Overview Of Applicable Laws

In the European Union, there are so-called horizontal and vertical laws. Horizontal laws are those that cover all foods. Examples are the laws regarding additives and those regarding the labeling of foodstuffs. Vertical laws cover foods with a so-called standard of identity, also called compositional regulations or "recipe laws.'' Examples of products for which such standards exist are cheese and bread.

In both cases, vertical as well as horizontal, there are laws that have been harmonized throughout the E.U. and laws that are still subject to national legislation. This situation will probably remain so, especially in view of the fact that in the treaty signed in Maastricht in February 1992 (1), the European Union officially laid down the "principle of subsidiarity,'' which states that the European Commission should not regulate what could be done just as well or better at the national level.

For products regulated solely at the national level, the principle of mutual recognition applies. If a product is legally produced in one E.U. country, it can also be sold in another E.U. country, unless this country has well-founded arguments to reject the product on the grounds of protection of consumer health, or one of the other reasons listed in Article 30 of the Treaty establishing the European Community (2). Other than in this situation, member states are not allowed to create unjustified trade barriers.

If one wants to place a new enzyme on the market, any of the four cases (horizontal versus vertical, harmonized versus national) can be applicable, meaning that all possibilities have to be assessed. The following factors are of importance when establishing how a specific enzyme is regulated.

1. The purpose of its use. Is the enzyme used only during processing of the food, or does it still have a specific function in the final food that is sold to the consumer?

2. The type of food in which the enzyme is to be used. Does the food in question have a standard of identity?

3. The country in which the enzyme is to be used in food. Applicable nonharmonized regulations will differ country by country.

4. The origin or source of the enzyme. Industrial enzymes can be obtained from plant, animal, or micro-bial sources. These may be regulated differently. Moreover, some countries have special requirements for enzymes produced by genetically modified organisms (gmos).

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