On the safety of fipronil

All medicinal products and pest control products used in the EU undergo a thorough assessment of their safety to consumers before they are authorised for use.

Acceptable daily intake: The European Food Safety Authority EFSA has assessed the acceptable daily intake (ADI) of fipronil to be 0.0002 mg per kg of body weight. ADI is an estimate of the amount of a substance that can be consumed on a daily basis over a lifetime without a risk to health. ADI is expressed as milligrams of the substance per kilogram of body weight per day and it applies to both adults and children. A so-called safety factor is used between the highest dose found in animal tests to have adverse effects and the acceptable daily intake. For fipronil, this factor is 100.

Acute reference dose: EFSA has assessed the safety of fipronil also in short-term exposure. This acute reference dose, ARfD, is for fipronil 0.009 mg per kg of body weight per day. ARfD is defined as an estimate of the amount of a substance that can be ingested in a period of 24 hours without acute health risks. A safety factor of 100 has been applied when setting the ARfd for fipronil.

The exposure of a consumer to the fipronil residues found in eggs is assessed by comparing the concentrations measured in the food and the consumption amounts of the foods with the ADI and ARfd values. An intake of fipronil from a food exceeding the ARfD does not directly mean that the food causes an acute risk to the consumer. However, the occurrence of adverse effects cannot be ruled out. The toxicity of fipronil and its sulfone metabolite are comparable and therefore they both need to be taken into account in the assessment.

Read more: EFSA Scientific report (2006) 65, 1-110. Conclusion on the peer review of fipronil.

Maximum residue limit (MRL) in food: The MRL refers to the maximum residual concentration of the substance in food. The MRL is set based on e.g. good agricultural practices, i.e., on the lowest possible level that will produce the desired effect. In practice, this means the maximum amounts are often much lower than concentrations acceptable in terms of health. The maximum residue limits are not safety limits and a concentration exceeding the MRL does not directly imply a health risk.

The maximum residue limit (MRL) set for fipronil in eggs and chicken meat is 0.005 mg/kg ((EC) No 396/2005) and it is set at the limit of analytical quantification. This MRL has been set for the sum of fipronil and its sulfone metabolite (expressed as fipronil). https://ec.europa.eu/food/plant/pesticides/max_residue_levels_en

When the compliance of a food is assessed, the measured residue limits are compared with the the MRL set for the substance (0.005 mg/kg). The EU Commission has issued to all member states guidelines (RASFF notif 2017.1065, fup297) which are in force until further notice for interpretation regarding actions to be taken, if fipronil residues are found in eggs or chicken meat in levels exceeding the limits at which the occurrence of acute risks cannot be ruled out.

Read more: Fipronil – Guidelines for risk management

Assessments by authorities: German Authorities (Bundesinstitut für Risikobewertung, BfR) have published in relation to this incident assessments of the safety of fipronil to consumers, if found in eggs or chicken meat. The assessments will be updated, if considered necessary based on new data.

30.7.2017: BfR assessed consumer exposure to fipronil based on results of individual tests on eggs and chicken meat, using the highest concentrations measured in Belgium, which were max. 1.2 mg/kg for eggs and 0.0156 mg/kg for chicken meat (the worst case scenario). Using European consumption figures as the basis, the intake of fipronil exceeded the acute reference dose 1.6-fold only in the group of some small children. The occurrence of acute adverse effects cannot be ruled out on the basis of this.

8.8.2017 and 11.8.2017: BfR assessed the safety of eggs and chicken meat based on the results of official German analyses. The highest fipronil levels measured were 0.45 mg/kg in eggs, and 0.175 mg/kg in chickens reared for laying and egg laying hens No acute risk was identified for any consumer groups, as the intake of fipronil was only 23% and 62% of the ARfD, respectively.

11.8.2017: BfR has on 11.7.2017 published an assessment which is in force until further notice of the safety of fipronil to consumers where exposure to fipronil has been prolonged and the consumption of foods follows average consumption levels. In addition to eggs and chicken meat, all products that can cause exposure to fipronil were taken into account in the estimate. Based on both German and European food consumption data, the intake of fipronil does not exceed the ADI in any consumer group and thus health risks are not probable according to available data.

Read more: http://www.bfr.bund.de/en/a-z_index/fipronil-201485.html

French Authorities ( French Agency for Food, Environmental and Occupational Health & Safety, Anses) have published assessments of the safety of fipronil to consumers, if found in eggs or chicken meat (21.8.2017).

Read more: https://www.anses.fr/en/content/assessment-risks-associated-consumption-eggs-and-egg-products-contaminated-fipronil-updated

Fipronil as a medicinal product: Fipronil is authorised also in Finland as an ectoparasiticide, but it may not be used on animals intended for use as food or for production of food such as eggs.

Read more: Prescription-free ectoparasiticides for pets, (in Finnish)

Fipronil as a biocide: Plant protection products containing fipronil are no longer used in Finland, and on EU level the authorisation of fipronil as an active substance expires on 30.9.2017. However, there is one biocidal product containing fipronil on the market in Finland. It is intended for combating cockroaches. It is designed exclusively for professional use in industrial, residential and public buildings, and a valid pest management licence is required to use it.

Read more on biocides: http://www.tukes.fi/en/Branches/Chemicals-biocides-plant-protection-products/Biocides/