food safety

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 recommended analysis methods for botanicals in Belgium by Joris Geelen

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

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

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

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

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

EFSA sets new maximum for glutamates by Joris Geelen

Glutamic acid and its salts (E 620-625), commonly referred to as glutamates, are authorized food additives in the EU. The addition of glutamates is generally permitted up to a maximum level of 10 g/kg of food. In salt substitutes, seasonings and condiments, there is no numerical maximum permitted level for glutamates and they must be used in line with good manufacturing practices.  

EFSA re-assessed the safety of glutamates used as food additives and derived a group acceptable daily intake (ADI) of 30 mg/kg body weight per day for all six of these additives (corresponding to 2,1 g using a body weight of 70 kg). This safe level of intake is based on the highest dose at which scientists observed no adverse effects on test animals in toxicity studies.

We will keep an eye on the reactions of the European commission and Member states to see what effect this advice will have in practice. 

Lithuania notifies draft order establishing maximum limit for trans fats by Nikolaas Tilkin-Franssens

The Order of the Minister for Health of the Republic of Lithuania establishing the maximum limits for trans fatty acids in foods aims to meet dietary recommendations which urge to limit the intake of trans fatty acids (TFA). In accordance with earlier EFSA opinions (2004 and 2010), a reduction of TFA intakes may contribute to a reduction in the prevalence of non-communicable diseases. Statistics show that the disease and death toll of vascular diseases have a considerable impact on the Baltic State. For that reason limits on on the presence of TFA for foods placed on the Lithuanian market are adopted.

The draft order introduces a maximum limit of 2 gram of trans fatty acids per 100 gram of the total fat content. For foods with a fat content of less than 3%, the maximum limit is will be 10 g per 100g of the total fat content. Ruminant fats and other foods with naturally present TFA are exempted from the restriction.

With its notification Lithuania does not await a potential European ban which has been anticipated by the European Commission (see following link). Lithuania is not the first country to adopt restrictions on TFA. Denmark, Norway, Iceland, Hungary, Austria, Switzerland and Sweden already have regulations of TFA in force.

EFSA publishes advice on follow-on formulae with lower protein content by Joris Geelen

After a safety assessment EFSA concluded that follow-on formula with a protein content of at least 1.6 g/100 kcal made from either cow or goat’s milk is safe and suitable for infants. Current EU legislation sets the minimum protein content at 1.8 g/100 kcal.

EFSA also considered follow-on formulae containing protein from other sources than cow or goats’ milk. The available data did not allow EFSA to establish the safety and suitability of follow-on formulae with a similar protein content made from soy protein isolates or protein hydrolysates. 

Scientific Opinion on the safety and suitability for use by infants of follow-on formulae with a protein content of at least 1.6 g/100 kcal

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.

No evidence of harmful effects of isoflavones in food supplements for post-menopausal women according to EFSA - How does this affect restrictions on isoflavones at national level? by Lara Skoblikov

In a recent publication, EFSA delivered a scientific opinion on the possible association between the intake of isoflavones at a daily dose in the range of 35–150 mg/day from food supplements and harmful effects on breast, uterus and thyroid in peri- and post-menopausal women. EFSA concluded that the evidence reviewed does not suggest there are harmful effects on the three target organs.

However, EFSA found that there is no data to assess the safety of these substances for women during the transition period to menopause and for women with a history or family history of breast cancer, women on medication for thyroid diseases or other chronic conditions. The Panel decided further that it was not possible to directly extrapolate observations from the target organ to the others.

Isoflavones are naturally occurring substances which are found, among other sources, in soy, alfalfa, red clover and kudzu root. Maximum levels for the use of isoflavones in food supplements are currently in force in Belgium (40 mg/day, as glycosides of the main component), France (1 mg/kg bw/day, as aglycone) and Italy (80 mg/day total isoflavones). In France, the following warning should in addition be included in the label: “not suitable for women who have a personal or family history of breast cancer”.

These restrictions constitute obstacles to trade. Member States can maintain them only as long as they can justify they are necessary in view of the protection of public health, based on the latest available scientific evidence.

Now, do the conclusions from EFSA affect the abovementioned restrictions? This remains to be seen.

First of all, EFSA’s assessments are generally regarded as very reliable, but are not capable of automatically overruling existing national legislation. Only the Member States themselves can amend or repeal legislation and only the Court of Justice of the EU and national courts can declare it unlawful. In practice, Member States have shown reluctance to revise their rules or administrative practice on the basis of a risk assessment by EFSA.

Secondly, EFSA’s conclusions apply to peri- and post-menopausal women and consider only three organs. This means that if Member States can demonstrate with scientific evidence that a risk to health exists with regard to target groups/aspects falling outside of the scope of EFSA’s assessment, they would be able to keep their national restrictions.

Note however that while Member States may, under the precautionary principle, take protective measures without having to wait for the reality and the seriousness of those risks to be fully demonstrated, purely hypothetical risks that have not been scientifically confirmed, cannot be accepted. Furthermore, the measures should be the least restrictive to achieve the objective pursued. In this sense, labelling the Court of Justice of the EU has accepted labelling requirements as a ‘least restrictive’ measure.

Nevertheless, even the French labelling warning constitutes a barrier to trade and requires a showing of necessity as well as of proportionality. France needs to demonstrate and actual (potential) risk which is not hypothetical and the warning should not go further than strictly necessary for the protection of health. In this light, it could be wondered whether it would be strictly necessary to require the warning irrespective of the amount of isoflavones in a product. Currently, the warning is mandatory for all food supplements containing even the smallest amount of soy.

New Regulation sets maximum levels for PAH in certain food supplements by Lara Skoblikov

Commission Regulation (EU) 2015/1933 of 27 October 2015  lays down maximum levels for Polycyclic Aromatic Hydrocarbons (PAHs) in cocoa fibre, banana chips, food supplements, dried herbs and dried spices. 

For food supplements containing botanicals and their preparations and food supplements containing propolis, royal jelly, spirulina or their preparations, the maximum level of Benzo(a)pyrene is set on 10 μg/kg and the maximum sum of benzo(a)pyrene, benz(a)anthracene, benzo(b)fluoranthene and chrysene is set on 50 μg/kg.

Belgium notifies the BELFRIT list of plants to the European Commission by Sebastian MELCHOR

Belgium has submitted a draft of the Royal Decree amending the Royal Decree of 29 August 1997 on the manufacture and trade of foods composed of or containing plants or plant preparations to the European Commission.

The draft Royal Decree amends the current positive and negative list of plants for the use in foods, incorporating the BELFRIT list of plants into their national legislation. The notification to the European Commission allows the Commission and the Member States to submit objections to the draft during a three-month standstill period. 

The draft Royal Decree allows foods not complying with the new rules to be marketed until exhaustion of stocks and maximum two years after its adoption.

EFSA: Data on chemicals in food: an annual overview for the general public by Sebastian MELCHOR

Traces of chemicals are sometimes detected in food and drinks: pesticides in fruit and vegetables, veterinary drugs in meat and other animal-derived products, or environmental contaminants in various foodstuffs. Regular controls help to ensure compliance with food safety rules and standards and protect consumers from potential risks. But how high are the levels of these substances in food and do they exceed existing official limits?

A new EFSA report aims to give non-specialists a balanced view of the findings of annual EU-wide monitoring of levels of chemicals in food. The report provides context that is sometimes lacking when examples of chemicals detected in food are reported by the media. For example, EFSA’s analyses of data collected from across Europe show that exceeding official limits is the exception rather than the rule.

The European Commission’s acting Director General for Health and Food Safety, Ladislav Miko said: “This new report aimed at the European public translates complex scientific data on food in a more accessible and understandable way. I very much welcome this new way of reporting on issues that matter to people who are concerned about what's in their food and hope we will see more of this type of food information from EFSA in the future.”

Europe-wide cooperation on chemical data collection

EFSA’s Executive Director, Bernhard Url said: ”Across the European Union efforts are made at local, national and European level to collect, monitor and analyse the occurrence of chemicals in plants, animals, food and drinks. EFSA acts as an information hub for many of these activities, helping also to coordinate and harmonise them so that more and better data are available for scientific evaluation.”

These data provide the scientific basis for decision-making by national and European authorities responsible for food safety and/or public health. They also help to measure the impact of existing controls, understand if new safety assessments or control measures are needed and to set priorities for future research funding and data collection activities.

The Commission asked EFSA to include snapshots of the important work it does annually on pesticide residues in food and on veterinary drug residues in animals and animal-derived foods. In addition, the results of recent ad hoc reports covering chemical contaminants in food should be included; this first issue of the report, therefore, also summarises recent data collection work on arsenic in food and drinking water and ethyl carbamate in spirit drinks.

Mr Url added: “This report contains an overview of some of EFSA’s data work on chemicals from 2014-2015 and is the first EFSA publication to highlight this role specifically to the general public. We hope that EU citizens interested in food safety issues will find it useful and insightful.”

Background

  • Scientific risk assessors like EFSA help to safeguard against potential adverse effects of chemicals in food, where possible, by establishing safe intake levels. This scientific advice informs decision-makers who regulate the use of chemicals in food or seek to limit their presence in the food chain. EFSA’s work would not be possible without the on-going Europe-wide data collection efforts of local, national and European organisations.
  • As well as its data collection and reporting activities on chemicals in food, EFSA produces regular reports on potential biological contaminants such as bacteria, fungi, enzymes and viruses present in the food chain.