In a document (in Italian) published by the country’s Ministry of Health, the guidelines aim to address previous laws that only advise on the purity requirements of substances used in vitamins and mineral supplements.
“Supplements are particular food products that, as "concentrated sources ", can contain nutrients and/or a vast and heterogeneous range of substances with a physiological effect, such as botanicals or probiotics,” the guidelines state.
“Consequently the manufacture of an integrator, with the varying nature and characteristics of the ingredients used, meets specific "critical points" to be identified and managed for the purpose of quality and safety.”
The guidance intends to mirror Regulation (EU) 609/2013 that detail purity values for substances used in specific food groups that include foods for infants, special medical purposes and weight management.
The Regulation dictates that these foods contains an attached Union list of permitted substances that include amino acids, vitamins, minerals, carnitine, taurine, nucleotides, choline and inositol.
‘GMP emphasis’
“Italy has extended to food supplements the principles of EU law that apply to the purity of amino acids when used in so-called Foods for Special Groups,” explains Luca Bucchini, co-founder and managing director of regulation consultants Hylobates.
“It is also significant that Italy is emphasising its recently published GMPs for food supplements,” he continues. “I think it underlines Italy's role as the main EU market for food supplements.
“Importantly the Ministry emphasises that such GMP, though not formally a regulation, should be used by inspectors to check producers.”
Ministry efforts also place the country behind Denmark in defining purity requirements for amino acids and other substances in food supplements within the EU.
This is despite the fact that purity is recognised as the most significant factor in the safety of amino acids, which are intrinsically safe.
“It’s a welcome step in the direction of protecting consumers in the EU, and increasing the quality of European food supplements,” adds Bucchini.
“Denmark and Italy have taken these steps because progress at the European level has been difficult even if most countries would support EU-wide rules.
“When compared with Denmark, Italy, in line with EU law, has recognised the role of the European Pharmacopeia as well, while Denmark based its rules chiefly on the Food Chemical Codex (FCC).”
Bucchini also points to previous work by a coalition, who recently worked on specifications for countries that have no official guidelines.
“I hope that this will lead to EU-level harmonisation, and I understand that this is what Member States hope too.”
International standards
Further details in the Ministry of Health’s guidance point to purity requirements, outlined in Regulation (EU) 609/2013 that states, "For Union list substances where purity criteria has not yet been adopted at Union level, criteria generally accepted and recommended by international bodies or agencies such as the FAO / WHO Joint Expert Committee on Food Additives (JECFA) and the European Pharmacopoeia (Eur.Ph) should be applied ...”
“This is also in order to guarantee a high level of public health protection, purity."
Bucchini adds that it is really important for manufacturers check if the raw materials that they purchase comply with any of the standards by checking specifications.
“This is not always the case at this time,” he says. “JECFA have few standards for amino acids, and it is generally considered that they may not be ideal for nutritional use (because they were devised for amino acids used as additives).
“FCC and Eur.Ph. have some differences, but are considered both acceptable; quality managers may consider differences on a case by case basis in terms of specific contaminants.”