ISSN 1977-0677
doi:10.3000/19770677.L_2013.279.eng
Official Journal
of the European Union
L 279
English edition
Legislation
Volume 56
19 October 2013
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ISSN 1977-0677 doi:10.3000/19770677.L_2013.279.eng |
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Official Journal of the European Union |
L 279 |
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English edition |
Legislation |
Volume 56 |
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(1) Text with EEA relevance |
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EN |
Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period. The titles of all other Acts are printed in bold type and preceded by an asterisk. |
II Non-legislative acts
INTERNATIONAL AGREEMENTS
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19.10.2013 |
EN |
Official Journal of the European Union |
L 279/1 |
Information on the entry into force of the Fisheries Partnership Agreement between the Gabonese Republic and the European Community
The European Union and the Gabonese Republic signed, on 6 June 2007, in Brussels, a Fisheries Partnership Agreement between the Gabonese Republic and the European Community (1).
The European Community notified on that same day that it had completed the necessary internal procedures to conclude the agreement. The Gabonese Republic notified on 11 June 2007.
The Protocol accordingly entered into force on 11 June 2007 pursuant to Article 17 thereof.
(1) OJ L 109, 26.4.2007, p. 3.
REGULATIONS
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19.10.2013 |
EN |
Official Journal of the European Union |
L 279/2 |
COMMISSION DELEGATED REGULATION (EU) No 1002/2013
of 12 July 2013
amending Regulation (EU) No 648/2012 of the European Parliament and of the Council on OTC derivatives, central counterparties and trade repositories with regard to the list of exempted entities
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 648/2012 of the European Parliament and of the Council of 4 July 2012 on OTC derivatives, central counterparties and trade repositories (1), and in particular Article 1(6) thereof,
Whereas:
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(1) |
The Commission has assessed the international treatment of public bodies charged with or intervening in the management of public debt and central banks and presented its conclusions to the European Parliament and the Council (2). In particular, the Commission has conducted a comparative analysis of the treatment of such public bodies and central banks in the legal orders of a significant number of third countries, as well as of the risk-management standards applicable to the derivative transactions entered into by those bodies and by central banks in those jurisdictions. |
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(2) |
Following this analysis, the Commission concluded that central banks and public bodies charged with or intervening in the management of public debt should be exempted from the clearing and reporting obligation applicable to over-the-counter (OTC) derivatives pursuant to the rules on OTC derivatives introduced in Japan and the United States of America. |
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(3) |
Adding central banks and public bodies charged with or intervening in the management of the public debt from Japan and from the United States of America to the list of exempted entities referred to in Regulation (EU) No 648/2012 should promote neutral market conditions in the application of OTC derivatives reforms with regard to transactions with central banks across those jurisdictions and contribute to greater international coherence and consistency. |
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(4) |
The exercise of monetary responsibilities and the management of sovereign debt have a combined impact on the functioning of interest rate markets and should be coordinated to ensure that these two functions are performed efficiently. As Regulation (EU) No 648/2012 excludes from its scope Union central banks and other Union public bodies managing debt so as not to impede their ability to perform tasks of common interest, the application of different rules to such functions when they are exercised by third-country entities would be detrimental to their effectiveness. In order to ensure that third country central banks and other public bodies charged with or intervening in the management of the public debt continue to be in a position to perform their tasks adequately, third-country public bodies charged with or intervening in the management of the public debt should also be exempted from Regulation (EU) No 648/2012, |
HAS ADOPTED THIS REGULATION:
Article 1
In Article 1(4) of Regulation (EU) No 648/2012, the following point (c) is added:
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‘(c) |
the central banks and public bodies charged with or intervening in the management of the public debt in the following countries:
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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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 12 July 2013.
For the Commission
The President
José Manuel BARROSO
(1) OJ L 201, 27.7.2012, p. 1.
(2) COM(2013) 158 final.
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19.10.2013 |
EN |
Official Journal of the European Union |
L 279/4 |
COMMISSION DELEGATED REGULATION (EU) No 1003/2013
of 12 July 2013
supplementing Regulation (EU) No 648/2012 of the European Parliament and of the Council with regard to fees charged by the European Securities and Markets Authority to trade repositories
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 648/2012 of the European Parliament and of the Council of 4 July 2012 on OTC derivatives, central counterparties and trade repositories (1), and in particular Article 72(3) thereof,
Whereas:
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(1) |
Article 62 of Regulation (EU) No 1095/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Securities and Markets Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/77/EC (2) provides that the revenues of the European Securities and Markets Authority (ESMA) consist of fees paid to ESMA in the cases specified in Union legislation, together with contributions from national public authorities and a subsidy from the Union. |
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(2) |
A registration fee should be charged to trade repositories established in the Union to reflect ESMA’s costs for processing the application for registration. The costs associated with assessing the application increase where a trade repository intends to cover at least three derivative classes or to offer ancillary services. Therefore, the registration fee should be calculated with regard to these two objective criteria. |
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(3) |
The provision of ancillary services and of reporting services in more than three derivative classes are also expected to have a direct impact on the future turnover of the trade repository. Therefore, for the purpose of charging registration fees, trade repositories should be classified into three different categories of expected total turnover (high, medium and low expected total turnover), to which different registration fees should apply, depending on whether they intend to provide ancillary services or reporting services in more than three derivative classes, or both. |
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(4) |
If, after registration, a trade repository starts offering ancillary services or starts operating in more than three derivative classes, thereby falling into an upper category in terms of expected total turnover, the trade repository should pay the difference between the registration fee initially paid and the registration fee corresponding to the new category of expected total turnover in which it falls. |
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(5) |
In order to discourage unfounded applications, registration fees should not be reimbursed if an applicant withdraws its application during the registration process, nor if registration is refused. |
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(6) |
To ensure an efficient use of ESMA’s budget and, at the same time, alleviate the financial burden on Member States and the Union, it is necessary to ensure that trade repositories pay at least all the costs related to their supervision. Fees should be set at a level such as to avoid a significant accumulation of deficit or surplus for activities related to trade repositories. If significant deficits or surplus become recurrent, the Commission should revise the level of the fees and charges. |
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(7) |
In order to ensure a fair and clear allocation of fees which, at the same time, reflects the actual administrative effort devoted to each supervised entity, the supervisory fee should be calculated on the basis of the turnover generated by a trade repository’s core activities. The supervisory fees charged to a trade repository should be proportionate to the activity of that individual trade repository compared to the total activity of all registered and supervised trade repositories within a given financial year. However, given that there are some fixed administrative costs for the supervision of trade repositories, a minimum supervisory fee should be established. |
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(8) |
As only limited data will be available regarding the activity of a trade repository in the year in which it is registered, the initial annual supervisory fee should be calculated on the basis of the registration fee and the supervisory effort ESMA has put into supervising that trade repository that year. |
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(9) |
Trade repositories are relatively new entities that provide new regulated financial services and therefore a reliable measure of their turnover does not yet exist. Nonetheless, in order to estimate the trade repositories’ turnover, several indicators should be taken into account, in particular the trade repositories’ core financial revenues generated from centrally collecting and maintaining records of derivatives, excluding any revenues arising from ancillary services, the number of trades reported for a certain period and the number of trades outstanding at the end of each period. In the first year of operation of the trade repository, the supervisory fee should correspond to the supervisory effort carried out by ESMA for its supervision since the date of registration until the end of the year, on the basis of registration fees determined according to the expected total turnover level. |
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(10) |
Trade repositories registered in 2013 will not start providing reporting services before the end of 2013 and their level of activity in 2013 is likely to be almost non-existent. Therefore, their annual supervisory fee for 2014 should be calculated on the basis of their applicable turnover during the first half of 2014. |
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(11) |
In view of the nascent stage of the trade repositories industry and possible future developments, the method of calculating the turnover of trade repositories should be reviewed if necessary. The Commission should assess the appropriateness of the methodology for the calculation of turnover set out in this Regulation within four years of the entry into force of this Regulation. |
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(12) |
Rules should be provided for fees to be charged to third country trade repositories that apply for recognition in the Union pursuant to the relevant provisions of Regulation (EU) No 648/2012, in order to cover recognition and annual supervisory administrative costs. In this regard, ESMA’s costs are based on the necessary expenditure relating to the recognition of such third country trade repositories pursuant to Article 77(2) of that Regulation, the conclusion of cooperation arrangements with the competent authorities of the third country where the applicant trade repository is registered pursuant to Article 75(3) of that Regulation, and the supervision of recognised trade repositories. The costs associated with the conclusion of cooperation arrangements will be shared among the trade repositories recognised from the same third country. |
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(13) |
The supervisory functions exercised by ESMA in respect of recognised third country trade repositories mainly relate to the implementation of cooperation arrangements, including the effective exchange of data between relevant authorities. The cost of providing those functions should be covered by supervisory fees charged to recognised trade repositories. As those costs will be much lower than the costs incurred by ESMA for providing direct supervision of registered trade repositories in the Union, the supervisory fees for recognised trade repositories should be significantly lower than the minimum supervisory fee charged to registered trade repositories directly supervised by ESMA. |
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(14) |
In view of possible future developments, it is appropriate that the methodology for the calculation of the applicable turnover, as well as the level of registration, recognition and supervision fees be reviewed and updated when necessary. |
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(15) |
National competent authorities incur costs when carrying out work pursuant to Regulation (EU) No 648/2012 and, in particular as a result of any delegation of tasks in accordance with Article 74 of Regulation (EU) No 648/2012. The fees charged by ESMA to trade repositories should also cover those costs. In order to avoid competent authorities incurring a loss or profit from carrying out delegated tasks or from assisting ESMA, ESMA should reimburse only the actual costs incurred by that national competent authority. |
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(16) |
This Regulation should form the basis for ESMA’s right to charge fees to trade repositories. In order to immediately facilitate effective and efficient supervisory and enforcement activity, it should enter into force on the third day following that of its publication, |
HAS ADOPTED THIS REGULATION:
CHAPTER I
GENERAL PROVISIONS
Article 1
Subject matter
This Regulation lays down rules on the fees that the European Securities and Markets Authority (ESMA) shall charge trade repositories for their registration, supervision and recognition.
Article 2
Recovery of supervisory costs in full
The fees charged to trade repositories shall cover:
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(a) |
all costs relating to the registration and supervision of trade repositories by ESMA in accordance with Regulation (EU) No 648/2012, including those costs resulting from the recognition of trade repositories; |
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(b) |
all costs for the reimbursement of competent authorities that have carried out work pursuant to Regulation (EU) No 648/2012, in particular as a result of any delegation of tasks in accordance with Article 74 of Regulation (EU) No 648/2012. |
Article 3
Applicable turnover
1. The applicable turnover of a trade repository for a given financial year (n) shall be the sum of one third of each of the following:
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(a) |
the revenues generated from the core functions of centrally collecting and maintaining records of derivatives of the trade repository on the basis of the audited accounts of the previous year (n-1), divided by the total revenues generated from the core functions of centrally collecting and maintaining records of derivatives of all registered trade repositories during the previous year (n-1); |
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(b) |
the number of trades reported to the trade repository during the previous year (n-1), divided by the total number of trades reported to all registered trade repositories during the previous year (n-1); |
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(c) |
the number of recorded outstanding trades on 31 December of the previous year (n-1), divided by the total number of recorded outstanding trades on 31 December of the previous year (n-1) in all registered trade repositories. |
The applicable turnover of a given trade repository (‘TRi’ in the formula below) as referred to in the first subparagraph shall be calculated as follows:
2. Where the trade repository did not operate during the full year (n-1), the applicable turnover shall be estimated according to the formula set out in paragraph 1 by extrapolating for the trade repository, and for each of the elements referred to in points (a), (b) and (c) of paragraph 1, the values calculated for the number of months during which the trade repository operated in year (n-1) to the whole year (n-1).
Article 4
Adjustment of fees
1. Fees charged to trade repositories shall be set at a level such as to avoid a significant accumulation of deficit or surplus.
Where there is a recurrent significant surplus or deficit, the Commission shall revise the level of fees.
2. Where the fees charged to trade repositories in year (n) are insufficient to cover ESMA’s total necessary expenditure for registration, supervision and recognition of trade repositories, ESMA shall increase in year (n+1) the supervisory fees to be charged to the trade repositories that were registered during the full year (n) and are still registered in year (n+1) by the necessary amount.
3. The adjustment of fees for deficits covered by paragraph 2 shall be calculated for each individual trade repository in proportion to its applicable turnover in year (n).
CHAPTER II
FEES
Article 5
Types of fees
1. Trade repositories established in the Union that apply for registration in accordance with Article 55(1) of Regulation (EU) No 648/2012 shall be charged the following types of fees:
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(a) |
registration fees according to Article 6; |
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(b) |
annual supervisory fees according to Article 7. |
2. Trade repositories established in third countries that apply for recognition in accordance with Article 77(1) of Regulation (EU) No 648/2012 shall be charged the following types of fees:
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(a) |
recognition fees according to Article 8(1); |
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(b) |
annual supervisory fees for recognised trade repositories according to Article 8(2). |
Article 6
Registration fee
1. The registration fee to be paid by individual applicant trade repositories shall be calculated according to the supervisory effort necessary for the assessment and examination of the application, as well as the expected total turnover of the trade repository as specified in paragraphs 2 to 6.
2. For the calculation of the registration fee, the following activities shall be taken into consideration:
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(a) |
the provision by the trade repository of ancillary services such as trade confirmation, trade matching, credit event servicing, portfolio confirmation or portfolio compression services; |
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(b) |
the provision of repository services in three or more classes of derivatives by the trade repository. |
3. For the purposes of paragraph 2, a trade repository shall be deemed to offer ancillary services in any of the following situations:
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(a) |
where it provides direct ancillary services; |
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(b) |
where an entity belonging to the same group as the trade repository provides indirect ancillary services; |
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(c) |
where an entity with which the trade repository has concluded an agreement in the context of the trading or post-trading chain or business line to cooperate in the provision of services provides the ancillary services. |
4. Where a trade repository does not engage in either of the activities set out in paragraph 2, the trade repository concerned is deemed to have a low expected total turnover and shall pay a registration fee of EUR 45 000.
5. Where a trade repository engages in one of the two activities set out in paragraph 2, the trade repository is deemed to have a medium expected total turnover and shall pay a registration fee of EUR 65 000.
6. Where a trade repository engages in both activities set out in paragraph 2, the trade repository is deemed to have a high expected total turnover and shall pay a registration fee of EUR 100 000.
7. In case of a material change in the provision of services, as a consequence of which the trade repository owes a higher registration fee pursuant to paragraphs 4, 5 and 6 than the registration fee paid initially, the trade repository shall be charged the difference between the initially paid registration fee and the higher applicable registration fee resulting from that material change.
Article 7
Annual supervisory fee for registered trade repositories
1. A registered trade repository shall be charged an annual supervisory fee.
2. The total annual supervisory fee for a given financial year (n) shall be calculated as follows:
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(a) |
the basis for the calculation of the total annual supervisory fee for a given financial year (n) shall be the estimate of expenditure relating to the supervision of trade repositories as included in the ESMA’s budget for that year, set out and approved in accordance with Article 63 of Regulation (EU) No 1095/2010; |
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(b) |
the total annual supervisory fee for a given financial year (n) shall be calculated by deducting the following from the estimate of expenditure according to point (a):
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(c) |
a registered trade repository shall pay an annual supervisory fee resulting from dividing the total annual supervisory fee calculated pursuant to point (b) between all trade repositories registered in year n-1, in proportion to the ratio of the trade repository’s applicable turnover to the total applicable turnover of all registered trade repositories calculated pursuant to Article 3(1), and adjusted pursuant to paragraphs 2 and 3 of Article 4. |
3. In no case shall the trade repository pay an annual supervisory fee of less than EUR 30 000.
4. By way of derogation from paragraphs 2 and 3, a registered trade repository shall pay, in the year of its registration, an initial supervisory fee equal to the lower of the following:
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(a) |
the registration fee due in accordance with Article 6; |
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(b) |
the registration fee due in accordance with Article 6 multiplied by the ratio between the working days from its date of registration until the end of the year and 60 working days. |
This calculation shall be made as follows:
Article 8
Fee for recognition of third country trade repositories
1. A trade repository applying for recognition shall pay an application fee calculated as the sum of the following:
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(a) |
EUR 20 000; |
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(b) |
the amount resulting from dividing EUR 35 000 among the total number of trade repositories from the same third country that are either recognised by ESMA, or that have applied for recognition but have not been yet recognised. |
2. A trade repository recognised in accordance with Article 77(1) of Regulation (EU) No 648/2012 shall pay an annual supervisory fee of EUR 5 000.
CHAPTER III
PAYMENT AND REIMBURSEMENT CONDITIONS
Article 9
General payment modalities
1. All fees shall be payable in euro. They shall be paid as specified in Articles 10, 11 and 12.
2. Any late payments shall incur a daily penalty equal to 0,1 % of the amount due.
Article 10
Payment of registration fees
1. The registration fee referred to in Article 6 shall be paid in full at the time the trade repository applies for registration.
2. Registration fees shall not be reimbursed if a trade repository withdraws its application for registration before ESMA adopts the reasoned decision to register or refuse registration, or if registration is refused.
Article 11
Payment of annual supervisory fees
1. The annual supervisory fee referred to in Article 7 for a given financial year shall be paid in two instalments.
The first instalment shall be due on 28 February of that year and shall amount to two thirds of the estimated annual supervisory fee. If the applicable turnover calculated pursuant to Article 3 is not yet available at that time, the calculation on the turnover shall be based on the last applicable turnover available pursuant to Article 3.
The second instalment shall be due on 31 August. The amount of the second instalment shall be the annual supervisory fee calculated according to Article 7 reduced by the amount of the first instalment.
2. ESMA shall send the invoices for the instalments to the trade repositories at least 30 days before the respective payment date.
Article 12
Payment of recognition fees
1. The recognition fees referred to in Article 8(1) shall be payable in full at the time the trade repository applies for recognition. They shall not be reimbursed.
2. Each time a new application for recognition of a third country trade repository is made, ESMA shall recalculate the amount referred to in Article 8(1)(b).
ESMA shall reimburse equally among the trade repositories already recognised from the same third country the difference between the amount charged pursuant to Article 8(1)(b) and the amount resulting from the recalculation. That difference shall be reimbursed either through direct payment or through reduction of the fees charged the subsequent year.
3. The annual supervisory fee for a recognised trade repository shall be due by the end of February each financial year. ESMA shall send a payment invoice to a recognised trade repository at least 30 days before that date.
Article 13
Reimbursement of competent authorities
1. Only ESMA shall charge fees to trade repositories for their registration, supervision and recognition.
2. ESMA shall reimburse a competent authority for the actual costs incurred as a result of carrying out tasks pursuant to Regulation (EU) No 648/2012 and, in particular as a result of any delegation of tasks in accordance with Article 74 of Regulation (EU) No 648/2012.
CHAPTER IV
TRANSITIONAL AND FINAL PROVISIONS
Article 14
Fees in 2013
1. Trade repositories which apply for registration in 2013 shall pay the registration fee referred to in Article 6 in full 30 days after the entry into force of this Regulation or at the date of submission of the application for registration, whichever is the later.
2. Trade repositories registered in 2013 shall pay for 2013, an initial annual supervisory fee calculated in accordance with Article 7(4) in full 60 days after the entry into force of this Regulation or 30 days after the adoption of the decision on registration, whichever is the later.
3. Third country trade repositories which apply for recognition in 2013 shall pay the recognition fee referred to in Article 8(1) in full 30 days after the entry into force of this Regulation or at the date of submission of the application, whichever is the later.
4. Third country trade repositories recognised in 2013 shall pay, for 2013, an annual supervisory fee calculated in accordance with Article 8(3) in full 60 days after the entry into force of this Regulation or 30 days after the adoption of the decision on recognition, whichever is the later.
Article 15
Annual supervisory fee for 2014 for trade repositories registered in 2013
1. Trade repositories registered in 2013 shall be charged an annual supervisory fee for 2014 calculated according to Article 7 on the basis of their applicable turnover during the period from 1 January 2014 to 30 June 2014, as set out in paragraph 2 of this Article.
2. For the purposes of calculating supervisory fees for 2014 for trade repositories registered in 2013 pursuant to Article 7, the applicable turnover of a trade repository shall be the sum of one third of each of the following:
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(a) |
the revenues generated from the core functions of centrally collecting and maintaining records of derivatives of the trade repository during the period from 1 January 2014 to 30 June 2014, divided by the total revenues generated from the core functions of centrally collecting and maintaining records of derivatives of all registered trade repositories during the period from 1 January 2014 to 30 June 2014; |
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(b) |
the number of trades reported to the trade repository during the period from 1 January 2014 to 30 June 2014, divided by the total number of trades reported to all registered trade repositories during the period from 1 January 2014 to 30 June 2014; |
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(c) |
the number of recorded outstanding trades on 30 June 2014, divided by the total number of recorded outstanding trades on 30 June 2014 in all registered trade repositories. |
3. The annual supervisory fee for 2014 for trade repositories registered in 2013 shall be paid in two instalments.
The first instalment shall be due on 28 February 2014 and shall correspond to the registration fee paid by the trade repository in 2013 pursuant to Article 6.
The second instalment shall be due on 31 August. The amount of the second instalment shall be the annual supervisory fee calculated according to paragraphs 1 and 2 reduced by the amount of the first instalment.
Where the amount paid by a trade repository in the first instalment is higher than the annual supervisory fee calculated according to paragraphs 1 and 2, ESMA shall reimburse the trade repository the difference between the amount paid in the first instalment and the annual supervisory fee calculated according to paragraphs 1 and 2.
4. ESMA shall send the invoices for the instalments of the annual supervisory fee for 2014 to the trade repositories registered in 2013 at least 30 days before the payment date.
5. When the audited accounts for 2014 become available, trade repositories registered in 2013 shall report to ESMA any change in the indicators referred to in points (a), (b) or (c) of paragraph 2 used for the calculation of the applicable turnover according to paragraph 2, stemming from the difference between the final data and the provisional data used for the calculation.
Trade repositories will be charged the difference between the annual supervisory fee for 2014 actually paid and the annual supervisory fee for 2014 to be paid as a consequence of any change to the indicators referred to in points (a), (b) or (c) of paragraph 2 used for the calculation of the applicable turnover according to paragraph 2.
ESMA shall send the invoice for any additional payment to be made by a trade repository as a consequence of a change in any of the indicators referred to in points (a), (b) or (c) of paragraph 2 used for the calculation of the applicable turnover according to paragraph 2, at least 30 days before the respective payment date.
Article 16
Entry into force
This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all the Member States.
Done at Brussels, 12 July 2013.
For the Commission
The President
José Manuel BARROSO
(1) OJ L 201, 27.7.2012, p. 1.
(2) OJ L 331, 15.12.2010, p. 84.
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19.10.2013 |
EN |
Official Journal of the European Union |
L 279/10 |
COMMISSION REGULATION (EU) No 1004/2013
of 15 October 2013
amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for 8-hydroxyquinoline, cyproconazole, cyprodinil, fluopyram, nicotine, pendimethalin, penthiopyrad and trifloxystrobin in or on certain products
(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 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (1), and in particular Article 14(1)(a) thereof,
Whereas:
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(1) |
For pendimethalin and trifloxystrobin maximum residue levels (MRLs) were set in Annex II and Part B of Annex III to Regulation (EC) No 396/2005. For cyproconazole, cyprodinil, fluopyram, nicotine and penthiopyrad MRLs were set in Part A of Annex III to Regulation (EC) No 396/2005. For 8-hydroxyquinoline, no specific MRLs were set in Annex II and III nor was the substance included in Annex IV to Regulation (EC) No 396/2005, so the default value of 0.01 mg/kg applies. |
|
(2) |
In the context of a procedure for the authorisation of the use of a plant protection product containing the active substance 8-hydroxyquinoline on tomatoes, an application was made in accordance with Article 6(1) of Regulation (EC) No 396/2005 for modification of the existing MRL. |
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(3) |
As regards cyproconazole, such an application was made for mustard seed and gold of pleasure. As regards cyprodinil, such an application was made for radishes and cucurbits (inedible peel). As regards pendimethalin, such an application was made for salsify, celeriac, swedes, turnips, celery and herbal infusions (roots). As regards trifloxystrobin, such an application was made for beans (with pods). |
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(4) |
In accordance with Article 8 of Regulation (EC) No 396/2005 these applications were evaluated by the Member States concerned and the evaluation reports were forwarded to the Commission. |
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(5) |
The European Food Safety Authority, hereinafter "the Authority", assessed the applications and the evaluation reports, examining in particular the risks to the consumer and, where relevant, to animals and gave reasoned opinions on the proposed MRLs (2). It forwarded these opinions to the Commission and the Member States and made them available to the public. |
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(6) |
The Authority concluded in its reasoned opinions that, as regards the use of cyproconazole on mustard seed and gold of pleasure, the submitted data are sufficient to set new MRLs for the northern EU use only. As regards the use of pendimethalin on celeriac, swedes, turnips and celery, the Authority concluded that the submitted data are not sufficient to set new MRLs. |
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(7) |
As regards all other applications, the Authority concluded that all requirements with respect to data were met and that the modifications to the MRLs requested by the applicants were acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. It took into account the most recent information on the toxicological properties of the substances. Neither the lifetime exposure to these substances via consumption of all food products that may contain these substances, nor the short-term exposure due to high consumption of the relevant crops and products showed that there is a risk that the acceptable daily intake (ADI) or the acute reference dose (ARfD) is exceeded. |
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(8) |
As regards penthiopyrad the applicant submitted further data confirming that the metabolism of penthiopyrad in genetically modified crop is comparable to the one occuring in its conventional counterpart. To avoid trade barriers for the importation of sunflower seed, rape seed, soya bean and cotton seed higher MRLs are necessary. The new MRLs for those products should therefore be set in Part A of Annex III to Regulation (EC) No 396/2005. |
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(9) |
As regards fluopyram, by Regulation (EU) No 270/2012 (3) provisional MRLs were set for several products until 31 December 2013, pending the submission of further residue data. Such data were submitted to Germany, the evaluating Member State for that substance, on 17 December 2012. In order to provide the necessary time for the evaluating Member State to evaluate those data and prepare an evaluation report, for the Authority to evaluate that report and for the Commission to take its decision, it is appropriate to extend the validity of these MRLs until two years from the publication of this Regulation. |
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(10) |
As regards nicotine, by Regulation (EU) No 812/2011 (4) provisional MRLs were set for tea, herbal infusions, spices, rose hips and fresh herbs until 14 August 2013, pending the submission and evaluation of new data and information on the natural occurrence or formation of nicotine in the concerned products. The Commission was informed of a research project which is being carried out to investigate on the sources of nicotine resulting in those crops. In view of the expected duration of the study and in order to provide the necessary time for the Commission to take its decision, it is appropriate to extend the validity of these MRLs until three years from the publication of this Regulation. |
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(11) |
Based on the reasoned opinions of the Authority and taking into account the factors relevant to the matter under consideration, the appropriate modifications to the MRLs fulfil the relevant requirements of Article 14(2) of Regulation (EC) No 396/2005. |
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(12) |
Regulation (EC) No 396/2005 should therefore be amended accordingly. |
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(13) |
In the interest of legal certainty, the provisions concerning nicotine should apply from 15 August 2013. |
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(14) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
HAS ADOPTED THIS REGULATION:
Article 1
Annexes II and III to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
It shall, however, apply from 15 August 2013 for nicotine in rose hips of code number 0154050, fresh herbs of code number 0256000, tea of code number 0610000, herbal infusions of code number 0630000 and spices of code number 0800000.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 15 October 2013.
For the Commission
The President
José Manuel BARROSO
(2) EFSA scientific reports available online: http://www.efsa.europa.eu:
Reasoned opinion on the modification of the existing MRL for 8-hydroxyquinoline in tomatoes. EFSA Journal 2013;11(5):3224 [20 pp.]. doi:10.2903/j.efsa.2013.3224.
Reasoned opinion on the modification of the existing MRLs for cyproconazole in mustard seed and gold of pleasure. EFSA Journal 2013;11(4):3194 [26 pp.]. doi:10.2903/j.efsa.2013.3194.
Reasoned opinion on the modification of the existing MRLs for cyprodinil in radishes and cucurbits inedible peel. EFSA Journal 2013;11(4):3184 [24 pp.]. doi:10.2903/j.efsa.2013.3184.
Reasoned opinion on the modification of the existing MRLs for pendimethalin in various crops. EFSA Journal 2013;11(5):3217 [27 pp.]. doi:10.2903/j.efsa.2013.3217.
Reasoned opinion on the modification of the existing MRL for trifloxystrobin in beans with pods. EFSA Journal 2013;11(4):3199 [24 pp.]. doi:10.2903/j.efsa.2013.3199.
(4) OJ L 208, 13.8.2011, p. 1.
ANNEX
Annexes II and III to Regulation (EC) No 396/2005 are amended as follows:
|
(1) |
In Annex II, the columns for pendimethalin and trifloxystrobin are replaced by the following: ‘Pesticide residues and maximum residue levels (mg/kg)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
(2) |
Part A of Annex III is amended as follows:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
(3) |
In Part B of Annex III, the column for pendimethalin is replaced by the following: ‘Pesticide residues and maximum residue levels (mg/kg)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
(1) For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.
(2) Indicates lower limit of analytical determination
(3) Pesticide-code combination for which the MRL as set in Annex III Part B applies.
(F)= Fat soluble
Trifloxystrobin (F) (R)
|
(R) |
= |
The residue definition differs for the following combinations pesticide-code number: Trifloxystrobin- code 1000000: the sum of trifloxystrobin and its metabolite (E, E)-methoxyimino- {2-[1-(3-trifluoromethyl-phenyl)-ethylideneamino-oxymethyl]-phenyl}-acetic acid (CGA 321113)’ |
(4) For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.
(5) Indicates lower limit of analytical determination
(F)= Fat soluble
Cyprodinil (F) (R)
|
(R) |
= |
The residue definition differs for the following combinations pesticide-code number: Cyprodinil - code 1000000: Sum cyprodinil and metabolite CGA 304075 |
Fluopyram (R)
Fluopyram - code 1000000: sum fluopyram and fluopyram-benzamide (M25) expressed as fluopyram
|
(+) |
The European Food Safety Authority identified some information on residue trials as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 19 October 2015, or, if that information is not submitted by that date, the lack of it.
|
Nicotine
|
(+) |
Scientific evidence is not conclusive to demonstrate that nicotine occurs naturally in the concerned crop and to elucidate its mechanism of formation. When re-viewing the MRL, the Commission will take into account the information, if it is submitted by 19 October 2016, or, if that information is not submitted by that date, the lack of it.
|
|
(+) |
The following MRLs apply to dried wild mushrooms: 2,3 mg/kg for ceps, 1,2 mg/kg for dried wild mushrooms other than ceps. These MRLs shall be reviewed by 30 November 2014. Confirmatory data including any scientific evidence on the natural occurrence or formation of nicotine in the concerned crop will be evaluated. Reassessment of data may lead to modification of MRLs
|
|
(+) |
Scientific evidence is not conclusive to demonstrate that nicotine occurs naturally in the concerned crop and to elucidate its mechanism of formation. When re-viewing the MRL, the Commission will take into account the information, if it is submitted by 19 October 2016, or, if that information is not submitted by that date, the lack of it.
|
(6) For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.
(7) Indicates lower limit of analytical determination’
(8) For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.
(9) Indicates lower limit of analytical determination
(F)= Fat soluble’
|
19.10.2013 |
EN |
Official Journal of the European Union |
L 279/57 |
COMMISSION IMPLEMENTING REGULATION (EU) No 1005/2013
of 17 October 2013
approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications [Emmental français est-central (PGI)]
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,
Whereas:
|
(1) |
Regulation (EU) No 1151/2012 repealed and replaced Council Regulation (EC) No 510/2006 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (2). |
|
(2) |
In accordance with the first subparagraph of Article 9(1) of Regulation (EC) No 510/2006, the Commission has examined France’s application for the approval of amendments to the specification for the protected geographical indication ‘Emmental français est-central’, registered under Commission Regulation (EC) No 1107/96 (3). |
|
(3) |
Since the amendments in question are not minor, the Commission published the amendment application in the Official Journal of the European Union (4), as required by Article 6(2) of Regulation (EC) No 510/2006. As no statement of objection under Article 7 of that Regulation has been received by the Commission, the amendments to the specification should be approved, |
HAS ADOPTED THIS REGULATION:
Article 1
The amendments to the specification published in the Official Journal of the European Union regarding the name in the Annex to this Regulation are hereby approved.
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 17 October 2013.
For the Commission, On behalf of the President,
Dacian CIOLOȘ
Member of the Commission
(1) OJ L 343, 14.12.2012, p. 1.
(2) OJ L 93, 31.3.2006, p. 12.
(3) OJ L 148, 21.6.1996, p. 1.
(4) OJ C 352, 16.11.2012, p. 17.
ANNEX
Agricultural products intended for human consumption listed in Annex I to the Treaty:
Class 1.3. Cheeses
FRANCE
Emmental français est-central (PGI)
|
19.10.2013 |
EN |
Official Journal of the European Union |
L 279/59 |
COMMISSION IMPLEMENTING REGULATION (EU) No 1006/2013
of 18 October 2013
concerning the authorisation of L-cystine as a feed additive for all animal species
(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 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
Whereas:
|
(1) |
Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. |
|
(2) |
In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of L-cystine as a feed additive in the functional group ‘amino acids, their salts and analogues’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
|
(3) |
That application concerns the authorisation of L-cystine as a feed additive for all animal species, to be classified in the additive category ‘nutritional additives’. |
|
(4) |
The European Food Safety Authority (‘the Authority’) concluded in its opinion of 13 March 2013 (2) that, under the proposed conditions of use, L-cystine does not have an adverse effect on animal health, human health or the environment and that it may be considered efficacious to contribute to the requirements for sulphur-containing amino acids in all animal species. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. |
|
(5) |
The assessment of that substance shows that the conditions for authorisation, provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that substance should be authorised, as specified in the Annex to this Regulation. |
|
(6) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
HAS ADOPTED THIS REGULATION:
Article 1
The substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘amino acids, their salts and analogues’, is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 18 October 2013.
For the Commission
The President
José Manuel BARROSO
(1) OJ L 268, 18.10.2003, p. 29.
(2) EFSA Journal 2013; 11(4):3173.
ANNEX
|
Identification number of the additive |
Name of the holder of authorisation |
Additive |
Composition, chemical formula, description, analytical method |
Species or category of animal |
Maximum age |
Minimum content |
Maximum content |
Other provisions |
End of period of authorisation |
||||||||||||||
|
mg/kg of complete feed with a moisture content of 12 % |
|||||||||||||||||||||||
|
Category of nutritional additives. Functional group: amino acids, their salts and analogues |
|||||||||||||||||||||||
|
3c391 |
— |
L-cystine |
|
All animal species |
— |
— |
— |
|
8 November 2023 |
||||||||||||||
(1) Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/authorisation/evaluation_reports/Pages/index.aspx
|
19.10.2013 |
EN |
Official Journal of the European Union |
L 279/61 |
COMMISSION IMPLEMENTING REGULATION (EU) No 1007/2013
of 18 October 2013
adding to the 2013/14 fishing quotas of anchovy in the Bay of Biscay the quantities withheld by France and Spain in the fishing season 2012/13 pursuant to Article 4(2) of Council Regulation (EC) No 847/96
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Regulation (EC) No 847/96 of 6 May 1996 introducing additional conditions for year-to-year management of TACs and quotas (1), and in particular Article 4(2) thereof,
Whereas:
|
(1) |
According to Article 4(2) of Regulation (EC) No 847/96, Member States may ask the Commission, before 31 October of the year of application of a fishing quota allocated to them, to withhold a maximum of 10 % of that quota to be transferred to the following year. The Commission is to add to the relevant quota the quantity withheld. |
|
(2) |
TAC and Member State quotas for the stock of anchovy in the Bay of Biscay (ICES subarea VIII) are set for an annual management season running from 1 July to 30 June of the following year. |
|
(3) |
Council Regulation (EU) No 694/2012 of 27 July 2012 establishing the fishing opportunities for anchovy in the Bay of Biscay for the 2012/13 fishing season (2) fixes the fishing quotas for anchovy in the Bay of Biscay (ICES subarea VIII) for the period starting on the 1 July 2012 and ending on the 30 June 2013. |
|
(4) |
Council Regulation (EU) No 713/2013 of 23 July 2013 establishing the fishing opportunities for anchovy in the Bay of Biscay for the 2013/14 fishing season (3) fixes the fishing quotas for anchovy in the Bay of Biscay (ICES subarea VIII) for the period starting on the 1 July 2013 and ending on the 30 June 2014. |
|
(5) |
Pursuant to the relevant fishing opportunities Regulations and after taking into account exchanges of fishing opportunities in accordance with Article 20(5) of Council Regulation (EC) No 2371/2002 of 20 December 2002 on the conservation and sustainable exploitation of fisheries resources under the Common Fisheries Policy (4) and quota transfers in accordance with Article 4(2) of Regulation (EC) No 847/96 quotas for anchovy in the Bay of Biscay available to France and Spain at the end of fishing season 2012/13 amounted respectively to 4 876 tonnes and 16 460 tonnes. |
|
(6) |
At the end of fishing season 2012/13, France and Spain reported catches of anchovy in the Bay of Biscay for a respective total amount of 4 805,1 tonnes and 11 275,2 tonnes. |
|
(7) |
Pursuant to Article 4(2) of Regulation (EC) No 847/96, France and Spain have both requested that part of their anchovy’s quota in the Bay of Biscay for their fishing season 2012/13 be withheld and transferred to the following fishing season. Within the limits indicated in that Regulation, the quantities withheld should be added to the quota for fishing season 2013/14. |
|
(8) |
The measures provided for in this Regulation are in accordance with the opinion of the Committee for Fisheries and Aquaculture, |
HAS ADOPTED THIS REGULATION:
Article 1
1. The fishing quota for anchovy fixed for France in the Bay of Biscay in Regulation (EU) No 713/2013 is increased by 70,9 tonnes.
2. The fishing quota for anchovy fixed for Spain in the Bay of Biscay in Regulation (EU) No 713/2013 is increased by 1 646 tonnes.
Article 2
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 18 October 2013.
For the Commission
The President
José Manuel BARROSO
(2) OJ L 203, 31.7.2012, p. 26.
(3) OJ L 201, 26.7.2013, p. 8.
(4) OJ L 358, 31.12.2002, p. 59.
|
19.10.2013 |
EN |
Official Journal of the European Union |
L 279/63 |
COMMISSION IMPLEMENTING REGULATION (EU) No 1008/2013
of 18 October 2013
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 Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 18 October 2013.
For the Commission, On behalf of the President,
Jerzy PLEWA
Director-General for Agriculture and Rural Development
(1) OJ L 299, 16.11.2007, p. 1.
(2) OJ L 157, 15.6.2011, p. 1.
ANNEX
Standard import values for determining the entry price of certain fruit and vegetables
|
(EUR/100 kg) |
||
|
CN code |
Third country code (1) |
Standard import value |
|
0702 00 00 |
MA |
53,1 |
|
MK |
47,7 |
|
|
ZZ |
50,4 |
|
|
0707 00 05 |
MK |
54,3 |
|
TR |
126,8 |
|
|
ZZ |
90,6 |
|
|
0709 93 10 |
TR |
144,2 |
|
ZZ |
144,2 |
|
|
0805 50 10 |
AR |
100,6 |
|
CL |
101,0 |
|
|
IL |
97,0 |
|
|
TR |
87,3 |
|
|
ZA |
102,0 |
|
|
ZZ |
97,6 |
|
|
0806 10 10 |
BR |
254,7 |
|
TR |
151,4 |
|
|
ZZ |
203,1 |
|
|
0808 10 80 |
CL |
154,8 |
|
NZ |
116,7 |
|
|
US |
156,2 |
|
|
ZA |
120,6 |
|
|
ZZ |
137,1 |
|
|
0808 30 90 |
TR |
126,8 |
|
ZZ |
126,8 |
|
(1) Nomenclature of countries laid down by Commission Regulation (EC) No 1833/2006 (OJ L 354, 14.12.2006, p. 19). Code ‘ZZ’ stands for ‘of other origin’.
|
19.10.2013 |
EN |
Official Journal of the European Union |
L 279/65 |
COMMISSION IMPLEMENTING REGULATION (EU) No 1009/2013
of 18 October 2013
fixing the allocation coefficient to be applied to applications for import licences for olive oil lodged from 14 to 15 October 2013 under the Tunisian tariff quota and suspending the issue of import licences for the month of October 2013
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1),
Having regard to Commission Regulation (EC) No 1301/2006 of 31 August 2006 laying down common rules for the administration of import tariff quotas for agricultural products managed by a system of import licences (2), and in particular Article 7(2) thereof,
Whereas:
|
(1) |
Article 3(1) and (2) of Protocol No 1 (3) to the Euro-Mediterranean Agreement establishing an association between the European Communities and their Member States, of the one part, and the Republic of Tunisia, of the other part (4), opens a tariff quota at a zero rate of duty for imports of untreated olive oil falling within CN codes 1509 10 10 and 1509 10 90, wholly obtained in Tunisia and transported direct from that country to the European Union, up to the limit laid down for each year. |
|
(2) |
Article 2(2) of Commission Regulation (EC) No 1918/2006 of 20 December 2006 opening and providing for the administration of tariff quota for olive oil originating in Tunisia (5) lays down monthly quantitative limits for the issue of import licences. |
|
(3) |
Import licence applications have been submitted to the competent authorities under Article 3(1) of Regulation (EC) No 1918/2006 in respect of a total quantity exceeding the limit laid down for the month of October in Article 2(2) of that Regulation. |
|
(4) |
In these circumstances, the Commission must set an allocation coefficient allowing import licences to be issued in proportion to the quantity available. |
|
(5) |
Since the limit for the month of October has been reached, no more import licences can be issued for that month, |
HAS ADOPTED THIS REGULATION:
Article 1
The quantities for which import licence applications were lodged for 14 and 15 October 2013 under Article 3(1) of Regulation (EC) No 1918/2006 shall be multiplied by an allocation coefficient of 39,536727 %.
The issue of import licences in respect of amounts applied for as from 21 October 2013 shall be suspended for October 2013.
Article 2
This Regulation shall enter into force on 19 October 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 18 October 2013.
For the Commission, On behalf of the President,
Jerzy PLEWA
Director-General for Agriculture and Rural Development
(1) OJ L 299, 16.11.2007, p. 1.
(2) OJ L 238, 1.9.2006, p. 13.
(3) OJ L 97, 30.3.1998, p. 57.
(5) OJ L 365, 21.12.2006, p. 84.
DECISIONS
|
19.10.2013 |
EN |
Official Journal of the European Union |
L 279/66 |
POLITICAL AND SECURITY COMMITTEE DECISION EUPOL RD CONGO/1/2013
of 8 October 2013
extending the mandate of the Head of Mission of the European Union police mission undertaken in the framework of reform of the security sector (SSR) and its interface with the system of justice in the Democratic Republic of the Congo (EUPOL RD Congo)
(2013/511/CFSP)
THE POLITICAL AND SECURITY COMMITTEE,
Having regard to the Treaty on European Union, and in particular the third paragraph of Article 38 thereof,
Having regard to Council Decision 2010/576/CFSP of 23 September 2010 on the European Union police mission undertaken in the framework of reform of the security sector (SSR) and its interface with the system of justice in the Democratic Republic of the Congo (EUPOL RD Congo) (1), and in particular Article 10(1) thereof,
Whereas:
|
(1) |
Pursuant to Article 10(1) of Decision 2010/576/CFSP, the Political and Security Committee ('PSC') is authorised, in accordance with the third paragraph of Article 38 of the Treaty, to take the relevant decisions for the purpose of exercising political control and strategic direction of EUPOL RD Congo. This authorisation includes the power to appoint a Head of Mission, upon a proposal of the High Representative of the Union for Foreign Affairs and Security Policy ('High Representative'). |
|
(2) |
On 8 October 2010, following a proposal by the High Representative, the PSC, pursuant to Decision EUPOL RD Congo/1/2010 (2), appointed Chief Superintendent Jean-Paul RIKIR as Head of Mission of EUPOL RD Congo with effect from 1 October 2010. |
|
(3) |
On 16 September 2011, following a proposal by the High Representative, the PSC, pursuant to Decision EUPOL RD Congo/1/2011 (3), extended the mandate of Chief Superintendent Jean-Paul RIKIR as Head of Mission of EUPOL RD Congo until 30 September 2012. |
|
(4) |
On 25 September 2012, following a proposal by the High Representative, the PSC, pursuant to Decision EUPOL RD Congo/1/2012 (4), extended the mandate of Chief Superintendent Jean-Paul RIKIR as Head of Mission of EUPOL RD Congo until 30 September 2013. |
|
(5) |
On 23 September 2013, the Council adopted Decision 2013/467/CFSP (5) extending the duration of EUPOL RD Congo until 30 September 2014. |
|
(6) |
On 10 September 2013, the High Representative proposed the extension of the mandate of Chief Superintendent Jean-Paul RIKIR as Head of Mission of EUPOL RD Congo until 30 September 2014. |
|
(7) |
Since the current mandate of Chief Superintendent Jean-Paul RIKIR as Head of Mission of EUPOL RD Congo expired on 30 September 2013, this Decision should apply from 1 October 2013, |
HAS ADOPTED THIS DECISION:
Article 1
The mandate of Chief Superintendent Jean-Paul RIKIR as Head of Mission of the European Union police mission undertaken in the framework of reform of the security sector (SSR) and its interface with the system of justice in the Democratic Republic of the Congo (EUPOL RD Congo) is hereby extended until 30 September 2014.
Article 2
This Decision shall enter into force on the date of its adoption.
It shall apply from 1 October 2013.
Done at Brussels, 8 October 2013.
For the Political and Security Committee
The Chairperson
W. STEVENS
(1) OJ L 254, 29.9.2010, p. 33.
(2) OJ L 266, 9.10.2010, p. 60.
(3) OJ L 245, 22.9.2011, p. 21.
(4) OJ L 264, 29.9.2012, p. 13.
(5) OJ L 252, 24.9.2013, p. 27.
|
19.10.2013 |
EN |
Official Journal of the European Union |
L 279/67 |
COMMISSION IMPLEMENTING DECISION
of 17 October 2013
concerning a financial contribution by the Union to certain Member States to support voluntary surveillance studies on honeybee colony losses for the season 2013–2014
(notified under document C(2013) 6742)
(Only the Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Italian, Latvian, Lithuanian, Polish, Portuguese, Slovak, Spanish and Swedish texts are authentic)
(2013/512/EU)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Decision 2009/470/EC of 25 May 2009 on expenditure in the veterinary field (1), and in particular Article 23 thereof,
Whereas:
|
(1) |
The Communication from the Commission to the European Parliament and the Council on honeybee health (2) gives an overview of the Commission’s actions already undertaken and ongoing as regards honeybee health in the EU. The main subject issue of the Communication is the increased mortality of bees observed worldwide. |
|
(2) |
In 2009 the EFSA project ‘Bee mortality and bee surveillance in Europe’ (3) concluded that the surveillance systems in the EU are, in general, weak and that there is a lack of data at Member States level and a lack of comparable data at EU level. |
|
(3) |
In order to improve the availability of data on bee mortality the Commission decided to assist and support certain surveillance studies in Member States on honeybee losses. |
|
(4) |
Commission Implementing Decision 2012/362/EU (4) granted a financial contribution to the voluntary surveillance study programs on honeybee colony losses implemented by Belgium, Denmark, Germany, Estonia, Greece, Spain, France, Italy, Latvia, Lithuania, Hungary, Poland, Portugal, Slovakia, Finland, Sweden and the United Kingdom for the season 2012–2013. |
|
(5) |
The studies provide for three field visits in the apiaries to be carried out before winter, after winter and during the productive season. |
|
(6) |
It is important in this type of study to have comparable data in relation with the losses which are collected in different years. This is particularly valid for surveillance studies on honeybee losses because the climatic conditions alter significantly the results. Therefore, such studies if conducted only for one year can only give partial data which do not offer enough grounds to draw conclusions or trends on such losses. |
|
(7) |
For the reasons explained above, it is opportune to continue the voluntary surveillance studies on honeybee colony losses in the season starting with the pre-winter control in fall 2013, to be finalised with the post-winter and full productive season controls in 2014. |
|
(8) |
The studies to be carried out in the season 2013–2014 are based on the document ‘Basis for a pilot surveillance project on honey bee colony losses’ (5) produced by the EU reference laboratory (EURL) for bee health listed in Part II of Annex VII to Regulation (EC) No 882/2004 of the European Parliament and of the Council (6), which provides guidance to Member States to elaborate their voluntary surveillance studies programs. |
|
(9) |
The same Member States which took part to the first voluntary surveillance studies on honeybee colony losses in 2012–2013 were invited to send to the Commission their programs for the season 2013–2014 based on the technical document of the EURL for bee health. |
|
(10) |
Belgium, Denmark, Germany, Estonia, Greece, Spain, France, Italy, Latvia, Lithuania, Hungary, Poland, Portugal, Slovakia, Finland, Sweden and the United Kingdom have drawn up voluntary surveillance study programs on honeybee colony losses in line with the technical document ‘Basis for a pilot surveillance project on honey bee colony losses’ and have requested EU financial support. |
|
(11) |
A financial contribution should be granted as from 1 July 2013 to the voluntary surveillance study programs on honeybee colony losses implemented by Belgium, Denmark, Germany, Estonia, Greece, Spain, France, Italy, Latvia, Lithuania, Hungary, Poland, Portugal, Slovakia, Finland, Sweden and the United Kingdom. |
|
(12) |
Under Council Regulation (EC) No 1290/2005 (7), veterinary measures are to be financed under the European Agricultural Guarantee Fund. For financial control purposes, Articles 9, 36 and 37 of that Regulation are to apply. |
|
(13) |
The payment of the financial contribution should be subject to the condition that the surveillance study programs planned have actually been carried out and that the authorities supply all the necessary information to the Commission and to the EURL for bee health. |
|
(14) |
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
HAS ADOPTED THIS DECISION:
Article 1
1. The Union shall grant Belgium, Denmark, Germany, Estonia, Greece, Spain, France, Italy, Latvia, Lithuania, Hungary, Poland, Portugal, Slovakia, Finland, Sweden and the United Kingdom financial assistance for their surveillance study programs on honeybee colony losses.
2. The financial contribution by the Union
|
(a) |
shall be at the rate of 70 % of the eligible costs to be incurred by each Member State referred to in paragraph 1 for the surveillance study programmes on honeybee colony losses and specified in Annex I for the period from 1 July 2013 to 30 September 2014; |
|
(b) |
shall not exceed the following:
|
|
(c) |
shall not exceed EUR 348 per visit of an apiary. |
Article 2
1. The maximum overall contribution authorised by this Decision for the costs incurred for the programmes referred to in Article 1 is set at EUR 1 847 930 to be financed from the General Budget of the European Union.
2. Expenditure relating to staff costs for performing laboratory tests, sampling or monitoring, and to consumables and overheads dedicated to the surveillance studies shall be eligible in accordance with the rules set out in Annex III.
3. The Union’s financial assistance shall be paid following presentation and approval of the reports and supporting documents referred to Article 3(2) and (3).
Article 3
1. The programs shall be carried out in accordance with the technical document ‘Basis for a pilot surveillance project on honey bee colony losses’ and in accordance with the surveillance study programs on honeybee colony losses presented by the Member States.
2. Belgium, Denmark, Germany, Estonia, Greece, Spain, France, Italy, Latvia, Lithuania, Hungary, Poland, Portugal, Slovakia, Finland, Sweden and the United Kingdom shall submit to the Commission:
|
— |
no later than 1 March 2014 an intermediate technical report on the first visit provided for in the surveillance study program, and |
|
— |
no later than 31 October 2014 a final technical report on the second and third visits provided for in the surveillance study program, |
|
— |
the technical report should be in conformity to a model to be established by the Commission in cooperation with the EU Reference Laboratory for bee health. |
3. Belgium, Denmark, Germany, Estonia, Greece, Spain, France, Italy, Latvia, Lithuania, Hungary, Poland, Portugal, Slovakia, Finland, Sweden and the United Kingdom shall submit to the Commission:
|
— |
no later than 31 December 2014, a paper version and an electronic version of their financial report drawn up in accordance with Annex II, |
|
— |
on request by the Commission, the supporting documents, evidencing all the expenditure referred to in the application for reimbursement. |
4. The outcome of the studies shall be made available to the Commission and the EU Reference Laboratory for bee health.
Article 4
This Decision is addressed to the Kingdom of Belgium, the Kingdom of Denmark, the Federal Republic of Germany, the Republic of Estonia, the Hellenic Republic, the Kingdom of Spain, the French Republic, the Italian Republic, the Republic of Latvia, the Republic of Lithuania, Hungary, the Republic of Poland, the Portuguese Republic, the Slovak Republic, the Republic of Finland, the Kingdom of Sweden and the United Kingdom of Great Britain and Northern Ireland.
Done at Brussels, 17 October 2013.
For the Commission
Tonio BORG
Member of the Commission
(1) OJ L 155, 18.6.2009, p. 30.
(2) COM(2010) 714 final.
(3) Available at: http://www.efsa.europa.eu/en/efsajournal/doc/154r.pdf
(4) Commission Implementing Decision 2012/362/EU of 4 July 2012 concerning a financial contribution by the Union to certain Member States to support voluntary surveillance studies on honeybee colony losses (OJ L 176, 6.7.2012, p. 65).
(5) Available at: http://ec.europa.eu/food/animal/liveanimals/bees/docs/annex_i_pilot_project_en.pdf
(6) Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (OJ L 165, 30.4.2004, p. 1).
(7) Council Regulation (EC) No 1290/2005 of 21 June 2005 on the financing of the common agricultural policy (OJ L 209, 11.8.2005, p. 1).
ANNEX I
|
MS |
Number of apiaries |
Number of visits per apiary foreseen in the surveillance study |
Total direct costs (Laboratory tests + visits for sampling and monitoring) |
Overheads (7 %) |
Total cost |
EU contribution (70 %) |
|
BE |
150 |
3 |
35 830 |
2 508 |
38 338 |
26 837 |
|
DK |
200 |
3 |
155 430 |
10 880 |
166 310 |
116 417 |
|
DE |
220 |
3 |
214 212 |
14 995 |
229 207 |
160 445 |
|
EE |
196 |
3 |
86 606 |
6 062 |
92 668 |
64 868 |
|
EL |
200 |
3 |
104 701 |
7 329 |
112 030 |
78 421 |
|
ES |
203 |
3 |
197 659 |
13 836 |
211 495 |
148 047 |
|
FR |
396 |
3 |
385 581 |
26 991 |
412 572 |
288 801 |
|
IT |
195 |
3 |
189 870 |
13 291 |
203 161 |
142 212 |
|
LV |
193 |
3 |
115 234 |
8 066 |
123 300 |
86 310 |
|
LT |
193 |
3 |
93 822 |
6 568 |
100 390 |
70 273 |
|
HU |
196 |
3 |
152 483 |
10 674 |
163 157 |
114 209 |
|
PL |
190 |
3 |
170 915 |
11 964 |
182 879 |
128 015 |
|
PT |
145 |
3 |
38 930 |
2 725 |
41 655 |
29 159 |
|
SK |
200 |
3 |
123 151 |
8 621 |
131 772 |
92 240 |
|
FI |
161 |
3 |
156 764 |
10 973 |
167 737 |
117 416 |
|
SE |
150 |
3 |
99 318 |
6 952 |
106 270 |
74 389 |
|
UK |
200 |
3 |
146 691 |
10 268 |
156 959 |
109 871 |
|
Total |
|
|
2 467 197 |
172 703 |
2 639 900 |
1 847 930 |
ANNEX II
MODEL FOR A FINANCIAL REPORT ON VOLUNTARY SURVEILLANCE STUDIES ON HONEYBEE COLONY LOSSES
|
Total expenditure for the project (real costs, VAT excl.) |
||
|
Member State: |
|
Number of apiaries visited: |
|
|
|
Total number of colonies sampled: |
|
Laboratory costs |
|||
|
Staff category |
Number of working days |
Daily rate |
Total |
|
… |
|
|
|
|
… |
|
|
|
|
|
|
|
|
|
Consumables (description) |
Quantity |
Unit cost |
Total |
|
… |
|
|
|
|
… |
|
|
|
|
Sampling and monitoring costs (apiary visits) |
|||
|
Staff category |
Number of working days |
Daily rate |
Total |
|
… |
|
|
|
|
… |
|
|
|
|
|
|
|
|
|
Consumables (description) |
Quantity |
Unit cost |
Total |
|
… |
|
|
|
|
… |
|
|
|
Certification by the beneficiary
We certify that:
|
— |
the expenditure listed above was incurred in the performance of tasks described in the technical document ‘Basis for a pilot surveillance project on honey bee colony losses’ (1) and directly related to the implementation of the surveillance study programme for which financial support was granted according to Commission Implementing Decision 2013/512/EU, |
|
— |
the expenditure was actually incurred, accurately accounted for and eligible under the provisions of Implementing Decision 2013/512/EU, |
|
— |
all supporting documents relating to the expenditure are available for auditing, |
|
— |
no other Union contribution was requested for the projects listed in Commission Implementing Decision 2013/512/EU. |
Date:
Name and signature of the financial officer responsible:
(1) Available at http://ec.europa.eu/food/animal/liveanimals/bees/docs/annex_i_pilot_project_en.pdf
ANNEX III
ELIGIBILITY RULES
1. Laboratory costs
|
— |
Staff costs shall be limited to actual attributable labour costs (basic salary, social charges and retirement costs) accrued in implementation of the study and performing laboratory tests. To this end monthly time sheets have to be maintained. |
|
— |
Daily rate will be calculated on a 220 working days/year. |
|
— |
Reimbursement of consumables shall be based on actual costs incurred by Member States to perform the tests at the laboratory. |
|
— |
Staff costs for coordination, planning and transport are not eligible. Test kits, reagents and all consumables shall only be reimbursed if used specifically in the performance of the following tests. |
|
— |
Varroa count (washing) to be carried out on all colonies visited at the first visit and on symptomatic colonies in the following visits. |
|
— |
Detection and characterisation of the small hive beetle (Aethina tumida) and the tropilaelaps mite) to be carried out at the clinical inspection. |
|
— |
Clinical observation (including symptom observation foulbrood, nosema, viruses) microsporidian parasite (nosema spp.) spore counts, cultures, microscopic examination and biochemical tests to identify the causal agent European foulbrood (Melissococcus plutonius) and American foulbrood (Paenibacillus larvae) on symptomatic colonies. |
|
— |
American foulbrood — confirmation of the identity of the causal agent American foulbrood and European foulbrood via Polymerase Chain Reaction (PCR) on symptomatic colonies. |
|
— |
CBPV test (PCR) on symptomatic colonies. |
2. Sampling and monitoring costs
|
— |
Costs for sampling and monitoring can only be claimed if they are directly linked to visits of apiaries and are limited to the time actually spent at the apiaries. Staff costs shall be limited to actual attributable labour costs (basic salary, social charges and retirement costs) accrued in implementation of the study, To this end monthly time sheets have to be maintained. |
|
— |
Staff costs for coordination, planning and transport are not eligible. |
|
— |
Daily rate will be calculated on a 220 working days/year. |
|
— |
Reimbursement of consumables shall be based on actual costs incurred by Member States and shall only be reimbursed if used specifically during visits to the apiaries. |
3. Overheads
A flat rate contribution of 7 % calculated on the basis of all direct eligible costs may be claimed.
4. The expenditure submitted by the Member States for a financial contribution by the Union shall be expressed in euro and shall exclude value added tax (VAT) and all other taxes.
ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS
|
19.10.2013 |
EN |
Official Journal of the European Union |
L 279/73 |
DECISION No 1/2013 OF THE EU-MONACO JOINT COMMITTEE ESTABLISHED UNDER THE AGREEMENT BETWEEN THE EUROPEAN COMMUNITY AND THE PRINCIPALITY OF MONACO ON THE APPLICATION OF CERTAIN COMMUNITY ACTS ON THE TERRITORY OF THE PRINCIPALITY OF MONACO
of 12 July 2013
amending the Annex to the Agreement
(2013/513/EU)
THE JOINT COMMITTEE,
Having regard to the Agreement between the European Community and the Principality of Monaco on the application of certain Community acts on the territory of the Principality of Monaco (1), signed in Brussels on 4 December 2003 (hereinafter referred to as ‘the Agreement’), and in particular Article 1(1) thereof,
Whereas:
|
(1) |
Since the entry into force of the Agreement on 1 May 2004, the Union has adopted a number of acts that fall within its scope and some acts appearing in the Annex have been repealed. A Decision of the Joint Committee is therefore necessary to update the Annex to include the new acts and to delete the acts that have been repealed. |
|
(2) |
It is recalled that acts of the European Commission adopted in application of the acts listed in the Annex to the Agreement are applicable on the territory of Monaco without the need for a Joint Committee Decision, as provided for by Article 1(2) of the Agreement, |
HAS ADOPTED THIS DECISION:
Article 1
The text set out in the Annex to the Agreement between the European Community and the Principality of Monaco on the application of certain Community acts on the territory of the Principality of Monaco is replaced by the text set out in the Annex to this Decision.
Article 2
This Decision shall enter into force on the day of its adoption.
Done at Monaco, 12 July 2013.
For the Joint Committee
The President
Stéphane VALÉRI
(1) OJ L 332, 19.12.2003, p. 42.
ANNEX
‘ANNEX
I. MEDICINAL PRODUCTS
ACTS REFERRED TO
|
1. |
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended by:
|
|
2. |
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, as amended by:
|
|
3. |
Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products, as amended by:
|
|
4. |
Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products, as amended by:
|
|
5. |
Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11). |
|
6. |
Commission Regulation (EC) No 668/2009 of 24 July 2009 implementing Regulation (EC) No 1394/2007 of the European Parliament and of the Council with regard to the evaluation and certification of quality and non-clinical data relating to advanced therapy medicinal products developed by micro, small and medium-sized enterprises (OJ L 194, 25.7.2009, p. 7). |
|
7. |
Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin, as amended by:
|
|
8. |
Commission Regulation (EU) No 488/2012 of 8 June 2012 amending Regulation (EC) No 658/2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 150, 9.6.2012, p. 68). |
|
9. |
Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products, as amended by Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (OJ L 209, 4.8.2012, p. 4). |
|
10. |
Commission Implementing Regulation (EU) No 198/2013 of 7 March 2013 on the selection of a symbol for the purpose of identifying medicinal products for human use that are subject to additional monitoring (OJ L 65, 8.3.2013, p. 17). |
|
11. |
Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (OJ L 152, 16.6.2009, p. 1). |
|
12. |
Directive 2009/35/EC of the European Parliament and of the Council of 23 April 2009 on the colouring matters which may be added to medicinal products (OJ L 109, 30.4.2009, p. 10). |
|
13. |
Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121), as amended by Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 (OJ L 348, 31.12.2010, p. 1). |
|
14. |
Commission Regulation (EC) No 658/2007 of 14 June 2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 155, 15.6.2007, p. 10). |
|
15. |
Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.12.2006, p. 1), as amended by:
|
|
16. |
Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 92, 30.3.2006, p. 6). |
|
17. |
Commission Regulation (EC) No 2049/2005 of 15 December 2005 laying down, pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council, rules regarding the payment of fees to, and the receipt of administrative assistance from, the European Medicines Agency by micro, small and medium-sized enterprises (OJ L 329, 16.12.2005, p. 4). |
|
18. |
Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (OJ L 91, 9.4.2005, p. 13). |
|
19. |
Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (OJ L 50, 20.2.2004, p. 44), as amended by Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009 (OJ L 87, 31.3.2009, p. 109). |
|
20. |
Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (OJ L 50, 20.2.2004, p. 28) as amended by Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009 (OJ L 87, 31.3.2009, p. 109). |
|
21. |
Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (OJ L 262, 14.10.2003, p. 22). |
|
22. |
Council Regulation (EC) No 953/2003 of 26 May 2003 to avoid trade diversion into the European Union of certain key medicines (OJ L 135, 3.6.2003, p. 5), as amended by:
|
|
23. |
Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ L 18, 22.1.2000, p. 1), as amended by Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 (OJ L 188, 18.7.2009, p. 14). |
|
24. |
Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products (OJ L 228, 17.8.1991, p. 70). |
|
25. |
Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems (OJ L 40, 11.2.1989, p. 8). |
|
26. |
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34), as amended by:
|
|
27. |
Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (OJ L 33, 8.2.2003, p. 30) (only as regards the collection and testing of blood and blood components used as starting materials for manufacturing medicinal products). |
|
28. |
Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (OJ L 102, 7.4.2004, p. 48) (only as regards the procurement, donation, coding and testing of tissue and cells, as well as the coding of donations and packaging thereof, used as starting materials for advanced therapy medicinal products as referred to in Regulation (EC) No 1394/2007 of the European Parliament and of the Council). |
II. COSMETICS
ACTS REFERRED TO
|
1. |
Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (OJ L 262, 27.9.1976, p. 169), as amended by:
Directive 76/768/EEC will be repealed with effect from 11 July 2013 and will be replaced by Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59). |
|
2. |
Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59), as amended by:
|
|
3. |
Commission Directive 80/1335/EEC of 22 December 1980 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products (OJ L 383, 31.12.1980, p. 27), as amended by Commission Directive 87/143/EEC of 10 February 1987 (OJ L 57, 27.2.1987, p. 56). |
|
4. |
Commission Directive 82/434/EEC of 14 May 1982 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products (OJ L 185, 30.6.1982, p. 1), as amended by Commission Directive 90/207/EEC of 4 April 1990 (OJ L 108, 28.4.1990, p. 92). |
|
5. |
Commission Directive 83/514/EEC of 27 September 1983 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products (OJ L 291, 24.10.1983, p. 9). |
|
6. |
Commission Directive 85/490/EEC of 11 October 1985 on the approximation of laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products (OJ L 295, 7.11.1985, p. 30). |
|
7. |
Commission Directive 93/73/EEC of 9 September 1993 on the methods of analysis necessary for checking the composition of cosmetic products (OJ L 231, 14.9.1993, p. 34). |
|
8. |
Commission Directive 95/17/EC of 19 June 1995 laying down detailed rules for the application of Council Directive 76/768/EEC as regards the non-inclusion of one or more ingredients on the list used for the labelling of cosmetic products (OJ L 140, 23.6.1995, p. 26), as amended by:
Commission Directive 95/17/EC will be repealed with effect from 11 July 2013. |
|
9. |
Commission Directive 95/32/EC of 7 July 1995 relating to methods of analysis necessary for checking the composition of cosmetic products (OJ L 178, 28.7.1995, p. 20). |
|
10. |
Commission Directive 96/45/EC of 2 July 1996 relating to methods of analysis necessary for checking the composition of cosmetic products (OJ L 213, 22.8.1996, p. 8). |
|
11. |
Commission Decision of 8 May 1996 establishing an inventory and a common nomenclature of ingredients employed in cosmetic products (OJ L 132, 1.6.1996, p. 1) as amended by Commission Decision 2006/257/EC (OJ L 97, 5.4.2006, p. 1). |
III. MEDICAL DEVICES
ACTS REFERRED TO
|
1. |
Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 189, 20.7.1990, p. 17), as amended by:
|
|
2. |
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1), as amended by:
|
|
3. |
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1), as amended by:
|
|
4. |
Commission Decision 2002/364/EC of 7 May 2002 on common technical specifications for in vitro diagnostic medical devices (OJ L 131, 16.5.2002, p. 17), as amended by:
|
|
5. |
Commission Directive 2003/12/EC of 3 February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices (OJ L 28, 4.2.2003, p. 43). |
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6. |
Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin (OJ L 105, 26.4.2003, p. 18). |
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7. |
Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices (OJ L 210, 12.8.2005, p. 41). |
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8. |
Commission Decision 2010/227/EU of 19 April 2010 on the European Databank on Medical Devices (Eudamed) (OJ L 102, 23.4.2010, p. 45). |
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9. |
Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices (OJ L 72, 10.3.2012, p. 28). |
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10. |
Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin (OJ L 212, 9.8.2012, p. 3).’ |