16 Traceability and Recalls

All Oiva evaluation guidelines for approved food establishments.

16.1 Traceability of foods other than those of animal origin

Guide/version: 2185/04.02.00.01/2021/4, valid from 1.7.2021

To be taken into consideration:
All food business operators with activities involving foods of non-animal origin (cf. Oiva Evaluation Guidelines 16.9) are the subject of control in this section.

The traceability rules apply to all stages of the production, processing and distribution of food.

It is irrelevant whether or not the foods are physically in the possession of the operator. What matters most is what operator's ownership and responsibility the food is in.

Approved Food Establishments: the traceability information of food shall be stored at least two years.

Registered Food Premises: the traceability information of food shall be stored at least one year.

All food business operators must be able to demonstrate, by means of information and records, the traceability of foodstuffs by applying a "one step back, one step forward" approach. Consumers are not considered as traceable customers. The operator must have in place systems and procedures which enable the operator to identify and demonstrate through information and records

• the natural or legal person who supplied the food
• other businesses to which the operator has supplied its products (consignment-specific identification).

For this purpose, the operator must have in place systems and procedures which allow this information to be made available to the competent authorities on demand.

Foods placed on the market or likely to be placed on the market must have adequate and appropriate labelling or identification data to facilitate their traceability.

It is highly recommended that the operator also has and is aware of

• the dates of reception and dispatch
• the quantity of each item of food product
• the items of foods received and dispatched, in a form and to an extent that they can be reliably and sufficiently clearly linked to the names shown on the labelling of the foods concerned.

The food business operator must have in place an (appropriately designed) system which allows the operator with sufficient accuracy to link the information on the batches of food the operator receives and dispatches to each other. The system and procedure are not defined by law. What is important is information, not the system used to access it. The decision on the level of detail of the system should be left to the food business operator, taking the nature, size and effectiveness of the food business into consideration. It is the responsibility of the competent food control authority to assess whether the traceability system used by the food business operator is adequate in relation to the nature, size and effectiveness operator's activities.

Food lot refers to a set of food sales units that are produced, manufactured (= "production lot", "production batch") or packaged under practically the same conditions. The food producer, manufacturer, packager or first seller established within the European Union determines food lot and enters the identification on the lot. A batch of food may not exceed the production of one day. A consignment delivered by the operator (delivery lot) may contain several food lots of food of the same product name.

These Evaluation Guidelines also provide instructions as a separate section below, on the control of the traceability of lots of seeds intended for sprout production and of lots of sprouts for which traceability requirements are stricter than those listed above.

It is recommended that section 13.1 General labelling be controlled at the same time.

Matters to be controlled:
The implementation of in-house control is evaluated by checking the following matters, a total of 1 to 3 foods, preferably from different categories of food, taking the nature and scope of activities into consideration, primarily:

• which operator has supplied the foods (raw materials) received by the operator
• which operator the operator has sent foods to
• whether the traceability system used by the food business operator is adequate in relation to the nature, size and effectiveness operator's activities.

And additionally applying

• dates of receipt and dispatch
• the names of the foods received and dispatched, in a form and to an extent that they can be reliably and sufficiently clearly linked to the names shown on the labelling of the foodstuffs concerned
• the volume or quantity of the food.

→ What is key is the information and its availability - not the format (paper, pdf, IT system ...) it is in.

The adequacy and suitability of in-house control and, where appropriate, the plan is checked in accordance with Oiva Evaluation Guidelines 1.6 and its Annex “Adequacy and Suitability of Own-check Activities”.

Control of traceability of batches of seed intended for sprout production and of batches of sprouts

‘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.

From the point of view of the food business operator, a "batch" ( = a lot) 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.

From the point of view of the food business operator, when the food business operator supplies (dispatches) sprouts from the food establishment, sprouts which have a different taxonomic name are also considered to be one batch if they are mixed in the same packaging.

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:

1. an accurate description of the seeds or sprouts, including the taxonomic name of the plant;
2. the volume or quantity of the seeds or sprouts supplied;
3. 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;
4. the name and address of the food business operator to whom the seeds or sprouts are dispatched;
5. the name and address of the consignee (owner), if different from the food business operator to whom the seeds or sprouts are dispatched;
6. a reference identifying the batch, as appropriate;
7. the date of dispatch.

The information a) - g) 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.

The food business operators must transmit the relevant information referred to in a) - g) on a daily basis. The records referred to in a) - g) shall be updated on a daily basis and kept available for a sufficient time after the sprouts can be assumed to have been consumed.

The food business operator shall provide the information referred to in a) - g) to the competent authority, upon request, without undue delay.

• The information referred to (a - g) may be kept on records and provided in any appropriate form so as to be easily retrievable by the food business operator to whom the seed or sprouts are supplied.
• The information must be updated each day that batches are received or dispatched.
• Indication of the country of origin or place of provenance is mandatory where failure to do so could mislead the consumer as to the true country of origin or place of provenance of the food.

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 section 1 to all food business operators to which the seeds are dispatched until they are packaged for sale at retail.

Traceability requirements for seeds and sprouts imported into the Union

Consignments of sprouts or seeds intended for the production of sprouts imported into the Union and originating in or dispatched from third countries must be accompanied by a certificate in accordance with the model set out in the Annex to Commission Regulation (EU) No 704/2014 stating that

• the sprouts or seeds were produced under conditions which comply with the general hygiene rules applicable to primary production and associated operations set out in Part A of Annex I to Regulation (EC) No 852/2004
• the sprouts were produced under conditions which comply with the traceability requirements laid down in Implementing Regulation (EU) No 208/2013 (4) (see list a - g above)
• the sprouts have been produced in establishments approved in accordance with the requirements laid down in Article 2 of Regulation (EU) No 210/2013
• the sprouts comply with the microbiological criteria laid down in Annex I to Regulation (EC) No 2073/2005.
• The certificate and, when applicable, the results of microbiological tests on Enterobacteriaceae as referred to in Article 4 of Commission Regulation (EU) No 704/2014 must be drawn up in the official language or languages of the third country of dispatch and the Member State into which the import into the EU takes place or be accompanied by an official translation into the official language or languages of that Member State.
• 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.
• The original of the certificate must accompany the consignment until it reaches its destination as indicated in the certificate.
• In the case of splitting of the consignment, a copy of the certificate must accompany each part of the consignment.
• Food business operators producing sprouts using imported seeds must make the certificate and, where applicable, the results of these tests available on demand of the competent authorities.

Operations comply with requirements.

• The operator is able to demonstrate by means of information and records the traceability of foods of non-animal origin applying the "one step forward, one step back" approach.
• The operator has in place an appropriate traceability system in relation to its operations from which traceability information for foods of non-animal origin is consistently available, easy to read, easy to interpret and can be linked to the food names.
• Traceability management of batches of seeds and seeds intended for the production of sprouts is implemented as required in the list a - g.
• Where the operator is the first consignee of seeds and sprouts imported into the Union in the territory of the Union, the operator has received, retained and provided with the batches the right certificate in accordance with the model set out in the Annex to Commission Regulation (EU) No 704/2014.

There are small issues with the operations that do not impair food safety or mislead consumers.

There are some minor shortcomings, for example:

• There are occasional minor ambiguities in traceability that do not compromise food safety (most importantly potential recalls) and which do not give rise to suspicion that ambiguous traceability information could mislead the customer (consumer or other actor).
• Traceability information (items) and labelling (product names) are not consistent so as to leave no room for interpretation. The accuracy of the information can be verified by combining and comparing other information. However, the information needs to be made sufficiently consistent as a matter of urgency and the system needs to be improved so that the names adequately match each other. Alternatively, information or a link that enables accurate linkability must be added to the system.
• Linkability of the traceability information in the operator's electronic system with product names (and items) is not entirely consistent or clear. The correctness of the information (the linkability of dates and other relevant information) can be verified by connecting and comparing other information. The system needs to be improved.
• Batch (lot) identification is properly used, but the use of batch (lot) identification or its linkability to products (items) is not always completely consistent or clear. In this case, the operator needs to develop the system and supplement the way batch identification is used.
• The traceability information of the food (e.g. consignment note) dispatched by the operator lacks the operator's contact information or name is not the operator's official name but, however, the supplier can be reliably identified by other means (e.g. name, logo and business ID).
• The traceability information of the foods (items) received by the operator (e.g. consignment note) lacks the contact details of the consignor but, however, the consignor can be reliably identified by other means (e.g. name, logo and business ID).

Generally; minor shortcomings in the system, systematic nature or individual inaccuracy in the information or records are acceptable where they do not prevent the competent authority from verifying where and when the particular food has been dispatched and/or to whom the operator subject to control has dispatched the particular food.

• Traceability management of batches (lots) of sprouts or seeds intended for the production of sprouts is not always fully implemented as required in the list a - g. In this case, the shortcoming detected could mainly be isolated and it should be possible to verify the implementation of the information in the list a) - g) by, for example, checking the information from the operator who received the consignment.
• Where the operator is the first consignee of seeds and sprouts imported into the Union in the territory of the Union, the operator has received, retained and provided with the batches the right certificate in accordance with the model set out in the Annex to Commission Regulation (EU) No 704/2014 - in this case the shortcoming detected could mainly be an isolated administration issue in respect of the right certificate, such as a failure by the operator to supply the certificate with the batches to one of the recipients.

There are issues with the operations which impair food safety or mislead consumers. These issues must be rectified within a set period of time.

There are major shortcomings, for example:

• The traceability of foods (items) of non-animal origin is subject to a number of ambiguities and/or shortcomings.
• Traceability information and labelling (product names, items) are not sufficiently consistent and leave too much room for interpretation.
• Linking the traceability information in the operator's electronic system with product names (and/or items) is neither consistent nor clear. The accuracy of the information can be laboriously verified by connecting and comparing other information.
• The use of the batch (lot) identification and its link to product batches (lots) is neither consistent nor clear. In this case, the operator needs to develop the system and supplement the way batch identification is used.
• The traceability information (e.g. consignment note) of the food (items) dispatched by the operator lacks the name of the recipient or in many cases is not the official name of the recipient. However, the supplier can be sufficiently reliably identified by other means (e.g. name, logo and business ID), ultimately by so-called cross-checking.
• The traceability information (e.g. consignment note) of the food (items) received by the operator lacks the name of the consignor or in many cases is not the official name of the consignor. However, the consignor can be sufficiently reliably identified by other means (e.g. name, logo and business ID), ultimately by so-called cross-checking.
• In practice, the operator has no systematic way of ensuring the traceability of food (items, names) that could be interpreted as being a traceability system – the key question is whether the operator would, if necessary, be able to carry out any recall with the effectiveness required.

Generally; traceability information is missing or leaves too much to interpretation, so it is clear that traceability management cannot be assured. The operator must implement an appropriate traceability system relative to its operations as a matter of urgency.

• Traceability management of batches (lots) of sprouts and seeds intended for the production of sprouts is not implemented as required in the list a - g. A number of shortcomings have been detected.
• Where the operator is the first consignee of seeds and sprouts imported into the Union in the territory of the Union, the operator has received, but not retained or provided with the batches (lots) the right certificate in accordance with the model set out in the Annex to Commission Regulation (EU) No 704/2014. The shortcoming detected is not isolated.
• The operator does not have an appropriate systematic system for compliant operations even though 'papers' are available.

There are issues with the operations that jeopardise food safety or seriously mislead the consumer, or the operator has failed to comply with the orders issued. These issues must be rectified with immediate effect.

Issues requiring immediate rectification include, for example:

• The operator is unable to identify the lots (batches) of food and/or the food, i.e. the operator does not know what the food (item) is.
• The operator does not know who has dispatched lot of food (item) which the operator is in possession of.
• The operator does not know and is unable to indicate to whom the operator has sent a lot or lots of food (items).
• There is no traceability information for foods or the traceability information is incorrect.
• The traceability information and food information do not match.
• The suppliers of the lots received and / or the consignees of the lots dispatched cannot be identified.
• There is no traceability management (list a - g) of batches of sprouts and seeds intended for the production of sprouts.
• Where the operator is the first consignee of seeds and sprouts imported into the Union in the territory of the Union and the operator has not received with the batches the right certificate in accordance with the model set out in the Annex to Commission Regulation (EU) No 704/2014.
• Where the operator is the first consignee of seeds and sprouts imported into the Union in the territory of the Union and the operator has still not provided with the batches the right certificate in accordance with the model set out in the Annex to Commission Regulation (EU) No 704/2014. The shortcoming detected is not isolated.

Legislation and guidelines (with any amendments) pertaining to the subject:

• Regulation (EC) No 178/2002 of the European Parliament and of the Council 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, Articles 8, 17, 18 and 19
• Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers Articles 8, para. 5, 6 and 8
• Commission Implementing Regulation (EU) No 208/2013 laying down traceability requirements for sprouts and seeds intended for the production of sprouts
• Commission Regulation (EU) No 704/2014 amending Regulation (EU) No 211/2013 laying down certification requirements for import into the Union of sprouts and seeds intended for the production of sprouts
• Finnish Food Act 297/2021 14 § 1 mom.
• Maa- ja metsätalousministeriön asetus elintarvikehygieniasta 318/2021 22 § ja 36 §
• Decree of the Ministry of Agriculture and Forestry on the provision of food information to consumers (834/2014).

Updates in version 4:

• Guidance 10250 is replaced by guidance 2185/04.02.00.01/2021
• Finnish Food Act 297/2021 14 § 1 mom.
• Maa- ja metsätalousministeriön asetus elintarvikehygieniasta 318/2021 22 § ja 36 §
• Approved Food Establishments: the traceability information of food shall be stored at least two years.
• Registered Food Premises: the traceability information of food shall be stored at least one year.

16.2 The mandatory system for the identification and traceability of beef lots

Guide/version: 2186/04.02.00.01/2021/4, valid from 1.7.2021

To be taken into consideration:
This point is controlled, when the operator

• slaughters bovine animals or cuts beef
• manufactures, has manufactured for it and/or packages food products
• imports or brokers (from the internal market or third countries) food products:
• stores, markets or exports food products.

Beef must be traceable between establishments and operators, as well as at all stages of the preparation and production of meat in approved food establishments and registered food premises as the mandatory system (see the list of legislation) for the identification and traceability of beef lots requires.

The labelling system laid down for beef and beef products apply to chilled and frozen beef which is considered to include:

• carcass and quarters
• cut beef
• minced beef
• thick skirts
• neck, where it is used to make minced meat.

The traceability information and the other information required by the mandatory system for the identification and traceability of beef lots shall be stored two years. Considering retail stores the period of storing the information is at least one year.

Fat removed from the carcass before weighing, muscles of the head, viscera and ongue, for example, are excluded from the scope of the beef labelling system.

The labelling provisions for beef and beef products do not apply to raw meat preparations and meat products. However, cut or minced beef intended for use as raw material for them must be traceable.

It is recommended that point 13.4 Labelling of Meat Required by Specific Legislation is controlled at the same time.

Matters to be controlled:
The implementation of own-check is evaluated by random checks, on e.g. 1-3 different lots/raw materials/products, taking the scope and nature of operations into consideration:

• The system regarding labelling beef and beef products and the associated documents and records. The evaluation of the following matters – implementation in practice and description in the plan:
  • a description of the process of beef and how different lots of beef are kept separate, and of the associated work stages;
  • a description of the tracing and labelling of beef;
  • a description of the determination of the lot identification mark and the markings used in the labelling of beef;
  • records of received and dispatched and/or sold beef, including the amount and the markings;
  • in slaughterhouses, recordings of bovine animals brought in for slaughter;
  • a plan for the recall of incorrectly marked products from the market, and the associated informing plan;
  • a plan for the familiarizing of the personnel in the system regarding labelling beef and beef products; and
  • the name of the person responsible for the system regarding labelling beef and beef products.
• Documents related to traceability (i.e. commercial documents, such as delivery notes and similar, and the information systems of the company).

The adequacy and suitability of own-check activities and, where appropriate, the plan is controlled by applying the Annex to Guideline 1.6: "Adequacy and Suitability of Own-check Activities".

Operations comply with requirements.

Beef is at all stages of handling, production or manufacturing traceable by individual lot to the operators who have delivered it and to the operators to whom it has been delivered. Beef is appropriately labelled and traceable by individual lot to the individual lots it originates from. The operator has records of received and dispatched and/or sold beef, including the amounts and the indications or marks. The labelling and marking of lot is used appropriately. The own-check includes a written description, complete with all the required points, of the system regarding labelling beef and beef products.

There are small issues with the operations that do not impair food safety or mislead consumers.

Beef is traceable to the operators who have delivered it and to the operators to whom it has been delivered. Beef is traceable to the individual lots it originates from. There are some minor shortcomings affecting traceability in labelling, documents, records, lot identification marks or internal traceability. The own-check includes a written description of the system regarding labelling beef and beef products, but it is not up-to-date or some essential required point is not included in it (but is implemented in practical operations, however). These include, for example:

• Required markings on several carcases or quarters or thick skirts are not clear, but can be interpreted as a whole (approved food establishments).
• Documents related to traceability are unclear or deficient in part, but the validity of the information can be verified by connecting and comparing other information.
• The identifiability (internal traceability of beef lots) of individual lots of beef does not meet the requirements of the system regarding labelling beef and beef products completely.
• The ability to link beef lot information stored in the electronic information system to products is open to interpretation. The validity of the records and information (amounts, dates and other required data are linkable) can be verified by connecting and comparing other data.
• The lot identification mark and/or labelling is not used in a way that is systematic or linkable, or is too open to interpretation in some parts.
• The mandatory description provided in the own-check of the tracing and labelling of beef is not completely up-to-date, or some required point is missing.
• In general; minor shortcomings regarding a systematic approach in operation, or an individual inaccuracy in commercial documents or records, despite of which, however, it is possible to verify the effectiveness of the mandatory beef lot identification (marking) and traceability system.

There are issues with the operations which impair food safety or mislead consumers. These issues must be rectified within a set period of time.

There are several shortcomings related to the traceability of beef to the operators who have delivered it and to the operators to whom it has been delivered. Beef lots cannot in all respects be traced with adequate certainty to the individual lots it is said to be originating from. The mandatory traceability of beef lots is not under control due to significant shortcomings in labelling, lot marking, records or commercial documents. The own-check provides a written description of the system regarding labelling beef and beef products, but it is not up-to-date in its essential parts, or several required points are missing from it, or a written description is not provided at all. Such defects/shortcomings include, for example:

• Information of lots of beef of several operators is deficient.
• Invoices and lot identification markings related to deliveries of beef lots can be presented and linked to the lots, but commercial documents (what, when, where) are missing.
• Required health marks are missing from a significant part of carcasses or quarters or thick skirts, or the health marks are so unclear as a whole that they cannot be interpreted.
• The ability to link lot information stored in the electronic information system to products is highly uncertain. The validity of the data (dates and other required data are linkable) cannot be verified with adequate certainty by connecting and comparing other data.
• There is no system in place as concerns the use of a mandatory beef lot identifying code and linking it to products, or the system is not used.
• The description provided in the in-house control plan of the tracing and labelling of beef is not up-to-date in almost any respects, or several required points are missing or a written description is not provided at all.

There are issues with the operations which jeopardise food safety or considerably mislead consumers, or the operator has failed to comply with orders that have been issued. These issues must be rectified with immediate effect.

Beef cannot be traced and/or no indications or lot markings or health marks are provided on beef. Such shortcomings include, for example:

• Beef cannot be identified (is it beef at all) or traced in any way.
• The operator is not able to identify or indicate which operator has send the beef lots or to which operator the beef lots have been delivered to.
• There is no link at all between the beef lot identification and the animal or animals in question. There are no documents, labelling or records.
• The records of the operator concerning beef that has been received and dispatched and/or sold, including the amount and labelling of the beef, is completely uncertain or false and gives rise to justified suspicions of even knowingly committed fraud.

Legislation and guidelines (with any amendments) pertaining to the subject:

• Regulation (EC) No 1760/2000 of the European Parliament and of the Council 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, Article 3 and Articles 12-14
• Commission Regulation (EC) No 1825/2000 laying down detailed rules for the application of Regulation (EC) No 1760/2000 of the European Parliament and of the Council as regards the labelling of beef and beef products, Articles 1-5
• Commission Regulation (EC) No 275/2007 amending Regulation (EC) No 1825/2000 laying down detailed rules for the application of Regulation (EC) No 1760/2000 of the European Parliament and of the Council as regards the labelling of beef and beef products
• Decree No 1391/2006 of the Ministry of Agriculture and Forestry on the identification and registration of bovine animals
• Decree No 434/2008 of the Ministry of Agriculture and Forestry on the system regarding labelling beef, Sections 1 - 3
• Evira's Guide 16024/1 on the labelling and traceability of beef.

Updates in version 4:

• Guideline 10250 is replaced by guideline 2186/04.02.00.01/2021
• The name of the guideline has been changed.
• The list of legislation has been updated.
• Added: The traceability information and the other information required by the mandatory system for the identification and traceability of beef lots shall be stored two years. Considering retail stores the period of storing the information is at least one year.
• Into the gudeline text has been added terms "mandatory", "beef" and "code of beef lot" in order to emphasize that the guideline 16.2 is based on strict special legislation enacted especially and only for beef.

16.4 Traceability of Fish and Fishery Products under Dioxin Derogation

Guide/version: 2188/04.02.00.01/2021/3, valid from 1.7.2021

To be taken into consideration:
This point is to be controlled, when the operator

• imports, stores, brokers, packages, sells or exports from Finland fish or fishery products under temporary dioxin derogation
• manufactures or has manufactured for it fishery products from fish under dioxin derogation.

The derogation applies to wild caught salmon (Salmo salar) originating in the Baltic Region, herring (Clupea harengus) larger than 17 cm or unsorted, char (Salvelinus spp.), river lamprey (Lampetra fluviatilis) and trout (Salmo trutta), and products thereof.

Fish under dioxin derogation and products made from such fish may not be delivered without a lot-specific analysis certificate (showing that the limit values of dioxin and dioxin-like PCBs are not exceeded) to other member states apart from Finland and Sweden. Salmon and products thereof may also be delivered to Latvia. These delivery restrictions apply to all operators.

If the operator delivers fish under dioxin derogation or products thereof to countries other than Finland or Sweden (salmon Latvia), the operator must be able to produce for each delivery lot a lot-specific analysis certificate showing that the limit values of dioxin and dioxin-like PCBs are not exceeded (cf. the definition of "lot" in this case, Commission Regulation (EU) No 589/2014). Where the operator only delivers fish under dioxin derogation and products thereof to Finland or Sweden (salmon Latvia), no analysis certificate is needed.

An indication of the delivery restriction must be attached on the primary production site and approved food establishment to the traceability information (for instance to commercial document) accompanying fishery products under dioxin derogation.

Approved Food Establishments: the traceability information of food shall be stored at least two years.

Registered Food Premises: the traceability information of food shall be stored at least one year.

It is recommended that point 16.9 Traceability of Foodstuffs of Animal Origin is controlled at the same time.

Matters to be controlled:
The implementation of own-check is evaluated by controlling the following matters:

• The operator identifies the requirements of dioxin derogation provisions and has them under control alongside of traceability information.
• Operation is evaluated by checks of e.g. 1-3 different lots/raw materials/products, taking the scope and nature of operations into consideration. For example, there will be time to check more lots in a small-capacity establishment that only guts and fillets fish than in a large establishment that also manufactures processed products.

1. Approved establishments that handle fish and/or fishery products under dioxin derogation:

• Commercial documents bear the required indication of delivery restrictions.
• Compliance with delivery restrictions.
• Analysis certificate, if fish and/or fishery products under dioxin derogation have been delivered to countries other than those to which the derogation applies.
• Separation between fish under dioxin derogation and other fish.
  • e.g. lots of salmon and lots of rainbow trout may not be mixed without keeping records of mixings
  • clear, systematic management of marking and traceability can be demonstrated during storage and production.

2. Registered food premises that receive fish under dioxin derogation and broker/sell it to other operators and/or (possibly) manufacture products from such fish:

• Compliance with delivery restrictions.
• Forward to the receiving operator the indication of delivery restrictions required in commercial documents.
• Management of commercial documents.
• Separate storage of documents demonstrating the management of dioxin derogation or some other form of records are not required, but the operator shall be able to demonstrate by means of commercial documents, if fish or products under dioxin derogation has been received and if it has been delivered further.
• Separation between fish under dioxin derogation and other fish
  • oe.g. lots of salmon and lots of rainbow trout may not be mixed without keeping records of mixings.
  • clear, systematic management of separation and traceability can be demonstrated during storage and possible further delivery.

The adequacy and suitability of own-check activities and, where appropriate, the plan is controlled by applying the Annex to Guideline 1.6: "Adequacy and Suitability of Own-check Activities".

Operations comply with requirements.

1. Approved establishments:

• Traceability information (for instance commercial documents) bear the required indication of delivery restrictions.
• Delivery restriction is complied with.
• If fish or fishery products under dioxin derogation have been delivered to countries other than those to which the derogation applies, an analysis certificate can be presented for each lot showing that the limit value for the dioxin level is not exceeded.
• Fish under dioxin derogation is not mixed with other fish at any point unless the mixing is documented.

2. Registered establishments:

• Traceability information (for instance commercial documents) bear the required indication of delivery restrictions.
• Compliance with delivery restrictions.
• Forward the indication of delivery restrictions required in commercial documents.
• Is able to demonstrate by means of traceability information (like commercial documents), if fish exempt from dioxin regulations has been received and if it has been delivered further.
• Fish under dioxin derogation is not mixed with other fish at any point unless the mixing is documented.

There are small issues with the operations which do not impair food safety or mislead consumers.

The operator's operations meet in the main parts the aforementioned requirements. There are some minor shortcomings, such as:

1. Approved establishments:

• The indication of delivery restrictions is provided in the document of each delivery lot with the exception of a random shortcoming (human error). As concerns such an exception, the operator is able to demonstrate by means of commercial documents, however, that the products have been delivered to Finland or Sweden (salmon Latvia) and the recipient has not delivered them further to a commercial operator.
• There are some minor inaccuracies in the operator's processes as regards the separation of fish under dioxin derogation to the extent that there is cause to improve the management of separation.

2. Registered establishments:

• For example, a small operator who has handled fish under dioxin derogation on a very random basis and has not had all the requirements laid down in dioxin derogation provisions under control. The operator is able to demonstrate by means of commercial documents, however, that the products have been delivered to Finland or Sweden (salmon Latvia) and the recipient has not delivered them further to a commercial operator.
• There are some minor inaccuracies in the operator's processes as regards the separation of fish under dioxin derogation to the extent that there is cause to improve the management of separation.

There are issues with the operations which impair food safety or mislead consumers. These issues must be rectified within a set period of time.

Such defects/shortcomings include, for example:

1. Approved establishments:

• The operator does not use at all in commercial documents the indication of delivery restrictions on products on which it should be used. The operator is able to demonstrate by means of commercial documents, however, that the products have been delivered to Finland or Sweden (salmon Latvia) and the recipient has not delivered them further to a commercial operator.
• The operator's compliance with delivery restrictions cannot be satisfactorily demonstrated. Concrete immediate improvements of operations are necessary.
• Separation cannot be satisfactorily demonstrated for all lots.

2. Registered establishments:

• The operator's compliance with delivery restrictions cannot be satisfactorily demonstrated.
• Separation cannot be satisfactorily demonstrated for all lots.

There are issues with the operations which jeopardise food safety or considerably mislead consumers, or the operator has failed to comply with orders that have been issued. These issues must be rectified with immediate effect.

Such issues include:

• The operator has itself delivered fish or fishery products under dioxin derogation to a country or countries other than Finland, Sweden or Latvia (salmon).
• The operator is not able to demonstrate where the products have been delivered to.
• The operator does not use at all the indication of delivery restrictions in documents in which it should be used and is unable to demonstrate that products have only been delivered to Finland, Sweden (or Latvia salmon).
• Separation cannot be verified at all for any of the lots.

2. Registered establishments:

• The operator has itself delivered fish or fishery products under dioxin derogation to a country or countries other than Finland, Sweden or Latvia (salmon).
• The operator is not able to demonstrate at all where the products have been delivered to.
• Separation cannot be verified at all for any of the lots

In case of all the examples under the grade POOR, if one of the examples is realised, the controlling inspector of the establishment should inform Finnish Food Authority (ruokahygienia[at]ruokavirasto.fi) about the matter without delay as well, to make it possible to forward information about the problem also to the central authority of the country of destination so that the authority can proceed with investigation.

Legislation and guidelines (with any amendments) pertaining to the subject:

• Commission Regulation (EC) No 1881/2006 setting maximum levels for certain contaminants in foodstuffs, Article 7
• Regulation (EC) 178/2002 of the European Parliament and of the Council 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; Articles 14, 17 and 18
• Commission Regulation (EC) 931/2011 on the traceability requirements set for food of animal origin, Article 3
• Regulation (EC) No 854/2004 of the European Parliament and of the Council laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption, Articles 14 and 15
• Commission Regulation (EU) No 589/2014 laying down methods of sampling and analysis for the control of levels of dioxins, dioxin-like PCBs and non-dioxin like PCBs in certain foodstuffs and repealing Regulation No 252/2012, Annex 1 Definitions and abbreviations, 1.11 "Lot"
• Finnish Food Act 297/2021 14 § 1 mom.
• Maa- ja metsätalousministeriön asetus elintarvikehygieniasta 318/2021 22 § ja 36 §
• Finnish Food Authority's Guide 16023/5 Control of fishery products.

Updates in version 3:

• Guideline 10251 is replaced by guideline 2188/04.02.00.01 /2021
• Finnish Food Act 297/2021 14 § 1 mom.
• Maa- ja metsätalousministeriön asetus elintarvikehygieniasta 318/2021 22 § ja 36 §.
• Approved Food Establishments: the traceability information of food shall be stored at least two years.
• Registered Food Premises: the traceability information of food shall be stored at least one year.
• Updated text: In case of all the examples under the grade POOR, if one of the examples is realised, the controlling inspector of the establishment should inform Finnish Food Authority (ruokahygienia[at]ruokavirasto.fi) about the matter without delay as well, to make it possible to forward information about the problem also to the central authority of the country of destination so that the authority can proceed with investigation.

16.5 Management of and Preparedness for Special Situations

Guide/version: 2189/04.02.00.01/2021/3, valid from 1.7.2021

To be taken into consideration:

• This Guideline is applied to all approved establishments.
• The purpose of this point is to evaluate the management of and preparedness for abnormal situations that are relevant as regards the securing of the safety of foodstuffs and from the viewpoint of the establishment's own operation.
• Preparedness for abnormal situations should be based on a risk assessment carried out by the establishment.
• The management of abnormal situations refers to e.g. preventing products from reaching the market unless they can be proven to be safe, or e.g. the production facilities being cleaned thoroughly after an animal disease incident.
• Recalls of foodstuffs that have already reached the market, and preparedness for recalls are evaluated in point 16.6.
• Preparedness for abnormal situations refers to e.g. the operator taking into consideration the actions that will most probably be necessary due to an abnormal situation, such as where can foodstuffs be delivered to be destroyed.
• Situations that jeopardise the safety of food production in an unexpected and substantial manner can be considered to be abnormal situations. Abnormal situations can include, for example:
  • Electricity black-out and its effects on the production of foodstuffs.
  • Serious and exceptional disturbances related to the quality and safety ofwater, and the effects of such disturbances on foodstuffs to be manufactured or foodstuffs that have already been manufactured.
  • Process disturbances, such as failure of a production line.
  • Animal disease situations and their effects on food production processes, such as reception of live animals.
  • Other abnormal situations with potential to affect the safety of foodstuffs, such as accidents, floods, fires, biohazards, vandalism, etc.

Matters to be controlled:

• Written instructions for action in case of abnormal situations that are relevant to the establishment's own operations.
• Instructions for actions in abnormal situations regarding foodstuffs to be manufactured or foodstuffs that have already been manufactured.
• Securing food safety also after abnormal situations, e.g. cleaning activities.
• Implemented actions in possible abnormal situations; for example, destruction of contaminated foodstuff batches.
• Own-check records maintained of possible abnormal situations, and actions taken due to them.
• The adequacy and suitability of own-check activities and, where appropriate, the plan are controlled by applying the Annex to Guideline 1.6: "Adequacy and Suitability of Own-check Activities".

Operations comply with requirements.

Operations comply with requirements as regards the matters that are controlled. For example:

• The operator has written instructions for abnormal situations to ensure that no food safety risk is caused to the consumer.
• Actions concerning foodstuffs to be manufactured or foodstuffs that have already been manufactured have been taken into consideration in instructions and actions.
• Food safety also after abnormal situations has been taken into consideration in instructions and actions; e.g. cleaning of processes.
• The actions taken due to abnormal situations, if any, have been appropriate and adequate.
• Adequate own-check records have been maintained of abnormal situations, if any, and actions taken due to them.

There are small issues with the operations which do not impair food safety or mislead consumers.

For example:

• The operator has instructions for abnormal situations to ensure that no food safety risk is caused to the consumer.
• The actions taken due to abnormal situations have been appropriate and adequate, but there are some minor shortcomings in the own-check records maintained of abnormal situations and actions taken.

There are issues with the operations which impair food safety or mislead consumers. These issues must be rectified within a set period of time.

For example:

• The operator does not have instructions for abnormal situations to ensure that no food safety risk is caused to the consumer.
• The actions taken due to abnormal situations have not been appropriate or adequate, and food safety has been impaired.
• There are shortcomings in the records maintained of actions taken, and food safety has been impaired.

There are issues with the operations which jeopardise food safety or considerably mislead consumers, or the operator has failed to comply with orders that have been issued. These issues must be rectified with immediate effect.

For example:

• The operator has failed to take corrective actions in abnormal situations, and food safety has been jeopardised.

Legislation and guidelines (with any amendments) pertaining to the subject:

• Regulation (EC) No 178/2002 on food law
• Regulation (EC) No 852/2004 on the hygiene of foodstuffs
• Regulation (EC) No 853/2004 on hygiene rules for food of animal origin
• Commission Implementing regulation (EU) 2019/627
• Implementing Regulation (EC) No 2074/2005
• Finnish Food Act 297/2021
• Decree of the Ministry of Agriculture and Forestry on food control 315/2021.

Updates in version 3:

• Guideline number 2189/04.02.00.01/2021/4 en replaces Guideline number 10311/3 en
• List of legislation has been updated.

16.6 Recalls

Guide/version: 2190/04.02.00.01/2021/3, valid from 1.7.2021

To be taken into consideration:
This point is to be controlled, when the operator

• manufactures, has manufactured for it and/or packages food products
• imports and/or brokers (from the internal market and/or third countries) food products
• stores, markets, serves or exports food products.

If the operator has not been an initiating or involved party in a recall process, the control only applies to the content of the own-check plan with respect to recalls.

Retail operators whose activities do not affect the packaging, labelling, safety or integrity of foodstuffs are not required to implement communication to consumers or authorities. However, they are required to take actions that promote the recall together with the operator responsible for the recall as well as authorities.

It is recommended that point 16.1 Traceability of Foodstuffs is controlled at the same time.

Matters to be controlled:
The adequacy and suitability of own-check activities and, where appropriate, the plan are controlled by applying the Annex to Guideline 1.6: "Adequacy and Suitability of Own-check Activities”.

The implementation of in-house control is evaluated by controlling the following matters:

• Preparedness for recalls is included in the own-check system.
• The changes necessary due to recalls have been made in own-check activities.
• Records and documents exist about the recalls that have been implemented.
• The lots of foodstuffs which the recall concerned are not mixed up with other lots of foodstuffs.

Operations comply with requirements.

Recall activities have been appropriate and adequate. Activities have been recorded and the records and documents related to recalls are stored for the period of time defined in provisions.

The own-check system contains appropriate and adequate instructions for actions in case of recalls.

There are small issues with the operations that do not impair food safety or mislead consumers.

Recall activities have been appropriate and adequate, but there are some minor shortcomings in the records of activities. Such minor shortcomings include, for example

• there are only minor differences in the quantities of recalled products, and products that have been destroyed, returned and sold to consumers.

The records and documents related to recalls are stored for the period of time defined in provisions.

The instructions provided in the own-check system for actions in case of recalls are slightly deficient. For example,

• the person responsible for communication to consumers is not named.

There are issues with the operations which impair food safety or mislead consumers. These issues must be rectified within a set period of time.

Recall activities have not been recorded and documents have not been stored, although recall processes have been carried out. Recall activities have been slightly deficient. For example,

• the scope of communication to consumers has been inadequate
• the operator has not initiated a recall process although they have had cause to suspect that the product does not meet regulations related to the safety of foodstuffs.
• there is a risk of recalled products being mixed up with the operator's other products.
• there are significant differences in the quantities of recalled products, and products that have been destroyed, returned and sold to consumers.

The instructions in the own-check system for actions in case of recalls are inadequate. For example,

• the person responsible for communication to authorities has not been appointed
• there are no advance plans for where to place recalled products in the operator's facilities.

There are issues with the operations which jeopardise food safety or considerably mislead consumers, or the operator has failed to comply with orders that have been issued. These issues must be rectified with immediate effect.

The are no records of activities related to recalls and documents have not been stored, although recall processes have been carried out. Despite known incompliance of foodstuffs with regulations, the required activities have not been implemented at all, or incorrect or inadequate activities have been carried out. For example,

• authorities or consumers / other operators have not been informed, although it would have been necessary
• recalled lots of products have not been separated from other lots.

Recalls have not been taken into account in the own-check system.

Provisions and guidelines pertaining to the topic:

• Regulation of the European Parliament and of the Council laying down the general principles and requirements of food law, 178/2002/EC, Articles 14 and 19
• Finnish Food Act 297/2021, Section 6.

Updates in version 3:

• Finnish Food Act number has been changed.
• Guideline no. 2190/04.02.00.01/2021/3 replaces the guideline no. 10252/2.

16.8 Traceability of Meat of Swine, Sheep, Goats and Poultry

Guide/version: 2191/04.02.00.01/2021/3, valid from 1.7.2021

The control of this particular issue is based in (only) one particular regulation, Commission Implementing Regulation (EU) No 1337/2013.

The control to be carried out in this point covers all stages of production and distribution in food business operations as far as fresh, chilled and frozen meat of swine, sheep, goats and poultry is concerned.

Food business operators shall have in place an identification and registration system ((EU) No 1337/2013, Article) which they use at each stage of the production and distribution of the meat referred to in the title of this Guideline to be able to indicate the country of origin or place of provenance of the meat. The system shall be applied in such a way as to ensure the link between the meat and the animal or group of animals from which it has been obtained. This applies to all the stages of the production and distribution of the meat, from slaughter to packaging. The requirements laid down for the identification and registration system include the following:

• Each food business operator is responsible for the application of the identification and registration system within the stage of production and distribution at which they operate.
• Each food business operator shall use the system to record, in particular, the arrival at and the departure from the establishment of the operator, of animals, carcases or cuts, as appropriate, and to ensure a correlation between arrivals and departures.
• Each operator shall verify the transmission of the information relating to the indications of the country of origin or place of provenance of the meat, as appropriate, together with the meat, to the operators at the subsequent stages of production and distribution.
• The food business operator who packs or labels the meat referred to in the title of this Guideline shall ensure the correlation between the batch code identifying the meat supplied to the consumer or mass caterer and the relevant batch or batches of meats from which the pack or labelled batch is constituted.

For the purposes of this Guideline, the identification and registration system (referred in Commission Implementing Regulation (EU) No 1337/2013) refers to a structured and systematic manner in which the required information on the country of origin or place of provenance is identified, recorded and transmitted.

Approved Food Establishments: the traceability information of food shall be stored at least two years.

Registered Food Premises: the traceability information of food shall be stored at least one year.

The size of a batch cannot exceed the production of one day. The use of the packaging date or some other date indication alone as the batch code is not recommended. A date indication can be considered an adequate batch code in cases where the operator only handles animals and/or the meat of animals originating in the same country of origin or place of provenance, and possibly also in other corresponding cases.

The control to be carried out in this point covers all stages of production and distribution in food business operations as far as fresh, chilled and frozen meat of swine, sheep, goats and poultry is concerned.

It is recommended that point 13.4 Labelling of Meat Required by Specific Legislation is controlled at the same time.

Matters to be controlled:
The implementation of own-check is evaluated by random checks (on e.g. 1-3 different received batches, production batches or consignments, or products/packages, taking the scope and nature of operations into consideration) of the following matters:

• The use of the identification and registration system provided for in Regulation (EU) No 1337/2013, the clarity and systematic nature of documentation.
• Records: the arrival at and the departure from the establishment of the food business operator, of animals, carcases or cuts, as appropriate
• Correlation between arrivals and departures of animals, carcases or cuts.
• The transmission of information to the operators at the subsequent stages of production and distribution.
• As concerns food business operators who pack or label the meat referred to in the title of this Guideline, correlation between the batch code identifying the meat supplied to the consumer or mass caterer and the relevant batch or batches of meats from which the pack or labelled batch is constituted.

The adequacy and suitability of own-check activities and, where appropriate, the plan are controlled by applying the Annex to Guideline 1.6: "Adequacy and Suitability of Own-check Activities."

Operations comply with requirements.

The operator has an identification and registration system in place and uses it, and the controlling inspector becomes concinced that the requirements of the system are met.

There are small issues with the operations that do not impair food safety or mislead consumers.

The operator can be construed to use, in practice, the activities required by the identification and registration system. Some occasional shortcomings can be found in practical activities, but notwithstanding these, the accuracy of the information on the country of origin or place of provenance of the meat can be verified for all batches as well as the practices used to transmit the required information. Minor shortcomings can include, for example:

• An individual record or document is missing.
• However, the controlling inspector becomes concinced on the basis of records/ documentation related to the same batch that the information is accurate.
• Correlation between information on the arrival and departure of animals, carcases or cuts is not indicated in a completely systematic manner. However, the controlling inspector becomes concinced on the basis of other own-check records and commercial documents that the information is accurate.
• As concerns operators who pack or label the meat referred to in the title of this Guideline: the operator uses only a date indication as the batch code identifying the meat supplied to the consumer or mass caterer and is not able to present appropriate justification for the use of only a date indication.

In general; minor shortcomings regarding a systematic approach in operation, or an individual inaccuracy in documentation, despite of which, however, the controlling inspector becomes concinced that the information on the country of origin or place of provenance of the meat is accurate for all lots.

There are issues with the operations that are not in compliance with legislation or impair food safety or mislead consumers. These issues must be rectified within a set period of time.

The operator has some clear shortcomings in the management and verification of traceability which need to be rectified within a set period of time. Such shortcomings may include, for example:

• The operator is of the opinion that they are using an identification and registration system, some documentation has been carried out, but the controlling inspector does not become concinced that the operator is always able to reliably indicate the country of origin or place of provenance by means of the system.
• The operator has an identification and registration system in use, but records/indications are missing to the extent that makes it impossible to consider the use of the system systematic and therefore it is not possible to verify the fulfilment of requirements.
• Animals, carcases or cuts delivered to the operator's facilities have not in each case been accompanied by information on the country of origin or place of provenance and the operator is unable to demonstrate that they have observed the matter and reacted to it (e.g. a written complaint to the supplier). However, based on other evidence, the controlling inspector becomes concinced that information given related to information on the country of origin or place of provenance has not been misleading.

In general; data is missing to the extent that it is no longer a question of an individual defect, and thereby the management of the identification and registration system and the fulfilment of requirements can not be satisfactorily demonstrated.

There are issues with the operations which jeopardise food safety or considerably mislead consumers, or the operator has failed to rectify the issues within the set period of time.

Such issues include, for example:

• The operator has no information on the country of origin or place of provenance of meat batches.
• The operator has failed to transmit information on the country of origin or place of provenance of meat batches.
• As concerns operators who pack or label the meat referred to in the title of this Guideline: the operator uses only a date indication as the batch code identifying the meat supplied to the consumer or mass caterer, although meat batches with different information on the country of origin or place of provenance are packed continuously during the same day. As a result of this, the batch code identifying the meat and the relevant batch or batches of meat from which the pack or labelled batch is constituted do not correlate and it is not possible to verify the origin of the meat.

Legislation and guidelines (with any amendments) pertaining to the subject:

• Commission Implementing Regulation (EU) No 1337/2013 laying down rules for the application of Regulation (EU) No 1169/2011 of the European Parliament and of the Council as regards the indication of the country of origin or place of provenance for fresh, chilled and frozen meat of swine, sheep, goats and poultry, Articles 1, 2, 3, 4
• Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004, Articles 1, 2, 8, 9 and 26, and ANNEX XI
• Maa- ja metsätalousministeriön asetus elintarvikehygieniasta 318/2021 22 § ja 36 §.

Updates to version 3:

• Guideline 10327 is replaced by guideline 2191/04.02.00.01/2021
• Emphasized that control of this particular demand is based in (only) one particular regulation, Commission Implementing Regulation (EU) No 1337/2013 that enacts the issue.
• Maa- ja metsätalousministeriön asetus elintarvikehygieniasta 318/2021 22 § ja 36 § on lisätty.
• Approved Food Establishments: the traceability information of food shall be stored at least two years.
• Registered Food Premises: the traceability information of food shall be stored at least one year.

16.9 Traceability of foods of animal origin

Guide/version: 157/04.02.00.01/2020/2, valid from 1.7.2021

To be taken into consideration:
All food business operators with activities involving food of animal origin (cf. Oiva Evaluation Guidelines 16.1) are the subject of control in this section.

• The mandatory beef labelling system has its own specific legislation and the implementation of this is evaluated separately in section 16.2
• Specific rules have been laid down for the indication of the country of origin or place of provenance for pig meat, poultry, sheep and goat meat and the implementation of its traceability is evaluated separately in section 16.8.

It is irrelevant whether or not the foods are physically in the possession of the operator. What matters most is in who's operator's ownership and responsibility the food is.

Approved Food Establishments: the traceability information of food shall be stored at least two years.

Registered Food Premises: the traceability information of food shall be stored at least one year.

All food business operators must be able to verify the traceability of foodstuffs applying the "one step back, one step forward" approach. Consumers are not included in traceable customers. The following information on food of animal origin must be made available to the recipient upon receipt of a consignment:

1. an accurate description of the food
   1. the names of the foods received and dispatched, in a form and to an extent that the names can be reliably and sufficiently clearly linked to the names shown on the labelling (or other information) of the foods concerned
2. the quantity of the food
3. the name and address of the food business operator that has dispatched the food
4. the name and address of the consignor (owner) if different from the food business operator who has dispatched the food
5. the name and address of the food business operator to whom the food has been dispatched
6. the name and address of consignee (owner), if different to the food business operator to whom the food has been dispatched, name and address
7. a reference identifying the lot, batch or consignment, as appropriate; and
8. the date of dispatch.

The food business operator must have in place a designed system which allows the operator with sufficient accuracy to link the information on the lots of food it receives and dispatches to each other. The system and procedure are not defined by law. What is important is the information, not the system used to access it. The decision on the level of detail of the system should be left to the food business operator, taking into account the nature, size and effectiveness of food business establishment's activity. It is the responsibility of the competent food control authority to evaluate whether the traceability system used by the food business operator is adequate in relation to the nature, size and effectiveness of the operator's activity.

Identification mark
The identification mark is also a key traceability tool. From a traceability point of view, the identification mark affixed to the packaging identifies the establishment which last processed the food and the Member State in which it is located. In addition, the national Approved Establishments Decree (795/2014) provides that the document of dispatch accompanying the food dispatched from an establishment must bear the identification mark itself or information included in the identification mark used by the dispatching establishment.

Health mark
The meat inspected must be marked with the 'health mark', under the responsibility of the official veterinarian to indicate that the meat is fit for human consumption. At the same time, a clearly legible health mark is also a key tool for tracing meat.

Food lot refers to
Food lot refers to a set of food sales units that are produced, manufactured
(= "production batch") or packaged under practically the same conditions. The food producer, manufacturer, packager or first seller established within the European Union determines the lot of food and marks the code on the lot. A lot of food may not exceed the production of one day. A consignment delivered by the operator (delivery lot) may contain several food lots of food of the same product name.

It is recommended that sections 12.6 and 13.1 be controlled at the same time

Matters to be controlled:
The implementation of in-house control is evaluated by controlling the following matters in various foods of animal origin from different categories of food, however, taking the nature and scope of operation into consideration:

• See the above list a) - h)
  • It is recommended that particular attention be paid to the traceability information of food of animal origin within EU internel markets.
• The operator knows and is able to connect with sufficient accuracy (= the inspector is convinced of sufficient information linkability) the information on the lots it has received and dispatched with each other.
  • Information means traceability information (such as consignment notes and related commercial vouchers), records and other records such as information obtained from the operator's information systems. All the above may also be in electronic form only.
• Use of the establishment's own identification mark.
• Use of the establishment's own health mark on meats.
• The health mark on meat received from a dispatch from anothet operator; the health mark of another establishment on meat must be absolutely clear.
  • It is recommended that special attention be paid to the marks on meat within intra-EU trade.

The adequacy and suitability of in-house control and, where appropriate, the plan must be verified in accordance with Oiva Evaluation Guidelines 1.6 and its Annex “Adequacy and Suitability of Own-check Activities”.

Operations comply with requirements.

• The operator is able to demonstrate that points a) - h) on the list shown earlier in these evaluation guidelines are met.
• The operator has in place a systematically implemented traceability system, containing the traceability information available as soon as reasonably expected Traceability information is consistent, easy to read, understandable and easily linkable to the food names.
• Traceability can be verified by comparing the information with, for example, labels on the food or similar identification information.
• The use of the identification mark (and the use of the identification mark information) complies with regulatory requirements.
• The health markings on the various meats in the possession of the operator are clearly legible and can be linked to the traceability information corresponding to the meats.
• Also the operator manages the country of origin information by means of information (records) and documents in so far as it is subject to requirements.

There are small issues with the operations that do not impair food safety or mislead consumers.

• The operator does not have some individual traceability information of food of animal origin receives required on the (see points a) - h)) on the list shown earlier) and there is an acceptable reason for this lack of information.
• The consignment of food of animal origin dispatched by the operator is missing the information required for food of animal origin (see points a) - h)) on the list shown earlier) as a result of an isolated human error that can be explained.
• The unique reference for a batch or consignment of food of animal origin is occasionally missing from the traceability identification. The accuracy of the information can be verified by connecting and comparing other information. A similar occasional lack of information limited to a single data field can be interpreted as a human error.
• For example, the dates are missing (= the data system does not print the dates) from the traceability information and / or the in-house control records and the operator has not separately recorded these. The accuracy of the data (the linkability of time and other required information) is verifiable by connecting and comparing other data (typically any "delivery note" of a lot received vs. a possible "delivery note" of a lot dispatched).
• The linkability of traceability information (typically point a) on the list shown above is the most open to interpretations) and the labelling has minor issues.
• Generally; minor systematic omissions or a single inaccuracy in information or records. However, these do not preclude verification of the correctness of the lot and/or consignment information and the place and time of dispatch and/or delivery of the food.

There are issues with the operations which impair food safety or mislead consumers. These issues must be rectified within a set period of time.

Such errors / omissions include, for example:

• The operator can provide traceability information for most of the food it receives, but there is something missing in all of the information received (see points a) - h) on the list shown above) = the operator's traceability system is not sufficiently effective/functional.
• The operator can provide traceability information for most of the food it dispatches, but there is something missing in all the information sent (see points a) - h) on the list shown earlier) = the operator's traceability system is not sufficiently effective/functional.
• The operator is unable to provide food traceability information (such as "consignment notes / delivery notes") for several (> 2) lots of food it has received. However, the operator may obtain the missing information by requesting it from the consignor of the food in question. There can be no assurance of an overall traceability management of traceability system.
• The operator has most of the traceability information, but the operator is unable to provide food traceability information (such as consignment lists) for several (three, even two, is already = 'several') lots of food it has dispatched. However, the operator may obtain the missing information by requesting it from the recipient of the food in question. There can be no assurance of an overall traceability management of a traceability system.
• There are significant issues and/or vagueness in the linkability of traceability information and packaging labels (most typically there are most shortcomings and room for interpretation in point a) in the list shown earlier).
• The health markings on the various meats in the possession of the operator are clearly legible, but linkability to the traceability information corresponding to the meats, incl. country of origin information (when it is required), leaves too much room for interpretation.

Generally; traceability information is missing so that it is no longer a question of isolated harm and thus traceability controllability cannot be assured.

There are issues with the operations that jeopardise food safety or seriously mislead the consumer, or the operator has failed to comply with the orders issued. These issues must be rectified with immediate effect.

Issues requiring immediate rectification include, for example:

• Traceability information incl. labellings is missing so that the foods are not traceable and/or identifiable.
• The consignors of the food lots received and / or the consignees of the food lots dispatched cannot be identified = names and contact details are missing or incorrect.
• The health markings on the various meats in possession of the operator are so unclear that they do not allow identifying the number of establishment or code of the EU Member State.
• The operator possesses meats with no identification mark, even though the traceability information of the meats concerned indicates that the meats have been processed in an approved food establishment.
• The operator possesses meats (quarters of carcasses, halves of carcasses) which do not bear a health mark, even though the traceability information indicates that the meats concerned have been processed in an approved food establishment.

Legislation and guidelines (with any amendments) pertaining to the subject:

• Commission Implementing Regulation (EU) No 931/2011 on the traceability requirements set by Regulation (EC) No 178/2002 of the European Parliament and of the Council for food of animal origin
• Regulation 178/2002/EC of the European Parliament and of the Council 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, Articles 3, 8, 17(1) and 18
• Regulation (EC) No 853/2004 of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin, Articles 5, 6 and 7 ANNEX II SECTION I
• Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers Article 9
• Food Act 297/2021 14 § 1 mom.
• Maa- ja metsätalousministeriön asetus elintarvikehygieniasta 318/2021 22 § ja 36 §
• Decree of the Ministry of Agriculture and Forestry on the provision of food information to consumers (834/2014)

16.9 is intended only for verifying the traceability of food of animal origin (Cf, completely renewed guideline 16.1).

Imports of food of animal origin to Finland from other Member States of the European Union and certain other countries (special agreement countries) are called places of first arrivals. Evaluation Guideline 16.9 also contains the subject areas of discontinued control of places of first arrivals, which must, in any case be controlled in relation to the traceability of food of animal origin (see the Legislation related to the topic in the Evaluation Guidelines).

Updates to version 2:

• Food Act 297/2021 14 § 1 mom.
• Maa- ja metsätalousministeriön asetus elintarvikehygieniasta 318/2021 22 § ja 36 §
• Approved Food Establishments: the traceability information of food shall be stored at least two years.
• Registered Food Premises: the traceability information of food shall be stored at least one year.