Evaluation guidelines for food contact material operations

Guidance no 7246/04.02.00.01/2022/2

1 General

This Guide describes the assessment of the operations of food contact material objects of control and the grounds for it from a food safety perspective. The Guide has been made available both to municipal food inspectors and food contact material operators. The Guide supplements the Finnish Food Authority's Guide on control of materials and articles intended to come into contact with food (Guide number 4217/04.02.00.01/2021). Both municipal food inspectors and food contact material operators can use the Guide when preparing for a control visit by the food control authority.

The Guide has opened up in more detail the mutual relationship between the assessment of food contact material operations made in control and the legislation, recommendations and guidelines on food contact materials and their use as an aid to the assessment. In addition, general guidelines for assessment are provided in the appendices separately for the manufacture, import and wholesale of food contact materials.

This Guide does not apply to the control of food contact material safety and other compliance to be carried out in food establishments. In food establishments, food contact material control is carried out in accordance with 14.1 Oiva inspection guidelines as part of the regular control of food and food establishment operations.

This Guide aims to increase the coherence and fairness of control in different parts of Finland and between different food control units, and to increase the awareness of operators of the requirements laid down for food contact material operations. However, case-by-case assessment needs to be carried out as food contact material operations vary widely in terms of the types of material handled, the processes and the scope of operations, and the existing legislation also gives room for manoeuvre in different ways for different types of material.

The authority's actions must be based on the authority conferred on it by law and laws must be strictly complied with in the actions of an authority. The Finnish Food Authority's guidelines are not legally binding on other authorities or operators, but they provide inspectors and operators with guidelines and examples of how the Food Authority considers that legislation should be applied. In the event of contradiction, matters concerning the application of legislation are ultimately settled in a court of law.

The Guide has been prepared in cooperation with municipal food inspectors. Satu Luoma, Pirjo Suominen, Sari Tiinanen, Annika Porthin, Mikko Lappalainen, Katri Syrjä, Vladimir Vanhanen, Tiina Päätalo Anne Rönnskog, Vladimir Vanhanen and Ville Välttilä from municipal control units have been involved in writing the Guide.

2 Glossary to the 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 material

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.

3 Brief description of the legislation on food contact materials

EU legislation has been fully harmonised in Finland with regard to food contact materials. This means that EU directives concerning food contact materials have been implemented in Finland by national decree and EU regulations are in force as such. In Finland, the national Food Act (297/2021) also applies to food contact materials, food contact material operations and their control. Under section 13 of the Food Act, a food contact material operator must submit a registration notification of its operations to the food control authority before starting operations. Any suspension or discontinuation of food contact material operations shall also be notified to the food control authority. Under the Food Act (section 15) the operator also is also required to have an own-check process.

The legislation is available on the Food Authority's website: https://www.ruokavirasto.fi/en/foodstuffs/food-sector/packages-and-other-food-contact-materials/rules-for-food-contact-materials/.

You can find useful links for operators and inspectors (incl, recommendations and sector guidelines) here: https://www.ruokavirasto.fi/en/foodstuffs/food-sector/packages-and-other-food-contact-materials/useful-online-links-about-contact-materials/.

The following is a brief review of the legislation applying to food contact materials and operators in the sector.

Framework Regulation (EC) 1935/2004 concerning materials and articles intended to come into contact with food lays down general safety requirements for all food contact materials, regardless of the type of material. The Regulation shall apply to all materials and articles which are intended to be brought into contact directly or indirectly with food, which are already in contact with food, or which may be assumed to come into contact with food. Other EU legislation on food contact materials has been adopted on the basis of this Regulation.

EU Regulation 1935/2004 (Article 5) allows for the preparation of material-specific EU-level specific legislation for the 17 different food contact materials listed in Annex I to the Regulation. So far, however, the only material-specific EU legislation is for

plastic (Plastic Regulation (EU) 10/2011, Recycled Plastic Regulation (EU) 1616/2022,
ceramics (Directives 1984/500/EEC and 2005/31/EC, which have been implemented by Ministry of Trade and Industry Decree 165/2006),
regenerated cellulose (Directive 2004/14/EC, implemented by Ministry of Trade and Industry Decree 697/2005), and
active and intelligent food contact materials and articles (Regulation (EC) 450/2009).

Of the 17 food contact materials listed in Annex I to the Framework Regulation, 13 remain unharmonised and without material-specific EU-level specific legislation. In addition, there is no specific legislation for materials that are not included in that list of legislation or for combinations of different materials, of which today food contact materials constitute a large part. However, the Framework Regulation also lays down general requirements for these food contact materials.

At the EU level, there are provisions on ingredients transferred from food contact materials for some individual substances. These provisions include:

The N-nitrosamine provision on rubber teats and soothers (Directive 93/11/EEC, enacted by Ministry of Trade and Industry Decision 903/1994)
Commission Regulation (EC) 1895/2005 on the restriction of use of certain epoxy derivatives in food contact materials
Commission Regulation (EU) 213/2018 on bisphenol A in varnishes and epoxy coatings.

Restrictions on imports of polyamide and melamine kitchenware from The People's Republic of China and Hong Kong have been laid down in Regulation (EU) 284/2011.

In Finland, there is one national measure that applies to all food contact materials, the so-called heavy metal decision 268/1992 (Ministry of Trade and Industry). It applies to food contact materials manufactured in Finland or imported directly from third countries which do not have harmonised EU legislation. Although there is harmonised legislation on ceramic articles intended to come into contact with food (Directives 84/500/EEC, 2005/31/EC), which has been enacted nationally in Finland by Ministry of Trade and Industry Decree 165/2006, the national heavy metal decision applies to ceramic products that have a lip line and/or which are intended for young children. Food contact materials and articles where, for example, the decoration or printing is clearly childlike and which the consumer therefore interprets as an article intended for children, are considered as food contact materials intended for children. The heavy metals decision does not apply to food contact materials imported from the EU internal market if they are legally on the market in this other EU country. The possibility for the operator to make a declaration that the product is legally on the market in another EU country and the possibility to use the SOLVIT service in case of conflict is discussed in section 4 of the Guide.

The legislation lays down migration limit values for nickel (Ni), lead (Pb), chromium (Cr) and cadmium (Cd) and lower migration limit values (1/10) for food contact materials for young children.

Regulation (EC) No 2023/2006 imposes an obligation on food contact material operators to establish a documented quality management system to ensure good manufacturing practice. The content of quality management has been laid down in the appendixes, including measures to prevent the set-off phenomenon of printing inks and requirements related to the use of recycled plastics. This quality management system is also called own-check, which is also required by the Food Act. The Food Authority has instructed the contact material operator on the own-check process in the Guide on control of materials and articles intended to come into contact with food and on its website.

4 Principle of mutual recognition

Products lawfully marketed in one Member State may be sold in any Member State even if they do not meet the national requirements of the importing country. This is provided for in Regulation (EC) 2019/515 (Mutual Recognition Regulation).

However, the presence on or access to the market for a product may be affected in situations where the product is unsafe, or the restriction has another objective mentioned in Article 36 TFEU, or another overriding reason of public interest. However, such a situation occurs very rarely in the case of food contact materials and, as a rule, they may be on the market in Finland if it can be demonstrated that they are legally on the market in another EU country. However, in the case of non-harmonised food contact materials, a situation may arise as the Framework Regulation allows the drawing up and maintenance of national regulations in the absence of material-specific legislation at EU level. An operator can be instructed to submit a so-called self-notification to the authority as assurance that the food contact material is legally on the market in another Member State.

Each Member State has a product control point as required by the Market Surveillance Regulation 2019/1020 which advises operators on the free movement of products and the national requirements of the Member States. In Finland, the product contact point is the Finnish Safety and Chemicals Agency (Tukes). Problems encountered by companies and citizens in the field of administrative cooperation in the EU/EEA are resolved by the SOLVIT network. SOLVIT is an out-of-court problem-solving procedure that is available to operators free of charge. Each country has a local SOLVIT Centre (home centre) which can be best reached through the following link: https://ec.europa.eu/solvit/index_en.htm.

Efforts are made to find practical solutions to the problems faced by customers in informal cooperation with the authorities. For example, if an operator has problems exporting products legally sold in Finland to another Member State, they can be instructed to contact the SOLVIT network to resolve the issue. SOLVIT solutions for services and products can be found on the following website: https://ec.europa.eu/solvit/problems-solved/goods-services/index_en.htm.

5 Legislation, recommendations and guidelines for demonstrating the safety of food contact materials

It is the responsibility of the operator to demonstrate to the inspector that the food contact materials manufactured, imported and distributed by wholesalers comply with the safety requirements of Framework Regulation (EC) 1935/2004 with regard to chemical composition and traceability, for example. Since the safety requirements of the Framework Regulation for the chemical composition of food contact materials are not very detailed, the operator must provide a detailed justification (safety references) for meeting the requirements of the Framework Regulation.

It is not the task of the inspector to choose the safety reference to be used on behalf of the operator or to carry out the risk assessment on behalf of the operator, and the operator is responsible for ensuring that the safety justification has been correctly chosen and that the risk assessment has been adequately carried out. The inspector can, however, guide the operator to the sources of correct safety references. It is the responsibility of the operator to provide the most comprehensive safety references possible for the food contact material based on precise knowledge of the raw materials and manufacturing process of the contact materials.

The operator must always comply with EU legislation, where it exists, as a safety reference. As there is only limited material-specific EU legislation, the national material-specific legislation, official recommendations or industry-specific guidelines or standards of some other EU country can be accepted in Finland as a safety reference for non-harmonised materials. They may have very different standards of content. For some materials, this may mean that the operator chooses several safety references for the material to adequately demonstrate the safety of the food contact material. However, where several safety references have been chosen, there must be no contradiction between the limit values and the requirements presented in them.

In the absence of EU law, the primary safety reference should be the national legislation of an EU Member State, a resolution and technical guideline of the Council of Europe (e.g. a resolution applying to metals and alloys, technical guidelines concerning paper and paperboard, etc.), or any other official recommendation of an EU Member State (e.g. the recommendations of the German BfR).

In the absence of the above, the safety reference can also be found in the industry's own guidelines and standards. For example Cepi's Food Contact Guidelines for the Compliance of Paper and Board Materials and Articles explain how the requirements of EU and national legislation are interpreted in the industry. Standards exist for metals coming into contact with food, such as EN 602 standard for aluminium or the AISI 304 standards for stainless steel.

The legislation of non-EU countries may only be used as a safety reference if there is no legislation or official guidelines on the material concerned in the EU area. Examples of non-EU legislation include: Swiss printing ink legislation and US FDA regulations.

The above examples of safety references are only examples and do not represent all available possible safety references. It is important for the operator to carefully choose the safety reference and to be able to justify to the inspector what has been chosen and on what basis.

6 Declarations of compliance and other documentation demonstrating compliance

In the declaration of compliance, the food contact material operator demonstrates that the contact material meets the requirements of the Framework Regulation 1935/2004 (Articles 3, 15, 16 and 17) and any applicable material-specific legislation; or, in the absence of material-specific legislation, any other safety reference of its choice. Point 5 of this Guide discusses the choice of safety reference in more detail.

Preparing the declaration of compliance is part of the operator's own-check process and it is prepared for the purpose of trade between operators and for the purpose of the statutory communication of the safety and compliance of the food contact material in the supply chain. Declarations shall also be made available to the competent authority during control visits.

For food contact materials covered by material-specific EU-level specific legislation, this legislation includes a requirement to prepare a declaration of compliance which can be used to ensure the safety and other compliance of the material or article at different stages of the transaction. Although the declaration of compliance is not a legal requirement for all materials, it is in practice the best way for an operator to demonstrate that the food contact material meets the requirements of the Framework Regulation.

Guidance on how to prepare a declaration of compliance with regard to all food contact materials can be found in the Council of Europe's general resolution on food contact materials (EDQM) in the Food Authority's Guide on control of contact materials and articles intended to come into contact with food and on websites.

Manufacturers and importers of food contact materials are responsible for preparing the declaration of compliance and for ensuring that the declaration contains the information necessary to ensure the safety and other compliance of the contact material. Other documentation demonstrating compliance, such as information on material composition, test results, migration calculations or risk assessment results (so-called supporting documentation), are also important for demonstrating the compliance of food contact materials. At least some of the migration tests carried out in the laboratory may be replaced by mathematical calculations and so also form part of the supporting documentation for the declaration of compliance. The supporting documentation supplements the declaration of compliance and serves as a basis for the assurances to be given in it. Both the manufacturer and the importer must make the documentation available in control.

The previous operator is responsible for providing the information needed for risk assessment to the next operator in the supply chain and dialogue between the operators is of paramount importance for the provision of adequate information. Traceability must not be broken during the provision of information. This is why, for example, the manufacturer and the importer must ensure that their information in the declaration of compliance is provided to the next operator. Importers may (after authorisation from the manufacturer) add their contact details to the manufacturer's declaration of compliance or prepare a new declaration of compliance in their name using the information provided by the manufacturer.

Obtaining declarations of compliance from the manufacturer or importer and forwarding them to the food business operator is also part of the wholesaler's own-check process. Wholesalers must check that the content of the declarations of compliance is adequate to ensure the safety and compliance of the food contact materials and that it contains the necessary information on the manner/conditions of use of the contact material. Where appropriate, the wholesaler must ask the supplier to update/supplement the incomplete declaration of compliance. With regard to non-harmonised materials, additional information may also be provided in other ways, e.g. by email, which is then stored as part of the own-check records.

Based on the conditions of use stated in the declaration of compliance, the wholesaler can instruct the food establishment on safe use and compile, for example, marketing material about the product and name the products as descriptively as possible, for example, in the list of wholesale sales descriptions.

Sales descriptions are particularly important for small-scale food businesses, which are relieved of the need to obtain declarations of compliance. It has been agreed in Finland that an operator of small-scale food businesses such as kiosks, cafés and small restaurants that buy their food contact materials from a wholesaler does not have to ask for declarations of compliance but can ensure the intended use and conditions of the use of the contact material on the basis of labelling and sales descriptions. Where appropriate, the food business operator asks the wholesaler for more information on whether a product is suitable for the use for which the operator is obtaining it. In case of doubt about the safety or compliance of the food contact material or otherwise for control purposes, declarations of compliance may be requested from the wholesaler.

When buying food contact materials directly from the importer or manufacturer, the declaration of compliance must accompany all food business operations regardless of the scope. However, in the case of regular deliveries, it does not have to accompany each consignment, but it is enough to provide it when making the supply contract.

Declarations of compliance must be less than three years old, as during that period there are often changes in legislation, or at the very least some changes in raw materials and their suppliers. It is recommended that the food contact material operator undertakes to automatically submit a new declaration of compliance to its contract customers at least whenever changes in legislation or raw materials have occurred and otherwise every three years. Ultimately, the user of the material or article must ensure that the declarations of compliance submitted for them are not obsolete. The relevance of a declaration of compliance more than three years old can no longer be fully assured, especially in the later stages of the supply chain.

6.1 Content of the declaration of compliance

Material-specific legislation lays down requirements for the content of the declaration of compliance. The Plastic Regulation 10/2011 (Annex IV) lays down in more detail the content of the declaration of compliance. The Commission has also drawn up so-called DoC guidance (EN) on the content of the declaration of compliance for plastic contact food materials in different stages of the supply chain. Where applicable, this may also be used as a template for declarations of compliance for other materials.

The Council of Europe (EDQM) has published a resolution on non-harmonised food contact materials. Under this resolution, a declaration of compliance must be prepared for non-harmonised food contact materials following the model presented in the resolution. The EDQM will later supplement the content requirements for the demonstration of compliance with separate technical guidance, which will also include a form for preparing a declaration of compliance, but the technical guidance has not yet been published at the time of writing this guide.

Regulation 1935/2004 provides for the possibility for Member States to maintain or adopt national provisions where the requirement is not provided for at the EU level. Several EU countries therefore require a declaration of compliance to be prepared for all food contact materials, either in national law or in official instructions.

In Finland, no national legislation has been issued regarding declarations of compliance, but the recommendation concerning all food contact materials has been recorded in the Finnish Food Authority's Guide on control of materials and articles intended to come into contact with food. The Guide and Food Authority website also contain recommendations on the general content for this declaration. The website also contains a tool with sufficient content for the preparation of a declaration of compliance. In Finland, it has been agreed that for non-harmonised materials the declaration of compliance model in the EDQM general resolution can be used to define the Food Authority's guidance on the matter.

Control of food contact material operations is carried out regularly in accordance with the municipal food control plan. Control covers both the assessment of operations and an assessment of the safety and compliance of food contact materials. The Finnish Food Authority has provided general guidance on the control of food contact materials. This is also available to operators on the Food Authority website . This evaluation guide supplements the general guide on control.

The guide on control states the criteria for determining control frequency based on the risk classification (in Finnish) of the food contact material operations. For control purposes, the Food Authority has prepared inspection form templates: manufacturing and converting and importing and wholesaling and distributing, which may be supplemented by the municipal control authority based on its needs. However, the headings on the form and the related assessment scale may not be changed because they correspond to the heading and assessment of the joint control data system of Environmental health care (VATI). Control data is collected accordingly. An inspection may take the form of a comprehensive inspection covering the entire operation or may focus on only a limited number of points on the inspection form. The inspector must always record in the inspection report which matters/stages of operations/food contact materials the inspection has concerned, so that it is also clear to the operator which matters have been assessed.

When assessing food contact material operations, the legislation in force, i.e. the Framework Regulation and the material- and substance-specific EU-level specific legislation adopted on the basis thereof, shall primarily be taken into account. In the case of a non-harmonised material, the assessment also takes into account the safety references chosen by the operator and the extent to which the operator is able to demonstrate compliance with them.

The inspector carrying out the food contact material control should have an adequate level of knowledge of EU-level food control material legislation, Council of Europe resolutions and technical guidelines as well as the Food Authority guidelines. It is the responsibility of the manufacturer and/or importer to indicate which guide or recommendation has been followed, how it has been followed and why the safety reference in question has been chosen. The manufacturer and/or importer operator always has a burden of proof, which means that the operator must be able to tell the inspector what safety references the safety of the food contact material is based on. When assessing the safety and other compliance of the food contact material in control, the inspector need not systematically assess whether the material meets the requirements of the chosen safety reference, but the operator is asked to explain how the operator complies with that safety reference in its operations. If the safety reference chosen by the operator provides, for example, maximum migration or restrictions on the use for some ingredients, the operator must be able to demonstrate that they are implemented. The operator is asked to explain what the restriction is and to show the calculations, tests or any other own-check records showing that it has been implemented.

The Food Authority has provided guidance on the own-check of food contact material operators in its Guide on control of food contact materials and on its website . The separate assessment guides for manufacturers, importers and wholesalers appended to this guide provide more substantive requirements for the own-check process.

Through the own-check process, the manufacturer, importer and wholesaler of food contact materials manage the hazards associated with their operations and ensure that the FCMs and FCM operations meet the requirements laid down for them in provisions applicable to food. The operator shall record the results of the own-check process with sufficient accuracy.

Under Framework Regulation (EC) 1935/2004, food contact materials must be manufactured in compliance with good manufacturing practices. Good manufacturing practices must extend to all stages of the production, processing and distribution of FCMs , except for the production of starting substances.

Through the own-check process, the food contact material operator ensures that the food contact materials (both intermediate and final contact materials) comply with the requirements of the Framework Regulation and any specific material-specific requirements, and that their operations comply with good manufacturing practices.

Many food contact material operators have a certified quality management system (e.g. ISO 22000, BRC-IOP or SFS-EN 15593) to cover the good manufacturing practices required by the GMP Regulation. However, a certified quality system or a quality system meeting a certain standard is not an official requirement. The scope of quality systems often goes beyond the own-check process required by the authority but may also focus on slightly different matters, which should be taken into account in control. The quality system audit reports may be taken into account, as appropriate, when carrying out the control of FCM operations, where they have assessed the same matters as the control being carried out. If the results of the quality management system audit have been taken into account in the assessment, the extent to which they have contributed to the assessment should be recorded in the inspection report.

In the inspection, the assessment should always be carried out in relation to legislation and the minimum requirements defined by the authority, not the requirements of the quality management standard. Attention must also be paid to the fact that the ISO 9001 quality management system as such does not meet all the quality management requirements of the GMP Regulation and, if it is presented for control, the inspector must ensure that it has been supplemented to meet the requirements of the GMP Regulation.

The operator is asked to demonstrate how the own-check process ensures the requirements of legislation and compliance with the guidance drawn up by the Food Authority as well as the safety of the food contact material. The inspection focuses on seven different topics:

Information on the quality management system
Compositional management of products
Tests carried out on products
Certificates demonstrating product compliance
Product labelling
Traceability
Processing methods/processes.

Assessment is on a scale of A-D as follows:

Grade description	Minimum measures
A = Compliant	No measures or guidance and advice
B = Minor shortcomings, which do not, however, impair food safety	Guidance and advice, agreement with the operator on when, at the latest, the minor shortcomings will be rectified or agreement that they will be checked in the next scheduled inspection.
C = Issues that impair food safety	Request to rectify the shortcomings identified within a set period of time. Inspection after the set period of time within two weeks of the set period at the latest.
D = Issues or repeated failure to comply with official requests that jeopardise food safety	Given a request to rectify the shortcomings identified with immediate effect à Initiate the preparation of coercive measures.

The items to be assessed are interlinked and partly overlapping, and this must be taken into account in the assessment. It is important to ensure that each matter is assessed under only one item and that the same shortcoming does not lower the grade in assessments of other items.

Separate appendices discuss the content requirements for the own-check process as well as general evaluation guidelines for each item inspected for inspections of manufacturers, importers and wholesalers separately. There is a wide range of food control materials operations, each type of material has its own distinct manufacturing stages and the scope of operations varies. The measures required to ensure safety vary according to the stage in the supply chain at which the company operates (manufacturer, importer, wholesale). Current legislation also gives room for manoeuvre in different ways for different types of materials. In the assessment, case-by-case consideration cannot be completely avoided and the operation must always be assessed in relation to its nature and scope.

Food contact material manufacturers, importers and wholesalers are responsible for the safety and compliance of food contact materials, including documentation, their own marketing and labelling. Retailers selling FCMs directly to the consumer, on the other hand, are responsible for ensuring that the information provided to the consumer on the FCMs sold to the consumer is correct during the sale and that their own marketing does not provide misleading information about the use or composition of the FCM. Food establishments are responsible for ensuring that FCMs are used in contact with the food for which they are intended and that their use is in accordance with the instructions provided in the documents and labelling.

Cooperation between control units is very important in FCM control so that the shortcomings identified and advice, as well as other control measures to rectify them, are directed at the right party. The inspector must contact the control authority in the municipality of FCM manufacture or import with a low threshold in order to take matters forward if the food business operator or the FCM wholesaler has taken its own measures, e.g. a request to the supplier for additional information does not achieve the desired effect.

If the shortcomings cannot be rectified, operators must be prepared to change suppliers if the shortcomings in the FCM compliance documentation are so great that the safety of the FCM cannot be fully assured despite the request for additional information.

In the case of withdrawals, too, cooperation between the different control units is very important in order to carry out the withdrawal effectively in all stages of distribution.

Appendix 1. FCM manufacturer's own-check process and assessment of it

Content of the manufacturer's own check / quality management system

Through the own-check process, the food contact material manufacturer manages the hazards associated with its operations and ensures that the FCMs manufactured and the FCM operations meet the requirements laid down for them in provisions applying to food. The operator shall record the results of the own-check process with sufficient accuracy.

Under Framework Regulation (EC) 1935/2004, food contact materials must be manufactured in compliance with good manufacturing practices. Good manufacturing practices must extend to all stages of the production, processing and distribution of FCMs, except for the production of starting substances.

The manufacturer is responsible for ensuring that it operates in accordance with good manufacturing practices and that the FCMs (both intermediate and final contact materials) it makes meet the requirements of the Framework Regulation and any specific material-specific requirements. The manufacturer ensures good manufacturing practices through its own-check process. Especially in smaller companies, not all documents/instructions that are part of the own-check process need to be in writing.

The Food Authority website contains own-check guidelines.

The manufacturer should take into account among other things the following in the own-check process

Mapping of the work stages related to manufacturing and identification of the hazards related to food contact materials in respect of each work stage and a definition of methods to manage these, the organisation of their follow-up and, where appropriate, corrective measures to be taken at each work stage.
A plan on how to implement, where appropriate, the withdrawal of food contact materials that have been manufactured and forwarded to customers if the FCMs are found to have shortcomings that may jeopardise food safety.

A manufacturer may have to withdraw products it has manufactured from the market if it detects or otherwise becomes aware that errors have occurred in the raw materials, manufacturing process or downstream processing that result in food safety being jeopardised. The withdrawal plan shows, among other things, who is responsible for which measure, who notifies customers and which authority is notified, how information in the supply chain is managed and what is done with the food contact materials to be withdrawn. The Food Authority and the local food control authority must always be notified of withdrawals. You can find the notification form here. If the food contact materials have already reached the consumer, the need for a notice to consumers is assessed. You can find guidelines on the withdrawal of products here.
Procedures to ensure staff competence, i.e. in practice, how to ensure that the employees have sufficient information for their jobs on the raw materials in food contract materials and their handling, the manufacturing process (recipes, dosages, process quantities) the composition and structure of the food contact materials, the purpose of the contact material to be manufactured and the restrictions of use, etc. The manufacturer must also establish what purpose the food contact material will be used for in order to be able to sell the right, safe contact material for the intended use. This requires the manufacturer to engage in dialogue with customers, which in turn makes it is necessary to ensure that the salespeople have sufficient information on the food contact materials manufactured. Also any warehouse employees must have information about which materials and articles are food contact materials and how they should be handled, for example, to prevent cross-contamination during storage, loading and transport.
Procedures to ensure the safety and compliance of the food contact materials manufactured, including.
- Information on what documents are requested for raw materials, intermediate materials and process chemicals and what requirements have been laid down for the content of the documents. How to ensure documents are kept up-to-date and where are they stored. How the adequacy of the content of documents and the safety and compliance of raw materials or intermediate materials is ensured in the documents?
  
  The manufacturer must have access to all documents demonstrating the safety and other compliance of the raw materials, intermediate materials and process chemicals used in FCM manufacture such as information on composition, technical information, declarations of conformity, any test results and the results of the risk assessment. The manufacturer must have the recipes / descriptions of the structure of the product in its own-check process.
How to ensure the conditions during the manufacturing process (e.g. dosage, time, temperature or pressure quantities) are correct and what records are kept of them.
What measures are taken to avoid chemical cross-contamination at different stages in manufacture.
How to ensure that the printing ink dries sufficiently and that the printing inks do not migrate from the printing surface to the surface that comes into contact with the food through the so-called set-off phenomenon.
The manufacturer ensures the safety and compliance of the food contact material/intermediate material it manufactures by testing it in a laboratory.

The manufacturer must prepare a scheduled sampling plan to test the safety and compliance of the food contact materials it manufactures. General guidance on the testing of food contact materials is provided on the Food Authority website.

Procedures for forwarding information and documentation on the compliance of food contact materials to customers, also taking into account the labelling requirements arising from the Framework Regulation and labelling if the product to be manufactured goes for direct sale to the consumer.

The manufacturer is required to forward the documentation demonstrating the compliance of the food contact materials to its customers. Documentation means in particular the declarations of compliance of intermediate materials and final food contact materials and, where appropriate, to their supporting documentation. The provision of declarations of compliance is sufficient as a rule for food establishments. Where intermediate materials are sent for further processing, the declaration of compliance must be accompanied by the additional information required by the downstream operator, e.g. more detailed information on the composition, risk assessments carried out and test results.

The manufacturer must ensure that food contact materials sold to the consumer have the labelling required by Article 15 of the Framework Regulation (EC) 1935/2004. Labelling must be both in Finnish and Swedish.
Procedures to ensure the traceability of food contact materials.

Traceability must be demonstrated in concrete terms and it must be possible to make the link between the food contact material documents. The manufacturer shall be able to demonstrate where the raw materials and intermediate materials used in the manufacture of the food contact materials were sourced (where, what, how much, when) and where the food contact materials and intermediate materials manufactured have been delivered (what, where, how much and when).

Assessment point by point

1. Information on the quality management system

The main focus of the inspection is on the general content of the own-check process , which is assessed only with regard to the matters below. Assessment of the other content and its implementation is carried out separately in each item to be assessed.

In this item, the inspection form inspects, for example

Whether the company has an own-check process and whether it has been deployed.
Whether it has defined the responsibilities for the safety of food contact materials.
How the employees' safety competence in contact materials is ensured.
What the own-check update policies are.
The own-check process must be updated/assessed regularly, large-scale operators at least once a year, small operators at least every other year.
How the company is prepared for deviations and disruptions and whether the company has an adequate withdrawal plan.

A = Compliant
- The manufacturer has prepared an own-check or standard-based quality management system to ensure the safety and other compliance of products and good manufacturing practices and complies with this system in its own operations.
- The own-check process adequately takes into account the requirements of EU Regulation 2023/2006 and the Food Authority's guidelines.

The own-check process can be, for example, a quality system in accordance with a standard or, in small-scale operations, work instructions. However, the own-check process always includes document management with regard to the traceability documentation of food contact materials and documentation demonstrating safety. Documentation demonstrating safety and other compliance includes: Raw material specifications, declarations of compliance of materials, test results, results of risk assessment (e.g. HACCP), etc.

The manufacturer can ensure the safety and other compliance of the products manufactured by carrying out an own-check.

B = Good, there may be minor shortcomings, which do not, however, impair food safety
- The manufacturer has prepared an own-check or standard-based quality management system to ensure the safety and other compliance of products and good manufacturing practices and mostly complies with this system in its own operations.
- The own-check process mostly adequately takes into account the requirements of EU Regulation 2023/2006 and the Food Authority's Guide on the own-check of food contact material operations.
- Despite minor shortcomings, the manufacturer can, by means of its own-check process, ensure an adequate level of safety and other compliance of the products manufactured.

C = Issues impairing food safety, to be rectified within a set period of time
- The manufacturer has an own-check process, but it has not adequately taken into account the requirements of EU Regulation 2023/2006 for the quality management system and the Food Authority's guidelines.
- There are significant shortcomings in the own-check process and it would appear that food safety will be jeopardised.
- Compliance with the own-check plan cannot fully ensure good manufacturing practices and the safety and other compliance of food contact materials.

D = Issues jeopardising food safety, to be rectified with immediate effect

Issues in general matters of quality management do not pose an immediate risk to food safety. This is why a D rating is only given if a C rating has been given repeatedly and the issues have not been rectified within a set period of time.
- The manufacturer has not prepared an own-check plan to ensure good manufacturing practice.
  AND
- despite having been requested to do so, the manufacturer has not begun to prepare an own-check plan.

2. Compositional management of products

The main focus of the inspection in this point is on the work stages related to the compositional management of food contact materials and the associated company-specific procedures and documentation.

The things checked with regard to manufacturing in this point on the inspection form include.

Whether the manufacturer has ensured the reliability and competence of the suppliers of raw materials and intermediate materials in food contact material safety issues, including legislation. Whether among other things assurance has been obtained that Finnish suppliers have submitted a registration notification to the food control authority.
Whether the manufacturer has specified which legislation or other safety reference requirements the raw materials to be procured must meet.
Whether the manufacturer has documented guidelines and procedures (recipes / product descriptions / product specifications) for the products to be manufactured.
Whether sufficient information and documentation (raw material specifications, declarations of compliance, test results, risk assessment results, etc) have been obtained with regard to the safety and compliance of the raw materials used or imported food contact materials. Whether, for example, there is information on dual-use additives and aromas, substances that are subject to restrictions and non-intentionally added substances (NIAS).
The effect of the age of declarations of compliance on the assessment of intermediates:
- Grade A – age of declarations of compliance, 0-3 years
- Grade B – age of declarations of compliance, 3-5 years
- Grade C – age of declarations of compliance, 5-7 years
- Grade D – age of declarations of compliance, more than 7 years.

NB! The information needed varies depending on the customer. For food establishments, less information on the composition of the food contact material in the declaration of compliance is enough if the contact material is no longer modified by the food establishment. Conversely, the downstream processor of food contact materials usually needs more detailed compositional information in order to assess the impact of their own operations on the safety of the food contact material manufactured.

Whether the company has agreed procedures for determining the future conditions of use of the food contact material so that it is able to provide the customer with safe, suitable material for the intended use.

A = Compliant
- The manufacturer has written guidelines and procedures (recipes/product descriptions/product specifications) for the contact materials to be manufactured and procedures to determine customer needs for the products ordered.
- The manufacturer has determined beforehand the requirements to be met by the different raw materials and intermediate materials, as well as to use operators who have been found to be reliable in the supply of raw materials and who are aware of food contact material requirements. Assurance has been obtained that Finnish suppliers of intermediate materials have submitted a registration notification to the food control authority.
- The documents concerning raw materials and intermediate materials must include adequate information on the chemical composition of the food contact materials and types of material.
B = Good, there may be minor shortcomings, which do not, however, impair food safety
- The manufacturer has guidelines and procedures (recipes/product descriptions/product specifications) for most of the contact materials to be manufactured, and the manufacturer has procedures to determine customer needs for the products ordered, but no information has been given for a few products.
- The manufacturer has determined beforehand the requirements to be met by the different main raw materials and mostly uses operators who have been found to be reliable in the supply of raw materials and who are aware of food contact material requirements.
- The documents concerning raw materials and intermediate materials mostly contain sufficient information on chemical composition and types of material with regard to safety and intended use.
C = Issues impairing food safety, to be rectified within a set period of time

The safety and compliance of raw materials and intermediate materials or their suitability for their intended use cannot be fully ensured.
The manufacturer has not determined beforehand which requirements must be met by the raw materials and intermediate materials and has failed to ensure the reliability of all suppliers.
The manufacturer has no written guidelines and procedures (recipes/product descriptions/product specifications) for most of the food contact materials manufactured.
There are shortcomings and/or missing parts in the safety information on raw materials or intermediate materials (e.g. insufficient information on substances subject to restrictions, dual use substances or NIAS) or in their declarations of compliance.

D = Issues jeopardising food safety, to be rectified with immediate effect

The safety and compliance of raw materials and intermediate materials or their suitability for their intended use cannot be ensured at all.
The manufacturer has no written guidelines and procedures (recipes/product descriptions/product specifications) for the food contact materials manufactured.
The manufacturer has not determined beforehand which requirements must be met by the raw materials and has failed to ensure the reliability of raw material suppliers.
No information has been obtained on the chemical composition of raw materials or intermediate materials.
OR
Despite having been requested to do so, the manufacturer has failed to initiate measures to rectify the shortcomings identified during the previous inspection.

3.Testing

The main focus of the inspection in this point is on the tests and mathematical calculations carried out to ensure the safety and compliance of contact materials and their scope and documentation.

This point of the inspection form checks, for example

Whether the manufacturer has a scheduled sampling plan for the testing of food contact materials or to define calculations to replace them.
Whether the manufacturer has commissioned tests or calculations to determine the migration and organoleptic properties of the ingredients.
Whether the safety references against which the tests have been carried out are relevant.
Whether the results of the tests/calculations comply with legislation and the limit values of the safety references chosen.
Whether the manufacturer, where appropriate, has taken corrective measures in response to the excesses over limit values and whether a record has been kept of the corrective measures taken.
Whether the test results and calculations are documented and verifiable.

A = Compliant
- The manufacturer has a scheduled and comprehensive sampling plan that it implements.
- The manufacturer has up-to-date and comprehensive test results and/or calculations of the contact materials manufactured.
- The manufacturer is aware of the material safety requirements and has been able to choose the right legislation or other safety reference for its own tests/calculations.
- The results of the samples are in order. If the results have exceeded the limit value, the manufacturer has undertaken to investigate the reasons for the excesses and has taken corrective measures.

B = Good, there may be minor shortcomings, which do not, however, impair food safety
- The manufacturer has a scheduled and largely comprehensive sampling plan that it mostly implements.
- The manufacturer lacks some of the test results or migration calculations, but they are still available for most of the food contact materials to be manufactured. The manufacturer has commissioned tests/calculations for the materials, but they are not sufficiently comprehensive in all respects.
- The manufacturer is aware of the material safety requirements and has been able to choose the right legislation or mostly some other safety reference for its own tests/calculations.

C = Issues impairing food safety, to be rectified within a set period of time
- The manufacturer is not able to demonstrate that the materials have undergone adequate tests demonstrating safety and compliance.
- The manufacturer lacks sufficient test results / calculations for a large part of the final food contact materials and has not taken steps to obtain the missing test results or to commission the tests itself.
- The manufacturer is not aware of the material safety requirements and has not always been able to choose the right legislation or other safety reference for its own tests/calculations.
- The results of the tests/calculations are mostly unsatisfactory and the manufacturer has not voluntarily initiated corrective measures.
D = Issues jeopardising food safety, to be rectified with immediate effect
- The manufacturer has no sampling plan at all.
- The manufacturer has not commissioned any tests or done calculations to replace tests for the contact materials it has manufactured.
- The manufacturer is not aware of the legislation applying to food contact materials and has not chosen the right safety references for its research.
- Despite having been requested to do so, the manufacturer has not initiated measures to rectify the situation and to commission the necessary tests or to prepare the calculations.

4. Documentation demonstrating compliance

The main focus of the inspection in this point is on the declarations of compliance prepared to ensure the safety and compliance of contact materials and their content.

This point of the inspection form checks, for example

Whether the manufacturer has prepared declarations of compliance for the food contact materials it has manufactured.
Whether the declarations of compliance contain sufficient information on the food contact material (name, structure, types of material, specific migration limit (SML) substances, dual-use substances).
Whether the declarations of compliance contain sufficient justification for the safety and compliance of the materials (legislation and other safety references, tests, risk assessment).
Whether the declarations of compliance contain sufficient information on the conditions and restrictions of use (food types, use temperatures, contact time guidelines, repeated use).
Whether the declarations of compliance contain other necessary information, such as information on recycled material or additional information for active and intelligent materials.
Whether the declarations of compliance are updated regularly.
What additional documentation of compliance the manufacturer has for the materials/articles in addition to the actual declaration of compliance.
Whether the manufacturer has procedures in its own-check process of the provision of declarations of compliance to its customers.

A = Compliant
- The manufacturer has prepared declarations of compliance for the food contact materials to be manufactured, based on information from the raw material / intermediate material supplier, own risk assessment and tests and/or mathematical calculations carried out for the products.
- The declarations of compliance contain sufficient information to ensure the safety and other compliance of the food contact materials.
- The manufacturer has policies to ensure that the declaration of compliance and other information demonstrating compliance are provided to the next operator and is systematically provided.
B = Good, there may be minor shortcomings
- The manufacturer has prepared declarations of compliance for most of the food contact materials to be manufactured, based on information from the raw material / intermediate material supplier, own risk assessment and tests and/or mathematical calculations carried out for the products.
- There are minor shortcomings in the declarations of compliance, but these do not prevent assurance of the safety and other compliance of the food contact material.
- The manufacturer has policies to ensure that the declaration of compliance and other information demonstrating compliance is provided to the next operator. However, provision is not systematic and is based only on customer requests.
C = Issues impairing food safety, to be rectified within a set period of time
- The manufacturer prepared declarations of compliance for only a small part of the food contact materials to be manufactured.
- The content of the declarations of conformity is clearly incomplete (incl. shortcomings in the legal framework, in the information on use or in traceability) and does not allow full assurance of the safety of the food contact materials.
- The manufacturer has no procedures in place for the declaration of compliance and other information demonstrating compliance to be provided to the next operator, and the provision of these is haphazard.
D = Issues jeopardising food safety, to be rectified with immediate effect
- The manufacturer has not prepared declarations of compliance for the food contact materials it manufactures, or they are so incomplete as to not enable the safety and other compliance of the contact materials to be ensured.
- The manufacturer does not have agreed policies for how the declaration of compliance and other information demonstrating compliance is to be provided to the next operator and nor is it provided.
  OR
- Despite having been requested to do so, the manufacturer has not initiated measures to bring the declaration of compliance to an adequate level in terms of content.

5. Product labelling

The main focus of the inspection in this point is on the labelling of food contact materials primarily intended for use by the consumer (Article 15 of EU Regulation 1935/2004). In business-to-business sales, it controlled that at least the corresponding information is given in the documents. In addition to the declaration of compliance, documentation here refers to, for example, commercial documents, which may contain some of this information.

The information shall be visibly, clearly and indelibly marked on the materials and articles or on their packaging or on their labels or on a notice in the immediate vicinity. The latter option is possible with regard to the name or trade name and the address of the manufacturer, processor or seller only if, for technical reasons, it is not possible to affix the information or the label containing the information to the material or article at the manufacturing or marketing stage.

This point of the inspection form checks, for example

The manufacturer's procedures for ensuring the labelling before the product is placed on the market and, for example, whether the labelling contains
- Text, symbol, etc. indicating the contact with food (not mandatory for food contact materials which, because of their properties, are clearly intended for contact with food)
- Instructions for safe use (e.g. restrictions on use must be in accordance with the conditions of use indicated in the declaration of compliance)
- Contact details of the company (name, address or city). An internet address is accepted as the only contact information only if the link opens directly to pages with sufficient contact information.
- Traceability marking
- With regard to active materials and articles, information on the permitted use, the name and quantity of substances released by the active component.
In addition, assurance has been obtained that food contact materials intended for the consumer are labelled in Finnish and Swedish. In business-to-business selling, there is no need to use both Swedish and Finnish for the provision of information, and documents in English are also accepted.
Labelling and marketing do not mislead the consumer.

A = Compliant
- The manufacturer has ensured that products sold directly to the consumer are labelled in Finnish and Swedish in accordance with Article 15 of Regulation 1935/2004.
- The information has been visibly, clearly and indelibly marked on the materials and articles or on their packaging or on their labels or on a notice in the immediate vicinity.
- In business-to-business selling, the same information has been provided either on the labelling or in documentation.

B = Good, there may be minor shortcomings
- The manufacturer has ensured that products sold directly to the consumer are labelled in Finnish and Swedish in accordance with Article 15 of Regulation 1935/2004, but with minor shortcomings.
- However, these shortcomings are not reflected in the restrictions and instructions for use or in the traceability markings and use of the products would not appear to be unsafe due to these shortcomings.
- The information has been mostly visibly, clearly and indelibly marked on the materials and articles or on their packaging or on their labels or on a notice in the immediate vicinity.
- In business-to-business selling, the same information has been provided either on the labelling or in documentation, but there may be minor shortcomings.

C = Issues impairing food safety, to be rectified within a set period of time
- The manufacturer has failed to ensure that products sold directly to the consumer are labelled in Finnish and Swedish in accordance with Article 15 of Regulation 1935/2004.
- Labelling is incomplete and it would appear that the food contact materials are therefore not safe to use.
- There are numerous shortcomings in the information provided in business-to-business selling.
D = Issues jeopardising food safety, to be rectified with immediate effect
- The manufacturer has failed entirely to ensure that the products sold directly to the consumer are labelled in Finnish and Swedish in accordance with Article 15 of Regulation 1935/2004 or, that the relevant information is included in the documents in business-to-business selling.
- Labelling and/or information provided to companies is clearly incomplete and the safety of the use of the food contact materials cannot therefore be ensured.
  AND
- Despite have been requested to do so, the manufacturer has not initiated measures to supplement the incomplete labelling.

6.Traceability

The main focus of the inspection in this point is on ensuring the adequate traceability of food contact materials (Article 17 of EU Regulation 1935/2004,). It is recommended to ensure traceability also in practice through example food contact materials.

This point of the inspection form checks, for example

What kind of procedures the manufacturer has to ensure traceability and what kind of markings and documents tracing is based on.
Whether traceability is carried out as required by legislation.

Under Framework Regulation 1935/2004 (Article 2), "traceability" means the ability to trace and follow a material or article through all stages of manufacture, processing and distribution.

Under Article 17 of the Regulation, the manufacturer must have in place systems and procedures to allow identification of the companies from which and to which the materials and articles and, where appropriate, substances or products covered by this Regulation and its implementing measures used in their manufacture are delivered. This information shall be made available to the competent authorities on request.

A = Compliant
- The manufacturer has adequate procedures required by legislation to ensure traceability and they cover all the food contact materials to be manufactured.
- Traceability also works in practice at least one step back and one step forward (for products sold directly to the consumer, e.g. an estimate of the time of sale by delivery batch).
- Traceability records are at an adequate level and there is no vagueness or ambiguity. The manufacturer has defined the retention period of the traceability records taking into account the lifecycle (time on the market life/use time) of the products).

B = Good, there may be minor shortcomings
- The manufacturer has adequate procedures as required by legislation to ensure traceability, but for some products there is minor ambiguity. However, traceability works in practice.
- There are minor shortcomings in traceability records and ambiguous interpretation cannot be completely avoided. However, ambiguities can be supplemented by other means.

C = Issues impairing food safety, to be rectified within a set period of time
- The manufacturer does not have adequate procedures to ensure traceability, and ensuring traceability in practice is not a systematic activity.
- Most of the food contact materials are not traceable one step back and one step forward.
- Traceability records leave a number of ambiguities which cannot be supplemented by other means.
D = Issues jeopardising food safety, to be rectified with immediate effect
- Traceability is not ensured in any way and no plan whatsoever has been prepared to ensure it.
- Traceability in practice cannot be ensured and a number of untraceable products can be identified.
- There are no traceability records.
  OR
- Despite having been requested to do so, the wholesaler has not rectified the shortcomings identified in traceability.

7. Processing methods/processes

The main focus of the inspection in this point is to ensure that the manufacture of food contact materials is controlled and that the requirements of EU Regulation 2023/2006 for good manufacturing practices (GMP) are taken into account and implemented.

This point of the inspection form checks, for example

Whether the manufacturer has a description of its own manufacturing processes and sufficient information about what occurs at the various work stages.
Whether the manufacturer has identified critical work stages in its process and set up critical control or monitoring points for them.
Whether the manufacturer has adequate procedures (including corrective actions) to follow and verify the critical control and monitoring points.
Whether the manufacturer is aware of the presence and quantities of SML and dual-use substances that may be present in the final food contact material.
Whether the manufacturer is aware of the existence of NIAS in the manufacturing process and whether it has carried out a risk assessment and measures to prevent the formation of NIAS.
If printing is part of the process, whether the procedures are adequate to prevent the set-off phenomenon.
Whether the manufacturer has taken measures to prevent cross-contamination during the manufacturing, storage and transport of food contact materials.

A = Compliant
- The processes involved in the operation have been described and the critical work phases and/or those requiring following have been identified and managed.
- The manufacturer has established what impurities or reaction intermediates, degradation or reaction products may be formed in the production process (NIAS), and is aware of the measures that can be taken to minimise them.
- Measures to ensure the drying of printing inks are adequate and verifiable.
- The manufacturer ensures the functioning of the process through regular monitoring and records.
- Where appropriate, corrective measures have been initiated without delay and have been in the right direction, adequate and effective.
B = Good, there may be minor shortcomings
- The processes involved in operations have largely been described and the critical work stages have been identified and managed.
- The manufacturer has largely established what impurities or reaction intermediates, degradation or reaction products may be formed in the production process (so-called NIAS), and has taken measures to minimise NIAS. Measures to ensure the drying of printing inks are largely adequate and verifiable.
- The manufacturer ensures the functioning of the process by monitoring and records and, where appropriate, by examining samples. There are minor shortcomings in the monitoring and/or recording, but these do not adversely affect the safety of food contact materials.
- Where appropriate, corrective measures have been initiated without delay and have been adequate and effective. However, for a small number of corrective measures, there are no entries.
C = Issues impairing food safety, to be rectified within a set period of time
- The processes involved in operations are mostly not described, the critical work stages are not identified and nor are they systematically managed.
- The manufacturer is not sufficiently clear about what impurities or reaction intermediates, degradation or reaction products may be formed in the production process (NIAS), and has not taken measures to minimise NIAS.
- Measures to ensure the drying of inks appear to be adequate but cannot be verified, so it is not possible to be absolutely certain.
- The manufacturer ensures the functioning of the process through monitoring and records, but there are many shortcomings.
- Such shortcomings in the storage and transport conditions of raw materials and intermediate materials could jeopardise their further processing into safe final food contact material.
- There are no records of the corrective measures and therefore their adequacy and effectiveness cannot be verified.

D = Issues jeopardising food safety, to be rectified with immediate effect
- The processes involved in operations are not described and the critical work stages are not identified and so not systematically managed.
- It is not possible to verify the management of the processes because there are no records at all of critical or monitoring work stages and possible corrective measures.
- The manufacturer is unclear about what impurities or reaction intermediates, degradation or reaction products may be formed in the production process (NIAS), and is not aware by what process controls/conditions they can be minimised.
- No measures have been taken to ensure the drying of printing inks.
  OR
- Despite having been requested to do so, the manufacturer has not initiated measures to describe the processes and to identify and ensure the management of critical work stages.

Appendix 2. FCM importers’ own-check process and assessment of it (both internal market and third country imports)

Content of the importer's own-check / quality management system

Through the own-check system, the food contact material importer manages the hazards associated with its operations and ensures that the food contact materials imported and the food contact material operations meet the requirements laid down for them in provisions applying to food. The operator shall record the results of own-check process with sufficient accuracy.

Under Framework Regulation (EC) 1935/2004, food contact materials must be manufactured in compliance with good manufacturing practices. Good manufacturing practices must extend to all stages of the production, processing and distribution of food contact materials, except for the production of starting substances.

The importer of contact materials must ensure the reliability of the contact material supplier and that the imported contact materials are manufactured in accordance with good manufacturing practices. In practice, this can be done by determining whether the company supplying the contact materials/manufacturing company has a quality management system to ensure good manufacturing practices. In addition, the importer can, for example, by interviewing ensure that the supplier has sufficient knowledge of contact material legislation in the EU.

The importer must also ensure good manufacturing practices in its own operations through its own-check process. Especially in smaller companies, not all documents/instructions that are part of the own-check process need to be in writing.

The Food Authority website contains general guidance on the own-check of contact material operations.

The importer should take into account among other things the following in the own-check process

Mapping of the work stages related to importing and identification of the hazards related to food contact materials in respect of each work stage and definition of methods to manage these, the organisation of their follow-up and, where appropriate, corrective measures to be taken at each work stage.
A plan on how to implement, where appropriate, the withdrawal of contact materials that have been imported and forwarded to customers if the contact materials are found to have shortcomings that may jeopardise food safety.

The withdrawal plan shows, among other things, who is responsible for which measure, who notifies which authority, how information in the supply chain is managed and what is done with the food contact materials to be withdrawn. The Food Authority and the local food control authority must always be notified of withdrawals. You can find the notification form here. If the food contact materials have already reached the consumer, the need for a notice to consumers is assessed. You can find guidelines on the withdrawal of products here.
Procedures to ensure the competence of the employees, i.e. in practice, how to ensure that the purchasing staff has sufficient competence to purchase food contact materials, including what requirements have been laid down for them. Also, salespeople have sufficient knowledge of the composition, purpose and limitations of the use of contact materials to enable them to provide them correctly to customers. This requires exchange of information between suppliers, the importer and its customers. The importer must also establish what purpose the food contact material will be used for in order to be able to sell the right, safe contact material for the intended use. Also, any warehouse employees must have information about which materials and articles are food contact materials and how they should be handled, for example, to prevent cross-contamination during storage, loading and transport.
Procedures for ensuring the safety and compliance of imported food contact materials, i.e. information on the procurement and storage of declarations of compliance of contact materials and supporting documents and on the verification of the adequacy of the content of these documents. The updating policies of these documents is also included in the own-check process. In line with the recommendation of the Food Authority, the declarations of compliance must be updated at least every three years or whenever there have been changes in the composition of the product or in the legislation concerning the contact material.

The importer is responsible for the safety and compliance of the food contact material it imports. This is why the importer must have at its disposal all the documentation demonstrating the safety and other compliance of the food contact material, incl. compositional information, technical information, especially for intermediate materials, declarations of compliance, test results and, where appropriate, the results of the manufacturer's risk assessment.

The importer must follow the legislation on food contact materials so as to be able to determine which legislation the contact materials to be obtained must comply meet. It is a good idea to define these in the own-check process, for example, by material type. In the absence of material-specific legislation, another material-specific safety reference must be determined, the requirements of which must be met for products put on sale.
Procedures for the preparation, where appropriate, for the sampling of food contact materials and for the testing of compliance in the laboratory.

The importer should be prepared for the testing of samples in the laboratory on a spot check basis and whenever there is any doubt about the safety or compliance of the food contact material, for example, if the manufacturer's tests are to be supplemented.
Procedures for forwarding information and documentation on the compliance of food contact materials to customers, also taking into account the labelling requirements arising from the Framework Regulation and labelling if the product to be traded goes for direct sale to the consumer.

The importer is required to forward the documentation demonstrating the compliance of the food contact materials to its customers. Documentation means in particular the declarations of compliance of intermediate materials and final food contact materials and, where appropriate, depending on the customer, to their supporting documentation. As a rule, the provision of declarations of compliance is sufficient for food establishments.

The importer must ensure that food contact materials sold to the consumer have the labelling required by Article 15 of Framework Regulation (EC) 1935/2004. Labelling must be both in Finnish and Swedish. In particular, assurance must be obtained that the instructions for use and restrictions on use contained in the original packaging have been translated into Finnish and Swedish. Regarding contact materials which are not intended for sale to the consumer but for use by another company, e.g. for packaging material for food establishments or for further processing by a contact material operator, information corresponding to the labelling may also be provided in the documentation.

Procedures to ensure the traceability of food contact materials.

Traceability must be demonstrated in concrete terms and it must be possible to make the link between the food contact material documents. The importer must be able to demonstrate where the products in distribution were procured (where, what, how much, when) and delivered (what, where, how much and when).

Assessment point by point

1. Information on the quality management system

The main focus of the inspection is on the general content of the own-check process, which is assessed in this point only with regard to the matters below. Assessment of the other content and its implementation is carried out separately in each assessment item.

This point of the inspection form checks, for example

Whether the company has an own-check process and whether it has been deployed in operations.
Whether it has defined the responsibilities for the safety of food contact materials.
How the employees' safety competence in contact materials is ensured.
What the own-check update policies are.

The own-check process must be updated/assessed regularly, large-scale operators at least once a year, small-scale operators at least every other year.
How the company is prepared for deviations and disruptions and whether the company has an adequate withdrawal plan.

A = Compliant

The importer has prepared an own-check or standard-based quality management system to ensure the safety and other compliance of products and good manufacturing practices and complies with this system in its own operations.
The own-check process adequately takes into account the requirements of EU Regulation 2023/2006 and the Food Authority's guidelines.

The own-check process can be, for example, a quality management system or, in small-scale operations, work instructions. Especially in smaller companies, not all documents/instructions that are part of the own-check process need to be in writing. However, the own-check process always includes document management with regard to the traceability documentation of food contact materials and documents demonstrating safety. Documentation demonstrating safety and other compliance include: Raw material specifications, declarations of compliance of materials, research results, results of risk assessment, etc.

The importer can ensure the safety and other compliance of the products imported by carrying out the own-check process.

B = Good, there may be minor shortcomings, which do not, however, impair food safety
- The importer has prepared an own-check or standard-based quality management system to ensure the safety and other compliance of products and good manufacturing practices and mainly complies with this system in its own operations.
- The own-check process mostly adequately takes into account the requirements of EU Regulation 2023/2006 and Food Authority's Guide on the own-check of food contact material operations.
- Despite minor shortcomings, the importer can, by means of the own-check process, ensure an adequate level of safety and other compliance of the products imported.

C = Issues impairing food safety, to be rectified within a set period of time

The importer has an own-check process, but it has not adequately taken into account the requirements of EU Regulation 2023/2006 for the quality management system and the Food Authority's guidelines.
There are significant shortcomings in the own-check process and it would appear that food safety will be jeopardised.
Compliance with the own-check process cannot fully ensure good manufacturing practices and the safety and other compliance of food contact materials.

D = Issues jeopardising food safety, to be rectified with immediate effect.

Issues in general matters of quality management do not pose an immediate risk to food safety. This is why a grade D is only given if a grade C has been given repeatedly and the issues have not been rectified within a set period of time.

The importer has not prepared an own-check process to ensure good manufacturing practices
AND
Despite having been requested to do so, the importer has not begun to prepare an own-check process.

2. Compositional management of products

This point of the inspection form inspects with regard to imports for example

Whether the importer has ensured the reliability and competence of the raw material suppliers in food contact material safety matters, including legislation. Whether among other things assurance has been obtained that Finnish suppliers have submitted a registration notification to the food control authority.
Whether, with regard to the food contact materials imported, the importer has determined which legal or other safety reference requirements they must meet?
Whether sufficient information and documentation (declarations of compliance, test results, risk assessment results, etc) have been obtained with regard to the safety and compliance of the imported intermediate materials and food contact materials.

Effect of the age of declarations of compliance on the assessment of imported contact materials:
- Grade A – age of declarations of compliance, 0-3 years
- Grade B – age of declarations of compliance, 3-5 years
- Grade C – age of declarations of compliance, 5-7 years
- Grade D – age of declarations of compliance, more than 7 years.

Whether the importer is aware of the presence and quantities of SML and dual-use substances and their amounts that may be present in the imported food contact material.

The compositional information needed varies depending on the customer. For food establishments, less compositional information on the food contact material in the declaration of compliance is enough if the contact material is no longer modified by the food establishment. Conversely, the downstream processor of food contact materials usually needs more detailed compositional information in order to assess the impact of their own operations on the safety of the contact material manufactured.

Whether the company has agreed procedures for determining the future conditions of use of the food contact material so that it is able to provide the customer with safe, suitable material for the intended use.

A = Compliant

The importer has determined beforehand, for example by type of material, what different requirements must be met by the food contact materials and intermediate materials made of different raw materials, as well as to use operators who have been found to be reliable in the supply of raw materials and who are aware of food contact material requirements.
The importer has determined the composition and suitability of the imported food contact materials for the use for which they will be marketed.
Suppliers who are aware of food contact material legislation and who have available the required and sufficient information on the chemical composition and types of material of the food contact materials have been selected as reliable operators.

B = Good, there may be minor shortcomings,, which do not, however, impair food safety
- The importer has mostly determined, for example by type of material, the composition and suitability of the imported food contact materials for the use for which they will be marketed.
- Suppliers who are aware of food contact material legislation and who mostly have available the required and sufficient information on the chemical composition and types of material of the food contact materials have been selected as reliable operators.
- Documentation obtained from the supplier demonstrating the safety and compliance of food contact materials mainly contains sufficient information on chemical composition and types of material.

C = Issues impairing food safety, to be rectified within a set period of time
- The importer has not adequately determined the chemical composition and material types of contact materials and has not defined in advance which requirements these must meet.
- The reliability of suppliers and their knowledge of contact materials have not been ensured. The importer does not know whether the Finnish suppliers have submitted a registration notification to the food control authority or whether they have effective own-check process.
- The importer does not have sufficient information on the chemical composition of the food contact materials and material types B6 and so is unable to forward the information to its customers.

D = Issues jeopardising food safety, to be rectified with immediate effect
- The importer has not in any way determined the composition and suitability of the food contact materials for the intended use.
- Contact materials are obtained haphazardly and the reliability of the suppliers is not ensured.
- No compositional information is available on the imported contact materials and so the importer has not forwarded it to its customers.
  OR
- Despite having been requested to do so, the importer has not initiated measures to rectify the shortcomings.

3. Testing

The main focus of the inspection in this point is on the tests and mathematical calculations carried out to ensure the safety and compliance of food contact materials and their scope and documentation.

This point of the inspection form checks, for example

Whether the importer has a sampling plan for the testing of food contact materials or to determine calculations to replace it?

The importer must be prepared to ensure, where appropriate, by sampling, the reliability of the results obtained from the manufacturer or, if they are missing or incomplete, to supplement them with their own testing.

Whether the importer has commissioned tests or calculations to determine the migration and organoleptic properties of the ingredients.
Whether the safety references against which the tests have been commissioned are justified.
Whether the results of the tests/calculations comply with legislation and the limit values of the safety references chosen.
Whether the importer, where appropriate, has taken corrective measures in response to the excesses over limit values and whether a record has been kept of the corrective measures taken.
Whether the test results and calculations are documented and verifiable.

A = Compliant
- The importer has up-to-date and comprehensive test results/calculations of the food contact materials it imports.
- However, where no test reports have been obtained from the manufacturer, sufficient compositional information on the contact material has been obtained from it for the purpose of commissioning the importer's own tests/calculations, or the importer has undertaken to find an alternative supplier from which adequate tests are available.
- The importer has commissioned tests/calculations for some of the materials by spot tests or based on doubt.
- The importer is aware of the material safety requirements and has been able to choose the right legislation or other safety reference for its own tests/calculations.
B = Good, there may be minor shortcomings, which do not, however, impair food safety
- The importer has test results/calculations for most of the contact materials imported.
- It has been difficult to obtain the test results or the calculations replacing them, and despite its best efforts, the importer has been unable to find a replacement food contact material supplier who could provide the necessary test results/calculations. However, the importer has declarations of compliance for such contact materials which contain sufficient information on test results, but the test conditions, etc. have not been specified in more detail.
- The importer has commissioned tests/calculations for a small part of the materials by spot tests or based on doubt.
- The importer is mostly aware of the food material safety requirements and is able to determine safety references.
C = Issues impairing food safety, to be rectified within a set period of time
- The importer lacks test results for most of the food contact materials.
- The importer has not started to find an alternative food contact material supplier who could provide the test results and there are not even declarations of compliance containing sufficient information on the contact materials.
- Nor has the importer commissioned test/calculations to replace incomplete test data and does not have the competence to determine adequate safety references.
D = Issues jeopardising food safety, to be rectified with immediate effect
- The importer has no test results whatsoever for imported intermediate materials and final food contact materials.
  OR
- Despite having been requested to do so, the importer has not initiated measures to rectify the issue, to obtain alternative suppliers who could provide test results or to commission tests/calculations itself to ensure safety.

4. Documentation demonstrating compliance

The main focus of the inspection in this point is on the declarations of compliance prepared to ensure the safety and compliance of contact materials and their content.

This point of the inspection form checks, for example

Whether the importer has prepared declarations of compliance for the intermediate and final food contact materials it has imported or supplemented the manufacturer's declarations of compliance with its own information?
Whether the declarations of compliance contain sufficient information on the food contact material (name, structure, types of material, specific migration limit (SML) substances, dual-use substances).
Whether the declarations of compliance contain sufficient justification for the safety and compliance of the materials (legislation and other safety references, tests, risk assessment).
Whether the declarations of compliance contain sufficient information on the conditions and restrictions of use (food types, use temperatures, contact time guidelines, repeated use).
Whether the declarations of compliance contain other necessary information, including information on recycled material or additional information for active and intelligent materials.
Whether the declarations of compliance are updated regularly.
What other documentation demonstrating compliance the importer has for the materials/articles to supplement the actual declaration of compliance.
Whether the importer has procedures in its own-check process of the provision of declarations of compliance to its customers.

A = Compliant
- The importer has prepared declarations of compliance for the food contact materials imported based on the product manufacturer's declarations of compliance and their supporting documentation or has added its own contact details to the manufacturer's declaration of compliance if the manufacturer has consented to this.
- The declarations of compliance contain sufficient information to ensure the safety of the food contact materials.
- The importer has policies to ensure that the declaration of compliance and other information demonstrating compliance are provided to the next operator and is systematically provided.
B = Good, there may be minor shortcomings
- The importer has prepared declarations of compliance for most of the food contact materials imported based on the product manufacturer's declarations of compliance and their supporting documentation. Some of the declarations of compliance forwarded by the importer lack its contact details, but most of them contain the details.
- There are minor shortcomings in the information contained in the declarations of compliance but these do not prevent assurance of the safety of the food contact materials.
- The importer has policies on how to provide the declaration of compliance and other information demonstrating compliance to the next operator but these have not always been complied with.

C = Issues impairing food safety, to be rectified within a set period of time
- The importer has declarations of compliance for only some of the food contact materials imported.
- The content of the declarations of compliance is clearly incomplete (incl. shortcomings in the legal framework, in the information on use or traceability) and does not allow full assurance of the safety of the food contact materials.
- The importer has no policies to provide declarations of compliance and other information demonstrating compliance to the next operator.

D = Issues jeopardising food safety, to be rectified with immediate effect
- There are no declarations of compliance whatsoever for the contact materials imported.
  OR
- Despite having been requested to do so, the importer has not prepared declarations of compliance for the food contact materials imported or has not agreed to supplement the manufacturer's declaration of compliance with its own information.

5. Product labelling

The main focus of the inspection in this point is on the labelling of food contact materials primarily intended for use by the consumer (Article 15 of EU Regulation 1935/2004). The business-to-business selling point checks that at least the corresponding information is provided in the documents. In addition to the declaration of compliance, documentation here means, for example, commercial documents, which may contain some of this information.

This point of the inspection form checks, for example

The importer's procedures for ensuring the labelling before the product is placed on the market and, for example, whether the labelling contains
- Text, symbol, etc. indicating the use of the food (not mandatory for food contact materials which, because of their properties, are clearly intended for contact with food).
- Instructions for safe use (e.g. restrictions on use must be in accordance with the conditions of use indicated in the declaration of compliance)
- Contact details of the company (name, address or city). An internet address is accepted as the only contact information only if the link opens directly to a website containing sufficient contact information.
- Traceability marking
- With regard to active materials and articles, information on the permitted use, the name and quantity of substances released by the active component.
In addition, assurance has been obtained that food contact materials intended for the consumer are labelled in Finnish and Swedish.
In the case of imported food contact materials, the importer is responsible for the Finnish and Swedish labelling. These may not contradict the original labelling. For example, any restrictions on use and warning statements must be translated into Finnish and Swedish for food contact materials sold to the consumer.
In business-to-business selling, there is no need to use both Swedish and Finnish for the provision of information, and documents in English are also accepted.
Labelling and marketing do not mislead the consumer.

A = Compliant
- The importer has ensured that products sold directly to the consumer are labelled in Finnish and Swedish in accordance with Article 15 of Regulation 1935/2004.
- The information has been visibly, clearly and indelibly marked on the materials and articles or on their packaging or on their labels or on a notice in the immediate vicinity.
- In business-to-business selling, the same information has been provided either on the labelling or in documents.
- The importer has ensured that the packaging labels for which it has responsibility correspond to the originals and do not contradict each other.
B = Good, there may be minor shortcomings
- The importer has ensured that products sold directly to the consumer are labelled in Finnish and Swedish in accordance with Article 15 of Regulation 1935/2004, but the labelling contains minor shortcomings.
- However, these shortcomings are not reflected in the traceability markings or in the restrictions and instructions for use and nor would it appear that the use of the products is unsafe due to these shortcomings.
- The information has been mostly visibly, clearly and indelibly marked on the materials and articles or on their packaging or on their labels or on a notice in the immediate vicinity.
- In business-to-business selling, the same information has been provided either on the labelling or in documents, but it may contain minor shortcomings.
- The markings drawn up by the importer itself in Finnish and Swedish contain minor shortcomings compared to the original markings of the contact material. However, these shortcomings do not prevent assurance that the consumer can safely use the food contact material.
C = Issues impairing food safety, to be rectified within a set period of time
- The importer has not ensured in all respects that products sold directly to the consumer are labelled in Finnish and Swedish in accordance with Article 15 of Regulation 1935/2004.
- Labelling is incomplete and it would appear that the food contact materials are therefore not safe to use.
- There are numerous shortcomings in the information provided in business-to-business selling.
- The Finnish and Swedish labelling prepared by the importer does not correspond to the original labels with regard to restrictions on use or warning statements. It would appear that the consumer will therefore be unable to safely use the food contact material.

D = Issues jeopardising food safety, to be rectified with immediate effect
- The importer has not ensured at all that products sold directly to the consumer are labelled in Finnish and Swedish in accordance with Article 15 of Regulation 1935/2004.
- Despite having been requested to do so, the importer has not initiated measures to supplement the incomplete labelling.
- Labelling and/or information provided to companies is incorrect and the safe use of the food contact materials cannot therefore be ensured.

6. Traceability

The main focus of the inspection in this point is on ensuring the adequate traceability of food contact materials (Article 17 of Regulation 1935/2004,). It is recommended to ensure traceability also in practice through example food contact material.

This point of the inspection form checks, for example

What kind of procedures the importer has to ensure food contact material traceability and what kind of markings and documentation tracing is based on.
Whether traceability is carried out as required by legislation.

Under Framework Regulation 1935/2004 (Article 2), "traceability" means the ability to trace and follow a material or article through all stages of manufacture, processing and distribution.

Under Article 17 of the Regulation, the importer must have in place systems and procedures to allow identification of the businesses from which and to which the materials and articles and, where appropriate, substances or products covered by this Regulation and its implementing measures used in their manufacture are delivered. This information shall be made available to the competent authorities on request.

A = Compliant
- The importer has adequate procedures, as required by legislation, to ensure traceability and they cover all imported products.
- Traceability also works in practice at least one step back and one step forward (for products sold to the consumer, e.g. an estimate of the time of sale by delivery batch).
- Traceability records are at an adequate level and there is no vagueness or ambiguity. The importer has defined the retention period of the traceability records taking into account the lifecycle (time on the market life/use time) of the products).

B = Good, there may be minor shortcomings
- The importer has adequate procedures as required by legislation to ensure traceability, but there is minor ambiguity in respect of some products. However, traceability works in practice at least one step back and one step forward.
- There are minor shortcomings in traceability records and ambiguous interpretation cannot be completely avoided. However, ambiguities can be supplemented by other means.

C = Issues impairing food safety, to be rectified within a set period of time
- The importer does not have adequate procedures to ensure traceability, and ensuring traceability in practice is not a systematic activity.
- Most of the food contact materials are not traceable one step back and one step forward.
- Traceability records leave a number of ambiguities which cannot be supplemented by other means.
D = Issues jeopardising food safety, to be rectified with immediate effect
- Traceability is not ensured in any way and no plan whatsoever has been prepared to ensure it.
- Traceability cannot be ensured in practice in respect of any product.
- There are no traceability records.
  AND
- Despite having been requested to do so, the wholesaler has not rectified the shortcomings identified in traceability.

7. Processing methods/processes

The main focus of the inspection in this point is to ensure that the import of food contact materials is controlled and that the requirements of EU Regulation 2023/2006 for good manufacturing practices (GMP) are taken into account and implemented.

This point of the inspection form checks, for example

Whether the importer provides a description of its own import processes (e.g. conclusion of procurement contracts with the supplier; assurance of compliance with the food contact materials imported by requesting the necessary documentation demonstrating safety and by regular updating of the documentation; ascertaining the intended use and conditions of use of the contact material from the customer and provision of the contact material accordance with this; providing declarations of compliance to the customer; preparation of labelling and marketing material, etc.).
Whether the importer has identified critical work stages in its process and set up critical control or monitoring points for them.
Whether the importer has adequate procedures (including corrective measures) to follow and verify the critical control and monitoring points.
Whether the importer has taken measures to prevent cross-contamination during the transport and storage of food contact materials.

A = Compliant
- The work stages involved in the import process have been described and the critical work stages or those requiring monitoring have been identified and managed.
- The importer ensures the functioning of the process by regular monitoring and records and, where appropriate, by examining samples.
- Where appropriate, corrective measures have been initiated without delay and have been in the right direction, adequate and effective.
B = Good, there may be minor shortcomings
- The work stages involved in the import process have mostly been described and the critical work stages or those requiring monitoring have been identified and managed.
- The importer ensures the functioning of the process mostly by regular monitoring and records and, where appropriate, by examining samples. There are minor shortcomings in the monitoring and/or records, but these do not adversely affect the safety of food contact materials.
- Where appropriate, corrective measures have mostly been initiated without delay and have been adequate and effective. However, for a small number of corrective measures, there are no entries.

C = Issues impairing food safety, to be rectified within a set period of time
- The importer is unable to reliably describe the functioning of the work stages in the import process and cannot ensure that they are managed.
- The shortcomings in the storage and transport conditions of food contact materials may jeopardise their chemical safe use.
- The importer has no procedures for regular monitoring of the functioning of the import process and there are many shortcomings in the records.
- There are no records of the corrective measures and therefore their adequacy and effectiveness cannot be verified.

D = Issues jeopardising food safety, to be rectified with immediate effect
- The importer is unable to reliably describe the functioning of the work stages in the import process and cannot ensure that they are managed.
- The importer has no procedures for regular monitoring of the functioning of the process and there are no records of the monitoring.
- The shortcomings in the storage and transport conditions of food contact materials may jeopardise their chemical safety.
- There are no records of the corrective measures and therefore their adequacy and effectiveness cannot be verified.
  AND
- Despite having been requested to do so, the importer has not initiated corrective measures to rectify the shortcomings, even though the previous inspection has given a grade C and agreed that the shortcomings will be rectified within a set period of time.

Appendix 3. FCM wholesaler's own-check process and assessment of it

Content of the wholesaler's/distiributor's own check / quality management system

Through the own-check process, the wholesaler manages the hazards associated with its operations and ensures that the food contact materials traded and the food contact material operations meet the requirements laid down for them in provisions applying to food. The operator shall record the results of the own-check process with sufficient accuracy.

Under Framework Regulation (EC) 1935/2004, food contact materials must be manufactured in compliance with good manufacturing practices. Good manufacturing practices must extend to all stages of the production, processing and distribution of food contact materials, except, however, for the production of starting substances.

The wholesaler of contact materials must ensure the reliability of the food contact material supplier and that the contact materials procured for wholesale are manufactured in accordance with good manufacturing practices. In practice, this can be done by determining whether the company supplying/manufacturing the contact materials has a quality management system to ensure good manufacturing practices. Food contact material companies in Finland must additionally ensure whether they are subject to food control, i.e. whether they have submitted a registration notification of their operations and location to the local food control authority.

The wholesaler must also ensure good manufacturing practices in its own operations through its own-check process. Especially in smaller companies, not all documents/instructions that are part of the own-check process need to be in writing.

The Food Authority website contains general guidance on the own-check of contact material operations.

The wholesaler/distributor should take into account among other things the following in the own-check process

Mapping of the work stages related to wholesale and identification of the food safety hazards related to food contact materials in respect of each work stage and determination of methods to manage these, the organisation of their follow-up and, where appropriate, corrective measures to be taken in each work stage.
A plan on how to implement, where applicable, the withdrawal of food contact materials that have been sold if they are found to have shortcomings that may jeopardise food safety.

The withdrawal plan shows, among other things, who is responsible for which measure, who notifies which authority, how information in the supply chain is managed, what is done with the food contact materials to be withdrawn. The Food Authority and the local food control authority must always be notified of withdrawal You can find the notification form here. If the food contact materials have already reached the consumer, the need for a notice to consumers is assessed. You can find guidelines on the withdrawal of products here.

Procedures to ensure the competence of the employees, i.e. in practice, how to ensure that the buying staff has sufficient competence to buy food contact materials, including what requirements have been laid down for them. Also, salespeople must have sufficient information on the composition, intended use and limitations of use of the food contact materials to enable them to provide customers with the correct information on the materials. This requires the exchange of information between wholesale and customers. Some of the information can also be provided through sales descriptions and labelling. This is particularly recommended in the case of a wholesale outlet where operators of small-scale food businesses buy the food contact materials they use. Also, any warehouse employees must have information about which materials and articles are food contact materials and how they should be handled, for example, to prevent cross-contamination during storage, loading and transport.
Procedures for ensuring the safety and compliance of food contact materials traded, i.e. information on the acquisition and storage of declarations of compliance of contact materials and supporting documentation and on the verification of the adequacy of the content of these documents. The updating policies of these documents is also included in the own-check process. In line with the recommendation of the Food Authority, the declarations of compliance must be updated at least every three years or whenever there have been changes in the composition of the product or in the legislation concerning the contact material.

The wholesaler must follow the legislation on food contact materials so as to be able to determine which legislation the contact materials to be obtained must comply meet. It is a good idea to define these in the own-check process, for example, by material type. In the absence of material-specific legislation, another material-specific safety reference must be defined, the requirements of which must be met for products put on sale.
Procedures for preparing for the sampling of contact materials and for examining compliance, if such defects are found in the contact material traded that make sampling necessary, e.g. the suspicion of the hazard materialising is obvious.

Regular sampling is not required by the wholesale distributor, but the readiness for it must be predefined.
Procedures for forwarding information and documentation on the compliance of food contact materials to customers, also taking into account the labelling requirements arising from the Framework Regulation and labelling if the product traded goes for sale to the consumer. For contact materials that are not intended for sale to the consumer but for use by another company, information corresponding to the labelling may also be provided in the documentation.

The wholesaler is required to forward the documentation demonstrating the compliance of the food contact materials to its customers. Documentation means in particular the declarations of compliance of intermediate materials and final food contact materials and, where appropriate, their supporting documentation. For food establishment, it is generally sufficient to provide declarations of compliance and to ensure that the sales descriptions are informative (small food establishments have been given relief from providing documentation, see point 1 of the Oiva inspection guideline on the control of food contact materials at food establishments). Where intermediate materials are sent for further processing, the declaration of compliance must be accompanied by the supplementary information required by the downstream operator, e.g. more detailed information on the composition, risk assessments carried out and test results.
Ensuring the timeliness and correctness of labelling and sales descriptions on a regular basis.

Food establishments which procure the food contact materials they use from wholesale do not need to obtain separate declarations of compliance for them, but can, as a general rule, rely on the information provided in the wholesale marketing on the safe use of the contact material or on the labelling if the contact material is packed in the consumer packaging. It is recommended that wholesalers selling food contact materials to food establishments supplement the labelling of contact materials by, for example, adding supplementary information on the function and conditions of use of the contact material to the wholesale descriptions (system or shelf edges). They will then be able to reduce additional enquiries about the contact materials and the extra burden of having to provide documentation. An example of a good sales description is e.g. "disposable gloves for the short-term handling of fatty foods" or e.g. "plastic film for fatty foods" or "plastic film for the protection of vegetable".

Procedures to ensure the traceability of food contact materials.

Traceability must able to be demonstrated in concrete terms and the food contact material documents must able to be connected to each other. The wholesaler must be able to demonstrate where the products in distribution were obtained (where, what, how much, when) and delivered (what, where, how much, when).

Assessment point by point

1. Information on the quality management system/ own-check process

The main focus of the inspection is on the general content of the own-check process, which is assessed only with regard to the matters below. Assessment of the other content and its implementation is carried out separately in each assessment item.

This point of the inspection form checks, for example

Whether the company has an own-check process and whether it has been deployed in operations.
Whether it has defined the responsibilities for the safety of food contact materials.
Does the own-check process cover all forms of wholesale (store + distance selling channels)
How the employees' food safety competence in contact materials is ensured.
What the quality management system update policies are. The own-check process must be updated/assessed regularly, large-scale operators at least once a year, small-scale operators at least every other year.
How the company is prepared for deviations and disruptions and whether the company has an adequate withdrawal plan.

A = Compliant

The wholesaler has prepared an own-check or standard-based quality management system to ensure the safety and other compliance of products and good manufacturing practices and complies with this system in its own operations.
Own-check adequately takes into account the requirements of EU Regulation 2023/2006 and the Food Authority's guidelines.

The own-check process can be, for example, a quality management system or, in small-scale operations, work instructions. However, own-check always includes document management with regard to the traceability documentation and declarations of compliance of contact materials.

The wholesaler can ensure the safety and other compliance of the contact materials it distributes by complying with the own-check process.

B = Good, there may be minor shortcomings, which do not, however, impair food safety
- The wholesaler has prepared an own-check or standard-based quality management system to ensure the safety and other compliance of products and good manufacturing practices and mainly complies with this system in its own operations.
- The own-check process mostly adequately takes into account the requirements of EU Regulation 2023/2006 and Food Authority's Guide on the own-check of food contact material operations.
- Despite minor shortcomings, the wholesaler can, by complying with an own-check / quality management system, ensure an adequate level of safety and other compliance of the products with regard to wholesale distribution.

C = Issues impairing food safety, to be rectified within a set period of time
- The wholesaler has an own-check process, but it has not sufficiently taken into account the requirements of EU Regulation 2023/2006 for the quality management system or the Food Authority's guidelines.
- There are significant shortcomings in the own-check process and it would appear that food safety will be jeopardised.
- Compliance with the own-check process cannot fully ensure good manufacturing practices and the safety and other compliance of the food contact materials.

D = Issues jeopardising food safety, to be rectified with immediate effect

Issues in general matters of quality management do not pose an immediate risk to food safety. This is why a grade D is only given if a grade C has been given repeatedly and the issues have not been rectified within a set period of time.
- The wholesaler has not prepared an own-check process to ensure good manufacturing practice.
  AND
- Despite having been repeatedly requested to do so, the wholesaler has not begun to prepare an own-check process.

2. Compositional management of products

This point of the inspection form with regard to wholesale inspects among other things

Whether the wholesaler has ensured the reliability and competence of the suppliers with regard to food contact material safety issues, including legislation. Whether among other things assurance has been obtained that Finnish suppliers have submitted a registration notification to the Food Authority.
For the contact materials obtained, whether the wholesaler has defined what legal or other safety reference requirements they must meet and what compositional information is required on the contact materials for the declarations of compliance.
Whether the wholesaler possesses all the contact material information to be provided to the next operator in the supply chain for risk assessment (e.g. product types of material, declarations of compliance containing information on the composition/structure of the contact material, substances subject to a restriction, dual-use substances and NIAS).
Effect of the age of the declaration of conformity on the assessment:
- Grade A – age of declarations of compliance, 0-3 years
- Grade B - age of declarations of compliance, 3-5 years
- Grade C - age of declarations of compliance, 5-7 years
- Grade D – age of declarations of compliance, more than 7 years.

NB! The information needed varies depending on the customer. For food establishments, less compositional information on the food contact material in the declaration of compliance is enough if the contact material is no longer modified by the food establishment. Whereas the downstream processor of food contact materials usually needs more detailed compositional information in order to assess the impact of their own operations on the safety of the contact material manufactured.

Whether the company has agreed procedures for determining the future conditions of use of the food contact material so that it is able to provide the customer with safe, suitable material for the intended use.

A = Compliant
- The wholesaler has defined, for example, the material-specific safety requirements that contact materials must meet and there is sufficient information on the contact materials, their types of material and composition.
- Suppliers who are aware of food contact material legislation and who have available the required and sufficient information on the chemical composition and types of material of the food contact materials have been selected as reliable operators. Assurance has been obtained that the Finnish suppliers of intermediate materials have submitted a registration notification to the food control authority.
- There is sufficient information on contact materials about their material types and composition to be passed on to the next operator.
B = Good, there may be minor shortcomings, which do not, however, impair food safety
- The wholesaler has defined, e.g. by material type, what safety requirements the contact materials purchased for sale must meet.
- Suppliers who are aware of food contact material legislation and who have available the required and sufficient information on the chemical composition and types of material of the food contact materials have mostly been selected as reliable operators. Information exists that most of the suppliers have submitted a registration notification to the food control authority.
- Sufficient information exists on most of the food contact materials, their types of material and chemical composition.

C = Issues impairing food safety, to be rectified within a set period of time
- The wholesaler has not defined, for example, what material-specific safety requirements the contact materials must meet and there is insufficient information on most of the contact materials, their types of material and composition.
- The reliability of the suppliers and their knowledge of contact materials have not been ensured at an adequate level. Assurance has not been obtained that they have submitted a registration notification to the food control authority.
- For most of the contact materials, there are no declarations of conformity or other information available that adequately reflect the chemical composition of the products and the types of materials, nor do they allow the safety of the composition of the products to be ensured.

D = Issues jeopardising food safety, to be rectified with immediate effect
- Contact materials are obtained haphazardly and the reliability of the suppliers is not ensured in any way.
- The wholesaler has not in any way determined the composition and suitability of the food contact materials for the intended use.

No compositional information is available on the food contact materials and the operator has not been able in this respect to meet its obligation to forward the information.
OR
Despite having been requested to do so, the wholesaler has not initiated measures to rectify the shortcomings.

3. Testing

The main focus of the inspection in this point is on the tests and mathematical calculations carried out to ensure the safety and compliance of contact materials and their scope and documentation.

This point in the inspection form checks, for example

Whether the wholesaler is prepared to examine samples, where appropriate, e.g. due to safety concerns. Under normal conditions sampling and tests are not required from wholesale distributors.
If tests have been carried out, whether the results of the tests and calculations are documented and verifiable and whether, where appropriate, corrective measures have been taken and whether they are adequate.

A = Compliant
- The wholesaler has adequate procedures and capability to initiate sampling and examining samples in its own-check process, if it becomes aware of a defect in the of safety of contact material that justifies sampling.

B = Good, there may be minor shortcomings, which do not, however, impair food safety
- The wholesaler has mostly adequate procedures and capability to initiate sampling and examining samples in its own-check process, if it becomes aware of a defect in the safety of contact material that justifies sampling.

C = Issues impairing food safety, to be rectified within a set period of time
- The wholesaler is not prepared to examine the samples in any way.

D = Issues jeopardising food safety, to be rectified with immediate effect
- The wholesaler is not prepared to examine samples in any way and has not initiated any measures to rectify the situation despite having been requested to do so.

4. Documentation demonstrating compliance

The main focus of the inspection in this point is the declarations of compliance and their content obtained to ensure the safety and compliance of contact materials and forwarded to customers.

This point in the inspection form checks, for example

Whether the wholesaler has obtained declarations of compliance for the food contact materials in wholesale.
Whether the wholesaler has adequate own-check procedures to verify the adequacy of the content of the declarations of compliance (to be checked against the legislation and the requirements laid down for various materials in the own-check process).
Whether the declarations of compliance contain sufficient information on the food contact material (name, structure, types of material, specific migration limit (SML) substances, dual-use substances).
Whether the declarations of compliance contain sufficient justification for the safety and compliance of the materials (safety references, tests, risk assessment).
Whether the declarations of compliance contain sufficient information on the conditions and restrictions of use (food types, use temperatures, contact time guidelines, repeated use).
Whether the declarations of compliance contain other necessary information, including information on recycled material or additional information for active and intelligent materials.
Whether the declarations of compliance are updated regularly.
Whether the wholesaler has procedures for the provision of declarations of compliance and information on use to its customers, where applicable.

A = Compliant
- The wholesaler has obtained declarations of compliance for the food contact materials.
- The declarations of compliance contain sufficient information to ensure the safety of the food contact materials.
- The wholesaler has adapted the sales descriptions of food contact materials for food establishments as well as possible to reflect their intended use.
- The wholesaler has policies on how to provide a declaration of compliance to the next operator, where applicable.
B = Good, there may be minor shortcomings
- The wholesaler has obtained declarations of compliance for most of the food contact materials. However, there is not always clarification as to whether the customer needs a notification for its own-check process, but it has been delivered on request.
- There are minor shortcomings in the information contained in the declarations of compliance but these do not prevent assurance of the safety of the food contact materials.

C = Issues impairing food safety, to be rectified within a set period of time
- The wholesaler has declarations of compliance only for a small part of the contact materials sold, and the declarations have only haphazardly been forwarded to customers.
- The content of the declarations of compliance is clearly incomplete (incl. shortcomings in the legal framework, in the information on use or in traceability) and does not allow full assurance of the safety of the food contact materials.
- The wholesaler has no policies to provide declarations of compliance and the provision of other information demonstrating compliance to the next operator.
D = Issues jeopardising food safety, to be rectified with immediate effect
- There are no declarations of compliance whatsoever for the food contact materials and they have not been provided to customers on request.
  OR
- Despite having been requested to do so, the wholesaler has not started to obtain declarations of compliance for the food contact materials and has not updated its own-check process in this regard.

5. Product labelling

The main focus of the inspection in this point is on the labelling of food contact materials primarily intended for use by the consumer (Article 15 of EU Regulation 1935/2004). The business-to-business selling point checks that at least the corresponding information is provided in the documentation. In addition to the declaration of compliance, documentation here means, for example, commercial documents, which may contain some of this information. Where appropriate, the wholesale distributor must add the information to commercial documents, sales titles or marketing material.

This point in the inspection form checks, for example

The wholesaler's procedures to ensure labelling before the product is placed on the market and, for example, whether the labelling or other contact materials supplied to customers contains
- Text, symbol, etc. indicating food contact (not mandatory for food contact materials which, because of their properties, are clearly intended for contact with food).
- Instructions for safe use (e.g. restrictions on use must correspond to the conditions of use indicated in the declaration of compliance).
- The company's contact information (name, address or location) The internet address is accepted as the only contact information only if the link opens directly to a website containing sufficient contact information.
- Traceability marking
- With regard to active materials and articles, information on the permitted use, the name and quantity of substances released by the active component.

NB: In business-to-business selling, there is no need to use both Swedish and Finnish for the provision of information, and documents in English are also accepted.

If the customer communication about the intended use of the contact material is made to customers in wholesale solely through labelling (e.g. many food contact materials), the wholesaler must ensure that the labelling contains sufficient information to ensure the safe use of the contact materials.

Labelling and marketing do not mislead the consumer.

A = Compliant
- The wholesaler has ensured that products sold directly to the consumer are labelled in Finnish and Swedish in accordance with Article 15 of Regulation 1935/2004.
- The information has been visibly, clearly and indelibly marked on the materials and articles or on their packaging or on their labels or on a notice in the immediate vicinity.
- In business-to-business selling, the same information has been provided either on the labelling or in documents.
- The wholesaler has ensured that the labelling for which it is responsible (e.g. if the labelling added to documents, sales descriptions or marketing material) corresponds to the originals and there is no contradiction between them.
- The sales descriptions / marketing material of the products have been supplemented with information describing the intended use of the products.

B = Good, there may be minor shortcomings
- The wholesaler has ensured that products sold directly to the consumer are labelled in Finnish and Swedish in accordance with Article 15 of Regulation 1935/2004, but the labelling contains minor shortcomings.
- However, these shortcomings are not reflected in the traceability markings or in the restrictions and instructions for use and nor would it appear that the use of the products is unsafe due to these shortcomings.
- The information has been mostly visibly, clearly and indelibly marked on the materials and articles or on their packaging or on their labels or on a notice in the immediate vicinity.
- In business-to-business selling, the same information has been provided either on the labelling or in documents, but they may contain minor shortcomings.
- The wholesaler has ensured that the labelling for which it is responsible (e.g. if the labelling added to documents, sales descriptions or marketing material) corresponds mainly to the originals, but verification has not been systematic and therefore there are some minor shortcomings.
- Some of the sales descriptions / marketing material of the food contact materials have been supplemented with information describing the intended use of the products.
C = Issues impairing food safety, to be rectified within a set period of time
- The wholesaler has not ensured that products sold directly to the consumer are labelled in Finnish and Swedish in accordance with Article 15 of Regulation 1935/2004.
- Labelling is incomplete and it would appear that the food contact materials are therefore not safe to use.
- In business-to-business selling, there are many shortcomings in the information contained in the documents and they do not allow the food operator to verify how the food contact materials should be used correctly.
- The wholesaler has not ensured that the labelling for which it is responsible (e.g. if the labelling added to documents, sales descriptions or marketing material) corresponds to the original labelling or there are contradictions compared to the documentation.

D = Issues jeopardising food safety, to be rectified with immediate effect
- The wholesaler has not at all ensured that products sold directly to the consumer are labelled in Finnish and Swedish in accordance with Article 15 of Regulation 1935/2004.
- Labelling and/or information provided to companies is clearly incomplete or incorrect and the safety of the use of the food contact materials cannot therefore be ensured.
  AND
- Despite having been requested to do so, the wholesaler has not initiated measures to supplement the incomplete labelling.

6. Traceability

The main focus of the inspection in this point is on ensuring the adequate traceability of food contact materials (Article 17 of EU Regulation 1935/2004). It is recommended to ensure traceability also in practice through example the food contact material.

This point in the inspection form checks, for example

What kind of procedures the wholesaler has to ensure traceability and what kind of markings and documentation tracing is based on.
Whether traceability is carried out as required by legislation.

Under Framework Regulation 1935/2004 (Article 2), "traceability" means the ability to trace and follow a material or article through all stages of manufacture, processing and distribution.

Under Article 17 of the Regulation, the wholesaler must have in place systems and procedures to allow identification of the businesses from which and to which the materials and articles and, where appropriate, substances or products covered by this Regulation and its implementing measures used in their manufacture are supplied. This information shall be made available to the competent authorities on request.

A = Compliant
- The wholesaler has adequate procedures as required by legislation to ensure traceability and they cover all the food contact materials to be manufactured.
- Traceability also works in practice at least one step back and one step forward (for products sold directly to consumers, e.g. an estimate of the time of sale by delivery batch).
- Traceability records are at an adequate level and there is no vagueness or ambiguity. The wholesaler has defined the retention period of the traceability records taking into account the lifecycle (time on the market life/use time) of the products).
B = Good, there may be minor shortcomings
- The wholesaler has adequate procedures as required by legislation to ensure traceability, but for some products there is minor ambiguity. However, traceability works in practice at least one step back and one step forward.
- There are minor shortcomings in traceability records and ambiguous interpretation cannot be completely avoided. However, ambiguities can be supplemented by other means.

C = Issues impairing food safety, to be rectified within a set period of time
- The wholesaler does not have adequate procedures in place to ensure traceability, and ensuring traceability in practice is not a systematic activity.
- Most of the food contact materials are not traceable one step back and one step forward.
- Traceability records leave a number of ambiguities which cannot be supplemented by other means.
D = Issues jeopardising food safety, to be rectified with immediate effect
- Traceability is not ensured in any way and no plan whatsoever has been prepared to ensure it.
- Traceability in practice cannot be ensured and a number of untraceable products can be identified.
- There are no traceability records.
  OR
- Despite having been requested to do so, the wholesaler has not rectified the shortcomings identified in traceability.

7. Processing methods/processes

The main focus of the inspection in this point is to ensure that the wholesale distribution process of food contact materials is managed and that the requirements of EU Regulation 2023/2006 for good manufacturing practices (GMP) are taken into account and implemented.

This point in the inspection form checks, for example

Whether the wholesaler provides a description of its own wholesale distribution processes (e.g. conclusion of procurement contracts with the supplier; assurance of compliance with the food contact materials sold by requesting the necessary documentation demonstrating safety and by regular updating of the documentation; ascertaining the intended use and conditions of use of the contact material from the customer and provision of the contact material accordance with this; providing declarations of compliance to the customer; preparation of labelling, sales descriptions and marketing material, etc.).
Whether the wholesaler has identified critical work stages in its process and set up critical control or monitoring points for them.
Whether the wholesaler has adequate procedures (including corrective measures) to follow and verify the critical control and monitoring points.
Whether the wholesaler has taken measures to prevent cross-contamination during the storage and transport of food contact materials.

A = Compliant
- The work stages involved in the wholesale distribution process have been described and the critical work stages or those requiring monitoring have been identified and managed.
- The wholesaler ensures the functioning of the process through regular monitoring and records.
- Where appropriate, corrective measures have been initiated without delay and have been in the right direction, adequate and effective.

B = Good, there may be minor shortcomings
- The work stages involved in the wholesale distribution process have mostly been described and the critical work stages or those requiring monitoring have been identified and managed.
- The wholesaler ensures the functioning of the process mostly by regular monitoring and records and, where appropriate, by examining samples.
- Where appropriate, corrective measures have been initiated without delay and have mostly been adequate and effective. For a small number of corrective measures, there are no entries.
C = Issues impairing food safety, to be rectified within a set period of time
- The wholesaler is unable to reliably describe the wholesaler's work stages and nor can it be ensured that they are managed.
- The shortcomings in the storage and transport conditions of food contact materials may jeopardise their chemical safety.
- The wholesaler has no procedures for the regular monitoring of the functioning of the work stages and there are many shortcomings in the records.
- There are no records of the corrective measures and therefore their adequacy and effectiveness cannot be verified.
D = Issues jeopardising food safety, to be rectified with immediate effect
- The wholesaler is unable to reliably describe the work stages included in wholesale and nor can it be ensured that they are managed.
- The wholesaler has no procedures for the regular monitoring of the functioning of the work stages and there are no records of the monitoring.
- The shortcomings in the storage and transport conditions of food contact materials may jeopardise their chemical safety.
- There are no records of the corrective measures and therefore their adequacy and effectiveness cannot be verified.
  AND
- Despite having been requested to do so, the wholesaler has not initiated measures to rectify the shortcomings.

Updated version 2

2.3.2023 updated chapter 7, part 4 - spesified which operator has meant.

Evaluation guidelines for food contact material operations to authorities and to business operators

1 General

2 Glossary to the Guide

3 Brief description of the legislation on food contact materials

4 Principle of mutual recognition

5 Legislation, recommendations and guidelines for demonstrating the safety of food contact materials

6 Declarations of compliance and other documentation demonstrating compliance

6.1 Content of the declaration of compliance

7 Regulatory control, related assessment of operations and the operator's own-check process

8 Sharing of responsibility for the safety and compliance of food contact materials among different operators and cooperation among control units

Appendix 1. FCM manufacturer's own-check process and assessment of it

Content of the manufacturer's own check / quality management system

Assessment point by point

Appendix 2. FCM importers’ own-check process and assessment of it (both internal market and third country imports)

Content of the importer's own-check / quality management system

Assessment point by point

Appendix 3. FCM wholesaler's own-check process and assessment of it

Content of the wholesaler's/distiributor's own check / quality management system

Assessment point by point