ISSN 1977-0677

Official Journal

of the European Union

L 147

European flag  

English edition

Legislation

Volume 57
17 May 2014


Contents

 

II   Non-legislative acts

page

 

 

REGULATIONS

 

*

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 ( 1 )

1

 

*

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 ( 1 )

29

 

*

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

44

 

 

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

68

 

 

DECISIONS

 

 

2014/285/CFSP

 

*

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)

70

 

 

2014/286/EU

 

*

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 ( 1 )

71

 

 

2014/287/EU

 

*

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 ( 1 )

79

 

 

2014/288/EU

 

*

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)

88

 

 

2014/289/EU

 

*

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)  ( 1 )

114

 

 

ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS

 

 

2014/290/EU

 

*

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

116

 


 

(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:

(a)

the following point (f) is added:

‘(f)

an electronic label in the format and containing the information set out in Annex I is made available to dealers for each household dishwasher model placed on the market from 1 January 2015 with a new model identifier. It may also be made available to dealers for other household dishwasher models;’;

(b)

the following point (g) is added:

‘(g)

an electronic product fiche as set out in Annex II is made available to dealers for each household dishwasher model placed on the market from 1 January 2015 with a new model identifier. It may also be made available to dealers for other household dishwasher models.’;

(2)

in Article 4, point (b) is replaced by the following:

‘(b)

household dishwashers offered for sale, hire or hire- purchase where the end-user cannot be expected to see the household dishwasher displayed, are marketed with the information provided by suppliers in accordance with Annex IV. Where the offer is made through the internet and an electronic label and an electronic product fiche have been made available in accordance with Article 3(f) and 3(g) the provisions of Annex VIII shall apply instead;’;

(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:

(a)

the following point (f) is added:

‘(f)

an electronic label in the format and containing the information set out in Annex II is made available to dealers for each household refrigerating appliance model placed on the market from 1 January 2015 with a new model identifier. It may also be made available to dealers for other household refrigerating appliance models;’;

(b)

the following point (g) is added:

‘(g)

an electronic product fiche as set out in Annex III is made available to dealers for each household refrigerating appliance model placed on the market from 1 January 2015 with a new model identifier. It may also be made available to dealers for other household refrigerating appliance models.’;

(2)

in Article 4, point (b) is replaced by the following:

‘(b)

household refrigerating appliances offered for sale, hire or hire purchase where the end-user cannot be expected to see the product displayed, are marketed with the information to be provided by the suppliers in accordance with Annex V. Where the offer for is made through the internet and an electronic label and an electronic product fiche have been made available in accordance with Article 3(f) and 3(g) the provisions of Annex X shall apply instead;’;

(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:

(a)

the following point (f) is added:

‘(f)

an electronic label in the format and containing the information set out in Annex I is made available to dealers for each household washing machine model placed on the market from 1 January 2015 with a new model identifier. It may also be made available to dealers for other household washing machine models;’;

(b)

the following point (g) is added:

‘(g)

an electronic product fiche as set out in Annex II is made available to dealers for each household washing machine model placed on the market from 1 January 2015 with a new model identifier. It may also be made available to dealers for other household washing machine models.’;

(2)

in Article 4, point (b) is replaced by the following:

‘(b)

household washing machines offered for sale, hire or hire-purchase where the end-user cannot be expected to see the product displayed are marketed with the information to be provided by suppliers in accordance with Annex IV. Where the offer is made through the internet and an electronic label and an electronic product fiche have been made available in accordance with Article 3(f) and 3(g) the provisions of Annex VIII shall apply instead;’;

(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:

(a)

in paragraph 1, the following point (f) is added:

‘(f)

an electronic label in the format and containing the information set out in Annex V is made available to dealers for each television model placed on the market from 1 January 2015 with a new model identifier. It may also be made available to dealers for other television models;’;

(b)

in paragraph 1, the following point (g) is added:

‘(g)

an electronic product fiche as set out in Annex III is made available to dealers for each television model placed on the market from 1 January 2015 with a new model identifier. It may also be made available to dealers for other television models.’;

(2)

in Article 4, point (b) is replaced by the following:

‘(b)

televisions offered for sale, hire or hire-purchase, where the end-user cannot be expected to see the television displayed, are marketed with the information to be provided by the suppliers in accordance with Annex VI. Where the offer is made through the internet and an electronic label and an electronic product fiche have been made available in accordance with Article 3(1)(f) and 3(1)(g) the provisions in Annex IX shall apply instead;’;

(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:

(a)

in paragraph 1, the following point (h) is added:

‘(h)

an electronic label in the format and containing the information set out in Annex III is made available to dealers for each air conditioner model placed on the market from 1 January 2015 with a new model identifier, respecting energy efficiency classes set out in Annex II. It may also be made available to dealers for other air conditioner models;’;

(b)

in paragraph 1, the following point (i) is added:

‘(i)

an electronic product fiche as set out in Annex IV is made available to dealers for each air conditioner model placed on the market from 1 January 2015 with a new model identifier. It may also be made available to dealers for other air conditioner models.’;

(2)

in Article 4, point (b) is replaced by the following:

‘(b)

air conditioners offered for sale, hire or hire purchase where the end-user cannot be expected to see the product displayed, are marketed with the information provided by suppliers in accordance with Annexes IV and VI. Where the offer is made through the internet and an electronic label and an electronic product fiche have been made available in accordance with Article 3(1)(h) and 3(1)(i) the provisions of Annex IX shall apply instead;’;

(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:

(a)

the following point (f) is added:

‘(f)

an electronic label in the format and containing the information set out in Annex I is made available to dealers for each household tumble drier model placed on the market from 1 January 2015 with a new model identifier. It may also be made available to dealers for other household tumble drier models;’;

(b)

the following point (g) is added:

‘(g)

an electronic product fiche as set out in Annex II is made available to dealers for each household tumble drier model placed on the market from 1 January 2015 with a new model identifier. It may also be made available to dealers for other household tumble drier models.’;

(2)

in Article 4, point (b) is replaced by the following:

‘(b)

household tumble driers offered for sale, hire or hire-purchase where the end-user cannot be expected to see the product displayed, as specified in Article 7 of Directive 2010/30/EU, are marketed with the information provided by suppliers in accordance with Annex IV to this Regulation. Where the offer is made through the internet and an electronic label and an electronic product fiche have been made available in accordance with Article 3(f) and 3(g) the provisions of Annex VIII shall apply instead;’;

(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:

(a)

in paragraph 1, the following point (f) is added:

‘(f)

an electronic label in the format and containing the information set out in point 1 of Annex I is made available to dealers for each lamp model placed on the market from 1 January 2015 with a new model identifier. It may also be made available to dealers for other lamp models.’;

(b)

in paragraph 2, the following point (e) is added:

‘(e)

an electronic label in the format and containing information set out in point 2 of Annex I is made available to dealers for each luminaire model placed on the market from 1 January 2015 with a new model identifier. It may also be made available to dealers for other luminaire models.’;

(2)

Article 4 is amended as follows:

(a)

in paragraph 1, point (a) is replaced by the following:

‘(a)

each model offered for sale, hire or hire-purchase where the final owner cannot be expected to see the product displayed is marketed with the information to be provided by suppliers in accordance with Annex IV. Where the offer is made through the internet and an electronic label has been made available in accordance with Article 3(1)(f) the provisions in Annex VIII shall apply instead;’;

(b)

in paragraph 2, the following point (d) is added:

‘(d)

each model offered for sale, hire or hire-purchase through the internet and for which an electronic label has been made available in accordance with Article 3(2)(e) is accompanied by the label in accordance with Annex VIII.’;

(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:

(a)

in paragraph 1, the following point (f) is added:

‘(f)

an electronic label in the format and containing the information set out in Annex II is made available to dealers for each vacuum cleaner model placed on the market from 1 January 2015 with a new model identifier. It may also be made available to dealers for other vacuum cleaner models;’;

(b)

in paragraph 1, the following point (g) is added:

‘(g)

an electronic product fiche as set out in Annex III is made available to dealers for each vacuum cleaner model placed on the market from 1 January 2015 with a new model identifier. It may also be made available to dealers for other vacuum cleaner models.’;

(2)

in Article 4, point (b) is replaced by the following:

‘(b)

vacuum cleaners offered for sale, hire or hire-purchase where the end-user cannot be expected to see the product displayed, as specified in Article 7 of Directive 2010/30/EU, are marketed with the information provided by suppliers in accordance with Annex V to this Regulation. Where the offer is made through the internet and an electronic label and an electronic product fiche have been made available in accordance with Article 3(1)(f) and 3(1)(g) the provisions in Annex VIII shall apply instead;’;

(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:

(a)

in paragraph 1, the following point (f) is added in the first subparagraph:

‘(f)

an electronic label in the format and containing the information set out in point 1.1 of Annex III is made available to dealers for each space heater model conforming to the seasonal space heating energy efficiency classes set out in point 1 of Annex II;’;

(b)

in paragraph 1, the following point (g) is added in the first subparagraph:

‘(g)

an electronic product fiche as set out in point 1 of Annex IV is made available to dealers for each space heater model, whereby for heat pump space heaters models, the electronic product fiche is made available to dealers at least for the heat generator.’;

(c)

in paragraph 1, the following subparagraph is added:

‘From 26 September 2019 an electronic label in the format and containing the information set out in point 1.2 of Annex III shall be made available to dealers for each space heater model conforming to the seasonal space heating energy efficiency classes set out in point 1 of Annex II.’;

(d)

in paragraph 2, the following point (f) is added in the first subparagraph:

‘(f)

an electronic label in the format and containing the information set out in point 2.1 of Annex III is made available to dealers for each combination heater model conforming to the seasonal space heating energy efficiency classes and water heating energy efficiency classes set out in points 1 and 2 of Annex II;’;

(e)

in paragraph 2, the following point (g) is added in the first subparagraph:

‘(g)

an electronic product fiche as set out in point 2 of Annex IV is made available to dealers for each combination heater model, whereby for heat pump combination heaters models, the electronic product fiche is made available to dealers at least for the heat generator.’;

(f)

in paragraph 2, the following subparagraph is added:

‘From 26 September 2019 an electronic label in the format and containing the information set out in point 2.2 of Annex III shall be made available to dealers for each combination heater model conforming to the seasonal space heating energy efficiency classes and water heating energy efficiency classes set out in points 1 and 2 of Annex II.’;

(g)

in paragraph 3, the following point (c) is added:

‘(c)

an electronic product fiche, as set out in point 3 of Annex IV, is made available to dealers for each temperature control model.’;

(h)

in paragraph 4, the following point (c) is added:

‘(c)

an electronic product fiche, as set out in point 4 of Annex IV, is made available to dealers for each solar device model.’;

(i)

in paragraph 5, the following point (f) is added:

‘(f)

an electronic label in the format and containing the information set out in point 3 of Annex III is made available to dealers for each model comprising a package of space heater, temperature control and solar device conforming to the seasonal space heating energy efficiency classes set out in point 1 of Annex II;’;

(j)

in paragraph 5, the following point (g) is added:

‘(g)

an electronic product fiche as set out in point 5 of Annex IV is made available to dealers for each model comprising a package of space heater, temperature control and solar device.’;

(k)

in paragraph 6, the following point (f) is added:

‘(f)

an electronic label in the format and containing the information set out in point 4 of Annex III is made available to dealers for each model comprising a package of combination heater, temperature control and solar device conforming to the seasonal space heating energy efficiency classes and water heating energy efficiency classes set out in points 1 and 2 of Annex II;’;

(l)

in paragraph 6, the following point (g) is added:

‘(g)

an electronic product fiche as set out in point 6 of Annex IV is made available to dealers for each model comprising a package of combination heater, temperature control and solar device.’;

(2)

Article 4 is amended as follows:

(a)

in paragraph 1, point (b) is replaced by the following:

‘(b)

space heaters offered for sale, hire or hire-purchase, where the end-user cannot be expected to see the space heater displayed, are marketed with the information provided by the suppliers in accordance with point 1 of Annex VI, except where the offer is made through the internet, in which case the provisions in Annex IX shall apply;’;

(b)

in paragraph 2, point (b) is replaced by the following:

‘(b)

combination heaters offered for sale, hire or hire-purchase, where the end-user cannot be expected to see the combination heater displayed, are marketed with the information provided by the suppliers in accordance with point 2 of Annex VI, except where the offer is made through the internet, in which case the provisions in Annex IX shall apply;’;

(c)

in paragraph 3, point (b) is replaced by the following:

‘(b)

packages of space heater, temperature control and solar device offered for sale, hire or hire-purchase, where the end-user cannot be expected to see the package of space heater, temperature control and solar device displayed, are marketed with the information provided in accordance with point 3 of Annex VI, except where the offer is made through the internet, in which case the provisions in Annex IX shall apply;’;

(d)

in paragraph 4, point (b) is replaced by the following:

‘(b)

packages of combination heater, temperature control and solar device offered for sale, hire or hire-purchase, where the end-user cannot be expected to see the package of combination heater, temperature control and solar device displayed, are marketed with the information provided in accordance with point 4 of Annex VI, except where the offer is made through the internet, in which case the provisions in Annex IX shall apply;’;

(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:

(a)

in paragraph 1, the following point (f) is added in the first subparagraph:

‘(f)

an electronic label in the format and containing the information set out in point 1.1 of Annex III is made available to dealers for each water heater model conforming to the water heating energy efficiency classes set out in point 1 of Annex II;’;

(b)

in paragraph 1, the following point (g) is added in the first subparagraph:

‘(g)

an electronic product fiche as set out in point 1 of Annex IV is made available to dealers for each water heater model, whereby for heat pump water heaters models, the electronic product fiche is made available to dealers at least for the heat generator.’;

(c)

in paragraph 1, the following subparagraph is added:

‘From 26 September 2017 an electronic label in the format and containing the information set out in point 1.2 of Annex III shall be made available to dealers for each water heater model conforming to the water heating energy efficiency classes set out in point 1 of Annex II.’;

(d)

in paragraph 2, the following point (f) is added in the first subparagraph:

‘(f)

an electronic label in the format and containing the information set out in point 2.1 of Annex III is made available to dealers for each hot water storage tank model in accordance with the energy efficiency classes set out in point 2 of Annex II;’;

(e)

in paragraph 2, the following point (g) is added in the first subparagraph:

‘(g)

an electronic product fiche as set out in point 2 of Annex IV is made available to dealers for each hot water storage tank model.’;

(f)

in paragraph 2, the following subparagraph is added:

‘From 26 September 2017 an electronic label in the format and containing the information set out in point 2.2 of Annex III shall be made available to dealers for each hot water storage tank model, in accordance with the energy efficiency classes set out in point 2 of Annex II.’;

(g)

in paragraph 3, the following point (c) is added:

‘(c)

an electronic product fiche, as set out in point 3 of Annex IV, is made available to dealers for each solar device model.’;

(h)

in paragraph 4, the following point (f) is added:

‘(f)

an electronic label in the format and containing the information set out in point 3 of Annex III is made available to dealers for each model comprising a package of water heater and solar device, in accordance with the water heating energy efficiency classes set out in point 1 of Annex II;’;

(i)

in paragraph 4, the following point (g) is added:

‘(g)

an electronic product fiche as set out in point 4 of Annex IV is made available to dealers for each model comprising a package of water heater and solar device.’;

(2)

Article 4 is amended as follows:

(a)

in paragraph 1, point (b) is replaced by the following:

‘(b)

water heaters offered for sale, hire or hire-purchase, where the end-user cannot be expected to see the water heater displayed, are marketed with the information provided by the suppliers in accordance with point 1 of Annex VI, except where the offer is made through the internet, in which case the provisions in Annex X shall apply;’;

(b)

in paragraph 2, point (b) is replaced by the following:

‘(b)

hot water storage tanks offered for sale, hire or hire-purchase, where the end user cannot be expected to see the hot water storage tank displayed, are marketed with the information provided by the suppliers in accordance with point 2 of Annex VI; except where the offer is made through the internet in which case the provisions in Annex X shall apply;’;

(c)

in paragraph 3, point (b) is replaced by the following:

‘(b)

packages of water heater and solar device offered for sale, hire or hire purchase, where the end-user cannot be expected to see the package of water heater and solar device displayed, are marketed with the information provided in accordance with point 3 of Annex VI, except where the offer is made through the internet, in which case the provisions in Annex X shall apply;’;

(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:

(a)

“display mechanism” means any screen, including tactile screen, or other visual technology used for displaying internet content to users;

(b)

“nested display” means visual interface where an image or data set is accessed by a mouse click, mouse roll-over or tactile screen expansion of another image or data set;

(c)

“tactile screenf” means a screen responding to touch, such as that of a tablet computer, slate computer or a smartphone;

(d)

“alternative text” means text provided as an alternative to a graphic allowing information to be presented in non-graphical form where display devices cannot render the graphic or as an aid to accessibility such as input to voice synthesis applications.

(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:

(a)

be an arrow in the colour corresponding to the energy efficiency class of the product on the label;

(b)

indicate on the arrow the energy efficiency class of the product in white in a font size equivalent to that of the price; and

(c)

have one of the following two formats:

Image

(4)

In the case of nested display, the sequence of display of the label shall be as follows:

(a)

the image referred to in point 3 of this Annex shall be shown on the display mechanism in proximity to the price of the product;

(b)

the image shall link to the label;

(c)

the label shall be displayed after a mouse click, mouse roll-over or tactile screen expansion on the image;

(d)

the label shall be displayed by pop up, new tab, new page or inset screen display;

(e)

for magnification of the label on tactile screens, the device conventions for tactile magnification shall apply;

(f)

the label shall cease to be displayed by means of a close option or other standard closing mechanism;

(g)

the alternative text for the graphic, to be displayed on failure to display the label, shall be the energy efficiency class of the product in a font size equivalent to that of the price.

(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:

(a)

“display mechanism” means any screen, including tactile screen, or other visual technology used for displaying internet content to users;

(b)

“nested display” means visual interface where an image or data set is accessed by a mouse click, mouse roll-over or tactile screen expansion of another image or data set;

(c)

“tactile screen” means a screen responding to touch, such as that of a tablet computer, slate computer or a smartphone;

(d)

“alternative text” means text provided as an alternative to a graphic allowing information to be presented in non-graphical form where display devices cannot render the graphic or as an aid to accessibility such as input to voice synthesis applications.

(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:

(a)

be an arrow in the colour corresponding to the energy efficiency class of the product on the label;

(b)

indicate on the arrow the energy efficiency class of the product in white in a font size equivalent to that of the price; and

(c)

have one of the following two formats:

Image

(4)

In the case of nested display, the sequence of display of the label shall be as follows:

(a)

the image referred to in point 3 of this Annex shall be shown on the display mechanism in proximity to the price of the product;

(b)

the image shall link to the label;

(c)

the label shall be displayed after a mouse click, mouse roll-over or tactile screen expansion on the image;

(d)

the label shall be displayed by pop up, new tab, new page or inset screen display;

(e)

for magnification of the label on tactile screens, the device conventions for tactile magnification shall apply;

(f)

the label shall cease to be displayed by means of a close option or other standard closing mechanism;

(g)

the alternative text for the graphic, to be displayed on failure to display the label, shall be the energy efficiency class of the product in a font size equivalent to that of the price.

(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:

(a)

“display mechanism” means any screen, including tactile screen, or other visual technology used for displaying internet content to users;

(b)

“nested display” means visual interface where an image or data set is accessed by a mouse click, mouse roll-over or tactile screen expansion of another image or data set;

(c)

“tactile screen” means a screen responding to touch, such as that of a tablet computer, slate computer or a smartphone;

(d)

“alternative text” means text provided as an alternative to a graphic allowing information to be presented in non-graphical form where display devices cannot render the graphic or as an aid to accessibility such as input to voice synthesis applications.

(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:

(a)

be an arrow in the colour corresponding to the energy efficiency class of the product on the label;

(b)

indicate on the arrow the energy efficiency class of the product in white in a font size equivalent to that of the price; and

(c)

have one of the following two formats:

Image

(4)

In the case of nested display, the sequence of display of the label shall be as follows:

(a)

the image referred to in point 3 of this Annex shall be shown on the display mechanism in proximity to the price of the product;

(b)

the image shall link to the label;

(c)

the label shall be displayed after a mouse click, mouse roll-over or tactile screen expansion on the image;

(d)

the label shall be displayed by pop up, new tab, new page or inset screen display;

(e)

for magnification of the label on tactile screens, the device conventions for tactile magnification shall apply;

(f)

the label shall cease to be displayed by means of a close option or other standard closing mechanism;

(g)

the alternative text for the graphic, to be displayed on failure to display the label, shall be the energy efficiency class of the product in a font size equivalent to that of the price.

(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:

(a)

“display mechanism” means any screen, including tactile screen, or other visual technology used for displaying internet content to users;

(b)

“nested display” means visual interface where an image or data set is accessed by a mouse click, mouse roll-over or tactile screen expansion of another image or data set;

(c)

“tactile screen” means a screen responding to touch, such as that of a tablet computer, slate computer or a smartphone;

(d)

“alternative text” means text provided as an alternative to a graphic allowing information to be presented in non-graphical form where display devices cannot render the graphic or as an aid to accessibility such as input to voice synthesis applications.

(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:

(a)

be an arrow in the colour corresponding to the energy efficiency class of the product on the label;

(b)

indicate on the arrow the energy efficiency class of the product in white in a font size equivalent to that of the price; and

(c)

have one of the following two formats:

Image

(4)

In the case of nested display, the sequence of display of the label shall be as follows:

(a)

the image referred to in point 3 of this Annex shall be shown on the display mechanism in proximity to the price of the product;

(b)

the image shall link to the label;

(c)

the label shall be displayed after a mouse click, mouse roll-over or tactile screen expansion on the image;

(d)

the label shall be displayed by pop up, new tab, new page or inset screen display;

(e)

for magnification of the label on tactile screens, the device conventions for tactile magnification shall apply;

(f)

the label shall cease to be displayed by means of a close option or other standard closing mechanism;

(g)

the alternative text for the graphic, to be displayed on failure to display the label, shall be the energy efficiency class of the product in a font size equivalent to that of the price.

(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:

(a)

“display mechanism” means any screen, including tactile screen, or other visual technology used for displaying internet content to users;

(b)

“nested display” means visual interface where an image or data set is accessed by a mouse click, mouse roll-over or tactile screen expansion of another image or data set;

(c)

“tactile screen” means a screen responding to touch, such as that of a tablet computer, slate computer or a smartphone;

(d)

“alternative text” means text provided as an alternative to a graphic allowing information to be presented in non-graphical form where display devices cannot render the graphic or as an aid to accessibility such as input to voice synthesis applications.

(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:

(a)

be an arrow in the colour corresponding to the energy efficiency class of the product on the label;

(b)

indicate on the arrow the energy efficiency class of the product in white in a font size equivalent to that of the price; and

(c)

have one of the following two formats:

Image

(4)

In the case of nested display, the sequence of display of the label shall be as follows:

(a)

the image referred to in point 3 of this Annex shall be shown on the display mechanism in proximity to the price of the product;

(b)

the image shall link to the label;

(c)

the label shall be displayed after a mouse click, mouse roll-over or tactile screen expansion on the image;

(d)

the label shall be displayed by pop up, new tab, new page or inset screen display;

(e)

for magnification of the label on tactile screens, the device conventions for tactile magnification shall apply;

(f)

the label shall cease to be displayed by means of a close option or other standard closing mechanism;

(g)

the alternative text for the graphic, to be displayed on failure to display the label, shall be the energy efficiency class of the product in a font size equivalent to that of the price.

(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:

(a)

“display mechanism” means any screen, including tactile screen, or other visual technology used for displaying internet content to users;

(b)

“nested display” means visual interface where an image or data set is accessed by a mouse click, mouse roll-over or tactile screen expansion of another image or data set;

(c)

“tactile screen” means a screen responding to touch, such as that of a tablet computer, slate computer or a smartphone;

(d)

“alternative text” means text provided as an alternative to a graphic allowing information to be presented in non-graphical form where display devices cannot render the graphic or as an aid to accessibility such as input to voice synthesis applications.

(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:

(a)

be an arrow in the colour corresponding to the energy efficiency class of the product on the label;

(b)

indicate on the arrow the energy efficiency class of the product in white in a font size equivalent to that of the price; and

(c)

have one of the following two formats:

Image

(4)

In the case of nested display, the sequence of display of the label shall be as follows:

(a)

the image referred to in point 3 of this Annex shall be shown on the display mechanism in proximity to the price of the product;

(b)

the image shall link to the label;

(c)

the label shall be displayed after a mouse click, mouse roll-over or tactile screen expansion on the image;

(d)

the label shall be displayed by pop up, new tab, new page or inset screen display;

(e)

for magnification of the label on tactile screens, the device conventions for tactile magnification shall apply;

(f)

the label shall cease to be displayed by means of a close option or other standard closing mechanism;

(g)

the alternative text for the graphic, to be displayed on failure to display the label, shall be the energy efficiency class of the product in a font size equivalent to that of the price.

(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:

(a)

“display mechanism” means any screen, including tactile screen, or other visual technology used for displaying internet content to users;

(b)

“nested display” means visual interface where an image or data set is accessed by a mouse click, mouse roll-over or tactile screen expansion of another image or data set;

(c)

“tactile screen” means a screen responding to touch, such as that of a tablet computer, slate computer or a smartphone;

(d)

“alternative text” means text provided as an alternative to a graphic allowing information to be presented in non-graphical form where display devices cannot render the graphic or as an aid to accessibility such as input to voice synthesis applications.

(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:

(a)

be an arrow in the colour corresponding to the energy efficiency class of the product on the label;

(b)

indicate on the arrow the energy efficiency class of the product in white in a font size equivalent to that of the price; and

(c)

have one of the following two formats:

Image

(4)

In the case of nested display, the sequence of display of the label shall be as follows:

(a)

the image referred to in point 3 of this Annex shall be shown on the display mechanism in proximity to the price of the product;

(b)

the image shall link to the label;

(c)

the label shall be displayed after a mouse click, mouse roll-over or tactile screen expansion on the image;

(d)

the label shall be displayed by pop up, new tab, new page or inset screen display;

(e)

for magnification of the label on tactile screens, the device conventions for tactile magnification shall apply;

(f)

the label shall cease to be displayed by means of a close option or other standard closing mechanism;

(g)

the alternative text for the graphic, to be displayed on failure to display the label, shall be the energy efficiency class of the product in a font size equivalent to that of the price.’


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:

(a)

“display mechanism” means any screen, including tactile screen, or other visual technology used for displaying internet content to users;

(b)

“nested display” means visual interface where an image or data set is accessed by a mouse click, mouse roll-over or tactile screen expansion of another image or data set;

(c)

“tactile screen” means a screen responding to touch, such as that of a tablet computer, slate computer or a smartphone;

(d)

“alternative text” means text provided as an alternative to a graphic allowing information to be presented in non-graphical form where display devices cannot render the graphic or as an aid to accessibility such as input to voice synthesis applications.

(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:

(a)

be an arrow in the colour corresponding to the energy efficiency class of the product on the label;

(b)

indicate on the arrow the energy efficiency class of the product in white in a font size equivalent to that of the price; and

(c)

have one of the following two formats:

Image

(4)

In the case of nested display, the sequence of display of the label shall be as follows:

(a)

the image referred to in point 3 of this Annex shall be shown on the display mechanism in proximity to the price of the product;

(b)

the image shall link to the label;

(c)

the label shall be displayed after a mouse click, mouse roll-over or tactile screen expansion on the image;

(d)

the label shall be displayed by pop up, new tab, new page or inset screen display;

(e)

for magnification of the label on tactile screens, the device conventions for tactile magnification shall apply;

(f)

the label shall cease to be displayed by means of a close option or other standard closing mechanism;

(g)

the alternative text for the graphic, to be displayed on failure to display the label, shall be the energy efficiency class of the product in a font size equivalent to that of the price.

(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

(1)

For the purpose of points 2 to 5 of this Annex the following definitions shall apply:

(a)

“display mechanism” means any screen, including tactile screen, or other visual technology used for displaying internet content to users;

(b)

“nested display” means visual interface where an image or data set is accessed by a mouse click, mouse roll-over or tactile screen expansion of another image or data set;

(c)

“tactile screen” means a screen responding to touch, such as that of a tablet computer, slate computer or a smartphone;

(d)

“alternative text” means text provided as an alternative to a graphic allowing information to be presented in non-graphical form where display devices cannot render the graphic or as an aid to accessibility such as input to voice synthesis applications.

(2)

The appropriate label made available by suppliers in accordance with Article 3 or in the case of a package where appropriate duly filled in based on the label and fiches provided by suppliers in accordance with Article 3, shall be shown on the display mechanism in proximity to the price of the product or package in accordance with the timetable set out in Article 3. If both a product and a package are shown, but with a price indicated only for the package, only the package label shall be displayed. 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:

(a)

be an arrow in the colour corresponding to the energy efficiency class of the product or package on the label;

(b)

indicate on the arrow the energy efficiency class of the product or package in white in a font size equivalent to that of the price; and

(c)

have one of the following two formats:

Image

(4)

In the case of nested display, the sequence of display of the label shall be as follows:

(a)

the image referred to in point 3 of this Annex shall be shown on the display mechanism in proximity to the price of the product or package;

(b)

the image shall link to the label;

(c)

the label shall be displayed after a mouse click, mouse roll-over or tactile screen expansion on the image;

(d)

the label shall be displayed by pop up, new tab, new page or inset screen display;

(e)

for magnification of the label on tactile screens, the device conventions for tactile magnification shall apply;

(f)

the label shall cease to be displayed by means of a close option or other standard closing mechanism;

(g)

the alternative text for the graphic, to be displayed on failure to display the label, shall be the energy efficiency class of the product or package in a font size equivalent to that of the price.

(5)

The appropriate product fiche made available by suppliers in accordance with Article 3 shall be shown on the display mechanism in proximity to the price of the product or package. 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 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

(1)

For the purpose of points 2 to 5 of this Annex the following definitions shall apply:

(a)

“display mechanism” means any screen, including tactile screen, or other visual technology used for displaying internet content to users;

(b)

“nested display” means visual interface where an image or data set is accessed by a mouse click, mouse roll-over or tactile screen expansion of another image or data set;

(c)

“tactile screen” means a screen responding to touch, such as that of a tablet computer, slate computer or a smartphone;

(d)

“alternative text” means text provided as an alternative to a graphic allowing information to be presented in non-graphical form where display devices cannot render the graphic or as an aid to accessibility such as input to voice synthesis applications.

(2)

The appropriate label made available by suppliers in accordance with Article 3 or in the case of a package where appropriate duly filled in based on the label and fiches provided by suppliers in accordance with Article 3, shall be shown on the display mechanism in proximity to the price of the product or package in accordance with the timetable set out in Article 3. If both a product and a package are shown, but with a price indicated only for the package, only the package label shall be displayed. 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:

(a)

be an arrow in the colour corresponding to the energy efficiency class of the product or package on the label;

(b)

indicate on the arrow the energy efficiency class of the product or package in white in a font size equivalent to that of the price; and

(c)

have one of the following two formats:

Image

(4)

In the case of nested display, the sequence of display of the label shall be as follows:

(a)

the image referred to in point 3 of this Annex shall be shown on the display mechanism in proximity to the price of the product or package;

(b)

the image shall link to the label;

(c)

the label shall be displayed after a mouse click, mouse roll-over or tactile screen expansion on the image;

(d)

the label shall be displayed by pop up, new tab, new page or inset screen display;

(e)

for magnification of the label on tactile screens, the device conventions for tactile magnification shall apply;

(f)

the label shall cease to be displayed by means of a close option or other standard closing mechanism;

(g)

the alternative text for the graphic, to be displayed on failure to display the label, shall be the energy efficiency class of the product or package in a font size equivalent to that of the price.

(5)

The appropriate product fiche made available by suppliers in accordance with Article 3 shall be shown on the display mechanism in proximity to the price of the product or package. 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.’


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:

(a)

In part B, footnote (1) is replaced by the following:

‘(1)

The sampling of such lots shall be performed in accordance with the rules set out in part L. Guidance for sampling large lots shall be provided in a guidance document available on the following website: http://ec.europa.eu/food/food/chemicalsafety/contaminants/guidance-sampling-final.pdf

The application of sampling rules in accordance with EN ISO 24333:2009 or GAFTA Sampling Rules 124, applied by food business operators to ensure compliance with provisions in legislation is equivalent to the sampling rules set out in part L.

For the sampling of lots for Fusarium-toxins, the application of sampling rules in accordance with EN ISO 24333:2009 or GAFTA Sampling Rules 124, applied by food business operators to ensure compliance with provisions in legislation is equivalent to the sampling rules set out in part B;’

(b)

In part B.2, Table 1 is replaced by the following table:

‘Table 1

Subdivision of lots into sublots depending on product and lot weight

Commodity

Lot weight (tonne)

Weight or number of sublots

No incremental samples

Aggregate sample Weight (kg)

Cereals and cereal products

> 300 and < 1 500

3 sublots

100

10

≥ 50 and ≤ 300

100 tonnes

100

10

< 50

3-100 (4)

1-10

(c)

In part B.3, the following sentence is added at the end of the first indent:

‘For lots > 500 tonnes, the number of incremental samples is provided for in part L.2 of Annex I.’

(d)

In part D.2 the following sentence is added after the first sentence:

‘This method of sampling is of also of application for the official control of the maximum levels established for ochratoxin A, aflatoxin B1 and total aflatoxins in spices with a relatively large particle size (particle size comparable with peanuts or larger e.g. nutmeg).’;

(e)

In part E, the first sentence is replaced by the following:

‘This method of sampling is of application for the official control of the maximum levels established for ochratoxin A, aflatoxin B1 and total aflatoxins in spices except in cases of spices with a relatively large particle size (heterogeneous distribution of mycotoxin contamination).’;

(f)

In part I, the heading and the first sentence are replaced by the following:

‘I.   METHOD OF SAMPLING FOR SOLID APPLE PRODUCTS

This method of sampling is of application for the official control of the maximum levels established for patulin in solid apple products, including solid apple products for infants and young children.’

(g)

In part I.1, second paragraph, the following sentences are deleted:

‘In case of liquid products the lot shall be thoroughly mixed insofar as possible by either manual or mechanical means immediately prior to sampling. In this case, a homogenous distribution of patulin can be assumed within a given lot. It is therefore sufficient to take three incremental samples from a lot to form the aggregate sample.’

(h)

New Parts L and M as set out in Annex I to this Regulation, are added.

(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.   Silos not accessible from above (closed silos) with individual sizes > 100 tonnes

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.   Silos not accessible from above (closed silos) with individual sizes < 100 tonnes

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.   Performance criteria

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

Criterion

Concentration Range

Recommended Value

Maximum permitted Value

Blanks

All

Negligible

 

 

 

 

Recovery — Aflatoxin M1

0,01-0,05 mg/kg

60 to 120 %

 

 

> 0,05 mg/kg

70 to 110 %

 

 

 

 

 

Recovery-Aflatoxins B1, B2, G1, G2

< 1,0 mg/kg

50 to 120 %

 

 

1-10 mg/kg

70 to 110 %

 

 

> 10 mg/kg

80 to 110 %

 

 

 

 

 

Reproducibility RSDR

All

As derived from Horwitz Equation (*)(**)

2 × value derived from Horwitz Equation (*)(**)

Repeatability RSDr may be calculated as 0,66 times Reproducibility RSDR at the concentration of interest.

Note:

Values to apply to both B1 and sum of B1 + B2 + G1 + G2

If sum of individual aflatoxins B1 + B2 + G1 + G2 are to be reported, then response of each to the analytical system must be either known or equivalent.

(b)

Performance criteria for ochratoxin A

Level

μg/kg

Ochratoxin A

RSDr %

RSDR %

Recovery %

< 1

≤ 40

≤ 60

50 to 120

≥ 1

≤ 20

≤ 30

70 to 110

(c)

Performance criteria for patulin

Level

μg/kg

Patulin

RSDr %

RSDR %

Recovery %

< 20

≤ 30

≤ 40

50 to 120

20-50

≤ 20

≤ 30

70 to 105

> 50

≤ 15

≤ 25

75 to 105

(d)

Performance criteria for deoxynivalenol

Level

μg/kg

Deoxynivalenol

RSDr %

RSDR %

Recovery %

> 100-≤ 500

≤ 20

≤ 40

60 to 110

> 500

≤ 20

≤ 40

70 to 120

(e)

Performance criteria for zearalenone

Level

μg/kg

Zearalenone

RSDr %

RSDR %

Recovery %

≤ 50

≤ 40

≤ 50

60 to 120

> 50

≤ 25

≤ 40

70 to 120

(f)

Performance criteria for Fumonisin B1 and B2 individually

Level

μg/kg

Fumonisin B1 and B2 individually

RSDr %

RSDR %

Recovery %

≤ 500

≤ 30

≤ 60

60 to 120

> 500

≤ 20

≤ 30

70 to 110

(g)

Performance criteria for T-2 and HT-2 toxin individually

Level

μg/kg

T-2 and HT-2 toxin individually

RSDr %

RSDR %

Recovery %

15-250

≤ 30

≤ 50

60 to 130

> 250

≤ 25

≤ 40

60 to 130

(h)

Performance criteria for citrinin

Level

μg/kg

Citrinin

RSDr %

Recommended RSDR %

Maximum allowed RSDR %

Recovery %

All

0,66 × RSDR

As derived from Horwitz Equation (*)(**)

2 × value derived from Horwitz Equation (*)(**)

70 to 120

(i)

Notes to the performance criteria for the mycotoxins:

The detection limits of the methods used are not stated as the precision values given at the concentrations of interest.

The precision values are calculated from the Horwitz equation, in particular the original Horwitz equation (for concentrations 1,2 × 10–7 ≤ C ≤ 0,138) (*) and the modified Horwitz equation (for concentrations C < 1,2 × 10–7) (**).

(*)

Horwitz equation for concentrations 1,2 × 10–7 ≤ C ≤ 0,138:

RSDR = 2(1-0.5logC)

(ref: W. Horwitz, L.R. Kamps, K.W. Boyer, J.Assoc.Off.Analy.Chem.,1980, 63, 1344)

(**)

Modified Horwitz equation (*) for concentrations C < 1,2 × 10–7:

RSDR = 22 %

(ref: M. Thompson, Analyst, 2000, 125, p. 385-386)

Where:

RSDR is the relative standard deviation calculated from results generated under reproducibility conditions [(sR/) × 100]

C is the concentration ratio (i.e. 1 = 100g/100g, 0,001 = 1 000 mg/kg)

This is a generalised precision equation which has been found to be independent of analyte and matrix but solely dependent on concentration for most routine methods of analysis.

4.3.1.2.   “Fitness-for-purpose” approach

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:

Formula

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.   Scope

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.   Terminology

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.   Validation procedure

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.   Determination of cut-off level and rate of false suspected results of blank samples

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.   Extension of the scope of the method

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.   Verification of methods already validated through collaborative trials

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.   Continuous method verification/on-going method validation

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.   Validation report

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


(1)  OJ L 115, 9.5.1996, p. 3.

(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.