novel foods

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

Novel food approval for hen egg white lysozyme hydrolysate by Joris Geelen

The European commission has authorized the use of hen egg white lysozyme hydrolysate in food supplements on the EU market. 

Lysozyme is a polypeptide with 129 amino acids that occurs naturally in chicken eggs has a significant history of consumption within the EU and it is also authorized as an additive (E1105). 

According to the assessment report of Ireland the novel food ingredient is produced by the hydrolysis of commercially available hen egg white lysozyme with a food grade protease (subtilisin). The difference with lysozyme is that it comprises a distinct set of peptides of varying amino acid length (primarily of di- and tri-peptides), many of which are rich in tryptophan.  

Hen egg white lysozyme hydrolysate complying with the specifications may be placed on the market in the EU as a novel food ingredient to be used in food supplements at a maximum daily dose of 1000 mg per day. 

The designation of the novel food on the labelling of food supplements containing it shall be “Hen egg white lysozyme hydrolysate”.

New Year, 125 New Functional Ingredients in the EU by Sebastian MELCHOR

The long-awaited Union list of novel foods has become law in the EU following publication in the Official Journal of Commission Implementing Regulation (EU) 2017/2470 on December 20. For the first time, any food business operator can use novel botanical extracts, vitamins, minerals, microalgae, proteins, etc. when following the conditions and specifications laid down in the Regulation.

Until now, only those companies to which the Commission decision authorizing the novel food was addressed, as well as those obtaining authorization through the substantial equivalence procedure could use the novel ingredients. Other companies needed to obtain the novel ingredients from those officially authorized suppliers.

Detailed conditions under which the novel food may be used, especially food categories and maximum levels, as well as additional specific labelling and other requirements are laid down for each of the ingredients, which include top-selling ingredients like chia seeds, noni juice, synthetic hydroxytyrosol, clostridium butyricum, bovine lactoferrin, low fat cocoa extract, etc.

From now on, once a novel food is authorized, it will be added to this positive list and there will be no need to apply for substantial equivalence to use it.

To protect the investment of the applicants, however, there is a period of 5 year of data protection, which means that the newly developed information used to get approval cannot be used by other applicants. This may provide a monopoly on the marketing of the food or food ingredient for 5 years, unless the applicant agrees to share the data or if another applicant obtains their own information to get approval.

Detailed rules on administrative and scientific requirements published

At the same time, two other Commission Regulations lay down the administrative and scientific requirements for authorization of novel food applications and traditional foods from third countries, which are subject to a fast-track procedure.

The legislative package can be found here:

Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods

Commission Implementing Regulation (EU) 2017/2468 of 20 December 2017 laying down administrative and scientific requirements concerning traditional foods from third countries in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods

Commission Implementing Regulation (EU) 2017/2469 of 20 December 2017 laying down administrative and scientific requirements for applications referred to in Article 10 of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods

 

Novel food approval for lactitol by Lara Skoblikov

DuPont Nutrition Biosciences ApS has obtained a novel food authorization for lactitol. 

Lactitol complying with the specifications may be placed on the market in the EU as a novel food ingredient to be used in food supplements in capsule or tablet form intended for the adult population with a maximum dose of 20 g lactitol per day.

Lactitol was already authorized as a food additive (for sweetening or other technological purposes) in several foods, including food supplements supplied in solid and syrup form. The novel food authorization now allows the use for a nutritional/physiological purpose.

Other food businesses may use lactitol obtained from Dupont or they may apply for their own authorization if they can demonstrate that their lactitol is substantially equivalent to the authorized ingredient. This will not be necessary anymore as of January 1, 2018, when all authorized novel foods are expected to be included in the generic Union list.

Novel food approval for a Japanese fermented soybean extract by Sebastian MELCHOR

Japan Bio Science Laboratory has obtained a novel food authorization to place on the EU market a fermented soybean extract which contains nattokinase isolated from natto, a foodstuff produced by the fermentation of non-GMO soybeans with a selected strain of Bacillus subtilis var. natto.

Natto is traditionally consumed in Japan and is rich in manganese, iron, Vitamin K and other nutrients.

The new novel food ingredient can be used in food supplements in capsule, tablet or powder form intended for the adult population, excluding pregnant and lactating women.

The maximum daily dose is 100 mg fermented soybean extract

The designation of the authorized fermented soybean extract is fermented soybean extract’.

 

Commission Implementing Decision (EU) 2017/115 of 20 January 2017 authorising the placing on the market of fermented soybean extract as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2017) 165), C/2017/0165 (OJ L 18, 24.1.2017, p. 50–52).

Chia seeds now authorized in fruit juices by Sebastian MELCHOR

Following a recent decision by the Irish competent authorities, chia seeds can now be used in fruit juices and fruit juices blends at up to 15 g/450 mL. Even if the decision is addressed to the applicant, any food operator can now market juices following the decision, under the following conditions:


This is the second extension of use of chia (Salvia hispanica), after a Commission Implementing Decision of 22 January 2013 authorized its use in the following product categories:

  1. Baked products: not more than 10 %
  2. Breakfast cereals: not more than 10 %
  3. Fruit, nut and seed mixes: not more than 10 %
  4. Pre-packaged Chia seed as such: not more than 15 g per day

New Regulation 2015/2283 on Novel Foods What is Really Novel and Impacts Your Business by Sebastian MELCHOR

You probably know that the new Novel Food Regulation has finally become law, and heard about insects, cloning, nanomaterials and other “newsy” pieces of information from the media. But the new rules have brought crucial changes that affect your daily practice and need to be acted upon. Some of them consecrate current administrative practices, while others are completely new. We summarize them below
 

1.    The definition of novel food has been expanded. For example, it is now clarified that all botanical extracts not used before May 15, 1997 are novel (the legislator has added “produced from” to the old formula “consisting of or isolated from plants”). Because of this expanded definition (which also includes vitamins and minerals manufactured with a new production process including nano-engineering), ingredients which were not novel until now may become novel as from the entry into force of the Regulation and will need to be authorized according to the new rules.  
 

2.    The concept of “new production process” is clarified: as a production process not used for food production within the EU before May 15, 1997.
 

3.    Traditional food from third countries benefit from a simplified procedure if they have been consumed (i) as part of the customary diet; of a (ii) significant number of people for (iii) at least 25 years. They should derive from primary production only. There is no further clarification on what those criteria mean in practice except that non-food uses or uses not related to normal diets do not count.
 

4.    The previous step of obtaining the green light from a national authority is over and a new centralised authorisation system will be in place as from 2018. The application will be treated directly by EFSA and the Commission. With new deadlines in place, the Commission expects that the average time goes down from 3.5 to 1.5 years.
 

5.    Once a novel food is authorized, it will be added to a positive list and there will be no need to apply for substantial equivalence in order to use it. This will occur only as from the beginning of 2018, when any pending substantial equivalence application will be obsolete and without purpose.
 

6.    To protect the investment of the applicants, there is a period of 5 year of data protection, which means that the newly developed information used to get approval cannot be used by other applicants. This may provide a monopoly on the marketing of the food or food ingredient for 5 years, unless the applicant agrees to share the data or if another applicant obtains their own information to get approval.
 

7.    You can now formally ask the authorities of the EU country where you are seeking to first market the novel food about whether there is information about human consumption before May 15, 1997. The Commission is still to set up the rules and deadlines for this consultation. A similar procedure for the Commission to determine whether a food falls into the definition of novel food is envisaged.

 
 

Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001
 

 

 

EU approves new probiotic strain as novel food by Sebastian MELCHOR

The EU has recently authorized the marketing of heat-treated milk products fermented with probiotic strain Bacteroides xylanisolvens (DSM 23964), in what constitutes another probiotic approval as a novel food in the EU after Clostridium butyricum (CBM 588) was authorized last December 2014.

Whilst there is no positive list of individual strains which enjoy a probiotic status at EU level, EFSA  has adopted a “Qualified Presumption of Safety” concept which provides a generic assessment system for use within EFSA that, in principle, can be applied to all requests received for the safety assessments of microorganisms deliberately introduced into the food chain. QPS status informs on the safety of a microorganism and is used without prejudice to any other legal requirements. Therefore, the species granted with QPS status (e.g. L. acidophilus, L. brevis, L. casei, L. helveticus, L. plantarum, L. reuteri, L. rhamnosus, etc.) have been granted a presumption of safety[1].

According to the EU specifications, heat-treated fermented milk products are produced with Bacteroides xylanisolvens (DSM 23964) as starter culture. The description is “semi-skimmed milk (between 1,5 % and 1,8 % fat) or skimmed milk (0,5 % fat or less) is pasteurised or ultra-heat-treated before starting the fermentation with Bacteroides xylanisolvens (DSM 23964). The resulting fermented milk product is homogenised and then heat-treated to inactivate Bacteroides xylanisolvens”.

Some Member States have adopted positive lists of probiotics[2] and others have laid down certain conditions for naming specific strains as such[3].

There is no EU-wide definition of the terms “probiotic bacteria” or “probiotics”, nor has their use in food been regulated under EU regulations.

Ban on the use of “probiotics” still in place  

The use of the term “probiotics” for foods is currently subject to a de facto ban in the EU. The ban has its origin in the qualification of the term as a health claim in the Commission Guidance on Nutrition and Health Claims of December 14, 2007 as it is argued that the naming of this category of substances contains an implied health benefit. The ban has been severely criticized for the lack of a sound legal basis, and has had significant implications for the probiotic industry. In addition, it has been stated  the ban jeopardizes the right of consumers to access the necessary information to make choices in full knowledge of facts, by restricting the provision of information about the true nature of foods containing probiotics.

 - COMMISSION IMPLEMENTING DECISION (EU) 2015/1291 of 23 July 2015 authorising the placing on the market of heat-treated milk products fermented with Bacteroides xylanisolvens (DSM 23964) as a novel food under Regulation (EC) No 258/97 of the European Parliament and of the Council

[1]       Opinion of the Scientific Committee on a request from EFSA on the introduction of a Qualified Presumption of Safety (QPS) approach for assessment of selected microorganisms referred to EFSA. The EFSA Journal (2007) 587, 1-16.

[2]          See, inter alia, the publication of the Belgian Superior Health Council No. 8651: Probiotics and their implications for Belgian public health. Part 1: Microbiological characterization, of February 1, 2012.

[3]       See Italian Ministry of Health’s Guidelines on Probiotics (Linee guida sui probiotici, Ministero della Salute, Dipartimento Sanita Pubblica Veterinaria, Sicurezza alimentare e degli organi collegiali I direzione generale igiene e sicurezza degli alimenti e della nutrizione ufficio IV; Commissione unica per la dietetica e la nutrizione; Revisione 2011).

New Novel Food Regulation likely to be approved on October 14 by Sebastian MELCHOR

The new Regulation on novel foods is on the agenda to be adopted by the European Parliament next week. 

The Regulation will introduce significant changes in the current novel food regime.

Authorizations are to become generic instead of addressed to the applicant, as is currently the case. This means that other companies will also be able to use an authorization. leaving no need anymore for the current "substantial equivalence" authorizations. Applicant-based authorizations will remain possible under specific data protection provisions. Existing authorizations will be added to the EU list of generic authorizations as well.

The procedure will be centralized with the EFSA, which should reduce the lengthy current application process of  three years on average.

Finally, a simplified notification procedure is foreseen for foods from third countries with a history of safe use of 25 years or more. 

New food and food ingredient on the EU market by Sebastian MELCHOR

Two Commission’s decisions authorizing placing on the market food and food ingredient were published on 28 July in in the Official Journal of the European Union.

  1. Refined Buglossoides oil extracted from the seeds of Buglossoides arvensis (L.) I.M.Johnst can be used in wide range of food categories: dairy products and analogues, cheese and cheese products, butter and other fat and oil emulsions including spreads (not for cooking or frying purposes), breakfast cereals, food supplements (excluding food supplements for infants and young children), dietary foods for special medical purposes as (excluding dietary foods for infants and young children), foods intended for use in energy-restricted diets for weight reduction. This Decision is addressed to Technology Crops International

  2. Heat - treated products fermented with Bacteroides xylanisolvens (DSM 23964) may be placed on the market in the Union as novel food in liquid, semi-liquid and spray-dried powder forms. The Decisions is addressed to Avitop GmbH.

In one of our next FCInt. NEWS we will explain:

1. What does it mean that the Novel Food Decision is addressed exclusively to the one company? and

2. How other food business operators can place the food on the market once it was authorized?

European Commission authorizes the use of oil from the micro-algae Schizochytrium sp. (ATCC PTA-9695) as a novel food ingredient by Sebastian MELCHOR

The European Commission has the use of oil from the micro-algae Schizochytrium sp. (ATCC PTA-9695) as a novel food ingredient. The ingredient is authorized for various uses and at specified maximum levels. the decision is directed at DSM Nutritional Products.