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Approval procedure in respect of establishments producing sprouted seeds

07/17/2017
 

INTRODUCTION

Production of sprouted seeds is considered as primary production within the meaning of Article 3, Paragraph 17 of European Parliament and Council Regulation (EC) No. 178/2002, which is subject to the general rules of hygiene laid down in Part A of Annex I to Regulation (EC) No. 852/2004.

Also production of sprouted seeds within the framework of operation of catering services is considered to represent primary production and shall be subject to all the following legislative regulations laid down for establishments producing sprouted seeds. For these reasons, production of sprouted seeds including production in all catering establishments in accordance with Section 16 of Act No. 110/1997 Coll., as amended falls within the remit of Czech Agriculture and Food Inspection Authority (SZPI).

In March 2013 four EU regulations were published in the Official Journal, reacting to infectious diseases caused by consumption of contaminated sprouted seeds. Therefore requirements are being established on traceability, microbiological criteria, rules for approval of establishments producing the sprouted seeds and certificates for imports into the EU. The requirements are laid down by the following legal provisions:

  • 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, as amended.
  • Commission Regulation (EU) No. 210/2013 of 11 March 2013 on the approval of establishments producing sprouts pursuant to Regulation of the European Parliament and of the Council (EC) No. 852/2004.
  • 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 carcasses and fresh poultry meat.
  • Commission Implementing Regulation (EU) No. 208/2013 of 11 March 2013 on requirements of sprouts and seeds intended for the production of sprouts.

The consolidated text, including amendments can be found on the Internet portal www.eur-lex.europa.eu.

REQUIREMENTS FOR THE PRODUCTION AND APPROVAL OF ESTABLISHMENTS

Producer of sprouts, such as is regarded also an operator of catering services, who produces sprouts, must be approved by a supervisory authority.

A/ PROCEDURE FOR THE APPROVAL OF THE ESTABLISHMENT ON THE PART OF SZPI INCLUDES:

  • Completion of the Application for Approval of a Food-processing Establishment Producing Sprouts.
  • In the case of a totally new producer of sprouts, which is not yet registered with SZPI shall be applied a summary Application for Registration and Approval of Food-processing Establishment Producing Sprouts.
  • On the basis of the submitted completed Application for Approval of a Food-processing Establishment Producing Sprouts or the aggregate Application for Registration and Approval of a Food-processing Enterprise producing sprouts the SZPI inspectors shall carry out an on-site inspection - checking compliance with the requirements referred to in Annex I of Regulation (EC) No. 852/2004 and moreover also the requirements set out in the Annex to Regulation (EU) No. 210/2013.
  • After the approval of the premises the inspector shall issue a Certificateof Approval of Food-processing Enterprise Producing Sprouts; a proforma model is given below. One copy of the Certificate of Approval of the Food-processing Enterprise Producing Sprouts shall be retained by the producer and the second shall be stored at a relevant SZPI inspectorate, under whose competence the producer falls.
  • Information on the approval of the premises shall be entered in the SZPI information system.
  • In accordance with Article 31, Para. 1f) of Regulation (EC) No. 882/2004 the information on approval of the premises shall be published on the SZPI website and posted to the TRACES system.

SZPI shall approve the establishment if the requirements set out in Annex I to Regulation (EC) No. 852/2004 are met, including in particular:

I. In accordance with Annex I of Part A, Section II, Point 2 and Section II, Point 5e) the food-processing establishment (hereinafter referred to as the “operator”) should store seeds for sprouting in appropriate conditions designed so as to prevent their harmful deterioration which poses a threat to life and protect them from contamination. At all stages of production and distribution, sprouts should be protected against any contamination likely to result in that the food will not be fit for human consumption. There should be established adequate procedures for pest control and for the prevention of access of domestic animals to places where foodstuffs are being prepared, where such are handled or stored.

  • In accordance with Annex I, Part A, Section II, Point 5b) and recommendations of EFSA, the operator should wash the seeds in potable water immediately before the germination process. Water which was used for washing of the seeds should not be re-used in the production of the sprouts.
  • In accordance with Annex I, Part A, Section II, Point 5c) for the purpose of preventing contamination in the production of sprouts potable water should be considered as the primary source of water for irrigation purposes. 
  • In accordance with the recommendations of EFSA the operators should ensure that from the end of production to the delivery to the market, including transport, the sprouts are stored in cool conditions. For reason that the commodity of sprouts has no appropriate temperature for storage laid down by relevant legislation, the temperature for processed vegetables, i.e. from 0°C to 5°C is recommended to the producers.

II. Personal hygiene

In accordance with Annex I, Part A, Section II, Point 5d) the operators should ensure medical fitness of workers handling the sprouts and their training as regards the health risks associated. The workers who manufacture or harvest sprouts should in particular maintain a high degree of personal cleanliness and should wear suitable, clean and if necessary protective clothing. Any person suffering from a disease or transmissible disease, which can be transmitted through foodstuffs, or is affected, for example with infected wounds, skin infections, sores or diarrhoea should not handle in general seeds or sprouts or enter into any area in which foodstuffs are handled, if there is any possibility of direct or indirect contamination. A thus affected person employed in the food-processing establishment producing sprouts who may come into contact with foodstuffs should without delay notify the disease or its symptoms and, if possible, their cause, to the operator of the food-processing establishment.

III. Transportation

In accordance with Annex I, Part A, Section II, Point 5a) and b) means of transportation or containers used for transporting foodstuffs should be kept clean and in good condition in order to protect foodstuffs from contamination and as required be designed and constructed so as to permit adequate cleaning and/or disinfection. The housing in vehicles or containers should not be used for transporting anything other than foodstuffs as this could cause contamination.

Moreover requirements set out in Annex to Regulation No. 210/2013 shall be met, including:

  • between and during the procedures the outer design and layout of establishments shall allow the use of correct hygiene practices, including protection from contamination. In particular surfaces (including surfaces of equipment) in areas in which food is handled and surfaces coming into contact with food must be maintained in sound condition, be easy to clean and, where necessary, able to be disinfected.
  • Adequate facilities must be provided for cleaning, disinfection and storage of working materials and equipment. Such equipment must be easy to clean and with an adequate supply of hot and cold water.
  • If necessary, adequate provision must be made for washing of foodstuffs. Every sink or other such device intended for the washing of food shall have an adequate supply of potable water and must be kept clean and, where necessary, disinfected.
  • All equipment which comes into contact with seeds and sprouts must be designed in such a way and of such materials and kept in such good order, repair and condition as to minimise the risk of contamination and to enable such to be kept clean and, where necessary, disinfected.
  • Procedures must be put in place to ensure that:
     a) the establishment producing sprouts is kept clean and, where necessary, disinfected;
     b) all materials which come into contact with seeds and sprouts shall be thoroughly cleaned and, where necessary, disinfected. Cleaning and disinfection must be carried out as frequently as to avoid the risk of contamination (the operatorshall set thefrequency itself, preferably at the end of each sprouting process).

B/ REQUIREMENTS FOR SEEDS USED TO PRODUCE SPROUTS

(grown in the Czech Republic, the EU, third countries)

Seeds used to produce sprouts must be produced under the terms of Annex I of Reg. 852/2004 in particular with the general rules of hygiene for primary production (Annex I, Part A, Reg. 852/2004):

  • In the case of seeds from imports from third countries this requirement will be documented by a copy of the Certificate in accordance with Regulation (EU) No. 211/2013, which the producer shall obtain from the importer of seeds where this information is disclosed. If the batch of the seeds originating from third countries is not accompanied by a copy of this Certificate, it shall not be used for the production of sprouts intended for human consumption. In accordance with Article 4, Para. 3 of Reg. 208/2013 the obligation to keep a copy of the Certificate accompanying seeds ends at the producer of sprouts, who is not to transmit it to his customers. Therefore the producer of sprouts should have a copy of the Certificate available.
  • In the case of seeds grown in the Czech Republic and the EU, the grower of seeds should be able to supply a declaration of seed production under hygienic conditions of primary production to the producer of sprouts.

C/ TRACEABILITY REQUIREMENTS OF SEEDS INTENDED FOR GERMINATION

(grown in the Czech Republic, the EU, third countries)

The traceability requirements are laid down in Article 3 and 4 of Regulation (EU) No: 208/2013. The producer of sprouts must have information about batches of seeds available from the grower of seeds intended for germination. This is in respect of:

  • the exact description of the seeds, including the taxonomic name of the plant,
  • the volume/quantities of seed delivered,
  • if the seeds are sent from another operator - the name and address of the entity which sent the seeds and the name and address of the consignor (owner), if it is different than the operator who  shipped the seeds,
  • the name and address of the consignee of seeds i.e. the name and address of the consignee (owner) if different than the operator to whom the seed is shipped, except in cases where such is the final consumer,
  • date of shipment.

As regards the format, which the operator uses for retention of records and exchange of relevant information within the context of the traceability requirements, it is possible to use any form allowing for the search of the information required. The information must be forwarded on a daily basis, must be updated daily and must remain available for a sufficiently long period of time after the sprouts have been used as intended. 5 years may be considered as a sufficiently long period.

D/ THE TRACEABILITY REQUIREMENTS ON SPROUTS

  • are laid down in Article 3 and 4 of Reg. No. 208/2013

The producer of sprouts is obliged to submit following information to the purchaser of sprouts, except in cases where such is the final consumer:

  • the exact description of the sprouts including the taxonomic name of the plant,
  • the volume/quantity of sprouts delivered,
  • if the sprouts are sent from another operator - the name and address of the entity which shipped the seeds and the name and address of the consignor (owner), if different than the operator which shipped the seeds,
  • the name and address of the consignee of the sprouts i.e. the name and address of the consignee (owner) if different from the operator to whom the sprouts are shipped, except in cases where these are final consumers,
  • where appropriate, a reference identifying the consignment,
  • date of shipment.

As regards the format that the operator is to use for retention of records and forwarding of the relevant information within the context of the traceability requirements any form may be used that will allow to trace the information required. The information must be forwarded on a daily basis, must be updated daily and must remain available for a sufficiently long period of time after the sprouts have been used as intended. Two years may be considered as a sufficiently long period.

E/ REQUIREMENTS FOR COMPLIANCE WITH MICROBIOLOGICAL CRITERIA

  • Are laid down in Regulation (EC) No. 2073/2005, as amended
  1. The microbiological requirements for the batch of seeds intended for the production of sprouts

Meeting microbiological criteria includes compliance with the safety criteria in respect of Salmonella spp. as set out in Chapter 1 of Point 1.18 of Regulation No. 2073/2005, as amended, and meeting of the safety criteria in respect of Escherichia coli producing shiga toxin (hereinafter referred to as ´STEC´) serotypes O157, O26, O111, O103, O145 and O104:H4 as set out in Chapter 1 of Point 1.29 of Reg. No. 2073/2005, as amended.

In accordance with Chapter 3 of Point 3.3 of Annex I of Regulation No. 2073/2005, as amended, the Rules for sampling of Sprouting Seeds the producer of sprouts will carry out a preliminary examination of a part of the seeds and further a sampling and testing of the sprouts or the used irrigation water during the production of the sprouts (at the earliest 48 hours after the initiation of the sprouting process):

  1. Preliminary examination of all batches of seeds

The operator engaged in the production of sprouts has an obligation to examine each batch prior to the actual germination process - the operator shall carry out a preliminary examination of a representative sample of all batches of seeds.

The representative sample shall consist of at least 0.5% of the weight of the batch of seeds in incremental samples weighing 50 g or shall be selected on the basis of structured statistically equivalent sampling strategy controlled by the competent authority. The relevant records of the process of sampling should be retained to be available to the competent authority, in order to be able to demonstrate correct sampling. For the purposes of implementation of the preliminary examination the operator of food-processing establishment must germinate seeds in a representative sample for a period of 48 hours minimum under identical conditions as in respect of the remainder of the batch of seeds. It is recommended to test each new batch as soon as possible after purchase (delivery). A representative sample of seeds shall be subjected to the working procedure for the production of sprouts. At the earliest after 48 hours after the initiation of the sprouting process of a representative sample where the highest concentration of Salmonella spp. and STEC is expected, two samples of sprouted seeds are removed from the production environment:

1. a sample consisting of 5 sub-units (n = 5) min. of 25 g size (better sample of 100 g); for the purposes of analysis these are kept discrete in order to test for Salmonella spp.

2. a sample consisting of 5 sub-units (n = 5) min. of 25 g size (better sample of 100 g); for the purposes of analysis these are kept discrete in order to test for STEC.

The samples at a temperature for unstable samples (1 °C to 8 °C) are to be delivered to the laboratory.

The sample is analysed according to Point 1.18 (Salmonella spp.) and 1.29 (STEC) of Chapter I of Regulation No. 2073/2005. The appropriate laboratory for the determination of STEC required reference method CEN/ ISO TS 13136 within the Czech Republic is exclusively the Veterinary Research Institute in Brno - NRL for E. coli.

In the case of testing of a new batch of seeds intended for germination the producer of sprouts with own production of sprouts shall wait until the results of the laboratory analyses are available. In the event that the batch is contaminated, it will be excluded from production of sprouts. An investigation should follow in order to determine the cause of contamination; whether it be the used batch of seeds, contaminated irrigation water or water intended for the purpose of washing of the seeds, infected worker or the growth medium (if used). Information concerning contamination should be also received by the supplier of the specific batch of seeds. The premises where the preliminary examination of seeds took place, including all equipment should be cleaned and disinfected.

  1. Frequency of sampling and testing of sprouts and irrigation water

Within the framework of routine production of sprouts (monitoring of production) the producers shall at least once per month take a sample from one batch of sprouts for a microbiological examination at a stage when the likelihood of finding Salmonella spp. and bacteria STEC is at its highest; in any case 48 hours after commencement of germination process at the earliest.

Samples of the sprouts are analysed according to Point 1.18 (Salmonella spp. - absence in 25 g) and 1.29 (STEC - absence in 25g) of Chapter I of Regulation No. 2073/2005. The appropriate laboratory for the determination of STEC through the required reference method of CEN/ ISO TS 13136 within the Czech Republic is exclusively the Veterinary Research Institute in Brno - NRL for E coli.

The request for sampling of the sprouts (monitoring of production) may be substituted by the operator by analysis of five samples of 200 ml of water, which was used for irrigation of the sprouts (which was in contact with the entire batch); if the operator has a sampling plan including procedures for sampling and places for sampling from the used irrigation water. In this case the requirements set out in Points 1.18 (Salmonella spp.) and 1.29 (STEC) of Chapter I of Regulation No. 2073/2005 are to be applied to the irrigation water, with a critical 'absence in 200ml´.

  1. Collection of finished products

During their shelf-life the sprouts when placed on the market shall, comply with the microbiological criteria laid down in Regulation (EC) No. 2073/2005, namely Annex I Chapter 1:

  • Point 1.18 - absence of Salmonella spp. in 25g; n = 5
  • Point 1.29 - absence of STEC in 25g; n = 5 
  • Point 1.2 or 1.3 - limit of absence in 25g or 100 KTJ/g for Listeria monocytogenes if the period of shelf life is <5 days or the producer has an appropriate study available; n = 5.
  1. Alternative option to meet the microbiological criteria

Preliminary examination of a representative sample of each batch of seeds - testing of seeds intended for germination by the supplier is an alternative option. It is at the discretion of the producer of sprouts to require the supplier of seeds intended for germination to perform a preliminary testing of the batch for STEC (in accordance with Point 1.29), Salmonella spp. (Point 1.18) However, the result shall be demonstrated by laboratory analyses (testing reports), which the producer of sprouts should have available on request the from seed supplier in respect of each batch and to submit the latter to the supervisory authority.

For more go to: https://ec.europa.eu/food/sites/food/files/safety/docs/biosafety_fh_guidance_essa_sprouts-and-seeds_20170117.pdf.

The obligation to test the sprouts within the framework of production monitoring 1 x per month / 1 batch lies with the producer of sprouts; it cannot be replaced by analyses from a the seed supplier. The same applies to testing of products marketed during the ´best before´ period and the implementation of smears from the production environment and equipment for the monitoring of presence of L. monocytogenes.

In respect of the preliminary examination of a representative sample of each batch of seeds intended for germination, testing of sproutswithin the framework of production monitoring (1 x per month/ 1 batch) reduction of the number of units forming the sample for the testing for STEC, Salmonella may be adopted after a prior consent of the supervisory authority, i.e. n = 5 to n = 1 (Article 5, Para. 3 of Regulation 2073/2005). The number of units may be reduced if the operator of a food-processing establishment is able to demonstrate by documents from a previous period that effective HACCP-based procedures are in situ.

  1. In case of certain establishments of public catering, which for financial reasons cannot compy with the above requirements of microbiological criteria, we recommend that finished product for the preparation of meals (sprouted seeds, germ) purchased through the open market is used.