Source: http://www.legalweek.com/ViewItem.asp?id=23949

Republic of Ireland: What are you eating?

With food scares throughout Europe and ever increasing regulation governing the sale and manufacture of foodstuffs, those in the industry await the European Parliament's Food Supplement Directive with some trepidation. David Cullen and Marcella Clarke report

Far reaching and fiercely debated legislation is underway in Ireland to control, with ever increasing regulation, what foodstuffs can be sold and used in manufacturing - and rightly so.

In 2005, we have had yet another food outrage in Europe, not this time caused by BSE or foot-and-mouth disease, but by the seemingly harmless dry ingredient, Sudan 1, a banned carcinogenic food dye used in making red chilli powder. Most recent statistics reveal this substance contaminated more than 600 products, and has spread to 14 European Union (EU) countries. It is estimated that to recall just one of the affected products costs - including sales loss, destruction, management time and consultants fees, plus the 'softer' costs such as brand damage - in excess of ¤150m (£102m).

The European Commission (EC) Labelling, Presentation and Advertising of Foodstuffs Regulations 2000 sets down general labelling requirements. These include provisions for the name of the food, the list of ingredients, the appropriate date mark, the name and address of the manufacturer, packer or EC seller and, in certain circumstances, conditions of storage or use and place of origin. Also contained in the regulations are rules on quantitative ingredient declarations, on the making of rules and on the provision of nutritional information.

Specific rules prohibit manufacturers from making a claim that any food, including a supplement, has tonic properties, or that it prevents, treats or cures a human disease. A 'disease' includes any injury, ailment or adverse condition, whether of body or mind.

Regarding claims that may be stated on vitamins and minerals, on 10 June, 2002, the European Parliament published the Food Supplement Directive (2002/46/EC), which states which ingredients, and at what levels, may be present. 

The Directive aims to create a single market in food supplements throughout the EU by harmonising such products' regulation.

Due for implementation by August 2005, the new law is to give consumers sufficient information to be confident a supplement is safe and of good quality.

The Directive establishes a 'positive list' of vitamins and mineral sources that may be used in the manufacture of food supplements. It is proposed the Directive will, at a later stage, be extended to cover other food supplements, including herb and plant extracts, fatty acids, amino acids and fibre extracts.

Only vitamins and minerals considered essential are currently allowed on the positive list. 

Various ingredients have been omitted from it, including around 40 trace elements such as the mineral boron, contained in supplements for women going through the menopause. Vitamin E is another 'victim' - it occurs naturally in many different forms, but the list only contains alpha tocopherol which is a synthetic variant. 

Similarly, two organic forms of selenium are excluded from the list, while two other synthetic forms are included.

The Directive also puts an upper limit on the amount of vitamins and minerals contained in supplements, based on the recommended daily allowance (RDA). Three times the RDA may become the highest dose allowed. However, some health professionals argue this is wholly inadequate for sufferers of diseases such as osteoporosis. The Directive's introduction in 2005 is, therefore, predicted to impact consumers relying on such specialist products.

Substances omitted from the positive list may not be provided after July 2005, unless a full scientific dossier has been compiled and submitted for consideration by the European Food Safety Authority (EFSA) prior to July 2005, and provided the EFSA has not decided the substance is unsafe. Data requirements specified for the preparation of the scientific dossier are extremely onerous and will cost considerable amounts of money to put together. Currently it is estimated that the cost to get an unclassified nutrient on the positive list might be ¤80,000 to ¤130,000 (£54,500 to £88,600) per ingredient (without any certainty of success). This will be beyond the financial capacity of many smaller manufacturers.

In 2004, health food shops accounted for about 15% of sales of vitamins and dietary supplements in Western Europe. However, such stores need to offer a wide range of products in various forms and dosages. By standardising and restricting the selection allowed on the European market, the Directive potentially threatens the existence of health food stores by diminishing their competitiveness compared to drugstores and supermarkets. It is reported that were the Directive implemented in its current form, about a third of healthfood stores would go out of business as a direct result.

A further potential threat comes from unregulated internet retailers, which might gain a growing consumer base because of restrictions imposed by the Directive. Critics claim the Directive opens the opportunity for under-thecounter products and undermines safety standards, which are the Directive's declared goal.

Furthermore, natural products cannot be patented, so manufacturers have little incentive to get theirs on the positive list. More likely additions are vitamins and minerals that are produced in laboratories and so may give manufacturers exclusive rights.

It is therefore expected that the Directive's implementation will transform sales of vitamins and dietary supplements in the EU. Concentration of large pharmaceutical companies is predicted to increase at the cost of smaller national producers, while hundreds of products and ingredients are likely to disappear from shelves. 

At the same time, the number of health-food stores is expected to decline sharply, while drugstores, pharmacies and internet sales are predicted to benefit.

Not surprisingly, the Directive's implementation has been opposed by numerous parties, particularly consumers, manufacturers and retailers. A landmark challenge before the European Court of Justice (ECJ) brought by the Alliance for Natural Health and Nutri-Link against the Directive, has led Advocate General Geelhoed, to deliver an opinion in favour of the Alliance's case.

Advocate General Geelhoed, stated that in his

opinion: " [The] Food Supplements Directive infringes the principle of proportionality, because basic principles of Community law, such as the requirements of legal protection, of legal certainty and of sound administration, have not properly been taken into account. It is therefore invalid under EU law." However, this opinion is not a determinative 'ruling', as it is up to ECJ judges to make the final decision, expected around June.

An appropriate system banning substances that might pose a risk to health could be to produce a 'negative list' for ingredients where there is a demonstrable lack of safety. The system proposed by the EU could see ingredients being banned simply because companies lacked the financial capacity to meet the high data threshold required for scientific dossiers demanded by EU authorities. In this way, ingredients that have been part of the human diet for thousands of years, and which are increasingly difficult to derive from conventional foods, could become unavailable, and impossible to supplement.

David Cullen is a partner and Marcella Clarke a legal assistant at William Fry Solicitors' life sciences and healthcare group.

Author: David Cullen & Marcella Clarke

Source: Legal Week