Belgium’s Federal Public Service Health, Food Chain Safety and the Environment has published guidance documents on the recently enacted Belgian Royal Decree Regarding the Placement on the Market of Substances Manufactured at the Nanoscale. Under the Royal Decree, substances placed on the market in Belgium in the nanoscale state, as defined, will have to be registered before January 1st, 2016. The registration deadline for mixtures containing such substances is January 1, 2017.
Nanomaterial is defined as a substance containing particles, in an unbound state or as an aggregate or agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 to 100 nanometers. “Placing on the market” in Belgium means “the introduction, the import or the precarious possession for the purpose of selling or making available to third parties, the offer to sell, the sale, the offer to rent, the renting, or the cession, free or against payment.”
The following nanomaterials would not have to be registered:
- Medicinal products for human or veterinary use;
- Products intended to come into contact with foodstuff;
- Animal feed;
- Technological aids or other products that may be used for processing ingredients of agricultural origin;
- Non-chemically modified natural substances;
- Unintentional byproducts of human activity;
- Pigments contained in mixtures, articles or complex objects; and
- Nanomaterials not “placed on the market” in Belgium (e.g., produced solely for export).
In 2013, France was the first European country establishing nanomaterial registration requirements, followed in 2014 by Denmark. The growing trend of national nanomaterial registries reveals increasing concern regarding the safety of nanoscale materials in the EU — and perhaps some impatience with the European Commission’s slow but measured consideration of nanomaterial-specific regulation.