Own check of a food industry operator

A food industry operator’s own-check measures to ensure the safety and other compliance of food contact materials

The food safety of packing and other food contact materials is managed through own-check in a food establishment. In practice, this means that a food industry operator manages the own-checking of the chemical, microbiological and sensory qualities of contact materials.

The microbiological safety of food contact materials in a food establishment is ensured by inspecting the cleanliness of the food contact materials upon delivery and by guaranteeing good hygiene while storing and using food contact materials.

Packing materials must be stored adequately separated from contaminants such as waste and food (for example separate storage room or shelf, covered storage, no direct contact with the floor, only a day’s need brought to a workstation). Proper cleaning of contact materials is important to achieve sufficient hygiene. This means that a suitable cleansing product and method should be used with every material, as well as timely cleaning.

To ensure chemical safety, a food establishment’s own-check plan should describe the principles of food contact material acquisition. Already during product development, or at the latest with food contact material acquisitions, operators must ensure that the food contact materials can be used with food and that they are suitable for the intended use. Every time the product or the production process is changed, the food contact materials’ suitability to the new situation must be re-evaluated.

Choosing reliable suppliers

It is vital that a food industry operator chooses reliable food contact material suppliers (manufacturers, importers, distributors). A food industry operator must ensure that the contact material operator’s processes fulfil their legal requirements:

  • In Finland, a food contact material operator must notify a municipal food control authority about their business. This is to ensure that the food contact material operator is covered by food control and monitoring. This notification requirement is not applied to all operators in the EU area, but in Finland the notification requirement is stated in the Food Act.
  • Food contact material operators must have a quality management system, accordant with EU regulation 2023/2006, to ensure proper forms of production and the chemical safety and regulatory compliance of food contact materials. The requirement of an effective quality management system is applied to all food contact material operators in the EU area. The requirement is similar to the self-monitoring obligation of a food industry operator. In practice, they must have a written own-check plan, and there is no official requirement for certifying the quality management system.  
  • A food contact material operator must submit an appropriate declaration of compliance and/or other potential guarantees of the product’s suitability to be used with food.  

Documents addressing regulatory compliance and their content

When buying food contact materials for food (for exaple packing materials) directly from their manufacturer or importer, a food industry operator must request from the food contact material operator the documents proving the regulatory compliance of the delivered materials and articles.

The operator must regularly ensure that the documents describing the regulatory compliance of the food contact materials for food are up to date. Monitoring the currency of the documents is primarily the responsibility of the food industry operator. However, with a food contact material operator that regularly delivers packaging to a food industry operator, it might be worthwhile to make an agreement of updating the documents whenever there are changes in the packaging production or its raw materials. The documents should also be updated at least every three years with such food contact materials as packaging and articles that are ordered often and thus have alternating batches. Since legislation and the ingredients of the materials seldom remain unchanged for years, Finnish Food Authority recommends that documents are updated at least every three years.

If packaging or other food contact materials for food are ordered as single orders, the documents addressing regulatory compliance must be attached to every delivery.

Documents establishing regulatory compliance for devices and furniture are valid for as long as they are used, assuming that they have not been altered when repaired or maintained.

Documents declaring regulatory compliance must always mention that the materials and articles fulfil at least the requirements defined in the EU framework regulation 1935/2004. In addition, there must be a mention of the basis of regulatory compliance and safety (safety reference). If material-specific EU legislation exists, it must always be included in the safety basis. If none exists, the safety basis can be another EU country’s national legislation or official recommendations, recommendations or standards from an EU-based industry association, or ultimately, legislation from a non-EU country.

For example with plastic materials, a basis for fulfilling the requirements of regulation 1935/2004 must always be the fulfilment of the requirements of EU plastics regulation 10/2011. With paper and paperboard products that have no material-specific legislation, the safety basis can be, for example, the fulfilment of Germany’s official recommendations (BfR XXXVI), and with stainless steel, the basis can be the fulfilment of certain stainless steel standards, or the fulfilment of the requirements in Council of Europe’s resolution on metals and its technical document.

Food additives contained in contact materials for food

If so called dual-use additives are used in producing food contact materials for food, it must always be mentioned in the documents describing regulatory compliance. A food industry operator must check whether these dual-use additives and flavouring have been used in the food contact material and ensure that they have no technological effects on the food. Their concentration must not exceed the maximum permitted levels if such a level has been defined in the foodadditives legislation and/or legislation on flavourings. This can take place if, for example, an foodadditive or flavouring, already found in the food, migrates into the food from the packaging.

Instructions for evaluating chemical risks caused by contact materials

Suitability for contact with food – following instructions during production

Different foods set different requirements for materials and articles that come into contact with them. Especially cheeses, that are often rich in fat, set special requirements for the quality of the contact materials, because the migration of chemical substances has been discovered to be more extensive with fatty than non-fatty foods. Also, the sourness in fermented milk products can increase the chance of migration, and generally, migration has been discovered to be grater the hotter the food.

Thus the documents must always include information about what kind of food contact the material is suitable for, for example, whether it is suitable for contact with food rich in fat in room temperature or in cold storage, or if it can come into contact with hot food. The more work stages there are in the handling of packed food, the greater the requirements for the material that comes into contact with it. For example, heating the food in the microwave in its original packaging always requires packaging that has been tested for the effects that the microwave heating has on the packaging’s chemical durability and the migration of substances into the food.

Restrictions for the use of the packaging must always be checked in its documentation, and operators must ensure that this information is conveyed to the food processing staff. If the documents for example reveal that the packaging must not be used with food that has a temperature of over 65 degrees Celsius, it must be taken into account in the food processing. If necessary, the food handling process must be altered to allow the use of the packaging, or, if that is impossible, the packaging must be changed.

Shaping/manufacturing contact materials for food in a food establishment

With packaging that is shaped during packing (for example boxes for cold cuts or bottle preforms), the operator must make sure that they follow instructions provided by the manufacturer of the package preform. Restrictions on temperature and time are one of the potentially critical control points of the manufacturing process, and they are placed to control chemical risks of the packaging. Monitoring the shaping temperature and time requires monitoring and bookkeeping inside the food establishment.

If an operator uses a 3D printer for example to print parts for a device used in handling food, they must make sure that they follow instructions provided by the printer supplier and use materials provided by the supplier. Also with 3D printing, restrictions on temperature and time are one of the potentially critical control points in the manufacturing process, and they are placed to control chemical risks of the packaging. Monitoring the printing temperature and time requires monitoring and bookkeeping inside the food establishment. If raw materials are ordered independently elsewhere or the printer is used for printing something else than what has been agreed upon with the supplier, the regulatory compliance of the printed products must be ensured with necessary tests and confirmed with documents declaring the regulatory compliance of the raw materials. In this case, the food industry operator also becomes a contact material operator and they are bound by the responsibility to declare regulatory compliance as contact material operators. Further instructions can be found in Finnish Food Authority’s guideline number 17018.

Special features of ensuring regulatory compliance of devices and furniture

With devices and furniture, regulatory compliance is ensured upon acquisition by requesting documentation that declare their regulatory compliance. The documents are valid during the device’s/furniture’s operating life, assuming that the materials are not changed during repair or maintenance. With device and furniture maintenance, the regulatory compliance of potential spare parts and repair materials must be ensured, and a note should be made of the new spare parts or materials and their suppliers in the maintenance bookkeeping.With old devices and surfaces, information about material types, usage history and maintenance should be gathered as precisely as possible. When buying second-hand devices, it is best to avoid buying devices without information about their materials and/or usage history, especially if the information cannot be found out.

Furthermore, corroded or broken surfaces can cause chemical substances to migrate into food, and therefore monitoring the condition of the surfaces should be a part of the maintenance plan of the facilities and devices.

Inspecting food contact materials upon delivery

An inspection must be performed on the packing materials and other contact materials for food when they are delivered to the food establishment. The inspector must ensure that the materials match the order and that the materials are clean and the packaging intact. Depending on the nature of business, the delivery inspection can also include checking the documentation declaring regulatory compliance of the food contact materials, if this has not been done during the earlier production stages, for example during product development.  Before packing, it is always important to ensure that the correct packing material is being used. This is especially important when the packaging has a general printing and the proper package labelling is added as a sticker on the packaging, for example.

Instructions for the Oiva inspection and alleviations for small-scale operators

Instructions for the Oiva inspection (version 14.1) offer some alleviations to small-scale manufacturing operators in ensuring the safety of packing materials and other contact materials for food. If materials are acquired from a wholesaler, the products must only include the wine glass and fork symbol, or the product name must reveal the intended use. With very fatty and/or hot foods, it is advisable to contact the wholesaler by email to ensure the packing material’s suitability for the intended use, even if it has the wine glass and fork symbol.

Traceability

Food Contact materials for food must also be traceable one step forward and one step back in the food establishment. The easier it is to connect a packing material batch to a food product batch, the easier it is to specify which food products must be withdrawn in a potential withdrawal situation due to contact materials. An operator should at the very least be aware of when the packing material batch has been put to use, what products have been packed with it during the period and where they have been delivered.