Becarre natural

The plants decree has been published July 17th, 2014 "laying down the list of plants, other than mushrooms, authorized in food supplements and their conditions of use".

You'll find here below a reading of the publication - especially annexes II et III

Pour lire ce texte en FRANCAIS, cliquez ici

Becarre Natural

Model for Annex II - Becarre Natural (PDF)

Becarre Natural

Plants decree - Journal Officiel (PDF)

Becarre Natural

Italian list, partly from BelFrIt (PDF)

Becarre Natural

German List (draft) (PDF)

The plant decree was published on July 17, 2014 in the official journal, laying down the list of plants, other than mushrooms, authorized in food supplements and their conditions of use. Its implementation is January 2015, 1st. The list of fungi, and probably essential oils, will be the subject of further publication.

This decree includes 14 articles, describing the terms used and the applications, and 3 annexes.

Annex I

Annex I lists the 540 authorized plants (at the date of June 2014), with :

Becarre naturalTheir scientific name and family : synonyms exist in several cases . If necessary, you can also visit the website www.theplantlist.org

Becarre naturalTheir vernacul name

Becarre naturalThe part(s) used

Becarre naturalThe substances to be monitored : it is not necessarily substances to be absent or undetectable, but substances that the decree specifically request to be checked.

Becarre naturalThe restrictions of use: mainly specific labeling warnings (child, pregnant women), sometimes about the process.

Annex II

Annex II contains information that may be provided by operators in the sector in order to understand the preparation. As such, a model was proposed by Synadiet and Food Supplements Europe. This model is split into several parts. There is no obligation to complete each field, as indeed it's just a model-form :

Plant (ie. Raw Material)

Becarre naturalPlant Description : Scientific name, vernacular name, family, existing monograph, risk of falsification (by another similar plant for example)

Becarre naturalCulture method (geographical origin, method of cultivation, specific agreements, licensing, 338/97) and collection (collected plant parts , mechanical or manual cleaning, drying)

Becarre naturalParts of the plant used and its identification (controls, markers, purity)

Production process (starting from the plant)

Becarre naturalGeographical location of the process (unit), manufacturer, preparation before process (grinding, separation, ...)

Becarre naturalDescription of the extraction process from the raw material (ex. if it is extracted from an oleoresin, it is necessary to mention the process from the plant): solvent (concentration and quality) for extraction, purification, and any other step (elimination of compounds or hazardous compunds).

Becarre naturalOther information related to the process, definition of a batch, size

Plant preparation (ex. Plant extract for BECARRE Natural)

Becarre naturalName , PER (Plant Extract Ratio: final ratio after extraction and before any other addition and the the initial amount of extracted plant - dry /dry if it is a dry extract), DER (Drug Extract Ratio: ratio between the final ratio of the preparation and the initial amount, so after addition any additives or carrier ...). A product without carrier shows a PER = DER. Sometimes indicated, the NER is the native ratio, so the ratio plant:extract - depending on the solvent used - extracting enough dry matter to get an extract (see 'focus-on' on the extraction)

Becarre naturalFull composition (in%, with the nature and purpose of each component, purity criteria additives - 231/2012)

Becarre naturalStandardization (markers, actives) with a detailed method of analysis (validated / internal validation) and the standard used as a reference

Becarre naturalSubstances to be monitored : with reference to Annex I or any other molecule needing to be monitored

Becarre naturalImpurities (eg 2009/32), contaminants, bacteriological controls, other controls, see ... 1881/2006, 629/2008, 1259/2011, etc

Becarre naturalStatements, other data : nutritional data, GMO (1829 and 1830/2003) Irradiation (1999/2, 1883/2003), allergens (2007/68, 2000/13), ...) ...

Becarre naturalStability data with the reference (ICH ?), does it need homogenization, ...

In addition, BECARRE Natural completed the form of a preparation to additional food safety information, although Annex III is not needed..
Exposure Level : consumption of the plant, of the extract
Risk analysis : toxicity studies, genotoxicity, mutagenicity, safety, NOAEL
Traditional use
• Possible evolution of the process

This raises the question of the need or not of Annex III.

Reading the conditions of Annex III applications and since many different extracts of plants exist on the market, it leads to understand that many extracts will be subject to Annex III (see on the right: "Which products are concerned")..

Annex III may as well correspond to a 'simple' analysis of the literature of available toxicological data and / or made by the producer, as an extensive risk analysis in the case of conflicting studies, or molecules interaction, or whenever the specific analysis needs.

This text is intended for all players acting in the production, processing and distribution of food supplements. It refers to the other decrees of this sector, such as the European Directive 2002/46 / EC and its amendments, including national decrees (2006/352, 1170/2009).

It gives the list of plants authorized on the market and / or mutual recognition by Article 16.

Annex III

This third part relates to the safety of the plant preparation, and it must be completed when there is a doubt, or when the plant preparation does not have enough history to justify its safety. Regarding the safety for the consumer, it is provided by the manufacturer of the food supplements, with the support - in our view - of each manufacturer involved. In the case where the final product contains only the extract as a single ingredient, Annex III refers to that ingredient on the basis of information provided by the producer of the preparation.

It shall disclose information relating to:

Becarre naturalThe exposure levels : consumption of the plant, and plant extract, including other sources

Becarre naturalThe toxicological data (data from the manufacturer/seller itself or from the literature) on the plant preparation, process, risk analysis, ...

Becarre naturalThe additional risk of safety in the event of an alert or a specific risk: Additional studies of toxicity, genotoxicity, mutagenicity, safety, NOAEL

Which products are concerned by Annex III ?

An Annex III does not need to be complicated - according to the information available, it can be a single file of bibliographic data related to the extract - and can be made by the manufacturer of the food supplements as needed with the assistance of a consultant.

It is important to understand that Annex III is applicable when the plant preparation cannot refer to an existing and traditional use enough to guarantee the safety of a plant preparation (or food supplements), as it exists and has existed on the market.

Thus, a plant extract may be traditionally produced in a PER of 15:1 and by using a high solvent (eg, pure ethanol). It is this extract which is known, and can prove its safety - and so would not need an Annex III.

A manufacturer who would like to promote from the same plant a 4:1 water extract (thinking it's safer) must then prove that there is a history of use to confirm the safety of its extract as it's not the process of the known extract (he could may be check the possible traditional use in infusion it is a water extract). If it can not, the aqueous preparation 4:1 then requires Annex III with safety proofs (toxicology studies to provide ...) when the 15:1 ethanolic extract would not.

Traditionallity therefore focuses on the extract as it is known or defined - and it must be shown that the plant preparation is in accordance with the traditional preparation - and the text of Annex III confirms that it is wrong to think that a water extract or a low ethanol extract or a low PER extracts could be considered - without further consideration - free of Annex III.
Indeed, a water extraction will undoubtedly gives a different molecules profile, or brings molecules which would be asent in case of a strong ethanol extract, and the related activity can be then toxic.
Speaking of food safety, we can refer only to what is clearly known.
Of course, the example is also true for the opposite: a 4:1 extract low ethanol extracts cannot refer to the data of a water extract if the water extract is traditionally used.

The traditional use can be justified by various ways, including probably monographs, references in pharmacopoeia (with specific description of the extract and not only of the plant), references to EMA, relation to the WEU (Well Established Use ), or from pharmaceutical agency, etc ... describing the extract (plant part, solvents and concentration processes, ratio), and with the Annex II to confirm that the plant extract that is offered is conform to traditional extract.

Reminder of Annex III

Exposure Level

Forecast consumption of the plant and the plant preparation, including the quantity (maximum exposure and average), frequency and duration. potential consumption of the plant and the plant preparation through other food sources. Terms of use of the plant preparation. Known consumption data of the plant and the plant preparation.

Toxicological Data

Constituents responsible for adverse effects (identification, assay). Toxicological data from the literature for the preparation of plant and similar preparations (safety limits or tolerable doses of active substances or markers, potential toxicity incl. secondary metabolites). Changes in the manufacturing process, particularly in relation to traditional use and alleged and / or objective consequence on the composition . Risk analysis demonstrating the safety under the proposed conditions (target, recommended daily ...). Information collected through the monitoring of worldwide alerts. This information also concern an updating of bibliographic data on new components identified in the plant and neighboring species and their toxic effects. Possible contraindications , particularly for certain populations (pregnant women, breastfeeding women, children ...). Interactions molecular known and assumed.

Additional Toxicity data if specific risks have been identified

If chimiotaxonomy or chemical analysis of data shows the existence of a specific risk linked in particular to the presence of identified chemicals, conducting toxicological studies is required as appropriate: toxicokinetics, genotoxicity, toxicity subchronic, other studies based on the information available (reproduction, development, nervous system, immunology, carcinogenicity ...).

Gontran Gaillot