05 Hygiene of Food Production

All Oiva evaluation guidelines for approved food establishments.

5.1 General Hygiene and Risk Control in Food Handling

Guide/version: 2229/04.02.00.01/2021/8, valid from 2.1.2023

To be taken into consideration:

This guideline is applied to all food premises.
The evaluation referred to in this Guideline is to be carried out where a risk factor related to the manufacture or some other form of handling of food is managed during production using a suitable method described in the own-check and the matter is not included in any other evaluation point. For example:

Management of physical hazards and risks (e.g. broken glass, fragments of metal)
Elimination of the risk caused by toxins, such as adequate and appropriate processing of false morels through repeated boiling and rinsing in connection with manufacture
Controlling the risk of EHEC food poisoning in the preparation or serving of medium-cooked (semi-cooked) minced meat burgers by a method chosen by the operator. This issue will be evaluated according to Annex 1.

Also other matters not included in any specific/other evaluation point are evaluated in this point. For example:
- Process control based on physical or chemical properties of the foodstuffs, e.g. pH measurements during production processes
- Washing operations of the food containers of other food establishments (not owned by the establishment itself)
- Handling hygiene, washing operations and verification of cleanliness regarding the receptacles for by-products returned to the establishment.
Matters related to general food production and handling hygiene, such as cleaning, work hygiene, hand hygiene, storage temperatures, chilling etc for which there are specific guidelines, are not to be inspected according to this Guideline.
The controllability, basic structure and coverage of the hazard analysis of the own-check system and other HACCP procedures included in it are assessed on a general level in point 1.6.
The prevention of cross contamination at the various stages of production is evaluated in approved establishments in point 5.2.
Temperature management during food production and processing (e.g., cooking, pasteurisation or other heating, thawing and chilling) is controlled in point 6.5.
The freezing treatment of fishery products to eliminate parasite risk is controlled in point 8.8.

Matters to be controlled:

The risk management methods described in the operator’s own-check plan are followed
Proper use of the risk management methods that are controlled (e.g. management of physical hazards) and regular verification of the effectiveness of the risk management methods
Compliance of food and operating practices with regulatory requirements and food safety with regard to areas covered by the inspection
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.

Requirements and the risk management methods described in the operator’s own-check plan are complied with.

The risk management methods used in the manufacturing processes are suitable and adequate and appropriately applied.

Good hygiene is maintained as regards the controlled matters.

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

For example:

The risk management methods used in the manufacturing processes are suitable and adequate, consistent with the methods described in own-check activities and appropriately applied, but there are some minor shortcomings related to the regular verification of the effectiveness of the methods and/or associated records.

There are some minor shortcomings in the hygiene of operations as regards the controlled matters, but food safety is not impaired.

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

For example:

There are shortcomings in the use of risk management methods and food safety is impaired. For example, the risk management methods described in the own-check activities and evaluated as adequate and suitable are not used in practice.

The effectiveness of risk management methods is not verified through regular monitoring.

There is no information available on the corrective actions in cases of deviations and the deviations impair food safety.

There are shortcomings in the hygiene of operations as regards the controlled matters and food safety is impaired.

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

For example:

Adequate methods for the elimination of known risk factors are not applied and food safety is therefore jeopardised.

There are major shortcomings in the implementing of planned own-check activities which jeopardise food safety.

As regards the controlled matters, operations are carried out unhygienically and food safety is jeopardised.

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

General Food Regulation (EC) No 178/2002
Regulation (EC) No 852/2004 on the hygiene of foodstuffs
Regulation (EC) No 853/2004 laying down specific hygiene rules for food of animal origin
Finnish Food Act 297/2021
Decree of the Ministry of Agriculture and Forestry on food hygiene 318/2021
Preparing and serving medium-cooked minced meat burgers - Recommendations for food business operators.

Updates in version 8:

Guidelines for registered and approved food premises were combined in Oiva assessment guideline 5.1 Hygiene in thawing, chilling, freezing and quick-freezing; issues related to food temperature management; and the freezing treatment of fishery products were removed from the contents of guideline REH 5.1. In the future, the guideline will be applied to both registered and approved food premises.
Guideline line name changed (formerly, REH 5.1 Risk control in food preparing, HEH 5.1 General hygiene in food production).
List of areas covered by the inspection and assessment guidelines were modified. For example, the areas covered by the inspection and the evaluation examples included in annex to guideline 1.6 “Adequacy and Suitability of Own-Check Activities” were removed.
The control results for registered food business operators are also shown in the public Oiva report.

5.2 Separation of Activities Requiring Different Hygiene Levels

Guide/version: 2132/04.02.00.01/2021/2, valid from 1.7.2021

To be taken into consideration:

This Guideline is applied to all establishments.
The purpose of this point is to evaluate the separation, either in time or through operational arrangements, of activities requiring different hygiene levels (e.g. manufacture of meat preparations and meat products) during production.
However, compliance with the conditions laid down in the approval decision is always evaluated in point 1.2.
Matters to be evaluated in this point also include the separation of areas, production stages and foodstuffs of different hygiene levels, as well as the prevention of cross-contamination. For example:
- Areas of different hygiene levels
- Separation of raw materials and finished products
- Separation of uncooked and cooked finished products
- Separation of unpackaged and packaged foodstuffs
- Separation of meat specified to be heated (the actual heating procedure is evaluated in point 6.5)
- Separation of pigs kept under controlled housing conditions from regular pigs to verify that Trichinella samples are taken from regular pigs
- Prevention of cross-contamination at various production stages, for example in the slaughter line.
The approvals of activities are evaluated in point 1.2.
The separation of materials and products other than foodstuffs from foodstuffs is evaluated in point 5.6.
Separation of TSE risk material is evaluated in point 8.1.
Separation of by-products of categories 2 and 3 from foodstuffs is evaluated in point 5.7.

Matters to be controlled:

The separation of activities requiring different hygiene levels in practice, in time or through structural or operational arrangements.
The prevention of cross-contamination in practice between activities requiring different hygiene levels.
For example, the separation of meat specified to be heated.
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
A description in the own-check plan of how activities requiring different hygiene levels are separated in time or through operational arrangements, and compliance with the operational practices described in own-check.

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

Activities requiring different hygiene levels are separated in time or through structural or operational arrangements.

Cross-contamination between activities is prevented.

Own-check activities are adequate and suitable as regards separation.

For example:

Activities, areas, etc. requiring different hygiene levels are mostly separated in time or through structural or operational arrangements.

The possibility of cross-contamination between activities is mostly prevented.

There are some minor shortcomings in the separation of activities requiring different hygiene levels; for example, the transfer routes of products of different hygiene levels (raw materials/finished products/unpackaged/ packaged), but the shortcoming does not impair food safety.

Activities related to handling of cooked and uncooked foods in the same facilities or using the same equipment are separated from each other.

For example:

Activities requiring different hygiene levels are not adequately separated in time or through structural or operational arrangements, and the shortcoming impairs food safety.

Activities requiring different hygiene levels are carried out using the same utensils, but the cleaning of equipment and utensils between the activities is inadequate, and the shortcoming impairs food safety.

Cooked and uncooked foods are handled in the same facilities at the same time, which exposes cooked products to a contamination risk.

For example:

Activities requiring different hygiene levels are not separated in time or through structural or operational arrangements, and cross-contamination between activities is not prevented, and the shortcoming jeopardises safety.

Cooked foods are handled using the same equipment previously used to handle uncooked foods (separated in time) and the equipment has not been cleaned between these activities, which causes a direct risk of contamination to the foods.

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
Regulation (EC) No 853/2004 on hygiene rules for food of animal origin
Finnish Food Act 291/2021
Decree of the Ministry of Agriculture and Forestry on food hygiene 318/2021.

Updates in version 2:

Guide no. 2132/04.02.00.01/2021 replaces guideline no. 10280
List of legislation has been updated.

5.3 Hygiene of Water Supply Points and Equipment Using Water

Guide/version: 2133/04.02.00.01/2021/5, valid from 2.1.2024

To be taken into consideration:

This Guideline is applied to all establishments.
The purpose of this point is to evaluate water supply points and equipment using water in terms of their cleanliness and hygienic suitability in connection with various activities. The maintenance of water supply points and water equipment is evaluated specifically in point 2.3 "Maintenance of Fixtures, Equipment, Water Equipment and Utensils".
Water supply points and equipment using water refer to, for example, water taps, tap filters, water hoses, water basins and tanks, cleaning and disinfection equipment using water or steam, or e.g. a recycled water system. Disinfection equipment refers to, for example, equipment designed for the disinfection of working utensils used for hide removal, splitting of carcasses or cutting of meat.
The production of ice as well as chilling carried out using water and ice are evaluated in point 5.4 "Hygiene in Thawing, Chilling and Freezing".
Temperature monitoring of hot water used for disinfection is evaluated in point 8.11 “Temperature Management of Water used in Disinfection of Working Utensils”.

Matters to be controlled:

Cleanliness of water supply points
Cleanliness of equipment using water
Items provided at hand washing points
Hygienic suitability of water supply points and equipment using water, for example
- functionality and cleaning effectiveness of touch free hand washing points
- the manner in which the disinfection equipment is used and the length of the cleaning time to ensure that working utensils are clean
Volume and exchange of hot (minimum +82°C) water used for disinfection are adequate
Cleanliness, hygienic suitability and hygienic effectiveness of disinfection equipment using hot (minimum +82°C) water
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:

Water supply points are clean.

Items provided at hand washing points and the functionality of the points are adequate.

Water taps, hoses and other equipment using water are hygienic.

Disinfection equipment is clean and hygienic, and the desired disinfection result is achieved with it.

Corrective actions have been adequate and appropriate. Deviations and corrective actions have been recorded.

For example:

There are some minor shortcomings in the cleanliness of water supply points.

There are some minor shortcomings in the items provided at hand washing points. However, food safety is not impaired.

There are some minor shortcomings in the hygiene of water taps and hoses, but food safety is not impaired.

There are some minor shortcomings in the records of deviations and corrective actions. Corrective actions have been adequate and appropriate.

For example:

There are shortcomings in the cleanliness of water supply points which impair food safety.

There are several shortcomings in the items provided at hand washing points, or there are shortcomings in the hygiene of water taps and hoses which impair food safety.

There are shortcomings in the cleanliness of disinfection equipment or in the use of hot water which impair food safety.

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.

For example:

There are serious shortcomings in the cleanliness of water supply points which jeopardise food safety.

At several hand washing points, the items provided are completely inadequate.

There are serious shortcomings in the hygiene of water taps and hoses.

There are serious shortcomings in the cleanliness of disinfection equipment or in the use of hot water which jeopardise food safety.

Corrective actions are not taken when deviations are detected and the shortcomings jeopardise the safety of foods.

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
Regulation (EC) No 853/2004 on Hygiene Rules for Food of Animal Origin
Regulation (EC) No 854/2004 on Official Controls on Products 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 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 10591 is replaced by guideline 8014/04.02.00.01/2021.

5.4 Hygiene in Thawing, Chilling and freezing

Guide/version: 2134/04.02.00.01/2021/4, valid from 2.1.2023

To be taken into consideration:

The purpose of this point is to evaluate hygiene in thawing, chilling, quick-freezing, freezing and ice production, as well as storage of ice.
Hygiene in thawing refers to e.g. the hygiene of the water used or produced in the thawing process.
Chilling refers to chilling by means of air, water, or ice. Hygiene in air chilling refers to e.g. the management of condensation water in chillers. Hygiene in water chilling refers to e.g. the hygiene of the water chilling systems and the chilling water used for the chilling of poultry meat and fishery products.
As concerns ice, the Guideline pertains to the hygiene of the ice water systems and ice.
Quick-freezing refers to a freezing method in which maximum crystal formation progresses as quickly as possible depending on the type of food. Freezing refers to both quick-freezing and other freezing methods that are slower than quick-freezing.
Hygiene in quick-freezing and freezing is evaluated both as concerns foodstuffs quick-frozen/frozen for own production and foodstuffs intended for marketing as quick-frozen/frozen products.
The compliance of water intended for human consumption with requirements is evaluated at approved establishments in point 1.4 and at registered food premises in point 2.1
The compliance of clean water with requirements is evaluated at approved establishments in point 1.5 and at registered food premises in point 5.1.
Freezing of products and temperature management in storages of frozen products is evaluated in point 6.6.
Temperature management in thawing and chilling is controlled in point 6.5.
The freezing treatment carried out due to the parasite risk in fish is evaluated in point 8.8.
Own-check testing of water and ice is evaluated at approved establishments in point 17.3 and at registered food premises in point 17.1.

Matters to be controlled:

Hygiene in the thawing, chilling, quick-freezing and freezing of foodstuffs.
The cleanliness and hygienic suitability of the equipment and instruments used in thawing, cooling and freezing.
Method of use of water used for thawing.
Hygienic draining of water produced in thawing.
Visible presence of condensation water and, if needed, the control of condensation water in chilling.
The hygiene of production, storage and use of ice used as a foodstuff or of ice used in food production.
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.

Thawing based on the use of water is implemented in a hygienic manner and the water produced in thawing is drained in a hygienic manner.

Chilling is implemented in a hygienic manner. No condensation water is produced in air chilling, or the production and draining of a small volume of condensation water is under control so that condensation water cannot run onto products or along floors, and the contamination of foodstuffs is prevented.

The production and storage of ice for use in the production of foodstuffs or ice used as a foodstuff is organised in a hygienic and appropriate manner. The use of ice water is hygienic and appropriate.

For example:

There are some minor shortcomings in thawing hygiene. For example, the draining of water produced in thawing is not carried out in a controlled way, but food safety is not impaired.

There are some minor shortcomings in the water or ice chilling, but food safety is not impaired.

Some condensation water is produced in air chilling, but the production and draining of condensation water is under control so that condensation water cannot run onto products, and the contamination of foodstuffs is prevented.

The production and storage of ice is, as a rule, organised in a hygienic and appropriate manner, but there may be some minor shortcomings in the use of ice water which do not impair food safety. For example, the predetermined cleaning frequency of the ice machine has not always been observed, but upon visual inspection the machine seems clean.

For example:

There are shortcomings in thawing based on the use of water which result in impaired food safety. For example, the method used for draining water produced in thawing can pose a risk of contamination.

There are shortcomings in water chilling which result in impaired food safety. For example, there are shortcomings in hygiene of the water chilling equipment for poultry.

Condensation water is produced in air chilling and the production and draining of the condensation water are not adequately under control. There is a possibility of condensation water running onto unpackaged foodstuffs causing a contamination risk to the foodstuffs and impairing food safety.

There are shortcomings in the production, storage or use of ice or ice water, and food safety is impaired. For example, the ice machine is dirty or equipment in contact with ice is stored unhygienically.

For example:

There are shortcomings in thawing which result in food safety being jeopardised. For example, water produced in thawing of raw meat contaminates ready-to-eat foods.

There are shortcomings in water chilling which result in food safety being jeopardised. For example, the cleaning of the water chilling equipment for poultry has been neglected.

Condensation water is produced in air chilling and the production and draining of the condensation water are not adequately under control, or condensation water is drained in a manner that does not prevent the contamination of foodstuffs. For example, condensation water accumulates onto a dirty surface structure and from there runs onto unpackaged foodstuffs, and contaminates them.

There are shortcomings in the production, storage or use of ice or ice water and food safety 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
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 8014/04.02.00.01/2021/2: Control of water and ice in food premises.

Updates in version 4:

The guideline is applied to both registered and approved food premises. In registered food premises, the hygiene of thawing, chilling and freezing was previously controlled in point 5.1.
Guideline name changed (formerly HEH 5.1 Hygiene in thawing, chilling and quick-freezing)
The correct evaluation points for following matters to be controlled were added under “To be taken into consideration”: compliance of water intended for human consumption and clean water and own-check studies of water and ice in registered food premises.
Evaluation examples were added.

5.5 Hygiene in Wrapping and Packing

Guide/version: 2230/04.02.00.01/2021/5, valid from 2.1.2023

To be taken into consideration:

This guideline is applied to all food premises where foodstuffs are wrapped and/or packed.
The guideline concerns the cleanliness and intactness of all materials in which foodstuffs are wrapped or packaged and where food is stored or transported.
Packaging material refers to any material in which foodstuffs are wrapped or packaged.
Wrapping refers placing the foodstuff in a wrapper or cover that is in direct contact with the foodstuff in question and the wrapper itself refers the wrapper or cover, e.g. a milk carton.
Packing refers to the packing of one of several wrapped foodstuffs in another container, and outer packaging refers the container itself.
Transport container refers to the container in which unpackaged foodstuffs are placed for transport, such as a GN container.
Reusable transport packaging refers to returnable containers in which wrapped foodstuffs are carried from one food establishment to another and which are shared by several food establishments; containers for e.g. bread and meat.
The order and cleanliness of storage facility for packaging materials is evaluated in Guideline 3.1
The hand hygiene of wrapping and packaging is evaluated in a registered food premises in guideline 4.2 and in an approved food establishments in guideline 4.1
The suitability of packaging material for food use is evaluated in Guideline 14.1.

Matters to be controlled:

Cleanliness and intactness of wrapping, packages and transport containers. For example, cans and glass jars must be intact and clean, and the seams and lids must be tight.
Cleanliness and cleaning methods of reusable transport packaging used to store and transport own products.
Wrapping and packing hygiene and ensuring compliance. The products should not be contaminated during wrapping and packaging. Note, e.g. the suitability and hygiene of the wrapping and packing place, the hygiene of the packaging equipment and dusty packing materials during packing. Other activities in the immediate area must not interfere with wrapping/packing or endanger the hygiene of the operation.
Reusable (food use) wrappers and packaging should be easy to clean and disinfect if necessary.
Handling and storage of wrapping and packaging materials. The materials must be stored in the place reserved for them and in suitable conditions.
Import of packaging materials into processing facilities, for example only the amount needed for packaging during the day or production batch at a time.
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.

Wrapping, packages and transport containers are clean and intact and handled and stored in such a way as not to become contaminated.

Reusable transport packaging and their cleaning methods are adequate.

Wrapping and packaging of foodstuffs is carried out hygienically in a space suitable for the operation.

For example:

Small flaws in the cleanliness intactness of the wrapping and packaging materials. For example, the packaging materials are mildly dusty.

Small flaws in the cleaning methods of reusable transport packaging, which, however, do not impair food safety.

Small flaws in the packaging areas of other than easily perishable foodstuffs.

For example:

Flaws in the cleanliness or intactness of the wrapping and packaging materials that impair food safety. Some of the packaging materials are broken and partially dirty.

Unwrapped foodstuffs are packed in reusable packaging that are not easy to clean.

Wrapping and packaging of foodstuffs is carried out in premises that are not intended for wrapping or packaging of foodstuffs.

For example:

Wrapping, packages and transport containers are handled and stored unhygienically.

Cleanliness or intactness of the wrapping and packaging materials have not been taken care of. Wraps and packaging materials clearly broken and dirty.

Wrapping and packaging is carried out in premises that are not suitable for wrapping and packing food. Conditions are unhygienic.

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

Regulation (EC) No 852/2004 on the hygiene of foodstuffs.
Finnish Food Act 297/2021.

Updates in version 5:

Guideline no. 2230/04.02.00.01/2021/5 replaces guideline no. 2135/04.02.00.01/2021
Combined Oiva assessment guideline 5.5. for registered food premises and approved food establishments
In the future, the guideline will be applied to both registered food premises and approved food establishments.

5.6 Hygiene in Storage and Warehousing of Foodstuffs

Guide/version: 2136/04.02.00.01/2021/3, valid from 2.1.2023

To be taken into consideration:

This guideline is applied to all food premises.
The purpose of the guideline is to evaluate hygiene in storage and warehousing of foodstuffs as concerns raw materials and foodstuffs to be delivered to the market or used by the operator itself.
This guideline is applied to both packaged foods and unpackaged foods.
Hygiene during sale and serving of foodstuffs is evaluated in registered food premises in point 7.1
Hygiene in transport of foodstuffs is evaluated in point 15.3.
Temperature management of chilled foodstuffs is evaluated in point 6.2.
Temperature management of foods that are to be stored hot is evaluated in registered food premises in point 6.3.
The cleanliness and order of surfaces and facilities is evaluated in points 3.1 and 3.2.
Handling and storage of packaging materials is evaluated in point 5.5.
The suitability of packaging materials and other contact materials for food contact is evaluated in point 14.1.
The separation of substances causing allergies or intolerances is evaluated in point 10.1.

Matters to be controlled:

Warehousing and storage conditions for foodstuffs
Separation of materials, articles and products other than foodstuffs from foodstuffs
Stock rotation of foodstuffs
The suitability of foodstuffs kept and stored in food premises
- Concerns, for example, foodstuffs used in production and serving, and stored in opened wrappings, packages or open containers for this purpose
Shelf-life management, for example:
- Removing foodstuffs that have passed their final date of use from food storage facilities
- Marking and shelf-life management of food, semi-finished products and intermediate products manufactured in food premises
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.

Foods and raw materials are stored in facilities reserved for them under suitable conditions in compliance with legislation.

The warehousing and storage of articles and products other than foodstuffs does not result in impaired food safety with respect to foodstuffs.

Products are in order in storage and stock rotation is effective, i.e., older products are taken from storage before newer products.

Shelf-lifes are appropriately managed, i.e. expired raw materials or products are removed from storages.

Condensation water is not produced onto raw materials and finished foodstuffs.

For example:

There are some shortcomings in stock rotation or order of storages which do not impair food safety.

Small quantities of items not belonging in food storage facilities are stored there but food safety is not impaired.

The shelf-lifes of opened packaging and/or intermediate products are mainly appropriately managed by the food premises. There may be occasional minor shortcomings for example in marking the date of opening of a package or other management method of the shelf-life.

For example:

Foodstuffs are stored and warehoused in facilities or under conditions that impair food safety. For example, a large amount of condensation water or ice is formed on the surface of food packages.

There are expired foodstuffs in the storage.

Materials, articles or products which can impair food safety are stored in food storage facilities. For example, detergents are stored in immediate proximity to foodstuffs, so that there is a risk of food contamination.

Dirty storage pallets are used in storage facilities.

Packages of foodstuffs are stored directly on the floor.

Foodstuffs that should be stored wrapped or packed are stored unprotected.

The shelf-lifes of foodstuffs stored in opened packages for manufacturing or serving are not under control.

For example:

Foodstuffs are stored and warehoused in facilities or under conditions that jeopardise food safety.

Former foodstuffs not fit for human consumption are stored in the food storage facilities.

The warehousing and storage of products other than foodstuffs jeopardises food safety. E.g. dangerous substances, TSE risk material or dirty materials are stored in immediate proximity to foodstuffs.

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

Regulation (EC) No 178/2002 on food law
Regulation (EC) No 852/2004 on the hygiene of foodstuffs
Regulation (EC) No 853/2004 on hygiene rules for food of animal origin
Finnish Food Act 297/2021
Decree of the Ministry of Agriculture and Forestry on food hygiene 318/2021.

Updates in version 3:

The matters included in the former guideline REH 6.1 (Storage of foodstuffs) were incorporated into this guideline.
The guideline will be applied to both registered and approved food premises.
The correct evaluation points were added under “To be taken into consideration” for the following issues: food hygiene and management of shelf-life and sale period of products sold or used for serving; hygiene of transport conditions; temperature management of foods stored hot; storage of packaging materials; compliance of packaging and food contact materials; and separation of allergens.
Removed from the evaluation examples “Packaging materials are stored under cover”. The subject is evaluated in point 5.5
Evaluation examples were added and modified.

5.7 Hygiene in Handling and Storage of By-products

Guide/version: 2137/04.02.00.01/2021/6, valid from 2.1.2024

To be taken into consideration:

This Guideline is applied to all approved establishments.
The production of by-products as part of normal production processes at the establishment is included within the scope of the approval of the establishment as referred to in the Food Act, and within the scope of food control. Other by-product operations are covered by legislation and control pertaining to the by-product or feed sector.
This Guideline is applied to the collection, handling, classification, sorting, storage, and identification of animal by-products at food establishments.
The purpose of this point is to evaluate hygiene in the handling and storage of by-products in as far that it may cause a risk to food safety. This means that the separation of different categories of by-products from each other or the storage of by-products outside food production facilities are not evaluated, for example.
Operations carried out at the establishment that are included within the scope of the by-product legislation and control, such as the separation of different categories of by-products from each other, as well as operations carried out in the by-product department are as a whole evaluated in point 5.8. The results of the evaluations based on Guideline 5.8 are not presented in the Oiva report, but only in the inspection report.
Handling of TSE risk material is evaluated in point 8.1.
Dispatching of by-products, commercial documents, and transport conditions and temperatures are evaluated in point 15.5.

Matters to be controlled:

The collection, handling, classification, sorting, storage, warehousing, and identification of animal by-products in food production facilities.
The separation of by-products from foodstuffs and the prevention of cross-contamination of foodstuffs.
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:

The establishment has a hygienic system in place for removal of by-products. By-products not fit for use as food are removed as quickly as possible, particularly from food production facilities where unpackaged foodstuffs are handled.

By-products are identifiable (marked at the establishment in an identifiable manner) and kept separate from foodstuffs during collection and storage.

Containers and utensils intended for the collection, handling, and storage of by-products are not used for the collection, handling, and storage of foodstuffs.

The handling and storage of animal by-products is in food businesses carried out under conditions that prevent cross-contamination, and if appropriate, in a dedicated part of the establishment.

Facilities intended for storage of by-products are adequate, hygienic, and adequately separated from the storage of foodstuffs.

Own-check activities are adequate and suitable.

For example:

There are occasionally some minor shortcomings in the identification of storage containers; however, there is no risk of confusion with foodstuffs at any stage.

There are some minor shortcomings in the records of corrective actions, but corrective actions have been appropriate and adequate.

For example:

By-product containers are damaged or they leak, or they are over-filled or not kept adequately clean, resulting in impaired hygiene and food safety at the establishment.

Identification of by-products is deficient or missing from some containers in a manner that results in impaired food safety.

Cross-contamination is not prevented in an adequate manner, and the handling and storage of by-products impairs food safety.

Corrective actions have not been recorded although it becomes known that deviations have occurred, or corrective actions taken because of deviations have been inappropriate or inadequate.

Category 3 by-product containers are used for the storage of foodstuffs, or vice versa, and food safety is impaired.

For example:

Containers and utensils intended for the collection, handling, and storage of category 1 or 2 by-products are used for the collection, handling, and storage of foodstuffs, or vice versa, and food safety is impaired.

Cross-contamination is not prevented, and the handling and storage of by-products jeopardises food safety; for example, category 1 or 2 by-products and unpackaged foodstuffs are stored in the same premises.

Corrective actions have not been recorded even when records are required, or corrective actions have not been taken, or they have been inadequate, and 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 2017/625 on official controls
Regulation (EC) No 178/2002 on food law
Regulation (EC) No 852/2004 on the hygiene of foodstuffs, Annex II
Regulation (EC) No 853/2004 laying down specific hygiene rules for food of animal origin, Annex III, Section I, Chapter IV, and Section II, Chapter IV
Finnish Food Act 297/2021, Section 6
Decree of the Ministry of Agriculture and Forestry on food control 315/2021
Decree of the Ministry of Agriculture and Forestry on food hygiene 318/2021, Section 36 and 38
Regulation (EC) No 1069/2009 on by-products, Articles 4, 7-10, 21, 25-26 and 29
Finnish Food Authority's Guide “Handling and control of animal by-products at food establishments”.

Updates in version 6:

List of guidelines has been updated.

5.8 Production and Traceability of By-products

Guide/version: 2138/04.02.00.01/2021/4, valid from 2.1.2024

This evaluation is not presented in the Oiva report, but only in the inspection report.

To be taken into consideration:

This Guideline is applied to all approved food establishments.
The production of by-products as part of normal production processes at the establishment is included within the scope of the approval of the establishment as referred to in the Food Act, and within the scope of food control. Other by-product operations are covered by legislation and control pertaining to the by-product and/or feed sector.
This Guideline is applied to the collection, handling, classification, sorting, storage, identification, and transport of animal by-products to the extent that operations are covered by legislation pertaining to by-product and/or feed sector and the operations do not cause a risk to food safety.
The purpose of this point is to evaluate the separation of different by-product categories from each other, and the operations carried out in the by-product department or in establishments of the type referred to in the Regulation on by-products that are operated in conjunction with the food establishment. In addition, operations related to transports and covered by legislation pertaining to by-product and/or feed sector are evaluated. The results of these evaluations are not presented in the Oiva report, but only in the inspection report.
An establishment that handles or delivers for feed use by-products produced in their own food production shall be registered as a feed business operator. If the establishment receives by-products from other food establishments for delivery as raw material for feed for fur animals, the establishment shall be registered as a collection centre. If the establishment manufactures pet food in primary packaging, the approval of a pet food establishment is required.
An establishment that dispatches by-products is always responsible for delivering by-products for transport to an appropriately registered or approved carrier. The dispatching establishment is also responsible for the dispatch of by-products to a permitted destination, even if transport is outsourced. Also the drafting of a commercial document and making sure it includes all information required by the legislation, is the responsibility of the sender.
Regardless of whether the establishment arranges the transport of by-products itself or outsources transport, the dispatching establishment shall always have records of the dispatched by-products.
Where the by-product operations of the establishment can cause a risk to food safety at the establishment, the operations are evaluated in point 5.7 "Hygiene in Handling and Storage of By-products".
Where the by-product operations of the establishment can cause a risk to food safety during transport, the operations are evaluated in point 15.5 "Dispatch of By-products, Commercial Documents and Transport Conditions".

Matters to be controlled:

Separation of different categories of by-products at all stages of operation.
Collection, handling, classification, sorting, storage, warehousing and identification of animal by-products in the by-product department.
The usability as feed of by-products delivered for feed use, and verification of this.
Identification markings of by-product categories in transport.
Commercial documents in transport of by-products (transport documents), including the traceability of by-products.
Monitoring of dispatched quantities of by-products.
By-products are dispatched to a destination where they are permitted to be dispatched according to legislation.
If the handling of by-products has been outsourced, by-products are delivered to an appropriately registered or approved carrier for transport.

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:

By-products of different categories are separated from each other during collection and storage. If different by-product categories are combined, the whole batch is handled as the lower category by-product.

Dispatched by-products (packaging, container or vehicle) are provided with identification marking as specified in the Regulation on by-products (by-product category and marking text) and there is no risk of confusion between categories.

Dispatched by-products are accompanied by a commercial document filled out in compliance with the requirements laid down in the Regulation on by-products to verify traceability and identifiability.

The establishment maintains records of dispatches and quantities of different categories of by-products and stores the associated commercial documents and health certificates for at least two years.

By-products are only dispatched from the establishment to a destination permitted by legislation, such as an operator registered or approved pursuant to the Regulation on by-products (for example to a processing plant or a fur animal feed manufacturer).

The establishment is registered as a feed business operator, if it delivers by-products for feed use. The operation is covered by the own-check system.

Any establishments of the type referred to in the Regulation on by-products that are operated in conjunction with the food establishment are approved/ registered and included in Finnish Food Authority's lists of by-product establishments. An own-check system is in place for them.

If by-products to be used as feed are not delivered immediately after collection, they are chilled / frozen / acidified without undue delay. The microbiological quality and usability as feed of by-products to be delivered for feed use are monitored.

The labelling of acidified feed intended for fur animals and finished pet food (not raw material for feed) complies with requirements.

The carrier who transports by-products is an appropriately registered or approved operator.

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

For example:

The sorting of by-products and the mixing of different categories of by-products is in practice carried out appropriately and the identification markings are correct, but the operator does not have defined the categories of the mixed ingredients based on the risk category referred to in the Regulation of by-products.

There are occasionally some minor shortcomings or inaccuracies in identification markings or commercial documents. However, by-products are traceable and identifiable, and there is no risk of confusion between different categories of by-products.

By-products are delivered for feed use accompanied by appropriate documents and in a manner that ensures their usability as feed is not reduced, but feeds are not covered by the own-check plan.

There are some minor shortcomings in the own-check system of an establishment of the type referred to in the Regulation on by-products which is operated in conjunction with the food establishment, or the own-check system is not up-to-date in all respects.

The labelling of acidified feed for fur animals and finished pet food does not comply with requirements in all respects.

The operator does not have in place a system for verifying that by-products delivered for feed use are usable as feed.

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 clear issues with operations.

For example:

There are shortcomings of such a nature in commercial documents and identification markings that by-products are not completely traceable and there is a possibility of risk of confusion between different categories of by-products.

No records are kept of dispatched quantities of by-products.

The establishment is not registered as a feed business operator, although it delivers by-products for feed use.

There are clear shortcomings in the own-check system of an establishment of the type referred to in the Regulation on by-products which is operated in conjunction with the food establishment.

There are clear shortcomings in the microbiological quality of by-products delivered for feed use.

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 severe issues with operations, or the operator has failed to rectify the issues within the set period of time.

For example:

The operator has failed to fulfil the orders issued with the grade to be corrected.

The commercial documents or transport containers/packages do not present any of the information referred to in the Regulation on by-products, and by-products are not traceable because of this.

The destination of dispatched by-products is not allowed in the Regulation on by-products.

The carrier who transports by-products is not an appropriately registered or approved operator.

An establishment of the type referred to in the Regulation on by-products is operated in conjunction with the food establishment, such as a collection centre or an establishment manufacturing pet food, but it has not been registered / approved as specified in the Regulation on by-products.

An establishment of the type referred to in the Regulation on by-products does not have an own-check system in place.

No labelling is provided on acidified feed for fur animals / finished pet food.

Spoiled by-products or by-products that based on their category are not usable as feed are delivered for feed use.

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

Regulation (EC) No 1069/2009 on by-products, Articles 4, 7-10, 21-23
Regulation (EU) No 142/2011 implementing the Regulation on by-products; Article 17, Annex VIII
Animal By-Product Act 517/2015
Decree of the Ministry of Agriculture and Forestry 783/2015, Section 5, Annex 3
Finnish Feed Act 1263/2020, Sections 6, 7, 14, 19, 21, 22
Finnish Food Authority's Guide “Handling and control of animal by-products at food establishments”
Finnish Food Authority's Guide ”Delivering animal by-products for feed use from meat and fish establishments” (in Finnish).

Updates in version 4:

List of legislation and guidelines has been updated.