Health risk assessment of printing inks

With the 21st Ordinance amending the Consumer Goods Ordinance, specific regulations for printing ink components were published. Annex 14 of the Consumer Goods Ordinance contains a positive list of substances that can be used for the printing of food contact materials and, where applicable, specific migration limits or other restrictions. The list includes substances from the categories monomers, colorants, solvents, additives and photoinitiators. In addition, the use of substances contained in the positive list of the European Plastics Regulation (EU) No. 10/2011 is possible (where necessary with the restrictions specified there).

Substances with a migration of less than ten micrograms per kilogram of food (10 ppb) may also be used if the printing ink does not come into direct contact with food under normal or foreseeable conditions of use and the substances are not classified as mutagenic, toxic for reproduction or carcinogenic accordingto the CLP Regulation.

The list of substances in Annex 14 of the Consumer Goods Ordinance can be supplemented by an amending regulation. For this purpose, a dossier can be submitted to the Federal Ministry of Food and Agriculture (BMLEH) at any time, which has to include all documents required for a risk assessment. As is usual in the area of food contact materials, the data requirements are based on the “Note for Guidance for the Preparation of an Application for the Safety Assessment of a Substance to be used in Plastic Food Contact Materials” (Note for Guidance) of the European Food Safety Authority (EFSAshort forEuropean Food Safety Authority), taking into account ink-specific issues where necessary.

The BfRshort forGerman Federal Institute for Risk Assessment evaluates the dossiers submitted to the BMLEH from a health perspective and on the basis of the EFSAshort forEuropean Food Safety Authority Note for Guidance. The dossier should be prepared accordingly by completing the questionnaire contained in the Note for Guidance. Information can be found in the Download:guideline Technical_guidance_for_printing_inks_2025-05-06.pdf (PDF, 232 B, not accessible)provided on the BfRshort forGerman Federal Institute for Risk Assessment website. It should be noted that the time between submission of the dossier and the final decision on inclusion of the substance in the Regulation depends significantly on the quality and completeness of the dossier submitted.

If a read-across approach is chosen for existing toxicological data gaps, the guidance developed by ECHAshort forEuropean Chemicals Agency or the EFSAshort forEuropean Food Safety Authority guidance on the formation of substance categories and read-across should be noted and a scientific justification for this approach has to be submitted.

The submitting companies are requested to complete the Download:substance overviewtemplate_substance_overview.xlsx (XLSX, 12 B, not accessible) provided by the BfRshort forGerman Federal Institute for Risk Assessment and submit it with the dossier documents.

The following documents must be submitted to the BfRshort forGerman Federal Institute for Risk Assessment for an evaluation:

• a complete version of the dossier in paper form
• an electronic version of the complete dossier in a searchable format, e.g. as a Word document or PDF file (to be uploaded to a BfRshort forGerman Federal Institute for Risk Assessment server). The server address will be provided by the BfRshort forGerman Federal Institute for Risk Assessment.
• If the dossier contains data to be treated confidentially, two versions of the dossier - confidential and non-confidential - are required. In the case of requests under the Freedom of Information Act, the data will be forwarded in this form.
• The submitter of the documents confirms that he/she is the rights holder of the documents or has been commissioned by the rights holder.

Requests for the inclusion of a new substance in the Printing Inks Ordinance must always be addressed to the BMLEH. The dossier documents themselves can then be sent either to the BMLEH or directly to the BfRshort forGerman Federal Institute for Risk Assessment at the following address:

Bundesinstitut für Risikobewertung (BfRshort forGerman Federal Institute for Risk Assessment)
FG Sicherheit von Lebensmittelkontaktmaterialien
Max-Dohrn-Str. 8-10
10589 Berlin
Germany

The BfRshort forGerman Federal Institute for Risk Assessment aims to harmonize its risk assessments with those of other national European authorities, such as the Swiss Federal Food Safety and Veterinary Office (BLV) and the Dutch National Institute for Public Health and the Environment (https://www.rivm.nl/en).

Further information can be found on the BMLEH website: 

www.bmleh.de/DE/themen/verbraucherschutz/lebensmittelsicherheit/lebensmittelverpackungen/lebensmittelverpackungen_node.html

If you have any questions regarding the preparation of dossiers and the necessary documents, please contact either 

• the BMLEH Division 313 (313@bmleh.bund.de) or
• the BfRshort forGerman Federal Institute for Risk Assessment at fcm@bfr.bund.de.