EFSA News

The European Food Safety Authority (EFSA) is the agency of the European Union (EU) that provides independent scientific advice and communicates on existing and emerging risks associated with the food chain. EFSA was established in February 2002, is based in Parma, Italy and had a budget for 2008 of €65.9 million.

The work of EFSA covers all matters with a direct or indirect impact on food and feed safety, including animal health and welfare, plant protection and plant health and nutrition. EFSA supports the European Commission, the European Parliament and EU member states in taking effective and timely risk management decisions that ensure the protection of the healthof European consumers and the safety of the food and feed chain. EFSA also communicates to the public in an open and transparent way on all matters within its remit.

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Published on: 26 July 2017

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Adama Makhteshim submitted a request to the competent national authority in the Netherlands to set maximum residue levels (MRL) for the active substance fluazinam in onions, shallots and garlic. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under consideration. An adequate analytical method for enforcement is available to control the residues of fluazinam in plant matrices. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of fluazinam according to the intended agricultural practices is unlikely to present a risk to consumer health.


© European Food Safety Authority, 2015

Modification of the existing maximum residue levels for fluazinam in onions, shallots and garlic


Published on: 26 July 2017

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Hungary, and co-rapporteur Member State, the Netherlands, for the pesticide active substance Clonostachys rosea strain J1446, currently approved as Gliocladium catenulatum strain J1446, are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of Clonostachys rosea strain J1446 as a fungicide in agriculture and horticulture. The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.


© European Food Safety Authority, 2015

Peer review of the pesticide risk assessment of the active substance Clonostachys rosea strain J1446 (approved in Regulation (EU) No 540/2011 as Gliocladium catenulatum strain J1446)


Published on: 26 July 2017

Guidance of the EFSA Panel on Genetically Modified Organisms assists applicants in the preparation and presentation of their applications by describing elements and data requirements for the risk assessment and monitoring of genetically modified (GM) plants. This note to the guidance provides a scientific rationale and further instructions for the use of bioinformatic analyses to identify GM plant sequences with sufficient identity to promote homologous recombination and impact on horizontal gene transfer from plants to microorganisms. The evaluation of the extent of identity between GM event DNA sequences and the DNA present in microbial genomes, with bioinformatic analyses, is considered necessary to perform a proper problem formulation to define the probability for horizontal gene transfer in the environmental risk assessment of GM plants. Further details on how to perform such analyses are outlined and include a complete description of all sequences present in the insert, and recommendations on the algorithms, parameters and databases to be used as well as on a relevant length of sequence identity between the GM plant sequences and those present in microbial genomes.


© European Food Safety Authority, 2015

Explanatory note on DNA sequence similarity searches in the context of the assessment of horizontal gene transfer from plants to microorganisms


Published on: 25 July 2017

The qualified presumption of safety (QPS) concept was developed to provide a harmonised generic pre-evaluation to support safety risk assessments of biological agents performed by EFSA's scientific Panels. The identity, body of knowledge, safety concerns and antimicrobial resistance of valid taxonomic units were assessed. Safety concerns identified for a taxonomic unit are, where possible and reasonable in number, reflected as ‘qualifications’ which should be assessed at the strain level by the EFSA's scientific Panels. No new information was found that would change the previously recommended QPS taxonomic units and their qualifications. Between the end of September 2016 and March 2017, the QPS notification list was updated with 87 applications for market authorisation. From these, 32 biological agents already had a QPS status, and 37 were not included in the evaluation as they are filamentous fungi or enterococci. Streptomyces species (Streptomyces cinnamonensis, Streptomyces mobaraensis and Streptomyces violaceoruber), Bacillus circulans (three notifications) and Escherichia coli (seven notifications) were re-confirmed not suitable for QPS. Streptomyces rubiginosus and Streptomyces netropsis, not evaluated within the previous mandate, were also not recommended for QPS. Streptomyces spp. and E. coli will be excluded from further QPS evaluations within the current QPS mandate. Hyphomicrobium denitrificans, which has never been evaluated before, was not recommended for the QPS list and for Pseudomonas amyloderamosa, the QPS assessment was not applicable because it is not a validated species. Lactobacillus animalis was a new taxonomic unit recommended to have the QPS status.


© European Food Safety Authority, 2015

Update of the list of QPS-recommended biological agents intentionally added to food or feed as notified to EFSA 6: suitability of taxonomic units notified to EFSA until March 2017