08 Specific Requirements for Food Production

All Oiva evaluation guidelines for approved food establishments.

8.1 Processing of TSE Risk Material

Guide/version: 2146/04.02.00.01/2021/5, valid from 2.1.2024

To be taken into consideration:

This Guideline is applied to all establishments where TSE risk material of bovine, ovine or caprine animals is processed, also when no specific approval is required for the processing of TSE risk material.
Technical matters related to TSE approval, such as application for required approvals, approval documents, own-check activities (up-to-date status and consistency with approval decision) and the facilities related to the approval are evaluated in point 1.3.
BSE/TSE sampling is evaluated in point 17.1.
The separation of material of animal origin from wastewater in facilities where TSE risk material is being separated is evaluated in point 1.1 in connection with approval of the facilities, structures and equipment of the establishment.
The handling and storage of by-products other than TSE risk material are evaluated in point 5.7 insofar as the operations fall under the Food Act, and in point 5.8 insofar as the operations fall under legislation on by-products. The results of the evaluations based on Guideline 5.8 are not presented in the Oiva report, but only in the inspection report.
The dispatching of and commercial documents related to by-products are evaluated in point 15.5 insofar as the operations fall under the Food Act, and in point 5.8 insofar as the operations fall under legislation on by-products.

Matters to be controlled:

Compliance of TSE operations and processing of TSE risk material with requirements, and prevention of cross-contamination of foodstuffs.
Where a specific approval is required for TSE operations, compliance of TSE operations with the TSE approval decision and any specific conditions laid down in the approval decision.
Correct determination of TSE risk material and verification by the operator of compliance with the age limits laid down in TSE provisions.
Placing of the carcass, other parts of the slaughtered animal, and by-products in quarantine, keeping in quarantine and releasing from quarantine.
Marking and separation of TSE risk material.
Processing, dispatching, reception, and commercial documents of the carcasses or other parts of the slaughtered animal containing TSE risk material.
Cutting of meat from the head of bovine animals aged over 12 months.
The adequacy and suitability of own-check activities as concerns the processing of TSE risk material, and the own-check plan, if appropriate, are controlled applying the Annex to Guideline 1.6: "Adequacy and Suitability of Own-check Activities".

Excellent: Operations are in line with the requirements. Operations comply with requirements.

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

TSE operations are carried out in compliance with the TSE approval decision and any specific conditions laid down in the approval decision. Processing of TSE risk material complies with requirements.
TSE risk material is marked and kept separate from foodstuffs in a manner that prevents cross-contamination. All parts of animal that legislation defines as TSE risk material are treated as such. The carcass, other parts of the slaughtered animal, and by-products are kept in quarantine until the TSE examination result is confirmed.

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

For example:

There are some minor shortcomings in the records related to TSE operations at the establishment as concerns deviations and corrective action taken, but corrective actions have been appropriate and adequate.
There are some minor shortcomings in the marking of containers used for the collection and storage of TSE risk material, or in the staining of TSE risk material, but there is no risk of confusion with foodstuffs.

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

For example:

TSE operations are not carried out in compliance with the TSE approval decision or with any specific conditions laid down in the approval decision, and food safety is impaired.
There are repeatedly shortcomings in the TSE marking of carcasses or in the sealing of the foramen magnum and the plugging of the bolt hole.
Shortcomings occur on a regular basis or continue for a prolonged period of time.

Poor: 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. 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:

TSE operations are not carried out in compliance with the TSE approval decision or with any specific conditions laid down in the approval decision, and food safety is jeopardised.
TSE risk material is not removed.
There are shortcomings in the marking of containers used for the collection and storage of TSE risk material, or in the staining of TSE risk material, which cause a risk of confusion between TSE risk material and foodstuffs.
The result of the TSE examination is not waited for before continuing the processing of carcasses, other parts of the slaughtered animal, and by-products.

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

Regulation (EC) No 999/2001, rules regarding TSEs
Regulation (EC) No 1069/2009 on by-products
Regulation (EC) No 852/2004 on the hygiene of foodstuffs
Regulation (EC) No 853/2004 on hygiene rules for food of animal origin
Finnish Food Act 297/2021
Decree of the Ministry of Agriculture and Forestry on zoonoses 316/2021, Chapter 7
Finnish Food Authority's Guide “TSE actions at slaughterhouses and cutting plants”
Finnish Food Authority 's Guide “Handling and control of animal by-products at food establishments”.

Updates in version 5:

List of guidelines has been updated.

8.2 Sensory Monitoring of Cleanliness of Carcasses and Organs

Guide/version: 2147/04.02.00.01/2021/4, valid from 2.1.2024

To be taken into consideration:

This Guideline is applied to slaughterhouses and low-capacity slaughterhouses that slaughter ungulates, as well as to reindeer slaughterhouses and game handling establishments for the evaluation of the sensory monitoring of the cleanliness of carcasses and organs.
This Guideline is also applied to slaughterhouses and low-capacity slaughterhouses that slaughter poultry for the evaluation of the sensory monitoring of the cleanliness of carcasses and organs.
The adequacy and effectiveness of monitoring and corrective actions can be evaluated on the basis of observations during the inspection of the arriving carcasses at the cutting plant.
Microbiological sampling from the surface of carcasses, carried out to monitor process hygiene, is evaluated in point 17.1 "Sampling and Own-check Tests".
Management of lactic acid decontamination of bovine carcasses is evaluated in point 8.3.

Matters to be controlled:

Cleanliness of carcasses and organs
Organisation of sensory monitoring of cleanliness of carcasses and organs
- implementation of own-check activities
- records of implementation
- records of deviations
- corrective actions carried out due to deviations
- Implementation of the HACCP system, if appropriate
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".

Excellent: Operations are in line with the requirements. Operations comply with requirements.

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

Carcasses in the chilling room are clean according to the sensory assessment and there is no visible faecal or other contamination on them.
Sensory monitoring of the cleanliness of carcasses and organs comprises of adequate own-check, implementation, record keeping, corrective actions, and an adequate implementation of the HACCP system, if appropriate.
Own-check activities are adequate and suitable in relation to the nature and scope of the operations at the establishment.
Corrective actions have been adequate.

For example:

Carcasses in the chilling room are clean according to the sensory assessment and there is no visible faecal or other contamination on them.
There are some minor shortcomings in the sensory monitoring of the cleanliness of carcasses and organs, or in the own-check activities or in the implementation of the HACCP system, but they do not impair food safety.

For example:

According to the sensory assessment, there is some faecal or other contamination on carcasses in the chilling room, which impairs food safety.
There are shortcomings that impair food safety in the sensory monitoring of the cleanliness of carcasses and organs, or in the own-check activities or in the implementation of the HACCP system.

For example:

According to the sensory assessment, there is faecal or other contamination on carcasses in the chilling room to the extent that food safety is jeopardised.
There are shortcomings that jeopardise food safety in the sensory monitoring of the cleanliness of carcasses and organs, or in the own-check activities or in the implementation of HACCP system.

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

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
Finnish Food Act 297/2021
Decree of the Ministry of Agriculture and Forestry on food hygiene 318/2021.

Updates in version 4:

To be taken in the consideration: This guideline is also applied to slaughterhouses and low-capacity slaughterhouses that slaughter poultry fot the evaluation of the sensory monitoring of the cleanliness of carcasses and organs. And organs has been added to the sentence.
The section Matters to be controlled: HACCP system has been replaced by the implementation of the HACCP system.
In Oiva evaluation guidelines good, to be corrected and good: The HACCP system has been replaced by the implementation of the HACCP system. In Oiva evaluation guidelines excellent: the HACCP system has been replaced by the adequate implementation of the HACCP system.

8.3 Management of Lactic Acid Decontamination of Bovine Carcasses

Guide/version: 2148/04.02.00.01/2021/4, valid from 2.1.2024

To be taken into consideration:

This Guideline is applied to slaughterhouses and low-capacity slaughterhouses that slaughter domestic bovine animals (incl. Bubalus and Bison species) and to reindeer slaughterhouses.
The purpose of this point is to evaluate the reduction of the surface contamination of bovine carcasses using lactic acid, and the monitoring of the reduction of surface contamination.
As the use of lactic acid may not affect the obligation of the food business operator to comply with good hygienic slaughter practices and operational procedures, it is recommended that the sensory monitoring of the cleanliness of carcasses and organs (point 8.2) is evaluated at the same time as this point.

Matters to be controlled:

Compliance of the lactic acid solution with requirements.
Fulfilment of the pre-conditions for lactic acid treatment, and its compliance with requirements.
The implementation of the HACCP system, incl. sampling before lactic acid treatment as required by the Regulation on microbiological criteria of foodstuffs, lactic acid concentration during treatment, lactic acid temperature during treatment.
Documentation of lactic acid treatment.
Notification of the operators receiving the carcasses about the lactic acid treatment.
Documentation of the above-mentioned notifications.
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”.

Excellent: Operations are in line with the requirements. Operations comply with requirements.

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

Operations meet the specified requirements and the operator has unexpected and occasional shortcomings under control through own-check activities. Implementation of the HACCP system complies with the requirements.

For example:

Minor non-compliances with regulatory requirements; for example, occasional deficiencies in record keeping.
However, corrective actions have been adequate and appropriate.

For example:

Non-compliances requiring corrective actions with regulatory requirements of the process, or in record keeping.
The nature of the non-compliances and the standard of the corrective actions cause food safety to be impaired.

For example:

Serious non-compliances with regulatory requirements of the process requiring immediate corrective actions.
Lactic acid treatment is carried out on carcasses on which visible faecal contamination is observed.
The nature of the non-compliances and the standard of corrective actions cause food safety to be jeopardised.

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

Regulation (EC) No 852/2004 on the hygiene of foodstuffs
Regulation (EC) No 853/2004 on hygiene rules for food of animal origin
Commission Regulation (EU) No 101/2013 concerning the use of lactic acid to reduce microbiological surface contamination on bovine carcasses
Finnish Food Act 297/2021
Decree of the Ministry of Agriculture and Forestry on food hygiene 318/2021.

Updates in version 4:

The section Matters to be controlled: HACCP system has been replaced by the implementation of the HACCP system.

8.4 Management of Trichinella Risk

Guide/version: 2150/04.02.00.01/2021/5, valid from 2.1.2024

To be taken into consideration:

This Guideline is applied to slaughterhouses, low-capacity slaughterhouses and game handling establishments that slaughter species susceptible to Trichinella infection.
Pigs housed under controlled housing conditions are exempt from Trichinella examination.
The competence of the external laboratory used to analyse the samples is evaluated in point 1.6.

Matters to be controlled:

Sampling for Trichinella examination is in compliance with regulatory requirements and the orders of the Finnish Food Authority.
Samples and carcasses are linkable and traceable
Health marking of carcasses before the results of the Trichinella examination are received
Cutting of pig carcasses before the results of the Trichinella examination are received
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 performance of Trichinella examination, and quality assurance of low-capacity slaughterhouses performing Trichinella examinations of official meat inspection. (Doesn`t affect the Oiva evaluation).

Excellent: Operations are in line with the requirements. Operations comply with requirements.

Trichinella sampling is carried out in compliance with regulatory requirements. Samples can be traced to carcasses or groups of carcasses.

Carcasses with a health marking are not removed from the slaughterhouse facilities or processed until the Trichinella examination has been completed. Any deviating arrangements applied to pig carcasses have been approved by the competent authority of the establishment, and the arrangements meet other regulatory requirements specified for them.

The performance of Trichinella sampling is verified through own-check activities in compliance with regulatory requirements. The actions to be taken at the establishment in case of Trichinella infection is detected, are also included in the own-check system. Any deficiencies in operations are detected through own-check system and corrective actions are carried out appropriately.

There are some minor shortcomings in the implementation of the own-check system at the establishment. For example:

Trichinella sampling is carried out on all the animals for which sampling is required by legislation, but samples cannot always be traced to a specific group of animals in a case where all the samples have tested negative.

To be corrected: 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 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 time of period.

For example:

Carcasses with a health marking have been removed from the slaughterhouse facilities without the approval of the competent authority prior to the completion of the Trichinella examination, but the carcasses have not been processed otherwise.
The management of Trichinella risk is deficient at the establishment, corrective actions have not been carried out or they have been inadequate.

For example:

Trichinella sampling is not carried out in compliance with regulatory requirements (for example, no samples are taken, samples are taken from a wrong point, or samples are too small).
Carcasses that are to be sampled are not identifiable (for example, pigs from ordinary conditions and from controlled housing conditions).
The results of the Trichinella examination are not waited for before starting the processing of carcasses, or the conditions laid down for any deviating arrangements applied to pig carcasses are not complied with.

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

Commission Regulation (EC) No 2015/1375
Commission Implementing Regulation (EU) No 2019/627
Finnish Food Act 297/2021
Decree of the Ministry of Agriculture and Forestry on food hygiene 318/2021
Regulation of the Finnish Food Safety Authority exempting pigs born and reared under recognized controlled housing conditions from Trichinella examination, 1/2015
Finnish Food Authority's Guide 5736/04.02.00.01/2020/2 ”Sianruhojen terveysmerkintä, paloittelu ja leikkaaminen ennen kuin trikiinitutkimuksen tulos on valmis” (in Finnish).

Updates in version 5:

List of legislation and guidelines has been updated. The number of the guideline has been added to Finnish Food Authority`s Guide "Sianruhojen terveysmerkintä, paloittelu ja leikkaaminen ennen kuin trikiinitutkimuksen tulos on valmis".
To be taken in the consideration: the competence of the laboratory has been replaced by the competence of the external laboratory.
Matters to be controlled: The last sentence has been added: The performance of Trichinella examination, and quality assurance of low-capacity slaughterhouses performing Trichinella examinations of official meat inspection. (Doesn`t affect the Oiva evaluation).

8.5 Production of Minced Meat and Meat Preparations

Guide/version: 2151/04.02.00.01/2021/3, valid from 2.1.2024

To be taken into consideration:

This point is applied to establishments approved for the production of minced meat or meat preparations
The temperature requirements specified for the production of minced meat and meat preparations are evaluated in point 6.5 "Temperature Management in Food Production Processes"
Matters related to the connective tissue protein of minced meat are evaluated in Guideline 13.4
The use of additives in meat preparations is evaluated in point 11.1 "Additives, Flavourings and Enzymes".

Matters to be controlled:

Muscles or offals permitted by legislation are used as raw material for minced meat and / or meat preparations..
Age of the raw material used for minced meat.
Microbiological requirements for mechanically separated meat used for the production of meat preparations intended to be heated.
Minced meat and meat preparations may not be re-frozen after thawing.
The adequacy and suitability of own-check and, where appropriate, the plan are controlled applying the Annex to Guideline 1.6: "Adequacy and Suitability of Own-check Activities".

Excellent: Operations are in line with the requirements. Operations comply with requirements.

The raw material used for the production of minced meat and / or meat preparations meets regulatory requirements.
The age of the raw material used for the production of minced meat meets regulatory requirements.
Mechanically separated meat used for the production of meat preparations intended to be heated meets the microbiological requirements laid down for minced meat.

The grade can be Good e.g. in cases where:

The raw material used for the production of minced meat and / or meat preparations meets regulatory requirements.
There are some minor shortcomings in the monitoring of the age of the raw material used for the production of minced meat, but they do not impair food safety.
The have been some minor shortcomings in the microbiological quality of the mechanically separated meat used for the production of meat preparations intended to be heated.

The grade can be To be corrected e.g. in cases where:

There are shortcomings in the monitoring of the age of the raw material used for the production of minced meat, or the meat used as raw material is too old, and its use impairs food safety.
Mechanically separated meat used for the production of meat preparations intended to be heated does not meet the microbiological requirements laid down for minced meat.

The grade can be Poor e.g. in cases where:

Scrap cuttings and trimmings (other than whole muscle cuttings), mechanically separated meat, meat containing skin, or meat of the head with the exception of the masseters, the non-muscular part of the linea alba, the region of the carpus and the tarsus, or bone scrapings, or the muscles of the diaphragm with the serosa unremoved are used as raw material for minced meat.
The age of the raw material used for the production of minced meat is not known, or it is too old, and its use jeopardises food safety.
Mechanically separated meat has been used in meat preparations intended to be heated, although the microbiological tests of mechanically separated meat have not been carried out or included in the sampling plan.

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

Regulation (EC) No 852/2004 on the Hygiene of Foodstuffs
Regulation (EC) No 853/2004 on Hygiene Rules for Food of Animal Origin, Annex III, Section V
Regulation /EC) No 2073/2005 on Microbiological Criteria for Foodstuffs
Finnish Food Act 297/2021.

Updates in version 3:

The age of the raw material used for the production of meat preparations has been removed from the grading examples.

8.6 Production of Mechanically Separated Meat

Guide/version: 2152/04.02.00.01/2021/3, valid from 2.1.2024

To be taken into consideration:

This Guideline is applied to establishments that produce mechanically separated meat.
The temperature requirements specified for the production of mechanically separated meat are evaluated in point 6.5 "Temperature Management in Food Handling Processes"
The time and temperature limits applied to the freezing of mechanically separated meat and to the storage of frozen mechanically separated meat are evaluated in Guideline 6.6 "Temperature Management of Quick-frozen and Frozen Foodstuffs"
The labelling of the prepacked food products containing mechanically separated meat is evaluated in point 13.1 "Mandatory Food Information (Packaged and Unpackaged Foodstuffs".

Matters to be controlled:

The raw material for mechanically separated meat is derived from animal parts permitted by legislation.
The age of the raw material used for mechanically separated meat
The period of use of meat separated mechanically using high pressure (excluding freezing)
Mechanically separated meat produced using high pressure or low pressure is marked during production as "mechanically separated meat" instead of as "meat", for example.
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".

Excellent: Operations are in line with the requirements. Operations comply with requirements.

The raw material used for the production of mechanically separated meat and its age meet regulatory requirements.

Meat separated mechanically using high pressure must be chilled immediately to a temperature of not more than 2 °C, if it is not used within one hour after production.

Mechanically separated meat produced using high pressure or low pressure is marked during production as mechanically separated meat; mechanically separated meat produced using low pressure, for example, is not marked as meat.

The grade can be Good e.g. in cases where:

The raw material used for the production of mechanically separated meat meets regulatory requirements.
The raw material used for the production of mechanically separated meat is slightly too old occasionally, but this does not impair food safety.
There have been deviations regarding the period of use of meat separated mechanically using high pressure, but the deviations have not impaired food safety.

The grade can be To be corrected e.g. in cases where:

There are shortcomings in the monitoring of the age of the raw material used for the production of mechanically separated meat, or the raw material for deboning is too old, and its use impairs food safety.
There have been deviations regarding the period of use of meat separated mechanically using high pressure to the extent that they have impaired food safety.
Mechanically separated meat produced using high pressure or low pressure is marked incorrectly during production; mechanically separated meat produced using low pressure, for example, has been marked as meat.

The grade can be Poor e.g. in cases where:

Poultry feet, neck skin, or heads, or bones of the head, feet, tails, femur, tibia, fibula, humerus, radius and ulna of other animals are used for the production of mechanically separated meat.
The age of the raw material used for the production of mechanically separated meat is not known, or it is too old, and its use jeopardises food safety.
Mechanically separated meat produced using high pressure has been used to manufacture other products than heat-treated meat products.

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

Regulation (EC) No 852/2004 on the hygiene of foodstuffs
Regulation (EC) No 853/2004 on hygiene rules for food of animal origin, Annex III, Section V
Finnish Food Act 297/2021.

Updates in version 3:

The names of the evaluation guidelines have been updated
The word "quick-frozen" has been changed to "frozen" to follow the wording of the legislation
An error in the section "Excellent" regarding quick-freezing has been corrected to chilling
The definition of raw material has been updated in the section of "To be corrected"
An example of a shortcoming causing a "Poor" grade has been added.

8.7 Production of Dried Reindeer Meat

Guide/version: 2153/04.02.00.01/2021/4, valid from 2.1.2023

To be taken into consideration:

This Guideline is applied to the production of dried reindeer meat based on the traditional outdoor air-drying method in a meat product establishment located in the Finnish reindeer husbandry area.
Compliance with the requirements specified for approval for production of dried reindeer meat is evaluated in point 1.2.
Production of dried reindeer meat using some other method than the traditional outdoor air-drying method, or in a meat product establishment located outside the reindeer husbandry area, is evaluated in point 5.1.
This Guideline is not applied to the production of dried reindeer meat in the place of primary production in the reindeer husbandry area.

Matters to be controlled:

The requirements of the Decree of Ministry of Agriculture and Forestry on food hygiene 318/2021 are complied with in the production of dried reindeer meat, taking the limitation of the scope of the Decree as defined in 59 § into account.
Inspection of the hygiene of the handling of reindeer meat as it is prepared for the drying process in the indoor facilities of the meat product establishment.
Inspection of the handling of reindeer meat before and after drying as the meat is hung in the drying rack and removed from the rack.
Inspection of the hygiene of the handling of dried reindeer meat after the drying process in the indoor facilities of the meat product establishment.
Inspection to verify that vermin and birds cannot contaminate reindeer meat during the drying process.
Inspection to verify the free circulation of air round the reindeer meat during the drying process.
Inspection to verify that the drying of reindeer meat is carried out in a suitable period of the year and at a suitable outdoor temperature.
Only inspected reindeer meat is dried in the drying rack.
The adequacy and suitability of own-check and, where appropriate, the plan are controlled applying the Annex to Guideline 1.6: "Adequacy and Suitability of Own-Check Activities".

Excellent: Operations are in line with the requirements. Operations comply with requirements.

Reindeer meat is handled in a hygienic manner as it is prepared for drying, hung in the drying rack and removed from the rack, and handled after the drying process.
Reindeer meat intended to be dried is prepared for drying in appropriate indoor facilities at the meat product establishment.
Reindeer meat is after drying handled in appropriate indoor facilities at the meat product establishment.
Vermin and birds cannot contaminate reindeer meat during the drying process.
Reindeer meat is dried in a suitable period of the year.
Reindeer meat is hung for drying in a manner that verifies free circulation of air.
Only inspected reindeer meat is dried in the drying rack.
Own-check is adequate and suitable as regards the controlled matters.
The operator has sudden and random shortcomings under control through own-check.

For example:

Reindeer meat is dried under highly varying conditions, but the drying process is still adequately under control to ensure that the meat is not spoiled.
There are some minor shortcomings in own-check as regards the controlled matter.

For example:

Reindeer meat is dried under conditions that are sometimes unsuitable resulting in delayed drying of the meat; for example, unsuitable period of the year or outdoor temperature. The safety of the meat is impaired.
Air circulation round the drying meat is not effective; for example, the pieces of meat are hung too close to each other. The drying of meat is delayed and the safety of meat is impaired.
Also other meat and products than inspected reindeer meat are dried in the drying rack.
There are shortcomings in own-check as regards the controlled matter which impair food safety.

For example:

Reindeer meat is not handled in a hygienic manner as it is prepared for drying, hung in the drying rack and removed from the rack, and handled after the drying process.
Vermin or birds can contaminate the meat during the drying process.
Meat is dried under unfavourable climate conditions or air circulation round the drying meat is not adequate, resulting in inadequately controlled drying of the meat and jeopardised safety of the meat.
There are shortcomings in own-check as regards the controlled matter which jeopardise food safety.

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

Regulation (EC) No 852/2004 on the Hygiene of Foodstuffs
Regulation (EC) No 853/2004 on Hygiene Rules for Food of Animal Origin
Implementing Regulation (EC) No 2074/2005
Commission delegated regulation (EU) 2019/624
Finnish Food Act 297/2021
Decree of the Ministry of Agriculture and Forestry on Food Hygiene 318/2021
Evira's Guide 16033: Approval of an Establishment (available only in Finnish and in Swedish).

Updates in version 4:

Reference to other Oiva quidelines has been updated.

8.8 Parasite Checks and Freezing Treatment of Fishery Products

Guide/version: 2154/04.02.00.01/2021/5, valid from 2.1.2023

To be taken into consideration:

This point is evaluated at food premises where:
- Fish is gutted or filleted (parasite checks, all fish species)
- Ready-to- eat fishery products are produced, and the treatment of the fish is not adequate to kill the viable parasites (freezing treatment).
Fish species exempt from the freezing treatment are salmon and rainbow trout farmed in the Atlantic, rainbow trout and sturgeon farmed in Finland, and Baltic herring and sprat caught in the Baltic Sea. In addition, other farmed fish species may be exempted from freezing treatment if the conditions laid down in the Evira decision (1773/0959/2012) are met.
It is recommended that the inspection of point 8.10 Organoleptic quality of fishery products be carried out at the same time.

Matters to be controlled:

Parasite checks of fresh fish are carried out in compliance with Annex II, Chapter II of Regulation (EC) No 2074/2005.
Freezing treatment required due to parasite risk: freezing treatment is carried out for ready-to-eat fishery products, if other treatment of the fish is not adequate to kill viable parasites, in compliance with Annex III, Section VIII, Chapter III, Part D of Regulation (EC) No 853/2004, unless they have been exempted from the freezing treatment.
Submission of information on the type of freezing treatment (combination of time and temperature) to the receiving food business operator in a commercial document, product label, contract or other document.
Fishery products with a national exemption from the freezing treatment (Baltic herring and sprat) are only supplied to the Finnish market. Considering approved establishments: the receiving food business operator is informed of this supply restriction in the submitted documents.
When ready-to-eat fishery products placed on the market from farmed fish species other than salmon and rainbow trout farmed in the Atlantic, or rainbow trout and Atlantic sturgeon farmed in Finland have been exempted from the freezing treatment, the operator has the documents provided by the fish farmer as required by the Evira decision (1773/0959/2012).
The adequacy and suitability of own-check, and the plan, are controlled applying the Annex to Guideline 1.6: "Adequacy and Suitability of Own-check Activities".

Excellent: Operations are in line with the requirements. Operations comply with requirements.

While gutting the fish, visual inspections for parasites are performed continuously (manual evisceration) or for a representative number of fish (at least 10/batch; mechanical evisceration).

Fish fillets or slices are inspected visually for parasites during trimming and filleting or slicing.

A record is kept of parasite findings.

In freezing treatment, the product temperature is brought down to – 20 °C for at least 24 hours or to – 35 °C for at least 15 hours. The freezing treatment is documented, and the receiving operator is informed of the type of treatment used, in writing.

The receiving operator is informed of any restrictions for placing the product on the market in commercial documents or otherwise in writing (approved establishments).

For example:

Parasite inspections are mainly performed in compliance with the requirements, but individual batches have not been inspected, or there are minor shortcomings in the records.

As a rule, the freezing treatment is carried out in compliance with requirements, but there are minor shortcomings in the records.

The operator receiving products subjected to freezing treatment is not always informed of the type of the freezing treatment (time and temperature combination).

For example:

Parasite checks are only carried out on a random basis.

All products or product groups that require the freezing treatment due to a parasite risk do not undergo the treatment.

Documents concerning products with a national exemption from the freezing treatment do not contain information on supply restrictions (approved establishments).

For example:

Parasite checks are not carried out.

Fish with parasites in the parts intended for human consumption have been used as foodstuffs.

The freezing treatment is not carried out on any of the product groups that require the treatment due to a parasite risk.

Fishery products with a national exemption from the freezing treatment, the manufacturing process of which is not adequate to kill viable parasites, have been supplied to other EU countries.

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

Commission Regulation (EC) No 853/2004, Annex III, Section VIII, Part D
Commission Regulation (EC) No 2074/2005, Annex II, Chapter II
Decree of the Ministry of Agriculture and Forestry on food hygiene 318/2021, 31 §, 38 §, 43 §
Evira's Guide 16023: Control of fishery products
Decision of Evira 1773/0959/2012: Exemption of farmed fish from the freezing treatment required for certain fishery products, 15 March 2012.

Updates in version 5:

The guideline will also be applied to registered food premises. Earlier, in registered food premises, the freezing treatment was inspected in point 5.1.
A clarification was added to the section “To be taken into consideration” on the placing on the market of national fishery products exempted from the freezing requirement and to the examples that the requirement for a written notification of the delivery restriction only applies to approved food premises.
The sections “To be taken into consideration” and “Matters to be controlled” were specified, and evaluation examples were modified.
The recommendation to examine the point 8.10 Organoleptic quality of fishery products at the same time was added.

8.9 Quality Control for Raw Material of Egg Products

Guide/version: 2156/04.02.00.01/2021/4, valid from 2.1.2023

To be taken into consideration:

This Guideline is applied to all establishments that produce egg products.
For the purposes of this Guideline, raw material refers to the eggs used at egg product establishments for the production of egg products and are procured to the establishment from egg-packing centres and producers.
The shells of eggs used in the manufacture of egg products must be fully developed and contain no breaks.
However, cracked eggs may be used for the manufacture of egg products if the establishment of production or a packing centre delivers them directly to the processing establishment, where they must be broken as soon as possible.
Eggs must not be broken unless they are clean and dry. An egg is considered to be dirty, if the amount of dirt or dirt spots on the surface of the shell exceeds 1/16 of the area of the egg, or if there are lumps of dirt or blood on the shell.
Dirty eggs can be washed with a detergent suitable for this purpose.
Only water tested for at least Escherichia coli and intestinal enterococci and subjected to an assessment of colour and smell may be used to clean eggs. The egg producer can do an organoleptic examination of the water at the primary production site.

Matters to be controlled:

How is quality control for eggs used for the production of egg products implemented at the egg product establishment.
The adequacy and suitability of own-check activities and, were appropriate, the plan are controlled by applying the Annex to Guideline 1.6: "Adequacy and Suitability of Own-check Activities".

Excellent: Operations are in line with the requirements. Operations comply with requirements.

The own-check provides a description of how the egg product establishment verifies the quality of the raw material used for egg products.
The egg product establishment controls the quality of the raw material and removes any eggs that do not meet the criteria laid down for production.

The grade can be Good e.g. in cases where:

There are some minor shortcomings in the description provided in the own-check how the egg product establishment verifies the quality of the raw material used for egg products.
The egg product establishment controls the quality of the raw material and removes any eggs that do not meet the criteria laid down for production.

The grade can be To be corrected e.g. in cases where:

There are clear shortcomings in the description provided in the own-check how the egg product establishment verifies the quality of the raw material used for egg products.
The egg product establishment controls the quality of the raw material, but eggs that do not meet the criteria laid down for production have gone undetected into the production of egg products resulting in impaired food safety.

The grade can be Poor e.g. in cases where:

The own-check does not provide a description of how the egg product establishment verifies the quality of the raw material used for egg products.
Eggs that do not meet the criteria laid down for production have been used in the production of egg products resulting in food safety being jeopardised.

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

Regulation (EC) No 853/2004 on hygiene rules for food of animal origin; Section X, Chapter II, points II and III
Decree of the Ministry of Agriculture and Forestry on food hygiene 318/2021
Finnish Food Authority's Guide 6478/04.02.00.01/2021 Quality of raw material for liquid egg.

Updates in version 4:

Reference to Evira's Guide Quality of raw material for liquid egg to Finnish Food Authority's Guide has been updated.

8.10 Organoleptic quality of fishery products

Guide/version: 7618/04.02.00.01/2022/2, valid from 2.1.2024

The evaluation is not shown in the Oiva report, only in the inspection report.

To be taken into consideration:

This guideline applies to all food premises where the following fishery products are handled or sold:
- Fresh whole or gutted fish
- Live or fresh shellfish
Organoleptic checks should be carried out as part of official controls whenever possible during landing, reception, production, storage and retail of fishery products.
Organoleptic inspection ensures that the fishery products are fit for human consumption on the basis of their organoleptic characteristics.
In organoleptic examination, the freshness rating criteria in accordance with Annex I to Regulation (EC) No 2406/96 shall be used, whenever applicable. Fish freshness is evaluated based on the appearance of the skin, outer slime, eyes, gills, peritoneum and meat as well as meat firmness and the odour of the fish. For shellfish, the properties examined for freshness rating include the surface and colour of and meat adherence to the shell or shield; the firmness of the meat; the odour; and the presence of foreign matter.
Operators handling fishery products shall carry out organoleptic checks as part of their own-check activity. As comes to the species listed in Regulation (EC) No 2406/96, food business operators must ensure that fishery products meet the basic freshness criteria according to the regulation. For other species, the applicable criteria to be used are defined by the operator.
Laboratory tests are not required to assess organoleptic quality.
Parasite checks of fresh fish are evaluated in point 8.8.
Shelf-life testing of products in approved food premises are evaluated in point 17.10 and in registered food premises in point 17.1.
It is recommended that when inspecting this point, the inspection of point 8.8 Parasite checks and freezing treatment of fishery products is also carried out.

Matters to be controlled:

Organoleptic quality of fishery products when the operator receives fishery products, during production, storage, distribution and retail of fishery products.
Fishery products are fit for human consumption on the basis of their organoleptic characteristics.
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”.

Excellent: Operations are in line with the requirements. Operations comply with requirements.

Fresh fishery products are organoleptically examined as part of the operator's own-check activities and only fishery products of good organoleptic quality are used and sold for human consumption.

Fishery products meet the basic organoleptic criteria for freshness.

For example:

Fresh fishery products are subjected to organoleptic checks as part of the operator's own-check activities, but some batches remain unchecked.

There are small issues in the procedures of organoleptic checks or determination of evaluation criteria for organoleptic checks as part of the own-checks.

Fishery products meet the basic organoleptic criteria for freshness.

For example:

The organoleptic examination of fishery products is not carried out at all as part of the operator's own-check activities or the plan for managing the organoleptic quality is very incomplete.

Fishery products of clearly impaired organoleptic quality are used for human consumption. For example, some fish show significant damage or signs of decay.

For example:

Products of poor organoleptic quality, such a batch of fish with several specimens in the state of decay, is supplied for human consumption.

Dead crayfish are received or delivered for human consumption.

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

Regulation (EC) No 178/2002 on food law, art. 14
Regulation (EC) No 852/2004 on the hygiene of foodstuffs
Regulation (EC) No 853/2004 laying down specific hygiene rules for food of animal origin, Annex III, section VIII, chapter V, point A
Commission Implementing Regulation (EU) No 2019/627, art. 70 and Annex VI, Section I, Chapter III, Part A
Council Regulation (EC) No 2406/96
Food Act 297/2021
Finnish Food Authority’s Guide Kalastustuoteohje 3039/04.02.00.01/2022 (only in Finnish and Swedish).

Updates to version 2:

To be taken into consideration, added/modified:
- Organoleptic checks should be carried out as part of official controls whenever possible during landing, reception, production, storage and retail of fishery products.
- In organoleptic examination, the freshness rating criteria in accordance with Annex I to Regulation (EC) No 2406/96 shall be used, whenever applicable.
- As comes to the species listed in Regulation (EC) No 2406/96, food business operators must ensure that fishery products meet the basic freshness criteria according to the regulation. For other species, the applicable criteria to be used are defined by the operator.
Matters to be controlled, added: Fishery products are fit for human consumption on the basis of their organoleptic characteristics.
Evaluation examples, added to B: There are small issues in the procedures of organoleptic checks or determination of evaluation criteria for organoleptic checks as part of the own-checks.
Evaluation examples, added to C: or the plan for managing the organoleptic quality is very incomplete.
Finnish Food Authority’s Guide Kalastustuoteohje updated to the list of guidelines.

8.11 Temperature Management of Water used in Disinfection of Working Utensils

Guide/version: 2143/04.02.00.01/2021/3, valid from 2.1.2023

To be taken into consideration:

This Guideline is applied to slaughterhouses, game processing plants and cutting plants, as well as to production establishments of minced meat, meat preparations and mechanically separated meat.
If some other method than steam or water at a temperature of at least 82°C is used at the establishment for the disinfection of working utensils, the method is evaluated in applicable parts in this point.
The practices of the personnel of the establishment as regards the use of knife sterilisers is evaluated in point 4.1.

Matters to be controlled:

Management and monitoring of the temperature of water used in disinfection of working utensils, if appropriate.
The adequacy and suitability of own-check control and, where appropriate, the plan are controlled applying the Annex to Guideline 1.6: "Adequacy and Suitability of Own-check Activities".

Excellent: Operations are in line with the requirements. Operations comply with requirements.

The temperature of water used for the disinfection of working utensils is at least 82°C. Temperatures are monitored and monitoring data are recorded in compliance with own-check.

There are some minor shortcomings in the monitoring of the temperature of water used for the disinfection of working utensils at the establishment. For example:

There are some minor shortcomings in the records related to temperature monitoring as concerns deviations and corrective action taken, but corrective actions have been appropriate and adequate.

The monitoring of the temperature of water used for the disinfection of working utensils has been deficient. For example:

Temperature measurements have not been carried out to an adequate extent to verify detection of deficiencies.

The monitoring of the temperature of water used for the disinfection of working utensils has been neglected. For example:

Temperatures have not been measured.

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

Regulation (EC) No 853/2004 on hygiene rules for food of animal origin.

Updates in version 3:

Number of the chapter has been changed.