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)
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Address https://gelex.eu/eli/EU/regulation/2013/211@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 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, 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, 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 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. 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 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. Appropriate certification 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,
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; (i) originating from the same third country; (ii) covered by the same certificate(s); (iii) conveyed by the same means of transport. (b) consignment means a quantity of sprouts or seeds intended for the production of sprouts and which is:
(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.
(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 traceability 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 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 accompanied 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 originating 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 Barroso
ANNEX
Grp_certificate_for_the_import_of_sprouts_or_seeds_intended_for_the_production_of. sprouts. 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. Quantity (Kgs) I.21. Temperature of product Ambient Chilled I.22. Number of packages I.23. Seal/Container No I.24. Type of packaging I.25. Commodities declared for: Human consumption I.26. I.27. I.28. Identification of the commodities Manufacturing plant Number of packages Nature of commodity Net weight Batch number Part II: Certification COUNTRY Certificate for the import of sprouts or seeds intended for the production of sprouts II. Health information II.a Certificate reference No I, the undersigned, hereby declare that I am aware of the relevant provisions of Regulation (EC) No 852/2004 and certify that: the seeds described above were produced under conditions which comply with Regulation (EC) No 852/2004 and in particular with the general hygiene provisions for primary production and associated operations set out in Part A of Annex I thereto; the sprouts were produced in establishments approved in accordance with the requirements laid down in Article 2 of Regulation (EU) No 210/2013; the sprouts were produced under conditions which comply with the traceability requirements laid down in Implementing Regulation (EU) No 208/2013 and respect the microbiological criteria laid down in Annex I to Regulation (EC) No 2073/2005. Notes Part I: Box reference I.7: Insert the ISO code of the country of origin of the seeds. Box reference I.11: Name of the place of origin which must be the same as the country of origin in box 1.7. Please indicate the name and address of the establishment collecting seeds and/or sprouts. Delete as appropriate. Box reference I.15: Registration number (railway wagons or container and road vehicles), flight number (aircraft) or name (ship). In the case of transport in containers, the total number of containers and their registration number and where there is a serial number of the seal it must be indicated in box I.23. In case of unloading and reloading, the consignor must inform the competent authorities of the appropriate place of controls in the European Union.(optional). Box reference I.19: Use the appropriate Harmonised System (HS) code of the World Customs Organisation: (optional). Box reference I.20: Indicate total gross weight and total net weight. Box reference I.23: for containers or boxes, the container number and the seal number (if applicable) must be included. Box reference I.28: Manufacturing plant: insert the name of the establishments of production of seeds. Part II: The colour of the signature shall be different to that of the printing. The same rule applies to stamps other than those embossed or watermark. Official inspector Name (in capital letters): Qualification and title: Date: Signature: Stamp
ANNEX MODEL CERTIFICATE FOR THE IMPORT OF SPROUTS OR SEEDS INTENDED FOR THE PRODUCTION OF SPROUTS
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. Quantity (Kgs) I.21. Temperature of product Ambient Chilled I.22. Number of packages I.23. Seal/Container No I.24. Type of packaging I.25. Commodities declared for: Human consumption I.26. I.27. I.28. Identification of the commodities Manufacturing plant Number of packages Nature of commodity Net weight Batch number Part II: Certification COUNTRY Certificate for the import of sprouts or seeds intended for the production of sprouts II. Health information II.a Certificate reference No I, the undersigned, hereby declare that I am aware of the relevant provisions of Regulation (EC) No 852/2004 and certify that: the seeds described above were produced under conditions which comply with Regulation (EC) No 852/2004 and in particular with the general hygiene provisions for primary production and associated operations set out in Part A of Annex I thereto; the sprouts were produced in establishments approved in accordance with the requirements laid down in Article 2 of Regulation (EU) No 210/2013; the sprouts were produced under conditions which comply with the traceability requirements laid down in Implementing Regulation (EU) No 208/2013 and respect the microbiological criteria laid down in Annex I to Regulation (EC) No 2073/2005. Notes Part I: Box reference I.7: Insert the ISO code of the country of origin of the seeds. Box reference I.11: Name of the place of origin which must be the same as the country of origin in box 1.7. Please indicate the name and address of the establishment collecting seeds and/or sprouts. Delete as appropriate. Box reference I.15: Registration number (railway wagons or container and road vehicles), flight number (aircraft) or name (ship). In the case of transport in containers, the total number of containers and their registration number and where there is a serial number of the seal it must be indicated in box I.23. In case of unloading and reloading, the consignor must inform the competent authorities of the appropriate place of controls in the European Union.(optional). Box reference I.19: Use the appropriate Harmonised System (HS) code of the World Customs Organisation: (optional). Box reference I.20: Indicate total gross weight and total net weight. Box reference I.23: for containers or boxes, the container number and the seal number (if applicable) must be included. Box reference I.28: Manufacturing plant: insert the name of the establishments of production of seeds. Part II: The colour of the signature shall be different to that of the printing. The same rule applies to stamps other than those embossed or watermark. Official inspector Name (in capital letters): Qualification and title: Date: Signature: Stamp
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
Commission Regulation (EU) No 211/2013 lays down certification requirements for sprouts or seeds intended for the production of sprouts imported into the Union.
- 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
In order to maintain the highest level of consumer protection while third countries take the necessary corrective actions to establish a robust certification system, it is appropriate to allow, as an alternative in the country of origin, the certification requirement on the general hygiene provisions for primary production to be replaced by a microbiological test for seeds intended for the production of sprouts before export to the Union takes place. For that reason, the model certificate in the Annex to Regulation (EU) No 211/2013 also needs to be amended.
- 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
Regulation (EU) No 211/2013 is amended as follows:
- 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
For reasons of harmonisation and clarity, model certificates currently laid down in Commission Regulation (EC) No 2074/2005, Commission Regulation (EU) No 211/2013 and Commission Implementing Regulation (EU) 2016/759 should be incorporated into this Regulation. As a result, Regulation (EC) No 2074/2005 and Implementing Regulation (EU) 2016/759 should be amended accordingly and Regulation (EU) No 211/2013 should be repealed.
- 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
Regulation (EU) No 211/2013 is repealed. References to Regulation (EU) No 211/2013 shall be construed as references to this Regulation and read in accordance with the correlation table set out in Annex VI to this Regulation.
- 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
Consignments of products of animal origin accompanied by the relevant certificates issued accordance with Regulation (EC) No 2074/2005, Regulation (EU) No 211/2013 and Implementing Regulation (EU) 2016/759 may be accepted for the entry into the Union until 13 March 2020 provided that the certificate was signed before 14 December 2019. Until 13 March 2020, consignments of rendered animal fats and greaves may enter the Union when using the certificate for meat products set out in Annex III to Decision 2007/777/EC and consignments of reptile meat, insects and other products of animal origin refer
- 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
Regulation (EU) No 211/2013 This Regulation Article 1 Article 1(2)(b)(ii) Article 2 Article 2(2) Article 3 Article 27 Article 4 — Article 5 — Annex Part XV of Annex III
- 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.
- 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
- 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) Regulation · Grade B
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.
- 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
- 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.
- ESSA hygiene guideline for the production of sprouts and seeds for sprouting 2017/C 220/03 Notice · Grade B
The EU sprouted seeds market is a highly specialised niche segment of the fresh produce market with approximately 120 professional production establishments throughout the EU. After the EHEC crisis in 2011 and EFSA's Scientific Opinion on the risk posed by Shiga toxin-producing Escherichia coli (STEC) and other pathogenic bacteria in seeds and sprouted seeds, new EU legislation entered into force to enhance the safety of this product segment across Europe. Different national guidelines were created to help in the implementation of these specific rules. The purpose of this European guideline, w
- ESSA hygiene guideline for the production of sprouts and seeds for sprouting 2017/C 220/03 Notice · Grade B
All personnel involved in sanitation should receive training to understand the cleaning and disinfection plan, the handling of chemical substances and the separation of cleaning products from the production process. Sprout producers should keep records of the dates of training, the topics that have been covered and the participating employees. Control of incoming seeds Food producers are under obligation of the EU's general food law regulation (Regulation (EC) No 178/2002) to only put safe products on the market. This means that sprout producers will be held responsible for any contamination t
- ESSA hygiene guideline for the production of sprouts and seeds for sprouting 2017/C 220/03 Notice · Grade B
If seeds are imported from non-EU country, import certificate as required by Commission Regulation (EU) No 211/2013 for each batch of imported seeds;
- ESSA hygiene guideline for the production of sprouts and seeds for sprouting 2017/C 220/03 Notice · Grade B
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, amended by Commission Regulation (EU) No 704/2014 on certification requirements for import into the Union of sprouts and seeds intended for the production of sprouts.