botanicals

NEW ITALIAN “BELFRIT” DECREE PUBLISHED by Joris Geelen

The Italian authorities have published the highly anticipated decree on botanicals which integrates the so-called “BELFRIT” list, authorizing the use of more than 1000 plants and mushrooms in food supplements.

The decree includes a positive list of plants and mushrooms authorized for use in food supplements, together with mandatory warnings and maximum levels. Compared to Belgium, who published their version of the list last year, Italy has less restrictions, as shown in the following examples:

  • Contrary to Belgium and France, there are no maximum levels for anthranoid containing plants like Aloe or Rheum spp. (which are being disputed on EU level), Black cohosh, Hawthorn, Chamomile, Crocus, Devil's claw, Echinacea, Ginger, Hedera, Hops, Saw palmetto, Nettle, Valerian. Note that for most of them there is an EMA monograph;

  • Some plants do not have mandatory warnings as it is the case in Belgium e.g. Curcuma, Chaste tree, Verbena;

  • The decree authorizes stevia leaves, cannabis seeds and oil.

Besides this, and similar to France, the decree includes a list of information necessary for the correct and safe use of botanicals :

  • a clear definition of botanical preparation;

  • information and websites for the identification of plants; and

  • information on the preparation, the traditional use and the production process of the final product.

A separate decree on other substances establishes maximum levels for certain naturally occurring botanical substances with a physiological effect or of possible concern (for example EGCG and isoflavones).

As a transitional measure, foodstuffs that do not comply with the provisions of the new decree, but are compliant with the provisions of the former decree of 9 July 2012, can still be placed on the market until exhaustion of stocks.

Analysis

From the examples one could conclude that Italy takes a more liberal approach to risk management than Belgium. Where Belgium has a maximum limit for certain plants or substances of concern, Italy often resorts to less restrictive measures, mandatory warnings. On the other hand, in Italy there are no provisions exempting botanicals when these compounds have been removed or reduced to safe levels. Moreover, there are no official procedures for consulting the Italian Commission for Dietetics and Nutrition (CUDN), as is the case for the respective advisory commission in Belgium.

In our practice we help our clients to prepare the information necessary for the correct and safe use of botanicals, as part of a due diligence process. However, the authorities would most probably only ask for this information after a problem has arisen.

Overall, we remain positive about this decree. This harmonization together with the digital notification system has made the access to the European market more streamlined. 

Decree regulating the use of vegetable substances and preparations in food supplements, replacing the Decree of the Minister for Health of 9 July 2012

New recommended analysis methods for botanicals in Belgium by Joris Geelen

The Belgian authorities have published a new list of recommended analytical methods for the use of certain botanicals in food supplements. The list was drafted for 119 plants and is based on the scientific advice of the Advisory Commission on Botanicals. These methods can be used to verify if the food supplements comply with the maximum levels or if substances of concern are below the threshold mentioned in the Belgian Royal decree on Botanicals

EFSA updates advice on the risks from pyrrolizidine alkaloids by Joris Geelen

Pyrrolizidine alkaloids (PAs) are a large group of toxins produced by different plant species. EFSA was asked by the European Commission to deliver a scientific opinion on the risks for human health related to the presence of PAs in honey, tea, herbal infusions and food supplements.

A new exposure assessment including new occurrence data was used to update the risk characterisation. EFSA established a new Reference Point of 237 μg/kg body weight per day to assess the carcinogenic risks of PAs. It was furthermore concluded that, although no occurrence data were available, exposure to PAs from pollen, tea, herbal infusions could potentially present a risk of both acute and chronic effects in the consumer. It was also noted that consumption of food supplements based on PA-producing plants could potentially result in exposure levels causing acute/short-term toxicity. 

In Belgium a maximum level for toxic pyrrolizidine alkaloids of 4 µg/kg applies for the use of 4 botanicals of the Boraginaceae family in food supplements.

New Italian “BELFRIT” decree on botanicals expected by Joris Geelen

The Italian authorities recently notified to the European commission a new draft decree (2017/276/I) which will update the list of botanicals authorized in food supplements.

The Italian Commission for Dietetics and Nutrition (CUDN) executed a thorough evaluation of the plants and mushrooms which were not yet on the former Italian list of plants, but mentioned in the list of plants drafted in the so-called “BELFRIT” project, a close cooperation between Belgium, France and Italy to harmonize the legislation on botanicals in food supplements. With this decree one single list of plants and one for mushrooms will apply.

Besides this, and similar to France, the decree also integrates in annex a summary of information necessary for the correct and safe use of botanicals :

§  a clear definition of botanical preparation;

§  information and websites for the identification of plants; and

§  information on the preparation, the traditional use and the production process of the final product.

As a transitional measure, foodstuffs that do not comply with the provisions of the new decree, but are conform with the provisions of the former decree, can still be placed on the market until exhaustion of stock.

The end of the standstill period is September 29, once the European commission and the member states approve this new decree Italy will join Belgium and officially publish the so-called “BELFRIT-list”. After this all eyes will be on the proverbial ‘lanterne rouge’, France to follow suit.

We will conduct a thorough analysis and inform you about the exact changes in anticipation of the publication.

ANALYSIS: Belgian “BELFRIT” Decree opens the door to more than 1,000 plants in the EU by Joris Geelen

On February 10th Belgium published the highly anticipated new decree authorizing more than 1000 botanicals in food supplements. In addition, new maximum levels and mandatory warnings for about 250 plants will have to be taken into account when notifying food supplements or marketing food products with plants. 

The current update of the lists is the proverbial fruiting of the close cooperation between Belgium, France and Italy, known as the “BELFRIT project”.[1]

Implications EU-wide: A new safe harbor?

In the first place, the new Belgian Decree will directly affect all food businesses operating in Belgium, who will have to comply with the new rules. As a transitional measure, products placed on the market before February 20, 2017 and complying with the former decree may be placed on the market until February 20th of 2019. Derogations to the Decree can be obtained by submitting a scientific dossier demonstrating the safety of the food.

The Belgian Decree could be the first step in the harmonization of botanicals in the EU. However, the list is already extremely valuable for food companies who are operating EU wide and are currently facing a plethora of national rules and guidelines on the use of botanicals.

EU law requires that food law is based on risk analysis, using the available scientific evidence and undertaken in an independent, objective and transparent manner.[2] This means that Member States may not apply restrictions to ingredients unless they can demonstrate that an ingredient poses a (potential) risk to health, in such way as to justify the restriction. This obligation becomes even stricter when dealing with products legally manufactured and/or marketed in one Member State

This is where the practical importance of the BELFRIT list comes into play.

The BELFRIT plants have been carefully assessed one by one on the basis of the available scientific evidence by a committee of highly regarded experts from three Member States. Potential risks have been identified and, where necessary, maximum levels, mandatory warnings or prohibitions have been imposed. In addition, the novel food status under Regulation 258/97[3] has been excluded for every permitted plant. The list has been notified to the European Commission, has been reviewed by the other Member States and has been amended following their comments. It can therefore be assumed that where a potential risk of a plant is described in the available literature, it will most likely have been identified and addressed by the BELFRIT experts. This makes it in practice difficult for other Member States to collect sufficient scientific evidence to justify a ban or restriction of a permitted BELFRIT plant complying with the applicable conditions of use.

In addition, Member States without extensive expertise on botanicals would feel reassured that BELFRIT plants have been thoroughly examined and would therefore be less inclined to take a too cautious approach on botanicals unknown to them.

Some concrete examples

§  The UK has adopted a guidance list of botanical ingredients with recorded food use.[4] However, this list is not binding and food business operators are obliged to assess the safety of the botanical ingredients they place on the market. Permitted BELFRIT plants have been considered safe under the given conditions by the BELFRIT experts, which makes it unlikely that the UK authorities would be able to demonstrate a potential safety risk for these plants.

§  France has adopted a shorter positive list of plants,[5] partly corresponding with the Belgian Decree. Those plants not included in the French list may be used on the basis of mutual recognition. It would be very unlikely that the French authorities refuse any permitted BELFRIT plants, especially since they have been themselves involved in the safety assessments.

§  Malta may not have much expertise on botanicals but has published the BELFRIT list on their website for reference. The authorities are relying on the assessment of the BELFRIT experts.

Since the Belgian Decree is not binding in other Member States, the list can currently only function as a safe harbor instrument as described above. Relying on the list does not provide legal certainty and will not entirely remove the risk of refusal of botanical ingredients in other Member States. In particular, it should be kept in mind that new scientific evidence revealing potential risks may become available over time. Also, the medicinal status is not excluded for permitted BELFRIT plants and depends on the used dose and other particularities of a product. As EU law stands, it is still possible that the same product is classified as a food in one Member State and as a medicine in another.[6]

What are the main changes in the lists?

It has clearly been a herculean work for the experts to verify the different Member State lists, check the accepted Latin names and do a literature research to identify possible risks. Now, let us look more in detail at the changes in the lists, with some particular examples.

A.    Changes in the list of prohibited plants (“list 1”)

 

There are a several changes to the list of prohibited plants. The most difficult point for the Belgian authorities were the plants which were authorized in Italy but prohibited in Belgium; especially because Italy does not have an official list of prohibited plants. Some of those plants remained on the list of prohibited plants, for several other plants additional conditions were implemented to assure safety.

§  Several plants were added because they could contain toxic substances, e.g.:

-        Santalum album L. and the fruit of Durio zibethinus L., although they are still allowed in Italy

-        Tetradium ruticarpum (A.Juss.) T.G.Hartley although in the past the fruit, used in tea, had been authorized;

§  A few plants were removed, e.g.:

-        Stevia rebaudiana (Bertoni) Bertoni, which is evidently not toxic and which is authorized in Germany after Mensch und Natur AG won their court case[7] in which was confirmed that the novel food decision[8] is not binding on any persons other than the person or persons whom that decision specifies as its addressees.

-        Stephania tetrandra S. Moore which is not toxic by itself but was prohibited because of the possible risk of adulteration with Aristolochia species.[9]

§  Others were moved to list 3 (authorized plants) with additional conditions of use, e.g.:

-        several Artemisia species and Tanacetum vulgare L. with a daily maximum of 6 mg thuyone;

-        Berberis and Coptis species : limit of 10 mg isoquinoline alkaloids (expressed as berberine);

-        Preparations of the leaf of Hedera helix L are now authorized in food supplements only for those preparations mentioned in the well-established use monograph of EMA[10] at 70% of the dose mentioned therein;

An attentive observer might have noticed that there are also some remarkable differences with the version of the decree notified to the European Commission:

§  The maximum values applied in practice to food with preparations of Cannabis sativa L. were removed.[11] This does not seem to increase transparency regarding the applicable maximum levels.

§  Griffonia simplicifolia (DC.) Baill. which was initially moved from list 1 to list 3 with the mandatory warnings “Do not use during pregnancy” and “Not to be used by people being treated for depression”, based on the scientific evaluation of the Advisory Commission in Belgium, was moved back to the list of prohibited plants by a risk management decision regarding 5-HTP, for which possible side effects and interactions with other drugs are not well known;

B.     Changes in the list of authorized mushrooms (“list 2”)

§  Three Boletus species and four other mushrooms were added: Grifola umbellata (Pers.) Pilat, Lasiosphaeria gigantea Batch Ex Pers., Bovista plumbea Pers. and Wolfiporia extensa (Peck) Ginns;

C.    Changes in the list of authorized plants (“list 3”)

The number of authorized plants in Belgium has increased significantly, from about 645 to more than 1000. Consequently, a considerable number of new conditions of use are now applicable.

Below we highlight some of the most important changes for often used plants:

§  Green tea leaves: the recommended daily dose was lowered to 600 mg tannins (calculated as epigallocatechin-3-gallate). Note also, that only the use of the following extraction solvents is accepted: water, alcohol with a maximum content of 25%.

§  The following maximum levels apply to supplements with anthranoid containing plants of the genus:

-        Frangula, Picramnia, Rhamnus, Rumex and/or Aloe : 14 mg total anthranoids;

-        Senna :18 mg total anthranoids;

-        Rheum : 25 mg total anthranoids.

§  Ginger (Zingiber officinale Rosc., rhizome):

Since Domperidone became a prescription-only drug in Belgium and restrictions were imposed in the UK due to increased risk of adverse cardiac effects, the number of food supplements with ginger extracts on the market increased, including for pregnant women, even though there was insufficient data to conclude on the safety of this population group at risk. This was the main reason that the maximum level of 5 g for ginger was revised.

The new recommended daily dose may not lead to an intake higher than the amount equivalent to 1,5 g of dried rhizome for adolescents and adults and 0,75 g of dried rhizome for children between 6 and 12 years. When a product is indicated (or not contraindicated) for pregnant women, a maximum level of 1 g dried rhizome applies and extracts are a priori not allowed unless an additional scientific dossier is submitted for a risk evaluation. The use for children under 6 years is not authorized.

§  For Cohosh (Actaea heracleifolia (Kom.) J.Compton and Actaea racemosa L.), a new maximum level equivalent to 30 mg dried rhizome applies. The labeling must include the following warnings: “Consult your doctor about the use and intake period.” and “Do not use in case of liver disease.”;

§  The level of toxic pyrrolizidin alkaloids in preparations of Borage was increased from 1 to 4 µg/kg, just like for the oil of echium seeds, both based on the level mentioned in the Novel food authorization of refined echium oil;[12]

§  For Cinchona species, a maximum of 100 mg quinine and a mandatory warning “Do not administer to children under 12 years.” is applicable;

§  Sambucus nigra L., Sorghum bicolor (L.) Moench,: 5 mg hydrogen cyanide (free and bound).

§  Preparations of Bambusa species need to undergo a heat treatment, for the degradation of the cyanogenic glycosides.

§  New mandatory warnings are applicable to products with, e.g.:

-        Embelia ribes Burm.f., Ginkgo biloba L., Melilotus, Commiphora, Verbena and Vitex species : “Do not use during pregnancy or lactation”;

-        Curcuma longa L., Allium and Salix species: “Consult your physician or pharmacist with concomitant use of anticoagulants”.

-        Harpagophytum species: “Do not use in case of gastric or duodenal ulcers or gallstones”.

-        For Panax species “Consult your physician or pharmacist with concomitant use of antidiabetics.”

-        Plantago afra L. and Plantago ovata Forssk. : “No concomitant use with medicine”;

-        Thymus species: “Do not use during pregnancy. Do not administer to children under 12 years.”


A brief history

The Belgian decree on botanicals, first published 20 years ago, was a herald that proclaimed legislation and a regulatory practice which is now more or less commonplace in several European countries. Already in 1997, long before the Food Supplement Directive,[13] Belgium was one of the first countries to introduce a notification procedure, a scientific risk evaluation by an Advisory Commission and the three lists of plants.

Around the same time, the authorities of Belgium, France and Italy, each assisted by a renowned scientific expert, had decided to develop a common approach for the evaluation of botanicals. As a first result the three parties drafted a common list of traditionally used plants safe to use in food supplements and accompanying articles on traditional knowledge. When they proposed the list to the European Commission and the Member States, a momentum for change was created and the common list was seen as the missing piece in the puzzle.

Italy has adopted the entire list without additional conditions of use, alongside of its original list as national legislation in 2014 and they plan to adopt a decree with only one list. France has adopted a decree with a part of the list and has published additional lists of authorized plants with conditions on its website in 2015. Belgium took the long official route and notified their amending decree to the European Commission in April 2015. After submitting scientific justifications for the additional mandatory warnings to the European Commission in 2016, Belgium finally published the decree on February 10th, 2017.

Most other Member States acknowledge the importance of EU harmonization in this area
and have urged the European Commission to harmonize botanicals at EU level. The European Commission has always been open to this idea and supported the project, but made clear the support of the majority of Member States would be needed in order to take this initiative to EU level. All eyes are on Italy and France now.

In conclusion, the new Belgian decree shows that in the absence of European harmonization, and even with an undecided European Commission, Member States can take initiative to guarantee the safety, quality and effectiveness of food supplements. Although many more plants are now authorized, we also see a trend toward more and stricter conditions of use, even with limitations for the type of preparations that can be used. While true EU harmonization of botanicals remains a project for the future, the new list can already serve as a safe harbor in other Member States, for any firm that wants to break new grounds.

 

[1]       Project BELFRIT Harmonizing the Use of Plants in Food Supplements in the European Union: Belgium, France and Italy – A first Step, Guillaume Cousyn, Stefania Dalfrà, Bruno Scarpa, Joris Geelen, Robert Anton, Mauro Serafini and Luc Delmulle, EFFL Volume 8 (2013), Issue 3, Pages 187 - 196

[2]       Cf. Article 6 of Regulation 178/2002.

[3]       Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (OJ L 43, 14.2.1997, p. 1–6).

[4]       MHRA list of herbal ingredients.

[5]       Arrêté du 24 juin 2014 établissant la liste des plantes, autres que les champignons, autorisées dans les compléments alimentaires et les conditions de leur emploi.

[6]       Cf. CJEU Judgment of of 21 March 1991 in Case C-369/88, Criminal proceedings against Jean-Marie Delattre, 1991 I-01487.

[7]       CJEU Judgment of 14 April 2011 in case C-327/09, Mensch und Natur AG v Freistaat Bayern, Report of Cases 2011 I-02897.

[8]       Commission Decision 2000/196/EC of 22 February 2000 refusing the placing on the market of ‘Stevia rebaudiana Bertoni: plants and dried leaves’ as a novel food or novel food ingredient under Regulation No 258/97 (OJ 2000 L 61, p. 14).

[9]       Tankeu et al., Differentiation between two "fang ji" herbal medicines, Stephania tetrandra and the nephrotoxic Aristolochia fangchi, using hyperspectral imaging, Phytochemistry. 2016 Feb;122:213-22. doi: 10.1016/j.phytochem.2015.11.008. Epub 2015 Nov 26, https://www.ncbi.nlm.nih.gov/pubmed/26632529

[10]     Committee on Herbal Medicinal Products (HMPC) European Union herbal monograph on Hedera helix L., folium; 24 November 2015 EMA/HMPC/586888/2014, http://www.ema.europa.eu/docs/en_GB/document_library/Herbal_-_Herbal_monograph/2016/01/WC500199890.pdf

[11]     A derogation can only be permitted provided that the following maximum limits of Δ9-tetrahydrocannabinol (THC) are not exceeded: Seed oil: 10 mg/kg ; Seed and flower seeds: 5 mg/kg ; Other foods and drink : 0.2 mg/kg

[12]     2008/558/EC: Commission Decision of 27 June 2008 authorising the placing on the market of refined echium oil as novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council OJ L 180, 9.7.2008, p. 17–19

        http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:180:0017:0019:en:PDF

[13]      Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51–57).