Date: Oct 12, 2017
Colorants used in the manufacture of materials and articles intended for food contact applications in the European Union (EU) are not yet specifically regulated at the EU level. In other words, there is currently
Date: Oct 12, 2017
Colorants used in the manufacture of materials and articles intended for food contact applications in the European Union (EU) are not yet specifically regulated at the EU level. In other words, there is currently no Union-wide directive or regulation specifically regulating such colorants, used to import colors to plastics, paper, coatings, and other types of materials used in contact with food.
First, as in most jurisdictions, manufacturers of finished food contact materials or articles must ensure that any colorants or pigments used do not color the food they contact. Manufacturers and distributors of colored food contact materials and articles must review their products to determine that they meet the general safety requirements of the Framework Regulation when used as intended. As part of the general safety assessment, it would be advisable to establish that the colorant(s) being used meets the applicable purity specifications in one or more EU Member States and/or in the Council of Europe Resolution AP(89)1 on colorants. The details of an assessment of these colorants when used in the EU Member States is discussed below.
1. Harmonized EU legislation applicable to colorants used in the manufacture of food-contact materials and articles
At the EU level, all food contact materials and articles containing colorants must comply with the Framework Regulation (EC) No 1935/2004, as amended, which is the overarching legislation that applies to all food contact materials or articles placed on the market in the EU. Article 3.1 of the Framework Regulation sets out that materials and articles shall be manufactured in accordance with good manufacturing practice so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities which could a) endanger human health, or b) bring about an unacceptable change in the composition of the food, or c) bring about a deterioration in its organoleptic characteristics. Further, all colored materials and articles, intended for food contact applications, must be manufactured in accordance with the requirements of Regulation (EC) No 2023/2006 on good manufacturing practice for materials and articles intended to come into contact with food, as amended.
(a) The regulation of colorants used in the manufacture of plastic food contact materials and articles
The Plastics Regulation (EU) No 10/2011, as amended, specifically regulates plastic materials or articles intended to be placed on the market in the EU. With respect to colorants used in plastic materials and articles, Article 6.2 of the Plastics Regulation outlines that “colorants (…) may be used in the manufacture of plastic layers in plastic materials and articles subject to national law.” In other words, colorants used in plastic materials and articles are not subject to the positive list requirements of the Plastics Regulation, although, if they are listed on the Plastics Regulation (as is the case with carbon black, for instance), then it would be advisable to demonstrate that they meet applicable restrictions or specifications as part of the safety assessment.
Some restrictions set out in the Plastics Regulation may also indirectly apply to colorants used in plastic food contact materials and articles because they set purity specification or migration limits pertinent to a determination of the safety of the use of the colorant. For example, Annex II of the Plastics Regulation sets out that plastic materials and articles shall not release primary aromatic amines (PAAs) in a detectable quantity into food, and prescribes a detection limit a 0.01 mg/kg for the sum total of PAAs (apart from those specifically listed in the Plastics Regulation’s positive list). Further, Annex II of the Plastics Regulation also sets specific migration limits for barium, cobalt, copper, iron, lithium, manganese, zinc, aluminium and nickel in the final plastic materials or articles.
Some colorants may form PAAs or contain the aforementioned elements. Given that the Plastics Regulation does not specify or restrict the origin of PAAs or these elements, migration from colorants in plastic materials or articles would also need to be taken into consideration in determining whether applicable restrictions for these substances are met.
Finally, it is noteworthy that Germany maintains non-legally binding purity requirements for colorants used in the manufacture of polymeric food contact materials and articles. These are set out in BfR Recommendation IX (Colorants for Plastics and other Polymers Used in Commodities). While Germany’s Recommendations are not legally binding, they are widely regarded and should be consulted as informative to a safety decision.
(b) Colorants used in the manufacture of food contact materials and articles other than plastics
As already mentioned, there is also no harmonized legislation specifically regulating the use of colorants in the manufacture of food contact materials and articles other than plastics at the EU level. That said, it is noteworthy that the European Commission is working on a draft harmonized measure on printed food contact materials and articles. While not applicable to c