free movement of goods

Switzerland: Legal reform opens up nutritional supplements market by Lara Skoblikov

In May 2017, a new Swiss legal regime on foodstuff has come into play in line with the food regulations applicable in the European Union (EU). As a result, companies finally have the opportunity to market food supplements in Switzerland without having to make drastic changes to their products and go through the burdensome authorization procedures. In fact, the absence of a notification requirement for food supplements makes Switzerland one of the most favorable countries to market in Europe. Still, the Swiss standards contain some particularities that should be kept in mind when entering the market.

Switzerland is not part of the EU and maintains its own set of food standards. Up until now, Switzerland was applying the so-called “positive principle”, according to which any food or food ingredient not expressly authorized under Swiss standards required express pre-marketing authorization, a procedure that could take months. This constraint particularly affected innovative products with unconventional ingredients among which many food supplements.

The new rules on foodstuff aim to facilitate the entry of food products originating from the EU member states into Switzerland and vice versa. Following the example of the EU, the “positive principle” has been abandoned. Instead, foods and food ingredients may be used freely unless they are prohibited or restricted under Swiss regulations. In practice, this means a significant liberalization of the use of ingredients. Still, maximum levels for vitamins and minerals, the express prohibition of certain plants and other substances have to be respected. Also, it is prohibited to sell foods that are unsafe, have medicinal properties or are novel foods.

An important change in the revised Order on Food Supplements is that it classifies food supplements as foodstuffs, which means that general food regulations apply mutatis mutandis to food supplements. This includes the Orders on food labelling and claims and the use of food additives, which have also been revised and are now almost fully in line with their European counterparts.

This logic applies equally to novel foods, which are foods or food ingredients that have not been consumed to a sufficient degree before 15 May 1997. Both in Switzerland and the EU their use is reliant on pre-market approval involving a thorough safety assessment. Considering the use of unique substances in innovative food supplements it places a significant red tape on their marketing potential. Under the new regime, Switzerland will accept novel foods authorized in the EU and foods that have a history of consumption before 1997 in any of the EU countries.

Unquestionably a major benefit of targeting the Swiss market is the absence of the obligation to register or notify food supplements. Almost every country in the EU requires that food supplements are notified prior to their commercialization, which can delay or complicate their marketing and may involve the payment of a fee. In the absence of such requirement, the commercialization in Switzerland is a favorable opportunity as it does not create additional administrative burdens or costs.

Considering all the above, food supplements compliant with EU standards in terms of composition and labelling will usually find easy entry into Switzerland.

The sting in the tail comes with some particular disparities left between the new Swiss rules and its European foundations. This is because in the absence of full harmonization of EU food supplement legislation, the EU countries have maintained their own maximum levels for nutrients and rules on the use botanical preparations and other substances. Switzerland now adds this rather chaotic system by setting its own maximum levels vitamins and minerals, which are nevertheless for the most part in line with the general EU trend. They have also set maximum levels for amino acids, fatty acids and some other substances, minimum amounts for their label declaration and mandatory warnings in some cases. Such restrictions are less common in the EU countries. Therefore, it will remain indispensable to verify compliance of a food supplements’ composition and labelling when introducing it into Switzerland or an EU country.

Finally, in certain areas where the EU is failing to take initiative, Switzerland has done so. For example, the Swiss Labelling Ordinance sets out clear conditions for the use of the terms “vegetarian”, “ovo vegetarian”, “lacto vegetarian” and “vegan”, something that the EU has been attempting for years now. Another example is the authorization of three insect species as food ingredients, something which could be considered especially courageous compared to the EU who maintains a cautious and legalistic approach by considering all insects novel foods.

All in all, the goal of removing the barriers to trade appears to be achieved by the reform and Switzerland can now be considered a serious food supplement market in Europe.

 

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

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.