On these web pages you will find the common questions asked by the Ruokavirasto (Finnish Food Authority) with their answers. The question-and-answer pairs are listed by subject. Because many things may belong to more than one topic, you may want to look at several points if you do not immediately find the answer on the first topic page.
This first page contains general questions about food contact materials.
Are serviettes, tablecloths, kitchen roll and kitchen scissors food contact materials?
Yes, they are.
Are oven gloves and mitts made of fabric interpreted as being food contact materials?
Generally, all kitchenware has been interpreted as being contact material, but based on current interpretation oven gloves and mitts have not.
Are the packaging labels, that are used in the foodstore's service counter, contact materials?
Yes, they are. The foodstore shall ensure their compliance and suitability for intended use, in the same way as the compliance and suitability of other food contact materials that are used by the store.
Are the utensils and appliances used in food preparation food contact materials?
Yes, they are. Also, the materials used to repair such appliances (e.g. materials used for patching or welding) are contact materials and must comply with the requirements set out for contact materials.
Is the machinery and equipment used in the manufacture of food packaging materials considered as being food contact materials?
No, these are not food contact materials.
What are the requirements of the law for food packaging and containers?
According to EU’s framework regulation 1935/2004, the main requirement is that a material or article coming into contact with food (so called contact materials) may not, under usual or expected usage conditions, release such quantities of substances into food that they might
- endanger human health
- bring about an unacceptable change in the composition of the food o
- deteriorate the food’s sensory properties.
In addition to food packaging and tableware, this requirement applies to all other devices and utensils that are directly or indirectly in contact with food during the manufacturing process.
Do contact materials require some kind of separate approval by an authorised research institution or how is a material/product verified as being approved as a contact material?
There is no formal authorisation procedure for contact materials. On the other hand, authorisation has been given for the constituents from which some materials (plastic and regenerated cellulose, constituents used in active and intelligent materials) may be made. A manufacturer who knows the composition of the contact material and has examined its suitability for food contact is obliged to provide the business customers with so-called compliance documentation attesting chemical suitability for food contact, the justification for this (e.g. legislation, examinations, etc.) as well as instructions for use (at least food types, temperature limits and contact time restrictions). The requirement comes from Regulation (EU) 1935/2004 (Article 16). The consumer is informed about the correct use of contact materials on the labelling of contact materials.
From which authority can a declaration of compliance for food contact material be obtained?
No authority issues declarations of compliance for contact materials. The manufacturer and the importer of the food contact material are responsible preparing the declaration of compliance. The manufacturer best knows the composition of the product and the manufacturing process, and they must have had laboratory tests performed on the contact material to establish whether or not constituents in the material migrate into the food and the amounts involved. The importer must request the manufacturer to provide a declaration of compliance when importation begins.
What legal information must be included in the declaration of compliance for the contact material?
The declaration of compliance must apply to the entire product and must therefore also take into account all the parts used in the contact material and also, for example, the dyes used in the labelling. The entire material must comply with the general requirements of Framework Regulation (EU) 1935/2004 and the declaration must include assurance to this effect. In addition, the declaration must demonstrate safety references for all parts of the contact material. If the contact material consists of a single constituent, only one safety reference (e.g. Plastics Regulation) may be indicated. If, for example, the contact material is made of many different materials or layers of material, a safety reference must be demonstrated for each of these separate materials or layers. For example, is the material is printed, plastic-coated board, a safety reference must be indicated for the board, plastic and printing inks.
How do you have to deal with the Normpak certificate required in Sweden and Norway? Some Swedish and Norwegian companies still require a certificate of conformity issued by such an external entity, even though it contains exactly the same information as the certificate under the Plastic Directive.
There should not be any specific requirements, but the declaration of conformity referred to in Framework Regulation 1935/2004 should be sufficient for these products. If em. However, the NORMPAK certificate contains sufficient information to establish conformity, it may be accepted as a declaration of conformity. However, its existence is not a requirement within the EU.
Is it enough in Finland for the food contact material to comply with the requirements of US FDA regulations?
Food contact materials marketed in the EU should always primarily comply with the general requirements of Regulation (EU) 1935/2004 as well as with any specific rules for each material at EU level. If there is no specific material- or substance-specific rules at EU level for the food contact material referred to, the safety reference may be considered as being, for example, EU countries' national acts or guidance provided by the authorities, industries' own instructions or standards or ultimately the statutes of a non-EU country such as Switzerland or the US FDA. For example, with plastic material the Plastics Regulation (EU) 10/2011 serves as a safety reference, with paper and board, the German recommendations (BfR XXXVI), with printing inks, Swiss Ink Legislation (SR 817.023.21) or EuPiA Guidelines etc. may be used as references. In some cases, if the required safety reference is not found in the EU area, US FDA regulations may be used as a safety reference.
What are “dual use” – substances and what information about them must the declaration of compliance contain?
The “dual use substances are food additives or food flavorings that are accep to use in food and that are used also manufacturing food contact materials. The declaration of compliance must indicate if dual-use substances have been used and state what dual-use substances have been used (name, E number). If no dual-use substances are used, it is recommended although not necessary to mention it. Indicating it will reduce the questions contact material operators are asked by food premises.
On the other hand, the quantity of dual-use substances does not need to be automatically reported and it is up to the food business operator to ask more if the operator considers that the additive concerned is of significance in the food.
Why is it important to indicate dual-use substances in the declaration of compliance?
Food business operators need information on dual-use substances for their own risk assessment. Dual-use substances are food additives or flavourings, the use of which is subject to restrictions in the legislation applying to them. A food business operator must ensure that the food complies with legal requirements and assess the impact on food safety and regulatory compliance of any food additives and flavourings migrating from contact materials.
Instructions for food operators on risk assessment and own-check can be found on the Finnish Food Authority's website: foodstuffs/food-sector/packages-and-other-food-contact-materials/own-check-of-a-food-industry-operator/
Is it necessary to provide the regulator with compliance documentation such as examination results or a declaration of compliance for a material component in an inspection, or is it enough to just provide a declaration of compliance for the final contact material?
The regulator must, on request, be provided with all the documentation related to the compliance of the contact material in the operator's possession. Inspection of the contact material manufacturer and the importer requires periodic inspection of not only the declaration of compliance of the actual contact material, but also the so-called compliance documentation (e.g. examination results, results of risk assessment, raw material specifications, declarations of compliance of intermediate materials) and comparison of the information they contain with the compliance of the final contact material.
Whereas wholesalers who are not themselves the importer are no longer required to provide this documentation, they must have a declaration of compliance for the final contact material sold. If the wholesaler distributor's declaration of compliance for a product on sale is clearly inadequate or there is reason to doubt the information it contains otherwise, the regulator will contact the control unit supervising the importer or manufacturer and ask them for control assistance to clarify the matter.
Is it necessary to state the exact examination results or is it enough for the certificate of compliance to generally mention that the examination results show that the requirements are met?
The level of requirement for reporting examination results varies depending on the material. With regard to plastics, the examinations/calculations made must always be indicated as they form the justification for the assurance that the amounts of migration (total migration and specific migration of restricted substances) remain below the limits in the Plastics Regulation. With regard to other materials, reporting the results is not so finely regulated. However, it is advisable to refer to examinations that have been carried out, even though they need not necessarily be spelt out. In general, assurance that a product meets the requirements of the safety reference prescribed for it also includes the fact that examinations or calculations, as the case may be, verify that the limits laid down in the safety reference have been undercut.