September 2017 at the latest.

Article 3

Grace period

Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall be as short as possible and shall expire by 8 September 2018 at the latest.

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.

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(1)  OJ L 309, 24.11.2009, p. 1.

(2)  Commission Directive 2008/69/EC of 1 July 2008 amending Council Directive 91/414/EEC to include clofentezine, dicamba, difenoconazole, diflubenzuron, imazaquin, lenacil, oxadiazon, picloram and pyriproxyfen as active substances (OJ L 172, 2.7.2008, p. 9).

(3)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

(4)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

(5)  Commission Directive 2010/39/EU of 22 June 2010 amending Annex I to Council Directive 91/414/EEC as regards the specific provisions relating to the active substances clofentezine, diflubenzuron, lenacil, oxadiazon, picloram and pyriproxyfen (OJ L 156, 23.6.2010, p. 7).

(6)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of confirmatory data submitted for the active substance diflubenzuron. EFSA Journal 2012;10(9):2870. [26 pp.] doi:10.2903/j.efsa.2012.2870. Available online: www.efsa.europa.eu/efsajournal.htm

(7)  European Food Safety Authority; Conclusion on the peer review on the review of the approval of the active substance diflubenzuron regarding the metabolite PCA. EFSA Journal 2015;13(8):4222. [30 pp.] doi:10.2903/j.efsa.2015.4222. Available online: www.efsa.europa.eu/efsajournal.htm

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19.5.2017

EN

Official Journal of the European Union

L 128/14

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/856

of 18 May 2017

amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance fluroxypyr

(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 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular the second alternative of Article 21(3) and Article 78(2) thereof,

Whereas:

(1)

Commission Implementing Regulation (EU) No 736/2011 (2) approved fluroxypyr as an active substance in accordance with Regulation (EC) No 1107/2009 subject to certain conditions requiring the Member States concerned to ensure that the applicant at whose request fluroxypyr was approved provide further confirmatory information on six points, one of which concerned the relevance of the impurities present in the technical specifications.

(2)	On 25 June 2012 and 5 September 2013 the applicant submitted additional information intended to address the confirmatory data requirements to the rapporteur Member State Ireland within the time period provided for its submission.

(3)

Ireland assessed the additional information provided by the applicant. It submitted its own assessment, in the form of an addendum to the draft assessment report, to the other Member States, the Commission and the European Food Safety Authority, hereinafter ‘the Authority’, on 22 December 2014 and invited them to comment on the assessment.

(4)	The Authority published a Technical Report (3) summarising the outcome of this consultation process for fluroxypyr on 22 July 2015.

(5)	The draft assessment report, the addendum and the Technical Report were reviewed by the Member States and the Commission within the Standing Committee on Plants, Animals, Food and Feed and finalised on 23 March 2017 in the format of the Commission review report for fluroxypyr.

(6)	The Commission invited the applicant to submit its comments on the Commission review report for fluroxypyr.

(7)

N-methyl-2-pyrrolidone (NMP) is classified under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (4) as toxic for reproduction category 1B and has a general concentration limit of 0,3 %. The presence of NMP in the technical material below 3 g/kg would be highly unlikely to pose any risk to consumers. Hence the Commission has concluded that the additional information provided showed that a maximum level for the toxicologically relevant impurity NMP should be set at less than 3 g/kg (< 0,3 %) in the technical material.

(8)	In order to ensure a high level of protection for consumers it is, therefore, appropriate to establish a maximum level for this impurity in the commercially manufactured active substance.

(9)	The Annex to Commission Implementing Regulation (EU) No 540/2011 (5) should therefore be amended accordingly.

(10)	Member States should be allowed sufficient time to amend or withdraw authorisations for plant protection products containing fluroxypyr.

(11)	For plant protection products containing fluroxypyr, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should, at the latest, expire on 8 September 2018.

(12)	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

Amendment to Implementing Regulation (EU) No 540/2011

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.

Article 2

Transitional measures

Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary amend or withdraw existing authorisations for plant protection products containing fluroxypyr as the active substance by 8 September 2017 at the latest.

Article 3

Grace period

Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall be as short as possible and shall expire by 8 September 2018 at the latest.

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.

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(1)  OJ L 309, 24.11.2009, p. 1.

(2)  Commission Implementing Regulation (EU) No 736/2011 of 26 July 2011 approving the active substance fluroxypyr, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 195, 27.7.2011, p. 37).

(3)  EFSA (European Food Safety Authority), 2015. Technical report on the outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for fluroxypyr in light of confirmatory data. EFSA supporting publication 2015:EN-857. 43 pp.

(4)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

(5)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

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19.5.2017

EN

Official Journal of the European Union

L 128/17

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/857

of 18 May 2017

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

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(1)  OJ L 347, 20.12.2013, p. 671.

(2)  OJ L 157, 15.6.2011, p. 1.

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19.5.2017

EN

Official Journal of the European Union

L 128/19

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/858

of 18 May 2017

on the minimum selling price for skimmed milk powder for the ninth partial invitation to tender within the tendering procedure opened by Implementing Regulation (EU) 2016/2080

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1),

Having regard to Commission Implementing Regulation (EU) 2016/1240 of 18 May 2016 laying down rules for the application of Regulation (EU) No 1308/2013 of the European Parliament and of the Council with regard to public intervention and aid for private storage (2), and in particular Article 32 thereof,

Whereas:

(1)	Commission Implementing Regulation (EU) 2016/2080 (3) has opened the sale of skimmed milk powder by a tendering procedure.

(2)	In the light of the tenders received for the ninth partial invitation to tender, a minimum selling price should not be fixed.

(3)	The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets,

HAS ADOPTED THIS REGULATION:

Article 1

For the ninth partial invitation to tender for the selling of skimmed milk powder within the tendering procedure opened by Implementing Regulation (EU) 2016/2080, in respect of which the period during which tenders were to be submitted ended on 16 May 2017, a minimum selling price has not been fixed.

Article 2

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

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(1)  OJ L 347, 20.12.2013, p. 671.

(2)  OJ L 206, 30.7.2016, p. 71.

(3)  Commission Implementing Regulation (EU) 2016/2080 of 25 November 2016 opening the sale of skimmed milk powder by a tendering procedure (OJ L 321, 29.11.2016, p. 45).

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19.5.2017

EN

Official Journal of the European Union

L 128/20

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COUNCIL DECISION (EU) 2017/859

of 11 May 2017

on the position to be adopted, on behalf of the European Union, within the EEA Joint Committee concerning an amendment to Protocol 31 to the EEA Agreement, on cooperation in specific fields outside the four freedoms (Budget Line 02.03.01 Internal Market and Budget line 02.03.04 Internal Market Governance Tools)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 in conjunction with Article 218(9) thereof,

Having regard to Council Regulation (EC) No 2894/94 of 28 November 1994 concerning arrangements for implementing the Agreement on the European Economic Area (1), and in particular Article 1(3) thereof,

Having regard to the proposal from the European Commission,

Whereas:

(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, Protocol 31 to the EEA Agreement.

(3)	Protocol 31 to the EEA Agreement contains provisions on cooperation in specific fields outside the four freedoms.

(4)	It is appropriate to continue the cooperation of the Contracting Parties to the EEA Agreement in Union actions funded from the general budget of the European Union regarding the operation and development of the internal market of goods and services.

(5)	In addition, the cooperation of the Contracting Parties to the EEA Agreement should be extended to Union actions funded from the general budget of the European Union regarding internal market governance tools.

(6)	Protocol 31 to the EEA Agreement should therefore be amended in order to allow for this extended cooperation to take place from 1 January 2017.

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

HAS ADOPTED THIS DECISION:

Article 1

The position to be adopted, on behalf of the Union, within the EEA Joint Committee on the proposed amendment to Protocol 31 to the EEA Agreement, on cooperation in specific fields outside the four freedoms, shall be based on the draft decision of the EEA Joint Committee attached to this Decision.

Article 2

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

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(1)  OJ L 305, 30.11.1994, p. 6.

(2)  OJ L 1, 3.1.1994, p. 3.

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19.5.2017

EN

Official Journal of the European Union

L 128/23

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COUNCIL DECISION (EU) 2017/860

of 11 May 2017

on the position to be adopted, on behalf of the European Union, within the EEA Joint Committee concerning an amendment to Protocol 31 to the EEA Agreement, on cooperation in specific fields outside the four freedoms (Budget Line 33.02.03.01)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 in conjunction with Article 218(9) thereof,

Having regard to Council Regulation (EC) No 2894/94 of 28 November 1994 concerning arrangements for implementing the Agreement on the European Economic Area (1), and in particular Article 1(3) thereof,

Having regard to the proposal from the European Commission,

Whereas:

(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, Protocol 31 to the EEA Agreement.

(3)	Protocol 31 to the EEA Agreement contains provisions on cooperation in specific fields outside the four freedoms.

(4)	It is appropriate to continue the cooperation of the Contracting Parties to the EEA Agreement in Union actions funded from the general budget of the European Union regarding company law.

(5)	Protocol 31 to the EEA Agreement should therefore be amended in order to allow for this extended cooperation to take place from 1 January 2017.

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

HAS ADOPTED THIS DECISION:

Article 1

The position to be adopted, on behalf of the Union, within the EEA Joint Committee on the proposed amendment to Protocol 31 to the EEA Agreement, on cooperation in specific fields outside the four freedoms, shall be based on the draft decision of the EEA Joint Committee attached to this Decision.

Article 2

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

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(1)  OJ L 305, 30.11.1994, p. 6.

(2)  OJ L 1, 3.1.1994, p. 3.

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19.5.2017

EN

Official Journal of the European Union

L 128/25

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COUNCIL DECISION (EU) 2017/861

of 11 May 2017

on the position to be adopted, on behalf of the European Union, within the EEA Joint Committee concerning an amendment to Protocol 3 to the EEA Agreement, concerning products referred to in Article 8(3)(b) of the Agreement

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 in conjunction with Article 218(9) thereof,

Having regard to Council Regulation (EC) No 2894/94 of 28 November 1994 concerning arrangements for implementing the Agreement on the European Economic Area (1), and in particular Article 1(3) thereof,

Having regard to the proposal from the European Commission,

Whereas:

(1)	The Agreement on the European Ecoomic 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, Protocol 3 to the EEA Agreement. That Protocol determines specific trade arrangements for certain agricultural and processed agricultural products between the Contracting Parties.

(3)

Article 2(2) of Protocol 3 to the EEA Agreement stipulates that the customs duties set out in the Annexes to Table I of that Protocol can be adapted by the EEA Joint Committee, taking account of mutual concessions. Iceland and the European Union have agreed to eliminate tariffs for certain products listed in Protocol 3 to the EEA Agreement. These concessions will apply only to products originating, respectively, in the European Union and in Iceland, within the meaning of the Regional Convention on pan-Euro-Mediterranean preferential rules of origin.

(4)	Protocol 3 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,

HAS ADOPTED THIS DECISION:

Article 1

The position to be adopted, on behalf of the Union, within the EEA Joint Committee on the proposed amendment to Protocol 3 to the EEA Agreement, concerning products referred to in Article 8(3)(b) of the Agreement, shall be based on the draft decision of the EEA Joint Committee attached to this Decision.

Article 2

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

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(1)  OJ L 305, 30.11.1994, p. 6.

(2)  OJ L 1, 3.1.1994, p. 3.

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