17 Food Testing

All Oiva evaluation guidelines for approved food establishments.

17.1 Sampling and Own-check Testing

Guide/version: 2192/04.02.00.01/2021/6, valid from 1.9.2022

To be taken into consideration:

This Guideline is applied to establishments other than storage establishments.
This Guideline is applied to the deployment testing of raw milk and crude material of milk in establishments handling milk that uses more than 5 million kilos of raw milk per year.
The competence of the laboratory used to analyse the samples is evaluated in point 1.6 "General Compliance of Own-check with Requirements".
The own-check of water and ice is evaluated in point 17.3.
The national salmonella own-check control of the meat sector is evaluated in point 17.4.
STEC own-check control is evaluated in point 17.5.
Listeria own-check control is evaluated in point 17.6.
The National Campylobacter control program’s own-check control (broiler caeca) is evaluated in point 17.7.
The quality testing of raw milk is evaluated in point 17.9.
The shelf life tests of products are evaluated in point 17.10.
Other Guidelines related to food testing: 17.8, 17.11-17.16 and 17.18.

Matters to be controlled:
Tests designed for verification of the safety of the foodstuffs, such as:

sampling for salmonella of meat products not included in the national salmonella control programme, such as minced meat, meat preparations, certain meat products, MSM, carcasses of horses, sheep and goats
sampling for salmonella of milk, egg and fishery products, as well as raw goat's milk intended for consumption as such
Cronobacter spp. (Enterobacter sakazakii) of infant formulae
sampling of milk products for staphylococcal enterotoxin, when required due to the result of the process hygiene criteria
TSE sampling
sampling of salmonella of consignments of raw meat and minced meat with special guarantees.

Own-check tests concerning process hygiene, such as:

samples taken from the surface of carcasses for testing of slaughter hygiene
neck skin samples for quantification of Campylobacter taken from broiler and chicken carcasses in poultry slaughterhouses
sampling of minced meat, meat preparations and mechanically separated meat for aerobic micro-organisms and E. coli
sampling of milk products for Enterobacter, coagulase positive staphylococcus, E. coli and B. cereus
sampling of certain fishery products for Enterobacter, coagulase positive staphylococcus, and E. coli
sampling of egg products for Enterobacter
concentration of 3-OH-butyric acid in the dry matter of egg products, lactic acid content of raw material used in manufacture of egg products, and quantity of eggshell remains, egg membranes and any other particles in processed egg product.
deployment testing of raw milk and crude material of milk in establishment handling milk
- (a) raw cows’ milk used to prepare dairy products has a plate count at 30 °C of less than 300 000 per ml; and
- (b) heat treated cows’ milk used to prepare dairy products has a plate count at 30 °C of less than 100 000 per ml
verification of the cleanliness of equipment, surfaces, and the production environment (surface cleanliness sampling).

Execution of sampling

Frequency of sampling and number of sample units. Where appropriate, the derogations granted by the controlling inspector regarding the taking of sample units to be taken into consideration.
Any deviations found in the tests referred to above, the implemented corrective actions, and the records of these
Trend analysis carried out by the operator
Sampling and handling of samples
The adequacy and suitability of own-check activities and, where appropriate, the plan (sampling and testing 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 sampling and testing plan complies with requirements, or appropriate grounds are presented in it, or it complies with Finnish Food Authority's sampling recommendation. Sampling has been carried out according to plan.

Sampling has been carried out in a hygienic manner.

Own-check sampling related to process hygiene is carried out appropriately to demonstrate the acceptable effectiveness of the production process, i.e., the operator monitors the trends indicated by the sample results.

The corrective actions taken in case limit values have been exceeded in tests related to the safety of foodstuffs have been appropriate and adequate.

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.

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

The plan for the sampling of products and/or the production environment does not comply with requirements, or there are some minor shortcomings in the grounds presented in the plan. Or, the operator has opted to follow Finnish Food Authority's sampling recommendation, but the sampling plan of the operator is not completely consistent with the recommendation.
The plans for the sampling of products and the production environment comply with requirements, or appropriate grounds are presented in the plans, or they comply with Finnish Food Authority's sampling recommendation. As a rule, sampling is carried out according to plans, but in some individual cases sampling has not been carried out.
The number of sample units is not completely in compliance with requirements or with the grounds presented in the sampling plan, occasionally the number of tested sample units is too low.

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.

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

There is no sampling plan at all, but sampling has been carried out to some extent.
The sampling plan does not comply with requirements, or there are clear shortcomings in the grounds presented in the plan. Or, the operator has opted to follow Finnish Food Authority's sampling recommendation, but the sampling plan of the operator deviates significantly from the recommendation.
The number of tested samples is considerably lower than the planned number.
Sample units are not tested of the samples, or the number of tested sample units is continuously too low, without a sampling plan presenting sampling grounds.
The hygiene level is not adequate in the sampling and handling and storage of samples, and samples may become contaminated or deteriorated.
Own-check sampling related to process hygiene is not carried out to demonstrate the acceptable effectiveness of the production process. In case limit values are exceeded, no actions are taken to e.g. improve the hygiene level in the production of foodstuffs or in slaughtering operations.
The majority of sampling of the production environment is carried out from surfaces that are not in contact with the product.
The results of surface cleanliness sampling of equipment or other surfaces in contact with foodstuffs repeatedly exceed the limit values laid down in the own-check plan, but no actions are taken due to the results.

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.

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

No sampling is carried out or only to a very limited extent, although sampling should be carried out.
As a rule, there are shortcomings in the sampling and handling or identification of samples that render the samples unusable for tests.
Own-check sampling related to food safety is not carried out appropriately to demonstrate the safety of the foodstuffs. No actions are taken in case limit values are exceeded to investigate contamination, for example.

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 IX, Chapter II, point III and Section X
Commission Regulation (EC) 2073/2005 on microbiological criteria for foodstuffs
Commission Regulation (EC) No 1688/2005 implementing Regulation (EC) No 853/2004 of the European Parliament and of the Council as regards special guarantees concerning salmonella for consignments to Finland and Sweden of certain meat and eggs
Commission Implementing Regulation (EU) 2018/307 extending the special guarantees concerning Salmonella spp. laid down in Regulation (EC) No 853/2004 of the European Parliament and of the Council to meat derived from broilers (Gallus gallus) intended for Denmark
EFTA Surveillance Authority Decision No 1/19/COL extending the special guarantees concerning Salmonella spp. laid down in Regulation (EC) No 853/2004 of the European Parliament and of the Council to meat and eggs of domestic fowl (Gallus gallus), and meat derived from turkeys intended for Iceland
Finnish Food Act 297/2021, Sections 15 and 35
Decree of the Ministry of Agriculture and Forestry on food hygiene 318/2021
Finnish Food Authority's Guide Microbiological criteria for foodstuffs, application of Commission Regulation (EC) 2073/2005.

Updates in version 5:

Deployment testing of raw milk and crude material of milk in establishment handling milk has been added to the matters to be controlled.

17.3 Own-check Testing of Water and Ice

Guide/version: 2193/04.02.00.01/2021/5, valid from 2.1.2024

To be taken into consideration:

This Guideline is applied to all approved establishments.
This Guideline does not pertain to the control of the supplier of domestic water.
The use and own-check of domestic water and clean water in food processes is controlled by the food control authorities.
The scope of the own-check and the frequency of the tests carried out depend on the type of the foodstuffs produced, the scope of operation (production volumes and seasonal nature) as well as the nature of the processes. The water source used (e.g. domestic water from a water utility company or domestic water from own well) as well as the cleaning methods used are also of relevance.
Sampling should primarily be focused on the control of the water used for food processes and the water and ice used during the processes.
The source of the domestic water used at the establishment and the potential contamination risk resulting from recycled water are evaluated in point 1.4 "Compliance of Domestic Water with Requirements".
The source of the clean water used at the establishment is evaluated in point 1.5 "Compliance of Clean Water with Requirements".
The competence of the laboratory used to analyse the samples is evaluated in point 1.6 "General Compliance of Own-check with Requirements".
Serious disturbances related to the quality and safety of water, and the effects of such disturbances on foodstuffs to be manufactured or foodstuffs that have already been manufactured are evaluated in point 16.5 "Management of and Preparedness for Special Situations".

Matters to be controlled:

With regard to the quality control of domestic water, clean water (fishery sector establishments) and ice, the following are to be controlled:
- Organoleptic monitoring of water
- Storage of information requested/obtained from supplier of domestic water or
  municipal control authority regarding quality of domestic water
- Risk-based monitoring of water quality (sampling and tests)
- Corrective actions in abnormal situations, if any; for example, if sample results have been poor
- Compliance with any instructions for use of water issued by control authorities or the water utility company
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 needs for own-check of water and ice have been appropriately assessed. Own-check is adequate taking the quality and quantity of the foodstuffs produced by the food establishment into consideration.

Own-check testing of domestic water, clean water (fishery sector establishments) and ice has been carried out at the establishment according to plan.

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

There are some minor shortcomings in the assessment of the needs for own-check of water and ice, but food safety is not impaired. Own-check is adequate in essence taking the quality and quantity of the foodstuffs produced by the food establishment into consideration, and food safety is not impaired.
There are some minor shortcomings in the execution of own-check related to domestic water, clean water (fishery sector establishments) and ice; for example, some individual samples have not been taken, but food safety is not impaired.

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

There are some minor shortcomings in the assessment of the needs for own-check of water and ice, and food safety is impaired. Own-check is not adequate taking the quality and quantity of the foodstuffs produced by the food establishment into consideration, and food safety is impaired.
There is no sampling plan in place, but sampling has been carried out adequately, however.
There are shortcomings in the execution of own-check related to domestic water, clean water (fishery sector establishments) and ice resulting in impaired food safety; for example, several samples have not been taken.

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

There are shortcomings in the assessment of the needs for own-check of water and ice, and food safety is jeopardised because of this. Own-check is not adequate taking the quality and quantity of the foodstuffs produced by the food establishment into consideration, and food safety is jeopardised.
There are shortcomings in the execution of own-check related to domestic water, clean water (fishery sector establishments) and ice, and the safety of foodstuffs is jeopardised because of this; for example, no sampling has been carried out at all.

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
Finnish Food Act 297/2021
Decree of the Ministry of Agriculture and Forestry on Food Hygiene 318/2021
Finnish Food Authority’s Guide 3039/04.02.00.01/2022: Control of Fishery Products (available in Finnish and in Swedish)
Finnish Food Authority’s Guide 8014/04.02.00.01/2021: Control of Water and Ice in Food Establishments (available in Finnish and in Swedish)

Updates in version 5:

Guideline 16023 is replaced by guideline 3039/04.02.00.01/2022.
Guideline 10591 is replaced by guideline 8014/04.02.00.01/2021.

17.4 National Salmonella Control in Meat Sector

Guide/version: 2194/04.02.00.01/2021/5, valid from 11.4.2023

To be taken into consideration:

This Guideline is applied to slaughterhouses and cutting plants which handle beef and the meat of swine, chicken, turkey, duck, goose, or guinea fowl, and the purpose of this point is to evaluate the implementation of the national salmonella control programme at these establishments. The sampling carried out at the aforementioned establishments within the national salmonella control programme shall cover:
- Samples of lymphatic glands from swine and cattle, and surface swipe samples of carcasses (slaughterhouses)
- Samples of cut/crushed meat from swine, cattle, ducks, geese, and guinea fowls (cutting plants)
- Samples of neck skin from chickens, turkeys and hens (slaughterhouses)
- Samples of skin/surface muscle from chickens, turkeys and hens (cutting plants)
Salmonella sampling in compliance with the Regulation on microbiological criteria for foodstuffs is evaluated in point 17.1 "Sampling and Own-check Testing". Salmonella sampling in compliance with the Regulation on microbiological criteria for foodstuffs includes e.g. the salmonella samples taken in slaughterhouses from horses, sheep and goats, and the samples taken in meat sector establishments from minced meat and meat preparations (also as concerns e.g. chickens, turkeys and hens).
The competence of the laboratory used to analyse the samples is evaluated in point 1.6 "General Compliance of Own-check with Requirements".
Situations where animals need to be slaughtered separately due to salmonella or lack of salmonella test results are evaluated with respect to the operation of the animal shed in point 9.7 "Separation of Animals Delivered to a Slaughterhouse” and with respect the slaughter process in point 5.2 "Separation of Activities Requiring Different Hygiene Levels".
The heating treatment of meat due to salmonella is evaluated with respect to the effectiveness of the heating treatment in point 6.5 "Temperature Management in Food Production Processes", and with respect to overall compliance with the heating requirement, handling hygiene and identification of carcasses in point 5.2 " Separation of Activities Requiring Different Hygiene Levels".
Actions taken based on detection of salmonella (316/2021, Section 42) are evaluated e.g. in points 3.2 "Cleanliness of Surfaces, Fixtures, Equipment, and Utensils", and16.9 "Traceability of Foods of Animal Origin". However, the increase in sampling is evaluated in this point.
Salmonella matters related to egg production are evaluated in point 15.2 "Management of Salmonella Certificates in Egg Production".

Matters to be controlled:

The quantity of samples taken for testing and the distribution of sampling between different species and according to the country of origin of meat as well as to randomised and targeted samples.
The random nature and the distribution of randomised sampling over time
Sampling, and handling and identification of samples
Information accompanying samples to the laboratory
Increase in the quantity of samples taken after detection of salmonella
The adequacy and suitability of own-check 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.

Salmonella control complies with requirements in relation to the matters evaluated in this point.

Operations and the planned own-checks comply with requirements in essence, but there are some minor shortcomings in them; however, these do not have any essential effect on the quality or quantity of the samples tested, or on the test results. The grade can be Good e.g. in cases where:

The quantity of salmonella samples taken in one year is a little short of the quantity required by legislation or the quantity defined in the sampling plan prepared by the Finnish Food Authority for the slaughterhouse.
The proportion of samples taken from domestic and foreign meat at the cutting plant is slightly different than the proportion of meat cutting.
Sometimes samples are taken from several successive animals in the slaughtering sequence, which makes random sampling non-randomised.
There are occasionally shortcomings in the information accompanying samples to the laboratory.

There are shortcomings in the operations and/or planned own-checks which have an essential effect on the quality or quantity of the samples tested, or on the test results. The grade can be To be corrected e.g. in cases where:

There are significant or frequently occurring shortcomings in the quantities of samples taken for testing, or the quantity of samples has not been increased after detection of salmonella.
A slaughterhouse required to take two samples per year has failed to take one of the required samples.
Randomised sampling is not carried out on a random basis.
Sampling for salmonella is not included in the own-check plan of the establishment, but operation complies with requirements.
There are repeatedly major shortcomings in the information accompanying samples to the laboratory.

Sampling for salmonella has not been carried out or samples have not been sent for testing, or there are, as a rule, shortcomings in the handling or identification of samples, or in the information accompanying samples to the laboratory that render the samples unsuitable for testing.

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

Regulation /EC) No 2073/2005 on microbiological criteria for foodstuffs
Decree of the Ministry of Agriculture and Forestry on zoonoses, 316/2021
Finnish Food Authority's Guide: Microbiological criteria for foodstuffs, application of Commission Regulation (EC) 2073/2005, Guide for food business operators.

Updates in version 5

In the section “To be taken into consideration” the reference to guideline 5.1 has been changed to 5.2.

17.5 Own-check of STEC

Guide/version: 2195/04.02.00.01/2021/5, valid from 11.4.2023

To be taken into consideration:

This Guideline is applied to surface swab sampling for STEC at slaughterhouses where 100 or more than 100 bovine animals are slaughtered per year.
The competence of the laboratory used to analyse the samples is evaluated in point 1.6 "General Compliance of Own-check with Requirements ".
Matters related to the cleanness of the animals to be slaughtered and separation of dirty animals are evaluated in points 9.3 "Animal Transport" and 9.7 "Separation of Animals Delivered to Slaughterhouse".
Matters related to slaughter and working hygiene are evaluated in points 4.1 "Working hygiene of personnel" and 5.2 " Separation of Activities Requiring Different Hygiene Levels".

Matters to be controlled:

Quantity of samples to be tested
The random nature and the distribution of sampling over time
Sampling, and handling and identification of samples
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.

STEC control complies with requirements in relation to the matters evaluated in this point.

Sometimes samples are taken from several successive animals in the slaughtering order, making sampling non-randomised.
The quantity of STEC samples taken in one year is a little short of the quantity defined in the sampling plan prepared by Finnish Food Authority for the slaughterhouse.

Samples are repeatedly sent to the laboratory too late after sampling, which makes it impossible to test them within the required time limits due to reasons for which the slaughterhouse operator is responsible.
There are significant shortcomings in the quantity of samples taken for testing or samples are taken in large quantities at once on a few days during the year.
Sampling for STEC is not included in the own-check plan of the establishment, but operation complies with requirements.
Slaughterhouse where 100 or more than 100 bovine animals are slaughtered per year has failed to take one of the two required samples to be taken during one year.

Sampling for STEC has not been carried out or samples have not been sent for testing, or as a rule, there are shortcomings in sampling, and handling or identification of samples that render the samples unusable for tests.

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

Decree of the Ministry of Agriculture and Forestry on zoonoses 316/2021
Finnish Food Authority's Guide: Microbiological criteria for foodstuffs, application of Commission Regulation (EC) 2073/2005, Guide for food business operators.

Updates in version 5:

In the section “To be taken into consideration” the references to other guidelines have been clarified and the reference to guideline 5.1 has been changed to 5.2.

17.6 Own-check of Listeria

Guide/version: 2196/04.02.00.01/2021/5, valid from 1.9.2022

To be taken into consideration:

This point is evaluated at establishments producing ready-to-eat foodstuffs. However, this point is not evaluated at establishments producing only preserves.
The competence of the laboratory used to analyse the samples is evaluated in point 1.6 "General Compliance of Own-check with Requirements".
Shelf-life testing of food products is evaluated in point 17.10.

Matters to be controlled:

Frequency of sampling and number of sample units. Where appropriate, the derogations granted by the controlling inspector regarding the taking of sample units to be taken into consideration.
Frequency of sampling from the production environment.
Any deviations found in the tests referred to above, the implemented corrective actions, and the records of these.
Sampling and handling of samples.
The adequacy and suitability of own-check activities, and the plan (sampling and analysis 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.

Sampling plans for listeria from the products and the production environment present appropriate grounds or comply with Finnish Food Authority's sampling recommendations. Sampling has been carried out according to plan.

For example:

There are some minor shortcomings in the grounds presented in the sampling plan for listeria from the products and/or the production environment. Or, the operator has opted to follow Finnish Food Authority's sampling recommendation, but the sampling plan of the operator is not completely consistent with the recommendation.
Sampling plans for listeria from the products and the production environment present appropriate grounds or comply with Finnish Food Authority's sampling recommendation. As a rule, sampling is carried out according to plans, but in some individual cases sampling has not been carried out.
The number of sample units is not completely in compliance with requirements, occasionally the number of sample units that are tested is too low.

For example:

There is no sampling plan at all, but sampling has been carried out to some extent.
There are clear shortcomings in the grounds presented in the sampling plan for listeria from the products and/or the production environment. Or, the operator has opted to follow Finnish Food Authority's sampling recommendation, but the sampling plan of the operator deviates significantly from the recommendation.
The number of tested samples is considerably lower than the planned number.
Sampling is not carried out at all from some product group.
Sample units are not tested of the samples, or the number of tested sample units is continuously too low.
The majority of sampling of the production environment is carried out from surfaces that are not in contact with the product, and no grounds are presented for this.
The hygiene level is not adequate in the sampling and handling and storage of samples, and samples may become contaminated or deteriorated.

For example:

No sampling has been carried out or only to a very limited extent.
As a rule, there are shortcomings in the sampling and handling or identification of samples that render the samples unfit for testing.

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

Regulation (EC) No 178/2002/EY on food law
Regulation (EC) No 2073/2005 on microbiological grounds for foodstuffs, Article 3
Finnish Food Authority's Guide, "Microbiological grounds for foodstuffs, application of Commission Regulation (EC) 2073/2005".

Updates in version 5:

Sampling and handling of samples has been added to the matters to be controlled.

17.7 Own-check of Campylobacter

Guide/version: 2197/04.02.00.01/2021/4, valid from 1.7.2021

To be taken into consideration:

This Guideline is applied to broiler slaughterhouses, that slaughter over 150 000 broilers per year.
The purpose of this point is to evaluate in certain parts the fulfilment of the requirements laid down in the Decree of the Ministry of Agriculture and Forestry on control of zoonoses (316/2021).
The fulfilment of Campylobacter process hygiene criteria sampling (neck skin samples) in poultry slaughterhouses according to Regulation (EC) No 2073/2005 is evaluated in point 17.1 Sampling and Own-check Testing.
The competence of the laboratory used to analyse the samples is evaluated in point 1.6 "General Compliance of Own-check with Requirements ".
Practical arrangements related to slaughtering animals as the last animals of the day when campylobacter has been found in the animals of one building of the holding place in successive slaughtering operations (316/2021, Section 49) are evaluated in point 9.7 "Separation of Animals Delivered to Slaughterhouse".

Matters to be controlled:

Quantity of slaughtering batches and slaughtered birds subjected to testing
The random nature and the distribution of sampling over time
Sampling, and handling and identification of samples
Monitoring of slaughtering batches tested positive for campylobacter to enable the slaughterhouse operator to identify the buildings of the holding places where campylobacter has been found in the animals in two successive slaughtering operations.
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.

Control of campylobacter complies with requirements at the slaughterhouse with respect to the matters controlled in this point.

Sometimes samples of slaughtering batches are taken from successive birds in the slaughtering sequence or sometimes sampling is in some other respect not evenly distributed in the whole slaughtering batch, which makes sampling non-randomised.
The operator has failed to take some individual samples or samples from an individual slaughtering batch.

The slaughterhouse operator identifies also slaughtering batches that must be slaughtered as the last batch of the day based on the results of campylobacter tests of previous slaughtering batches received from the same building of the holding.

Samples are repeatedly sent to the laboratory too late after sampling, which makes it impossible to test them within the required time limits due to reasons for which the slaughterhouse operator is responsible.
Sampling for campylobacter is not included in the own-check plan of the establishment, but operation complies with requirements.
There are significant or frequently occurring shortcomings in the quantities of samples taken for testing.

The grade can also be To be corrected, if the slaughterhouse operator has failed to identify slaughtering batches that should have been slaughtered as the last animals of the day based on the results of campylobacter tests of previous slaughtering batches received from the same building of the holding.

Sampling for campylobacter has not been carried out or samples have not been sent for testing, or as a rule, there are shortcomings in sampling, and handling or identification of samples that render the samples unusable for tests.

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

Decree of the Ministry of Agriculture and Forestry on zoonoses 316/2021
Finnish Food Authority's Guide: Microbiological criteria for foodstuffs, application of Commission Regulation (EC) 2073/2005, Guide for food business operators.

Updates in version 4:

Guideline No. 2197/04.02.00.01/2021 replaces guideline No. 10317.
Legislative references have been updated.

17.8 Own-check of Histamine in Fishery Products

Guide/version: 2198/04.02.00.01/2021/5, valid from 2.1.2024

To be taken into consideration:

This point is evaluated at approved food establishments that handle (manufacture, import (from the internal market and/or third countries), trade) fishery products from fish species in which high histidine concentrations occur (e.g. Scombridae (mackerels, sardines, tuna), Clupeidae (herrings, excluding Baltic herring and sprat from the Baltic Sea), Engraulidae (anchovies), Coryfenidae (mahi-mahi/dolphinfish), Pomatomidae (bluefish)).
The own-check sampling frequency may be reduced if the fishery product supplier carries out regular histamine monitoring. However, own-check tests of a manufacturer cannot be completely replaced by tests carried out by the supplier of the raw material.
The competence of the laboratory and methods used to analyse the own-check samples are evaluated in point 1.6 "General Compliance of Own-check with Requirements".

Matters to be controlled:

As part of their own-checks, the operator has identified the species presenting a histamine risk and implemented measures to control the risks.
The frequency of sampling is adequate in relation to the scale and nature of the operation. Products manufactured from the risk species are tested as part of own-checks to verify compliance with the permitted histamine levels laid down in Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs.
The number of sample units tested complies with Regulation (EC) No 2073/2005 or is in accordance with a derogation granted by the control authority.
The adequacy and suitability of own-check activities, 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.

The sampling plan for histamine presents appropriate grounds or complies with Finnish Food Authority's sampling recommendations.
Sampling has been carried out according to plan.

For example:

There are some minor shortcomings in the grounds presented for the sampling plan. Or, the operator has opted to follow Finnish Food Authority's sampling recommendation, but the sampling plan of the operator is not completely consistent with the recommendation.
The sampling plan presents appropriate grounds or complies with Finnish Food Authority's sampling recommendation. As a rule, sampling is carried out according to plans, but in some individual cases sampling has not been carried out.
The number of sample units is not completely in compliance with requirements, occasionally the number of sample units that are tested is too low.

For example:

There is no sampling plan at all or there is no justification for not taking any samples.
There are clear shortcomings in the grounds presented for the sampling plan. Or, the operator has opted to follow Finnish Food Authority's sampling recommendation, but the sampling plan of the operator deviates significantly from the recommendation.
The number of tested samples is considerably lower than the planned number.
No samples have been taken of risk products manufactured in the food establishment.
Only one sample unit for each sample is tested, or the number of tested sample units is continuously too low and there is no justification for reducing the number of sample units.

For example:

No samples have been taken and the operator is unable to present any evidence to demonstrate risk management despite a previous notice.

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

Regulation (EC) No 178/2002 on food law
Regulation (EC) 2073/2005 on microbiological criteria for foodstuffs, article 3
Regulation (EC) 853/2004 laying down specific hygiene rules for food of animal origin, annex III, Section VIII, Chapter V, Part B
Finnish Food Authority's Guide 4095/04.02.00.01/2020: Elintarvikkeiden mikrobiologiset vaatimukset (available only in Finnish and Swedish), annexes 2 and 6
Finnish Food Authority's Kalastustuoteohje 3039/04.02.00.01/2022 (available only in Finnish and Swedish)

Updates in version 5:

Matters to be controlled modified: Products manufactured from the risk species are tested as part of own-checks to verify compliance with the permitted histamine levels laid down in Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs.
The number of sample units can also be in accordance with a derogation granted by the control authority.
The evaluation criteria for C modified: or there is no justification for not taking any samples; No samples have been taken of risk products manufactured in the food establishment; and there is no justification for reducing the number of sample units.
Reference to the Finnish Food Authority's Guide Kalastustuoteohje and to annexes 2 and 6 of the Guide Elintarvikkeiden mikrobiologiset vaatimukset has been added.

17.9 Quality Testing of Raw Milk

Guide/version: 2199/04.02.00.01/2021/3, valid from 1.7.2021

To be taken into consideration:

This Guideline is applied to the evaluation of the operation of an establishment that receives raw milk, with respect to the implementation of quality testing of raw milk. The milk sector operator shall initiate procedures to verify that the raw milk received at the establishment meets the criteria laid down in Regulation 853/2004 as regards plate count, somatic cell count and residues of conventional antibiotic substances tested using the Delvotest or a similar method. Procedures refer to the establishment taking care of the implementation of the referred tests. If the supplier of the raw milk is responsible for the referred tests, the receiving establishment shall ensure that the test results are made available to the establishment on a regular basis.
The residues of medicines and other substances in raw milk are evaluated more specifically in points 17.11 – 17.14.
In addition, monitoring of the temperature and organoleptic evaluation of the raw milk lots received will be assessed.
Milk establishment shall have a plan provide descriptions of the implementation of the referred tests and inspections, as well as instructions for action in case quality deviations are detected, and instructions for reporting to the control authorities.

Matters to be controlled:

Results of plate count and somatic cell count tests of the received raw milk produced at the place of primary production, as well as the testing of milk for residues of antimicrobials.
Temperature of raw milk to be received, an organoleptic evaluation and the result of an antimicrobial residue study.
Any deviations found in the tests referred to above, the implemented corrective actions, and the records of these.
Procedures defined in the plan in case quality deviations are detected in raw milk, and instructions for reporting to control authorities.
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.

Quality testing of raw milk is implemented, operation is described in the plan, records are maintained of actions taken, and reporting is implemented.

Own-check records contain information on results of plate count and somatic cell count tests of the received raw milk produced at the place of primary production, as well as results of the testing of milk for residues of antimicrobials.
The temperature of the raw milk received is checked, an organoleptic evaluation is carried out on the raw milk, an antimicrobial residue study is completed or the result of the antimicrobial residue study is checked. Records are available of any deviations found in the referred tests and corrective actions taken. Corrective actions have been adequate and appropriate.
The plan describes procedures for deviations and instructions for reporting to the control authority. Reporting to the authorities has been implemented.

The quality testing obligations are fulfilled with respect to raw milk, operation is described in the plan, but records are not complete.

Results of plate count and somatic cell count tests of raw milk, as well as results of the testing of raw milk for residues of antimicrobials have been monitored, but all the results are not included in the own-check records.
The temperature of the raw milk received is checked, an organoleptic evaluation is carried out on the raw milk, an antimicrobial residue study is completed or the result of the antimicrobial residue study is checked, but not all results are in the operator’s own-check record-keeping.
There are some minor shortcomings in the records of deviations or corrective actions. However, corrective actions have been adequate.
The plan describes procedures for deviations and instructions for reporting to the control authorities. Reporting to the authorities has been implemented.

There are shortcomings in the fulfilment of quality testing obligations with respect to raw milk, and in records and reporting. Operation and corrective actions are described in the plan.

Results of plate count and somatic cell count tests of raw milk, as well as results of the testing of milk for residues of antimicrobials have been monitored, but all the results are not included in the own-check records.
The temperature of the raw milk received is checked, an organoleptic evaluation is carried out on the raw milk, an antimicrobial residue study is completed or the result of the antimicrobial residue study is checked, but not all results are in the operator’s own-check record-keeping.
Deviations have not been recorded although it becomes known that deviations have occurred or corrective actions taken because of deviations have been inappropriate or inadequate.
The plan provides inadequate instructions for actions in case deviations are detected and for reporting to the control authorities. There are shortcomings in reporting to the authorities.

There are serious shortcomings in the fulfilment of quality testing obligations with respect to raw milk, and in records and reporting. Operation and corrective actions are inadequately described in the plan.

Results of plate count and somatic cell count tests of raw milk, as well as results of the testing of milk for residues of antimicrobials are not monitored, and they are not included in the own-check records.
Acceptance inspections are not carried out for raw milk. Arrangements for acceptance inspections are not described in the plan.
Deviations have not been recorded although it becomes known that deviations have occurred or corrective actions taken because of deviations have been inappropriate or inadequate.
The plan does not provide a description of quality criteria for raw milk, quality control and actions in case quality deviations are detected in raw milk. There are shortcomings in reporting to the authorities.

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

Regulation (EC) No 853/2004 on hygiene rules for food of animal origin, Annex III, Section IX, Chapter I, Part III
Finnish Food Act 297/2021
Decree of the Ministry of Agriculture and Forestry on food hygiene 318/2021.

Updates in version 3:

Guideline number 2199/04.02.00.01/2021/3 en replaces Guideline number 10319/2 en
List of legislation has been updated
The reference to the control of the acceptance of raw milk has been adapted to the aforementioned decree.

17.10 Shelf-life Testing of Products

Guide/version: 2200/04.02.00.01/2021/2, valid from 1.7.2021

To be taken into consideration:

This Guideline is applied to establishments, which produce food products for which shelf-life testing is required.
Shelf-life testing is not required for example for the following products:
- Foods consumed on the day of manufacture
- Foodstuffs quick-frozen or frozen immediately after manufacture
- Canned food.
In small-scale operations commonly used shelf lives can be used for fresh (not vacuum / modified atmosphere packed) meat or fish and dairy products with a minimum heat treatment equivalent of pasteurization.
If the shelf-life used in products is half of the shelf-life usually used in equivalent products, there is no need for shelf-life testing either.
This guideline is not applied for example to the following establishments:
- Storage establishment
- Egg packing centres.
The competence of the laboratory used to perform shelf-life studies is evaluated in point 1.6 "General Compliance of Own-check with Requirements".
The labelling related to the shelf-life of products is evaluated in point 13.1 "General Labelling"

Matters to be controlled:

The coverage of the determination of shelf-life studies for product groups with different durability.
Compliance of the shelf-life studies of ready-to-eat foods with requirements (listeria).
The adequacy of the shelf-life studies conducted in laboratory (chosen analyses).
The sufficiency of the justification (literature, analyses) for the shelf-lives given to products.
Ensuring the shelf-life after substantial changes.
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.

Required shelf-life studies have been made.

All product groups have been assessed and the scope of shelf-life studies (literature or laboratory analyses) to different product groups is justifiable.Shelf-life studies of ready-to-eat foods comply with the requirements (listeria).

Shelf-lives of products are based on shelf-life studies and the shelf-lives are appropriate.

The correct shelf-life is ensured after substantial changes in the process.

Necessary and/or required shelf-life studies have been done, but there are at most a few small issues. The issues are such that they do not impair food safety. The shelf-lives of products are appropriate.

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

The shelf-life studies have been done in a slightly lower temperature than the actual storage temperature of the product.
Some substantial parameter affecting the shelf-life of a product has not been analysed.

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

The shelf-lives have not been appropriately determined to all product groups.
Required shelf-life studies have not been done regarding ready to eat foods (listeria).
Shelf-life studies in the laboratory have been done in a completely wrong temperature.
Shelf-life that has been given based on shelf-life studies is so long that the microbiological quality and/or safety of a product is impaired.
The correct shelf-life has not been ensured after substantial changes in the process which affect the self-life.

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

The shelf-lives have not been appropriately determined.
The shelf-life is so long that microbiological safety of a product is 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
Decree of the Ministry of Agriculture and Forestry on food hygiene 318/2021
Commission Regulation (EC) 2073/2005 on microbiological criteria for foodstuffs, art. 3, Annex II
Finnish Food Authority's Guide Microbiological criteria for foodstuffs, application of Commission Regulation (EC) 2073/2005.

Updates in version 2:

Guideline No. 2200/04.02.00.01/2021 replaces guideline No. 10592
Legislative references have been updated.

17.11 Residues of Medicinal Products

Guide/version: 2201/04.02.00.01/2021/4, valid from 1.9.2022

This evaluation is at present not presented in the Oiva report, but only in the control report.

The purpose of this topical area is to control that the operator has recognised the risks related to residues of medicinal products authorised to be used for production animals (also other medicines in addition to antimicrobials, such as pain killers or anti-parasite drugs) and substances banned from use for production animals, and the operator is taking actions for the management of these risks when receiving animals or foodstuffs of animal origin to the establishment. Typical methods for management include own-check tests and documentary controls. The operator shall report all detected or suspected shortcomings to the authority responsible for the control of the establishment, and take corrective actions to eliminate such shortcomings. The consideration of residues of medicinal products is part of the verification of the chemical safety of food.

To be taken into consideration:

This point is to be evaluated for establishments, primarily slaughterhouses, low-capacity slaughterhouses and milk sector establishments. Where considered appropriate, the Guideline is also applied to other establishments that receive animals or foodstuffs of animal origin (e.g. egg-packing centres, and fish sector establishments), taking into account the nature and scope of operations at the establishment.
This point can also be controlled on discretionary basis when the operator manufactures, has manufactured for it, packs, imports (from the internal market and/or third countries) or brokers (e.g. agency business) foodstuffs or ingredients of foodstuffs for which regulatory maximum levels for residues of medicinal products have been set (e.g. any residues of anti-parasite drugs in beef).
The purpose of this Guideline is to evaluate risk management related to any residues of medicinal products in raw milk (risk assessment and required management methods). The quality testing of raw milk is evaluated in point 17.9.
The checking of information related to the food chain is evaluated in Guideline 9.2.
The sampling and testing plan related to own-check testing (e.g. compliance of methods with requirements, and laboratories) is evaluated in Guideline 13.1.
The checking of the identification documents of horses is evaluated in point 9.5.

Matters to be controlled:
The risks related to residues of medicinal products (also other medicines authorised to be used for production animals in addition to antimicrobials) and banned substances shall be identified as part of the establishment's own-check activities taking the nature and scope of the operation into account, and the means required to identify and eliminate these risks shall be included in the own-check of the establishment. It is also to be controlled that the operator has complied with its own-check in relation to residues of medical products, if any. In this point, control shall cover the whole topical area which comprises the following:

When checking food chain information related to the animal received or information related to another foodstuff, the operator has also taken possible residues of medicinal products or banned substances into consideration. The checking and assessment of medication data should be included in the assessment of the food chain information by the operator, in addition to the checking of the adequacy of the withdrawal period.
Residues of medicinal products are also included in the establishment's sampling and testing plan. It shall particularly be controlled in this point that the tests for residues of antimicrobials included in own-check activities have been taken into account and the tests are carried out in compliance with the requirements laid down in provisions and in accordance with the plan. In some cases the operator can carry out checks related to residues of medicinal products as documentary controls (e.g. small-scale milk sector establishments or importers of foodstuffs / procurement agreements on foodstuffs).
The own-check provides procedures to prevent food containing residues of medicinal products from being delivered for consumption when the food is suspected to contain, or found in e.g. own-check testing to contain residues of medicinal products in levels exceeding the limit values specified in legislation, or substances banned from use for production animals.
Records are maintained of own-check tests and results of the tests, deviations and actions taken, including reporting to the authority responsible for the control of the establishment. It can be evaluated on the basis of the records if the corrective actions taken as needed due to test results or documentary controls have been adequately extensive and executed adequately swiftly, and if abnormal situations have been reported in compliance with sector-specific provisions to the authority responsible for the control of the establishment.
The operator shall identify also for foodstuffs e that the operator has e.g. imported the most relevant risks related to residues of medicinal products in the foodstuffs concerned (e.g. foodstuffs imported from a third country where medicinal products not authorised in the EU are used for production animals). Risk management can be demonstrated on the basis of e.g. procurement contracts or product specifications. In addition, the operator is able to present, for example, analysis certificates or audit documents for the verification of risk management. NOTE! Batch-specific verification is not necessary The results of regulatory tests, if any, can also be utilised as part of the operator's own-check.
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:

Risks related to residues of medicinal products have been identified and the management of these risks is included in the own-check with respect to also other medicines in addition to antimicrobials through e.g. the statement that when food chain information is checked, medication data should be considered as a whole in addition to the adequacy of withdrawal periods, and that e.g. exceptionally and abnormally high use levels should be reported to the inspector controlling the establishment.
The operator must demonstrate that products of animal origin meet the legal requirements, including those concerning residues of medicinal products. In practice, the easiest way to prove compliance is usually to examine samples.
Medication data have been checked as part of the food chain information for every animal or group of animals delivered to the slaughterhouse. If any deviations have been detected in the information in addition to inadequate withdrawal periods or for some other reason, these have also been reported to the authority responsible for the control of the establishment. Suspicion can be based on e.g. the available data indicating an exceptionally high level of medication for the animal delivered for slaughter or fresh puncture marks detected in the animal already before meat inspection. Also when receiving foodstuffs of animal origin, the operator has taken actions to verify that the foodstuffs do not contain residues of medicinal products in levels exceeding the permissible limits.
The sampling and testing plan of the establishment is adequate and at least the tests for antimicrobials required by sector-specific provisions are included in it. Tests have been carried out according to the plan on a regular basis and in an adequate scope.
Animals delivered for slaughter have been sampled on a regular basis to test for residues of antimicrobials. A sample quantity that can be considered adequate is e.g. 0.2% of the number of slaughtered animals. Also, in poultry slaughterhouses it would be useful to take some samples to detect possible residues. At milk sector establishments, every batch of raw milk received at the establishment has been tested for residues of antimicrobials in compliance with sector-specific provisions . A small-scale establishment can apply the relaxations allowed by provisions and instead of tests for antimicrobials, the establishment has checked for every milk batch the information provided by the supplier of the raw milk.
The own-check provides clear procedures to prevent food containing residues of medicinal products from being delivered for consumption. For example, if a test for residues of antimicrobials gives a positive result in own-check, or it is suspected that the animal or foodstuff contains residues of medicinal products in levels exceeding the limit values, the animal or foodstuff concerned is set aside to await the completion of the analyses. Also other situations that are possible in the sector concerned are included in the own -check (e.g. an animal has to be slaughtered during the withdrawal period for humane reasons, or a milk batch being delivered to the establishment is known to contain residues of medicinal products).
Records have been maintained of own-check tests or documentary controls and their results. Records have also been maintained of any deviations that have been detected, and corrective actions taken due to them, including reporting to the authority responsible for the control of the establishment.
Based on the records, it can be verified that, when necessary, the establishment has followed the procedures described in the own-check and the procedures have been made more specific in each case. If corrective actions have been taken, they have been initiated immediately and have been adequate in relation to the nature of the matter (e.g. foodstuff containing residues of medicinal products delivered for disposal, and recalls, if appropriate).
The operator has identified relevant risks related to residues of medicinal products also as concerns foodstuffs imported by the operator. Quality criteria in terms of residues of medicinal products have been defined for foodstuffs in e.g. procurement agreements in case where the production site of the foodstuffs involves known risk factors. Risk management can be demonstrated on the basis of e.g. procurement contracts or product specifications. In addition, the operator is able to present, for example, analysis certificates or audit documents for the verification of risk management. NOTE! The necessity of chemical analyses as well as the required tests and the analysis frequency are determined based on the nature and effectiveness of operation.

Risks related to residues of medicinal products have been identified at least with respect to antimicrobials, and the management of the risks is included in the own-check. For example:

Medication data including adequacy of withdrawal periods are checked, as a rule, as part of food chain information for animals or groups of animals delivered to the slaughterhouse, and inadequate withdrawal periods are reported appropriately to the authority responsible for the control of the establishment.
No individual cases of suspected shortcomings have been reported to the controlling inspector. Also when receiving foodstuffs of animal origin, the operator has taken actions to verify that the foodstuffs do not contain residues of antimicrobials in levels exceeding the permissible limits.
The sampling and testing plan is adequate and the tests for antimicrobials required by sector-specific provisions are included in it. Testing has as a rule been carried out according to the plan, but in some parts tests have been made irregularly or in slightly lower numbers than planned. However, food safety has not been jeopardised.
The own-check provides procedures to prevent food containing residues of medicinal products from being delivered for consumption.
As a rule, the procedures have been followed and action taken has prevented the food from being delivered for consumption. Sometimes the case has been reported to the authority responsible for the control of the establishment after a short delay, and the start of corrective actions may also have been slightly delayed because of this.
Records have been maintained of own-check tests or documentary controls and their results, but there are some occasional inaccuracies in the records. For example, all results have not been recorded, if they have been acceptable. As a rule, records have also been maintained of any deviations that have been detected, and corrective actions taken due to them, including reporting to the authority responsible for the control of the establishment, but the corrective actions taken have in some cases been described somewhat inaccurately, making it difficult to verify that they have been adequate.
The operator has identified relevant risks related to residues of medicinal products also as concerns foodstuffs imported by the operator.
If appropriate, quality criteria with respect to residues of medicinal products have been defined in e.g. procurement agreements, but the operator is unable to present any evidence to support this, e.g. analysis certificates.

Risks related to residues of medicinal products have not been adequately identified even with respect to antimicrobials, and the risks are not adequately included in the own-check of the establishment. For example:

Medication data have been checked irregularly as part of food chain information for animals or groups of animals delivered to the slaughterhouse.
Inadequate withdrawal periods have been reported to the authority responsible for the control of the establishment in most cases, but often after a delay. Food safety is impaired.
Suspicions of shortcomings have only rarely been reported to the authority responsible for the control of the establishment. When receiving foodstuffs of animal origin, the operator has not taken any actions to verify that the foodstuffs do not contain residues of antimicrobials in levels exceeding the permissible limits.
Testing for residues of antimicrobials is included in the sampling and testing plan, but it does not meet sector-specific requirements due to e.g. inadequate numbers of samples.
Tests/controls have been carried out, but on an irregular basis and/or in lower numbers than planned.
The own-check does not provide clear procedures for cases where food is found to contain residues of medicinal products. The establishment aims at preventing such food from being delivered for consumption, but this cannot be verified. The cases are mostly reported to the controlling inspector after a long delay, which has clearly delayed the start of corrective actions or it has not been possible to take any actions.
Records have been maintained of own-check tests or documentary controls and their results, but there are several inaccuracies and shortcomings in the records.
Records have been maintained on a random basis of any deviations that have been detected, and corrective actions taken due to them, including reporting to the authority responsible for the control of the establishment, but the corrective actions taken have been described inaccurately and deficiently, making it impossible to verify that they have been adequate.
The operator has not considered the possible risks related to residues of medicinal products as concerns foodstuffs imported by the operator. Quality criteria with respect to residues of medicinal products have not been defined for foodstuffs in e.g. procurement agreements and the operator is unable to present any kind of analysis certificates to support risk management.

Risks related to residues of medicinal products have not been identified and the management of the risks is not included in any way in the own-check of the establishment. Food safety is jeopardised.

The operator has controlled medication data as part of food chain information on a random basis. Inadequate withdrawal periods are only occasionally reported to the controlling inspector, although the matter has been pointed out to the operator. Food safety is jeopardised.
The sampling and testing plan of the establishment does not specifically include tests for antimicrobials, although they are required by sector-specific provisions.
Testing has been carried out, however, but only occasionally. Food safety is jeopardised.
The own-check does not provide procedures for cases where foodstuffs are found to contain residues of medicinal products and this is not considered in operations in any specific way. Deviations have been reported to the authority responsible for the control of the establishment on a random basis or not at all, although deviations have been detected. Food safety is jeopardised.
Records have been maintained of the results of own-check tests on a random basis or not at all.
There are no records of detected deviations or any corrective actions taken due to them, including reporting to the authority responsible for the control of the establishment, to make it possible to review operations later.
Quality criteria for foodstuffs with respect to residues of medicinal products are not under control. Shortcomings requiring immediate rectification include, for example, cases where the chemical analysis of a foodstuff has shown that the maximum regulatory level of a medicinal product is exceeded, but no corrective actions have been taken in the operation, or the action taken has been inappropriate or inadequate. Food safety is jeopardised.
The operator has failed to fulfil the orders issued with the grade To be corrected.

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
Finnish Food Act 297/2021
Decree of the Ministry of Agriculture and Forestry on food hygiene 318/2021
Finnish Act on the Medication of Animals 387/2014
Regulation (EC) No. 470/2009 of the European Parliament and of the Council laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin
Commission Regulation (EU) 37/2010 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin
Commission Implementing Regulation (EU) 2019/627 laying down uniform practical arrangements for the performance of official controls on products of animal origin intended for human consumption (Art. 3)
Finnish Food Authority’s guideline 5911/04.02.00.01/2020/2: Chemical analyses for demonstration of compliance of foodstuffs with requirements.

Updates in version 4

The number of Guideline “Chemical analyses for demonstration of compliance of foodstuffs with requirements” has been updated.
Legislative references have been updated
The guidelines have been clarified with regard to the "Excellent" assessment.

17.12 Pesticide Residues

Guide/version: 2202/04.02.00.01/2021/10, valid from 2.1.2024

To be taken into consideration:
This point is to be controlled when the operator manufactures or has manufactured for it, packages, imports (from the internal market and/or third countries) or brokers (e.g. agency business)

Foods intended for infants or young children, including baby foods, infant formulae, follow-on formulae and dietary foods for special medical purposes intended for infants
Significant quantities (>500,000 kg/year) of fruit or berries, incl. fresh, frozen and dried
Significant quantities (>500,000 kg/year) of vegetables, incl. fresh, frozen and dried
Significant quantities (>10,000 kg/year) of nuts or seeds
Significant quantities (>10,000 kg/year) of spices
Significant quantities (>10,000 kg/year) of tea or herbal infusions.

This point can be controlled on a discretionary basis (e.g. specific issues, previous control data, suspicions, recalls, the control unit’s own control projects) irrespective of the production quantity, when the operator manufactures, has manufactured for it, packages, imports (from the internal market and/or third countries) or brokers foods or ingredients of foods for which legislative maximum residue levels of pesticide have been set in Regulation (EC) No 396/2005, incl.

Fruit and berries
Vegetables
Pulses, dry
Nuts
Spices
Cereals
Oil seeds and oilfruits
Sugar plants
Coffee, tea, herbal infusions and cocoa
Hops
Products of animal origin – terrestrial animals
- Meat, preparations of meat, offal, blood and animal fats (fresh, chilled or frozen, salted, in brine, dried or smoked or processed as flours or meals), other processed products such as sausages and food preparations based on sausages
- Milk and cream (not concentrated, nor containing added sugar or sweetening matter), butter and other fats derived from milk, cheese and curd
- Birds’ eggs (fresh, preserved or cooked), shelled eggs and egg yolks (fresh, dried, cooked by steaming or in boiling water, moulded, frozen or otherwise preserved, whether or not containing added sugar or other sweetening matter)
- Honey and other products of terrestrial animals.

This Guideline applies to retail stores and catering establishments only if they import the foods referred to (from the internal market and/or third countries).

Legislative requirements apply to all operator in the food chain regardless of the scope and effectiveness of operations. The Oiva guidelines have taken into account the risk-based approach by limiting the functions on which regulatory control should primarily be focused.

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 own-check activities is evaluated (where necessary by random checks on e.g. 1-3 products, taking into consideration the nature and scope of operations) by examining the following matters:

Foods containing residues of plant protection products exceeding the set maximum level are not placed on the market or used as ingredients in food products.

The operator identifies and manages the relevant hazards related to residues of plant protection products with regard to foods.
Risk management related to food products or raw materials of food products can be demonstrated (by means of e.g. procurement contracts or product specifications) and verified (based on e.g. analysis certificates or audits).
NOTE! Batch-specific verification is not required. The scope and effectiveness of operation determine the frequency of analysis. Testing results from sampling carried out by authorities can also be utilised.

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

The operator identifies the hazards which are relevant to foodstuffs and related to residues of plant protection products and has these hazards under control.

Risk management can be demonstrated on the basis of e.g. procurement contracts or product specifications. In addition, the operator is able to present, for example, analysis certificates or audit documents for the verification of risk management.

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

The management of residues of plant protection products complies in main parts with the aforementioned requirements. There are some minor shortcomings, such as:

Risk management can be demonstrated on the basis of e.g. procurement contracts or product specifications, but this cannot be supported by presentation of e.g. analysis certificates.

There are clear shortcomings in the management of risks related to residues of plant protection products. Shortcomings include, for example:

Risk management cannot be demonstrated in any way.

Risks related to plant protection products are not under control. Such shortcomings requiring immediate rectification or recall include:

A chemical analysis has shown that the maximum level fixed in legislation is exceeded or an active substance that is not authorised in the EU is used in the plant protection product, but no corrective actions have been taken or the actions taken have not been adequate.
The operator is unable to present any evidence to demonstrate risk management despite being requested or ordered to do so.

Legislation and guidelines pertaining to the topic:

Regulation (EC) No 396/2005 of the European Parliament and of the Council on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (incl. amendments)
Decree of the Ministry of Trade and Industry on pesticide residues in children's foods, 1215/2007
Commission Delegated Rehulation (EU) 2016/127 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for infant formula and follow-on formula and as regards requirements on information relating to infant and young child feeding
Chemical hazards of foodstuffs and domestic water (Evira publication 13/2013)
Finnish Food Authority’s guideline 5911/04.02.00.01/2020/2: Chemical analyses for the demonstration of compliance of foodstuffs with requirements.

Updates in version 10:

Title updated from Residues of Plant Protection Products to Pesticide Residues.
Legislation has been updated

17.13 Environmental Contaminants

Guide/version: 2203/04.02.00.01/2021/9, valid from 2.1.2024

Heavy metals, dioxins and PCB compounds, PFAS compounds, radioactive substances

foods for infants and young children (incl. infant formulae, follow-on formulae, food intended for the particular use of infants, and beverages intended for infants and young children)
significant quantities (> 50,000 kg/year) of wild-caught fish or of fishery products derived thereof
significant quantities (> 50,000 kg/year) of rice or rice products
significant quantities (> 50,000 kg/year) of wild berries or mushrooms.

Where wild-caught fish is concerned, it is recommended that Guideline 16.4. (Traceability of Fish and Fishery Products Exempt from Dioxin Regulations) is controlled at the same time).

This point can also be controlled on discretionary basis, irresprective of the production quantity, when the operator manufactures when the operator manufactures, has manufactured for it, packages, imports (from the internal market and/or third countries) or brokers (e.g. agency business) foods or ingredients of foods for which regulatory maximum levels for environmental contaminants have been set¹,²:

e.g. milk and dairy products, infant formulae and follow-on formulae, processed cereal-based food and other foods intended for infants and young children, food for special medical purposes intended for infants and young children, drinks for infants and young children, meat and meat products, offal, fish meat (i.e. muscle meat of fish) and fishery products, fish liver and products derived from it, eggs and egg products, crustaceans, molluscs, cephalopods, pulses, cereals, vegetables, mushrooms, fruiting vegetables, fruit, berries, fats and oils, food supplements, soybeans, cocoa and chocolate products, preserves, canned beverages, fruit juices, fruit juice concentrates and fruit nectars, honey, rice, rice waffles, rice waffle biscuits, rice biscuits and rice cakes.

This Guideline is applied on discretionary basis only to retail stores and catering establishments that import the aforementioned foods (from the internal market and/or third countries).

Legislative requirements apply to all operators in the food chain regardless of the scope and effectiveness of their operations. The risk based approach has been taken into account in Oiva guidelines by limiting the functions on which regulatory control should primarily be focused. The point should also be controlled on discretionary basis (e.g. specific problems, previous control data, suspicion, withdrawals, the control unit's own control projects) when the operator manufactures, has manufactured for it, packs, imports (from the internal market and/or third countries) or brokers foodstuffs or ingredients of foods for which regulatory maximum levels for environmental contaminants have been set.

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 own-check activities is evaluated (where necessary, by random checks on e.g. 1-3 products, taking the scope and nature of operations into consideration) by checking the following matters:

Foods containing environmental contaminants (heavy metals, dioxins and PCBs, PFAS compounds,radioactive substances) in levels exceeding the maximum levels set are not placed on the market or used as ingredients in food products.

The operator identifies the relevant hazards related to environmental contaminants that are to be particularly taken into account for the food product (e.g. wild-caught fish - heavy metals, particularly mercury; wild berries and mushrooms – radioactive substances; rice – inorganic arsenic) and has these hazards under control.
Risk management related to food products or raw materials of food products can be demonstrated (by means of e.g. procurement contracts or product specifications) and verified (based on e.g. analysis certificates or audits).
NOTE! Batch-specific verification is not required. The scope and effectiveness of operation determine the frequency of analysis – testing results from sampling carried out by authorities can also be utilised. The analysis certificates are not necessary for fish and fishery products exempt from dioxin regulations, provided the food products are intended to the markets to which the derogation applies.

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

The operator identifies the hazards related to environmental contaminants and has these hazards under control.

Risk management can be demonstrated on the basis of e.g. procurement contracts or product specifications. In addition, the operator is able to present, for example, analysis certificates or audit documents for the verification of risk management.

The management of environmental contaminants complies in main parts with the aforementioned requirements. There are some minor shortcomings, such as:

Risk management can be demonstrated on the basis of e.g. procurement contracts or product specifications, but this cannot be supported by presentation of e.g. analysis certificates.

There are clear shortcomings in the management of risks related to environmental contaminants. Shortcomings include, for example:

Risk management cannot be demonstrated in any way.

Risks related to environmental contaminants are not under control. Such shortcomings requiring immediate rectification or recall include:

A chemical analysis has shown that the maximum level set in legislation is exceeded, but no corrective actions have been taken or the actions taken have not been adequate.
The operator is unable to present any evidence to demonstrate risk management despite being requested or ordered to do so.

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

¹Commission Regulation (EU) 2023/915 on maximum levels for certain contaminants in food and repealing Regulation (EC) No 1881/2006
²Commission Recommendation on the protection and information of the public with regard to exposure resulting from the continued radioactive caesium contamination of certain wild food products as a consequence of the accident at the Chernobyl nuclear power station (2003/274/Euratom)
Council Regulation laying down Community procedures for contaminants in food (EEC) No 315/93
Chemical hazards of foodstuffs and domestic water (Evira publication 13/2013)
Finnish Food Authority’s guideline 5911/04.02.00.01/2020/2: Chemical analyses for the demonstration of compliance of foodstuffs with requirements.

Updates in version 9:

Legislation updated.

17.14 Mycotoxins

Guide/version: 2204/04.02.00.01/2021/8, valid from 2.1.2024

Aflatoxins, ochratoxin A, patulin, deoxynivalenol (DON), zearalenone (ZEN), fumonisins, citrinin, ergot sclerotia, ergot alkaloids

To be taken into consideration:
This point is to be controlled when the operator manufactures, has manufactured for it, packages, imports (from the internal market and/or third countries) or brokers (e.g. agency business) the following products for which regulatory maximum levels for mycotoxins or ergot sclerotia have been listed in Section 2 of the Annex to Commission Regulation (EU) 2023/915.

foods intended for infants or young children, including baby foods, infant formulae, follow-on formulae and dietary foods for special medical purposes intended for infants
significant quantities (> 500,000 kg/year) of cereals or cereal products,
significant quantities (> 10,000 kg/year) of nuts, peanuts or dried fruits or derived products thereof
significant quantities (> 500,000 kg/year) fruit juices, concentrates or nectars.

This point can be controlled on a discretionary basis (e.g. specific issues, previous control data, suspicions, recalls, the control unit’s own control projects) irrespective of the production quantity, when the operator manufactures, has manufactured for it, packages, imports (from the internal market and/or third countries) or brokers (e.g. agency business) foods or ingredients of foods for which regulatory maximum levels for mycotoxins or ergot sclerotia have been listed in Section 2 of the Annex to Commission Regulation (EU) 2023/915 incl.

peanuts and other oil seeds, almonds, pistachios, apricot seeds, hazel nuts, Brazil nuts, other nuts
dried fruits, raisins
cereal and cereal products, incl. maize and rice (e.g. pasta, bread, cakes, pastries, biscuits, cookies, cereal snacks, breakfast cereals)
raw milk, heat-treated milk
spices and spice mixes
processed cereal-based food and other food intended for infants and young children
infant formulae and follow-on formulae
dietary foods for special medical purposes intended for infants
coffee (roasted coffee beans, ground roasted coffee, instant coffee), grape juice (incl. grape juice concentrates and nectars)
liquorice root and extract
fruit juices (incl. concentrated fruit juices and nectars), apple juice and solid apple products (incl. apple compote and purée), refined maize oil
food supplements based on rice fermented with red yeast (Monascus purpureus)
other than wheat gluten sold directly to consumers.

This Guideline is applied to retail sales and catering establishments only if they import (from the internal market and/or third countries) the aforementioned foods.

Legislative requirements apply to all operators in the food chain regardless of the scope and effectiveness of their operations. The Oiva guidelines have taken the risk-based approach into account by limiting the operations in which regulatory control should primarily be focused.

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 own-check activities is evaluated (where necessary, by random checks on e.g. 1-3 products, taking the scope and nature of operations into consideration) by checking the following matters:

Foods containing mycotoxins (aflatoxins, ochratoxin A, patulin, deoxynivalenol (DON), zearalenone (ZEN), fumonisins, citrinin) and/or ergot sclerotia in levels exceeding the maximum levels set are not placed on the market or used as ingredients in food products.

The operator identifies and manages the relevant hazards related to mycotoxins and ergot sclerotia that are particularly to be taken into account in respect of foods.
Risk management related to food products or raw materials of food products can be demonstrated (by means of e.g. procurement contracts or product specifications) and verified (based on e.g. analysis certificates or audits).
NOTE! Batch-specific verification is not required. The scope and effectiveness of operation determine the frequency of analysis – testing results from sampling carried out by authorities can also be utilised.

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

The operator identifies the hazards related to mycotoxins and/or ergot sclerotia and has these hazards under control.

Risk management can be demonstrated on the basis of e.g. procurement contracts or product specifications. In addition, the operator is able to present, for example, analysis certificates or audit documents for the verification of risk management.

The management of mycotoxins and/or ergot sclerotia complies in main parts with the aforementioned requirements. There are some minor shortcomings, such as:

Risk management can be demonstrated on the basis of e.g. procurement contracts or product specifications, but this cannot be supported by presentation of e.g. analysis certificates.

There are clear shortcomings in the management of risks related to mycotoxins and/or ergot sclerotia. Shortcomings include, for example:

Risk management cannot be demonstrated in any way.

Risks related to mycotoxins and/or ergot sclerotia are not under control. Such shortcomings requiring immediate rectification or recall include:

A chemical analysis (a microscopic analysis for ergot sclerotia) has shown that the maximum level set in legislation is exceeded, but no corrective actions have been taken or the actions taken have not been appropriate/adequate.
The operator is unable to present any evidence to demonstrate risk management despite being requested or ordered to do so.

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

Commission Regulation (EU) 2023/915 on maximum levels for certain contaminants in food and repealing Regulation (EC) No 1881/2006
Council Regulation laying down Community procedures for contaminants in food (EEC) No 315/93
Chemical hazards of foodstuffs and domestic water (Evira publication 13/2013)
Finnish Food Authority’s guideline 5911/04.02.00.01/2020/2: Chemical analyses for the demonstration of compliance of foodstuffs with requirements.

Updates in version 8:

Ergot alkaloids added to the list
Legislation updated

17.15 Process Contaminants

Guide/version: 2205/04.02.00.01/2021/9, valid from 2.1.2024

PAH compounds, 3-MCPD, glycidyl fatty acid esters, acrylamide

children's foods (incl. infant formulae, follow-on formulae and foods intended for the particular nutritional use of infants)
vegetable oils and fats
foodstuffs produced using traditional smoking processes (NOTE! The Guideline does not pertain to foods manufactured using smoke flavourings, e.g. liquid smoke, or to the ingredients of such foods).

This point is also to be checked when the operator manufactures and places foods on the market that are covered by the regulation on acrylamide¹:

French fries, other cut (deep fried) products and sliced potato crisps from fresh potatoes; potato crisps, snacks, crackers and other potato products from potato dough; bread; breakfast cereals (excluding porridge); fine bakery wares: cookies, biscuits, rusks, cereal bars, scones, cornets, wafers, crumpets and gingerbread, as well as crackers, crisp breads and bread substitutes; coffee (roast coffee and instant coffee); coffee substitutes; grain-based infant formulae and follow-on formulae.

This point can also be controlled on discretionary basis, when the operator manufactures, has manufactured for it, packages, imports (from the internal market and/or third countries) or brokers (e.g. agency business) foodstuffs or ingredients of foodstuffs for which regulatory maximum levels for process contaminants have been set²:

e.g. smoked meat and smoked meat products, smoked muscle meat of fish (fish meat), smoked fishery products, oils and fats, cocoa beans and products derived from these, coconut oil, smoked bivalve molluscs, food and processed cereal-based food for infants and young children, baby formulae and follow-on formulae (including milk-based products), foods for special medical purposes intended for infants, cocoa fibre and products derived from cocoa fibre intended for use as an ingredient in food, banana chips, food supplements containing botanicals and their preparations, dried herbs, dried spices (with the exception of cardamom and smoked Capsicum spp), hydrolysed plant protein, soy sauce.

This Guideline is applied to retail stores and catering establishments where traditional smoking is carried out and/or where foods are produced and placed on the market, which are foods that are covered by the regulation on acrylamide. In addition, this Guideline is applied on discretionary basis only to retail stores and catering establishments that import the aforementioned foodstuffs (from the internal market and/or third countries) or where foods susceptible to the formation of acrylamide are produced and placed on the market.

Legislative requirements apply to all operators in the food chain regardless of the scope and effectiveness of their operation. The risk based approach has been taken into account in Oiva guidelines by limiting the functions on which regulatory control should primarily be focused. The point should also be controlled on discretionary basis (e.g. specific problems, previous control data, suspicion, withdrawals, the control unit's own control projects) when the operator manufactures, has manufactured for it, packs, imports (from the internal market and/or third countries) or brokers foodstuffs or ingredients of foodstuffs for which regulatory maximum levels for process contaminants have been fixed or the operator produces and places foods susceptible to the formation of acrylamide on the market.

Matters to be controlled:
PAH compounds, 3-MCPD, glycidyl fatty acid esters: 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". The implementation of own-check activities is evaluated (where necessary, by random checks on e.g. 1-3 products, taking the scope and nature of operations into consideration) by checking the following matters:

Foodstuffs containing process contaminants (PAH compounds, 3-MCPD, glycidyl fatty acid esters) in levels exceeding the maximum levels set are not placed on the market or used as ingredients in food products.

Operator manufactures, has manufactured for it, packages, imports (from the internal market and/or third countries) or brokers (e.g. agency business) foodstuffs or ingredients of foodstuffs:

The operator identifies the relevant hazards related to process contaminants that are to be particularly taken into account for the food product (e.g. smoked products – PAH compounds, soy sauce – 3-MCPD, vegetable oils and fats - glycidyl fatty acid esters) and has these hazards under control.
Risk management related to food products or raw materials of food products can be demonstrated (by means of e.g. procurement contracts or product specifications) and verified (based on e.g. analysis certificates or audits).
NOTE! Batch-specific verification is not required. The scope and effectiveness of operation determine the frequency of analysis – testing results from sampling carried out by authorities can also be utilised.

Operator smokes foodstuffs itself:

The cleanliness of the smoking equipment is looked after.
The instructions for use provided by the equipment manufacturer as well as good manufacturing practices (e.g. avoiding "over-smoking") are complied with.
Analyses related to own-check activities have been carried out (NOTE! The scope and effectiveness of operation determine the frequency of analysis); testing results from sampling carried out by authorities can also be utilised.
An analysis certificate demonstrating compliance with regulations is the strongest assurance of risk management.
Products subject to Finland’s PAH derogation ((EU) 2023/915, Article 7) (traditionally hot smoked meat and meat products as well as traditionally hot smoked small fish and fishery products made from small fish) are supplied only to the Finnish market. Approved food establishments control that the information to be submitted to the receiving food establishment contains an indication of the restriction with regard to the delivery of products subject to the PAH derogation. The delivery restriction does not apply to situations where it can be demonstrated on the basis of analyses that the levels are below the general maximum levels laid down for smoked fish and meat and for products made thereof.

Acrylamide: The in-house control is assessed by checking the following:

The operator identifies and controls the hazards related to acrylamide.
The mitigation measures required in the regulation on acrylamide as to the food produced are described in the in-house controls and the monitoring of the implementation can be detected/indicated as applicable³.
A plan for analysis and sampling has been added to the in-house controls and this has been adhered to (the obligation to have a plan for sampling and analysis does not apply to so-called local operations)³.

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

The operator identifies the hazards related to process contaminants and has these hazards under control.

Operator manufactures, has manufactured for it, packages, imports (from the internal market and/or third countries) or brokers (e.g. agency business) foodstuffs or ingredients of foodstuffs:

Risk management can be demonstrated on the basis of e.g. procurement contracts or product specifications. In addition, the operator is able to present, for example, analysis certificates or audit documents for the verification of risk management.

Operator smokes foodstuffs itself:

The cleanliness of the smoking equipment is looked after.
The instructions for use provided by the equipment manufacturer and/or good manufacturing practices are complied with.
Chemical analyses have been carried out to support risk management.
Any specific condition (PAH derogation) concerning the placing on the market is to be notified to the receiving operator in commercial documents or otherwise in writing. (Approved food establishments).

Foods that are covered by the regulation on acrylamide (depending on the requirement level³):

The mitigation measures required for the food in the regulation on acrylamide and their implementation are described in the in-house controls.
The implementation of the mitigation measures can be detected/indicated as applicable.
A plan for analysis and sampling has been added to the in-house control and it has been adhered to (the obligation to have a plan for sampling and analyses does not apply to so-called local operations).
The contract or any documentation related to it has taken into account or it has been ensured by other means that all the food suppliers have implemented all of the mitigation measures confirmed in the regulation.
The standard procedures lead to a level of acrylamide below the benchmark.

The management of process contaminants complies in main parts with the aforementioned requirements. There are some minor shortcomings, such as:

Operator manufactures, has manufactured for it, packages, imports (from the internal market and/or third countries) or brokers (e.g. agency business) foodstuffs or ingredients of foodstuffs:

Risk management can be demonstrated on the basis of e.g. procurement contracts or product specifications, but this cannot be supported by presentation of e.g. analysis certificates.

Operator smokes foodstuffs itself:

There are some minor shortcomings in the cleanliness of the smoking equipment, but it is clean in the main parts.
Good manufacturing practices are complied with in the main parts, but some minor shortcomings are found; however, they do not impair food safety.

Foods that are covered by the regulation on acrylamide:

The mitigation measures for the food required by the regulation on acrylamide are described in the in-house controls, but there are small deficiencies as to how they are implemented or how the implementation is followed up. Small deficiencies (depending on the requirement level³) are for example:
- The work practices show that the mitigation measures are not completely adhered to.
- Recording of the follow-up of the implementation has not been carried out systematically.
- The plan for sampling and analysis has not been adhered to in detail (a small part of the planned analyses is missing).
- There is no documentation to show that all the food suppliers have implemented all of the mitigation measures as established in the regulation.
- The standard procedures are not supported by evidence that the level is below the benchmark.

There are clear shortcomings in the management of risks related to process contaminants. Shortcomings include, for example:

Operator manufactures, has manufactured for it, packages, imports (from the internal market and/or third countries) or brokers (e.g. agency business) foodstuffs or ingredients of foodstuffs:

Risk management cannot be demonstrated in any way.

Operator smokes foodstuffs itself:

The smoking equipment is visibly extremely dirty.
The instructions for use for the smoking equipment are not known.
Good manufacturing practices are not complied with in smoking (e.g. "over-smoking").
The receiving operator has not been notified in writing that products subject to the PAH derogation may only be supplied to the Finnish market. (Approved food establishments)

Foods that are covered by the regulation on acrylamide:

The mitigation measures required by the regulation on acrylamide are described in the in-house control, but it cannot be demonstrated that they have been implemented and/or the lack of implementation is evident, for example (depending on the requirement level³):
- Very dark cooking oil or large amounts of loose fragments in the cooking oil (which is not due to variations during the activity or the properties of the oil).
- The instructions for use by a manufacturer of a semi-manufactured product are not known or they are not being followed.
- Very dark cooking (a clearly burned product).
- Specified processing temperatures or times are not being adhered to.
- The plan for sampling and analysis has not been adhered to (most of the planned analyses are missing).
- There is no documentation to show that the suppliers of the foods have carried out all of the mitigation measures as established in the regulation.
- Standard procedures are not described.

Risks related to process contaminants are not under control. Such shortcomings requiring immediate rectification or recall include:

Operator manufactures, has manufactured for it, packages, imports (from the internal market and/or third countries) or brokers (e.g. agency business) foodstuffs or ingredients of foodstuffs:

A chemical analysis has shown that the maximum level set in legislation is exceeded, but no corrective actions have been taken or the actions taken have not been adequate.
The operator is unable to present any evidence to demonstrate risk management despite being requested or ordered to do so.

Operator smokes foodstuffs itself:

A chemical analysis has shown that the maximum level set in legislation is exceeded, but no corrective actions have been taken or the actions taken have not been adequate.
Products subject to Finland’s PAH derogation have been supplied to other EU countries.

Foods that are coved by the regulation on acrylamide:

The risks related to acrylamide are not under control, for example (depending on the requirement level³):
- The mitigation measures required in the regulation on acrylamide and/or the plan for sampling and analysis are not described in the in-house controls and they are not being implemented.
- There is a plan for sampling and analysis but all of the results are missing.
- The results from the analyses show that the benchmark levels have been exceeded but no corrective measures (measures required by the regulation) have been taken or there is no written explanation for why it has been omitted.

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

¹Commission Regulation establishing mitigation measures and benchmark levels for the reduction of the presence of acrylamide in food (EU) 2017/2158
²Commission Regulation (EU) 2023/915 on maximum levels for certain contaminants in food and repealing Regulation (EC) No 1881/2006
³Evira’s guideline 17056/1: Guideline on the reduction of the presence of acrylamide in food and benchmark levels in accordance with Commission Regulation (EU) 2017/2158
Council Regulation laying down Community procedures for contaminants in food (EEC) No 315/93
Chemical hazards of foodstuffs and domestic water (Evira publication 13/2013)
Finnish Food Authority’s guideline 4222/04.02.00.01/2021: Ways to reduce PAH compounds in smoking.
Finnish Food Authority’s guideline 5911/04.02.00.01/2020/2: Chemical analyses for the demonstration of compliance of foodstuffs with requirements.

Updates in version 9:

Legislation updated.

17.16 Other Contaminants*

Guide/version: 2206/04.02.00.01/2021/9, valid from 2.1.2024

*Nitrate, erucic acid, melamine, tropane alkaloids, hydrocyanic acid, pyrrolizidine alkaloids, opium alkaloids, delta-9-tetrahydrocannabinol (Δ9-THC) equivalents

children's foods (incl. processed cereal-based food for infants and young children, infant formulae, follow-on formulae and young-child formulae)
significant quantities (> 50 000 kg/year) of spinach, fresh lettuce, iceberg type lettuces or rucola
significant quantities (> 100 000 kg/year) of vegetable oils and fats.

This point can also be controlled on a discretionary basis, irrespective of production quantity, when the operator manufactures, has manufactured for it, packages, imports (from the internal market and/or third countries) or brokers (e.g. agency business) foodstuffs or ingredients of foodstuffs for which regulatory maximum levels for nitrate, melamine, erucic acid, tropane alkaloids, hydrocyanic acid, pyrrolizidine alkaloids, opium alkaloids and delta-9-tetrahydrocannabinol (Δ9-THC) equivalents have been set¹:

nitrate: spinach, fresh lettuce, iceberg type lettuces, rucola, cereal-based processed foods and other foods intended for infants and young children
melamine: foods, infant formulae, follow-on formulae and young-child formulae
erucic acid: vegetable oils and fats that have been placed on the market for the final consumer or as a food ingredient, camelina oil, mustard oil and borage oil, mustard (seasoning)
tropane alkaloids: cereal-based processed foods and other foods intended for infants and young children that contain millet, sorghum, buckwheat, maize or products derived from these, millet, sorghum, maize and buckwheat grains, maize for popping, milling products of millet, sorghum and maize and buckwheat, herbal infusions
hydrocyanic acid: linseeds, apricot kernels, almonds, cassava root, cassava flour and tapioca flour
pyrrolizidine alkaloids: cumin, food supplements containing botanical preparation, pollen products, tea, herbal infusions and dried herbs
opium alkaloids: poppy seeds and bakery products containing poppy seeds
delta-9-tetrahydrocannabinol (Δ9-THC) equivalents: hemp seed and hemp seed oil

This Guideline is applied on discretionary basis only to retail stores and catering establishments that import the aforementioned foodstuffs (from the internal market and/or third countries).

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 own-check activities is evaluated (where necessary, by random checks on e.g. 1-3 products, taking the scope and nature of operations into consideration) by checking the following matters:

Foodstuffs containing contaminants in levels exceeding the maximum levels set are not placed on the market or used as ingredients in food products.

The operator identifies the relevant hazards related to contaminants that are to be particularly taken into account for the food product (e.g. spinach, lettuces, rucola – nitrate; vegetable oils and fats and foodstuffs containing them – erucic acid; children's foods containing sorghum, millet or buckwheat – tropane alkaloids; linseed – hydrocyanic acid) and has these hazards under control.
Risk management related to food products or raw materials of food products can be demonstrated (by means of e.g. procurement contracts or product specifications) and verified (based on e.g. analysis certificates or audits).
NOTE! Batch-specific verification is not required. The scope and effectiveness of operation determine the frequency of analysis – testing results from sampling carried out by authorities can also be utilised.

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

The operator identifies the hazards related to contaminants and has these hazards under control.

Risk management can be demonstrated on the basis of e.g. procurement contracts or product specifications. In addition, the operator is able to present, for example, analysis certificates or audit documents for the verification of risk management.

The management of contaminants complies in main parts with the aforementioned requirements. There are some minor shortcomings, such as:

Risk management can be demonstrated on the basis of e.g. procurement contracts or product specifications, but this cannot be supported by presentation of e.g. analysis certificates.

There are clear shortcomings in the management of risks related to contaminants. Shortcomings include, for example:

Risk management cannot be demonstrated in any way.

Risks related to contaminants are not under control. Such shortcomings requiring immediate rectification or recall include:

A chemical analysis has shown that the maximum level set in legislation is exceeded, but no corrective actions have been taken or the actions taken have not been adequate.
The operator is unable to present any evidence to demonstrate risk management despite being requested or ordered to do so.

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

¹Commission Regulation (EU) 2023/915 on maximum levels for certain contaminants in food and repealing Regulation (EC) No 1881/2006.
Council Regulation laying down Community procedures for contaminants in food (EEC) No 315/93
Chemical hazards of foodstuffs and domestic water (Evira publication 13/2013)
Finnish Food Authority’s guideline 5911/04.02.00.01/2020/2: Chemical analyses for the demonstration of compliance of foodstuffs with requirements.

Updates in version 9:

The legislation has been updated.
Added pyrrolizidine alkaloids, opium alkaloids and Δ9 -THC equivalents to the list of contaminants for which a regulatory maximum level (EU) 2023/915 has been set.