26.3.2010

EN

Official Journal of the European Union

L 80/1

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COMMISSION REGULATION (EU) No 254/2010

of 10 March 2010

approving a control programme for Salmonella in poultry in certain third countries in accordance with Regulation (EC) No 2160/2003 of the European Parliament and of the Council and amending Annex I to Regulation (EC) No 798/2008 as regards the Salmonella control status of certain third countries

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Council Directive 90/539/EEC of 15 October 1990 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs (1), and in particular Article 21(1) thereof,

Having regard to Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of Salmonella and other specified food-borne zoonotic agents (2), and in particular Article 10(2) thereof,

Whereas:

(1)

Commission Regulation (EC) No 798/2008 of 8 August 2008 laying down a list of third countries, territories, zones or compartments from which poultry and poultry products may be imported into and transit through the Community and the veterinary certification requirements (3) provides that the commodities covered by that Regulation are only to be imported into and transit through the Union from the third countries, territories, zones or compartments listed in Annex I thereto.

(2)

Regulation (EC) No 2160/2003 lays down rules for the control of Salmonella in different poultry populations in the Union. Admission to or retention on the list of third countries provided for in Union legislation from which Member States are authorised to import animals covered by that Regulation is subject to the submission to the Commission by the third country concerned of a control programme for Salmonella with equivalent guarantees as those contained in the national control programmes for Salmonella in the Member States.

(3)

In accordance with Commission Regulation (EC) No 584/2008 (4), Salmonella control programmes concerning breeding and productive poultry of turkeys, hatching eggs thereof, day-old chicks of turkeys and slaughter poultry and poultry for restocking of turkeys provided for in Regulation (EC) No 2160/2003, are to apply from 1 January 2010 within the Union.

(4)

Canada, Israel and the United States have submitted to the Commission a control programme for Salmonella in breeding flocks of turkeys, hatching eggs thereof and day-old chicks of turkeys. These programmes provide the guarantees required by Regulation (EC) No 2160/2003 and should therefore be approved.

(5)

Certain third countries currently listed in Annex I to Regulation (EC) No 798/2008 have not yet submitted any control programme for Salmonella in flocks of turkeys to the Commission, or alternatively the programmes submitted by them do not provide guarantees equivalent to those required by Regulation (EC) No 2160/2003. Imports of breeding and productive poultry of turkeys, hatching eggs thereof, day-old chicks of turkeys and slaughter poultry and poultry for restocking of turkeys should therefore no longer be authorised from those third countries from 1 January 2010.

(6)

Israel has submitted to the Commission a control programme for Salmonella in day-old chicks of Gallus gallus, intended for flocks of laying hens and broilers, supplementing the control programme of Israel approved by Commission Decision 2007/843/EC (5). Control programmes for Salmonella in flocks of breeding hens and hatching eggs thereof and day-old chicks of Gallus gallus were also submitted by Brazil. These programmes provide the guarantees required by Regulation (EC) No 2160/2003 and should therefore be approved.

(7)	The list of third countries, territories, zones or compartments and the model veterinary certificates for the import of breeding and productive poultry, day old chicks and hatching eggs set out in Annex I to Regulation (EC) No 798/2008 should therefore be amended accordingly.

(8)	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 control programme in accordance with Article 10(1) of Regulation (EC) No 2160/2003 is hereby approved as regards Salmonella:

(a)	in breeding flocks of turkeys, hatching eggs thereof and day-old chicks of turkeys submitted by Canada, Israel and the United States;

(b)	in day-old chicks of Gallus gallus intended for flocks of laying hens or broilers submitted by Israel;

(c)	in breeding hens of Gallus gallus, hatching eggs thereof and day-old chicks of Gallus gallus submitted by Brazil.

Article 2

Annex I to Regulation (EC) No 798/2008 is amended in accordance with the Annex to this Regulation.

Article 3

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

It shall apply from 1 January 2010.

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(1)  OJ L 303, 31.10.1990, p. 6.

(2)  OJ L 325, 12.12.2003, p. 1.

(3)  OJ L 226, 23.8.2008, p. 1.

(4)  OJ L 162, 21.6.2008, p. 3.

(5)  OJ L 332, 18.12.2007, p. 81.

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26.3.2010

EN

Official Journal of the European Union

L 80/10

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COMMISSION REGULATION (EU) No 255/2010

of 25 March 2010

laying down common rules on air traffic flow management

(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 551/2004 of the European Parliament and of the Council of 10 March 2004 on the organisation and the use of the airspace in the single European sky (the airspace Regulation) (1) and in particular Article 6(7) thereof,

Whereas:

(1)	The Commission is required to lay down measures regarding air traffic flow management (hereinafter ATFM) with a view to optimising available capacity in the use of airspace and enhancing ATFM processes.

(2)

The European Organisation for the Safety of Air Navigation (Eurocontrol) has been mandated in accordance with Article 8(1) of Regulation (EC) No 549/2004 of the European Parliament and of the Council of 10 March 2004 laying down the framework for the creation of the single European sky (the framework Regulation) (2) to develop implementing rules for ATFM. This Regulation is based on the resulting mandate report of 7 December 2007.

(3)	The uniform application of specific rules and procedures within the airspace of the single European sky is critical for the achievement of the optimum use of available air traffic control capacity through the efficient management and operation of the ATFM function.

(4)

This Regulation should not cover military operations and training as referred to in Article 1(2) of Regulation (EC) No 549/2004. However military aircraft operating as general air traffic should be subject to ATFM measures when operating or intending to operate within airspace or airports to which ATFM measures apply.

(5)	In accordance with Article 13 of Regulation (EC) No 549/2004, Member States’ essential security or defence policy interests should be safeguarded in the definition and implementation of ATFM measures.

(6)

A single central unit for ATFM in charge of planning, coordination and execution of ATFM measures has been established by Eurocontrol taking into consideration the recommendations of the International Civil Aviation Organisation (ICAO). Member States should be required to take the necessary measures to ensure that the central unit for ATFM optimises the overall effects of ATFM measures on the European air traffic management network (hereinafter EATMN).

(7)	ATFM measures should be based on principles laid down by ICAO and all parties in the ATFM system should adhere to rules that ensure that air traffic control capacity is used safely and to the maximum extent possible.

(8)

ATFM measures should take into account the availability of routes and airspace in particular through the application of the flexible use of airspace by all relevant parties including the airspace management cell laid down by Commission Regulation (EC) No 2150/2005 of 23 December 2005 laying down common rules for the flexible use of airspace (3).

(9)	In order to optimise available capacity of the EATMN, including airports, procedures aimed at increasing the consistency between airport slots and flight plans should be established.

(10)	It is appropriate to provide Member States and parties involved in ATFM processes with sufficient time to comply with requirements for air traffic flow management.

(11)	The measures provided for in this Regulation are in accordance with the opinion of the Single Sky Committee,

HAS ADOPTED THIS REGULATION:

Article 1

Subject matter and scope

1.   This Regulation lays down the requirements for air traffic flow management (hereinafter ATFM) in order to optimise the available capacity of the European air traffic management network (hereinafter EATMN) and enhance ATFM processes.

2.   This Regulation shall apply within the airspace referred to in Article 1(3) of Regulation (EC) No 551/2004 to:

(a)	all flights intended to operate or operating as general air traffic and in accordance with the instrument flight rules (hereinafter IFR) in whole or in part;

(b)	all phases of flights referred to in point (a) and air traffic management.

3.   This Regulation shall apply to the following parties, or agents acting on their behalf, involved in ATFM processes:

(a)	operators of aircraft,

(b)	air traffic service (hereinafter ATS) units, including ATS reporting offices and aerodrome control services;

(c)	aeronautical information services;

(d)	entities involved in airspace management;

(e)	airport managing bodies;

(f)	the central unit for ATFM;

(g)	local ATFM units;

(h)	slot coordinators of coordinated airports.

Article 2

Definitions

For the purposes of this Regulation the definitions provided for in Article 2 of Regulation (EC) No 549/2004 and Article 2 of Council Regulation (EEC) No 95/93 (4) shall apply.

The following definitions shall also apply:

1.	‘air traffic flow management (ATFM) measure’ means the actions taken to perform air traffic flow management and capacity management;

2.	‘operator’ means a person, organisation or enterprise engaged in or offering to engage in an aircraft operation;

3.	‘instrument flight rules (IFR)’ means instrument flight rules as defined in Annex 2 of the 1944 Chicago Convention on International Civil Aviation (hereinafter Chicago Convention);

4.	‘air traffic services (ATS) reporting office’ means an ATS unit established for the purpose of receiving reports concerning ATS and flight plans submitted before the first delivery of an air traffic control clearance;

5.	‘local air traffic flow management (ATFM) unit’ means a flow management entity operating on behalf of one or more other flow management entities as the interface between the central unit for ATFM and an ATS unit or a group of such units;

6.	‘critical event’ means an unusual situation or crisis involving a major loss of EATMN capacity, or a major imbalance between EATMN capacity and demand, or a major failure in the information flow in one or several parts of the EATMN;

7.	‘air traffic flow management (ATFM) departure slot’ means a calculated take-off time attributed by the central unit for ATFM with a time tolerance managed by the local ATS unit;

8.	‘route and traffic orientation’ means policies and procedures for the use of routes by aircraft;

9.	‘multiple flight plan’ means more than one flight plan for the same intended flight between two airports;

10.	‘air traffic service (ATS) unit sector configuration’ means the four dimensional description of an ATS unit airspace sector, or group of sectors, which may be operated on a permanent or temporary basis;

11.	‘aerodrome taxi time’ means the pre-determined time value from off-block to take-off, expressed in minutes and valid during normal airport operations;

12.	‘updated flight position’ means aircraft position, updated by surveillance data, flight plan data or position reports;

13.	‘air traffic control clearance’ means the authorisation for an aircraft to proceed under conditions specified by an air traffic control unit;

14.	‘flight plan suspension’ means the process initiated by an entity performing ATFM to ensure that a change is made to the flight plan by the operator before the execution of the flight;

15.	‘air service’ means a flight or a series of flights carrying passengers, cargo or mail for remuneration or hire;

16.	‘operational log’ means a log of the ATFM system, converted into a database to allow quick search of ATFM data.

Article 3

Air traffic flow management framework

1.   The planning, coordination and execution of the ATFM measures by the parties referred to in Article 1(3) shall comply with the ICAO provisions specified in the Annex.

2.   ATFM shall be governed by the following principles:

(a)

ATFM measures shall: (i) prevent excessive air traffic demand compared with declared air traffic control (ATC) capacity of sectors and airports; (ii) use EATMN capacity to the maximum extent possible in order to optimise the efficiency of the EATMN and minimise adverse effects on operators; (iii) optimise the EATMN capacity made available through the development and application of capacity enhancing measures by ATS units; (iv) support the management of critical events;

(b)	local ATFM units and the central unit for ATFM shall be considered as part of the ATFM function.

3.   The allocation of ATFM departure slots shall give priority to flights according to the order of their planned entry into the location at which the ATFM measure will apply, unless specific circumstances require application of a different priority rule which is formally agreed and is of benefit to the EATMN.

The first subparagraph may be applied to flights which are unable to accept the re-routing option to avoid or alleviate congested areas, taking into consideration the location and extent of the congested area.

Article 4

General obligations of Member States

1.   Member States shall ensure that the ATFM function is available to parties referred to in Article 1(3) on a 24 hour basis.

2.   The definition and implementation of ATFM measures shall be compatible with Member States security and defence requirements, in order to ensure efficiency in airspace planning, allocation and use for the benefit of parties referred in Article 1(3).

3.   Consistent procedures shall be established for the cooperation between the parties involved in ATFM function, ATS units and entities involved in airspace management, in order to optimise the use of the airspace.

4.   A common reference document containing the policies, procedures and description for route and traffic orientation shall be created. Where applicable, publication of route availability in national aeronautical information publications shall be fully consistent with this common reference document.

5.   Common procedures for requesting exemption from an ATFM departure slot shall be drawn up in accordance with the ICAO provisions specified in the Annex. Those procedures shall be coordinated with the central unit for ATFM and published in national aeronautical information publications.

Article 5

Obligations of Member States concerning the central unit for ATFM

Member States shall ensure that the central unit for ATFM:

(a)	optimises the overall performance effects on the EATMN through planning, coordination and implementation of ATFM measures;

(b)	consults with operators on the definition of ATFM measures;

(c)	ensures the effective implementation of ATFM measures, together with local ATFM units;

(d)	in coordination with local ATFM units identifies alternative routings to avoid or alleviate congested areas, taking into account the overall performance effects on the EATMN;

(e)	offers a re-routing to those flights that would optimise the effect of point (d);

(f)	provides information on ATFM in a timely manner to operators and ATS units, including: (i) planned ATFM measures; (ii) impact of ATFM measures on take-off time and flight profile of individual flights;

(g)	monitors the occurrences of missing flight plans and multiple flight plans that are filed;

(h)	suspends a flight plan when, considering the time tolerance, the ATFM departure slot cannot be met and a new estimated off-block time is not known;

(i)	monitors the number of exemptions granted in accordance with Article 4(5).

Article 6

General obligations of ATS units

1.   When an ATFM measure has to be applied, ATS units shall coordinate through the local ATFM unit with the central unit for ATFM in order to ensure that the choice of measure is made with respect to the optimisation of the overall performance effects on the EATMN.

2.   When necessary, ATS reporting offices shall facilitate the exchange of information between pilots or operators and the local or the central unit for ATFM.

3.   ATS units shall ensure that ATFM measures applied to airports are coordinated with the airport managing body concerned, in order to ensure efficiency in airport planning and usage for the benefit of parties referred to in Article 1(3).

4.   ATS units shall notify to the central unit for ATFM through the local ATFM unit all events that may impact air traffic control capacity or air traffic demand.

5.   ATS units shall provide the central unit for ATFM with the following data and subsequent updates, in a timely manner and ensuring its quality:

(a)	availability of airspace and route structures,

(b)	ATS unit sector configurations and activations,

(c)	aerodrome taxi times,

(d)	air traffic control sector and airport capacities,

(e)	route availability including availability through application of flexible use of airspace in accordance with Regulation (EC) No 2150/2005,

(f)	updated flight positions,

(g)	deviations from flight plans,

(h)	airspace availability including availability through application of flexible use of airspace in accordance with Regulation (EC) No 2150/2005,

(i)	actual flight take-off times.

The data shall be made available to parties referred to in Article 1(3) and provided free of charge to, and by, the central unit for ATFM.

6.   The ATS unit at the departure airport shall ensure that:

(a)	where a flight is subject to an ATFM departure slot, that slot is included as part of the air traffic control clearance;

(b)	flights adhere to ATFM departure slots;

(c)	flights not adhering to their estimated off blocks time, taking into account the established time tolerance, are not given take-off clearance;

(d)	flights whose flight plan has been rejected or suspended are not given take-off clearance.

Article 7

General obligations of operators

1.   Each intended flight shall be covered by a single flight plan. The filed flight plan shall correctly reflect the intended flight profile.

2.   All relevant ATFM measures and changes thereto shall be incorporated into the planned flight operation and communicated to the pilot.

3.   Where departing from an airport not subject to an ATFM departure slot, operators are responsible for adhering to their estimated off blocks time, taking into account a time tolerance as laid down in relevant ICAO provisions specified in the Annex.

4.   Where a flight plan has been suspended in accordance with Article 5(h), the operator concerned shall arrange for updating or cancelling the flight plan.

Article 8

General obligations of airport managing bodies

Airport managing bodies shall notify to the central unit for ATFM, directly or through the local ATFM unit or ATS units or both, all events that may impact air traffic control capacity or air traffic demand. They shall inform the local ATFM unit and ATS units where the notification is done directly.

Article 9

Consistency between flight plans and airport slots

1.   Member States shall ensure that, where requested by an airport slot coordinator or a managing body of a coordinated airport, the central unit for ATFM or the local ATFM unit shall provide them with the accepted flight plan of a flight operating at that airport, before that flight takes place. The airport slot coordinators or the managing bodies of coordinated airports shall arrange access to the accepted flight plans provided by the central unit for ATFM or the local ATFM unit.

2.   Before flight, operators shall provide airports of departure and arrival with the necessary information to enable a correlation to be made between the flight designator contained in the flight plan and that notified for the corresponding airport slot.

3.   Any operator, airport managing body and ATS unit shall be entitled to report to the airport slot coordinator on repeated operation of air services at times that are significantly different from the allocated airport slots or with the use of slots in a significantly different way from that indicated at the time of allocation, where this causes prejudice to airport or air traffic operations.

4.   Member States shall ensure that the central unit for ATFM reports to the airport slot coordinators on repeated operation of air services at significantly different times from the allocated airport slots or with the use of slots in a significantly different way from that indicated at the time of allocation, where this causes prejudice to ATFM.

Article 10

Obligations concerning critical events

1.   Member States shall ensure that ATFM procedures for handling critical events are established and published by the central unit for ATFM, in order to minimise disruption to the EATMN.

2.   In the preparation for critical events, ATS units and airport managing bodies shall coordinate the relevance and content of the contingency procedures with operators affected by critical events, including any adjustment to priority rules.

The contingency procedures shall include:

(a)	organisational and coordination arrangements,

(b)	ATFM measures to manage access to affected areas to prevent excessive air traffic demand compared with declared capacity of the whole or part of the airspace or airports concerned,

(c)	circumstances, conditions and procedures for the application of priority rules for flights, which respect Member States’ essential security or defence policy interests,

(d)	recovery arrangements.

Article 11

Monitoring of compliance to ATFM measures

1.   Member States shall ensure that where adherence to ATFM departure slots at an airport of departure is 80 % or less during a year, the ATS unit at that airport shall provide relevant information of non-compliance and the actions taken to ensure adherence to ATFM departure slots. Such actions shall be indicated in a report to be submitted by the Member State concerned to the Commission.

2.   The ATS unit at that airport concerned shall provide relevant information on any failure to adhere to flight plan rejections or suspensions at that airport and of the actions taken to ensure adherence. Such actions shall be indicated in a report to be submitted by the Member State concerned to the Commission.

3.   Member States shall ensure that:

(a)	the central unit for ATFM notifies a Member State which grants exemptions in excess of 0,6 % of that Member State’s annual departures;

(b)	where a Member State has been notified under point (a), it shall produce a report providing details of the exemptions granted to be submitted to the Commission.

4.   Member States shall ensure that where a non-compliance to ATFM measures resulting from application of Article 5(g) is identified, the central unit for ATFM shall notify the operator of the non-compliance.

5.   Operators shall submit a report to the central unit for ATFM on each non-compliance to ATFM measures providing details of the circumstances that resulted in a missing flight plan or multiple flight plans and the actions taken to correct such non-compliance.

6.   Member States shall ensure that the central unit for ATFM produces an annual report providing details of missing flight plans, or multiple flight plans that are filed and that the report is submitted to the Commission.

7.   Member States shall conduct an annual review of adherence to ATFM measures to ensure that parties referred to in Article 1(3) improve the level of adherence to those measures.

Article 12

Performance assessment

1.   When implementing Article 11, Member States shall ensure that the central unit for ATFM produces annual reports indicating the quality of the ATFM that shall include details of:

(a)	causes of ATFM measures;

(b)	impact of ATFM measures;

(c)	adherence to ATFM measures;

(d)	contributions by parties referred to in Article 1(3) to the optimisation of the overall network effect.

2.   Member States shall ensure that an archive of ATFM data listed in Article 6(5), flight plans, operational logs and relevant contextual data is created and maintained by the central unit for ATFM.

The data referred to in the first subparagraph shall be retained for 2 years from their submission and made available to the Commission, Member States, ATS units and operators.

That data shall be made available to airport coordinators and airport operators to assist their regular assessment of the declared capacity.

Article 13

Safety requirements

Member States shall ensure that a safety assessment, including hazard identification, risk assessment and mitigation, is conducted, before any significant changes to ATFM systems and procedures are introduced, including an assessment of a safety management process addressing the complete lifecycle of the air traffic management system.

Article 14

Additional requirements

1.   Member States shall ensure that personnel of the parties referred to in Article 1(3) involved in ATFM activities are:

(a)	made duly aware of the provisions of this Regulation;

(b)	adequately trained and competent for their job functions.

2.   Member States shall take the necessary measures to ensure that parties referred to in Article 1(3) with responsibilities for ATFM functions:

(a)	develop and maintain operations manuals containing the necessary instructions and information to enable their operations personnel to apply the provisions of this Regulation;

(b)	ensure that these manuals are consistent, accessible and kept up-to-date and that their update and distribution are subject to appropriate quality and documentation configuration management;

(c)	ensure that the working methods and operating procedures comply with this Regulation.

Article 15

Penalties

Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission by 26 September 2011 at the latest and shall notify it without delay of any subsequent amendment affecting them.

Article 16

Entry into force and application

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

It shall apply from 26 September 2011.

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(1)  OJ L 96, 31.3.2004, p. 20.

(2)  OJ L 96, 31.3.2004, p. 1.

(3)  OJ L 342, 24.12.2005, p. 20.

(4)  OJ L 14, 22.1.1993, p. 1.

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26.3.2010

EN

Official Journal of the European Union

L 80/17

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COMMISSION REGULATION (EU) No 256/2010

of 25 March 2010

entering a name in the register of protected designations of origin and protected geographical indications (Alubia de La Bañeza-León (PGI))

THE EUROPEAN COMMISSION,

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

Having regard to 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 (1), and in particular the first subparagraph of Article 7(4) thereof,

Whereas:

(1)	Pursuant to the first subparagraph of Article 6(2) and in accordance with Article 17(2) of Regulation (EC) No 510/2006, Spain’s application to register the name ‘Alubia de La Bañeza-León’ was published in the Official Journal of the European Union  (2).

(2)	As no statement of objection pursuant to Article 7 of Regulation (EC) No 510/2006 has been received by the Commission, that name should therefore be entered in the register,

HAS ADOPTED THIS REGULATION:

Article 1

The name contained in the Annex to this Regulation is hereby entered in the register.

Article 2

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

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(1)  OJ L 93, 31.3.2006, p. 12.

(2)  OJ C 186, 8.8.2009, p. 28.

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26.3.2010

EN

Official Journal of the European Union

L 80/19

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COMMISSION REGULATION (EU) No 257/2010

of 25 March 2010

setting up a programme for the re-evaluation of approved food additives in accordance with Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives

(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 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (1), and in particular Article 32 thereof,

After consulting the European Food Safety Authority,

Whereas:

(1)	Regulation (EC) No 1333/2008 requires the Commission to set up a programme for the re-evaluation, by the European Food Safety Authority (hereinafter referred to as ‘EFSA’), of the safety of food additives that were already permitted in the Union before 20 January 2009.

(2)

In 2007, the Commission presented a report to the European Parliament and the Council on the progress of the re-evaluation of food additives (2). That report provides a summary of the recent additive re-evaluations undertaken by the Scientific Committee on Food (‘SCF’) and EFSA and describes the related actions taken by the European Commission on the basis of the scientific opinions.

(3)

The re-evaluation of food colours has already been started with priority, since these food additives have the oldest evaluations by the SCF. The re-evaluation of certain colours (namely E 102 Tartrazine, E 104 Quinoline Yellow, E 110 Sunset Yellow FCF, E 124 Ponceau 4R, E 129 Allura Red AC and E 122 Carmoisine, E 160d lycopene) has already been completed. In addition, some food additives such as E 234 Nisin and E 214–219 Para-hydroxybenzoates were re-evaluated in recent years since new scientific data was requested or became otherwise available. As a consequence, those additives do not need to be re-evaluated again.

(4)	Taking into account that sweeteners have the most recent evaluations they should be re-evaluated the last.

(5)

The order of priorities for the re-evaluation of the currently approved food additives should be set on the basis of the following criteria: the time since the last evaluation of a food additive by the SCF or by EFSA, the availability of new scientific evidence, the extent of use of a food additive in food and the human exposure to the food additive taking also into account the outcome of the Report from the Commission on Dietary Food Additive Intake in the EU (3) of 2001. The report ‘Food additives in Europe 2000 (4)’ submitted by the Nordic Council of Ministers to the Commission, provides additional information for the prioritisation of additives for re-evaluation.

(6)

For efficiency and practical purposes, the re-evaluation should, as far as possible, be conducted by group of food additives according to the main functional class to which they belong. EFSA should however be in a position to start the re-evaluation of a food additive or a group of food additives with higher priority, on a request from the Commission or on its own initiative, if new scientific evidence emerges that indicates a possible risk for human health or which in any way may affect the assessment of the safety of a food additive.

(7)	Deadlines for the re-evaluation should be established in accordance with that order of priorities. In duly justified cases and only when such re-evaluation may delay substantially the re-evaluation of other food additives, the deadlines laid down in this Regulation may be revised.

(8)	More specific deadlines for individual food additives or groups of food additives may be set in the future, in order to allow the smooth running of the re-evaluation process or in case of emerging concern.

(9)

In order for the re-evaluation procedure to be effective, it is important that EFSA acquires from the interested parties all data relevant to the re-evaluation and that the interested parties are informed well in advance when additional data is necessary for the completion of the re-evaluation of a food additive.

(10)	Business operators interested in the continuity of the approval of a food additive under re-evaluation should submit any data relevant to the re-evaluation of the food additive. Where possible, business operators should take steps to submit information collectively.

(11)

EFSA should make public one or more open calls for data on all food additives to be re-evaluated. Any technical and scientific information about a food additive which is necessary for its re-evaluation, in particular toxicological data and data relevant for the estimation of the human exposure to the relevant food additive, should be submitted by the interested parties to EFSA within the set time limits.

(12)

The food additives to be re-evaluated by EFSA have been previously assessed for their safety by the SCF and many of them have been used since long time. The information to be submitted for their re-evaluation should include existing data on which the previous evaluation of a food additive was based and any new data relevant to the food additive made available since its last evaluation by the SCF. That information should be as comprehensive as possible in order to allow EFSA to complete its re-evaluation and form an up-to-date opinion and should be submitted following to the extent possible the applicable guidance on submissions for food additive evaluations (currently the guidance established by the SCF on 11 July 2001 (5)).

(13)

EFSA may require additional information in order to complete the re-evaluation of a food additive. In that case EFSA should request the necessary data in good time either by an open call for data or by contacting the parties that submitted data on the food additive. The interested parties should submit the requested information within a time period that is set by EFSA having considered, where relevant, the views of the interested parties.

(14)

Regulation (EC) No 1333/2008 provides that the approval of food additives should also take into account environmental factors. Therefore, in the framework of the re-evaluation of a food additive the interested parties should inform the Commission and EFSA of any information relevant to any environmental risks from the production, use or waste of that additive.

(15)	Where the requested information necessary for the completion of the re-evaluation of a particular food additive is not provided, the food additive may be removed from the Union list of approved food additives.

(16)	The re-evaluation procedure of food additives must fulfil transparency and public information requirements while guaranteeing the confidentiality of certain information.

(17)	By the date of entry into force of this Regulation, the Commission will make available to the public a list of approved food additives that are being re-evaluated with the date of their latest evaluation by the ‘SCF’ or EFSA.

(18)	The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council opposed them,

HAS ADOPTED THIS REGULATION:

Article 1

Subject matter and scope

1.   This Regulation sets up a programme for the re-evaluation by the European Food Safety Authority (hereinafter referred to as ‘EFSA’) of approved food additives, as provided for in Article 32 of Regulation (EC) No 1333/2008.

2.   Approved food additives, for which the re-evaluation by EFSA is already completed at the time of the adoption of this Regulation, shall not be re-evaluated again. Those food additives are listed in Annex I.

Article 2

Definitions

For the purposes of this Regulation, the following definitions shall apply:

(a)

‘approved food additive’ means a food additive authorised before 20 January 2009 and listed in Directive 94/35/EC of the European Parliament and of the Council of 30 June 1994 on sweeteners for use in foodstuffs (6), Directive 94/36/EC of the European Parliament and of the Council of 30 June 1994 on colours for use in foodstuffs (7) or in Directive 95/2/EC of the European Parliament and of the Council of 20 February 1995 on food additives other than colours and sweeteners (8);

(b)	‘business operator’ means any natural or legal person responsible for ensuring that the requirements of Regulation (EC) No 1333/2008 are met within the food business under its control;

(c)	‘interested business operator’ means a business operator interested in the continuity of the authorisation of one or more approved food additives;

(d)	‘original dossier’ means a dossier on the basis of which the food additive was evaluated and permitted for use in food before 20 January 2009.

Article 3

Priorities for the re-evaluation of approved food additives

1.   Approved food additives shall be re-evaluated in the following order and within the following deadlines:

(a)	the re-evaluation of all approved food colours listed in Directive 94/36/EC shall be completed by 31 December 2015;

(b)	the re-evaluation of all approved food additives other than colours and sweeteners listed in Directive 95/2/EC shall be completed by 31 December 2018;

(c)	the re-evaluation of all approved sweeteners listed in Directive 94/35/EC shall be completed by 31 December 2020.

2.   For certain food additives within the functional classes referred to in paragraph 1 more specific deadlines are set out in Annex II to this Regulation. Those food additives shall be evaluated first among the other food additives of the same functional class.

3.   By way of derogation from paragraphs 1 and 2, EFSA may at any moment start the re-evaluation of a food additive or a group of food additives with priority, on a request from the Commission or on its own initiative, if new scientific evidence emerges that

(a)	indicates a possible risk for human health or

(b)	may in any way affect the safety assessment of that food additive or group of food additives.

Article 4

Re-evaluation procedure

When re-evaluating an approved food additive, EFSA shall:

(a)	examine the original opinion and the working documents of the Scientific Committee on Food (‘SCF’) or EFSA;

(b)	examine, where available, the original dossier;

(c)	examine the data submitted by the interested business operator(s) and/or any other interested party;

(d)	examine any data made available by the Commission and Member States;

(e)	identify any relevant literature published since the last evaluation of each food additive.

Article 5

Call for data

1.   In order to acquire the data from the interested business operators and/or other interested parties, EFSA shall make open call(s) for data for the food additives under re-evaluation. In specifying the timetable for data submission, EFSA shall allow a reasonable time period after the entry into force of this Regulation, to allow the interested business operator and/or any other interested party to meet this duty.

2.   The data referred to in paragraph 1 may comprise among others:

(a)	study reports from the original dossier as evaluated by the SCF or EFSA or the Joint FAO/WHO Expert Committee on Food Additives (JECFA),

(b)	information on the data on the safety of the food additive concerned not previously reviewed by the SCF or the JECFA,

(c)	information on the specifications of the food additives presently in use, including information on particle size and relevant physicochemical characteristics and properties,

(d)	information on the manufacturing process,

(e)	information on analytical methods available for determination in food,

(f)	information on the human exposure to the food additives from food (e.g. consumption pattern and uses, actual use levels and maximum use levels, frequency of consumption and other factors influencing exposure),

(g)	reaction and fate in food.

Article 6

Submission of data

1.   The interested business operator(s) and any other interested party shall submit the data related to the re-evaluation of a food additive as referred to in Article 5(2), within the period set by EFSA in its call for data. In the submission the interested business operator and the other interested parties shall include the data requested by EFSA by following, to the extent possible, the applicable guidance on submissions for food additive evaluations (9).

2.   Where there are several interested business operators they may, when possible, submit the data collectively.

3.   If during the re-evaluation additional information considered to be relevant for the re-evaluation of a particular food additive is needed, EFSA shall request from the interested business operators, and shall invite other interested parties, to submit this information by an open call for data. It shall set a deadline within which that information shall be submitted having considered, where relevant, the interested business operator's and/or other interested parties' view of the time required. In such cases, EFSA shall make the request for the additional information well in advance so that the overall deadlines for the re-evaluation as set out in Article 3(1) and in Annex II are not affected.

4.   Information which has not been submitted within the deadline set by EFSA shall not be taken into account in the re-evaluation. However, in exceptional cases, EFSA may decide with the agreement of the Commission to take into account information submitted after the deadline, if that information is significant for the re-evaluation of a food additive.

5.   Where the requested information has not been submitted to EFSA within the set deadlines, the food additive may be removed from the Union list in accordance with the procedure laid down in Article 10.3 of Regulation (EC) No 1333/2008 (10).

Article 7

Other information

In the framework of the re-evaluation of a food additive, the interested business operator(s) or any other interested party shall inform EFSA and the Commission of any information available in relation to any environment risks from the production, use or waste of that food additive.

Article 8

Confidentiality

1.   Confidential treatment may be given to information the disclosure of which might significantly harm the competitive position of business operators or other interested parties.

2.   Information relating to the following shall not, in any circumstances, be regarded as confidential:

(a)	the name and address of the interested business operator;

(b)	the chemical name and a clear description of the substance;

(c)	information for the use of the substance in or on specific foodstuffs or food categories;

(d)	information that is relevant to the assessment of the safety of the substance;

(e)	the method(s) of analysis in food.

3.   For the purposes of paragraph 1, the interested business operator(s) and the other interested parties shall indicate which of the information provided they wish to be treated as confidential. Verifiable justification shall be given in such cases.

4.   On a proposal from EFSA, the Commission shall decide after consulting the interested business operator and/or the other interested parties which information may remain confidential and shall notify the EFSA and the Member States accordingly.

5.   The Commission, EFSA and the Member States shall, in accordance with Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (11), take the necessary measures to ensure appropriate confidentiality of the information received under this Regulation, except for information which must be made public if circumstances so require in order to protect human health, animal health or the environment.

6.   The implementation of paragraphs 1 to 5 shall not affect the circulation of information between the Commission, EFSA and the Member States.

Article 9

Monitoring progress

Every year in December, EFSA shall inform the Commission and the Member States on the progress of the re-evaluation programme.

Article 10

Entry into force

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

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(1)  OJ L 354, 31.12.2008, p. 16.

(2)  COM(2007) 418 final.

(3)  COM(2001) 542 final.

(4)  Food Additives in Europe 2000, Status of safety assessments of food additives presently permitted in the EU, Nordic Council of Ministers, TemaNord 2002:560.

(5)  Guidance on submissions for food additive evaluations by the Scientific Committee on Food. Opinion expressed on 11 July 2001. SCF/CS/ADD/GEN/26 final.

(6)  OJ L 237, 10.9.1994, p. 3.

(7)  OJ L 237, 10.9.1994, p. 13.

(8)  OJ L 61, 18.3.1995, p. 1.

(9)  Currently the Opinion expressed by the SCF on 11 July 2001. SCF/CS/ADD/GEN/26 Final.

(10)  OJ L 354, 31.12.2008, p. 16.

(11)  OJ L 145, 31.5.2001, p. 43.

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26.3.2010

EN

Official Journal of the European Union

L 80/28

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COMMISSION REGULATION (EU) No 258/2010

of 25 March 2010

imposing special conditions on the imports of guar gum originating in or consigned from India due to contamination risks by pentachlorophenol and dioxins, and repealing Decision 2008/352/EC

(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 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (1), and in particular Article 53(1)(b)(ii) thereof,

Whereas:

(1)

Article 53(1) of Regulation (EC) No 178/2002 provides for the possibility to adopt appropriate emergency measures for food and feed imported from a third country in order to protect public health, animal health or the environment, where the risk cannot be contained satisfactorily by means of measures taken by the Member States individually.

(2)

In July 2007, high levels of pentachlorophenol (PCP) and dioxins have been found in the EU in certain batches of guar gum originating in or consigned from India. Such contamination constitutes a threat to public health within the European Union if no measures are taken to avoid the presence of pentachlorophenol and dioxins in guar gum.

(3)

In response to this finding of elevated levels of PCP and dioxins, the Food and Veterinary Office of the European Commission (FVO) carried out an urgent inspection visit to India in October 2007. The objective was to gather information on the possible source of the contamination and to assess the control measures put in place by the Indian authorities to avoid the re-occurrence of this contamination. The inspection team concluded that there was insufficient evidence of the cause of the contamination incident, and the investigation carried out by the Indian authorities was inadequate to provide any conclusions. With availability of sodium pentachlorophenolate and its use in the guar gum industry, and with a largely self regulated industry, there were inadequate controls in place to ensure that this contamination does not occur again.

(4)

Therefore, Commission Decision 2008/352/EC of 29 April 2008 imposing special conditions governing guar gum originating in or consigned from India due to contamination risks of those products by pentachlorophenol and dioxins (2) provides that each consignment of guar gum and compound feedingstuffs and foodstuffs containing at least 10 % guar gum originating in or consigned from India, has to be accompanied by an original analytical report, endorsed by a representative of the competent authority from the country where the laboratory is located, demonstrating that the product does not contain more than 0,01 mg/kg PCP. The competent authorities in the Member States have to sample and analyse consignments of these products with a frequency of 5 % in order to verify that the level of 0,01 mg/kg PCP is not exceeded. The Community Reference Laboratory for Dioxins and PCBs in Feed and Food has carried out a study on the correlation between PCP and dioxins in contaminated guar gum from India. From this study it can be concluded that guar gum containing a level of PCP below the level of 0,01 mg/kg does not contain unacceptable levels of dioxins.

(5)	A follow-up inspection mission of the FVO took place in October 2009 to assess the control measures put in place by the Indian authorities to prevent contamination of guar gum with PCP and dioxins and to follow-up the recommendations of the mission that took place in October 2007.

(6)

Several serious deficiencies were observed during that inspection mission. The status of PCP in industrial use in India is not clear and at the time of the mission no evidence of any action being taken to stop its production or sale was presented. Samples are taken by the exporting private company without any official supervision. Non-conformities found by the laboratory at a frequency of about 2,5 % of samples analysed are notified to the exporting company without notifying the competent authority. As there was no knowledge on the part of the competent authority of these non-compliances, no action was taken regarding the non-conforming lots.

(7)

The findings indicate that the contamination of guar gum with PCP and/or dioxins cannot be regarded as an isolated incident and that only the effective analysis by the approved private laboratory has prevented contaminated product being further exported to the European Union. Taking into account that there has been no improvement in the control system additional measures should be taken in order to reduce possible risks.

(8)	Given that it cannot be excluded that guar gum originating in India is exported to the EU via another third country, it is appropriate to foresee random controls on the presence of PCP in guar gum consigned from countries other than India.

(9)	Therefore, Decision 2008/352/EC should be amended accordingly. However, taking into account the nature of the amending provisions, which have a direct application and are binding in their entirety, it is appropriate to replace that Decision with a Regulation.

(10)	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

Scope

This Regulation shall apply to:

(a)	guar gum, falling within CN code 1302 32 90, originating in or consigned from India, and intended for animal or human consumption;

(b)	feed and food containing at least 10 % guar gum originating in or consigned from India.

Article 2

Certification

1.   Each consignment of the products referred to in Article 1 presented for import shall be accompanied by:

(a)	a health certificate, provided in the Annex, certifying that the product imported does not contain more than 0,01 mg/kg pentachlorophenol (PCP) and

(b)

an analytical report, issued by a laboratory accredited according to EN ISO/IEC 17025 for the analysis of PCP in feed and food, indicating the results of sampling and analysis for the presence of PCP, the measurement uncertainty of the analytical result, as well as the limit of detection (LOD) and the limit of quantification (LOQ) of the analytical method.

2.   The certificate accompanied by an analytical report shall be signed by an authorised representative of the Ministry of Commerce and Industry of India and the validity of the certificate shall not exceed 4 months from the date of its issue.

3.   The analysis referred to in paragraph 1(b) must be performed on a sample, taken by the competent Indian authorities from the consignment in accordance with the provisions of Commission Directive 2002/63/EC of 11 July 2002 establishing Community methods of sampling for the official control of pesticide residues in and on products of plant and animal origin and repealing Directive 79/700/EEC (3). The extraction before analysis shall be performed with an acidified solvent. The analysis shall be carried out according to the modified version of the QuEChERS method as set out on the website of the Community Reference Laboratories for Residues of Pesticides (4) or according to an equally reliable method.

Article 3

Identification

Each consignment of the products referred to in Article 1 shall be identified by means of a code which shall be indicated on the health certificate, on the analytical report containing the results of sampling and analysis, and on any commercial documents accompanying the consignment. Each individual bag or other packaging form of the consignment shall be identified with that code.

Article 4

Prior notification

Feed and food business operators or their representatives shall give prior notification to the control point referred to in Article 5(4) of the estimated date and time of arrival of all consignments of products referred to in Article 1.

Article 5

Official controls

1.   The competent authorities of the Member States shall carry out documentary, identity and physical checks, including laboratory analysis on the consignments of products referred to in Article 1.

2.   Identity and physical checks, including sampling and analysis to control the presence of PCP, shall be carried out on at least 5 % of the consignments.

3.   Consignments shall be kept under official control for a maximum of 15 working days pending the availability of the results of the laboratory analysis.

4.   The checks referred to in paragraph 1 shall be carried out at control points specifically designated by the Member States for that purpose.

5.   Member States shall make the list of control points available to the public and communicate it to the Commission.

6.   The competent authorities of the Member States shall also perform at random physical checks, including sampling and analysis to control the presence of PCP on guar gum consigned from countries other than India.

Article 6

Splitting of a consignment

Consignments shall not be split until all official controls have been completed. If a consignment is split, a certified copy of the health certificate provided for in Article 2(1)(a), shall accompany each part of the split consignment until its release into free circulation.

Article 7

Costs

All costs resulting from the official controls referred to in Article 5(1), including sampling, analysis, storage and any measures taken following non-compliance, shall be borne by the feed and food business operator.

Article 8

Release into free circulation

The release into free circulation of consignments shall be subject to the presentation by the feed and food business operator or their representative to the custom authorities of the evidence that:

(a)	the official controls referred to in Article 5(1) have been carried out and

(b)	the results from physical checks, where such checks were required, have been favourable.

Article 9

Non-compliant products

Any product found to contain more than 0,01 mg/kg PCP, taking into account the expanded measurement uncertainty, following controls performed in accordance with Article 5, shall not enter the feed and food chain. The non-compliant products shall be safely disposed of, in accordance with the provisions of Article 19 of 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 (5).

Article 10

Reports

Member States shall inform the Commission through the Rapid Alert System for Food and Feed (RASFF) of all consignments which are found to contain PCP above 0,01 mg/kg taking into account the expanded measurement uncertainty.

Member States shall submit to the Commission every three months a report on all analytical results of the controls referred to in Article 5(1). Those reports shall be submitted during the month following each quarter.

Article 11

Repeal

Commission Decision 2008/352/EC is repealed.

References to the repealed Decision shall be construed as references to this Regulation.

Article 12

Transitional provisions

By way of derogation from Article 2(1), Member States shall authorise the imports of consignments of products referred to in Article 1 which left the country of origin before 1 April 2010 accompanied by an analytical report as provided for by Decision 2008/352/EC.

Article 13

Entry into force

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

It shall apply from the date of entry into force.

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(1)  OJ L 31, 1.2.2002, p. 1.

(2)  OJ L 117, 1.5.2008, p. 42.

(3)  OJ L 187, 16.7.2002, p. 30.

(4)  http://www.crl-pesticides.eu/library/docs/srm/QuechersForGuarGum.pdf

(5)  OJ L 191, 28.5.2004, p. 1.

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26.3.2010

EN

Official Journal of the European Union

L 80/32

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COMMISSION REGULATION (EU) No 259/2010

of 25 March 2010

entering a name in the register of protected designations of origin and protected geographical indications (Colline Pontine (PDO))

THE EUROPEAN COMMISSION,

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

Having regard to 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 (1), and in particular the first subparagraph of Article 7(4) thereof,

Whereas:

(1)	Pursuant to the first subparagraph of Article 6(2) and in accordance with Article 17(2) of Regulation (EC) No 510/2006, Italy’s application to register the name ‘Colline Pontine’ was published in the Official Journal of the European Union  (2).

(2)	As no statement of objection under Article 7 of Regulation (EC) No 510/2006 has been received by the Commission, that name should therefore be entered in the register,

HAS ADOPTED THIS REGULATION:

Article 1

The name contained in the Annex to this Regulation is hereby entered in the register.

Article 2

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

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(1)  OJ L 93, 31.3.2006, p. 12.

(2)  OJ C 197, 21.8.2009, p. 14.

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26.3.2010

EN

Official Journal of the European Union

L 80/34

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COMMISSION REGULATION (EU) No 260/2010

of 25 March 2010

entering a name in the register of protected designations of origin and protected geographical indications (Chirimoya de la Costa tropical de Granada-Málaga (PDO))

THE EUROPEAN COMMISSION,

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

Having regard to 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 (1), and in particular the first subparagraph of Article 7(4) thereof,

Whereas:

(1)	Pursuant to the first subparagraph of Article 6(2) and in accordance with Article 17(2) of Regulation (EC) No 510/2006, Spain’s application to register the name ‘Chirimoya de la Costa tropical de Granada-Málaga’ was published in the Official Journal of the European Union  (2).

(2)	As no statement of objection pursuant to Article 7 of Regulation (EC) No 510/2006 has been received by the Commission, that name should therefore be entered in the register,

HAS ADOPTED THIS REGULATION:

Article 1

The name contained in the Annex to this Regulation is hereby entered in the register.

Article 2

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

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(1)  OJ L 93, 31.3.2006, p. 12.

(2)  OJ C 197, 21.8.2009, p. 10.

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26.3.2010

EN

Official Journal of the European Union

L 80/36

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COMMISSION REGULATION (EU) No 261/2010

of 25 March 2010

amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products (1), and in particular Article 12 thereof,

Whereas:

(1)

According to Article 67(3) of 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 (2), the revenue of the European Medicines Agency (hereinafter the Agency) consists of a contribution from the Union and fees paid by undertakings to the Agency. Regulation (EC) No 297/95 lays down the categories and levels of such fees.

(2)	Article 12 of Regulation (EC) No 297/95 requires that the fees of the Agency be updated each year by reference to the inflation rate.

(3)	Those fees should therefore be updated by reference to the inflation rate of 2009. The inflation rate in the Union, as published by the Statistical Office of the European Union (Eurostat), was 1 % in 2009.

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

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

(6)	For reasons of legal certainty, this Regulation should not apply to valid applications which are pending on 1 April 2010.

(7)	Pursuant to Article 12 of Regulation (EC) No 297/95, the update has to be made with effect from 1 April 2010. It is therefore appropriate that this Regulation enters into force as a matter of urgency and applies from that date,

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EC) No 297/95 is amended as follows:

1.

Article 3 is amended as follows: (a) Paragraph 1 is amended as follows: (i) point (a) is amended as follows: — in the first subparagraph, ‘EUR 251 600’ is replaced by ‘EUR 254 100’, — in the second subparagraph, ‘EUR 25 200’ is replaced by ‘EUR 25 500’, — in the third subparagraph, ‘EUR 6 300’ is replaced by ‘EUR 6 400’, (ii) point (b) is amended as follows: — in the first subparagraph, ‘EUR 97 600’ is replaced by ‘EUR 98 600’, — in the second subparagraph, ‘EUR 162 600’ is replaced by ‘EUR 164 200’, — in the third subparagraph, ‘EUR 9 700’ is replaced by ‘EUR 9 800’, — in the fourth subparagraph, ‘EUR 6 300’ is replaced by ‘EUR 6 400’, (iii) point (c) is amended as follows: — in the first subparagraph, ‘EUR 75 500’ is replaced by ‘EUR 76 300’, — in the second subparagraph, ‘EUR 18 900 to EUR 56 600’ is replaced by ‘EUR 19 100 to EUR 57 200’, — in the third subparagraph, ‘EUR 6 300’ is replaced by ‘EUR 6 400’, (b) Paragraph 2 is amended as follows: (i) the first subparagraph of point (a) is amended as follows: — ‘EUR 6 300’ is replaced by ‘EUR 6 400’, (ii) point (b) is amended as follows: — in the first subparagraph, ‘EUR 75 500’ is replaced by ‘EUR 76 300’, — in the second subparagraph, ‘EUR 18 900 to EUR 56 600’ is replaced by ‘EUR 19 100 to EUR 57 200’, (c) In paragraph 3, ‘EUR 12 500’ is replaced by ‘EUR 12 600’. (d) In paragraph 4, ‘EUR 18 900’ is replaced by ‘EUR 19 100’. (e) In paragraph 5, ‘EUR 6 300’ is replaced by ‘EUR 6 400’. (f) Paragraph 6 is amended as follows: (i) in the first subparagraph, ‘EUR 90 200’ is replaced by ‘EUR 91 100’; (ii) in the second subparagraph, ‘EUR 22 500 to EUR 67 600’ is replaced by ‘EUR 22 700 to EUR 68 300’.

2.	In Article 4, ‘EUR 62 800’ is replaced by ‘EUR 63 400’.

3.

Article 5 is amended as follows: (a) Paragraph 1 is amended as follows: (i) point (a) is amended as follows: — in the first subparagraph, ‘EUR 125 800’ is replaced by ‘EUR 127 100’, — in the second subparagraph, ‘EUR 12 500’ is replaced by ‘EUR 12 600’, — in the third subparagraph, ‘EUR 6 300’ is replaced by ‘EUR 6 400’, — the fourth subparagraph is amended as follows: — ‘EUR 62 800’ is replaced by ‘EUR 63 400’, — ‘EUR 6 300’ is replaced by ‘EUR 6 400’, (ii) point (b) is amended as follows: — in the first subparagraph, ‘EUR 62 800’ is replaced by ‘EUR 63 400’, — in the second subparagraph, ‘EUR 106 300’ is replaced by ‘EUR 107 400’, — in the third subparagraph, ‘EUR 12 500’ is replaced by ‘EUR 12 600’, — in the fourth subparagraph, ‘EUR 6 300’ is replaced by ‘EUR 6 400’, — the fifth subparagraph is amended as follows: — ‘EUR 31 400’ is replaced by ‘EUR 31 700’, — ‘EUR 6 300’ is replaced by ‘EUR 6 400’, (iii) point (c) is amended as follows: — in the first subparagraph, ‘EUR 31 400’ is replaced by ‘EUR 31 700’, — in the second subparagraph, ‘EUR 7 800 to EUR 23 500’ is replaced by ‘EUR 7 900 to EUR 23 700’, — in the third subparagraph, ‘EUR 6 300’ is replaced by ‘EUR 6 400’, (b) Paragraph 2 is amended as follows: (i) in point (a), ‘EUR 6 300’ is replaced by ‘EUR 6 400’; (ii) point (b) is amended as follows: — in the first subparagraph, ‘EUR 37 700’ is replaced by ‘EUR 38 100’, — in the second subparagraph, ‘EUR 9 400 to EUR 28 300’ is replaced by ‘EUR 9 500 to EUR 28 600’, — in the third subparagraph, ‘EUR 6 300’ is replaced by ‘EUR 6 400’, (c) In paragraph 3, ‘EUR 6 300’ is replaced by ‘EUR 6 400’. (d) In paragraph 4, ‘EUR 18 900’ is replaced by ‘EUR 19 100’. (e) In paragraph 5, ‘EUR 6 300’ is replaced by ‘EUR 6 400’. (f) Paragraph 6 is amended as follows: (i) in the first subparagraph, ‘EUR 30 100’ is replaced by ‘EUR 30 400’; (ii) in the second subparagraph, ‘EUR 7 500 to EUR 22 500’ is replaced by ‘EUR 7 600 to EUR 22 700’.

4.	In Article 6, ‘EUR 37 700’ is replaced by ‘EUR 38 100’.

5.	Article 7 is amended as follows: (a) in the first paragraph, ‘EUR 62 800’ is replaced by ‘EUR 63 400’; (b) in the second paragraph, ‘EUR 18 900’ is replaced by ‘EUR 19 100’.

6.

Article 8 is amended as follows: (a) Paragraph 1 is amended as follows: (i) in the second subparagraph, ‘EUR 75 500’ is replaced by ‘EUR 76 300’; (ii) in the third subparagraph, ‘EUR 37 700’ is replaced by ‘EUR 38 100’; (iii) in the fourth subparagraph, ‘EUR 18 900 to EUR 56 600’ is replaced by ‘EUR 19 100 to EUR 57 200’; (iv) in the fifth subparagraph, ‘EUR 9 400 to EUR 28 300’ is replaced by ‘EUR 9 500 to EUR 28 600’. (b) Paragraph 2 is amended as follows: (i) in the second subparagraph, ‘EUR 251 600’ is replaced by ‘EUR 254 100’; (ii) in the third subparagraph, ‘EUR 125 800’ is replaced by ‘EUR 127 100’; (iii) in the fifth subparagraph, ‘EUR 2 700 to EUR 216 800’ is replaced by ‘EUR 2 700 to EUR 219 000’; (iv) in the sixth subparagraph, ‘EUR 108 500’ is replaced by ‘EUR 109 600’. (c) In paragraph 3, ‘EUR 6 300’ is replaced by ‘EUR 6 400’.

Article 2

This Regulation shall not apply to valid applications pending on 1 April 2010.

Article 3

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

It shall apply from 1 April 2010.

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(1)  OJ L 35, 15.2.1995, p. 1.

(2)  OJ L 136, 30.4.2004, p. 1.

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26.3.2010

EN

Official Journal of the European Union

L 80/40

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COMMISSION REGULATION (EU) No 262/2010

of 24 March 2010

amending for the 122nd time Council Regulation (EC) No 881/2002 imposing certain specific restrictive measures directed against certain persons and entities associated with Usama bin Laden, the Al-Qaida network and the Taliban

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 881/2002 of 27 May 2002 imposing certain specific restrictive measures directed against certain persons and entities associated with Usama bin Laden, the Al-Qaida network and the Taliban, and repealing Council Regulation (EC) No 467/2001 prohibiting the export of certain goods and services to Afghanistan, strengthening the flight ban and extending the freeze of funds and other financial resources in respect of the Taliban of Afghanistan, (1) and in particular Article 7(1)(a) and 7a(1) (2) thereof,

Whereas:

(1)	Annex I to Regulation (EC) No 881/2002 lists the persons, groups and entities covered by the freezing of funds and economic resources under that Regulation.

(2)

On 10 March 2010 the Sanctions Committee of the United Nations Security Council decided to remove one natural person and two legal persons or entities from its list of persons, groups and entities to whom the freezing of funds and economic resources should apply (the list). On 11 March 2010, it decided to add two natural persons to the list and to amend identifying data concerning six natural persons and one legal person or entity on the list.

(3)	Annex I to Regulation (EC) No 881/2002 should therefore be updated accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

Annex I to Regulation (EC) No 881/2002 is hereby amended as set out in 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.

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(1)  OJ L 139, 29.5.2002, p. 9.

(2)  Article 7a was inserted by Regulation (EU) No 1286/2009 (OJ L 346, 23.12.2009, p. 42).

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26.3.2010

EN

Official Journal of the European Union

L 80/44

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COMMISSION REGULATION (EU) No 263/2010

of 25 March 2010

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 Regulation (EC) No 1580/2007 of 21 December 2007 laying down implementing rules for Council Regulations (EC) No 2200/96, (EC) No 2201/96 and (EC) No 1182/2007 in the fruit and vegetable sector (2), and in particular Article 138(1) thereof,

Whereas:

Regulation (EC) No 1580/2007 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 XV, Part A thereto,

HAS ADOPTED THIS REGULATION:

Article 1

The standard import values referred to in Article 138 of Regulation (EC) No 1580/2007 are fixed in the Annex hereto.

Article 2

This Regulation shall enter into force on 26 March 2010.

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(1)  OJ L 299, 16.11.2007, p. 1.

(2)  OJ L 350, 31.12.2007, p. 1.

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26.3.2010

EN

Official Journal of the European Union

L 80/46

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COMMISSION REGULATION (EU) No 264/2010

of 25 March 2010

amending the representative prices and additional import duties for certain products in the sugar sector fixed by Regulation (EC) No 877/2009 for the 2009/10 marketing year

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 951/2006 of 30 June 2006 laying down detailed rules for the implementation of Council Regulation (EC) No 318/2006 as regards trade with third countries in the sugar sector (2), and in particular Article 36(2), second subparagraph, second sentence thereof,

Whereas:

(1)	The representative prices and additional duties applicable to imports of white sugar, raw sugar and certain syrups for the 2009/10 marketing year are fixed by Commission Regulation (EC) No 877/2009 (3). These prices and duties have been last amended by Commission Regulation (EU) No 253/2010 (4).

(2)	The data currently available to the Commission indicate that those amounts should be amended in accordance with the rules and procedures laid down in Regulation (EC) No 951/2006,

HAS ADOPTED THIS REGULATION:

Article 1

The representative prices and additional duties applicable to imports of the products referred to in Article 36 of Regulation (EC) No 951/2006, as fixed by Regulation (EC) No 877/2009 for the 2009/10, marketing year, are hereby amended as set out in the Annex hereto.

Article 2

This Regulation shall enter into force on 26 March 2010.

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(1)  OJ L 299, 16.11.2007, p. 1.

(2)  OJ L 178, 1.7.2006, p. 24.

(3)  OJ L 253, 25.9.2009, p. 3.

(4)  OJ L 79, 25.3.2010, p. 11.

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26.3.2010

EN

Official Journal of the European Union

L 80/48

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COUNCIL DECISION 2010/179/CFSP

of 11 March 2010

in support of SEESAC arms control activities in the Western Balkans, in the framework of the EU Strategy to combat the illicit accumulation and trafficking of SALW and their ammunition

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on European Union, and in particular Article 26(2) thereof,

Whereas:

(1)	The excessive and uncontrolled accumulation and spread of small arms and light weapons (SALW) has fuelled insecurity in south-eastern Europe, exacerbating conflict in the region and undermining post-conflict peace building, thus posing a serious threat to peace and security in the region.

(2)	On 15-16 December 2005, the European Council adopted the EU Strategy to combat the illicit accumulation and trafficking of SALW and their ammunition (EU SALW Strategy) which sets the guidelines for EU action in the field of SALW.

(3)

The EU SALW Strategy identifies among its objectives the fostering of effective multilateralism so as to forge mechanisms, whether international, regional or within the EU and its Member States, for countering the supply and destabilising the spread of SALW and their ammunition. The EU SALW Strategy also identifies the Western Balkans as one of the regions most affected by the illicit trade and excessive accumulation of weapons.

(4)

Under the auspices of the United Nations Development Programme (UNDP) and the former Stability Pact for South-Eastern Europe (since 2008 known as Regional Cooperation Council), a ‘South-Eastern and Eastern Europe Clearinghouse for the Control of Small Arms and Light Weapons’ (SEESAC) has been established. SEESAC is located in Belgrade, and consists of a technical support unit, which supports a number of regional and national level operational activities.

(5)	The objectives pursued by SEESAC include preventing the proliferation and excessive accumulation of SALW and their ammunition throughout south-east Europe. SEESAC places particular emphasis on the development of regional projects to address the reality of cross-border flows of weapons.

(6)

The EU previously supported SEESAC by Council Decision 2002/842/CFSP of 21 October 2002, implementing Joint Action 2002/589/CFSP, extended and amended by Council Decisions 2003/807/CFSP of 17 November 2003 and 2004/791/CFSP of 22 November 2004. The implementation of these Decisions has been positively assessed by the Council,

HAS ADOPTED THIS DECISION:

Article 1

1.   The EU shall pursue the promotion of peace and security in the Western Balkans by supporting effective multilateralism and for relevant regional initiatives aiming at reducing the risk posed to peace and security by the proliferation and excessive accumulation of SALW and their ammunition.

2.   In order to achieve the objective referred to in paragraph 1, the EU will support a SEESAC project which aims to reduce the threat posed by SALW to security in the Western Balkans. The activities to be supported by the EU shall have the following specific objectives:

—	to improve the management and security of unsafe and unstable stockpiles of weapons and ammunition,

—	to reduce the available stockpiles of weapons and ammunition through destruction activities,

—	to enhance controls on SALW, including through the implementation of international and national instruments on marking and tracing in the Western Balkans countries and improvement of the weapons registration process. A detailed description of the project is set out in the Annex.

Article 2

1.   The High Representative of the Union for Foreign Affairs and Security Policy (HR), shall be responsible for the implementation of this Decision.

2.   The technical implementation of the project referred to in Article 1(2) shall be carried out by SEESAC. It shall perform its task under the responsibility of the HR. For this purpose, the HR shall enter into the necessary arrangements with SEESAC.

Article 3

1.   The financial reference amount for the implementation of the project referred to in Article 1(2) shall be EUR 1 600 000.

2.   The expenditure financed by the amount set out in paragraph 1 shall be managed in accordance with the procedures and rules applicable to the general budget of the European Union.

3.   The Commission shall supervise the proper management of the expenditure referred to in paragraph 1. For this purpose, it shall conclude a financing agreement with UNDP, acting on behalf of SEESAC. The agreement shall stipulate that SEESAC is to ensure the visibility of the EU contribution, appropriate to its size.

4.   The Commission shall endeavour to conclude the financing agreement referred to in paragraph 3 as soon as possible after the entry into force of this Decision. It shall inform the Council of any difficulties in that process and of the date of conclusion of the financing agreement.

Article 4

The HR shall report to the Council on the implementation of this Decision on the basis of regular reports prepared by SEESAC. These reports shall form the basis for the evaluation carried out by the Council. The Commission shall report on the financial aspects of the implementation of the project.

Article 5

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

2.   This Decision shall expire 24 months after the date of conclusion of the financing agreement referred to in Article 3(3), or six months after the date of its adoption if no financing agreement has been concluded within that period.

Article 6

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

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26.3.2010

EN

Official Journal of the European Union

L 80/52

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COMMISSION DECISION

of 25 March 2010

on amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products

(notified under document C(2010) 1867)

(Text with EEA relevance)

(2010/180/EU)

THE EUROPEAN COMMISSION,

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

Having regard to 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 (1), and in particular Article 16f thereof,

Having regard to the opinion of the European Medicines Agency, formulated on 6 November 2008 by the Committee for Herbal Medicinal Products,

Whereas:

(1)	Mentha x piperita L. can be considered as a herbal substance, a herbal preparation or a combination thereof within the meaning of Directive 2001/83/EC and complies with the requirements set out in that Directive.

(2)	It is therefore appropriate to include Mentha x piperita L. in the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products established by Commission Decision 2008/911/EC (2).

(3)	In order to avoid duplications and possible contradictions between the Annexes and Articles 1 and 2 of Decision 2008/911/EC, it is appropriate to remove the references to single substances in those Articles.

(4)	Decision 2008/911/EC should therefore be amended accordingly.

(5)	The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Medicinal Products for Human Use,

HAS ADOPTED THIS DECISION:

Article 1

Decision 2008/911/EC is amended as follows:

1.

Articles 1 and 2 are replaced by the following: ‘Article 1 A list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products is established in Annex I. Article 2 The indications, the specified strengths and the posology, the route of administration and any other information necessary for the safe use of the herbal substance as a traditional medicinal product relevant for the herbal substances listed in Annex I are set out in Annex II.’.

2.	Annexes I and II are amended in accordance with the Annex to this Decision.

Article 2

This Decision is addressed to the Member States.

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(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 328, 6.12.2008, p. 42.

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