12 Special Requirements for Specific Food Products

All Oiva evaluation guidelines for registered food premises.

12.1 Food Supplements

Guide/version: 2169/04.02.00.01/2021/6, valid from 1.7.2021

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

  • manufactures or has manufactured for it
  • imports or brokers (from the internal market or third countries) food supplements within the meaning of Food Supplement Regulation 78/2010.

It is recommended that the following points be controlled at the same time

  • 11.2. Nutritional Fortification (substances whose use is prohibited under Part A or restricted under Part B of Annex III of the Fortified Food Regulation (EC) Nr. 1925/2006), and
  • 11.4. Novel Foods and New Processes
    to verify the compliance also of other characteristic substances, and
  • 13.1. Mandatory food information and
  • 13.3. Marketing,
    to verify the compliance of also other labelling with requirements.

This point is only controlled in retail stores (incl. distance selling) and catering establishments if the retail store or catering establishment itself manufactures, has manufactured for it or imports (from the internal market and/or third countries) food supplements.

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".

Matters to be controlled:
The implementation of own-check activities is evaluated (by random checks on e.g. 1-3 products, taking the scope and nature of operations into consideration) by checking the compliance with the requirements as regards food supplements:

  • the food supplement meets the criteria set out in the definition of a food supplement,
  • the food supplement is not a medicinal product and does not contain hormones or doping substances,
  • the composition of the food supplement with respect to characteristic substances and their amounts is consistent with the labelling information,
  • the food supplement only contains authorised vitamins and minerals and their compounds,
  • the compounds of vitamins and/or minerals used in the product meet the purity criteria set out for them (applies to operators who manufacture food supplements or have them manufactured),
  • the amount of vitamin and/or mineral that is the characteristic substance of the food supplement is significant (at least 15% of the daily reference intake in the recommended daily dose) in the final product,
  • the characteristic substance or the amount of the substance does not present a hazard to health,
  • the amounts of characteristic substances are appropriately indicated,
  • the labelling of the food supplements provides the mandatory information referred to in the Decree on Food Supplements,
  • a notification has been submitted to Finnish Food Authority on the food supplement.

Compliance with requirements can be verified by means of, for example:

  • inspections of labelling, recipes and documents,
  • where necessary, analysis certificates and/or own-check tests.

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

The operator has verified that food supplements meet the aforementioned criteria.

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

The operator has verified in main parts that food supplements meet the aforementioned criteria. There are some minor shortcomings, such as:

  • there are some minor shortcomings in labelling or documents, but notwithstanding these, the compliance of the product with requirements can be verified (e.g. the names of the categories of nutrients or substances that characterise the product are not provided or there is no mention of the nature of those nutrients or substances),
  • notifications have only been submitted to Finnish Food Authority on part of food supplements to be placed on the market.

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.

There are shortcomings in the operator's own-check activities resulting in the non-compliance of food supplements with the aforementioned requirements. Essential shortcomings include:

  • the food supplement does not meet the criteria set out in the definition of a food supplement (for example, a conventional foodstuff or medicine is placed on the market as a food supplement),
  • it is not possible to verify the category of the product (food supplement/medicine) because of deficient or completely missing documentation,
  • the vitamin or mineral which is the characteristic substance in the food supplement is not present in a significant amount in the final product,
  • some of the mandatory labelling referred to in the Decree on Food Supplements is missing completely (for example, the amount of characteristic substances is not indicated in labelling),
  • notifications have not been submitted to Finnish Food Authority on food supplements to be placed on the market.

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

The operator has failed to verify that food supplements meet the aforementioned requirements. Shortcomings requiring immediate rectification or recall include:

  • the characteristic substances (vitamins, minerals or their compounds, or other substances) contained in the food supplement are not permitted (for example, the food supplement contains hormones, doping substances or harmful substances),
  • the amount of the added vitamin, mineral or some other characteristic substance is so large in the daily dose of the food supplement that it causes a health hazard to the consumer (for example, UL values are exceeded with respect to some vitamins and minerals, to be evaluated specifically in each case).

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

  • Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers, Annex XIII (daily reference intakes)
  • Criminal Code of Finland 1889/39, Chapter 44, Sections 6 and 16 (doping offence and definition of a doping substance)
  • Finnish Food Act 297/2021, Section 6 (notification obligation)
  • Finnish Narcotics Act 373/2008
  • Government Decree on psychoactive substances prohibited on the consumer market 1130/2014
  • Government Decree 705/2002 on doping substances as referred to in Chapter 44, Section 16 (1) of the Criminal Code
  • Decree 78/2010 of the Ministry of Agriculture and Forestry on food supplements
  • Directive 2002/46/EC of the European Parliament and of the Council on the approximation of the laws of the Member States relating to food supplements (latest consolidated version) (permitted sources of nutrients)
  • Decision 415/2019 of the Finnish Medicines Agency on medicinal products list
  • Evira's Guide 17012/5: Food Supplement Guide
  • Commission Guidance (December 2012): Guidance document for competent authorities with regard to setting of tolerances for nutrient values declared on a label, and on the control of compliance with them http://ec.europa.eu/food/food/labellingnutrition/nutritionlabel/guidance_tolerances_december_2012_fi.pdf.


Updates in version 6

  • New recommendations on rows to control at the same time have been added.
  • The Food Act has been updated.
  • Guideline no 2169/04.02.00.01/2021 is replaced by guideline no 10237.

12.2 Foods for Specific Groups

Guide/version: 2170/04.02.00.01/2021/5, valid from 1.7.2021

To be taken into consideration:
This point is evaluated when the operator manufactures, has manufactured for it, imports (from the internal market or third countries) and/or packs or brokers (agency business) foods for specific groups within the meaning of Regulation (EU) No 609/2013:

  1. Infant formulae and follow-on formulae
  2. Baby foods
  3. Foods for special medical purposes
  4. Total diet replacements for weight control.

Compliance with requirements can be verified by means of

  • inspections of labelling, recipes and documents, for example
  • where necessary, analysis certificates and/or own-check tests.

It is recommended that the following points be controlled at the same time

  • 13.1. Mandatory food information (packaged and unpackaged foodstuffs) and
  • 13.3. Marketing (excl. infant formulae and food for special medical purposes which are controlled in this Guideline also with respect to marketing), to verify the compliance of also other labelling with requirements.

This point is only controlled in retail stores and catering establishments if the retail store or catering establishment itself manufactures, has manufactured for it, imports (from the internal market and/or third countries) and/or packs or brokers foods for specific groups.

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".

Matters to be controlled:
The implementation of own-check activities is evaluated by random checks (on e.g. 1-3 products, taking the scope and nature of operations into consideration) of the following matters separately in each group:

1. Infant formulae and follow on formulae:

  • The criteria specified for the composition and purity of infant formulae and follow-on formulae are met:
    • the formula is ready for use as such or nothing more is required than the addition of water
    • the formula does not contain any substance in such a quantity as to endanger the health of infants and young children
    • the criteria specified for the composition of the formulae are met (energy, protein, fatty acids, carbohydrates, vitamins, minerals and other substances)
    • approved sources of protein are used in the manufacture of the formula
    • the vitamins, minerals and certain other nutrients and their chemical compounds used in the manufacture of the formula are approved
    • the chemical compounds of the vitamins, minerals and certain other nutrients used in the manufacture of the formula meet the purity criteria specified for them (concerns manufacturing and having manufactured)
    • Guidelines 17.12-17.16 are to be controlled at the same time to verify that the infant formula or follow-on formula does not contain any contaminants or residues of plant protection products in amounts exceeding the maximum approved amounts
  • Labelling requirements are met, not only with respect to general labelling but also as concerns labelling requirements specified for infant formulae and follow-on formulae (the requirements apply in part also to presentation and advertising):
    • the formula is sold as a prepacked product under the name infant formula or follow-on formula (preceded by "milk-based", as necessary)
    • labelling contains the age recommendation for infant formula and follow-on formula as well as any other mandatory statements
    • nutrition labelling meets requirements and is consistent with the composition of the formula
    • labelling does not include text or information prohibited on infant formula and follow-on formula
    • only specifically authorised nutrition and health claims are used in the labelling of infant formula
  • Infant formula may not be marketed to consumers and no promotional devices targeted at consumers may be used; instead, any advertising is to be restricted to publications specialising in baby care intended for health care professionals, as well as scientific publications. Advertising material may only contain information of a scientific and factual nature.
  • A notification has been submitted to Finnish Food Authority about placing on the market of an infant formula.

2. Baby foods

  • The criteria specified for the composition and purity of cereal-based and other baby foods are met:
    • the baby food does not contain any substance in such a quantity as to endanger the health of children
    • the criteria specified for the composition of cereal-based baby foods in each group are met
    • the criteria specified for the composition of other baby foods are met
    • the vitamins, minerals and certain other nutrients and their chemical compounds used in the manufacture of the baby food are approved
    • the chemical compounds of the vitamins, minerals and certain other nutrients used in the manufacture of the baby food meet the purity criteria specified for them (concerns manufacturing and having manufactured)
    • Guidelines 17.12-17.16 are to be controlled at the same time to verify that the baby food does not contain any contaminants or residues of plant protection products in amounts exceeding the maximum approved amounts
  • Labelling requirements are met, not only with respect to general labelling but also as concerns labelling requirements specified for baby food:
    • labelling contains the age recommendation for baby food as well as any other mandatory statements and any specific additional labelling, where appropriate
    • nutrition labelling meets requirements and is consistent with the composition of the formula.

3. Foods for special medical purposes

  • The product meets the definition of a food for special medical purposes
  • The criteria specified for the composition and purity of foods for special medical purposes are met
    • the composition and quality of the product ensure that it satisfies the special medical needs of the patient
    • nutritionally complete food for special medical purposes meets the specific composition criteria specified for it
    • the vitamins, minerals and certain other nutrients and their chemical compounds used in the manufacture of the product are approved
    • the chemical compounds of the vitamins, minerals and certain other nutrients used in the manufacture of the product meet the purity criteria specified for them (concerns manufacturing and having manufactured)
  • Labelling requirements are met, not only with respect to general labelling but also as concerns labelling requirements specified for foods for special medical purposes
    • the product is sold as prepacked food under the name " food for special medical purposes"
    • nutrition labelling meets requirements and is consistent with the composition of the formula
    • labelling contains the mandatory additional labelling specified for food for special medical purposes, and any specific additional labelling, where appropriate
    • labelling contains an indication of the illness, disorder or medical condition for the treatment of which the product is intended, expressed in the form "For the dietary management of . . ." Marketing is in all other respects to be controlled in accordance with Guideline 13.3 Marketing (nutrition and health claims)
    • nutrition or health claims are not used on the label or in the advertising
    • the packaging or advertising is not attributed to the property of preventing, treating or curing human diseases, nor does it describe or refer to such properties.
  • A notification has been submitted to Finnish Food Authority on a food for special medical purposes.

4. Total diet replacements for weight control

  • The product meets the definition of a total diet replacement for weight control
  • The criteria specified for the composition and purity of total diet replacements for weight control are met
    • the composition and quality of the product make it suitable for use as the sole source of nourishment for purposes of weight control
    • a low-calorie diet product (LCD) meets the specific criteria for composition specified for these products
    • the vitamins, minerals and certain other nutrients and their chemical compounds used in the manufacture of the product are approved
    • the chemical compounds of the vitamins, minerals and certain other nutrients used in the manufacture of the product meet the purity criteria specified for them (concerns manufacturing and having manufactured)
  • Labelling requirements are met, not only with respect to general labelling but also as concerns labelling requirements specified for total diet replacements for weight control
    • nutrition labelling meets requirements and is consistent with the composition of the product
    • a low-calorie diet product (LCD) is marketed as a prepacked product under the name total diet replacement for weight control
    • the labelling of a low-calorie diet product contains the mandatory additional labelling specified for total diet replacements.

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

The composition and labelling of foods for specific groups meet the aforementioned requirements.

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

The composition and labelling of foods for specific groups meet the aforementioned requirement in main parts. There are some minor shortcomings, such as:

  • there are some minor shortcomings in labelling or documents, but notwithstanding these, it is possible to verify the compliance of the product with requirements.
  • notifications have only been submitted to Finnish Food Authority on part of products to be placed on the market.

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

The composition and labelling of foods for specific groups uses do not meet the aforementioned requirements but there are essential shortcomings in them, such as:

  • nutrition labelling is deficient, unclear or difficult to read
  • the amount indicated in the recipe or labelling is not consistent with the amount used in production
  • it cannot be verified that the chemical compounds of the vitamins, minerals and certain other nutrients used in the manufacture of the product are approved and meet the purity criteria specified for them, because of shortcomings in documentation
  • notifications have not been submitted to Finnish Food Authority on products to be placed on the market.
  • the labelling of an infant formula does not bear a statement concerning the superiority of breast feeding, or some other mandatory statement
  • pictures, statements or nutrition and health claims that have not specifically been authorised are used in the labelling of an infant formula
  • nutrition or health claims are presented on the label or in the advertising of food for special medical purposes.
  • a baby food, food for special medical purposes or total diet replacement for weight control does not meet the composition criteria specified for it
  • the labelling of a food for special medical purposes does not state that the product must be used under supervision of a health care professional.

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.

There are issues requiring immediate rectification, and where necessary, recall in the composition and labelling of foods for specific groups, such as

  • the product contains some substance in an amount that causes a health hazard to the consumer (not enough/too much)
  • an infant formula, follow-on formula or food for special medical purposes intended for infants does not meet the composition criteria specified for it
  • a baby food, food for special medical purposes or total diet replacement for weight control deviates significantly from the composition criteria specified for it
  • the vitamins, minerals, certain other nutrients and their chemical compounds used in the manufacture of the product are not approved in the product group concerned or do not meet the purity criteria specified for them
  • nutrition labelling is missing completely
  • as regards infant formulae and follow-on formulae
    • the name is not right, or is missing completely
    • labelling does not provide instructions for preparation, use, storage and disposal, and a warning against the health hazards of inappropriate preparation and storage
  • the labelling of a food for special medical purposes does not contain
    • an indication of the disease, disorder or medical condition for the treatment of which the product is intended
    • where appropriate, an indication of whether the product is suitable for use as the sole source of nourishment
    • where appropriate, an indication that the product is intended for a specific age group
    • where appropriate, a statement that the product poses a health hazard when consumed by persons who do not have the diseases, disorders or medical conditions for which the product is intended.
    • where appropriate, a statement concerning adequate precautions and contra-indications
    • where appropriate, a warning that the product is not for parenteral use
    • where appropriate, instructions for the appropriate preparation, use and storage of the product after the opening of the container.
  • the labelling or advertising of food for special medical purposes is attributed to the property of preventing, treating or curing human diseases, or it describes or refers to such properties in the product.
  • the labelling of a total diet replacement for weight control does not provide the required instructions for preparation and use.

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

  • Regulation (EU) No 609/2013 of the European Parliament and of the Council on food intended for infants and young children, food for special medical purposes and total diet replacement for weight control
  • Commission Delegated Regulation (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
    • Shall apply from 22 February 2020, except in respect of infant formula and follow-on formula manufactured from protein hydrolysates, to which it shall apply from 22 February 2022.
  • Commission Delegated Regulation (EU) 2016/128 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for food for special medical purposes
  • Decree KTM 1216/2007 of the Ministry of Trade and Industry on infant formulae and follow-on formulae
    • Applies only to infant formula and follow-on formula manufactured from protein hydrolysates.
  • Decree of the Ministry of Social Affairs and Health on information material regarding the feeding of infants and young children 267/2010
  • Decision 1997/789 of the Ministry of Trade and Industry on baby foods
  • Decision 904/1997 of the Ministry of Trade and Industry on weight loss products.


Updates in version 6

  • Guideline no 10238/5 is replaced by guideline no 2170/04.02.00.01/2021/5.
  • Updated the date of applying of infant formula and follow-on formula manufactured from protein hydrolysates.

12.3 Foodstuffs with Protected Status

Guide/version: 2171/04.02.00.01/2021/5, valid from 1.7.2021

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

  • manufactures, has manufactured for it and/or packages
  • imports and/or brokers (from the internal market and/or third countries) or exports
  • sells by distance selling as packaged
  • sells in a store as unpackaged
  • sells/serves in a facility of a mass caterer as unpackaged

food products with a protected status according to EU's scheme for protection of names, or food products with an ingredient with a protected status indicated in the labelling.

There are three different types of name protection systems. Two of them, protected designation of origin (PDO) and protected geographical indication (PGI), delimitate the manufacture and/or production of the product to its traditional geographical area. The third protection scheme, traditional speciality guaranteed (TSG), on the other hand, protects the traditional manufacturing method and ingredients of the product.

As of 4 January 2016, the use of a symbol indicating that the name is registered has been mandatory with products introduced on the market. Verbal indications ("protected designation of origin", "protected geographical indication", "traditional speciality guaranteed") are still permitted, but not mandatory.

The operator shall submit a notification for prior inspection indicating the name and the manufacturing location of the protected product to the competent food control authority before the introduction of the product on the market. For products with a protected name that were already on the market at the beginning of the year 2015 this notification had had to be submitted by the end of 2015.

Food products that do not have a protected status may not be marketed using expressions referring to a food product with a protected status using expressions such as "style", "produced like", "manufactured like", etc. This needs to be taken into consideration if point 13.1, Mandatory food information (packaged and unpackaged foodstuffs).

Matters to be controlled:
The conditions on which the name of the food product is registered are met as concerns manufacture and packaging. Control is based on a comparison of the ingredients and processes used with the approved product specification of the food product concerned.

The EU symbol (logo) indicating the protected status is presented in the labelling, and the symbol is correct in shape, size and colours.

The labelling requirements related to protected names are met in a case where a protected product is used as an ingredient in another product.

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

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

The product with a protected status is manufactured and packaged in compliance with the product specification registered for the product. Labelling indicates clearly both the registered name of the food product and the correct symbol of the protection scheme.

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

The product with a protected status is manufactured and packaged in compliance with the product specification registered for the product. Labelling indicates both the registered name of the food product and the correct symbol of the protection scheme. There are some minor shortcomings in labelling, such as

  • the symbol is too small (under 15 mm, or under 10 mm on small packages)
  • a clearly incorrect tone of colour on the symbol
  • an error in the voluntary text statement. (In addition to the symbol, labelling may contain the indication "protected designation of origin", "protected geographical indication" or "traditional speciality guaranteed", or the corresponding abbreviations "PDO", "PGI", or "TSG". Corresponding indications in the language of the country of production are also permitted.)

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

The food product is not manufactured or packaged in compliance with the product specification. For example

  • butter which is a required ingredient is replaced with vegetable oil
  • flakes not indicated in the specification are used in addition to flour
  • the manufacturing method differs slightly from the one described in the product specification (baking time, temperature, manufacturing conditions, etc.).
  • the colouring of the symbol indicating the protected status is incorrect, or the symbol is missing completely
  • when a food product with a protected status is used as an ingredient in another product and this is indicated in marketing or labelling, the protected status is used slightly wrong, for example
    • another ingredient of a similar type as the ingredient with a protected status is used (Kitkan viisas vendace caught in the lakes of the Koillismaa highlands/vendace caught somewhere else, or Lapin Puikula potato from Lapland/some other potato)
    • the amount of the ingredient with a protected status is so small that the characteristics of the product are not essentially due to it
    • the marketing of the food product creates the impression that the product has a protected status.

The operator has not submitted the notification referred to in Section 54 of the Finnish Food Act prior to placing a product with a protected status on the market or notified about the suspension or discontinuation of the manufacture of the product.

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

The food product deviates considerably from the product specification in terms of manufacture or packaging. For example

  • the raw material used in a food product benefiting from the PDO designation comes from outside the area indicated in the specification, or production or packaging takes place outside the area indicated in the specification
  • the significant production stage recorded in the specification of a food product benefiting from the PGI designation does not take place in the area indicated in the specification
  • the recipe or the manufacturing method differs essentially from the one described in the specification
  • the marketing or labelling of a food product indicates a food product with a protected status as an ingredient, although it is not.
  • the food is marketed as a name protection product even though the food in question has no name protection.

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

  • Regulation of the European Parliament and of the Council (EC) No 1151/2012 on quality schemes for agricultural products and foodstuffs
  • Commission Implementing Regulation (EU) No 668/2014 laying down rules for the application of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs
  • Commission Communication – Guidelines on the labelling of foodstuffs using protected designations of origin (PDOs) or protected geographical indications (PGIs) as ingredients (2010/C 341/03)
  • Finnish Food Act 279/2021, Sections 6 and 54
  • Decree 123/2020 of the Ministry of Agriculture and Forestry on the registration of products with a protected name and on the notification of the manufacture of a registered name-protected product
  • Finnish Food Authority’s Guide 17049/5: Guide for control of protection of names for foodstuffs
  • eAmbrosia database of the European Commission: https://ec.europa.eu/info/food-farming-fisheries/food-safety-and-quality/certification/quality-labels/geographical-indications-register/
  • GIview database of the European Commission: https://www.tmdn.org/giview/.


Updates in version 5:

  • Guideline No 10239/4 is replaced by Guideline No 2171/04.02.00.01/2021/5
  • The Food Act Number and Sections have been updated
  • Number of the Decree of the Ministry of Agriculture and Forestry has been updated
  • References to Commission databases and links have been updated.

12.4 Other Product-specific Requirements (Composition and Labelling of Berry and Fruit Preparations)

Guide/version: 2172/04.02.00.01/2021/4, valid from 1.7.2021

To be taken into consideration:
This point is to be controlled when general labelling is provided for mass caterers and end consumers in compliance with the Food Information Regulation (No. 1169/2011), as well as in cases where the operator

  • manufactures, has manufactured for it or packages
  • imports or brokers (from the internal market or third countries) the following food products packaged:
    • jams, jellies and marmalades
    • juices and similar preparations.

It is recommended that points 13.1 Mandatory food information and 13.2 Nutrition Labelling are controlled at the same 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".

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

Control of the compliance of product-specific labelling with requirements, i.e. is the correct information provided in labelling/label:

  • product name
  • composition
  • other labelling referred to in specific labelling.

Compliance with requirements can be verified by means of, for example:

  • inspections of labelling, recipes and documents
  • where necessary, analysis certificates and/or own-check tests.

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

The composition and labelling of berry and fruit preparations comply with the requirements laid down in legislation.

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

The composition of berry and fruit preparations and the labelling referred to in specific legislation comply in main parts with the requirements laid down in legislation. There are some minor shortcomings in labelling, such as:

  • there are some minor shortcomings in labelling, but notwithstanding these, it is possible to verify the compliance of the product with requirements
  • the name of the food product is not exactly compliant with legislation
  • no instructions are provided for the dilution of a fruit or vegetable juice (for juices designed to be diluted for consumption).

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.

There are some essential defects or deficiencies in labelling, such as:

  • recipes are outdated or not in use
  • a misleading name
  • the berry content of a jam is missing or is incorrect
  • the total sugar content indication for a jam is missing or is incorrect
  • the indication "made with concentrate" or "partially made with concentrate" (if appropriate) is missing for a juice
  • sugar has been added in a fruit juice in violation of legislation
  • there is no indication of the juice content of a juice.

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.

Labelling is missing completely or there are defects that require immediate rectification or withdrawal, such as:

  • counterfeit products.

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

  • Regulation (EC) 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety; Articles 17 - 19
  • Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers
  • Council Directive relating to fruit jams, jellies and marmalades and sweetened chestnut purée intended for human consumption (2001/113/EC)
  • Council Directive relating to fruit juices and certain similar products intended for human consumption (2001/112/EC)
  • Finnish Food Act 287/2021, Sections 1, 2 and 6
  • Decree (474/2003) of the Ministry of Trade and Industry on fruit jams, jellies, marmalades and certain similar products, Sections 3, 5 and 6, and Annexes 1-3,
  • Decree (662/2013) of the Ministry of Agriculture and Forestry on fruit juices and certain similar products, Sections 3, 6 and 7, and Annexes 1-3
  • Decree (264/2012) of the Ministry of Agriculture and Forestry on requirements laid down for certain food products, Sections 8 and 9
  • Finnish Food Authority’s Guide 6529/4. Composition and labelling of fruit jams, jellies and marmalades – guide for control authorities and operators
  • Finnish Food Authority’s Guide 6530/3. Composition and labelling of fruit and vegetable juices and certain similar products – guide for control authorities and operators
  • Finnish Food Authority’s Guide 17068/2. Food Information Guide for food control authorities and food sector operators
  • Evira's Guide 17055/1. Guide for control of labelling.


Updates in version 4:

  • The control of own-check activities has been clarified.
  • Guideline No 10240/4 is replaced by Guideline No 2172/04.02.00.01/2021/4
  • The Food Act Number and Sections have been updated
  • Guideline numbers for jam and juice guidelines have been updated.

12.6 Special guarantees for salmonella

Guide/version: 153/04.02.00.01/2021/2, valid from 1.7.2021

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

  • into Finland from the internal market of raw refrigerated/deep-frozen food of animal origin covered by special guarantees for salmonella
    • special guarantees for salmonella include: raw beef, pig and poultry (chicken, turkey, guinea fowl, duck and goose) meat (including offal and blood) or minced meat made of these as well as raw chicken eggs.

It is recommended that these sections are controlled at the same time

  • 15.1 Reception of foods
  • 16.9 Traceability of foods of animal origin
  • 17.1 Sampling and own-check testing.

Matters to be controlled:
The implementation of own-check control is evaluated by random sampling (for example, 1 to 3 products, taking the nature and scope of operations into consideration) of compliance with the special guarantees for salmonella:

  • Consignments of meat shall be accompanied by commercial documents in accordance with Regulation (EC) No 1688/2005 (Annex IV), or the commercial document may also be provided to the operator in electronic form
  • Consignments of meat shall be accompanied by a laboratory test certificate for salmonella, if required by law, the certificate may also be provided to the operator in electronic form
  • Consignments of eggs must be accompanied by the intra trade certificate ((EC) No 1688/2005, Annex V)
  • The required documents can be connected to each other and to the foods
  • The food has not been introduced/placed on the market until the required documents have been made available to the operator and the operator has carried out an acceptance inspection
  • sampling and testing plan concerning salmonella has been followed (Food Act 297/2021, 15 §) (controlled: 17.1 Sampling and Own-check Testing)
  • The adequacy and suitability of own-check activities and, where appropriate, the plan is controlled by applying the Annex to Guideline 1.6: "Adequacy and Suitability of Own-check".

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

The operator has verified that the foodstuffs covered by the special salmonella guarantees are accompanied by the documentation required by law. The documents and the food can be reliably connected to each other.

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

The operator has largely verified that the documents required by law and accompanying foods covered by the special guarantees for salmonella comply with the requirements. Minor shortcomings include:

  • there are minor omissions in the labelling or documents, but the documents and the food can still, however, be linked to each other
  • the documents are in a language other than the permitted languages (Finnish, Swedish or English), but the information required is clearly evident from the documents.

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.

There are shortcomings in the operator's own-check control, which is why the documents accompanying the foods covered by the special guarantees for salmonella are not compliant. Major shortcomings include:

  • the documents required by law are not directly linkable to the food, but the documents and the food are reasonably linkable using e.g. invoices and consignment notes
  • there are omissions in the salmonella certificates.

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

The operator has not verified that the document requirements for foods covered by the special salmonella guarantees are met. Issues requiring immediate rectification include, for example:

  • The operator has brought into use the food received or supplied food directly for sale even though all the documents required by law are missing
  • The operator has brought into use the food received or supplied the food directly for sale even though the commercial document/intra trade certificate required by law is missing
  • the operator has brought into use the food received or supplied food directly for sale even though the salmonella certificate required by law is missing
  • The documents required by law and the food are unable to be connected to each other even using invoice or consignment note information
  • There are major omissions in the salmonella certificates.

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

  • 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 (=Salmonella requirements for food of animal origin imported into Finland)
  • Commission Regulation (EC) No 427/2012 on the extension of special guarantees concerning salmonella to eggs intended for Denmark (= exception in the salmonella requirements when importing eggs from Denmark into Finland)
  • Commission Regulation (EU) No 2018/307 extending the special guarantees concerning salmonella to meat derived from broilers (Gallus gallus) intended for Denmark (=exception in the salmonella requirements when importing broiler meat from Denmark into Finland)
  • EFTA Surveillance Authority Decision 1/19/COL extending the specific guarantees for Salmonella spp to the meat and eggs derived from chicken and meat derived from turkeys intended for Iceland (=exception in the salmonella requirements when importing eggs, broiler meat and turkey meat from Iceland to Finland)
  • Food Act 297/2021
  • Finnish Food Authority Guideline 2529/04.02.00.01/2021/2 concerning requirements for special guarantees for salmonella, Guideline for Food Control Authorities and Food Business Operators
    https://www.ruokavirasto.fi/en/about-us/services/guides--instructions--and-forms/companies/import-and-export/Intra-EU-trade-operators-of-foodstuffs-of-animal-origin/.


Updates in version 2:

  • Matters to be controlled/added: sampling and testing plan concerning salmonella has been followed (controlled: 17.1 Sampling and Own-check Testing)
  • Food Act number has been updated
  • Link has been added to the Guideline 2529/04.02.00.01/2021/2 concerning requirements for special guarantees for salmonella.