NEW REGULATION REINFORCES THE MUTUAL RECOGNITION PRINCIPLE by Nikolaas Tilkin-Franssens

The new regulation on the mutual recognition of goods lawfully marketed in another Member State (Regulation 2019/515) has been published introducing several measures to strengthen the application of the fundamental EU principle. The concept of mutual recognition derives from European Union case law in the application of the free movement of goods embedded in the European Treaties. It essentially requires EU member states to guarantee the introduction of goods which have been lawfully marketed in another member state. In case a member state restricts the market access it needs to clearly justify why market access has been restricted.

The new Regulation, replacing former Regulation 764/2008, elaborates on the technical application of the above principle in order to minimise unlawful EU barriers to trade. It establishes a set of rules and procedures to guarantee the appropriate application of the mutual recognition principle. Different from the preceding Regulation, it introduces the Mutual Recognition Declaration. This concerns a self-voluntary declaration which can be used to demonstrate the lawful marketing of goods in a member state to the authorities of another member state. The structure and content of the mutual recognition declaration is further established in the Annex of Regulation 2019/515. Further, the Regulation determines the procedure by which a member state can assess whether goods have been legally marketed in another member state. Important to note is that the economic operator retains his right to market the goods during the assessment. Only where the goods pose a serious risk to safety or health of persons or to the environment or similar goods are generally prohibited on grounds of public morality or public security the member state of destination may temporary suspend the entry of the concerned goods. In such case the competent authority needs to notify the economic operator as well as the European Commission and the other member states. In its assessment the competent authority shall take account of the mutual recognition declaration, if available. Following the assessment, the competent authority shall notify and duly justify its administrative decision. It shall provide for the remedies and procedures available under its national law and a reference to the SOLVIT procedure. SOLVIT is an alternative, non-judicial mechanism to settle disputes between individuals or business and member states regarding the application of EU law. In case an administrative matter limiting the free movement rights of an economic operator is brought before a SOLVIT centre, the European Commission will provide an opinion on whether the administrative decision is compatible with the principle of mutual recognition. Lastly, the new mutual recognition Regulation aims to raise awareness of the free movement principles and promote the exchange of information through Product Contact Points in the different member states. Regulation 2019/515 will enter into force on 18 April 2019 and apply from 19 April 2020.

Regulation (EU) 2019/515 of the European Parliament and of the Council of 19 March 2019 on the mutual recognition of goods lawfully marketed in another Member State and repealing Regulation (EC) No 764/2008 - link

FRENCH FOOD SAFETY AUTHORITY CAUTIONS THE USE OF ARTHRITIS SUPPLEMENTS by Nikolaas Tilkin-Franssens

A recent report advises against the consumption of food supplements containing glutamine and/or chondroitin sulfate for certain population groups. The undesired adverse effects can include digestive problems, abdominal pain, rash, itching, hepatitis or haemorrhagic lesions of the skin. At present, food supplements and medicinal products containing glucosamine and chondroitin sulfate are widely available.

Although the French Food Safety Authority, named ANSES, also recognises in its report that both glucosamine and chondroitin sulfate contain compounds naturally found in the connecting tissues and cartilage of our the human body which promote the structure and elasticity of cartilage tendons and skin. For certain risk groups the consumption of both substances should be avoided. The identified risk groups are:

(i) people with diabetes or pre-diabetic, asthmatic or treated with anti-vitamin K,

(ii) (for food supplements based on glucosamine) people with a food allergy to crustaceans or insects.

(iii) people whose diet is controlled for sodium, potassium or calcium, as these supplements can be an important source.

(iv) children and pregnant or breastfeeding women.

ANSES advises food producers to take account of the risk groups and appropriately inform consumers. In addition, it calls for the establishment of harmonised European Union maximum use levels for both glucosamine and chondroitin sulfate.

ANSES (29/03/2019) - Les compléments alimentaires à visée articulaire déconseillés à certaines populations - link

ASA SCRUTINIZES USE OF FOLATE VERSUS FOLIC ACID AND THEIR RELATED CLAIMS by Nikolaas Tilkin-Franssens

The UK Advertisement Standards Authority found a recent Kellog’s advertisement to exaggerate the meaning of an authorized claim relating folate to maternal tissue growth during pregnancy.

The concerned TV ad showed a pregnant women together with the statement “made with Folic Acid feeding development”. Below that statement it added that “a serving of Special K cereals contains folic acid contributing to maternal tissue growth during pregnancy”. According to Kellog’s, the used statements were based on the claim “folate contributes to maternal tissue growth during pregnancy” which has been authorized under the European Nutrition and Health Claims Regulation 1924/2006. In practice, the actual wording of claims made on foods may deviate from the approved wording provided that the alternative wording is considered to have the same meaning for consumers and the conditions of use are respected.

As a result, the Authority accepted that the names folate - for which the claim is authorized - and its synthetic form folic acid can be used interchangeably. Kellogg’s had argued in terms of consumer understanding the term folic acid is preferred as it would be more commonly known, be generally perceived as a beneficial nutrient for pregnant women and be more easily absorbed by the human body. Further, the product did comply with the conditions of use because the product is a source of folic acid.

However, the Authority argued that addition of “made with Folic Acid feeding development” would imply a beneficial effect on foetal development different from the authorized claim. While there is an authorized claim for folic acid on the reduction of risk of neural tube defects in the developing foetus, a portion of Special K does not contribute the required 400 micrograms in order to make use of that claim. This made the Authority decide the ad exceeded the flexibility given on the use of authorized claims.

ASA Ruling on Kellogg Marketing and Sales Company (UK) Ltd (6 March 2019) - link

LIST OF TRADITONALLY USED DENOMINATIONS PUBLISHED by Nikolaas Tilkin-Franssens

The European Commission has published the list of generic descriptors which are excluded from the scope of the Nutrition and Health Claims Regulation 1924/2006. Although the listed denominations could imply a health effect they are exempted from the Regulation’s restrictions due to their traditionally use in certain member states. The given exemptions are language and country specific.

Commission Regulation (EU) 2019/343 of 28 February 2019 providing derogations from Article 1(3) of Regulation (EC) No 1924/2006 of the European Parliament and of the Council on nutrition and health claims made on food for the use of certain generic descriptors - link

RITUAL SLAUGHTER PRECLUDES USE OF EU ORGANIC LOGO by Nikolaas Tilkin-Franssens

The European Court of Justice ruled that halal meat cannot bear the EU organic farming logo. The Court has taken the stance ritual slaughter – as opposed to slaughter with pre-stunning – ‘does not allow the animal’s suffering to be kept to a minimum’.

The high standard of animal welfare in all locations and at all stages of production is a fundamental standard of organic farming in line with EU Regulation 834/2007 of 28 June 2007 on organic production and labelling of organic products. The latter Regulation demands that ‘any suffering, including mutilation, shall be kept to a minimum during the entire life of the animal, including at the time of slaughter’. The Court argued that the application of pre-stunning is shown to be the least compromising technique in terms of pain, distress and suffering of slaughtered animals.

Judgment of the European Union Court of Justice (26 February 2019) - Case C-497/17: Oeuvre d’assistance aux bêtes d’abattoirs (OABA) v Ministre de l'Agriculture et de l'Alimentation and Others - link

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