Guide on control of foodcontactmaterials

Guide number 4217/04.02.00.01/2021

1 INTRODUCTION

A material or article intended to come into contact with food, referred to as a food contact material (hereinafter "FCM"), means materials and articles intended to come into direct or indirect contact with food. Examples include food packaging, tableware and kitchen utensils, small kitchen appliances used in food preparation, single-use articles, disposable gloves, food industry processing equipment including pipes, hoses, seals and pumps, as well as food storage tanks. Products used in the manufacture of food contact materials, such as intermediate materials (for example plastic granulates used to manufacture plastic films or pulp used to manufacture paper), coatings, adhesives and printing inks, are also considered food contact materials. Food contact materials may consist of any type of material, including plastics, paper, paperboard, metals and combinations thereof, ceramics, regenerated cellulose, rubber, silicone, ion-exchange resins, wood, stone, leather or textiles.

The safety of packaging materials and other food contact materials forms an integral part of food safety. Food contact material safety is of broad importance because all foods come into contact with a wide variety of materials and articles at different stages of the food chain, and there is always a possibility that constituents from those materials may migrate into food.

Responsibility for the safety of food contact materials lies with all operators in the supply and use chain, including manufacturers, contract manufacturers, importers, wholesalers, distributors, marketers and food business operators. Competent authorities verify compliance by inspecting operators' processes, self-monitoring systems, documentation demonstrating compliance and, where necessary, by taking samples. Food contact materials used in food businesses are also assessed during Oiva inspections of food establishments.

The fundamental objective of food contact material legislation is to minimise the migration of chemicals from materials and articles into food to a level that does not endanger human health.

Purpose of the Guideline

This guideline is intended for authorities responsible for enforcement under the Finnish Food Act. Its purpose is to ensure the safety of food contact materials, harmonise food safety control procedures and promote equal treatment of operators. The guideline may also be useful for businesses in the sector when establishing quality management systems or self-monitoring programmes required under good manufacturing practice.

The activities of public authorities must be based on powers conferred by law and carried out in strict compliance with legislation. Official guidelines are not legally binding on other authorities or operators. Questions concerning the application of legislation are ultimately decided by courts of law. This guideline contains interpretations concerning the application of legislation. The interpretations presented represent the Finnish Food Authority's view of how the legislation should be applied.

Terms and definitions of this guide

This Guide uses the following terms and their definitions. Control complies with the guidelines issued in conjunction with each term.

Dual-use substance

An authorised food additive (Regulation (EC) 1333/2008) or flavouring (Regulation (EC) 1334/2008) used also in the manufacture of food contact materials. Food business operators need to know what dual-use substances a food contact material contains so that they can assess whether food that is in contact with a food contact material containing such substances is still in compliance. Upon request, the food business operator shall be provided with the names of the dual-use substances and information on their quantity (e.g. level in contact material or migration information). The Plastic Regulation (EC) 10/2011 requires a food contact material operator to report dual-use substances in the declaration of compliance. The general resolution of the Council of Europe on contact materials, which serves as a general guide for non-harmonised materials, also guides the reporting of dual-use substances in the declaration of compliance.

Food contact materials

The Food Act (297/2021) defines food contact material as follows: Food contact material means materials and articles which are in direct or indirect contact with food, or which are intended to be, or can be assumed to be brought into contact with food.

Final materials and articles, as well as so-called intermediate materials, from which final food contact materials or articles are made, are considered food contact materials.

Final food contact materials are materials and articles which are in contact, are intended to come into contact with, or can be assumed to come into direct contact as such with primary production products and food products at any stage of preparation.

Intermediate materials are materials or mixtures of materials used in the manufacture of the final food contact material, e.g. plastic granules, plastic additive mixtures (masterbatch), printing inks, adhesive mixtures, pulp, ceramic glazing and clay mixtures, and plastic films used as a single layer in multi-layer materials.

Individual chemicals used in the manufacture of food contact materials or their intermediate materials are not food contact materials. However, the manufacturer must have adequate information on them with regard to their safety.

This Guide uses the abbreviation FCM for food contact material.

Harmonised FCM <> non-harmonised FCM

Harmonised FCM means a material or article for which specific legislation for each material at the EU level has been adopted pursuant to the Food Contact Materials Framework Regulation (EC) 1935/2004. Such materials include plastic, ceramics and regenerated cellulose. Whereas non-harmonised FCMs are all materials and articles for which there is no specific legislation for each material at the EU level, such as paper and paperboard and metals.

Food contact material operator

The Food Act (297/2021) defines a food contact material operator as follows: A food contact material operator means an operator who places food contact materials on the market.

This Guide also uses terms such as manufacturer, importer or wholesaler to specify the food contact material operator.

Food contact material operations

The Food Act (297/2021) defines food contact material operations as follows: Food contact material operations means the manufacture of food contact materials and intermediate materials and articles used in their manufacture, the wholesale of food contact materials as well as imports of food contact materials from the internal market and from outside of the European Union.

Imports of food contact materials

Imports of food contact materials means imports of intermediate or final contact materials and articles, both from the internal market and from third countries. An importer from the internal market and an importer from a third country have the same responsibility for ensuring the safety and compliance of the food contact materials they import.

An importer can be the sole importer of food contact materials, or the import can take place in connection with other activities, such as grocery stores, which import the food contact materials they sell to consumers themselves. Conversely, activities in which a food business operator, e.g. a bakery, imports food contact materials that it uses for its own activities, e.g. packages its own food products, are not considered food contact material operations. Such operations are included in registered food premises and are monitored as part of planned monitoring under Oiva inspections.

It is also possible that the import takes place through a so-called intermediary, without this intermediary ever owning the imported food contact material. The actual sale takes place between a foreign food contact material operator and a Finnish food contact material operator or retailer of food contact materials, while the intermediary acts as a representative and marketer for the products. In such so-called agency activities, the intermediary acts on behalf of the importer in providing information and is responsible for ensuring sufficient and correct information concerning the safety and compliance of food contact materials in marketing.

Wholesale of food contact materials

Wholesale of food contact materials means the sale and distribution of contact materials to another company, e.g. a downstream processor of contact materials or a food establishment. Sales can take place either remotely online and/or through a wholesale store. From the food control aspect, wholesale can also have a double role covering both the sale of food and the sale of food contact materials. In such operations, the sale of food is monitored in accordance with Oiva inspection guideline 14.1 and the wholesale sale of food contact materials in accordance with the Food Authority's guide 4217/04.02.00.01/2021 . The inspector must take into account that the shortcomings identified in the control of food contact material must not affect the grade issued in the Oiva inspection report.

The operator may engage in both the import and wholesale of food contact materials, and the retail trade, in which case the inspection focuses primarily on the import and wholesale trade. Retail sales are not controlled regularly and systematically, but where appropriate can be inspected in connection with complaints or withdrawals for example.

Renting food contact materials for use by a food business operator, e.g. box pools or container rental, is treated as the wholesale of food contact materials and is subject to the same rules as the wholesale of contact materials for food business operators, including the obligation to register with the local food control authority. Rental of contact materials directly to the consumer is treated as a retail activity and does not require registration with local food control authority.

Manufacture of food contact materials

The manufacture of food contact materials means the manufacture of intermediate materials, their downstream processing and the manufacture of the final food contact material and article.

Downstream processing of food contact materials means the further processing of an intermediate material into the final food contact material, e.g. printing of contact materials with printing inks, the assembly of bags or packing boxes, the manufacture of containers or the manufacture of multi-layer film, e.g. by lamination. Downstream processing is also often referred to in control as conversion.

A contract manufacturer has the same responsibility for the food contact material as the manufacturer, so when this guide refers to manufacturing, it always also means having the product manufactured, even if this is not specifically mentioned.

Migration

The transfer of substances from a food contact material to food is called migration. Migration can occur in several different ways or even at the same time including through diffusion, adhesion or the set off phenomenon, depending on the type of food contact material. Set off means a situation where the printing side of a printed food contact material transfers printing ink constituents to the non-printing side of the printed material when the printed sheets are stacked or rolled up. The printer's job is to ensure through its own-check process that there is no set-off or other migration of harmful substances in the ink from the printed material to the food.

Own-check

The own-check of food contact material operations means a documented quality management system in accordance with Commission Regulation (EC) 2023/2006 to ensure good manufacturing practices. Under the Food Act (297/2021), a food contact material operator shall have a system by which the operator identifies and manages the hazards related to its operations and ensures that the operations conform to the requirements laid down in food legislation. The operator shall record the results of its own-check process with sufficient accuracy.

OML/ORL

OML = overall migration limit (e.g. Plastic Regulation (EU) 10/2011)/ ORL = overall release limit (incl. EDQM general resolution). The overall migration limit from food contact material describes the total amount of all substances that can migrate into the food.

SML/SRL

SML = specific migration limit (e.g. Plastic Regulation 10/2011) / SRL = specific release limit (incl. EDQM general resolution). Specific migration limit for a substance with restrictions describes the maximum migration permitted for a single chemical substance.

2 GENERAL REQUIREMENTS APPLICABLE TO FOOD CONTACT MATERIALS

2.1 Scope of Food Contact Material Legislation

In addition to foodstuffs, the Finnish Food Act (297/2021) also applies to food contact materials. A food contact material operator must ensure that food contact materials are suitable for food contact use and that they do not endanger human health, cause unacceptable changes in the composition of food, or adversely affect its organoleptic characteristics. The operator must also ensure that information provided on food contact materials does not mislead consumers. The Food Act also includes requirements concerning the traceability of food contact materials (14 §) and the self-monitoring obligation of food contact material operators (15 §). The provisions concerning official controls laid down in the Food Act likewise apply to food contact materials. These are described in more detail in section 6.4 of this guide.

The requirements of the Food Act are based on the requirements set out in the Contact Materials Regulation (EC) 1935/20041 (hereinafter referred to as the Framework Regulation) and Regulation (EC) 2023/2006 (hereinafter referred to as the GMP Regulation) for contact materials and contact material activities. The registration notification for contact material activities is provided for in Section 13 of the Food Act. The requirement is based on Article 10 of the Control Regulation (EU) 625/2017 and is described in more detail in Section 5 of these instructions.

The compliance of food contact materials is generally regulated by the Framework Regulation, in addition to which some special provisions have been laid down under the Framework Regulation for materials and substances. According to the Framework Regulation, food contact material legislation applies to materials and articles intended to come into direct or indirect contact with food and which, in their finished state:

are intended to come into contact with food;
are already in contact with food; or
can reasonably be expected to come into contact with food.

The legislation on food contact materials does not apply to:

antiques;
edible coverings and coatings that form part of a food and may be consumed together with that food (for example cheese rinds and wafer ice-cream cones); or
fixed public or private water-supply installations and equipment.2.2 General Safety Requirements for All Food Contact Materials.

2.2 General safety requirements for all FCM

Article 3 of the Framework Regulation lays down the general safety requirements applicable to all food contact materials and articles regardless of the material from which they are made. Food contact materials and articles must be manufactured in compliance with good manufacturing practice so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities that could:

endanger human health;
bring about an unacceptable change in the composition of the food; or
bring about a deterioration in the organoleptic characteristics of the food.

In addition, the labelling, advertising and presentation of materials and articles must not mislead consumers.

The safety and hygiene of food contact materials are also regulated by Regulation (EC) No 852/2004 on the hygiene of foodstuffs. Annex II to the Regulation provides that surfaces in food handling areas, including equipment surfaces, and particularly surfaces that come into contact with food, must be maintained in a sound condition and be easy to clean and, where necessary, disinfect. This generally requires the use of smooth, washable, corrosion-resistant and non-toxic materials unless the food business operator can demonstrate to the competent authority that alternative materials are suitable. Furthermore:

equipment must be constructed from materials that minimise the risk of contamination (Annex II, Chapter V); and
wrapping and packaging materials must not be a source of contamination (Annex II, Chapter X).

In addition, Annex III to Regulation (EC) No 853/2004 laying down specific hygiene rules for food of animal origin requires that packaging materials must not be a source of contamination for the packaged product.

In practice, the compliance and safety of a food contact material are based on the following:

Sufficient information on the composition of the food contact material and the raw materials and intermediate materials used in its manufacture.
Adequate knowledge of food contact material legislation, including relevant food legislation such as food additive and flavouring legislation in the case of dual-use substances.
Effective control of the operator's own processes, including monitoring and record-keeping.
Testing of materials and articles against applicable legal requirements or selected safety references.
Assessment of organoleptic characteristics.
Determination of the composition of the food contact material where necessary.
Verification of compliance with migration and/or total content requirements through laboratory testing, calculations or modelling.
Risk assessment of the food contact material and substances migrating from it.
Maintenance and updating of safety and compliance information, including document control and traceability procedures.
Communication of information throughout the food contact material supply chain by means of documentation and labelling. This is essential in order for the next operator in the supply chain to carry out its own quality and safety assurance activities.
Compliance by food business operators with the instructions for use specified by the manufacturer of the food contact material.

2.3 Information and Labelling of Food Contact Materials

In order to ensure that consumers are able to use food contact materials safely, sufficient information must be provided in accordance with Article 15 of the Framework Regulation.

Products intended to be marketed to consumers (whether sold or supplied free of charge) that are not yet in contact with food must be accompanied by the following information:

the words"for food contact", a specific indication concerning their intended use, or the symbol provided in Annex II to the Framework Regulation; however, such information is not necessarily required on articles whose intended use in contact with food is obvious by their nature (for example, a coffee cup);
any special instructions required for safe and appropriate use;
the name or trade name and address or registered office of the manufacturer, producer or seller established within the Union who is responsible for placing the product on the market;
appropriate identification or marking enabling traceability in accordance with Article 17; and
in the case of active materials and articles, information concerning permitted use and other relevant details, including the identity and quantity of substances released by the active component, enabling food business operators to comply with applicable food legislation and food-labelling requirements.

At the retail stage, this information must generally appear on the article itself, on its packaging, or on an attached label.

For plastic food contact materials, the above general labelling requirements must be supplemented by the additional information required under Article 14a of Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food. Active and intelligent food contact materials are furthermore subject to the specific labelling requirements laid down in Commission Regulation (EC) No 450/2009 on active and intelligent materials and articles intended to come into contact with food.

Food business operators must have access to the same information concerning food contact materials as that provided to consumers. Within the supply chain between food contact material operators and food business operators, information relating to labelling may be transmitted through Declarations of Compliance and/or other documents demonstrating compliance and/or commercial documentation.

2.4 Declaration of Compliance

The safety and compliance of food contact materials in accordance with Article 3 of the Framework Regulation must be demonstrated by documentation. According to Article 16 of the Framework Regulation, specific measures adopted under the Regulation require materials and articles within their scope to be accompanied by a written declaration stating that they comply with the applicable rules. This document is commonly referred to as a Declaration of Compliance (DoC).

A Declaration of Compliance must be provided at all stages of trade except the retail stage. In practice, this means that a Declaration of Compliance is required in all business-to-business transactions. The same principle is applied to other material types, with the exception of ceramic materials, for which a Declaration of Compliance must also be available at the retail stage.

For harmonised materials, meaning materials covered by specific EU legislation applicable in Finland, the Declaration of Compliance must be prepared in accordance with the content requirements established in the relevant material-specific legislation.

The Declaration of Compliance and its content are regulated in the specific legislation issued under the Framework Regulation, including for the following types of materials.

Plastic contact materials - Plastics Regulation (EU) 10/2011 (Article 16 and Annex IV);
Recycled plastic materials - Recycled Plastics Regulation (EU) 1616/2022 (Articles 5 and 29 and Annex III forms);
Ceramic contact materials - Regulation (KTMa) 165/2006, Article 5, Annex 3;
Regenerated cellulose - Regulation (KTMa) 697/2005, Article 6.

2.4.1 General Guidance on the Content of the Declaration of Compliance

Although there is still relatively little EU-level specific legislation governing food contact materials, some EU Member States have established national requirements or guidance on the provision and content of declarations of compliance for all food contact materials and articles. In addition, the Council of Europe (EDQM) has issued a general resolution concerning non-harmonised materials, providing recommendations on declarations of compliance and their content.

The Finnish Food Authority (Ruokavirasto) has stated that a Declaration of Compliance should accompany a material or article regardless of the material type involved. Operators must be able to demonstrate compliance with the inertness requirements set out in Article 3 of the Framework Regulation, and a Declaration of Compliance is considered the most effective means of doing so. As legislation does not regulate the content of Declarations of Compliance for non-harmonised materials, the declaration may be presented in various formats, provided that all information necessary to demonstrate safety is included. The presentation must, however, be clear and identifiable as relating to the specific product for which it has been issued.

The Finnish Food Authority recommends that operators use the guidance on declarations of compliance provided in the Council of Europe (EDQM) General Resolution (Section 8.3) when preparing declarations of compliance for non-harmonised materials. In addition, the Finnish Food Authority has published general guidance on its website for preparing declarations of compliance. The website also includes tools (available in Finnish and English) for drafting Declarations of Compliance containing sufficient information.

Where food contact materials are supplied regularly under a contractual arrangement, it is sufficient for compliance documentation to be provided at the start of deliveries and thereafter at least once every three years. However, if there are changes in the composition of the food contact material or in the legislation applicable to the material, updated compliance documentation must always be provided to contract customers. For one-off orders or deliveries, the compliance documentation should be supplied on an order- or delivery-specific basis.

The operator may provide the Declaration of Compliance either in paper form or electronically, for example by making it available to customers through an online store, provided that traceability and version control are ensured.

Information required for a EU Declaration of Conformity under the Packaging and Packaging Waste Regulation (PPWR) (EU) 40/2025 may also be included as a separate section within the Declaration of Compliance. However, it should be noted that the purpose and legal basis of the PPWR EU Declaration of Conformity are not related to food safety. Consequently, such information must be clearly distinguished from information provided for food safety purposes so that the reader understands that these are separate sets of information. Food safety-related information is based on the requirements of the Framework Regulation and must be readily identifiable. If it is not possible to distinguish food safety-related information sufficiently clearly from PPWR-related information, the competent authority may require separate documents to be prepared.

2.4.2 Supporting Documentation for the Declaration of Compliance

Appropriate documentation must be available to demonstrate compliance. Such documentation must be made available to the competent authorities upon request (Framework Regulation, Article 16).

In addition to the declaration of compliance itself, manufacturers, contract manufacturers, and importers of food contact materials are required to maintain supporting documentation for the declaration and provide it to inspectors upon request. Wholesalers must possess up-to-date declarations of compliance.

Supporting documentation demonstrates the basis on which the compliance of the food contact material and the corresponding declaration of compliance are founded. Such documentation may include, for example, composition data for the food contact material, laboratory test results, risk assessments of migrating substances, calculations and modelling of substance migration, and similar evidence.

The Council of Europe (EDQM) has published guidance on supporting documentation demonstrating compliance for non-harmonised food contact materials. The Finnish Food Authority recommends using this guidance when determining what compliance-related documentation is required in addition to the declaration of compliance itself.

2.5 Traceability

The term “traceability” of food contact materials refers to the ability to trace and follow a material or article through all stages of production, processing and distribution (Framework Regulation, Article 2).

More detailed provisions regarding traceability are laid down in Article 17 of the Framework Regulation.

The traceability of materials and articles shall be ensured at all stages in order to facilitate control, the withdrawal of defective products from the market, consumer information, and the attribution of responsibility.

Taking due account of technological feasibility, business operators shall have in place systems and procedures enabling them to identify the businesses from which, and to which, materials and articles and, where appropriate, substances or products covered by this Regulation and its implementing measures and used in their manufacture have been supplied. This information shall be made available to the competent authorities on demand.

Materials and articles placed on the market within the Community shall be identifiable by an appropriate system that allows their traceability through labelling or relevant documentation or information.

With regard to retention periods for documentation related to the traceability of packaging materials, the same principle based on food product shelf life that is applied in food traceability guidance may also be applied correspondingly.

Traceability also extends to various compliance-related documents and to whether they can be linked to one another and to the product itself. As a minimum requirement, the declaration of compliance and its supporting documentation, such as test results, must be traceable to the food contact material concerned, for example through the product name, article number, or another unique product identifier.

3 PRODUCT-SPECIFIC REQUIREMENTS

3.1 EU Legislation and Finnish National Legislation Applicable to Specific Materials

Whenever material-specific legislation exists at EU level, it must be complied with, as it forms part of the legal framework applicable in Finland. EU Regulations are directly applicable as such, while Directives have been implemented into Finnish legislation through national measures. The latest amended or consolidated version of each legal act should always be applied.

In addition to the Framework Regulation applicable to all food contact materials, several material-specific and substance-specific measures have been adopted within the European Union, including:

Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food;
Decree of the Ministry of Trade and Industry 165/2006 on ceramic materials and articles intended to come into contact with food, implementing Council Directive 84/500/EEC and Commission Directive 2005/31/EC;
Decree of the Ministry of Trade and Industry 697/2005 on materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs, implementing Directive 2004/14/EC;
Commission Regulation (EU) 2022/1616 on recycled plastic materials and articles intended to come into contact with foods;
Commission Regulation (EC) No 450/2009 on active and intelligent materials and articles intended to come into contact with food;
Commission Regulation (EC) No 1895/2005 on the restriction of use of certain epoxy derivatives in materials and articles intended to come into contact with food;
Decision of the Ministry of Trade and Industry 903/1994 concerning the migration of N-nitrosamines and N-nitrosatable substances from materials and articles intended to come into contact with food;
Commission Regulation (EU) 2024/3190 on the use of bisphenol A (BPA) and other hazardous bisphenols and hazardous bisphenol derivatives in certain materials and articles intended to come into contact with food; and
Commission Regulation (EU) No 284/2011 laying down specific conditions and detailed procedures for the import of polyamide and melamine plastic kitchenware originating in or consigned from the People's Republic of China and the Hong Kong Special Administrative Region, China.

In addition, Finland has one national measure applicable to non-harmonised food contact materials. Decision of the Ministry of Trade and Industry 268/1992 concerning the migration of certain heavy metals from materials and articles intended to come into contact with food.

This Decision applies to all food contact materials and is relevant to non-harmonised food contact materials imported from third countries or manufactured in Finland. It establishes migration limits for lead, nickel, chromium, and cadmium. For food contact materials intended for infants and young children, the limit values for heavy metals are set at one-tenth of the limit values specified in the Decision. The decision will also apply to ceramic contact materials with a lip border.

Testing in accordance with this Decision is not required for materials or articles that are covered by material-specific EU legislation or lawfully marketed in another EU Member State. In such cases, the operator may provide a self-declaration to the competent authority confirming that the product is lawfully marketed in another Member State.

Finnish legislation concerning food contact materials is compiled on the websites of the Ministry of Agriculture and Forestry and the Finnish Food Authority. The most reliable source for the latest consolidated version of EU legislation is EUR-Lex, where legislation can be searched by entering the number and year of the legal act and selecting the most recent consolidated version.

3.2 Materials and Articles for Which No Harmonised EU Legislation Exists

Even where no material-specific legislation exists, operators remain responsible for the safety of the food contact materials and articles they place on the market. They must be able to demonstrate compliance with the requirements of Article 3 of the Framework Regulation.

For non-harmonised food contact materials, the operator must select an appropriate safety reference against which compliance and safety will be assessed. Preference should be given to:

national legislation or official guidance by authorities of another EU Member State;
legislation or official guidance issued by a European country outside the EU; or
recognised material-specific safety standards.

The following provides illustrative examples of the most common safety references applicable to the most common non-harmonised materials.

The Finnish Food Authority recommends that operators apply the Council of Europe (EDQM) Resolution on Food Contact Materials and the related technical guides, which are widely recognised by both authorities and industry throughout Europe. These publications are available free of charge from the EDQM website upon registration.

The EDQM has published a general resolution applicable to all food contact materials and material-specific technical guides supplementing the general resolution.

Technical guides are available, among others, for:

metals and alloys (2024);
paper and board (2021); and
cork materials (2025).

Paper and board constitute the most important category of food contact materials for which no harmonised EU legislation exists. The primary safety reference is the EDQM Technical Guide for Paper and Board Used in Food Contact Materials and Articles.

In Finland, operators may also use recommendations published by the German Federal Institute for Risk Assessment (Bundesinstitut für Risikobewertung, BfR) as a safety reference. These recommendations are also available in English and are widely recognised in Europe.

The BfR has also issued recommendations for silicone materials, waxes and several other categories of non-harmonised food contact materials.

Switzerland has developed national legislation concerning printing inks used in food packaging. In addition, the European Printing Ink Association (EuPIA) has developed industry guidance and internal criteria regarding substances that may or may not be used in printing inks intended for food packaging applications.

The Nordic Council of Ministers has also published guidance on printing inks, including TemaNord 2012:521, together with inspection checklists intended for official control authorities, the printing ink industry, printing ink distributors and food business operators.

Food contact material safety relating to printing inks is particularly complex because of the critical manufacturing stages involved in printing processes. The guidance describes the main printing processes and identifies important control points that are useful for both official controls and operators' quality assurance systems.

In addition, operators must comply with the requirements of the GMP Regulation concerning the handling of printing inks and the prevention of set-off, whereby substances from the printed side of a package transfer to the food-contact side.

For metallic food contact materials, the EDQM Technical Guide for Metals and Alloys (link above) is considered the preferred safety reference. The migration limits established in that guide may also be used as reference values when assessing metals migrating from other non-harmonised food contact materials.

The United States Food and Drug Administration (FDA) has developed its own legislation concerning food contact materials. FDA requirements may be used as a safety reference where no relevant EU legislation exists, no national legislation from another EU Member State exists and no official guidance from another European country is available. However, where a suitable European safety reference is available, FDA legislation alone cannot be relied upon as the safety reference for materials placed on the European market.

The Finnish Food Authority maintains links to material-specific safety references and other useful resources for both operators and inspectors on its website.

4 ENSURING FOOD CONTACT MATERIAL SAFETY THROUGH SELF-MONITORING

According to Commission Regulation (EC) No 2023/2006 on good manufacturing practice for materials and articles intended to come into contact with food (the GMP Regulation), a business must have a quality management system that covers the expertise required for its operations, quality assurance, quality control and documentation. In practice, this corresponds to the self-monitoring obligation laid down in Section 15 of the Finnish Food Act for operators in the food contact materials sector.

In addition to manufacturers, the self-monitoring obligation applies to all stages of the food contact material distribution chain, including import activities (both acquisitions from within the EU and imports from third countries) and wholesale distribution activities.

A quality management system or self-monitoring programme does not require approval by the competent authority and does not have to be based on any particular quality management standard. However, it is considered good practice for the operator and the inspector to discuss the programme and for the inspector to provide comments and suggestions concerning its adequacy. Not every element of self-monitoring needs to be documented in writing, particularly in small-scale food contact material operations. Where necessary, the competent authority may request that the operator supplement its self-monitoring arrangements.

Operators may also use recognised standards when establishing a GMP quality management system or self-monitoring programme, including:

SFS-EN 15593 Packaging - Management of hygiene in the production of packaging for foodstuffs - Requirements
SFS-EN ISO 22000 Food safety management systems - Requirements for any organization in the food chain
BRC/IOP Packaging Materials Global Standard.

According to the GMP Regulation, good manufacturing practice requires the operator to ensure, among other things:

Adequate knowledge of applicable food contact material legislation, its own manufacturing processes and other matters relevant to risk management, together with the maintenance of staff competence and training.
A quality management system including a quality assurance programme covering hazard analysis, process control, establishment of finished product criteria and identification of control points.
Monitoring of the implementation of quality assurance measures, including process monitoring, corrective actions and finished-product testing.
Documentation and maintenance of records, together with communication of relevant information throughout the supply chain.
Effective traceability of food contact materials and articles.

In particular, food contact material operators must take into account the specific requirements set out in the Annex to the GMP Regulation concerning the use of printing inks on the non-food-contact side of materials and articles (i.e. measures intended to prevent the so-called set-off phenomenon), as well as the additional requirements established for the quality assurance system of recycled plastic manufacturing processes and for the handling of production scrap.

Product Withdrawal and Recall Procedures

Under the Finnish Food Act, operators in the food contact materials sector are required to initiate the withdrawal or recall of non-compliant products from the market in accordance with Article 19 of Regulation (EC) No 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. This obligation applies in the same manner as it applies to food business operators.

The operator's self-monitoring system should therefore include agreed procedures for implementing withdrawals and recalls of food contact materials.

The Finnish Food Authority has published guidance on self-monitoring for food contact material activities and provides recommendations tailored to different types of operators (manufacturers, importers and wholesalers). Operators may also use the guidances and inspection forms published by the Finnish Food Authority when developing their self-monitoring programmes. These checklists summarise the issues that competent authorities expect operators to address within their quality management systems.

Use of Food Contact Materials in Food Businesses

Although the retail sale of food contact materials is not subject to a self-monitoring obligation under food contact material legislation, the use of food contact materials in food businesses must be addressed within the food business operator's own self-monitoring system.

The Finnish Food Authority has issued guidance explaining how food business operators should take food contact material safety into account in their operations and self-monitoring procedures.

4.1 Testing to Demonstrate Compliance

As a general rule, testing and calculations are required to demonstrate the compliance of a food contact material. These may relate to migration of substances, total content of substances, transfer of odour, taste or colour to food or transfer of such properties to food simulants.

Responsibility for arranging such testing lies primarily with the manufacturer of the food contact material. However, importers must ensure that the relevant test reports are available before deciding to place a product on the market.

The specific testing requirements depend on:

the material type;
whether the product is a finished food contact material or an intermediate material intended for further processing;
the material structure;
the intended conditions of use; and
any applicable material-specific legislation.

Material-specific legislation, such as the regulations on plastics and ceramics, specifies which requirements must be demonstrated through testing. Evidence from testing is also required to demonstrate the safety of materials for which no material-specific EU legislation exists (e.g. paper and board, metals, printing inks, etc.), in order to verify their safety.

For the assessment and testing of the safety and compliance of such non-harmonised materials, the operator shall select the necessary studies and tests in accordance with the chosen safety reference. The choice of safety reference must be justifiable. Guidance on safety references for non-harmonised materials is provided in Section 3 of this guidance document. Where necessary, the operator shall carry out its own risk assessment of substances that may migrate from the food contact material.

Under Regulation (EU) No 10/2011 on plastic materials and articles, testing for specific migration limits is not mandatory where mathematical modelling can demonstrate that even the complete transfer of the residual amount of a substance present in the article cannot exceed the applicable specific migration limit. However, where non-compliance of a product is to be demonstrated, the estimated migration value must always be confirmed by practical testing. In addition, the overall migration of plastic food contact materials must always be determined in accordance with the requirements of the Plastics Regulation.

Particularly in the testing of plastic and ceramic articles, the so-called worst-case principle may be applied. Under this approach, a product is selected for testing from a range of articles made of the same material, having the same shape, and intended for the same use, where the ratio of food-contact surface area to volume is the highest. In practice, this generally means testing the smallest product within a series of products of the same shape. In practice, this usually means testing the smallest article within a product range.

Whenever possible, testing should be carried out using the food simulants and test conditions described in guidance issued by the JRC (Joint Research Centre) of the European Commission, which serves as the EU Reference Laboratory for food contact materials.

The EDQM technical guidelines provide guidance on the necessary studies and test methods for the non-harmonized material in question. Example EDQM has published guidelines for substances migrating from printing inks to food or food simulants and the technical guideline of metal release from enamelware.

The Finnish Customs Laboratory serves as Finland's National Reference Laboratory for food contact material testing. In addition, several laboratories in Finland have been approved by the Finnish Food Authority to perform food contact material analyses for operators' self-monitoring purposes under the Finnish Food Act (MMM) 297/2021.

Specialised laboratories elsewhere in Europe may also be used for self-monitoring purposes. However, analyses of official control samples must be carried out only by officially designated control laboratories or by the National Reference Laboratory.

5 REGISTRATION NOTIFICATION OF FCM OPERATIONS TO THE FOOD CONTROL AUTHORITIES

Manufacturers, importers (including both intra-Union acquisitions and imports from third countries) and wholesalers of food contact materials are required to notify the competent local food control authority in Finland of their activities and business premises. This obligation is laid down in Section 13 of the Finnish Food Act.

Where a retailer of food contact materials imports food contact materials from another EU Member State or from a third country, the retailer must also submit a registration notification concerning the import activity, even though the retail sale of food contact materials itself is not subject to registration.

The registration requirement also applies to importers and wholesale distributors operating through online stores that do not maintain their own storage or sales premises, including businesses selling food contact materials through their own online stores or through third-party online platforms.

Food establishments that import food contact materials solely for their own use, for example for packaging food manufactured by the establishment itself, are no longer required to submit a separate notification regarding the import of food contact materials. Such activities are supervised as part of food business controls and the Oiva inspection system.

New businesses and businesses that make substantial changes to their operations must submit a registration notification no later than four weeks before commencing the activity. In addition, any interruption or discontinuation of operations must be notified without delay.

The notification should primarily be submitted through the Environmental Health Electronic Notification Service (Ilppa). Contact details of local food control authorities are available through the Finnish Food Authority.

Upon receipt of a notification, the competent local authority must record the relevant information concerning the operator and the activity in the national environmental health information management system (Vati) and notify the operator that the information has been entered into the system. Such notification may be provided electronically or by another appropriate means. A fee is charged for processing the registration notification in accordance with the fee schedule approved by the relevant food control unit.

Although the registration obligation has been in force since 2010, there are still operators who are unaware of the requirement. Competent authorities should therefore actively identify food contact material operators within their jurisdiction who have not yet submitted a registration notification and encourage them to do so. It is recommended that authorities provide guidance on registration through the Ilppa system on their websites to facilitate compliance.

The Finnish Food Authority provides information on the registration requirement on its website. Information is also made available to businesses through the Enterprise Finland service.

Importance of Registration

The registration requirement ensures that all food contact material operators become aware of their responsibilities relating to food safety and are subject to official control on an equal basis. Effective official control requires competent authorities to have adequate information on operators and the establishments where activities are carried out. Registration also assists authorities in targeting control activities appropriately and facilitates communication with operators.

Where activities are conducted in more than one municipality, a registration notification must be submitted to the competent authority in each municipality where the activity takes place. For example, if an importer has its head office within the jurisdiction of one food control unit and a logistics warehouse related to import or wholesale activities within another jurisdiction, registration notifications should generally be submitted to both authorities, particularly where documentation or quality-management activities are carried out at both locations.

Warehousing and logistics operations related to imports or wholesale distribution may also be provided by a third-party service provider engaged by the food contact material operator.

An operator may centralise activities relating to compliance verification and document management at a single location, such as an import warehouse. In such cases, a separate registration notification for the head office may not be necessary. However, supervision of food contact material activities cannot generally be carried out exclusively through head-office controls. Verification of traceability and practical implementation of labelling requirements typically requires inspections at warehouses or other locations involved in import or wholesale activities.

Where activities fall within the jurisdiction of more than one food control unit, overlapping planned controls should be avoided. Competent authorities should agree among themselves on how supervisory responsibilities are divided so that operators are not subject to unnecessary costs arising from duplicate planned inspections. This does not prevent inspections from being carried out at multiple locations where such inspections are considered necessary for verifying compliance. Further information on official controls of food contact material operators is provided in Chapters 6 and 7 of this Guideline.

5.1 Exceptions Relating to Food Contact Material Activities

5.1.1 Food Establishments that Blow Bottles from Preforms or Thermoform Trays During Packaging Operations

A food business operator that merely forms the final packaging article immediately before filling, for example by blow-moulding PET bottle preforms into bottles or thermoforming trays from plastic sheet, is generally not regarded as a food contact material operator in Finland.

Instead, the supplier of the packaging material (for example, the supplier of bottle preforms) is responsible for compliance and must be registered as a food contact material operator. In addition, the supplier must provide the food business operator with detailed instructions on how the material must be processed into the final food contact article, including information on forming temperature, forming time and pressure, to ensure compliance and safety. The food business operator must follow these instructions.

If the operator deviates from the supplier's instructions, responsibility for ensuring compliance transfers to the food business operator. In such cases the food business operator becomes responsible for ensuring the suitability of the material for food contact use and must arrange, where necessary, compliance testing and other supporting studies.

In order for the above exemption to apply, the Declaration of Compliance provided by the supplier for the packaging preform must demonstrate compliance not only for the preform itself but also for the final package produced from it when the supplier's instructions are followed.

5.1.2 3D printing in food establishments

If a food business operator uses a 3D printer to manufacture, for example, equipment parts or other food contact materials and follows the instructions provided by the printer manufacturer and the raw material supplier, the operator will generally not be required to register as a food contact materials business operator. This is subject to the condition that the printer supplier is registered as a food contact materials business operator, supplies not only the printer but also the raw materials, and has verified the compliance and suitability for the intended use of the final printable product used by the food business operator.

The printer supplier must provide the food business operator with detailed instructions on the use of the printer and the raw material (for example, instructions concerning printing temperature, printing time, and the quantity of raw material to be used). The food business operator must follow these instructions and monitor, as part of its own-check system, the manufacturing conditions used during production. The instructions should also include an image or description of the product whose compliance has been verified by the printer supplier. The instructions must be presented to the competent supervisory authority upon request.

If the food business operator deviates from the instructions provided (for example, by printing products other than those verified as safe by the printer supplier or by sourcing raw materials from another supplier), this exemption regarding registration and compliance verification will no longer apply. In such cases, the food business operator will also be considered a food contact materials business operator and must, among other obligations, verify through appropriate testing that the printed article complies with the applicable requirements.

6.1 Finnish Food Authority

The Finnish Food Authority (Ruokavirasto) plans, directs, and develops official controls related to food contact materials. The Authority provides annual training for inspectors and also participates in training events organized for businesses. Ruokavirasto coordinates the food contact materials control network, which includes representatives from municipal authorities as well as personnel from Finnish Customs and the Customs Laboratory. In addition, Ruokavirasto may organize various control or research projects related to food contact materials supervision.

Within Pikantti, the extranet platform for inspectors, materials from training sessions organized by Ruokavirasto and meetings of the food contact materials control network are maintained in the workspace dedicated to the food contact materials control network.

Training materials and records of meetings of the food contact materials control network are maintained in the relevant workspace of the Pikantti extranet available to inspectors.

6.2 Municipal Food Control Units

Municipal food control units supervise both food contact materials activities and the use of food contact materials in food businesses within their area of responsibility.

The objective of official controls in both sectors is for the competent authority to assess how the safety and compliance of materials and articles are ensured in the company’s operations and whether they meet the requirements of Regulation (EC) No 1935/2004. In food businesses, it is particularly important to ensure that food contact materials are used correctly and in accordance with the instructions for use provided for them.

Official controls are subject to a basic supervisory fee in accordance with the Finnish Food Act (297/2021). In addition, a fee is charged for each inspection, based on the tariff approved by the competent control unit. The fee may not exceed the actual costs incurred by the inspection.

It is desirable that some inspectors within control units specialize in the inspection of food contact materials activities, as this type of supervision differs from traditional food control due to the specific legislation governing food contact materials and the diversity of manufacturing processes involved. Participation in the Finnish Food Authority’s food contact materials control network is recommended as an effective way to deepen expertise in food contact materials matters.

The European Commission’s FCM-BTSF (Better Training for Safer Food) courses also provide valuable training for the supervision of food contact materials activities, and participation is recommended whenever such courses are offered. Inspectors who have completed an FCM-BTSF course are expected to share the knowledge and expertise gained during the training at least within their own control unit, thereby contributing to the development of competence in food contact materials supervision.

6.3 Customs Authorities

Compliance control of food contact materials and articles in connection with imports from countries outside the EU and trade within the EU internal market. The Customs authority is also responsible for monitoring compliance with the specific import conditions laid down in Commission Regulation (EU) No 284/2011 on special conditions and detailed procedures for the import of plastic kitchenware originating in or consigned from China and Hong Kong.

Each year, Finnish Customs takes several hundred samples of imported food contact materials. The Customs Laboratory also conducts migration testing and reviews declarations of compliance and other documentation demonstrating compliance, as well as the content of such documents.

In addition, Customs supervises the compliance of packaging used for packaged non-animal-origin foods and composite products imported either from countries outside the EU or through trade within the EU internal market whether imported from third countries or placed on the market through intra-Union trade.

6.4 Other Competent Authorities Performing Controls in the Food Sector

With regard to food business operations, in addition to the authorities mentioned above, official control of food contact materials is carried out by the following bodies:

Finnish Food Authority Official Veterinarians: supervision of the use of materials and articles in slaughterhouses and establishments operating in connection with them.
Border Control Veterinarians: monitoring compliance with food contact material requirements for packaged foods of animal origin imported from countries outside the EU.
Environmental Health Authorities of the Finnish Defence Forces: supervision of the use of materials and articles in food establishments within their sector.
Finnish Supervisory Acency: supervision of the use of materials in premises where alcoholic beverages are manufactured or handled, and monitoring compliance of alcoholic beverage packaging materials for products imported from countries outside the EU and from the EU internal market.

6.5 Powers and Duties of Competent Authorities During Food Contact Material Inspections

Under the Food Act (297/2021), food control authorities have essentially the same powers, duties and enforcement authority in food contact material establishments as they have in food businesses. Competent authorities therefore have the right to:

enter business premises;
carry out inspections;
obtain information and documents required for official controls, including confidential information where necessary;
take samples; and
initiate administrative enforcement measures when required.

Authorities therefore have the right to obtain and inspect documentation demonstrating the compliance of food contact materials and articles at all stages of the supply chain. Risk assessments and laboratory analyses carried out to verify compliance are the responsibility of the business operator as part of its GMP system and own-check procedures. Upon request, the operator must make available to the competent authority the results of risk assessments, test reports from sample analyses, and any mathematical calculations used to demonstrate compliance. Where necessary, food control authorities belonging to different control units must cooperate in the supervision of compliance documentation.

Any administrative enforcement measures shall be taken in accordance with the provisions of the Finnish Food Act. The Finnish Food Authority (Ruokavirasto) has prepared a guidance (FI, SE) document on the use of administrative enforcement measures under the Food Act in official food control.

If administrative enforcement measures become necessary, authorities shall follow the relevant procedures established in the Food Act.

7 Objectives and Implementation of Official Controls on Food Contact Materials

The primary objective of the requirements applicable to food contact materials is to protect consumer health by ensuring that materials and articles placed on the market are safe and otherwise compliant. The legislation also aims to prevent misleading marketing practices and to ensure the free movement of goods within the European Union.

Article 24 of Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food and Article 5 of Regulation (EU) 625/2017 on official controls require competent authorities to carry out regular controls of materials and articles intended to come into contact with food. Achievement of these objectives requires that official controls be implemented in accordance with the Finnish Food Act (297/2021).

Official control activities consist of:

supervision of food contact material operators; and
supervision of the safe use of food contact materials in food businesses.

Controls may include both:

documentary checks; and
verification of practical operations, including manufacturing and quality management processes.

Official controls should be organised on a risk-based basis. Retail sales of food contact materials are not subject to routine control programmes. However, controls may be performed where necessary, for example in response to consumer complaints, product withdrawals or recalls or official sampling activities.

7.1 Risk Classification of Food Contact Material Activities and Determination of Inspection Frequency

The Finnish Food Authority has issued guidance on the risk classification of food establishments and food contact material activities and on determining the need for official controls.

Food contact material activities are classified into three risk categories. The corresponding target inspection frequencies are 0,35 inspection per year, 0,5 inspection per year or once a year. Information required for risk classification is initially obtained from the operator's registration notification submitted under Section 13 of the Finnish Food Act and is subsequently updated during inspections. Consequently, both the risk classification and the inspection frequency may change if the nature or scope of the activity changes.

Factors used to assess the scale of an operator's activities include:

number of material categories handled;
annual production volume (units or kilograms) a year;
production and storage area;
number of employees; and
annual turnover a year.

Risk classification may be increased where:

the activity involves manufacturing or further processing of food contact materials; or
the products are specifically intended for infants and young children, such as baby bottles or baby food packaging.

Reduced control requirements or exemptions from the basic annual control fee may be granted where operations are genuinely small-scale and low-risk. However, such reductions are not generally available where activities involve:

direct importation from third countries; or
printing using printing inks on food contact materials.

These activities are considered to require regular official controls regardless of the scale of operation. Examples of this risk classification can be found on the website of Ruokavirasto.

7.2 Risk-based Prioritisation of Food Contact Material Control

Supervision of contact material operations is primarily prioritized for those operators who manufacture, further process, or import contact materials and market their products more widely (including wholesale) or whose products are widely used

In the food contact material control, the control is focused on packaging and other materials, machines, equipment, tools and supplies used in the food business (e.g. containers, transport containers, work tools, disposable gloves). In the food business, the control is not focused on contact materials packaged in consumer packaging sold in stores, because their control is carried out at earlier stages of the supply chain (manufacturing, import, wholesale). Special attention is paid to packaging that is shaped into its final shape in the food premises (bottles, deep-drawing boxes, including 3D-printed contact materials).

Materials Prioritised During Inspections

Inspection activities should prioritise food contact materials intended for:

direct food contact;
use by infants and young children;
contact with fatty foods;
contact with hot foods;
contact with highly acidic foods;
prolonged contact with food.
food contact materials manufactured from recycled materials;
materials produced using surface biocides; and
materials containing dual-use substances.

7.3 Guidance Documents and Inspection Forms Prepared for Food Contact Material Controls

In addition to this general guideline, the Finnish Food Authority has prepared several supporting documents for use in official controls, including:

Food Contact Material Activity Evaluation Guideline for Control Authorities and Operators
inspection forms for manufacturing and further processing activities;
inspection forms for importing activities;
inspection forms for wholesale distribution activities;
a withdrawal and recall form for food contact materials; and
a model Free Sale Certificate for export purposes.

Current guidance documents and forms are published on the Finnish Food Authority website: https://www.ruokavirasto.fi/en/foodstuffs/food-sector/instructions-and-legislation/#novel-foods-and-processes

Free sale cetification form can be found here (only in Finnish): https://www.ruokavirasto.fi/globalassets/teemat/vienti/vientitodistukset/yleistodistukset/certificate-of-free-sale_yleismalli_kontaktimateriaalit_nettisivuille.pdf

The Authority has also prepared specific guidance for inspectors concerning the inspection of food contact material manufacturing processes. This material is available to inspectors through the Pikantti extranet system.

For supervision of food contact material safety in food businesses, the Authority has issued Oiva Inspection Guideline 14.1, which is applied both to registered and approved food establishments.

Inspection forms have also been developed to support inspections carried out under Oiva Guideline 14.1. Although their use is not mandatory, the Finnish Food Authority recommends that inspections follow their structure and content.

7.4 Content of Inspections of Food Contact Material Activities Conducted by Municipal Food Control Units

Controls of food contact material operators are carried out in accordance with the Finnish Food Authority's Food Contact Material Activity Evaluation Guideline for Control Authorities and Operators.

During the inspection, both the implementation of the operator’s quality management system (self-monitoring programme) in practice and the compliance of the products are reviewed. Conducting the inspection requires familiarity with the relevant legislation and the Finnish Food Authority’s guidance documents applicable to the sector.

The inspection focuses primarily on how the operator’s quality management system is implemented in practice, including the verification of the chemical compliance of products. Before carrying out the first inspection, the supervisory authority should request the operator’s GMP quality management system documentation and/or self-monitoring plan for prior review, as this helps target the inspection in accordance with the established priorities. It is also useful to review the company’s website in advance in order to gain an overall understanding of its operations.

The inspection itself consists of seven assessment areas, which are

general requirements of GMP quality management system;
control of product composition;
product testing and investigations;
declarations of compliance for products;
labelling of food contact materials;
traceability of food contact materials;
manufacturing and handling method/processes.

The assessment areas are evaluated using a four-grade scale: A, B, C and D, where

A corresponds to a compliant situation;
B to a good situation where minor deficiencies may exist;
C to a situation requiring corrective action, where deficiencies or shotrcomings that impair food safety have been identified an must be corrected within a specific timeframe and
D to a poor situation, where deficiencies or shortcomings tha jeopardise food safety an mus be corrected immediately.

The different assessment areas carry different weights from a food safety perspective. The overall evaluation is based on a risk assessment that takes into account the scale and nature of the operator’s activities. The inspection results are not published; however, they are generally public documents and are available upon request.

During the first inspection, all items included in the inspection form should be reviewed. For subsequent inspections, it is not always necessary to examine every assessment area during each visit. Instead, the inspection may focus on selected parts of the inspection form and examine them in greater depth, for example with respect to specific products or particular stages of the manufacturing process.

7.5 Supervision of Food Contact Material Safety in Food Businesses

Within food businesses, food contact material safety is evaluated in accordance with Oiva Guideline 14.1, and the results are published through the Oiva reporting system.

Inspections focus on:

assessing compliance of food contact materials used in food operations; and
evaluating whether those materials are used safely and in accordance with their intended conditions of use.

Food contact material safety inspections should be conducted at least once every three years in each food business. It is recommended that several food contact materials be selected for document review so that compliance and appropriate use can be assessed comprehensively.

An Oiva grade is generally not reduced because of a single deficiency unless the issue presents an immediate food safety risk. Assessment is based on the overall implementation of food contact material safety management, making comprehensive inspection coverage important.

Food wholesalers frequently operate both as food businesses and as food contact material operators. In such cases it is important to distinguish between the two regulatory roles.

When carrying out Oiva inspections only food contact materials used by the wholesaler in its own food operations are evaluated and deficiencies relating to separately regulated food contact material activities must not influence the wholesaler's Oiva rating. When inspecting food contact material activities as such, the focus is instead on the compliance of food contact materials supplied to customers.

Other competent authorities may also use Oiva Guideline 14.1 as inspection support. However, their inspection results are not published through the Oiva system and are recorded in their own information management systems.

7.6 Recording Inspection Results in the Vati System

The results of official controls are recorded for each inspection target in Vati, the shared environmental health information management system used by environmental health authorities. Instructions for the use of Vati are available on Pikantti, the extranet maintained by the Finnish Food Authority (Ruokavirasto).

In the inspection report provided to the inspected operator, the supervisory authority states the outcome of the inspection and identifies any issues requiring corrective action. The authority instructs the operator to implement the necessary corrections and sets a deadline for their completion. Where necessary, the inspector initiates administrative enforcement measures based on the findings of the inspection.

Entry into Force

This guideline enters into force on 15 August 2026 and replaces the previous version published on 15 June 2021.

Changes made to the previous guidance

The structure and wording of the guideline have been revised to improve clarity. The text has been streamlined, hyperlinks have been reviewed and updated, and the legislative references have been updated to reflect current legislation.

Guide on control of materials and articles intended to come into contact with food