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March 23, 2009

Q&A: EU Testing of Food Additives

Humane Society International/Europe

Processed foods often contain artificial flavourings to improve or enhance their taste, as well as other chemical additives to alter the food’s appearance or texture, delay spoiling, and/or prevent the growth of harmful bacteria. Testing to evaluate the safety of these additives can consume thousands of animals.

Who are major manufacturers of food additives in Europe?

Many of the largest suppliers of food additives are members of the Federation of European Food Additives, Food Enzymes and Food Cultures Industries.

How are food additives regulated in the EU?

Under European legislation, additives—including colourants, sweeteners, preservatives and emulsifiers—must be explicitly authorised at EU level before they can be used in foods. The overall legal framework for the regulation of these substances is provided by Directive 89/107/EEC [PDF], together with implementing Directives 95/2/EC, 94/35/EC and 94/36/EC. This legislation is administered by the European Commission Directorate General for Health and Consumer Protection, with scientific input from the European Food Safety Authority Panel on Food Additives, Flavorings and Food Contact Materials (EFSA AFC Panel).

With respect to safety assessments, the framework Directive provides that: "Food additives can be approved only provided that … they present no hazard to the health of the consumer at the level of use proposed, so far as can be judged on the scientific evidence available." Moreover, "[t]o assess the possible harmful effects of a food additive or derivatives thereof, it must be subjected to appropriate toxicological testing and evaluation. The evaluation should also take into account, for example, any cumulative, synergistic or potentiating effect of its use and the phenomenon of human intolerance to substances foreign to the body." Guidance prepared by the European Commission's former Scientific Committee on Food [PDF]—which has since been replaced by the EFSA AFC Panel—outlines a battery of "core tests," including the following:

  • 3 month repeated-dose general toxicity studies in rodents and dogs
  • 12-24 month repeated-dose general toxicity and cancer studies in rats and mice
  • Genetic toxicity studies of at least 3 varieties (rodent and/or in vitro)
  • Reproductive toxicity in at least 2 generations of rodents
  • Prenatal developmental toxicity in rodents and rabbits
  • Absorption, distribution, metablolism and elimination studies in rodents

How are chemical flavourings regulated in the EU?

With respect to food flavorings, the core legislation, Directive 88/388/EEC (3) [PDF], provides that, "Member States shall take all measures necessary to ensure that ... flavorings do not contain any element or substance in a toxicologically dangerous quantity…." Specific toxicological testing requirements are not laid down under this directive. Consequently, data needs are left to the discretion of the EFSA AFC Panel. In the case of smoke flavouring, however, specific testing requirements imposed pursuant to Regulation (EC) 2065/2003 [PDF] include the following:

  • 3 month repeated-dose general toxicity studies in rodents and dogs
  • Genetic toxicity studies of at least 3 varieties (rodent and/or in vitro)

How does the EU regulate food contact materials?

Food contact materials are regulated under the framework Regulation No. 1935/2004, which establishes general requirements for all food contact materials, as well as a number of specific directives authorising the use of individual substances and groups of substances. The framework regulation requires that any materials coming into contact with food must be sufficiently inert to preclude contamination of the food or endangerment of human health. Guidance concerning toxicological testing requirements for food contact materials has been prepared by the EFSA AFC Panel and provides for a tiered approach based on a substance's potential to be transferred into food. In the worst case, for "high-migration" substances, the core set of required toxicological tests includes the following:

  • 3 month repeated-dose general toxicity studies in rodents and dogs
  • 12-24 month repeated-dose general toxicity and cancer studies in rats and mice
  • Genetic toxicity studies of at least 3 varieties (rodent and/or in vitro)
  • Reproductive toxicity in at least 2 generations of rodents
  • Pre-natal developmental toxicity in rodents and rabbits
  • Absorption, distribution, metablolism and elimination studies in rodents

How many animals are used in to test food additives and related substances?

Some of the tests above consume hundreds or thousands of animals per study. In 2005, the testing of human and veterinary food additives in the EU consumed nearly 38,000 animals, or approximately 3.7 percent of all animals used in toxicological and other safety evaluations, according to European Commission statistics [PDF].

Are animal tests accurate predictors of the potential human health hazards of chemical additives?

Not necessarily. Animal tests may under- or over-estimate the hazards of food additives.

What are the alternatives?

In vitro genetic toxicity and embryotoxicity tests endorsed as scientifically valid by the European Centre for the Validation of Alternative Methods (ECVAM) can be used to evaluate the safety assessment of food additives and related substances.

What is HSI Europe doing to help animals used in food additives testing?

HSI Europe has been at the forefront of lobbying efforts to ensure that all available, validated non-animal methods and testing strategies achieve expeditious regulatory acceptance in the EU. Additionally, HSI Europe and affiliate organisations The Humane Society of the United States and Humane Society Legislative Fund have assumed a leading role in supporting implementation of the vision of “twenty-first century toxicology” articulated by the U.S. National Research Council, which would see animal tests that are decades old, costly, slow and of dubious relevance to people replaced by ultra-modern, efficient and human-relevant non-animal methods. HSI Europe is calling for a “big biology” project to meet this challenge, akin to the Human Genome Project of the 1990s, and are forging an international, multi-stakeholder consortium make this landmark vision a reality as quickly as possible. 

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