13.5.2014   

EN

Official Journal of the European Union

L 138/1

(1)

Council Regulation (EC) No 147/2003 (2) imposes a general ban on the provision of financing, financial assistance, technical advice, assistance or training related to military activities to any person, entity or body in Somalia.

(2)

On 5 March 2014, the UN Security Council adopted UN Security Council Resolution (UNSCR) 2142 (2014) reaffirming the arms embargo on Somalia and renewing, until 25 October 2014, its determination that the arms embargo is not to apply to deliveries of weapons, ammunition or military equipment or to the provision of advice, assistance or training intended solely for the development of the Security Forces of the Federal Government of Somalia to provide security for the Somali people, except in relation to deliveries of certain items as set out in the Annex to UNSCR 2111 (2013) which require an advance approval by the Sanctions Committee established pursuant to UNSCR 751 (1992).

(3)

UNSCR 2142 (2014) modifies the notification requirements in relation to deliveries of weapons, ammunition or military equipment or the provision of advice, assistance or training to Somalia's Security Forces, as well as for the exemption procedure in relation to deliveries of items set out in the Annex to UNSCR 2111 (2013).

(4)

On 12 May 2014, the Council adopted Decision 2014/270/CFSP (3) amending Decision 2010/231/CFSP in accordance with UNSCR 2142 (2014). Some of those amendments fall within the scope of the Treaty and regulatory action at the level of the Union is therefore necessary in order to implement them, in particular with a view to ensuring their uniform application by economic operators in all Member States.

(5)

Regulation (EC) No 147/2003 should therefore be amended accordingly,

13.5.2014   

EN

Official Journal of the European Union

L 138/3

(1)

On 12 April 2005, the Council adopted Regulation (EC) No 560/2005.

(2)

The Council carried out a review of the list set out in Annex IA to Regulation (EC) No 560/2005, in accordance with Article 11a(6) of that Regulation.

(3)

The Council has determined that there are no longer grounds for keeping one person on the list set out in Annex IA to Regulation (EC) No 560/2005.

(4)

In addition, the information in relation to two persons on the list set out in Annex IA to Regulation (EC) No 560/2005 should be updated.

(5)

Regulation (EC) No 560/2005 should therefore be amended accordingly,

13.5.2014   

EN

Official Journal of the European Union

L 138/5

(1)

Regulation (EU) No 1303/2013, in Part Two, lays down common provisions applicable to the European Regional Development Fund (ERDF), the European Social Fund (ESF), the Cohesion Fund, the European Agricultural Fund for Rural Development (EAFRD) and the European Maritime and Fisheries Fund (EMFF), which now operate under a common framework (the ‘European Structural and Investment Funds’ or ‘ESI Funds’). In addition, Part Three of that Regulation contains general provisions that apply to the ERDF, the ESF and the Cohesion Fund, but do not apply to the EAFRD and the EMFF, and Part Four of that Regulation contains general provisions which apply to the ERDF, the ESF, the Cohesion Fund and the EMFF, but do not apply to the EAFRD. This Regulation therefore lays down provisions which are applicable to all ESI Funds, as well as provisions applicable only to the ERDF and the Cohesion Fund or to the ERDF, the ESF, the Cohesion Fund and the EMFF.

(2)

It is necessary to establish detailed rules on criteria for determining the level of financial correction which the Commission may apply under the performance framework for each priority included in the programmes supported by the ESI Funds.

(3)

Such financial corrections may be applied only if several conditions are jointly met. The level of financial correction should be set on the basis of flat rates related to a coefficient, calculated with reference to the level of physical completion and financial absorption. External factors contributing to a serious failure to achieve targets set under the performance framework by 2023, other than factors excluding the financial correction, should be considered on a case-by-case basis and could be grounds for a lower rate of correction than would otherwise apply on the basis of the coefficient.

(4)

In the provisions on criteria for determining the level of financial corrections to be applied under the performance framework, a special allocation for the Youth Employment Initiative should be treated separately.

(5)

Specific rules should clarify the provisions on the purchase of land with support provided by financial instruments.

(6)

A coherent framework for combining grants for technical support and a financial instrument in a single operation requires that this is only allowed for the purpose of technical preparation of the prospective investment for the benefit of the final recipient.

(7)

To ensure that implementation of financial instruments is entrusted to bodies which have appropriate capacity to implement them in line with the objectives and priorities of the ESI Funds and in the most efficient manner, the criteria for selecting such bodies should be set out together with their role, liability and responsibilities.

(8)

To ensure sound financial management of financial instruments providing guarantees, the contributions from programmes should be based on a prudent ex ante risk assessment, taking into account an appropriate multiplier ratio.

(9)

To ensure that financial instruments are implemented in compliance with applicable law, specific provisions should be made for their management and control, including audit.

(10)

To ensure sound financial management of programme contributions to financial instruments, any withdrawal of such contributions should be appropriately reflected in the relevant payment applications.

(11)

To ensure consistent calculation of eligible capitalised interest rate subsidies and guarantee fee subsidies, specific rules for their calculation should be set out.

(12)

To promote rapid and efficient deployment of funds to the real economy and sound financial management, while assuring reasonable remuneration for bodies implementing financial instruments, criteria for determining management costs and fees on the basis of performance, applicable thresholds, and rules on reimbursement of capitalised management costs and fees for equity-based instruments and micro-credit should be set out.

(13)

In line with the principle of sound financial management, revenues generated by operations should be taken into account when the public contribution is calculated.

(14)

It is necessary to determine the method for calculating an operation's discounted net revenue, taking into account the reference periods applicable to the sector of that operation, the profitability normally expected of the type of investment concerned, the application of the polluter pays principle and, if appropriate, considerations of equity linked to the relative prosperity of the Member State or region concerned.

(15)

The reference periods applicable to sectors based on historical data recorded and stored for revenue-generating projects of the 2007-2013 programming period should be set out.

(16)

It is necessary to define the costs and revenues to be taken into account in the calculation of the discounted net revenues as well as the conditions for the determination of a residual value and the financial discount rate.

(17)

The 4 % discount rate proposed as an indicative benchmark should be based on the current long-term rate of return from an international portfolio of investments calculated as a mean return of 3 % from the assets adjusted upwards by 1 %, which is the percentage by which the average long-term government bond yield in the Union area has fallen since the financial discount rate for the 2007-2013 programming period was set.

(18)

The polluter-pays principle requires that the environmental costs of pollution and prevention be borne by those who cause pollution and that charging systems reflect the full costs, including capital costs, of environmental services, the environmental costs of pollution and of the preventive measures implemented and the costs linked to the scarcity of the resources used.

(19)

To reduce administrative burdens, beneficiaries should be allowed to use existing methods and corresponding rates set out under other Union policies in order to calculate indirect costs, if the operations and beneficiaries are of a similar type.

(20)

To ensure that operations supported under the ESI Funds which might use a flat rate for indirect costs set under other Union policies are similar to operations financed under those other policies, it is necessary to define the intervention categories and investment priorities or measures under which they fall.

(21)

The methodology to be used for carrying out the quality review of major projects should be established. The quality review by independent experts is a prerequisite for submission of a major project to the Commission by a Member State using the notification procedure provided for in Regulation (EU) No 1303/2013.

(22)

If a Member State chooses to use the notification procedure, it should decide whether the major project is to be assessed by independent experts supported by technical assistance of the Commission or, in agreement with the Commission, by other independent experts.

(23)

The capacity, competence and impartiality of independent experts carrying out the quality review of major projects are among the main factors determining whether the outcome of the review is of good quality and reliable. Therefore, certain requirements should be set out for independent experts to ensure that their work on the quality review is reliable and of high quality. All independent experts should meet these requirements, regardless if their work is supported by technical assistance at the initiative of the Commission or by a Member State. It should be the responsibility of the Member State to verify that the independent experts meet the requirements before seeking the Commission's agreement with a selection of independent experts.

(24)

Since only major projects that have been appraised positively by the independent experts can be selected for submission to the Commission using the notification procedure, it is necessary to set out clear criteria for this purpose. It is also necessary to set out the steps of this review process and the parameters for the appraisal of quality to be used in the review, in order to ensure that the quality review of each major project is based on the same methodological approach and that the quality review is carried out in a manner which contributes to improving the quality of the major projects reviewed.

(25)

Regulation (EU) No 1303/2013 requires the managing authority to establish a system to record and store, in computerised form, data on each operation necessary for monitoring, evaluation, financial management, verification and audit, including data on individual participants. It is therefore necessary to set out a list of data to be recorded and stored in that system.

(26)

Certain data is relevant for particular types of operations or for some of the ESI Funds only; the applicability of data requirements should therefore be specified. Regulation (EU) No 1303/2013 and Regulation (EU) No 1304/2013 of the European Parliament and of the Council (2) set out specific requirements for the recording and storage of data on individual participants in operations supported by the ESF, which need to be taken into account.

(27)

The list of data should take into account the reporting requirements set out under Regulation (EU) No 1303/2013 and the Fund-specific Regulations in order to ensure that the data necessary for financial management and monitoring, including data needed to prepare payment applications, accounts and implementation reports exists for every operation in a form in which it can be easily aggregated and reconciled. The list should take into account that certain basic data on operations in computerised form is necessary for effective financial management of operations and to fulfil the requirement to publish basic information on operations. Certain other data is necessary to effectively plan and carry out verifications and audit work.

(28)

The list of data to be recorded and stored should not prejudge the technical characteristics or structure of the computerised systems set up by managing authorities or pre-determine the format of the data recorded and stored, unless these are specifically stated in this Regulation. Nor should it prejudge the means by which data is entered or generated within the system; in some cases, the data included in the list may require the entry of multiple values. Nevertheless, it is necessary to set out certain rules on the nature of this data, to ensure that the managing authority can fulfil its responsibility for monitoring, evaluation, financial management, verification and audit, including where this requires processing of data on individual participants.

(29)

In order to ensure that expenditure under operational programmes can be checked and audited, it is necessary to set out the criteria with which an audit trail should comply to be considered adequate.

(30)

It is necessary to provide, in relation to the audit work pursuant to Regulation (EU) No 1303/2013, that the Commission and the Member States should prevent any unauthorised disclosure of or access to personal data, and to specify the purposes for which the Commission and the Member States can process such data.

(31)

The audit authority is responsible for audits of operations. To ensure that the scope and effectiveness of such audits are adequate and that they are carried out to the same standards in all Member States, it is necessary to set out the conditions that they should meet.

(32)

It is necessary to set out in detail the sampling basis for operations to be audited, which the audit authority should observe in establishing or approving the sampling method, including the determination of the sampling unit, certain technical criteria to be used for the sample and where necessary factors to be taken into account in taking additional samples.

(33)

The audit authority should draw up an audit opinion covering the accounts referred to in Regulation (EU) No 1303/2013. To ensure that the scope and the content of audits on accounts are adequate and that they are carried out to the same standards in all Member States, it is necessary to set out the conditions that they should meet.

(34)

To ensure legal certainty and equal treatment of all Member States in making financial corrections, consistent with the principle of proportionality, it is necessary to set out the criteria for determining serious deficiencies in the effective functioning of management and control systems, define the main types of such deficiencies and set out the criteria for establishing the level of financial correction to be applied and criteria for applying flat rates or extrapolated financial corrections.

(35)

In order to allow for the prompt application of the measures provided for in this Regulation, this Regulation should enter into force on the day following that of its publication in the Official Journal of the European Union,

(a)

provisions supplementing Part Two of that Regulation applicable to the ERDF, the ESF, the Cohesion Fund, the EAFRD and the EMFF (hereinafter referred to as the ‘ESI Funds’) as regards the following:

(b)

provisions supplementing Part Three of that Regulation applicable to the ERDF and the Cohesion Fund as regards the methodology to be used in carrying out the quality review of major projects;

(c)

provisions supplementing Part Four of that Regulation applicable to the ERDF, the ESF, the Cohesion Fund and the EMFF as regards the following:

(a)

the final value achieved for each output indicator and key implementation step selected for the performance framework under a given priority shall be divided by the respective target values in order to obtain their final achievement rate expressed as a percentage of the target;

(b)

the average of the final achievement rates for all the output indicators and key implementation steps selected for the performance framework under a given priority shall be determined. For that purpose, where a final achievement rate is calculated to be in excess of 100 %, it shall count as 100 %;

(c)

the final value achieved for the financial indicator selected for the performance framework under a given priority shall be divided by the respective target value in order to obtain its final achievement rate expressed as a percentage of the target. For that purpose, where a final achievement rate is calculated to be in excess of 100 %, it shall count as 100 %;

(d)

the average of the final achievement rates for all the output indicators and key implementation steps selected for the performance framework under a given priority shall be divided by the final achievement rate for the financial indicator selected for the performance framework under a given priority.

(a)

for an achievement/absorption coefficient below 65 % but not less than 60 %, a flat rate of 5 % shall be applied;

(b)

for an achievement/absorption coefficient below 60 % but not less than 50 %, a flat rate of 10 % shall be applied;

(c)

for an achievement/absorption coefficient below 50 %, a flat rate of 25 % shall be applied.

(a)

final recipients receiving support from financial instruments are selected with due account taken of the nature of the financial instrument and the potential economic viability of investment projects to be financed. The selection shall be transparent and justified on objective grounds and shall not give rise to a conflict of interest;

(b)

final recipients shall be informed that funding is provided under programmes co-financed by the ESI Funds, in accordance with the requirements laid down in Article 115 of Regulation (EU) No 1303/2013 for the ERDF, the ESF and the Cohesion Fund, in Article 66(1)(c)(i) of Regulation (EU) No 1305/2013 of the European Parliament and of the Council (3) for the EAFRD and in a future Union legal act establishing the conditions for the financial support for maritime and fisheries policy for the programming period 2014-2020 for the EMFF (the ‘EMFF Regulation’);

(c)

financial instruments provide support in a way which is proportionate and has the least distortive effect on competition;

(d)

preferential remuneration of private investors or public investors operating under the market economy principle, as referred to in Article 37(2)(c) and Article 44(1)(b) of Regulation (EU) No 1303/2013, is proportionate to the risks taken by these investors and limited to the minimum necessary to attract such investors, which shall be ensured through terms and conditions and procedural safeguards.

(a)

the irregularity occurred at the level of final recipients or, in the case of a fund of funds, at the level of financial intermediaries or final recipients;

(b)

the bodies implementing financial instruments complied with paragraph 1 of this Article in relation to the programme contributions affected by the irregularity;

(c)

the amounts affected by the irregularity could not be recovered notwithstanding that the bodies implementing financial instruments pursued all applicable contractual and legal measures with due diligence.

(a)

entitlement to carry out relevant implementation tasks under Union and national law;

(b)

adequate economic and financial viability;

(c)

adequate capacity to implement the financial instrument, including organisational structure and governance framework providing the necessary assurance to the managing authority;

(d)

existence of an effective and efficient internal control system;

(e)

use of an accounting system providing accurate, complete and reliable information in a timely manner;

(f)

agreement to be audited by Member State audit bodies, the Commission and the European Court of Auditors.

(a)

robustness and credibility of the methodology for identifying and appraising financial intermediaries or final recipients as applicable;

(b)

the level of management costs and fees for the implementation of the financial instrument and the methodology proposed for their calculation;

(c)

terms and conditions applied in relation to support provided to final recipients, including pricing;

(d)

the ability to raise resources for investments in final recipients additional to programme contributions;

(e)

the ability to demonstrate additional activity in comparison to present activity;

(f)

in cases where the body implementing the financial instrument allocates its own financial resources to the financial instrument or shares the risk, proposed measures to align interests and to mitigate possible conflicts of interest.

(a)

an appropriate multiplier ratio shall be achieved between the amount of the programme contribution set aside to cover expected and unexpected losses from new loans or other risk-sharing instruments to be covered by the guarantees and the value of corresponding disbursed new loans or other risk-sharing instruments;

(b)

the multiplier ratio shall be established through a prudent ex ante risk assessment for the specific guarantee product to be offered, taking into account the specific market conditions, the investment strategy of the financial instrument, and the principles of economy and efficiency. The ex ante risk assessment may be reviewed where it is justified by subsequent market conditions;

(c)

the programme contribution committed to honour guarantees shall reflect that ex ante risk assessment;

(d)

if the financial intermediary or the entity benefiting from the guarantees has not disbursed the planned amount of new loans or other risk-sharing instruments to final recipients, the eligible expenditure shall be reduced proportionally.

(a)

the operation complies with applicable law, the relevant programme and the relevant funding agreement, both during the appraisal and selection process of the operation and during the set-up and implementation of the financial instrument;

(b)

funding agreements contain provisions on audit requirements and on the audit trail in accordance with point 1(e) of Annex IV to Regulation (EU) No 1303/2013;

(c)

management verifications are carried out throughout the programming period and during the set-up and implementation of the financial instruments in accordance with Article 125(4) of Regulation (EU) No 1303/2013 for the ERDF, the ESF, the Cohesion Fund and the EMFF, and in accordance with Article 58(1) and (2) of Regulation (EU) No 1305/2013 for the EAFRD;

(d)

supporting documents for expenditure declared as eligible are:

(e)

supporting documents allowing verification of compliance with Union and national law and with the conditions of funding include at least:

(a)

the managing authority shall mandate a firm which shall operate under a common framework established by the Commission to carry out on-the-spot verifications on the operation within the meaning of Article 125(5)(b) of Regulation (EU) No 1303/2013;

(b)

the audit authority shall mandate a firm which shall operate under a common framework established by the Commission to carry out audits on the operation.

(a)

the disbursement of contributions provided by the ESI Funds programme;

(b)

the resources paid back from investments or from the release of resources committed for guarantee contracts;

(c)

the quality of measures accompanying the investment before and after the investment decision to maximise its impact; and

(d)

the contribution of the financial instrument to the objectives and outputs of the programme.

(a)

3 % for the first 12 months after the signature of the funding agreement, 1 % for the next 12 months, thereafter 0,5 % per annum, of the programme contributions paid to the fund of funds, calculated pro rata temporis from the date of effective payment to the fund of funds until the end of the eligibility period, repayment to the managing authority or the date of winding up, whichever is earlier; and

(b)

0,5 % per annum of programme contributions paid by the fund of funds to financial intermediaries, calculated pro rata temporis from the moment of effective payment by the fund of funds until repayment to the fund of funds, the end of the eligibility period or the date of winding up, whichever is earlier.

(a)

a base remuneration which shall be calculated as follows:

(b)

a performance-based remuneration which shall be calculated as follows:

(a)

for a fund of funds, 7 % of the total amount of programme contributions paid to the fund of funds;

(b)

for a financial instrument providing equity, 20 % of the total amount of programme contributions paid to the financial instrument;

(c)

for a financial instrument providing loans, 8 % of the total amount of programme contributions paid to the financial instrument;

(d)

for a financial instrument providing guarantees, 10 % of the total amount of programme contributions paid to the financial instrument;

(e)

for a financial instrument providing micro-credit, 10 % of the total amount of programme contributions paid to the financial instrument;

(f)

for a financial instrument providing grants, interest rate subsidies or guarantee fee subsidies in accordance with Article 37(7) of Regulation (EU) No 1303/2013, 6 % of the total amount of programme contributions paid to the financial instrument.

(a)

where applicable, user charges shall be fixed in compliance with the polluter-pays principle, and, if appropriate, shall take into account affordability considerations;

(b)

revenue shall not include transfers from national or regional budgets or national public insurance systems;

(c)

where an operation adds new assets to complement a pre-existing service or infrastructure, both contributions from new users and additional contributions from existing users of the new or enlarged service or infrastructure shall be taken into account.

(a)

replacement costs of short-life equipment ensuring the technical functioning of the operation;

(b)

fixed operating costs, including maintenance costs, such as staff, maintenance and repair, general management and administration, and insurance;

(c)

variable operating costs, including maintenance costs, such as consumption of raw materials, energy, other process consumables, and any maintenance and repair needed to extend the lifetime of the operation.

(a)

the Member State's specific macroeconomic conditions and international macroeconomic trends and conjunctures; or

(b)

the nature of the investor or the implementation structure, such as public private partnerships; or

(c)

the nature of the sector concerned.

(a)

the operations supported by the ERDF under intervention field codes 056, 057 or 060-065 as set out in Table 1 of Annex to Commission Implementing Regulation (EU) No 215/2014 (5) and carried out under one of the investment priorities laid down in Article 5(1)(a) and (b), (2)(b), (3)(a) and (c), and (4)(f) of Regulation (EU) No 1301/2013 of the European Parliament and of the Council (6);

(b)

the operations supported by the ESF under intervention field code 04 as set out in Table 6 of Annex to Commission Implementing Regulation (EU) 215/2014 and contributing to strengthening research, technological development and innovation in accordance with Article 3(2)(c) of Regulation (EU) No 1304/2013;

(c)

the operations supported by the EAFRD in accordance with Articles 17, 26 or 35 of Regulation (EU) No 1305/2013 which contribute to the Union priority laid down in Article 5(1) of that Regulation. Where the operation is programmed in accordance with Articles 17 and 26 of Regulation (EU) No 1305/2013, only operations implemented by an operational group of the European Innovation Partnership funded under Article 35(1)(c) of that Regulation shall be considered;

(d)

the operations supported by the EMFF and programmed in accordance with Articles 28, 37 or 41(5) of the future Union legal act establishing the conditions for the financial support for maritime and fisheries policy for the programming period 2014-2020.

(a)

the operations supported by the ERDF under intervention field codes 085, 086 or 087 as set out in Table 1 of Annex to Commission Implementing Regulation (EU) No 215/2014 and carried out under one of the investment priorities laid down in Article 5(5)(a) and (6)(d) of Regulation (EU) No 1301/2013;

(b)

the operations supported by the ESF under intervention field code 01 as set out in Table 6 of Annex to Commission Implementing Regulation (EU) No 215/2014 and contributing to supporting the shift towards a low carbon, climate resilient, resource-efficient and environmentally sustainable economy in accordance with Article 3(2)(a) of Regulation (EU) No 1304/2013;

(c)

the operations supported by the EAFRD in accordance with Articles 17 and 25 of Regulation (EU) No 1305/2013 which contribute to the Union priority laid down in Article 5(4) or (5) of that Regulation;

(d)

the operation supported by the EMFF and programmed in accordance with Articles 36, 38, 39(1), 46(1)(e) and (i), 54, 79c (1)(b) of the future Union legal act establishing the conditions for the financial support for maritime and fisheries policy for the programming period 2014-2020,

(a)

significant technical experience of all stages of the project cycle;

(b)

broad international experience of the investment sectors concerned;

(c)

significant expertise in the analysis and evaluation of socioeconomic benefits;

(d)

significant knowledge and experience of relevant Union law, policies and procedures;

(e)

independence from all authorities involved directly or indirectly in the approval, implementation, or operation of the major project;

(f)

no conflict of interest at any level in relation to the major project;

(g)

no commercial interest in relation to the major project;

(h)

the necessary linguistic competence.

(a)

the independent experts shall verify that the operation is a major project within the meaning of Article 100 of Regulation (EU) No 1303/2013, that the major project is not a completed operation within the meaning of Articles 2(14) and 65(6) of that Regulation, and that the major project is included within the relevant operational programme;

(b)

the independent experts shall check the completeness, consistency and accuracy of the information under points (a) to (i) of the first subparagraph of Article 101 of Regulation (EU) No 1303/2013 provided for in the format referred to in the fifth paragraph of Article 101 of Regulation (EU) No 1303/2013;

(c)

the independent experts shall appraise the quality of the major project on the basis of the criteria set out in Annex II to this Regulation;

(d)

the independent experts shall produce an independent quality review report (hereinafter the ‘IQR report’) in the format provided for in the third subparagraph of Article 102(1) of Regulation (EU) No 1303/2013. In the IQR report, the independent experts shall formulate and justify their statements in an unambiguous manner for the elements referred to in this paragraph.

(a)

the audit trail shall allow the application of the selection criteria established by the monitoring committee for the operational programme to be verified;

(b)

in relation to grants and repayable assistance under Article 67(1)(a) of Regulation (EU) No 1303/2013, the audit trail shall allow the aggregate amounts certified to the Commission to be reconciled with the detailed accounting records and supporting documents held by the certifying authority, managing authority, intermediate bodies and beneficiaries as regards operations co-financed under the operational programme;

(c)

in relation to grants and repayable assistance under Articles 67(1)(b) and (c) and 109 of Regulation (EU) No 1303/2013 and under Article 14(1) of Regulation (EU) No 1304/2013, the audit trail shall allow the aggregate amounts certified to the Commission to be reconciled with the detailed data relating to outputs or results and supporting documents held by the certifying authority, managing authority, intermediate bodies and beneficiaries, including where applicable documents on the method of setting the standard scales for unit costs and the lump sums, as regards operations co-financed under the operational programme;

(d)

in relation to costs determined in accordance with Articles 67(1)(d) and 68(1)(a) of Regulation (EU) No 1303/2013, the audit trail shall demonstrate and justify the calculation method, where applicable, and the basis on which the flat rates have been decided, and the eligible direct costs or costs declared under other chosen categories to which the flat rate applies;

(e)

in relation to costs determined in accordance with Article 68(1)(b) and (c) of Regulation (EU) No 1303/2013, Article 14(2) of Regulation (EU) No 1304/2013 and Article 20 of Regulation (EU) No 1299/2013, the audit trail shall allow the eligible direct costs to which the flat rate applies to be substantiated;

(f)

the audit trail shall allow the payment of the public contribution to the beneficiary to be verified;

(g)

for each operation, as appropriate, the audit trail shall include the technical specifications and financing plan, documents concerning the grant approval, documents relating to public procurement procedures, reports by the beneficiary and reports on verifications and audits carried out;

(h)

the audit trail shall include information on management verifications and audits carried out on the operation;

(i)

without prejudice to Article 19(3) and Annexes I and II to Regulation (EU) No 1304/2013, the audit trail shall allow data in relation to output indicators for the operation to be reconciled with targets and reported data and result for the programme;

(j)

for financial instruments, the audit trail shall include the supporting documents referred to in Article 9(1)(e) of this Regulation.

(a)

that the operation was selected in accordance with the selection criteria for the operational programme, was not physically completed or fully implemented before the beneficiary submitted the application for funding under the operational programme, has been implemented in accordance with the approval decision and fulfilled any conditions applicable at the time of the audit concerning its functionality, use, and objectives to be attained;

(b)

that the expenditure declared to the Commission corresponds to the accounting records and that the required supporting documentation demonstrates an adequate audit trail as set out in Article 25 of this Regulation;

(c)

that for expenditure declared to the Commission determined in accordance with Articles 67(1)(b) and (c) and 109 of Regulation (EU) No 1303/2013 and Article 14(1) of Regulation (EU) No 1304/2013, outputs and results underpinning payments to the beneficiary have been delivered, participant data or other records related to outputs and results are consistent with the information submitted to the Commission and that the required supporting documentation demonstrates an adequate audit trail as set out in Article 25 of this Regulation.

(i)

a random selection of the sample items;

(ii)

the use of probability theory to evaluate sample results, including measurement and control of the sampling risk and of the planned and achieved precision.

(a)

the total amount of eligible expenditure declared in accordance with Article 137(1)(a) of Regulation (EU) No 1303/2013 agrees with the expenditure and the corresponding public contribution included in payment applications submitted to the Commission for the relevant accounting year and, if there are differences, that adequate explanations have been provided in the accounts for the reconciling amounts;

(b)

the amounts withdrawn and recovered during the accounting year, the amounts to be recovered as at the end of the accounting year, the recoveries carried out pursuant to Article 71 of Regulation (EU) No 1303/2013, and the irrecoverable amounts presented in the accounts correspond to the amounts entered in the accounting systems of the certifying authority and are based on decisions by the responsible managing authority or certifying authority;

(c)

expenditure has been excluded from the accounts in accordance with Article 137(2) of Regulation (EU) No 1303/2013, where applicable, and that all the required corrections are reflected in the accounts for the accounting year concerned;

(d)

the programme contributions paid to financial instruments and advances of State aid paid to beneficiaries are supported by the information available from the managing authority and from the certifying authority.

(a)

the relative importance of the serious deficiency or serious deficiencies in the context of the management and control system as a whole;

(b)

the frequency and extent of the serious deficiency or serious deficiencies;

(c)

the degree of risk of loss for the Union budget.

(a)

where the serious deficiency or serious deficiencies in the management and control system is so fundamental, frequent or widespread that it represents a complete failure of the system that puts at risk the legality and regularity of all expenditure concerned, a flat rate of 100 % shall be applied;

(b)

where the serious deficiency or serious deficiencies in the management and control system is so frequent and widespread that it represents an extremely serious failure of the system that puts at risk the legality and regularity of a very high proportion of the expenditure concerned, a flat rate of 25 % shall be applied;

(c)

where the serious deficiency or serious deficiencies in the management and control system is due to the system not fully functioning or functioning so poorly or so infrequently that it puts at risk the legality and regularity of a high proportion of the expenditure concerned, a flat rate of 10 % shall be applied;

(d)

where the serious deficiency or serious deficiencies in the management and control system is due to the system not functioning consistently so that it puts at risk the legality and regularity of a significant proportion of the expenditure concerned, a flat rate of 5 % shall be applied.

13.5.2014   

EN

Official Journal of the European Union

L 138/45

(1)

Pursuant to Article 18(1) of Regulation (EU) No 1299/2013, it is necessary to lay down specific rules on eligibility of expenditure for cooperation programmes with regard to staff costs, office and administrative expenditure, travel and accommodation costs, external expertise and services costs and equipment expenditure (hereinafter ‘expenditure categories’).

(2)

To allow flexibility in the application of the eligibility rules to cooperation programmes Member States participating in a given cooperation programme should be allowed to decide that a given expenditure category does not apply to a specific priority axis of a given cooperation programme.

(3)

It should be specified how the specific rules on eligibility of expenditure for cooperation programmes laid down in this Regulation fit into the general legal framework on eligibility rules applicable to all ESI Funds as set out in Articles 65 to 71 of Regulation (EU) No 1303/2013 of the European Parliament and of the Council (2).

(4)

For each expenditure category, a list of different expenditure elements should be set out.

(5)

It should be clarified that, as a general rule, gifts are ineligible. However, the distribution of small items related to promotion, communication, publicity or information should be eligible.

(6)

The different elements of staff costs should be determined, together with rules on the calculation, accounting and reimbursement of staff costs in general and of part-time assignment or service contracts on an hourly basis in particular.

(7)

The different elements of office and administrative expenditure should be listed, together with rules on the calculation, accounting and reimbursement of such cost elements either as direct or indirect costs, in particular where combined with flat rates under Regulation (EU) No 1303/2013.

(8)

The different elements of travel and accommodation costs should be listed, together with rules on the calculation, accounting and reimbursement regardless of whether such expenditure is incurred by the beneficiary or directly by its staff. The conditions under which travel and accommodation costs should be accounted for if spent outside the Union part of the programme area as referred to in Article 20 of Regulation (EU) No 1299/2013 should also be clarified.

(9)

The different elements of external expertise and service costs should be listed.

(10)

The different elements of equipment expenditure should be listed, together with rules on the eligibility of second-hand equipment.

(11)

In order to allow for the prompt application of the measures provided for in this Regulation, this Regulation should enter into force on the day following that of its publication in the Official Journal of the European Union,

(a)

staff costs;

(b)

office and administrative expenditure;

(c)

travel and accommodation costs;

(d)

external expertise and services costs; and

(e)

equipment expenditure.

(a)

fines, financial penalties and expenditure on legal disputes and litigation;

(b)

costs of gifts, except those not exceeding EUR 50 per gift where related to promotion, communication, publicity or information;

(c)

costs related to fluctuation of foreign exchange rate.

(a)

full time;

(b)

part-time with a fixed percentage of time worked per month;

(c)

part-time with a flexible number of hours worked per month; or

(d)

on an hourly basis.

(a)

salary payments related to the activities which the entity would not carry out if the operation concerned was not undertaken, fixed in an employment/work contract, an appointment decision (both hereinafter referred to as ‘employment document’) or by law, relating to responsibilities specified in the job description of the staff member concerned;

(b)

any other costs directly linked to salary payments incurred and paid by the employer, such as employment taxes and social security including pensions as covered by Regulation (EC) No 883/2004 of the European Parliament and of the Council (3) provided that they are:

(i)

on a real cost basis (proven by the employment document and payslips); or

(ii)

under simplified cost options as set out in Article 67(1)(b) to (d) of Regulation (EU) No 1303/2013; or

(iii)

as a flat rate in accordance with Article 19 of Regulation (EU) No 1299/2013.

(a)

a fixed percentage of the gross employment cost, in line with a fixed percentage of time worked on the operation, with no obligation to establish a separate working time registration system; or

(b)

a flexible share of the gross employment cost, in line with a number of hours varying from one month to the other worked on the operation, based on a time registration system covering 100 % of the working time of the employee.

(i)

dividing the monthly gross employment cost by the monthly working time fixed in the employment document expressed in hours; or

(ii)

dividing the latest documented annual gross employment cost by 1 720 hours in accordance with Article 68(2) of Regulation (EU) No 1303/2013.

(a)

office rent;

(b)

insurance and taxes related to the buildings where the staff is located and to the equipment of the office (e.g. fire, theft insurances);

(c)

utilities (e.g. electricity, heating, water);

(d)

office supplies;

(e)

general accounting provided inside the beneficiary organisation;

(f)

archives;

(g)

maintenance, cleaning and repairs;

(h)

security;

(i)

IT systems;

(j)

communication (e.g. telephone, fax, internet, postal services, business cards);

(k)

bank charges for opening and administering the account or accounts where the implementation of an operation requires a separate account to be opened;

(l)

charges for transnational financial transactions.

(a)

travel costs (e.g. tickets, travel and car insurance, fuel, car mileage, toll, and parking fees);

(b)

the costs of meals;

(c)

accommodation costs;

(d)

visa costs;

(e)

daily allowances.

(a)

studies or surveys (e.g. evaluations, strategies, concept notes, design plans, handbooks);

(b)

training;

(c)

translations;

(d)

IT systems and website development, modifications and updates;

(e)

promotion, communication, publicity or information linked to an operation or to a cooperation programme as such;

(f)

financial management;

(g)

services related to the organisation and implementation of events or meetings (including rent, catering or interpretation);

(h)

participation in events (e.g. registration fees);

(i)

legal consultancy and notarial services, technical and financial expertise, other consultancy and accountancy services;

(j)

intellectual property rights;

(k)

verifications under Article 125(4)(a) of Regulation (EU) No 1303/2013 and Article 23(4) of Regulation (EU) No 1299/2013;

(l)

certification and audit costs on programme level under Articles 126 and 127 of Regulation (EU) No 1303/2013;

(m)

the provision of guarantees by a bank or other financial institution where required by Union or national law or in a programming document adopted by the monitoring committee;

(n)

travel and accommodation for external experts, speakers, chairpersons of meetings and service providers;

(o)

other specific expertise and services needed for operations.

(a)

office equipment;

(b)

IT hardware and software;

(c)

furniture and fittings;

(d)

laboratory equipment;

(e)

machines and instruments,

(f)

tools or devices;

(g)

vehicles;

(h)

other specific equipment needed for operations.

(a)

no other assistance has been received for it from the ESI Funds;

(b)

its price does not exceed the generally accepted price on the market in question;

(c)

it has the technical characteristics necessary for the operation and complies with applicable norms and standards.

13.5.2014   

EN

Official Journal of the European Union

L 138/51

(1)

The manufacturer of light commercial vehicles, Great Wall Motor Company Limited, has informed the Commission that the average specific CO2 emissions in 2010 specified for that manufacturer in Commission Delegated Regulation (EU) No 114/2013 (2) are incorrect. The manufacturer has provided detailed evidence demonstrating that the average specific CO2 emissions in 2010 were significantly higher than the value indicated in that Regulation.

(2)

The Commission has assessed the evidence provided by Great Wall Motor Company Limited and considers that it is appropriate to correct the value.

(3)

Delegated Regulation (EU) No 114/2013 should therefore be amended accordingly,

13.5.2014   

EN

Official Journal of the European Union

L 138/52

(1)

Article 22(1) of Directive 97/78/EC provides that if in the territory of a third country a disease or any other phenomenon or circumstance liable to present a serious threat to animal health manifests itself or spreads, or if any other serious animal health reason so warrants, the Commission acting on its own initiative or at the request of a Member State, is to adopt measures without delay, including special conditions in respect of products coming from all or part of the third country concerned.

(2)

Regulation (EC) No 1069/2009 of the European Parliament and of the Council (2) lays down public and animal health rules for animal by-products and derived products, in order to prevent and minimise risks to public and animal health arising from those products, and in particular to protect the safety of the feed chain. It also categorises those products into specific categories which reflect the level of risk to public and animal health.

(3)

Article 41(3) of Regulation (EC) No 1069/2009, lays down requirements for the import of animal by-products and derived products of Category 3 material.

(4)

Commission Regulation (EU) No 142/2011 (3), lays down implementing rules for Regulation (EC) No 1069/2009, including specific requirements for the treatment or processing of animal by-products and derived products destined for feeding to farmed animals, excluding fur animals.

(5)

Blood products intended for the production of feed for farmed animals, including spray dried blood and plasma of porcine animals, must have been produced in accordance with Section 2 of Chapter II of Annex X to Regulation (EU) No 142/2011. With reference to point B of that Section blood products are to be submitted to any of the processing methods 1 to 5 or processing method 7 as set out in Chapter III of Annex IV to that Regulation, or another method which ensures that the blood products comply with the microbiological standards for derived products set out in Chapter I of Annex X to Regulation (EU) No 142/2011. Regulation (EU) No 142/2011 also provides, in particular in column 6 of row 2 in Table 1 of Section 1 of Chapter I of Annex XIV, that blood products not intended for human consumption that could be used as feed intended for dispatch to or for transit through the Union are to be accompanied by health certificate in accordance with the model health certificate set out in Chapter 4(B) of Annex XV.

(6)

Porcine diarrhoea caused by a deltacoronavirus occurs in Asia and North America. This virus has never been detected in the Union. Spray dried blood and blood plasma of porcine animals is a traditional ingredient for feed for piglets. Inappropriate heat treatment or contamination after heat treatment may lead to the spread of the virus with such products.

(7)

Therefore it is necessary to review the requirements for the import of spray dried blood and blood plasma of porcine animals intended for the production of feed for farmed porcine animals.

(8)

Scientific observation indicates that porcine coronaviruses are inactivated in swine faeces if heated to and held at a temperature of 71 °C for 10 minutes or left at room temperature of 20 °C for 7 days. The virus did not survive in experimentally infected dry feed stored at a temperature of 24 °C for more than 2 weeks. In third countries the commonly applied temperature for spray drying of blood and blood plasma is 80 °C throughout the substance.

(9)

Based on this information available, it appears opportune to require that spray dried blood and blood plasma of porcine origin introduced from third countries and intended for feeding of porcine animals has been subjected to a high temperature treatment followed by subsequent storage for a certain time at room temperature in order to mitigate the risk of contamination after the treatment.

(10)

Due to the need to protect animal health in the Union and the serious threat posed by the blood products concerned, the Commission should adopt provisional safeguard measures. Accordingly, the introduction of those products into Union should be accompanied by a health certificate in accordance with the model set out in the Annex to this Regulation.

(11)

The provisional safeguard measures should apply from the day following the publication of this Regulation and last for a period of 12 months. They may be amended in the light of a risk assessment based on new scientific information.

(12)

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

13.5.2014   

EN

Official Journal of the European Union

L 138/57

(1)

In accordance with Regulation (EU) No 575/2013 of the European Parliament and of the Council (2) institutions established in the Union are currently reporting their compliance with the own funds requirements on a quarterly basis. In order to minimise inconsistencies between the reference dates set for institutions and the dates set for central counterparties (CCPs) for the calculation and reporting of the information related to the hypothetical capital, the reference dates set for CCPs should cover at least the reference dates already set for institutions. However, a higher frequency of reporting of the information related to the hypothetical capital would also accommodate the fact that clearing members established in third countries can have different reporting dates. Furthermore, there might be large variations in own funds requirements and for them to have an updated view of those requirements, clearing members and their competent authorities might want to monitor those exposures more frequently than quarterly.

(2)

In normal situations, the reporting dates for CCPs should not be delayed by more than one week with respect to the date of calculation. A week provides CCPs with sufficient time in order to perform all the internal controls and complete the necessary approval process before reporting the required data. If a CCP develops a fully automated system the reporting date can be close to the calculation date. Currently, however, CCPs might not have the capability to complete the entire process within this time and might therefore need to develop their internal processes and infrastructures in order to be able to do so. Against this background, a transitional provision should be introduced to give CCPs sufficient time to develop the necessary internal processes and infrastructures and, at the same time, to start reporting the information related to the hypothetical capital to their clearing members.

(3)

Pursuant to Regulation (EU) No 648/2012 the losses following the default of a clearing member would, in the first instance, be covered by the initial margin and by the default fund contribution of the defaulting member itself. Where those prove to be insufficient, the losses are covered by the pre-funded financial resources that are contributed by CCPs to their respective default waterfalls and by the pre-funded default fund contributions of the non-defaulting members. During this period, the frequency of reporting should be increased in order to keep the other non-defaulting clearing members and the competent authorities updated on all the information related to the hypothetical capital needed to calculate the clearing members' own fund requirements. CCPs should have the technical capabilities and the internal processes in place in order to compute and deliver the information related to the hypothetical capital under those stress situations.

(4)

Pursuant to Regulation (EU) No 648/2012, a CCP has to replenish its pre-funded own financial resources in the default waterfall within one month. For this reason, the frequencies of calculation and reporting in these situations should be higher than the norm. Daily reporting of the information related to hypothetical capital could be less meaningful because it might take time to establish the total size of the losses following the clearing member's default. Given that they may face a broad range of different scenarios, competent authorities should also have the option to request a higher frequency in periods of stress based on an assessment of the situation that should take into account the degree of actual or foreseen depletion of the pre-funded financial resources available to the CCP (both those contributed by the CCP itself and those contributed by clearing members). The higher frequency should apply until those resources are restored to levels required by the relevant legislation.

(5)

The high frequency of reporting in periods of stress can be very demanding given the newly introduced reporting requirement. This may pose challenges as regards the technical implementation for at least some CCPs. To mitigate this, it is appropriate to have a later date of application for the requirements of higher frequency of reporting. That will allow CCPs to improve their internal processes and upgrade their systems.

(6)

The provisions in this Regulation are closely linked, since they deal with the calculation and reporting of the hypothetical capital of a CCP. To ensure coherence between those provisions, which should enter into force at the same time, and to facilitate a comprehensive view and compact access to them by persons subject to those obligations, it is desirable to include all the relevant implementing technical standards required by Regulation (EU) No 648/2012 in a single Regulation.

(7)

This Regulation is based on the draft implementing technical standards submitted by the European Banking Authority to the Commission.

(8)

The European Banking Authority has conducted open public consultations on the draft implementing technical standards on which this Regulation is based, analysed the potential related costs and benefits and requested the opinion of the Banking Stakeholder Group established in accordance with Article 37 of Regulation (EU) No 1093/2010 of the European Parliament and of the Council (3),

(a)

the reference days for that calculation shall be as follows:

January 31, February 28 (or February 29 in a leap year), March 31, April 30, May 31, June 30, July 31, August 31, September 30, October 31, November 30, December 31;

(b)

the day on which the CCP shall undertake that calculation (day of calculation) shall be respectively:

February 1, March 1, April 1, May 1, June 1, July 1, August 1, September 1, October 1, November 1, December 1, January 1.

(a)

where, following the default of one clearing member, a CCP is obliged to use any portion of the pre-funded financial resources that it contributed to the default waterfall in accordance with Article 43 of Regulation (EU) No 648/2012;

(b)

where, following the default of one clearing member a CCP is obliged to make use of the default fund contributions of non-defaulting clearing members in accordance with Article 42 of Regulation (EU) No 648/2012.

13.5.2014   

EN

Official Journal of the European Union

L 138/65

(1)

In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For Bacillus pumilus QST 2808 the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Implementing Decision 2011/253/EU (3).

(2)

In accordance with Article 6(2) of Directive 91/414/EEC the Netherlands received on 3 December 2010 an application from AgraQuest Inc., now Bayer CropScience, for the inclusion of the active substance Bacillus pumilus QST 2808 in Annex I to Directive 91/414/EEC. Implementing Decision 2011/253/EU confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

(3)

For that active substance, the effects on human and animal health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 8 May 2012.

(4)

The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’). The Authority presented to the Commission its conclusion (4) on the pesticide risk assessment of the active substance Bacillus pumilus QST 2808 on 26 July 2013. The draft assessment report 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 20 March 2014 in the format of the Commission review report for Bacillus pumilus QST 2808.

(5)

It has appeared from the various examinations made that plant protection products containing Bacillus pumilus QST 2808 may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve Bacillus pumilus QST 2808.

(6)

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.

(7)

A reasonable period should be allowed to elapse before approval in order to permit Member States and the interested parties to prepare themselves to meet the new requirements resulting from the approval.

(8)

Without prejudice to the obligations provided for in Regulation (EC) No 1107/2009 as a consequence of approval, taking into account the specific situation created by the transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009, the following should, however, apply. Member States should be allowed a period of six months after approval to review authorisations of plant protection products containing Bacillus pumilus QST 2808. Member States should, as appropriate, vary, replace or withdraw authorisations. By way of derogation from that deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier, as set out in Directive 91/414/EEC, of each plant protection product for each intended use in accordance with the uniform principles.

(9)

The experience gained from inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 (5) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the Directives which have been adopted until now amending Annex I to that Directive or the Regulations approving active substances.

(10)

In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (6) should be amended accordingly.

(11)

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

(a)

in the case of a product containing Bacillus pumilus QST 2808 as the only active substance, where necessary, amend or withdraw the authorisation by 29 February 2016 at the latest; or

(b)

in the case of a product containing Bacillus pumilus QST 2808 as one of several active substances, where necessary, amend or withdraw the authorisation by 29 February 2016 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or those substances, whichever is the latest.

13.5.2014   

EN

Official Journal of the European Union

L 138/70

(1)

Commission Directive 2011/30/EU (2) included fenbutatin oxide as active substance in Annex I to Council Directive 91/414/EEC (3) with the condition that Member States concerned ensure that the applicant at whose request fenbutatin oxide has been included provides further confirmatory information on the genotoxicological potential and ecotoxicological relevance of the impurity SD 31723 and to the spectra, storage stability and methods of analysis in the formulation by 31 May 2013.

(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)

The applicant at whose request fenbutatin oxide had been approved did not submit the confirmatory information by the deadline of 31 May 2013. By mail of 27 June 2013 it confirmed to the Commission its intention not to submit such information.

(4)

Consequently, it is appropriate to withdraw the approval of fenbutatin oxide.

(5)

Commission Directive 2011/30/EU should therefore be repealed.

(6)

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

(7)

Member States should be provided with time to withdraw authorisations for plant protection products containing fenbutatin oxide.

(8)

For plant protection products containing fenbutatin oxide, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, this period should, at the latest, expire 18 months after entry into force of this Regulation.

(9)

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

13.5.2014   

EN

Official Journal of the European Union

L 138/72

(1)

Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2) sets out the active substances deemed to have been approved under Regulation (EC) No 1107/2009.

(2)

The approvals of the active substances Bacillus subtilis (Cohn 1872) Strain QST 713, identical with strain AQ 713, clodinafop, metrafenone, pirimicarb, rimsulfuron, spinosad, thiamethoxam, tolclofos-methyl and triticonazole will expire on 31 January 2017. Applications have been submitted for the renewal of the approval of these active substances. As the requirements laid down in Commission Implementing Regulation (EU) No 844/2012 (3) apply to those active substances, it is necessary to allow applicants sufficient time to complete the renewal procedure in accordance with that Regulation. Consequently, the approvals of those active substances are likely to expire before a decision has been taken on their renewal. It is therefore necessary to extend their approval periods.

(3)

Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

(4)

In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, as regards cases where no supplementary dossier in accordance with Implementing Regulation (EU) No 844/2012 is submitted no later than 30 months before the respective expiry date laid down in the Annex to this Regulation, the Commission will set the expiry date at the same date as before this Regulation or at the earliest date thereafter.

(5)

In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, as regards cases where the Commission will adopt a Regulation providing that the approval of an active substance referred to in the Annex to this Regulation is not renewed because the approval criteria are not satisfied, the Commission will set the expiry date at the same date as before this Regulation or at the date of the entry into force of the Regulation providing that the approval of the active substance is not renewed, whichever date is later.

(6)

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

13.5.2014   

EN

Official Journal of the European Union

L 138/75

(1)

Commission Regulation (EC) No 1881/2006 (2) establishes maximum levels for cadmium in a range of foodstuffs.

(2)

The Scientific Panel on Contaminants in the Food Chain (CONTAM Panel) of the European Food Safety Authority (EFSA) adopted an opinion on cadmium in food on 30 January 2009 (3). In that opinion, EFSA established a tolerable weekly intake (TWI) of 2,5 μg/kg body weight for cadmium. In its ‘Statement on tolerable weekly intake for cadmium’ (4), EFSA took into account the recent risk assessment carried out by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) (5) and confirmed the TWI of 2,5 μg/kg body weight.

(3)

In the scientific opinion on cadmium in food, the CONTAM Panel concluded that the mean dietary exposures to cadmium in European countries are close to or slightly exceeding the TWI of 2,5 μg/kg body weight. Certain subgroups of the population may exceed the TWI by about 2 fold. The CONTAM Panel further concluded that, although adverse effects on kidney function are unlikely to occur for an individual exposed at this level, exposure to cadmium at the population level should be reduced.

(4)

According to the scientific opinion on cadmium in food of the CONTAM Panel, the food groups that contribute to the major part of the dietary cadmium exposure, primarily because of the high consumption, are cereals and cereals products, vegetables, nuts and pulses, starchy roots or potatoes and meat and meat products. Highest cadmium concentrations were detected in the food commodities seaweed, fish and seafood, chocolate and foods for special dietary uses as well as in fungi, oilseeds and edible offal.

(5)

In a refined exposure assessment carried out by EFSA in its scientific report on ‘Cadmium dietary exposure in the European population’ (6) using the new Comprehensive Food Consumption database which contains updated information on food consumption figures for the different Member States and for different age groups of the population, more detailed information on the particular food commodities that contribute to exposure are given by age group. For adults, starchy roots and tubers, grains and grain based products and vegetables and vegetable products are major contributors to exposure. For children and adolescents, starchy roots and tubers, grain and grain based products and sugar and confectionary are main contributors to exposure, while for infants and toddlers it is starchy roots and tubers, grains and grain based products, vegetables and vegetable based products, milk and dairy products and foods for infants and small children that contribute most. The refined exposure assessment shows that overall exposure is the result of not only a few main contributors but the addition of contributions of a number of different food groups.

(6)

Maximum levels have been established for cadmium in a wide range of foodstuffs, including cereals, vegetables, meat, fish, seafood, offals and food supplements. For some foodstuffs that are important contributors to the exposure for certain population groups (chocolate and cocoa products, foods for infants and young children) maximum levels have not yet been established. It is therefore necessary to establish maximum levels of cadmium for those foodstuffs.

(7)

Maximum levels for contaminants are set according to the ALARA principle (‘as low as reasonably achievable’) both for commodities for which maximum levels for cadmium currently already exist (such as vegetables, meat, fish, seafood, offals and food supplements) and for commodities for which maximum levels are newly set (such as cocoa and chocolate products) using occurrence data and food consumption patterns of the European Union citizen.

(8)

Chocolate and cocoa powder sold to the final consumer can contain high levels of cadmium and are an important source of human exposure. They are frequently consumed by children, e.g. chocolate as such or as sweetened cocoa powders used in cocoa beverages. When establishing maximum levels of cadmium, occurrence data for different types of chocolates and for cocoa powders sold to the final consumer should be considered. Since cadmium levels in cocoa products are related to their cocoa content, it is appropriate to establish different maximum levels of cadmium for products containing different percentages of cocoa. This should ensure that the maximum levels may also be complied with by chocolates with a higher percentage of cocoa.

(9)

In some regions of cocoa producing countries, cadmium levels in soil can be naturally high. Therefore, occurrence data of cocoa and chocolate products provided by countries with high cadmium levels in soil should be taken into account when establishing maximum levels of cadmium.

(10)

Infant formulae and follow-on formulae contribute significantly to cadmium exposure of infants and young children. Infant formulae and follow-on formulae manufactured from soya protein isolates, alone or in a mixture with cows' milk proteins, can contain higher cadmium levels than milk based products since soya beans naturally take up cadmium from the soil. Soya based formulae are an important alternative for infants suffering from lactose intolerance, therefore sufficient market supply must be ensured. It is therefore appropriate to set a higher maximum level for soya based products.

(11)

Processed cereal based foods and other baby foods for infants and young children are an important source of exposure to cadmium for infants and young children. A particular maximum level of cadmium should therefore be established for processed cereal based and other baby foods.

(12)

Reduced exposure of a very vulnerable group of consumers could be achieved by the establishment of a maximum level for certain categories of food for particular nutritional uses (e.g. food for special medical purposes for infants). However, in absence of data to substantiate such a maximum level, occurrence data should be collected in view of the possible establishment of a specific maximum level in the future.

(13)

For certain specific vegetables (salsify, parsnips, celery, horseradish), compliance with current maximum levels is difficult and occurrence data provided by the Member States show that natural background levels are higher and comparable with those of celeriac. Since consumption of those commodities is low and effects on human exposure are negligible, it is appropriate to raise the maximum levels of cadmium for parsnips, salsify, celery and horseradish to that of celeriac.

(14)

Certain fish species are currently exempted from the default maximum level for fish of 0,05 mg/kg. For the fish species bonito (Sarda sarda), common two-banded seabream (Diplodus vulgaris), eel (Anguilla anguilla), grey mullet (Mugil labrosus labrosus), horse mackerel (Trachurus species), louvar (Luvarus imperialis), sardinops (Sardinops species) and wedge sole (Dicologoglossa cuneata) new occurrence data show that the exemption is no longer necessary and that the default maximum level can be complied with following good fishery practices. Specific maximum levels are therefore no longer necessary for those fish species.

(15)

For bullet tuna (Auxis species), anchovy (Engraulis species) and swordfish (Xiphias gladius), new occurrence data show a lower maximum level can be complied with following good fishery practices. The maximum levels for those fish species should therefore be adjusted.

(16)

For sardines (Sardina pilchardus) and bichique (Sicyopterus lagocephalus), occurrence data show that compliance with the existing maximum levels is difficult, as natural background levels can be higher. For both fish species, the consumption is low and has negligible effects on human exposure. It is therefore appropriate to set higher maximum levels for those two fish species to ensure market supply.

(17)

Regulation (EC) No 1881/2006 should therefore be amended accordingly.

(18)

Member States and food business operators should be allowed time to adapt to the new maximum levels established by this Regulation for cocoa products and foods for infants and young children. The date of application of the maximum levels of cadmium for those commodities should therefore be deferred.

(19)

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