The use of food colorings is still permitted in medicines, without any assessment of the specific risks linked to the vulnerabilities and pathologies of the subjects for whom they are intended.
Drug tablets that are supposed to treat intestinal disorders can thus be made ‘shiny’ with titanium dioxide, which ‘induces changes in the colon and rectum which can develop, over time, into cancer‘. (1)
The proposed reform of Medicines Directive 2001/83/EC however – rather than strengthening the protection of the most vulnerable consumers, as they are forced to take drugs – extends the exemptions in favor of Big Pharma. (2)
1) Food colourings, concept
Food Colors Regulation (EC) No 1333/2008 defines food colors as ‘substances that give color to a food or restore its original color, and include natural components of foods and other elements of natural origin, not normally consumed as food or used as a typical ingredient of foods.
They are dyes […] preparations obtained from foods and other basic edible materials of natural origin obtained through a physical and/or chemical process involving the selective extraction of pigments in relation to their nutritional or aromatic components‘. (3)
Foods and their extracts, when used to color foods, can be classified as coloring foods (coloring foods) or food coloring (colors), based on the selectivity of extraction of the substances responsible for the color. Carefully check beforehand that the food matrix does not qualify as novel foods. (4)
2) Food safety
The security of all food ingredients, including additives in which colorants are included, constitutes a pre-requisite for their entry into the European single market (General Food Law, EC Reg. No 178/02, article 14). From theory to practice, numerous food additives are a cause for concern due to public health risks that the European Commission has so far managed with bias and years of delay.
There is no shortage of examples, from the carcinogenic titanium dioxide – the use of which is still permitted in medicines and toothpastes, despite the specific risks identified in the literature (5) – to azo dyes (Southampton colours). Substances widely used, over the decades, on foods (and medicines) also intended for the most vulnerable population groups (newborns, children, pregnant women, elderly people). (6)
3) Food colorings in medicines. Safety and ‘transparency’ on the label
The use of food colorants authorized in medicines and veterinary medicines is still regulated by Directive 2009/35/EC which therefore considers them safe only, regardless of the specific vulnerabilities of the ‘target population’ for which the medicines are intended. (7) The only provisions contained in the directive concern:
– the use of only authorized food colourants, contained in the positive list of food additives in the EU; (8)
– compliance with the general specifications for aluminum coloring pigments and the specific specifications for individual food colourings; (9)
– the provision of a transitional period for the marketing of products containing food additives excluded from the list of authorized substances. With some regrettable exceptions introduced by the Commission, for medicines, in cases of titanium dioxide and canthaxanthin. (10)
Transparency is also denied ex law on the label of medicines for human use, ex lawwhere the Medicines Directive 2001/83/EC does not prescribe the exact indication of ‘colouring additives’. Limiting ourselves to classifying these substances in the broad and opaque category of ‘excipients’, like all the components of medicines other than the ‘active substance’ (i.e. the active ingredient in the medicine) and the packaging material.
4) Colorants used in medicines, justifications for use and risk assessment
Theoretical justification to allow the use of colorants in medicines is to ‘help patients distinguish between different medicines’. Without lingering on the essential marketing function, aimed at increasing the attractiveness of the product, which:
– does not in itself justify the introduction of potentially dangerous substances for the health of the subjects to whom the drugs are aimed, e
– deserves specific risk assessments, which however are still entrusted to specific EMA (European Medicines Agency) guidelines.
All excipients used in the formulation and production of medicines, including dyes, should in fact be used taking into consideration the reference target population (i.e. children, elderly) and possible adverse effects. The specific EMA guidelines should therefore be followed both on the medicines to be authorised, and for modifications of already authorized medicines, and in the clinical research phase of drug development (11,12). However, their concrete application may be (strongly) doubted by reading the composition of numerous medicines and food supplements authorized in the EU.
5) Uses and classifications
Many colorants are still used in medicines in tablets, capsules and syrups. The main distinctions concern:
– solubility. Tinctures (dyes), water-soluble, and pigments (pigments), insoluble in water;
– origin. Natural or synthetic. (13)
An opaque classification of colorants used in medicines distinguishes:
1) organic dyes and related lacquers (lakes, coming from lake, obtained from insects). Despite the name, this category also includes dyes of synthetic origin (i.e. azo dyes), which have a high coloring power and are cheaper than natural ones. Unlike natural lacquers, which are used in dispersion because they are insoluble, they are mainly used in the form of water-soluble salts;
2) inorganic or mineral colors. They have good light stability and in some cases are opaque, such as the infamous titanium dioxide or iron oxides (yellow and red);
3) natural colors, or vegetable and animal colors. They can be obtained by extraction from plants, trees or animals, or obtained by synthesis. The former are generally less stable to light, heat and certain pH ranges. Among these are caramel, annatto, curcumin, riboflavin, anthocyanin and cochineal red (considered among the most dangerous, due to carmine capable of causing allergic reactions, skin cancer and hyperactivity in children, e.g. ADD and ADHD).
6) Medicines Directive, reform proposal
Big Pharma did not allow the reform of medicines – like that of veterinary drugs, finalized in 2020 – to be implemented by means of regulations, i.e. identical rules to be applied at the same time in the European Union. The reform of the now obsolete Medicines Directive 2001/83/EC will therefore pass through a new directive, which will be implemented in the 27 Member States with the usual variations, at national level, which are a structural cause of asymmetries in consumer protection and obstacles to the free movement of goods in the internal market.
6.1) Colorants in medicines, no greater protection
The reform project, adopted in Brussels on 26.4.23 and still under examination by the ENVI (Environment, Public Health and Food Safety) Commission of the European Parliament, (14) in the part relating to colourants:
– confirms the possibility of using colorants already authorized for food use in medicines for human use, without introducing any greater protection for specific segments of the population or for those subject to specific pathologies and vulnerabilities for which the medicines are therefore intended,
– introduces a new list of colorants excluded from the list of food additives and yet authorized for exclusive use in medicines, subject to possible opinion from EMA, also while awaiting a decision from the Commission which will in any case have to consider the opinion of EFSA (European Food Safety Authority ).
7) Provisional conclusions
The pharmaceutical lobby wins hands down, once again, as easy to predict. In a Europe where – it is worth remembering – neither President Ursula with der Leyen nor the European Commissioner for Food Safety and Public Health Stella Kyriakides have been able to offer credible explanations on how 4 million euros ‘rained’ into the husband’s account of the latter, who historians will remember as the ‘Vaccine Commissioner’. (15) Whose contracts were negotiated on behalf of the European Union by Sandra Gallina, general director of DG Sante who – as Roberto Burioni recalled – ‘she graduated from interpreter school and first encountered healthcare in July 2020‘. (16)
#ProfitsOverPeople, until when?
Dario Dongo and Andrea Adelmo Della Penna
Footnotes
(1) Marta Strinati. Stop to titanium dioxide, interview with Francesco Cubadda, ISS expert. GIFT (Great Italian Food Trade).
(2) Proposal for a directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC (COM/2023/192 final) http://tinyurl.com/yx36jut8
(3) Reg. (EC) No 1333/2008, Annex I, point 2
(4) Dario Dongo, Andrea Adelmo Della Penna. Coloring foods and their extracts. Ingredients or additives? GIFT (Great Italian Food Trade). 24.12.22
(5) Marta Strinati. New study on the risks of titanium dioxide present in toothpastes and medicines. GIFT (Great Italian Food Trade).
(6) Marta Strinati. The role of ultraprocessed foods in inflammatory bowel disease. GIFT (Great Italian Food Trade).
(7) Directive 2009/35/EC on the coloring matters which may be added to medicinal products (recast) http://tinyurl.com/mpnk5p2w
(8) Reg. (EC) No 1333/2008, Annex II, part B, point 1
(9) The specifications are reported in Reg. (EU) No 231/2012. Directive 81/716/EEC, which defined the analysis methods for checking the purity criteria of some food additives, including colourants, was repealed by Reg. (EC) No 1333/2008.
(10) Reg. (EU) No 1129/2011 reports that this colorant (E 161g) was authorized only in Strasbourg saucisses, and subsequently no longer used. Its presence in the positive list of food colorings exists exclusively for its use in medicines for human and veterinary use (recital 14)
(11) EMA Committee for Medicinal Products for Human Use, CMPH. (2007). Guideline on excipients in the dossier for application for marketing authorization of a medicinal product. EMEA/CHMP/QWP/396951/2006 http://tinyurl.com/yc3dyhas
(12) EMA Committee for Veterinary Medicinal Products, CVMP. (2023). Guideline on excipients in the dossier for application for marketing authorization for veterinary medicinal products (EMA/CVMP/QWP/307647/2023) http://tinyurl.com/4h8ecbcx
(13) Šuleková M. et al. (2017) Organic Coloring Agents in the Pharmaceutical Industry. Folia Veterinaria 61(3):32-46, https://doi.org/10.1515/fv-2017-0025
(14) The reform provides for a complete overhaul of the legislation on medicinal products for human use which includes, in a separate proposal (COM(2023) 193 final), a new regulation updating the requirements for the authorization and supervision of medicinal products and incorporating different categories of medicinal products hitherto regulated with separate provisions (e.g. orphan medicinal products, medicinal products for pediatric use)
(15) Dario Dongo. 4 million euros rained into the account of the European Commissioner for vaccines. Egalité. 16.5.21
(16) See note 14 to the previous article by Dario Dongo. Food supplements with turmeric extracts, possible health risks. GIFT (Great Italian Food Trade). 24.8.22
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
Graduated in Food Technologies and Biotechnologies, qualified food technologist, he follows the research and development area. With particular regard to European research projects (in Horizon 2020, PRIMA) where the FARE division of WIISE Srl, a benefit company, participates.
