Slide background
Slide background




Guidance to assess the risks to bees from the use of biocides

ID 21360 | | Visite: 825 | Documenti Chemicals ECHAPermalink: https://www.certifico.com/id/21360

Guidance to assess the risks to bees from the use of biocides

Guidance to assess the risks to bees from the use of biocides (02/2024)

ID 21360 | 14.02.2024

This Guidance provides technical advice on how to perform the hazard and exposure assessment and risk characterisation for biocidal active substances and biocidal products with respect to assessment of risks to bees from the use of biocides.

In December 2019, ECHA received a mandate from the European Commission to develop guidance for assessing the risk to pollinators (including bees) from the exposure to biocides. According to the mandate, ECHA should take into account the revised EFSA Guidance document on the risk assessment of plant protection products on bees, which was published in May 2023.

The mandate also stated that the ECHA Guidance on pollinators should specify the information required to enable a conclusion by the evaluating authority on whether the biocidal product complies with the criteria under BPR Article 19(1)(b)(iv) concerning bees and other arthropod pollinators. However, due to the current lack of data on non-bee pollinators, this guidance document only covers the risk assessment to bees from the use of biocides.
ECHA has developed this guidance document together with a group of experts from different Member States, as well as with the support from stakeholder organizations.

This guidance document provides a methodology to assess the risk to honey bees that are exposed to biocides. This is done by following a tiered approach for the exposure and the effect assessment. In the risk assessment of honey bees, the magnitude dimension of the Specific Protection Goals (SPGs) is applied as a threshold for acceptable effects. In regard to bumble bees and solitary bees, a risk assessment methodology is provided but the magnitude dimension of the SPG is not defined due to current lack of knowledge.

This guidance considers two main routes of exposure to bees, via intake of contaminated pollen and nectar through the diet, and via contact, when the bees come to physical contact with the biocidal product.

In the risk assessment, a tiered approach is applied both for exposure and effect assessments, i.e., an exposure-Tier and an effect-Tier have been defined. In the exposure tiers, residue intake or residue deposition need to be quantified by calculating the Predicted Exposure Quantity (PEQ) to address the dietary and the contact exposure of the bees from the use of a biocide through the different routes of exposure. In the effect tiers, the imposed exposure is called ‘Dose’ in the laboratory tests or ‘Estimated Exposure Dose’ in the higher tier tests.

The routes of exposure to bees for both exposure and effect assessments are approached considering both acute and chronic effects, and adults and larvae as different life-stages. Thereby, four risk cases have been defined: acute-contact; acute-dietary; chronic-dietary; larvae-dietary. For each of these risk cases, a PEQj is derived in the exposure estimation with suffix j indicating the specific risk case.

The guidance proposes a risk assessment approach to assess the risk to bees from product type (PT) 18 (insecticides, acaricides and products to control other arthropods) emission scenarios. The possible sources of exposure covered in the guidance are application of manure/sludge from animal housing, spraying on walls and foundation of buildings, irrigation of private gardens with treated water, and large scale spraying of trees, bushes or natural water bodies. Bee exposure through direct consumption of bait products is not considered in this guidance. Also, for spot applications by spraying, no quantitative risk assessment is required.The focus of the guidance is on PT18 uses. However, a risk assessment may be required for a biocidal product under a PT other than PT18 when the potential exposure to bees is considered significant enough to warrant further consideration and if the product contains an active substance with an insecticidal mode of action.

In the effects assessment, the lower tier assessment will define dose response curves (DRC), which are parameters to describe the steepness of the dose-response relationship obtained from the standard laboratory test.

As part of the effect assessment, this guidance document includes two additional aspects for honey bees: considering and assessing whether the concerned compound presents increasing toxic effects due to long-term exposure to low doses – Time Reinforced Toxicity (TRT) and potential concerns due to sublethal effects.

The guidance also provides advice for higher tier effect assessment as a potential way for refinement, in case unacceptable effects are observed in the lower tier assessment. Furthermore, a risk assessment scheme for metabolites and biocidal products (mixtures), and considerations of risk mitigation measures, and instructions for use are included in the document.

This guidance document for the risk assessment of bees from the use of biocides is developed by taking into account the existing guidance available by EFSA for the risk assessment of plant protection products. For further information on the detailed aspect of the risk assessment methodology as well as the scientific background information, the reader is referred to the EFSA guidance (Revised guidance on the risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees)) and its supplementary documents.

...

Fonte: ECHA

Collegati

DescrizioneLinguaDimensioneDownloads
Scarica questo file (Guidance to assess the risks to bees from the use of biocides.pdf)Guidance to assess the risks to bees from the use of biocides
ECHA 2024
EN4084 kB139

Tags: Chemicals Regolamento BPR Guida ECHA

Articoli correlati

Ultimi archiviati Chemicals

Nov 18, 2024 152

Rettifica regolamento delegato 2023/707 - 18.11.2024

Rettifica regolamento delegato 2023/707 - 18.11.2024 ID 22953 | 18.11.2024 Rettifica del regolamento delegato 2023/707 della Commissione, del 19 dicembre 2022, che modifica il regolamento (CE) n. 1272/2008 per quanto riguarda i criteri e le classi di pericolo per la classificazione, l’etichettatura… Leggi tutto
REACH Authorisation List
Nov 13, 2024 105

REACH Authorisation Decisions List / Last update: 13.11.2024

REACH Authorisation Decisions List / Last update: 13.11.2024 ID 21612 | Last update: 13.11.2024 REACH Authorisation Decisions List of authorisation decisions adopted on the basis of Article 64 of Regulation (EC) No 1907/2006 (REACH). The list also includes reference to related documentation… Leggi tutto
Logo di produzione biologica UE
Nov 11, 2024 133

Regolamento delegato (UE) 2024/2867

Regolamento delegato (UE) 2024/2867 / Logo di produzione biologica UE ID 22907 | 11.11.2024 Regolamento delegato (UE) 2024/2867 della Commissione, del 2 settembre 2024, che modifica il regolamento (UE) 2018/848 del Parlamento europeo e del Consiglio per quanto riguarda la presentazione del logo di… Leggi tutto
Nov 07, 2024 156

Direttiva 1999/2/CE

Direttiva 1999/2/CE ID 22885 | 07.11.2024 Direttiva 1999/2/CE del Parlamento europeo e del Consiglio del 22 febbraio 1999 relativa al ravvicinamento delle legislazioni degli Stati membri concernenti gli alimenti e i loro ingredienti trattati con radiazioni ionizzanti GU L 66/16 del 13.3.1999… Leggi tutto
Ott 28, 2024 115

Decreto 4 agosto 2011 n. 158

Decreto 4 agosto 2011 n. 158 / Recepimenti Direttiva ID 22820 | 28.10.2024 Decreto 4 agosto 2011 n. 158 Regolamento recante recepimento della direttiva 2010/59/UE della Commissione del 26 agosto 2010 che modifica la direttiva 2009/32/CE del Parlamento europeo e del Consiglio per il ravvicinamento… Leggi tutto
Direttiva 2009 32 CE   Solventi da estrazione uso alimentare
Ott 28, 2024 198

Direttiva 2009/32/CE

Direttiva 2009/32/CE / Solventi da estrazione uso alimentare ID 22819 | 28.10.2024 Direttiva 2009/32/CE del Parlamento europeo e del Consiglio, del 23 aprile 2009, per il ravvicinamento delle legislazioni degli Stati membri riguardanti i solventi da estrazione impiegati nella preparazione dei… Leggi tutto
Ott 28, 2024 96

Direttiva 88/344/CEE

Direttiva 88/344/CEE / Solventi da estrazione Direttiva 88/344/CEE del Consiglio del 13 giugno 1988 per il ravvicinamento delle legislazioni degli Stati Membri riguardanti i solventi da estrazione impiegati nella preparazione dei prodotti alimentari e dei loro ingredienti (GU L 157 del 24.6.1988)… Leggi tutto
Decreto Legislativo 4 febbraio 1993 n  64   Solventi da estrazione uso alimentare
Ott 28, 2024 118

Decreto Legislativo 4 febbraio 1993 n. 64

Decreto Legislativo 4 febbraio 1993 n. 64 / Solventi da estrazione uso alimentare ID 22817 | 28.10.2024 / Testo consolidato allegato Decreto Legislativo 4 febbraio 1993 n. 64Attuazione della direttiva 88/344/CEE in materia di solventi da estrazione impiegati nella preparazione dei prodotti… Leggi tutto

Più letti Chemicals

Notifica HACCP
Apr 05, 2022 85842

Notifica ai fini registrazione Regolamento CE n. 852/2004

Notifica ai fini della registrazione (Reg. CE n. 852/2004) - Ex notifica sanitaria alimentare ID 7901 | 06.03.2019 / Modello notifica allegato [panel]Regolamento (CE) 852/2004...Articolo 6 Controlli ufficiali, registrazione e riconoscimento 1. Gli operatori del settore alimentare collaborano con le… Leggi tutto