The German Ink Ordinance (GIO) will come into force in January 2027

Background

As early as 2021, the regulator responded to findings by the Federal Institute for Risk Assessment (BfR) regarding printing ink residues in foodstuffs that posed a health risk and, by means of the Twenty-first Ordinance amending the Consumer Goods Ordinance (BedGgstV), the regulator introduced a national regulation on printing inks. The regulator extended the originally envisaged implementation period and added 16 further substances, assessed by the BfR, to the positive list. The date of entry into force is now imminent. The regulations will apply from 1 January 2027.

The positive list principle and migration limits

The German printing ink regulation has not been introduced as a separate regulation alongside the Consumer Goods Regulation, but has been integrated into it. It specifies and supplements the EU legal framework at national level for printing inks and varnishes on food contact materials.  

At the heart of the new regulation is the positive list principle. In principle, only substances listed in Annex 14 of the BedGgstV and complying with the restrictions, specifications and purity requirements set out therein may be used in printing inks for food packaging. Nanomaterials are only permitted where this is expressly stipulated.

Specific migration limits apply to listed substances. Where no such limit exists, a general limit of 60 mg/kg of food applies.

Exceptions for unlisted substances

For printing inks not intended to come into direct contact with food, Section 4(7) of the BedGgstV also permits unlisted substances under strict conditions. This exception is particularly relevant for external labelling such as best-before dates or batch numbers. It is subject to the condition that the substances in question are not classified as mutagenic, carcinogenic or toxic to reproduction (CMR substances). Furthermore, a strict transitional standard applies to such substances under Section 8(7) of the BedGgstV. Their migration into food must not be detectable; for substances that are not nanomaterials, a detection limit of 0.01 mg/kg of food applies.

Furthermore, Section 4(10) of the BedGgstV contains an exemption provision. The requirements specific to printing inks do not apply to printed food contact materials where migration of substances from the printing ink into the food is ruled out. However, this exclusion must be substantiated on a sound basis, for example by demonstrating the presence of a functional barrier or through migration testing.

For unintentionally introduced substances (NIAS), Section 4(11) of the BedGgstV also requires a risk assessment in accordance with internationally recognised scientific principles.

Practical implications

Companies should use the remaining three months to ensure that their formulations, approval processes and customer declarations are aligned with the new requirements. The priority is to verify whether the printing inks used comply with the positive list and meet the requirements for good manufacturing practice, traceability and technical documentation.

For inks that do not comply with the positive list, clear restrictions on use and robust safety assessments must be prepared. Compliance with the positive list alone is not sufficient – the decisive factor is the final assessment of the specific printed packaging structure, taking into account the substrate, barrier properties and conditions of use.

A sell-off provision applies to existing stock. Printed food contact materials placed on the market before 1 January 2027 may continue to be sold until stocks are depleted.