The German Federal Ministry of Food, Agriculture and Consumer Protection (BMELV) published the fifth draft of the German "Twenty-first Ordinance amending the Consumer Goods Ordinance" on July 14, 2014. The draft Ordinance, commonly referred to as the "draft Printing Inks Ordinance" would apply to printing inks applied to both the food-contact and nonfood-contact sides of food-contact materials. It contains positive lists of monomers and other starting substances, colorants (pigments and dyes), solvents, additives and photoinitiators, which may be used in the manufacture of printing inks for food-contact materials. These are found in Table 1 of Annex 14. While some of the substances are subject to specific migration limits (SMLs), for substances where no SMLs are listed, a generic SML of 60 milligram per kilogram of food (mg/kg) from the printed food-contact material to food would apply. The draft Ordinance outlines that substances in the nano-scale (nanomaterials) may only be used if they are explicitly listed as such on the positive list.
Certain monomers and additives listed in the Plastics Regulation, (EU) No. 10/2011, may also be used in printing inks, subject to any applicable limitations/specifications set out therein. Substances that appear neither on the Printing Inks Ordinance, nor the Plastics Regulation may also be used, provided that the printing ink is not intended to come in direct contact with food, and, further, that the substances are not classified as "mutagenic," "carcinogenic," or "reproduction-toxic" (CMRs). These substances, which include substances in nanoform, may not migrate to the food in a detectable amount (i.e., may not migrate to food in excess of the "non-detect" ("ND") limit of 0.01 mg/kg). The fifth draft introduced a new list of pigments (Table 2 of Annex 14) that may also be used during the printing of food-consumer articles in which it is foreseeable that the printing inks may come into direct contact with foodstuffs, although not intended to do so (given that such substances would not benefit from the exemption from the positive list requirement even if they are not detectable at 0.01 mg/kg and are not CMRs). The pigments in Table 2 of Annex are only permitted for use for 48 months following the promulgation of the draft Ordinance in accordance with the current wording.
It is noteworthy that the draft Ordinance prescribes that a Declaration of Compliance will be required for the printed food-contact material, the printing ink, and the substances intended to be used in the manufacture of the printing ink.
Certain provisions of the draft Ordinance (notably the positive lists set out in Table 1 of Annex 14) would not apply until 24 months after the promulgation of the draft Ordinance. Food-contact materials and articles placed on the market in Germany within the first 24 months that do not fully comply compositionally with this draft Ordinance, may be marketed until the exhaustion of stocks. The deadline by which German industry had to submit comments on the fifth draft of the Printing Inks Ordinance was August 5, 2014. It is expected that the draft Ordinance will be notified to the European Commission shortly. Thereafter, the European Commission and EU Member States will have the opportunity to submit comments on the draft during a three month period known as the "standstill period". If the Commission/EU Member States submit a detailed opinion on the draft (i.e., object to it), this three month period will be extended by another three months. During this standstill period, Germany may not take any steps to adopt the draft Printing Inks Ordinance.