EFSA performs environmental risk assessments (ERAs) for single potential stressors such as plant protection products, genetically modified organisms and feed additives and for invasive alien species that are harmful for plant health. In this risk assessment domain, the EFSA Scientific Committee recognises the importance of more integrated ERAs considering both the local and landscape scales, as well as the possible co-occurrence of multiple potential stressors that fall under the remit of EFSA, which are important when addressing ecological recovery. In this scientific opinion, the Scientific Committee gathered scientific knowledge on the potential for the recovery of non-target organisms for the further development of ERA. Current EFSA guidance documents and opinions were reviewed on how ecological recovery is addressed in ERA schemes. In addition, this scientific opinion is based on expert knowledge and data retrieved from the literature. Finally, the information presented in this opinion was reviewed by experts from the relevant EFSA Panels, European risk assessment bodies and through an open consultation requesting input from stakeholders. A conceptual framework was developed to address ecological recovery for any assessed products, and invasive alien species that are harmful for plant health. This framework proposes an integrative approach based on well-defined specific protection goals, scientific knowledge derived by means of experimentation, modelling and monitoring, and the selection of focal taxa, communities, processes and landscapes to develop environmental scenarios to allow the assessment of recovery of organisms and ecological processes at relevant spatial and temporal scales.
Just Published: February, 2016
Scientific Opinions: Opinions of the Scientific Committee/Scientific Panel
The EFSA performs environmental risk assessment (ERA) for single potential stressors such as plant protection products, genetically modified organisms and feed additives, and for invasive alien species that are harmful to plant health. This ERA focusses primarily on the use or spread of such potential stressors in an agricultural context, but also considers the impact on the wider environment. It is important to realise that the above potential stressors in most cases contribute a minor proportion of the total integrated pressure that ecosystems experience. The World Wildlife Fund listed the relative attribution of threats contributing to the declines in animal populations as follows: 37% from exploitation (fishing, hunting, etc.), 31% habitat degradation and change, 13% from habitat loss, 7% from climate change, and only 5% from invasive species, 4% from pollution and 2% from disease. In this scientific opinion, the Scientific Committee gathered scientific knowledge on the extent of coverage of endangered species in current ERA schemes that fall under the remit of EFSA. The legal basis and the relevant ecological and biological features used to classify a species as endangered are investigated. The characteristics that determine vulnerability of endangered species are reviewed. Whether endangered species are more at risk from exposure to potential stressors than other nontarget species is discussed, but specific protection goals for endangered species are not given. Due to a lack of effect and exposure data for the vast majority of endangered species, the reliability of using data from other species is a key issue for their ERA. This issue and other uncertainties are discussed when reviewing the coverage of endangered species in current ERA schemes. Potential tools, such as population and landscape modelling and trait-based approaches, for extending the coverage of endangered species in current ERA schemes, are explored and reported.
In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS) Austria received an application from the company Sumitomo Chemical Agro Europa S.A.S. to set maximum residue limits (MRLs) for fenpyrazamine in blueberries and cane fruits in support of the import of these berries from the United States. Austria drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA. According to EFSA the submitted supervised residue trials are sufficient to derive a MRL proposal of 4 mg/kg in blueberries. From a combined residue data set on blackberries and raspberries a MRL of 5 mg/kg is derived for the whole group of cane fruits. Adequate analytical enforcement methods are available. Based on the risk assessment results, EFSA concludes that the authorized use of fenpyrazamine in the United States on blueberries and cane fruits will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.
In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS), Spain, received an application from Cheminova Agro S.A. to modify the existing maximum residue level (MRL) for the active substance pyriproxyfen in bananas. In order to accommodate for the intended use of pyriproxyfen, Spain proposed to raise the existing MRL from the limit of quantification of 0.05 mg/kg to 0.5 mg/kg. According to EFSA the data are sufficient to derive a MRL proposal of 0.7 mg/kg for the proposed use on bananas. Adequate analytical enforcement methods are available to control the residues of pyriproxyfen in banana. Based on the risk assessment results, EFSA concludes that the proposed use of pyriproxyfen on banana will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a consumer health risk.
According to Article 12 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance bitertanol. Although this active substance is no longer authorised within the European Union due to certain impurities of unknown toxicological relevance, MRLs established by the Codex Alimentarius Commission (CXLs) are still in place. Based on lacking toxicological characterisation of the impurities, it was not possible for EFSA to perform an assessment of these CXLs and their incorporation in European legislation cannot be recommended. Nevertheless, available data allowed EFSA to propose a marker residue and a limit of quantification (LOQ) for enforcement against potential illegal uses.
Scientific Reports of EFSA
Following a request from the European Commission, EFSA was tasked to periodically update its database of host plants of Xylella fastidiosa which was published in April 2015. An extensive literature search approach was used for updating the database in order to catch all new scientific developments published on the topic. Furthermore, the outputs of investigations conducted on host plants affected by X. fastidiosa in the Italian and French outbreaks were included. Literature screening and data extraction were performed using the Distiller platform. The protocol and the guideline applied for the Extensive Literature Search and for the update of the database are described in this report. The current version of the database includes reports of hosts of X. fastidiosa published up to 20 November 2015. The current list of X. fastidiosa host plant species consists of 359 plant species (including hybrids) from 204 genera and 75 different botanical families. Compared to the previous database, 44 new species and 2 new hybrids, 15 new genera and 5 new families were found. The majority of the additional species (70%) were reported in Apulia, Corsica and southern France.
On 22 January 2015, Croatia submitted to the European Commission (EC) a request to revise its bovine spongiform encephalopathy (BSE) monitoring programme. The EC requested the European Food Safety Authority (EFSA) to provide scientific and technical assistance on an assessment of the capacity of the proposed revised monitoring programme in Croatia to allow the detection of BSE, both classical and atypical strains, with a design prevalence of at least one case per 100,000 animals in the adult cattle population of the EU26 group (EU25 and Croatia). Under this revision Croatia would stop testing all healthy slaughtered cattle and would test all ‘at risk’ cattle of active surveillance above 36 months of age. The EC resolved that the EU26 should be considered as a unique epidemiological unit for this assessment. Data related to the EU26 were updated to run the Cattle Transmissible Spongiform Encephalopathies Monitoring Model (C-TSEMM), previously applied to similar assessments. This model allows the estimation of the design prevalence of the same surveillance regime applied by a group of countries. Using data up to 2014, the current EU25 surveillance regime would allow the detection of BSE in the EU25 with a design prevalence of at least 1 per 3,769,555 of the cattle adult population, lower (i.e. more sensitive) than the minimum requirement of 1 case per 100,000. The addition of Croatia to the EU25 epidemiological unit (EU26) assuming the current EU25 surveillance regime resulted in an ability in EU26 to detect BSE with a design prevalence of at least 1 per 3,789,838 of the adult cattle population. It is recommended:  to run the C-TSEMM model on an annual basis with updated data;  to monitor MS data in order to evaluate the surveillance coverage and  to identify any shortcomings affecting the overall sensitivity of the surveillance system.