17 Food testing

All Oiva evaluation guidelines for registered food premises.

17.1 Sampling and Own-check Testing

Guide/version: 2246/04.02.00.01/2021/4, valid from 2.1.2024

To be taken into consideration:

Point 17.1 is excluded from the evaluation,
- if a sampling and testing plan is not attached to the own-check plan, because it is not required due to the nature and scope of operation, see the Finnish Food Authority's sampling guide for more details.
In order to verify compliance with the plan, the operator shall be able to present in writing to the inspector testing results or certificates of the own-check tests carried out.
When evaluating the appropriateness and adequacy of the actions taken by the operator based on the testing results, the results obtained from both own-check samples and regulatory control samples are taken into account (both may result in the need for corrective actions).
The results of regulatory samples do not affect the Oiva grade as such, even if the results are poor. If the operator has taken appropriate and adequate actions based on poor results obtained from regulatory samples, the Oiva grade in terms of corrective actions is A or B.
The analyses of trends are examined in terms of changes in test results. If the operator uses a two-step method (satisfactory or unsatisfactory) a trend curve of the results of surface samples cannot be drawn. In this case, the lack of a curve will not reduce the Oiva grade. The operator shall monitor the number of deviations (unsatisfactory results) and changes in the number of deviations at different sampling times.
For small service points and retail service sales, trends can be analysed in terms of the number of deviations, see the Finnish Food Authority's sampling guide for more details.

Matters to be controlled:

Compliance with sampling and testing plan
Laboratory/laboratories used.
Adequate competence of the sampler
Sample testing results
Records of reviews of results
The analyses of trends of results or deviations
Corrective actions and records of corrective actions
Sampling of salmonella of consignments of raw meat and minced meat with special guarantees
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.

Activities comply with the sampling and testing plan included in the own-check plan. The own-check samples specified to be tested in food regulations are tested in a laboratory approved by Finnish Food Authority (when a Finnish laboratory is used). The sampler has adequate competence as concerns the taking and handling of samples.

Testing results are reviewed and the trends of the results or deviations are analysed appropriately. Appropriate and adequate actions are taken based on deviations. The reviews of the results and any corrective actions taken are recorded.

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.

There are some minor shortcomings as concerns compliance with the sampling and testing plan, such as not keeping to the sampling schedule, but samples have previously been taken on a regular basis according to the plan.

The own-check samples specified to be tested in food regulations are tested in a laboratory approved by Finnish Food Authority (when a Finnish laboratory is used). The sampler has adequate competence as concerns the taking and handling of samples.

Testing results are reviewed and appropriate and adequate actions are taken based on deviations. The reviews of the results or corrective actions are not recorded. Trends are not analysed or worsening trends do not result in actions.

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.

Samples are taken, but sampling is not implemented in compliance with the sampling and testing plan. The own-check samples specified to be tested in food regulations are tested in a Finnish laboratory not approved by Finnish Food Authority. The sampler does not have adequate competence as concerns the taking and handling of samples.

The results obtained are not adequately taken into account. Deviations that may indicate impaired food safety (e.g. hygiene indicator bacteria) have not always resulted in actions or actions have been inappropriate or inadequate.

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.

Samples are not taken at all or only to a very limited extent, although the sampling and testing plan prepared by the operator specifies otherwise. The operator has not complied with the orders issued to them.

Testing results are not reviewed. Deviations that may indicate impaired food safety have not resulted in actions or actions have been inappropriate or inadequate (e.g. a product testing positive for a pathogen has not resulted in removal from the market).

Legislation and guidelines pertaining to the topic:

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety; Article 19
Regulation of the European Parliament and of the Council on the hygiene of foodstuffs, 852/2004/EC; Article 4
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
Finnish Food Authority's Guide "Microbiological criteria for foodstuffs - guide for food business operators".

Updates in version 4:

Clarification and modification of the assessment of the analyses of trends.

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.

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 setting 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 setting 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.