food supplements

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

NEW ITALIAN “BELFRIT” DECREE PUBLISHED by Joris Geelen

The Italian authorities have published the highly anticipated decree on botanicals which integrates the so-called “BELFRIT” list, authorizing the use of more than 1000 plants and mushrooms in food supplements.

The decree includes a positive list of plants and mushrooms authorized for use in food supplements, together with mandatory warnings and maximum levels. Compared to Belgium, who published their version of the list last year, Italy has less restrictions, as shown in the following examples:

  • Contrary to Belgium and France, there are no maximum levels for anthranoid containing plants like Aloe or Rheum spp. (which are being disputed on EU level), Black cohosh, Hawthorn, Chamomile, Crocus, Devil's claw, Echinacea, Ginger, Hedera, Hops, Saw palmetto, Nettle, Valerian. Note that for most of them there is an EMA monograph;

  • Some plants do not have mandatory warnings as it is the case in Belgium e.g. Curcuma, Chaste tree, Verbena;

  • The decree authorizes stevia leaves, cannabis seeds and oil.

Besides this, and similar to France, the decree includes a list of information necessary for the correct and safe use of botanicals :

  • a clear definition of botanical preparation;

  • information and websites for the identification of plants; and

  • information on the preparation, the traditional use and the production process of the final product.

A separate decree on other substances establishes maximum levels for certain naturally occurring botanical substances with a physiological effect or of possible concern (for example EGCG and isoflavones).

As a transitional measure, foodstuffs that do not comply with the provisions of the new decree, but are compliant with the provisions of the former decree of 9 July 2012, can still be placed on the market until exhaustion of stocks.

Analysis

From the examples one could conclude that Italy takes a more liberal approach to risk management than Belgium. Where Belgium has a maximum limit for certain plants or substances of concern, Italy often resorts to less restrictive measures, mandatory warnings. On the other hand, in Italy there are no provisions exempting botanicals when these compounds have been removed or reduced to safe levels. Moreover, there are no official procedures for consulting the Italian Commission for Dietetics and Nutrition (CUDN), as is the case for the respective advisory commission in Belgium.

In our practice we help our clients to prepare the information necessary for the correct and safe use of botanicals, as part of a due diligence process. However, the authorities would most probably only ask for this information after a problem has arisen.

Overall, we remain positive about this decree. This harmonization together with the digital notification system has made the access to the European market more streamlined. 

Decree regulating the use of vegetable substances and preparations in food supplements, replacing the Decree of the Minister for Health of 9 July 2012

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 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.

New Belgian decree on nutrients published by Joris Geelen

The decree removes maximum levels for several vitamin B sources, increases the maximum level of Vitamin C to 1 gram and introduces new mandatory warnings.

What will change?

The maximum levels are mainly based on the advice of the Superior Health Council of June 2015.[1]

The decree introduces the following changes: 

  • removal of the existing maximum levels for: vitamin B1 (thiamin), vitamin B2 (riboflavin), vitamin B12, pantothenic acid, biotin and chloride;

  • new maximum levels for boron (3 mg) and fluoride (1.7 mg);

  • increased maximum levels for the following nutrients: vitamin C (1000 mg), vitamin D (75 µg), vitamin E (39 mg), vitamin K (210 µg), folic acid (500 µg), iron (45 mg) and copper (2 mg); and

  • decreased maximum levels for manganese, from 5.25 to 1 mg and for nicotinic acid and inositol hexanicotinate (vitamin B3) the level is reduced from 54 to 10 mg

To ensure safe use, the following warnings will become mandatory in the labeling of foodstuffs containing (a daily dose that exceeds) the following levels of nutrients: 

  • 25 μg vitamin K: “Not suitable for people taking coumarin anticoagulants.”;

  • 1000 mg potassium: “Not suitable for elderly people or people with a renal disorder, insulin-resistant diabetes or people with arterial hypertension.”;

  • 10 mg zinc: “The intake of zinc should be limited to a period of a few weeks/months.”; and

  • Nicotinic acid or inositol hexanicotinate: “Not suitable for pregnant or lactating women”.


Other changes?

Furthermore, the decree simplifies the existing notification requirement for fortified foods. The notification procedure no longer requires a full list of ingredients of the fortified food product. Information on the added nutrients (type and amount) per recommended daily intake or quantity of the nutrient equivalent to the average daily nutrient intake, now suffices.

Lastly, the decree adds an additional provisions on mutual recognition. A written application can be submitted to the Belgian authorities with evidence showing that the product has been legally marketed in another Member State. Under the previous decree, firms could submit requests for derogation from the maximum levels to the Superior Health Council. 


When will it be applicable?

The decree was published on October 31, 2017. As a transitional measure, foodstuffs already placed on the market that do not comply with the provisions of the decree, but do comply with the provisions of the previous decree, can still be placed on the market until November 10, 2019. 

 

What about the other EU countries and the Commission?

Besides Belgium, most EU Member States have adopted maximum levels for vitamins and minerals.

Italy[2] and France[3] have set legally binding maximum levels for all vitamins and most minerals.  

Recently the Netherlands, one of the most liberal EU countries regarding the addition of nutrients or other substances, announced their intention to set a maximum level for vitamin B6. The levels, based on a report of the Dutch Food Safety Authority (NVWA), would be 21 mg for adults and 3-13 mg per day for children, depending on the age. The former would be lower than the upper level of 25 mg published by EFSA, and significantly higher than the low levels in Belgium (6 mg) and Italy (9.5 mg).

Germany is currently working on new maximum levels for vitamins and minerals.

 

Comments

As long as there are no EU-wide maximum levels set for vitamins and minerals, EU countries still have the right to set their own maximum levels in national regulation. This is often done based on a risk assessment of their local scientific bodies, and not by directly applying the tolerable upper intake levels for vitamins and minerals set by EFSA.

Although it is good to see that Member States are applying science-based policies, it is clear that, as long as the European Commission does not cut the Gordian knot and finally adopt EU-wide maximum levels, EU countries will each set their own levels based on their interpretation of the science. As a result, the mutual recognition principle does not always ensure EU wide acceptance when it comes to maximum levels of vitamins and minerals.

Recently though, in the case C-672/15, the Court found that, whilst France could maintain its own maximum levels, the absence of a procedure for authorizing food supplements marketed in other EU countries with levels above those limits made the legislation contrary to the principle of mutual recognition.

In its judgement the court also confirmed that maximum limits should be based on the most reliable scientific data available and the most recent results of international research. They may not be based merely on national scientific opinions, if recent international scientific opinions concluding in favor of the possibility of setting higher limits are also available on the date of the adoption of the measure at issue.

 

[1]        Opinion No° 9285 of the Superior Health Council in respect of the dietary recommendations for Belgium, issued on 7 September 2016 (http://www.health.belgium.be/nl/advies-9285-voedingsaanbevelingen-voor-belgie-2016, available in Dutch and French)

[2]        Apporti giornalieri di vitamine e minerali ammessi negli integratori alimentari (http://www.salute.gov.it/imgs/C_17_pagineAree_1268_listaFile_itemName_5_file.pdf)

[3]      Arrêté du 9 mai 2006 relatif aux nutriments pouvant être employés dans la fabrication des compléments alimentaires.

European commission authorized two new mineral substances by Joris Geelen

The European Commission has recently authorized two new mineral substances for use in food and food supplements.

Commission Regulation 2017/1203/EC of 5 July 2017 amended Directive 2002/46/EC for food supplements and Regulation 1925/2006/EC on the addition of vitamins and minerals and of certain other substances to foods. The two new mineral substances that were added are:

  • Organic silicon (monomethylsilanetriol) as source of silicium; and

  • Calcium phosphoryl oligosaccharides (POs-Ca®) as source of calcium.

The full text of this regulation is available on : http://eur-lex.europa.eu/eli/reg/2017/1203/oj

Italy: increased maximum levels for vitamin B12, vitamin D and vitamin K by Joris Geelen

Italy has adopted new maximum levels for vitamin B12, vitamin D and vitamin K in food supplements, in line with the levels proposed by the European Food Safety Authority (EFSA). The new maxima for these three vitamins are :

  • 1000 µg vitamin B12;
  • 50 µg vitamin D; and
  • 180 µg vitamin K.

This proactive stance can be acclaimed, especially because recently a ruling of the Court of Justice of the EU once more confirmed that national maximum levels should be based on the most recent results of international research, which should be understood as entailing an obligation to update the levels whenever newly established data becomes available.


Apporti giornalieri di vitamine e minerali ammessi negli integratori alimentari Revisione maggio 2017

French law on vitamins and minerals contrary to EU law, Court of Justice of the EU by Sebastian MELCHOR

The French law which rejects food supplements from other EU countries with vitamins and minerals above the French national limits is contrary to EU law, according to a recent ruling of the Court of Justice of the EU.

The Court found that, whilst France could maintain its own maximum levels, the absence of a procedure for authorizing food supplements marketed in other EU countries with levels above those limits made the legislation contrary to the principle of mutual recognition.

It is expected that the ruling puts an end to a long-standing practice in France of refusing food supplements with vitamin and mineral levels above informally established maximum limits, irrespective of whether the products have been lawfully marketed in other EU countries.

PRACTICAL CONSEQUENCES

The ruling may have a significant impact on food supplement sellers in France, who so far have been prevented from using vitamins and minerals exceeding informally established maximum levels (often slightly higher than the legal limits), even if the products are lawfully marketed in other Member States.

These informal levels correspond with recommendations of the French Food Safety Agency, sometimes decades old. In practice, new scientific information cannot be successfully invoked since the authorities base their assessment exclusively on the old recommendations. This has resulted in France maintaining certain stricter standards compared to the rest of the EU.

For example, France applies a maximum vitamin C level of 250 mg/day in food supplements, while Belgium and Italy have raised their maximum levels to 1000 mg/day since they acknowledge that no toxicity has been established for this level in the generally accepted scientific data, including the most recent national and international scientific publications.

COURT REMINDS FRANCE HOW MAXIMUM LEVELS SHOULD BE SET

Furthermore, the Court reminded France that setting maximum limits should be done on a case-by-case basis, taking into account the upper safe levels established after a comprehensive scientific assessment of the risks for public health. The analysis should be based not on general or hypothetical considerations, but on relevant scientific data.

The Court left to the national court to determine the conformity to EU law of the French system, which is based on the adoption of maximum limits in relation to the recommended daily allowances (RDAs) i.e. a value equal to three times the RDA for nutrients presenting the least risk, equal to RDAs for those presenting a risk of the upper safe level being exceeded and a value below those allowances or even zero for the nutrients involving the most risk.

SCIENTIFIC REPORTS CANNOT BE NATIONAL ONLY

Finally, the Court confirmed that maximum limits should be based on the most reliable scientific data available and the most recent results of international research. They may not be based merely on national scientific opinions, if recent international scientific opinions concluding in favor of the possibility of setting higher limits are also available on the date of the adoption of the measure at issue.

CONSULT LATEST DATA, COURT SAYS

The ruling explains that France should first of all implement a procedure in their legislation enabling firms to obtain the authorization to use levels of vitamins and minerals above the legal limits for food legally marketed or manufactured in other EU Countries.

In addition, since the most recent scientific data concluding in favor of higher limits should be taken into account when establishing legal maximum levels, any new scientific data should also be taken into account when assessing products marketed or manufactured in other EU Countries. Referring to old assessments if new information has become available, nationally or internationally, would run counter to the principles set out in the ruling.

Judgment of the Court of 27 April 2017 in Case C‑672/15, Noria Distribution SARL

New Belgian “BELFRIT” decree on botanicals applicable by Joris Geelen

Belgium has published a new decree, updating the three lists of botanicals. These new lists are based those drafted in the so-called “BELFRIT” project, a close cooperation between Belgium, France and Italy to harmonize the legislation on botanicals in food supplements.

The number of plants authorized in food supplements in Belgium has increased significantly, from about 645 to more than 1000 plants. Consequently a considerable number of new conditions of use are now applicable. New maximum levels and mandatory warnings for about 250 plants will have to be taken into account when notifying food supplements.

As a transitional measure, foodstuffs that do not comply with the provisions of the new decree, but are conform with the provisions of the former decree, can still be placed on the market until February 20th of 2019. Therefore non-compliant products can not be sold until the end of the expiry date, after the transition period. They will have to be withdrawn from the market.

Royal Decree of 29 August 1997 concerning botanicals - Consolidated version (Dutch and French)

How the Food Information for Consumers Regulation (FIC) will change food supplements labelling by Sebastian MELCHOR

Regulation 1169/2011 on the provision of food information to consumers (the FIC Regulation) will be applicable as from December 13, 2014. This is the second of a series of news alerts specifically addressing how those rules will impact foods manufacturers and distributors. Food supplements are classified by EU law as foodstuffs. As such, the legal provisions that apply to regular food generally apply to food supplements too. This News Alert looks at FIC rules which particularly impact food supplements labels.

Presentation of food supplements’ mandatory particulars

FIC defines mandatory food information as particulars that EU provisions require to be provided to the final consumer. Such information must be marked in a conspicuous place in such a way as to be easily visible, clearly legible and, where appropriate, indelible. The minimum font size (1.2 mm) set out in FIC is new. The presentation of warnings and statements that are mandatory in the label of food supplements (e.g. ‘Do not exceed recommended daily dose’ or ‘Keep out of reach of young children’) must also follow these new provisions.

The names of any allergens on the list of ingredients must be emphasized through a typeset that clearly distinguishes it from the rest of the ingredients - for example, by means of font, style or background colour. The most common solution is to bold the name (or the part of the name) of the ingredient.

Food additives must be designated by the name of that category, followed by their specific name or, if appropriate, E number (e.g. glazing agent - hydroxypropyl methyl cellulose or glazing agent - E 464). The name of the food additive category should always appear as first. The decision whether to use to name or E number is quite important, for instance when the product contains aspartame. If this sweetener is designated in the list of ingredients only by reference to the E number, the additional labelling particular is ‘contains aspartame (a source of phenylalanine)’. Otherwise, if the designation is by the specific name, the additional labelling particular is ‘contains a source of phenylalanine’.

Food supplements placed on the market after December 12, 2014 to which caffeine is added with a physiological purpose should bear in the same field of vision as the name (food supplement) the warning: ‘Contains caffeine. Not recommended for children or pregnant women’. The caffeine content should be expressed per portion as recommended for daily consumption on the labelling.

Mandatory particulars, such as the instructions for use, must be indicated with words and numbers, pictograms or symbols being only an additional means to express such particulars. Food supplements in powder or in other forms which require mixing of the product with water or other liquids should therefore include written instructions and not only depictions.

Nutrition declaration

Food supplements are exempted from the mandatory nutrition declaration. Nevertheless, if provided voluntarily, such information must comply with FIC. This applies to all seven mandatory nutrients: energy, fat, saturates carbohydrate, sugars, protein, and salt. Pursuant to Food Supplements Directive 2002/46/EC, the amount of the nutrients or substances with a nutritional or physiological effect present in the product, have to be declared on the labelling. For consistency, the European Commission advises using the same terminology for food supplements as for other foods. Thus, ‘Reference Intakes’ should replace ‘Recommended Daily Allowance’. As a general rule the nutrition declaration is required for the food as sold, but where appropriate, it can instead also relate to the food as prepared. Most of food supplements bear nutrition and health claims which should refer to the food ready for consumption. Therefore, when it comes to food supplements that bear nutrition and health claims and need preparing before consumption, nutrition labelling relating to the food as prepared might be more convenient for both consumer and producer. On the other hand where there are various preparation options – such as with water, with milk or with juice, such obligation may force a choice of only one option.

For nutrition declaration purposes as well as the declaration of the vitamins and minerals present in food supplements, the names listed in Annex XIII of FIC should be used. For instance, ‘Thiamin’ cannot be replaced with B1 or ‘Folic acid’with B9.

COOL

The indication of the country of origin or of the place of provenance (COOL) is mandatory for certain foodstuffs (e.g. beef, honey, olive oil). It also should be provided whenever its absence is likely to mislead consumers as to the true country of origin or place of provenance of that product. In some cases, producers indicate the origin of a food on a voluntary basis to draw consumers’ attention to the qualities of their product (e.g. ‘Product of USA’, ‘Produced in EU’). Such indications should also comply with harmonised criteria. Moreover, where the country of origin or the place of provenance of a food is given and where it is not the same as that of its primary ingredient (i.e. ingredient that represents more than 50 % or which is usually associated with the name of the food) COOL of the primary ingredient must be indicated as different to that of the food. With regard to food supplements, the origin of plant extract or even of the capsule may have impact on the correct labelling.

Responsibilities

FIC applies to food business operators (FBO) at all stages of the food chain, where their activities concern the provision of food information to consumers. The operator under whose name the food is marketed is responsible for the food information. For imported food where FBO does not operate in the EU, the importer may be responsible for the food information. It is mandatory to indicate on the label the name or business name and address of the food business operator responsible for food information. Although, it will be still possible to mention more that one FBO on the label (e.g. ‘produced by… for …’), there should be clear indication which FBO is responsible for food information. Some companies have already been using the statement: ‘food business operator responsible for the food information: … ’.

Labeling, advertising, presentation

It is worth bearing in mind that not only labels are affected by FIC but also information concerning a food and made available to the final consumer by means of a other label accompanying material, or any other means including modern technology tools or verbal communication. This includes also advertising and presentation. 
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Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers changes the EU’s legal regime on food labelling, advertising and promotion, replacing two EU directives.

As with all regulations, FIC is binding in its entirety and directly applicable in all Member States. This should mean that food information provisions are the same in all EU countries. Member States will continue to be responsible for enforcement of food law, as well as monitoring and verifying the compliance of food business operators.