The world of vegetable matrices is rapidly evolving and promises great satisfactions in the field of food supplements and health in general. However, it is not simple to guarantee quality raw materials, due to different regulations not harmonized between countries and some regulatory holes.
Annex 1 of the Ministerial Decree (DM) of 10 August 2018 defines the type of plants allowed in food supplements. It is a unique list that combines the previous positive list proposed by the Ministry and the Belfrit list (annexes 1 and 1bis of the Ministerial Decree of 9 July 2012).
In food supplements, as specified in point 3.2 of annex 2 of the DM, only “substances and preparations deriving from plants or parts of them that have matured a traditional history of consumption as evidence of their safety” are allowed. The preparation techniques must be “traditional”, otherwise the EU regulation 2015/2283 on novel foods will take over, too.
Contamination risk throughout the supply chain
The increased consumption of medicinal herbs in the world has raised the problem of their safety for human use. In some cases, the adverse events documented in the literature are attributable to the poor quality of both raw materials of plant origin and finished products.
The problems associated with the low quality standards of plant raw materials are substantially due to contamination from heavy metals, pesticides, mycotoxins, micro-organisms or even other types of plants. And the problem can affect all levels of the supply chain, starting from the seed, the cultivation, the harvesting phase, the extraction and transport procedures. “The picture is clearly more complicated and complex than synthetic products, for which standardization is easier and feasible”», explains Marinella Trovato, general secretary of SISTE (Italian Society of Applied Sciences in Medicinal Plants and Health Products).
Short supply chain
The responsability for the food supplement is in head of the person who places it on the market. “Unfortunately, the official bodies, ASL and zooprofilattici institutes and the Istituto Superiore di Sanità inspective visits are ativated in the most cases in case of an alert”, underlines Marinella Trovato.
“The Italian legislation is one of the most severe and for this reason it is of greater guarantee. For the most part, the problem of contamination is attributable to raw materials imported from countries that have legislation distant from ours- said Heide De Togni, Pegaso’s technical director -. For this reason we prefer to use italian raw materials, and in the case of plants that can not be grown in Italy, we choose suppliers in Canada or in those European countries that have legislation similar to ours, and with easily reached locations. We do not have a structure that allows us to organize audits in countries such as China or the Eastern countries in general.
The size of the company is an important factor in the quality assurance processes of raw materials. “Having your own laboratory can help amortize the costs of analytics, given that the controls to which the raw materials are subjected are so many, – says Francesco Nicotra, Sales Director of EPO (Extracts Pianti Officinali, srl) -. We also look for to create positive synergies with our suppliers and customers and therefore upstream and downstream the supply chain. In this way we can make sure that the checks carried out are correct and appropriate to our needs. To give a concrete example, when possible we try to create partnerships with farmers, to whom we supply our selected seeds. It is a positive model that not only guarantees quality but also reduces costs and processing times”.
Waiting for harmonized guidelines
The choice of the short supply chain, according to Marinella Trovato, is certainly an interesting option, but not always applicable “70% of the raw materials of plant origin comes from abroad, – says Found -. Investing on the cultivation of plants that currently do not grow in Italy could be interesting and would reduce many of the current problems. The real issue, however, remains the lack of legislative harmonization between countries and even some regulatory holes. The real step forward will only be done when we will have clear and unambiguous rules at least at European level”.
70 thousand species interesting for health
That of plant matrices is certainly a complicated world. The checks to be carried out to guarantee quality raw materials are many, difficult to standardize. There are so many plants, 70 thousand species could be interesting for health and of these until today only 5000 (WHO data) have been studied. “There is still much to do and perhaps for this reason that of vegetable matrices is a fascinating world that can respond to the lack of active ingredients of the pharmaceutical industry. It is a sector in very strong evolution that will give satisfaction “, concluded Marinella Trovato.