Commission Decision
of 16 March 2011
on the approval of plans submitted by third countries in accordance with Article 29 of Council Directive 96/23/EC
(notified under document C(2011) 1630)
(Text with EEA relevance)
(2011/163/EU)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC1, and in particular the fourth subparagraph of Article 29(1) and Article 29(2) thereof,
Whereas:
Directive 96/23/EC lays down measures to monitor the substances and groups of residues listed in Annex I thereto. Pursuant to Directive 96/23/EC, the inclusion and retention on the lists of third countries from which Member States are authorised to import animals and animal products covered by that Directive are subject to the submission by the third countries concerned of a plan setting out the guarantees which they offer as regards the monitoring of the groups of residues and substances listed in that Annex. Those plans are to be updated at the request of the Commission, particularly when certain checks render it necessary.
Commission Decision 2004/432/EC of 29 April 2004 on the approval of residue monitoring plans submitted by third countries in accordance with Council Directive 96/23/EC2 approves the plans provided for in Article 29 of Directive 96/23/EC (the plans) submitted by certain third countries listed in the Annex thereto for the animals and animal products indicated in that list.
In the light of the recent plans submitted by certain third countries and additional information obtained by the Commission, it is necessary to update the list of third countries from which Member States are authorised to import certain animals and animal products, as provided for in Directive 96/23/EC and currently listed in the Annex to Decision 2004/432/EC (the list).
The United Arab Emirates has submitted a plan for camel milk to the Commission. That plan provides sufficient guarantees and should be approved. Therefore, camel milk should be included in the entry for the United Arab Emirates in the list.
Brunei has submitted a plan for aquaculture to the Commission. That plan provides sufficient guarantees and should be approved. Therefore, Brunei should be included in the list as regards aquaculture.
The Commission requested that the former Yugoslav Republic of Macedonia provide information on the implementation of its plan for equidae for slaughter. In the absence of a reply from the former Yugoslav Republic of Macedonia there are not sufficient guarantees for approval. The entry for that third country concerning equidae for slaughter should therefore be deleted from the list. The former Yugoslav Republic of Macedonia has been informed accordingly.
The entry for Malaysia in the list includes poultry but the plan provided by Malaysia and the additional information obtained by the Commission do not provide sufficient guarantees in respect of poultry. However, the only establishment processing such raw material currently approved in accordance with Article 12 of Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption3 imports all its raw material from a Member State. In order to permit the continuation of that activity, the entry for Malaysia should include poultry but it should be restricted to raw material imported from other third countries included in the list for such material or from Member States. Malaysia has been informed accordingly. A footnote setting out this limitation should be included in the list for that third country.
The Commission requested that Russia provide information on the implementation of its plan for equidae for slaughter. In the absence of a reply from Russia there are not sufficient guarantees for approval. The entry for that third country concerning equidae for slaughter should be deleted from the list. Russia has been informed accordingly.
The Commission requested that Ukraine provide information on the implementation of its plan for equine animals and products. In the absence of a reply from Ukraine there are not sufficient guarantees for approval. The entry for that third country concerning equine animals and products should be deleted from the list. Ukraine has been informed accordingly.
The United States has been asked to provide information on the implementation of its plan for equine animals and products. However, the United States did not provide the respective guarantees as the slaughter of equidae for export to the Union has ceased in that third country. The entry for that that third country concerning equine animals and products should therefore be deleted from the list. The United States has been informed accordingly.
A Commission inspection to Uruguay has revealed serious shortcomings concerning the implementation of the plan for rabbit and farmed game. For rabbit, there was no residue monitoring plan in place and for farmed game, no sampling or testing was possible because of a cessation in production. The entries for Uruguay concerning rabbit and farmed game should therefore be deleted from the list. Uruguay has been informed accordingly.
Certain third countries export animal products derived from raw material originating from Member States or from other third countries that comply with the provisions of Directive 96/23/EC for such materials and which are therefore included in the list. In order to ensure that animal products imported into the Union are covered by an approved plan, third countries that import such raw material for subsequent export to the Union should include a statement in their plan to that effect.
In order to avoid any disruption to trade, a transitional period should be laid down to cover the relevant consignments from the former Yugoslav Republic of Macedonia, Russia, Ukraine and Uruguay, which were dispatched to the Union before the date of application of this Decision.
Decision 2004/432/EC has been amended several times. In the interests of clarity of Union legislation, it should be repealed and replaced by this Decision.
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS DECISION:
F4Article 1
F171
Subject to paragraphs 1A to 1F, the Secretary of State may, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales) specify, in a document published for the purposes of this point—
a)
the relevant third countries who may submit relevant plans to the appropriate authority;
b)
the relevant animals and animal products for which those relevant plans are approved.
1A.
The Secretary of State may not specify under paragraph 1 any plans from the United Arab Emirates as being approved for—
a)
milk, except in the case of plans relating only to camel’s milk;
b)
products for human consumption using aquaculture animals, other than those products produced only with raw material of animal origin obtained from the United Kingdom or from third countries which have submitted a relevant plan.
1B.
The Secretary of State may not specify under paragraph 1 any plans from Russia as being approved for farmed game, other than plans relating only to farmed reindeers from the Murmansk and Yamalo-Nenets regions.
1C.
The Secretary of State may not specify under paragraph 1 any plans from Singapore as being approved for equine animals, wild game or farmed game, other than plans relating only to commodities of fresh meat originating from New Zealand, destined for Great Britain and being transited with or without storage through Singapore and unloaded and reloaded there.
1D.
The Secretary of State may not specify under paragraph 1 any plans from Bosnia and Herzegovina or Tunisia as being approved for aquaculture animals, other than plans relating only to finfish.
1E.
The Secretary of State may not specify under paragraph 1 any plans from South Africa as being approved for farmed game, other than plans relating only to ratites.
1F.
The Secretary of State may not specify under paragraph 1 any plans from Iran or New Caledonia as being approved for aquaculture animals, other than plans relating only to crustaceans.
1G.
In paragraph 1—
“relevant third country” means the third countries listed in the table set out in the Annex;
“relevant animals and animal products” means the animals and animal products set out in the table in the Annex;
“relevant plans” means the plans provided for in Article 29 of Directive 96/23/EC or under the correlating provisions of, or under, Regulation (EU) 2017/625.
2
F18In this Decision, “appropriate authority” means the Secretary of State (in relation to England), the Welsh Ministers (in relation to Wales) and the Scottish Ministers (in relation to Scotland); but the “appropriate authority” is the Secretary of State if consent is given by:
a
in relation to Wales, the Welsh Ministers;
b
in relation to Scotland, the Scottish Ministers.
3
In this Decision, “third country” means any country or territory other than the British Islands.
Article 2
1
Third countries using raw material imported from other third countries approved for production of food of animal origin in accordance with this Decision F5... to be exported to F6Great Britain and which are unable to provide a residue monitoring plan equivalent to that required by Article 7 of Directive 96/23/EC F7or under the correlating provisions of Regulation (EU) 2017/625 for such raw material shall complement the plan with the following statement:
The competent authority of [third country] ensures that animal products for human consumption exported to F8Great Britain, in particular products produced from raw material imported into [third country], shall only come from establishments approved in accordance F9with Article 126 of Regulation (EU) 2017/625 and having reliable procedures in place to guarantee that raw material of animal origin used in such food originates only from F10the United Kingdom or third countries listed for the respective raw material in the Annex to Commission Decision 2011/163/EU without a restrictive footnote as provided for in Article 2(2) of the Decision.
F192
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Article 2aF15Matters relating to the exercise of powers under this Decision
1.
The powers exercisable by the Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), under Article 1(1)(a) and (b) may be exercised only where it is necessary or appropriate to do so in the light of an assessment of the risk to animal or public health in the United Kingdom, taking into account the matters specified in this Article.
2.
Any assessment which is relied on for the purposes of paragraph 1 must be appropriate to the circumstances and have been approved by the Secretary of State, the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales).
3.
For the purpose of submission for approval under paragraph 2, an assessment of a residue monitoring plan submitted by the central competent authority of the third country must take into account the extent to which it complies with the regulatory requirements in the United Kingdom and must set out the following information—
a)
legislation on the use of the substances listed in Annex 1 to Directive 96/23/EC and, in particular, provisions on their prohibition or authorisation, distribution and placing on the market and the rules governing their administration, in so far as that legislation is different from that in force in the United Kingdom;
b)
the infrastructure of the relevant competent authorities in the third country (with, in particular, details of the type and size of the bodies involved in implementing the plans);
c)
a list of approved laboratories, with details of their capacity for processing samples;
d)
national tolerances for authorised substances in cases where no maximum United Kingdom residue levels have been set under Regulation (EC) No 470/2009;
e)
a list of the substances to be detected, methods of analysis, standards for interpreting the findings and, in the case of the substances listed in Annex 1 to Directive 96/23/EC, the number of samples to be taken, and the reasons for this number;
f)
the number of official samples to be taken in relation to the number of animals of the species concerned slaughtered in preceding years in accordance with the frequencies laid down in Annex 4 to Directive 96/23/EC;
g)
details of the rules governing the collection of official samples, and in particular the rules concerning the particulars to appear on official samples;
h)
the type of measures laid down by the competent authorities in the third country with regard to animals or products in which residues have been detected;
i)
confirmation that the relevant competent authority of the third country coordinates the activities of the central and regional departments responsible for monitoring the various residues to prevent the fraudulent or unlawful use of substances or products on stock farms;
j)
confirmation that the relevant competent authority of the third country collects residue monitoring data needed to evaluate the means used and the results, and will supply a report of the data to the Secretary of State, the Scottish Ministers and the Welsh Ministers annually by 31st March each year.
4.
The plan must provide for the detection of groups of residues or substances according to type of animal, in accordance with Annex 2 to Directive 96/23/EC, and in accordance with the sampling rules and levels set down in Annex 3 and Annex 4 to that Directive, and must specify in particular the measures for the detection of—
a)
the relevant substances in animals in accordance with Annex 2 to that Directive, or in the drinking water, and in all places where animals are bred or kept;
b)
residues of such substances found in live animals, their excrement and body fluids or in animal tissues, meat, milk, eggs or honey.
5.
Compliance with the requirements of, and adherence to the assurances offered by, the plans submitted by third countries must be verified by means of checks carried out by the relevant competent authority in the third country, and, where such checks reveal the use of unauthorised products or substances for the treatment of the animals in a given batch, or the presence of such products or substances in all or part of a batch originating in the same establishment, the Secretary of State, the Scottish Ministers and the Welsh Ministers may—
a)
impose remedial measures, after making enquiries of the competent authorities of the third country and concluding that the third country has failed to fulfil its obligations and the assurances in the residue monitoring plan;
b)
send United Kingdom experts to visit the third country, at that country’s expense, in order to verify that remedial measures have been taken.
6.
A third country (“TC1”) using raw material imported from another third country approved for production of food of animal origin in accordance with Commission Decision 2011/163/EU and which is unable to provide a residue monitoring plan, must provide an assurance that animal products for human consumption exported to Great Britain must only come from establishments approved by the competent authority of TC1 as having reliable procedures in place.
7.
Where the Scottish Ministers or the Welsh Ministers request that the Secretary of State exercise a power under Article 1(1)(a) or (b) the Secretary of State must have regard to that request.
F11Article 3
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Article 4
Decision 2004/432/EC is repealed.
Article 5
F12...
It shall apply from 15 March 2011.
C1F1ANNEX
Word in Annex Table omitted (1.7.2022) by virtue of The Import of Animals and Animal Products and Approved Countries (Amendment) Regulations 2022 (S.I. 2022/735), regs. 1(2), 12(5)
Word in Annex inserted (E.W.S.) (31.12.2020) by The Import of, and Trade in, Animals and Animal Products (Miscellaneous Amendments) (EU Exit) Regulations 2020 (S.I. 2020/1462), regs. 1(3), 59(5)(a)(i) (with regs. 69-71)
Words in Annex inserted (E.W.S.) (31.12.2020) by The Import of, and Trade in, Animals and Animal Products (Miscellaneous Amendments) (EU Exit) Regulations 2020 (S.I. 2020/1462), regs. 1(3), 59(5)(a)(ii) (with regs. 69-71)
Words in Annex inserted (E.W.S.) (28.3.2021) by The Approved Country Lists (Animals and Animal Products) (Amendment) Regulations 2021 (S.I. 2021/211), regs. 1(2), 7(2)(a)
Words in Annex omitted (E.W.S.) (28.3.2021) by virtue of The Approved Country Lists (Animals and Animal Products) (Amendment) Regulations 2021 (S.I. 2021/211), regs. 1(2), 7(2)(b)
Annex: power to amend conferred (31.12.2020) by The Trade in Animals and Animal Products (Legislative Functions) and Veterinary Surgeons (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1225), regs. 1(3), 12; 2020 c. 1, Sch. 5 para. 1(1)
Code ISO2 | Country | Bovine | Ovine/caprine | Porcine | Equine | Poultry | Aqua-culture | Milk | Eggs | Rabbit | Wild game | Farmed game | Honey |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
AD | Andorra | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | |||||||
AE | United Arab Emirates | F16. . . | F16. . . | ||||||||||
AL | Albania | F16. . . | F16. . . | F16. . . | |||||||||
AM | Armenia | F16. . . | F16. . . | ||||||||||
AR | Argentina | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | |
AU | Australia | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | ||||
BA | Bosnia and Herzegovina | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | ||||
BD | Bangladesh | F16. . . | |||||||||||
BF | Burkina Faso | F16. . . | |||||||||||
BJ | Benin | F16. . . | |||||||||||
BN | Brunei | F16. . . | |||||||||||
BR | Brazil | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | |||||||
BW | Botswana | F16. . . | |||||||||||
BY | Belarus | F16. . . | F16. . . | F16. . . | F16. . . | ||||||||
BZ | Belize | F16. . . | |||||||||||
CA | Canada | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . |
CH | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | |
CL | Chile | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | ||||
CM | Cameroon | F16. . . | |||||||||||
CN | China | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | |||||||
CO | Colombia | F16. . . | F16. . . | ||||||||||
CR | Costa Rica | F16. . . | |||||||||||
CU | Cuba | F16. . . | F16. . . | ||||||||||
DO | Dominican Republic | F16. . . | |||||||||||
EC | Ecuador | F16. . . | |||||||||||
ET | Ethiopia | F16. . . | |||||||||||
FK | Falklands Islands | F16. . . | F16. . . | F16. . . | |||||||||
FO | Faeroe Islands | F16. . . | |||||||||||
GH | Ghana | F16. . . | |||||||||||
GE | Georgia | F16. . . | |||||||||||
GL | Greenland | F16. . . | F16. . . | ||||||||||
GT | Guatemala | F16. . . | F16. . . | ||||||||||
HN | Honduras | F16. . . | |||||||||||
F13IS | Iceland (13) | ||||||||||||
ID | Indonesia | F16. . . | |||||||||||
IL | Israel 8 | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | ||||||
IN | India | F16. . . | F16. . . | F16. . . | |||||||||
IR | Iran | F16. . . | |||||||||||
JM | Jamaica | F16. . . | |||||||||||
JP | Japan | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | ||||||
KE | Kenya | F16. . . | |||||||||||
KG | Kyrgyzstan | F16. . . | |||||||||||
KR | South Korea | F16. . . | F16. . . | ||||||||||
LK | Sri Lanka | F16. . . | |||||||||||
MA | Morocco | F16. . . | F16. . . | ||||||||||
MD | Moldova | F16. . . | F16. . . | F16. . . | F16. . . | ||||||||
ME | Montenegro | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | ||||
MG | Madagascar | F16. . . | F16. . . | ||||||||||
MKD | North Macedonia | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | |||
MM | Republic of the Union of Myanmar | F16. . . | F16. . . | ||||||||||
MU | Mauritius | F16. . . | F16. . . | ||||||||||
MX | Mexico | F16. . . | F16. . . | F16. . . | |||||||||
MY | Malaysia | F16. . . | F16. . . | ||||||||||
MZ | Mozambique | F16. . . | |||||||||||
NA | Namibia | F16. . . | F16. . . | ||||||||||
NC | New Caledonia | F16. . . | F16. . . | F16. . . | |||||||||
NI | Nicaragua | F16. . . | F16. . . | ||||||||||
NZ | New Zealand | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | ||||
PA | Panama | F16. . . | |||||||||||
PE | Peru | F16. . . | |||||||||||
PH | Philippines | F16. . . | |||||||||||
PM | Saint Pierre and Miquelon | F16. . . | |||||||||||
PN | Pitcairn Islands | F16. . . | |||||||||||
PY | Paraguay | F16. . . | |||||||||||
RS | Serbia | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | ||
RU | Russia | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | ||||
RW | Rwanda | F16. . . | |||||||||||
SA | Saudi Arabia | F16. . . | |||||||||||
SG | Singapore | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | |||
SL | Sierra Leone | F16. . . | |||||||||||
SM | San Marino | F16. . . | F16. . . | F16. . . | F16. . . | ||||||||
SV | El Salvador | F16. . . | |||||||||||
SZ | Eswatini | F16. . . | |||||||||||
TH | Thailand | F16. . . | F16. . . | F16. . . | |||||||||
TN | Tunisia | F16. . . | F16. . . | ||||||||||
TR | Turkey | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | |||||||
TW | Taiwan | F16. . . | F16. . . | ||||||||||
TZ | Tanzania | F16. . . | F16. . . | ||||||||||
UA | Ukraine | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | ||||
UG | Uganda | F16. . . | F16. . . | ||||||||||
US | United States | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | |
UY | Uruguay | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | F16. . . | |||||
VE | Venezuela | F16. . . | |||||||||||
VN | Vietnam | F16. . . | F16. . . | ||||||||||
ZA | South Africa | F16. . . | F16. . . | ||||||||||
XK | Kosovo | F16. . . | |||||||||||
ZM | Zambia | F16. . . | |||||||||||
Hereafter understood as the State of Israel, excluding the territories under Israeli administration since June 1967, namely the Golan Heights, the Gaza Strip, East Jerusalem and the rest of the West Bank. | |||||||||||||
This is subject to any specific certification requirements for imports F14... in such form as the Secretary of State may, with the consent of the appropriate authority, publish from time to time. | |||||||||||||
Substituted by Commission Implementing Decision (EU) 2020/1141 of 29 July 2020 amending Decision 2011/163/EU on the approval of residue monitoring plans submitted by third countries in accordance with Article 29 of Council Directive 96/23/EC (notified under document number C(2020) 5076) (Text with EEA relevance).