Packaging must not release substances into food that can be harmful to health. The FSVO has therefore issued clear regulations – for plastics, printing inks and the use of Bisphenol A.
Why packaging is regulated by law
Packaging contains substances that may migrate into the foodstuff – and therefore end up in your body. This can pose a risk to health.
Printing inks used on packaging may also contain substances with hazardous properties. The use of substances in packaging is therefore regulated by legislation – including printing inks.
These regulations are set out in the Food Contact Materials Ordinance (available in German, French and Italian only). Annex 2 sets out which substances may be used in layers of plastic, while Annex 10 regulates substances in printing inks.
Bisphenol A
Bisphenol A (BPA) is a synthetic substance. It was long used to manufacture plastic materials such as polycarbonate bottles and containers – including for food packaging.
Tin can coatings also contained BPA.
The European Food Safety Authority (EFSA) has set a very low tolerable daily intake for BPA. As a result, the substance has been banned in plastics, coatings and printing inks in Switzerland since 2025.
Only the substances that have been assessed by the FSVO may be used in printing inks – these are listed in Annex 10 to the Food Contact Materials Ordinance.
Substances that do not have any properties that are hazardous to health and that cannot migrate to foodstuffs are also permitted.
In the B2B sector, a Declaration of Compliance must be enclosed with printing inks and printed materials – as proof of compliance with the legal requirements.
FAQs on printing inks
Yes. The ordinance applies to all FCMs. However, the list of permitted substances in Annexes 2 and 10 applies only to FCM printing inks used to print on the non-food-contact side of the food contact material.
Substances listed in Annex 2 without restrictions on use (column 10).
Substances listed in Annex 10.
All salts of substances for which ‘yes’ is indicated in Annex 10, Table 3, column 2, from permitted acids, phenols or alcohols, subject to the restrictions in columns 3 and 4 of Table 3.
All other substances whose migration is not detectable and which are not classified as CMR substances (see details below).
Substances that were listed in Part B may continue to be used, provided the following requirements are met:
Migration of the substance into food or food simulants is not measurable with statistical significance by an analytical method with a detection limit of 0.01mg/kg and
the substance is not classified as ‘mutagenic’, ‘carcinogenic’ or ‘reprotoxic’ (CMR substances) in category 1A, 1B or 2 according to the criteria in Art. 6 of the Swiss Ordinance on Protection against Dangerous Substances and Preparations (ChemO, 813.11) (self-monitoring).
If a printing ink is marketed or used in accordance with the new legislation, all requirements must be met. If, for example, non-listed substances are used in printing inks, a declaration of compliance must also be available.
As part of their self-monitoring, manufacturers of FCM printing inks or intermediate products document their compliance with legal requirements when selecting all substances used to manufacture the product. To do this, they go through the following monitoring steps:
Are all raw materials or their constituents listed in Annex 2 or Annex 10 of SR 817.023.21? If yes: OK
If no: evaluate substances as part of self-monitoring
Carry out self-monitoring: the non-listed raw material or constituent must pass the following checks:
The origin of the raw material and its composition are transparent
Possible CMR properties of unlisted constituents of the raw material in question must be ruled out.
Use of the corresponding substance under the conditions set out above is therefore permitted for the manufacture of printing inks or intermediate products. Self-monitoring must be documented so it can be retraced at a later date or checked by third parties (auditors, enforcement authorities).
The requirements apply from the printing ink raw materials stage.
For example, a pigment that is not listed is compliant if it does not have CMR properties and does not migrate from the final printed FCM. Precursor substances for the production of the pigment are considered NIAS further down the supply chain and must be assessed accordingly.
We recommend the following procedure to clarify whether a substance has any potential CMR properties:
Verification of the harmonised classification of the substance in accordance with ChemO
If there is no harmonised classification for the substance, clarify endpoints ‘M’ and ‘C’.
For endpoint ‘M’, analyse toxicity data in the REACH registration dossier or existing data from toxicity studies. If no toxicity data is available, in silico methods with suitable SAR or QSAR models can be used.
Endpoint ‘C’ is clarified by read-across or a literature search (expert judgement).
The exclusion of CMR properties of a substance should be done as early as possible in the supply chain. Provide relevant information to customers in the declaration of compliance or in accompanying documents.
A Declaration of Compliance (DoC) must be issued at each stage of the production process for food contact materials and articles. This obligation applies to all intermediate stages up to and including the final packaged food product, but does not extend to the retail stage.
The DoC accompanies the product when supplied to customers. It is based on confidential internal documentation, which is generally only accessible to enforcement authorities.
The DoC must contain comprehensive information on all substances that may migrate into food, including both Intentionally Added Substances (IAS) and Non-Intentionally Added Substances (NIAS).
The information required depends on the respective stage of manufacture. The content of the DoC will therefore vary:
From the raw material manufacturer to the printing ink manufacturer: the DoC must provide information on all relevant substances present in the raw materials.
From the printing ink manufacturer to the converter/printer: the DoC must provide information on all relevant substances present in the printing ink, as well as their reaction products and the foreseeable migration under standard printing conditions.
From the converter/printer to the food business operator: the DoC must provide information on all migrating substances relevant to the intended use of the packaging.
From the food business operator to downstream users: the DoC must provide information on all migrating substances that may transfer into the packaged food
Manufacturers of packaging or other FCMs and fillers are responsible for the final food packaging or the final FCM and compliance with legal regulations. Manufacturers of raw materials and printing inks are responsible for the composition of preparations in accordance with the requirements set out in the Ordinance. Due to the complexity of the process, all stakeholders in the supply chain must share relevant information – if necessary under appropriate confidentiality agreements and also upstream in the supply chain. This ensures that products can be formulated that are suitable for their intended use and consequently fulfil all legal responsibilities. Upstream operators cannot issue declarations of compliance covering the legal responsibility of manufacturers of packaging or other FCMs and fillers.
Manufacturers of precursor materials and printing ink manufacturers produce documents containing sufficient information on substances or their degradation and reaction products and impurities. This ensures that downstream businesses can also ensure compliance with the Ordinance. To this end, manufacturers must in particular specify the identity and content of all substances that may be present in a quantity at which migration from the finished article into a food or food simulant can be expected, as well as the corresponding migration or content limits.
No. The migration and content limits refer to the finished FCM and not to printing inks or other intermediate materials. However, printing inks become part of the FCM during printing. The limits defined for individual substances must also be met by the components of the dry or cured printing ink layer.
No. Listing in the Ordinance merely indicates that the substance may be used to manufacture printing inks for FCMs. To ensure the legally required safety of substances in end use, migration must not exceed the specified limits using GMP regulations for printing and the manufacture of printing inks.
Listing in Annex 10 is not currently required for some components of printing inks. These include polymers (provided the monomers they contain are listed), aids to polymerisation, pigment additives and certain salts of listed substances.
These substances may only migrate from FCMs into food in quantities that do not pose a risk to human health, as stipulated in Article 49 of the overarching Foodstuffs and Consumer Products Ordinance (RS 817.02) A corresponding risk assessment must be carried out as part of self-monitoring.
However, this exception does not apply to substances used for the polymerisation or curing of the printing ink on the substrate, such as photoinitiators and additives used in this process. These must either be listed in Annexes 2 or 10 or comply with the No-CMR and No-Migration rule.
The manufacturers of new substances or substances previously listed in Part B. The aim is to ensure that the substances can be used by printing ink manufacturers as raw materials for the manufacture of printing inks for FCMs.
The Ordinance does not expressly regulate NIAS. However, substances may only migrate from FCMs into food in quantities that do not pose a risk to human health. This is stipulated in Article 49 of the overarching Foodstuffs and Consumer Products Ordinance (RS 817.02) and expressly includes NIAS.
A corresponding risk assessment must be carried out as part of self-monitoring.
The EFSA Note for Guidance (2008) and subsequent EFSA publications on this topic are decisive for the assessment of NIAS.
For assessing the migration of components of printing inks applied to the surface of food packaging materials and other FCMs, please refer to the relevant publications of the EFSA, JRC and the Council of Europe The recommended testing methods for assessing the migration of printing ink components depend on the FCM used. In general, testing under the worst-case scenario (using a screening approach) is recommended. A substitute for testing the compliance of the final printed FCM is generally not possible.
The printing ink itself is not tested as such, as its composition may change during the printing process. However, testing may be necessary for individual substances in the raw materials. It is also important to note that the FCMs used greatly influence the migration properties of the printing ink components.
International institutions and market participants have developed guidance on compliance of printing inks and compliance documentation for FCMs in general. These guidance documents are not legally binding, but may help to meet the legal requirements for printing inks.
