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EFSA-Assessments Require Extensive Testing –Now More Transparent Than Ever

For an application for authorisation of a regulated product in Europe, the competent authority the EUROPEAN FOOD SAFETY AUTHORITY (EFSA) requires extensive product tests from the applicants. This may also involve tests with vertebrate animals. The impressive extent of testing is recommended to the industry in the applicable EFSA guidelines. The European consumer might not be aware of this, but since the entry into force of the European Transparency Regulation (EU) 2019/1381) in March 2021, all interested parties have been enabled to see all this data. Now that the dimension is clear: how could vertebrate animal testing in safety assessments of the food chain be reduced? Could data sharing be an option?

On 27 March 2021, the European Transparency Regulation (EU) 2019/13811 became applicable. It was adopted in April 2018 to “increase(s) the transparency of the EU risk assessment in the food chain, strengthen(s) the reliability, objectivity and independence of the studies used by European Food Safety Authority (EFSA), and ensure(s) the long-term sustainability of EFSA by revisiting its governance.2 ” It was originally established in response to the European citizens’ initiative: “Ban glyphosate and protect people and the environment from toxic pesticides” (2017). It gives all actors in the food chain – consumers, scientists, non-governmental organisations, politicians, administrators and industry (i.e. competitors from third countries worldwide and from Europe) – the opportunity to follow up in unprecedented detail applicants’ data submitted during authorisation processes for regulated products assessed by EFSA. Examples of regulated products are feed additives, pesticides, novel foods, food improvement agents, food contact materials, nutrition, products concerning biological hazards and welfare and genetically modified organisms.

Having completed nearly three years of transparent risk assessment in the European Food Chain leads us to our question today:

Are many vertebrate animals needed to establish the safety and efficacy of a regulated product by the EFSA Scientific Panels?

The authors ask this question because the consumer might not be aware that extensive animal testing is indeed involved in the safety and efficacy assessments by EFSA: A high level of safety and efficacy in the food chain comes at a price. This price does not only involve high costs for the industry to gather all data requested by EFSA, but it may also involve animals’ lives. The authors ask this question now because before EFSA risk assessments were transparent, this kind of data had not been to the same extent publicly available. This has changed fundamentally. Currently, all data of any valid EFSA application is proactively and automatically published in the publicly accessible EFSA Portal: OPEN.EFSA. The applicant has to properly justify legal grounds to make some of the data confidential, such as e.g. information about the manufacturing process or data of natural persons involved in the testing of vertebrate animals. While this portal offers an incredible abundance of information, it has so far not been completely mapped for the “substances” filter3 – not to talk about the individual dossier information sets. It is therefore very hard to search systematically. The authors acknowledge at this point that an overabundance of unsorted information rather induces in-transparency than transparency.