EHJ October 2003 page 312

For many years now, food campaigners have been concerned about the growing number of claims made by food manufacturers concerning the health giving properties of their products. Existing EU legislation prohibits the attribution to foods of properties such as the prevention, treatment or cure of disease, but these principles are open to varying interpretations and can be unsatisfactory for dealing with certain types of claim.

As a result, some member states have adopted their own national legislation which threatens to undermine the single market. Although it is a tricky issue to regulate upon, the Commission has decided to try and give consumers better protection by proposing a regulation to tighten up existing rules and to outlaw some of the more misleading claims that appear on foodstuffs. The UK Food Standards Agency, which is backing the proposal, is currently consulting on the Commission’s text.

Scope and definitions

Under the regulation, which would apply to both food delivered to the final consumer and to food supplied to restaurants, hospitals, schools, canteens and similar mass caterers, a health claim would be defined as any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health.

All health claims would be subject to an EU authorisation procedure. A nutrition claim would be one that states, suggests or implies that a food has particular nutrition properties due to either the energy which it does or does not provide or the nutrients or other substances which it does or does not contain. The proposal contains a list of nutrition claims which would be permitted.

A Community register, listing the permitted nutrition claims and the authorised health claims, would be established.

General principles

Under the draft regulation nutrition and health claims
must not:

• be false or misleading;
• give rise to doubt about the safety and/or the nutritional adequacy of other foods;
• state or imply that a balanced and varied diet cannot provide appropriate quantities of nutrients in general; or
• refer to changes in bodily functions in improper or alarming terms either textually or through pictorial, graphic or symbolic representations.

In order for a food to carry a health or nutrition claim it would have to respect specific nutrient profiles to be established by the Commission. These would be based on the amount of sugars, salt/sodium and different fats contained in food. Beverages containing more than 1.2 per cent by volume alcohol would be prohibited from carrying health or nutrition claims other than those referring to a reduction in the alcohol or energy content.

A number of general rules for claims are set out. For example the presence, absence or reduced content of the substance in question must have been shown to have a beneficial nutritional or physiological effect and this effect must be capable of being understood by the average consumer. Food business operators would have to justify the use of any claims which in turn must be based on, or substantiated by, generally accepted scientific data. The competent authorities would have the right to ask businesses to produce the necessary scientific work and data to establish compliance.

Nutrition claims

A list of permitted nutrition claims is set out and defined in the annex to the proposal. These include such claims as “low energy”, “fat free” and “no added sugars” etc. Comparative nutrition claims would only be allowed where the foods being compared were easily identified by the average consumer or clearly indicated. The difference being claimed would have to be stated and the comparison must relate to the same quantity of food. The composition of the food would have to be compared with a range of other foods of the same category not allowed to bear a claim, including foods of other brands.

Health claims

An authorisation procedure would be established for all health claims, to be managed by the European Food Safety Authority (EFSA.) Only authorised health claims would be allowed and then, only if the following information was included on the label:

• a statement indicating the importance of a balanced diet and a healthy lifestyle;
• the quantity of the food and pattern of consumption required to obtain the claimed beneficial effect;
• where appropriate, a statement addressed to persons who should avoid using the food; and
• where appropriate, a warning not to exceed quantities of the product that may represent a risk to health.

The following would be prohibited:

• claims which make reference to general, non-specific benefits of the nutrient or food for overall good health, well-being;
• claims which make reference to psychological and behavioural functions;
• claims which make reference to slimming or weight control, or to the rate or amount of weight loss which may result from their use or to a reduction in the sense of hunger or an increase in the sense of satiety or to the reduction of the available energy from the diet; and
• claims which make reference to the advice of doctors or other health professionals, or their professional associations, or charities, or suggest that health could be affected by not consuming the food.

Claims describing the role of a nutrient or other substance in growth, development and normal body functions would be allowed if they were based on generally accepted scientific data and were well understood by the average consumer. Claims relating to disease risk reduction would also be allowed, where authorised, providing the label stated that diseases have multiple risk factors and that altering one of these factors may not have a beneficial effect.

COM (2003) 424. Proposal for a Regulation of the European Parliament
and of the Council on nutrition and health claims made on foods.
Brussels. 16.07.03.
http://europa.eu.int/eur-lex/en/com/pdf/2003/com2003_0424en01.pdf

Proposed ambient air quality directive

Heavy metals and polycyclic aromatic hydrocarbons (PAHs) are the fourth area to be tackled under the 1996 ambient air quality directive. However, unlike previous directives the new one will not contain mandatory air quality standards. This is because cost benefit analyses have shown that the cost of meeting possible standards in the case of heavy metals such as arsenic, cadmium and nickel would on the whole outweigh the likely increase in health benefits. This was also true for PAHs in the industrial sector, though in the area of solid fuel consumption for domestic heating it was thought costs and benefits would be broadly equal, though the picture differed from one region to another. As regards traffic related PAHs, analysts were unable predict future baseline concentrations as it was unclear what effect existing pollution legislation and traffic reduction measures would have on emissions.

As a result of the impracticality of setting mandatory standards, the draft directive confines itself to requiring member states to assess ambient air quality for arsenic, cadmium, nickel, benzo(a)pyrene and total gaseous mercury, and to monitor the total deposition of arsenic, cadmium, mercury and PAHs. To assess the contribution of benzo(a)pyrene, member states would have to monitor other relevant PAHs at a limited number of sites. They would be required to ensure, by all necessary measures not entailing excessive costs, that concentrations of benzo(a)pyrene in ambient air did not exceed a target value of 1 ng/m3 applying to the benzo(a)pyrene content in PM10 fraction averaged over a calendar year.

The draft directive proposes assessment thresholds for arsenic (6 ng/m3), cadmium (5 ng/m3), nickel (20 ng/m3) and benzo(a)pyrene (1 ng/m3) and the methods for determining their exceedance. In zones and agglomerations where these thresholds were exceeded, fixed measurement of ambient air concentrations would be mandatory. Where levels were below the threshold, indicative monitoring may be used to assess air quality except for benzo(a)pyrene for which fixed measurements would be mandatory in all agglomerations.

The proposal goes on to establish the minimum number of sampling points to be set up and to list the criteria for determining the location of the sites dedicated to arsenic, cadmium, nickel and benzo(a)pyrene. For mercury and PAHs other than benzo(a)pyrene, sites would have to be selected such that geographical variation and long-term trends could be identified. The same would apply to the monitoring sites for deposition, where co-location with sites for soil monitoring would be preferable, says the proposal. Sites dedicated to PAH would have to be co-located with those for benzo(a)pyrene.

Data quality objectives for the monitoring data are set out, as are requirements for the use of air quality models, along with reference methods for the sampling and analysis of arsenic, cadmium, mercury, nickel and PAHs. For zones and agglomerations where thresholds were exceeded, member states would have to submit details to the Commission who would them make this public.

Member states would have to make available to the public and interested parties clear and comprehensible information on ambient air concentrations of arsenic, cadmium, mercury, nickel and PAHs, as well as the deposition rates of arsenic, cadmium, mercury, and PAHs. The information provided would have to indicate any annual exceedence of the target value for benzo(a)pyrene, giving the reasons, the area covered and the
health effects.

COM (2003) 423. Proposal for a Directive of the European Parliament and of the Council relating to arsenic, cadmium, mercury, nickel and polycyclic aromatic hydrocarbons in ambient air. Brussels. 16.07.03.
http://europa.eu.int/eur-lex/en/com/pdf/2003/com2003_0423en01.pdf