14 Packaging Materials and Food Contact Materials

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All Oiva evaluation guidelines for approved food establishments.

14.1 Packaging Materials and Other Food Contact Materials

Guide/version: 2178/04.02.00.01/2021/11, valid from 2.1.2026

To be taken consideration:

This point is to be controlled in retail stores and catering facilities as well as other registered food premises and approved food establishments in cases where the operator handles, manufactures, has manufactured for it, stores, packages, imports (from the internal market or third countries), transports or suppliers (e.g. agency business) foodstuffs. If the food business includes selling food in online (their own webstore or on a platform maintained by another party), the inspection also covers these activities. The inspection focuses only on food contact materials used and manufactured in food operations, not, for example, consumer-packaged contact materials sold in retail stores.

  • The implementation of own-check is assessed by inspecting the safety of food contact materials selected on a risk basis.
  • The inspection targets packaging and other materials, machines, equipment, utensils, and supplies that come into contact with food (e.g., containers, transport tanks, food equipment, disposable gloves, packaging materials).
  • At the inspection site, priority is given on a risk basis to materials that come into contact with fatty foods and/or foods exposed to high and/or fluctuating temperatures and/or foods stored for long periods.
  • A large production volume/market leadership of the foodstuff is also a basis for risk-based inspection of materials.

Additionally note:

  • When the inspection targets machines, equipment, or supplies that come into contact with food, it is recommended to also check their condition and integrity under section 2.3 and cleanliness under section 3.2.
  • Production hygiene related to packaging is inspected under section 5.5.
  • Own-check concerning contact materials is inspected as part of the overall own-check review under section 1.6.

Matters to be controlled:

Operator’s actions will be inspected for the following aspects, depending on the activity:

  • Own-check related to food contact materials and own-check documents, as well as documents ensuring compliance and traceability of food contact materials.
  • If the operator manufactures/modifies the final food contact material themselves, they must ensure the safety and compliance of the final food contact material. Measures and tests for, taken by the supplier of the food contact material, may be considered, if they cover the final product. If the supplier’s measures and tests do not cover the final food contact material, the food business operator is obliged to ensure the safety and compliance of the final contact material themselves, e.g., through testing.
    The Finnish Food Authority has outlined certain simplifications for food business operators when they modify the final contact material themselves.
  • Ensuring correct use and right conditions of the use for food contact materials (e.g., only packaging films, bags, containers, and disposable gloves suitable for the purpose are used for fatty foods, foods sold hot, or foods stored hot; Aluminum materials (e.g., pots, foil) are not used for acidic foods, and steel utensils are not used with aluminum containers).
  • Corrective actions in situations where the operator has identified that legal requirements are not met.

The Finnish Food Authority has prepared an inspection form to support inspectors who is carry out inspections according to this guideline. The form can be used partially or fully depending on the scope of the inspection. It is stored in the extranet (Pikantti) for control authorities, in the workspace of the food contact materials control network.

General principles and requirements for ensuring the safety of food contact materials:

  • The glass-and-fork symbol or text indicating food use (e.g., “for food use”) can generally be considered sufficient proof of suitability when food contact materials are purchased through Finnish wholesale/central retail chains or retail stores, and the intended use is clear when look the product name and/or packaging (e.g., grill bag, bread bag, cheese film), or the intended use has otherwise been confirmed (e.g., by email).
    • However, markings indicating food use are not necessarily required for items that are obviously intended for dietary use.
  • The operator has declaration of compliance for those food contact materials, which have been purchased directly from their manufacturer or importer or through a foreign online store. The declarations must be traceable. Declarations of compliance must not be too old. The Finnish Food Authority considers that declarations older than three years should no longer be accepted, as legislation concerning materials often changes during that time (e.g., the plastics regulation has changed almost annually), and raw materials and suppliers rarely remain the same for years. Therefore, older declarations rarely suffice as proof of compliance.
    • Declarations of compliance must contain sufficient and appropriate information, at least:
      • Name and contact details of the manufacturer, importer, or seller of the food contact material;
      • Identification details of the food contact material (name, structure);
      • Date of issuance;
      • Legislation that the food contact material complies (always at least Regulation (EC) 1935/2004), and additionally material-specific regulations where applicable);
      • Additional information required by material-specific legislation, e.g., for plastics: confirmation that overall migration limit is not exceeded; details of substances subject to restrictions (at least one of the following: FCM number, reference number, CAS number, chemical name, limit value), and confirmation that limits are not exceeded);
      • Information on dual-use additives, if present;
      • Restrictions on use, such as food types for which the material is suitable, temperature and contact time limitations.
    • For harmonized food contact materials (example plastic), requirements for the content of declarations of compliance are specified in the relevant legislation, e.g., for plastics in Regulation (EU) 10/2011, Annex IV; for recycled plastics in Regulation (EU) 1616/2022, Annex III A and B. For non-harmonized materials, content recommendations are based on the EDQM general resolution. Remember always select the latest consolidated version of the legislation.
  • In industrial and large-scale food operations where maintaining a HACCP system is required, the operator must conduct a risk assessment if food contact materials contain substances subject to restrictions and/or dual-use substances (food additives or flavorings). The Finnish Food Authority provides guidance on such risk assessments on its website.
  • Old industrial equipment does not require declarations of compliance, but their suitability must otherwise be documented, along with service records and the proof of safety for materials used in repairs.
  • If the food business operator modifies/manufactures the final food contact material themselves as part of their operations, they must ensure the safety of the final food contact material. The inspection includes reviewing safety documents received from the supplier of the intermediate products, checking records related to adherence to instructions (e.g., temperature, time, pressure) and verifying compliance with manufacturing conditions.
  • Materials, articles, equipments, and machines must be used according to their usage/suitability instructions (corresponding to usage instructions on packaging and to instructions in the declaration of compliance for other contact materials).
  • Contact materials must be traceable, i.e., the operator must be able to demonstrate, where the food contact materials have been obtained and estimate the period during which they were used/are being used in food operations.
  • If the operator imports (from the internal market and/or third countries) pre-packaged food or supply forward such products, compliance with the safety requirements for the packaging materials of these products, must also be ensured (e.g., through mention in the purchase agreement or product specification).

The evaluation of the food contact material safety  should be enough large and it should cover all the food operations. The volyme and scope of the activity must be taken into account in such a way, that the inspection is more extensive in larger and riskier activities than in small-scale activities. A single shortcoming in the safety of food contact materials does not usually result in a lower rating, and the evaluation should consider the whole activities. The deficiencies presented in the rating below, are only examples of shortcomings, that may be observed during the inspections, and the list is not a complete list of all shortcomings, that may be observed when giving the rating in question. 

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

Operation meets the above-mentioned requirements. The operator has clear knowledge, and where necessary, adequate documents as regards the food grade quality of materials, and they are used correctly.

Food contact materials are traceable, i.e. the operator is able to demonstrate where the food contact materials were sourced and to estimate from the packaging materials the time during which they have been used/used in the food house.

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

The operation mostly meets the above-mentioned requirements. There are minor deficiencies that do not prevent ensuring that contact materials are generally compliant and used correctly.

However, some small shortcomings are observed.

Examples of individual shortcomings that do not yet decrease food safety:

  • For a small portion of items that come into contact with food, suitability for use has not been ensured.
  • A small number of declarations of compliance have inadvertently not been updated, have not yet been obtained, or contain some incomplete information. However, shortcomings do not concern identification details of food contact materials or usage instructions, so they do not prevent safe use of the food contact material.
  • Fatty foods are handled with disposable gloves whose suitability for this use has not been ensured, e.g., PVC (vinyl) gloves with the glass-and-fork symbol but no information on suitability for contact with fatty foods.
  • Food contact materials are mostly traceable.

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

The operator does not have sufficient knowledge of the quality and suitability of the packaging and other food contact materials used, nor has any attempt been made to verify these aspects. It is suspected that the materials used are not compliant or suitable for their intended purpose, or that they are used incorrectly.

Examples of deficiencies that compromise food safety:

  • A large portion of items, that come into contact with food, have lack markings indicating food use, and the operator cannot otherwise demonstrate their suitability for food contact.
  • They are lack of declarations of compliance i.e the declarations are missing for several food contact materials used in the operation.
  • Declarations of compliance presented by the operator, are clearly incomplete and/or several years old (recommendation: less than three years). Shortcomings concern the identification details or usage conditions, meaning that the operator cannot ensure safe use.
  • The operator has not ensured the suitability of food contact materials for their intended use during ordering or procurement and operator has no actual knowledge of their suitability for the intended use.
  • Fatty foods are handled with disposable gloves, that are not suitable for handling fatty foods.
  • The operator cannot demonstrate the deliverer or origin of food contact materials or estimate the period during which they were used, i.e., contact materials are not traceable.
  • The operator cannot demonstrate that the pre-packaged foods they have imported (from the internal market and/or third countries) or brokered comply with food legislation requirements regarding packaging materials (e.g., mention in purchase agreement or product specification).

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

The operation has shortcomings that endanger food safety or seriously mislead consumers, or the operator has not complied with given orders. Shortcomings must be corrected immediately

It is evident that food contact materials are used in a way that endangers food safety. The operator has no knowledge of the quality or suitability of the food contact materials used for their intended purpose.

Examples of deficiencies that endanger food safety:

  • No declarations of compliance exist, and the operator has not verified the suitability of items purchased from Finnish wholesalers, retailers, or foreign online stores for use as food contact materials.
  • Packaging and food contact materials used in the operation are not suitable for their intended purpose or are used under conditions for which they are not suitable (e.g., excessively high temperatures compared to those stated in the declaration of compliance, or used for food types for which the material is not suitable, or migration of dual-use additives causes the food to fail additive regulation requirements; aluminum materials (e.g., pots, foils) are used for acidic foods and/or steel utensils are used with aluminum containers).
  • Despite given orders, the operator has not taken corrective actions to address deficiencies.
  • The operator is aware of a hazard or off-flavor/odor in food caused by the food contact material but has not initiated a product recall.

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

  • Regulation of the European Parliament and of the Council on materials and articles intended to come into contact with food (EC) No 1935/2004
  • Finnish Food Act 297/2021
  • Commission Regulation on plastic materials and articles intended to come into contact with food (EU) No 10/2011
  • Commission Regulation (EU) No 1616/2022 on recycled plastic materials and articles intended to come into contact with food
  • Commission Regulation (EC) No 450/2009 on active and intelligent materials and articles intended to come into contact with food
  • Commission Regulation (EU) No 284/2011 laying down specific conditions and detailed procedures for the import of polyamide and melamine plastic kitchenware originating in or consigned from the People’s Republic of China and Hong Kong Special Administrative Region, China
  • Commission Regulation (EC) No 1895/2005 of 18 November 2005 on the restriction of use of certain epoxy derivatives in materials and articles intended to come into contact with food
  • Finnish Degree (KTM) 165/2006 on ceramic materials and articles intended to come into contact with food (dir. 2005/31/EY, 84/500/ETY)
  • Finnish Degree (KTM) 697/2005 on regenerated cellulose materials and articles intended to come into contact with food (dir 2004/14/EY)
  • Finnish decision 268/1992 (KTM) on heavy metals migrating from food contact materials
  • Commission Regulation (EU) 2024/3190 of 19 December 2024 on the use of bisphenol A (BPA) and other bisphenols and bisphenol derivatives with harmonised classification for specific hazardous properties in certain materials and articles intended to come into contact with food, amending Regulation (EU) No 10/2011 and repealing Regulation (EU) 2018/213
  • Ruokavirasto’s Guide for control of food contact materials, No 4217/04.02.00.01/2021

Updates in version 11

 Updated the entire guide. Simplified the structure of the guide, revised the assessment principles, and simplified the wording. Added the preparation/modification of contact materials as part of the activity.