Official Journal L115

Official Journal

L 115

of the European Union ★ ★ ★

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Volume 60

Legislation

English edition

4 May 2017

Contents

II

Non-legislative acts

INTERNATIONAL AGREEMENTS ★

Council Decision (EU) 2017/768 of 18 July 2016 on the signing, on behalf of the European Union and its Member States, and provisional application of a Protocol to the Euro-Mediterranean Agreement establishing an Association between the European Communities and their Member States, of the one part, and the Arab Republic of Egypt, of the other part, to take account of the accession of the Republic of Croatia to the European Union ............................

1

Protocol to the Euro-Mediterranean Agreement establishing an Association between the European Communities and their Member States, of the one part, and the Arab Republic of Egypt, of the other part, to take account of the accession of the Republic of Croatia to the European Union ................................

3

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Council Decision (EU) 2017/769 of 25 April 2017 on the ratification and accession by Member States, in the interest of the European Union, to the Protocol of 2010 to the International Convention on Liability and Compensation for Damage in Connection with the Carriage of Hazardous and Noxious Substances by Sea, with the exception of the aspects related to judicial cooperation in civil matters ................................................................................... 15

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Council Decision (EU) 2017/770 of 25 April 2017 on the ratification and accession by Member States, in the interest of the European Union, to the Protocol of 2010 to the International Convention on Liability and Compensation for Damage in Connection with the Carriage of Hazardous and Noxious Substances by Sea, with regard to the aspects related to judicial cooperation in civil matters .............................................................................................. 18

REGULATIONS ★

Commission Regulation (EU) 2017/771 of 3 May 2017 amending Regulation (EC) No 152/2009 as regards the methods for the determination of the levels of dioxins and polychlorinated biphenyls (1) .................................................................................................................... 22

(1) Text with EEA relevance.

EN

(Continued overleaf)

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.

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Commission Implementing Regulation (EU) 2017/772 of 3 May 2017 amending Implementing Regulation (EU) No 908/2014 as regards the list of measures for which certain information on beneficiaries is to be published ........................................................................................ 43 Commission Implementing Regulation (EU) 2017/773 of 3 May 2017 establishing the standard import values for determining the entry price of certain fruit and vegetables ................................. 45

DIRECTIVES ★

Commission Directive (EU) 2017/774 of 3 May 2017 amending, for the purpose of adopting specific limit values for chemicals used in toys, Appendix C to Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards phenol (1) ....................................................................................................................... 47

DECISIONS ★

Council Decision (EU) 2017/775 of 25 April 2017 appointing an alternate member, proposed by the Republic of Finland, of the Committee of the Regions .............................................. 50

(1) Text with EEA relevance.

4.5.2017

Official Journal of the European Union

EN

L 115/1

II (Non-legislative acts)

INTERNATIONAL AGREEMENTS COUNCIL DECISION (EU) 2017/768 of 18 July 2016 on the signing, on behalf of the European Union and its Member States, and provisional application of a Protocol to the Euro-Mediterranean Agreement establishing an Association between the European Communities and their Member States, of the one part, and the Arab Republic of Egypt, of the other part, to take account of the accession of the Republic of Croatia to the European Union THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 217, in conjunction with Article 218(5) thereof, Having regard to the Act of Accession of the Republic of Croatia, and in particular Article 6(2) thereof, Having regard to the proposal from the European Commission, Whereas: (1)

The Euro-Mediterranean Agreement establishing an Association between the European Communities and their Member States, of the one part, and the Arab Republic of Egypt, of the other part (1) (‘the Agreement’), was signed on 25 June 2001. The Agreement entered into force on 1 June 2004.

(2)

The Republic of Croatia became a Member State of the European Union on 1 July 2013.

(3)

In accordance with Article 6(2) of the Act of Accession of the Republic of Croatia, the accession of the Republic of Croatia to the Agreement is to be agreed by means of a protocol to the Agreement concluded between the Council, acting unanimously on behalf of the Member States, and the Arab Republic of Egypt.

(4)

On 14 September 2012, the Council authorised the Commission to open negotiations with the Arab Republic of Egypt. The negotiations were successfully concluded by the initialling of a Protocol in Brussels on 29 October 2015.

(5)

Article 8(3) of the Protocol provides for its provisional application before its entry into force.

(6)

The Protocol should be signed, subject to its conclusion, and applied on a provisional basis,

HAS ADOPTED THIS DECISION:

Article 1 The signing on behalf of the Union and its Member States of the Protocol to the Euro-Mediterranean Agreement establishing an Association between the European Communities and their Member States, of the one part, and the Arab Republic of Egypt, of the other part to take account of the accession of the Republic of Croatia to the European Union, is hereby authorised, subject to the conclusion of the Protocol. (1) OJ L 304, 30.9.2004, p. 39.

L 115/2

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4.5.2017

The text of the Protocol is attached to this Decision. Article 2 The President of the Council is hereby authorised to designate the person(s) empowered to sign the Protocol on behalf of the European Union and its Member States. Article 3 The Protocol shall be applied on a provisional basis with effect from 1 July 2013, in accordance with Article 8(3) thereof, pending the completion of the procedures necessary for its conclusion. Article 4 This Decision shall enter into force on the date of its adoption.

Done at Brussels, 18 July 2016. For the Council The President F. MOGHERINI

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L 115/3

PROTOCOL to the Euro-Mediterranean Agreement establishing an Association between the European Communities and their Member States, of the one part, and the Arab Republic of Egypt, of the other part, to take account of the accession of the Republic of Croatia to the European Union THE KINGDOM OF BELGIUM, THE REPUBLIC OF BULGARIA, THE CZECH REPUBLIC, THE KINGDOM OF DENMARK, THE FEDERAL REPUBLIC OF GERMANY, THE REPUBLIC OF ESTONIA, IRELAND, THE HELLENIC REPUBLIC, THE KINGDOM OF SPAIN, THE FRENCH REPUBLIC, THE REPUBLIC OF CROATIA, THE ITALIAN REPUBLIC, THE REPUBLIC OF CYPRUS, THE REPUBLIC OF LATVIA, THE REPUBLIC OF LITHUANIA, THE GRAND DUCHY OF LUXEMBOURG, HUNGARY, THE REPUBLIC OF MALTA, THE KINGDOM OF THE NETHERLANDS, THE REPUBLIC OF AUSTRIA, THE REPUBLIC OF POLAND, THE PORTUGUESE REPUBLIC, ROMANIA, THE REPUBLIC OF SLOVENIA, THE SLOVAK REPUBLIC, THE REPUBLIC OF FINLAND, THE KINGDOM OF SWEDEN, THE UNITED KINGDOM OF GREAT BRITAIN AND NORTHERN IRELAND

Contracting Parties to the Treaty on European Union, the Treaty on the Functioning of the European Union, hereinafter referred to as the ‘Member States’, and

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THE EUROPEAN UNION, hereinafter referred to as the ‘Union’

of the one part, and THE ARAB REPUBLIC OF EGYPT, hereinafter referred to as ‘Egypt’

of the other part, hereinafter referred to together as the ‘Contracting Parties’ for the purposes of this Protocol, Whereas: (1)

Euro-Mediterranean Agreement establishing an Association between the European Communities and their Member States, of the one part, and the Arab Republic of Egypt, of the other part (‘the Agreement’, was signed in Luxembourg on 25 June 2001 and entered into force on 1 June 2004;

(2)

The Treaty of Accession of the Republic of Croatia to the European Union was signed in Brussels on 9 December 2011 and entered into force on 1 July 2013;

(3)

Pursuant to Article 6(2) of the Act of Accession of the Republic of Croatia its accession to the Agreement is to be agreed by the conclusion of a protocol to the Agreement;

(4)

Consultations pursuant to Article 21(2) of the Agreement have taken place in order to ensure that account has been taken of mutual interests of the Union and Egypt,

HAVE AGREED AS FOLLOWS:

Article 1 The Republic of Croatia hereby accedes as Party to the Euro-Mediterranean Agreement establishing an Association between the European Communities and its Member States, of the one part, and the Arab Republic of Egypt, of the other part and shall respectively adopt and take note, in the same manner as the other Member States of the Union, of the texts of the Agreement, as well as of the Joint Declarations, Declarations and Exchanges of Letters. CHAPTER I AMENDMENTS TO THE TEXT OF THE AGREEMENT, INCLUDING ITS ANNEXES AND PROTOCOLS

Article 2 Agricultural products, processed agricultural products and fish and fishery products The table annexed to the Protocol 1 of the Agreement shall be modified by the table in Annex to this Protocol.

Article 3 Rules of origin For the period between 1 July 2013 and 31 January 2016, Protocol 4 shall be amended as follows: 1. Annex IVa shall be replaced by the following: ‘ANNEX IVA TEXT OF THE INVOICE DECLARATION

The invoice declaration, the text of which is given below, must be made out in accordance with the footnotes. However, the footnotes do not have to be reproduced.

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L 115/5

Bulgarian version Износителят на продуктите, обхванати от този документ (митническо разрешение № … (1)) декларира, че освен където е отбелязано друго, тези продукти са с … преференциален произход (2).

Spanish version El exportador de los productos incluidos en el presente documento [autorización aduanera no … (1)] declara que, salvo indicación expresa en sentido contrario, estos productos gozan de un origen preferencial … (2).

Czech version Vývozce výrobků uvedených v tomto dokumentu (číslo povolení … (1)) prohlašuje, že kromě zřetelně označených mají tyto výrobky preferenční původ v … (2).

Danish version Eksportøren af varer, der er omfattet af nærværende dokument, (toldmyndighedernes tilladelse nr. … (1)), erklærer, at varerne, medmindre andet tydeligt er angivet, har præferenceoprindelse i … (2).

German version Der Ausführer (Ermächtigter Ausführer; Bewilligungs-Nr. … (1)) der Waren, auf die sich dieses Handelspapier bezieht, erklärt, dass diese Waren, soweit nicht anders angegeben, präferenzbegünstigte … (2) Ursprungswaren sind.

Estonian version Käesoleva dokumendiga hõlmatud toodete eksportija (tolli luba nr … (1)) deklareerib, et need tooted on … (2) sooduspär itoluga, välja arvatud juhul, kui on selgelt näidatud teisiti.

Greek version Ο εξαγωγέας των προϊόντων που καλύπτονται από το παρόν έγγραφο [άδεια τελωνείου υπ' αριθ. … (1)] δηλώνει ότι, εκτός εάν δηλώνεται σαφώς άλλως, τα προϊόντα αυτά είναι προτιμησιακής καταγωγής … (2).

English version The exporter of the products covered by this document (customs authorisation No … (1)) declares that, except where otherwise clearly indicated, these products are of … (2) preferential origin.

French version L'exportateur des produits couverts par le présent document [autorisation douanière no … (1)] déclare que, sauf indication claire du contraire, ces produits ont l'origine préférentielle … (2).

Croatian version Izvoznik proizvoda obuhvaćenih ovom ispravom (carinsko ovlaštenje br. … (1)) izjavljuje da su, osim ako je drugačije izričito navedeno, ovi proizvodi … (2) preferencijalnog podrijetla.

Italian version L'esportatore delle merci contemplate nel presente documento [autorizzazione doganale n. … (1)] dichiarache, salvo indicazione contraria, le merci sono di origine preferenziale … (2).

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Latvian version To produktu eksportētājs, kuri ietverti šajā dokumentā (muitas atļauja Nr. … (1)), deklarē, ka, izņemot tur, kur ir citādi skaidri noteikts, šiem produktiem ir preferenciāla izcelsme … (2). Lithuanian version Šiame dokumente išvardintų produktų eksportuotojas (muitinės liudijimo Nr … (1)) deklaruoja, kad, jeigu kitaip nenurodyta, tai yra … (2) preferencinės kilmės produktai. Hungarian version A jelen okmányban szereplő áruk exportőre (vámfelhatalmazási szám: … (1)) kijelentem, hogy egyértelmű eltérő jelzés hiányában az áruk preferenciális … (2) származásúak. Maltese version L-esportatur tal-prodotti koperti b'dan id-dokument (awtorizzazzjoni tad-dwana nru … (1)) jiddikjara li, ħlief fejn indikat b'mod ċar li mhux hekk, dawn il-prodotti huma ta' oriġini preferenzjali … (2). Dutch version De exporteur van de goederen waarop dit document van toepassing is (douanevergunning nr. … (1)), verklaart dat, behoudens uitdrukkelijke andersluidende vermelding, deze goederen van preferentiële … oorsprong zijn (2). Polish version Eksporter produktów objętych tym dokumentem (upoważnienie władz celnych nr … (1)) deklaruje, że z wyjątkiem gdzie jest to wyraźnie określone, produkty te mają … (2) preferencyjne pochodzenie. Portuguese version O exportador dos produtos abrangidos pelo presente documento [autorização aduaneira n.o … (1)], declara que, salvo declaração expressa em contrário, estes produtos são de origem preferencial … (2). Romanian version Exportatorul produselor ce fac obiectul acestui document [autorizația vamală nr. … (1)] declară că, exceptând cazul în care în mod expres este indicat altfel, aceste produse sunt de origine preferențială … (2). Slovenian version Izvoznik blaga, zajetega s tem dokumentom (pooblastilo carinskih organov št. … (1)) izjavlja, da, razen če ni drugače jasno navedeno, ima to blago preferencialno poreklo … (2). Slovak version Vývozca výrobkov uvedených v tomto dokumente [číslo povolenia … (1)] vyhlasuje, že okrem zreteľne označených, majú tieto výrobky preferenčný pôvod v … (2). Finnish version Tässä asiakirjassa mainittujen tuotteiden viejä (tullin lupa nro … (1)) ilmoittaa, että nämä tuotteet ovat, ellei toisin ole selvästi merkitty, etuuskohteluun oikeutettuja … (2) alkuperätuotteita. Swedish version Exportören av de varor som omfattas av detta dokument (tullmyndighetens tillstånd nr … (1)) försäkrar att dessa varor, om inte annat tydligt markerats, har förmånsberättigande … ursprung (2).

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L 115/7

Arabic version

..............................................................................................................................................................................

(3)

(Place and date) ..................................................................................................................................................................................

(Signature of exporter; in addition the name of the person signing the declaration has to be indicated in clear script) (1) When the invoice declaration is made out by an approved exporter within the meaning of Article 23 of the Protocol, the authorisation number of the approved exporter must be entered in this space. When the invoice declaration is not made out by an approved exporter, the words in brackets must be omitted or the space left blank. (2) Origin of products to be indicated. When the invoice declaration relates in whole or in part, to products originating in Ceuta and Melilla within the meaning of Article 38 of the Protocol, the exporter must clearly indicate them in the document on which the declaration is made out by means of the symbol ‘CM’. (3) These indications may be omitted if the information is contained on the document itself.’. 2. Annex IVb shall be replaced by the following: ‘ANNEX IVB TEXT OF THE INVOICE DECLARATION EUR-MED

The invoice declaration EUR-MED, the text is which is given below, must be made in accordance with the footnotes. However, the footnotes do not have to be reproduced. Bulgarian version Износителят на продуктите, обхванати от този документ (митническо разрешение № … (1)) декларира, че освен където ясно е отбелязано друго, тези продукти са с … преференциален произход (2). — cumulation applied with . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (name of the country/countries) — no cumulation applied (3) Spanish version El exportador de los productos incluidos en el presente documento [autorización aduanera no … (1)] declara que, salvo indicación expresa en sentido contrario, estos productos gozan de un origen preferencial … (2). — cumulation applied with . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (name of the country/countries) — no cumulation applied (3) Czech version Vývozce výrobků uvedených v tomto dokumentu (číslo povolení … (1)) prohlašuje, že kromě zřetelně označených mají tyto výrobky preferenční původ v … (2). — cumulation applied with . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (name of country/countries) — no cumulation applied (3) Danish version Eksportøren af varer, der er omfattet af nærværende dokument, (toldmyndighedernes tilladelse nr. … (1)), erklærer, at varerne, medmindre andet tydeligt er angivet, har præferenceoprindelse i … (2). — cumulation applied with . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (name of country/countries) — no cumulation applied (3)

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German version Der Ausführer (Ermächtigter Ausführer; Bewilligungs-Nr. … (1)) der Waren, auf die sich dieses Handelspapier bezieht, erklärt, dass diese Waren, soweit nicht anderes angegeben, präferenzbegünstigte … (2) Ursprungswaren sind. — cumulation applied with . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (name of country/countries) — no cumulation applied (3) Estonian version Käesoleva dokumendiga hõlmatud toodete eksportija (tolli luba nr. … (1)) deklareerib, et need tooted on … (2) soodus päritoluga, välja arvatud juhul kui on selgelt näidatud teisiti. — cumulation applied with . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (name of country/countries) — no cumulation applied (3) Greek version Ο εξαγωγέας των προϊόντων που καλύπτονται από το παρόν έγγραφο (άδεια τελωνείου υπ'αριθ. … (1)) δηλώνει ότι, εκτός εάν δηλώνεται σαφώς άλλως, τα προϊόντα αυτά είναι προτιμησιακής καταγωγής … (2). — cumulation applied with . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (name of country/countries) — no cumulation applied (3) English version The exporter of the products covered by this document (customs authorization No … (1)) declares that, except where otherwise clearly indicated, these products are of … (2) preferential origin. — cumulation applied with . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (name of country/countries) — no cumulation applied (3) French version L'exportateur des produits couverts par le présent document (autorisation douanière no … (1)) déclare que, sauf indication claire du contraire, ces produits ont l'origine préférentielle … (2)). — cumulation applied with . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (name of country/countries) — no cumulation applied (3) Croatian version Izvoznik proizvoda obuhvaćenih ovom ispravom (carinsko ovlaštenje br. … (1)) izjavljuje da su, osim ako je to drugačije izričito navedeno, ovi proizvodi … (2) preferencijalnog podrijetla. — cumulation applied with . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (name of the country/countries) — no cumulation applied (3) Italian version L'esportatore delle merci contemplate nel presente documento (autorizzazione doganale n. … (1)) dichiara che, salvo indicazione contraria, le merci sono di origine preferenziale … (2). — cumulation applied with . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (name of country/countries) — no cumulation applied (3) Latvian version To produktu eksportētājs, kuri ietverti šajā dokumentā (muitas atļauja Nr. … (1)), deklarē, ka, izņemot tur, kur ir citādi skaidri noteikts, šiem produktiem ir preferenciāla izcelsme … (2). — cumulation applied with . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (name of country/countries) — no cumulation applied (3)

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EN


L 115/9

Lithuanian version Šiame dokumente išvardytų produktų eksportuotojas (muitinės liudijimo Nr … (1)) deklaruoja, kad, jeigu kitaip nenurodyta, tai yra … (2) preferencinės kilmės produktai. — cumulation applied with . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (name of country/countries) — no cumulation applied (3) Hungarian version A jelen okmányban szereplő áruk exportőre (vámfelhatalmazási szám: … (1)) kijelentem, hogy egyértelmű eltérő jelzés hiányában az áruk preferenciális … (2) származásúak. — cumulation applied with . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (name of country/countries) — no cumulation applied (3) Maltese version L-esportatur tal-prodotti koperti b'dan id-dokument (awtorizzazzjoni tad-dwana nru … (1)) jiddikjara li, ħlief fejn indikat b'mod ċar li mhux hekk, dawn il-prodotti huma ta' oriġini preferenzjali … (2). — cumulation applied with . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (name of country/countries) — o cumulation applied (3) Dutch version De exporteur van de goederen waarop dit document van toepassing is (douanevergunning nr. … (1)), verklaart dat, behoudens uitdrukkelijke andersluidende vermelding, deze goederen van preferentiële … oorsprong zijn (2). — cumulation applied with . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (name of country/countries) — no cumulation applied (3) Polish version Eksporter produktów objętych tym dokumentem (upoważnienie władz celnych nr … (1)) deklaruje, że z wyjątkiem gdzie jest to wyraźnie określone, produkty te mają … (2) preferencyjne pochodzenie. — cumulation applied with . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (name of country/countries) — no cumulation applied (3) Portuguese version O exportador dos produtos abrangidos pelo presente documento (autorização aduaneira n.o … (1)) declara que, salvo declaração expressa em contrário, estes produtos são de origem preferencial … (2). — cumulation applied with . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (name of country/countries) — no cumulation applied (3) Romanian version Exportatorul produselor ce fac obiectul acestui document (autorizația vamală nr. … (1)) declară că, exceptând cazul în care în mod expres este indicat altfel, aceste produse sunt de origine preferențială … (2). — cumulation applied with . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (name of the country/countries) — no cumulation applied (3) Slovenian version Izvoznik blaga, zajetega s tem dokumentom (pooblastilo carinskih organov št … (1)) izjavlja, da, razen če ni drugače jasno navedeno, ima to blago preferencialno poreklo … (2). — cumulation applied with . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (name of the country/countries) — no cumulation applied (3)

L 115/10

EN


4.5.2017

Slovak version Vývozca výrobkov uvedených v tomto dokumente (číslo povolenia … (1)) vyhlasuje, že okrem zreteľne označených, majú tieto výrobky preferenčný pôvod v … (2). — cumulation applied with . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (name of country/countries) — no cumulation applied (3) Finnish version Tässä asiakirjassa mainittujen tuotteiden viejä (tullin lupa n:o … (1)) ilmoittaa, että nämä tuotteet ovat, ellei toisin ole selvästi merkitty, etuuskohteluun oikeutettuja … alkuperätuotteita (2). — cumulation applied with . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (name of country/countries) — no cumulation applied (3) Swedish version Exportören av de varor som omfattas av detta dokument (tullmyndighetens tillstånd nr. … (1)) försäkrar att dessa varor, om inte annat tydligt markerats, har förmånsberättigande … ursprung (2). — cumulation applied with . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (name of country/countries) — no cumulation applied (3) Arabic version

— cumulation applied with . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (name of country/countries) — no cumulation applied (3) ..............................................................................................................................................................................

(4)

(Place and date) ..................................................................................................................................................................................

(Signature of exporter; in addition the name of the person signing the declaration has to be indicated in clear script) (1) When the origin declaration is made out by an approved exporter, the authorisation number of the approved exporter must be entered in this space. When the origin declaration is not made out by an approved exporter, the words in brackets shall be omitted or the space left blank. (2) Origin of products to be indicated. When the origin declaration relates, in whole or in part, to products originating in Ceuta and Melilla, the exporter must clearly indicate them in the document on which the declaration is made out, by means of the symbol ‘CM’. (3) Complete and delete where necessary. (4) These indications may be omitted if the information is contained on the document itself.’. CHAPTER II TRANSITIONAL PROVISIONS

Article 4 Goods in transit 1. The provisions of the Agreement may be applied to goods exported from either Egypt to Croatia or from Croatia to Egypt, which comply with the provisions of Protocol 4 to the Agreement and that on the date of accession of Croatia are either en route or in temporary storage, in a customs warehouse or in a free zone in Egypt or in Croatia.

4.5.2017

EN


L 115/11

2. Preferential treatment may be granted in such cases, subject to the submission to the customs authorities of the importing country, within four months from the date of accession of Croatia, of a proof of origin issued retrospectively by the customs authorities of the exporting country. CHAPTER III FINAL AND GENERAL PROVISIONS

Article 5 Egypt undertakes that it shall neither make any claim, request or referral nor modify or withdraw any concession pursuant to Articles XXIV.6 and XXVIII of the GATT 1994 in relation to this enlargement of the Union. Article 6 In due time after the initialling of this Protocol, the Union shall communicate to its Member States and Egypt, the Croatian language version of the Agreement. Subject to the entry into force of this Protocol, the language version referred to in the first sentence of this Article shall become authentic under the same conditions as the, Bulgarian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish Swedish and Arabic language versions of the Agreement. Article 7 This Protocol and its Annex shall form an integral part of the Agreement. Article 8 1. This Protocol shall be approved by the Council of the European Union on behalf of the Union and its Member States, and by Egypt, in accordance with their own procedures. The Contracting Parties shall notify each other of the completion of the procedures necessary for that purpose. The instruments of approval shall be deposited with the General Secretariat of the Council of the European Union. 2. This Protocol shall enter into force on the first day of the second month following the date on which all the Parties have notified each other of the completion of the procedures necessary for this purpose. 3.

Pending the date of its entry into force, the Protocol shall apply provisionally with effect from 1 July 2013. Article 9

This Protocol is drawn up in duplicate in Bulgarian, Croatian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish, Swedish and Arabic languages, each of these texts being equally authentic. IN WITNESS WHEREOF, the undersigned Plenipotentiaries, duly authorised to this effect, have signed this Protocol.

L 115/12

EN


Съставено в Брюксел на десети април през две хиляди и седемнадесета година. Hecho en Bruselas, el diez de abril de dos mil diecisiete. V Bruselu dne desátého dubna dva tisíce sedmnáct. Udfærdiget i Bruxelles den tiende april to tusind og sytten. Geschehen zu Brüssel am zehnten April zweitausendsiebzehn. Kahe tuhande seitsmeteistkümnenda aasta aprillikuu kümnendal päeval Brüsselis. Έγινε στις Βρυξέλλες, στις δέκα Απριλίου δύο χιλιάδες δεκαεπτά. Done at Brussels on the tenth day of April in the year two thousand and seventeen. Fait à Bruxelles, le dix avril deux mille dix-sept. Sastavljeno u Bruxellesu desetog travnja godine dvije tisuće sedamnaeste. Fatto a Bruxelles, addì dieci aprile duemiladiciassette. Briselē, divi tūkstoši septiņpadsmitā gada desmitajā aprīlī. Priimta Briuselyje du tūkstančiai septynioliktųjų metų balandžio dešimtą dieną. Kelt Brüsszelben, a kétezer-tizenhetedik év április havának tizedik napján. Magħmul fi Brussell, fl-għaxar jum ta' April fis-sena elfejn u sbatax. Gedaan te Brussel, tien april tweeduizend zeventien. Sporządzono w Brukseli dnia dziesiątego kwietnia roku dwa tysiące siedemnastego. Feito em Bruxelas, em dez de abril de dois mil e dezassete. Întocmit la Bruxelles la zece aprilie două mii șaptesprezece. V Bruseli desiateho apríla dvetisícsedemnásť. V Bruslju, dne desetega aprila leta dva tisoč sedemnajst. Tehty Brysselissä kymmenentenä päivänä huhtikuuta vuonna kaksituhattaseitsemäntoista. Som skedde i Bryssel den tionde april år tjugohundrasjutton.

За държавите-членки Por los Estados miembros Za členské státy For medlemsstaterne Für die Mitgliedstaaten Liikmesriikide nimel Για τα κράτη μέλη For the Member States Pour les États membres Za države članice Per gli Stati membri Dalībvalstu vārdā – Valstybių narių vardu A tagállamok részéről Għall-Istati Membri Voor de lidstaten W imieniu Państw Członkowskich Pelos Estados-Membros Pentru statele membre Za členské štáty Za države članice Jäsenvaltioiden puolesta För medlemsstaterna

За Европейския съюз Рог la Unión Europea Za Evropskou unii For Den Europæiske Union Für die Europäische Union Euroopa Liidu nimel Για την Ευρωπαϊκή Ένωση For the European Union Pour l'Union européenne Za Europsku uniju Per l'Unione europea Eiropas Savienības vārdā – Europos Sąjungos vardu Az Európai Unió részéről Għall-Unjoni Ewropea Voor de Europese Unie W imieniu Unii Europejskiej Pela União Europeia Pentru Uniunea Europeană Za Európsku úniu Za Evropsko unijo Euroopan unionin puolesta För Europeiska unionen

4.5.2017

4.5.2017

EN

Official Journal of the European Union За Арабска република Египет Por la República Árabe de Egipto Za Egyptskou arabskou republiku For Den Arabiske Republik Egypten Für die Arabische Republik Ägypten Egiptuse Araabia Vabariigi nimel Για την Αραβική Δημοκρατία της Αιγύπτου For the Arab Republic of Egypt Pour la République arabe d'Égypte Za Arapsku Republiku Egipat Per la Repubblica araba d'Egitto Ēģiptes Arābu Republikas vārdā – Egipto Arabų Respublikos vardu az Egyiptomi Arab Köztársaság részéről Għar-Repubblika Għarbija tal-Eġittu Voor de Arabische Republiek Egypte W imieniu Arabskiej Republiki Egiptu Pela República Árabe do Egipto Pentru Republica Arabă Egipt Za Egyptskú arabskú republiku Za Arabsko republiko Egipt Egyptin arabitasavallan puolesta För Arabrepubliken Egypten

L 115/13

L 115/14


EN

4.5.2017

ANNEX AGRICULTURAL PRODUCTS, PROCESSED AGRICULTURAL PRODUCTS AND FISH AND FISHERY PRODUCTS MODIFICATIONS TO PROTOCOL 1 OF THE AGREEMENT CONCERNING THE ARRANGEMENTS APPLICABLE TO IMPORTS INTO THE EUROPEAN UNION OF AGRICULTURAL PRODUCTS, PROCESSED AGRICULTURAL PRODUCTS AND FISH AND FISHERY PRODUCTS ORIGINATING IN EGYPT

The concessions referred to in this Annex will replace, for the products of subheading 0810 10 00, the concessions currently applied in the framework of the Association Agreement (Protocol 1). For all products not referred to in this Annex the concessions currently applied remain unchanged.

CN Code

Description

0810 10 00

Fresh strawberries, from 1 October to 30 April

Reduction of the MFN customs duty (%)

Tariff quota (tonnes net weight)

Reduction of the customs duty beyond the tariff quota (%)

100 %

10 000

—

100 %

94

—

Specific provisions

Specific provisions in Protocol 1 paragraph 5 not applicable

4.5.2017

EN


L 115/15

COUNCIL DECISION (EU) 2017/769 of 25 April 2017 on the ratification and accession by Member States, in the interest of the European Union, to the Protocol of 2010 to the International Convention on Liability and Compensation for Damage in Connection with the Carriage of Hazardous and Noxious Substances by Sea, with the exception of the aspects related to judicial cooperation in civil matters THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 100(2), in conjunction with point (a)(v) of Article 218(6) thereof, Having regard to the proposal from the European Commission, Having regard to the consent of the European Parliament (1), Whereas: (1)

The International Convention on Liability and Compensation for Damage in Connection with the Carriage of Hazardous and Noxious Substances by Sea, 1996 (‘1996 HNS Convention’) aims to ensure adequate, prompt and effective compensation of persons who suffer damage caused by spills of hazardous and noxious substances, when carried by sea. The 1996 HNS Convention filled a significant gap in the international regulation of liability in the context of maritime transport.

(2)

In 2002, the Council adopted Decision 2002/971/EC (2). In accordance with that Decision, Member States were to take the necessary steps to ratify or accede to the 1996 HNS Convention, within a reasonable time and, if possible, before 30 June 2006. Four Member States have subsequently ratified that Convention. The 1996 HNS Convention has not entered into force.

(3)

The 1996 HNS Convention has been amended by the Protocol of 2010 to the 1996 HNS Convention (‘Protocol of 2010’). Pursuant to Article 2 and Article 18(1) of the Protocol of 2010, the 1996 HNS Convention and the Protocol of 2010 are to be read, interpreted and applied together as one, single instrument, as between the parties to the Protocol of 2010.

(4)

A text consolidating the 1996 HNS Convention and the Protocol of 2010 (‘2010 HNS Convention’) was prepared by the International Maritime Organization (‘IMO’) Secretariat and approved by the IMO Legal Committee at its 98th meeting. The 2010 HNS Convention is not an instrument open to signature or ratification. The 2010 HNS Convention will take effect once the Protocol of 2010 enters into force in Member States.

(5)

In accordance with Article 20(8) of the Protocol of 2010, the expression of consent by a State to be bound by the Protocol of 2010 nullifies any prior expression of consent by that State to be bound by the 1996 HNS Convention. As a result, States that are Contracting Parties to the 1996 HNS Convention will cease to be so the moment they express their consent to be bound by the Protocol of 2010 in accordance with Article 20, and in particular paragraphs (2), (3) and (4) thereof, of that Protocol.

(6)

Directive 2004/35/EC of the European Parliament and of the Council (3) aims to prevent and remedy environ mental damage caused by numerous occupational activities, including the transport by sea of dangerous goods. However, it does not apply to cases of personal injury, to damage to private property or to any economic loss, and does not affect any rights of compensation for such damage. The subject matter of that Directive and of the 2010 HNS Convention therefore partially overlap, but not to a large extent. Member States retain their competence for aspects of the 2010 HNS Convention which do not affect common rules.

(1) Consent given on 5.4.2017 (not yet published in the Official Journal). (2) Council Decision 2002/971/EC of 18 November 2002 authorising the Member States, in the interest of the Community, to ratify or accede to the International Convention on Liability and Compensation for Damage in Connection with the Carriage of Hazardous and Noxious Substances by Sea, 1996 (the HNS Convention) (OJ L 337, 13.12.2002, p. 55). (3) Directive 2004/35/EC of the European Parliament and of the Council of 21 April 2004 on environmental liability with regard to the prevention and remedying of environmental damage (OJ L 143, 30.4.2004, p. 56).

L 115/16

EN


4.5.2017

(7)

As was the case with its predecessor, the 2010 HNS Convention is particularly important for the interests of the Union and its Member States, as it provides for improved protection of the victims of damage in connection with the carriage of HNS by sea, including in the context of environmental damage, in line with the 1982 United Nations Convention on the Law of the Sea.

(8)

In order for States to become Contracting Parties to the Protocol of 2010, and thereby to the 2010 HNS Convention, they have to submit to the Secretary-General of the IMO, at the same time as their instrument of consent, relevant data on the total quantities of contributing cargo under the 2010 HNS Convention (‘HNS contributing cargo’) during the preceding calendar year, in accordance with Article 20(4) thereof. For that purpose, States are required to set up a system for the reporting of HNS contributing cargo prior to expressing their consent to be bound by the Protocol of 2010.

(9)

At its 100th meeting in 2013, the IMO Legal Committee endorsed Guidelines on the reporting of HNS contributing cargo, which were developed to facilitate the adoption by ratifying States of legislation on reporting prior to the entry into force of the Protocol of 2010 and to contribute to the global, uniform and effective implementation of the relevant requirements of the 2010 HNS Convention.

(10)

In order to ensure legal certainty for all relevant stakeholders, Member States should inform each other and the Council and the Commission in an appropriate manner of their systems for the reporting of HNS contributing cargo. That information could be made available in an informal manner through existing channels, such as the Council preparatory bodies.

(11)

The exchange of best practices among Member States on the setting up of the system for the reporting of HNS contributing cargo could facilitate the efforts of Member States in developing such a reporting system.

(12)

As was the case with the 1996 HNS Convention, in the absence of a regional economic integration organisation (‘REIO’) clause only sovereign States may be party to the Protocol of 2010. Therefore, it is not possible for the Union to ratify or accede to the Protocol of 2010, and thereby to the 2010 HNS Convention.

(13)

The ratification of the Protocol of 2010 by all Member States within a given timeframe should ensure a level playing field within the Union for all actors concerned by the application of the 2010 HNS Convention.

(14)

Taking into account the international nature of the HNS regime, a global level playing field for all actors concerned by the application of the 2010 HNS Convention should be aimed for. For that reason, there is a need for global coverage of the Protocol of 2010.

(15)

Member States should, therefore, be authorised to ratify or accede to, as appropriate, the Protocol of 2010 for the parts thereof falling under exclusive Union competence, with the exception of the aspects related to judicial cooperation in civil matters. The provisions of the 2010 HNS Convention falling within the competence conferred upon the Union in respect of judicial cooperation in civil matters are to be the subject of a Decision adopted in parallel to this Decision,


Article 1 Member States are hereby authorised, for the parts falling under the exclusive competence of the Union, to ratify or accede to, as appropriate, the Protocol of 2010 in the interest of the Union, with the exception of the aspects related to judicial cooperation in civil matters, and subject to the conditions laid down in this Decision.

Article 2 1. Member States shall endeavour to take the necessary steps to deposit the instruments of ratification of, or accession to, the Protocol of 2010 within a reasonable time and, if possible, by 6 May 2021.

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L 115/17

2. Member States shall inform each other and the Council and the Commission in an appropriate manner when the system for the reporting of HNS contributing cargo becomes operational. 3. Member States shall seek to exchange best practices, in particular on the system for the reporting of HNS contributing cargo under the Protocol of 2010. Article 3 When ratifying or acceding to the Protocol of 2010, Member States shall inform the Secretary-General of the Internat ional Maritime Organization in writing that such ratification or accession has taken place in accordance with this Decision and Council Decision (EU) 2017/770 (1). Article 4 This Decision shall enter into force on the day following that of its publication in the Official Journal of the European Union. Article 5 This Decision is addressed to the Member States in accordance with the Treaties.

Done at Luxembourg, 25 April 2017. For the Council The President I. BORG

(1) Council Decision (EU) 2017/770 of 25 April 2017 on the ratification and accession by Member States, in the interest of the European Union, to the Protocol of 2010 to the International Convention on Liability and Compensation for Damage in Connection with the Carriage of Hazardous and Noxious Substances by Sea, with regard to the aspects related to judicial cooperation in civil matters (see page 18 of this Official Journal).

L 115/18

EN


4.5.2017

COUNCIL DECISION (EU) 2017/770 of 25 April 2017 on the ratification and accession by Member States, in the interest of the European Union, to the Protocol of 2010 to the International Convention on Liability and Compensation for Damage in Connection with the Carriage of Hazardous and Noxious Substances by Sea, with regard to the aspects related to judicial cooperation in civil matters THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 81, in conjunction with point (a)(v) of Article 218(6) thereof,

Having regard to the proposal from the European Commission,

Having regard to the consent of the European Parliament (1),

Whereas:

(1)

The International Convention on Liability and Compensation for Damage in Connection with the Carriage of Hazardous and Noxious Substances by Sea, 1996 (‘1996 HNS Convention’) aims to ensure adequate, prompt and effective compensation of persons who suffer damage caused by spills of hazardous and noxious substances, when carried by sea. The 1996 HNS Convention filled a significant gap in the international regulation of liability in the context of maritime transport.

(2)

In 2002, the Council adopted Decision 2002/971/EC (2). In accordance with that Decision, Member States were to take the necessary steps to ratify or accede to the 1996 HNS Convention, within a reasonable time and, if possible, before 30 June 2006. Four Member States have subsequently ratified that Convention. The 1996 HNS Convention has not entered into force.

(3)

The 1996 HNS Convention has been amended by the Protocol of 2010 to the 1996 HNS Convention (‘Protocol of 2010’). Pursuant to Article 2 and Article 18(1) of the Protocol of 2010, the 1996 HNS Convention and the Protocol of 2010 are to be read, interpreted and applied together as one, single instrument, as between the parties to the Protocol of 2010.

(4)

A text consolidating the 1996 HNS Convention and the Protocol of 2010 (‘2010 HNS Convention’) was prepared by the International Maritime Organization (‘IMO’) Secretariat and approved by the IMO Legal Committee at its 98th meeting. The 2010 HNS Convention is not an instrument open to signature or ratification. The 2010 HNS Convention will take effect once the Protocol of 2010 enters into force in Member States.

(5)

In accordance with Article 20(8) of the Protocol of 2010, the expression of consent by a State to be bound by the Protocol of 2010 nullifies any prior expression of consent by that State to be bound by the 1996 HNS Convention. As a result, States that are Contracting Parties to the 1996 HNS Convention will cease to be so the moment they express their consent to be bound by the Protocol of 2010 in accordance with Article 20, and in particular paragraphs (2), (3) and (4) thereof, of that Protocol.

(6)

As was the case with its predecessor, the 2010 HNS Convention is particularly important for the interests of the Union and its Member States, as it provides for improved protection of the victims of damage in connection with the carriage of HNS by sea, including in the context of environmental damage, in line with the 1982 United Nations Convention on the Law of the Sea.

(1) Consent given on 5.4.2017. (2) Council Decision 2002/971/EC of 18 November 2002 authorising the Member States, in the interest of the Community, to ratify or accede to the International Convention on Liability and Compensation for Damage in Connection with the Carriage of Hazardous and Noxious Substances by Sea, 1996 (the HNS Convention) (OJ L 337, 13.12.2002, p. 55).

4.5.2017

EN


L 115/19

(7)

In order for States to become Contracting Parties to the Protocol of 2010, and thereby to the 2010 HNS Convention, they have to submit to the Secretary-General of the IMO, at the same time as their instrument of consent, relevant data on the total quantities of contributing cargo under the 2010 HNS Convention (‘HNS contributing cargo’) during the preceding calendar year, in accordance with Article 20(4) thereof. For that purpose, States are required to set up a system for the reporting of HNS contributing cargo prior to expressing their consent to be bound by the Protocol of 2010.

(8)

Articles 38, 39 and 40 of the 2010 HNS Convention affect Union secondary legislation on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters, as laid down in Regulation (EU) No 1215/2012 of the European Parliament and of the Council (1).

(9)

The Union therefore has exclusive competence in relation to Articles 38, 39 and 40 of the 2010 HNS Convention inasmuch as that Convention affects the rules laid down in Regulation (EU) No 1215/2012.

(10)

The exchange of best practices among Member States on the setting up of the system for the reporting of HNS contributing cargo could facilitate the efforts of Member States in developing such a reporting system.

(11)

As was the case with the 1996 HNS Convention, in the absence of a regional economic integration organisation (‘REIO’) clause only sovereign States may be party to the Protocol of 2010. Therefore, it is not possible for the Union to ratify or accede to the Protocol of 2010, and thereby to the 2010 HNS Convention.

(12)

The ratification of the Protocol of 2010 by all Member States within a given timeframe should ensure a level playing field within the Union for all actors concerned by the application of the 2010 HNS Convention.

(13)

Taking into account the international nature of the HNS regime, a global level playing field for all actors concerned by the application of the 2010 HNS Convention should be aimed for. For that reason, there is a need for global coverage of the Protocol of 2010.

(14)

Member States should, therefore, be authorised to ratify or accede to, as appropriate, the Protocol of 2010 with regard to the aspects related to judicial cooperation in civil matters for which the Union has exclusive competence. The provisions of the 2010 HNS Convention falling within the competence conferred upon the Union other than the provisions related to judicial cooperation in civil matters are to be the subject of a Decision adopted in parallel to this Decision.

(15)

When ratifying or acceding to the Protocol of 2010, Member States should make a declaration on the recognition and enforcement of judgments falling within the scope of the 2010 HNS Convention.

(16)

The United Kingdom and Ireland are bound by Regulation (EU) No 1215/2012 and are therefore taking part in the adoption and application of this Decision.

(17)

In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, Denmark is not taking part in the adoption of this Decision and is not bound by it or subject to its application,


Article 1 Member States are hereby authorised to ratify or accede to, as appropriate, the Protocol of 2010 in the interest of the Union with regard to the aspects related to judicial cooperation in civil matters for which the Union has exclusive competence, subject to the conditions laid down in this Decision. (1) Regulation (EU) No 1215/2012 of the European Parliament and of the Council of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (OJ L 351, 20.12.2012, p. 1).

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Article 2 1. Member States shall endeavour to take the necessary steps to deposit the instruments of ratification of, or accession to, the Protocol of 2010 within a reasonable time and, if possible, by 6 May 2021. 2. Member States shall inform each other and the Council and the Commission in an appropriate manner when the system for the reporting of HNS contributing cargo becomes operational. 3. Member States shall seek to exchange best practices, in particular on the system for the reporting of HNS contributing cargo under the Protocol of 2010. Article 3 When ratifying or acceding to the Protocol of 2010, Member States shall also deposit the Declaration set out in the Annex to this Decision. Article 4 This Decision shall enter into force on the day following that of its publication in the Official Journal of the European Union. Article 5 This Decision is addressed to the Member States in accordance with the Treaties.

Done at Luxembourg, 25 April 2017. For the Council The President I. BORG

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ANNEX

Declaration to be deposited by Member States when ratifying or acceding to the Protocol of 2010, in accordance with Article 3: ‘Judgments on matters covered by the Convention as amended by the Protocol of 2010, when given by a court of … (1), shall be recognised and enforced in … (2) in accordance with the relevant European Union rules on the subject (3). Judgments on matters covered by the Convention as amended by the Protocol of 2010, when given by a court of the Kingdom of Denmark, shall be recognised and enforced in … (4) in accordance with the 2005 Agreement between the European Community and the Kingdom of Denmark on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (5). Judgments on matters covered by the Convention as amended by the Protocol of 2010, when given by a court of a third State bound by the Lugano Convention on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters of 30 October 2007 (6), shall be recognised and enforced in … (7) in accordance with that Convention. (1) All Member States of the European Union, with the exception of the Member State making the Declaration and Denmark. (2) The Member State making the Declaration. (3) At present, these rules are laid down in Regulation (EU) No 1215/2012 of the European Parliament and of the Council of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (OJ L 351, 20.12.2012, p. 1). (4) The Member State making the Declaration. (5) OJ L 299, 16.11.2005, p. 62. (6) OJ L 339, 21.12.2007, p. 3. (7) The Member State making the Declaration.’.

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REGULATIONS COMMISSION REGULATION (EU) 2017/771 of 3 May 2017 amending Regulation (EC) No 152/2009 as regards the methods for the determination of the levels of dioxins and polychlorinated biphenyls (Text with EEA relevance) THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (1), and in particular Article 11(4) thereof, Whereas: (1)

Commission Regulation (EC) No 152/2009 (2) includes methods for the determination of the levels of polychlorinated dibenzo-p-dioxins (PCDDs), polychlorinated dibenzofurans (PCDFs), dioxin-like polychlorinated biphenyls (PCBs) and non-dioxin-like PCBs in feed.

(2)

EU reference laboratory for dioxins and PCBs in feed and food has provided evidence that analytical results for dioxins and PCBs in certain cases are not reliable when the performance criteria provided for in Part B of Annex V to Regulation (EC) No 152/2009 are not applied by laboratories performing the analysis of samples taken by feed business operators in accordance with Regulation (EC) No 183/2005 of the European Parliament and of the Council (3). It is therefore appropriate to make the application of the performance criteria for the analysis of samples obligatory.

(3)

Given that the method of using a decision limit to ensure, with a certain probability, that an analytical result is above the maximum level, as provided for in Commission Decision 2002/657/EC (4), is no longer applied for the analysis of dioxins, furans and PCBs in feed, it is appropriate to delete that method and to keep only the method of the expanded uncertainty using the coverage factor of 2, which gives a level of confidence of approximately 95 %.

(4)

Guidance documents for the measurement uncertainty and for the estimation of the Limit of Detection (LOD) and Limit of Quantification (LOQ) have been developed. It is appropriate to make reference to them.

(5)

In line with the reporting requirements for bioanalytical screening methods provided for in Part B of Annex V to Regulation (EC) No 152/2009, it is appropriate to provide also for physico-chemical methods, to be used for screening, specific reporting requirements in Chapter II of that Part.

(6)

Given that the analysis of dioxins, dioxin-like PCBs and non-dioxin-like PCBs are in most cases determined together, it is appropriate to align the performance criteria for the non-dioxin-like PCBs provided for in point 3.3 of Chapter III of Part B of Annex V to Regulation (EC) No 152/2009 to the performance criteria for dioxins and dioxin-like PCBs. This is a simplification without substantial changes in practice as for non-dioxin-like PCBs the relative intensity of qualifier ions compared to target ions is > 50 %.

(1) OJ L 165, 30.4.2004, p. 1. (2) Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed (OJ L 54, 26.2.2009, p. 1). (3) Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene (OJ L 35, 8.2.2005, p. 1). (4) Commission Decision 2002/657/EC of 14 August 2002 implementing Council Directive 96/23/EC concerning the performance of analytical methods and the interpretation of results (OJ L 221, 17.8.2002, p. 8).

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(7)

Following experience gained, it is appropriate to adapt some technical specifications such as recoveries of isotope-labelled standards provided for in points 7.3 and 7.5 of Chapter III of Part B of Annex V to Regulation (EC) No 152/2009.

(8)

Furthermore, there are several other minor modifications proposed to the current provisions to improve the consistency in the terminology used, requiring replacing the whole Part B of Annex V to Regulation (EC) No 152/2009 to maintain the readability of the text.

(9)

Regulation (EC) No 152/2009 should therefore be amended accordingly.

(10)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1 Part B of Annex V to Regulation (EC) No 152/2009 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, 3 May 2017. For the Commission The President Jean-Claude JUNCKER

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ANNEX

In Annex V to Regulation (EC) No 152/2009, Part B ‘DETERMINATION OF THE LEVELS OF DIOXINS (PCDD/PCDF) AND PCBs’ is replaced by the following:

‘B. DETERMINATION OF THE LEVELS OF DIOXINS (PCDD/PCDF) AND PCBs

CHAPTER I

Methods of sampling and interpretation of analytical results 1.

Scope and definitions The samples intended for the official control of the levels of polychlorinated dibenzo-p-dioxins (PCDDs), polychlorinated dibenzofurans (PCDFs), dioxin-like polychlorinated biphenyls (PCBs) (1) and non dioxin-like PCBs in feed shall be taken in accordance with the provisions of Annex I. The quantitative requirements in relation to the control of substances or products uniformly distributed throughout the feed as provided for in point 5.1. of Annex I shall be applied. Aggregate samples thus obtained shall be considered representative for the lots or sublots from which they are taken. Compliance with maximum levels laid down by Directive 2002/32/EC shall be established on the basis of the levels determined in the laboratory samples. For the purposes of this Part B, the definitions laid down in Annex I to Commission Decision 2002/657/EC (2) shall apply.

(1) Table of TEF (= toxic equivalency factors) for PCDDs, PCDFs and dioxin-like PCBs: WHO-TEFs for human risk assessment based on the conclusions of the World Health Organization (WHO) — International Programme on Chemical Safety (IPCS) expert meeting which was held in Geneva in June 2005 (Martin van den Berg et al., The 2005 World Health Organization Re-evaluation of Human and Mammalian Toxic Equivalency Factors for Dioxins and Dioxin-like Compounds. Toxicological Sciences 93(2), 223–241 (2006)). Congener

TEF value

Dibenzo-p-dioxins (“PCDDs”) and Dibenzo-pfurans '(“PCDFs”)

Congener

TEF value

“Dioxin-like” PCBs Non-ortho PCBs + Mono-ortho PCBs

2,3,7,8-TCDD

1

1,2,3,7,8-PeCDD

1

Non-ortho PCBs

1,2,3,4,7,8-HxCDD

0,1

PCB 77

0,0001

1,2,3,6,7,8-HxCDD

0,1

PCB 81

0,0003

1,2,3,7,8,9-HxCDD

0,1

PCB 126

0,1

1,2,3,4,6,7,8-HpCDD

0,01

PCB 169

0,03

OCDD

0,0003

Mono-ortho PCBs

2,3,7,8-TCDF

0,1

PCB 105

0,00003

1,2,3,7,8-PeCDF

0,03

PCB 114

0,00003

2,3,4,7,8-PeCDF

0,3

PCB 118

0,00003

1,2,3,4,7,8-HxCDF

0,1

PCB 123

0,00003

1,2,3,6,7,8-HxCDF

0,1

PCB 156

0,00003

1,2,3,7,8,9-HxCDF

0,1

PCB 157

0,00003

2,3,4,6,7,8-HxCDF

0,1

PCB 167

0,00003

1,2,3,4,6,7,8-HpCDF

0,01

PCB 189

0,00003

1,2,3,4,7,8,9-HpCDF

0,01

OCDF

0,0003

Abbreviations used: “T” = tetra; “Pe” = penta; “Hx” = hexa; “Hp” = hepta; “O” = octa; “CDD” = chlorodibenzodioxin; “CDF” = chlorodiben zofuran; “CB” = chlorobiphenyl. (2) Commission Decision 2002/657/EC of 14 August 2002 implementing Council Directive 96/23/EC concerning the performance of analytical methods and interpretation of results (OJ L 221, 17.8.2002, p. 8).

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In addition to those definitions, the following definitions shall apply for the purpose of this Part B: “Screening methods” means methods used for selection of those samples with levels of PCDD/Fs and dioxinlike PCBs that exceed the maximum levels or the action thresholds. They shall allow a cost-effective high sample-throughput, thus increasing the chance to discover new incidents with high exposure and health risks to consumers. Screening methods shall be based on bioanalytical or GC-MS methods. Results from samples exceeding the cut-off value used to check compliance with the maximum level shall be verified by a full re-analysis from the original sample using a confirmatory method. “Confirmatory methods” means methods that provide full or complementary information enabling the PCDD/Fs and dioxin-like PCBs to be identified and quantified unequivocally at the maximum or in case of need at the action threshold. Such methods utilize gas chromatography/high resolution mass spectrometry (GC-HRMS) or gas chromatography/tandem mass spectrometry (GC-MS/MS).

2.

Compliance of the lot or sublot with the maximum level

2.1.

As regards non-dioxin-like PCBs The lot or sublot complies with the maximum level if the analytical result for the sum of PCB 28, PCB 52, PCB 101, PCB 138, PCB 153 and PCB 180 (hereafter referred to as non-dioxin-like PCBs) does not exceed the maximum level laid down by Directive 2002/32/EC, taking into account the expanded measurement uncertainty (1). The lot or sublot does not comply with the maximum level as laid down by Directive 2002/32/EC, if the mean of two upper-bound (2) analytical results obtained from duplicate analysis (3), taking into account the expanded measurement uncertainty, exceeds the maximum level beyond reasonable doubt, i.e. the analysed concentration after deduction of the expanded measurement uncertainty is used to assess compliance. The expanded measurement uncertainty is calculated using a coverage factor of 2 which gives a level of confidence of approximately 95 %. A lot or sublot is non-compliant if the mean of the measured values minus the expanded uncertainty of the mean is above the maximum level. The rules, mentioned in the paragraphs above under this point, shall apply for the analytical result obtained on the sample for official control. In case of analysis for defence or reference purposes, the national rules shall apply.

2.2.

As regards PCDD/Fs and dioxin-like PCBs The lot or sublot complies with the maximum level if the result of a single analysis — performed by a screening method with a false-compliant rate below 5 %, indicates that the level does not exceed the respective maximum level of PCDD/Fs and the sum of PCDD/Fs and dioxin-like PCBs laid down by Directive 2002/32/EC, — performed by a confirmatory method, does not exceed the respective maximum level of PCDD/Fs and the sum of PCDD/Fs and dioxin-like PCBs laid down by Directive 2002/32/EC, taking into account the expanded measurement uncertainty.

(1) The principles described in the “Guidance Document on Measurement Uncertainty for Laboratories performing PCDD/F and PCB Analysis using Isotope Dilution Mass Spectrometry” (http://ec.europa.eu/food/safety/animal-feed_en) shall be followed when applicable. (2) The concept of “upper-bound” requires using the limit of quantification for the contribution of each non-quantified congener. The concept of “lower-bound” requires using zero for the contribution of each non-quantified congener. The concept of “medium-bound” requires using half of the limit of quantification calculating the contribution of each non-quantified congener. (3) Duplicate analysis: Separate analysis of the analytes of interest using a second aliquot of the same homogenized sample. In general, the requirements for duplicate analysis as provided for in Annex II, Chapter C, point 3 apply. However, for methods with the use of 13C-labelled internal standard for the relevant analytes, the duplicate analysis is only necessary if the result of the first determination is not compliant. The duplicate analysis is necessary to exclude the possibility of internal cross-contamination or an accidental mix-up of samples. In case the analysis is performed in the course of a contamination incident, confirmation by duplicate analysis may be omitted in case the samples selected for analysis are through traceability linked to the contamination incident and the level found is significantly above the maximum level.

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For screening assays a cut-off value shall be established for decisions on sample compliance with the respective maximum levels set for either PCDD/Fs, or for the sum of PCDD/Fs and dioxin-like PCBs.

The lot or sublot does not comply with the maximum level as laid down by Directive 2002/32/EC if the mean of two upper-bound (1) analytical results obtained from duplicate analysis (2) using a confirmatory method, taking into account the expanded measurement uncertainty, exceeds the maximum level beyond reasonable doubt, i.e. the analysed concentration after deduction of the expanded measurement uncertainty is used to assess compliance.

The expanded measurement uncertainty is calculated using a coverage factor of 2 which gives a level of confidence of approximately 95 %. A lot or sublot is non-compliant if the mean of the measured values minus the expanded uncertainty of the mean is above the maximum level.

The sum of the estimated expanded uncertainties of the separate analytical results of PCDD/Fs and dioxinlike PCBs shall be used for the sum of PCDD/Fs and dioxin-like PCBs.

The rules, mentioned in the paragraphs above under this point, shall apply for the analytical result obtained on the sample for official control. In case of analysis for defence or reference purposes, the national rules shall apply.

3.

Results exceeding action thresholds as laid down in Annex II to Directive 2002/32/EC

Action thresholds serve as a tool for the selection of samples in those cases where it is necessary to identify a source of contamination and to take measures for its reduction or elimination. Screening methods shall establish the appropriate cut-off values for selection of those samples. Where significant efforts are necessary to identify a source and to reduce or eliminate the contamination, it is appropriate to confirm exceedance of the action thresholds by duplicate analysis using a confirmatory method and taking into account the expanded measurement uncertainty (3).

CHAPTER II

Sample preparation and requirements for methods of analysis used in offical control of the levels of dioxins (PCDD/Fs) and dioxin-like PCBs in feed

1.

Field of application

The requirements set out in this Chapter shall be applied where feed is analysed for the official control of the levels of 2,3,7,8-substituted PCDD/Fs and dioxin-like PCBs and as regards sample preparation and analytical requirements for other regulatory purposes, which includes the controls performed by the feed business operator to ensure compliance with the provisions of Regulation (EC) No 183/2005 of the European Parliament and of the Council (4). (1) The concept of “upper-bound” requires using the limit of quantification for the contribution of each non-quantified congener to the Toxic Equivalent (TEQ). The concept of “lower-bound” requires using zero for the contribution of each non-quantified congener to the TEQ. The concept of “medium-bound” requires using half of the limit of quantification calculating the contribution of each nonquantified congener to the TEQ. (2) In general, the requirements for duplicate analysis as provided for in Annex II, Chapter C, point 2 apply. However, for confirmatory methods with the use of 13C-labelled internal standard for the relevant analytes, the duplicate analysis is only necessary if the result of the first determination is not compliant. The duplicate analysis is necessary to exclude the possibility of internal cross-contamination or an accidental mix-up of samples. In case the analysis is performed in the course of a contamination incident, confirmation by duplicate analysis may be omitted in case the samples selected for analysis are through traceability linked to the contamination incident and the level found is significantly above the maximum level. (3) Identical explanation and requirements for duplicate analysis for control of action thresholds as in footnote 2 above for maximum levels. (4) Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene (OJ L 35, 8.2.2005, p. 1).

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Monitoring for the presence of PCDD/Fs and dioxin-like PCBs in feed may be performed with two different types of analytical methods: (a) Screening methods The goal of screening methods is to select those samples with levels of PCDD/Fs and dioxin-like PCBs that exceed the maximum levels or the action thresholds. Screening methods shall ensure cost-effective high sample-throughput, thus increasing the chance to discover new incidents with high exposure and health risks of consumers. Their application shall aim to avoid false-compliant results. They may comprise bioanalytical and GC-MS methods. Screening methods compare the analytical result with a cut-off value, providing a yes/no-decision over the possible exceedance of the maximum level or action threshold. The concentration of PCDD/Fs and the sum of PCDD/Fs and dioxin-like PCBs in samples suspected to be non-compliant with the maximum level shall be determined or confirmed by a confirmatory method. In addition, screening methods may give an indication of the levels of PCDD/Fs and dioxin-like PCBs present in the sample. In case of application of bioanalytical screening methods the result is expressed as Bioanalytical Equivalents (BEQ), whereas in case of application of physico-chemical GC-MS methods it is expressed as Toxic Equivalents (TEQ). The numerically indicated results of screening methods are suitable for demonstrating compliance or suspected noncompliance or exceedance of action thresholds and give an indication of the range of levels in case of follow-up by confirmatory methods. They are not suitable for purposes such as evaluation of background levels, estimation of intake, following of time trends in levels or re-evaluation of action thresholds and maximum levels. (b) Confirmatory methods Confirmatory methods allow the unequivocal identification and quantification of PCDD/Fs and dioxinlike PCBs present in a sample and provide full information on congener level. Therefore, those methods allow the control of maximum levels and action thresholds, including the confirmation of results obtained by screening methods. Furthermore, results may be used for other purposes such as determina tion of low background levels in feed monitoring, following of time trends, exposure assessment and building of a database for possible re-evaluation of action thresholds and maximum levels. They are also important for establishing congener patterns in order to identify the source of a possible contamination. Such methods utilise GC-HRMS. For confirming compliance or non-compliance with the maximum level, also GC-MS/MS can be used.

2.

Background

For calculation of TEQ concentrations, the concentrations of the individual substances in a given sample shall be multiplied by their respective Toxic Equivalency Factor (TEF) (see footnote 1 of Chapter I) and subsequently summed to give the total concentration of dioxin-like compounds expressed as TEQs. For the purposes of this Part B, the accepted specific limit of quantification of an individual congener means the lowest content of the analyte that can be measured with reasonable statistical certainty, fulfilling the identification criteria as described in internationally recognised standards, for example, in standard EN 16215:2012 (Animal feed — Determination of dioxins and dioxin-like PCBs by GC-HRMS and of indicator PCBs by GC-HRMS) and/or in EPA methods 1613 and 1668 as revised. The limit of quantification of an individual congener may be identified as (a) the concentration of an analyte in the extract of a sample which produces an instrumental response at two different ions to be monitored with a S/N (signal/noise) ratio of 3:1 for the less intensive raw data signal; or

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(b) if for technical reasons the signal-to-noise calculation does not provide reliable results, the lowest concentration point on a calibration curve that gives an acceptable (≤ 30 %) and consistent (measured at least at the start and at the end of an analytical series of samples) deviation to the average relative response factor calculated for all points on the calibration curve in each series of samples. The limit of quantification (LOQ) is calculated from the lowest concentration point taking into account the recovery of internal standards and sample intake. Bioanalytical screening methods will not give results at the congener level but merely an indication (1) of the TEQ level, expressed in BEQ to acknowledge the fact that not all compounds present in a sample extract that produce a response in the test may fulfill or meet all requirements of the TEQ-principle. Screening and confirmatory methods may only be applied for control of a certain matrix if the methods are sensitive enough to detect levels reliably at the action threshold or maximum level.

3.

Quality assurance requirements

3.1.

Measures shall be taken to avoid cross-contamination at each stage of the sampling and analysis procedure.

3.2.

The samples shall be stored and transported in glass, aluminum, polypropylene or polyethylene containers suitable for storage without any influence on the levels of PCDD/Fs and dioxin-like PCBs in the samples. Traces of paper dust shall be removed from the sample container.

3.3.

The sample storage and transportation shall be performed in a way that maintains the integrity of the feed sample.

3.4.

Insofar as relevant, each laboratory sample shall be finely grinded and mixed thoroughly using a process that has been demonstrated to achieve complete homogenisation (for example, ground to pass a 1 mm sieve). Samples shall be dried before grinding if the moisture content is too high.

3.5.

Control of reagents, glassware and equipment for possible influence of TEQ- or BEQ-based results shall be carried out.

3.6.

A blank analysis shall be performed by carrying out the entire analytical procedure omitting only the sample.

3.7.

For bioanalytical methods, all glassware and solvents used in analysis shall be tested to be free of compounds that interfere with the detection of target compounds in the working range. Glassware shall be rinsed with solvents or heated at temperatures suitable to remove traces of PCDD/Fs, dioxin-like compounds and interfering compounds from its surface.

3.8.

Sample quantity used for the extraction shall be sufficient to fulfill the requirements with respect to a sufficiently low working range including the concentrations of maximum levels or action threshold.

3.9.

The specific sample preparation procedures used for the products under consideration shall follow internat ionally accepted guidelines.

4.

Requirements for laboratories

4.1.

In accordance with the provisions of Regulation (EC) No 882/2004, laboratories shall be accredited by a recognised body operating in accordance with ISO Guide 58 to ensure that they are applying analytical quality assurance. Laboratories shall be accredited following the EN ISO/IEC 17025 standard. The principles as described in the Technical Guidelines for the estimation of measurement uncertainty and limits of quanti fication for PCDD/F and PCB analysis shall be followed when applicable (2)

(1) Bioanalytical methods are not specific to those congeners included in the TEF-scheme. Other structurally related AhR-active compounds may be present in the sample extract which contribute to the overall response. Therefore, bioanalytical results cannot be an estimate but rather an indication of the TEQ level in the sample. 2 ( ) “Guidance Document on Measurement Uncertainty for Laboratories performing PCDD/F and PCB Analysis using Isotope Dilution Mass Spectrometry” (http://ec.europa.eu/food/safety/animal-feed_en), “Guidance Document on the Estimation of LOD and LOQ for Measurements in the Field of Contaminants in Feed and Food” (http://ec.europa.eu/food/safety/animal-feed_en).

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4.2.

Laboratory proficiency shall be proven by the continuous successful participation in inter-laboratory studies for the determination of PCDD/Fs and dioxin-like PCBs in relevant feed matrices and concentration ranges.

4.3.

Laboratories applying screening methods for the routine control of samples shall establish a close cooperation with laboratories applying the confirmatory method, both for quality control and confirmation of the analytical result of suspected samples.

5.

Basic requirements to be met by analytical procedure for dioxins (PCDD/Fs) and dioxin-like PCBs

5.1.

Low working range and limits of quantification For PCDD/Fs, detectable quantities shall be in the upper femtogram (10– 15g) range because of extreme toxicity of some of these compounds. For most PCB congeners a limit of quantification in the nanogram (10– 9g) range is already sufficient. For the measurement of the more toxic dioxin-like PCB congeners (in particular non-ortho-substituted congeners), the lower end of the working range shall reach the low picogram (10– 12g) levels. For all other PCB congeners a limit of quantification in the nanogram (10– 9g) range is sufficient.

5.2.

High selectivity (specificity)

5.2.1.

A distinction is required between PCDD/Fs and dioxin-like PCBs and a multitude of other, coextracted and possibly interfering compounds present at concentrations up to several orders of magnitude higher than those of the analytes of interest. For GC-MS methods, a differentiation among various congeners is required, such as between toxic (for example, the seventeen 2,3,7,8-substituted PCDD/Fs, and twelve dioxin-like PCBs) and other congeners.

5.2.2.

Bioanalytical methods shall be able to detect the target compounds as the sum of PCDD/Fs, and/or dioxinlike PCBs. Sample clean-up shall aim at removing compounds causing false non-compliant results or compounds that may decrease the response, causing false compliant results.

5.3.

High accuracy (trueness and precision, bioassay apparent recovery)

5.3.1.

For GC-MS methods, the determination shall provide a valid estimate of the true concentration in a sample. High accuracy is required to avoid the rejection of a sample analysis result on the basis of poor reliability of the determined TEQ level. Accuracy is expressed as trueness (difference between the mean value measured for an analyte in a certified material and its certified value, expressed as a percentage of this value) and precision (RSDR relative standard deviation calculated from results generated under reproducibility conditions).

5.3.2.

For bioanalytical methods, the bioassay apparent recovery shall be determined. Bioassay apparent recovery means the BEQ level calculated from the TCDD or PCB 126 calibration curve corrected for the blank and then divided by the TEQ level determined by the confirmatory method. It aims at correcting factors like the loss of PCDD/Fs and dioxin-like compounds during the extraction and clean-up steps, co-extracted compounds increasing or decreasing the response (agonistic and antagonistic effects), the quality of the curve fit, or differences between the TEF values and the Relative Potency (REP) values. The bioassay apparent recovery is calculated from suitable reference samples with representative congener patterns around the level of interest.

5.4.

Validation in the range of maximum level and general quality control measures

5.4.1.

Laboratories shall demonstrate the performance of a method in the range of the maximum level, for example, 0,5x, 1x and 2x the maximum level with an acceptable coefficient of variation for repeated analysis, during the validation procedure and during routine analysis.

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5.4.2.

Regular blank controls and spiking experiments or analysis of control samples (preferably, if available, certified reference material) shall be performed as internal quality control measures. Quality control charts for blank controls, spiking experiments or analysis of control samples shall be recorded and checked to make sure the analytical performance is in accordance with the requirements.

5.5.

Limit of quantification

5.5.1.

For a bioanalytical screening method, the establishment of the limit of quantification (LOQ) is not an indis pensable requirement but the method shall prove that it can differentiate between the blank and the cut-off value. When providing a BEQ level, a reporting level shall be established to deal with samples showing a response below this level. The reporting level shall be demonstrated to be different from procedure blank samples at least by a factor of three, with a response below the working range. It shall therefore be calculated from samples containing the target compounds around the required minimum level, and not from an S/N ratio or an assay blank.

5.5.2.

The LOQ for a confirmatory method shall be about one fifth of the maximum level.

5.6.

Analytical criteria For reliable results from confirmatory or screening methods, the following criteria shall be met in the range of the maximum level for the TEQ or BEQ value, respectively, whether determined as total TEQ or total BEQ (as the sum of PCDD/Fs and dioxin-like PCBs) or separately for PCDD/Fs and dioxin-like PCBs:

Screening with bioanaly tical or physico-chemical methods

False-compliant rate (*)

Confirmatory methods