Italy suggests purity values ​​for amino acids in food supplements


In a document (In Italian) published by the country’s health ministry, the guidelines aim to respond to previous laws that only advise on the purity requirements of substances used in vitamins and mineral supplements.

“Supplements are particular food products which, as ‘concentrated sources’, may contain nutrients and / or a wide and heterogeneous range of substances with physiological effect, such as plants or probiotics. “directions indicate.

“Consequently, the manufacture of an integrator, with the nature and variable characteristics of the ingredients used, responds to specific“ critical points ”to be identified and managed with a concern for quality and safety.

The guidance is intended to reflect Regulation (EU) 609/2013 which details the purity values ​​for substances used in specific food groups which include infant foods, special medical uses and weight management.

The regulation states that these foods contain an attached Union list of permitted substances which include amino acids, vitamins, minerals, carnitine, taurine, nucleotides, choline and inositol.

“Focus on GMP”

“Italy has extended to food supplements the principles of EU law which apply to the purity of amino acids when used in so-called foods for special groups”,Explains Luca Bucchini, co-founder and CEO of regulatory consultancy Hylobates.

“It is also significant that Italy emphasizes its recent publication BPFfor food supplements’,he keeps on. “I think this underlines Italy’s role as the EU’s main market for dietary supplements.

“It is important to note that the ministry emphasizes that these GMPs, although not officially a regulation, should be used by inspectors to verify producers. “

The ministry’s efforts also put the country behind Denmark in setting purity requirements for amino acids and other substances in food supplements within the EU.

This despite the fact that purity is recognized as the most important factor in the safety of amino acids, which are inherently safe.

“This is a welcome step in the direction of consumer protection in the EU and the improvement of the quality of European food supplements”,adds Bucchini.

“Denmark and Italy have taken these steps because progress at European level has been difficult, although most countries would support EU-wide rules.

“Compared to Denmark, Italy, in accordance with EU law, has also recognized the role of the European Pharmacopoeia, while Denmark has based its rules mainly on the Codex of Food Chemicals (FCC). “

Bucchini also points to the previous work of a coalition, which recently worked on Characteristicsfor countries that do not have official guidelines.

“I hope this will lead to harmonization at EU level, and I understand that this is also what the Member States are hoping for. “

International standards

Further details in the directives of the Ministry of Health indicate the purity requirements, described in Regulation (EU) 609/2013 which states, “For substances on the Union list for which the purity criteria have not yet been adopted at Union level, the criteria generally accepted and recommended by international bodies or agencies such as the Joint Committee of FAO / WHO experts on food additives (JECFA) and the European Pharmacopoeia (Eur.Ph) should be applied … “

“This is also to ensure a high level of public health protection, purity.”

Bucchini adds that it is very important for manufacturers to check whether the raw materials they buy meet any of the standards by checking the specifications.

“This is not always the case at the moment”,he said. “JECFA has few standards for amino acids, and it is generally considered that they may not be ideal for nutritional use (because they were designed for amino acids used as additives).

“FCC and Eur.Ph. have some differences, but are considered acceptable; quality managers can consider the differences on a case-by-case basis in terms of specific contaminants.


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