Importing food supplements with 'coral calcium' into the EU? The lawyer Dario Dongo answers

Dear Dario good morning,

on a recent trip to the United States I noticed the spread of food supplements with the ingredient 'coral calcium'and I ask you if it is possible - if any, under what conditions - the import of this type of food supplements in the EU.

Many thanks as always,

Angelo


The lawyer Dario Dongo, Ph.D. in international food law, answers

Dear Angelo good morning,

the 'coral calcium'is actually used as an ingredient in food supplements marketed in the US. A brief insight.

1) Coral calcium

This is not real coral - since environmental legislation protects coral reefs, at least in this respect - but of deposit limestone, previously produced by corals as a protective coating.

1.1) Training

The Anthozoans  (Phylum CnidariaClass anthozoa) are a class of marine invertebrates, small polyps that feed on organic particles in water and aggregate to form coral. With the help of single-celled colonial algae (zooxanthellae).

And granules of calcium carbonate are aggregated with a 'glue' of which some traces remain. (1) And the fossil residues, essential for the construction of new corals, supplement their endowment with possible additions of precious mix of trace elements (eg silicon, iodine).

1.2) Composition and use

The CD 'coral calciumit consists mainly of calcium carbonate (20-24%) and magnesium (10-12%), as well as more than 70 minerals. Attention should be paid to its possible lead content in excessive quantities. (2)

Its use in food supplements, according to some, it is not more useful than other forms of calcium (eg algae). (3) And it could have contraindications (gastrointestinal problems) in cases of excessive intake. (4)

1.3) Possible health benefits

A scientific review (Xu et al., 2020) of the Chinese universities of Wenzhou (Zhejiang) and Qingdao (Shandong) recalls some health benefits associated with calcium inputs from various marine organisms (e.g. algae and microalgae, oyster and clam shells, fish cartilage) that it is characterized by appreciable bioavailability and biological functions. (4)

The contribution of 'coral calcium', in particular, it has been related to the regulation of blood pressure, bone metabolism and the contrast to osteoporosis, the prevention of colon cancer metastasis. Its antioxidant action has shown, in experiments on mice, the ability to slow down senescence and prevent hepatic steatosis.

1.4) USA, previous complaints by health claims unfounded

The phenomenon coral calcium' in the USA it is attributed to marketing fraudulent fraud by Robert R. Barefoot and others, sanctioned by the FTA (Federal Trade Commission) in 2004 (5) for having (falsely) boasted its ability to cure over 200 diseases (eg cancer, diabetes, arthritis, ALS, Alzheimer's, cardiovascular disease).

FDA (Food and Drug Administration) has therefore entered the 'coral calcium'on the list of' special guards', as an ingredient in food supplements to which they are attributed fakes health claims related to hypothetical cancer prevention. (6)

2) 'Coral calcium'in the European Union, lo status quo

The reg. EU 2017/2470 and Novel Food Catalog do not refer to the 'coral calcium'nor to corals, their deposits and residues (7,8). The introduction in the European Union of food supplements that contain it as an ingredient must in any case be preceded by the verification of its status, pursuant to reg. EU 2015/2283. This analysis can lead, in the specific case, to four possible outcomes.

2.1) Traditional ingredients of food supplements

A) Minerals, vitamins and other substances used in compliance with directive 2002/46 / EC (food supplements), reg. CE 1925/2006 (food fortification) or reg. EU 609/2013 (foods intended for particular nutritional uses) resulting from a traditional production process (prior to 15.5.97).

B) Traditional ingredient of food supplements. The ingredient is not considered novel food if its use can be demonstrated 'exclusively in food supplements', in the European Union, before 15.5.97. (9)

2.2) Ingredients novel food, traditional foods from third countries

C) novel food. If the operator is unable to demonstrate with reasonable certainty that the ingredient in question can be qualified as'traditional ingredient of food supplements', pursuant to the previous paragraph, a procedure must be activated for its authorization as'novel food'.

D) Traditional food from third countries. The research of scientific bibliography and gray literature (10) can also reveal that the ingredient, even if it does not have a relevant history of consumption in Italy, has it instead in third countries. If this hypothesis occurs, it is possible to adopt the specific simplified procedure. (11)

3) Possible criticalities

The food business operator has the primary responsibility for ensuring product safety, as we have seen. (12) And the distributor - pharmacy or parapharmacy, herbalist, supermarket chain, shop online and - is in turn responsible for ensuring the compliance of foods, in this case food supplements, with all applicable regulations. (13)

Possible criticalities are linked to the possible qualification of the 'coral calcium' how novel food, pursuant to reg. EU 2015/2283. The demonstration of its traditional use in the EU must be supported by in-depth research that ends in evidential evidence, otherwise its authorization must be requested as novel food for use as an ingredient in food supplements (14,15).

4) Provisional conclusions

THEupcycling (virtuous reuse) of by-products of marine organisms can provide calcium of natural origin with high bioavailability, also reducing the risk of environmental pollution linked to other production processes (Xu et al., 2020).

Sustainability of the production of 'coral calcium'is very doubtful, as the collection of bottom debris also harms the formation of new corals. The only guarantee can be offered by 'coral calcium'from coral grown in aquaculture. (17)

Other sources of calcium from marine organisms appear in any case preferable both from this point of view and to guarantee their availability to vegetarian and vegan consumers. In fact, sediments qualify as products of animal origin.

cordially

Dario

Notes

(1) Walter Goldberg (2018). Coral Food, Feeding, Nutrition, and Secretion: A Review
Chapter in Results and Problems in Cell Differentiation. https://link.springer.com/chapter/10.1007/978-3-319-92486-1_18 In: Kloc, M., Kubiak, J. (eds). Marine Organisms as Model Systems in Biology and Medicine. Results and Problems in Cell Differentiation, vol 65. Springer, Cham. https://doi.org/10.1007/978-3-319-92486-1_18 18

(2) Abhijit Trailokya, Ambrish Srivastava, Milind Bhole, Nitin Zalte (2017). Calcium and Calcium Salts. Journal of The Association of Physicians of India. Vol. 65. https://www.japi.org/article/files/calcium_and_calcium_salts.pdf

(3) Uenishi K, Fujita T, Ishida H, Fujii Y, Ohue M, Kaji H, Hirai M, Kakumoto M, Abrams SA. Fractional absorption of active absorbable algal calcium (AAACa) and calcium carbonate measured by a dual stable-isotope method. Nutrients. 2010 Jul; 2 (7): 752-61. doi: 10.3390 / nu2070752. Epub 2010 Jul 12. PMID: 22254052; PMCID: PMC3257682

(4) Yangli Xu, Jian Ye, Deqing Zhou, Laijin Su (2020). Research progress on applications of calcium derived from marine organisms. Sci rep. 2020; 10:18425. doi:10.1038/s41598-020-75575-8

(5) Marketers of Coral Calcium Product Are Prohibited from Making Disease Treatment and Cure Claims in Advertising. FTA (Federal Trade Commission). https://www.ftc.gov/news-events/news/press-releases/2004/01/marketers-coral-calcium-product-are-prohibited-making-disease-treatment-cure-claims-advertising 22.1.04

(6) 187 Fake Cancer “Cures” Consumers Should Avoid. US https://bit.ly/3whvZ4B FDA (Food and Drug Administration). Web archives. Last update 04/25/2017

(7) Commission EU Reg. 2017/2470, establishing the Union list of novel foods pursuant to reg. EU 2015/2283 of the European Parliament and of the Council on novel foods. Consolidated text at 26.7.22 on Eur-Lex, https://eur-lex.europa.eu/legal-content/IT/TXT/?qid=1660941103754&uri=CELEX%3A32017R2470

(8) Novel Food Catalog. European Commission. https://webgate.ec.europa.eu/fip/novel_food_catalogue/

(9) See reg. EU 2283/2015, art. 3.2.a, letters 'ix' and 'x'

(10) The gray literature ('gray literature') is that produced outside the system of scientific publications. It includes public and private documents, from organizations and individual authors

(11) Dario Dongo, Giulia Torre. Notification of traditional foods from third countries such as Novel Foods in the EU. GIFT (Great Italian Food Trade). 4.3.22

(12) Giulia Torre, Dario Dongo. Food safety, ABC operators responsibility. GIFT (Great Italian Food Trade). 6.4.18

(13) Dario Dongo, Pierluigi Copparoni. Responsibility of the distributor, insights. GIFT (Great Italian Food Trade). 22.5.18

(14) Coral LLC indicates that the use of coral in medicine dates back to 830 BC by the Arabs and mid-1600s by the Spaniards. The source cited is the book 'Fossil stony coral minerals and their nutritional application: A world life research institute publication'(https://coralcalcium.com/minerals_post/the-history-of-coral/). A hint of sure interest that nevertheless deserves further feedback and insights

(15) The Italian food supplement manufacturer LongLife in turn markets a product based on 'coral calcium', with raw material imported from the Caribbean, which is characterized negatively by the presence of the silicon dioxide coloring additive. V. Marta Strinati. Silicon dioxide, additive at risk still in use. GIFT (Great Italian Food Trade). 20.5.21

(16) The application for authorization to use thecoral calcium' how novel food must be accompanied by a dossier scientific evidence to prove its food safety. To this end, it will be first of all to characterize the substance, which is inevitably subject to variations linked to the aquatic ecosystems where it is collected. Without neglecting the presence of organic matter or the levels of heavy metal contamination

(17) Leal, MC, Ferrier-Pagès, C., Petersen, D. and Osinga, R. (2016). Coral aquaculture: applying scientific knowledge to ex situ production. Rev Aquacult, 8: 136-153. https://doi.org/10.1111/raq.12087



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