EU prepares for maximum levels challenge

EASIn the European Union, discussions continue towards harmonising the rules on maximum levels for vitamins and minerals in foodstuffs. With all 27 Member States currently applying their own maximum levels for these substances, huge differences prevail across borders. The result is a minefield of confusion for both consumers and the food industry, and in response the European Commission's recently published Orientation Paper on the issue could hold the key to how harmonisation could take place.

Maximum levels in the different EU Member States differ dramatically. The use of vitamin C in a food supplement for example, is allowed at a daily maximum level of 60mg in Spain; 135mg in Greece; 180mg in Belgium and France, and up to 2000mg in the Czech Republic. Additionally, some Member States, including the Netherlands and Sweden, generally apply safety levels for vitamins and minerals while others refer to guidance levels, as in the UK. To add a further complication, national differences among certain population groups, such as children or adults, can be a barrier for companies targeting all 27 EU Member States with vitamin and mineral supplements.

In practice, it is imperative for businesses to be aware of all existing national levels in the EU when formulating a vitamin and/or mineral supplement. Grouping countries with similar acceptable levels could be a useful strategic tool, albeit not as straightforward as it seems because of the member State differences. Is a maximum level of 180mg for vitamin C, for example, out of place if another Member State supports an upper safe level of 1000mg? For many companies, introducing a low dosage food supplement which is acceptable in several markets is not the best solution, even if these vitamin and mineral supplements make up the largest part of the food supplement market. This could be, for example, because high level dosage is necessary in order to substantiate a claim.

Traditionally maximum levels for vitamins and minerals have in many European countries been based on a 'recommended daily allowance' (RDA) which was considered to meet the requirements of most healthy individuals. When the EU Food Supplement Directive was passed in 2002 however, it was decided that safe maximum levels should be established by scientific risk assessment taking into account vitamin and mineral intake from other dietary sources.

The Commission's Orientation Paper has further expanded on this. It states that RDAs should serve as indicators to detect deficiencies in the population, and to categorise nutrients on the basis of their risk of exceeding their upper intake levels. It also states that maximum levels should not differ among the various population groups at this stage, because the specificities of these groups have already been taken into account.

Member States met for the first time in September to discuss the Orientation Paper, and while the process is moving forward, the Commission admitted the move towards harmonisation will be a complex and lengthy process. When it gets there, harmonisation will ultimately lead to pan-EU maximum levels, allowing industry to sell the same vitamin and/or mineral formulation across all Member States. Before it gets there however, much more discussion will be needed to bring the EU's 27 Member States closer to consensus.

Pieter Lagae, Regulatory and Marketing Adviser, EAS, 50 Rue de l'Asssociation, 1000 Brussels, Belgium. Tel: (+32 2) 218 14 70, Fax: (+32 2) 219 73 42, email [email protected], visit

Hide comments


  • Allowed HTML tags: <em> <strong> <blockquote> <br> <p>

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.