Food Packaging Regulations: From Swiss Compliance to the German Printing Ink Ordinance

For years, food manufacturers and packaging converters have relied on the Swiss Ordinance Annex 10 (Swiss Ordinance) as the European standard governing the suitability of inks used on non-direct food-contact packaging.

However, with the introduction of the German Printing Ink Ordinance, in effect from 1st January 2027, the compliance landscape is shifting. The new regulation has significant implications for businesses using printing inks for food-contact packaging where products are supplied into the German market.

While the two regulations share many similarities, food manufacturers and packaging converters should not assume that compliance with one automatically guarantees compliance with the other. This article outlines what food manufacturers and packaging converters need to know about the German Printing Ink Ordinance, including steps to demonstrate compliance.

The German Printing Ink Ordinance (GIO) is a German national regulation that governs the intentional use of substances in printing inks intended for use on food-contact materials and articles. The regulation applies to both direct food-contact and non-direct food-contact packaging applications. The primary goal of the German Printing Ink Ordinance is to protect consumers by preventing the migration of harmful chemicals into food.

Published in December 2021, as the 21st Ordinance amending the Consumer Goods Ordinance, the GIO includes a transition period, originally until 1st of January 2026 and now delayed until 31st December 2026. Following the end of the transition period, from 1st January 2027, compliance must be demonstrated for the final food-contact article, rather than the printing ink in isolation.

The GIO includes a positive list of permitted substances for the production of printing inks for use on food-contact materials and articles and establishes migration limits for listed substances. Only substances listed either on the positive list or in EU Regulation 10/2011 with no restriction can be used for direct food-contact (DFC) packaging applications.

For non-direct food-contact (nDFC) packaging applications, certain non-listed substances may also be used, provided they are not classified as CMR substances, and adhere to strict migration limits.

CMR substances are carcinogenic, mutagenic, or toxic to reproduction. In the EU, they are classified under the CLP Regulation (EC) No 1272/2008.

The German Printing Ink Ordinance introduces new food-contact materials compliance requirements for companies supplying products into Germany.

All businesses that produce or supply packaged food products or food packaging into the German market must comply with the GIO by 1^st January 2027, regardless of their location. This includes food manufacturers and packaging converters that operate in Germany, as well as businesses that import packaged food or supply printed packaging into German facilities.

Both the Swiss Ordinance and the German Printing Ink Ordinance use positive lists of permitted intentionally added substances (IAS) and similar risk assessment and migration principles for governing the use of substances not on the positive list.

NIAS (non-intentionally added substances), such as impurities and by-products, are included in the scope of both the Swiss Ordinance and the GIO and are managed through risk assessment.

As such, food manufacturers and packaging converters may assume that compliance with the Swiss Ordinance automatically translates to compliance with the GIO, but this is not the case.

The key differences between the two ordinances are outlined in the table below:

	German Printing Ink Ordinance	Swiss Ordinance (SO)
Scope	IAS for DFC and nDFC packaging	IAS for nDFC packaging only
Positive list	Yes, but fewer substances than SO	Yes
Specific migration limit defined	Yes	Yes
Use of non-listed substance in nDFC applications	Allowed, as long as not CMR under CLP, and migration concentration <10ppb and not used in DFC applications	Allowed, as long as not CMR under CLP, and migration concentration <10ppb
Statement of composition required	Yes	Yes

In short, the German Printing Ink Ordinance covers inks for use in direct food-contact packaging, which are out of scope in the Swiss Ordinance. In addition, the positive list under the GIO is more restrictive, meaning that a substance accepted under the Swiss Ordinance is not automatically accepted under the German Printing Ink Ordinance.

Ink suitability alone does not demonstrate compliance with the German Printing Ink Ordinance.

Discussions around the GIO often focus on whether a printing ink formulation is suitable for use. However, compliance under the GIO is assessed on the final food-contact article.

Ink manufacturers provide information on intentionally added substances (IAS) and non-intentionally added substances (NIAS), while food manufacturers and packaging converters must assess whether the finished article complies with the applicable migration requirements for its intended purpose.

Demonstrating compliance may involve consideration of ink formulations, risk assessment via migration calculations, and where appropriate, migration testing of the finished food contact articles.

Migration behaviours depend on a range of factors, including:

• Type of food being packed
• Substrate type and its thickness
• Storage conditions
• Intended use conditions, including storage time and temperature
• Printing area and ink coverage

Step 1: Understand the application

Food manufacturers and packaging converters must first determine whether the end-use application is:

• Direct food contact (DFC)
• Non-direct food contact (nDFC)
  
  

Step 2: Assess ink suitability for end-use packaging 

1. Obtain information from ink manufacturers

Food packaging manufacturers and packaging converters should obtain sufficient composition information to determine whether the printing ink is suitable for the intended end-use application.

This information is typically supplied by the ink manufacturer through a statement of composition (SoC), including details of

• Intentionally added substances (IAS)
• Known non-intentionally added substances (NIAS)
• Their listing and migration limits where applicable
  
  

2. Evaluate migration

Where non-listed substances are present in non-direct food contact packaging applications, food manufacturers and packaging converters must demonstrate that they are permitted and comply with migration limits as set out in the GIO.

This will involve:

• Verification that any non-listed substances are not classified as CMR under CLP legislation
• Assessment of compliance with applicable migration limits via migration calculations and/or testing, where required
• Risk assessment of known NIAS and other relevant non-listed substances
  
  

Step 3: Build compliance documentation

Food manufacturers and packaging converters are responsible for demonstrating that the final printed food-contact article complies with the applicable requirement of the German Printing Ink Ordinance for its intended use. To do this, they will need to compile evidence of risk assessment.

Domino is committed to helping food manufacturers and packaging converters simplify compliance activities related to the GIO and other food-contact packaging regulations. Domino’s ink development teams and compliance experts provide:

DFC packaging compliant ink solutions: For direct food-contact packaging applications, Domino offers a range of ink solutions developed using substances that are listed on the GIO positive list and/or permitted under the relevant provisions referenced by the GIO for food-contact packaging applications.

Statements of composition (SoC): Domino can provide documentation to support customer compliance efforts, including statements of composition. Our compliance experts can provide information on relevant migratable substances to support compliance assessment.

Migration testing support: Where food-contact migration testing is required, Domino’s experts can provide customers with the names of approved testing houses for migration testing. Domino’s experts also collaborate with third-party analytical specialists, providing formulation information and additional support to simplify the process.

Expert support: Domino’s ink development and compliance experts keep abreast of regulatory developments, including evolving food packaging regulations, which may impact product development and application testing. Domino’s experts collaborate with many different industry organisations to stay up to date with regulatory changes and understand their potential impact on customers. In this way, our ink and compliance specialists can advise on best practices to ensure ongoing compliance.

Does Swiss Ordinance compliance guarantee German Printing Ink Ordinance compliance?

No. The German Printing Ink Ordinance is broader in scope than the Swiss Ordinance List, including direct food-contact packaging as well as non-direct food-contact packaging. In addition, the GIO has a more restrictive positive list, meaning that a substance listed on the Swiss Ordinance will not automatically be listed in the GIO, or may have requirements (e.g. migration limits) different to that of the GIO.

What is a statement of composition?

A statement of composition (SoC) is a compliance document that discloses the intentionally added substances (IAS) and known non-intentionally added substances (NIAS) in a printing ink with relevance to migration for food-contact compliance assessments. Statements of composition support any risk assessment activities (e.g. migration testing and calculations).

Who is responsible for food-contact material compliance?

The food manufacturer or packaging converter is ultimately responsible for demonstrating compliance of the final food-contact article for its intended use. The ink manufacturer supports this process by providing information on the relevant substances, but compliance is assessed based on the finished article rather than the ink alone.

When is food-contact migration testing required?

The need for migration testing depends on the composition of the ink, the packaging structure, and the intended end-use application. Demonstrating compliance may involve a combination of formulation information, risk assessment, migration calculations, and migration testing of the final food-contact article where appropriate.

Where available data and migration risk assessment are insufficient to demonstrate compliance with applicable migration limits, migration testing may be required to verify compliance of the finished article.

While the German Printing Ink Ordinance shares similarities with the Swiss Ordinance List, they are not interchangeable. Achieving compliance with the GIO means food manufacturers and packaging converters must evaluate all finished food-contact materials and articles – including inks – against the GIO’s more restrictive positive list, thoroughly assess migration risks for any substances not explicitly covered, and maintain comprehensive documentation to demonstrate compliance.

Domino is committed to helping businesses meet the requirements of the German Printing Ink Ordinance. By offering direct food-contact packaging ink solutions, alongside expert guidance and support for migration assessment activities, Domino can help food manufacturers and packaging converters navigate new and upcoming food-contact regulations and ensure the suitability of their packaging.

Find out more: https://www.domino-printing.com/en-gb/services/consumables