11 Composition of foodstuffs

All Oiva evaluation guidelines for registered food premises.

11.1 Additives, Flavourings and Enzymes

Guide/version: 2165/04.02.00.01/2021/2, valid from 3.3.2020

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)

additives, flavourings (incl. smoke flavourings), enzymes, mixtures thereof or premixtures containing these substances and ingredients,
foodstuffs in which additives, flavourings (incl. smoke flavourings), enzymes, mixtures thereof or premixtures containing these substances and ingredients are/have been used.

Where control concerns foodstuffs which the operator manufactures, has manufactured for it or imports for marketing to consumers, it is recommended that point 13.1 Mandatory food information (packaged and unpackaged foodstuffs) is controlled at the same time, verifying that additives, flavourings and enzymes are appropriately included in the list of ingredients and the packaging bears any warning labelling that is needed.

The use of additives, flavourings and enzymes is not controlled in retail stores or catering establishments where only compound ingredients are used in the manufacture and preparation of foods. This point is to be evaluated if the retail store or catering establishment itself imports (from the internal market and/or third countries) foodstuffs manufactured using additives, flavourings or enzymes.

Since there is as of yet no list of enzymes approved for food use in the EU, as far as enzymes are concerned, control covers the compliance of enzyme mixtures with labelling requirements.

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 compliance with requirements with respect to additives, flavourings and enzymes. 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 following matters are to be controlled separately for each activity:

1. Use of additives, flavourings and enzymes, mixtures thereof or premixtures containing these substances and ingredients in the manufacture of foodstuffs:

Additives and flavourings are authorised for use in the foodstuffs in which they are used and their maximum amounts specified for each food group are not exceeded
- the operator is able to present recipe calculations, and where necessary, own-check tests that supplement them
The labelling and purity criteria specified for additives, flavourings and enzymes are fulfilled
- information (labelling and product specification or some other documentation) has been obtained from suppliers of improvement agents, or if this information is missing, information has been requested, which makes it possible to verify compliance and which can be used e.g. as a basis for recipe calculations. Risk management related to purity requirements can also be demonstrated on the basis of procurement contracts and/or audits of suppliers of improvement agents.
- where necessary, the operator who uses mixtures has supplemented the information received from the supplier by means of own-check tests.

2. Import of foodstuffs containing additives or flavourings (from the internal market or third countries):

Additives and flavourings are permitted in the foodstuffs imported by the operator and their maximum amounts specified for each food group are not exceeded
- the operator is able to demonstrate by means of records or documents (e.g. procurement contract, product specification, analysis certificate and/or supplier audit) that the foodstuffs comply with requirements in terms of additives and flavourings,
- where necessary, the operator has supplemented information received from the supplier with own-check tests.

3. Operator manufactures additives, flavourings and enzymes, mixtures thereof or premixtures containing these substances and ingredients, or has them manufactured:

The purity criteria specified for additives and flavourings as well as other specific criteria for raw materials, manufacture and composition are fulfilled
- the operator is able to present information received from raw material suppliers (e.g. product specifications, analysis certificates, etc.), recipe calculations, and where necessary, own-check tests for the verification of compliance with requirements.
Additive, flavouring and enzyme preparations only contain additives and carriers authorised for use in them and the specified maximum amounts are not exceeded.
- the operator has performed the required recipe calculations, and where necessary, has supplemented them with own-check tests, or the operator is able to present some other documentation that proves compliance with requirements.
The labelling requirements specified for additives, flavourings and enzymes as well as premixtures containing these substances and ingredients are met and labelling is consistent with recipe information.
- all mandatory information can be found in labelling and associated documents,
- the operator is able to present information received from raw material suppliers (e.g. product specifications, analysis certificates, etc.), recipe calculations, and where necessary, own-check tests for the verification of the consistency of the recipe and labelling.
Additives and flavourings are authorised for use in the foodstuffs for the manufacture of which they are marketed.
The additives, flavourings and enzymes as well as premixtures containing these substances and ingredients that are supplied to customers are accompanied with appropriate information (labelling and product specification or some other documentation) enabling the customer to verify compliance with composition and purity criteria and to perform recipe calculations and prepare labelling for the final product. Documentation related to purity criteria is not required to be provided separately with each batch.

4. Import of additives, flavourings, enzymes, mixtures thereof or premixtures containing these substances and ingredients (from the internal market or third countries):

The labelling requirements and purity criteria specified for additives, flavourings and enzymes as well as ther specific criteria for raw materials, manufacture and composition are fulfilled
- the operator is able to present information (product specifications, labelling and associated documents, analysis certificates, etc.) obtained from the manufacturer, or if this information is missing, the required information, which makes it possible to verify compliance with requirements,
- where necessary, the importer has supplemented information received from the manufacturer with own-check tests.
Additives and flavourings are authorised for use in the foodstuffs for the manufacture of which they are marketed.
The additives, flavourings and enzymes as well as premixtures containing these substances and ingredients that are supplied to customers are accompanied with appropriate information (labelling and product specification or some other documentation) enabling the customer to verify compliance with composition and purity criteria and to perform recipe calculations and prepare labelling for the final product. Documentation related to purity criteria is not required to be provided separately with each batch.

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

Operations that involve additives, flavourings and enzymes comply with 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.

Operation is mainly implemented in compliance with the aforementioned requirements. There are some minor shortcomings, for example:

1. In the use of additives, flavourings and enzymes, mixtures thereof or premixtures containing them and ingredients in the manufacture of foodstuffs

the operator is unable to present documented recipe calculations, but the inspector carrying out control can verify from the recipe by calculating that the content of the additive or flavouring does not exceed the permitted maximum amount in the foodstuff,
there are some minor shortcomings in the labelling of the additive, flavouring or enzyme, and in associated documents, but notwithstanding these, it is possible to perform the required recipe calculations or verify that the product is intended for food use.

2. In the import of foodstuffs containing additives or flavourings (from the internal market or third countries)

there are some minor shortcomings, inaccuracies or errors in the operator's documents, but notwithstanding these, it is possible to verify the compliance of the product with requirements.

3. In manufacturing additives, flavourings and enzymes, mixtures thereof or premixtures containing them or in having them manufactured

there are some minor shortcomings, inaccuracies or errors in recipes, own-check tests, purity criteria documents or labelling, and in associated documents, but notwithstanding these, it is possible to verify the compliance of the product with requirements.

4. In the import of additives, flavourings, enzymes, mixtures thereof or premixtures containing these substances and ingredients (from the internal market or third countries)

there are some minor shortcomings, inaccuracies or errors in purity criteria documents or labelling, and in associated documents, but notwithstanding these, it is possible to verify the compliance of the product with requirements.

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.

Operations related to additives, flavourings and enzymes do not comply with the aforementioned requirements but show some essential shortcomings, for example:

1. In the use of additives, flavourings and enzymes, mixtures thereof or premixtures containing these substances and ingredients in the manufacture of foodstuffs

an additive or flavouring is used in the manufacture of the foodstuff which is authorised for food use in the EU, but which is not authorised to be used in the foodstuff concerned,
additives, flavourings or enzymes are not shown in the recipe
the amount of the additive or flavouring in the foodstuff exceeds the maximum permitted amount in the foodstuff concerned. Where the limit is exceeded considerably (to be evaluated specifically in each case), a recall procedure shall be initiated and the grade will be POOR
the composition of the additives or flavourings used in the manufacture of the foodstuffs cannot be verified, because of deficiencies in or complete lack of documentation, for example
- there is no indication "for food use" or comparable information that would make it possible to verify that the additive, flavouring or enzyme is intended for food use,
- there is no information on the amount of an additive or flavouring for which a content limit in food has been specified,
the certificate of a smoke flavouring preparation is missing completely or is so deficient that the compliance of the preparation with requirements cannot be verified.

2. In the import of foodstuffs containing additives or flavourings (from the internal market or third countries)

the information provided on an additive or flavouring for which a maximum content has been specified in legislation is deficient to the extent that it is completely impossible to verify compliance with requirements,
an additive or flavouring is used in the foodstuff which is authorised for food use in the EU, but which is not authorised to be used in the foodstuff concerned,
the amount of the additive or flavouring in the foodstuff exceeds the maximum permitted amount in the foodstuff concerned. Where the limit is exceeded considerably (to be evaluated specifically in each case), a recall procedure shall be initiated and the grade will be POOR.

3. & 4. In the manufacture or import of additives, flavourings, enzymes, mixtures thereof or premixtures containing these substances and ingredients (from the internal market or third countries) or in having them manufactured

an additive or flavouring which is authorised for use in the EU is marketed for use in a foodstuff in which its use is not authorised,
the recipes of mixtures of additives, flavourings or enzymes and ingredients are deficient or missing completely (pertains to manufacturing and having manufactured),
additives, flavourings or enzymes contain additives or carriers which are authorised in the EU, but not authorised for use in the additives, flavourings or enzymes concerned, however,
the content of the additive or carrier in the additive, flavouring or carrier exceeds the permitted maximum amount. Where the limit is exceeded considerably (to be evaluated specifically in each case), a recall procedure shall be initiated and the grade will be POOR,
there are no documents regarding compliance with the purity criteria specified for additives and flavourings as well as other specific criteria for raw materials, manufacture and composition, or the documents are deficient to the extent that compliance with requirements cannot be verified, for example
- it cannot be verified that the amount of heavy metals does not exceed the permitted maximum amount,
the labelling of additives, flavourings and enzymes or premixtures of these substances and ingredients, or the associated documents, are deficient to the extent that the operator who carries out further processing cannot verify that the foodstuffs manufactured by them comply with requirements, for example
- there is no information on the amount of an additive or flavouring for which a content limit in food has been specified (e.g. the P2O5 content of phosphate or the coumarin content of cinnamon is not indicated),
- there is no indication "for food use" or comparable information that would make it possible to verify that the additive, flavouring or enzyme is intended for food use.

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

1. In the use of additives, flavourings and enzymes, mixtures thereof or premixtures containing these substances and ingredients in the manufacture of foodstuffs

an additive or flavouring is used that has not been authorised for food use in the EU,
the maximum amount specified for an additive or flavouring authorised for food use is exceeded considerably (to be evaluated specifically in each case).

2. In the import of foodstuffs containing additives, flavourings or enzymes (from the internal market or third countries)

an additive or flavouring is used in the foodstuff that has not been authorised for food use in the EU,
the maximum amount specified for an additive or flavouring authorised for food use is exceeded considerably (to be evaluated specifically in each case).

an additive or flavouring not authorised in the EU is marketed for use in the manufacture of foodstuffs,
additives, flavourings or enzymes contain additives or carriers not authorised in the EU,
additives, flavourings or enzymes contain authorised additives or carriers, but the maximum content is exceeded considerably (to be evaluated specifically in each case).

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

Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives,
Commission Regulation (EU) No 231/2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council,
Commission Regulation (EC) No 889/2009 on organic production (additives in organic products),
Regulation (EC) No 1334/2008 of the European Parliament and of the Council on flavourings and certain food ingredients with flavouring properties for use in and on foods,
Commission Implementing Regulation (EU) No 1321/2013 establishing the Union list of authorised some flavouring primary products for use as such in or on foods and/or for the production of derived smoke flavourings,
Regulation (EC) No 1332/2008 of the European Parliament and of the Council on food enzymes,
Finnish Food Authority's Guide 5731/04.02.00.01/2020: Guide on control of food improvement agents.

Updates in version 2

The control of own-check activities has been clarified.
Guideline no 2165/04.02.00.01/2021/2 is replaced by guideline no 10233/2.

11.2 Nutritional Fortification

Guide/version: 2166/04.02.00.01/2021/5, valid from 2.1.2024

To be taken into consideration:
This point is controlled, when the operator manufactures, has manufactured for it or imports (from the internal market and/or third countries) fortified food products within the meaning of Fortification Regulation EC No 1925/2006.

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

13.1 Mandatory food information (packaged and unpackaged foodstuffs) and
13.2 Nutrition Labelling
13.3 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 or imports (from the internal market and/or third countries) fortified foodstuffs.

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:

the vitamins, minerals and their compounds used for the fortification of a food product are authorised;
the compounds of vitamins and minerals used for the fortification of food products meet the purity criteria set out for them (applies to manufacturing and having manufactured)
the content of the added vitamin or mineral is significant in the final product (15% of the daily reference intake for solids and 7.5 % of the daily reference intake for liquids);
the amount of the added substances does not cause a health hazard;
a food to which it is compulsory to add vitamins and/or minerals according to law, has been fortified in accordance with the requirements in the legislation
- There is a compulsory requirement to fortify fat-free homogenised milk. It has to be fortified with vitamin D3 (a minimum of 1µg/100 ml). The requirement refers to milk that is to be marketed in Finland. There is no requirement to fortify milk intended to be sold outside Finland only, or milk that has been legally produced in another EU or EEA country. But the requirement for fortification does refer to homogenised, fat-free organically produced milk manufactured in another EU or EEA country.
substances which are prohibited in Annex III, Part A or which are in breach of the restrictions in Part B of the regulation on fortification of foods have not been used in the manufacturing of the food;
added vitamins and minerals are appropriately indicated in nutrition labelling;
a notification has been submitted to Finnish Food Authority about the placing on the market of a food product fortified with a vitamin or a mineral.

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.

Nutritional fortification and the labelling of fortified foods comply with the aforementioned requirements.

Nutritional fortification and the labelling of fortified foods comply in main parts with the aforementioned requirements. 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.
only some of the foods fortified with vitamins or minerals placed on the market have been notified to the Finnish Food Authority.
- NOTE: If not all fortified foods 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 some essential shortcomings in fortification and the labelling of fortified foods, such as:

it is not possible to verify that the vitamin or mineral compound used is authorised, because documentation is deficient or completely missing.
the amount of the added vitamin or mineral is not indicated in labelling
the added vitamin or mineral is not present in the food product in a significant amount
the amount of vitamin, mineral or some other substance indicated in the recipe is not consistent with the amount used in production
notifications have not been submitted to Finnish Food Authority about the food products fortified with a vitamin or mineral placed on the market.
the food contains substances exceeding the maximum amount specified in Annex III, Part B of the EU Regulation for fortified food (trans fats), or the required additional labelling is missing (assessed on a case-by-case basis).

There are defects requiring immediate rectification and/or recall as concerns nutritional fortification, for example:

use of unauthorised vitamins, minerals or their compounds for fortification of food
the content of the added vitamin, mineral or some other substance is so high in the food product that it endangers the safety of the consumer (to be evaluated specifically in each case).
the food contains substances whose use in food is prohibited according to Annex III, Part A in the regulation on fortification of foods
the food contains substances exceeding the maximum limit in Annex III, Part B of the EU Regulation for fortified food (to be assessed on a case-by-case basis).

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

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
Decree (726/2007) of the Ministry of Trade and Industry on the national measures required by the entry into force of Regulation (EC) No. 19025/2006 of the European Parliament and of the Council on the addition of vitamins and minerals and of certain other substances to foods
Decree of the Ministry of Agriculture and Forestry (754/2016) on the addition of vitamin D to skimmed homogenised milk
Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers
Finnish Food Act (297/2021, Section 6)
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 https://ec.europa.eu/food/system/files/2016-10/labelling_nutrition-vitamins_minerals-guidance_tolerances_1212_en.pdf
Guideline 6538/04.02.00.01/2021 of the Food Authority: Guidelines for the control of fortified foods.
Guideline 6539/04.02.00.01/2021 of the Food Authority: Guide on withdrawal of fortified foods.

Updates in version 5:

Removed packing and brokering (agent activity) from the To be taken into consideration section.
Added Marketing 13.3 as the recommended Oiva line to be inspected at the same time.
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.
Added clarifications to examples
Corrected Finnish Food Authority guide numbers, guide 6538/04.02.00.01/2021 replaces guide 17059 and guide 6539/04.02.00.012021 replaces guide 17051.

11.3 Genetically Modified Ingredients

Guide/version: 2167/04.02.00.01/2021/4, valid from 1.7.2021

To be taken into consideration:

This Guideline only applies to retail stores or catering establishments if they import the foods referred to (from the internal market and/or third countries).
The Guideline does not apply if the operator does not use “high-risk foods” that might be genetically modified (soy, maize, rapeseed, rice, papaya or linseed) or the “GMO free” marketing claim.

This point is controlled, when

the operator manufactures, has manufactured for it or imports (from the internal market or third countries) foods that are or contain genetically modified organisms or ingredients made of such organisms.
the operator manufactures, has manufactured for it or imports (from the internal market of third countries) “high-risk foods” that very probably could be or contain genetically modified organisms or ingredients made of such organisms (plants that are farmed outside the EU as genetically modified varieties, such as soy or maize from the USA, rapeseed from Canada, rice from China or papaya from Thailand or the USA).
the operator uses on its products the voluntary "GMO free" or comparable marketing claim.

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 controlling the following matters:

The operator has ensured, based on e.g. a batch-specific agreement or an analysis certificate, that any “high-risk foods” that could contain a genetically modified substance (soya, maize, rapeseed, rice, papaya or linseed) comply with what has been ordered, i.e. they either are or are not genetically modified.
The operator can, by means of documents and/or analyses conducted in the operator’s own check or on behalf of the goods supplier, demonstrate that the foods only contain genetically modified organisms authorised in the EU for use in food.
- The use of genetically modified organisms not authorised in the EU is prohibited.
GMO labelling complies with legislation.
- The list of ingredients or elsewhere in labelling shall indicate if the food is genetically modified or an ingredient of the food contains more than 0.9 % of a GM substance.
The traceability requirements laid down in legislation on genetically modified organisms and food are met.
- An indication of genetic modification, a unique identifier, a 5-year filing obligation for documents.
The voluntary “GMO free” or comparable marketing claim used in the product must not mislead the consumer.
It is allowed to use the “GMO free” marketing claim for
- A food of plant origin where a genetically modified variety authorised in the EU exists for a food or an ingredient of it and the content of the genetically modified substance in the food is 0% and this can be demonstrated by batch-specific analysis certificates.
- A food of animal origin where the animal has been fed with regular feed (maximum presence of 0.9% of a genetically modified ingredient) throughout its lifecycle.
It is permitted to use the “Animal fed with GMO-free feed” or comparable claim for
- A food of animal origin where the animal has been fed with GMO-free feed (presence of 0% of a genetically modified ingredient) throughout its lifecycle and the GMO-freeness of the feed has been ensured by batch-specific analysis certificates.

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

The operator has in their own-check activities identified and assessed requirements related to any GM foods as well as “high-risk foods” and is able to demonstrate by means of documents (e.g. appropriate procurement contracts, product specifications, analysis certificates and/or audits) that the management of critical points is under control.

If the operator uses the “GMO free” or a comparable marketing claim, the requirements for the claims are meet.

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

documents related to ”high-risk foods” possibly containing a genetically modified substance show some minor shortcomings, inaccuracies or errors, but notwithstanding these, it is possible to verify that the management of critical points is under control
GM foods or ingredients authorised in the EU are indicated, but labelling does not fulfil exactly the conditions laid down in legislation
there are some minor shortcomings or errors in traceability documents on genetically modified organisms or food, but notwithstanding these, they can be traced
documents or analysis certificates of the products marketed using the "GMO free" or comparable marketing claim show some minor shortcomings, inaccuracies or errors, but notwithstanding these, it is possible to verify that the "GMO free" or comparable marketing claims used by the operator are not misleading to the consumer.

There are some clear shortcomings in the management of documents related to any GM foods or ingredients, or in the labelling of such foodstuffs or ingredients. Such issues include, for example:

no documentation can be presented regarding the genetic modification, or non-modification, of ”high-risk foods” possibly containing a GM substance
GM foods or ingredients authorised in the EU that have been used are not indicated in the labelling
there are no traceability documents on genetically modified organisms or foods, or the documents contain essential shortcomings or errors, and the traceability of the products cannot be verified
documents or analysis certificates of the products marketed using the "GMO free" or comparable marketing claim are missing or they contain some essential shortcomings or errors, which makes it impossible to verify that the marketing claims are not misleading to the consumer.

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

an analysis has shown the foodstuff to contain a GM substance unauthorised in the EU; but the operator has failed to take corrective actions
no documentation can be presented regarding the genetic modification, or non-modification, of “high-risk foods” possibly containing a GM substance, and the operator has failed to take corrective action despite being requested or ordered to do so
GM foods or ingredients authorised in the EU that have been used are not indicated in labelling despite a request or order to do so
the operator is unable to present traceability documents on genetically modified organisms or foods, despite a request or order to do so
the "GMO free" or comparable marketing claim used by the operator is misleading to the consumer, and the operator has failed to take corrective actions despite being requested or ordered to do so.

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

Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed
Regulation (EC) No 1830/2003 of the European Parliament and of the Council concerning the traceability and labelling of genetically modified organisms (GMOs) and the traceability of food and feed products produced from GMOs and amending Directive 2001/18/EC
Finnish Food Authority Guide 2323/04.02.00.01/2020: Control guideline for genetically modified foods
Finnish Food Authority Guide 2424/04.02.00.01/2020: Use of the voluntary ”GMO free” marketing claim in food and feed
Finnish Food Authority Guide 2681/04.02.00.01/2020: Guideline on the recall of unauthorised genetically modified food and feed.

Updates in version 4:

Added use of the “GMO free” or comparable marketing claim to the definition of the excellent grade
Terms of use of the ”GMO free” or comparable marketing claim opened up
Text stylised
Guide No 2167/04.02.00.01/2021 replaces Guide No 10235.

11.4 Novel Foods and New Processes

Guide/version: 2168/04.02.00.01/2021/4, valid from 2.1.2024

To be taken into consideration:

This point is controlled, when a food business operator

manufactures, contracts another party to manufacture, imports (from the internal market and/or from third countries) sells, or serves food or food ingredients whose use as food is not widely known. Such foods or ingredients of foods include:
- wild plants that are not generally used as food
- exotic plants from non-EU countries (particularly in food supplements)
- insects
- new extracts made from a foods of animal origin, mushrooms, or plants
- new synthetic food ingredients.
uses other than a generally used production method/process that causes significant changes in the composition or structure of the foods or food ingredients, affecting their nutritional value, metabolism, or concentration of undesirable substances. Such production methods/processes include:
- nanotechnology
- UV processing
- pasteurisation methods not based on heating (e.g. high-pressure pasteurisation).

Matters to be controlled:

e 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 checking the following:

The operator knows the novel food status of the foods, food ingredients, and processes they use, i.e.
- whether the food has an established history of food use to a significant degree in the EU before 15 May 1997, or
- whether they use a manufacturing process that has not been used in food production in the EU before 15 May 1997, and whether the new manufacturing process will cause significant changes in the composition or structure of the food, affecting its nutritional value, metabolism, or concentration of unwanted substances (applies to both manufacture and outsourced manufacture).
The authorized novel foods used by the operator meet the conditions for their use.
The operator does not use foods, food ingredients, or manufacturing processes that are considered as unauthorized novel foods.

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

The operator has, as part of its own-check activities, assessed the novel food status of any foods, food ingredients, and manufacturing processes that could be considered potential novel foods. The operator has also ensured that it does use any unauthorized novel foods.

The authorized novel foods used by the operator meet the conditions for their use.

There are minor deficiencies, inaccuracies, or errors in the management of the requirements for novel foods and/or new manufacturing processes. However, these do not prevent the verification of the novel food status or the acceptability of the food, food ingredient, or manufacturing process. For example:

minor inaccuracies in the name of the authorised novel food.

There are clear shortcomings in the management of the requirements for novel foods and/or new manufacturing processes. For example:

it is suspected that the food, food ingredient of food or manufacturing process used by the operator is considered an unauthorised novel food, but the operator has not confirmed its novel food status.

The operator is not able to comply with the requirements for novel foods and/or new manufacturing processes. There are shortcomings requiring an immediate correction or recall. For example:

the operator uses foods, food ingredients, and/or manufacturing processes that are considered unauthorized novel foods which have not undergone the safety assessment required by the Novel Food Regulation;
it is suspected that the food, food ingredient, or manufacturing process used by the operator is considered an unapproved novel food, and the operator has not confirmed the novel food status of said food, food ingredient, or manufacturing process despite being issued a request or order for doing so.

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

Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods
Commission Implementing Regulation (EU) 2017/2470 on the Union list of approved novel foods (latest consolidated version) (authorized novel foods with their conditions of use)
Finnish Food Authority Guidance (4317/04.02.00.01/2021/7) for the recall of unauthorized novel foods
The Novel Food Status Catalogue of the European Commission (novel food statuses of different foodstuffs): https://food.ec.europa.eu/safety/novel-food/novel-food-catalogue_en

Updates in version 4

The instructions’ scope of application has been expanded to food service activities
Compliance with authorized novel foods added to the list of matters to be controlled
Union list of authorized novel foods added to the list of legislation
Updated the number of the recall guidance and the link to the novel food status catalogue