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Commission Implementing Regulation (EU) 2024/334 of 19 January 2024 amending Implementing Regulation (EU) 2021/405 as regards the lists of third countries with an approved control plan and authorised for the entry into the Union of consignments of certain live, chilled, frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods and fishery products

Type Implementing Regulation

Publication 2024-01-22

State In force

Text As published

Department European Commission, SANTE

Source EUR-Lex

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Image omitted; see official source	Official Journal of the European Union	EN Series L

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	2024/334	22.1.2024

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) ¹, and in particular Article 127(2) thereof,

Whereas:

(1) Regulation (EU) 2017/625 lays down rules for official controls and other control activities performed by the competent authorities of the Member States in order to verify compliance with Union legislation in the area of, among others, food safety at any stage of production, processing and distribution. In particular, Article 126(2), point (a), of that Regulation provides that a delegated act may require that only consignments of certain animals and goods from a third country or region thereof which appears on a list drawn up by the Commission for that purpose are to enter the Union.

(2) Commission Delegated Regulation (EU) 2022/2292 ² supplements Regulation (EU) 2017/625 to ensure that consignments of food-producing animals and certain goods intended for human consumption from third countries or regions thereof comply with the relevant requirements established in the rules on food safety referred to in Article 1(2), point (a), of Regulation (EU) 2017/625 or with requirements recognised to be at least equivalent thereto. In particular, Article 3 of Delegated Regulation (EU) 2022/2292 identifies the animals and goods intended for human consumption that are subject to the requirement to come from a third country or region thereof which appears on the list referred to in Article 126(2), point (a), of Regulation (EU) 2017/625.

(3) Commission Implementing Regulation (EU) 2021/405 ³ lays down the lists of third countries or regions thereof from which the entry into the Union of consignments of certain animals and goods intended for human consumption is permitted in accordance with Article 126(2)(a) of Regulation (EU) 2017/625.

(4) Article 20(6) of Commission Implementing Regulation (EU) 2021/405 provides for a list of third countries or regions thereof authorised for the entry into the Union of consignments of treated raw materials to produce gelatine and collagen, referred to in point 4(b)(iii) of Section XIV, Chapter I, of Annex III to Regulation (EC) No 853/2004 of the European Parliament and of the Council ⁴. Section XIV of Annex III to that Regulation lays down requirements for gelatine, while Section XV of that Annex lays down requirements for collagen. Section XV of Annex III to Regulation (EC) No 853/2004 should therefore be referred to in Article 20(6) of Implementing Regulation (EU) 2021/405.

(5) Article 6(1) of Delegated Regulation (EU) 2022/2292 provides that, in addition to the requirements laid down in Regulation (EU) 2017/625, consignments of food-producing animals, products of animal origin and composite products are to enter the Union only from a third country that has in place a control plan for pharmacologically active substances, pesticides and contaminants.

(6) Article 7 of Delegated Regulation (EU) 2022/2292 provides that, in addition to the conditions laid down in Regulation (EU) 2017/625, consignments of food-producing animals, products of animal origin and composite products are to enter the Union only from a third country that complies with the requirements provided for in Article 6(1) and is included in the list of third countries approved for the entry into the Union of the concerned food-producing animals or products of animal origin set out in Annex -I to Implementing Regulation (EU) 2021/405.

(7) Article 8(1) of Delegated Regulation (EU) 2022/2292 provides that, by way of derogation from Article 7, consignments of food-producing animals, products of animal origin and composite products may enter the Union from third countries that do not have an approved control plan for pharmacologically active substances, pesticides and contaminants but ensure that the food-producing animals and products of animal origin, including those used in composite products, originate in a Member State or a third country included in the list set out in Annex -I to Implementing Regulation (EU) 2021/405. Article 8(2) of Delegated Regulation (EU) 2022/2292 provides that In addition to the requirements laid down in Article 127(3) of Regulation (EU) 2017/625, the Commission is to decide on the inclusion of a third country in the list referred to in Article 126(2), point (a), of that Regulation only if the competent authority of that third country provides the Commission with evidence and guarantees of compliance with the requirements laid down in Article 8(1). Such evidence and guarantees should consist of information on the procedures in place in that third country to guarantee the traceability and origin of those food-producing animals and those products of animal origin.

(8) Bangladesh, Chile, the Falkland Islands, Guernsey, New Caledonia, Nicaragua, and Uruguay are listed in Annex -I to Implementing Regulation (EU) 2021/405 and marked with an ‘O’ indicating their intention to export to the Union composite products manufactured using processed aquaculture products, and/or processed milk and/or processed egg products obtained from a Member State or from a third country or region thereof that has in place control plans for pharmacologically active substances, pesticides and contaminants. However, Bangladesh, Chile, the Falkland Islands, Guernsey, New Caledonia, Nicaragua, and Uruguay have informed the Commission that they are not interested in exporting such composite products to the Union. That marking ‘O’ for Bangladesh, Chile, the Falkland Islands, Guernsey, New Caledonia, Nicaragua, and Uruguay in Annex -I should therefore be deleted.

(9) Colombia is currently listed in Annex -I to Implementing Regulation (EU) 2021/405 with an ‘X’ for milk. Following an audit carried out by the Commission from 24 July to 4 August 2023, it was found that Colombia cannot guarantee the non-use of oestradiol 17-beta in heifers and cows, as required by the Article 10 of Delegated Regulation (EU) 2022/2292, concerning the prohibition on the use in stock farming of certain substances having a hormonal or thyrostatic action and of β-agonists, milk from which is used to produce shelf-stable composite products intended for the Union market. Colombia’s listing for milk with an ‘X’ should therefore be deleted. As Colombia already exports composite products to the Union containing processed milk obtained from a Member State or from a third country that has in place control plans for pharmacologically active substances, pesticides and contaminants and is listed Annex -I to Implementing Regulation (EU) 2021/405 with an ‘X’ for milk, Colombia should therefore be marked with an ‘O’ for milk.

(10) Israel ⁵ is currently listed in Annex -I to Implementing Regulation (EU) 2021/405 with an ‘X’ for eggs. However, Israel has informed the Commission that it is not interested in exporting eggs to the Union anymore. The marking ‘X’ for ‘eggs’ should therefore be deleted from that Annex.

(11) Jamaica is currently listed in Annex -I to Implementing Regulation (EU) 2021/405 with an ‘X’ for honey. As Jamaica has not submitted to the Commission the control plan for honey, the marking ‘X’ for ‘honey’ should therefore be deleted from that Annex.

(12) Kenya and Mozambique are listed in Annex -I to Implementing Regulation (EU) 2021/405 with an ‘O’ indicating their intention to export to the Union composite products manufactured using processed milk and/or processed egg products obtained from a Member State or from a third country or region thereof that has in place control plans for pharmacologically active substances, pesticides, and contaminants. However, Kenya and Mozambique have failed to submit to the Commission evidence and guarantees of compliance with Article 8(1) of Delegated Regulation (EU) 2022/2292. The marking for Kenya and Mozambique in Annex -I should therefore be deleted.

(13) Morocco and Rwanda have submitted control plans for honey. The plans provide sufficient guarantees and should therefore be approved. The entries for Morocco and for Rwanda for ‘honey’ should be listed in Annex -I to Implementing Regulation (EU) 2021/405 accordingly.

(14) Montenegro is listed in Annex -I to Implementing Regulation (EU) 2021/405 with an ‘X’ for ‘ovine/caprine’ with a footnote referring to ovine species only. However, Montenegro has included caprine animals in its control plan. The footnote for Montenegro restricting the entry to ovine meat in that Annex should therefore be deleted.

(15) Montenegro has submitted a control plan, which covers casings. The plan provides sufficient guarantees and should therefore be approved. Montenegro’s entry for ‘casings’ should be listed in Annex -I to Implementing Regulation (EU) 2021/405 accordingly.

(16) New Caledonia is listed in Annex -I to Implementing Regulation (EU) 2021/405 and marked with a ‘P’ indicating its intention to export to the Union composite products manufactured using processed products derived from molluscs originating either in Member States or in third countries or regions thereof listed in Annex VIII to Implementing Regulation (EU) 2021/405. However, New Caledonia has informed the Commission that it is not interested in exporting such composite products to the Union. The marking ‘P’ for New Caledonia in Annex -I should therefore be deleted.

(17) South Africa has submitted a control plan for marine gastropods which covers the subcategory ‘molluscs/marine gastropods from aquaculture’. That plan provides relevant guarantees on food safety and should therefore be approved. South Africa should therefore be listed in Annex -I to Implementing Regulation (EU) 2021/405 marked with an ‘M’ and listed in Annex VIII to that Implementing Regulation.

(18) Azerbaijan is listed in Annex IX to Implementing Regulation (EU) 2021/405 with the remark ‘only caviar from wild catch’. Azerbaijan has submitted a control plan for aquaculture which covers finfish products (caviar and roes). The plan provides relevant guarantees on food safety and should therefore be approved. Azerbaijan should therefore be listed in Annex -I accordingly and the remark ‘only caviar from wild catch’ in Annex IX to that Implementing Regulation changed to ‘Aquaculture: finfish and caviar (product of finfish)’.

(19) Chile is listed in Annex IX to Implementing Regulation (EU) 2021/405 with the remark ‘Aquaculture: only finfish’. Chile’s control plan covers finfish and finfish products (caviar, and roes). The remark ‘Aquaculture: only finfish’ in the entry for Chile in Annex IX to Implementing Regulation (EU) 2021/405 should therefore be changed to ‘Aquaculture: finfish and caviar (product of finfish)’.

(20) Implementing Regulation (EU) 2021/405 should therefore be amended accordingly.

(21) With regard to consignments of shelf-stable composite products manufactured using processed milk products of Colombian origin which have already been dispatched from Colombia at the date when this Regulation enters into force, for reasons of predictability and legal certainty it is appropriate to provide for a transitional period for entry of such consignments into the Union.

(22) 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

Implementing Regulation (EU) 2021/405 is amended as follows:

(1) Article 20(6) is replaced by the following:

‘6. Consignments of treated raw materials for the production of gelatine and collagen, referred to in point 4(b)(iii) of Chapter I of Section XIV and point 4(b)(iii) of Chapter I of Section XV respectively, of Annex III to Regulation (EC) No 853/2004, shall only be authorised for the entry into the Union if they come from the third countries or regions thereof authorised for the entry of consignments of treated raw materials derived from those commodities into the Union in accordance with Article 19 of this Regulation.’

;

(2) Annex -I is replaced by the text set out in Annex I to this Regulation.

(3) Annex VIII is amended in accordance with Annex II to this Regulation.

(4) Annex IX is amended in accordance with Annex III 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.

Article 3

Consignments of shelf-stable composite products manufactured from processed milk products of Colombian origin, which have been dispatched to the Union from Colombia before the date of entry into force of this Implementing Regulation may enter the Union until two months after the entry into force of this Regulation. Consignments of shelf-stable composite products manufactured from processed milk products sourced from Member States or third countries listed for milk in Annex -I to Implementing Regulation (EU) 2021/405 are not affected by this transitional period and may continue to enter the Union.

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

Done at Brussels, 19 January 2024.

For the Commission

The President

Ursula VON DER LEYEN

OJ L 95, 7.4.2017, p. 1, ELI: http://data.europa.eu/eli/reg/2017/625/oj.

Commission Delegated Regulation (EU) 2022/2292 of 6 September 2022 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council with regard to requirements for the entry into the Union of consignments of food-producing animals and certain goods intended for human consumption (OJ L 304, 24.11.2022, p. 1, ELI: http://data.europa.eu/eli/reg_del/2022/2292/oj).

Commission Implementing Regulation (EU) 2021/405 of 24 March 2021 laying down the lists of third countries or regions thereof authorised for the entry into the Union of certain animals and goods intended for human consumption in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council (OJ L 114, 31.3.2021, p. 118, ELI: http://data.europa.eu/eli/reg_impl/2021/405/oj).

Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (OJ L 139, 30.4.2004, p. 55, ELI: http://data.europa.eu/eli/reg/2004/853/oj).

Hereinafter understood as the State of Israel, excluding the territories under the administration of the State of Israel after 5 June 1967, namely the Golan Heights, the Gaza Strip, East Jerusalem and the rest of the West Bank.

ANNEX I

Annex -I to Implementing Regulation (EU) 2021/405 is replaced by the following:

‘ANNEX -I

List of third countries or regions thereof with approved control plans for certain food-producing animals and products of animal origin intended for human consumption, as referred to in Article 2a, Article 3, Article 6, first paragraph, Article 7, first paragraph, Article 10, second paragraph, Articles 11, 15, 16, 21 and Article 25, points (a) and (c)

Country ISO Code	Third country⁶ or regions thereof	Bovine	Ovine/ caprine	Porcine	Equine	Poultry	Aquaculture²²	Milk	Eggs	Rabbit	Wild game	Farmed game	Honey	Casings
AD	Andorra	X	X	Δ	X		P						X
AE	United Arab Emirates						Δ P	X⁷ O	O				X⁸
AL	Albania		X				X¹⁹ P	O	X					X
AM	Armenia						X¹⁹ P	O	O				X
AR	Argentina	X	X		X	X	X¹⁹ P	X	X	X	X	X	X	X
AU	Australia	X	X		X		X M	X	X		X	X	X	X
AZE	Azerbaijan						X²¹ P
BA	Bosnia and Herzegovina	X	X	X		X	X¹⁹ P	X	X				X
BD	Bangladesh						X P
BF	Burkina Faso												X
BJ	Benin												X
BN	Brunei						X²⁰ P	O	O
BR	Brazil	X			X	X	X P	O	O				X	X
BW	Botswana	X					P
BY	Belarus				X¹³		X¹⁹ P	X	X				X	X
BZ	Belize						X²⁰ P	O	O
CA	Canada	X	X	X	X	X	X M	X	X	X	X	X	X
CH	Switzerland¹²	X	X	X	X	X	X¹⁹ M	X	X	X	X	X	X	X
CL	Chile	X	X¹⁰	X		X	X¹⁹ M	X			X		X	X
CM	Cameroon												X
CN	China					X	X P	O	X	X			X	X
CO	Colombia						X P	O	Δ
CR	Costa Rica						X P	O	O
CU	Cuba						X²⁰ P	O	O				X
DO	Dominican Republic												X
EC	Ecuador						X P	O	O
EG	Egypt													X
ET	Ethiopia												X
FK	Falkland Islands	X	X¹⁰				X¹⁹
FO	Faroes						X¹⁹ P	O	O
GB	United Kingdom¹¹	X	X	X	X	X	X¹⁹ Δ M	X	X	Δ	X	X	X	X
GE	Georgia												X
GG	Guernsey						M	X
GL	Greenland		X¹⁰				M					X
GT	Guatemala						X²⁰ P	O	O				X
HK	Hong Kong						Δ P		Δ
HN	Honduras						X P	O	O
ID	Indonesia						X P	O	O
IL	Israel⁹					X	X¹⁹ P	X					X
IM	Isle of Man	X	X¹⁰	X			X¹⁹ M	X	O				X
IN	India					O	X P	O	X				X	X
IR	Iran						X²⁰ X²¹ P	O	O					X
JE	Jersey	X					M	X	O
JM	Jamaica						M
JP	Japan	X		Δ		X	X¹⁹ M	X	X				Δ	X
KE	Kenya						X¹⁹ P
KR	South Korea					X	X M	O	O				Δ
LB	Lebanon												X	X
LK	Sri Lanka						X P	O	O
MA	Morocco					X	X¹⁹ Δ M	O	O				X	X
MD	Moldova					X	X¹⁹ P	X	X				X
ME	Montenegro	X	X	X		X	X¹⁹ P	X	X				X	X
MG	Madagascar						X P	O	O				X
MK	North Macedonia	X	X	X		X	X¹⁹ P	X	X		X		X
MM	Myanmar/Burma						X P	O	O				X
MN	Mongolia													X
MU	Mauritius						X¹⁹ P	O	O				Δ
MX	Mexico			Δ			X P	O	X				X
MY	Malaysia					Δ	X P	O	O
MZ	Mozambique						X²⁰ P
NA	Namibia	X	X¹⁰				P				X
NC	New Caledonia						X⁶					X	X
NG	Nigeria						X²⁰ P	O	O
NI	Nicaragua						X²⁰ P						X
NZ	New Zealand	X	X	O	X	O	X¹⁹ M	X	O	O	X	X	X	X
PA	Panama						X P	O	O
PE	Peru						X M
PH	Philippines						X P	O	O
PK	Pakistan													X
PM	Saint Pierre and Miquelon					X	P
PN	Pitcairn Islands												X
PY	Paraguay	X					P							X
RS	Serbia	X	X	X	X¹³	X	X¹⁹ P	X	X	X	X		X	X
RU	Russia	X	X	X		X	O P	X	X			X¹⁴	X	X
RW	Rwanda												X
SA	Saudi Arabia						X P	O	O
SG	Singapore	Δ	Δ	Δ	X¹⁵	Δ	X¹⁹ P	Δ	Δ		X¹⁵	X¹⁵
SM	San Marino	X		Δ			O P	X	O				X
SV	El Salvador												X
SZ	Eswatini	X					P
TG	Togo												X
TH	Thailand	O		O		X	X M	Δ	Δ				X
TN	Tunisia						X¹⁹ M	O	O					X
TR	Turkey					X	X¹⁹ M	X	X				X	X
TW	Taiwan						X P	O	X				X
TZ	Tanzania						X²⁰ P	O	O				X
UA	Ukraine	X		X		X	X¹⁹ M	X	X	X			X	X
UG	Uganda												X
US	United States	X	X¹⁶	X		X	X M	X	X	X	X	X	X	X
UY	Uruguay	X	X		X		X¹⁹ M	X			X		X	X
UZ	Uzbekistan													X
VE	Venezuela						X²⁰ P	O	O
VN	Viet Nam						X M	O	O				X
WF	Wallis and Futuna												X
XK	Kosovo¹⁷					Δ
ZA	South Africa						M P				X	X¹⁸
ZM	Zambia												X

’.

List of third countries and territories (not limited to third countries recognised by the Union).

Camel milk only.

Only the region of Ras al Khaimah.

Ovine species only.

In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, for the purposes of this Annex, references to the United Kingdom do not include Northern Ireland.

In accordance with the Agreement of 21 June 1999 between the European Community and the Swiss Confederation on trade in agricultural products (OJ L 114, 30.4.2002, p. 132).

Export to the Union of live Equidae intended for slaughter (food-producing animals only).

Reindeer only.

Only for consignments of fresh meat originating from New Zealand, destined to the Union and being unloaded, with or without storage, in Singapore and being reloaded in an approved establishment during transit through Singapore.

Caprine species only.

This designation is without prejudice to positions on status and is in line with UNSCR 1244/1999 and the ICJ Opinion on the Kosovo declaration of independence.

Ratites only.

Finfish and finfish products only.

Crustaceans only.

Finfish products only (e.g. Roes and caviar).

Aquaculture covers finfish, including eels, and products of finfish (such as roes and caviar), and crustaceans. The third countries or regions thereof listed for live, chilled, frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods in Annex VIII are marked with an “M” in this column.

ANNEX II

In Annex VIII to Implementing Regulation (EU) 2021/405, the following entry for South Africa is added after the entry for Vietnam:


‘ZA	South Africa	Only marine gastropods’

ANNEX III

Annex IX to Implementing Regulation (EU) 2021/405 is amended as follows:

(a) the entry for Azerbaijan is replaced by the following:


‘AZ	Azerbaijan	Only products of finfish (caviar and roes) whether wild catch or aquaculture origin’

(b) the entry for Chile is replaced by the following:


‘CL	Chile	Aquaculture: Only finfish and caviar (product of finfish)’

ELI: http://data.europa.eu/eli/reg_impl/2024/334/oj

ISSN 1977-0677 (electronic edition)

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