On July 5, 2016 Germany notified the European Commission (EC) of the Twenty-First-Regulation amending the Consumer Goods Regulation.
The draft regulation generally applies to printed FCMs and articles such as packaging, napkins, cardboard cups, and paper plates. “In order to protect consumers from possible health risks involving printed food contact materials and articles, the draft Regulation makes provision for a list of substances permitted for use in printing inks for printing food contact materials and articles, including toxicologically derived maximum quantities for the transfer of these substances to foodstuffs (positive list).
Germany justified the regualtiom as follwos:
"Food contact materials and articles are printed for information and advertising purposes. The printing inks used contain chemical substances which, if no precautions are taken, can migrate to foodstuffs and be ingested by consumers.
Investigations conducted as part of official inspections and a research project initiated by the Federal Ministry of Food and Agriculture have demonstrated that foodstuffs available on the German market are frequently contaminated with constituents of printing inks in quantities that exceed thresholds which are justifiable from the point of view of health. In addition, the presence of a whole raft of printing ink chemicals whose potential toxicological impact is unknown has been proven in foodstuffs, in part in appreciable quantities. According to an appraisal from the Federal Institute for Risk Assessment, the presence, for example, of benzophenone, 4-methylbenzophenone, primary aromatic amines and petroleum-derived hydrocarbons, which has been demonstrated in various foodstuffs, can result in damage to one's health (damage to the kidneys, liver and lymph nodes, as well as having carcinogenic properties). In the opinion of the Federal Institute for Risk Assessment, constituents of printing inks in relation to which no toxicological information is available, or toxicological information that is insufficient for assessment purposes, should not be transferred to foodstuffs because a health risk cannot be ruled out. As regards certain substances in printing inks, the Standing Committee on the Food Chain and Animal Health at the European Commission has also recommended peak values regarding transfer to foodstuffs (total benzophenone and 4-methylbenzophenone: 0.6 mg per kg of foodstuff). In order to protect consumers from possible health risks, these regulations are therefore to be enacted on the basis of corresponding risk assessments.
The regulatory approaches (positive list, use of substances that have not been assessed) are essentially guided by the stipulations that exist for food contact materials at European level in relation to certain types of material."
The notification can be downloaded by clicking the following link:
The standstill for this notification ends on October 6, 2016. Before this date the decision on the draft regulation is pending.