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.

France adjusts maximum nutrient levels for food supplements after ECJ ruling by Nikolaas Tilkin-Franssens

On 17 January 2018, the French Directorate-General for Competition, Consumer Affairs and Fraud Control (DGCCRF) indicated that it will lift the current maximum limits for the vitamins B1, B2, B5, B8, B12 and vitamin K.

The strict application of maximum levels by the French authorities has been the subject of a Court of Justice ruling last April 2017 (see our news item posted on 5 May 2018). The Court argued that under current EU law, diverging maximum limits between member states may be applied if they are based on the most reliable scientific data available and the most recent results of international research. The data relied on by the French authorities was outdated and based on national scientific evidence.

As a consequence, the DGCCRF has presented a proposal for the establishment of new maximum levels of vitamins and minerals for use in food supplements taking into account the recommended values established by EFSA (See Recommandations sanitaires relatives aux nutriments). Eventually, the values in the Decree on nutrients (Arrêté du 9 mai 2006 relatif aux nutriments pouvant être employés dans la fabrication des compléments alimentaires) will be updated on the basis of the proposal. For the time being, the values in the proposal are to be applied as indicative limits.

Novel food consultation request formalized by Nikolaas Tilkin-Franssens

An implementing Regulation adopted on 19 March 2018 determines the procedure for the ´consultation process´ regarding the novel food status of foods and food ingredients. Under the Novel Food Regulation (Regulation 2015/2283), food business operators are responsible to consider the novel food status of the foods and ingredients they use. In order to assist in the assessment a request may be directed to the Member States. The Regulation formalizes the procedure for the concerned requests.

The consultation request should be directed to the Member State where the operator intends to first market the food, and the request should also be limited to that Member State. Further, the implementing Regulation imposes formal and material requirements. Following the submission, the Member State shall decide on its validity.

Following the validity of the request, the Member State shall conclude on the novel food status within 4 months. The concerned Member State shall notify the operator, the other Member States and the European Commission. The Commission shall make the decision and related information publicly available on its website.

Food business operators can request confidential treatment of – a part of – the information they provide to the Member State in their consultation request. Important however is that confidentiality shall not affect the exchange of information between the Commission and the Member States necessary to consider the consultation requests.

Commission Implementing Regulation (EU) 2018/456 of 19 March 2018 on the procedural steps of the consultation process for determination of novel food status in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods

EFSA publishes new Guidance on novel food submissions by Nikolaas Tilkin-Franssens


With the recent entry into force of the new novel food Regulation (Regulation (EU) 2015/2283) on 1 January 2018, the European Food Safety Authority has published a guidance on the presentation of new applications. The Guidance contains a checklist regarding the documentation required by article 10 of Regulation 2015/2283 and tables in order to summarise the accompanying scientific studies .

Administrative guidance on the submission of applications for authorisation of a novel food pursuant to Article 10 of Regulation (EU) 2015/2283



The Authority responsible for food safety compliance (NVWA) has adopted a new policy on public interventions in relation to infringements of compositional requirements applicable to food products. Foods covered in particular are food supplements, herbal preparations, fortified foods, food for specific groups and novel foods.

The document provides a classification of infringements based on the potential implication on public health, misleadingness towards consumers and the targeted population group. Further, the respective responses to infringements are listed. In general, the policy adheres to administrative sanctions, although under certain conditions Dutch law prescribes the mandatory application of criminal sanctions. Worth mentioning, the inspection on the composition of food supplements and herbal preparation is mainly focused on the authorized sources of vitamins and minerals, the Dutch maximum limits for vitamin D and A and the existing national restrictions on the use of plant substances.

Specifiek interventiebeleid samenstelling levensmiddelen (31 January 2018)


In the preparation of the United Kingdom´s leave from the European Union, the European Commission has issued a notice clarifying the possible implications for food businesses. If no -transitional- agreement is reached before the divorce date, being 30 March 2019, the EU legal framework will cease to apply to  the United Kingdom. This will bring about important legal consequences which should be anticipated by economic operators active in the commercialization of food products at both sides of the Channel.

Foods originating from the UK will need to continue compliance with EU standards. This applies for instance to the lists of authorised food additives and sources of vitamins and minerals or the use of food contact materials. Of particular importance are the EU rules concerning food labelling. It will be necessary to provide the business name and address of an EU established importer on UK sourced products.

The notice continues listing other potential issues including the introduction of border controls, the import restrictions for foods of animal origin and the cessation of UK authorities being a EU contact point. The latter implies that certificates issued by UK control bodies permitting the use of organic logos shall no longer be valid.

With no definite Brexit plan ready, not to mention the absence of food-specific arrangements, awareness of the potential implications for affected business is of utmost importance.

Commission Notice to stakeholders withdrawal of the United Kingdom and EU Food Law

UK - ASA RULING ON PFIZER BEAUTY CLAIM by Nikolaas Tilkin-Franssens

The UK Advertising Standards Authority considered the use of a claim relating the use of a food supplement drink containing collagen indicating dermal skin action to be in breach of the Advertising Codes on Food Supplements and claims. The latter is a voluntary standard reiterating the requirements and restrictions under the EU Nutrition and Health Claims Regulation (Regulation 1924/2006). The body argued that the statement had to be considered a specific claim which requires express authorization in accordance with Regulation 1924/2006.

UK ASA - Pfizer Consumer Healthcare Ltd (03 January 2018)


The German Federal Institute for Risk Assessment (BfR) has published new maximum amounts for the safe use of vitamins and minerals in food supplements. The indicated levels apply to persons from 15 years of age. In the publication the established values are further explained and substantiated. Though it must be stressed that the proposed values concern a mere recommendation and as such higher levels do not preclude commercialization in Germany. The levels may however serve as a marker for the safe use of the concerned nutrients in food supplements.

Höchstmengen für Vitamine und Mineralstoffe in Nahrungsergänzungsmitteln German (English summary)


The European Food and Food Safety Authority (EFSA) found that orthosilicic acid-vanillin complex (OSA-VC) is safe for use as an ingredient in food supplements at the proposed uses. The substance will, upon authorization by the European Commission, find approval as a novel food substance and therefore provide an additional source for the dietary intake of silicon. The EFSA panel did however propose that parameters are adopted in the final authorization to limit the ethanol, phosphorus and phosphate ion residuals in the manufacturing process.

EFSA Scientific Opinion on the Safety of orthosilicic acid-vanillin complex (OSA-VC) as a novel food ingredient to be used in food supplements as a source of silicon and bioavailability of silicon from the source

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


ASA withholds implicit ´as much as´ nutrition claim by Nikolaas Tilkin-Franssens

The recent Advertising Standards Authority (ASA) case deals with a Heinz baked beans tv ad. The commercial highlights the nutritional content of baked beans displaying the authorized claims ‘high in protein’, ‘high in fibre’ and ‘low in fat’. However prior to displaying the authorized claims for baked beans, the commercial makes an assertion about the protein, fibre and low fat content of an unidentified drink. A comment follows which associates the nutritional features of that unidentified drink with baked beans.

ASA found that such amounts to a ‘as much as’ claim which is not permitted under the Nutrition and Health Claims Regulation 1924/2006.

ASA Ruling of  29 November 2017 on HJ Heinz Foods UK Ltd Find: link