food supplements

EXTRACTS OF HEMP CONTAINING CBD ARE NOVEL FOODS, COMMISSION SAYS by Joris Geelen

On January 15, 2019 the European Commission decided to modify the entries relating to “Cannabis sativa” and “CBD” in the EU’s “Novel Food Catalogue”, making it more difficult for products with cannabinoids to enter the EU market without a pre-market approval as novel foods according to Regulation 2015/2283.

Following that decision, all extracts of hemp and derived products containing cannabinoids are now considered novel. Hemp seeds, flour and seed oil remain permitted.

What has changed? 

The Novel Food Catalogue entry for Cannabis sativa has been changed as follows:

“[…] Some products derived from the Cannabis sativa plant or plant parts such as seeds, seed oil, hemp seed flour, defatted hemp seed have a history of consumption in the EU and therefore, are not novel. Other specific national legislation may restrict the placing on the market of this product as a food or food ingredient in some Member States. Therefore, it is recommended to check with the national competent authorities”.

The entry for CBD now refers to the wider class of “cannabinoids” which states:

“[...] extracts of Cannabis sativa L. and derived products containing cannabinoids are considered novel foods as a history of consumption has not been demonstrated. This applies to both the extracts themselves and any products to which they are added as an ingredient (such as hemp seed oil). This also applies to extracts of other plants containing cannabinoids. Synthetically obtained cannabinoids are considered as novel[1].

In conclusion, hemp seeds, flour and seed oil are not novel. All extracts of hemp and derived products containing cannabinoids are considered novel.

The sit-down 

The decision follows a meeting of the EU Novel Foods PAFF Committee on October 16, 2018, where two branch organizations were invited to outline the traditional food use of hemp extracts. Their presentation failed to convince the EC because no new information on the history of use of cannabidiol was provided.

Where we go from here? 

Firms who want to market ingredients from other plant parts, hemp extracts or derived products have following options under Regulation 2015/2283 on novel foods:

1.      Demonstrate the significant history of use of their ingredient through the official consultation procedure provided for in article 4;  

2.     Submit a notification for a traditional food from third countries, as referred to in Section II, if the history of safe food use in a third country for at least 25 years can be demonstrated; or

3.     Submit a dossier for the registration of a novel food, as referred to in Section I.

A scientific opinion of the EFSA on the safety of a purified CBD extract as a novel food is expected in the coming months.[2]

The Novel Food Catalogue is a non-exhaustive list of ingredients, which serves as orientation on whether a product will need an authorization under to the Novel Food Regulation. If food ingredients were used exclusively in food supplements, new uses in other foods also require authorization. Information on the history of significant consumption can be send to the national authorities for verification. The EC amends the Catalogue based information provided by the Member States.

[1]             The full entry reads as follows: “the hemp plant (Cannabis sativa L.) contains a number of cannabinoids and the most common ones are as follows: delta-9-tetrahydrocannabinol (Δ9-THC), its precursor in hemp, delta-9-tetrahydrocannabinolic acid A (Δ9-THCA-A), delta-9-tetrahydrocannabinolic acid B (Δ9-THCA-B), delta-8-tetrahydrocannabinol (Δ8-THC), cannabidiol (CBD), its precursor in hemp cannabidiolic acid (CBDA), cannabigerol (CBG), cannabinol (CBN), cannabichromene (CBC), and delta-9-tetrahydrocannabivarin (Δ9-THCV). Without prejudice to the information provided in the novel food catalogue for the entry relating to Cannabis sativa L., extracts of Cannabis sativa L. and derived products containing cannabinoids are considered novel foods as a history of consumption has not been demonstrated. This applies to both the extracts themselves and any products to which they are added as an ingredient (such as hemp seed oil). This also applies to extracts of other plants containing cannabinoids. Synthetically obtained cannabinoids are considered as novel!”

[2]          Summary available here: https://ec.europa.eu/food/sites/food/files/safety/docs/novel-food_sum_ongoing-app_trans-cannabidiol.pdf

New Belgian decree on nutrients published by Joris Geelen

The decree removes maximum levels for several vitamin B sources, increases the maximum level of Vitamin C to 1 gram and introduces new mandatory warnings.

What will change?

The maximum levels are mainly based on the advice of the Superior Health Council of June 2015.[1]

The decree introduces the following changes: 

  • removal of the existing maximum levels for: vitamin B1 (thiamin), vitamin B2 (riboflavin), vitamin B12, pantothenic acid, biotin and chloride;

  • new maximum levels for boron (3 mg) and fluoride (1.7 mg);

  • increased maximum levels for the following nutrients: vitamin C (1000 mg), vitamin D (75 µg), vitamin E (39 mg), vitamin K (210 µg), folic acid (500 µg), iron (45 mg) and copper (2 mg); and

  • decreased maximum levels for manganese, from 5.25 to 1 mg and for nicotinic acid and inositol hexanicotinate (vitamin B3) the level is reduced from 54 to 10 mg

To ensure safe use, the following warnings will become mandatory in the labeling of foodstuffs containing (a daily dose that exceeds) the following levels of nutrients: 

  • 25 μg vitamin K: “Not suitable for people taking coumarin anticoagulants.”;

  • 1000 mg potassium: “Not suitable for elderly people or people with a renal disorder, insulin-resistant diabetes or people with arterial hypertension.”;

  • 10 mg zinc: “The intake of zinc should be limited to a period of a few weeks/months.”; and

  • Nicotinic acid or inositol hexanicotinate: “Not suitable for pregnant or lactating women”.


Other changes?

Furthermore, the decree simplifies the existing notification requirement for fortified foods. The notification procedure no longer requires a full list of ingredients of the fortified food product. Information on the added nutrients (type and amount) per recommended daily intake or quantity of the nutrient equivalent to the average daily nutrient intake, now suffices.

Lastly, the decree adds an additional provisions on mutual recognition. A written application can be submitted to the Belgian authorities with evidence showing that the product has been legally marketed in another Member State. Under the previous decree, firms could submit requests for derogation from the maximum levels to the Superior Health Council. 


When will it be applicable?

The decree was published on October 31, 2017. As a transitional measure, foodstuffs already placed on the market that do not comply with the provisions of the decree, but do comply with the provisions of the previous decree, can still be placed on the market until November 10, 2019. 

 

What about the other EU countries and the Commission?

Besides Belgium, most EU Member States have adopted maximum levels for vitamins and minerals.

Italy[2] and France[3] have set legally binding maximum levels for all vitamins and most minerals.  

Recently the Netherlands, one of the most liberal EU countries regarding the addition of nutrients or other substances, announced their intention to set a maximum level for vitamin B6. The levels, based on a report of the Dutch Food Safety Authority (NVWA), would be 21 mg for adults and 3-13 mg per day for children, depending on the age. The former would be lower than the upper level of 25 mg published by EFSA, and significantly higher than the low levels in Belgium (6 mg) and Italy (9.5 mg).

Germany is currently working on new maximum levels for vitamins and minerals.

 

Comments

As long as there are no EU-wide maximum levels set for vitamins and minerals, EU countries still have the right to set their own maximum levels in national regulation. This is often done based on a risk assessment of their local scientific bodies, and not by directly applying the tolerable upper intake levels for vitamins and minerals set by EFSA.

Although it is good to see that Member States are applying science-based policies, it is clear that, as long as the European Commission does not cut the Gordian knot and finally adopt EU-wide maximum levels, EU countries will each set their own levels based on their interpretation of the science. As a result, the mutual recognition principle does not always ensure EU wide acceptance when it comes to maximum levels of vitamins and minerals.

Recently though, in the case C-672/15, the Court found that, whilst France could maintain its own maximum levels, the absence of a procedure for authorizing food supplements marketed in other EU countries with levels above those limits made the legislation contrary to the principle of mutual recognition.

In its judgement the court also confirmed that maximum limits should be based on the most reliable scientific data available and the most recent results of international research. They may not be based merely on national scientific opinions, if recent international scientific opinions concluding in favor of the possibility of setting higher limits are also available on the date of the adoption of the measure at issue.

 

[1]        Opinion No° 9285 of the Superior Health Council in respect of the dietary recommendations for Belgium, issued on 7 September 2016 (http://www.health.belgium.be/nl/advies-9285-voedingsaanbevelingen-voor-belgie-2016, available in Dutch and French)

[2]        Apporti giornalieri di vitamine e minerali ammessi negli integratori alimentari (http://www.salute.gov.it/imgs/C_17_pagineAree_1268_listaFile_itemName_5_file.pdf)

[3]      Arrêté du 9 mai 2006 relatif aux nutriments pouvant être employés dans la fabrication des compléments alimentaires.

European commission authorized two new mineral substances by Joris Geelen

The European Commission has recently authorized two new mineral substances for use in food and food supplements.

Commission Regulation 2017/1203/EC of 5 July 2017 amended Directive 2002/46/EC for food supplements and Regulation 1925/2006/EC on the addition of vitamins and minerals and of certain other substances to foods. The two new mineral substances that were added are:

  • Organic silicon (monomethylsilanetriol) as source of silicium; and

  • Calcium phosphoryl oligosaccharides (POs-Ca®) as source of calcium.

The full text of this regulation is available on : http://eur-lex.europa.eu/eli/reg/2017/1203/oj

Switzerland: Legal reform opens up nutritional supplements market by Lara Skoblikov

In May 2017, a new Swiss legal regime on foodstuff has come into play in line with the food regulations applicable in the European Union (EU). As a result, companies finally have the opportunity to market food supplements in Switzerland without having to make drastic changes to their products and go through the burdensome authorization procedures. In fact, the absence of a notification requirement for food supplements makes Switzerland one of the most favorable countries to market in Europe. Still, the Swiss standards contain some particularities that should be kept in mind when entering the market.

Switzerland is not part of the EU and maintains its own set of food standards. Up until now, Switzerland was applying the so-called “positive principle”, according to which any food or food ingredient not expressly authorized under Swiss standards required express pre-marketing authorization, a procedure that could take months. This constraint particularly affected innovative products with unconventional ingredients among which many food supplements.

The new rules on foodstuff aim to facilitate the entry of food products originating from the EU member states into Switzerland and vice versa. Following the example of the EU, the “positive principle” has been abandoned. Instead, foods and food ingredients may be used freely unless they are prohibited or restricted under Swiss regulations. In practice, this means a significant liberalization of the use of ingredients. Still, maximum levels for vitamins and minerals, the express prohibition of certain plants and other substances have to be respected. Also, it is prohibited to sell foods that are unsafe, have medicinal properties or are novel foods.

An important change in the revised Order on Food Supplements is that it classifies food supplements as foodstuffs, which means that general food regulations apply mutatis mutandis to food supplements. This includes the Orders on food labelling and claims and the use of food additives, which have also been revised and are now almost fully in line with their European counterparts.

This logic applies equally to novel foods, which are foods or food ingredients that have not been consumed to a sufficient degree before 15 May 1997. Both in Switzerland and the EU their use is reliant on pre-market approval involving a thorough safety assessment. Considering the use of unique substances in innovative food supplements it places a significant red tape on their marketing potential. Under the new regime, Switzerland will accept novel foods authorized in the EU and foods that have a history of consumption before 1997 in any of the EU countries.

Unquestionably a major benefit of targeting the Swiss market is the absence of the obligation to register or notify food supplements. Almost every country in the EU requires that food supplements are notified prior to their commercialization, which can delay or complicate their marketing and may involve the payment of a fee. In the absence of such requirement, the commercialization in Switzerland is a favorable opportunity as it does not create additional administrative burdens or costs.

Considering all the above, food supplements compliant with EU standards in terms of composition and labelling will usually find easy entry into Switzerland.

The sting in the tail comes with some particular disparities left between the new Swiss rules and its European foundations. This is because in the absence of full harmonization of EU food supplement legislation, the EU countries have maintained their own maximum levels for nutrients and rules on the use botanical preparations and other substances. Switzerland now adds this rather chaotic system by setting its own maximum levels vitamins and minerals, which are nevertheless for the most part in line with the general EU trend. They have also set maximum levels for amino acids, fatty acids and some other substances, minimum amounts for their label declaration and mandatory warnings in some cases. Such restrictions are less common in the EU countries. Therefore, it will remain indispensable to verify compliance of a food supplements’ composition and labelling when introducing it into Switzerland or an EU country.

Finally, in certain areas where the EU is failing to take initiative, Switzerland has done so. For example, the Swiss Labelling Ordinance sets out clear conditions for the use of the terms “vegetarian”, “ovo vegetarian”, “lacto vegetarian” and “vegan”, something that the EU has been attempting for years now. Another example is the authorization of three insect species as food ingredients, something which could be considered especially courageous compared to the EU who maintains a cautious and legalistic approach by considering all insects novel foods.

All in all, the goal of removing the barriers to trade appears to be achieved by the reform and Switzerland can now be considered a serious food supplement market in Europe.

 

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.

Italy: increased maximum levels for vitamin B12, vitamin D and vitamin K by Joris Geelen

Italy has adopted new maximum levels for vitamin B12, vitamin D and vitamin K in food supplements, in line with the levels proposed by the European Food Safety Authority (EFSA). The new maxima for these three vitamins are :

  • 1000 µg vitamin B12;
  • 50 µg vitamin D; and
  • 180 µg vitamin K.

This proactive stance can be acclaimed, especially because recently a ruling of the Court of Justice of the EU once more confirmed that national maximum levels should be based on the most recent results of international research, which should be understood as entailing an obligation to update the levels whenever newly established data becomes available.


Apporti giornalieri di vitamine e minerali ammessi negli integratori alimentari Revisione maggio 2017

French law on vitamins and minerals contrary to EU law, Court of Justice of the EU by Sebastian MELCHOR

The French law which rejects food supplements from other EU countries with vitamins and minerals above the French national limits is contrary to EU law, according to a recent ruling of the Court of Justice of the EU.

The Court found that, whilst France could maintain its own maximum levels, the absence of a procedure for authorizing food supplements marketed in other EU countries with levels above those limits made the legislation contrary to the principle of mutual recognition.

It is expected that the ruling puts an end to a long-standing practice in France of refusing food supplements with vitamin and mineral levels above informally established maximum limits, irrespective of whether the products have been lawfully marketed in other EU countries.

PRACTICAL CONSEQUENCES

The ruling may have a significant impact on food supplement sellers in France, who so far have been prevented from using vitamins and minerals exceeding informally established maximum levels (often slightly higher than the legal limits), even if the products are lawfully marketed in other Member States.

These informal levels correspond with recommendations of the French Food Safety Agency, sometimes decades old. In practice, new scientific information cannot be successfully invoked since the authorities base their assessment exclusively on the old recommendations. This has resulted in France maintaining certain stricter standards compared to the rest of the EU.

For example, France applies a maximum vitamin C level of 250 mg/day in food supplements, while Belgium and Italy have raised their maximum levels to 1000 mg/day since they acknowledge that no toxicity has been established for this level in the generally accepted scientific data, including the most recent national and international scientific publications.

COURT REMINDS FRANCE HOW MAXIMUM LEVELS SHOULD BE SET

Furthermore, the Court reminded France that setting maximum limits should be done on a case-by-case basis, taking into account the upper safe levels established after a comprehensive scientific assessment of the risks for public health. The analysis should be based not on general or hypothetical considerations, but on relevant scientific data.

The Court left to the national court to determine the conformity to EU law of the French system, which is based on the adoption of maximum limits in relation to the recommended daily allowances (RDAs) i.e. a value equal to three times the RDA for nutrients presenting the least risk, equal to RDAs for those presenting a risk of the upper safe level being exceeded and a value below those allowances or even zero for the nutrients involving the most risk.

SCIENTIFIC REPORTS CANNOT BE NATIONAL ONLY

Finally, the Court confirmed that maximum limits should be based on the most reliable scientific data available and the most recent results of international research. They may not be based merely on national scientific opinions, if recent international scientific opinions concluding in favor of the possibility of setting higher limits are also available on the date of the adoption of the measure at issue.

CONSULT LATEST DATA, COURT SAYS

The ruling explains that France should first of all implement a procedure in their legislation enabling firms to obtain the authorization to use levels of vitamins and minerals above the legal limits for food legally marketed or manufactured in other EU Countries.

In addition, since the most recent scientific data concluding in favor of higher limits should be taken into account when establishing legal maximum levels, any new scientific data should also be taken into account when assessing products marketed or manufactured in other EU Countries. Referring to old assessments if new information has become available, nationally or internationally, would run counter to the principles set out in the ruling.

Judgment of the Court of 27 April 2017 in Case C‑672/15, Noria Distribution SARL

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).

New Belgian “BELFRIT” decree on botanicals applicable by Joris Geelen

Belgium has published a new decree, updating the three lists of botanicals. These new lists are based those drafted in the so-called “BELFRIT” project, a close cooperation between Belgium, France and Italy to harmonize the legislation on botanicals in food supplements.

The number of plants authorized in food supplements in Belgium has increased significantly, from about 645 to more than 1000 plants. Consequently a considerable number of new conditions of use are now applicable. New maximum levels and mandatory warnings for about 250 plants will have to be taken into account when notifying food supplements.

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 February 20th of 2019. Therefore non-compliant products can not be sold until the end of the expiry date, after the transition period. They will have to be withdrawn from the market.

Royal Decree of 29 August 1997 concerning botanicals - Consolidated version (Dutch and French)

Germany: products with more than 20 mcg of vitamin D may be considered medicinal products by Lara Skoblikov

The German Federal Office of Consumer Protection and Food Safety has issued a Recommendation on the demarcation between food supplements containing vitamin D and medicinal products, concluding that a product with a level of vitamin D up to 20 µg per daily dose can still be considered a food supplement. The recommendation is based on a report of the Joint Expert Committee of the Federal Office of Consumer Protection and Food Safety (BVL) and the Federal Institute for Drugs and Medical Devices (BfArM).

Higher dosages, according to the report, would go beyond completely or partially covering the daily needs of the nutrient and would be considered medicinal products, even though dosages up to 100 µg/day are considered toxicologically safe.

Foods for Special Medical Purposes falling under Regulation 609/2013 may contain dosages higher than 20 µg/day, when this can be justified for the intended target group.

In order to avoid any risks, it is recommended to follow the recommendation when marketing food supplements in Germany.

We should however note that the legal validity of the Recommendation is somewhat questionable.

Under Directive 2001/83, products are medicinal either by virtue of presentation or by virtue of their action if they are used with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis. The reasoning of the German authorities that a daily dosage of 20 µg/day of vitamin D would be sufficient to cover the average nutritional needs does not automatically mean that a higher dosage indeed exerts a pharmacological, immunological or metabolic action. If this were true, it could be argued that any product with vitamins or minerals in dosages above their reference intakes should be classified as medicinal products, which is not the case in practice. 

It is also interesting to note that the Court of Justice of the EU has repeatedly ruled that the absence of a nutritional need for a substance is not a valid justification for banning a product. See for example Case C-192/01, Commission v. Denmark. 

Can Germany set an upper level for vitamin D in foods? Certainly they can. But they would have to justify this either by demonstrating that an exceeded vitamin D level would actually exert a pharmacological, immunological or metabolic action (in which case the product would be a medicine), or by demonstrating on the basis of the latest scientific data that there is a potential risk to public health associated with higher vitamin D levels.