Germany implements measures to regulate printing inks and varnishes for food contact materials and articles (FCM).
The German Federal Ministry of Food and Agriculture (BMEL) has issued its Twenty-First Regulation to amend the Consumer Goods Ordinance (BedGgstV). Published on December 7, 2021, it introduces new regulations for the use of printing inks and varnishes on FCM.
Stakeholders should be aware of several important provisions:
- Defines printing inks as inks or varnishes that are applied to FCM in a printing or painting process but does not include mixtures for coloring FCM and decorative paints for FCM made of ceramics or glass that are applied during a firing process
- Provides a definition for nanomaterials in printing inks, which includes fullerenes, graphene flakes and single-walled carbon nanotubes with one or more external dimensions smaller than one nanometer
- Provides a positive list of more than 500 substance entries that are allowed for the manufacture of printing inks or varnishes applied to FCM. These include polymers made from monomers or other starting substances, as well as monomers or other starting materials or colorants, solvents, photoinitiators or other additives that are subject to any restrictions, specifications and purity requirements. Table 1 to Appendix 14 details specific migration limits as well as non-detectable requirements for some of the listed substances in foodstuffs
- Allows monomers or other starting materials and additives in printing inks to be used in the manufacture of food contact printed materials and articles, if these comply with Annex I ‘Substances’ and Article 8 ‘General Requirement on Substances’ of Regulation (EU) 10/2011 on food contact plastics
- Permits the use of substances other than those in Table 1 to Appendix 14 in printing inks if they are not intended to come into direct contact with food
- Permits a list of pigments with specifications to be used in printing inks for food contact materials and articles (Table 2 to Appendix 14)
- Restricts the migration of seven metals and primary aromatic amines (PAA) in food contact printed materials and articles (Table 4 to Appendix 14):
- Barium: no more than 1.0 mg/kg
- Iron: no more than 48 mg/kg
- Cobalt: no more than 0.05 mg/kg
- Copper: no more than 5.0 mg/kg
- Lithium: no more than 0.6 mg/kg
- Manganese: no more than 0.6 mg/kg
- Zinc: no more than 25.0 mg/kg
- Primary aromatic amines (PAA) other than those mentioned in Table 1 to Appendix 14: no more than 0.01 mg/kg (sum of PAA) and no more than 0.002 mg/kg (each PAA under point 7 to Appendix 1 in BedGgstV)
The Ordinance entered into force on December 8, 2021, and its provisions will come into effect on January 1, 2026. Compliant products placed onto the market before December 31, 2025, can remain on the market until stocks are exhausted.
There is also a provision to allow food contact printed materials and articles manufactured using pigments in Table 2 of Appendix 14 to remain on the market after December 31, 2026, until stocks are exhausted. Finally, § 4(9) in conjunction with the list of pigments in Table 2 to Appendix 14 will cease to apply on January 1, 2027
SGS Food Contact Material Services
SGS’s technical experts have extensive experience of testing materials and articles in contact with food. They can ensure that your products meet the appropriate regulations for food contact materials and pave the way for compliance. SGS offers the full range of testing, including migration tests, along with expert advice on emerging regulations, compliance issues and documentation review. In the end, it’s only trusted because it’s tested. Learn more about SGS’s Food Contact Material Services.
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