COMMISSION IMPLEMENTING REGULATION (EU) No 208/2013  
of 11 March 2013  
on traceability requirements for 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 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 (  1 ), and in particular 
Article 18(5) thereof,  
Whereas:  
(1) Regulation (EC) No 178/2002 lays down the general 
principles governing food and feed in general, and food 
and feed safety in particular, at Union and national level. 
Article 18 of that Regulation provides that the tracea ­
bility of food, feed, food-producing animals, and any 
other substance intended to be, or expected to be, incor ­
porated into a food or feed is to be established at all 
stages of production, processing and distribution.  
(2) That Article also provides that food business operators 
must be able to identify any person from whom they 
have been supplied with food and they are also to have 
in place systems and procedures to identify the other 
businesses to which their products have been supplied. 
That information is to be made available to the 
competent authority upon demand.  
(3) Following the outbreak of Shiga toxin-producing  E. coli  
(STEC) in May 2011 in the Union, consumption of 
sprouts was identified as the most likely origin of the 
outbreaks.  
(4) 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 (  2 ). 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.  
(5) Traceability is an efficient tool ensuring food safety, since 
it allows tracing a food through all stages of production, 
processing and distribution, thereby allowing rapid 
reaction in case of food-borne outbreaks. In particular, 
traceability of certain food of non-animal origin may 
assist in the removal of unsafe food from the market, 
thereby protecting consumers.  
(6) In order to ensure the traceability pursuant to Article 18 
of Regulation (EC) No 178/2002, the names and 
addresses of both the food business operator supplying 
the sprouts or seeds intended for the production of 
sprouts and the food business operator to whom such 
seeds or sprouts were supplied should always be 
available. The requirement relies on the ‘one-step back’- 
‘one-step forward’ approach which implies that food 
business operators have in place a system enabling 
them to identify their immediate supplier(s) and their 
immediate customer(s), except when they are final 
consumers.  
(7) The conditions for the production of sprouts may pose a 
potentially high public health risk, as they may result in a 
significant multiplication of food-borne pathogens. In the 
case of a food-borne outbreak linked to the consumption 
of sprouts, rapid tracing of the commodities concerned is 
therefore essential to limit the public health impact of 
such outbreak.  
(8) In addition, the trade in seeds intended for the 
production of sprouts is widespread, increasing the 
need for traceability.  
(9) Specific rules for the traceability of sprouts and of seeds 
intended for the production of sprouts should therefore 
be laid down in this Regulation.  
(10) In particular, it is appropriate to lay down the 
requirement that food business operators provide 
additional information on the volume or quantity of 
such seeds or sprouts, the date of dispatch, together 
with a reference identifying the batch and a detailed 
description of the seeds or sprouts.EN L 68/16 Official Journal of the European Union 12.3.2013  
( 1 ) OJ L 31, 1.2.2002, p. 1.  
( 2 ) EFSA Journal  2011; 9(11):2424.(11) In order to reduce the administrative burden on food 
business operators, it is appropriate to allow for flexi ­
bility as regards the format in which food business 
operators keep on records and transmit the relevant 
information as part of the traceability requirements.  
(12) 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  
Subject matter  
This Regulation lays down rules on the traceability of batches 
of: 
(i) sprouts;  
(ii) seeds intended for the production of sprouts.  
This Regulation shall not apply to sprouts after they have 
undergone a treatment which eliminates microbiological 
hazards, compatible with European Union legislation.  
Article 2  
Definitions  
For the purposes of this Regulation, the following definitions 
apply:  
(a) ‘sprouts’ means the product obtained from the germination 
of seeds and their development in water or another 
medium, harvested before the development of true leaves 
and which is intended to be eaten whole, including the seed;  
(b) ‘batch’ means a quantity of sprouts or seeds intended for the 
production of sprouts, with the same taxonomic name, 
which is dispatched from the same establishment to the 
same destination on the same day. One or more batches 
can make up a consignment. However, seeds with a 
different taxonomic name, which are mixed in the same 
packaging and intended to be germinated together and 
sprouts thereof are also considered as one batch.  
In addition the definition of ‘consignment’ in Article 2 of 
Commission Regulation (EU) No 211/2013 (  1 ) shall apply for 
the purpose of this Regulation.  Article 3  
Traceability requirements  
1. Food business operators, at all stages of production 
processing and distribution, shall ensure that the following 
information concerning the batches of seeds intended for the 
production of sprouts, or the batches of sprouts is kept on 
records. The food business operator shall also ensure that the 
information needed to comply with these provisions is trans ­
mitted to the food business operator to whom the seeds or 
sprouts are supplied:  
(a) an accurate description of the seeds or sprouts, including 
the taxonomic name of the plant;  
(b) the volume or quantity of the seeds or sprouts supplied;  
(c) where the seeds or sprouts had been dispatched from 
another food business operator, the name and address of:  
(i) the food business operator from which the seeds or 
sprouts have been dispatched;  
(ii) the consignor (owner) if different from the food 
business operator from which the seeds or sprouts 
have been dispatched;  
(d) the name and address of the food business operator to 
whom the seeds or sprouts are dispatched;  
(e) the name and address of the consignee (owner), if different 
from the food business operator to whom the seeds or 
sprouts are dispatched;  
(f) a reference identifying the batch, as appropriate;  
(g) the date of dispatch.  
2. The information referred to in paragraph 1 may be kept 
on records and transmitted in any appropriate form, provided 
that it is easily retrievable by the food business operator to 
whom the seeds or sprouts are supplied.  
3. The food business operators must transmit the relevant 
information referred to in paragraph 1 on a daily basis. The 
records referred to in paragraph 1 shall be updated on a daily 
basis and kept available for a sufficient time after the sprouts 
can be assumed to have been consumed.EN 12.3.2013 Official Journal of the European Union L 68/17  
( 1 ) See page 26 of this Official Journal.4. The food business operator shall provide the information 
referred to in paragraph 1 to the competent authority, upon 
request, without undue delay.  
Article 4  
Traceability requirements for imported seeds and sprouts  
1. Consignments of seeds intended for the production of 
sprouts and consignments of sprouts shall be accompanied, 
when imported into the Union, by a certificate as provided in 
Article 3 of Regulation (EU) No 211/2013.  
2. The food business operator importing seeds or sprouts 
shall keep the certificate referred to in paragraph 1 for a 
sufficient time after the sprouts can be assumed to have been 
consumed.  
3. All food business operator handling the imported seeds 
intended for the production of sprouts shall provide copies of the certificate referred to in paragraph 1 to all food business 
operators to which the seeds are dispatched until those seeds 
are received by the producer of the sprouts.  
Where seeds intended for the production of sprouts are sold 
packaged at retail, all food business operators handling the 
imported seeds shall provide copies of the certificate referred 
to in paragraph 1 to all food business operators to which the 
seeds are dispatched until they are packaged for sale at retail.  
Article 5  
Entry into force and application  
This Regulation shall enter into force on the twentieth day 
following that of its publication in the  Official Journal of the 
European Union . 
It shall apply from 1 July 2013.  
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 L 68/18 Official Journal of the European Union 12.3.2013