The German Federal Ministry of Food, Agriculture and Consumer Protection (BMELV) has published the fifth draft of its proposed ordinance to regulate printing inks used in food packaging materials. Officially known as the "Twenty-first ordinance amending the Consumer Goods Ordinance," the proposal sets out a positive list of substances that may be used in the manufacture of printing inks for food-contact materials, along with specific migration limits.
Substances on the positive list include monomers and other raw materials, such as dyes, solvents and photoinitiators. The draft ordinance specifies that only substances for which a risk assessment or appropriate and sufficient toxicological data are available may be included on the positive list.
Printing inks are not the subject of a harmonized directive or regulation at the European Union (EU) level, although they are subject to the general requirements of the EU Framework Regulation (EC) No. 1935/2004 and Good Manufacturing Practice Regulation (EC) No 2023/2006, as are all materials used in food packaging. As a consequence, the use of printing inks is subject to regulation in accordance with the national laws of each Member State. Most Member States, however, do not have any specific provisions regulating printing inks as a whole. Thus, the German ordinance, when effective, is likely to be the de facto standard for the use of printing inks throughout Europe.
The inclusion of materials in nano form is specifically addressed in the draft ordinance, which states that substances in the form of nanomaterials may only be used in printing inks if they are explicitly listed on the positive list. Nanomaterials are defined as materials that:
- Are of natural origin and accumulate during the manufacturing process or are deliberately manufactured;
- Contain particles in a free state as an aggregate or as an agglomerate; and
- Where at least 50% of the particles, relative to the number and size distribution, exhibit one or more dimensions in the range from 1 to 100 nanometers.
In addition to the substances on the Printing Ink Ordinance’s positive list, monomers and additives on the positive list in the Plastics Regulation, (EU) No. 10/2011, also may be used in printing inks. Importantly, BMELV has acknowledged that the positive list in the draft ordinance is incomplete and, therefore, will undergo continuous updating prior to the ordinance becoming effective, according to an update on the draft ordinance on the European Printing Inks Association’s (EuPIA) website.
The draft ordinance applies to printing inks on packaging that directly contacts food as well as printing inks used on the non-food contact side of the packaging. In this latter case, the inks may contain substances other than those on the positive list, if those substances are not classified as “mutagenic,” “carcinogenic” or “reproductive-toxins.” Further, these ink components should be found not to migrate to food using an analytical method sensitive to 0.01 milligram per kilogram of food.
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.
BMELV allowed only a short window for comments. No date has been specified for publication of the final ordinance.
Author George Misko is a partner at Keller and Heckman. Founded in 1962, the respected law firm has a broad practice in the areas of regulatory law, litigation and business transactions, serving both domestic and international clients. Reach him at [email protected].