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European Union (EU)

Food regulation in the EU, particularly in the food safety area has been increasingly consolidated and harmonized over the years. However, to date, some member states are still not fully harmonized and some national legislation may still be in place. This section discusses European food legislation in the area of food safety as it impacts the region as a whole.

Key principles: Regulation (EC)178/2002

EU food safety policy applies as a general principle, an integrated "farm to fork" approach, wherein the objective is to ensure a high level of human life and health protection, while taking into account the protection of animal health and welfare, plant health and the environment.

On the 28th of January 2002, the European Parliament and the Council adopted Regulation (EC)178/2002 laying down the general principles and requirements of EU general food law.  This regulation provides a framework to ensure:

  • A coherent approach in the development of food legislation
  • A mutual recognition for specific nationally-regulated areas
  • The free movement of food and feed within the EU.

In addition, it establishes as a basic principle that the business operator has primary responsibility for complying with food law, and in particular with food safety. Relevant authorities of the Member States in turn have the responsibility of putting in place adequate and effective controls to complement and support this principle.

The European Food Safety Authority (EFSA)

The Regulation also establishes the principles of risk analysis in relation to food and created the European Food Safety Authority (EFSA) as an independent agency responsible for risk assessment regarding food and feed safety for the EU.

EFSA works in close collaboration with national risk assessment bodies and in open consultation with its stakeholders to provide independent scientific advice and clear communication on existing and emerging risks.

European regulations regarding food ingredients

Under the EU framework, Danisco’s food protection solutions can either be regarded as traditional food ingredients or food improvement agents. Food cultures are considered as traditional food ingredients if they have a long history of safe use in foods. These can be marketed without pre-market authorization in all European Member States except Denmark where a pre-market notification process is in place since 1973. The Danish legislation on additives concerns food cultures, molds fungi and yeasts fungi, enzymes and nutritional ingredients. Applicant for one of those products needs to seek for an approval.

In contrast, additives require pre-market approval; a favorable scientific opinion from EFSA is essential for explicit authorization prior to use in foods at the EU level.  Food additives such as Nisaplin® and Natamax™ are authorized at EU level and may be marketed in all the Member States, as well as for Iceland, Liechtenstein and Norway.

Natural flavorings are in the scope of the current Directive on flavourings !988/388/EEC, but do not need premarket approval before they are placed on the market. The directive includes provisions for the use of the word “natural” for flavorings.

The regulatory framework for flavorings is currently under revision as part of FIAP (Food Improvement Agents Package). The new regulation on flavorings is expected to be finally adopted in late 2008, but will not as such has an impact on the status and use of natural flavorings.

Regulation on organic production

On 1st of January 2009, the new EU regulation (EC) No 834/2007 will come into force in all Member States, repealing the previous one (EC) No 2092/91. It was designed to ensure fair competition within the EU, while maintaining and justifying consumer confidence in organic label.

For the EU, “organic production is an overall system of farm management and food production that combines best environmental practices, a high level of biodiversity, the preservation of natural resources, the application of high animal welfare standards and a production method in line with the preference of certain consumers for products produced using natural substances and processes.