The European food sector has called for different methods to be used more in scientific and regulatory risk assessments.

FoodDrinkEurope said New Approach Methodologies (NAMs) can improve the relevance of data available for food safety risk assessment and avoids animal use. NAMs are any non-animal based approaches that can help provide toxicological information in chemical hazard assessments.

The call comes as some traditional animal-based approaches are more than 60 years old, plus there is political and societal pressure to phase out animal testing.

NAMs, using a combination of human exposure scenarios, in vitro hazard assessment, computational approaches and physiologically based toxicokinetic/toxicodynamic data, are better suited to address risk assessment questions, said FoodDrinkEurope, a trade association representing the EU food and drink manufacturing sector.

The group added another challenge, which is how new vegan ingredients will be assessed, as certification bodies such as European Vegetarian Union, Vegan Action and Vegan Society require no animal testing.

Use of validated methods
FoodDrinkEurope said there needs to be more flexibility and consistency in the use of NAMs to assess the safety of food ingredients.

“As the food industry, we are pleased to see that the use of NAMs has been considered in the risk assessment of certain contaminants. However, despite this progress, NAMs are not consistently mentioned in the risk assessment frameworks for ingredients, with little flexibility for alternative approaches to be applied.

“A NAMs-based approach provides more informative data and can be quicker to perform, without the unnecessary use of animals. The length of time associated with traditional animal studies impacts the competitiveness of European businesses and speed to market,” said the group.

The group cited recent European Food Safety Authority (EFSA) scientific guidance on data needed for a risk assessment of flavorings to be used in or on foods, that had a request for more animal test data.

This requirement for animal tests, without acknowledging the potential for use of NAMs, is creating a barrier to innovation, without adding value to the risk assessment process, said FoodDrinkEurope.

Industry said it needs contemporary and effective scientific ways to assess the safety of new ingredients and materials. A NAMs-based approach provides better data and can be faster. EFSA has several pilots ongoing on the use of NAMs to fill gaps in risk assessment.

FoodDrinkEurope warned innovation could slow in Europe if regulatory acceptance of NAMs in food safety risk assessments hinders the use of modern methods to evaluate new ingredients.

Experts express disagreement with remarks
Meanwhile, a consortium trying to improve chemical risk assessment in the EU has raised concerns about comments made in relation to NAMs.

Leaders of three projects working on accelerating chemical safety assessment without the use of animals, recently wrote to Virginijus Sinkevičius, Commissioner for the Environment, Oceans and Fisheries, and members of the European Parliament about remarks on the subject.

Speaking at an EU Parliament Committee on Environment, Public Health and Food Safety meeting in March, Aurel Ciobanu-Dordea said: “The granularity. . . of the results which is given by non-animal methods is different, far less precise than the animal tests.”

Consortium members said they disagreed with this and asked for clarification from officials as to the extent to which it applied to NAMs.

“While this opinion may be reflecting a genuine lack of readiness by regulatory communities to utilize chemical safety data exclusively produced by NAMs, we are concerned that the European Commission and Parliament may be misguided into believing that the current scientific knowledge and application of NAMs are insufficiently mature to be useful in assessing chemical safety,” they said.

“Moreover, confidence in the primacy of animal tests for chemical safety assessments may also be misplaced. For these reasons, we believe that excluding NAMs from the process of assessing chemical hazards would be unwise – especially because alternative test methods have already been validated for some regulatory endpoints and are continuing to develop towards assessing complex adverse outcomes with greater precision than traditional animal tests.

“We are therefore concerned by official statements that may unintentionally impede further efforts at modernizing chemical safety data by impacting the confidence in alternative methods, and by extension the human and environmental safety assessments they inform.”

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