European Union: EU Agrees Rules on Fortification of Foods

The European Union has agreed harmonised rules on the addition of vitamins, minerals and other substances to foods. The Regulation is expected to be formally adopted and published shortly in the EU's Official Journal. The final text represents the compromise between the European Parliament ("EP"), the Council (that is, Member States' Ministers) and the European Commission that was approved by the EP in May 2006. Certain minor amendments were made to the Common Position that had previously been agreed by the Council, but the main provisions remain unchanged. The new Regulation is closely linked to the Nutrition and Health Claims Regulation.

Current laws on fortification or enrichment of foods vary across the Community. The Regulation aims to set out an EU-wide common regulatory framework for the addition of vitamins, minerals and other fortifying substances, whilst addressing concerns relating to the safety of over-consumption of certain vitamins and minerals.

The Regulation will not affect provisions in national legislation that require the addition of vitamins or minerals to particular foods (for example, in the UK white and brown bread must contain certain specified quantities of various nutrients). Furthermore, there are already detailed EU rules governing food supplements (that is, supplements taken by the consumer separately from food products) that will not be affected by the Regulation.

The Regulation:

• sets out an EU-wide "positive" list of vitamins and minerals (and the specific permitted formulations of those vitamins and minerals) that may be added to foods. Any vitamins or minerals not on this list will not be allowed to be added to foods. This list may be amended from time to time
• sets out the framework for establishing the minimum and maximum levels of the permitted vitamins and minerals in a food or food category. When setting the permitted levels, the following factors will be taken into account:

• the outcome of a scientific risk assessment based on generally acceptable scientific data

• intakes of vitamins and minerals from other dietary sources

• the contribution of individual foods to the overall diet of the population

• any nutrient profile established for the particular food in accordance with the Nutrition and Health Claims Regulation

• imposes labelling requirements for any fortified foods. The Regulation requires a fortified product to display the total amounts of vitamins and minerals in that food. In this regard, the Nutrition and Health Claims Regulation, which requires various conditions to be met before any nutrition or health claim may be made, is also relevant

• gives powers to the European Food Safety Authority (the "EFSA") to scrutinise substances other than vitamins and minerals in due course. If necessary, use of such substances may be restricted or forbidden in the future

• prohibits the addition of vitamins and minerals to unprocessed foodstuffs (including fruit, vegetables, meat, poultry and fish). Fortification of alcoholic drinks, other than fortified tonic wine, will also be forbidden.

The Regulation will enter into force 20 days after its publication in the EU's official journal.

Transitional provisions will apply. Business will not need to comply with the Regulation for up to six months (the "date of application"). In addition, there is a transitional period that will allow businesses to continue to market products that do not comply with the Regulation for up to three years, provided that they were labelled or placed on the market prior to the date of application.

In addition, vitamins and minerals not on the approved list may continue to be added to foods for seven years following the date of entry into force of the Regulation, provided that each of the following conditions is fulfilled:

• the substance has been used for addition to foods prior to the entry into force of the Regulation

• a dossier supporting use of the substance is submitted to the Commission within three years of the Regulation coming into force

• the EFSA has not given an unfavourable opinion in respect of the use of that substance.

A Community-wide register collating the various information associated with the Regulation will be made open to the public. The register will contain:

• the list of permitted vitamins and minerals
• the list of the permitted formulations of those vitamins and minerals
• details of the maximum and minimum amounts of vitamins and minerals which may be added to various foods
• information on national provisions on the mandatory addition of vitamins and minerals
• details of the foodstuffs to which vitamins and minerals may not be added
• a list of any substances for which a dossier has been submitted under the transitional provisions described above
• details of any other substances whose use is prohibited or restricted.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.