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)
Grade B
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Address https://gelex.eu/eli/EU/regulation/2013/208@2013-03-11/en
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, 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 traceability of food, feed, food-producing animals, and any other substance intended to be, or expected to be, incorporated 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. 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.
(11) In order to reduce the administrative burden on food business operators, it is appropriate to allow for flexibility 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: This Regulation shall not apply to sprouts after they have undergone a treatment which eliminates microbiological hazards, compatible with European Union legislation.
(i) sprouts;
(ii) seeds intended for the production of sprouts.
Article 2 Definitions
For the purposes of this Regulation, the following definitions apply: In addition the definition of consignment in Article 2 of Commission Regulation (EU) No 211/2013 shall apply for the purpose of this Regulation.
(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.
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 transmitted 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.
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 Barroso
Versions
Cited by
- Commission Regulation (EU) No 704/2014 of 25 June 2014 amending Regulation (EU) No 211/2013 on certification requirements for import into the Union of sprouts and seeds intended for the production of sprouts (Text with EEA relevance) Regulation · Grade B
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 traceability requirements laid down in Implementing Regulation (EU)
- Commission Regulation (EU) No 704/2014 of 25 June 2014 amending Regulation (EU) No 211/2013 on certification requirements for import into the Union of sprouts and seeds intended for the production of sprouts (Text with EEA relevance) Regulation · Grade B
COUNTRY: Certificate to EU Part I: Details of dispatched consignment I.1. Consignor Name Address Tel. I.2. Certificate reference No I.2.a. I.3. I.4. I.5. Consignee Name Address Postcode Tel. I.6. I.7. Country of origin ISO code I.8. Region of origin Code I.9. Country of destination ISO code I.10. I.11. Place of origin of seeds and/or sprouts Name Address I.12. I.13. Place of loading I.14. Date of departure I.15. Means of transport Aeroplane Ship Railway wagon Road vehicle Other Identification Documentation references I.16. I.17. I.18. Description of commodity I.19. Commodity code (HS code) I.2
- 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) Regulation · Grade B
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 was adopted. That implementing Regulation lays down rules on the traceability of consignments of sprouts and of seeds intended for the production of sprouts.
- 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) Regulation · Grade B
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. Appropriate certification requirements should therefore be laid down for such commodities imported into the Union.
- 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) Regulation · Grade B
the definition of sprouts in Article 2(a) of Implementing Regulation (EU) No 208/2013 shall apply;
- 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) Regulation · Grade B
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 traceability requirements laid down in Implementing Regulation (EU)
- 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) Regulation · Grade B
Part I: Details of dispatched consignment COUNTRY Certificate to EU I.1. Consignor Name Address Tel. I.2. Certificate reference No I.2.a. I.3. I.4. I.5. Consignee Name Address Postcode Tel. I.6. I.7. Country of origin ISO code I.8. Region of origin Code I.9. Country of destination ISO code I.10. I.11. Place of origin of seeds and/or sprouts Name Address I.12. I.13. Place of loading I.14. Date of departure I.15. Means of transport Aeroplane Ship Railway wagon Road vehicle Other Identification Documentation references I.16. I.17. I.18. Description of commodity I.19. Commodity code (HS code) I.20
- Commission Implementing Regulation (EU) 2019/628 of 8 April 2019 concerning model official certificates for certain animals and goods and amending Regulation (EC) No 2074/2005 and Implementing Regulation (EU) 2016/759 as regards these model certificates (Text with EEA relevance) Regulation · Grade B
sprouts means sprouts as defined in point (a) of Article 2 of Commission Implementing Regulation (EU) No 208/2013;
- Commission Implementing Regulation (EU) 2019/628 of 8 April 2019 concerning model official certificates for certain animals and goods and amending Regulation (EC) No 2074/2005 and Implementing Regulation (EU) 2016/759 as regards these model certificates (Text with EEA relevance) Regulation · Grade B
COUNTRY Official certificate to the EU Part I: Details of dispatched consignment I.1. Consignor/Exporter Name Address Tel. No I.2. Certificate reference No I.2.a IMSOC reference No I.3. Central Competent Authority I.4. Local Competent Authority I.5. Consignee/Importer Name Address Postal code Tel. No I.6. Operator responsible for the consignment Name Address Postal code I.7. Country of origin ISO I.8. I.9. Country of destination ISO I.10. I.11 Place of dispatch Name Address Approval No I.12. Place of destination Name Address I.13. Place of loading I.14. Date and time of departure I.15. Means o
- Commission Regulation (EU) No 209/2013 of 11 March 2013 amending Regulation (EC) No 2073/2005 as regards microbiological criteria for sprouts and the sampling rules for poultry carcases and fresh poultry meat (Text with EEA relevance) Regulation · Grade B
In order to ensure the protection of public health in the Union and in view of that EFSA Opinion, 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 and Commission Implementing Regulation (EU) No 208/2013 of 11 March 2013 on traceability requirements for sprouts and seeds intended for the production of sprouts were adopted.
- Commission Regulation (EU) No 209/2013 of 11 March 2013 amending Regulation (EC) No 2073/2005 as regards microbiological criteria for sprouts and the sampling rules for poultry carcases and fresh poultry meat (Text with EEA relevance) Regulation · Grade B
the definition of sprouts in Article 2(a) of Commission Implementing Regulation (EU) No 208/2013 of 11 March 2013 on traceability requirements for sprouts and seeds intended for the production of sprouts;
- Commission Regulation (EU) No 209/2013 of 11 March 2013 amending Regulation (EC) No 2073/2005 as regards microbiological criteria for sprouts and the sampling rules for poultry carcases and fresh poultry meat (Text with EEA relevance) Regulation · Grade B
Sampling rules for sprouts For the purposes of this Section, the definition of batch in Article 2(b) of Implementing Regulation (EU) No 208/2013 will apply.
- Council Decision (EU) 2017/1391 of 17 July 2017 on the position to be adopted, on behalf of the European Union, within the Sanitary and Phytosanitary Management Sub-Committee established by the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and Ukraine, of the other part, as regards the modification of Annex V to that Agreement Decision · Grade B
Ukraine undertakes to approximate its legislation to the following Union legislation within the timeframes listed below, in accordance with Article 64(4) of this Agreement. Union legislation Deadline for approximation Chapter I — General legislation (public health) Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organisation of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC 2016 Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the orga
- Commission Implementing Regulation (EU) 2025/636 of 25 March 2025 amending Annexes III and V to Implementing Regulation (EU) 2020/2235 as regards model animal health certificates, model official certificates, model animal health/official certificates and private attestation, for the entry into the Union or transit through the Union to a third country of consignments of certain categories of animals and goods intended for human consumption (Text with EEA relevance) Regulation · Grade B
under conditions which comply with the traceability requirements laid down in Commission Implementing Regulation (EU) No 208/2013 and respect the criteria laid down in Annex I to Commission Regulation (EC) No 2073/2005.]
- Council Decision (EU) 2016/2354 of 12 December 2016 on the position to be adopted, on behalf of the European Union, within the Sanitary and Phytosanitary Sub-Committee established by the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and Georgia, of the other, as regards the modification of Annex XI-B to that Agreement Decision · Grade B
In accordance with Article 55(4) of this Agreement, Georgia shall approximate its legislation to the following Union legislation within the timeframes as listed below. Union legislation Deadline for approximation Section 1 — Veterinary Council Regulation (EC) No 21/2004 of 17 December 2003 establishing a system for the identification and registration of ovine and caprine animals and amending Regulation (EC) No 1782/2003 and Directives 92/102/EEC and 64/432/EEC 2015 Commission Regulation (EC) No 1505/2006 of 11 October 2006 implementing Council Regulation (EC) No 21/2004 as regards the minimum
- Council Decision (EU) 2016/877 of 23 May 2016 on the position to be adopted, on behalf of the European Union, within the Sanitary and Phytosanitary Subcommittee established by the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and the Republic of Moldova, of the other part Decision · Grade B
In accordance with Article 181(4) of this Agreement, the Republic of Moldova shall approximate its legislation to the following Union legislation within the timeframes as listed below. Union legislation Deadline for approximation Section 1 — General 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, with the exception of Articles 58, 59 and 62 2016 Commission Regulation (EC) No 1304/2003
- Council Decision 2019/1748 of 7 October 2019 on the position to be taken on behalf of the European Union within the Sanitary and Phytosanitary Management Sub-Committee established by the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and Ukraine, of the other part, as regards the modification of Annex V to Chapter 4 of that Agreement Act · Grade B
Ukraine undertakes to approximate its legislation to the following Union legislation with the deadlines for adoption as listed below, in accordance with Article 64(4) of this Agreement. Union legislation Deadline for adoption Chapter I – General legislation (public health) Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organization of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC 2018 Council Directive No 97/78/EC of 18 December 1997 laying down the principles governi
- Council Decision (EU) 2023/187 of 23 January 2023 on the position to be adopted on behalf of the European Union within the Sanitary and Phytosanitary Sub-Committee established by the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and Georgia, of the other part, as regards the modification of Annex XI-B to that Agreement Decision · Grade B
In accordance with Article 55(1) of this Agreement, Georgia shall approximate its legislation to the following Union legislation within the timeframes listed below. Union legislation Deadline for approximation Section 1 - Veterinary 1. Regulation (EC) No 1760/2000 of the European Parliament and of the Council of 17 July 2000 establishing a system for the identification and registration of bovine animals and regarding the labelling of beef and beef products and repealing Council Regulation (EC) No 820/97. 2015 2. Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 Ma
- Commission Delegated Regulation (EU) 2019/625 of 4 March 2019 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 certain animals and goods intended for human consumption (Text with EEA relevance) Regulation · Grade B
sprouts means sprouts as defined in point (a) of Article 2 of Commission Implementing Regulation (EU) No 208/2013;
- Commission Regulation (EU) No 210/2013 of 11 March 2013 on the approval of establishments producing sprouts pursuant to Regulation (EC) No 852/2004 of the European Parliament and of the Council (Text with EEA relevance) Regulation · Grade B
In order to ensure the protection of public health in the Union and in view of that EFSA Opinion, Commission Regulation (EU) No 209/2013 amending Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs, Commission Regulation (EU) No 211/2013 and Commission Implementing Regulation (EU) No 208/2013 were adopted.