European Union: European Council Adopts Regulation On The Fortificaton Of Foods

On 12 October 2006, a new EU Regulation setting out harmonised rules on the addition of vitamins, minerals and other substances to foods (the "Regulation") was finally agreed by the Council following a legislative process initiated in November 2003.

Although the Regulation was agreed on 12 October, it was formally adopted only on 20 December as it contained reference to the wrong comitology procedure. As such, it needs to be amended in the same way as the new Nutrition and Health Claims Regulation, which also contained reference to the wrong comitology procedure when it was adopted (see "Next Steps" section of previous article for more detail). The Regulation will enter into force on 19 January and shall apply from 1 July 2007.

The addition of vitamins and minerals to foods is currently regulated in EU Member States by differing national rules which impedes the free movement of such foods, creates disparate conditions of competition and therefore impacts negatively on the internal market. As a result, it was deemed necessary to adopt Community rules harmonising national provisions.

The aim of the Regulation is to ensure the effective functioning of the internal market whilst protecting consumers. Markos Kyprianou, the European Commissioner for Health and Consumer Protection, welcomed the European Parliament’s vote on the Regulation back in May 2006, commenting that "the fortification of food must be done in a way that is safe and transparent….Food manufacturers throughout the EU will now be able to work under the same, clear, science-based rules".

The Regulation sets out an EU-wide list of vitamins and minerals together with the specific permitted formulations that may be voluntarily added to foods. Only those vitamins and minerals listed in Annex I in the forms listed in Annex II of the Regulation may be added to foods. Subject to the transitional provisions indicated below, vitamins and minerals not listed will be prohibited from being added to foods once the Regulation applies. The Regulation will not, however, affect national rules on mandatory fortification, for example, the requirement for white and brown flour in the UK to be fortified with specific vitamins and minerals (for example, folic acid).

The Regulation sets out the basis on which minimum and maximum permitted levels of the listed vitamins and minerals in a food or food category may be established by the European Commission following assessment by the European Food Safety Authority ("EFSA"). When setting maximum permitted levels, the total amount of vitamins/minerals in the food will be considered, meaning that naturally occurring vitamins/minerals will also be taken into account. In addition, the following points will be taken into account when setting maximum permitted levels:

• the results of scientific risk assessments by the EFSA based on generally acceptable scientific data (which will take into account the varying degrees of sensitivity of different groups of consumers) and
• intakes of vitamins and minerals from other dietary sources.

The following factors shall also be taken into account where vitamin and mineral intakes for the population are close to the upper safe levels:

• the contribution of individual foods to the overall diet of the population and
• the nutrient profile established for the particular food or food category in accordance with the Nutrition and Health Claims Regulation (see previous article for more information on nutrient profiles).

The amount of vitamins or minerals added to foods will also be subject to a "significant quantity" requirement to ensure that consumers are not misled as to the nutritional value of a particular food. In general, the relevant amount will be 15% of the recommended daily allowance, as specified in the Annex to Directive 1990/496 (as amended).

However, the Regulation does allow for lower levels to be set in the future for specific foods or categories of foods.

Where substances other than vitamins or minerals are used under conditions that results in the consumption of an amount greatly exceeding the amount normally expected to be consumed as part of a balanced and varied diet and/or it would otherwise represent a potential risk to consumers, the use of such substances may be prohibited or restricted. If information provided by the EFSA indicates that such a substance has a harmful effect on health, the Commission may take a decision prohibiting or restricting the use of the substance and/or any ingredient containing the substance.

If, however, a potential harmful effect on health is identified but there is scientific uncertainty, the Commission may decide to place the substance/ingredient containing the substance in "Annex III, Part C" to the Regulation. Food business operators and other interested parties may at any time submit scientific evidence demonstrating the safety of any substances placed in Annex III, Part C.

However, a decision must be taken by the Commission within four years of a substance being placed in Annex III, Part C as to whether its use should be generally allowed, prohibited or restricted.

In the absence of specific rules in the Regulation (or other Community rules) regarding the prohibition or restriction of use of substances or ingredients containing substances other than vitamins or minerals, relevant national Member State rules will continue to apply.

Under the Regulation it will not be permitted for vitamins and minerals to be added to the following categories of foods:

• alcoholic beverages containing more than 1.2% by volume of alcohol (with the exception of fortification for the protection of traditional wine recipes, provided such products are notified to the Commission, were marketed prior to the adoption of the Regulation and no claims regarding health/nutritional benefits are made) and
• unprocessed foods such as fruit, vegetables, meat, poultry and fish.

There is also the opportunity for the list of prohibited foods to be extended in the future under the Regulatory Committee with Scrutiny procedure¹.

Nutrition labelling for fortified products will be compulsory under the Regulation so that consumers will be able to assess the overall nutritional quality of the food. The Regulation requires the labelling of energy value (calories), protein, carbohydrate, sugars, fat, saturates, fibre and sodium as well as the total amounts of vitamins and minerals present when added to the food. While the Regulation allows the labelling of products to include a statement to the effect that the addition of the vitamins and minerals to the product is in compliance with the Regulation, any other nutrition or health claim that is made must also comply with the requirements of the new Nutrition and Health Claims Regulation (see previous article).

The Regulation will enter into force on 19 January 2007 (ie 20 days after it was published in the EU’s Official Journal). However, businesses will not need to comply with its provisions until 1 July 2007 (the "date of application").

Foods placed on the market or labelled prior to the date of application which do not comply with the Regulation may be marketed for up to three years. However, this provision will not allow new products to continue to be placed on the market or labelled. Member States may also allow in their territory the use of vitamins and minerals not on the approved list for up to seven years after the Regulation enters into force provided that the following conditions are fulfilled:

• such vitamins and minerals were already used in foods marketed in the Community before the Regulation entered into force and
• a dossier supporting use of the substance is submitted to the Commission by that Member State within three years of the Regulation coming into force, and the EFSA does not give an unfavourable opinion based on this dossier.

A Community-wide register collating the information associated with the Regulation will also be compiled and publicly available. The register will contain:

• the list of permitted vitamins and minerals in Annex I
• the list of the permitted formulations of those vitamins and minerals in Annex II
• details of the maximum and minimum amounts of vitamins and minerals which may be added to various foods together with any associated conditions
• information on national provisions on the mandatory addition of vitamins and minerals
• details of the foods to which vitamins and minerals may not be added
• a list of any substances for which a dossier has been submitted under the transitional provision detailed above
• information about the "other substances" included in Annex III whose use is prohibited (Part A) or restricted (Part B) or still under consideration (Part C) and
• information about the substances in Annex III Part C where a decision has been made to allow the use of this substance.

Footnote

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.