ISSN 1977-0677

Official Journal

of the European Union

L 125

European flag  

English edition

Legislation

Volume 60
18 May 2017


Contents

 

II   Non-legislative acts

page

 

 

REGULATIONS

 

*

Commission Delegated Regulation (EU) 2017/836 of 11 January 2017 amending Annex III to Regulation (EU) No 978/2012 of the European Parliament and of the Council applying a scheme of generalised tariff preferences

1

 

*

Commission Implementing Regulation (EU) 2017/837 of 17 May 2017 correcting the Polish and Swedish language versions of Implementing Regulation (EU) 2015/1998 laying down detailed measures for the implementation of the common basic standards on aviation security ( 1 )

3

 

*

Commission Implementing Regulation (EU) 2017/838 of 17 May 2017 amending Regulation (EC) No 889/2008 as regards feed for certain organic aquaculture animals ( 1 )

5

 

*

Commission Regulation (EU) 2017/839 of 17 May 2017 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of nitrites (E 249-250) in golonka peklowana ( 1 )

7

 

*

Commission Implementing Regulation (EU) 2017/840 of 17 May 2017 concerning the non-approval of the active substance orthosulfamuron, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market ( 1 )

10

 

*

Commission Implementing Regulation (EU) 2017/841 of 17 May 2017 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances alpha-cypermethrin, Ampelomyces quisqualis strain: aq 10, benalaxyl, bentazone, bifenazate, bromoxynil, carfentrazone ethyl, chlorpropham, cyazofamid, desmedipham, diquat, DPX KE 459 (flupyrsulfuron-methyl), etoxazole, famoxadone, fenamidone, flumioxazine, foramsulfuron, Gliocladium catenulatum strain: j1446, imazamox, imazosulfuron, isoxaflutole, laminarin, metalaxyl-m, methoxyfenozide, milbemectin, oxasulfuron, pendimethalin, phenmedipham, pymetrozine, s-metolachlor, and trifloxystrobin ( 1 )

12

 

*

Commission Implementing Regulation (EU) 2017/842 of 17 May 2017 renewing the approval of the low-risk active substance Coniothyrium minitans strain CON/M/91-08 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 ( 1 )

16

 

*

Commission Implementing Regulation (EU) 2017/843 of 17 May 2017 approving the active substance Beauveria bassiana strain NPP111B005, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 ( 1 )

21

 

 

Commission Implementing Regulation (EU) 2017/844 of 17 May 2017 establishing the standard import values for determining the entry price of certain fruit and vegetables

25

 

 

DIRECTIVES

 

*

Commission Directive (EU) 2017/845 of 17 May 2017 amending Directive 2008/56/EC of the European Parliament and of the Council as regards the indicative lists of elements to be taken into account for the preparation of marine strategies ( 1 )

27

 

 

DECISIONS

 

*

Decision (EU) 2017/846 of the European Parliament of 16 March 2017 extending the term of office of the Committee of Inquiry to investigate alleged contraventions and maladministration in the application of Union law in relation to money laundering, tax avoidance and tax evasion

34

 

*

Commission Implementing Decision (EU) 2017/847 of 16 May 2017 granting a derogation requested by Denmark pursuant to Council Directive 91/676/EEC concerning the protection of waters against pollution caused by nitrates from agricultural sources (notified under document C(2017) 2891)

35

 

*

Commission Decision (EU) 2017/848 of 17 May 2017 laying down criteria and methodological standards on good environmental status of marine waters and specifications and standardised methods for monitoring and assessment, and repealing Decision 2010/477/EU ( 1 )

43

 

 

Corrigenda

 

*

Corrigendum to Commission Delegated Regulation (EU) 2015/1011 of 24 April 2015 supplementing Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Union and third countries in drug precursors, and repealing Commission Regulation (EC) No 1277/2005 ( OJ L 162, 27.6.2015 )

75

 


 

(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

18.5.2017   

EN

Official Journal of the European Union

L 125/1


COMMISSION DELEGATED REGULATION (EU) 2017/836

of 11 January 2017

amending Annex III to Regulation (EU) No 978/2012 of the European Parliament and of the Council applying a scheme of generalised tariff preferences

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union, in particular Article 207,

Having regard to Regulation (EU) No 978/2012 of the European Parliament and of the Council of 25 October 2012 applying a scheme of generalised tariff preferences and repealing Council Regulation (EC) No 732/2008 (1), and in particular Article 10(4) thereof,

Whereas:

(1)

A beneficiary country under the Generalised Scheme of Tariff Preferences (‘GSP’) may request to benefit from additional tariff preferences under the special incentive arrangement for sustainable development and good governance (GSP+). For that purpose, Article 9(1) of Regulation (EU) No 978/2012 establishes specific eligibility criteria for the granting of the tariff preferences provided under the GSP+. The country should be considered vulnerable due to a lack of sufficient diversification and insufficient integration with the international trading system. It should have ratified all the conventions listed in Annex VIII to Regulation (EU) No 978/2012 and the most recent available conclusions of the relevant monitoring bodies should not identify a serious failure to effectively implement any of those conventions. In relation to any of the relevant conventions, the country should not have formulated a reservation which is prohibited by the convention or which, for the exclusive purposes of Article 9 of Regulation (EU) No 978/2012, is considered to be incompatible with the object and purpose of that convention. It should accept without reservation the reporting requirements imposed by each convention and give the binding undertakings referred to in points (d), (e) and (f) of Article 9(1) of Regulation (EU) No 978/2012.

(2)

A GSP beneficiary country wishing to benefit from GSP+ has to submit a request accompanied by comprehensive information concerning ratification of the relevant conventions, its reservations and the objections to those reservations made by other parties to the convention, and its binding undertakings.

(3)

The Commission has been empowered to adopt delegated acts to amend Annex III to Regulation (EU) No 978/2012 in order to grant GSP+ to a requesting country by adding it to the list of GSP+ beneficiary countries.

(4)

On 12 July 2016, the Commission received a GSP+ request from the Democratic Socialist Republic of Sri Lanka (‘Sri Lanka’).

(5)

The Commission has examined the GSP+ request from Sri Lanka in accordance with the provisions of Article 10(1) of Regulation (EU) No 978/2012, and the Commission has established that Sri Lanka meets the conditions. Sri Lanka should therefore be granted GSP+ from the date of entry into force of this Regulation. Annex III to Regulation (EU) No 978/2012 should be amended accordingly.

(6)

Pursuant to Article 13 of Regulation (EU) No 978/2012, the Commission should keep under review the status of ratification of the relevant conventions, the effective implementation of those conventions, as well as the cooperation with the relevant monitoring bodies by the government of Sri Lanka,

HAS ADOPTED THIS REGULATION:

Article 1

In Annex III to Regulation (EU) No 978/2012, the following country and the corresponding alphabetical code are inserted under columns B and A, respectively:

‘Sri Lanka

LK’.

Article 2

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

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 11 January 2017.

For the Commission

The President

Jean-Claude JUNCKER


(1)  OJ L 303, 31.10.2012, p. 1.


18.5.2017   

EN

Official Journal of the European Union

L 125/3


COMMISSION IMPLEMENTING REGULATION (EU) 2017/837

of 17 May 2017

correcting the Polish and Swedish language versions of Implementing Regulation (EU) 2015/1998 laying down detailed measures for the implementation of the common basic standards on aviation security

(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 300/2008 of the European Parliament and of the Council of 11 March 2008 on common rules in the field of civil aviation security and repealing Regulation (EC) No 2320/2002 (1), and in particular Article 4(3) thereof,

Whereas:

(1)

The Polish language version of Commission Implementing Regulation (EU) 2015/1998 (2) contains an error in point 11.4.3(a) of the Annex as regards the list of competencies requiring recurrent training at specific intervals.

(2)

The Swedish language version of Implementing Regulation (EU) 2015/1998 contains errors in the Annex, namely in points 8.1.1.2 and 9.1.1.3 as regards the requirement of a renewed screening; in point 8.3.1 as regards the object of the delivery obligation; in the first paragraph of point 9.1.3.5(b) as regards the scope of the validation method; in point 9.3.1 as regards the object of the delivery obligation; and in the introductory phrase of point 11.2.3.1 as regards persons covered by the training obligation.

(3)

The Polish and Swedish language versions of Implementing Regulation (EU) 2015/1998 should therefore be corrected accordingly. The other language versions are not affected.

(4)

The measures provided for in this Regulation are in accordance with the opinion of the Committee on Civil Aviation Security,

HAS ADOPTED THIS REGULATION:

Article 1

(does not concern the English language)

Article 2

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

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 17 May 2017.

For the Commission

The President

Jean-Claude JUNCKER


(1)  OJ L 97, 9.4.2008, p. 72.

(2)  Commission Implementing Regulation (EU) 2015/1998 of 5 November 2015 laying down detailed measures for the implementation of the common basic standards on aviation security (OJ L 299, 14.11.2015, p. 1).


18.5.2017   

EN

Official Journal of the European Union

L 125/5


COMMISSION IMPLEMENTING REGULATION (EU) 2017/838

of 17 May 2017

amending Regulation (EC) No 889/2008 as regards feed for certain organic aquaculture animals

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91 (1), and in particular Articles 15(2) and 16(1) thereof,

Whereas:

(1)

Regulation (EC) No 834/2007 establishes basic requirements for the organic production of aquaculture animals, including requirements with regard to feed. Detailed rules for implementing those requirements are laid down in Commission Regulation (EC) No 889/2008 (2).

(2)

Article 15(1)(d)(i) of Regulation (EC) No 834/2007 requires that fish and crustaceans are fed with feed that meets the animal's nutritional requirements at the various stages of its development.

(3)

Article 25l of Regulation (EC) No 889/2008 sets out specific rules on feed for certain aquaculture animals referred to in Sections 6, 7 and 9 of Annex XIIIa to that Regulation. The rules set out in that Article aim to prioritise naturally available feed, where it is available.

(4)

Under Article 25l(1) of Regulation (EC) No 889/2008, the animals concerned are to be fed with feed naturally available in ponds and lakes. Article 25l(2) of that Regulation permits the use of organic feed of plant origin or seaweed where natural feed resources are not available in sufficient quantities. Article 25l(3)(a) and (b) of that Regulation establish maximum percentages of fishmeal and fish oil that can be included in the feed ration of siamese catfish and shrimps where naturally available feed is supplemented.

(5)

Naturally occurring feed is limited or non-existent in the hatchery stage. Member States have indicated to the Commission that the rules on feeding penaeid shrimps, in particular Tiger shrimp (Penaeus monodon), set out in Article 25l(3)(b) of Regulation (EC) No 889/2008, would lead to malnutrition and increased mortality if applied in the juvenile stages in a hatchery environment.

(6)

Article 25l(1) of Regulation (EC) No 889/2008 requires the animals concerned to be fed with feed naturally available in ponds and lakes. The rule set out in that Article should concern only the grow-out stages where the animals are kept in ponds and lakes rather than hatchery environments where naturally available feed is insufficient. This is especially pertinent from 31 December 2016, since when, in accordance with Article 25e(3) of Regulation (EC) No 889/2008, juvenile aquaculture animals subject to non-organic management conditions can no longer be brought into an organic holding. Prior to this date, it was permitted to bring a proportion of non-organic juvenile animals into an organic holding, following a hatchery stage under non-organic management.

(7)

Furthermore, the expert group for technical advice on organic production (‘EGTOP’), set up by Commission Decision 2009/427/EC (3), has confirmed that the specific rules contained in Article 25l(3)(a) and (b) of Regulation (EC) No 889/2008 are suitable only for the grow-out stages (4). EGTOP considers that the limitations on fishmeal and fish oil set out in that Article do not allow the animal's nutritional requirements to be met during the early life stages while in a hatchery environment.

(8)

The Commission has identified the need to amend the rules on feeds for certain aquaculture animals by clarifying that these rules apply only to the grow-out stages. In arriving at this conclusion the Commission has taken into account the requirement to meet the animal's nutritional needs at the various stages of its development as set out in Article 15(1)(d)(i) of Regulation (EC) No 834/2007, the aim of Article 25l of Regulation (EC) No 889/2008 to prioritise naturally available feed where it is available, and the opinion of EGTOP.

(9)

Regulation (EC) No 889/2008 should therefore be amended accordingly.

(10)

The measures provided for in this Regulation are in accordance with the opinion of the Committee on organic production,

HAS ADOPTED THIS REGULATION:

Article 1

Article 25l, paragraph 1, of Regulation (EC) No 889/2008 is replaced by the following:

‘1.   In the grow-out stages, aquaculture animals as referred to in Annex XIIIa, Section 6, Section 7 and Section 9 shall be fed with feed naturally available in ponds and lakes.’

Article 2

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

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 17 May 2017.

For the Commission

The President

Jean-Claude JUNCKER


(1)  OJ L 189, 20.7.2007, p. 1.

(2)  Commission Regulation (EC) No 889/2008 of 5 September 2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control (OJ L 250, 18.9.2008, p. 1).

(3)  Commission Decision 2009/427/EC of 3 June 2009 establishing the expert group for technical advice on organic production (OJ L 139, 5.6.2009, p. 29).

(4)  Final report: http://ec.europa.eu/agriculture/organic/sites/orgfarming/files/final_report_egtop_on_aquaculture_part-c_en.pdf


18.5.2017   

EN

Official Journal of the European Union

L 125/7


COMMISSION REGULATION (EU) 2017/839

of 17 May 2017

amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of nitrites (E 249-250) in ‘golonka peklowana’

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (1), and in particular Article 10(3) thereof,

Whereas:

(1)

Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in foods and their conditions of use.

(2)

The Union list of food additives may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008 of the European Parliament and of the Council (2), either on the initiative of the Commission or following an application.

(3)

On 10 March 2016 an application was submitted by Poland for the authorisation of the use of nitrites (E 249-250) as a preservative in ‘golonka peklowana’. The application was subsequently made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008.

(4)

According to the applicant ‘golonka peklowana’ is a traditional Polish meat preparation in which nitrites apart from their preserving effect are used as a curing agent to achieve the desired colour, flavour and texture properties as expected by the consumers. ‘Golonka peklowana’ is offered to the consumers to be further heat-treated before consumption.

(5)

Recital 7 of Regulation (EC) No 1333/2008 stipulates that the approval of food additives should also take into account other factors relevant to the matter under consideration including, inter alia, traditional factors. Therefore, it is appropriate to maintain certain traditional products on the market in some Member States where the use of food additives comply with the general and specific conditions laid down in Regulation (EC) No 1333/2008.

(6)

In order to ensure uniform application of the use of additives covered by the present regulation, ‘golonka peklowana’ will be described in the guidance document describing the food categories in Part E of Annex II to Regulation (EC) No 1333/2008 on food additives (3).

(7)

Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission has to seek the opinion of the European Food Safety Authority (the Authority) in order to update the Union list of food additives set out in Annex II to Regulation (EC) No 1333/2008, except where the update in question is not liable to have an effect on human health. Nitrites are authorised for the use in meat products on a general basis, the use in meat preparations is restricted to certain traditional preparations and specific provisions are laid down for traditionally cured meat products. Since the application for the extension of use of nitrites is limited to the specific meat preparation that has been traditionally used it is not expected that the extension will have a significant impact on the overall exposure to nitrites. Therefore, the extended use of these additives constitutes an update of the Union list which is not liable to have an effect on human health and it is not necessary to seek the opinion of the Authority.

(8)

Annex II to Regulation (EC) No 1333/2008 should be amended accordingly.

(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Annex II to Regulation (EC) No 1333/2008 is amended in accordance with the Annex 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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 17 May 2017.

For the Commission

The President

Jean-Claude JUNCKER


(1)  OJ L 354, 31.12.2008, p. 16.

(2)  Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (OJ L 354, 31.12.2008, p. 1).

(3)  http://ec.europa.eu/food/safety/food_improvement_agents/additives/eu_rules_en


ANNEX

In Part E of Annex II to Regulation (EC) No 1333/2008, in food category 08.2 ‘Meat preparations as defined by Regulation (EC) No 853/2004’, the entry for nitrites (E 249-250) is replaced by the following:

 

‘E 249-250

Nitrites

150

(7)

only lomo de cerdo adobado, pincho moruno, careta de cerdo adobada, costilla de cerdo adobada, Kasseler, Bräte, Surfleisch, toorvorst, šašlõkk, ahjupraad, kiełbasa surowa biała, kiełbasa surowa metka, tatar wołowy (danie tatarskie) and golonka peklowana


18.5.2017   

EN

Official Journal of the European Union

L 125/10


COMMISSION IMPLEMENTING REGULATION (EU) 2017/840

of 17 May 2017

concerning the non-approval of the active substance orthosulfamuron, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market

(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 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2) thereof,

Whereas:

(1)

In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For orthosulfamuron the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2006/806/EC (3).

(2)

In accordance with Article 6(2) of Directive 91/414/EEC Italy received on 4 July 2005 an application from Isagro S.p.A. for the inclusion of the active substance orthosulfamuron in Annex I to Directive 91/414/EEC. Decision 2006/806/EC confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

(3)

For that active substance, the effects on human and animal health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 27 July 2012. In accordance with Article 6(3) of Commission Regulation (EU) No 188/2011 (4) additional information was requested from the applicant. The evaluation by Italy of the additional information submitted by the applicant was submitted in the format of addenda to the draft assessment report and compiled by the European Food Safety Authority (hereinafter ‘the Authority’) in August 2013.

(4)

The draft assessment report was reviewed by the Member States and the Authority. The Authority presented to the Commission its conclusion on the pesticide risk assessment of the active substance orthosulfamuron (5) on 3 September 2013. The Authority concluded that the information available on the nature of residues in primary and succeeding crops in combination with a lack of toxicological information and intake assessment on some plant metabolites does not allow finalising the assessment of the consumer risk. In addition, also the risk assessment to soil dwelling organisms and aquatic organisms could not be finalised. Moreover, the Authority identified concerns from some metabolites, and consequently the exposure assessment to groundwater could not be finalised.

(5)

The Commission invited the applicant to submit its comments on the conclusion of the Authority, and, in accordance with Article 9(1) of Regulation (EU) No 188/2011 on the draft review report. The applicant submitted its comments, which have been carefully examined.

(6)

However, despite the arguments put forward by the applicant, the concerns identified/referred to in recital 4 could not be eliminated.

(7)

Consequently it has not been demonstrated that it may be expected that, under the proposed conditions of use, plant protection products containing orthosulfamuron satisfy in general the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC.

(8)

Orthosulfamuron should therefore not be approved pursuant to Article 13(2) of Regulation (EC) No 1107/2009.

(9)

In accordance with Article 8(1)(b) of Directive 91/414/EEC, Member States were given the possibility to grant provisional authorisations for plant protection products containing orthosulfamuron for an initial period of three years. Commission Implementing Decision 2013/205/EU (6) allowed Member States to extend provisional authorisations for orthosulfamuron for a period ending on 30 April 2015 at the latest.

(10)

As all existing authorisations have expired, it is not necessary to provide an additional period to withdraw authorisations for plant protection products containing orthosulfamuron.

(11)

This Regulation does not prejudice the submission of a further application for orthosulfamuron in accordance with Article 7 of Regulation (EC) No 1107/2009.

(12)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Non-approval of active substance

The active substance orthosulfamuron is not approved.

Article 2

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, 17 May 2017.

For the Commission

The President

Jean-Claude JUNCKER


(1)  OJ L 309, 24.11.2009, p. 1.

(2)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

(3)  Commission Decision 2006/806/EC of 24 November 2006 recognising in principle the completeness of the dossier submitted for detailed examination in view of the possible inclusion of orthosulfamuron in Annex I to Council Directive 91/414/EEC (OJ L 329, 25.11.2006, p. 74).

(4)  Commission Regulation (EU) No 188/2011 of 25 February 2011 laying down detailed rules for the implementation of Council Directive 91/414/EEC as regards the procedure for the assessment of active substances which were not on the market 2 years after the date of notification of that Directive (OJ L 53, 26.2.2011, p. 51).

(5)  EFSA Journal 2013;11(9):3352. Available online: www.efsa.europa.eu.

(6)  Commission Implementing Decision 2013/205/EU of 25 April 2013 allowing Member States to extend provisional authorisations granted for the new active substances acequinocyl, aminopyralid, ascorbic acid, flubendiamide, gamma-cyhalothrin, ipconazole, metaflumizone, orthosulfamuron, Pseudomonas sp. strain DSMZ 13134, pyridalil, pyroxsulam, spiromesifen, thiencarbazone and topramezone (OJ L 117, 27.4.2013, p. 20).


18.5.2017   

EN

Official Journal of the European Union

L 125/12


COMMISSION IMPLEMENTING REGULATION (EU) 2017/841

of 17 May 2017

amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances alpha-cypermethrin, Ampelomyces quisqualis strain: aq 10, benalaxyl, bentazone, bifenazate, bromoxynil, carfentrazone ethyl, chlorpropham, cyazofamid, desmedipham, diquat, DPX KE 459 (flupyrsulfuron-methyl), etoxazole, famoxadone, fenamidone, flumioxazine, foramsulfuron, Gliocladium catenulatum strain: j1446, imazamox, imazosulfuron, isoxaflutole, laminarin, metalaxyl-m, methoxyfenozide, milbemectin, oxasulfuron, pendimethalin, phenmedipham, pymetrozine, s-metolachlor, and trifloxystrobin

(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 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular the first paragraph of Article 17 thereof,

Whereas:

(1)

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

(2)

The approval periods of the active substances bentazone, diquat, DPX KE 459 (flupyrsulfuron-methyl), famoxadone, flumioxazine, metalaxyl-m and pymetrozine were last extended by Commission Implementing Regulation (EU) 2016/549 (3). The approval of those substances will expire on 30 June 2017. Applications for the renewal of the inclusion of those substances in Annex I to Council Directive 91/414/EEC (4) were submitted in accordance with Article 4 of Commission Regulation (EU) No 1141/2010 (5).

(3)

The approval periods of the active substances carfentrazone ethyl, cyazofamid, fenamidone, foramsulfuron, imazamox, isoxaflutole, oxasulfuron, pendimethalin, and trifloxystrobin were last extended by Commission Implementing Regulation (EU) 2016/950 (6).The approval of those substances will expire on 31 July 2017.

(4)

The approval periods of the active substances alpha-cypermethrin, Ampelomyces quisqualis strain: aq 10, benalaxyl, bifenazate, bromoxynil, chlorpropham, desmedipham, etoxazole, Gliocladium catenulatum strain: j1446, imazosulfuron, laminarin, methoxyfenozide, milbemectin, phenmedipham, and s-metolachlor were extended by Commission Implementing Regulation (EU) No 1197/2012 (7). The approval of those substances will expire on 31 July 2017.

(5)

Applications for the renewal of the approval of substances listed in recitals 3 and 4 were submitted in accordance with Commission Implementing Regulation (EU) No 844/2012 (8).

(6)

Due to the fact that the assessment of the substances has been delayed for reasons beyond the control of the applicants, the approvals of those active substances are likely to expire before a decision has been taken on their renewal. It is therefore necessary to extend their approval periods.

(7)

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

(8)

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

(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex 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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 17 May 2017.

For the Commission

The President

Jean-Claude JUNCKER


(1)  OJ L 309, 24.11.2009, p. 1.

(2)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 Implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

(3)  Commission Implementing Regulation (EU) 2016/549 of 8 April 2016 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances bentazone, cyhalofop butyl, diquat, famoxadone, flumioxazine, DPX KE 459 (flupyrsulfuron-methyl), metalaxyl-M, picolinafen, prosulfuron, pymetrozine, thiabendazole and thifensulfuron-methyl (OJ L 95, 9.4.2016, p. 4).

(4)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

(5)  Commission Regulation (EU) No 1141/2010 of 7 December 2010 laying down the procedure for the renewal of the inclusion of a second group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of those substances (OJ L 322, 8.12.2010, p. 10).

(6)  Commission Implementing Regulation (EU) 2016/950 of 15 June 2016 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 2,4-DB, beta-cyfluthrin, carfentrazone ethyl, Coniothyrium minitans Strain CON/M/91-08 (DSM 9660), cyazofamid, deltamethrin, dimethenamid-P, ethofumesate, fenamidone, flufenacet, flurtamone, foramsulfuron, fosthiazate, imazamox, iodosulfuron, iprodione, isoxaflutole, linuron, maleic hydrazide, mesotrione, oxasulfuron, pendimethalin, picoxystrobin, silthiofam and trifloxystrobin (OJ L 159, 16.6.2016, p. 3).

(7)  Commission Implementing Regulation (EU) No 1197/2012 of 13 December 2012 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances acetamiprid, alpha-cypermethrin, Ampelomyces quisqualis Strain: AQ 10, benalaxyl, bifenazate, bromoxynil, chlorpropham, desmedipham, etoxazole, Gliocladium catenulatum Strain: J1446, imazosulfuron, laminarin, mepanipyrim, methoxyfenozide, milbemectin, phenmedipham, Pseudomonas chlororaphis Strain: MA 342, quinoxyfen, S-metolachlor, tepraloxydim, thiacloprid, thiram and ziram (OJ L 342, 14.12.2012, p. 27).

(8)  Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).


ANNEX

Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

(1)

in the sixth column, expiration of approval, of row 11 Bentazone, the date is replaced by ‘30 June 2018’;

(2)

In the sixth column, expiration of approval, of row 15 Diquat, the date is replaced by ‘30 June 2018’;

(3)

In the sixth column, expiration of approval, of row 19 DPX KE 459 (flupyrsulfuron-methyl), the date is replaced by ‘30 June 2018’;

(4)

In the sixth column, expiration of approval, of row 23 Pymetrozine, the date is replaced by ‘30 June 2018’;

(5)

In the sixth column, expiration of approval, of row 35 Famoxadone, the date is replaced by ‘30 June 2018’;

(6)

In the sixth column, expiration of approval, of row 37 Metalaxyl-M, the date is replaced by ‘30 June 2018’;

(7)

In the sixth column, expiration of approval, of row 39 Flumioxazine, the date is replaced by ‘30 June 2018’;

(8)

In the sixth column, expiration of approval, of row 41 Imazamox, the date is replaced by ‘31 July 2018’;

(9)

In the sixth column, expiration of approval, of row 42 Oxasulfuron, the date is replaced by ‘31 July 2018’;

(10)

In the sixth column, expiration of approval, of row 44 Foramsulfuron, the date is replaced by ‘31 July 2018’;

(11)

In the sixth column, expiration of approval, of row 46 Cyazofamid, the date is replaced by ‘31 July 2018’;

(12)

In the sixth column, expiration of approval, of row 53 Pendimethalin, the date is replaced by ‘31 July 2018’;

(13)

In the sixth column, expiration of approval, of row 59 Trifloxystrobin, the date is replaced by ‘31 July 2018’;

(14)

In the sixth column, expiration of approval, of row 60 Carfentrazone ethyl, the date is replaced by ‘31 July 2018’;

(15)

In the sixth column, expiration of approval, of row 62 Fenamidone, the date is replaced by ‘31 July 2018’;

(16)

In the sixth column, expiration of approval, of row 63 Isoxaflutole, the date is replaced by ‘31 July 2018’;

(17)

In the sixth column, expiration of approval, of row 78 Chlorpropham, the date is replaced by ‘31 July 2018’;

(18)

In the sixth column, expiration of approval, of row 83 Alpha-cypermethrin, the date is replaced by ‘31 July 2018’;

(19)

In the sixth column, expiration of approval, of row 84 Benalaxyl, the date is replaced by ‘31 July 2018’;

(20)

In the sixth column, expiration of approval, of row 85 Bromoxynil, the date is replaced by ‘31 July 2018’;

(21)

In the sixth column, expiration of approval, of row 86 Desmedipham, the date is replaced by ‘31 July 2018’;

(22)

In the sixth column, expiration of approval, of row 88 Phenmedipham, the date is replaced by ‘31 July 2018’;

(23)

In the sixth column, expiration of approval, of row 93 Ampelomyces quisqualis Strain: AQ 10, the date is replaced by ‘31 July 2018’;

(24)

In the sixth column, expiration of approval, of row 95 Laminarin, the date is replaced by ‘31 July 2018’;

(25)

In the sixth column, expiration of approval, of row 96 Methoxyfenozide, the date is replaced by ‘31 July 2018’;

(26)

In the sixth column, expiration of approval, of row 97 S-metolachlor, the date is replaced by ‘31 July 2018’;

(27)

In the sixth column, expiration of approval, of row 98 Gliocladium catenulatum Strain: J1446, the date is replaced by ‘31 July 2018’;

(28)

In the sixth column, expiration of approval, of row 99 Etoxazole, the date is replaced by ‘31 July 2018’;

(29)

In the sixth column, expiration of approval, of row 109 Bifenazate, the date is replaced by ‘31 July 2018’;

(30)

In the sixth column, expiration of approval, of row 110 Milbemectin, the date is replaced by ‘31 July 2018’.


18.5.2017   

EN

Official Journal of the European Union

L 125/16


COMMISSION IMPLEMENTING REGULATION (EU) 2017/842

of 17 May 2017

renewing the approval of the low-risk active substance Coniothyrium minitans strain CON/M/91-08 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011

(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 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 22(1) in conjunction with Article 20(1) thereof,

Whereas:

(1)

Commission Directive 2003/79/EC (2) included Coniothyrium minitans strain CON/M/91-08 as an active substance in Annex I to Council Directive 91/414/EEC (3).

(2)

Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

(3)

The approval of the active substance Coniothyrium minitans strain CON/M/91-08, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 October 2017.

(4)

An application for the renewal of the approval of Coniothyrium minitans strain CON/M/91-08 was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article.

(5)

The applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State.

(6)

The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (‘the Authority’) and the Commission on 29 May 2015.

(7)

The Authority communicated the renewal assessment report to the applicant and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public.

(8)

On 8 June 2016 the Authority communicated to the Commission its conclusion (6) on whether Coniothyrium minitans strain CON/M/91-08 can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the draft renewal report for Coniothyrium minitans strain CON/M/91-08 to the Standing Committee on Plants, Animals, Food and Feed on 6 December 2016.

(9)

The applicant was given the possibility to submit comments on the renewal report.

(10)

It has been established with respect to one or more representative uses of at least one plant protection product containing Coniothyrium minitans strain CON/M/91-08 that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate to renew the approval of Coniothyrium minitans strain CON/M/91-08.

(11)

The risk assessment for the renewal of the approval of Coniothyrium minitans strain CON/M/91-08 is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing Coniothyrium minitans strain CON/M/91-08 may be authorised. It is therefore appropriate not to maintain the restriction to use only as a fungicide.

(12)

The Commission further considers that Coniothyrium minitans strain CON/M/91-08 is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Coniothyrium minitans strain CON/M/91-08 is not a substance of concern and fulfils the conditions set in point 5 of Annex II to Regulation (EC) No 1107/2009. Coniothyrium minitans strain CON/M/91-08 is a wild-type strain naturally occurring in the environment. It is not pathogenic to humans or animals. The additional exposure of humans, animals and the environment by the uses approved under Regulation (EC) No 1107/2009 is expected to be negligible compared to exposure expected through realistic natural situations.

(13)

It is therefore appropriate to renew the approval of Coniothyrium minitans strain CON/M/91-08 as a low-risk substance. In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Implementing Regulation (EU) No 540/2011 should be amended accordingly.

(14)

In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions.

(15)

In accordance with Article 20(3) of Regulation (EC) No 1107/2009, in conjunction with Article 13(4) thereof, the Annex to Implementing Regulation (EU) No 540/2011 should be amended accordingly.

(16)

Commission Implementing Regulation (EU) 2016/950 (7) extended the approval period of Coniothyrium minitans strain CON/M/91-08 to 31 October 2017 in order to allow the renewal process to be completed before the expiry date of the approval of that substance. However, given that a decision on renewal has been taken ahead of this extended expiry date, this Regulation shall apply from 1 August 2017.

(17)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Renewal of the approval of active substance

The approval of the active substance Coniothyrium minitans strain CON/M/91-08, as specified in Annex I, is renewed subject to the conditions laid down in that Annex.

Article 2

Amendments to Implementing Regulation (EU) No 540/2011

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

Article 3

Entry into force and date of application

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 August 2017.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 17 May 2017.

For the Commission

The President

Jean-Claude JUNCKER


(1)  OJ L 309, 24.11.2009, p. 1.

(2)  Commission Directive 2003/79/EC of 13 August 2003 amending Council Directive 91/414/EEC to include Coniothyrium minitans as active substance (OJ L 205, 14.8.2003, p. 16).

(3)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

(4)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

(5)  Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).

(6)  EFSA Journal 2016;14(7):4517, 16 pp. Available online: www.efsa.europa.eu

(7)  Commission Implementing Regulation (EU) 2016/950 of 15 June 2016 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 2,4-DB, beta-cyfluthrin, carfentrazone ethyl, Coniothyrium minitans Strain CON/M/91-08 (DSM 9660), cyazofamid, deltamethrin, dimethenamid-P, ethofumesate, fenamidone, flufenacet, flurtamone, foramsulfuron, fosthiazate, imazamox, iodosulfuron, iprodione, isoxaflutole, linuron, maleic hydrazide, mesotrione, oxasulfuron, pendimethalin, picoxystrobin, silthiofam and trifloxystrobin (OJ L 159, 16.6.2016, p. 3).


ANNEX I

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

Coniothyrium minitans strain CON/M/91-08

Accession number in the culture collection of the ‘Deutsche Sammlung von Mikroorganismen’ (DSM), Germany: DSM 9660

CIPAC No 614

Not applicable

Minimum content of viable spores:

1 × 1012 CFU/kg

1 August 2017

31 July 2032

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Coniothyrium minitans strain CON/M/91-08, and in particular Appendices I and II thereof, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

the protection of operators and workers, taking into account that microorganisms are considered as potential sensitizers.

Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.

Conditions of use shall include risk mitigation measures, where appropriate.


(1)  Further details on identity and specification of active substance are provided in the review report.


ANNEX II

The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

(1)

in Part A, entry 71 on Coniothyrium minitans strain CON/M/91-08 is deleted;

(2)

in Part D, the following entry is added:

Number

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

‘11

Coniothyrium minitans strain CON/M/91-08

Accession number in the culture collection of the ‘Deutsche Sammlung von Mikroorganismen’ (DSM), Germany: DSM 9660

CIPAC No 614

Not applicable

Minimum content of viable spores:

1 × 1012 CFU/kg

1 August 2017

31 July 2032

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Coniothyrium minitans strain CON/M/91-08, and in particular Appendices I and II thereof, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

the protection of operators and workers, taking into account that microorganisms are considered as potential sensitizers.

Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.

Conditions of use shall include risk mitigation measures, where appropriate.’


(1)  Further details on identity and specification of active substance are provided in the review report.


18.5.2017   

EN

Official Journal of the European Union

L 125/21


COMMISSION IMPLEMENTING REGULATION (EU) 2017/843

of 17 May 2017

approving the active substance Beauveria bassiana strain NPP111B005, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011

(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 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2) thereof,

Whereas:

(1)

In accordance with Article 7(1) of Regulation (EC) No 1107/2009 France received on 6 November 2012 an application from Arysta Lifescience S.A.S. for the approval of the active substance Beauveria bassiana strain NPP111B005. In accordance with Article 9(3) of that Regulation, France, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (hereinafter ‘the Authority’) on 5 February 2013 of the admissibility of the application.

(2)

On 7 October 2014 the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority, assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

(3)

The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009. In accordance with Article 12(3) of Regulation (EC) No 1107/2009, it requested that the applicant supply additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the format of an updated draft assessment report on 3 July 2015.

(4)

On 6 October 2015 the Authority communicated to the applicant, the Member States and the Commission its conclusion (2) on whether the active substance Beauveria bassiana strain NPP111B005 can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority made its conclusion available to the public.

(5)

On 8 March 2016 the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the review report for Beauveria bassiana strain NPP111B005 and a draft Regulation providing that Beauveria bassiana strain NPP111B005 is approved.

(6)

The applicant was given the possibility to submit comments on the review report.

(7)

It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance, and in particular the uses which were examined and detailed in the review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate to approve Beauveria bassiana strain NPP111B005.

(8)

In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions.

(9)

In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (3) should be amended accordingly.

(10)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Approval of active substance

The active substance Beauveria bassiana strain NPP111B005, as specified in Annex I, is approved subject to the conditions laid down in that Annex.

Article 2

Amendments to Implementing Regulation (EU) No 540/2011

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

Article 3

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, 17 May 2017.

For the Commission

The President

Jean-Claude JUNCKER


(1)  OJ L 309, 24.11.2009, p. 1.

(2)  EFSA Journal 2015;13(10):4264 [34 pp.]. doi: 10.2903/j.efsa.2015.4264.

(3)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).


ANNEX I

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

Beauveria bassiana strain NPP111B005

Accession number in the CNCM (Collection Nationale de Culture de Microorganismes) — Institut Pasteur, Paris, France: I-2961.

Not applicable

Max. level of beauvericin 24 μg/L

7 June 2017

7 June 2027

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Beauveria bassiana strain NPP111B005, and in particular Appendices I and II thereof, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

the protection of operators and workers, taking into account that Beauveria bassiana strain NPP111B005 is to be considered, as any micro-organism, as a potential sensitizer, and paying special attention to exposure through inhalation,

the maximum level of the metabolite beauvericin in the formulated product.

Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.

Conditions of use shall include risk mitigation measures, where appropriate.


(1)  Further details on identity and specification of active substance are provided in the review report.


ANNEX II

In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

 

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

‘109

Beauveria bassiana strain NPP111B005

Accession number in the CNCM (Collection Nationale de Culture de Microorganismes) — Institut Pasteur, Paris, France: I-2961.

Not applicable

Max. level of beauvericin 24 μg/L

7 June 2017

7 June 2027

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Beauveria bassiana strain NPP111B005, and in particular Appendices I and II thereof, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

the protection of operators and workers, taking into account that Beauveria bassiana strain NPP111B005 is to be considered, as any micro-organism, as a potential sensitizer, and paying special attention to exposure through inhalation,

the maximum level of the metabolite beauvericin in the formulated product.

Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.

Conditions of use shall include risk mitigation measures, where appropriate.’


(1)  Further details on identity and specification of active substance are provided in the review report.


18.5.2017   

EN

Official Journal of the European Union

L 125/25


COMMISSION IMPLEMENTING REGULATION (EU) 2017/844

of 17 May 2017

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 Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (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, 17 May 2017.

For the Commission,

On behalf of the President,

Jerzy PLEWA

Director-General

Directorate-General for Agriculture and Rural Development


(1)  OJ L 347, 20.12.2013, p. 671.

(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

109,8

TN

158,2

TR

94,0

ZZ

120,7

0707 00 05

TR

126,8

ZZ

126,8

0709 93 10

TR

131,8

ZZ

131,8

0805 10 22 , 0805 10 24 , 0805 10 28

EG

55,2

MA

59,8

TR

41,8

ZA

88,5

ZZ

61,3

0805 50 10

AR

123,2

TR

65,0

ZA

144,7

ZZ

111,0

0808 10 80

AR

95,5

BR

108,5

CL

123,4

CN

130,6

NZ

136,2

US

107,1

ZA

99,3

ZZ

114,4


(1)  Nomenclature of countries laid down by Commission Regulation (EU) No 1106/2012 of 27 November 2012 implementing Regulation (EC) No 471/2009 of the European Parliament and of the Council on Community statistics relating to external trade with non-member countries, as regards the update of the nomenclature of countries and territories (OJ L 328, 28.11.2012, p. 7). Code ‘ZZ’ stands for ‘of other origin’.


DIRECTIVES

18.5.2017   

EN

Official Journal of the European Union

L 125/27


COMMISSION DIRECTIVE (EU) 2017/845

of 17 May 2017

amending Directive 2008/56/EC of the European Parliament and of the Council as regards the indicative lists of elements to be taken into account for the preparation of marine strategies

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Directive 2008/56/EC of the European Parliament and of the Council of 17 June 2008 establishing a framework for Community action in the field of marine environmental policy (Marine Strategy Framework Directive) (1), and in particular Article 24(1) thereof,

Whereas:

(1)

Annex III to Directive 2008/56/EC lays down the indicative lists of characteristics, pressures and impacts which are referred to in Articles 8(1), 9(1), 9(3), 10(1), 11(1) and 24 of that Directive.

(2)

In 2012, on the basis of the initial assessment of their marine waters made pursuant to Article 8(1) of Directive 2008/56/EC and as part of the first cycle of implementation of their marine strategies, Member States notified to the Commission a set of characteristics for good environmental status and their environmental targets, in accordance with Articles 9(2) and 10(2) of Directive 2008/56/EC, respectively. The Commission's assessment (2) of those Member State's reports, undertaken in accordance with Article 12 of that Directive, highlighted that more efforts were urgently needed if Member States and the Union are to reach good environmental status by 2020.

(3)

To ensure that the second cycle of implementation of the marine strategies of the Member States further contributes to the achievement of the objectives of Directive 2008/56/EC and yields more consistent determinations of good environmental status, the Commission recommended in its report on the first phase of implementation that, at Union level, the Commission services and Member States collaborate to revise, strengthen and improve Commission Decision 2010/477/EU (3) by 2015, aiming at a clearer, simpler, more concise, more coherent and comparable set of good environmental status criteria and methodological standards and, at the same time, review Annex III of the Marine Strategy Framework Directive, and if necessary revise it, and develop specific guidance to ensure a more coherent and consistent approach for assessments in the next implementation cycle.

(4)

The review of Annex III to Directive 2008/56/EC is needed to complement the review of Decision 2010/477/EU. Furthermore, the relationship between Annex III to Directive 2008/56/EC and the qualitative descriptors for determining good environmental status listed in Annex I to that Directive is only implicit in that Directive and, therefore, not sufficiently clear. The Commission, in a staff working paper from 2011 (4), explained relationships between the qualitative descriptors listed in Annex I to Directive 2008/56/EC, the elements set out in Annex III to that Directive, and the criteria and indicators set out in Decision 2010/477/EU, but could provide only a partial answer due to their inherent content. A revision of Annex III to Directive 2008/56/EC is needed in order to further clarify those relationships and facilitate implementation, better linking ecosystem elements, and anthropogenic pressures and impacts on the marine environment with the descriptors in Annex I to Directive 2008/56/EC and the outcome of the review of Decision 2010/477/EU.

(5)

Annex III to Directive 2008/56/EC should provide elements for assessment (Article 8(1) of that Directive) with regard to good environmental status (Article 9(1) of that Directive), provide elements for monitoring (Article 11(1) of that Directive), which are complementary to assessment (e.g. temperature, salinity), and provide elements for consideration when setting targets (Article 10(1) of the Directive). The relevance of these elements will vary by region and Member State due to differing regional characteristics. This means that elements need to be addressed only if they are considered ‘essential features and characteristics’ or ‘predominant pressures and impacts’ as referred to in points (a) and (b) of Article 8(1) of Directive 2008/56/EC, respectively, and if they occur in the relevant Member State's waters.

(6)

It is important to ensure that the elements set out in Annex III to Directive 2008/56/EC are clearly related to the qualitative descriptors of Annex I to that Directive and to the criteria and methodological standards on good environmental status of marine waters laid down by the Commission on the basis of Article 9(3) of Directive 2008/56/EC, as well as to their application in relation to Articles 8, 9, 10 and 11 of Directive 2008/56/EC. In this context, those elements need to be generic and generally applicable across the Union, considering that more specific elements can be laid down by the Commission on the basis of Article 9(3) of Directive 2008/56/EC or in the context of determining sets of characteristics for good environmental status under Article 9(1) of that Directive.

(7)

Tables 1 and 2 of Annex III to Directive 2008/56/EC should be clarified to more clearly relate to state elements (Table 1) and to pressure elements and their impacts (Table 2), and to directly link the elements listed in them with the qualitative descriptors laid down in Annex I of that Directive and through this with the criteria laid down by the Commission on the basis of Article 9(3) of Directive 2008/56/EC.

(8)

To guide the assessments on uses of marine waters under point (c) of Article 8(1) of Directive 2008/56/EC, and on human activities under point (b) of Article 8(1), and associated monitoring provided under Article 11 of that Directive, Table 2 should be extended to contain an indicative list of uses and human activities in order to ensure consistency in their assessment across the marine regions and subregions.

(9)

Annex III to Directive 2008/56/EC should therefore be amended accordingly.

(10)

The measures provided for in this Directive are in accordance with the opinion of the regulatory committee established under Article 25(1) of Directive 2008/56/EC,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Annex III to Directive 2008/56/EC is replaced by the text set out in the Annex to this Directive.

Article 2

1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 7 December 2018 at the latest. They shall forthwith communicate to the Commission the text of those provisions.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

3.   The obligation to transpose this Directive shall not apply to Member States without marine waters.

Article 3

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

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 17 May 2017.

For the Commission

The President

Jean-Claude JUNCKER


(1)  OJ L 164, 25.6.2008, p. 19.

(2)  Report from the Commission to the Council and the European Parliament — The first phase of implementation of the Marine Strategy Framework Directive (2008/56/EC) — The European Commission's assessment and guidance (COM(2014) 97 final, 20.2.2014).

(3)  Commission Decision 2010/477/EU of 1 September 2010 on criteria and methodological standards on good environmental status of marine waters (OJ L 232, 2.9.2010, p. 14).

(4)  Commission Staff Working Paper SEC(2011) 1255.


ANNEX

ANNEX III

Indicative lists of ecosystem elements, anthropogenic pressures and human activities relevant to the marine waters

(referred to in Articles 8(1), 9(1), 9(3), 10(1), 11(1) and 24)

Table 1

Structure, functions and processes of marine ecosystems

with particular relevance for point (a) of Article 8(1), and Articles 9 and 11

Theme

Ecosystem elements

Possible parameters and characteristics (Note 1)

Relevant qualitative descriptors laid down in Annex I (Notes 2 and 3)

Species

Species groups (Note 4) of marine birds, mammals, reptiles, fish and cephalopods of the marine region or subregion

Spatial and temporal variation per species or population:

distribution, abundance and/or biomass

size, age and sex structure

fecundity, survival and mortality/injury rates

behaviour including movement and migration

habitat for the species (extent, suitability)

Species composition of the group

(1); (3)

Habitats

Broad habitat types of the water column (pelagic) and seabed (benthic) (Note 5), or other habitat types, including their associated biological communities throughout the marine region or subregion

Per habitat type:

habitat distribution and extent (and volume, if appropriate)

species composition, abundance and/or biomass (spatial and temporal variation)

size and age structure of species (if appropriate)

physical, hydrological and chemical characteristics

Additionally for pelagic habitats:

chlorophyll a concentration

plankton bloom frequencies and spatial extent

(1); (6)

Ecosystems, including food webs

Ecosystem structure, functions and processes, comprising:

physical and hydrological characteristics

chemical characteristics

biological characteristics

functions and processes

Spatial and temporal variation in:

temperature and ice

hydrology (wave and current regimes; upwelling, mixing, residence time, freshwater input; sea level)

bathymetry

turbidity (silt/sediment loads), transparency, sound

seabed substrate and morphology

salinity, nutrients (N, P), organic carbon, dissolved gases (pCO2, O2) and pH

links between habitats and species of marine birds, mammals, reptiles, fish and cephalopods

pelagic-benthic community structure

productivity

(1); (4)

Notes related to Table 1

Note 1:

An indicative list of relevant parameters and characteristics for species, habitats and ecosystems is given, reflecting parameters affected by the pressures of Table 2 of this Annex and of relevance to criteria laid down in accordance with Article 9(3). The particular parameters and characteristics to be used for monitoring and assessment should be determined in accordance with the requirements of this Directive, including those of its Articles 8 to 11.

Note 2:

The numbers in this column refer to the respective numbered points in Annex I.

Note 3:

Only the state-based qualitative descriptors (1), (3), (4) and (6) which have criteria laid down in accordance with Article 9(3) are listed in Table 1. All other, pressure-based, qualitative descriptors under Annex I may be relevant for each theme.

Note 4:

These species groups are further specified in Part II of the Annex to Commission Decision (EU) 2017/848 of 17 May 2017 laying down criteria and methodological standards on good environmental status of marine waters and specifications and standardised methods for monitoring and assessment, and repealing Decision 2010/477/EU (see page 43 of this Official Journal).

Note 5:

These broad habitat types are further specified in Part II of the Annex to Decision (EU) 2017/848.

Table 2

Anthropogenic pressures, uses and human activities in or affecting the marine environment

2a.

Anthropogenic pressures on the marine environment

with particular relevance for points (a) and (b) of Article 8(1), and Articles 9, 10 and 11

Theme

Pressure (Note 1)

Possible parameters

Relevant qualitative descriptors laid down in Annex I (Notes 2 and 3)

Biological

Input or spread of non-indigenous species

Intensity of, and spatial and temporal variation in, the pressure in the marine environment and, where relevant, at source

For assessment of environmental impacts of the pressure, select relevant ecosystem elements and parameters from Table 1

(2)

Input of microbial pathogens

 

Input of genetically modified species and translocation of native species

 

Loss of, or change to, natural biological communities due to cultivation of animal or plant species

 

Disturbance of species (e.g. where they breed, rest and feed) due to human presence

 

Extraction of, or mortality/injury to, wild species (by commercial and recreational fishing and other activities)

(3)

Physical

Physical disturbance to seabed (temporary or reversible)

(6); (7)

Physical loss (due to permanent change of seabed substrate or morphology and to extraction of seabed substrate)

Changes to hydrological conditions

Substances, litter and energy

Input of nutrients — diffuse sources, point sources, atmospheric deposition

(5)

Input of organic matter — diffuse sources and point sources

Input of other substances (e.g. synthetic substances, non-synthetic substances, radionuclides) — diffuse sources, point sources, atmospheric deposition, acute events

(8); (9)

Input of litter (solid waste matter, including micro-sized litter)

(10)

Input of anthropogenic sound (impulsive, continuous)

(11)

Input of other forms of energy (including electromagnetic fields, light and heat)

Input of water — point sources (e.g. brine)

 


2b.

Uses and human activities in or affecting the marine environment

with particular relevance for points (b) and (c) of Article 8(1) (only activities marked * are relevant for point (c) of Article 8(1)), and Articles 10 and 13

Theme

Activity

Physical restructuring of rivers, coastline or seabed (water management)

Land claim

Canalisation and other watercourse modifications

Coastal defence and flood protection*

Offshore structures (other than for oil/gas/renewables)*

Restructuring of seabed morphology, including dredging and depositing of materials*

Extraction of non-living resources

Extraction of minerals (rock, metal ores, gravel, sand, shell)*

Extraction of oil and gas, including infrastructure*

Extraction of salt*

Extraction of water*

Production of energy

Renewable energy generation (wind, wave and tidal power), including infrastructure*

Non-renewable energy generation

Transmission of electricity and communications (cables)*

Extraction of living resources

Fish and shellfish harvesting (professional, recreational)*

Fish and shellfish processing*

Marine plant harvesting*

Hunting and collecting for other purposes*

Cultivation of living resources

Aquaculture — marine, including infrastructure*

Aquaculture — freshwater

Agriculture

Forestry

Transport

Transport infrastructure*

Transport — shipping*

Transport — air

Transport — land

Urban and industrial uses

Urban uses

Industrial uses

Waste treatment and disposal*

Tourism and leisure

Tourism and leisure infrastructure*

Tourism and leisure activities*

Security/defence

Military operations (subject to Article 2(2))

Education and research

Research, survey and educational activities*

Notes related to Table 2

Note 1:

Assessments of pressures should address their levels in the marine environment and, if appropriate, the rates of input (from land-based or atmospheric sources) to the marine environment.

Note 2:

The numbers in this column refer to the respective numbered points in Annex I.

Note 3:

Only pressure-based qualitative descriptors (2), (3), (5), (6), (7), (8), (9), (10) and (11), which have criteria laid down in accordance with Article 9(3), are listed in Table 2a. All other, state-based, qualitative descriptors under Annex I may be relevant for each theme.’


DECISIONS

18.5.2017   

EN

Official Journal of the European Union

L 125/34


DECISION (EU) 2017/846 OF THE EUROPEAN PARLIAMENT

of 16 March 2017

extending the term of office of the Committee of Inquiry to investigate alleged contraventions and maladministration in the application of Union law in relation to money laundering, tax avoidance and tax evasion

THE EUROPEAN PARLIAMENT,

having regard to the proposal by the Conference of Presidents,

having regard to Article 226 of the Treaty on the Functioning of the European Union,

having regard to Decision 95/167/EC, Euratom, ECSC of the European Parliament, the Council and the Commission of 19 April 1995 on the detailed provisions governing the exercise of the European Parliament's right of inquiry (1),

having regard to Decision (EU) 2016/1021 of the European Parliament of 8 June 2016 on setting up a Committee of Inquiry to investigate alleged contraventions and maladministration in the application of Union law in relation to money laundering, tax avoidance and tax evasion, its powers, numerical strength and term of office (2),

having regard to Rule 198(11) of its Rules of Procedure,

A.

whereas the Committee of Inquiry requested an extension of its term of office in order to enable it to implement its mandate fully and appropriately, taking into account the number of documents yet to be examined, the analyses commissioned, and the stakeholders to be heard;

1.

Decides to extend by three months the term of office of the Committee of Inquiry.

For the European Parliament

The President

A. TAJANI


(1)  OJ L 113, 19.5.1995, p. 1.

(2)  OJ L 166, 24.6.2016, p. 10.


18.5.2017   

EN

Official Journal of the European Union

L 125/35


COMMISSION IMPLEMENTING DECISION (EU) 2017/847

of 16 May 2017

granting a derogation requested by Denmark pursuant to Council Directive 91/676/EEC concerning the protection of waters against pollution caused by nitrates from agricultural sources

(notified under document C(2017) 2891)

(Only the Danish text is authentic)

THE EUROPEAN COMMISSION,

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

Having regard to Council Directive 91/676/EEC of 12 December 1991 concerning the protection of waters against pollution caused by nitrates from agricultural sources (1), and in particular the third subparagraph of paragraph 2 of Annex III thereto,

Whereas:

(1)

On 18 November 2002, the Commission adopted Decision 2002/915/EC (2) granting a derogation requested by Denmark pursuant to Directive 91/676/EEC concerning the protection of waters against pollution caused by nitrates from agricultural sources, allowing the application of livestock manure containing up to 230 kg nitrogen per hectare per year on certain cattle holdings within the framework of the Danish action programme 1999 to 2003. The derogation was extended by Commission Decision 2005/294/EC (3) in connection with the Danish action programme 2004 to 2007, by Commission Decision 2008/664/EC (4) in connection with the Danish action programme 2008-2012 and by Commission Implementing Decision 2012/659/EU (5) in connection with the Danish action programme 2008 to 2015.

(2)

The derogation granted by Implementing Decision 2012/659/EU concerned approximately (for the period 2014/2015) 1 500 cattle holdings, 425 102 livestock units and 205 165 hectares of arable land, corresponding respectively to 4,0 % of total number of holdings, 18,6 % of total livestock units and 8,2 % of the total arable area in Denmark.

(3)

On 4 February 2016, Denmark submitted to the Commission a request for renewal of the derogation under the third subparagraph of paragraph 2 of Annex III to Directive 91/676/EEC.

(4)

Denmark has an action programme covering the period 2016 to 2018, in conformity with Article 5 of Directive 91/676/EEC, by means of parts of Order on commercial livestock, livestock manure, silage, etc. no 1324 of 15 November 2016, Consolidated Act on farms' use of fertiliser and on plant cover no 388 of 27 April 2016 and Order on farms' use of fertiliser in the planning period 2016/2017 no 1055 of 1 July 2016, a new targeted catch crop scheme, obligatory part, as stated in Act on farms' use of fertiliser and on plant cover. In addition, Danish legislation includes a new general phosphorus regulation, according to Act on environmental approval etc. of livestock holdings and Order on commercial livestock, livestock manure, silage etc.

(5)

The Danish legislation implementing Directive 91/676/EEC includes limits for the application of nitrogen. Legislation limiting the application of phosphorus has been adopted and will enter into force in August 2017.

(6)

The Danish report on the ‘Status and trends of the aquatic environment and agricultural practice’ concerning the period 2012 to 2015 show an annual surplus of the national field balance of 80 kg N/ha in 2014 and a total nitrogen discharge to the sea from agriculture at approximately 70 % of the total in 2012. Denmark estimated that the land based nitrogen load to coastal waters needs to be reduced from 56,8 Mt to 44,7 Mt N, to support a good ecological status.

(7)

The Danish legislation should include a combined targeted scheme for voluntary and mandatory catch crops for 2017 and 2018. Under this scheme, the obligatory provisions for catch crops should enter into force automatically if the voluntary agreements for catch crops fail to deliver the environmental objectives. The areas under catch crops should be in addition to the national requirement for mandatory catch crops pursuant to the Danish Act on farms' use of fertiliser and on plant cover. These measures are necessary to ensure that the application of the current derogation would not lead to deterioration of water quality.

(8)

The information provided by Denmark in the context of the derogation granted by Implementing Decision 2012/659/EU shows that the derogation has not led to a deterioration of water quality as compared to areas not encompassed by the derogation. Data presented by Denmark on the implementation of Directive 91/676/EEC for the period 2012 to 2015 (6) shows that in Denmark for groundwater, around 16 % of monitoring stations have mean nitrate concentrations exceeding 50 mg/l and around 23 % of monitoring stations have mean nitrate concentrations exceeding 40 mg/l. Monitoring data show a stable trend in nitrate concentration in groundwater as compared to the previous reporting period (2008 to 2011). For surface water, most of monitoring points in surface waters shows mean nitrate concentrations below 50 mg/l and a stable trend in nitrate concentrations. The report covering the period 2012 to 2015 states that 2 out of 119 coastal waters were classified in a ‘good’ status.

(9)

The Commission, after examination of Denmark's request on the basis of the elements described in the third subparagraph of paragraph 2 of Annex III of Directive 91/676/EEC and in the light of the experience gained from the derogation as provided for in Decisions 2002/915/EC, 2005/294/EC, 2008/664/EC and Implementing Decision 2012/659/EU, considers that the amount of manure envisaged by Denmark, 230 kg nitrogen per hectare per year, will not prejudice the achievement of the objectives of Directive 91/676/EEC, subject to certain strict conditions being met.

(10)

In farms authorised to apply livestock manure containing up to 230 kg nitrogen per hectare per year, fertilisation plans are updated in a timely manner to ensure consistency with actual agricultural practices and permanent vegetal cover of arable area and catch crops are used to ensure recovering subsoil autumn losses of nitrates and limit nitrogen winter losses.

(11)

Directive 2000/60/EC of the European Parliament and the Council (7) provides for a comprehensive, cross-border approach to water protection organised around river basin districts, with the objective of achieving a good status for European bodies of water by 2015. Reducing nutrients is an integral part of that objective. The granting of a derogation under this Decision is without prejudice to the provisions pursuant to Directive 2000/60/EC and does not exclude that additional measures may be needed to fulfil obligations derived from it.

(12)

Directive 2007/2/EC of the European Parliament and of the Council (8) lays down general rules aimed at the establishment of the Infrastructure for Spatial Information in the Union for the purposes of environmental policies of the Union and policies or activities which may have an impact on the environment. Where applicable, the spatial information collected in the context of this Decision should be in line with the provisions set out in that Directive. In order to reduce the administrative burden and enhance data coherence, Denmark, when collecting the necessary data under this Decision should make use of the information generated under the Integrated Administration and Control System established pursuant to Chapter II of Title V of Regulation (EU) No 1306/2013 of the European Parliament and of the Council (9).

(13)

The measures provided for in this Decision are in accordance with the opinion of the Nitrates Committee set up pursuant to Article 9 of Directive 91/676/EEC,

HAS ADOPTED THIS DECISION:

Article 1

Derogation

The derogation requested by Denmark by letter of 4 February 2016, for the purpose of allowing application to the land of a higher amount of nitrogen from livestock manure than that provided for in the first sentence of the second subparagraph of paragraph 2 of Annex III to Directive 91/676/EEC, is granted subject to the conditions laid down in this Decision.

Article 2

Scope

This derogation applies to cattle farms on which the crop rotation includes more than 80 % of crops with high nitrogen uptake and long growing season and for which an authorisation has been granted in accordance with Article 5.

Article 3

Definitions

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

(a)

‘cattle farm’ means a holding with a yearly production of nitrogen in livestock manure above 300 kg of which at least two thirds are from cattle;

(b)

‘grass’ means permanent or temporary grassland;

(c)

‘crops being undersown by grass’ means silage cereals, silage maize, spring barley or spring barley and pea, to be undersown by grass before or after harvest;

(d)

‘crops with high nitrogen uptake and long growing season’ means any of the following:

(i)

grass;

(ii)

grass catch crops;

(iii)

forage beets;

(iv)

crops being undersown by grass;

(e)

‘soil profile’ means the soil layer below ground level to a depth of 0,90 m or to the average highest groundwater level where that level is less than 0,90 m below ground level;

Article 4

Conditions for the derogation

The derogation is granted on the following conditions:

(1)

As from August 2017 a phosphorus regulation shall enter into force establishing direct phosphorus ceilings at different levels throughout the country depending on geographical location and fertiliser type. Ceilings shall cover application of phosphorus from all types of fertilisers: organic fertilisers, including manure, biogas digestate, degassed plant biomass, sludge from sewage water treatment as well as industrial fertilisers. Stricter phosphorus application ceilings covering all types of fertilisers shall be applied in catchments of phosphorus vulnerable aquatic environment.

(2)

An indicator and monitoring system shall be in place concerning the amount of phosphorus applied on agricultural fields in Denmark. Should either the indicator system or the monitoring system show that the actual annual average phosphorus fertilisation rate on agricultural soils in Denmark might exceed or has actually exceeded the levels of average national phosphorus fertilisation to be reached over the period 2018 to 2025, the ceilings for maximum phosphorus application will be reduced accordingly.

(3)

A combined targeted scheme for voluntary and mandatory catch crops shall be in place based on the need to reduce nitrates contents in groundwater bodies and in coastal waters. Under the scheme, the obligatory provisions for catch crops shall enter into force automatically if the voluntary agreements for catch crops fail to deliver the environmental objectives.

(4)

The catch crops established under this scheme shall be additional to the national mandatory requirement of 10 or 14 % catch crops on the farms crop ground area, and may not be established on the same area used to meet the EFA requirement for catch crops.

Article 5

Annual authorisation and commitment

1.   Cattle farmers may submit an application for an annual authorisation to apply livestock manure containing up to 230 kg nitrogen per hectare per year to the competent authorities.

The time-limit for submitting the application shall be the same as the national deadline for applying for Single Payment and submitting the fertiliser quota and catch crops plan.

2.   Together with the application referred to in paragraph 1, the applicant shall submit a declaration that he fulfils the conditions laid down in Articles 7, 8 and 9.

Article 6

The granting of authorisations

Authorisations to apply an amount of cattle manure, including manure excreted by the animals themselves and treated manure, containing up to 230 kg nitrogen per hectare land each year shall be granted subject to the conditions laid down in Articles 7 to 9.

Article 7

Conditions regarding application of manure and other fertilisers

1.   The total nitrogen input shall not exceed the foreseeable nutrient demand of the crop, taking into account the nutrient supply from the soil. It shall not exceed maximum application standards, as laid down in Order on agricultural use of fertiliser in the planning period 2016/2017 No 1055 (1/07/16), and in corresponding orders in the following planning periods.

2.   A fertilisation plan shall be prepared for the whole acreage of the cattle farm. The plan shall be kept on the farm. It shall cover the period from 1 August to 31 July the following year. The fertilisation plan shall include the following:

(a)

a crop rotation plan specifying the following:

(1)

the acreage of parcels with crops with high nitrogen uptake and long growing season;

(2)

the acreage of parcels with other crops than those mentioned in point (1);

(3)

a sketch map indicating the location of the parcels referred to in points (1) and (2) respectively;

(b)

the number of livestock on the farm, a description of the housing and manure storage system, including the volume of manure storage available;

(c)

a calculation of the manure nitrogen and phosphorus produced on the farm;

(d)

a description of manure treatment, where applicable, and expected characteristics of the treated manure;

(e)

the amount, type and characteristics of manure delivered outside the farm or to the farm;

(f)

the foreseeable amount of nitrogen and phosphorus required for the crop in each parcel;

(g)

a calculation of nitrogen and phosphorus application from manure for each parcel;

(h)

a calculation of nitrogen and phosphorus application from chemical and other fertilisers for each parcel;

(i)

an indication of the time of application of manure and chemical fertilisers.

The fertilisation plan shall be revised no later than seven days following any change in agricultural practices at the cattle farm. The fertilisation account shall be submitted to the competent authorities by the end of March each year at the latest.

3.   Manure shall not be spread in the period from 31 August to 1 March on grassland which will be ploughed the following spring.

Article 8

Conditions regarding soil sampling and analyses

1.   Samples shall be taken from the upper 30 cm of the farmland soil and analysed for their content of nitrogen and phosphorus.

2.   The sampling and analyses shall be carried out at least once every four years for each area of the farm presenting homogeneous features with regard to crop rotation and soil characteristics.

3.   At least one sampling and analysis shall be carried out for each five hectares of farmland.

4.   The results of the analyses shall be available for inspection at the cattle farm.

Article 9

Conditions regarding land management

1.   80 % or more of the acreage available for manure application shall be cultivated with crops with high nitrogen uptake and long growing season.

2.   Grass catch crops shall not be ploughed before 1 March the year after they have been established.

3.   Temporary grasslands shall be ploughed in spring. A crop with high nitrogen uptake and long growing season shall be seeded as soon as possible, and no later than 3 weeks, after grass has been ploughed.

4.   Crops used in crop rotation shall not include leguminous plants or other plants fixing atmospheric nitrogen, except for the following:

(a)

clover in grassland with less than 50 % clover and alfalfa;

(b)

alfalfa in grassland with less than 50 % clover and alfalfa;

(c)

barley and pea undersown with grass;

5.   Nitrogen fertilisations standards for crops following temporary grassland shall be reduced by the previous crop nitrogen value according to Order on agricultural use of fertiliser in the planning period 2016/2017 No 1055 (1/07/16), and in corresponding orders in the following planning periods regarding fertilisation standards, table on fertilisation norms for agricultural crops and vegetables, and subsequent changes.

Article 10

Monitoring

1.   The competent authorities shall ensure that maps are drawn up showing the following:

(a)

the percentage of the cattle farms in each municipality which are covered by authorisations;

(b)

the percentage of the livestock in each municipality which is covered by authorisations;

(c)

the percentage of the agricultural land in each municipality which is covered by authorisations;

Those maps shall be updated every year.

Data on crop rotations and agricultural practices covered by authorisations shall be collected by the competent authorities. Those data shall be updated every year.

2.   The competent authorities shall monitor root zone water, surface waters and groundwater and shall provide the Commission with data on nitrogen and phosphorus in the soil profile and nitrates concentrations in surface and groundwater, both under derogation and non-derogation conditions.

The monitoring shall be carried out at farm field scale in the agricultural catchment national monitoring programme. The monitoring sites shall be representative of the main soil types, the prevalent fertilisation practices and the main crops. Reinforced monitoring shall be conducted in agricultural catchments on sandy soils.

In addition, nitrates concentrations in surface and groundwater shall be monitored in at least 3 % of all farms benefiting from authorisations.

3.   The competent authorities shall carry out surveys and continuous nutrient analyses in the agricultural catchment national monitoring programme and shall provide data on local land use, crop rotations and agricultural practices on cattle farms benefiting from an authorisation.

Information and data collected from nutrient analysis as referred to in Article 7 and from monitoring as referred to in Article 10(2) shall be used for model-based calculations of nitrogen and phosphorus losses from cattle farms benefitting from an authorisation based on scientific principles.

4.   The competent authorities shall quantify the percentages of the land under derogation which is covered by:

(a)

clover or alfalfa in grassland;

(b)

barley and pea undersown with grass.

Article 11

Verification

1.   The competent authorities shall ensure that applications for authorisation are submitted to administrative control. Where the control demonstrates that the conditions laid down in Articles 7, 8 and 9 are not fulfilled by the applicant, the application shall be refused, and the applicant shall be informed of the reasons for refusal.

2.   The competent authorities shall establish a programme for inspections of farms benefiting from authorisations.

The programme shall be based on risk analysis having regard to the results of controls of the previous years concerning the conditions laid down in Articles 7, 8 and 9 and the results of controls of compliance with national legislation transposing Directive 91/676/EEC.

3.   The inspections shall consist of field inspections and on the spot control for compliance with the conditions set out in Articles 7, 8 and 9 and shall cover annually at least 7 % of the farms benefitting from an authorisation. Where a farm is found not to comply with those conditions, the holder of the authorisation shall be fined in accordance with national law and shall not be eligible for an authorisation the following year.

4.   The competent authorities shall be granted the necessary powers and means to verify compliance with the conditions of the derogation granted under this Decision.

Article 12

Reporting

The competent authorities shall, every year by 31 December at the latest, submit a report to the Commission containing the following information:

(a)

maps showing the percentage of cattle farms, percentage of livestock, percentage of agricultural land covered by individual derogations for each municipality, as well as maps on local land use, referred to in Article 10(1);

(b)

the results of ground and surface water monitoring, as regards nitrates and phosphorus concentrations, including information on water quality trends, both under derogation and non-derogation conditions, as well as the impact of derogation on water quality, as referred to in Article 10(2);

(c)

the results of soil monitoring as regards nitrogen and phosphorus concentrations in the root zone water, both under derogation and non-derogation conditions, as referred to in Article 10(2);

(d)

results of the surveys on local land use, crop rotations and agricultural practices, referred to in Article 10(3);

(e)

results of model-based calculations of the magnitude of nitrogen and phosphorus losses from farms benefitting from an authorisation, referred to in Article 10(3);

(f)

tables showing the percentage of agricultural land under derogation covered by clover or alfalfa in grassland and by barley/pea undersown with grass, referred to in Article 10(4);

(g)

evaluation of the implementation of the derogation conditions, on the basis of controls at farm level and information on non-compliant farms, on the basis of the results of the administrative and field inspections, referred to in Article 11;

(h)

trends in livestock numbers and manure production for each livestock category in Denmark and in derogation farms.

The spatial data contained in the report shall, where applicable, fulfil the provisions of Directive 2007/2/EC. In collecting the necessary data, Denmark shall make use, where appropriate, of the information generated under the Integrated Administration and Control System set up in accordance with Article 67(1) of Regulation (EU) No 1306/2013.

Article 13

Period of application

This Decision shall apply until 31 December 2018.

Article 14

Addressee

This Decision is addressed to the Kingdom of Denmark.

Done at Brussels, 16 May 2017.

For the Commission

Karmenu VELLA

Member of the Commission


(1)  OJ L 375, 31.12.1991, p. 1.

(2)  Commission Decision 2002/915/EC of 18 November 2002 concerning a request for derogation under paragraph 2(b) of Annex III to and Article 9 of Council Directive 91/676/EEC concerning protection of waters against pollution caused by nitrates from agricultural sources (OJ L 319, 23.11.2002, p. 24).

(3)  Commission Decision 2005/294/EC of 5 April 2005 concerning a request for derogation under point 2(b) of Annex III to and Article 9 of Council Directive 91/676/EEC concerning the protection of waters against pollution caused by nitrates from agricultural sources (OJ L 94, 13.4.2005, p. 34).

(4)  Commission Decision 2008/664/EC of 8 August 2008 amending Decision 2005/294/EC concerning a request for derogation under point 2(b) of Annex III to and Article 9 of Council Directive 91/676/EEC concerning the protection of waters against pollution caused by nitrates from agricultural sources (OJ L 217, 13.8.2008, p. 16).

(5)  Commission Implementing Decision 2012/659/EU of 23 October 2012 on granting a derogation requested by the Kingdom of Denmark pursuant to Council Directive 91/676/EEC concerning the protection of waters against pollution caused by nitrates from agricultural sources (OJ L 295, 25.10.2012, p. 20).

(6)  Danish Environmental Protection Agency (ed.), Status and trends of the aquatic environment and agricultural practice in Denmark, Report to the European Commission for the period 2012-2015 in accordance with Article 10 of the Nitrates Directive (1991/676/EEC), September 2016.

(7)  Directive 2000/60/EC of the European Parliament and the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1).

(8)  Directive 2007/2/EC of the European Parliament and of the Council of 14 March 2007 establishing an Infrastructure for Spatial Information in the European Community (INSPIRE) (OJ L 108, 25.4.2007, p. 1).

(9)  Regulation (EU) No 1306/2013 of the European Parliament and of the Council of 17 December 2013 on the financing, management and monitoring of the common agricultural policy and repealing Council Regulations (EEC) No 352/78, (EC) No 165/94, (EC) No 2799/98, (EC) No 814/2000, (EC) No 1290/2005 and (EC) No 485/2008 (OJ L 347, 20.12.2013, p. 549).


18.5.2017   

EN

Official Journal of the European Union

L 125/43


COMMISSION DECISION (EU) 2017/848

of 17 May 2017

laying down criteria and methodological standards on good environmental status of marine waters and specifications and standardised methods for monitoring and assessment, and repealing Decision 2010/477/EU

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Directive 2008/56/EC of the European Parliament and of the Council of 17 June 2008 establishing a framework for community action in the field of marine environmental policy (Marine Strategy Framework Directive) (1), and in particular Articles 9(3) and 11(4) thereof,

Whereas:

(1)

Commission Decision 2010/477/EU (2) established criteria to be used by the Member States to determine the good environmental status of their marine waters and to guide their assessments of that status in the first implementation cycle of Directive 2008/56/EC.

(2)

Decision 2010/477/EU acknowledged that additional scientific and technical progress was required to support the development or revision of those criteria for some qualitative descriptors, as well as further development of methodological standards in close coordination with the establishment of monitoring programmes. In addition, that Decision stated that it would be appropriate to carry out its revision as soon as possible after the completion of the assessment required under Article 12 of Directive 2008/56/EC, in time to support a successful update of marine strategies that are due by 2018, pursuant to Article 17 of Directive 2008/56/EC.

(3)

In 2012, on the basis of the initial assessment of their marine waters made pursuant to Article 8(1) of Directive 2008/56/EC, Member States reported on the environmental status of their marine waters and notified to the Commission their determination of good environmental status and their environmental targets in accordance with Articles 9(2) and 10(2) of Directive 2008/56/EC, respectively. The Commission's assessment (3) of those Member State reports, undertaken in accordance with Article 12 of Directive 2008/56/EC, highlighted that more efforts were urgently needed if Member States are to reach good environmental status by 2020. The results showed the necessity to significantly improve the quality and coherence of the determination of good environmental status by the Member States. In addition, the assessment recognised that regional cooperation must be at the very heart of the implementation of Directive 2008/56/EC. It also emphasised the need for Member States to more systematically build upon standards stemming from Union legislation or, where they do not exist, upon standards set by Regional Sea Conventions or other international agreements.

(4)

To ensure that the second cycle of implementation of the marine strategies of the Member States further contributes to the achievement of the objectives of Directive 2008/56/EC and yields more consistent determinations of good environmental status, the Commission recommended in its report on the first phase of implementation that, at Union level, the Commission services and Member States collaborate to revise, strengthen and improve Decision 2010/477/EU, aiming at a clearer, simpler, more concise, more coherent and comparable set of good environmental status criteria and methodological standards and, at the same time, review Annex III of Directive 2008/56/EC, and if necessary revise it, and develop specific guidance to ensure a more coherent and consistent approach for assessments in the next implementation cycle.

(5)

On the basis of those conclusions, the review process started in 2013 when a roadmap, consisting of several phases (technical and scientific, consultation, and decision-making), was endorsed by the Regulatory Committee established under Article 25(1) of Directive 2008/56/EC. During this process, the Commission consulted all interested parties, including Regional Sea Conventions.

(6)

In order to facilitate future updates of the initial assessment of Member States' marine waters and their determination of good environmental status, and to ensure greater coherence in implementation of Directive 2008/56/EC across the Union, it is necessary to clarify, revise or introduce criteria, methodological standards, specifications and standardised methods to be used by Member States, compared to the elements currently set out in Decision 2010/477/EU. As a result, the number of criteria that Member States need to monitor and assess should be reduced, applying a risk-based approach to those which are retained in order to allow Member States to focus their efforts on the main anthropogenic pressures affecting their waters. Finally, the criteria and their use should be further specified, including providing for threshold values or the setting thereof, thereby allowing for the extent to which good environmental status is achieved to be measured across the Union's marine waters.

(7)

In accordance with the commitment taken by the Commission when adopting its communication to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: ‘Better regulation for better results — An EU agenda’ (4), this Decision should ensure coherence with other Union legislation. To ensure greater consistency and comparability at Union level of Member States' determinations of good environmental status and avoid unnecessary overlaps, it is appropriate to take into account relevant existing standards and methods for monitoring and assessment laid down in Union legislation, including Council Directive 92/43/EEC (5), Directive 2000/60/EC of the European Parliament and of the Council (6), Commission Regulation (EC) No 1881/2006 (7), Council Regulation (EC) No 1967/2006 (8), Directive 2008/105/EC of the European Parliament and of the Council (9), Directive 2009/147/EC of the European Parliament and of the Council (10) and Regulation (EU) No 1380/2013 of the European Parliament and of the Council (11).

(8)

For each of the qualitative descriptors listed in Annex I to Directive 2008/56/EC, and on the basis of the indicative lists in Annex III to that Directive, it is necessary to define the criteria, including the criteria elements and, where appropriate, the threshold values, to be used. Threshold values are intended to contribute to Member States' determination of a set of characteristics for good environmental status and inform their assessment of the extent to which good environmental status is being achieved. It is also necessary to set out methodological standards, including the geographic scales for assessment and how the criteria should be used. Those criteria and methodological standards are to ensure consistency and allow for comparison, between marine regions or subregions, of assessments of the extent to which good environmental status is being achieved.

(9)

To ensure comparability between the details of any updates by the Member States following the reviews of certain elements of their marine strategies, sent under Article 17(3) of Directive 2008/56/EC, specifications and standardised methods for monitoring and assessment should be defined, taking into account existing specifications and standards at Union or international level, including regional or subregional level.

(10)

Member States should apply the criteria, methodological standards, specifications and standardised methods for monitoring and assessment laid down in this Decision in combination with the ecosystem elements, anthropogenic pressures and human activities listed in the indicative lists of Annex III to Directive 2008/56/EC and by reference to the initial assessment made pursuant to Article 8(1) of that Directive, when determining a set of characteristics for good environmental status in accordance with Article 9(1) of that Directive, and when establishing coordinated monitoring programmes under Article 11 of that Directive.

(11)

In order to establish a clear link between the determination of a set of characteristics for good environmental status and the assessment of progress towards its achievement, it is appropriate to organise the criteria and methodological standards on the basis of the qualitative descriptors laid down in Annex I to Directive 2008/56/EC, taking into account the indicative lists of ecosystem elements, anthropogenic pressures and human activities laid down in Annex III to that Directive. Some of those criteria and methodological standards relate in particular to the assessment of environmental status or of predominant pressures and impacts under points (a) or (b) of Article 8(1) of Directive 2008/56/EC, respectively.

(12)

In cases where no threshold values are laid down, Member States should establish threshold values through Union, regional or subregional cooperation, for instance by referring to existing values or developing new ones in the framework of the Regional Sea Conventions. In cases where threshold values should be established through cooperation at Union level (for the descriptors on marine litter, underwater noise and seabed integrity), this will be done in the framework of the Common Implementation Strategy set up by the Member States and the Commission for the purposes of Directive 2008/56/EC. Once established through Union, regional or subregional cooperation, these threshold values will only become part of Member States' sets of characteristics for good environmental status when they are sent to the Commission as part of Member States' reporting under Article 17(3) of Directive 2008/56/EC. Until such threshold values are established through Union, regional or subregional cooperation, Member States should be able to use national threshold values, directional trends or pressure-based threshold values as proxies.

(13)

Threshold values should reflect, where appropriate, the quality level that reflects the significance of an adverse effect for a criterion and should be set in relation to a reference condition. Threshold values should be consistent with Union legislation and set at appropriate geographic scales to reflect the different biotic and abiotic characteristics of the regions, subregions and subdivisions. This means that even if the process to establish threshold values takes place at Union level, this may result in the setting of different threshold values, which are specific to a region, subregion or subdivision. Threshold values should also be set on the basis of the precautionary principle, reflecting the potential risks to the marine environment. The setting of threshold values should accommodate the dynamic nature of marine ecosystems and their elements, which can change in space and time through hydrological and climatic variation, predator-prey relationships and other environmental factors. Threshold values should also reflect the fact that marine ecosystems may recover, if deteriorated, to a state that reflects prevailing physiographic, geographic, climatic and biological conditions, rather than return to a specific state of the past.

(14)

In accordance with Article 1(3) of Directive 2008/56/EC, the collective pressure of human activities needs to be kept within levels compatible with the achievement of good environmental status, ensuring that the capacity of marine ecosystems to respond to human-induced changes is not compromised. This may entail, where appropriate, that threshold values for certain pressures and their environmental impacts are not necessarily achieved in all areas of Member States' marine waters, provided that this does not compromise the achievement of the objectives of Directive 2008/56/EC, while enabling the sustainable use of marine goods and services.

(15)

It is necessary to lay down threshold values which will be part of the set of characteristics used by Member States in their determination of good environmental status in accordance with Article 9(1) of Directive 2008/56/EC, and the extent to which the threshold values are to be achieved. Threshold values therefore do not, by themselves, constitute Member States' determinations of good environmental status.

(16)

Member States should express the extent to which good environmental status is being achieved as the proportion of their marine waters over which the threshold values have been achieved or as the proportion of criteria elements (species, contaminants, etc.) that have achieved the threshold values. When assessing the status of their marine waters in accordance with Article 17(2)(a) of Directive 2008/56/EC, Member States should express any change in status as improving, stable or deteriorating compared to the previous reporting period, in view of the often slow response of the marine environment to change.

(17)

Where threshold values, set in accordance with this Decision, are not met for a particular criterion, Member States should consider taking appropriate measures or carrying out further research or investigation.

(18)

Where Member States are required to cooperate at regional or subregional level, they should use, where practical and appropriate, existing regional institutional cooperation structures, including those under Regional Sea Conventions, as provided under Article 6 of Directive 2008/56/EC. Similarly, in the absence of specific criteria, methodological standards, including for integration of the criteria, specifications and standardised methods for monitoring and assessment, Member States should build upon, where practical and appropriate, those developed at international, regional or subregional level, for instance those agreed in the framework of the Regional Sea Conventions, or other international mechanisms. Otherwise, Member States may choose to coordinate amongst themselves within the region or subregion, where relevant. In addition, a Member State may also decide, on the basis of the specificities of its marine waters, to consider additional elements not laid down in this Decision and not dealt with at international, regional or subregional level, or to consider applying elements of this Decision to its transitional waters, as defined in Article 2(6) of Directive 2000/60/EC, in support of the implementation of Directive 2008/56/EC.

(19)

Member States should have sufficient flexibility, under specified conditions, to focus on the predominant pressures and their environmental impacts on the different ecosystem elements in each region or subregion in order to monitor and assess their marine waters in an efficient and effective manner and to facilitate prioritisation of actions to be taken to achieve good environmental status. For that purpose, firstly, Member States should be able to consider that some of the criteria are not appropriate to apply, provided this is justified. Secondly, Member States should have the possibility to decide not to use certain criteria elements or to select additional elements or to focus on certain matrices or areas of their marine waters, provided that this is based on a risk assessment in relation to the pressures and their impacts. Finally, a distinction should be introduced between primary and secondary criteria. While primary criteria should be used to ensure consistency across the Union, flexibility should be granted with regard to secondary criteria. The use of a secondary criterion should be decided by Member States, where necessary, to complement a primary criterion or when, for a particular criterion, the marine environment is at risk of not achieving or not maintaining good environmental status.

(20)

Criteria, including threshold values, methodological standards, specifications and standardised methods for monitoring and assessment should be based on the best available science. However, additional scientific and technical progress is still required to support the further development of some of them, and should be used as the knowledge and understanding become available.

(21)

Decision 2010/477/EU should therefore be repealed.

(22)

The measures provided for in this Decision are in accordance with the opinion of the Regulatory Committee,

HAS ADOPTED THIS DECISION:

Article 1

Subject matter

This Decision lays down:

(a)

criteria and methodological standards to be used by Member States when determining a set of characteristics for good environmental status in accordance with Article 9(1) of Directive 2008/56/EC, on the basis of Annexes I and III and by reference to the initial assessment made pursuant to Article 8(1) of that Directive, to assess the extent to which good environmental status is being achieved, in accordance with Article 9(3) of that Directive;

(b)

specifications and standardised methods for monitoring and assessment, to be used by Member States when establishing coordinated monitoring programmes under Article 11 of Directive 2008/56/EC, in accordance with Article 11(4) of that Directive;

(c)

a timeline for the establishment of threshold values, lists of criteria elements and methodological standards through Union, regional or subregional cooperation;

(d)

a notification requirement for criteria elements, threshold values and methodological standards.

Article 2

Definitions

For the purposes of this Decision, the definitions laid down in Article 3 of Directive 2008/56/EC shall apply.

The following definitions shall also apply:

(1)

‘subregions’ means the subregions listed in Article 4(2) of Directive 2008/56/EC;

(2)

‘subdivisions’ means subdivisions as referred to in Article 4(2) of Directive 2008/56/EC;

(3)

‘invasive non-indigenous species’ means ‘invasive alien species’ within the meaning of Article 3(2) of Regulation (EU) No 1143/2014 of the European Parliament and of the Council (12);

(4)

‘criteria elements’ means constituent elements of an ecosystem, particularly its biological elements (species, habitats and their communities), or aspects of pressures on the marine environment (biological, physical, substances, litter and energy), which are assessed under each criterion;

(5)

‘threshold value’ means a value or range of values that allows for an assessment of the quality level achieved for a particular criterion, thereby contributing to the assessment of the extent to which good environmental status is being achieved.

Article 3

Use of criteria, methodological standards, specifications and standardised methods

1.   Member States shall use primary criteria and associated methodological standards, specifications and standardised methods laid down in the Annex to implement this Decision. However, on the basis of the initial assessment or its subsequent updates carried out in accordance with Articles 8 and 17(2)(a) of Directive 2008/56/EC, Member States may consider, in justified circumstances, that it is not appropriate to use one or more of the primary criteria. In such cases, Member States shall provide the Commission with a justification in the framework of the notification made pursuant to Article 9(2) or 17(3) of Directive 2008/56/EC.

Pursuant to the obligation of regional cooperation laid down in Articles 5 and 6 of Directive 2008/56/EC, a Member State shall inform other Member States sharing the same marine region or subregion before it decides not to use a primary criterion in accordance with the first subparagraph.

2.   Secondary criteria and associated methodological standards, specifications and standardised methods laid down in the Annex shall be used to complement a primary criterion or when the marine environment is at risk of not achieving or not maintaining good environmental status for that particular criterion. The use of a secondary criterion shall be decided by each Member State, except where otherwise specified in the Annex.

3.   Where this Decision does not set criteria, methodological standards, specifications or standardised methods for monitoring and assessment, including for spatial and temporal aggregation of data, Member States shall build upon, where practical and appropriate, those developed at international, regional or subregional level, such as those agreed in the relevant Regional Sea Conventions.

4.   Until Union, international, regional or subregional lists of criteria elements, methodological standards, and specifications and standardised methods for monitoring and assessment are established, Member States may use those established at national level, provided that regional cooperation is pursued as laid down in Articles 5 and 6 of Directive 2008/56/EC.

Article 4

Setting of threshold values through Union, regional or subregional cooperation

1.   Where Member States are required under this Decision to establish threshold values through Union, regional or subregional cooperation, those values shall:

(a)

be part of the set of characteristics used by Member States in their determination of good environmental status;

(b)

be consistent with Union legislation;

(c)

where appropriate, distinguish the quality level that reflects the significance of an adverse effect for a criterion and be set in relation to a reference condition;

(d)

be set at appropriate geographic scales of assessment to reflect the different biotic and abiotic characteristics of the regions, subregions and subdivisions;

(e)

be set on the basis of the precautionary principle, reflecting the potential risks to the marine environment;

(f)

be consistent across different criteria when they relate to the same ecosystem element;

(g)

make use of best available science;

(h)

be based on long time-series data, where available, to help determine the most appropriate value;

(i)

reflect natural ecosystem dynamics, including predator-prey relationships and hydrological and climatic variation, also acknowledging that the ecosystem or parts thereof may recover, if deteriorated, to a state that reflects prevailing physiographic, geographic, climatic and biological conditions, rather than return to a specific state of the past;

(j)

be consistent, where practical and appropriate, with relevant values set under regional institutional cooperation structures, including those agreed in the Regional Sea Conventions.

2.   Until Member States have established threshold values through Union, regional or subregional cooperation as required under this Decision, they may use any of the following to express the extent to which good environmental status is being achieved:

(a)

national threshold values, provided the obligation of regional cooperation laid down in Articles 5 and 6 of Directive 2008/56/EC is complied with;

(b)

directional trends of the values;

(c)

pressure-based threshold values as proxies.

These shall follow, where possible, the principles set out in points (a) to (i) of paragraph 1.

3.   Where threshold values, including those established by Member States in accordance with this Decision, are not met for a particular criterion to the extent which that Member State has determined as constituting good environmental status in accordance with Article 9(1) of Directive 2008/56/EC, Member States shall consider, as appropriate, whether measures should be taken under Article 13 of that Directive or whether further research or investigation should be carried out.

4.   Threshold values established by Member States in accordance with this Decision may be periodically reviewed in the light of scientific and technical progress and amended, where necessary, in time for the reviews provided for in Article 17(2)(a) of Directive 2008/56/EC.

Article 5

Timeline

1.   Where this Decision provides for Member States to establish threshold values, lists of criteria elements or methodological standards through Union, regional or subregional cooperation, Member States shall endeavour to do so within the time-limit set for the first review of their initial assessment and determination of good environmental status in accordance with Article 17(2)(a) of Directive 2008/56/EC (15 July 2018).

2.   Where Member States are not able to establish threshold values, lists of criteria elements or methodological standards through Union, regional or subregional cooperation within the time-limit laid down in paragraph 1, they shall establish these as soon as possible thereafter, on condition that they provide, by 15 October 2018, justification to the Commission in the notification made pursuant to Article 9(2) or 17(3) of Directive 2008/56/EC.

Article 6

Notification

Each Member State shall send to the Commission, as part of the notification made pursuant to Article 17(3) of Directive 2008/56/EC, those criteria elements, threshold values and methodological standards established through Union, regional or subregional cooperation in accordance with this Decision, that it decides to use as part of its set of characteristics for determining good environmental status under Article 9(1) of Directive 2008/56/EC.

Article 7

Repeal

Decision 2010/477/EU is hereby repealed.

References to Decision 2010/477/EU shall be construed as references to this Decision.

Article 8

Entry into force

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

Done at Brussels, 17 May 2017.

For the Commission

The President

Jean-Claude JUNCKER


(1)  OJ L 164, 25.6.2008, p. 19.

(2)  Commission Decision 2010/477/EU of 1 September 2010 on criteria and methodological standards on good environmental status of marine waters (OJ L 232, 2.9.2010, p. 14).

(3)  Report from the Commission to the Council and the European Parliament — The first phase of implementation of the Marine Strategy Framework Directive (2008/56/EC) — The European Commission's assessment and guidance (COM(2014)097 final, 20.2.2014).

(4)  COM(2015) 215 final.

(5)  Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ L 206, 22.7.1992, p. 7).

(6)  Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1).

(7)  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).

(8)  Council Regulation (EC) No 1967/2006 of 21 December 2006 concerning management measures for the sustainable exploitation of fishery resources in the Mediterranean Sea, amending Regulation (EEC) No 2847/93 and repealing Regulation (EC) No 1626/94 (OJ L 409, 30.12.2006, p. 11).

(9)  Directive 2008/105/EC of the European Parliament and of the Council of 16 December 2008 on environmental quality standards in the field of water policy, amending and subsequently replacing Council Directives 82/176/EEC, 83/513/EEC, 84/156/EEC, 84/491/EEC, 86/280/EEC and amending Directive 2000/60/EC of the European Parliament and of the Council (OJ L 348, 24.12.2008, p. 84.).

(10)  Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (OJ L 20, 26.1.2010, p. 7).

(11)  Regulation (EU) No 1380/2013 of the European Parliament and of the Council of 11 December 2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC (OJ L 354, 28.12.2013, p. 22).

(12)  Regulation (EU) No 1143/2014 of the European Parliament and of the Council of 22 October 2014 on the prevention and management of the introduction and spread of invasive alien species (OJ L 317, 4.11.2014, p. 35).


ANNEX

Criteria and methodological standards for good environmental status of marine waters, relevant to the qualitative descriptors in Annex I to Directive 2008/56/EC, and to the indicative lists set out in Annex III to that Directive, and specifications and standardised methods for monitoring and assessment

This Annex is structured in two parts:

under Part I are laid down the criteria and methodological standards for determination of good environmental status under Article 9(3) of Directive 2008/56/EC, and specifications and standardised methods for monitoring and assessment under Article 11(4) of that Directive, to be used by Member States in relation to the assessment of predominant pressures and impacts under Article 8(1)(b) of Directive 2008/56/EC,

under Part II are laid down the criteria and methodological standards for determination of good environmental status under Article 9(3) of Directive 2008/56/EC, and specifications and standardised methods for monitoring and assessment, to be used by Member States in relation to the assessment of environmental status under Article 8(1)(a) of Directive 2008/56/EC.

PART I

Criteria, methodological standards, specifications and standardised methods for the monitoring and assessment of predominant pressures and impacts under point (b) of Article 8(1) of Directive 2008/56/EC

Part I considers the descriptors (1) linked to the relevant anthropogenic pressures: biological pressures (Descriptors 2 and 3), physical pressures (Descriptors 6 and 7) and substances, litter and energy (Descriptors 5, 8, 9, 10 and 11), as listed in Annex III to Directive 2008/56/EC.

Descriptor 2

Non-indigenous species introduced by human activities are at levels that do not adversely alter the ecosystems

Relevant pressure: Input or spread of non-indigenous species

Criteria, including criteria elements, and methodological standards

Criteria elements

Criteria

Methodological standards

Newly-introduced non-indigenous species.

D2C1 — Primary:

The number of non-indigenous species which are newly introduced via human activity into the wild, per assessment period (6 years), measured from the reference year as reported for the initial asessment under Article 8(1) of Directive 2008/56/EC, is minimised and where possible reduced to zero.

Member States shall establish the threshold value for the number of new introductions of non-indigenous species, through regional or subregional cooperation.

Scale of assessment:

Subdivisions of the region or subregion, divided where needed by national boundaries.

Use of criteria:

The extent to which good environmental status has been achieved shall be expressed for each area assessed as follows:

the number of non-indigenous species newly introduced via human activity, in the 6-year assessment period and a list of those species.

Established non-indigenous species, particularly invasive non-indigenous species, which include relevant species on the list of invasive alien species of Union concern adopted in accordance with Article 4(1) of Regulation (EU) No 1143/2014 and species which are relevant for use under criterion D2C3.

Member States shall establish that list through regional or subregional cooperation.

D2C2 — Secondary:

Abundance and spatial distribution of established non-indigenous species, particularly of invasive species, contributing significantly to adverse effects on particular species groups or broad habitat types.

Scale of assessment:

As used for assessment of the corresponding species groups or broad habitat types under Descriptors 1 and 6.

Use of criteria:

Criterion D2C2 (quantification of non-indigenous species) shall be expressed per species assessed and shall contribute to the assessment of criterion D2C3 (adverse effects of non-indigenous species).

Criterion D2C3 shall provide the proportion per species group and extent per broad habitat type assessed which is adversely altered, and thus contribute to their assessments under Descriptors 1 and 6.

Species groups and broad habitat types that are at risk from non-indigenous species, selected from those used for Descriptors 1 and 6.

Member States shall establish that list through regional or subregional cooperation.

D2C3 — Secondary:

Proportion of the species group or spatial extent of the broad habitat type which is adversely altered due to non-indigenous species, particularly invasive non-indigenous species.

Member States shall establish the threshold values for the adverse alteration to species groups and broad habitat types due to non-indigenous species, through regional or subregional cooperation.

Specifications and standardised methods for monitoring and assessment

1.

‘Newly-introduced’ non-indigenous species shall be understood as those which were not known to be present in the area in the previous assessment period.

2.

‘Established’ non-indigenous species shall be understood as those which were known to be present in the area in the previous assessment period.

3.

For D2C1: where it is not clear whether the new arrival of non-indigenous species is due to human activity or natural dispersal from neighbouring areas, the introduction shall be counted under D2C1.

4.

For D2C2: when species occurrence and abundance is seasonally variable (e.g. plankton), monitoring shall be undertaken at appropriate times of year.

5.

Monitoring programmes shall be linked to those for Descriptors 1, 4, 5 and 6, where possible, as they typically use the same sampling methods and it is more practical to monitor non-indigenous species as part of broader biodiversity monitoring, except where sampling needs to focus on main vectors and risk areas for new introductions.

Units of measurement for the criteria:

D2C1: the number of species per assessment area which have been newly introduced in the assessment period (6 years),

D2C2: abundance (number of individuals, biomass in tonnes (t) or extent in square kilometres (km2)) per non-indigenous species,

D2C3: the proportion of the species group (ratio of indigenous species to non-indigenous species, as number of species and/or their abundance within the group) or the spatial extent of the broad habitat type (in square kilometres (km2)) which is adversely altered.

Descriptor 3

Populations of all commercially-exploited fish and shellfish are within safe biological limits, exhibiting a population age and size distribution that is indicative of a healthy stock

Relevant pressure: Extraction of, or mortality/injury to, wild species, including target and non-target species

Criteria, including criteria elements, and methodological standards

Criteria elements

Criteria

Methodological standards

Commercially-exploited fish and shellfish.

Member States shall establish through regional or subregional cooperation a list of commercially-exploited fish and shellfish, according to the criteria laid down under ‘specifications’.

D3C1 — Primary:

The Fishing mortality rate of populations of commercially-exploited species is at or below levels which can produce the maximum sustainable yield (MSY). Appropriate scientific bodies shall be consulted in accordance with Article 26 of Regulation (EU) No 1380/2013.

Scale of assessment:

Populations of each species are assessed at ecologically-relevant scales within each region or subregion, as established by appropriate scientific bodies as referred to in Article 26 of Regulation (EU) No 1380/2013, based on specified aggregations of International Council for the Exploration of the Sea (ICES) areas, General Fisheries Commission for the Mediterranean (GFCM) geographical sub-areas and Food and Agriculture Organisation (FAO) fishing areas for the Macaronesian biogeographic region.

Use of criteria:

The extent to which good environmental status has been achieved shall be expressed for each area assessed as follows:

(a)

the populations assessed, the values achieved for each criterion and whether the levels for D3C1 and D3C2 and the threshold values for D3C3 have been achieved, and the overall status of the population on the basis of criteria integration rules agreed at Union level;

(b)

the populations of commercially-exploited species in the assessment area which were not assessed.

The outcomes of these population assessments shall also contribute to the assessments under Descriptors 1 and 6, if the species are relevant for assessment of particular species groups and benthic habitat types.

D3C2 (2) — Primary:

The Spawning Stock Biomass of populations of commercially-exploited species are above biomass levels capable of producing maximum sustainable yield. Appropriate scientific bodies shall be consulted in accordance with Article 26 of Regulation (EU) No 1380/2013.

D3C3 (2)  (3) — Primary:

The age and size distribution of individuals in the populations of commercially-exploited species is indicative of a healthy population. This shall include a high proportion of old/large individuals and limited adverse effects of exploitation on genetic diversity.

Member States shall establish threshold values through regional or subregional cooperation for each population of species in accordance with scientific advice obtained pursuant to Article 26 of Regulation (EU) No 1380/2013.

Extraction of, or mortality/injury to, non-commercially-exploited species (incidental by-catches) as a result of fishing activities, is addressed under criterion D1C1.

Physical disturbance to the seabed, including effects on benthic communities, as a result of fishing activities, are addressed by the criteria under Descriptor 6 (particularly criteria D6C2 and D6C3) and are to be fed into the assessments of benthic habitat types under Descriptors 1 and 6.

Specifications and standardised methods for monitoring and assessment

1.

A list of commercially-exploited species for application of the criteria in each assessment area shall be established by Member States through regional or subregional cooperation and updated for each 6-year assessment period, taking into account Council Regulation (EC) No 199/2008 (4) and the following:

(a)

all stocks that are managed under Regulation (EU) No 1380/2013;

(b)

the species for which fishing opportunities (total allowable catches and quotas) are set by Council under Article 43(3) of the Treaty on the Functioning of the European Union;

(c)

the species for which minimum conservation reference sizes are set under Regulation (EC) No 1967/2006;

(d)

the species under multiannual plans according to Article 9 of Regulation (EU) No 1380/2013;

(e)

the species under national management plans according to Article 19 of Regulation (EC) No 1967/2006;

(f)

any important species on a regional or national scale for small-scale/local coastal fisheries.

For the purposes of this Decision, commercially-exploited species which are non-indigenous in each assessment area shall be excluded from the list and thus not contribute to achievement of good environmental status for Descriptor 3.

2.

Regulation (EC) No 199/2008 establishes rules on the collection and management, in the framework of multi-annual programmes, of biological, technical, environmental and socioeconomic data concerning the fisheries sector which shall be used for monitoring under Descriptor 3.

3.

The term ‘populations’ shall be understood as the term ‘stocks’ within the meaning of Regulation (EU) No 1380/2013.

4.

For D3C1 and D3C2, the following shall apply:

(a)

for stocks managed under a multiannual plan according to Article 9 of Regulation (EU) No 1380/2013, in situations of mixed fisheries, the target fishing mortality and the biomass levels capable of producing maximum sustainable yield shall be in accordance with the relevant multiannual plan;

(b)

for the Mediterranean Sea and Black Sea regions, appropriate proxies may be used.

5.

The following methods for assessment shall be used:

(a)

for D3C1: if quantitative assessments yielding values for Fishing mortality are not available due to inadequacies in the available data, other variables such as the ratio between catch and biomass index (‘catch/biomass ratio’) may be used as an alternative method. In such cases, an appropriate method for trend analysis shall be adopted (e.g. the current value can be compared against the long-term historical average);

(b)

for D3C2: the threshold value used shall be in accordance with Article 2(2) of Regulation (EU) No 1380/2013. If quantitative assessments yielding values for Spawning Stock Biomass are not available due to inadequacies in the available data, biomass-related indices such as catch per unit effort or survey abundance indices may be used as an alternative method. In such cases, an appropriate method for trend analysis shall be adopted (e.g. the current value can be compared against the long-term historical average);

(c)

D3C3 shall reflect that healthy populations of species are characterised by a high proportion of old, large individuals. The relevant properties are the following:

(i)

size distribution of individuals in the population, expressed as:

the proportion of fish larger than mean size of first sexual maturation, or

the 95th percentile of the fish-length distribution of each population, as observed in research vessel or other surveys;

(ii)

genetic effects of exploitation of the species, such as size at first sexual maturation, where appropriate and feasible.

Other expressions of the relevant properties may be used following further scientific and technical development of this criterion.

Units of measurement for the criteria:

D3C1: annualised fishing mortality rate,

D3C2: biomass in tonnes (t) or number of individuals per species, except where other indices are used under point 5(b),

D3C3: under point 5(c): for (i), first indent: proportion (percentage) or numbers, for (i), second indent: length in centimetres (cm), and for (ii): length in centimetres (cm).

Descriptor 5

Human-induced eutrophication is minimised, especially adverse effects thereof, such as losses in biodiversity, ecosystem degradation, harmful algae blooms and oxygen deficiency in bottom waters

Relevant pressures: Input of nutrients; Input of organic matter

Criteria, including criteria elements, and methodological standards

Criteria elements

Criteria

Methodological standards

Nutrients in the water column: Dissolved Inorganic Nitrogen (DIN), Total Nitrogen (TN), Dissolved Inorganic Phosphorus (DIP), Total Phosphorus (TP).

Within coastal waters, as used under Directive 2000/60/EC.

Beyond coastal waters, Member States may decide at regional or subregional level to not use one or several of these nutrient elements.

D5C1 — Primary:

Nutrient concentrations are not at levels that indicate adverse eutrophication effects.

The threshold values are as follows:

(a)

in coastal waters, the values set in accordance with Directive 2000/60/EC;

(b)

beyond coastal waters, values consistent with those for coastal waters under Directive 2000/60/EC. Member States shall establish those values through regional or subregional cooperation

Scale of assessment:

within coastal waters, as used under Directive 2000/60/EC,

beyond coastal waters, subdivisions of the region or subregion, divided where needed by national boundaries.

Use of criteria:

The extent to which good environmental status has been achieved shall be expressed for each area assessed as follows:

(a)

the values achieved for each criterion used, and an estimate of the extent of the assessment area over which the threshold values set have been achieved;

(b)

in coastal waters, the criteria shall be used in accordance with the requirements of Directive 2000/60/EC to conclude on whether the water body is subject to eutrophication (5);

(c)

beyond coastal waters, an estimate of the extent of the area (as a proportion (percentage)) that is not subject to eutrophication (as indicated by the results of all criteria used, integrated in a manner agreed where possible at Union level, but at least at regional or subregional level).

Beyond coastal waters, the use of the secondary criteria shall be agreed at regional or subregional level.

The outcomes of the assessments shall also contribute to assessments for pelagic habitats under Descriptor 1 as follows:

the distribution and an estimate of the extent of the area (as a proportion (percentage)) that is subject to eutrophication in the water column (as indicated by whether the threshold values for criteria D5C2, D5C3 and D5C4, when used, have been achieved);

The outcomes of the assessments shall also contribute to assessments for benthic habitats under Descriptors 1 and 6 as follows:

the distribution and an estimate of the extent of the area (as a proportion (percentage)) that is subject to eutrophication on the seabed (as indicated by whether the threshold values for criteria D5C4, D5C5, D5C6, D5C7 and D5C8, when used, have been achieved).

Chlorophyll a in the water column

D5C2 — Primary:

Chlorophyll a concentrations are not at levels that indicate adverse effects of nutrient enrichment.

The threshold values are as follows:

(a)

in coastal waters, the values set in accordance with Directive 2000/60/EC;

(b)

beyond coastal waters, values consistent with those for coastal waters under Directive 2000/60/EC. Member States shall establish those values through regional or subregional cooperation.

Harmful algal blooms (e.g. cyanobacteria) in the water column

D5C3 — Secondary:

The number, spatial extent and duration of harmful algal bloom events are not at levels that indicate adverse effects of nutrient enrichment.

Member States shall establish threshold values for these levels through regional or subregional cooperation.

Photic limit (transparency) of the water column

D5C4 — Secondary:

The photic limit (transparency) of the water column is not reduced, due to increases in suspended algae, to a level that indicates adverse effects of nutrient enrichment.

The threshold values are as follows:

(a)

in coastal waters, the values set in accordance with Directive 2000/60/EC;

(b)

beyond coastal waters, values consistent with those for coastal waters under Directive 2000/60/EC. Member States shall establish those values through regional or subregional cooperation.

Dissolved oxygen in the bottom of the water column

D5C5 — Primary (may be substituted by D5C8):

The concentration of dissolved oxygen is not reduced, due to nutrient enrichment, to levels that indicate adverse effects on benthic habitats (including on associated biota and mobile species) or other eutrophication effects.

The threshold values are as follows:

(a)

in coastal waters, the values set in accordance with Directive 2000/60/EC;

(b)

beyond coastal waters, values consistent with those for coastal waters under Directive 2000/60/EC. Member States shall establish those values through regional or subregional cooperation.

Opportunistic macroalgae of benthic habitats

D5C6 — Secondary:

The abundance of opportunistic macroalgae is not at levels that indicate adverse effects of nutrient enrichment.

The threshold values are as follows:

(a)

in coastal waters, the values set in accordance with Directive 2000/60/EC;

(b)

should this criterion be relevant for waters beyond coastal waters, values consistent with those for coastal waters under Directive 2000/60/EC. Member States shall establish those values through regional or subregional cooperation.

Macrophyte communities (perennial seaweeds and seagrasses such as fucoids, eelgrass and Neptune grass) of benthic habitats

D5C7 — Secondary:

The species composition and relative abundance or depth distribution of macrophyte communities achieve values that indicate there is no adverse effect due to nutrient enrichment including via a decrease in water transparency, as follows:

(a)

in coastal waters, the values set in accordance with Directive 2000/60/EC;

(b)

should this criterion be relevant for waters beyond coastal waters, values consistent with those for coastal waters under Directive 2000/60/EC. Member States shall establish those values through regional or subregional cooperation.

Macrofaunal communities of benthic habitats

D5C8 — Secondary (except when used as a substitute for D5C5):

The species composition and relative abundance of macrofaunal communities, achieve values that indicate that there is no adverse effect due to nutrient and organic enrichment, as follows:

(a)

in coastal waters, the values for benthic biological quality elements set in accordance with Directive 2000/60/EC;

(b)

beyond coastal waters, values consistent with those for coastal waters under Directive 2000/60/EC. Member States shall establish those values through regional or subregional cooperation.

Specifications and standardised methods for monitoring and assessment

1.

In coastal waters, the criteria elements shall be selected in accordance with Directive 2000/60/EC.

2.

For D5C2 and D5C3, Member States may in addition use phytoplankton species composition and abundance.

3.

Information on the pathways (atmospheric, land- or sea-based) for nutrients entering the marine environment shall be collected, where feasible.

4.

Monitoring beyond coastal waters may not be necessary due to low risk, such as in cases where the threshold values are achieved in coastal waters, taking into account nutrient input from atmospheric, sea-based including coastal waters, and transboundary sources.

5.

Assessments under Directive 2000/60/EC shall be used for the assessments of each criterion in coastal waters.

6.

Values set in accordance with Directive 2000/60/EC shall refer either to those set by intercalibration under Commission Decision 2013/480/EU (6) or to those set in national legislation in accordance with Article 8 and Annex V of Directive 2000/60/EC. These shall be understood as the ‘Good-Moderate boundary’ for Ecological Quality Ratios.

7.

Species composition shall be understood to refer to the lowest taxonomic level appropriate for the assessment.

Units of measurement for the criteria:

D5C1: nutrient concentrations in micromoles per litre (μmol/l),

D5C2: chlorophyll a concentrations (biomass) in micrograms per litre (μg/l),

D5C3: bloom events as number of events, duration in days and spatial extent in square kilometres (km2) per year,

D5C4: photic limit as depth in metres (m),

D5C5: oxygen concentration in the bottom of the water column in milligrams per litre (mg/l),

D5C6: Ecological Quality Ratio for macroalgal abundance or spatial cover. Extent of adverse effects in square kilometres (km2) or as a proportion (percentage) of the assessment area,

D5C7: Ecological Quality Ratio for species composition and relative abundance assessments or for maximum depth of macrophyte growth. Extent of adverse effects in square kilometres (km2) or as a proportion (percentage) of the assessment area,

D5C8: Ecological Quality Ratio for species composition and relative abundance assessments. Extent of adverse effects in square kilometres (km2) or as a proportion (percentage) of the assessment area.

Where available, Member States shall use the units or ecological quality ratios provided for under Directive 2000/60/EC.

Descriptor 6

Sea-floor integrity is at a level that ensures that the structure and functions of the ecosystems are safeguarded and benthic ecosystems, in particular, are not adversely affected

Relevant pressures: Physical loss (due to permanent change of seabed substrate or morphology and to extraction of seabed substrate); physical disturbance to seabed (temporary or reversible)

Criteria, including criteria elements, and methodological standards

Criteria elements

Criteria

Methodological standards

Physical loss of the seabed (including intertidal areas).

D6C1 — Primary:

Spatial extent and distribution of physical loss (permanent change) of the natural seabed.

Scale of assessment:

As used for assessment of the benthic broad habitat types under Descriptors 1 and 6.

Use of criteria:

The outcomes of assessment of criterion D6C1 (the distribution and an estimate of the extent of physical loss) shall be used to assess criteria D6C4 and D7C1.

The outcomes of assessment of criterion D6C2 (the distribution and an estimate of the extent of physical disturbance pressures) shall be used to assess criterion D6C3.

The outcomes of assessment of criterion D6C3 (an estimate of the extent of adverse effect by physical disturbance per habitat type in each assessment area) shall contribute to the assessment of criterion D6C5.

Physical disturbance to the seabed (including intertidal areas).

D6C2 — Primary:

Spatial extent and distribution of physical disturbance pressures on the seabed.

Benthic broad habitat types or other habitat types, as used under Descriptors 1 and 6.

D6C3 — Primary:

Spatial extent of each habitat type which is adversely affected, through change in its biotic and abiotic structure and its functions (e.g. through changes in species composition and their relative abundance, absence of particularly sensitive or fragile species or species providing a key function, size structure of species), by physical disturbance.

Member States shall establish threshold values for the adverse effects of physical disturbance, through regional or subregional cooperation.

Criteria D6C1, D6C2 and D6C3 relate only to the pressures ‘physical loss’ and ‘physical disturbance’ and their impacts, whilst criteria D6C4 and D6C5 address the overall assessment of Descriptor 6, together with that for benthic habitats under Descriptor 1. Criteria D6C4 and D6C5 are presented under Part II of this Annex.

Specifications and standardised methods for monitoring and assessment

1.

Regarding methods for monitoring:

(a)

for D6C1, permanent changes to the seabed from different human activities shall be assessed (including permanent changes to natural seabed substrate or morphology via physical restructuring, infrastructure developments and loss of substrate via extraction of the seabed materials);

(b)

for D6C2, physical disturbances from different human activities shall be assessed (such as bottom-trawling fishing);

(c)

for coastal waters, the hydromorphology data and relevant assessments under Directive 2000/60/EC shall be used. Beyond coastal waters, data may be collated from mapping of infrastructure and licensed extraction sites.

2.

Regarding methods for assessment, the data shall be aggregated so that:

(a)

D6C1 is assessed as area lost in relation to total natural extent of all benthic habitats in the assessment area (e.g. by extent of anthropogenic modification);

(b)

D6C3 is assessed in relation to total natural extent of each benthic habitat type assessed.

3.

Physical loss shall be understood as a permanent change to the seabed which has lasted or is expected to last for a period of two reporting cycles (12 years) or more.

4.

Physical disturbance shall be understood as a change to the seabed from which it can recover if the activity causing the disturbance pressure ceases.

5.

For D6C3 species composition shall be understood to refer to the lowest taxonomic level appropriate for the assessment.

Units of measurement for the criteria:

D6C1: extent of the assessment area physically lost in square kilometres (km2),

D6C2: extent of the assessment area physically disturbed in square kilometres (km2),

D6C3: extent of each habitat type adversely affected in square kilometres (km2) or as a proportion (percentage) of the total natural extent of the habitat in the assessment area.

Descriptor 7

Permanent alteration of hydrographical conditions does not adversely affect marine ecosystems

Relevant pressures: Physical loss (due to permanent change of seabed substrate or morphology or to extraction of seabed substrate); Changes to hydrological conditions

Criteria, including criteria elements, and methodological standards

Criteria elements

Criteria

Methodological standards

Hydrographical changes to the seabed and water column (including intertidal areas).

D7C1 — Secondary:

Spatial extent and distribution of permanent alteration of hydrographical conditions (e.g. changes in wave action, currents, salinity, temperature) to the seabed and water column, associated in particular with physical loss (7) of the natural seabed.

Scale of assessment:

As used for assessment of the benthic broad habitat types under Descriptors 1 and 6.

Use of criteria:

The outcomes of assessment of criterion D7C1 (the distribution and an estimate of the extent of hydrographical changes) shall be used to assess criterion D7C2.

The outcomes of assessment of criterion D7C2 (an estimate of the extent of adverse effect per habitat type in each assessment area) shall contribute to the assessment of criterion D6C5.

Benthic broad habitats types or other habitat types, as used for Descriptors 1 and 6.

D7C2 — Secondary:

Spatial extent of each benthic habitat type adversely affected (physical and hydrographical characteristics and associated biological communities) due to permanent alteration of hydrographical conditions.

Member States shall establish threshold values for the adverse effects of permanent alterations of hydrographical conditions, through regional or subregional cooperation.

Specifications and standardised methods for monitoring and assessment

1.

Regarding methods for monitoring and assessment:

(a)

Monitoring shall focus on changes associated with infrastructure developments, either on the coast or offshore.

(b)

Environmental impact assessment hydrodynamic models, where required, which are validated with ground-truth measurements, or other suitable sources of information, shall be used to assess the extent of effects from each infrastructure development.

(c)

For coastal waters, the hydromorphology data and relevant assessments under Directive 2000/60/EC shall be used.

2.

Regarding methods for assessment, the data shall be aggregated so that:

(a)

D7C1 is assessed in relation to total natural extent of all habitats in the assessment area;

(b)

D7C2 is assessed in relation to total natural extent of each benthic habitat type assessed.

Units of measurement for the criteria:

D7C1: extent of the assessment area hydrographically altered in square kilometres (km2),

D7C2: extent of each habitat type adversely affected in square kilometres (km2) or as a proportion (percentage) of the total natural extent of the habitat in the assessment area.

Descriptor 8

Concentrations of contaminants are at levels not giving rise to pollution effects

Relevant pressures: Input of other substances (e.g. synthetic substances, non-synthetic substances, radionuclides)

Criteria, including criteria elements, and methodological standards

Criteria elements

Criteria

Methodological standards

(1)

Within coastal and territorial waters:

(a)

contaminants selected in accordance with Directive 2000/60/EC:

(i)

contaminants for which an environmental quality standard is laid down in Part A of Annex I to Directive 2008/105/EC;

(ii)

River Basin Specific Pollutants under Annex VIII to Directive 2000/60/EC, in coastal waters;

(b)

additional contaminants, if relevant, such as from offshore sources, which are not already identified under point (a) and which may give rise to pollution effects in the region or subregion. Member States shall establish that list of contaminants through regional or subregional cooperation.

(2)

Beyond territorial waters:

(a)

the contaminants considered under point (1), where these still may give rise to pollution effects;

(b)

additional contaminants, if relevant, which are not already identified under point (2)(a) and which may give rise to pollution effects in the region or subregion. Member States shall establish that list of contaminants through regional or subregional cooperation.

D8C1 — Primary:

Within coastal and territorial waters, the concentrations of contaminants do not exceed the following threshold values:

(a)

for contaminants set out under point 1(a) of criteria elements, the values set in accordance with Directive 2000/60/EC;

(b)

when contaminants under point (a) are measured in a matrix for which no value is set under Directive 2000/60/EC, the concentration of those contaminants in that matrix established by Member States through regional or subregional cooperation;

(c)

for additional contaminants selected under point 1(b) of criteria elements, the concentrations for a specified matrix (water, sediment or biota) which may give rise to pollution effects. Member States shall establish these concentrations through regional or subregional cooperation, considering their application within and beyond coastal and territorial waters.

Beyond territorial waters, the concentrations of contaminants do not exceed the following threshold values:

(a)

for contaminants selected under point 2(a) of criteria elements, the values as applicable within coastal and territorial waters;

(b)

for contaminants selected under point 2(b) of criteria elements, the concentrations for a specified matrix (water, sediment or biota) which may give rise to pollution effects. Member States shall establish these concentrations through regional or subregional cooperation.

Scale of assessment:

within coastal and territorial waters, as used under Directive 2000/60/EC,

beyond territorial waters, subdivisions of the region or subregion, divided where needed by national boundaries.

Use of criteria:

The extent to which good environmental status has been achieved shall be expressed for each area assessed as follows:

(a)

for each contaminant under criterion D8C1, its concentration, the matrix used (water, sediment, biota), whether the threshold values set have been achieved, and the proportion of contaminants assessed which have achieved the threshold values, including indicating separately substances behaving like ubiquitous persistent, bioaccumulative and toxic substances (uPBTs), as referred to in Article 8a(1)(a) of Directive 2008/105/EC;

(b)

for each species assessed under criterion D8C2, an estimate of the abundance of its population in the assessment area that is adversely affected;

(c)

for each habitat assessed under criterion D8C2, an estimate of the extent in the assessment area that is adversely affected.

The use of criterion D8C2 in the overall assessment of good environmental status for Descriptor 8 shall be agreed at regional or subregional level.

The outcomes of the assessment of criterion D8C2 shall contribute to assessments under Descriptors 1 and 6, where appropriate.

Species and habitats which are at risk from contaminants.

Member States shall establish that list of species, and relevant tissues to be assessed, and habitats, through regional or subregional cooperation.

D8C2 — Secondary:

The health of species and the condition of habitats (such as their species composition and relative abundance at locations of chronic pollution) are not adversely affected due to contaminants including cumulative and synergetic effects.

Member States shall establish those adverse effects and their threshold values through regional or subregional cooperation.

Significant acute pollution events involving polluting substances, as defined in Article 2(2) of Directive 2005/35/EC of the European Parliament and of the Council (8), including crude oil and similar compounds.

D8C3 — Primary:

The spatial extent and duration of significant acute pollution events are minimised.

Scale of assessment:

Regional or subregional level, divided where needed by national boundaries.

Use of criteria:

The extent to which good environmental status has been achieved shall be expressed for each area assessed as follows:

an estimate of the total spatial extent of significant acute pollution events and their distribution and total duration for each year.

This criterion shall be used to trigger assessment of criterion D8C4.

Species of the species groups, as listed under Table 1 of Part II, and benthic broad habitat types, as listed under Table 2 of Part II.

D8C4 — Secondary (to be used when a significant acute pollution event has occurred):

The adverse effects of significant acute pollution events on the health of species and on the condition of habitats (such as their species composition and relative abundance) are minimised and, where possible, eliminated.

Scale of assessment:

As used for assessment of the species groups or benthic broad habitat types under Descriptors 1 and 6.

Use of criteria:

The outcomes of assessment of criterion D8C4 shall contribute, where the cumulative spatial and temporal effects are significant, to the assessments under Descriptors 1 and 6 by providing:

(a)

an estimate of the abundance of each species that is adversely affected;

(b)

an estimate of the extent of each broad habitat type that is adversely affected.

The use of criterion D8C4 in the overall assessment of good environmental status for Descriptor 8 shall be agreed at regional or subregional level.

Specifications and standardised methods for monitoring and assessment

1.

For criteria elements under D8C1, the selection under points 1(b) and 2(b) of additional contaminants that may give rise to pollution effects shall be based on a risk assessment. For these contaminants, the matrix and threshold values used for the assessment shall be representative of the most sensitive species and exposure pathway, including hazards to human health via exposure through the food chain.

2.

For the purposes of this Decision:

(a)

Criterion D8C1: for the assessment of contaminants in coastal and territorial waters, Member States shall monitor the contaminants in accordance with the requirements of Directive 2000/60/EC and the assessments under that Directive shall be used where available. Information on the pathways (atmospheric, land- or sea-based) for contaminants entering the marine environment shall be collected, where feasible.

(b)

Criteria D8C2 and D8C4: biomarkers or population demographic characteristics (e.g. fecundity rates, survival rates, mortality rates, and reproductive capacity) may be relevant to assess the health effects.

(c)

Criteria D8C3 and D8C4: for the purposes of this Decision, monitoring is established as needed once the acute pollution event has occurred, rather than being part of a regular monitoring programme under Article 11 of Directive 2008/56/EC.

(d)

Criterion D8C3: Member States shall identify the source of significant acute pollution events, where possible. They may use the European Maritime Safety Agency satellite-based surveillance for this purpose.

3.

Contaminants shall be understood to refer to single substances or to groups of substances. For consistency in reporting, the grouping of substances shall be agreed at Union level.

4.

Species composition shall be understood to refer to the lowest taxonomic level appropriate for the assessment.

Units of measurement for the criteria:

D8C1: concentrations of contaminants in micrograms per litre (μg/l) for water, in micrograms per kilogram (μg/kg) of dry weight for sediment and in micrograms per kilogram (μg/kg) of wet weight for biota,

D8C2: abundance (number of individuals or other suitable units as agreed at regional or subregional level) per species affected; extent in square kilometres (km2) per broad habitat type affected,

D8C3: duration in days and spatial extent in square kilometres (km2) of significant acute pollution events per year,

D8C4: abundance (number of individuals or other suitable units as agreed at regional or subregional level) per species affected; extent in square kilometres (km2) per broad habitat type affected.

Descriptor 9

Contaminants in fish and other seafood for human consumption do not exceed levels established by Union legislation or other relevant standards

Relevant pressure: Input of hazardous substances

Criteria, including criteria elements, and methodological standards

Criteria elements

Criteria

Methodological standards

Contaminants listed in Regulation (EC) No 1881/2006.

For the purposes of this Decision, Member States may decide not to consider contaminants from Regulation (EC) No 1881/2006 where justified on the basis of a risk assessment.

Member States may assess additional contaminants that are not included in Regulation (EC) No 1881/2006. Member States shall establish a list of those additional contaminants through regional or subregional cooperation.

Member States shall establish the list of species and relevant tissues to be assessed, according to the conditions laid down under ‘specifications’. They may cooperate at regional or subregional level to establish that list of species and relevant tissues.

D9C1 — Primary:

The level of contaminants in edible tissues (muscle, liver, roe, flesh or other soft parts, as appropriate) of seafood (including fish, crustaceans, molluscs, echinoderms, seaweed and other marine plants) caught or harvested in the wild (excluding fin-fish from mariculture) does not exceed:

(a)

for contaminants listed in Regulation (EC) No 1881/2006, the maximum levels laid down in that Regulation, which are the threshold values for the purposes of this Decision;

(b)

for additional contaminants, not listed in Regulation (EC) No 1881/2006, threshold values, which Member States shall establish through regional or subregional cooperation.

Scale of assessment:

The catch or production area in accordance with Article 38 of Regulation (EU) No 1379/2013 of the European Parliament and of the Council (9).

Use of criteria:

The extent to which good environmental status has been achieved shall be expressed for each area assessed as follows:

for each contaminant, its concentration in seafood, the matrix used (species and tissue), whether the threshold values set have been achieved, and the proportion of contaminants assessed which have achieved their threshold values.

Specifications and standardised methods for monitoring and assessment

1.

When Member States establish the list of species to be used under D9C1, the species shall:

(a)

be relevant to the marine region or subregion concerned;

(b)

fall under the scope of Regulation (EC) No 1881/2006;

(c)

be suitable for the contaminant being assessed;

(d)

be among the most consumed in the Member State or the most caught or harvested for consumption.

2.

Exceedance of the standard set for a contaminant shall lead to subsequent monitoring to determine the persistence of the contamination in the area and species sampled. Monitoring shall continue until there is sufficient evidence that there is no risk of failure.

3.

For the purposes of this Decision, the sampling for the assessment of the maximum levels of contaminants shall be performed in accordance with Article 11 of Regulation (EC) No 882/2004 of the European Parliament and of the Council (10) and with Commission Regulation (EU) No 589/2014 (11) and Commission Regulation (EC) No 333/2007 (12).

4.

Within each region or subregion, Member States shall ensure that the temporal and geographical scope of sampling is adequate to provide a representative sample of the specified contaminants in seafood in the marine region or subregion.

Units of measurement for the criteria:

D9C1: concentrations of contaminants in the units set out in the Annex to Regulation (EC) No 1881/2006.

Descriptor 10

Properties and quantities of marine litter do not cause harm to the coastal and marine environment

Relevant pressure: Input of litter

Criteria, including criteria elements, and methodological standards

Criteria elements

Criteria

Methodological standards

Litter (excluding micro-litter), classified in the following categories (13): artificial polymer materials, rubber, cloth/textile, paper/cardboard, processed/worked wood, metal, glass/ceramics, chemicals, undefined, and food waste.

Member States may define further sub-categories.

D10C1 — Primary:

The composition, amount and spatial distribution of litter on the coastline, in the surface layer of the water column, and on the seabed, are at levels that do not cause harm to the coastal and marine environment.

Member States shall establish threshold values for these levels through cooperation at Union level, taking into account regional or subregional specificities.

Scale of assessment:

Subdivisions of the region or subregion, divided where needed by national boundaries.

Use of criteria:

The extent to which good environmental status has been achieved shall be expressed for each criterion separately for each area assessed as follows:

(a)

the outcomes for each criterion (amount of litter or micro-litter per category) and its distribution per matrix used under D10C1 and D10C2 and whether the threshold values set have been achieved;

(b)

the outcomes for D10C3 (amount of litter and micro-litter per category per species) and whether the threshold values set have been achieved.

The use of criteria D10C1, D10C2 and D10C3 in the overall assessment of good environmental status for Descriptor 10 shall be agreed at Union level.

The outcomes of criterion D10C3 shall also contribute to assessments under Descriptor 1, where appropriate.

Micro-litter (particles < 5mm), classified in the categories ‘artificial polymer materials’ and ‘other’.

D10C2 — Primary:

The composition, amount and spatial distribution of micro-litter on the coastline, in the surface layer of the water column, and in seabed sediment, are at levels that do not cause harm to the coastal and marine environment.

Member States shall establish threshold values for these levels through cooperation at Union level, taking into account regional or subregional specificities.

Litter and micro-litter classified in the categories ‘artificial polymer materials’ and ‘other’, assessed in any species from the following groups: birds, mammals, reptiles, fish or invertebrates.

Member States shall establish that list of species to be assessed through regional or subregional cooperation.

D10C3 — Secondary:

The amount of litter and micro-litter ingested by marine animals is at a level that does not adversely affect the health of the species concerned.

Member States shall establish threshold values for these levels through regional or subregional cooperation.

Species of birds, mammals, reptiles, fish or invertebrates which are at risk from litter.

Member States shall establish that list of species to be assessed through regional or subregional cooperation.

D10C4 — Secondary:

The number of individuals of each species which are adversely affected due to litter, such as by entanglement, other types of injury or mortality, or health effects.

Member States shall establish threshold values for the adverse effects of litter, through regional or subregional cooperation.

Scale of assessment:

As used for assessment of the species group under Descriptor 1.

Use of criteria:

The extent to which good environmental status has been achieved shall be expressed for each area assessed as follows:

for each species assessed under criterion D10C4, an estimate of the number of individuals in the assessment area that have been adversely affected.

The use of criterion D10C4 in the overall assessment of good environmental status for Descriptor 10 shall be agreed at Union level.

The outcomes of this criterion shall also contribute to assessments under Descriptor 1, where appropriate.

Specifications and standardised methods for monitoring and assessment

1.

For D10C1: litter shall be monitored on the coastline and may additionally be monitored in the surface layer of the water column and on the seabed. Information on the source and pathway of the litter shall be collected, where feasible;

2.

For D10C2: micro-litter shall be monitored in the surface layer of the water column and in the seabed sediment and may additionally be monitored on the coastline. Micro-litter shall be monitored in a manner that can be related to point-sources for inputs (such as harbours, marinas, waste-water treatment plants, storm-water effluents), where feasible.

3.

For D10C3 and D10C4: the monitoring may be based on incidental occurrences (e.g. strandings of dead animals, entangled animals in breeding colonies, affected individuals per survey).

Units of measurement for the criteria:

D10C1: amount of litter per category in number of items:

per 100 metres (m) on the coastline,

per square kilometre (km2) for surface layer of the water column and for seabed,

D10C2: amount of micro-litter per category in number of items and weight in grams (g):

per square metre (m2) for surface layer of the water column,

per kilogram (dry weight) (kg) of sediment for the coastline and for seabed,

D10C3: amount of litter/micro-litter in grams (g) and number of items per individual for each species in relation to size (weight or length, as appropriate) of the individual sampled,

D10C4: number of individuals affected (lethal; sub-lethal) per species.

Descriptor 11

Introduction of energy, including underwater noise, is at levels that do not adversely affect the marine environment

Relevant pressures: Input of anthropogenic sound; Input of other forms of energy

Criteria, including criteria elements, and methodological standards

Criteria elements

Criteria

Methodological standards

Anthropogenic impulsive sound in water.

D11C1 — Primary:

The spatial distribution, temporal extent, and levels of anthropogenic impulsive sound sources do not exceed levels that adversely affect populations of marine animals.

Member States shall establish threshold values for these levels through cooperation at Union level, taking into account regional or subregional specificities.

Scale of assessment:

Region, subregion or subdivisions.

Use of criteria:

The extent to which good environmental status has been achieved shall be expressed for each area assessed as follows:

(a)

for D11C1, the duration per calendar year of impulsive sound sources, their distribution within the year and spatially within the assessment area, and whether the threshold values set have been achieved;

(b)

for D11C2, the annual average of the sound level, or other suitable temporal metric agreed at regional or subregional level, per unit area and its spatial distribution within the assessment area, and the extent (%, km2) of the assessment area over which the threshold values set have been achieved.

The use of criteria D11C1 and D11C2 in the assessment of good environmental status for Descriptor 11 shall be agreed at Union level.

The outcomes of these criteria shall also contribute to assessments under Descriptor 1.

Anthropogenic continuous low-frequency sound in water.

D11C2 — Primary:

The spatial distribution, temporal extent and levels of anthropogenic continuous low-frequency sound do not exceed levels that adversely affect populations of marine animals.

Member States shall establish threshold values for these levels through cooperation at Union level, taking into account regional or subregional specificities.

Specifications and standardised methods for monitoring and assessment

1.

For D11C1 monitoring:

(a)

Spatial resolution: geographical locations whose shape and areas are to be determined at regional or subregional level, on the basis of, for instance, activities listed in Annex III to Directive 2008/56/EC.

(b)

Impulsive sound described as monopole energy source level in units of dB re 1 μΡa2 s or zero to peak monopole source level in units of dB re 1μΡa m, both over the frequency band 10 Hz to 10 kHz. Member States may consider other specific sources with higher frequency bands if longer-range effects are considered relevant.

2.

For D11C2 monitoring:

Annual average, or other suitable metric agreed at regional or subregional level, of the squared sound pressure in each of two ‘1/3-octave bands’, one centred at 63 Hz and the other at 125 Hz, expressed as a level in decibels in units of dB re 1 μΡa, at a suitable spatial resolution in relation to the pressure. This may be measured directly, or inferred from a model used to interpolate between, or extrapolated from, measurements. Member States may also decide at regional or subregional level to monitor for additional frequency bands.

Criteria relating to other forms of energy input (including thermal energy, electromagnetic fields and light) and criteria relating to the environmental impacts of noise are still subject to further development.

Units of measurement for the criteria:

D11C1: Number of days per quarter (or per month if appropriate) with impulsive sound sources; proportion (percentage) of unit areas or extent in square kilometres (km2) of assessment area with impulsive sound sources per year,

D11C2: Annual average (or other temporal metric) of continuous sound level per unit area; proportion (percentage) or extent in square kilometres (km2) of assessment area with sound levels exceeding threshold values.

PART II

Criteria and methodological standards, specifications and standardised methods for monitoring and assessment of essential features and characteristics and current environmental status of marine waters under point (a) of Article 8(1) of Directive 2008/56/EC

Part II considers the descriptors linked to the relevant ecosystem elements: species groups of birds, mammals, reptiles, fish and cephalopods (Descriptor 1), pelagic habitats (Descriptor 1), benthic habitats (Descriptors 1 and 6) and ecosystems, including food webs (Descriptors 1 and 4), as listed in Annex III to Directive 2008/56/EC (14).

Theme

Species groups of birds, mammals, reptiles, fish and cephalopods (relating to Descriptor 1)

Criteria, including criteria elements, and methodological standards

Criteria elements

Criteria

Methodological standards

Species of birds, mammals, reptiles and non-commercially-exploited species of fish and cephalopods, which are at risk from incidental by-catch in the region or subregion.

Member States shall establish that list of species through regional or subregional cooperation, pursuant to the obligations laid down in Article 25(5) of Regulation (EU) No 1380/2013 for data collection activities and taking into account the list of species in Table 1D of the Annex to Commission Implementing Decision (EU) 2016/1251 (15).

D1C1 — Primary:

The mortality rate per species from incidental by-catch is below levels which threaten the species, such that its long-term viability is ensured.

Member States shall establish the threshold values for the mortality rate from incidental by-catch per species, through regional or subregional cooperation.

Scale of assessment:

As used for assessment of the corresponding species or species groups under criteria D1C2-D1C5.

Use of criteria:

The extent to which good environmental status has been achieved shall be expressed for each area assessed as follows:

the mortality rate per species and whether this has achieved the threshold value set.

This criterion shall contribute to assessment of the corresponding species under criterion D1C2.

Species groups, as listed under Table 1 and if present in the region or subregion.

Member States shall establish a set of species representative of each species group, selected according to the criteria laid down under ‘specifications for the selection of species and habitats’, through regional or subregional cooperation. These shall include the mammals and reptiles listed in Annex II to Directive 92/43/EEC and may include any other species, such as those listed under Union legislation (other Annexes to Directive 92/43/EEC, Directive 2009/147/EC or through Regulation (EU) No 1380/2013) and international agreements such as Regional Sea Conventions.

D1C2 — Primary:

The population abundance of the species is not adversely affected due to anthropogenic pressures, such that its long-term viability is ensured.

Member States shall establish threshold values for each species through regional or subregional cooperation, taking account of natural variation in population size and the mortality rates derived from D1C1, D8C4 and D10C4 and other relevant pressures. For species covered by Directive 92/43/EEC, these values shall be consistent with the Favourable Reference Population values established by the relevant Member States under Directive 92/43/EEC.

Scale of assessment:

Ecologically-relevant scales for each species group shall be used, as follows:

for deep-diving toothed cetaceans, baleen whales, deep-sea fish: region,

for birds, small toothed cetaceans, pelagic and demersal shelf fish: region or subdivisions for Baltic Sea and Black Sea; subregion for North-East Atlantic Ocean and Mediterranean Sea,

for seals, turtles, cephalopods: region or subdivisions for Baltic Sea; subregion for North-East Atlantic Ocean and Mediterranean Sea,

for coastal fish: subdivision of region or subregion,

for commercially-exploited fish and cephalopods: as used under Descriptor 3.

Use of criteria:

The status of each species shall be assessed individually, on the basis of the criteria selected for use, and these shall be used to express the extent to which good environmental status has been achieved for each species group for each area assessed, as follows:

(a)

the assessments shall express the value(s) for each criterion used per species and whether these achieve the threshold values set;

(b)

the overall status of species covered by Directive 92/43/EEC shall be derived using the method provided under that Directive. The overall status for commercially-exploited species shall be as assessed under Descriptor 3. For other species, the overall status shall be derived using a method agreed at Union level, taking into account regional or subregional specificities;

(c)

the overall status of the species group, using a method agreed at Union level, taking into account regional or subregional specificities.

D1C3 — Primary for commercially-exploited fish and cephalopods and secondary for other species:

The population demographic characteristics (e.g. body size or age class structure, sex ratio, fecundity, and survival rates) of the species are indicative of a healthy population which is not adversely affected due to anthropogenic pressures.

Member States shall establish threshold values for specified characteristics of each species through regional or subregional cooperation, taking account of adverse effects on their health derived from D8C2, D8C4 and other relevant pressures.

D1C4 — Primary for species covered by Annexes II, IV or V to Directive 92/43/EEC and secondary for other species:

The species distributional range and, where relevant, pattern is in line with prevailing physiographic, geographic and climatic conditions.

Member States shall establish threshold values for each species through regional or subregional cooperation. For species covered by Directive 92/43/EEC, these shall be consistent with the Favourable Reference Range values established by the relevant Member States under Directive 92/43/EEC.

D1C5 — Primary for species covered by Annexes II, IV and V to Directive 92/43/EEC and secondary for other species:

The habitat for the species has the necessary extent and condition to support the different stages in the life history of the species.

Criteria elements

Table 1

Species groups  (16)

Ecosystem component

Species groups

Birds

Grazing birds

Wading birds

Surface-feeding birds

Pelagic-feeding birds

Benthic-feeding birds

Mammals

Small toothed cetaceans

Deep-diving toothed cetaceans

Baleen whales

Seals

Reptiles

Turtles

Fish

Coastal fish

Pelagic shelf fish

Demersal shelf fish

Deep-sea fish

Cephalopods

Coastal/shelf cephalopods

Deep-sea cephalopods

Specifications and standardised methods for monitoring and assessment relating to theme ‘Species groups of marine birds, mammals, reptiles, fish and cephalopods’

1.

For D1C1, data shall be provided per species per fishing metier for each ICES area or GFCM Geographical Sub-Area or FAO fishing areas for the Macaronesian biogeographic region, to enable its aggregation to the relevant scale for the species concerned, and to identify the particular fisheries and fishing gear most contributing to incidental catches for each species.

2.

‘Coastal’ shall be understood on the basis of physical, hydrological and ecological parameters and is not limited to coastal water as defined in Article 2(7) of Directive 2000/60/EC.

3.

Species may be assessed at population level, where appropriate.

4.

Wherever possible, the assessments under Directive 92/43/EEC, Directive 2009/147/EC and Regulation (EU) No 1380/2013 shall be used for the purposes of this Decision:

(a)

for birds, criteria D1C2 and D1C4 equate to the ‘population size’ and ‘breeding distribution map and range size’ criteria of Directive 2009/147/EC;

(b)

for mammals, reptiles and non-commercial fish, the criteria are equivalent to those used under Directive 92/43/EEC as follows: D1C2 and D1C3 equate to ‘population’, D1C4 equates to ‘range’ and D1C5 equates to ‘habitat for the species’;

(c)

for commercially-exploited fish and cephalopods, assessments under Descriptor 3 shall be used for Descriptor 1 purposes, using criterion D3C2 for D1C2 and criterion D3C3 for D1C3.

5.

Assessments of the adverse effects from pressures under criteria D1C1, D2C3, D3C1, D8C2, D8C4 and D10C4, as well as the assessments of pressures under criteria D9C1, D10C3, D11C1 and D11C2, shall be taken into account in the assessments of species under Descriptor 1.

Units of measurement for the criteria:

D1C2: abundance (number of individuals or biomass in tonnes (t)) per species.

Theme

Pelagic habitats (relating to Descriptor 1)

Criteria, including criteria elements, and methodological standards

Criteria elements

Criteria

Methodological standards

Pelagic broad habitat types (variable salinity (17), coastal, shelf and oceanic/beyond shelf), if present in the region or subregion, and other habitat types as defined in the second paragraph.

Member States may select, through regional or subregional cooperation, additional habitat types according to the criteria laid down under ‘specifications for the selection of species and habitats’.

D1C6 — Primary:

The condition of the habitat type, including its biotic and abiotic structure and its functions (e.g. its typical species composition and their relative abundance, absence of particularly sensitive or fragile species or species providing a key function, size structure of species), is not adversely affected due to anthropogenic pressures.

Member States shall establish threshold values for the condition of each habitat type, ensuring compatibility with related values set under Descriptors 2, 5 and 8, through regional or subregional cooperation.

Scale of assessment:

Subdivision of region or subregion as used for assessments of benthic broad habitat types, reflecting biogeographic differences in species composition of the habitat type.

Use of criteria:

The extent to which good environmental status has been achieved shall be expressed for each area assessed as:

(a)

an estimate of the proportion and extent of each habitat type assessed that has achieved the threshold value set;

(b)

a list of broad habitat types in the assessment area that were not assessed.

Specifications and standardised methods for monitoring and assessment relating to theme ‘Pelagic habitats’

1.

‘Coastal’ shall be understood on the basis of physical, hydrological and ecological parameters and is not limited to coastal water as defined in Article 2(7) of Directive 2000/60/EC.

2.

Assessments of the adverse effects from pressures, including under D2C3, D5C2, D5C3, D5C4, D7C1, D8C2 and D8C4, shall be taken into account in the assessments of pelagic habitats under Descriptor 1.

Units of measurement for the criteria:

D1C6: extent of habitat adversely affected in square kilometres (km2) and as a proportion (percentage) of the total extent of the habitat type.

Theme

Benthic habitats (relating to Descriptors 1 and 6)

Criteria, including criteria elements, and methodological standards

Criteria elements

Criteria

Methodological standards

Refer to Part I of this Annex for criteria D6C1, D6C2 and D6C3.

Benthic broad habitat types as listed in Table 2 and if present in the region or subregion, and other habitat types as defined in the second paragraph.

Member States may select, through regional or subregional cooperation, additional habitat types, according to the criteria laid down under ‘specifications for the selection of species and habitats’, and which may include habitat types listed under Directive 92/43/EEC or international agreements such as Regional Sea Conventions, for the purposes of:

(a)

assessing each broad habitat type under criterion D6C5;

(b)

assessing these habitat types.

A single set of habitat types shall serve the purpose of assessments of both benthic habitats under Descriptor 1 and sea-floor integrity under Descriptor 6.

D6C4 — Primary:

The extent of loss of the habitat type, resulting from anthropogenic pressures, does not exceed a specified proportion of the natural extent of the habitat type in the assessment area.

Member States shall establish the maximum allowable extent of habitat loss as a proportion of the total natural extent of the habitat type, through cooperation at Union level, taking into account regional or subregional specificities.

Scale of assessment:

Subdivision of region or subregion, reflecting biogeographic differences in species composition of the broad habitat type.

Use of criteria:

A single assessment per habitat type, using criteria D6C4 and D6C5, shall serve the purpose of assessments of both benthic habitats under Descriptor 1 and sea-floor integrity under Descriptor 6.

The extent to which good environmental status has been achieved shall be expressed for each area assessed as:

(a)

for D6C4, an estimate of the proportion and extent of loss per habitat type and whether this has achieved the extent value set;

(b)

for D6C5, an estimate of the proportion and extent of adverse effects, including the proportion lost from point (a), per habitat type and whether this has achieved the extent value set;

(c)

overall status of the habitat type, using a method agreed at Union level based on points (a) and (b), and a list of broad habitat types in the assessment area that were not assessed.

D6C5 — Primary:

The extent of adverse effects from anthropogenic pressures on the condition of the habitat type, including alteration to its biotic and abiotic structure and its functions (e.g. its typical species composition and their relative abundance, absence of particularly sensitive or fragile species or species providing a key function, size structure of species), does not exceed a specified proportion of the natural extent of the habitat type in the assessment area.

Member States shall establish threshold values for adverse effects on the condition of each habitat type, ensuring compatibility with related values set under Descriptors 2, 5, 6, 7 and 8, through cooperation at Union level, taking into account regional or subregional specificities.

Member States shall establish the maximum allowable extent of those adverse effects as a proportion of the total natural extent of the habitat type, through cooperation at Union level, taking into account regional or subregional specificities.

Criteria elements

Table 2

Benthic broad habitat types including their associated biological communities (relevant for criteria under Descriptors 1 and 6), which equate to one or more habitat types of the European nature information system (EUNIS) habitat classification  (18) . Updates to the EUNIS typology shall be reflected in the broad habitat types used for the purposes of Directive 2008/56/EC and of this Decision

Ecosystem component

Broad habitat types

Relevant EUNIS habitat codes (version 2016)

Benthic habitats

Littoral rock and biogenic reef

MA1, MA2

Littoral sediment

MA3, MA4, MA5, MA6

Infralittoral rock and biogenic reef

MB1, MB2

Infralittoral coarse sediment

MB3

Infralittoral mixed sediment

MB4

Infralittoral sand

MB5

Infralittoral mud

MB6

Circalittoral rock and biogenic reef

MC1, MC2

Circalittoral coarse sediment

MC3

Circalittoral mixed sediment

MC4

Circalittoral sand

MC5

Circalittoral mud

MC6

Offshore circalittoral rock and biogenic reef

MD1, MD2

Offshore circalittoral coarse sediment

MD3

Offshore circalittoral mixed sediment

MD4

Offshore circalittoral sand

MD5

Offshore circalittoral mud

MD6

Upper bathyal (19) rock and biogenic reef

ME1, ME2

Upper bathyal sediment

ME3, ME4, ME5, ME6

Lower bathyal rock and biogenic reef

MF1, MF2

Lower bathyal sediment

MF3, MF4, MF5, MF6

Abyssal

MG1, MG2, MG3, MG4, MG5, MG6

Specifications and standardised methods for monitoring and assessment relating to theme ‘Benthic habitats’

1.

The status of each habitat type shall be assessed using assessments (such as of sub-types of the broad habitat types) under Directive 92/43/EEC and Directive 2000/60/EC, wherever possible.

2.

Assessment of criterion D6C4 shall use the assessment made under criterion D6C1.

3.

Criteria D6C4 and D6C5 equate to the ‘range/area covered by habitat type within range’ and ‘specific structures and functions’ criteria of Directive 92/43/EEC.

4.

For D6C5, assessments of the adverse effects from pressures, including under criteria D2C3, D3C1, D3C2, D3C3, D5C4, D5C5, D5C6, D5C7, D5C8, D6C3, D7C2, D8C2 and D8C4, shall be taken into account.

5.

For D6C5, species composition shall be understood to refer to the lowest taxonomic level appropriate for the assessment.

Units of measurement for the criteria:

D6C4: extent of habitat loss in square kilometres (km2) and as a proportion (percentage) of the total extent of the habitat type,

D6C5: extent of habitat adversely affected in square kilometres (km2) and as a proportion (percentage) of the total extent of the habitat type.

Specifications for the selection of species and habitats under Themes ‘Species groups of marine birds, mammals, reptiles, fish and cephalopods’, ‘Pelagic habitats’ and ‘Benthic habitats’

The selection of species and habitats to be assigned to the species groups and pelagic and benthic broad habitat types shall be based on the following:

1.

Scientific criteria (ecological relevance):

(a)

representative of the ecosystem component (species group or broad habitat type), and of ecosystem functioning (e.g. connectivity between habitats and populations, completeness and integrity of essential habitats), being relevant for assessment of state/impacts, such as having a key functional role within the component (e.g. high or specific biodiversity, productivity, trophic link, specific resource or service) or particular life history traits (age and size at breeding, longevity, migratory traits);

(b)

relevant for assessment of a key anthropogenic pressure to which the ecosystem component is exposed, being sensitive to the pressure and exposed to it (vulnerable) in the assessment area;

(c)

present in sufficient numbers or extent in the assessment area to be able to construct a suitable indicator for assessment;

(d)

the set of species or habitats selected shall cover, as far as possible, the full range of ecological functions of the ecosystem component and the predominant pressures to which the component is subject;

(e)

if species of species groups are closely associated to a particular broad habitat type they may be included within that habitat type for monitoring and assessment purposes; in such cases, the species shall not be included in the assessment of the species group.

2.

Additional practical criteria (which shall not override the scientific criteria):

(a)

monitoring/technical feasibility;

(b)

monitoring costs;

(c)

adequate time series of the data.

The representative set of species and habitats to be assessed are likely to be specific to the region or subregion, although certain species may occur in several regions or subregions.

Theme

Ecosystems, including food webs (relating to Descriptors 1 and 4)

Criteria, including criteria elements, and methodological standards

Criteria elements

Criteria

Methodological standards

Trophic guilds of an ecosystem.

Member States shall establish the list of trophic guilds through regional or subregional cooperation.

D4C1 — Primary:

The diversity (species composition and their relative abundance) of the trophic guild is not adversely affected due to anthropogenic pressures.

Member States shall establish threshold values through regional or subregional cooperation.

Scale of assessment:

Regional level for Baltic Sea and Black Sea; subregional level for North-East Atlantic and Mediterranean Sea.

Subdivisions may be used where appropriate.

Use of criteria:

Where values do not fall within the threshold values, this may trigger further research and investigation to understand the causes for the failure.

D4C2 — Primary:

The balance of total abundance between the trophic guilds is not adversely affected due to anthropogenic pressures.

Member States shall establish threshold values through regional or subregional cooperation.

D4C3 — Secondary:

The size distribution of individuals across the trophic guild is not adversely affected due to anthropogenic pressures.

Member States shall establish threshold values through regional or subregional cooperation.

D4C4 — Secondary (to be used in support of criterion D4C2, where necessary):

Productivity of the trophic guild is not adversely affected due to anthropogenic pressures.

Member States shall establish threshold values through regional or subregional cooperation.

Specifications and standardised methods for monitoring and assessment

1.

Species composition shall be understood to refer to the lowest taxonomic level appropriate for the assessment.

2.

The trophic guilds selected under criteria elements shall take into account the ICES list of trophic guilds (20) and shall meet the following conditions:

(a)

include at least three trophic guilds;

(b)

two shall be non-fish trophic guilds;

(c)

at least one shall be a primary producer trophic guild;

(d)

preferably represent at least the top, middle and bottom of the food chain.

Units of measurement:

D4C2: total abundance (number of individuals or biomass in tonnes (t)) across all species within the trophic guild.


(1)  When this Decision refers to a ‘descriptor’, this refers to the relevant qualitative descriptors for determining good environmental status, as indicated under the numbered points in Annex I to Directive 2008/56/EC.

(2)  D3C2 and D3C3 are state-based criteria for commercially-exploited fish and shellfish but are shown under Part I for clarity reasons.

(3)  D3C3 may not be available for use for the 2018 review of the initial assessment and determination of good environmental status under Article 17(2)(a) of Directive 2008/56/EC.

(4)  Council Regulation (EC) No 199/2008 of 25 February 2008 concerning the establishment of a Community framework for the collection, management and use of data in the fisheries sector and support for scientific advice regarding the Common Fisheries Policy (OJ L 60, 5.3.2008, p. 1).

(5)  Guidance documents published in the context of the Common Implementation Strategy for Directive 2000/60/EC may be relevant in this assessment (e.g. ‘No 13 — Overall Approach to the Classification of Ecological Status and Ecological Potential’ and ‘No 23 — Eutrophication Assessment in the Context of European Water Policies’).

(6)  Commission Decision 2013/480/EU of 20 September 2013 establishing, pursuant to Directive 2000/60/EC of the European Parliament and of the Council, the values of the Member State monitoring system classifications as a result of the intercalibration exercise and repealing Decision 2008/915/EC (OJ L 266, 8.10.2013, p. 1).

(7)  Physical loss shall be understood as under point 3 of the specifications under Descriptor 6.

(8)  Directive 2005/35/EC of the European Parliament and of the Council of 7 September 2005 on ship-source pollution and on the introduction of penalties, including criminal penalties, for pollution offences (OJ L 255, 30.9.2005, p. 11).

(9)  Regulation (EU) No 1379/2013 of the European Parliament and of the Council of 11 December 2013 on the common organisation of the markets in fishery and aquaculture products, amending Council Regulations (EC) No 1184/2006 and (EC) No 1224/2009 and repealing Council Regulation (EC) No 104/2000 (OJ L 354, 28.12.2013, p. 1).

(10)  Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (OJ L 165, 30.4.2004, p. 1).

(11)  Commission Regulation (EU) No 589/2014 of 2 June 2014 laying down methods of sampling and analysis for the control of levels of dioxins, dioxin-like PCBs and non-dioxin-like PCBs in certain foodstuffs and repealing Regulation (EU) No 252/2012 (OJ L 164, 3.6.2014, p. 18).

(12)  Commission Regulation (EC) No 333/2007 of 28 March 2007 laying down the methods of sampling and analysis for the official control of the levels of lead, cadmium, mercury, inorganic tin, 3-MCPD and benzo(a)pyrene in foodstuffs (OJ L 88, 29.3.2007, p. 29).

(13)  These are the ‘Level 1 — Material’ categories from the Master List of categories of litter items from the Joint Research Centre ‘Guidance on Monitoring of marine litter in European seas’ (2013, ISBN 978-92-79-32709-4). The Master List specifies what is covered under each category, for instance ‘Chemicals’ refers to paraffin, wax, oil and tar.

(14)  Regulation (EC) No 199/2008 may be used for the collection of relevant fisheries-related data under Descriptors 1, 4 and 6.

(15)  Commission Implementing Decision (EU) 2016/1251 of 12 July 2016 adopting a multiannual Union programme for the collection, management and use of data in the fisheries and aquaculture sectors for the period 2017-2019 (OJ L 207, 1.8.2016, p. 113).

(16)  Relevant fisheries-related data should be used in application of Regulation (EC) No 199/2008.

(17)  Retained for situations where estuarine plumes extend beyond waters designated as Transitional Waters under Directive 2000/60/EC.

(18)  Evans, D. (2016). Revising the marine section of the EUNIS Habitat classification — Report of a workshop held at the European Topic Centre on Biological Diversity, 12 & 13 May 2016. ETC/BD Working Paper No A/2016.

(19)  Where not specifically defined in the EUNIS classification, the boundary between the upper bathyal and lower bathyal may be set as a specified depth limit.

(20)  ICES Advice (2015) Book 1, ICES special request advice, published 20 March 2015.


Corrigenda

18.5.2017   

EN

Official Journal of the European Union

L 125/75


Corrigendum to Commission Delegated Regulation (EU) 2015/1011 of 24 April 2015 supplementing Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Union and third countries in drug precursors, and repealing Commission Regulation (EC) No 1277/2005

( Official Journal of the European Union L 162 of 27 June 2015 )

On page 15, point (i) of the second subparagraph of Article 3(9):

for:

‘the date of expiry of validity where a term of validity has been fixed in accordance with Article 3(6) of this Regulation or in accordance with Article 3(5) of Regulation (EC) No 273/2004;’,

read:

‘the date of expiry of validity where a term of validity has been fixed in accordance with Article 3(7) of this Regulation or in accordance with Article 3(5) of Regulation (EC) No 273/2004;’.