WHAT IF NO BREXIT DEAL IS REACHED? UK AUTHORITIES CLARIFY by Nikolaas Tilkin-Franssens

As 29 March 2019 is approaching, the day by which Brexit will become official, the UK authorities are considering all potential scenario’s. One of which is the risk that no deal is reached with the European Union political counterparts. The UK authorities emphasize that all effort is being put in coming to an agreement. Although, the authorities found it necessary to inform UK citizens and businesses what the impact would be of a no deal-scenario on the supply and trade of goods. Essentially, no agreement would mean the immediate end of free movement of goods and accordingly customs procedures will apply as is the case for third country imports and exports at present.

Besides a general consideration, also specific topics, including the cultivation of genetically modified organisms and the production of organic food, are addressed in individual Guidances. Regarding the use of GMO’s, no significant changes are to be expected in a no deal-scenario as the national implementing acts will remain valid in the UK. The text would be amended to relate to a national context only. This means that prior authorization of GMO’s will remain applicable. Current authorizations will remain valid and only over time, due to a different territorial scope of authorizations, divergences in may occur. For organic food and feed, the authorities intend to keep a comparable framework in place. There is the notable change that the EU organic logo will have to be replaced by a UK specific logo. Additionally, Organic exports to the EU will be dependent on European recognition of local certifying bodies. Applications for recognition can only start when the UK becomes officially a third country and applications take up to 9 months. However, it is made clear that in such case a transition measure or equivalency arrangement would be negotiated. The organic production legislation will initially remain in place and amended to a UK context. There are no plans to make any substantial changes to the current requirements and procedures.

Guidance on how to prepare if the UK leaves the EU with no deal - link

FRANCE RECOMMENDS TO LIMIT IODINE INTAKE FROM ALGAE by Nikolaas Tilkin-Franssens

The French Food Safety Authority, ANSES, advises to keep the intake of algae limited due to the presence of iodine. Nowadays algae have become increasingly popular for use in food and particularly food supplements which led the Authority to evaluate the potential excessive intake. Although data on the intake by the French population is not available to assess current exposure levels, the Authority based its assessment on parameters which currently limit the intake.

As a benchmark in the assessment, the French legal iodine limit of 150 micrograms in food supplements was considered together with the upper limit established by EFSA of 600 micrograms per day.  The French Authority found that the consumption of foods together with foods supplements that are both made from algae creates a considerable risk to exceeding the upper intake levels for iodine.

Especially people with thyroid disorder, heart disease or kidney failure, people taking iodine or lithium containing medication and pregnant or breastfeeding women are recommended to avoid consumption of algae-based food and food supplements, without seeking medical advice.

The use of algae food supplements is neither recommended for addressing iodine deficiencies.

AVIS de l’Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail relatif au risque d’excès d’apport en iode lié à la consommation d’algues dans les denrées alimentaires - link

NOVEL FOOD AUTHORIZATIONS – SYNTHETIC ZEAXANTHIN, HOODIA PARVIFLORA, PYRROLOQUINOLINE QUINONE DISODIUM SALT AND 1-METHYLNICOTINAMIDE CHLORIDE by Nikolaas Tilkin-Franssens

The European Commission has authorized the use of a number of substances for use in food supplements. The authorization regarding synthetic zeaxanthin concerns an update of the current entry for zeaxanthin in the Union List of novel foods. In the future it will no longer be necessary to include “synthetic” in the labelling. Further, the Dried aerial parts of Hoodia parviflora are authorized for use in food supplements destined for the adult population at a maximum level of 9,4 mg per day. Because the application has been based on proprietary data the authorization comes with data protection providing an exclusive right to the application until 3 September 2023. The same applies the other 2 authorizations. 1-Methylnicotinamide chloride is authorized for use in food supplements with a maximum level of 58 mg per day for the adult population excluding pregnant and lactating. The applicant also obtained data protection valid for 5 years. The other recent authorization of Pyrroloquinoline quinone disodium salt also applies for food supplements intended for the adult population, excluding pregnant and lactating women. Proprietary use applies until 2 September 2023.

Commission Implementing Regulation (EU) 2018/1132 of 13 August 2018 authorising the change of the designation and specific labelling requirement of the novel food synthetic zeaxanthin - link

Commission Implementing Regulation (EU) 2018/1133 of 13 August 2018 authorising the placing on the market of dried aerial parts of Hoodia parviflora as a novel food - link

Commission Implementing Regulation (EU) 2018/1123 of 10 August 2018 authorising the placing on the market of 1-methylnicotinamide chloride as a novel food - link

Commission Implementing Regulation (EU) 2018/1122 of 10 August 2018 authorising the placing on the market of pyrroloquinoline quinone disodium salt as a novel food - link

NEW EFSA GUIDANCE FOR THE EVALUATION OF NANOTECHNOLOGIES by Nikolaas Tilkin-Franssens

An updated Guidance has been provided by EFSA regarding the evaluation of risks connected to the use of nanotechnology in food and feed. Areas of importance include novel foods, food contact materials, food/feed additives and pesticides. Due to new scientific evidence, the know-how on the physicochemical properties, exposure and hazards of nanomaterials has expanded. The Guidance incorporates these aspects and provides indications how they should be applied using and the appropriate testing methods.

EFSA - Guidance on risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain: Part 1, human and animal health - link

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

New advisory committee in the Netherlands by Joris Geelen

The Dutch government has set up the new Advisory Group 'Status determination Borderline medical products' with the assignment to evaluate the classification of products in case of doubt.

This advisory group consists of experts from the Healthcare Inspectorate and Youth in the Netherlands (IGJ i.o.), the Dutch Food and Consumer Product Safety Authority (NVWA), the Medicines Evaluation Board (MEB) and the Central Committee on Human Research (CCMO). The regulations in the field of market authorization and research with commodity law products, medical products and biocides are quite complex, so it is not always clear which legislation should be applied and which authority takes care of enforcement in case of violations of law.

This new Advisory Group will carry out the evaluation and advise the Dutch government in cases of products operating on the border of several laws. For supplements with plants, for example, this may be because of the daily dose or a claim. The four organizations mentioned can ask the opinion of this Advisory Group. It is therefore to be expected that discussions about the classification of products will be settled by this internal advisory group of the government.

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”.

GERMANY PUSHES AHEAD VEGETARIAN AND VEGAN DEFINITION by Sebastian MELCHOR

In the absence of a European definition on vegan and vegetarian products, the German authorities have been an avid partner for the European and local vegetarian associations in the creation of an official interpretation on what should be understood under the terms “vegetarian” and “vegan”. The EU Food Information to Consumers Regulation (Regulation 1169/2011) mandates the European Commission to provide a clarification on information related to suitability of a food for vegetarians or vegans, but there are no signs of progress at EU level. Instead the German Ministry of Agriculture has taken the initiative to establish a joint committee which is in the process of considering a corresponding definition. On the Ministry’s website an update is provided regarding the progress made so far, the challenges and the expected outcomes. A difficulty identified is the establishment of a concept viable for all different product groups. A draft opinion recommendation had already been presented on last 8 March but was not adopted by the overarching Food Code Commission. A second consultation is expected later this year. For the final adoption the agreement of the Ministry of Food and Agriculture the Federal Ministry for Economic Affairs and Energy is be required.

Press Release (13 June 2018): Sachstandsbericht: Temporärer Fachausschuss für "vegetarische und vegane Lebensmittel" (“Progress Update: Temporary Expert Committee for "Vegetarian and Vegan Foods")link.

BELGIUM – ADVICE ON USE OF UBIQUINONE AND UBIQUINOL FOR USE IN FOOD SUPPLEMENTS by Sebastian MELCHOR

In a recent report from the Belgian High Health Council, the latter body advises against the demand for a higher maximum use level of ubiquinol in food supplements. The assessment on the use of ubiquinone and ubiquinol originates from a request by the Belgian sector association NAREDI, to increase the permitted level ubiquinone from 200 mg/day to 300 mg/day allowed in food supplements. The report also considers the use of ubiquinol. For the latter compound currently no maximum permitted level applies in Belgium.

In the opinion of the Health Council nothing illustrates that there would be any benefit for the general, healthy population from the consumption of higher levels of ubiquinone. Similarly for ubiquinol, no evident health benefits were identified leading to the conclusion that a 200 mg/day would be appropriate. In its assessment the High Council refers to earlier EFSA opinions were the cause effect relationship of several proposed health claims could not be established as well as opinions from the Italian and Spanish authorities which advocated a maximum level of 200 mg/day for ubiquinone in food supplements.

Hoge gezondheidsraad - algemeen advies betreffende het gehalte aan “ubiquinon” in voedingssupplementen en advies betreffende de veiligheid van het ingrediënt “ubiquinol” in voedingssupplementen – link (dutch)/(french)

NEW REGULATION ON ORGANIC PRODUCTION AND LABELLING APPROVED BY EU PARLIAMENT by Nikolaas Tilkin-Franssens

In order to ensure the quality attributes related to organic production, the European parliament has approved the below named Regulation-proposal that would amend the current rules covering organic production and labelling. The initiative involves stricter controls on production and imports of organic produce. On the other hand, the rules intent to boost organic agriculture. It will now be possible for farms to combine both conventional and organic farming. On the other hand, safeguards are introduced to avoid potential contamination and guarantee corresponding labelling. The next step in the legislative procedure is the agreement of the Council of Ministers in order for the Regulation to enter into force and apply from 1 January 2021.

Draft Regulation on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 - link

EFSA OPINION ON GREEN TEA CATECHINS by Nikolaas Tilkin-Franssens

Due to concerns of potential liver damage related to the intake of catechins through food supplements, the European Food Safety Authority has assessed safe intake levels for green tea catechins. The panel of the Authority concluded that there is generally no risk from the consumption of green tea infusions as well as other beverages with an equivalent composition.

With the use of food supplements however, the daily intake of epigallocatechin gallate -the main catechin present in green tea- can go up to 1000 mg per day. The Panel concluded that doses equal to or above 800 mg/day can be associated with initial signs of liver damage. The available data was considered insufficient to establish a safe dose. Further studies on safe doses of catechins are therefore welcomed.

EFSA - Scientific opinion on the safety of green tea catechins (18 april 2018) link.

New positive list of other substances adopted in Spain by Sebastian MELCHOR

For the first time, Spanish manufacturers will be able to include very well known ingredients such as Omega-3 fatty acids, L-Carnitine, lycopene or fructooligosaccharides in the composition of food supplements without having to notify their products in another EU country and then use mutual recognition. This situation, the new law admits, was diminishing the competitiveness of Spanish companies within the framework of the EU market.

This is the result of a long-awaited list of other substances with a nutritional or physiological effect that may be used in the production of food supplements has finally been published in the Spanish Official Gazzette, nine years after the implementation of Directive 2002/46/EC.

However, the list of around 60 substances of Royal Decree 130/2018 falls short of the around 400 substances that, according to the same law, are currently being added to food supplements in the EU. Also, the list does not include any plants or botanical extracts, which means that the situation will not change much for the Spanish producers in practice.

A mutual recognition clause has been added, enshrining the now well accepted practice of allowing food supplements legally marketed in other EU countries, even if they contain botanical extracts or other substances not included in the Spanish positive list.

However, it remains to be seen whether the new maximum limits laid down in the Real Decreto 130/2018 [e.g. a maximum daily dose of 3 grams for omega-3 fatty acids (DHA + EPA)] and the mandatory warnings for some substances (e.g. "Must not be consumed by pregnant women and nursing mothers or by children" in products containing glucosamine) will also apply in spite of the mutual recognition clause, since the safety of these substances has been evaluated by the Scientific Committee of the Spanish Agency of Food Safety and Nutrition.

Real Decreto 130/2018, de 16 de marzo, por el que se modifica el Real Decreto 1487/2009, de 26 de septiembre, relativo a los complementos alimenticios.