Some foods and their extracts, often used to color foods, may come to be qualified as ingredients(coloringfoods) or coloring additives, depending on the circumstances. In some cases their use may be prohibited, due to food safety issues. In other cases it is subject to approval as a novel food.
The European Commission, Directorate General for Consumer Health, had published special guidelines in 2013. (1) Except to withdraw them in 2018. In the silence of Brussels, NATCOL’s(Natural Food Colours Association) handbook offers useful insights into the classification, production, use and sale of such products. (2)
1) Colouring foods, EU rules
Coloring foods used in food always fall under the definition of ‘food’ (EC reg. 178/2002). Therefore, they are subject to the requirements set for the generality of foods (e.g., the labeling, use of extraction solvents, contaminants, novel food authorization if applicable).
The Food Additives Regulation, after all, excludes from its scope foods with a secondary coloring effect, obtained by concentration and drying (EC Reg. 1333/08, Art. 3.2.a.ii). Which in fact do not involve selective extraction of pigments, as opposed to nutrients and/or flavorings.
Food extracts traditionally used for their coloring properties are also classified as coloring foods, according to practice, when they retain the characteristics of the original matrix. In other cases, food additive regulations, including the requirements of reg. EC 231/2012. (3)
2) Food ingredients or additives? The classification criteria
The status as an ingredient(coloring food) or food additive depends, in essence, on whether the coloring substances are physically and/or chemically selective in extraction. The amount of pigments in the extract should be compared with the pigments contained in the matter.
The ‘enrichment factor’ is used to assess whether an extraction is selective by comparing the ratio of pigments and nutritional or flavoring constituents in the extract with the same ratio in the raw material of origin (4,5).
2.1) Enrichment factor
The threshold value identified to assess a substantial difference between the composition of the extract and its source-and thus establish a quantitative boundary between selective and non-selective extraction, covering geographic, seasonal and varietal differences in raw materials-corresponds to an enrichment factor > 6.
Reference values for raw materials of origin, needed to calculate enrichment factors, were determined by the Joint Research Center (JRC), based on scientific literature and input from stakeholders. (6) Producers and users of extracts from matrices not on JRC’s list (Annex III) have the burden of proving to the competent authorities their classification as coloring foods.
2.2) Selective extraction
The answer to two questions helps decide whether the extraction can be qualified as selective or not:
1) does the primary extract retain the characteristic properties of the raw material of origin (color due to pigment concentration, aromatic properties, and nutritional values)?
2) Is the ratio of pigments to nutritional or flavoring constituents in the extract significantly different from that of the source raw material, as a result of physical and/or chemical extraction, resulting in selective pigment extraction?
In the case of a Yes/No answer to the two questions, non-selective extraction and the product as a food ingredient(coloring food) are considered. A Yes answer to Question 2 alone determines selectivity and classification as a food color additive, while a No/No answer requires analytical evaluation on a case-by-case basis.
2.3) Decision tree
A decision tree-to be followed along with the calculation of the enrichment factor and the two questions above-has also been prepared to assist the classification of primary extracts as ingredients(coloring foods) or food additives.
2.4) An application example
NATCOL provides an example of classification of two carrot extracts, A and B. The answers to the questions given as the basis for decision making show that:
- both extracts A and B are used primarily to impart color to a food, that B only through selective extraction,
- extract A retains the typical characteristics of the source material, confirmed by the similarity of the comparison of nutritional, coloring and aromatic constituents (instead absent in B),
- nutritional and flavoring enrichment factors are < 6 in A, much higher in B for the nutritional enrichment factor (while the flavoring factor is below the threshold).
Only extract A can be classified as coloring food. Extract B, even, cannot even be classified as a food color additive (since it lacks the requirements for purity specifications, e.g., carotenes ≥ 5%). Nor as an aroma, by defect of the characteristics. Nor, of course, as a technological adjuvant.
3) Responsibilities of food business operators
Food business operators first and foremost have the primary responsibility to ensure the safety of food, ingredients and substances intended to be used in it. Before even performing appropriate classification of substances as ingredients(coloring food) or as food additives, food business operators (FBOs) must therefore consider:
– The possible application of Novel Food Regulation No 2015/2283 (7,8),
– The possible need for food additive authorization in the EU, and compliance with its conditions of use,
– The absence (or compliance with limits) of contaminants already present in the raw material, or newly formed,
– the safe consumption of coloring foods, under the conditions of use established and communicated on the label, also taking into account the margins of exposure.
4) Labeling
The European Commission’s (defunct) guidelines omitted guidance on labeling requirements for coloring foods, despite the premise and the recent publication of the Food Information Regulation (EU reg. 1169/11). (9)
In contrast, NATCOL’s good practice manual focuses on the need to accurately distinguish on the label between ingredients(coloring food) and food additives. Also specifying the composition of the former and the possible need to indicate the QUID when compound ingredients are involved. With attention also to the data sheets to be provided for B2B information.
5) Interim Conclusions
Although the European Commission’s guidelines have no legal binding force, they are always useful in fostering common understanding among member state authorities, who in fact participate in their drafting through the PAFFCommittee (Standing Committee on Plants, Animals, Food and Feed). For the express purpose of ensuring the proper functioning of the internal market and a uniform level of consumer protection.
Food innovation based on the use of natural ingredients-as well as responding to a growing and widespread consumer interest-can contribute to the reduction of food safety risks related to inputs of chemically synthesized additives, which have already emerged in several contexts. Examples include azo dyes, nitrite preservatives, flavor enhancer sodium glutamate, and various others.
6) Natural ingredients, functional ingredients. Urgent reform in EU
It is time to review the regulation of natural functional ingredients, in harmonized interpretation of existing EU rules but also in reviewing them. Also from a perspective of approaching, for these substances alone, the GRAS(Generally Recognized As Safe) system adopted by the FDA(Food and Drug Administration) in the U.S. as early as 1958, without collateral damage.
Dario Dongo and Andrea Adelmo Della Penna
On the cover is the annatto (Bixa orellana), a plant native to Central and South America from whose seeds the dye of the same name is extracted (E 160b)
Notes
(1) European Commission. DG SANCO. Guidance notes on the classification of food extracts with coloring properties – Version 1. 29.11.13
(2) NATCOL (2021). Code of Practice for the Classification, Manufacturing, Use and Labelling of Colouring Foods (EU) https://natcol.org/wp-content/uploads/2021/09/NATCOL_CodeOfPractice_FullDocument_23_09_2021.pdf
(3) Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32012R0231&qid=1672071550043 Current consolidated version 31.10.22
(4) Enrichment factor, calculation formula.
Legend:
Fn = enrichment factor based on nutrient constituents,
Ff = enrichment factor based on flavoring constituents,
Cp = pigment content in the primary extract,
Cs = pigment content in the source material,
Np = content of nutrient constituents in the primary extract,
Ns = content of nutrient constituents in the source material,
Ap = content of flavoring constituents in the primary extract,
As = content of flavoring constituents in the source material
(5) Given the large variablity of flavoring constituents, it is recommended to refer to nutritional constituents, using total solids (everything but water) as the reference for calculating the enrichment factor
(6) Joint Research Centre, Institute for Reference Materials and Measurements, Bratinova, S. (2015). Provision of scientific and technical support with respect to the classification of extracts/concentrates with coloring properties either as food colors (food additives falling under Regulation (EC) No 1333/2008) or coloring foods, Publications Office. https://data.europa.eu/doi/10.2787/608023
(7) The reg. EU 2015/2283 can be applied, for example, to substances derived from supercritical CO2 extraction. V. Deborah Decorti. Cold pasteurization and supercritical CO2. GIFT (Great Italian Food Trade). 26.3.19
(8) Another example of the application of Novel Foods Regulation concerns microalgae extracts, to be checked on a case-by-case basis. V. Dario Dongo, Giulia Torre. Microalgae for food use and Novel Foods regulation, the state of the art in the EU. GIFT (Great Italian Food Trade). 29.1.22
(9) Andreas Reinhart (2014). Colouring Foods versus Food – Guidance Notes on the Classification of Food Extracts with Colouring Properties. European Food and Feed Law Review 9(2):105-113. http://www.jstor.org/stable/24326032
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.
