Alternatives to Animal Testing Recommendations from the European Food Safety Authority

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Alternatives to Animal Testing Recommendations from the European Food Safety Authority

Published: June 26, 2009
The Scientific Committee of the European Food Safety Authority (EFSA) released its scientific opinion report “Existing approaches incorporating replacement, reduction and refinement of animal testing: applicability in food and feed risk assessment” on June 9, 2009.

The EFSA is the EU authority charged with assessing the safety of food and feed. The current scientific opinion report reviewed existing types of internationally-recognized animal alternative test methods available for the types of toxicological studies used in EFSA risk assessments, and summarized their possible applications as replacement, reduction, or refinements to animal test methods.

The status of each toxicological endpoint was summarized in the EFSA report as follows1:

  • Toxicokinetic studies: several in vitro methods have been developed; however they cannot at present replace in vivomethods.
  • Acute toxicity testing: the classical oral test has been replaced by in vivo alternatives that require fewer animals and reduce pain and suffering. in vitromethods are available for estimating starting doses.
  • Skin irritation and corrosion testing: for skin irritation, at present only an in vivo method is accepted by regulatory authorities; however it is anticipated that an in vitro method will be accepted soon for regulatory purposes at OECD level. For corrosion, in vitromethods are available and must be used in Europe.
  • Skin sensitisation testing: only in vivo methods are accepted by regulatory authorities among which the Local Lymph Node Assay, LLNA, is the preferred refined method. An alternative in vivo method for the LLNA, and in silico and in vitromethods, are being developed.
  • Eye irritation testing: the in vivo Draize rabbit eye test is still the standard for eye irritation testing in Europe. However, four in vitromethods can be used to classify severe eye irritants without further testing on animals.
  • Testing for acute systemic and local toxicity is still required for plant protection products and animal feed additives to assess risk to workers. EFSA does not require such tests for risk assessment of food additives, food contact material or newly expressed proteins in GMO.
    Genotoxicity testing: initial testing is often done using in vitro methods, but positive results may need to be confirmed by in vivo testing.
    Repeated dose toxicity, reproduction and developmental toxicity studies, and ecotoxicity endpoints, are studies where there are complex endpoints and a lack of validated alternatives. For these methods, recommendations were made for the use of integrated testing and risk assessment strategies to reduce animal use.

Other approaches such as tiered testing, the threshold of toxicological concern, and the qualified presumption of safety were also recommended for reducing animal testing for specific applications. General strategies recommended include the review of all existing data prior to conducting new in vivo studies, and better communication to stakeholders of the existing EU regulation that validated and accepted alternative methods must be used.

The report notes that the implementation of such recommendations “should stimulate the development of new food and feed assessment approaches that would not only minimise the numbers of experimental animals and their suffering, but also work towards their replacement through the use of alternative techniques (Replacement, Reduction, and Refinement, i.e., the Three Rs approach).”

1There is some variation between alternative test methods accepted by regulatory authorities in the EU and in other geographic locations.