SCIENTIFIC DATA USED IN EFSA’S RISK ASSESSMENT TO BE MADE PUBLIC by Nikolaas Tilkin-Franssens

Following the fitness check of the General Food Law Regulation (completed on 15 January 2018, see executive summary) and a European Citizens Initiative to ban the use of glyphosate, the European Commission has presented a proposal to strengthen the core of EU Food Law to the European Parliament and the Council. Next to the amendment of the framework Regulation, General Food Law Regulation 178/2002, the proposal covers the revision of the legislation on GMOs, feed additives, smoke flavourings, food contact materials, food additives, food enzymes and flavourings, plant protection products and novel foods.

The purpose of the revision relates to improving the transparency of EU risk assessment with regard to food and feed. Particularly the functioning of the European Food and Feed Safety Authority is scrutinized. Therefore, the agreement reached on 11 February holds that all scientific information as part of an application with EFSA will be made public save for strictly confidential information. In addition, a set of additional, procedural safeguards will be introduced to guarantee independent and transparent risk assessment.

European Commission - Presse Release: Agreement on the Commission's proposal on transparency and sustainability of the EU risk assessment model in the food chain - Questions and Answers - link

IMMEDIATE INCREASE IN ENERGY LEVEL EXCEEDS AUTHORIZED VITAMIN C CLAIM by Nikolaas Tilkin-Franssens

In the view of the UK advertising body ASA, claiming a health benefit is immediate may exceed the flexibility to an approved health claim. In casu, ASA argued the words ‘feel the burst’, ‘fast’ and ‘direct’ accompanying the product name Dextro Energy would imply an instantaneous increase in energy levels. Included in the advertisement was the authorized claim that vitamin C contributes to the reduction of tiredness and fatigue. But according to the ASA opinion this does not extend to a sudden energy boost. Dextro also argued that the words “feel the burst” specifically related to a burst of flavor. This was not upheld by ASA.

UK Advertising Standards Authority - Ruling on Dextro Energy GmbH & Co KG (13 February 2019) - link

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

A GUIDE TO THE NEW SPANISH DECREE ON THE NOTIFICATION OF FOODS FOR SPECIFIC GROUPS by Nikolaas Tilkin-Franssens

On 27 December the Spanish Royal Decree regulating the notification of foods for specific population groups was published in the official national bulletin (Real Decreto 1412/2018, de 3 de diciembre, por el que se regula el procedimiento de comunicación de puesta en el mercado de los alimentos para grupos específicos de población). Successively, an information guide has been published by the Spanish authorities clarifying the situation of foods for specific groups as the new legislation on food for specific groups will gradually enter into full application in the following 2 years.

Foods for specific groups cover three main food groups that require to be notified in line with the European Union framework Regulation 609/2013. These comprise (i) infant and follow-on formula, (ii) processed-cereal based food and other baby food, (iii) food for special medical purposes and (iv) total diet replacement for weight control. In addition, the Spanish Decree differentiates between (a) infant formula, (b) follow-on formula prepared from protein hydrolysates and (c) follow-on formula containing other substances than those listed in Annex II of EU Regulation 2016/127.

At EU level, Regulation 609/2013 is supplemented by three delegated Commission Regulations regulating the compositional and specific labelling requirements of the individual food categories (Regulation 2016/127, Regulation 2016/128 and 2017/1798). The information guide provides a concise overview of the main changes with regard to composition and labelling as well as the specific dates these new requirements – different for the distinct food categories – will apply.

The obligation to notify the products with the member states they are placed on the market stems from the EU Regulations. The modalities, except for the provision of model of the label, are to be established by the member states. Royal Decree 1412/2018 being the result. The Spanish Decree requires that operators notify the competent authorities of the placing on the market as well as any changes to the labelling of the product or in case the product is taken from the market. At present, a notification fee of 927 euro applies for the first notification for one of the abovementioned products. A notification for the reason of modification amounts to 274,32 euro. In case the responsible operator has its registered office in Spain the notification needs to be presented with the competent body of the corresponding autonomous community. In other cases, the notification shall be directed to the Spanish food safety authority (AECOSAN) based in Madrid.

AECOSAN - Informe sobre la situación de los alimentos dietéticos /alimentos para grupos específicos con la aplicación del reglamento (ue) nº 609/2013 rev.2 - link

FIRST AUTHORIZATIONS FOR TRADITIONAL FOODS FROM THIRD COUNTRIES by Nikolaas Tilkin-Franssens

Three foods can be added to the food inventory of European producers and consumers. The decorticated grains of Digitaria exilis, berries of Lonicera caerulea L. and syrup from Sorghum bicolor (L.) Moench have received authorization for general consumption under the novel food Regulation (Regulation 2015/2283). The foods will be added to the Union list of novel foods established by EU Regulation Regulation 2017/2470. None of the foods is subject to conditions of use but a mandatory designation to be included in the labelling of the foodstuffs containing it.

Commission Implementing Regulation 2018/1991 of 13 December 2018 authorising the placing on the market of berries of Lonicera caerulea L. as a traditional food from a third country - link

Commission Implementing Regulation 2018/2016 of 18 December 2018 authorising the placing on the market of decorticated grains of Digitaria exilis as a traditional food from a third country - link

Commission Implementing Regulation 2018/2017 of 18 December 2018authorising the placing on the market of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country - link

FRANCE PROVIDES GUIDELINES ON THE SAFE USE OF ESSENTIAL OILS IN FOOD SUPPLEMENTS by Nikolaas Tilkin-Franssens

Due to the high concentration of chemical substances in essential oils, the toxicity, carcinogenicity or other potential adverse reactions should be observed by food supplement producers. Accordingly, the French Directorate General for Competition, Consumption and Fraud Prevention or DGCCRF has adopted guidelines for the safe use of essential oils in food supplements and published a list of plants which essential oils can be considered traditionally used for human consumption.

DGCCRF - Liste des plantes dont les huiles essentielles sont considérées comme traditionnelles - link

The list has no legal force and is not exhaustive. Next to the positive list also two lists of plants which essential oils are not permitted in food supplements are included. Essential oils derived from plants currently not included in the positive list can be added if their traditional use is demonstrated. Reference is made to the lists of essential oils frequently used by industry published on the website of the French food supplements’ association SYNADIET. In the view of DGCCRF the essential oils included in these lists may also be considered as traditionally used. Other essential oils which have no established traditional use may be authorized on the basis of mutual recognition of the submission of a safety dossier.

Inclusion in the positive list does not guarantee the essential oils from the listed plants are safe for use, meaning additional precautions should be considered. Producers are advised to take into account proper conditions of use, such as dosage and the inclusion of precautions for risk groups. In an additional guidance document, the Directorate-General provides further recommendations on the safety precautions that should be taken.

DGCCRF - Recommandations sanitaires pour l’emploi d’huiles essentielles dans les compléments alimentaires - link

The provided indications should assist producers to assess the risk linked to the presence of certain compounds in essential oils. Producers are however free to deviate from the list and provide self-acquired data to demonstrate the safety of essential oils for the intended target groups and corresponding doses. Overall, the use of essential oils is strictly discouraged for pregnant woman and children below the age of 6. Depending on the specific compounds present in a particular essential oil other warnings are prescribed.

DGCCRF - Compléments alimentaires - Huiles essentielles - link

BELGIUM LIMITS CAFFEINE CONTENT, OTHER SUBSTANCES IN FOOD SUPPLEMENTS by Joris Geelen

A new decree recently published by the Belgian authorities sets new maximum limits for caffeine, lutein, lycopene and red yeast rice in food supplements.

The decree updates an existing Royal decree on substances other than nutrients and plants or plant preparations which already included maximum limits for choline and ubiquinone and specified the chemical form of carnitine. The new limits are:

  • caffeine: maximum 80 mg/day (total content, including other sources e.g. plants);

  • lutein: between 2 and 10 mg/day;

  • lycopene: between 2.5 and 15 mg/day; and

  • red yeast rice (or any other source of monacolin K): maximum 10 mg/day of monacolin K.

For food supplements with red yeast rice several requirements apply:

  • The following warnings are mandatory: "This product is not suitable for pregnant or lactating women, children and adolescents, people over 70 years of age, people with liver, kidney or muscular problems, people taking medicinal products liable to interact (e.g. cholesterol-lowering drugs) or people intolerant to statins. In case of doubt, please seek advice from your doctor or pharmacist." ;

  • The maximum content of citrinin must be below 2000 µg/kg, in accordance with Regulation 212/2014/EC;

  • Only products complying with Regulation 2015/2283/EC on novel food ingredients are allowed;

  • The dose of monacolin K must be standardized (maximum 10% deviation); and

  • The content of monacolin K must be stated in the notification file.

The maximum levels are based on the advice of the Superior Health Council and the Mixed Commission.

Transitional measures

As a transitional measure, food supplements which were placed on the market or labeled before November 29, 2018, and which do not comply with the provisions of the new decree, may continue the to be marketed until exhaustion of stocks and until October 26, 2019 at the latest. However, the transitional measure does not apply to supplements with red yeast rice (or others source of monacolin K). For those products the new restrictions apply immediately.

Many other EU Member States apply a maximum limit of 200 mg of caffeine per day in food supplements following the EFSA advice on caffeine (e.g. France, Italy and Romania).

Consolidated version of the decree: Arrêté Ministeriel du 19 Février 2009 relatif à la fabrication et au commerce de compléments alimentaires contenant d’autres substances que des nutriments et des plantes ou des préparations de plantes

EU COURT DENIES COPYRIGHT FOR THE TASTE OF A FOOD by Nikolaas Tilkin-Franssens

Following a claim by a Dutch producer of a particular cheese named “Heksenkaas” the European Court of Justice was asked whether the taste of a food can be granted protection by a copyright. To that purpose the Court had to consider whether a taste could be considered a “work” in the sense of Directive 2001/29 on the harmonisation of certain aspects of copyright and related rights in the information society. The two essential conditions require first a work to be the author’s own intellectual creation and secondly to be something which is the expression of the author’s own intellectual creation. Moreover, the interpretation of copyrights should be in line with the Berne Convention for the Protection of Literary and Artistic Works making the subject matter protected by copyright must be expressed in a manner which makes it identifiable with sufficient precision and objectivity. In the view of the Court, a taste is however rather identified by subjective and variable markers such as sensations and experiences influenced by age, food preferences and consumption habits, as well as on the environment or context in which the product is consumed. This made the Court conclude a taste cannot be considered a work that can be protected by a copyright.

European Court of Justice, C‑310/17, Levola Hengelo BV v Smilde Foods BV (13 November 2018) - link

EU MOVES TO REGULATE HEMP DERIVED PRODUCTS by Joris Geelen

A proposed decree in Italy with maximum levels for tetrahydrocannabinol (THC) in food (2018/546/I) is the latest EU regulatory attempt to bring hemp and hemp derived products under a closer scrutiny, in the face of increasing demand for these products. 

In particular, the following maximum THC limits are laid down:  

  • Oil obtained from hemp seeds: 5.0 ppm;

  • Seeds of hemp, flour obtained from hemp seeds: 2.0 ppm;

  • Supplements containing foods derived from cannabis: 2.0 ppm.

Just a few months ago Italy authorized hemp oil and seeds with the publication of the new decree on botanicals.

 EU PERSPECTIVE

As it is the case with all plant extracts the regulation of hemp and hemp derived products follows a national approach in the EU[1], where a tenuous regulatory patchwork for hemp extracts and cannabidiol (CBD) exists:

  • Belgium: even though Cannabis sativa is on the list of prohibited plants, an exception is granted if analysis show that THC levels are below 10 ppm for hemp oil, 5 ppm for seeds and flour, and 0.2 ppm for other foods and drinks[2] Belgian authorities have published a document with questions and answers about the use of Cannabis in food supplements[3];

  • Romania: the seeds and oil are expressly authorized, and no limits are laid down;

  • Denmark: a maximum of 10 ppm of THC for oil, 5 ppm for seed and flour, 0.5 ppm for beer, tea, bread and other foodstuffs is laid down;[4]

  • Germany: the Federal Institute for Health Protection of Consumers and Veterinary Medicine (BgVV, now BfR), sets as a guideline the following limits: 5 ppm for edible oils, 0.15 ppm for all other foods and 0.005 ppm for non-alcoholic and alcoholic beverages.

Role of the Novel Food Regulation

At EU level, the novel food catalogue expressly states that Regulation 2015/2283 on novel foods is not applicable to most food ingredients from Cannabis sativa. However, for CBD, the said catalogue states that extracts of Cannabis sativa in which CBD levels are higher than the levels in the source would be considered novel.

Thus, cold pressed oil and non-purified extracts obtained through traditional methods are not considered novel. However, further concentration or the use of new production methods (e.g. supercritical CO2 extraction) run the risk to trigger the application of the Novel Food Regulation when no history of consumption before 1997 can be established. In such cases, a novel food approval would be required[5].

 Use in cosmetics

Cannabis as defined by the Single Convention on Narcotic Drugs is considered to be a narcotic. This means cannabis extracts are prohibited in cosmetic products, except for extracts of the leaves and seeds if they are not accompanied by the flowering or fruit-bearing buds.

CBD is therefore permitted as an ingredient of cosmetic products, unless it is prepared by extraction from the flowering or fruiting tops.

Recent international developments

The legalization of ‘medical marijuana’ in the US, Canada and in some EU countries have sparked a renewed interest in its non-psychoactive cousin “hemp”, mainly because of the presence of CBD.

 The World Health Organization has officially recommended on December 14, 2017, that CBD should not be internationally scheduled as a controlled substance. Moreover, CBD is no longer mentioned on the list of prohibited substances in competition sports of the World Anti-Doping Agency (WADA).

Over the last few years the hemp food sector has grown considerably and has reached a volume of €40 million in Europe and a global volume of €200 million. In the US, the CBD market is expected to become a billion-dollar industry by 2020.

Vegetarians like hemp for its high protein content, with all essential amino acids, vitamins, minerals and fiber. Its oil has an ideal fatty acid profile. The seeds are also gluten-free and can be fed to animals. Concentrations of CBD in hemp range from 1.5 to 3% by weight and it contains only low amounts of THC. Among several other physiological effects, evidence shows that CBD can act as an immunomodulator, it can help to improve sleep and elevate mood.


[1]         Except for Ephedra species, the use of which is prohibited EU-wide (Cf. Annex III of Regulation 1925/2006).

[2]        These levels derive from the risk assessment by the Food Standards Australia New Zealand (FSANZ).

[3] Cfr. https://www.health.belgium.be/fr/FAQ_cannabis_en_tant_que_ou_dans_les_denrees_alimentaires

[4]        Cf. EFFL, 2018, ISSN (Print) 1862–2720· ISSN (Online) 2190–8214, available at:  https://effl.lexxion.eu/data/article/13003/pdf/effl_2018_04-011.pdf.

[5]        In 2016 a Czech firm submitted a dossier for a novel food authorization of a highly purified CBD extract to the Czech authorities, which was later sent to EFSA (EFSA-Q-2018-00512). It is still under consideration and it remains unclear when it could be approved.

VEGETARIAN AND VEGAN ON THE EUROPEAN LEGISLATIVE AGENDA by Nikolaas Tilkin-Franssens

The European Commission has announced that it will initiate the process for the adoption of a regulatory framework for vegetarian and vegan food. the Decision follows from a citizens initiative and will consider the mandatory labelling of foods as respectively non-vegetarian, vegetarian, or vegan. The anticipated proposal will also involve the establishment of definitions on the terms ‘vegetarian’ and ‘vegan’.

Commission Decision (EU) 2018/1701 of 7 November 2018 on the proposed citizens' initiative entitled ‘Mandatory food labelling Non-Vegetarian/Vegetarian/Vegan’- link

UK ASKS INDUSTRY INPUT ON POST-BREXIT FOOD LABELLING TRANSITION by Nikolaas Tilkin-Franssens

Previously the UK authorities indicated the leave from the European Union would have an immediate impact on food labels in case no deal would be negotiated. In the no-deal scenario, prepacked food products would have to include a responsible operator (i.e. manufacturer, importer or distributor) established within the UK from 29 March 2019. However, in order to provide some leeway to businesses and secure food availability in Britain, the UK authorities opened a consultation to get feedback on the installation of a transition period. The deadline for the consultation is set on 4 December.

UK Department for Environment, Food and Rural Affairs - Food labelling: amending laws - link

EGG MEMBRANE HYDROLYSATE RECEIVES NOVEL FOOD AUTHORIZATION by Nikolaas Tilkin-Franssens

Egg membrane hydrolysate will be authorized for use in food supplements intended for the general adult population from 25 November. The authorization is based on proprietary data making the authorization, founded on the provided data, is exclusive to the applicant Biova. The egg origin of the ingredient should be labelled in correspondence with allergen labelling rules.

Commission Implementing Regulation (EU) 2018/1647of 31 October 2018 authorising the placing on the market of egg membrane hydrolysate as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 - link