COMMISSION REGULATION (EU) No 211/2013  
of 11 March 2013  
on certification requirements for imports into the Union of sprouts and seeds intended for the 
production of sprouts  
(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 48(1) thereof,  
Whereas:  
(1) Regulation (EC) No 882/2004 lays down general rules 
for the performance of official controls to verify 
compliance with rules aiming, in particular, at 
preventing, eliminating or reducing to acceptable levels 
risks to humans and animals either directly or through 
the environment.  
(2) Regulation (EC) No 178/2002 of the European 
Parliament and of the Council of 28 January 2002 
laying down the general principles and requirements of 
food law, establishing the European Food Safety 
Authority and laying down procedures in matters of 
food safety (  2 ), lays down the general principles 
governing food and feed in general, and food and feed 
safety in particular, at Union and national level. That 
Regulation provides that food and feed imported into 
the Union for placing on the market within the Union 
is to comply with the relevant requirements of food law 
or conditions recognised by the Union to be at least 
equivalent thereto.  
(3) Regulation (EC) No 852/2004 of the European 
Parliament and of the Council of 29 April 2004 on 
the hygiene of foodstuffs (  3 ) lays down general rules for 
food business operators on the hygiene of foodstuffs. 
That Regulation provides that food business operators 
are to ensure that all stages of production, processing 
and distribution of food under their control satisfy the 
relevant hygiene requirements laid down therein. In 
particular, Regulation (EC) No 852/2004 provides that 
food business operators carrying out primary production 
and those associated operations listed in Annex I thereto 
are to comply with the general hygiene provisions laid 
down in Part A of that Annex.  (4) Following the outbreak of Shiga toxin-producing  E. coli  
(STEC) in May 2011 in the Union, the consumption of 
sprouted seeds was identified as the most likely origin of 
the outbreaks.  
(5) On 20 October 2011, the European Food Safety 
Authority (‘EFSA’) adopted a Scientific Opinion on the 
risk posed by Shiga toxin-producing  Escherichia coli  
(STEC) and other pathogenic bacteria in seeds and 
sprouted seeds (  4 ). In its Opinion, EFSA concludes that 
the contamination of dry seeds with bacterial pathogens 
is the most likely initial source of the sprout-associated 
outbreaks. In addition, the Opinion states that, due to the 
high humidity and the favourable temperature during 
sprouting, bacterial pathogens present on dry seeds can 
multiply during sprouting and result in a public health 
risk.  
(6) In order to ensure the protection of public health in the 
Union and in view of that EFSA Opinion, Commission 
Implementing Regulation (EU) No 208/2013 (  5 ) was 
adopted. That implementing Regulation lays down rules 
on the traceability of consignments of sprouts and of 
seeds intended for the production of sprouts.  
(7) In order to ensure an adequate level of protection of 
public health, it is appropriate that sprouts and seeds 
intended for the production of sprouts imported into 
the Union also comply with the requirements laid 
down in Regulation (EC) No 852/2004, and, for 
sprouts, with the traceability requirements laid down in 
Implementing Regulation (EU) No 208/2013 and with 
the microbiological criteria laid down in Commission 
Regulation (EC) No 2073/2005 (  6 ). Appropriate certifi ­
cation requirements should therefore be laid down for 
such commodities imported into the Union.  
(8) Currently Union legislation does not provide for 
certificates for the import into the Union of sprouts 
and of seeds intended for the production of sprouts. It 
is therefore appropriate to set out in this Regulation a 
model certificate for the import of such commodities 
into the Union.  
(9) The measures provided for in this Regulation are in 
accordance with the opinion of the Standing 
Committee on the Food Chain and Animal Health and 
neither the European Parliament nor the Council has 
opposed them,EN L 68/26 Official Journal of the European Union 12.3.2013  
( 1 ) OJ L 165, 30.4.2004, p. 1.  
( 2 ) OJ L 31, 1.2.2002, p. 1.  
( 3 ) OJ L 139, 30.4.2004, p. 1.  ( 4 ) EFSA Journal  2011; 9(11):2424.  
( 5 ) See page 16 of this Official Journal.  
( 6 ) OJ L 338, 22.12.2005, p. 1.HAS ADOPTED THIS REGULATION:  
Article 1  
Scope  
This Regulation shall apply to consignments of sprouts or seeds 
intended for the production of sprouts imported into the Union 
excluding sprouts which have undergone a treatment which 
eliminates microbiological hazards compatible with European 
Union legislation.  
Article 2  
Definitions  
For the purposes of this Regulation:  
(a) the definition of ‘sprouts’ in Article 2(a) of Implementing 
Regulation (EU) No 208/2013 shall apply;  
(b) ‘consignment’ means a quantity of sprouts or seeds intended 
for the production of sprouts and which is:  
(i) originating from the same third country;  
(ii) covered by the same certificate(s);  
(iii) conveyed by the same means of transport.  
Article 3  
Certification requirement  
1. Consignments of sprouts or seeds intended for the 
production of sprouts imported into the Union and originating 
in or dispatched from third countries shall be accompanied by a 
certificate in accordance with the model set out in the Annex, 
attesting that the sprouts or seeds were produced under 
conditions which comply with the general hygiene provisions 
for primary production and associated operations set out in Part 
A of Annex I to Regulation (EC) No 852/2004 and the sprouts 
were produced under conditions which comply with the tracea ­bility requirements laid down in Implementing Regulation (EU) 
No 208/2013, have been produced in establishments approved 
in accordance with the requirements laid down in Article 2 of 
Commission Regulation (EU) No 210/2013 (  1 ) and respect the 
microbiological criteria laid down in Annex I to Regulation (EC) 
No 2073/2005.  
The certificate must be drawn up in the official language or 
languages of the third country of dispatch and the Member 
State in which the import into the EU takes place, or be accom ­
panied by a certified translation into that language or languages. 
If the Member State of destination so requests, certificates must 
also be accompanied by a certified translation into the official 
language or languages of that Member State. However, a 
Member State may consent to the use of an official Union 
language other than its own.  
2. The original of the certificate shall accompany the 
consignment until it reaches its destination as indicated in the 
certificate.  
3. In the case of splitting of the consignment, a copy of the 
certificate shall accompany each part of the consignment.  
Article 4  
Transitional provision  
For a transitional period until 1 July 2013, consignments of 
sprouts or seeds intended for the production of sprouts orig ­
inating in or dispatched from third countries may continue to 
be imported into the Union without the certificate provided for 
in Article 3.  
Article 5  
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, 11 March 2013.  
For the Commission  
The President  
José Manuel BARROSOEN 12.3.2013 Official Journal of the European Union L 68/27  
( 1 ) See page 24 of this Official Journal.ANNEX  
MODEL CERTIFICATE FOR THE IMPORT OF SPROUTS OR SEEDS INTENDED FOR THE PRODUCTION OF 
SPROUTS
EN L 68/28 Official Journal of the European Union 12.3.2013EN 12.3.2013 Official Journal of the European Union L 68/29