ISSN 1977-0677 |
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Official Journal of the European Union |
L 147 |
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English edition |
Legislation |
Volume 57 |
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(1) Text with EEA relevance |
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
REGULATIONS
17.5.2014 |
EN |
Official Journal of the European Union |
L 147/1 |
COMMISSION DELEGATED REGULATION (EU) No 518/2014
of 5 March 2014
amending Commission Delegated Regulations (EU) No 1059/2010, (EU) No 1060/2010, (EU) No 1061/2010, (EU) No 1062/2010, (EU) No 626/2011, (EU) No 392/2012, (EU) No 874/2012, (EU) No 665/2013, (EU) No 811/2013 and (EU) No 812/2013 with regard to labelling of energy-related products on the internet
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2010/30/EU of the European Parliament and of the Council of 19 May 2010 on the indication by labelling and standard product information of the consumption of energy and other resources by energy-related products (1), and in particular Articles 7 and 10 thereof,
Whereas:
(1) |
Directive 2010/30/EU requires the Commission to lay down details relating to the labelling of energy-related products by means of delegated acts which contain measures that ensure that potential end-users are provided with the information specified on the label and in the product fiche in case of distance selling, including mail order, by catalogue, telemarketing or through the internet. |
(2) |
Currently, it is specified that in the case of distance selling the information on the label is to be presented in a specific order. However, there is currently no requirement to display the label itself or the product fiche. Therefore, the ability of end-users to make better informed decisions about their purchases is affected in the case of distance selling because they are neither guided by the colour scale of the label, nor are they informed as to which energy labelling class is the best for the product group or provided with the additional information which is contained in the fiche. |
(3) |
Distance selling through the internet is increasingly becoming a significant share of the sales of energy-related products. When selling through the internet, it is possible to display the label and the fiche without involving an additional administrative burden. Therefore, dealers should display the label and fiche when selling through the internet. |
(4) |
For the label and fiche to be displayed on the internet, suppliers should for each model of an energy-related product provide dealers with an electronic version of the label and the fiche, e.g. through making them available on a website where they can be downloaded by dealers. |
(5) |
In order to implement the requirements of this Regulation as part of normal business cycles, suppliers should be obliged to make the label and fiche available electronically only for new models, including upgrades of existing models, which in practical terms means those with a new model identifier. For existing models supply of an electronic label and fiche should be on a voluntary basis. |
(6) |
Since displaying the label and the fiche next to the product may require more screen space, it should be allowed to have them displayed using a nested display. |
(7) |
Commission Delegated Regulations (EU) No 1059/2010 (2), (EU) No 1060/2010 (3), (EU) No 1061/2010 (4), (EU) No 1062/2010 (5), (EU) No 626/2011 (6), (EU) No 392/2012 (7), (EU) No 874/2012 (8), (EU) No 665/2013 (9), (EU) No 811/2013 (10), and (EU) No 812/2013 (11) should therefore be amended accordingly, |
HAS ADOPTED THIS REGULATION:
Article 1
Amendments to Delegated Regulation (EU) No 1059/2010
Delegated Regulation (EU) No 1059/2010 is amended as follows:
(1) |
Article 3 is amended as follows:
|
(2) |
in Article 4, point (b) is replaced by the following:
|
(3) |
a new Annex VIII is added in accordance with Annex I to this Regulation. |
Article 2
Amendments to Delegated Regulation (EU) No 1060/2010
Delegated Regulation (EU) No 1060/2010 is amended as follows:
(1) |
Article 3 is amended as follows:
|
(2) |
in Article 4, point (b) is replaced by the following:
|
(3) |
a new Annex X is added in accordance with Annex II to this Regulation. |
Article 3
Amendments to Delegated Regulation (EU) No 1061/2010
Delegated Regulation (EU) No 1061/2010 is amended as follows:
(1) |
Article 3 is amended as follows:
|
(2) |
in Article 4, point (b) is replaced by the following:
|
(3) |
a new Annex VIII is added in accordance with Annex III to this Regulation. |
Article 4
Amendments to Delegated Regulation (EU) No 1062/2010
Delegated Regulation (EU) No 1062/2010 is amended as follows:
(1) |
Article 3 is amended as follows:
|
(2) |
in Article 4, point (b) is replaced by the following:
|
(3) |
a new Annex IX is added in accordance with Annex IV to this Regulation. |
Article 5
Amendments to Delegated Regulation (EU) No 626/2011
Delegated Regulation (EU) No 626/2011 is amended as follows:
(1) |
Article 3 is amended as follows:
|
(2) |
in Article 4, point (b) is replaced by the following:
|
(3) |
a new Annex IX is added in accordance with Annex V to this Regulation. |
Article 6
Amendments to Delegated Regulation (EU) No 392/2012
Delegated Regulation (EU) No 392/2012 is amended as follows:
(1) |
Article 3 is amended as follows:
|
(2) |
in Article 4, point (b) is replaced by the following:
|
(3) |
a new Annex VIII is added in accordance with Annex VI to this Regulation. |
Article 7
Amendments to Delegated Regulation (EU) No 874/2012
Delegated Regulation (EU) No 874/2012 is amended as follows:
(1) |
Article 3 is amended as follows:
|
(2) |
Article 4 is amended as follows:
|
(3) |
a new Annex VIII is added in accordance with Annex VII to this Regulation. |
Article 8
Amendments to Delegated Regulation (EU) No 665/2013
Delegated Regulation (EU) No 665/2013 is amended as follows:
(1) |
Article 3 is amended as follows:
|
(2) |
in Article 4, point (b) is replaced by the following:
|
(3) |
a new Annex VIII is added in accordance with Annex VIII to this Regulation. |
Article 9
Amendments to Delegated Regulation (EU) No 811/2013
Delegated Regulation (EU) No 811/2013 is amended as follows:
(1) |
Article 3 is amended as follows:
|
(2) |
Article 4 is amended as follows:
|
(3) |
Annex VI is amended in accordance with Annex IX to this Regulation; |
(4) |
a new Annex IX is added in accordance with Annex IX to this Regulation. |
Article 10
Amendments to Delegated Regulation (EU) No 812/2013
Delegated Regulation (EU) No 812/2013 is amended as follows:
(1) |
Article 3 is amended as follows:
|
(2) |
Article 4 is amended as follows:
|
(3) |
Annex VI is amended in accordance with Annex X to this Regulation; |
(4) |
A new Annex X is added in accordance with Annex X to this Regulation. |
Article 11
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 5 March 2014.
For the Commission
The President
José Manuel BARROSO
(1) OJ L 153, 18.6.2010, p. 1.
(2) Commission Delegated Regulations (EU) No 1059/2010 of 28 September 2010 supplementing Directive 2010/30/EU of the European Parliament and of the Council with regard to energy labelling of household dishwashers (OJ L 314, 30.11.2010, p. 1).
(3) Commission Delegated Regulation (EU) No 1060/2010 of 28 September 2010 supplementing Directive 2010/30/EU of the European Parliament and of the Council with regard to energy labelling of household refrigerating appliances (OJ L 314, 30.11.2010, p. 17).
(4) Commission Delegated Regulation (EU) No 1061/2010 of 28 September 2010 supplementing Directive 2010/30/EU of the European Parliament and of the Council with regard to energy labelling of household washing machines (OJ L 314, 30.11.2010, p. 47).
(5) Commission Delegated Regulation (EU) No 1062/2010 of 28 September 2010 supplementing Directive 2010/30/EU of the European Parliament and of the Council with regard to energy labelling of televisions (OJ L 314, 30.11.2010, p. 64).
(6) Commission Delegated Regulation (EU) No 626/2011 of 4 May 2011 supplementing Directive 2010/30/EU of the European Parliament and of the Council with regard to energy labelling of air conditioners (OJ L 178, 6.7.2011, p. 1).
(7) Commission Delegated Regulation (EU) No 392/2012 of 1 March 2012 supplementing Directive 2010/30/EU of the European Parliament and of the Council with regard to energy labelling of household tumble driers (OJ L 123, 9.5.2012, p. 1).
(8) Commission Delegated Regulation (EU) No 874/2012 of 12 July 2012 supplementing Directive 2010/30/EU of the European Parliament and of the Council with regard to energy labelling of electrical lamps and luminaires (OJ L 258, 26.9.2012, p. 1).
(9) Commission Delegated Regulation (EU) No 665/2013 of 3 May 2013 supplementing Directive 2010/30/EU of the European Parliament and of the Council with regard to energy labelling of vacuum cleaners (OJ L 192, 13.7.2013, p. 1).
(10) Commission Delegated Regulation (EU) No 811/2013 of 18 February 2013 supplementing Directive 2010/30/EU of the European Parliament and of the Council with regard to energy labelling of space heaters, combination heaters, packages of space heater, temperature control and solar device and packages of combination heater, temperature control and solar device (OJ L 239, 6.9.2013, p. 1).
(11) Commission Delegated Regulation (EU) No 812/2013 of 18 February 2013 supplementing Directive 2010/30/EU of the European Parliament and of the Council with regard to energy labelling of water heaters, hot water storage tanks and packages of water heater and solar device (OJ L 239, 6.9.2013, p. 83).
ANNEX I
Amendments to the Annexes to Delegated Regulation (EU) No 1059/2010
The following Annex VIII is added:
‘ANNEX VIII
Information to be provided in the case of sale, hire or hire-purchase through the internet
(1) |
For the purpose of points 2 to 5 of this Annex the following definitions shall apply:
|
(2) |
The appropriate label made available by suppliers in accordance with Article 3(f) shall be shown on the display mechanism in proximity to the price of the product. The size shall be such that the label is clearly visible and legible and shall be proportionate to the size specified in point 2 of Annex I. The label may be displayed using a nested display, in which case the image used for accessing the label shall comply with the specifications laid down in point 3 of this Annex. If nested display is applied, the label shall appear on the first mouse click, mouse roll-over or tactile screen expansion on the image. |
(3) |
The image used for accessing the label in the case of nested display shall:
|
(4) |
In the case of nested display, the sequence of display of the label shall be as follows:
|
(5) |
The appropriate product fiche made available by suppliers in accordance with Article 3(g) shall be shown on the display mechanism in proximity to the price of the product. The size shall be such that the product fiche is clearly visible and legible. The product fiche may be displayed using a nested display, in which case the link used for accessing the fiche shall clearly and legibly indicate “Product fiche”. If nested display is used, the product fiche shall appear on the first mouse click, mouse roll-over or tactile screen expansion on the link.’ |
ANNEX II
Amendments to the Annexes to Delegated Regulation (EU) No 1060/2010
The following Annex X is added:
‘ANNEX X
Information to be provided in the case of sale, hire or hire-purchase through the internet
(1) |
For the purpose of points 2 to 5 of this Annex the following definitions shall apply:
|
(2) |
The appropriate label made available by suppliers in accordance with Article 3(f) shall be shown on the display mechanism in proximity to the price of the product. The size shall be such that the label is clearly visible and legible and shall be proportionate to the size specified in point 3 of Annex II. The label may be displayed using a nested display, in which case the image used for accessing the label shall comply with the specifications laid down in point 3 of this Annex. If nested display is applied, the label shall appear on the first mouse click, mouse roll-over or tactile screen expansion on the image. |
(3) |
The image used for accessing the label in the case of nested display shall:
|
(4) |
In the case of nested display, the sequence of display of the label shall be as follows:
|
(5) |
The appropriate product fiche made available by suppliers in accordance with Article 3(g) shall be shown on the display mechanism in proximity to the price of the product. The size shall be such that the product fiche is clearly visible and legible. The product fiche may be displayed using a nested display, in which case the link used for accessing the fiche shall clearly and legibly indicate “Product fiche”. If nested display is used, the product fiche shall appear on the first mouse click, mouse roll-over or tactile screen expansion on the link.’ |
ANNEX III
Amendments to the Annexes to Delegated Regulation (EU) No 1061/2010
The following Annex VIII is added:
‘ANNEX VIII
Information to be provided in the case of sale, hire or hire-purchase through the internet
(1) |
For the purpose of points 2 to 5 of this Annex the following definitions shall apply:
|
(2) |
The appropriate label made available by suppliers in accordance with Article 3(f) shall be shown on the display mechanism in proximity to the price of the product. The size shall be such that the label is clearly visible and legible and shall be proportionate to the size specified in point 2 of Annex I. The label may be displayed using a nested display, in which case the image used for accessing the label shall comply with the specifications laid down in point 3 of this Annex. If nested display is applied, the label shall appear on the first mouse click, mouse roll-over or tactile screen expansion on the image. |
(3) |
The image used for accessing the label in the case of nested display shall:
|
(4) |
In the case of nested display, the sequence of display of the label shall be as follows:
|
(5) |
The appropriate product fiche made available by suppliers in accordance with Article 3(g) shall be shown on the display mechanism in proximity to the price of the product. The size shall be such that the product fiche is clearly visible and legible. The product fiche may be displayed using a nested display, in which case the link used for accessing the fiche shall clearly and legibly indicate “Product fiche”. If nested display is used, the product fiche shall appear on the first mouse click, mouse roll-over or tactile screen expansion on the link.’ |
ANNEX IV
Amendments to the Annexes to Delegated Regulation (EU) No 1062/2010
The following Annex IX is added:
‘ANNEX IX
Information to be provided in the case of sale, hire or hire-purchase through the internet
(1) |
For the purpose of points 2 to 5 of this Annex the following definitions shall apply:
|
(2) |
The appropriate label made available by suppliers in accordance with Article 3(1)(f) shall be shown on the display mechanism in proximity to the price of the product in accordance with the timetable set out in Article 3(3). The size shall be such that the label is clearly visible and legible and shall be proportionate to the size specified in point 5 of Annex V. The label may be displayed using a nested display, in which case the image used for accessing the label shall comply with the specifications laid down in point 3 of this Annex. If nested display is applied, the label shall appear on the first mouse click, mouse roll-over or tactile screen expansion on the image. |
(3) |
The image used for accessing the label in the case of nested display shall:
|
(4) |
In the case of nested display, the sequence of display of the label shall be as follows:
|
(5) |
The appropriate product fiche made available by suppliers in accordance with Article 3(1)(g) shall be shown on the display mechanism in proximity to the price of the product. The size shall be such that the product fiche is clearly visible and legible. The product fiche may be displayed using a nested display, in which case the link used for accessing the fiche shall clearly and legibly indicate “Product fiche”. If nested display is used, the product fiche shall appear on the first mouse click, mouse roll-over or tactile screen expansion on the link.’ |
ANNEX V
Amendments to the Annexes to Delegated Regulation (EU) No 626/2011
The following Annex IX is added:
‘ANNEX IX
Information to be provided in the case of sale, hire or hire-purchase through the internet
(1) |
For the purpose of points 2 to 5 of this Annex the following definitions shall apply:
|
(2) |
The appropriate label made available by suppliers in accordance with Article 3(1)(h) shall be shown on the display mechanism in proximity to the price of the product in accordance with the timetable set out in Article 3(4) to 3(6). The size shall be such that the label is clearly visible and legible and shall be proportionate to the size specified in Annex III. The label may be displayed using a nested display, in which case the image used for accessing the label shall comply with the specifications laid down in point 3 of this Annex. If nested display is applied, the label shall appear on the first mouse click, mouse roll-over or tactile screen expansion on the image. |
(3) |
The image used for accessing the label in the case of nested display shall:
|
(4) |
In the case of nested display, the sequence of display of the label shall be as follows:
|
(5) |
The appropriate product fiche made available by suppliers in accordance with Article 3(1)(i) shall be shown on the display mechanism in proximity to the price of the product. The size shall be such that the product fiche is clearly visible and legible. The product fiche may be displayed using a nested display, in which case the link used for accessing the fiche shall clearly and legibly indicate “Product fiche”. If nested display is used, the product fiche shall appear on the first mouse click, mouse roll-over or tactile screen expansion on the link.’ |
ANNEX VI
Amendments to the Annexes to Delegated Regulation (EU) No 392/2012
The following Annex VIII is added:
‘ANNEX VIII
Information to be provided in the case of sale, hire or hire-purchase through the internet
(1) |
For the purpose of points 2 to 5 of this Annex the following definitions shall apply:
|
(2) |
The appropriate label made available by suppliers in accordance with Article 3(f) shall be shown on the display mechanism in proximity to the price of the product. The size shall be such that the label is clearly visible and legible and shall be proportionate to the size specified in point 4 of Annex I. The label may be displayed using a nested display, in which case the image used for accessing the label shall comply with the specifications laid down in point 3 of this Annex. If nested display is applied, the label shall appear on the first mouse click, mouse roll-over or tactile screen expansion on the image. |
(3) |
The image used for accessing the label in the case of nested display shall:
|
(4) |
In the case of nested display, the sequence of display of the label shall be as follows:
|
(5) |
The appropriate product fiche made available by suppliers in accordance with Article 3(g) shall be shown on the display mechanism in proximity to the price of the product. The size shall be such that the product fiche is clearly visible and legible. The product fiche may be displayed using a nested display, in which case the link used for accessing the fiche shall clearly and legibly indicate “Product fiche”. If nested display is used, the product fiche shall appear on the first mouse click, mouse roll-over or tactile screen expansion on the link.’ |
ANNEX VII
Amendments to the Annexes to Delegated Regulation (EU) No 874/2012
The following Annex VIII is added:
‘ANNEX VIII
Information to be provided in the case of sale, hire or hire-purchase through the internet
(1) |
For the purpose of points 2 to 4 of this Annex the following definitions shall apply:
|
(2) |
The appropriate label made available by suppliers in accordance with Article 3(1)(f) or Article 3(2)(e) shall be shown on the display mechanism in proximity to the price of the product. The size shall be such that the label is clearly visible and legible and shall be proportionate to the size specified in Annex I. The label may be displayed using a nested display, in which case the image used for accessing the label shall comply with the specifications laid down in point 3 of this Annex. If nested display is applied, the label shall appear on the first mouse click, mouse roll-over or tactile screen expansion on the image. |
(3) |
The image used for accessing the label in the case of nested display shall:
|
(4) |
In the case of nested display, the sequence of display of the label shall be as follows:
|
ANNEX VIII
Amendments to the Annexes to Delegated Regulation (EU) No 665/2013
The following Annex VII is added:
‘ANNEX VII
Information to be provided in the case of sale, hire or hire-purchase through the internet
(1) |
For the purpose of points 2 to 5 of this Annex the following definitions shall apply:
|
(2) |
The appropriate label made available by suppliers in accordance with Article 3(1)(f) shall be shown on the display mechanism in proximity to the price of the product in accordance with the timetable set out in Article 3(2). The size shall be such that the label is clearly visible and legible and shall be proportionate to the size specified in point 3 of Annex II. The label may be displayed using a nested display, in which case the image used for accessing the label shall comply with the specifications laid down in point 3 of this Annex. If nested display is applied, the label shall appear on the first mouse click, mouse roll-over or tactile screen expansion on the image. |
(3) |
The image used for accessing the label in the case of nested display shall:
|
(4) |
In the case of nested display, the sequence of display of the label shall be as follows:
|
(5) |
The appropriate product fiche made available by suppliers in accordance with Article 3(1)(g) shall be shown on the display mechanism in proximity to the price of the product. The size shall be such that the product fiche is clearly visible and legible. The product fiche may be displayed using a nested display, in which case the link used for accessing the fiche shall clearly and legibly indicate “Product fiche”. If nested display is used, the product fiche shall appear on the first mouse click, mouse roll-over or tactile screen expansion on the link.’ |
ANNEX IX
Amendments to the Annexes to Delegated Regulation (EU) No 811/2013
(a) |
In Annex VI the title is replaced by the following: ‘Information to be provided in the cases where end-users cannot be expected to see the product displayed, except on the internet’ |
(b) |
The following Annex IX is added: ‘ANNEX IX Information to be provided in the case of sale, hire or hire-purchase through the internet
|
ANNEX X
Amendments to the Annexes to Delegated Regulation (EU) No 812/2013
(a) |
In Annex VI the title is replaced by the following: ‘Information to be provided in the cases where end-users cannot be expected to see the product displayed, except on the internet’ |
(b) |
The following Annex X is added: ‘ANNEX X Information to be provided in the case of sale, hire or hire-purchase through the internet
|
17.5.2014 |
EN |
Official Journal of the European Union |
L 147/29 |
COMMISSION REGULATION (EU) No 519/2014
of 16 May 2014
amending Regulation (EC) No 401/2006 as regards methods of sampling of large lots, spices and food supplements, performance criteria for T-2, HT-2 toxin and citrinin and screening methods of analysis
(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 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 (1), in particular Article 11(4) thereof,
Whereas:
(1) |
Commission Regulation (EC) No 1881/2006 (2) provides for maximum limits for certain mycotoxins in certain foodstuffs. |
(2) |
Sampling plays a crucial part in the precision of the determination of the levels of mycotoxins, which are heterogeneously distributed in a lot. It is therefore necessary to set out criteria which the sampling methods should fulfil. |
(3) |
Commission Regulation (EC) No 401/2006 (3) establishes the criteria for the sampling for the control of the levels of mycotoxins. |
(4) |
It is necessary to amend the rules concerning the sampling of spices in order to take into account the differences in particle size which leads to the heterogeneous distribution of mycotoxin contamination in spices. Furthermore it is appropriate to establish rules for the sampling of large lots in order to ensure a uniform enforcement approach across the Union. It is also appropriate to clarify which method of sampling has to be applied for the sampling of apple juice. |
(5) |
The performance criteria for T-2 and HT-2 toxin need to be updated in order to take into account scientific and technological progress. Performance criteria for citrinin need to be established given the maximum level established for citrinin in food supplements based on rice fermented with the red yeast Monascus purpureus. |
(6) |
For the analysis of mycotoxins, screening methodologies are used more and more. It is appropriate to establish criteria with which the screening methods have to comply with for use for regulatory purposes. |
(7) |
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
Regulation (EC) No 401/2006 is amended as follows:
(1) |
Annex I is amended as follows:
|
(2) |
In Annex II, points 4.2 ‘General requirements’, 4.3 ‘Specific requirements’ and 4.4 ‘Estimation of measurement uncertainty, recovery calculation and reporting of results’ are replaced by the text set out in Annex II to this Regulation. |
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.
It shall apply from 1 July 2014.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 16 May 2014.
For the Commission
The President
José Manuel BARROSO
(1) OJ L 165, 30.4.2004, p. 1.
(2) Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs (OJ L 364, 20.12.2006, p. 5).
(3) Commission Regulation (EC) No 401/2006 of 23 February 2006 laying down the methods of sampling and analysis for the official control of the levels of mycotoxins in foodstuffs (OJ L 70, 9.3.2006, p. 12).
(4) Depending on the lot weight — see Table 2.’
ANNEX I
‘L. METHOD OF SAMPLING FOR VERY LARGE LOTS OR LOTS STORED OR TRANSPORTED IN A WAY WHEREBY SAMPLING THROUGHOUT THE LOT IS NOT FEASIBLE
L.1. General principles
In case the way of transport or storage of a lot does not enable to take incremental samples throughout the whole lot, sampling of such lots should preferably be done when the lot is in flow (dynamic sampling).
In the case of large warehouses destined to store food, operators should be encouraged to install equipment in the warehouse enabling (automatic) sampling across the whole stored lot.
When the sampling procedures as provided for in this part L are applied, the food business operator or his representative should be informed of the sampling procedure. If the sampling procedure is questioned by the food business operator or his representative, the food business operator or his representative shall enable the competent authority to sample throughout the whole lot at his/her own cost.
Sampling of a part of the lot is allowed, on the condition that the quantity of the sampled part is at least 10 % of the lot to be sampled. If a part of a lot of food of the same class or description has been sampled and identified as not satisfying Union requirements, it shall be presumed that the entire lot is also affected, unless further detailed assessment shows no evidence that the rest of the lot is unsatisfactory.
The relevant provisions, such as weight of the incremental sample, provided for in the other parts of this Annex are applicable for the sampling for very large lots or lots stored or transported in a way whereby sampling throughout the lot is not feasible.
L.2. Number of incremental samples to be taken in the case of very large lots
In the case of large sampled portions (sampled portions > 500 tonnes), the number of incremental samples to be taken = 100 incremental samples + √tonnes. However in case the lot is less than 1 500 tonnes and can be subdivided into sublots in accordance with the table 1 of part B and on the condition that the sublots can be separated physically, the number of incremental samples as provided for in part B have to be taken.
L.3. Large lots transported by ship
L.3.1. Dynamic sampling of large lots transported by ship
The sampling of large lots in ships is preferably carried out while the product is in flow (dynamic sampling).
The sampling is to be done per hold (entity that can physically be separated). Holds are however emptied partly one after the other so that the initial physical separation no longer exists after transfer into storage facilities. Sampling can therefore be performed based on initial physical separation or based on the separation after transfer into the storage facilities.
The unloading of a ship can last for several days. Normally, sampling has to be performed at regular intervals during the whole duration of unloading. It is however not always feasible or appropriate for an official inspector to be present for sampling during the whole operation of unloading. Therefore sampling of part of the lot is allowed to be undertaken (sampled portion). The number of incremental samples is determined by taking into account the size of the sampled portion.
Even if the official sample is taken automatically, the presence of an inspector is necessary. However if the automatic sampling is done with pre-set parameters which cannot be changed during the sampling and the incremental samples are collected in a sealed receptacle, preventing any possible fraud, then the presence of an inspector is only required at the beginning of the sampling, every time the receptacle of the samples needs to be changed and at the end of the sampling.
L.3.2. Sampling of lots transported by ship by static sampling
In cases where the sampling is done in a static way the same procedure as foreseen for storage facilities (silos) accessible from above has to be applied (see point L.5.1).
The sampling has to be performed on the accessible part (from above) of the lot/hold. The number of incremental samples is determined by taking into account the size of the sampled portion.
L.4. Sampling of large lots stored in warehouses
The sampling has to be performed on the accessible part of the lot. The number of incremental samples is determined by taking into account the size of the sampled portion.
L.5. Sampling of storage facilities (silos)
L.5.1. Sampling of silos (easily) accessible from above
The sampling has to be performed on the accessible part of the lot. The number of incremental samples is determined by taking into account the size of the sampled portion.
L.5.2. Sampling of silos not accessible from above (closed silos)
L.5.2.1.
Food stored in such silos cannot be sampled in a static way. Therefore when the food in the silo has to be sampled and there is no possibility to move the consignment, the agreement has to be made with the operator that he or she has to inform the inspector about when the silo will be unloaded, partially or completely, in order to enable sampling when the food is in flow.
L.5.2.2.
Contrary to the provision in part point L.1 (sampled part at least 10 %), the sampling procedure involves the release into a receptacle of a quantity of 50 to 100 kg and taking the sample from it. The size of the aggregate sample corresponds to the whole lot and the number of incremental samples relate to the quantity of the food from the silo released into the receptacle for sampling.
L.6. Sampling of loose food in large closed containers
Such lots can often only be sampled when unloaded. In certain cases it is not possible to unload at the point of import or control and therefore the sampling should take place when such containers are unloaded. The operator has to inform the inspector about the place and time of unloading the containers.
M. METHOD OF SAMPLING OF FOOD SUPPLEMENTS BASED ON RICE FERMENTED WITH RED YEAST MONASCUS PURPUREUS
This method of sampling is applicable to the official control of the maximum level established for citrinin in food supplements based on rice fermented with red yeast Monascus purpureus.
Sampling procedure and sample size
The sampling procedure is on the supposition that the food supplements based on rice fermented with red yeast Monascus purpureus are marketed in retail packages containing usually 30 to 120 capsules per retail package.
Lot size (number of retail packages) |
Number of retail packages to be taken for sample |
Sample size |
1-50 |
1 |
All capsules |
51-250 |
2 |
All capsules |
251-1 000 |
4 |
From each retail package taken for sample, half of the capsules |
> 1 000 |
4 + 1 retail package per 1 000 retail packages with a maximum of 25 retail packages |
≤ 10 retail packages: from each retail package, half of the capsules > 10 retail packages: from each retail package, an equal number of capsules is taken to result in a sample with the equivalent of the content of retail 5 packages’ |
ANNEX II
‘4.2. General requirements
Confirmatory methods of analysis used for food control purposes shall comply with the provisions of items 1 and 2 of Annex III to Regulation (EC) No 882/2004.
4.3. Specific requirements
4.3.1. Specific requirements for confirmatory methods
4.3.1.1.
It is recommended that fully validated confirmatory methods (i.e. methods validated by collaborative trials for relevant matrices) are used where appropriate and available. Other suitable validated confirmatory methods (e.g. methods validated in-house on relevant matrices belonging to the commodity group of interest) may also be used provided they fulfil the performance criteria set out in the following tables.
Where possible, the validation of in-house validated methods shall include a certified reference material.
(a) |
Performance criteria for aflatoxins
Note:
|
(b) |
Performance criteria for ochratoxin A
|
(c) |
Performance criteria for patulin
|
(d) |
Performance criteria for deoxynivalenol
|
(e) |
Performance criteria for zearalenone
|
(f) |
Performance criteria for Fumonisin B1 and B2 individually
|
(g) |
Performance criteria for T-2 and HT-2 toxin individually
|
(h) |
Performance criteria for citrinin
|
(i) |
Notes to the performance criteria for the mycotoxins:
|
4.3.1.2.
For in-house validated methods, as an alternative, a “fitness-for-purpose” approach (***) may be used to assess their suitability for official control. Methods suitable for official control must produce results with a standard measurement uncertainty (u) less than the maximum standard measurement uncertainty calculated using the formula below:
where:
— |
Uf is the maximum standard measurement uncertainty (μg/kg) |
— |
LOD is the limit of detection of the method (μg/kg) |
— |
α is a constant, numeric factor to be used depending on the value of C. The values to be used are set out in Table hereafter. |
— |
C is the concentration of interest (μg/kg) |
If the analytical method provides results with uncertainty measurements less than the maximum standard uncertainty the method shall be considered being equally suitable to one which meets the performance criteria given in point 4.3.1.1.
Table
Numeric values to be used for α as constant in formula set out in this point, depending on the concentration of interest
C (μg/kg) |
α |
≤ 50 |
0,2 |
51-500 |
0,18 |
501-1 000 |
0,15 |
1 001-10 000 |
0,12 |
> 10 000 |
0,1 |
(***) |
Ref: M. Thompson and R. Wood, Accred. Qual. Assur., 2006, 10, p. 471-478. |
4.3.2. Specific requirements for semi-quantitative screening methods
4.3.2.1.
The scope applies to bioanalytical methods based on immuno-recognition or receptor binding (such as ELISA, dip-sticks, lateral flow devices, immuno-sensors) and physicochemical methods based on chromatography or direct detection by mass spectrometry (e.g. ambient MS). Other methods (e.g. thin layer chromatography) are not excluded provided the signals generated relate directly to the mycotoxins of interest and allow that the principle described hereunder is applicable.
The specific requirements apply to methods of which the result of the measurement is a numerical value, for example a (relative) response from a dip-stick reader, a signal from LC-MS, etc., and that normal statistics apply.
The requirements do not apply to methods that do not give numerical values (e.g. only a line that is present or absent), which require different validation approaches. Specific requirements for these methods are provided in point 4.3.3.
This document describes procedures for the validation of screening methods by means of an inter-laboratory validation, the verification of the performance of a method validated by means of an inter-laboratory exercise and the single-laboratory validation of a screening method.
4.3.2.2.
Screening target concentration (STC): the concentration of interest for detection of the mycotoxin in a sample. When the aim is to test compliance with regulatory limits, the STC is equal to the applicable maximum level. For other purposes or in case no maximum level has been established, the STC is predefined by the laboratory.
Screening method: means method used for selection of those samples with levels of mycotoxins that exceed the screening target concentration (STC), with a given certainty. For the purpose of mycotoxin screening, a certainty of 95 % is considered fit-for-purpose. The result of the screening analysis is either “negative” or “suspect”. Screening methods shall allow a cost-effective high sample-throughput, thus increasing the chance to discover new incidents with high exposure and health risks to consumers. These methods shall be based on bio-analytical, LC-MS or HPLC methods. Results from samples exceeding the cut-off value shall be verified by a full re-analysis from the original sample by a confirmatory method.
“Negative sample” means the mycotoxin content in the sample is < STC with a certainty of 95 % (i.e. there is a 5 % chance that samples will be incorrectly reported as negative).
“False negative sample” means the mycotoxin content in the sample is > STC but it has been identified as negative.
“Suspect sample” (screen positive) means the sample exceeds the cut-off level (see below) and may contain the mycotoxin at a level higher than the STC. Any suspect result triggers a confirmatory analysis for unambiguous identification and quantification of the mycotoxin.
“False suspect sample” is a negative sample that has been identified as suspect.
“Confirmatory methods” means methods that provide full or complementary information enabling the mycotoxin to be identified and quantified unequivocally at the level of interest.
Cut-off level: the response, signal, or concentration, obtained with the screening method, above which the sample is classified as “suspect”. The cut-off is determined during the validation and takes the variability of the measurement into account.
Negative control (blank matrix) sample: a sample known to be free (1) of the mycotoxin to be screened for, e.g. by previous determination using a confirmatory method of sufficient sensitivity. If no blank samples can be obtained, then material with the lowest obtainable level might be used as long as the level allows the conclusion that the screening method is fit for purpose.
Positive control sample: sample containing the mycotoxin at the screening target concentration, e.g. a certified reference material, a material of known content (e.g. test material of proficiency tests) or otherwise sufficiently characterised by a confirmatory method. In the absence of any of the above, a blend of samples with different levels of contamination or a spiked sample prepared within laboratory and sufficiently characterised can be used, provided it can be proven that the contamination level has been verified.
4.3.2.3.
The aim of the validation is to demonstrate the fitness of purpose of the screening method. This is done by determination of the cut-off value and determination of the false negative and false suspect rate. In these two parameters performance characteristics such as sensitivity, selectivity, and precision are embedded.
Screening methods can be validated by inter-laboratory or by single laboratory validation. If inter-laboratory validation data is already available for a certain mycotoxin/matrix/STC combination, a verification of method performance is sufficient in a laboratory implementing the method.
4.3.2.3.1. Initial validation by single laboratory validation
Mycotoxins:
The validation shall be performed for every individual mycotoxin in the scope. In case of bio-analytical methods that give a combined response for a certain mycotoxin group (e.g. aflatoxins B1, B2, G1 & G2; fumonisins B1 & B2), applicability must be demonstrated and limitations of the test mentioned in the scope of the method. Undesired cross-reactivity (e.g. DON-3-glycoside, 3- or 15-acetyl-DON for immuno-based methods for DON) is not considered to increase the false negative rate of the target mycotoxins, but may increase the false suspect rate. This unwanted increasing will be diminished by confirmatory analysis for unambiguous identification and quantification of the mycotoxins.
Matrices:
An initial validation should be performed for each commodity, or, when the method is known to be applicable to multiple commodities, for each commodity group. In the latter case, one representative and relevant commodity is selected from that group (see table A).
Sample set:
The minimum number of different samples required for validation is 20 homogeneous negative control samples and 20 homogeneous positive control samples that contain the mycotoxin at the STC, analysed under intermediate precision (RSDRi) conditions spread over 5 different days. Optionally, additional sets of 20 samples containing the mycotoxin at other levels can be added to the validation set to gain insight to what extent the method can distinguish between different mycotoxin concentrations.
Concentration:
For each STC to be used in routine application, a validation has to be performed.
4.3.2.3.2. Initial validation through collaborative trials
Validation through collaborative trials shall be done in accordance with an internationally recognised protocol on collaborative trials (e.g. ISO 5725:1994 or the IUPAC International Harmonised Protocol) which requires inclusion of valid data from at least eight different laboratories. Other than that, the only difference compared to single laboratory validations is that the ≥ 20 samples per commodity/level can be evenly divided over the participating laboratories, with a minimum of two samples per laboratory.
4.3.2.4.
The (relative) responses for the negative control and positive control samples are taken as basis for the calculation of the required parameters.
Screening methods with a response proportional with the mycotoxin concentration
For screening methods with a response proportional with the mycotoxin concentration the following applies:
Cut-off = RSTC – t-value0,05 * SDSTC
RSTC = |
mean response of the positive control samples (at STC) |
t-value: |
one tailed t-value for a rate of false negative results of 5 % (see table B) |
SDSTC = |
standard deviationScreening methods with a response inversely proportional with the mycotoxin concentration |
Similarly, for screening methods with a response inversely proportional with the mycotoxin concentration, the cut-off is determined as:
Cut-off = RSTC + t-value0,05 * SDSTC
By using this specific t-value for establishing the cut-off value, the rate of false negative results is by default set at 5 %.
Fitness for purpose assessment
Results from the negative control samples are used to estimate the corresponding rate of false suspect results. The t-value is calculated corresponding to the event that a result of a negative control sample is above the cut off value, thus erroneously classified as suspect.
t-value= (cut off – meanblank)/SDblankfor screening methods with a response proportional with the mycotoxin concentration
or
t-value= (mean blank – cut off)/SDblankfor screening methods with a response inversely proportional with the mycotoxin concentration
From the obtained t-value, based on the degrees of freedom calculated from the number of experiments, the probability of false suspect samples for a one tailed distribution can either be calculated (e.g.. spread sheet function “TDIST”) or taken from a table for t-distribution.
The corresponding value of the one tailed t-distribution specifies the rate of false suspect results.
This concept is described in detail with an example in Analytical and Bioanalytical Chemistry DOI 10.1007/s00216 -013-6922-1.
4.3.2.5.
4.3.2.5.1. Extension of scope to other mycotoxins:
When new mycotoxins are added to the scope of an existing screening method, a full validation is required to demonstrate the suitability of the method.
4.3.2.5.2. Extension to other commodities:
If the screening method is known or expected to be applicable to other commodities, the validity to these other commodities shall be verified. As long as the new commodity belongs to a commodity group (see Table A) for which an initial validation has already been performed, a limited additional validation is sufficient. For this, a minimum of 10 homogeneous negative control and 10 homogeneous positive control (at STC) samples shall be analysed under intermediate precision conditions. The positive control samples shall all be above the cut-off value. In case this criterion is not met, a full validation is required.
4.3.2.6.
For screening methods that have already been successfully validated through a collaborative laboratory trial, the method performance shall be verified. For this a minimum of 6 negative control and 6 positive control (at STC) samples shall be analysed. The positive control samples shall all be above the cut-off value. In case this criterion is not met, the laboratory has to perform a root-cause analysis to identify why it cannot meet the specification as obtained in the collaborative trial. Only after taking corrective action it shall re-verify the method performance in its laboratory. In case the laboratory is not capable to verify the results from the collaborative trial, it will need to establish its own cut-off in a complete single laboratory validation.
4.3.2.7.
After initial validation, additional validation data are acquired by including at least two positive control samples in each batch of samples screened. One positive control sample is a known sample (e.g. one used during initial validation), the other is a different commodity from the same commodity group (in case only one commodity is analysed, a different sample of that commodity is used instead). Inclusion of a negative control sample is optional. The results obtained for the two positive control samples are added to the existing validation set.
At least once a year the cut-off value is re-established and the validity of the method is re-assessed. The continuous method verification serves several purposes:
— |
quality control for the batch of samples screened |
— |
providing information on robustness of the method at conditions in the laboratory that applies the method |
— |
justification of applicability of the method to different commodities |
— |
allowing to adjust cut-off values in case of gradual drifts over time. |
4.3.2.8.
The validation report shall contain:
— |
A statement on the STC |
— |
A statement on the obtained cut-off. |
Note: The cut-off must have the same number of significant figures as the STC. Numerical values used to calculate the cut-off need at least one more significant figure than the STC.
— |
A statement on calculated false suspected rate |
— |
A statement on how the false suspected rate was generated. |
Note: The statement on the calculated false suspected rate indicates if the method is fit-for-purpose as it indicates the number of blank (or low level contamination) samples that will be subject to verification.
Table A
Commodity groups for the validation of screening methods
Commodity groups |
Commodity categories |
Typical representative commodities included in the category |
High water content |
Fruit Juices |
Apple juice, grape juice |
Alcoholic beverages |
Wine, beer, cider |
|
Root and tuber vegetables |
Fresh ginger |
|
Cereal or fruit based purees |
Purees intended for infants and small children |
|
High oil content |
Tree nuts |
Walnut, hazelnut, chestnut |
Oil seeds and products thereof |
Oilseed rape, sunflower, cotton-seed, soybeans, peanuts, sesame etc. |
|
Oily fruits and products thereof |
Oils and pastes (e.g. peanut butter, tahina) |
|
High starch and/or protein content and low water and fat content |
Cereal grain and products thereof |
Wheat, rye, barley, maize, rice, oats Wholemeal bread, white bread, crackers, breakfast cereals, pasta |
Dietary products |
Dried powders for the preparation of food for infants and small children |
|
High acid content and high water content (2) |
Citrus products |
|
“Difficult or unique commodities” (3) |
|
Cocoa beans and products thereof, copra and products thereof, coffee, tea Spices, liquorice |
High sugar low water content |
Dried fruits |
Figs, raisins, currants, sultanas |
Milk and milk products |
Milk |
Cow, goat and buffalo milk |
Cheese |
Cow, goat cheese |
|
Dairy products (e.g. milk powder) |
Yogurt, cream |
Table B
One tailed t-value for a false negative rate of 5 %
Degrees of Freedom |
Number of replicates |
t-value (5 %) |
10 |
11 |
1,812 |
11 |
12 |
1,796 |
12 |
13 |
1,782 |
13 |
14 |
1,771 |
14 |
15 |
1,761 |
15 |
16 |
1,753 |
16 |
17 |
1,746 |
17 |
18 |
1,74 |
18 |
19 |
1,734 |
19 |
20 |
1,729 |
20 |
21 |
1,725 |
21 |
22 |
1,721 |
22 |
23 |
1,717 |
23 |
24 |
1,714 |
24 |
25 |
1,711 |
25 |
26 |
1,708 |
26 |
27 |
1,706 |
27 |
28 |
1,703 |
28 |
29 |
1,701 |
29 |
30 |
1,699 |
30 |
31 |
1,697 |
40 |
41 |
1,684 |
60 |
61 |
1,671 |
120 |
121 |
1,658 |
∞ |
∞ |
1,645 |
4.3.3. Requirements for qualitative screening methods (methods that do not give numerical values)
The development of validation guidelines for binary test methods is currently subject of various standardization bodies (e.g. AOAC, ISO). Very recently AOAC has drafted a guideline on this matter. This document can be regarded as the current state of the art in its field. Therefore methods that give binary results (e.g. visual inspection of dip-stick tests) should be validated according to this guideline
http://www.aoac.org/imis15_prod/AOAC_Docs/ISPAM/Qual_Chem_Guideline_Final_Approved_031412.pdf
4.4. Estimation of measurement uncertainty, recovery calculation and reporting of results (4)
4.4.1. Confirmatory methods
The analytical result must be reported as follows:
(a) |
Corrected for recovery, the level of recovery being indicated. The correction for recovery is not necessary in case the recovery rate is between 90-110 %. |
(b) |
As x +/– U whereby x is the analytical result and U is the expanded measurement uncertainty, using a coverage factor of 2 which gives a level of confidence of approximately 95 %. |
For food of animal origin, the taking into account of the measurement uncertainty can also be done by establishing the decision limit (CCα) in accordance with Commission Decision 2002/657/EC (5) (point 3.1.2.5 of Annex I — the case of substances with established permitted limit).
However if the result of the analysis is significantly (> 50 %) lower than the maximum level or much higher than the maximum level (i.e. more than 5 times the maximum level), and on the condition that the appropriate quality procedures are applied and the analysis serves only the purpose of checking compliance with legal provisions, the analytical result might be reported without correction for recovery and the reporting of the recovery rate and measurement uncertainty might be omitted in these cases.
The present interpretation rules of the analytical result in view of acceptance or rejection of the lot apply to the analytical result obtained on the sample for official control. In case of analysis for defence or referee purposes, the national rules apply.
4.4.2. Screening methods
The result of the screening shall be expressed as compliant or suspected to be non-compliant.
“Suspected to be non-compliant” means the sample exceeds the cut-off level and may contain the mycotoxin at a level higher than the STC. Any suspect result triggers a confirmatory analysis for unambiguous identification and quantification of the mycotoxin.
“Compliant” means that the mycotoxin content in the sample is < STC with a certainty of 95 % (i.e. there is a 5 % chance that samples will be incorrectly reported as negative). The analytical result is reported as “< level of STC” with the level of STC specified.’
(1) Samples are considered free of analyte if the amount present in the sample does not exceed more than 1/5th of the STC. If the level can be quantified with a confirmatory method, the level must be taken into consideration for the validation assessment.
(2) If a buffer is used to stabilise the pH changes in the extraction step, then this commodity group can be merged into one commodity group “High water content”.
(3) “Difficult or unique commodities” should only be fully validated if they are frequently analysed. If they are only analysed occasionally, validation may be reduced to just checking the reporting levels using spiked blank extracts.
(4) More details on procedures for the estimation of measurement uncertainty and on procedures for assessing recovery can be found in the report “Report on the relationship between analytical results, measurement uncertainty, recovery factors and the provisions of EU food and feed legislation” — http://ec.europa.eu/food/food/chemicalsafety/contaminants/report-sampling_analysis_2004_en.pdf
(5) Commission Decision 2002/657/EC of 14 August 2002 implementing Council Directive 96/23/EC concerning the performance of analytical methods and the interpretation of results (OJ L 221, 17.8.2002, p. 8).
17.5.2014 |
EN |
Official Journal of the European Union |
L 147/44 |
COMMISSION IMPLEMENTING REGULATION (EU) No 520/2014
of 16 May 2014
adding to the 2014 fishing quotas certain quantities withheld in the year 2013 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) |
Council Regulations (EU) No 1262/2012 (2), (EU) No 1088/2012 (3), (EU) No 1261/2012 (4), (EU) No 39/2013 (5) and (EU) No 40/2013 (6) fix fishing quotas for certain stocks for 2013 and specify which stocks may be subject to the measures provided for in Regulation (EC) No 847/96. |
(3) |
Council Regulations (EU) No 1262/2012, (EU) No 1180/2013 (7), (EU) No 24/2014 (8), and (EU) No 43/2014 (9) fix fishing quotas for certain stocks for 2014. |
(4) |
Certain Member States have requested, before 31 October of 2013, pursuant to Article 4(2) of Regulation (EC) No 847/96, that part of their quotas for 2013 be withheld and transferred to the following year. Within the limits indicated in that Regulation, the quantities withheld should be added to the quotas for 2014. |
(5) |
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
The fishing quotas fixed for 2014 in Regulations (EU) No 1262/2012, (EU) No 1180/2013, (EU) No 24/2014 and (EU) No 43/2014 are increased as set out in the Annex.
Article 2
This Regulation shall enter into force on the seventh 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, 16 May 2014.
For the Commission
The President
José Manuel BARROSO
(2) Council Regulation (EU) No 1262/2012 of 20 December 2012 fixing for 2013 and 2014 the fishing opportunities for EU vessels for certain deep-sea fish stocks (OJ L 356, 22.12.2012, p. 22).
(3) Council Regulation (EU) No 1088/2012 of 20 November 2012 fixing for 2013 the fishing opportunities for certain fish stocks and groups of fish stocks applicable in the Baltic Sea (OJ L 323, 22.11.2012, p. 2).
(4) Council Regulation (EU) No 1261/2012 of 20 December 2012 fixing for 2013 the fishing opportunities for certain fish stocks and groups of fish stocks applicable in the Black Sea (OJ L 356, 22.12.2012, p. 19).
(5) Council Regulation (EU) No 39/2013 of 21 January 2013 fixing for 2013 the fishing opportunities available to EU vessels for certain fish stocks and groups of fish stocks which are not subject to international negotiations or agreements (OJ L 23, 25.1.2013, p. 1).
(6) Council Regulation (EU) No 40/2013 of 21 January 2013 fixing for 2013 the fishing opportunities available in EU waters and, to EU vessels, in certain non- EU waters for certain fish stocks and groups of fish stocks which are subject to international negotiations or agreements (OJ L 23, 25.1.2013, p. 54).
(7) Council Regulation (EU) No 1180/2013 of 19 November 2013 fixing for 2014 the fishing opportunities for certain fish stocks and groups of fish stocks applicable in the Baltic Sea (OJ L 313, 22.11.2013, p. 4).
(8) Council Regulation (EU) No 24/2014 of 10 January 2014 fixing for 2014 the fishing opportunities for certain fish stocks and groups of fish stocks in the Black Sea (OJ L 9, 14.1.2014, p. 4).
(9) Council Regulation (EU) No 43/2014 of 20 January 2014 fixing for 2014 the fishing opportunities for certain fish stocks and groups of fish stocks, applicable in Union waters and, to Union vessels, in certain non-Union waters (OJ L 24, 28.1.2014, p. 1).
ANNEX
Coun-try ID |
Stock Id |
Species |
Zone name |
Final Quota 2013 (1) (in tonnes) |
Catches 2013 (in tonnes) |
Special Condition catches 2013 (in tonnes) |
Final quota |
Transferred quantity (in tonnes) |
BE |
ANF/07. |
Anglerfish |
VII |
1 702,800 |
1 127,900 |
134,600 |
74,14 % |
170,280 |
BE |
ANF/2AC4-C |
Anglerfish |
Union waters of IIa and IV |
343,800 |
136,800 |
0 |
39,79 % |
34,380 |
BE |
ANF/8ABDE. |
Anglerfish |
VIIIa, VIIIb, VIIId and VIIIe |
259,500 |
238,000 |
0 |
91,71 % |
21,500 |
BE |
COD/07A. |
Cod |
VIIa |
20,800 |
12,900 |
0 |
62,02 % |
2,080 |
BE |
COD/07D. |
Cod |
VIId |
67,100 |
52,200 |
0 |
77,79 % |
6,710 |
BE |
COD/7XAD34 |
Cod |
VIIb, VIIc, VIIe-k, VIII, IX and X, Union waters of CECAF 34.1.1 |
513,700 |
202,000 |
0 |
39,32 % |
51,370 |
BE |
HAD/07A. |
Haddock |
VIIa |
37,900 |
6,200 |
0 |
16,36 % |
3,790 |
BE |
HAD/2AC4. |
Haddock |
IV; Union waters of IIa |
85,400 |
78,400 |
0 |
91,80 % |
7,000 |
BE |
HAD/5BC6A. |
Haddock |
Union and international waters of Vb and VIa |
0,700 |
0 |
0 |
0 % |
0,070 |
BE |
HAD/6B1214 |
Haddock |
Union and international waters of VIb, XII and XIV |
2,800 |
0 |
0 |
0 % |
0,280 |
BE |
HKE/2AC4-C |
Hake |
Union waters of IIa and IV |
38,200 |
31,200 |
0 |
81,68 % |
3,820 |
BE |
HKE/571214 |
Hake |
VI and VII; Union and international waters of Vb; international waters of XII and XIV |
97,300 |
12,000 |
0 |
12,33 % |
9,730 |
BE |
HKE/8ABDE. |
Hake |
VIIIa, VIIIb, VIIId and VIIIe |
13,000 |
7,600 |
0 |
58,46 % |
1,300 |
BE |
LEZ/07. |
Megrims |
VII |
578,100 |
520,200 |
0 |
89,98 % |
57,810 |
BE |
LEZ/2AC4-C |
Megrims |
Union waters of IIa and IV |
6,900 |
0,400 |
0 |
5,80 % |
0,690 |
BE |
LEZ/8ABDE. |
Megrims |
VIIIa, VIIIb, VIIId and VIIIe |
25,000 |
18,200 |
0 |
72,80 % |
2,500 |
BE |
LIN/04-C. |
Ling |
Union waters of IV |
15,400 |
14,800 |
0 |
96,10 % |
0,600 |
BE |
LIN/6X14. |
Ling |
Union and international waters of VI, VII, VIII, IX, X, XII and XIV |
77,400 |
52,100 |
0 |
67,31 % |
7,740 |
BE |
MAC/2A34. |
Mackerel |
IIIa and IV; Union waters of IIa, IIIb, IIIc and Subdivisions 22-32 |
79,100 |
61,600 |
0 |
77,88 % |
7,910 |
BE |
NEP/07. |
Norway lobster |
VII |
16,200 |
13,600 |
0 |
83,95 % |
1,620 |
BE |
NEP/2AC4-C |
Norway lobster |
Union waters of IIa and IV |
1 034,800 |
286,800 |
0 |
27,72 % |
103,480 |
BE |
NEP/8ABDE. |
Norway lobster |
VIIIa, VIIIb, VIIId and VIIIe |
5,600 |
0,400 |
0 |
7,14 % |
0,560 |
BE |
PLE/07A. |
Plaice |
VIIa |
220,300 |
144,100 |
0 |
65,41 % |
22,030 |
BE |
PLE/7DE. |
Plaice |
VIId and VIIe |
1 556,300 |
1 391,100 |
0 |
89,39 % |
155,630 |
BE |
PLE/7HJK. |
Plaice |
VIIh, VIIj and VIIk |
1,200 |
0 |
0 |
0 % |
0,120 |
BE |
SOL/07D. |
Common sole |
VIId |
1 771,900 |
953,000 |
0 |
53,78 % |
177,190 |
BE |
SOL/07E. |
Common sole |
VIIe |
34,600 |
29,500 |
0 |
85,26 % |
3,460 |
BE |
SOL/24-C. |
Common sole |
Union waters of II and IV |
1 339,800 |
697,300 |
0 |
52,05 % |
133,980 |
BE |
SOL/7FG. |
Common sole |
VIIf and VIIg |
860,200 |
787,600 |
0 |
91,56 % |
72,600 |
BE |
SOL/7HJK. |
Common sole |
VIIh, VIIj and VIIk |
36,900 |
4,500 |
0 |
12,20 % |
3,690 |
BE |
SOL/8AB. |
Common sole |
VIIIa and VIIIb |
331,800 |
311,900 |
0 |
94,00 % |
19,900 |
BE |
WHG/07A. |
Whiting |
VIIa |
4,500 |
2,300 |
0 |
51,11 % |
0,450 |
BE |
WHG/7X7A-C |
Whiting |
VIIb, VIIc, VIId, VIIe, VIIf, VIIg, VIIh, VIIj and VIIk |
390,600 |
319,800 |
0 |
81,87 % |
39,060 |
DE |
ANF/07. |
Anglerfish |
VII |
353,900 |
310,413 |
0 |
87,71 % |
35,390 |
DE |
ANF/2AC4-C |
Anglerfish |
Union waters of IIa and IV |
369,600 |
248,831 |
0 |
67,32 % |
36,960 |
DE |
ARU/1/2. |
Greater silver smelt |
Union and international waters of I and II |
27,300 |
0 |
0 |
0 % |
2,730 |
DE |
ARU/34-C |
Greater silver smelt |
Union waters of III and IV |
11,200 |
0 |
0 |
0 % |
1,120 |
DE |
ARU/567. |
Greater silver smelt |
Union and international waters of V, VI and VII |
432,600 |
416,765 |
0 |
96,34 % |
15,835 |
DE |
BLI/5B67- |
Blue ling |
Union and international waters of Vb, VI, VII |
5,000 |
0 |
0 |
0 % |
0,500 |
DE |
BSF/56712- |
Black scabbardfish |
EU and international waters of V, VI, VII and XII |
57,500 |
0 |
0 |
0 % |
5,750 |
DE |
COD/03AS. |
Cod |
Kattegat |
1,200 |
0,481 |
0 |
40,08 % |
0,120 |
DE |
COD/3DX32. |
Cod |
EU waters of Subdivisions 25-32 |
4 711,350 |
0 |
540,701 |
11,48 % |
471,135 |
DE |
GFB/1234- |
Greater forkbeard |
EU and international waters of I, II, III and IV |
9,900 |
0 |
0 |
0 % |
0,990 |
DE |
GFB/567- |
Greater forkbeard |
EU and international waters of V, VI and VII |
11,000 |
0 |
0 |
0 % |
1,100 |
DE |
GHL/2A-C46 |
Greenland halibut |
Union waters of IIa and IV, Union and international waters of Vb and VI |
8,000 |
0 |
0 |
0 % |
0,800 |
DE |
HAD/2AC4. |
Haddock |
IV; Union waters of IIa |
700,990 |
233,909 |
436,130 |
95,58 % |
30,951 |
DE |
HAD/5BC6A. |
Haddock |
Union and international waters of Vb and VIa |
1,800 |
0 |
0 |
0 % |
0,180 |
DE |
HAD/6B1214 |
Haddock |
Union and international waters of VIb, XII and XIV |
4,000 |
0 |
0 |
0 % |
0,400 |
DE |
HER/1/2- |
Herring |
Union, Norwegian and international waters of I and II |
4 431,130 |
2 321,619 |
1 922,228 |
95,77 % |
187,283 |
DE |
HER/3D-R30 |
Herring |
Union waters of Subdivisions 25-27, 28.2, 29 and 32 |
1 416,000 |
0 |
1 415,315 |
99,95 % |
0,685 |
DE |
HER/5B6ANB |
Herring |
Union and international waters of Vb, VIb and VIaN |
4 481,680 |
4 032,643 |
0 |
89,98 % |
448,168 |
DE |
HER/7G-K. |
Herring |
VIIg, VIIh, VIIj and VIIk |
501,970 |
450,217 |
0 |
89,69 % |
50,197 |
DE |
HKE/2AC4-C |
Hake |
Union waters of IIa and IV |
171,250 |
92,375 |
0 |
53,94 % |
17,125 |
DE |
JAX/2A-14 |
Horse mackerel and associated by-catches |
Union waters of IIa, IVa; VI, VIIa-c, VIIe-k, VIIIa, VIIIb, VIIId and VIIIe; Union and international waters of Vb; international waters of XII and XIV |
27 659,260 |
24 834,294 |
49,803 |
89,97 % |
2 765,926 |
DE |
LEZ/2AC4-C |
Megrims |
Union waters of IIa and IV |
5,600 |
1,071 |
0 |
19,13 % |
0,56 |
DE |
LIN/04-C. |
Ling |
Union waters of IV |
104,160 |
45,061 |
0 |
43,26 % |
10,416 |
DE |
LIN/1/2. |
Ling |
Union and international waters of I and II |
8,900 |
0,663 |
0 |
7,45 % |
0,890 |
DE |
LIN/3A/BCD |
Ling |
IIIa; Union waters of IIIbcd |
4,150 |
0,410 |
0 |
9,88 % |
0,415 |
DE |
LIN/6X14. |
Ling |
Union and international waters of VI, VII, VIII, IX, X, XII and XIV |
93,070 |
2,589 |
0 |
2,78 % |
9,307 |
DE |
MAC/2A34. |
Mackerel |
IIIa and IV; Union waters of IIa, IIIb, IIIc and Subdivisions 22-32 |
871,140 |
836,766 |
0 |
96,05 % |
34,374 |
DE |
NEP/2AC4-C |
Norway lobster |
Union waters of IIa and IV |
531,650 |
419,588 |
0 |
78,92 % |
53,165 |
DE |
NEP/3A/BCD |
Norway lobster |
IIIa; Union waters of Subdivisions 22-32 |
12,500 |
3,139 |
0 |
25,11 % |
1,250 |
DE |
POK/56-14 |
Saithe |
VI; Union and international waters of Vb, XII and XIV |
85,270 |
0 |
0 |
0 % |
8,527 |
DE |
RNG/5B67- |
Roundnose grenadier |
EU and international waters of Vb, VI, VII |
8,500 |
0 |
0 |
0 % |
0,850 |
DE |
RNG/8X14- |
Roundnose grenadier |
EU and international waters of VIII, IX, X, XII and XIV |
41,000 |
0 |
0 |
0 % |
4,100 |
DE |
SOL/24-C. |
Common sole |
Union waters of II and IV |
658,500 |
560,818 |
0 |
85,17 % |
65,850 |
DE |
SOL/3A/BCD |
Common sole |
IIIa; Union waters of Subdivisions 22-32 |
22,400 |
8,892 |
0 |
39,70 % |
2,240 |
DE |
SPR/3BCD-C |
Sprat |
Union waters of Subdivisions 22-32 |
10 322,000 |
0 |
10 315,365 |
99,94 % |
6,635 |
DE |
USK/04-C. |
Tusk |
Union waters of IV |
20,800 |
1,817 |
0 |
8,74 % |
2,080 |
DE |
USK/1214EI |
Tusk |
Union and international waters of I, II and XIV |
4,700 |
0,297 |
0 |
6,32 % |
0,470 |
DE |
USK/3A/BCD |
Tusk |
IIIa, Union waters of Subdivisions 22-32 |
7,700 |
0,018 |
0 |
0,23 % |
0,770 |
DE |
USK/567EI. |
Tusk |
Union and international waters of V, VI and VII |
3,000 |
0 |
0 |
0 % |
0,300 |
DE |
WHB/1X14 |
Blue whiting |
Union and international waters of I, II, III, IV, V, VI, VII, VIIIa, VIIIb, VIIId, VIIIe, XII and XIV |
12 618,360 |
11 341,048 |
37,671 |
90,18 % |
1 239,641 |
DE |
WHG/56-14 |
Whiting |
VI, Union and international waters of Vb, international waters of XII and XIV |
2,000 |
0 |
0 |
0 % |
0,200 |
DK |
ANF/2AC4-C |
Anglerfish |
Union waters of IIa and IV |
756,580 |
196,140 |
0 |
25,92 % |
75,658 |
DK |
ARU/34-C |
Greater silver smelt |
Union waters of III and IV |
1 017,300 |
317,760 |
0 |
31,24 % |
101,730 |
DK |
ARU/567. |
Greater silver smelt |
Union and international waters of V, VI and VII |
422,500 |
124,850 |
0 |
29,55 % |
42,250 |
DK |
COD/03AS. |
Cod |
Kattegat |
71,700 |
56,730 |
0 |
79,12 % |
7,170 |
DK |
COD/3DX32. |
Cod |
EU waters of Subdivisions 25-32 |
15 204,390 |
0 |
5 869,290 |
38,60 % |
1 520,439 |
DK |
GHL/2A-C46 |
Greenland halibut |
Union waters of IIa and IV, Union and international waters of Vb and VI |
13,200 |
0 |
0 |
0 % |
1,320 |
DK |
HAD/2AC4. |
Haddock |
IV; Union waters of IIa |
1 470,160 |
1 282,900 |
0 |
87,26 % |
147,016 |
DK |
HER/1/2- |
Herring |
Union, Norwegian and international waters of I and II |
17 184,200 |
16 880,370 |
0 |
98,23 % |
303,830 |
DK |
HER/3D-R30 |
Herring |
Union waters of Subdivisions 25-27, 28.2, 29 and 32 |
2 204,000 |
0 |
2 197,030 |
99,68 % |
6,970 |
DK |
HER/5B6ANB |
Herring |
Union and international waters of Vb, VIb and VIaN |
247,500 |
208,370 |
0 |
84,19 % |
24,750 |
DK |
HKE/2AC4-C |
Hake |
Union waters of IIa and IV |
1 351,570 |
870,060 |
0 |
64,37 % |
135,157 |
DK |
HKE/3A/BCD |
Hake |
IIIa; Union waters of Subdivisions 22-32 |
816,800 |
210,910 |
0 |
25,82 % |
81,680 |
DK |
JAX/2A-14 |
Horse mackerel and associated by-catches |
Union waters of IIa, IVa; VI, VIIa-c, VIIe-k, VIIIa, VIIIb, VIIId and VIIIe; Union and international waters of Vb; international waters of XII and XIV |
7 868,710 |
6 681,950 |
43,700 |
85,47 % |
786,871 |
DK |
LEZ/2AC4-C |
Megrims |
Union waters of IIa and IV |
21,100 |
19,180 |
0 |
90,90 % |
1,920 |
DK |
LIN/04-C. |
Ling |
Union waters of IV |
204,330 |
83,180 |
0 |
40,71 % |
20,433 |
DK |
LIN/1/2. |
Ling |
Union and international waters of I and II |
8,900 |
0 |
0 |
0 % |
0,890 |
DK |
LIN/3A/BCD |
Ling |
IIIa; Union waters of IIIbcd |
63,310 |
56,380 |
0 |
89,05 % |
6,331 |
DK |
LIN/6X14. |
Ling |
Union and international waters of VI, VII, VIII, IX, X, XII and XIV |
5,600 |
0 |
0 |
0 % |
0,560 |
DK |
MAC/2A4A-N |
Mackerel |
Norwegian waters of IIa and IVa |
11 413,440 |
0 |
11 413,080 |
100,00 % |
0,360 |
DK |
NEP/2AC4-C |
Norway lobster |
Union waters of IIa and IV |
1 035,110 |
250,970 |
0 |
24,25 % |
103,511 |
DK |
NEP/3A/BCD |
Norway lobster |
IIIa; Union waters of Subdivisions 22-32 |
4 298,680 |
2 646,290 |
0 |
61,56 % |
429,868 |
DK |
PRA/2AC4-C |
Northern prawn |
Union waters of IIa and IV |
2 530,600 |
163,460 |
0 |
6,46 % |
253,060 |
DK |
SOL/24-C. |
Common sole |
Union waters of II and IV |
692,100 |
497,230 |
0 |
71,84 % |
69,210 |
DK |
SOL/3A/BCD |
Common sole |
IIIa; Union waters of Subdivisions 22-32 |
528,900 |
246,150 |
0 |
46,54 % |
52,890 |
DK |
SPR/3BCD-C |
Sprat |
Union waters of Subdivisions 22-32 |
27 569,000 |
0 |
27 113,080 |
98,35 % |
455,920 |
DK |
USK/04-C. |
Tusk |
Union waters of IV |
69,900 |
4,830 |
0 |
6,91 % |
6,990 |
DK |
USK/3A/BCD |
Tusk |
IIIa; Union waters of Subdivisions 22-32 |
16,300 |
0,820 |
0 |
5,03 % |
1,630 |
DK |
WHB/1X14 |
Blue whiting |
Union and international waters of I, II, III, IV, V, VI, VII, VIIIa, VIIIb, VIIId, VIIIe, XII and XIV |
3 417,510 |
2 165,250 |
14,710 |
63,79 % |
341,751 |
EE |
COD/3DX32. |
Cod |
EU waters of Subdivisions 25-32 |
1 633,670 |
0 |
248,622 |
15,22 % |
163,367 |
EE |
HER/03D.RG |
Herring |
Subdivision 28.1 |
12 332,440 |
11 898,247 |
0 |
96,48 % |
434,193 |
EE |
HER/3D-R30 |
Herring |
Union waters of Subdivisions 25-27, 28.2, 29 and 32 |
10 142,000 |
0 |
10 042,332 |
99,02 % |
99,668 |
EE |
RNG/5B67- |
Roundnose grenadier |
EU and international waters of Vb, VI, VII |
63,000 |
0 |
0 |
0 % |
6,300 |
EE |
SPR/3BCD-C |
Sprat |
Union waters of Subdivisions 22-32 |
29 810,000 |
0 |
29 805,065 |
99,98 % |
4,935 |
ES |
ANF/07. |
Anglerfish |
VII |
2 971,400 |
2 868,090 |
0 |
96,52 % |
103,310 |
ES |
ANF/8ABDE. |
Anglerfish |
VIIIa, VIIIb, VIIId and VIIIe |
1 070,400 |
1 019,850 |
0 |
95,28 % |
50,550 |
ES |
ANF/8C3411 |
Anglerfish |
VIIIc, IX and X; Union waters of CECAF 34.1.1 |
2 121,690 |
1 816,280 |
0 |
85,61 % |
212,169 |
ES |
GFB/567- |
Greater forkbeard |
EU and international waters of V, VI and VII |
588,220 |
568,360 |
19,830 |
99,99 % |
0,030 |
ES |
GHL/2A-C46 |
Greenland halibut |
Union waters of IIa and IV, Union and international waters of Vb and VI |
13,200 |
0,110 |
0 |
0,83 % |
1,320 |
ES |
HAD/6B1214 |
Haddock |
Union and international waters of VIb, XII and XIV |
3,300 |
0 |
0 |
0 % |
0,330 |
ES |
HKE/571214 |
Hake |
VI and VII; Union and international waters of Vb; international waters of XII and XIV |
12 446,040 |
11 941,040 |
0 |
95,94 % |
505,000 |
ES |
HKE/8ABDE. |
Hake |
VIIIa, VIIIb, VIIId and VIIIe |
8 631,140 |
6 619,750 |
1 709,730 |
96,50 % |
301,660 |
ES |
HKE/8C3411 |
Hake |
VIIIc, IX and X; Union waters of CECAF 34.1.1 |
9 882,200 |
7 099,500 |
0 |
71,84 % |
988,220 |
ES |
JAX/08C. |
Horse mackerel and associated by-catches |
VIIIc |
23 628,510 |
18 787,770 |
0 |
79,51 % |
2 362,851 |
ES |
JAX/09. |
Horse mackerel and associated by-catches |
IX |
10 840,780 |
10 127,150 |
0 |
93,42 % |
713,630 |
ES |
JAX/2A-14 |
Horse mackerel and associated by-catches |
Union waters of IIa, IVa; VI, VIIa-c, VIIe-k, VIIIa, VIIIb, VIIId and VIIIe; Union and international waters of Vb; international waters of XII and XIV |
7 075,130 |
5 880,240 |
0 |
83,11 % |
707,513 |
ES |
LEZ/07. |
Megrims |
VII |
5 437,900 |
4 539,310 |
0 |
83,48 % |
543,790 |
ES |
LEZ/56-14 |
Megrims |
Union and international waters of Vb; VI; international waters of XII and XIV |
427,400 |
212,710 |
0 |
49,77 % |
42,740 |
ES |
LEZ/8ABDE. |
Megrims |
VIIIa, VIIIb, VIIId and VIIIe |
685,100 |
581,130 |
0 |
84,82 % |
68,510 |
ES |
LEZ/8C3411 |
Megrims |
VIIIc, IX and X; Union waters of CECAF 34.1.1 |
1 158,770 |
735,070 |
0 |
63,44 % |
115,877 |
ES |
LIN/6X14. |
Ling |
Union and international waters of VI, VII, VIII, IX, X, XII and XIV |
2 456,700 |
1 621,160 |
0 |
65,99 % |
245,670 |
ES |
MAC/8C3411 |
Mackerel |
VIIIc, IX and X; Union waters of CECAF 34.1.1 |
20 223,800 |
15 444,990 |
620,400 |
79,44 % |
2 022,380 |
ES |
NEP/07. |
Norway lobster |
VII |
1 498,480 |
76,510 |
132,180 |
13,93 % |
149,848 |
ES |
NEP/08C. |
Norway lobster |
VIIIc |
68,700 |
21,950 |
0 |
31,95 % |
6,870 |
ES |
NEP/5BC6. |
Norway lobster |
VI; Union and international waters of Vb |
37,200 |
0,060 |
0 |
0,16 % |
3,720 |
ES |
NEP/8ABDE. |
Norway lobster |
VIIIa, VIIIb, VIIId and VIIIe |
131,200 |
0,570 |
0 |
0,43 % |
13,120 |
ES |
NEP/9/3411 |
Norway lobster |
IX and X; Union waters of CECAF 34.1.1 |
36,850 |
31,340 |
0 |
85,05 % |
3,685 |
ES |
POK/56-14 |
Saithe |
VI; Union and international waters of Vb, XII and XIV |
23,000 |
21,190 |
0 |
92,13 % |
1,810 |
ES |
RNG/5B67- |
Roundnose grenadier |
EU and international waters of Vb, VI, VII |
111,060 |
110,900 |
0 |
99,86 % |
0,160 |
ES |
RNG/8X14- |
Roundnose grenadier |
EU and international waters of VIII, IX, X, XII and XIV |
3 650,020 |
2 417,700 |
202,060 |
71,77 % |
365,002 |
ES |
SBR/09- |
Red Seabream |
EU and international waters of IX |
682,500 |
111,530 |
52,720 |
24,07 % |
68,250 |
ES |
SBR/10- |
Red Seabream |
EU and international waters of X |
10,000 |
0,510 |
0 |
5,10 % |
1,000 |
ES |
SBR/678- |
Red Seabream |
EU and international waters of VI, VII and VIII |
118,230 |
118,170 |
0 |
99,95 % |
0,060 |
ES |
WHB/1X14 |
Blue whiting |
Union and international waters of I, II, III, IV, V, VI, VII, VIIIa, VIIIb, VIIId, VIIIe, XII and XIV |
1 587,170 |
74,530 |
0 |
4,70 % |
158,717 |
ES |
WHB/8C3411 |
Blue whiting |
VIIIc, IX and X; Union waters of CECAF 34.1.1 |
21 487,890 |
14 538,070 |
0 |
67,66 % |
2 148,789 |
ES |
WHG/56-14 |
Whiting |
VI, Union and international waters of Vb, international waters of XII and XIV |
1,100 |
0 |
0 |
0 % |
0,110 |
ES |
WHG/7X7A-C |
Whiting |
VIIb, VIIc, VIId, VIIe, VIIf, VIIg, VIIh, VIIj and VIIk |
11,200 |
4,190 |
0 |
37,41 % |
1,120 |
FI |
COD/3DX32. |
Cod |
EU waters of Subdivisions 25-32 |
1 250,090 |
0 |
434,391 |
34,75 % |
125,009 |
FI |
HER/30/31. |
Herring |
Subdivisions 30-31 |
105 843,500 |
0 |
103 546,210 |
97,83 % |
2 297,290 |
FI |
HER/3D-R30 |
Herring |
Union waters of Subdivisions 25-27, 28.2, 29 and 32 |
19 556,000 |
0 |
18 052,464 |
92,31 % |
1 503,536 |
FI |
SPR/3BCD-C |
Sprat |
Union waters of Subdivisions 22-32 |
11 442,000 |
0 |
11 074,842 |
96,79 % |
367,158 |
FR |
ALF/3X14- |
Alfonsinos |
EU and international waters of III, IV, V, VI, VII, VIII, IX, X, XII and XIV |
31,200 |
19,300 |
0 |
61,86 % |
3,120 |
FR |
ANF/07. |
Anglerfish |
VII |
17 267,500 |
14 859,400 |
0 |
86,05 % |
1 726,750 |
FR |
ANF/2AC4-C |
Anglerfish |
Union waters of IIa and IV |
70,200 |
17,600 |
0 |
25,07 % |
7,020 |
FR |
ANF/8ABDE. |
Anglerfish |
VIIIa, VIIIb, VIIId and VIIIe |
7 397,600 |
6 154,300 |
0 |
83,19 % |
739,760 |
FR |
ANF/8C3411 |
Anglerfish |
VIIIc, IX and X; Union waters of CECAF 34.1.1 |
49,500 |
38,400 |
0 |
77,58 % |
4,950 |
FR |
ARU/1/2. |
Greater silver smelt |
Union and international waters of I and II |
8,900 |
0,200 |
0 |
2,25 % |
0,890 |
FR |
ARU/34-C |
Greater silver smelt |
Union waters of III and IV |
7,800 |
1,800 |
0 |
23,08 % |
0,780 |
FR |
ARU/567. |
Greater silver smelt |
Union and international waters of V, VI and VII |
7,800 |
0 |
0 |
0 % |
0,780 |
FR |
BLI/5B67- |
Blue ling |
Union and international waters of Vb, VI, VII |
2 239,640 |
1 694,000 |
0 |
75,64 % |
223,964 |
FR |
BSF/56712- |
Black scabbardfish |
EU and international waters of V, VI, VII and XII |
2 887,090 |
2 167,100 |
0 |
75,06 % |
288,709 |
FR |
BSF/8910- |
Black scabbardfish |
EU and international waters of VIII, IX and X |
31,900 |
7,400 |
0 |
23,20 % |
3,190 |
FR |
COD/07A. |
Cod |
VIIa |
11,600 |
0,500 |
0 |
4,31 % |
1,160 |
FR |
COD/07D. |
Cod |
VIId |
1 414,400 |
642,300 |
0 |
45,41 % |
141,440 |
FR |
COD/7XAD34 |
Cod |
VIIb, VIIc, VIIe-k, VIII, IX and X, Union waters of CECAF 34.1.1 |
8 182,100 |
4 016,200 |
0 |
49,09 % |
818,210 |
FR |
GFB/1012- |
Greater forkbeard |
EU and international waters of X and XII |
10,000 |
0 |
0 |
0 % |
1,000 |
FR |
GFB/1234- |
Greater forkbeard |
EU and international waters of I, II, III and IV |
10,000 |
0,600 |
0 |
6,00 % |
1,000 |
FR |
GFB/567- |
Greater forkbeard |
EU and international waters of V, VI and VII |
727,000 |
438,100 |
17,300 |
62,64 % |
72,700 |
FR |
GFB/89- |
Greater forkbeard |
EU and international waters of VIII and IX |
16,000 |
10,100 |
0 |
63,13 % |
1,600 |
FR |
GHL/2A-C46 |
Greenland halibut |
Union waters of IIa and IV, Union and international waters of Vb and VI |
598,400 |
305,600 |
0 |
51,07 % |
59,840 |
FR |
HAD/07A. |
Haddock |
VIIa |
95,900 |
0,700 |
0 |
0,73 % |
9,590 |
FR |
HAD/2AC4. |
Haddock |
IV; Union waters of IIa |
256,700 |
179,000 |
0 |
69,73 % |
25,670 |
FR |
HAD/5BC6A. |
Haddock |
Union and international waters of Vb and VIa |
103,100 |
51,700 |
0 |
50,15 % |
10,310 |
FR |
HAD/6B1214 |
Haddock |
Union and international waters of VIb, XII and XIV |
149,800 |
0 |
0 |
0 % |
14,980 |
FR |
HAD/7X7A34 |
Haddock |
VIIb-k, VIII, IX and X; Union waters of CECAF 34.1.1 |
8 878,000 |
8 778,600 |
0 |
98,88 % |
99,400 |
FR |
HER/5B6ANB |
Herring |
Union and international waters of Vb, VIb and VIaN |
590,200 |
586,600 |
0 |
99,39 % |
3,600 |
FR |
HER/7G-K. |
Herring |
VIIg, VIIh, VIIj and VIIk |
1 200,400 |
0,900 |
0 |
0,07 % |
120,040 |
FR |
HKE/2AC4-C |
Hake |
Union waters of IIa and IV |
1 032,750 |
800,800 |
0 |
77,54 % |
103,275 |
FR |
HKE/571214 |
Hake |
VI and VII; Union and international waters of Vb; international waters of XII and XIV |
17 925,400 |
16 129,600 |
0 |
89,98 % |
1 792,540 |
FR |
HKE/8ABDE. |
Hake |
VIIIa, VIIIb, VIIId and VIIIe |
18 839,000 |
13 633,600 |
0 |
72,37 % |
1 883,900 |
FR |
HKE/8C3411 |
Hake |
VIIIc, IX and X; Union waters of CECAF 34.1.1 |
951,700 |
368,700 |
0 |
38,74 % |
95,170 |
FR |
JAX/08C. |
Horse mackerel and associated by-catches |
VIIIc |
411,100 |
9,800 |
0 |
2,38 % |
41,110 |
FR |
JAX/2A-14 |
Horse mackerel and associated by-catches |
Union waters of IIa, IVa; VI, VIIa-c, VIIe-k, VIIIa, VIIIb, VIIId and VIIIe; Union and international waters of Vb; international waters of XII and XIV |
12 410,200 |
6 461,500 |
300 |
54,48 % |
1 241,020 |
FR |
LEZ/07. |
Megrims |
VII |
6 633,800 |
3 679,500 |
0 |
55,47 % |
663,380 |
FR |
LEZ/2AC4-C |
Megrims |
Union waters of IIa and IV |
35,200 |
6,800 |
0 |
19,32 % |
3,520 |
FR |
LEZ/56-14 |
Megrims |
Union and international waters of Vb; VI; international waters of XII and XIV |
1 665,600 |
95,600 |
0 |
5,74 % |
166,560 |
FR |
LEZ/8ABDE. |
Megrims |
VIIIa, VIIIb, VIIId and VIIIe |
1 194,700 |
849,700 |
0 |
71,12 % |
119,470 |
FR |
LEZ/8C3411 |
Megrims |
VIIIc, IX and X; Union waters of CECAF 34.1.1 |
62,100 |
12,900 |
0 |
20,77 % |
6,210 |
FR |
LIN/04-C. |
Ling |
Union waters of IV |
133,900 |
103,800 |
0 |
77,52 % |
13,390 |
FR |
LIN/1/2. |
Ling |
Union and international waters of I and II |
8,900 |
7,400 |
0 |
83,15 % |
0,890 |
FR |
LIN/6X14. |
Ling |
Union and international waters of VI, VII, VIII, IX, X, XII and XIV |
2 678,200 |
2 215,400 |
0 |
82,72 % |
267,820 |
FR |
MAC/2A34. |
Mackerel |
IIIa and IV; Union waters of IIa, IIIb, IIIc and Subdivisions 22-32 |
1 725,200 |
1 341,900 |
0 |
77,78 % |
172,520 |
FR |
MAC/2CX14- |
Mackerel |
VI, VII, VIIIa, VIIIb, VIIId and VIIIe; Union and international waters of Vb; international waters of IIa, XII and XIV |
16 821,900 |
13 367,400 |
1 322,300 |
87,32 % |
1 682,190 |
FR |
MAC/8C3411 |
Mackerel |
VIIIc, IX and X; Union waters of CECAF 34.1.1 |
1 037,100 |
221,300 |
642,700 |
83,31 % |
103,710 |
FR |
NEP/07. |
Norway lobster |
VII |
5 725,600 |
671,800 |
0 |
11,73 % |
572,560 |
FR |
NEP/08C. |
Norway lobster |
VIIIc |
14,600 |
0,500 |
0 |
3,42 % |
1,460 |
FR |
NEP/2AC4-C |
Norway lobster |
Union waters of IIa and IV |
30,800 |
0 |
0 |
0 % |
3,080 |
FR |
NEP/5BC6. |
Norway lobster |
VI; Union and international waters of Vb |
147,700 |
0 |
0 |
0 % |
14,770 |
FR |
NEP/8ABDE. |
Norway lobster |
VIIIa, VIIIb, VIIId and VIIIe |
4 195,500 |
2 430,900 |
0 |
57,94 % |
419,550 |
FR |
PLE/07A. |
Plaice |
VIIa |
20,000 |
0,300 |
0 |
1,50 % |
2,000 |
FR |
PLE/7DE. |
Plaice |
VIId and VIIe |
3 152,400 |
2 358,200 |
0 |
74,81 % |
315,240 |
FR |
PLE/7HJK. |
Plaice |
VIIh, VIIj and VIIk |
50,300 |
48,600 |
0 |
96,62 % |
1,700 |
FR |
POK/56-14 |
Saithe |
VI; Union and international waters of Vb, XII and XIV |
4 794,000 |
3 805,600 |
0 |
79,38 % |
479,400 |
FR |
RNG/5B67- |
Roundnose grenadier |
EU and international waters of Vb, VI, VII |
4 038,720 |
993,700 |
0 |
24,60 % |
403,872 |
FR |
RNG/8X14- |
Roundnose grenadier |
EU and international waters of VIII, IX, X, XII and XIV |
133,900 |
0,200 |
0 |
0,15 % |
13,390 |
FR |
SBR/678- |
Red Seabream |
EU and international waters of VI, VII and VIII |
78,500 |
51,200 |
0 |
65,22 % |
7,850 |
FR |
SOL/07D. |
Common sole |
VIId |
3 505,600 |
2 864,500 |
0 |
81,71 % |
350,560 |
FR |
SOL/07E. |
Common sole |
VIIe |
354,100 |
321,100 |
0 |
90,68 % |
33,000 |
FR |
SOL/24-C. |
Common sole |
Union waters of II and IV |
947,100 |
680,100 |
0 |
71,81 % |
94,710 |
FR |
SOL/7FG. |
Common sole |
VIIf and VIIg |
63,500 |
48,800 |
0 |
76,85 % |
6,350 |
FR |
SOL/7HJK. |
Common sole |
VIIh, VIIj and VIIk |
106,800 |
76,000 |
0 |
71,16 % |
10,680 |
FR |
SOL/8AB. |
Common sole |
VIIIa and VIIIb |
4 120,400 |
3 879,200 |
0 |
94,15 % |
241,200 |
FR |
USK/04-C. |
Tusk |
Union waters of IV |
47,700 |
10,900 |
0 |
22,85 % |
4,770 |
FR |
USK/1214EI |
Tusk |
Union and international waters of I, II and XIV |
7,700 |
6,900 |
0 |
89,61 % |
0,770 |
FR |
USK/567EI. |
Tusk |
Union and international waters of V, VI and VII |
625,040 |
228,200 |
0 |
36,51 % |
62,504 |
FR |
WHB/1X14 |
Blue whiting |
Union and international waters of I, II, III, IV, V, VI, VII, VIIIa, VIIIb, VIIId, VIIIe, XII and XIV |
8 319,000 |
7 181,600 |
0 |
86,33 % |
831,900 |
FR |
WHG/07A. |
Whiting |
VIIa |
3,300 |
0,600 |
0 |
18,18 % |
0,330 |
FR |
WHG/56-14 |
Whiting |
VI, Union and international waters of Vb, international waters of XII and XIV |
39,000 |
1,400 |
0 |
3,59 % |
3,900 |
FR |
WHG/7X7A-C |
Whiting |
VIIb, VIIc, VIId, VIIe, VIIf, VIIg, VIIh, VIIj and VIIk |
15 078,900 |
6 997,700 |
0 |
46,41 % |
1 507,890 |
IE |
ALF/3X14- |
Alfonsinos |
EU and international waters of III, IV, V, VI, VII, VIII, IX, X, XII and XIV |
1,100 |
0 |
0 |
0 % |
0,110 |
IE |
ANF/07. |
Anglerfish |
VII |
3 523,950 |
3 172,717 |
0 |
90,03 % |
351,233 |
IE |
ARU/34-C |
Greater silver smelt |
Union waters of III and IV |
7,800 |
0 |
0 |
0 % |
0,780 |
IE |
ARU/567. |
Greater silver smelt |
Union and international waters of V, VI and VII |
338,800 |
0 |
0 |
0 % |
33,880 |
IE |
BLI/5B67- |
Blue ling |
Union and international waters of Vb, VI, VII |
0,500 |
0,480 |
0 |
96,00 % |
0,020 |
IE |
BSF/56712- |
Black scabbardfish |
EU and international waters of V, VI, VII and XII |
0,100 |
0 |
0 |
0 % |
0,010 |
IE |
COD/07A. |
Cod |
VIIa |
175,100 |
159,692 |
0 |
91,20 % |
15,408 |
IE |
COD/7XAD34 |
Cod |
VIIb, VIIc, VIIe-k, VIII, IX and X, Union waters of CECAF 34.1.1 |
1 612,010 |
1 452,085 |
0 |
90,08 % |
159,925 |
IE |
GFB/567- |
Greater forkbeard |
EU and international waters of V, VI and VII |
26,700 |
17,567 |
0 |
65,79 % |
2,670 |
IE |
HAD/07A. |
Haddock |
VIIa |
541,640 |
491,903 |
0 |
90,82 % |
49,737 |
IE |
HAD/5BC6A. |
Haddock |
Union and international waters of Vb and VIa |
777,260 |
746,274 |
0 |
96,01 % |
30,986 |
IE |
HAD/6B1214 |
Haddock |
Union and international waters of VIb, XII and XIV |
105,400 |
105,358 |
0 |
99,96 % |
0,042 |
IE |
HER/07A/MM |
Herring |
VIIa |
2,500 |
0 |
0 |
0 % |
0,250 |
IE |
HER/1/2- |
Herring |
Union, Norwegian and international waters of I and II |
3 755,230 |
0 |
3 593,584 |
95,70 % |
161,646 |
IE |
HER/5B6ANB |
Herring |
Union and international waters of Vb, VIb and VIaN |
3 739,510 |
3 025,655 |
0 |
80,91 % |
373,951 |
IE |
HER/7G-K. |
Herring |
VIIg, VIIh, VIIj and VIIk |
16 643,450 |
14 790,997 |
0 |
88,87 % |
1 664,345 |
IE |
HKE/571214 |
Hake |
VI and VII; Union and international waters of Vb; international waters of XII and XIV |
1 972,160 |
1 772,351 |
0 |
89,87 % |
197,216 |
IE |
JAX/2A-14 |
Horse mackerel and associated by-catches |
Union waters of IIa, IVa; VI, VIIa-c, VIIe-k, VIIIa, VIIIb, VIIId and VIIIe; Union and international waters of Vb; international waters of XII and XIV |
41 195,510 |
37 398,143 |
0 |
90,78 % |
3 797,367 |
IE |
LEZ/07. |
Megrims |
VII |
3 386,900 |
3 053,295 |
0 |
90,15 % |
333,605 |
IE |
LEZ/56-14 |
Megrims |
Union and international waters of Vb; VI; international waters of XII and XIV |
487,300 |
384,113 |
0 |
78,82 % |
48,730 |
IE |
LIN/6X14. |
Ling |
Union and international waters of VI, VII, VIII, IX, X, XII and XIV |
692,520 |
619,345 |
0 |
89,43 % |
69,252 |
IE |
MAC/2CX14- |
Mackerel |
VI, VII, VIIIa, VIIIb, VIIId and VIIIe; Union and international waters of Vb; international waters of IIa, XII and XIV |
57 443,250 |
43 079,934 |
13 523,407 |
98,54 % |
839,909 |
IE |
NEP/*07U16 |
Norway lobster |
VII (Porcupine Bank — Unit 16) |
771,400 |
654,000 |
0 |
84,78 % |
77,140 |
IE |
NEP/07. |
Norway lobster |
VII |
9 352,420 |
7 762,505 |
654,000 |
89,99 % |
935,242 |
IE |
NEP/5BC6. |
Norway lobster |
VI; Union and international waters of Vb |
247,100 |
6,106 |
0 |
2,47 % |
24,710 |
IE |
PLE/07A. |
Plaice |
VIIa |
1 047,800 |
102,697 |
0 |
9,80 % |
104,780 |
IE |
POK/56-14 |
Saithe |
VI; Union and international waters of Vb, XII and XIV |
465,000 |
312,944 |
0 |
67,30 % |
46,500 |
IE |
RNG/5B67- |
Roundnose grenadier |
EU and international waters of Vb, VI, VII |
27,700 |
0 |
0 |
0 % |
2,770 |
IE |
RNG/8X14- |
Roundnose grenadier |
EU and international waters of VIII, IX, X, XII and XIV |
5,700 |
0 |
0 |
0 % |
0,570 |
IE |
SOL/7HJK. |
Common sole |
VIIh, VIIj and VIIk |
170,400 |
85,414 |
0 |
50,13 % |
17,040 |
IE |
USK/567EI. |
Tusk |
Union and international waters of V, VI and VII |
14,300 |
1,865 |
0 |
13,04 % |
1,430 |
IE |
WHB/1X14 |
Blue whiting |
Union and international waters of I, II, III, IV, V, VI, VII, VIIIa, VIIIb, VIIId, VIIIe, XII and XIV |
14 671,780 |
13 205,392 |
0 |
90,01 % |
1 466,388 |
IE |
WHG/07A. |
Whiting |
VIIa |
47,910 |
44,360 |
0 |
92,59 % |
3,550 |
IE |
WHG/56-14 |
Whiting |
VI, Union and international waters of Vb, international waters of XII and XIV |
92,370 |
72,363 |
0 |
78,34 % |
9,237 |
IE |
WHG/7X7A-C |
Whiting |
VIIb, VIIc, VIId, VIIe, VIIf, VIIg, VIIh, VIIj and VIIk |
7 668,960 |
6 902,221 |
0 |
90,00 % |
766,739 |
LT |
COD/3DX32. |
Cod |
EU waters of Subdivisions 25-32 |
4 353,400 |
0 |
1 743,276 |
40,04 % |
435,340 |
LT |
HER/3D-R30 |
Herring |
Union waters of Subdivisions 25-27, 28.2, 29 and 32 |
2 663,000 |
0 |
2 478,427 |
93,07 % |
184,573 |
LT |
SPR/3BCD-C |
Sprat |
Union waters of Subdivisions 22-32 |
10 355,000 |
0 |
10 353,744 |
99,99 % |
1,256 |
LV |
COD/3DX32. |
Cod |
EU waters of Subdivisions 25-32 |
6 283,000 |
0 |
2 441,400 |
38,86 % |
628,300 |
LV |
HER/03D.RG |
Herring |
Subdivision 28.1 |
18 463,000 |
18 462,300 |
0 |
100 % |
0,700 |
NL |
ANF/07. |
Anglerfish |
VII |
15,200 |
0,501 |
0 |
3,30 % |
1,520 |
NL |
ANF/2AC4-C |
Anglerfish |
Union waters of IIa and IV |
274,100 |
23,815 |
0 |
8,69 % |
27,410 |
NL |
ARU/1/2. |
Greater silver smelt |
Union and international waters of I and II |
20,700 |
0 |
0 |
0 % |
2,070 |
NL |
ARU/34-C |
Greater silver smelt |
Union waters of III and IV |
46,900 |
0 |
0 |
0 % |
4,690 |
NL |
ARU/567. |
Greater silver smelt |
Union and international waters of V, VI and VII |
3 147,100 |
1 430,210 |
0 |
45,45 % |
314,710 |
NL |
COD/07A. |
Cod |
VIIa |
1,000 |
0 |
0 |
0 % |
0,100 |
NL |
COD/07D. |
Cod |
VIId |
46,030 |
36,978 |
0 |
80,33 % |
4,603 |
NL |
COD/7XAD34 |
Cod |
VIIb, VIIc, VIIe-k, VIII, IX and X, Union waters of CECAF 34.1.1 |
2,600 |
0,922 |
0 |
35,46 % |
0,260 |
NL |
GFB/567- |
Greater forkbeard |
EU and international waters of V, VI and VII |
149,000 |
0 |
0 |
0 % |
14,900 |
NL |
HAD/07A. |
Haddock |
VIIa |
0,200 |
0 |
0 |
0 % |
0,020 |
NL |
HAD/2AC4. |
Haddock |
IV; Union waters of IIa |
184,790 |
169,231 |
0 |
91,58 % |
15,559 |
NL |
HAD/7X7A34 |
Haddock |
VIIb-k, VIII, IX and X; Union waters of CECAF 34.1.1 |
23,000 |
21,136 |
0 |
91,90 % |
1,864 |
NL |
HER/1/2- |
Herring |
Union, Norwegian and international waters of I and II |
5 479,850 |
5 425,883 |
10,620 |
99,21 % |
43,347 |
NL |
HER/5B6ANB |
Herring |
Union and international waters of Vb, VIb and VIaN |
2 370,260 |
2 130,949 |
0 |
89,90 % |
237,026 |
NL |
HER/7G-K. |
Herring |
VIIg, VIIh, VIIj and VIIk |
865,370 |
314,834 |
0 |
36,38 % |
86,537 |
NL |
HKE/2AC4-C |
Hake |
Union waters of IIa and IV |
81,020 |
42,102 |
0 |
51,96 % |
8,102 |
NL |
HKE/571214 |
Hake |
VI and VII; Union and international waters of Vb; international waters of XII and XIV |
238,150 |
76,346 |
1,177 |
32,55 % |
23,815 |
NL |
HKE/8ABDE. |
Hake |
VIIIa, VIIIb, VIIId and VIIIe |
24,800 |
0 |
6,700 |
27,02 % |
2,480 |
NL |
JAX/2A-14 |
Horse mackerel and associated by-catches |
Union waters of IIa, IVa; VI, VIIa-c, VIIe-k, VIIIa, VIIIb, VIIId and VIIIe; Union and international waters of Vb; international waters of XII and XIV |
64 263,580 |
52 455,973 |
2450,424 |
85,44 % |
6 426,358 |
NL |
LEZ/2AC4-C |
Megrims |
Union waters of IIa and IV |
27,600 |
15,124 |
0 |
54,80 % |
2,760 |
NL |
LIN/04-C. |
Ling |
Union waters of IV |
5,600 |
0 |
0 |
0 % |
0,560 |
NL |
LIN/6X14. |
Ling |
Union and international waters of VI, VII, VIII, IX, X, XII and XIV |
0,300 |
0,100 |
0 |
33,33 % |
0,030 |
NL |
MAC/2A34. |
Mackerel |
IIIa and IV; Union waters of IIa, IIIb, IIIc and Subdivisions 22-32 |
1 488,500 |
741,559 |
598,041 |
90,00 % |
148,900 |
NL |
MAC/2CX14- |
Mackerel |
VI, VII, VIIIa, VIIIb, VIIId and VIIIe; Union and international waters of Vb; international waters of IIa, XII and XIV |
19 082,230 |
13 711,312 |
3 462,695 |
90,00 % |
1 908,223 |
NL |
NEP/2AC4-C |
Norway lobster |
Union waters of IIa and IV |
1 219,270 |
862,899 |
0 |
70,77 % |
121,927 |
NL |
NEP/5BC6. |
Norway lobster |
VI; Union and international waters of Vb |
18,000 |
0 |
0 |
0 % |
1,800 |
NL |
PLE/07A. |
Plaice |
VIIa |
0,100 |
0 |
0 |
0 % |
0,010 |
NL |
PRA/2AC4-C |
Northern prawn |
Union waters of IIa and IV |
41,900 |
0 |
0 |
0 % |
4,190 |
NL |
SOL/24-C. |
Common sole |
Union waters of II and IV |
11 127,000 |
9 910,051 |
0 |
89,06 % |
1 112,700 |
NL |
SOL/3A/BCD |
Common sole |
IIIa; Union waters of Subdivisions 22-32 |
18,900 |
0 |
0 |
0 % |
1,890 |
NL |
SOL/7HJK. |
Common sole |
VIIh, VIIj and VIIk |
59,040 |
0 |
0 |
0 % |
5,904 |
NL |
WHB/1X14 |
Blue whiting |
Union and international waters of I, II, III, IV, V, VI, VII, VIIIa, VIIIb, VIIId, VIIIe, XII and XIV |
57 308,710 |
51 536,926 |
16,221 |
89,96 % |
5 730,871 |
NL |
WHG/7X7A-C |
Whiting |
VIIb, VIIc, VIId, VIIe, VIIf, VIIg, VIIh, VIIj and VIIk |
972,250 |
736,710 |
0 |
75,77 % |
97,225 |
PL |
BSF/56712- |
Black scabbardfish |
EU and international waters of V, VI, VII and XII |
38,500 |
0 |
0 |
0 % |
3,850 |
PL |
COD/3DX32. |
Cod |
EU waters of Subdivisions 25-32 |
19 438,400 |
0 |
11 794,652 |
60,68 % |
1 943,840 |
PT |
BSF/8910- |
Black scabbardfish |
EU and international waters of VIII, IX and X |
3 784,690 |
2 484,400 |
0 |
65,64 % |
378,469 |
PT |
GFB/1012- |
Greater forkbeard |
EU and international waters of X and XII |
40,000 |
6,400 |
0 |
16,00 % |
4,000 |
PT |
HKE/8C3411 |
Hake |
VIIIc, IX and X; Union waters of CECAF 34.1.1 |
4 624,560 |
3 191,100 |
0 |
69,00 % |
462,456 |
PT |
JAX/08C. |
Horse mackerel and associated by-catches |
VIIIc |
2 281,270 |
1 778,700 |
0 |
77,97 % |
228,127 |
PT |
JAX/09. |
Horse mackerel and associated by-catches |
IX |
22 413,800 |
20 088,700 |
0 |
89,63 % |
2 241,380 |
PT |
LEZ/8C3411 |
Megrims |
VIIIc, IX and X; Union waters of CECAF 34.1.1 |
106,200 |
81,300 |
0 |
76,55 % |
10,620 |
PT |
NEP/9/3411 |
Norway lobster |
IX and X; Union waters of CECAF 34.1.1 |
204,500 |
202,200 |
0 |
98,88 % |
2,300 |
PT |
SBR/09- |
Red Seabream |
EU and international waters of IX |
184,200 |
109,800 |
0 |
59,61 % |
18,420 |
PT |
SBR/10- |
Red Seabream |
EU and international waters of X |
1 128,000 |
571,700 |
0 |
50,68 % |
112,800 |
SE |
COD/3DX32. |
Cod |
EU waters of Subdivisions 25-32 |
16 032,100 |
0 |
5 287,710 |
32,98 % |
1 603,210 |
SE |
HAD/2AC4. |
Haddock |
IV; Union waters of IIa |
28,500 |
17,570 |
0 |
61,65 % |
2,850 |
SE |
HER/1/2- |
Herring |
Union, Norwegian and international waters of I and II |
57,340 |
50,550 |
0 |
88,16 % |
5,734 |
SE |
HER/30/31. |
Herring |
Subdivisions 30-31 |
11 892,500 |
0 |
10 937,740 |
91,97 % |
954,760 |
SE |
HER/3D-R30 |
Herring |
Union waters of Subdivisions 25-27, 28.2, 29 and 32 |
29 272,000 |
0 |
28 830,000 |
98,49 % |
442,000 |
SE |
HKE/3A/BCD |
Hake |
IIIa; Union waters of Subdivisions 22-32 |
178,400 |
27,060 |
0 |
15,17 % |
17,840 |
SE |
JAX/2A-14 |
Horse mackerel and associated by-catches |
Union waters of IIa, IVa; VI, VIIa-c, VIIe-k, VIIIa, VIIIb, VIIId and VIIIe; Union and international waters of Vb; international waters of XII and XIV |
677,300 |
0 |
0 |
0 % |
67,730 |
SE |
LIN/04-C. |
Ling |
Union waters of IV |
11,100 |
0,240 |
0 |
2,16 % |
1,110 |
SE |
LIN/3A/BCD |
Ling |
IIIa; Union waters of IIIbcd |
27,300 |
11,700 |
0 |
42,86 % |
2,730 |
SE |
MAC/2A34. |
Mackerel |
IIIa and IV; Union waters of IIa, IIIb, IIIc and Subdivisions 22-32 |
2 941,540 |
2 101,050 |
829,280 |
99,62 % |
11,210 |
SE |
NEP/3A/BCD |
Norway lobster |
IIIa; Union waters of Subdivisions 22-32 |
1 538,400 |
1 124,740 |
0 |
73,11 % |
153,840 |
SE |
PRA/2AC4-C |
Northern prawn |
Union waters of IIa and IV |
101,300 |
0 |
0 |
0 % |
10,130 |
SE |
SOL/3A/BCD |
Common sole |
IIIa; Union waters of Subdivisions 22-32 |
57,340 |
54,250 |
0 |
94,61 % |
3,090 |
SE |
SPR/3BCD-C |
Sprat |
Union waters of Subdivisions 22-32 |
50 490,000 |
0 |
50 489,430 |
100,00 % |
0,570 |
SE |
USK/04-C. |
Tusk |
Union waters of IV |
6,600 |
0 |
0 |
0 % |
0,660 |
SE |
USK/3A/BCD |
Tusk |
IIIa; Union waters of Subdivisions 22-32 |
7,700 |
1,030 |
0 |
13,38 % |
0,770 |
SE |
WHB/1X14 |
Blue whiting |
Union and international waters of I, II, III, IV, V, VI, VII, VIIIa, VIIIb, VIIId, VIIIe, XII and XIV |
29,710 |
26,710 |
0 |
89,90 % |
2,971 |
UK |
ALF/3X14- |
Alfonsinos |
EU and international waters of III, IV, V, VI, VII, VIII, IX, X, XII and XIV |
11,100 |
1,400 |
0 |
12,61 % |
1,110 |
UK |
ANF/07. |
Anglerfish |
VII |
6 533,860 |
6 152,200 |
197,500 |
97,18 % |
184,160 |
UK |
ANF/2AC4-C |
Anglerfish |
Union waters of IIa and IV |
7 893,800 |
4 778,900 |
314,100 |
64,52 % |
789,380 |
UK |
ARU/1/2. |
Greater silver smelt |
Union and international waters of I and II |
43,600 |
0 |
0 |
0 % |
4,360 |
UK |
ARU/34-C |
Greater silver smelt |
Union waters of III and IV |
17,900 |
0 |
0 |
0 % |
1,790 |
UK |
ARU/567. |
Greater silver smelt |
Union and international waters of V, VI and VII |
45,700 |
0 |
0 |
0 % |
4,570 |
UK |
BLI/5B67- |
Blue ling |
Union and international waters of Vb, VI, VII |
253,560 |
203,600 |
0 |
80,30 % |
25,356 |
UK |
BSF/56712- |
Black scabbardfish |
EU and international waters of V, VI, VII and XII |
76,860 |
56,900 |
0 |
74,03 % |
7,686 |
UK |
COD/07A. |
Cod |
VIIa |
120,400 |
107,400 |
0 |
89,20 % |
12,040 |
UK |
COD/07D. |
Cod |
VIId |
179,150 |
99,800 |
0 |
55,71 % |
17,915 |
UK |
COD/7XAD34 |
Cod |
VIIb, VIIc, VIIe-k, VIII, IX and X, Union waters of CECAF 34.1.1 |
883,500 |
548,100 |
0 |
62,04 % |
88,350 |
UK |
GFB/1012- |
Greater forkbeard |
EU and international waters of X and XII |
10,000 |
0 |
0 |
0 % |
1,000 |
UK |
GFB/1234- |
Greater forkbeard |
EU and international waters of I, II, III and IV |
14,500 |
2,100 |
0 |
14,48 % |
1,450 |
UK |
GFB/567- |
Greater forkbeard |
EU and international waters of V, VI and VII |
679,100 |
251,300 |
0 |
37,00 % |
67,910 |
UK |
GHL/2A-C46 |
Greenland halibut |
Union waters of IIa and IV, Union and international waters of Vb and VI |
535,000 |
344,500 |
0 |
64,39 % |
53,500 |
UK |
HAD/07A. |
Haddock |
VIIa |
615,000 |
154,400 |
0 |
25,11 % |
61,500 |
UK |
HAD/2AC4. |
Haddock |
IV; Union waters of IIa |
33 209,290 |
29 446,500 |
3 498,100 |
99,20 % |
264,690 |
UK |
HAD/5BC6A. |
Haddock |
Union and international waters of Vb and VIa |
3 926,500 |
3 875,900 |
0 |
98,71 % |
50,600 |
UK |
HAD/6B1214 |
Haddock |
Union and international waters of VIb, XII and XIV |
1 097,800 |
595,400 |
0 |
54,24 % |
109,780 |
UK |
HER/07A/MM |
Herring |
VIIa |
5 012,700 |
5 000,200 |
0 |
99,75 % |
12,500 |
UK |
HER/5B6ANB |
Herring |
Union and international waters of Vb, VIb and VIaN |
16 314,850 |
15 734,300 |
0 |
96,44 % |
580,550 |
UK |
HER/7G-K. |
Herring |
VIIg, VIIh, VIIj and VIIk |
23,800 |
1,200 |
0 |
5,04 % |
2,380 |
UK |
HKE/2AC4-C |
Hake |
Union waters of IIa and IV |
1 838,900 |
1 658,000 |
0 |
90,16 % |
180,900 |
UK |
HKE/571214 |
Hake |
VI and VII; Union and international waters of Vb; international waters of XII and XIV |
6 527,800 |
5 224,300 |
86,300 |
81,35 % |
652,780 |
UK |
JAX/2A-14 |
Horse mackerel and associated by-catches |
Union waters of IIa, IVa; VI, VIIa-c, VIIe-k, VIIIa, VIIIb, VIIId and VIIIe; Union and international waters of Vb; international waters of XII and XIV |
7 909,400 |
6 788,600 |
0 |
85,83 % |
790,940 |
UK |
LEZ/07. |
Megrims |
VII |
3 212,050 |
3 055,400 |
0 |
95,12 % |
156,650 |
UK |
LEZ/2AC4-C |
Megrims |
Union waters of IIa and IV |
2 043,600 |
1 686,900 |
0 |
82,55 % |
204,360 |
UK |
LEZ/56-14 |
Megrims |
Union and international waters of Vb; VI; international waters of XII and XIV |
1 179,300 |
527,400 |
0 |
44,72 % |
117,930 |
UK |
LIN/04-C. |
Ling |
Union waters of IV |
2 172,400 |
2 069,100 |
0 |
95,24 % |
103,300 |
UK |
LIN/1/2. |
Ling |
Union and international waters of I and II |
8,900 |
0,800 |
0 |
8,99 % |
0,890 |
UK |
LIN/6X14. |
Ling |
Union and international waters of VI, VII, VIII, IX, X, XII and XIV |
2 872,800 |
2 365,700 |
0 |
82,35 % |
287,280 |
UK |
MAC/2A34. |
Mackerel |
IIIa and IV; Union waters of IIa, IIIb, IIIc and Subdivisions 22-32 |
1 364,600 |
795,400 |
546,700 |
98,35 % |
22,500 |
UK |
NEP/07. |
Norway lobster |
VII |
7 740,000 |
6 872,000 |
118,200 |
90,31 % |
749,800 |
UK |
NEP/2AC4-C |
Norway lobster |
Union waters of IIa and IV |
15 949,850 |
8 423,600 |
0 |
52,81 % |
1 594,985 |
UK |
NEP/5BC6. |
Norway lobster |
VI; Union and international waters of Vb |
17 698,500 |
12 826,800 |
0 |
72,47 % |
1 769,850 |
UK |
PLE/07A. |
Plaice |
VIIa |
519,600 |
90,000 |
0 |
17,32 % |
51,960 |
UK |
PLE/7DE. |
Plaice |
VIId and VIIe |
1 822,400 |
1 680,400 |
0 |
92,21 % |
142,000 |
UK |
POK/56-14 |
Saithe |
VI; Union and international waters of Vb, XII and XIV |
4 485,830 |
3 647,500 |
0 |
81,31 % |
448,583 |
UK |
PRA/2AC4-C |
Northern prawn |
Union waters of IIa and IV |
730,700 |
0,200 |
0 |
0,03 % |
73,070 |
UK |
RNG/5B67- |
Roundnose grenadier |
EU and international waters of Vb, VI, VII |
192,900 |
6,000 |
0 |
3,11 % |
19,290 |
UK |
RNG/8X14- |
Roundnose grenadier |
EU and international waters of VIII, IX, X, XII and XIV |
11,400 |
0 |
0 |
0 % |
1,140 |
UK |
SBR/10- |
Red Seabream |
EU and international waters of X |
10,100 |
0 |
0 |
0 % |
1,010 |
UK |
SBR/678- |
Red Seabream |
EU and international waters of VI, VII and VIII |
5,400 |
0,400 |
0 |
7,41 % |
0,540 |
UK |
SOL/07D. |
Common sole |
VIId |
1 233,200 |
604,900 |
0 |
49,05 % |
123,320 |
UK |
SOL/07E. |
Common sole |
VIIe |
581,300 |
536,900 |
0 |
92,36 % |
44,400 |
UK |
SOL/24-C. |
Common sole |
Union waters of II and IV |
976,200 |
857,800 |
0 |
87,87 % |
97,620 |
UK |
SOL/7HJK. |
Common sole |
VIIh, VIIj and VIIk |
74,800 |
46,600 |
0 |
62,30 % |
7,480 |
UK |
USK/04-C. |
Tusk |
Union waters of IV |
105,300 |
74,600 |
0 |
70,85 % |
10,530 |
UK |
USK/567EI. |
Tusk |
Union and international waters of V, VI and VII |
264,760 |
77,800 |
0 |
29,39 % |
26,476 |
UK |
WHB/1X14 |
Blue whiting |
Union and international waters of I, II, III, IV, V, VI, VII, VIIIa, VIIIb, VIIId, VIIIe, XII and XIV |
14 939,800 |
13 498,600 |
0 |
90,35 % |
1 441,200 |
UK |
WHG/07A. |
Whiting |
VIIa |
31,700 |
20,200 |
0 |
63,72 % |
3,170 |
UK |
WHG/56-14 |
Whiting |
VI, Union and international waters of Vb, international waters of XII and XIV |
164,100 |
118,500 |
0 |
72,21 % |
16,410 |
UK |
WHG/7X7A-C |
Whiting |
VIIb, VIIc, VIId, VIIe, VIIf, VIIg, VIIh, VIIj and VIIk |
2 095,000 |
1 379,600 |
0 |
65,85 % |
209,500 |
(1) Quotas available to a Member State pursuant to the relevant fishing opportunities Regulations after taking into account exchanges of fishing opportunities in accordance with Article 20(5) of Council Regulation (EC) No 2371/2002 (OJ L 358, 31.12.2002, p. 59), quota transfers in accordance with Article 4(2) of Regulation (EC) No 847/96 and/or reallocation and deduction of fishing opportunities in accordance with Articles 37 and 105 of Council Regulation (EC) No 1224/2009 (OJ L 343, 22.12.2009, p. 1).
17.5.2014 |
EN |
Official Journal of the European Union |
L 147/68 |
COMMISSION IMPLEMENTING REGULATION (EU) No 521/2014
of 16 May 2014
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, 16 May 2014.
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 |
41,3 |
MK |
84,5 |
|
TR |
65,9 |
|
ZZ |
63,9 |
|
0707 00 05 |
AL |
41,5 |
MK |
41,5 |
|
TR |
125,0 |
|
ZZ |
69,3 |
|
0709 93 10 |
TR |
113,0 |
ZZ |
113,0 |
|
0805 10 20 |
EG |
44,1 |
IL |
74,1 |
|
MA |
40,7 |
|
TN |
68,6 |
|
TR |
53,3 |
|
ZZ |
56,2 |
|
0805 50 10 |
TR |
85,1 |
ZZ |
85,1 |
|
0808 10 80 |
AR |
100,1 |
BR |
88,0 |
|
CL |
102,6 |
|
CN |
127,0 |
|
MK |
32,3 |
|
NZ |
135,5 |
|
US |
190,9 |
|
UY |
78,1 |
|
ZA |
98,2 |
|
ZZ |
105,9 |
(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’.
DECISIONS
17.5.2014 |
EN |
Official Journal of the European Union |
L 147/70 |
POLITICAL AND SECURITY COMMITTEE DECISION EUTM MALI/2/2014
of 13 May 2014
on the acceptance of third States' contributions to the European Union military mission to contribute to the training of the Malian Armed Forces (EUTM Mali)
(2014/285/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 2013/34/CFSP of 17 January 2013 on a European Union military mission to contribute to the training of the Malian Armed Forces (EUTM Mali) (1), and in particular Article 8(2) thereof,
Whereas:
(1) |
Pursuant to Article 8(2) of Decision 2013/34/CFSP, the Council authorised the Political and Security Committee (PSC) to take the relevant decisions on acceptance of the proposed contributions by third States. |
(2) |
Following recommendation on contributions from Georgia, the Republic of Moldova, and Montenegro by the EU Mission Commander and the advice from the European Union Military Committee, the contributions from Georgia, the Republic of Moldova, and Montenegro should be accepted. |
(3) |
In accordance with Article 5 of Protocol No 22 on the position of Denmark, annexed to the Treaty on the European Union and to the Treaty on the Functioning of the European Union, Denmark does not participate in the elaboration and implementation of decisions and actions of the Union which have defence implications, |
HAS ADOPTED THIS DECISION:
Article 1
1. The contributions from Georgia, the Republic of Moldova, and Montenegro to the European Union military mission to contribute to the training of the Malian Armed Forces (EUTM Mali) are accepted and are considered to be significant.
2. Georgia, the Republic of Moldova, and Montenegro are exempted from financial contributions to the budget of EUTM Mali.
Article 2
This Decision shall enter into force on the date of its adoption.
Done at Brussels, 13 May 2014.
For the Political and Security Committee
The Chairperson
W. STEVENS
(1) OJ L 14, 18.1.2013, p. 19.
17.5.2014 |
EN |
Official Journal of the European Union |
L 147/71 |
COMMISSION DELEGATED DECISION
of 10 March 2014
setting out criteria and conditions that European Reference Networks and healthcare providers wishing to join a European Reference Network must fulfil
(Text with EEA relevance)
(2014/286/EU)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients' rights in cross-border healthcare (1), and in particular point (a) of Article 12(4) thereof,
Whereas:
(1) |
Article 12 of Directive 2011/24/EU provides that the Commission is to support the Member States in the development of European Reference Networks (‘Networks’) between healthcare providers and centres of expertise in the Member States, in particular in the area of rare diseases (2). For the purposes of this, the Commission shall adopt a list of specific criteria and conditions that must be fulfilled by European Reference Networks and healthcare providers wishing to join and become a Member of a Network (‘Member’). The Networks should improve access to diagnosis, treatment and the provision of high-quality healthcare to patients who have conditions requiring a particular concentration of resources or expertise, and could also be focal points for medical training and research, information dissemination and evaluation, especially for rare diseases. |
(2) |
According to Article 12(2) of Directive 2011/24/EU, each Network is to select at least three objectives from the list laid down in therein 12(2) of Directive 2011/24/EU and demonstrate that it has the necessary competences to pursue them effectively. In addition, Networks are required to fulfil the list of tasks or characteristics laid down in Article 12(4)(a)(i)-(vi) of Directive 2011/24/EU. This Decision sets out the specific list of criteria or conditions that will ensure the Networks fulfil these tasks. These criteria and conditions should provide the basis for the establishment and evaluation of the Networks. |
(3) |
Among the set of criteria and conditions necessary to enable Networks pursue the applicable objectives of Article 12(2) of Directive 2011/24/EU the Decision provides a list of criteria on the governance and coordination of the Networks that should ensure their transparent and effective functioning. Although Networks should be allowed to have different organisation models, it is appropriate to require that they all choose one of their Members as the coordinating Member. The coordinating Member shall appoint one person acting as the coordinator of the Network (‘Coordinator’). They should be governed by a board of the Network (‘Board’) composed of representatives from each Member in the Network. The Board should be in charge of producing and adopting the rules of procedure, work plans and progress reports and any other documents related to the activities of the Network. The Coordinator, assisted by the Board, should support and facilitate the internal coordination within the Network and with other healthcare providers. |
(4) |
The provision of highly specialised healthcare, one of the criteria to be fulfilled by the Networks, should be based on high quality, accessible and cost-effective healthcare services. It requires experienced, highly skilled and multidisciplinary healthcare teams and, most likely, advanced specialised medical equipment or infrastructures which commonly imply concentration of resources. |
(5) |
Healthcare providers who apply for membership of a Network should demonstrate that they fulfil the criteria and conditions laid down in this Decision. These criteria and conditions should guarantee that the services and healthcare are provided according to the highest possible quality criteria and available clinical evidence. |
(6) |
The required criteria and conditions for a healthcare provider would vary depending on the diseases or conditions specifically addressed by the Network of which they want to become a Member. It therefore appears necessary to establish two sets of criteria and conditions: a first set of horizontal criteria and conditions that should be fulfilled by all healthcare providers wishing to join a Network, regardless of the field of expertise or the medical procedure or treatment they perform, and a second set of criteria and conditions that may vary depending on the scope of the concrete area of expertise, disease or condition addressed by the Network they wish to join. |
(7) |
Among the first set of horizontal and structural criteria and conditions, those related to patients empowerment and patient-centred care; organisation, management and business continuity; research and training capacity appear to be essential in order to ensure that the objectives of the Networks are met. |
(8) |
Further horizontal and structural criteria and conditions related to the exchange of expertise, information systems and eHealth tools should help developing, sharing and spreading information and knowledge and fostering improvements in the diagnosis and treatment of diseases within and outside the Networks and to collaborate closely with other centres of expertise and networks at national and international level. Interoperable and semantically compatible information and communication technology (ICT) systems would facilitate the exchange of health data and patients' information, and the establishment and maintenance of shared databases and registries. |
(9) |
The ability to have an efficient and secure exchange of health data and other patient information as well personal data of the healthcare professionals in charge of the patient is a crucial aspect for the successful functioning of the Networks. The exchange of data should in particular take place in accordance with the specified purposes, necessity and legal grounds for the processing of data and be accompanied by appropriate safeguards and rights of the data subject. Personal data should be processed in compliance with Directive 95/46/EC of the European Parliament and of the Council (3). |
(10) |
This Decision respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union, as referred to in Article 6 of the Treaty on European Union and notably the right of human dignity, the right to the integrity of the person, the right to the protection of personal data and the right of access to healthcare. This Decision must be applied by the Member States in accordance with the rights and principles guaranteed in the Charter. |
(11) |
In particular, the Charter requires that in the field of biology and medicine the free and informed consent of the person concerned must be respected. As Clinical Trials could likely be one of the areas of work of the Networks it is important to recall that an extensive set of rules for the protection of subjects in clinical trials is foreseen in Directive 2001/20/EC of the European Parliament and of the Council (4). |
(12) |
In order to ensure the exchange of personal data in the context of the Networks, procedures concerning informed consent for processing this data could be simplified by using one single common consent model that needs to be subject to the requirements set out in Directive 95/46/EC with regard to the consent of the data subject. |
(13) |
The criteria and conditions related to expertise, clinical practice, quality, patient safety and evaluation should help in developing and spreading the best practices for quality and safety benchmarks. They should also thus ensure the offer of a high level of expertise, produce good practice guidelines, implement outcome measures and quality control and follow a multi-disciplinary approach as required by Article 12(4) of Directive 2011/24/EU. |
(14) |
Member States with no Member of a given Network may decide to designate healthcare providers with a special link to a given Network, following a transparent and explicit procedure. Those providers might be designated as Associated National Centres focusing in the provision of healthcare or as Collaborative National Centres focusing in the production of knowledge and tools to improve the quality of care. Member States may also wish to designate a national coordination hub with all types of Networks. That might help Member States to pursue Article 12(3)(a) of Directive 2011/24/EU particularly if the objectives of the Network are among those listed under Article 12(2)(f) and (h) of Directive 2011/24/EU. The Coordinator should facilitate the cooperation with these healthcare providers linked to a Network. Those healthcare providers shall support the objectives and respect the rules of the Network and share the work related with the cooperation activities of the Network, |
HAS ADOPTED THIS DECISION:
CHAPTER I
GENERAL PROVISIONS
Article 1
Subject matter
This Decision lays down:
(a) |
the criteria and conditions that the Networks referred to in Article 12 of Directive 2011/24/EU must fulfil; and |
(b) |
the criteria and conditions required from healthcare providers wishing to join a Network referred to in Article 12 of Directive 2011/24/EU. |
Article 2
Definitions
For the purpose of this Decision and in addition to the definitions laid down in Article 3 of Directive 2011/24/EU the following definitions shall apply:
(a) |
‘Member of a Network’ means healthcare providers that are in compliance with the list of criteria and conditions laid down in Article 5 of this Decision and have been awarded with the membership of a given Network; |
(b) |
‘Highly specialised healthcare’ means healthcare that involves high complexity of a particular disease or condition in its diagnosis or treatment or management and high cost of the treatment and resources involved; |
(c) |
Complex disease or condition' means a particular disease or disorder which combines a number of factors, symptoms, or signs that requires a multidisciplinary approach and well-planned organisation of services over time because it implies one or several of the following circumstances:
|
(d) |
‘Multidisciplinary healthcare team’ means a group of health professionals from several fields of healthcare, combining skills and resources, each providing specific services and collaborating on the same case and coordinating the healthcare to be provided to the patient; |
(e) |
‘Informed consent under the framework of European Reference Networks’ means any freely-given, specific, informed and explicit indication of a subject's wishes by which he or she, either by a statement or by a clear affirmative action, signifies agreement to the exchange of her or his personal and health data between healthcare providers and Members of a European Reference Network as provided in this Delegated Decision. |
CHAPTER II
EUROPEAN REFERENCE NETWORKS
Article 3
Criteria and conditions for Networks
Networks shall fulfil the criteria and conditions necessary to enable them pursue the applicable objectives of Article 12(2) of Directive 2011/24/EU set out in Annex I.
Article 4
Membership of the Networks
Networks shall be composed of healthcare providers identified as Members of the Network. For each network, one Member will act as Coordinator.
CHAPTER III
HEALTHCARE PROVIDERS
Article 5
Criteria and conditions for applicants of membership of a Network
All applicants wishing to join a given Network must have knowledge and expertise or offer a diagnosis or a treatment that focusses on a disease or condition falling within the field of specialisation of the Network and shall fulfil the criteria and conditions set out in Annex II.
CHAPTER IV
FINAL PROVISION
Article 6
This Decision shall enter into force on the 10th day following that of its publication in the Official Journal of the European Union.
Done at Brussels, 10 March 2014.
For the Commission
The President
José Manuel BARROSO
(2) COM(2008) 679 final.
(3) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).
(4) 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).
ANNEX I
CRITERIA AND CONDITIONS TO BE FULFILLED BY THE NETWORKS
(1) |
In order to enable Networks pursue the applicable objectives of Article 12(2) of Directive 2011/24/EU, each Network shall:
|
(2) |
To fulfil the requirement set out in point (i) of Article 12(4)(a) of Directive 2011/24/EU (‘have knowledge and expertise to diagnose, follow up and manage patients with evidence of good outcomes’), the Networks must:
|
(3) |
To fulfil the requirement set out in point (ii) of Article 12(4)(a) of Directive 2011/24/EU (‘follow a multi-disciplinary approach’), the Networks must:
|
(4) |
To fulfil the requirement set out in point (iii) of Article 12(4)(a) of Directive 2011/24/EU (‘offer a high level of expertise and have the capacity to produce good practice guidelines and to implement outcome measures and quality control’), the Networks must:
|
(5) |
To fulfil the requirement set out in point (iv) of Article 12(4)(a) of Directive 2011/24/EU (‘make a contribution to research’), the Networks must:
|
(6) |
To fulfil the requirement set out in point (v) of Article 12(4)(a) of Directive 2011/24/EU (‘organise teaching and training activities’), the Networks must:
|
(7) |
To comply with the requirement set out in point (vi) of Article 12(4)(a) of Directive 2011/24/EU (‘collaborate closely with other centres of expertise and networks at national and international level’), the Networks must:
|
ANNEX II
CRITERIA AND CONDITIONS FOR APPLICANTS FOR MEMBERSHIP OF A NETWORK
1. General criteria and conditions for all applicant healthcare providers
All applicants wishing to join a Network shall comply with the following criteria and conditions:
(a) |
as regards patient empowerment and patient-centred care, applicant providers must:
|
(b) |
with regard to organisation, management and business continuity, applicant providers must:
|
(c) |
with regard to research and training capacity, applicant providers must:
|
(d) |
with regard to the exchange of expertise, information systems and e-health tools, applicant providers must:
|
(e) |
with regard to expertise, good practices, quality, patient safety and evaluation, applicant providers must:
|
2. Specific criteria and conditions for applicant providers with regard to the area of expertise, disease or conditions the Networks they wish to join focus on
(a) |
with regard to competence, experience and outcomes of care, applicant providers must:
|
(b) |
with regard to the specific human, structural and equipment resources and the organisation of care, applicant providers must document:
|
17.5.2014 |
EN |
Official Journal of the European Union |
L 147/79 |
COMMISSION IMPLEMENTING DECISION
of 10 March 2014
setting out criteria for establishing and evaluating European Reference Networks and their Members and for facilitating the exchange of information and expertise on establishing and evaluating such Networks
(Text with EEA relevance)
(2014/287/EU)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients' rights in cross-border healthcare (1), and in particular Article 12(4)(b) and (c) thereof,
Whereas:
(1) |
Commission Delegated Decision 2014/286/EU (2) sets out the criteria and conditions that European Reference Networks (‘Networks’) and healthcare providers wishing to join such Networks must fulfil. |
(2) |
Pursuant to Article 12(4)(b) and (c) of Directive 2011/24/EU, the Commission is to decide the criteria for establishing and evaluating the Networks and the measures for facilitating the exchange of information and expertise on establishing and evaluating the Networks. |
(3) |
Networks should be established and healthcare providers approved as Members of the Networks on the basis of an open and transparent procedure. The procedure should include: (1) the call for interest; (2) Member States' endorsement of applications of their healthcare providers; (3) the submission of applications to the Commission; (4) the verification of the completeness of applications; (5) the technical assessment by an independent body of applications to form the Networks and of applications from individual healthcare providers wishing to be Members of a Network, to determine whether the applicants fulfil the criteria; (6) the communication of the assessment outcomes; (7) the approval of the Networks and their membership by Member States; and (8) the publication of the list of established Networks and of their Members. |
(4) |
In order to increase the coverage of the Networks, individual healthcare providers wishing to join a Network should be allowed to do so at any time. Their applications should be assessed according to the same procedure as that used to assess applications for the initial Network, including the endorsement of applications by the Member State in question. |
(5) |
In order to guarantee that the Network has genuine European Union added value and is big enough to enable the sharing of expertise and to improve access to care for patients across the Union, only applications from the minimum required numbers of healthcare providers and Member States, submitted in line with the call of interest, should be approved. If an insufficient number of healthcare providers apply or applications cover an insufficient number of Member States, the Commission should ask Member States to encourage their healthcare providers to join the proposed Network. |
(6) |
It might be difficult to reach the required minimum number of healthcare providers or Member States for some rare diseases or conditions due to a lack of expertise. It would therefore be a good idea to group healthcare providers that focus on related rare diseases or conditions in a thematic Network. Networks could also include providers of high technology services which usually require very high capital investment, such as laboratories, radiology services or nuclear medicine services. |
(7) |
Member States none of whose healthcare providers are Members of a Network should designate collaborative and associated national centres to encourage them to cooperate with the relevant Network. |
(8) |
Each Network's and healthcare provider's application, once their completeness has been established, should be technically assessed according to the criteria set out in Delegated Decision 2014/286/EU. The assessment should, on the basis of a common assessment manual, include an exhaustive documentation review and on-site audits of a selected number of applicants. It should be carried out by an independent assessment body appointed by the Commission. |
(9) |
Member States are invited to set up a Board of Member States which should decide on the approval of proposed Networks and on their membership. Member States' participation should be voluntary. Only a positive assessment issued by an assessment body should generally prompt Member States to approve the establishment of a Network and to grant membership of the Network. |
(10) |
Networks' Members should be licensed to use the ‘European Reference Network’ logo. The logo, owned by the European Union, should constitute the visual identity of the Networks and their Members. |
(11) |
Using a common evaluation manual, an independent evaluation body appointed by the Commission should periodically evaluate Networks and their Members. The evaluation should conclude with a technical evaluation report detailing the extent to which the objectives set out in Article 12(2) of Directive 2011/24/EU have been achieved and the criteria and conditions set out in Delegated Decision 2014/286/EU fulfilled. It should also describe the outcomes and performance of the Network and the contribution of its Members. A negative evaluation report should generally prompt Member States to approve the termination of a Network. Compliance with the requirement to have a minimum number of healthcare providers and Member States should be monitored after the evaluation so that the European Union added value of the Network can be maintained. |
(12) |
The assessment and evaluation manuals should be based on internationally recognised practices and contain the core principles and methodologies for carrying out assessments and evaluations. |
(13) |
The Commission should facilitate the exchange of information and expertise on establishing and evaluating the Networks. It should make general information on the Networks and their Members and the technical documentation and manuals on establishing and evaluating the Networks and their Members available to the public. It may offer to the Networks and their Members the use of specific communication media and tools. Conferences and experts meetings should be organised to provide a forum for technical and scientific debate among Networks. |
(14) |
The personal data related to establishing and evaluating the Networks should be processed in compliance with Regulation (EC) No 45/2001 of the European Parliament and of the Council (3) as appropriate. |
(15) |
The measures provided for in this Decision are in accordance with the opinion of the Committee set up under Article 16 of Directive 2011/24/EU, |
HAS ADOPTED THIS DECISION:
CHAPTER I
GENERAL PROVISIONS
Article 1
Subject matter
This Decision sets out:
(a) |
the criteria for establishing and evaluating the Networks referred to in Article 12 of Directive 2011/24/EU; and |
(b) |
the measures to facilitate the exchange of information and expertise on establishing and evaluating the Networks referred to in Article 12 of Directive 2011/24/EU. |
CHAPTER II
ESTABLISHMENT OF EUROPEAN REFERENCE NETWORKS
Article 2
Call for interest to establish a European Reference Network
1. The Commission shall publish a call for interest to establish Networks within two years following the entry into force of this Decision.
2. Any group of at least 10 healthcare providers established in at least 8 Member States may collectively respond by the deadline indicated in the call for interest with an application containing a proposal to establish a Network in a given field of expertise.
3. The content of the application shall be as set out in Annex I.
4. On receiving an application, the Commission shall verify whether the conditions on the minimum number of healthcare providers and Member States as set out in paragraph 2 are met.
5. If either of those conditions is not met, the application shall not be entitled to assessment and the Commission shall ask Member States to encourage their healthcare providers to join the proposed Network in order to help reach the required number(s).
6. After consulting the Member States, the Commission shall decide on the appropriate timing for the publication of subsequent calls for interest.
Article 3
Membership applications
1. The application containing a proposal to establish a Network shall be accompanied by a membership application for each healthcare provider concerned.
2. The content of the membership application shall be as set out in Annex II.
3. The membership application shall be accompanied by a written statement from the healthcare provider's Member State of establishment certifying that its participation in the proposal to establish a Network is in accordance with the Member State's national legislation.
Article 4
Technical assessment of applications
1. If the Commission concludes that the requirements set out in Article 2(2) and in Article 3(2) and (3) are fulfilled, it shall appoint an assessment body to assess applications.
2. The assessment body shall verify whether:
(a) |
the content of an application containing a proposal to establish a Network fulfils the requirements set out in Annex I to this Decision; |
(b) |
the content of the membership applications fulfils the requirements of Annex II to this Decision; |
(c) |
the proposed Network fulfils the requirement to provide highly specialised healthcare in point 1(a) of Annex I to Delegated Decision 2014/286/EU; |
(d) |
the proposed Network fulfils the other criteria and conditions set out in Annex I to Delegated Decision 2014/286/EU; |
(e) |
the applicant healthcare providers fulfil the criteria and conditions set out in Annex II to Delegated Decision 2014/286/EU. |
3. The assessment pursuant to points (d) and (e) of paragraph 2 shall only take place if the assessment body concludes that the proposal fulfils the requirements referred to in points (a), (b) and (c) of paragraph 2.
4. The assessment body shall draw up an assessment report on the application containing a proposal to establish a Network and the membership applications and send all reports to the Commission.
5. The assessment body shall send to each applicant healthcare provider the assessment report on the proposed Network and on its own membership application. The healthcare provider may send comments to the assessment body within two months of receiving the reports. On receiving the comments, the assessment body shall amend its assessment reports explaining whether the comments justify a change in its assessment.
Article 5
Approval of Networks and Members
1. On receiving an assessment report on a proposal for a Network and the proposed list of Members, drawn up pursuant to Article 4, and after verifying that the minimum number of healthcare providers and Member States set out in Article 2(2) is reached, Member States shall, within a Board of Member States as provided in Article 6, decide on the approval of the proposed Network and its Members.
2. By virtue of the approval referred to in paragraph 1, the proposed Networks shall be established as European Reference Networks.
3. If the minimum number of healthcare providers or of Member States set out in Article 2(2) is not reached, the Network shall not be established and the Commission shall ask Member States to encourage their healthcare providers to join the proposed Networks.
4. If a healthcare provider is given a negative assessment, it will be for that healthcare provider to decide whether it wants to submit its membership application, with the assessment report on the application, to the Board of Member States for review.
Article 6
Board of Member States
1. Member States are invited to set up a Board of Member States which shall decide whether or not to approve the proposals for Networks, their membership and the termination of a Network. If their decision differs from the assessment of the assessment body, the Member States shall give the reasons for this.
2. Member States wishing to be on the Board of Member States shall notify the Commission the national authority that shall represent them.
3. The Board of Member States shall adopt by a simple majority of its members its own rules of procedures, on the proposal of the Commission services.
4. The rules of procedure shall cover the functioning and decision-making process of the Board of Member States and specify which of its members are entitled to vote on the approval of a specific Network, which majority will determine the outcome of a vote, and what procedure to follow if the Board's decision differs from the assessment report on a Network proposal or membership application.
5. The Commission shall provide the secretariat of the Board of Member States.
6. The personal data of representatives of Member States on the Board of Member States shall be collected, processed and published in accordance with Regulation (EC) No 45/2001.
Article 7
Logo
When a Network is approved, the Commission shall license the use of a unique graphic identifier (‘logo’), which that Network and its Members shall use for the activities organised by the Network.
Article 8
Applications for membership of existing Networks
1. A healthcare provider wishing to join an existing Network shall submit a membership application to the Commission.
2. The content of the membership application shall be as set out in Annex II.
3. The membership application shall be accompanied by a written statement from the healthcare provider's Member State of establishment certifying that its participation in the Network is in accordance with the Member State's national legislation.
Article 9
Technical assessment of applications for membership of existing Networks
1. If the Commission concludes that the requirements set out in Article 8(2) and (3) are fulfilled, it shall appoint a body to assess the membership application.
2. The assessment body shall verify whether:
(a) |
the content of the membership application fulfils the requirements set out in Annex II to this Decision; and |
(b) |
the healthcare provider concerned fulfils the criteria and conditions set out in Annex II to Delegated Decision 2014/286/EU. |
3. The assessment pursuant to point (b) of paragraph 2 shall only take place if the assessment body concludes that the membership application fulfils the requirements referred to in point (a) of paragraph 2.
4. The assessment body shall draw up an assessment report and send it to the Commission and to the applicant healthcare provider. The healthcare provider may send comments to the assessment body within two months of receiving the report. On receiving of such comments, the assessment body shall amend its assessment report explaining whether the comments justify a change in its assessment.
Article 10
Approval of new Members
1. On receiving a positive assessment report drawn up pursuant to Article 9, the Board of Member States shall decide whether or not to approve the new Member.
2. If a healthcare provider is given a negative assessment, it will be for that healthcare provider to decide whether it wants to submit its membership application, with the assessment report on the application, to the Board of Member States for review.
Article 11
Termination of the Network
1. A Network shall be terminated in the following cases:
(a) |
one of the minimum numbers set out in Article 2(2) is no longer reached; |
(b) |
a negative evaluation report of the Network has been drawn up pursuant to Article 14; |
(c) |
by decision of the Board of the Network according to its rules and procedures; |
(d) |
if the Coordinator fails to request an evaluation of the Network within the five- year period after it was set up or since its last evaluation. |
2. The termination of a Network, on the grounds listed in paragraph 1(a) and (b), must be approved by the Board of Member States referred to in Article 6.
Article 12
Loss of membership
1. A Member of a Network may lose membership for any of the following reasons:
(a) |
voluntary withdrawal, according to the rules and procedures agreed by the Board of the Network; |
(b) |
by decision of the Board of the Network, according to the rules and procedures agreed by the Board; |
(c) |
if a Member State of establishment notifies to the Member of the Network that its participation in the Network no longer complies with national legislation; |
(d) |
if the Member refuses to be evaluated pursuant to Article 14; |
(e) |
if a negative evaluation report on the Member has been drawn up pursuant to Article 14; |
(f) |
if the Network where the Member participates is terminated. |
2. The relevant Member State shall inform the Commission of the reasons for the notification referred to in paragraph 1(c).
3. The Board of the Network shall inform the Commission in the cases referred to in point 1(a), (b) and (d).
4. The loss of membership on the grounds listed in paragraph 1(e) must be approved by the Board of Member States referred to in Article 6.
5. In any case of loss of membership, the Commission shall verify whether the minimum numbers of healthcare providers and of Member States set out in Article 2(2) are still reached. If not, it shall ask the Network to find new Members within the next two years or terminate the Network, inform the Board of Member States of the situation and ask Member States to encourage their healthcare providers to join the Network.
6. Loss of membership shall lead to the automatic loss of any of the rights and responsibilities associated with participation in the Network, including the right to use the logo.
Article 13
Assessment manual
1. In consultation with Member States and interested parties, the Commission shall draw up a detailed manual regarding the content of, documentation and procedure for the assessment referred to in Articles 4 and 9.
2. The assessment procedure shall include the verification of the documentation submitted by the applicants and on-site audits.
3. The body appointed by the Commission pursuant to Articles 4(1) and 9(1) to assess a proposal for a Network and applications for membership of the Network shall use the assessment manual.
CHAPTER III
EVALUATION OF EUROPEAN REFERENCE NETWORKS
Article 14
Evaluation
1. All Networks and their Members shall be periodically evaluated, at the latest every five years after their approval or last evaluation.
2. On receiving the request for evaluation from the Coordinator of a Network, the Commission shall appoint a body to evaluate the Network and its Members.
3. The evaluation body shall verify and assess:
(a) |
the fulfilment of the criteria and conditions set out in Delegated Decision 2014/286/EU; |
(b) |
the accomplishment of the objectives set out in Article 12(2) of Directive 2011/24/EU; and |
(c) |
the outcomes and performance of the Network and the contribution of each Member. |
4. The evaluation body shall draw up an evaluation report on the Network and send it to the Commission, the Board of the Network and the Members of the Network.
5. The evaluation body shall draw up an evaluation report on each Member of the Network and send it to the Commission and the Member in question.
6. The Coordinator and Members of the Network may send comments to the evaluation body within two months of receiving the report. On receiving the comments, the evaluation body shall amend its evaluation report explaining whether the comments justify a change in its evaluation.
7. Any termination of a Network or loss of membership on account of a negative evaluation must be approved by the Board of Member States referred to in Article 6. The Board of Member States may offer the Network or the Member in question one year to remedy the shortcomings identified before carrying out a new evaluation. That period of time shall only be offered to a specific Network or Member of a Network if the Board of the Network presents an improvement plan.
Article 15
Evaluation manual
1. In consultation with Member States and interested parties, the Commission shall draw up a manual regarding the content of and documentation and procedure for the evaluation of the Networks and their Members referred to in Article 14.
2. The evaluation procedure shall include the evaluation of the documentation submitted, including the self-evaluation reports, and on-site audits.
3. The body appointed by the Commission pursuant to Article 14(2) to evaluate a Network and its Members shall use the evaluation manual.
CHAPTER IV
EXCHANGE OF INFORMATION AND EXPERTISE
Article 16
Exchange of information on establishing and evaluating the Networks
1. The Commission shall facilitate the exchange of information and expertise on establishing and evaluating the Networks by:
(a) |
making general information on establishing and evaluating the Networks, including information on the assessment and evaluation manuals referred to in Articles 13 and 15 publicly available; |
(b) |
publishing a regularly updated list of the Networks and their Members, together with the positive assessment and evaluation reports of the Networks and the decisions of the Board of Member States, in accordance with its rules of procedure; |
(c) |
organising conferences and experts meetings for technical and scientific debate among the Members of Networks, if appropriate; |
(d) |
providing electronic media and communication tools to the Networks, if appropriate. |
2. For the purpose of publishing the list referred to in paragraph 1(b), any change in the Member acting as Coordinator of a Network or in the person nominated as Coordinator of a Network shall be communicated to the Commission by the Board of the Network.
CHAPTER V
FINAL PROVISIONS
Article 17
Revision
The Commission shall evaluate the functioning of this Implementing Decision five years after its entry into force.
Article 18
Entry into force
This Decision shall enter into force on the tenth day following that of its publication in the Official Journal of the European Union.
Done at Brussels, 10 March 2014.
For the Commission
The President
José Manuel BARROSO
(2) See page 71 of this Official Journal.
ANNEX I
CONTENT OF THE APPLICATION TO ESTABLISH A NETWORK
The application to establish a Network must be submitted according to the call for interest published by the Commission and must include:
(a) |
the name of the proposed Network; |
(b) |
the completed application form, with the self-assessment questionnaire and additional documentation required in the assessment manual; |
(c) |
evidence that all applicant healthcare providers share the same area of expertise and focus on the same health condition or conditions; |
(d) |
the name of the healthcare provider that will act as Coordinator of the Network and the name and contact details of the person who will represent the proposed Coordinator; |
(e) |
the names of all applicant healthcare providers. |
ANNEX II
CONTENT OF THE MEMBERSHIP APPLICATION
The application of healthcare providers must include:
(a) |
the title of the relevant proposed Network or existing Network; |
(b) |
the completed application form, with the self-assessment questionnaire and additional documentation required in the assessment manual; |
(c) |
the name and contact details of the healthcare provider's representative. |
17.5.2014 |
EN |
Official Journal of the European Union |
L 147/88 |
COMMISSION IMPLEMENTING DECISION
of 12 May 2014
as regards the standard reporting requirements for national programmes for the eradication, control and monitoring of certain animal diseases and zoonoses co-financed by the Union and repealing Decision 2008/940/EC
(notified under document C(2014) 2976)
(2014/288/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 27(10) thereof,
Whereas:
(1) |
Decision 2009/470/EC lays down the procedures governing the financial contribution from the Union towards the programmes for the eradication, control and monitoring of animal diseases and zoonoses. |
(2) |
Pursuant to Article 27(1) of Decision 2009/470/EC a Union financial measure is introduced to reimburse the expenditure incurred by the Member States for the financing of national programmes for the eradication, control and monitoring of the animal diseases and zoonoses listed in the Annex to that Decision. |
(3) |
Article 27(7) of Decision 2009/470/EC provides that Member States are to submit, for each approved programme, intermediate technical and financial reports and, by 30 April each year at the latest, an annual detailed technical report, including the assessment of the results achieved and detailed account of expenditure incurred for the previous year. |
(4) |
Commission Decision 2008/940/EC (2) defines the information that Member States having programmes for the eradication, monitoring and control of certain animal diseases approved for Union co-financing shall provide within the intermediate and final technical and financial reports. |
(5) |
Since the adoption of Decision 2008/940/EC and in the framework of simplification and improvement of the requirements and procedures in relation to the programmes, changes have been introduced as regards the measures considered eligible for Union financial contribution and the method of calculation of the reimbursement as laid down in the financing decisions approving the programmes for each calendar year. |
(6) |
In addition, in order to further improve the process of submission of reports, their processing and evaluation as well as the follow up of progress over the years, the intermediate and final reports for the implementation of the programmes should be submitted by the Member States on-line from 1 July 2015 onwards using electronic templates developed by the Commission for this purpose. The structure of the relevant reports should therefore be adapted for the electronic submission and processing of data. |
(7) |
Therefore, the standard requirements for the submission by Member States of applications for Union financing for the national programmes for the eradication, control and monitoring of certain animal diseases and zoonoses should be amended and made consistent with the amendments to relevant Union legislation and compatible with the on-line submission system. |
(8) |
In the second half of each year, the Commission requests from the Member States to provide updated information on the usage of funds for eligible measures under their programmes since the beginning of the year and estimations for the total needed budget for the whole year. On the basis of this information and in order to improve the usage of available funds the Commission prepares every year a Decision amending the financing decision for that year to reallocate funds between programmes that are expected not to use their initial allocation of funds and programmes reported to be in need of additional funds. |
(9) |
In order to optimise the efficiency of the exercise of reallocating funds amongst programmes, it is appropriate that the Member States also submit quantitative information on the activities already performed and expected to be performed, as well as unit cost data. Furthermore, to reduce administrative burden the submission of information for the reallocation of funds should be integrated within the submission of intermediate reports. |
(10) |
It is therefore appropriate that Decision 2008/940/EC is repealed and replaced by the current Decision. |
(11) |
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
Member States shall, in accordance with this Decision, submit intermediate and final reports as regards programmes approved pursuant to Article 27 of Decision 2009/470/EC.
Article 2
For the purposes of this Decision, the following definitions shall apply:
(a) |
‘intermediate reports’ means intermediate technical (3) and financial reports on the implementation of running programmes, to be submitted to the Commission as provided for in Article 27(7)(a) of Decision 2009/470/EC; |
(b) |
‘final reports’ means detailed technical and financial reports to be submitted to the Commission by 30 April each year at the latest for the entire of the preceding year of application of each approved programme, as provided for in Article 27(7)(b) of Decision 2009/470/EC; |
(c) |
‘payment applications’ means the payment applications relating to the expenditure incurred by a Member State to be submitted to the Commission, as provided for in Article 27(8) of Decision 2009/470/EC. |
Article 3
1. With regard to running programmes approved for co-financing by the Union in accordance with Article 27(5) of Decision 2009/470/EC, an intermediate report shall be submitted to the Commission by 31 August each year at the latest.
2. Intermediate reports shall provide all the relevant information in accordance with Annex I.
Article 4
Final reports and payment applications shall provide all the relevant information in accordance with Annex II, as well as:
(a) |
technical information in accordance with:
|
(b) |
information on the activities and costs, in accordance with Part I of Annex X and a signed declaration for each programme, in accordance with Part II of Annex X. |
Article 5
1. From 1 July 2015, the intermediate reports provided for in Article 3 and the final reports and payment applications provided for in Article 4 shall be submitted on-line by Member States using the corresponding standard electronic templates provided by the Commission, except for the programmes for the diseases referred to in Article 4(a)(vii).
2. In addition to the requirements of paragraph 1, a signed version of the part of the final reports and payment applications referred to in Article 4(b) shall be submitted to the Commission.
Article 6
Decision 2008/940/EC is repealed.
Article 7
Without prejudice to Article 5, this Decision shall apply to programmes for the eradication, control and monitoring of animal diseases to be implemented as from 1 January 2015.
Article 8
This Decision is addressed to the Member States.
Done at Brussels, 12 May 2014.
For the Commission
Tonio BORG
Member of the Commission
(1) OJ L 155, 18.6.2009, p. 30.
(2) Commission Decision 2008/940/EC of 21 October 2008 laying down standard reporting requirements for national programmes for the eradication, control and monitoring of certain animal diseases and zoonoses co-financed by the Community (OJ L 335, 13.12.2008, p. 61).
(3) Only intermediate financial report is due by 2015.
ANNEX I
Requirements for intermediate reports
ANNEX II
Requirements for final reports and payment applications
ANNEX III
Final technical report on ruminant diseases programmes
ANNEX IV
Technical report on zoonotic salmonella programmes
ANNEX V
Final technical report on swine diseases programmes
ANNEX VI
Final technical report on rabies programmes
ANNEX VII
Final technical report on tse monitoring and eradication programmes
ANNEX VIII
Final technical report on avian influenza surveillance programmes
ANNEX IX
Report on fish disease programmes
ANNEX X
PART I
Report on activities and costs
PART II
Signed declaration to accompany the final report/payment application
Member State:
Programme:
Year of implementation:
We certify that:
— |
the information provided in the final report and payment application is full, reliable and true that the declared activities were actually performed and that the cost declared are accurately accounted for and eligible under the provision of Decision …/Regulation (EC) No … (mention specific financing decision); …. |
— |
all supporting documents relating to the activities and expenditure are available for inspection, notably to justify the level of compensation for animals; |
— |
the programme was executed in accordance with the relevant Union legislation, in particular the rules on competition, the award of public contracts and state aid; |
— |
no other Union contribution was requested for this programme and all revenue accruing from operations under the programme is declared to the Commission; |
— |
control procedures apply, in particular to verify the accuracy of the amount of activities and expenditure declared, to prevent, detect and correct irregularities. |
Date
Name and signature of operational director
17.5.2014 |
EN |
Official Journal of the European Union |
L 147/114 |
COMMISSION IMPLEMENTING DECISION
of 15 May 2014
allowing Member States to extend provisional authorisations granted for the active substances pinoxaden and meptyldinocap
(notified under document C(2014) 3059)
(Text with EEA relevance)
(2014/289/EU)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular the fourth subparagraph of Article 8(1) thereof,
Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (2), and in particular Article 80(1)(a) thereof,
Whereas:
(1) |
In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Directive 91/414/EEC shall continue to apply to active substances for which a decision has been adopted in accordance with Article 6(3) of Directive 91/414/EEC before 14 June 2011. |
(2) |
In accordance with Article 6(2) of Directive 91/414/EEC, in March 2004 the United Kingdom received an application from Syngenta Crop Protection AG for the inclusion of the active substance pinoxaden in Annex I to Directive 91/414/EEC. Commission Decision 2005/459/EC (3) confirmed that the dossier was complete and could be considered as satisfying, in principle, the data and information requirements of Annex II and Annex III to that Directive. |
(3) |
In accordance with Article 6(2) of Directive 91/414/EEC, in August 2005 the United Kingdom received an application from Dow Agrosciences for the inclusion of the active substance meptyldinocap in Annex I to Directive 91/414/EEC. Commission Decision 2006/589/EC (4) confirmed that the dossier was complete and could be considered as satisfying, in principle, the data and information requirements of Annex II and Annex III to that Directive. |
(4) |
Confirmation of the completeness of the dossiers was necessary in order to allow them to be examined in detail and to allow Member States the possibility of granting provisional authorisations, for periods of up to three years, for plant protection products containing the active substances concerned, while complying with the conditions laid down in Article 8(1) of Directive 91/414/EEC and, in particular, the conditions relating to the detailed assessment of the active substances and the plant protection products in the light of the requirements laid down by that Directive. |
(5) |
For these active substances, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicants. The rapporteur Member State submitted the respective draft assessment reports to the Commission on 30 November 2005 (pinoxaden) and 25 October 2006 (meptyldinocap). |
(6) |
Following submission of the draft assessment reports by the rapporteur Member State, it has been found to be necessary to request further information from the applicants and to have the rapporteur Member States examine that information and submit their assessment. Therefore, the examination of the dossiers is still ongoing and it will not be possible to complete the evaluation within the timeframe provided for in Directive 91/414/EEC, read in conjunction with Commission Implementing Decision 2012/191/EU (5). |
(7) |
As the evaluation so far has not identified any reason for immediate concern, Member States should be given the possibility of prolonging provisional authorisations granted for plant protection products containing the active substances concerned for a period of 24 months in accordance with the provisions of Article 8 of Directive 91/414/EEC so as to enable the examination of the dossiers to continue. It is expected that the evaluation and decision-making process with respect to a decision on a possible approval in accordance with Article 13(2) of Regulation (EC) No 1107/2009 for pinoxaden and meptyldinocap will have been completed within 24 months. |
(8) |
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
Member States may extend provisional authorisations for plant protection products containing pinoxaden and meptyldinocap for a period ending on 31 May 2016 at the latest.
Article 2
This Decision shall expire on 31 May 2016.
Article 3
This Decision is addressed to the Member States.
Done at Brussels, 15 May 2014.
For the Commission
Tonio BORG
Member of the Commission
(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 309, 24.11.2009, p. 1.
(3) Commission Decision 2005/459/EC of 22 June 2005 recognising in principle the completeness of the dossier submitted for detailed examination in view of the possible inclusion of pinoxaden in Annex I to Council Directive 91/414/EEC (OJ L 160, 23.6.2005, p. 32).
(4) Commission Decision 2006/589/EC of 31 August 2006 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of aviglycine HCl, mandipropamid and meptyldinocap in Annex I to Council Directive 91/414/EEC (OJ L 240, 2.9.2006, p. 9).
(5) Commission Implementing Decision 2012/191/EU of 10 April 2012 allowing Member States to extend provisional authorisations granted for the new active substances amisulbrom, chlorantraniliprole, meptyldinocap, pinoxaden, silver thiosulphate and tembotrione (OJ L 102, 12.4.2012, p. 15).
ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS
17.5.2014 |
EN |
Official Journal of the European Union |
L 147/116 |
COUNCIL DECISION
of 14 April 2014
on the position to be taken on behalf of the European Union within the EU-Chile Association Committee regarding the modification of Annex XII to the Agreement establishing an association between the European Community and its Member States, of the one part, and the Republic of Chile, of the other part, setting out the lists of Chilean entities which procure in accordance with the provisions of Title IV of Part IV on government procurement
(2014/290/EU)
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular the first paragraph of Article 207(4) in conjunction with Article 218(9) thereof,
Having regard to the proposal from the European Commission,
Whereas:
(1) |
The Agreement establishing an association between the European Community and its Members States, of the one part, and the Republic of Chile, of the other part (1) (‘the Association Agreement’), was signed on 18 November 2002. |
(2) |
Annex XII to the Association Agreement provides lists of entities in the Republic of Chile (‘Chile’) which procure in accordance with the provisions on government procurement of Title IV of Part IV of the Association Agreement. |
(3) |
On 10 February 2012, Chile notified the Union of its intention to modify its coverage on government procurement set out in Annex XII to the Association Agreement, in accordance with Article 159(1) of that Agreement. On 18 October 2012, Chile provided additional information. The modification consists in the simplification of certain lists of entities in Annex XII to the Association Agreement, namely: in Appendix 1 A, the entities listed under each Ministry and regional government are replaced by a catch-all clause which covers all entities subordinated to the listed Ministries and regional governments and in Appendix 2 A, the details of the list of all entities at sub-central level are replaced by a catch-all phrase: ‘all municipalities’ (‘the modification of Annex XII to the Association Agreement’). Appendix 1 B and Appendix 2 B, as well as Appendix 3 to Appendix 5 of Annex XII to the Association Agreement, remain unchanged. |
(4) |
Following that notification, and in accordance with Article 159(2) and (3) of the Association Agreement, the Parties to the Association Agreement consider it is appropriate for the EU-Chile Association Committee (‘the Association Committee’) to take a decision to reflect the modification of Annex XII to the Association Agreement. |
(5) |
The position of the Union within the Association Committee should be based on the attached draft Decision, |
HAS ADOPTED THIS DECISION:
Article 1
The position to be taken on the Union's behalf within the EU-Chile Association Committee (‘the Association Committee’) regarding the modification of Annex XII to the Association Agreement setting out the lists of Chilean entities which procure in accordance with the provisions of Title IV of Part IV on Government Procurement, shall be based on the draft Decision of the Association Committee attached to this Decision.
Article 2
After its adoption, the Decision of the Association Committee shall be published in the Official Journal of the European Union.
Article 3
This Decision shall enter into force on the date of its adoption.
Done at Luxembourg, 14 April 2014.
For the Council
The President
C. ASHTON
(1) OJ L 352, 30.12.2002, p. 3.
DRAFT
DECISION No …/2014 OF THE EU-CHILE ASSOCIATION COMMITTEE
of …
relating to Annex XII to the Agreement establishing an association between the European Community and its Member States, of the one part, and the Republic of Chile, of the other part, concerning the lists of Chilean entities which procure in accordance with the provisions of Title IV of Part IV on government procurement
THE EU-CHILE ASSOCIATION COMMITTEE,
Having regard to the Agreement establishing an association between the European Community and its Member States, of the one part, and the Republic of Chile, of the other part (1) (‘the Association Agreement’), signed on 18 November 2002, and in particular to Article 159 thereof,
Whereas:
(1) |
Annex XII to the Association Agreement provides lists of entities in the Republic of Chile (‘Chile’) which procure in accordance with the provisions on government procurement of Title IV of Part IV of the Association Agreement. |
(2) |
On 10 February 2012, Chile notified the European Union of its intention to modify its coverage on government procurement set out in Annex XII to the Association Agreement. The modification consists in the simplification of certain lists of entities in Annex XII to the Association Agreement, namely: in Appendix 1 A, the entities listed under each Ministry and regional government are replaced with a catch-all clause which covers all entities subordinated to the listed Ministries and regional governments, and in Appendix 2 A, the details of the list of all entities at sub-central level is replaced by a catch-all phrase: ‘all municipalities’ (‘the modification of Annex XII to the Association Agreement’). Appendix 1 B and Appendix 2 B, as well as Appendix 3 to Appendix 5 of Annex XII to the Association Agreement, remain unchanged. |
(3) |
For the purposes of Annex XII to the Association Agreement, it is appropriate to proceed with the modification of Annex XII to the Association Agreement notified by Chile, |
HAS ADOPTED THIS DECISION:
Article 1
Annex XII to the Association Agreement containing the lists of Chilean entities which procure in accordance with the provisions of the Title IV of Part IV on government procurement is replaced by the text appearing in the Annex to this Decision.
Article 2
This Decision shall enter into force on the date of its adoption.
Done at …,
For the EU-Chile Association Committee
The President
(1) OJ L 352, 30.12.2002, p. 3.
ANNEX
‘ANNEX XII
(Referred to in Article 137 of the Association Agreement)
CHILE'S COVERAGE ON GOVERNMENT PROCUREMENT
Appendix 1
Entities at central level
Entities which procure in accordance with the provisions of this Title
SUPPLIES
Thresholds SDR 130 000
SERVICES
Specified in Appendix 4
Thresholds SDR 130 000
WORKS
Specified in Appendix 5
Thresholds SDR 5 000 000
A. |
LIST OF ENTITIES
|
Note to Section A)
Unless otherwise specified in this Appendix, all entities subordinated to the Ministries and regional governments listed above, are covered by this Agreement.
B. |
ALL OTHER CENTRAL PUBLIC ENTITIES INCLUDING THEIR REGIONAL AND SUB-REGIONAL SUBDIVISIONS PROVIDED THAT THEY DO NOT HAVE AN INDUSTRIAL OR COMMERCIAL CHARACTER. |
Appendix 2
Entities at subcentral level and bodies governed by public law
Entities which procure in accordance with the provisions of this Title
SUPPLIES
Thresholds SDR 200 000
SERVICES
Specified in Appendix 4
Thresholds SDR 200 000
WORKS
Specified in Appendix 5
Thresholds SDR 5 000 000
A. |
LIST OF ENTITIES
|
B. |
ALL OTHER SUB-CENTRAL PUBLIC ENTITIES INCLUDING THEIR SUBDIVISIONS AND ALL OTHER ENTITIES OPERATING IN THE GENERAL INTEREST AND SUBJECT TO EFFECTIVE AND MANAGERIAL OR FINANCIAL CONTROL BY PUBLIC ENTITIES, PROVIDED THAT THEY DO NOT HAVE AN INDUSTRIAL OR COMMERCIAL CHARACTER. |
Appendix 3
Entities operating in the utilities sector
SUPPLIES
Thresholds SDR 400 000
SERVICES
Specified in Appendix 4
Thresholds SDR 400 000
WORKS
Specified in Appendix 5
Thresholds SDR 5 000 000
A. |
LIST OF ENTITIES
|
B. |
ALL OTHER PUBLIC UNDERTAKINGS, AS DEFINED IN ARTICLE 138(C), WHICH HAVE AS ONE OF THEIR ACTIVITIES ANY OF THOSE REFERRED TO BELOW OR ANY COMBINATION THEREOF:
|
Appendix 4
Services
For the purposes of this Title and without prejudice to Article 137(2), no services of the Universal list of Services are excluded.
Appendix 5
Construction services
For the purposes of this Title and without prejudice to the provisions of Article 137(2), no construction services under the division of the CPC concerning construction work are excluded.’.