There currently is no comprehensive list of approved colorants for plastics in Europe. However, the Plastics Regulation (EU) No 10/2011 on plastic materials and articles intended to contact food, which took effect on May 1, 2011, imparts significant changes to the EU Plastics Directive (2002/72/EC, amended), which it replaces. In particular, it introduces substantial changes, on a transitional basis, to the testing conditions used to simulate potential migration of authorized substances to food. These changes could impact colorants used in plastic materials and articles. For example, some colorants may form primary aromatic amines that may migrate to food and the Plastics Regulation, like the Plastics Directive, sets a migration limit for primary aromatic amines. The changes, which in many cases require more stringent testing conditions, could result in an increase in the amount of primary aromatic amines found in food.

While the Plastics Regulation provides a positive list of permissible monomers and other starting substances and additives that are permitted in the manufacture of food contact plastic materials, colorants are excluded from the definition of additives required to be on the positive list. Notably, Article 6, paragraph 2 of the Plastics Regulations permits colorants to be used in the manufacture of plastic food contact articles subject to national law. Some Member States have additional regulations respecting colorants for plastics beyond those in the Plastics Regulation. We are aware that Belgium, Germany, Greece, Spain, the Netherlands, Italy, the Czech Republic, Slovenia, and Romania have in place certain requirements for colorants in food-contact materials. A Member State's requirements must be complied with if a colorant or product containing the colorant is first manufactured or placed on the market in that Member State; otherwise the colorant can be marketed in those countries in accordance with the principle of mutual recognition. Finally, colorants for plastics must comply with the requirements, especially those pertaining to safety, of the Framework Regulation, (EC) No 1935/2004, on materials and articles intended to come into contact with food.