Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009

Andersson, Niklas; Arena, Maria; Auteri, Domenica; Barmaz, Stefania; Grignard, Elise; Kienzler, Aude; Lepper, P.; Lostia, Alfonso; Munn, Sharon; Morte, Juan Manuel Parra; Pellizzato, Francesca; Tarazona, José; Terron, Andrea; Linden, Sander van der

doi:10.2903/j.efsa.2018.5311

Cited by 263 publications

(320 citation statements)

References 148 publications

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“…The experts agreed that chlorpyrifos is not an ED in humans, because, in line with other ED assessments recently conducted by EFSA and the guidance for the identification of EDs in the context of Regulation (EU) No 1107/2009 (ECHA and EFSA, ), an ED assessment is not scientifically necessary for chlorpyrifos. In all the studies conducted with chlorpyrifos, the NOAEL, the lowest observable adverse effect level (LOAEL) and the maximum tolerated dose (MTD) were based on erythrocyte AChE inhibition and clinical signs at high doses.…”

Section: Assessmentmentioning

confidence: 60%

“…The toxicological profile of the active substance chlorpyrifos was discussed at the Pesticides Peer Review Experts’ Meeting 01 in April 2019 and assessed based on the following guidance documents: SANCO/10597/2003‐rev. 10.1 (European Commission, ), Guidance on dermal absorption (EFSA PPR Panel, ), ECHA/EFSA Guidance for the identification of endocrine disruptors (EDs) (ECHA and EFSA, ) and Guidance on the application of the classification, labelling and packaging (CLP) Criteria (ECHA, ).…”

Section: Assessmentmentioning

confidence: 99%

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Statement on the available outcomes of the human health assessment in the context of the pesticides peer review of the active substance chlorpyrifos

2019

EFS2

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In July 2019, the European Commission asked EFSA to provide a statement on the available outcomes of the human health assessment in the context of the pesticides peer review for the renewal of approval of the active substance chlorpyrifos conducted in accordance with Commission Implementing Regulation (EC) No 844/2012. The current statement contains a summary of the main findings of the assessment related to human health following the pesticides peer review expert discussions in mammalian toxicology held between 1 and 5 April 2019, as well as EFSA's additional considerations, including whether the active substance can be expected to meet the approval criteria applicable to human health as laid down in Article 4 of Regulation (EC) No 1107/2009. The identified concerns are presented as follows.

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Section: Assessmentmentioning

confidence: 60%

Section: Assessmentmentioning

confidence: 99%

Statement on the available outcomes of the human health assessment in the context of the pesticides peer review of the active substance chlorpyrifos

2019

EFS2

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“…Regarding the assessment of the endocrine disrupting potential of pydiflumetofen discussed during the Pesticides Peer Review Experts’ Meeting 05 Mammalian toxicology – Ecotoxicology (joint session on ED, 7–8 May 2019), the oestrogen, androgen, thyroid and steroidogenesis (EATS) modalities were considered, according to the ECHA/EFSA guidance (), sufficiently investigated and no adversity was observed.…”

Section: Mammalian Toxicitymentioning

confidence: 99%

“…With regard to the assessment of endocrine disruption (ED) potential according to ECHA and EFSA (), as reported in Section 2, pydiflumetofen is not an endocrine disruptor in humans and this conclusion also applies to mammals as non‐target organisms.…”

Section: Ecotoxicologymentioning

confidence: 99%

Peer review of the pesticide risk assessment of the active substance pydiflumetofen

Arena¹,

Auteri²,

Brancato³

et al. 2019

EFS2

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The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State France and co‐rapporteur Member State Austria for the pesticide active substance pydiflumetofen and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of pydiflumetofen as a fungicide field application on pome fruits, grapes, potato, fruiting vegetables, cucurbits and Brassica vegetables. The reliable endpoints, appropriate for use in regulatory risk assessment and the proposed MRLs, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

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“…No data and assessment investigating the potential of fenamiphos to have endocrine disrupting properties to non‐target organisms, according to the ECHA and EFSA guidance (), were available.…”

Section: Ecotoxicologymentioning

confidence: 99%

Peer review of the pesticide risk assessment of the active substance fenamiphos

Abdourahime¹,

Anastassiadou²,

Arena³

et al. 2019

EFS2

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The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Greece and co‐rapporteur Member State Cyprus for the pesticide active substance fenamiphos 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 fenamiphos as a nematicide in fruiting vegetables (i.e. tomato, aubergine, cucumber, pepper and courgette), herbaceous ornamentals and in nursery stock (both perennial and herbaceous species). 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.

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Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009

Cited by 263 publications

References 148 publications

Statement on the available outcomes of the human health assessment in the context of the pesticides peer review of the active substance chlorpyrifos

Statement on the available outcomes of the human health assessment in the context of the pesticides peer review of the active substance chlorpyrifos

Peer review of the pesticide risk assessment of the active substance pydiflumetofen

Peer review of the pesticide risk assessment of the active substance fenamiphos

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