AMOROS Nature – NVH Italia – PHARMANAGER GROUP: Full integration of a phyto-chain

The safety of plants in food supplements: A European think tank driven by the EFSA

On 10 September 2009, the European Food Safety Authority published guidance for food authorities on the assessment of the safety of botanicals and botanical preparations for use in food supplements (1). The EFSA explained that this work, undertaken on the initiative of the EFSA itself, will also help the food industry manufacturers when examining the safety of the ingredients likely to be used in their products.

An approach based on safety...

The opinion of the EFSA's Scientific Committee specifies the data required to correctly carry out these safety assessments. It suggests a two-tiered scientific approach depending on the available knowledge on a given botanical and the substance(s) it contains. This way, botanicals or botanical preparations for which a large body of relevant knowledge already exists could benefit from a "presumption of safety" without any need for further testing. The botanicals or botanical preparations for which a presumption of safety is not possible based on available knowledge would be subject to a more extensive safety assessment, requiring additional data to be provided.

In collaboration with other EU Member States, the EFSA has also gathered existing information on a large number of botanicals reported to contain substances that may be of health concern when used in foods or food supplements. This compendium, which will be regularly updated, is intended to assist manufacturers and food safety authorities by highlighting potential safety issues which may require further consideration.

Today, the majority of Member States use the EFSA's compendium as a benchmark for assessing plant-based food supplements and for granting national authorisation.

as well as on traceability and quality.

The EFSA's guide also highlights the obligations defined by (EC) Regulation No. 178/2002 (2). In particular, the "farm to fork" traceability, and safety based on risk analysis (HACCP).

In 2011, Denmark was the first Member State to adopt the guidelines on the safety of food supplements following the publication of the EFSA's guide. Italy and Germany have also published their own guides (2013 and 2014). In France, since January 2015, a decree requires all operators to create a traceability, quality and safety file for nearly all the food supplements placed on the market in France containing at least one plant or plant preparation.

The common basis of these guides is full traceability and risk analysis at each stage of manufacture: Information on the plant in the field (geographical origin, growing and harvesting conditions, phytosanitary treatments, etc.), on the preparation of the plant (description of the ingredient manufacturing process, chemical composition, dosages of the markers responsible for the physiological effects, of the secondary metabolites, of the constituents responsible for the adverse side effects, etc.) and on the finished product (recommended daily dose, coherence of the plant combinations, evaluation of possible interactions, warnings or contra-indications, stability assessment, postmarketing surveillance).

AMOROS Nature – NVH Italia – PHARMANAGER GROUP: Successful synergy

This approach for assessing the safety of plants in food supplements, driven by the EFSA and already implemented by several countries, should be deployed in the majority of Member States in the next 5 to 10 years. To assist their customers with the regulatory change, AMOROS Nature, NVH Italia and PHARMANAGER GROUP have decided to pool their expertise and create a joint venture. Their objectives:

- Organise a phyto-chain to ensure total traceability, quality and safety.

- Provide regulatory scientific assistance for placing plant-based products on the market.

Mastering crops, plant quality and transformation	Mastering plant extracts
		Scientific and regulatory assistance	Distribution Technical and quality assistance
			Plants and herbal extracts
Mastering crops, traceability of the geographical origin, growing and harvesting conditions, phytosanitary treatments, etc.	Mastering the manufacturing process.	- Drawing up quality / safety files for food supplements - Labelling regulations - Notification of food supplements (Europe, other countries). - Health claim legislation, etc.	- Plants or plant extracts: a single contact person - Technical and quality assistance: product definition based on technical constraints and quality prerogatives. - Drawing up of detailed traceability/quality files
Chemical composition. Dosages of the markers responsible for the physiological effects, of the secondary metabolites, of the constituents responsible for the adverse side effects.		The scientific and regulatory database dedicated to food supplements
- Expertise in plant sourcing and supplier selection. - Equipment at the cutting edge of technology for producing and processing products: cutting, spraying, disinsectisation, debacterisation, etc. - Complete certificates of analysis, etc.	- Adaptation of extracts to technical constraints: Grain size distribution, titer, solubility, coating, etc. - Highly innovative: SolanRed®, Capsired®, technologies HRD® and BindGran® - Environmental responsibility

(1) Guidance on Safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplements
The botanical materials include whole, fragmented or cut plants, algae and fungi. The botanical preparations are the substances obtained from these products, by pressing, distillation or fermentation for example.
(2) (EC) Regulation No. 178/2002 that lays down the general principles and requirements of food law, establishes the European Food Safety Authority and lays down procedures in matters of food safety.