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 should 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: Koninklijk Besluit van 12 Februari 2009 betreffende de fabricage van en de handel in voedingssupplementen die andere stoffen bevatten dan nutriënten en planten of plantenbereidingen

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

 

CRANBERRY EXTRACT POWDER, REFINED SHRIMP PEPTIDE CONCENTRATE, AND BOVINE MILK BASIC WHEY PROTEIN ISOLATE AUTHORIZED AS NOVEL FOODS by Nikolaas Tilkin-Franssens

Three novel foods specifically targeted for use in special purpose foods will be added to the Union list of authorized novel foods following the Commission Regulations of 30 October 2018. Cranberry extract powder will be permitted for use in food supplements intended for adults. The approval was obtained with protection of proprietary data providing an exclusive authorization for the applicant Ocean Spray Cranberries Inc. until November 2023. Other applicants may obtain concurrent approval on the basis of legally obtained information supporting safety substantiation. Likewise, refined shrimp peptide concentrate and bovine milk basic whey protein isolate are authorized for use with proprietary data protection to the benefit of the applicants. The authorization of refined shrimp peptide concentrate relates to food supplements only, while bovine milk basic whey protein isolate shall be allowed in infant and follow-on formulae, total diet replacement foods for weight control, foods for special medical purposes as well as food supplements.

Basic whey protein isolate from bovine milk allergen will require milk allergen labelling. In addition, the warning “This food supplement should not be consumed by children/adolescents (depending on the age group the food supplement is intended for) under the age of three/eighteen years” should be included when used in food supplements.

Commission Implementing Regulation (EU) 2018/1631 of 30 October 2018 authorising the placing on the market of cranberry extract powder 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

Commission Implementing Regulation (EU) 2018/1633 of 30 October 2018 authorising the placing on the market of refined shrimp peptide concentrate 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

Commission Implementing Regulation (EU) 2018/1632 of 30 October 2018 authorising the placing on the market of bovine milk basic whey protein isolate 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

FRANCE SUSPENDS THE USE OF TITANIUM DIOXIDE by Nikolaas Tilkin-Franssens

On 30 October, France published a law which suspends the use of the food additive titanium dioxide with corresponding E-number 171. The measure has been taken based on article 54 of the General Food Law (EU Regulation 178/2002) which permits member state to take emergency measures where the Commission is considered not have acted adequately to a notified food safety risk. In April 2018, France had expressed safety concerns with the European Commission due to the publication of new scientific studies on titanium dioxide. The Commission then requested the EFSA to assess the studies. In its opinion of 26 June, the latter argued the studies were not conclusive on the asserted safety risks. Additional studies conducted under more realistic conditions would be needed. On that basis, the EFSA argued it would not reconsider its existing opinion on titanium dioxide as a food additive.

The Commission will have to put the matter to the attention of the other EU member states in the Standing Committee on the Food Chain and Animal Health. It shall then be decided whether the measure should be extended - for instance to all member states - amended or abrogated.

Article 53 - LOI n° 2018-938 du 30 octobre 2018 pour l'équilibre des relations commerciales dans le secteur agricole et alimentaire et une alimentation saine, durable et accessible à tous - link

ALTERATION OF FOOD SUPPLEMENTS’ ADDITIVES DIVISION by Nikolaas Tilkin-Franssens

The sections listing the authorized additives for use in food supplements have been revised by the European Commission. The update deletes the current third category 17.3 (food supplements supplied in a syrup-type or chewable form) as the application of this category raised complications in its differentation with liquid and solid food supplements. Syrup-type food supplements are now subject to the liquid food supplements list and chewable food supplements to the solid food supplements list.

Moreover, the introductory part of both sections now clarifies that the maximum levels of the indicated additives apply to the food supplements as ready for consumption. The latter should be interpreted as prepared for consumption in accordance with the instructions provided by the manufacturer.

Commission Regulation (EU) 2018/1497 of 8 October 2018 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards food category 17 and the use of food additives in food supplements - link

COMMISSION ADOPTS TRANS FAT BAN PROPOSAL by Nikolaas Tilkin-Franssens

With trans fatty acids posing a public health risk to consumers, the Commission adopted a proposal which would limit the content of trans fat, other than naturally occurring trans fat, in all foods to 2 grams per 100 gram fat. Following a Commission report published in 2015 on the potential mitigation measures for the overall reduction of trans fat intakes, it was considered a legal limit on industrial trans fats was the most effective means for the protection of consumer health. The report demonstrated that legal limits in the pioneer country Denmark had significantly lowered trans fats intake levels. The measure will override national initiatives which had been adopted or were in the make by various other EU Member States. The date of application of the ban is not yet known. It is currently notified as a technical barrier to trade allowing other countries to comment on the anticipated rules. The proposal however - provisionally - instigates that foods not complying with the new rules may be marketed until 1 April 2021.

EU Commission Proposal - COMMISSION REGULATION (EU) …/…of XXX amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards trans fat, other than trans fat naturally occurring in animal fat, in foods intended for the final consumer - link

DECEPTIVE QUALITY CLAIMS ADEQUATELY COVERED, COMMISSION ARGUES by Nikolaas Tilkin-Franssens

Following the report of the European consumer organization BEUC earlier in June, the Commission was asked a range of questions on whether it would take further initiatives in the field of food labelling. The BEUC report highlights food labelling practices to be considered misleading encouraging the European Commission to consider additional legislative measures or a stricter interpretation of the current rules. The questions were raised in the European Parliament to which Commissioner Andriukaitis has replied.

The first question related to whether the Commission had the intent to define the use of quality claims such as ‘natural’. ‘artisan’ and ‘natural’. In his reply Andriukaitis argued that quality terms are often linked to national practices and therefore should be addressed at member state level. A second practice brought forward in the report, is the display of fruit on the packaging while the food in reality barely contains any fruit. The Commission notes that EU legislation precludes misleading practices in general as well as specifically regarding the nature and quantity of food. Moreover, quantitative indication of ingredients is required where ingredients are emphasized by words or visually on the labelling. The application of these rules however lies with the Member States who are responsible to monitor compliance and interpret the rules in relation to the specific practices.

Consequently, the Commission asserts that current EU law is appropriate to deal with the alleged misleading practices and therefore it has no intention to adopt further rules or guidance.

Joint answer given by Mr Andriukaitis on behalf of the European Commission (Written questions: E-003659/18 , E-003973/18 , E-003879/18) - link