Almut Bitterhof, a food chemist by education, works in the European Commission, in the area of food safety since 1999. She is currently deputy Head of Unit in the unit "pesticides and biocides" in the Directorate General for Health - DG SANTE, dealing in particular with issues related to pesticides residues in food/feed. She is the chair of the residues section of the respective Regulatory Committee with Member States, the Standing Committee on Plants , Animals, Food and Feed, section Phytopharmaceuticals, which is in charge of setting maximum residue levels for pesticides in food and feed. Previously she already worked in the same Directorate-General in the area on contaminants legislation, as well as in a horizontal unit dealing with matters related to the European Food Safety Authority (EFSA) and in the Directorate of DG SANTE dealing with audits and inspections. When she joined the Commission in 1999 she came from the private sector heading a unit dealing in particular with product development and analytical methods.
Combined exposure to multiple chemicals: assessing risks across regulatory silosSee more
22/06 - 14:00Visit the agenda
Title of talk
Regulatory risk assessment of chemical in food and the need for targeted methodologies in specific policy areas
22/06 - 14:55
Abstract of talk
Consumers may be exposed to traces of different chemicals in food at the same time. Non-dietary routes of exposure also exist. Mixture exposure assessments based on a ‘multiple chemicals – multiple routes of exposure’ approach require work across regulatory silos dealing with different chemicals, many of those involved in different routes of exposure. The methodology developed by EFSA, which groups pesticides into cumulative assessment groups (CAGs) based on similar toxicological effects, has so far considered only pesticides and only exposure through food. This is due to the abundant availability of toxicological and monitoring data in the food sector, which is not the case for most other kinds of chemicals and other routes of exposure.
In the policy area of pesticides, the lawful application of plant protection product (PPP) formulations on specific crops can result in unintentional mixtures of residues in the food eaten by the consumer. Regulations (EC) 1107/2009 (PPP Regulation) and (EC) 396/2005 (MRL Regulation) require cumulative and synergistic effects to be considered when the methodology to do so is available. The EFSA/SANTE Action Plan of 23 February 2021 reflects the importance of both dietary and non-dietary routes of exposure and sets out clear priorities and timelines for the way forward.
While cumulative assessment groups (CAGs) offer a robust, data-based, scientific ground for the evaluation of combined exposure to pesticides, the methodology includes only pesticides and concerns only the dietary route of exposure. However, mixture assessment and the derivation of a ‘risk-cup’ able to support robust risk management decisions should also consider non-dietary exposures. In the absence of data, estimations of unaccounted exposures by a mixture assessment factor (MAF), based on robust scientific trials could supplement EFSA’s CAG methodology. However, this should consider the specific and already conservative EFSA CAG approach (MOE 100 @99.9th percentile). Compatibility with international practice should also be ensured in view of EU trade, especially at times when food and feed security are challenged.
Legal certainty can only rely on robust scientific evidence. Risk management decisions, e.g. withdrawal of approvals/non-approvals/substitutions of a substance when the ‘risk-cup is full’ must be supported by sound and sufficient scientific evidence that is unchallengeable in the courts.