Changes to the decree, pursuant to Article 5 of the Law of 28 July 2016, n. 154, not only serve to rationalise current interpretations but also increase competitiveness of the country’s agricultural and agri-food sector.
“Specifically, the law makes it easier for farmers to grow and harvest "officinal plants", and to do some of the processing,” explained Luca Bucchini, managing director of Hylobates Consulting.
“For example, drying or even producing essential oils will be permitted to farmers, without a full Hazard Analysis and Critical Control Point (HACCP) plan, unlike other processors of botanicals.
“Moreover, the law allows the growing of some herbs without the direct supervision of a licensed herbalist. The application of Good Agricultural Practices (GAP) becomes mandatory for medicinal plants, and is encouraged for all officinal plants.”
What are officinal plants?
Officinal plants, which class medicinal, aromatic and "perfume plants" plants, amongst others as legal for use after processing in a range of sectors including botanicals for food supplements and foods.
According to Bucchini, the category of officinal plants is new in the eyes of the law, as the overall aim is to create an “overarching concept, from medicinal plants to botanicals and aromatic plants used for food”.
“This makes sense as despite the final use under medicinal, food or even cosmetic law the growing and harvesting shares many similarities, and the species involved are often the same,” he added.
The decree text adopts the conclusions of the Table of supply chain of medicinal plants, established in 2013, where attempts were made to modernise existing legislation dating back to the 1930s.
As well as providing a new definition of officinal plants, the decree also looks to establish a number of medicinal plant species registers, in which officinal plants deemed suitable for marketing are listed and the methods and conditions for seed certification are established.
The decree also intends to regulate the spontaneous collection of these plants, in order to avoid the depletion of specific areas and encourage greater knowledge of the areas, plants and the environment.
The development of an integrated supply chain from the environmental point of view, is also encouraged in order to create profitable conditions for agricultural enterprises and to coordinate research in the sector.
Italian quality standard
With regional consideration in mind, the decree opens up the possibility of establishing, in compliance with European Union legislation, trademarks aimed at certifying compliance with quality standards in the supply chain of medicinal plants.
“I think there is a large issue with quality and adulteration in the plant sector,” said Bucchini. “Some suppliers are of the highest quality, and have their own certification schemes.”
“But third party schemes are needed, especially for the botanicals/food supplement sector. With long supply chains, adulteration and quality issues are a concern. Issues start with identification of the plant and contaminants from the fields and storage sites.”
From a countrywide point of view, the legislation serves to make better quality botanicals that are grown and harvested in Italy available to the herbal medicine industry, the food supplement industry and the food sector.
“This should make more quality raw materials available to businesses and consumers,” he said.
“Italy is the largest market for food supplements in Europe. Therefore, it is natural for Italy to take the lead on this initiative.
“However, other countries with suitable growing and harvesting conditions may follow, as there may be a premium on quality and EU-sourced botanicals.”
The Council of Ministers, as instructed by President and minister for Agricultural, Food and Forestry Policies, Paolo Gentiloni has approved this decree along with another, which introduces clearer rules on how community aid is distributed as part of the Agency for payments in agriculture (AGEA).