In a regular column for Health Food Business, the IHTA’s Phil Costigan looks at the the management of vitamins and minerals on the Irish market.

vitamins-and-mineralsReaders will remember that I reported in the June edition of HFBM that the food supplement industry in Ireland was developing and thriving consequent to an increasing number of consumers embracing supplementation to maintain their health. I can now report that our national regulators, the Food Safety Authority of Ireland (FSAI), aware that a large percentage of the public consume food supplements, have recently published a report outlining the process that the food supplement industry should use to establish maximum safe levels for 21 of the 30 vitamins and minerals permitted in food supplements in Ireland.

The FSAI have reported that the numbers of food supplements that have been notified to them has risen from 700 in 2007 to over 2,500 in 2017 – an increase of over 300%, and in early June, the Scientific Committee of the FSAI published their report titled ‘The Safety of Vitamins and Minerals in Food Supplements – Establishing Tolerable Upper Intake Levels and a Risk Assessment Approach for Products Marketed in Ireland’. The report can be downloaded from the FSAI website.

Readers will know that publication of the original Food Supplements Directive (2002/46/EC) had as its objective, the establishment of European harmonised rules to protect consumers of food supplements against potential health risks and misleading information. This goal was embraced by the industry as can be evidenced by the publication in 2007 and updated in 2014 of a Quality Guide- Promoting Best Practice by the European Federation of Associations of Health Product Manufacturers (EHPM). The Guide covers all aspects of manufacturing, quality control, packaging,
distribution and storage of food supplements. The Guide can be downloaded from the EHPM website.

8990-ehpm-report-for-web-1-638In addition, Food Supplements Europe (FSE) published in 2014 a Guide titled “Good Manufacturing Practice for Manufacturers of food supplements” and a publication titled “Risk Management approaches to the setting of Maximum levels of Vitamins and Minerals in Food Supplements for adults and children aged 4-10 years.” This was followed in 2016 by the publication of a further Guidance document titled ” Quality of Botanical preparations: Recommendations for the manufacturing of Botanical preparations, including extracts as food supplements. These and other related documents can be downloaded from the FSE website:

Industry has never been lax in its responsibilities towards its end customer, the consumer, and has endeavoured over the years to ensure that food supplement placed on the market reach optimum standards on safety, quality and efficacy. The raison d’etre of supplementation is to allow consumers have choice to take charge and care take their own health requirements. It is therefore disconcerting to read in a recent Press Release by the national regulator that in their view, it is not necessary to take food supplements to maintain a healthy lifestyle. The only food supplements that the FSAI recommends are 400μg folic acid per day for women who are sexually active and a 5μg vitamin D3 only supplement per day for all infants from birth to 12 months. Consumer demand does not reflect the regulators view and any visit to a health retail outlet will clearly display the ever increasing range of innovative new products stacked in rows side by side with the usual old favourites.

When the FSD was published back in 2002, readers will know that the harmonised objective was to also include the setting of upper safe levels for vitamins and minerals. Sixteen years later the EU regulators have not yet succeeded in achieving that objective and this has given rise to individual member states taking a national position on safe levels. The recent initiative by the FSAI Scientific Committee was to provide scientific advice to the FSAI for assessing the safety of vitamins and minerals in food supplements in Ireland and for the development of appropriate guidance for the food industry. The FSAI have stated that they will be developing a guidance document, in conjunction with food supplement industry representatives, to assist the industry in understanding the implications and findings of the Scientific Committee report and the actions they should take in
relation to their products. The IHTA as responsible stakeholders and representative of many business operators placing product on the market, plans to be proactive in any such consultation.

Phil Costigan is General Secretary of the Irish Health Trade Association (IHTA), which represents the interests of manufacturers, importers and distributors of natural health products in Ireland. The principal aim of the IHTA is to assist member companies in promoting the wellness of all people in Ireland. For more information on the IHTA, visit