Common approaches to shared challenges

Assessing food-based risks can be like comparing apples and pears.

EFSA’s main task is to assess risks in the EU food and feed chain, that is the possible adverse effects of food and feed for human and animal health, and the environment. ‘Risk assessment’ is a specialised field of applied science that involves reviewing scientific data and studies in order to evaluate risks associated with certain hazards.

Methodologies used in the scientific fields and disciplines determining EFSA’s risk assessments – chemistry, toxicology, microbiology, human and veterinary medicine, pathology, nutrition, to name a few – sometimes develop at different speeds and on different paths. Competing risk assessment methodologies can make accurate comparisons across scientific areas difficult, hampering the ability to deepen scientific knowledge and to improve the speed and efficiency of EFSA’s scientific decision-making. Different approaches also hinder the development of common criteria for collecting the essential scientific data without which EFSA’s risk assessments would not be possible. Such difficulties can limit EFSA’s capacity to provide the informed, timely and independent scientific advice that European decision-makers use to inform their risk management decisions.

How is EFSA helping to harmonise risk assessment methodologies?

EFSA is uniquely positioned to promote a more harmonised approach given its role as a hub for risk assessment expertise in Europe. The collective decisions of the Authority’s Scientific Committee, Panels and working groups depend on the expertise of scientists as well as research organisations and universities. Their participation in EFSA’s work and the feedback channelled through EFSA’s scientific networks support the accumulation and transfer of knowledge and best practices back to the scientific community. This creates more understanding of the need for common approaches and a greater commitment to meet this challenge.

EFSA’s Scientific Committee is at the forefront of the Authority’s efforts to develop and harmonise internationally-recognised risk assessment practices. Its guidance documents are re-shaping the way EFSA’s Scientific Panels – and risk assessors beyond Europe – evaluate risks in the food and feed chain. The Scientific Committee is itself a model of such harmonisation since its membership is composed of the Chairs of EFSA’s Scientific Panels and six other reputed experts in risk assessment (who are not Panel members). This channels into one forum a variety of experiences and scientific approaches shaped by different areas of scientific expertise and legal requirements that drive their work. Similarly, the Panels’ guidance documents, particularly for regulated products such as feed additives, pesticides and GMOs, are harmonising submission requirements for applicants and therefore leading to more uniform scientific testing strategies.

Also at the institutional level, cooperation with EU Member States continues to be critical to EFSA’s success; national food safety agencies share their insights with EFSA and one another through EFSA’s Advisory Forum. The Authority’s strategic cooperation agreements with other EU agencies, international organisations and food safety agencies in third countries are also promoting common approaches to risk assessment.

What scientific areas are benefitting as a result of EFSA’s efforts?

The Scientific Committee has done ground-breaking work to harmonise the core principles and tools of risk assessment. Its guidance on transparency in the scientific aspects of risk assessment have helped to define a standard structure and common set of criteria to be used for the selection of experts, inclusion/exclusion of data, confidentiality as well as the definition and communication in scientific opinions of underlying assumptions and uncertainties. These are now the norm for EFSA’s scientific opinions, shaping both technical requirements prior to risk assessment and how EU risk managers use EFSA’s scientific advice to inform decision-making.

Additionally, the 2005 guidance on substances that are both genotoxic (damaging DNA, the genetic material of cells) and carcinogenic (leading to cancer) was also a landmark piece of work as it is helping risk managers to distinguish between different levels of risk thereby allowing them to prioritise their decision-making. More recent guidance on genotoxicity testing strategies and standard protocols for animal studies are likely to have similar long-term impacts. These developments are underpinning and complementing the cross-cutting nature of many of the approaches developed by EFSA’s various Scientific Panels. For example, work carried out by the GMO, Plant Health, Pesticides and Feed Additives Panels is all feeding into a common approach to environmental risk assessment.

EFSA is also making a major contribution in harmonising approaches to new technologies. The Scientific Committee’s 2011 guidance on engineered nanomaterial applications is the first of its kind in the area of food and feed; dealing with risks arising from nanoscience and nanotechnology food-related applications, the guidance introduces standard requirements related to these technologies as used in food additives, enzymes and flavourings, food contact materials, novel foods, feed additives and pesticides. The Scientific Committee has also helped to guide the EU’s approach to the cloning of farmed animals for food production by providing scientific advice both on the food safety aspects as well as those relating to the health and welfare of animal clones and their offspring.

Finally, EFSA has re-structured internally both in support of its Science Strategy for 2012-2016 and to evolve with the risk assessment landscape that it has helped to define. These reforms will allow the Authority to be as flexible and reactive as possible to risk management needs while continuing to protect European consumers.