12 Special Requirements for Specific Food Products

All Oiva evaluation guidelines for registered food premises.

12.1 Food Supplements

Guide/version: 2169/04.02.00.01/2021/7, valid from 2.1.2024

To be taken into consideration:
This point is controlled, when a food business operator manufactures or contracts another party to manufacture, or imports (from the internal market or from third countries) food supplements that fall within the scope of Food Supplement Decree 78/2010.

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

• 11.4. Novel Foods and New Processes
  to also ensure the compliance of other characteristic substances, and
• 13.1. Mandatory food information and
• 13.3. Marketing,
  to also verify the compliance of other food information.

This point is only controlled in retail stores (incl. distance selling) and catering establishments only 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.

Matters to be controlled:
The adequacy and suitability of own-check activities and, where appropriate, the plan are controlled by applying the Annex to Guideline 1.6: "Adequacy and Suitability of Own-check Activities". The implementation of own-check activities is evaluated (by random checks on e.g. 1-3 products, taking the scope and nature of operations into consideration) by checking the following matters: 

• The composition and purity requirements set for the food supplement are met:
  • the food supplement meets the criteria set out in the definition of food supplements, i.e. it is
    • a pre-packaged food in dosage form,
    • a concentrated source of nutrients or other nutritionally or physiologically active substances,
    • intended to be consumed in small doses, and
    • insignificant in terms of the amount of energy it contributes to a person’s diet,
  • the vitamins, minerals, and their chemical compounds used in the preparation of the food supplement are permitted,
  • the chemical compounds of vitamins and minerals used in the manufacture of the food supplement meet the purity criteria for vitamins and minerals (applies to manufacture and outsourced manufacture),
  • the quantity 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),
  • the characteristic substance or the quantity of the substance used in the manufacture of the food supplement does not pose a health hazard, i.e.
    • the food supplement does not contain too much of a vitamin or mineral (exceeding UL values) or any other substance (restricted substances in Part B of Annex III to the Fortification Regulation),
    • no substances have been used in the manufacture of the food supplement that are
      • prohibited under Part A of Annex III to the Fortification Regulation
      • unauthorized novel foods (evaluated in row 11.4),
    • the impact of the substances in the list of medicines used in the manufacture of the food supplement on the classification of the food supplement (medicinal or not) has been ensured.

• The food information requirements for food supplements are met:
  • the food supplement is sold pre-packaged under the sales description ‘food supplement',
  • the composition of the food supplement with respect to characteristic substances and their quantities is consistent with the provided information,
  • the characteristic substances and their quantities are appropriately indicated,
  • the mandatory information required by the Food Supplement Decree has been provided,
  • where applicable, the mandatory information required by Part B of Annex III to the Fortification Regulation has been provided.

• A notification of placing a food supplement on the market and/or changing its composition has been submitted to the Finnish Food Authority.

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.

Operations comply with requirements.

The food supplements comply with the requirements presented above. 

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

The food supplements primarily comply with the requirements presented above. There are some minor shortcomings, such as: 

• there are some minor shortcomings in food information or documents, but notwithstanding these, it is possible to verify the product’s compliance with the necessary requirements
  • for example, the names of the categories of nutrients or substances characteristic of the product or a reference to the nature of these nutrients or substances is missing,
• only some of the food supplements placed on the market have been notified to the Finnish Food Authority.
  • NOTE: If not all food supplements placed on the market have been notified to the Finnish Food Authority despite repeated notices, the grade To Be Corrected shall be given. 

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 supplements do not comply with the requirements presented above and they contain essential shortcomings, such as:

• the food supplement does not meet the definition of a food supplement
  • for example, a conventional foodstuff is placed on the market as a food supplement,
• it is not possible to ascertain the classification of the product (food supplement/medicine) or its composition, as its documentation is incomplete or missing;
• the vitamin or mineral that is a characteristic substance of the food supplement is not present in a significant quantity in the recommended daily dose,
• some of the mandatory food information required by the Food Supplement Decree or Part B of Annex III to the Fortification Regulation is completely missing
• notifications of the food supplements placed on the market have not been submitted to the Finnish Food Authority.

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 supplements contain shortcomings requiring immediate correction and/or recalls, such as:

• the characteristic substances in the food supplement are not permitted
  • for example, a food supplement contains a prohibited nutrient compound or a substance prohibited by Part A of Annex III to the Fortification Regulation,
• the quantity of added vitamins, minerals, or other characteristic substances in the daily dose of the food supplement is so high that it endangers consumer safety
  • e.g. exceeding the UL values for some vitamins and minerals (always assessed on a case-by-case basis) or exceeding the maximum level set in Part B of Annex III to the Fortification Regulation.

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

• Decree 78/2010 of the Ministry of Agriculture and Forestry on food supplements (referred to as the "Food Supplement Decree" in these instructions)
• 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 nutrients and their sources)
• Regulation (EC) No 1925/2006 of the European Parliament and of the Council on the addition of vitamins and minerals and of certain other substances to foods (referred to as the "Fortification Regulation" in these instructions)
• 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)
• Finnish Food Act 297/2021, Section 6 (notification obligation)
• Decision 183/2022 of the Finnish Medicines Agency on medicinal products list (medicinal substances)
• Food Supplement Guide (17012/5) 
• Commission Guidance (December 2012): Guidance document for competent authorities on permitted deviations from the nutritional values indicated on the label and their monitoring https://food.ec.europa.eu/system/files/2016-10/labelling_nutrition-vitamins_minerals-guidance_tolerances_1212_en.pdf

Updates in version 7

• The instructions in their entirety have been refined and reorganised.
• Removed the section on transfers from the “Note” section.
• Inspection of prohibited or restricted substances in Annex III to the Supplementary Regulation added to the matters to be controlled.
• Drugs and doping agents removed from the matters to be controlled¨, as these are assessed in section 11.4 (Novel foods and new processes).
• Clarified and added examples to the assessment criteria, including a mention that the “Good” grade may change to the “To Be Corrected” grade if the operator does not submit its notifications to the Finnish Food Authority despite repeated notices.
• The list of legislation and guidelines has been updated: the Fortification Regulation has been added, the legislation on drugs and doping agents has been removed (narcotics and doping agents are assessed in section 11.4), and
• updated the number of the medicinal product list and the link to the Commission’s tolerance guideline.

12.2 Foods for Specific Groups

Guide/version: 2170/04.02.00.01/2021/8, valid from 2.1.2024

To be taken into consideration:
This point is evaluated when the operator manufactures, has manufactured for it or imports (from the internal market or third countries) 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, food for special medical purposes and total diet replacement for weight control which are controlled in this Guideline also with respect to marketing), to verify the compliance of also other labelling with requirements.
• 17.12-17.16, to verify that the infant formula, follow-on formula, infant food for special medical purposes or baby food does not contain contaminants or residues of plant protection products above the maximum levels laid down.

This point is only controlled in retail stores 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) foods for specific groups.

Matters to be controlled:
The adequacy and suitability of own-check activities and, where appropriate, the plan are controlled by applying the Annex to Guideline 1.6: "Adequacy and Suitability of Own-check Activities". The implementation of own-check activities is evaluated 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)
• The specific requirements applying to food information laid down for infant formulae and follow-on formulae are met (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 terminology 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
    • the only authorised indications relate to lactose and docosahexaenoic acid (DHA)
• 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 the Finnish Food Authority
  • about the placing on the market of an infant formula,
  • about the placing on the market of a follow-on formula that
    • has been made from protein hydrolysate, or
    • includes substances other than those mentioned in Annex II to Delegated Regulation (EU) 2016/127.

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)
• The specific labelling requirements laid down for baby foods are met:
  
  • 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 baby food.

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)
• The specific requirements concerning food information laid down for foods for special medical purposes are met:
  
  • 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 food
  • 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 . . ." 
  • 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 requirements specified for the composition and purity of total diet replacements for weight control are met:
  • total diet replacements for weight control meet 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)
• The specific requirements concerning food information laid down for total diet replacements for weight control:
  • the product is sold prepacked under the name total diet replacement for weight control
  • products are provided with the mandatory additional information defined for them and additional information to be provided as necessary
  • the nutrition labelling is compliant and consistent with the composition
  • total diet replacements for weight control do not refer to the speed or amount of potential weight loss following their use and no nutrition and health claims about them
    • the only claim authorised is the nutrition claim concerning added fibre
  • the statements “very low calorie diet” (VLCD) and “low calorie diet” (LCD) are used in compliance
  • notification has been submitted to the Food Authority of the placing on the market of a total diet replacement for weight control (applies to products placed on the market after 27 October 2022).

Operations comply with requirements.

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

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 placed on the market.
  • NOTE: If not all foods for specific groups placed on the market have been notified to the Finnish Food Authority despite repeated notices, a grade To Be Corrected shall be given.

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 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
• terminology, 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 or a total diet replacement for weight control
• 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
• some of the mandatory additional information is not provided for a total diet replacement for weight control.

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 and this could cause a serious health hazard (to be assessed case by case).

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
• 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
• Commission Delegated Regulation (EU) 2017/1798 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for total diet replacement for weight control
• Decree of the Ministry of Social Affairs and Health on information material regarding the feeding of infants and young children 267/2010
• Decision 789/1997 of the Ministry of Trade and Industry on baby foods.

Updates in version 8:

• Removed packing and brokering (agent activity) from the To be taken into consideration section.
• Added a mention that the grade Good may be changed to the grade To Be Corrected if the operator fails to submit notifications to the Finnish Food Authority despite repeated reminders.

12.3 Food products with registered names

Guide/version: 2171/04.02.00.01/2021/6, valid from 2.1.2024

The EU’s scheme for registration of names has three schemes:

• Protected designation of origin (PDO, in Finnish: SAN, in Spanish/Italian: DOP)
• Protected Geographical Indication (PGI, in Finnish: SMM, in Spanish/Italian, IGP)
• Traditional speciality guaranteed (TSG, in Finnish: APT, in Spanish: ETG, in Italian: STG)

The Protected Designation of Origin (PDO) and the Protected Geographical Indication (PGI) limit the manufacture and/or production of the product to a specific geographical area, as defined in the product specification/single document for each product. The Traditional Speciality Guaranteed (TSG) protects the traditional production method and ingredients of the product, but does not bind the manufacture/production to a defined geographical area.

To be taken into consideration:

This point is controlled when the operator

• manufactures foods protected by PDOs, PGIs or TSGs.

This point is also checked when the operator:

• has manufactured 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 the store unpackaged and/or
• sells/serves at the serving location unpacked

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.

Operators producing foods with registered names must 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.

Food business operators producing foods with registered names are inspected regularly - at least every two years. The inspection of an operator producing a food with a registered name shall ensure, in particular, that the operator uses the raw materials and manufacturing methods specified in its product specification/single document for the name-protected food in question. It is also essential to ensure that the preparation and packaging of the product with a registered name concerned takes place within the geographical area defined in the product specification/single document. The raw materials used in some products with a registered name must also come from a defined geographical area, this is also recorded in the product specification/single document for the product concerned. In addition, it must be ensured that the products are named correctly and that the logo indicating the protected name is used correctly.

In facilities other than those producing name-protected food, the inspection shall ensure that the food produced, packaged, imported, supplied, served or otherwise placed on the market by the operator under a name registered under the EU’s scheme for the registration of names is verifiably prepared, packaged, etc. in accordance with the definitions of the product specification/single document for the name-protected product concerned (e.g. raw materials, methods of manufacture, geographical location). If food with a registered name is used as an ingredient in another food or serving portion and the name-protected ingredient is present in the name of the food or portion, the inspection shall ensure that the conditions are met concerning the use or highlighting the name of the registered product in the name of the food, serving or in other labelling.

Foods other than those whose name is registered may not be marketed with terms referring to a name-protected food. Registered, i.e. protected names, are protected against misuse, imitation or associations, including in cases where the products are used as ingredients. A registered product may not be referred to, even if the correct origin of the product is marked or the registered name has been translated or accompanied, for example, by the words ‘quality', ‘type', ‘method', ‘produced like', ‘ imitation' or other equivalent expression, even when the product is used as an ingredient in another food. This needs to be taken into account when checking section 13.1 Mandatory food information (packaged and unpackaged foodstuffs).

The use of the name registration logo is mandatory for foodstuffs. Separate verbal indications ("protected designation of origin", "protected geographical indication", "traditional speciality guaranteed”, or their abbreviations) are permitted, but not mandatory. The name of the name-protected food shall always appear on the labelling in the language and format in which it is registered, but, if necessary, the name may also be translated into a language understood by the consumer.

Matters to be inspected:

• Manufacturing and packaging meet the conditions of the name protection granted to the foodstuff concerned (raw materials, manufacturing methods, geographical area). The verification shall be carried out by comparing the ingredients used (including, where appropriate, their origin), production methods and other activities with the definitions of the approved product specification/single document for the name-protected food in question. In particular, the raw materials, manufacturing methods and, where appropriate, packaging methods specified for the name-protected product in question in its product specification/single document shall be checked at the manufacturing stage of a foodstuff designated under the name-protected name.
• When inspecting locations that manufacture food that is not name-protected, it should particularly be examined how the operator verifies that the name-protected food placed on the market by the operator has been correctly named, prepared and packaged, etc., as specified in the product specification/single document for the product concerned. If the name of a registered food is used in a restaurant or other serving location, for example, in the name of the serving to be sold or served or in other marketing, the inspection must determine how the operator ensures that a genuine product protected by name is used as the raw material in the preparation of the dose/meal, i.e., the inspection must ensure that the prerequisites are met for using the name of a registered product in the name of the serving/meal or in any other marketing.
• 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 are controlled by applying the Annex to guideline 1.6 “Adequacy and Suitability of Own-Check Activities”. 

Operations comply with requirements.

Before placing the food product with a registered name on the market, the name-protected food manufacturer has notified the food control authority which name-protected food is produced and where the place of manufacture is located. The name-protected food is prepared and packaged in accordance with the product specification registered for the food in question (raw materials, manufacturing methods, geographical area, etc.). Labelling indicates clearly both the registered name of the food product and the correct symbol of the protection scheme. If the name of a meal or portion contains the name of a registered food, the genuine name-protected raw material must be utilised sufficiently in the meal/serving so that it provides it with its unique flavour, and the corresponding ‘common ingredient' has not been used in the same portion to partially or fully replace the name-protected ingredient.

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.)

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

• butter which is a required ingredient is replaced with vegetable oil
• flakes not indicated in the product 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 (such as Kitkan viisas vendace / 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 (e.g. flavour)
  • the marketing of the food product creates the impression that the product has a protected status

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 product specification, or production or packaging takes place outside the area defined in the product specification
• the significant production stage recorded in the product specification of a food product benefiting from the PGI designation does not take place in the area defined in the product specification
• the recipe or the manufacturing method differs essentially from the one described in the product specification
• the marketing or labelling of a food product/serving 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
• the serving location sells/offers for example
  • feta pizza/feta salad/feta pie, but the ingredient is not genuine feta, but salad cheese or ‘Mediterranean' cheese cube, etc.
  • Parmesan broiler serving, but not genuine Parmesan (Parmigiano Reggiano PDO) cheese but other matured cheese
• in the store/remote point of sale, there is a product sold under the name of Karelian pie that does not meet the definition of Karelian pie TSG in terms of composition, but might be, for example, rice pie
• faults found during the assessment, which need to be rectified in the shop/serving area, occur repeatedly

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:
  • eAmbrosia - the EU geographical indications register (europa.eu) (register for PDO and PGI products)
  • eAmbrosia - Traditional Specialities Guaranteed (europa.eu) (register for TSG products)
• European Commission GIview database: GIview (tmdn.org) (This database only contains the PDO and PGI products)  

Updates in version 6:

• Added definitions of name protection schemes
• Clarified the difference between name-protected food manufacturers and other operators producing/packaging/importing/supplying/selling/offering name-protected foods.
• Examples added
• Updated links to Commission databases

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.

Operations comply with requirements.

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

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).

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.

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.

12.5 Integrity of organic products

Guide/version: 2241/04.02.00.01/2021/3, valid from 1.9.2022

The matter is to be evaluated in accordance with the guidelines. For now, the result is seen only in the control report, if the matter has been controlled, and not in the Oiva report.

To be taken into consideration:
These guidelines apply in retail sales of organic products in retail stores. Inspection frequency is at least once every three years.

Control of the labelling of organic foods has three main objectives:

• Control of the integrity of an organic food, which in practice means verifying the traceability of the product
• Control of presentation to ensure that organic products are not intentionally or accidently switched and that the advert/guide/shelf label/sign information of the organic product is correct
• Control of organic marketing where the control authority assesses whether or not the food labelling misleads the consumer.

Matters to be controlled:
Control of marketing standards establishes how the operator has taken care of their obligations

• Whether the store is subject to organic control when manufacturing or packing organic products or whether the products marketed have been obtained from a supplier subject to control
  • in other words: whether the store has verified whether the supplier, for example a wholesaler, is subject to organic control by inspecting their documentary evidence (organic certificate)
• whether an acceptance inspection of delivery has been performed and can the accompanying document be unambiguously connected to the product batch concerned
• how organic labelling has been used in sales and marketing
• how the store manages the separation of non-organic and organic products
• whether non-organic products have been labelled as organic.

Operations comply with requirements.

• The origin/production method of the raw materials used or products sold can be verified by documents and the documents have all required indications. These indications are a reference of organic production and the number of the control body or authority.
• The organic labelling and other organic indications have been used in compliance with the requirements
• Operations relating to the organic products comply with the above requirements.

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

Operations have been implemented largely in compliance with the requirements. There are some minor shortcomings in, for exampl

• a lack of organic labelling in the procurement documents, but their seller is demonstrably subject to control (e.g. can be found on the Finnish Food Authority’s organic search tool)
• organic labelling cannot be connected to a certain controlled organic product but the control authority is convinced that the product is organic
• the organic logo, the EU leaf, is missing from the pre-packaged food but the control authority is convinced that the product is organic
• the mandatory number of the control body or authority or place of agricultural production is missing in conjunction with the logo, but the control authority is convinced that the product is organic
• organic references are missing from the list of ingredients
• the total percentage of the organic ingredients of the total quantity of agricultural ingredients is missing in a non-organic product containing organic ingredients
• the presentation has been arranged in a way that increases the risk of loose products being switched.

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

Operations relating to organic products do not comply with the above requirements and there are some critical non-compliances such as:

• the organic indications have been used in advertising but no organic meal or product is on sale
• organic indications (logos) have been used in advertising. The business has organic products but it is not possible to connect the indications to specific products.
• the sales brochure contains ambiguous references to an organic production method (e.g. organic-like turkey)
• organic indications have been used without that the organic integrity can be verified
• the operator is unable to provide evidence that the food has been procured from a business subject to organic control but is able to provide evidence within a short set period of time
• the brochure information concerning the food is incorrect and contradicts package labelling.

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 defects require immediate rectification or withdrawal such as:

• selling non-organic products as organic
• selling a product obtained from hunting or fishing as organic
• selling a product containing non-organic ingredients as organic
• lack of documentation of the origin of organic raw materials or products
• the operator is unable to provide evidence that the food has been procured from a business subject to organic control,
• the business has used organic labelling in advertising but the business has never sold organic foods.

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

• Finnish Food Act (297/2021, sections 3 and 4)
• Act No (1330/2021) on Organic Control
• Finnish Food Authority’s Guide 18245/2. Organic labelling control guide for municipalities
• Finnish Food Authority’s Guide (18247/4) Sale of organic foods in retail stores. 

Updates in version 3:

• Updated Act No (1330/2021) on Organic Control number.

12.6 Special guarantees for salmonella and notification on import from internal market

Guide/version: 153/04.02.00.01/2021/3, valid from 2.1.2024

To be taken into consideration:

This point is controlled when the operator

• imports into Finland from the internal market 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
• imports foods of animal origin according to the regulation of the Finnish Food Authority

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. Controlled that sampling and testing plan concerning salmonella has been followed (Food Act 297/2021, 15 §)

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
• The salmonella certificate contains the required information concerning the number of samples taken from the meat and salmonella analysis carried out in the country of departure and used methods of analysis (Instructions Requirements for special salmonella guarantees in the import of foodstuffs of animal origin for internal trade)
• 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 or the food consignment unit
• 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

Import reports:

• Import reports regarding certain foods of animal origin imported from the internal market have been made (Regulation of Finnish Food Authority 8/2021)

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".

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.

Internal market import reports have been made as required by the regulation.

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
• there are slight shortcomings in the salmonella certificates (for example the number of samples taken in the country of departure is slightly left open), which, however, do not give reason to question the reliability of the test results, the requirements according to the regulation are mainly fulfilled, the certificates can be connected to the commercial document and the food
• internal market import reports are mainly made according to the regulation

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
• the salmonella certificates contain quite large shortcomings, which indicate that analyses have been carried out, but the requirements according to the regulation are not fulfilled
• internal market import reports have not been made during the last year at all

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
• salmonella tests have not been carried out or there are large shortcomings in the certificates and the information in the certificate is not reliable
• despite request internal market import reports have not been made

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/  (The instructions will be updated)

Updates in version 3:

Matters to be controlled/added:

• The salmonella certificate contains the required information concerning the number of samples taken from the meat and salmonella analysis carried out in the country of departure and used methods of analysis (Instructions Requirements for special salmonella guarantees in the import of foodstuffs of animal origin for internal trade)
• Import reports regarding certain foods of animal origin imported from the internal market have been made (Regulation of Finnish Food Authority 8/2021)