COMMISSION IMPLEMENTING REGULATION (EU) No 209/2014  
of 5 March 2014  
amending Regulation (EU) No 605/2010 as regards animal and public health and veterinary 
certification conditions for the introduction of colostrum and colostrum-based products intended 
for human consumption into the Union  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European 
Union,  
Having regard to Council Directive 2002/99/EC of 16 December 
2002 laying down the animal health rules governing the 
production, processing, distribution and introduction of 
products of animal origin for human consumption (  1 ), and in 
particular the introductory phrase of Article 8, the first 
subparagraph of point (1) and point (4) of Article 8 and 
Article 9(4) thereof,  
Having regard to 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 (  2 ), and in 
particular the second paragraph of Article 9 thereof,  
Having regard to 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 consumption (  3 ), 
and in particular Articles 11(1) and the second paragraph of 
Article 16 thereof,  
Whereas:  
(1) Regulation (EC) No 853/2004 lays down specific rules 
for food business operators on the hygiene of food of 
animal origin. That Regulation provides that food 
business operators producing raw milk and dairy 
products and colostrum and colostrum-based products 
intended for human consumption are to comply with 
the relevant provisions of Annex III thereto.  
(2) In addition, Regulation (EC) No 853/2004 provides that 
food business operators importing products of animal 
origin from third countries are to ensure that 
importation takes place only, if the third country of 
dispatch appears on a list drawn up in accordance with 
Regulation (EC) No 854/2004 and the products satisfy, 
inter alia, the requirements of Regulation (EC) No 
853/2004 and any import conditions laid down in 
accordance with Union legislation governing import 
controls for products of animal origin.  (3) Commission Regulation (EU) No 605/2010 (  4 ) lays down 
the public and animal health conditions and the certifi ­
cation requirements for the introduction of consignments 
of raw milk and dairy products into the Union. It also 
lays down the list of third countries from which the 
introduction of such consignments into the Union is 
authorised.  
(4) Regulation (EU) No 605/2010 establishes different 
import conditions depending on the animal health 
status of the exporting third country as regards foot- 
and-mouth disease (FMD) and rinderpest. Third 
countries which are free from FMD without vaccination 
and rinderpest for the period for at least 12 months prior 
to import are listed in column A of Annex I to Regu ­
lation (EU) No 605/2010 and imports into the Union of 
raw milk and dairy products, derived from raw milk 
from those third countries, are authorised without 
having undergone a specific treatments.  
(5) The Commission received several requests from some 
Member States and trade partners to establish animal 
health conditions for the imports of colostrum and 
colostrum-based products for human consumption into 
the Union.  
(6) Regulation (EU) No 605/2010 does not apply to 
colostrum and colostrum-based products. However, 
colostrum represents the same animal health risks as 
raw milk for FMD. Colostrum can therefore be safely 
imported from countries which are already authorised 
for import of raw milk and listed in listed in column 
A of Annex I to Regulation (EU) No 605/2010.  
(7) Several commercial products are made of pasteurised or 
sterilised colostrum. However, since the effects of 
pasteurisation and sterilisation have not been validated 
for colostrum which has a high cell content, pasteurised 
or sterilised colostrum and colostrum-based products 
should only be imported from those third countries 
which are free from FMD without vaccination, listed in 
column A of Annex I to Regulation (EU) No 605/2010.  
(8) Articles 11, 12 and 13 of Council Directive 97/78/EC (  5 ) 
lay down the rules and conditions for the checks to be 
applied to consignment of products of animal originEN 6.3.2014 Official Journal of the European Union L 66/11  
( 1 ) OJ L 18, 23.1.2003, p. 11.  
( 2 ) OJ L 139, 30.4.2004, p. 55.  
( 3 ) OJ L 139, 30.4.2004, p. 206.  ( 4 ) Commission Regulation (EU) No 605/2010 of 2 July 2010 laying 
down animal and public health and veterinary certification 
conditions for the introduction into the European Union of raw 
milk and dairy products intended for human consumption 
(OJ L 175, 10.7.2010, p. 1).  
( 5 ) Council Directive 97/78/EC of 18 December 1997 laying down the 
principles governing the organisation of veterinary checks on 
products entering the Community from third countries (OJ L 24, 
30.1.1998, p. 9).imported into the Union but destined for a third country 
either by immediate transit or after storage in the Union.  
(9) In order to allow the introduction of colostrum and 
colostrum-based products into the Union, a new model 
health certificate for such commodities should be added 
in Part 2 of Annex II to Regulation (EU) No 605/2010 
and the model health certificate for raw milk and dairy 
products for human consumption intended for transit 
through or storage in the Union set out in Part 3 of 
Annex II to that Regulation should be amended in 
order to cover colostrum and colostrum-based products.  
(10) In order to include colostrum and colostrum-based 
products in the scope of the Common Veterinary Entry 
Document referred to in Article 2(1) of Commission 
Regulation (EC) No 136/2004 (  1 ), it is necessary to 
provide in the model of health certificates covering 
such products the appropriate Harmonised System code 
listed in Chapter 4 of Annex I to Commission Decision 
2007/275/EC (  2 ). 
(11) To avoid any disruption in trade, the use of animal 
health certificate for raw milk and dairy products for 
human consumption, intended for transit through or 
storage in the Union, issued in accordance with Regu ­
lation (EU) No 605/2010, should be authorised during a 
transitional period.  
(12) Regulation (EU) No 605/2010 should therefore be 
amended accordingly.  
(13) 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  
Amendments to Regulation (EU) No 605/2010  
Regulation (EU) No 605/2010 is amended as follows:  
(1) the title is replaced by the following:  
‘COMMISSION REGULATION (EU) No 605/2010  
of 2 July 2010  
laying down animal and public health and veterinary 
certification conditions for the introduction into the 
European Union of raw milk, dairy products, colostrum 
and colostrum-based products intended for human 
consumption ’; 
(2) in Article 1, point (a) of the first paragraph is replaced by 
the following:  ‘(a) the public and animal health conditions and certification 
requirements for the introduction into the European 
Union of consignments of raw milk, dairy products, 
colostrum and colostrum-based products;’;  
(3) Article 2 is replaced by the following:  
‘Article 2  
Importation of raw milk, dairy products, colostrum and 
colostrum-based products from third countries or parts 
thereof listed in column A of Annex I  
Member States shall authorise the importation of 
consignments of raw milk, dairy products, colostrum and 
colostrum-based products from the third countries or parts 
thereof listed in column A of Annex I.’;  
(4) Article 6 is replaced by the following:  
‘Article 6  
Transit and storage conditions  
The introduction into the European Union of consignments 
of raw milk, dairy products, colostrum and colostrum-based 
products not intended for importation into the European 
Union but destined for a third country either by immediate 
transit or after storage in the Union, in accordance with 
Articles 11, 12 or 13 of Directive 97/78/EC, shall only be 
authorised if the consignments comply with the following 
conditions:  
(a) they come from a third country or part thereof listed in 
Annex I for the introduction into the European Union 
of consignments of raw milk, dairy products, colostrum 
or colostrum-based products and comply with the 
appropriate treatment conditions for such consign ­
ments, as provided for in Articles 2, 3 and 4;  
(b) they comply with the specific animal health conditions 
for importation into the European Union of the raw 
milk, dairy products, colostrum or colostrum-based 
products concerned, as laid down in the animal health 
attestation in point II.1 of the relevant model health 
certificate set out in Part 2 of Annex II;  
(c) they are accompanied by a health certificate drawn up 
in accordance with the appropriate model set out in Part 
3 of Annex II for the consignment concerned and 
completed in accordance with the explanatory notes 
set out in Part 1 of that Annex;  
(d) they are certified as acceptable for transit, including for 
storage as appropriate, on the Common Veterinary 
Entry Document referred to in Article 2(1) of Regulation 
(EC) No 136/2004, signed by the official veterinarian of 
the border inspection post of introduction into the 
Union.’;EN L 66/12 Official Journal of the European Union 6.3.2014  
( 1 ) Commission Regulation (EC) No 136/2004 of 22 January 2004 
laying down procedures for veterinary checks at Community 
border inspection posts on products imported from third countries 
(OJ L 21, 28.1.2004, p. 11).  
( 2 ) Commission Decision 2007/275/EC of 17 April 2007 concerning 
lists of animals and products to be subject to controls at border 
inspection posts under Council Directives 91/496/EEC and 97/78/EC 
(OJ L 116, 4.5.2007, p. 9).(5) Article 8 is replaced by the following:  
‘Article 8  
Specific treatment  
Consignments of dairy products and colostrum-based 
products authorised for introduction into the European 
Union in accordance with Articles 2, 3, 4,6 or 7 from 
third countries or parts thereof where an outbreak of 
foot-and-mouth disease has occurred within the period of 
12 months preceding the date of signature of the health 
certificate, or which have carried out vaccination against 
that disease during that period, shall only be authorised 
for introduction into the European Union if such products 
have undergone one of the treatments listed in Article 4.’;  
(6) Annexes I and II are amended in accordance with the 
Annex to this Regulation.  Article 2  
Transitional provisions  
For a transitional period until 6 September 2014 the intro ­
duction into the European Union of consignments of raw 
milk and dairy products not intended for importation into 
the European Union but destined for a third country either 
by immediate transit or after storage in the Union, in 
accordance with Articles 11, 12 or 13 of Directive 97/78/EC, 
accompanied by a health certificate conforming to the model 
set out in Part 2 of Annex II to Regulation (EU) No 605/2010, 
in its version prior to the entry into force of this Regulation, 
shall be authorised, provided that the certificate has been signed 
within 26 July 2014.  
Article 3  
Entry into force  
This Regulation shall enter into force on the twentieth day 
following that of its publication in the  Official Journal of the 
European Union.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels, 5 March 2014.  
For the Commission  
The President  
José Manuel BARROSOEN 6.3.2014 Official Journal of the European Union L 66/13ANNEX  
Annexes I and II to Regulation (EU) No 605/2010 are amended as follows:  
(1) Annex I is replaced by the following:  
‘ANNEX I  
List of third countries or parts thereof authorised for the introduction into the European Union of consignments of raw 
milk, dairy products, colostrum (*) and colostrum-based products (*) and indicating the type of heat treatment required for 
such commodities  
“+”: third country is authorised  
“0”: third country is not authorised  
ISO code of 
third country  Third country or part thereof  Column A  Column B  Column C  
AE The Emirate of Dubai of the United Arab 
Emirates (  1 ) 0 0  + (  2 ) 
AD Andorra  +  +  +  
AL Albania  0  0  +  
AR Argentina  0  0  +  
AU Australia  +  +  +  
BR Brazil  0  0  +  
BW Botswana  0  0  +  
BY Belarus  0  0  +  
BZ Belize  0  0  +  
BA Bosnia and Herzegovina  0  0  +  
CA Canada  +  +  +  
CH Switzerland (**)  +  +  +  
CL Chile  0  +  +  
CN China  0  0  +  
CO Colombia  0  0  +  
CR Costa Rica  0  0  +  
CU Cuba  0  0  +  
DZ Algeria  0  0  +  
ET Ethiopia  0  0  +  
GL Greenland  0  +  +  
GT Guatemala  0  0  +  
HK Hong Kong  0  0  +  
HN Honduras  0  0  +  
IL Israel  0  0  +EN L 66/14 Official Journal of the European Union 6.3.2014ISO code of 
third country  Third country or part thereof  Column A  Column B  Column C  
IN India  0  0  +  
IS Iceland  +  +  +  
KE Kenya  0  0  +  
MA Morocco  0  0  +  
MG Madagascar  0  0  +  
MK (***)  former Yugoslav Republic of Macedonia  0  +  +  
MR Mauritania  0  0  +  
MU Mauritius  0  0  +  
MX Mexico  0  0  +  
NA Namibia  0  0  +  
NI Nicaragua  0  0  +  
NZ New Zealand  +  +  +  
PA Panama  0  0  +  
PY Paraguay  0  0  +  
RS (****)  Serbia  0  +  +  
RU Russia  0  0  +  
SG Singapore  0  0  +  
SV El Salvador  0  0  +  
SZ Swaziland  0  0  +  
TH Thailand  0  0  +  
TN Tunisia  0  0  +  
TR Turkey  0  0  +  
UA Ukraine  0  0  +  
US United States  +  +  +  
UY Uruguay  0  0  +  
ZA South Africa  0  0  +  
ZW  Zimbabwe  0  0  +  
(*) The colostrum and colostrum-based products can only be introduced into the European Union from countries authorised in colu mn 
A. 
(**) Certificates in accordance with the Agreement between the European Community and the Swiss Confederation on trade in 
agricultural products (OJ L 114, 30.4.2002, p. 132). 
(***) The former Yugoslav Republic of Macedonia; the definit ive nomenclature for this country will be agreed following the conc lusion of 
the negotiations currently taking place on this subject at UN level. 
(****) Not including Kosovo which is at present under international administration pursuant to United Nations Security Council Resolution 
1244 of 10 June 1999. 
( 1 ) Only dairy products from camels of the species  Camelus dromedarius.  
( 2 ) Dairy products from camels of the species  Camelus dromedarius  are authorised.’EN 6.3.2014 Official Journal of the European Union L 66/15(2) Annex II is amended as follows:  
(a) Part 1 is replaced by the following:  
‘PART 1  
Models of health certificates  
“Milk-RM”: Health certificate for raw milk from third countries or parts thereof authorised in 
column A of Annex I intended for further processing in the European Union before 
being used for human consumption.  
“Milk-RMP”: Health certificate for dairy products derived from raw milk for human consumption, 
from third countries or parts thereof authorised in column A of Annex I intended for 
importation into the European Union.  
“Milk-HTB”: Health certificate for dairy products derived from milk of cows, ewes, goats and buffaloes 
for human consumption from third countries or parts thereof authorised in column B of 
Annex I intended for importation into the European Union.  
“Milk-HTC”: Health certificate for dairy products for human consumption from third countries or 
parts thereof authorised in column C of Annex I intended for importation into the 
European Union.  
“Colostrum-C/CPB”: Health certificate for colostrum of cows, ewes, goats and buffaloes and colostrum-based 
products derived from colostrum of the same species from third countries or parts 
thereof listed in column A of Annex I for human consumption intended for importation 
into the European Union.  
“Milk/ Colostrum-T/S”: Animal health certificate for raw milk, colostrum, dairy products or colostrum-based 
products for human consumption, intended for transit through or storage in the 
European Union.  
Explanatory notes  
(a) The health certificates shall be issued by the competent authorities of the third country of origin, in 
accordance with the appropriate model set out in Part 2 of this Annex, according to the layout of the 
model that corresponds to the raw milk, colostrum, dairy products or colostrum-based products concerned. 
They shall contain, in the numbered order that appears in the model, the attestations that are required for 
any third country and, as the case may be, those supplementary guarantees that are required for the 
exporting third country concerned.  
(b) The original of the health certificate shall consist of a single sheet printed on either pages or, where more 
text is required, such that all the sheets form a whole and cannot be separated.  
(c) A separate, single health certificate must be presented for each consignment of the commodity concerned, 
exported to the same destination from a third country listed in the table in Annex I and transported in the 
same railway wagon, road vehicle, aircraft or ship.  
(d) The original of the health certificate and the labels referred to in the model certificate shall be drawn up in at 
least one official language of the Member State where border inspection takes place and of the Member State 
of destination. However, those Member States may allow it to be drawn up in another official language of 
the European Union instead of their own, accompanied, if necessary, by an official translation.  
(e) Where additional sheets are attached to the health certificate for the purpose of identifying the commodities 
making up the consignment, such additional sheets shall also be considered to form part of the original 
certificate, provided the signature and stamp of the certifying official veterinarian appear on each page.  
(f) Where the health certificate comprises more than one page, each page shall be numbered “–x (page number)  of 
y(total number of pages) –” on the bottom of the page and shall bear the certificate reference number allocated 
by the competent authority on the top of the page.  
(g) The original of the health certificate must be completed and signed by a representative of the competent 
authority responsible for verifying and certifying that the raw milk, colostrum, dairy products or colostrum- 
based products meet the health conditions laid down in Section IX of Chapter I of Annex III to Regulation 
(EC) No 853/2004 and in Directive 2002/99/EC.  
(h) The competent authorities of the exporting third country shall ensure that principles of certification 
equivalent to those laid down in Council Directive 96/93/EC (  1 ) are complied with.EN L 66/16 Official Journal of the European Union 6.3.2014(i) The colour of the signature of the official veterinarian shall be different from that of the printing on the 
health certificate. That requirement shall also apply to stamps other than embossed stamps or watermarks.  
(j) The original of the health certificate must accompany the consignment until it reaches the border inspection 
post of introduction into the European Union.  
(k) Where the model certificate states that certain statements shall be kept as appropriate, statements which are 
not relevant, may be crossed out and initialled and stamped by the certifying officer, or completely deleted 
from the certificate.  
___________  
( 1 ) OJ L 13, 16.1.1997, p. 28.’EN 6.3.2014 Official Journal of the European Union L 66/17(b) in Part 2, the following model certificate is added:
EN L 66/18 Official Journal of the European Union 6.3.2014EN 6.3.2014 Official Journal of the European Union L 66/19EN L 66/20 Official Journal of the European Union 6.3.2014(c) Part 3, is replaced by the following:  
‘PART 3
EN 6.3.2014 Official Journal of the European Union L 66/21EN L 66/22 Official Journal of the European Union 6.3.2014EN 6.3.2014 Official Journal of the European Union L 66/23