Packaging

Substances incorporated into packaging materials, such as printed plastics, can migrate into foodstuffs and endanger health. For this reason the FSVO has issued regulations governing packaging.

Packaging contains substances that may migrate into the foodstuff and thus into the human body. This may pose a threat to health.

Printing inks also contain substances that could pose a risk. The use of substances, including printing inks, in the manufacture of packaging is therefore regulated by legislation.

The food industry is subject to strict requirements that are set out in the Ordinance on Materials and Articles (in French). Annex 2 stipulates the substances that may be used for the plastic layers in utility articles made of plastic, (see “More information”).

Printing inks

Only the substances listed in Annex 10 and substances that have no CMR properties and cannot migrate into food may be used in the manufacture of printing inks. In addition, a declaration of compliance must be enclosed with the printing inks and printed materials.

FAQ on printing inks

Does the Ordinance apply to all food contact materials (FCM)?

Yes. The Ordinance applies to all FCM. However, the list of permitted substances in Annex 2 and 10 applies only to FCM printing inks used to print on the non-food-contact side of the food contact material.

Which substances are permitted in printing inks?

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).

Can substances listed in the previous Part B of Annex 10 (non-evaluated substances) continue to be used for FCM printing inks?

During the two-year transition period, continued use is possible under the previous conditions. Substances 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 be measurable with statistical significance by an analytical method with a detection limit of 0.01 mg/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.

How can raw material selection be carried out (self-monitoring)?

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

In any 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).

How can manufacturers check whether a substance has CMR properties?

We recommend the following procedure to clarify whether a substance has any CMR properties:

Verification of the harmonised classification of the substance in accordance with ChemO.
If there is no harmonised classification for the substance:

A) clarification of endpoint “M” in silico (with suitable SAR or QSAR models);

B)clarification of endpoint “C” by read-across or a literature search (expert judgement).

How are responsibilities organised along the supply chain?

Manufacturers of packaging or other FCM 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 – to ensure 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 FCM and fillers.

How is relevant information shared along the supply chain so that distributors of the finished packaging or other FCM can confirm compliance?

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.

Is there a requirement that raw materials or printing inks themself must meet the limit values in the Ordinance?

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.

Does the listing of substances in the Ordinance mean that printing inks or printed FCM containing these substances are safe?

No. Listing in the Ordinance merely indicates that the substance may be used to manufacture printing inks for FCM. 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.

Are there any substances that are exempt from the listing requirement?

Listing in Annex 10 is not currently required for some components of printing inks. These include polymers (provided the monomers they contain are listed), polymerisation aids, pigment additives and certain salts of listed substances.

Who can submit new substances to the FSVO for inclusion in Annex 10?

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 FCM.

How are “non-intentionally added substances” (NIAS) treated?

This is not explicitly addressed in the Ordinance. However, substances may be transferred to food from FCM only in quantities that do not pose a risk to human health, as stipulated in Article 49 of the overarching Foodstuffs and Utility Articles Ordinance (RS 817.2). This general requirement includes NIAS.
The FSVO regards the EFSA Note for Guidance (2008) and subsequent EFSA publications on this topic as decisive when assessing NIAS.

How should migration tests be carried out?

For assessing the migration of components of printing inks applied to the surface of food packaging materials and other FCM, please refer to the relevant publications of 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 FCM used greatly influence the migration properties of the printing ink components.

Bisphenol A

Bisphenol A (BPA) is a synthetic substance used to manufacture various plastic materials intended, among other things, for contact with foodstuffs. The substance may be contained in food can coatings, till receipts and toys, for example. BPA can be detected both in foodstuffs and in utility articles.