Current issue

Volume: [2016]

Issue

Just Published: February, 2016

Scientific Opinions: Opinions of the Scientific Committee/Scientific Panel

Ecological recovery in ERA

EFSA Scientific Committee
Simon More, Alicja Mortensen, Antonia Ricci, Vittorio Silano, Katrine Helle Knutsen, Guido Rychen, Hanspeter Naegeli, Dominique Turck, Michael John Jeger, Colin Ockleford, Diane Benford, Thorhallur Halldorsson, Anthony Hardy, Hubert Noteborn, Josef R. Schlatter, Roland Solecki
EFSA Journal 2016;14(2):4313 [85 pp.].
doi
10.2903/j.efsa.2016.4313
Abstract

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.

Endangered species in ERA

EFSA Scientific Committee
Simon More, Alicja Mortensen, Antonia Ricci, Vittorio Silano, Katrine Helle Knutsen, Guido Rychen, Hanspeter Naegeli, Dominique Turck, Michael John Jeger, Colin Ockleford, Diane Benford, Thorhallur Halldorsson, Anthony Hardy, Hubert Noteborn, Josef R. Schlatter, Roland Solecki
EFSA Journal 2016; 14(2):4312 [124 pp.].
doi
10.2903/j.efsa.2016.4312
Abstract

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.

Reasoned Opinions

Setting of import tolerances for fenpyrazamine in cane fruits and blueberries

European Food Safety Authority
EFSA Journal 2016;14(2):4384 [20 pp.].
doi
10.2903/j.efsa.2016.4384
Abstract

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.

Modification of the existing maximum residue level for pyriproxyfen in bananas

European Food Safety Authority
EFSA Journal 2016;14(1):4387 [18 pp.].
doi
10.2903/j.efsa.2016.4387
Abstract

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.

Review of the existing MRLs for bitertanol

European Food Safety Authority
EFSA Journal 2016;14(2):4386 [15 pp.].
doi
10.2903/j.efsa.2016.4386
Abstract

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.