In the European Union, the use of carmine in foods is regulated under the European Commission's directives governing food additives in general[19][20] and food dyes in particular[21] and listed under the names Cochineal, Carminic acid, Carmines and Natural Red 4 as additive E 120 in the list of EU-approved food additives.[22] The directive governing food dyes approves the use of carmine for certain groups of foods only[23] and specifies a maximum amount which is permitted or restricts it to the quantum satis.
The EU-Directive 2000/13/EC[24] on food labeling mandates that carmines (like all food additives) must be included in the list of ingredients of a food product with its additive category and listed name or additive number, that is either as Food colour carmines or as Food colour E 120 in the local language(s) of the market(s) the product is sold in.
Although concerns of hazards from allergic reactions were raised, the use of carmine in foods is not banned in the EU. However, the use of carmine in foods has been discouraged by the European Food Safety Authority (EFSA), and, although it is used predominantly as coloring in alcoholic beverages, it can still be found in foods such as supermarket Indian curries. A re-evaluation process of the approval status of several food colors (including carmine) was started by the "Panel on food additives, flavourings, processing aids and materials in contact with food" of EFSA in early 2006 and is scheduled to be completed by 2008.[25][26]
As of January 2012, EFSA has changed the way they allow use of Carmine E120 for pharmaceutical products. The EFSA had raised concerns over the increasing number of allergic reactions to carmine derived from insects (E120.360), when used within the British pharmacopeia. Pharmaceutical products which had previously contained insect-derived carmine, have been replaced with a synthesized version of the food colorant. Internal studies have shown that the new formulations of popular anti-nausea and weight-gain liquid medication had a significantly lower risk in terms of allergic reactions.[citation needed] The new formulation is known to be of plant origin, using calcium oxide in order to gauge color depth.[further explanation needed]