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04.June 2009 - 00:00
Directive 2002/46/EC and the European Commission proposal to harmonise maximum levels of vitamin and mineral food supplements
On the basis of Article 5 of Directive 2002/46/EC(1), the European Commission is preparing to propose maximum permitted levels for vitamins and mineral food supplements (and fortified foods) for harmonisation across the EU. The levels are expected to be derived from a risk management model, applied to ‘tolerable upper levels’, as developed or approved by the European Food Safety Authority.
We would like to raise the following questions:
1. Will population requirements in different geographic areas of the EU be adequately taken into account? For example, Scandinavians require considerably greater amounts of supplemental vitamin D3 than southern Europeans; will harmonised MPLs prevent Scandinavians from consuming sufficient vitamin D3?
2. On the basis of the above, would the intended purposes of the directive, namely the functioning of the single market and a high level of consumer protection, not be better served by creating a partial harmonisation measure for MPLs, whereby the relevant competent authorities of Member States are given legal authority to adjust MPLs for their own populations in order to meet their specific nutritional requirements?
3. Will the proposed MPLs, and the tolerable upper levels on which they are based, be determined using models on ‘the basis of the most reliable scientific data available and the most recent results of international research’ (paragraph 73 of Alliance for Natural Health and others v UK [2005]; ECJ Cases C 154/04 and C 155/04) which should include validation against levels in the diet or from supplements that are known to be safe and beneficial?
4. Will the proposals for MPLs take into account differences in the safety profile of different forms of the same nutrient? While most authorities for example currently recognise differences between two forms of vitamin B3, namely nicotinic acid and nicotinamide, differences with respect to other nutrients have thus far been ignored by the Commission.
(1) OJ L 183, 12.7.2002, p. 51.
4 June 2009
Answer given by Ms Vassiliou on behalf of the Commission
Article 5 of Directive 2002/46/EC on food supplements(1) lays down the following criteria to be taken into account when setting maximum amounts of vitamins and minerals present in food supplements:
(a) Upper safe levels of vitamins and minerals established by scientific risk assessment based on generally accepted scientific data, taking into account, as appropriate, the varying degrees of sensitivity of different consumer groups.
(b) Intake of vitamins and minerals from other dietary sources.
With regard to the Honourable Members' concerns on whether the population requirements in different geographic areas of the EU will be taken into account, it must be noted that the directive requires that due account be taken also of reference intakes of vitamins and minerals for the population. This value is the amount of a vitamin or mineral needed by the majority of the healthy members of the population. It is expected that the maximum amounts will cover population reference intakes as established by the Scientific Committee on Food(2). It should be noted that the European Food Safety Authority (EFSA) has been asked by the Commission to keep these reference intakes under review. Nevertheless, even though population requirements should be taken into account, the basis for the setting of maximum amounts will be safety.
The Commission, in its role as risk manager, is currently discussing with Member States and the relevant stakeholders, the development of a risk management methodology to be used for establishing maximum amounts of vitamins and minerals. EFSA, in its role as risk assessor, has set upper safe levels (UL) for vitamins and minerals based on the most reliable scientific data available, following a request by the Commission in relation to the first criterion mentioned above. The Commission will take proportionate risk management measures to ensure that the widest possible range of safe food supplements is available for consumers, while avoiding that excessive intake of vitamins and minerals may result in adverse effects.
The directive on food supplements aims to benefit both consumers and economic operators. Consumers will have access to a wide range of safe products whereas economic operators will benefit from the harmonised rules which will apply in the EU. It is expected that the setting of maximum amounts will further facilitate and consolidate such benefits for the industry. Therefore, the Commission does not consider the functioning of the single market to be better served by a partial harmonisation for maximum amounts. In the process of setting maximum amounts all relevant aspects will be considered.
Finally, Annexes I and II of the directive on food supplements provide lists of permitted vitamin and minerals and their forms that may be added to food supplements. Vitamins and minerals, and their forms, are included in the lists following their evaluation for safety and bioavailability by EFSA.
(1) OJ L 183, 12.7.2002.
(2) SCF (Scientific Committee for Food) (1992). Nutrient and energy intakes for the European Community. Opinion adopted by the Scientific Committee on Food on 12 December 1992. Reports of the Scientific Committee for Food, Thirsty-First Series. European Commission, Luxembourg, 1993. http://europa.eu.int/comm/food/fs/sc/scf/out89.pdf
On the basis of Article 5 of Directive 2002/46/EC(1), the European Commission is preparing to propose maximum permitted levels for vitamins and mineral food supplements (and fortified foods) for harmonisation across the EU. The levels are expected to be derived from a risk management model, applied to ‘tolerable upper levels’, as developed or approved by the European Food Safety Authority.
We would like to raise the following questions:
1. Will population requirements in different geographic areas of the EU be adequately taken into account? For example, Scandinavians require considerably greater amounts of supplemental vitamin D3 than southern Europeans; will harmonised MPLs prevent Scandinavians from consuming sufficient vitamin D3?
2. On the basis of the above, would the intended purposes of the directive, namely the functioning of the single market and a high level of consumer protection, not be better served by creating a partial harmonisation measure for MPLs, whereby the relevant competent authorities of Member States are given legal authority to adjust MPLs for their own populations in order to meet their specific nutritional requirements?
3. Will the proposed MPLs, and the tolerable upper levels on which they are based, be determined using models on ‘the basis of the most reliable scientific data available and the most recent results of international research’ (paragraph 73 of Alliance for Natural Health and others v UK [2005]; ECJ Cases C 154/04 and C 155/04) which should include validation against levels in the diet or from supplements that are known to be safe and beneficial?
4. Will the proposals for MPLs take into account differences in the safety profile of different forms of the same nutrient? While most authorities for example currently recognise differences between two forms of vitamin B3, namely nicotinic acid and nicotinamide, differences with respect to other nutrients have thus far been ignored by the Commission.
(1) OJ L 183, 12.7.2002, p. 51.
4 June 2009
Answer given by Ms Vassiliou on behalf of the Commission
Article 5 of Directive 2002/46/EC on food supplements(1) lays down the following criteria to be taken into account when setting maximum amounts of vitamins and minerals present in food supplements:
(a) Upper safe levels of vitamins and minerals established by scientific risk assessment based on generally accepted scientific data, taking into account, as appropriate, the varying degrees of sensitivity of different consumer groups.
(b) Intake of vitamins and minerals from other dietary sources.
With regard to the Honourable Members' concerns on whether the population requirements in different geographic areas of the EU will be taken into account, it must be noted that the directive requires that due account be taken also of reference intakes of vitamins and minerals for the population. This value is the amount of a vitamin or mineral needed by the majority of the healthy members of the population. It is expected that the maximum amounts will cover population reference intakes as established by the Scientific Committee on Food(2). It should be noted that the European Food Safety Authority (EFSA) has been asked by the Commission to keep these reference intakes under review. Nevertheless, even though population requirements should be taken into account, the basis for the setting of maximum amounts will be safety.
The Commission, in its role as risk manager, is currently discussing with Member States and the relevant stakeholders, the development of a risk management methodology to be used for establishing maximum amounts of vitamins and minerals. EFSA, in its role as risk assessor, has set upper safe levels (UL) for vitamins and minerals based on the most reliable scientific data available, following a request by the Commission in relation to the first criterion mentioned above. The Commission will take proportionate risk management measures to ensure that the widest possible range of safe food supplements is available for consumers, while avoiding that excessive intake of vitamins and minerals may result in adverse effects.
The directive on food supplements aims to benefit both consumers and economic operators. Consumers will have access to a wide range of safe products whereas economic operators will benefit from the harmonised rules which will apply in the EU. It is expected that the setting of maximum amounts will further facilitate and consolidate such benefits for the industry. Therefore, the Commission does not consider the functioning of the single market to be better served by a partial harmonisation for maximum amounts. In the process of setting maximum amounts all relevant aspects will be considered.
Finally, Annexes I and II of the directive on food supplements provide lists of permitted vitamin and minerals and their forms that may be added to food supplements. Vitamins and minerals, and their forms, are included in the lists following their evaluation for safety and bioavailability by EFSA.
(1) OJ L 183, 12.7.2002.
(2) SCF (Scientific Committee for Food) (1992). Nutrient and energy intakes for the European Community. Opinion adopted by the Scientific Committee on Food on 12 December 1992. Reports of the Scientific Committee for Food, Thirsty-First Series. European Commission, Luxembourg, 1993. http://europa.eu.int/comm/food/fs/sc/scf/out89.pdf