Evaluation Report Mutual Recognition

Transcription

1 HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE II bij het besluit d.d. 3 oktober 2014 tot toelating van het middel Mirazyl Box, Mierenlokdoos Natria, Edialux Mierenlokdoos, Luxan Mierenlokdoos, toelatingnummer N Evaluation Report Mutual Recognition Mirazyl Box Mierenlokdoos Natria Edialux Mierenlokdoos Luxan Mierenlokdoos Biocidal product assessment report related to product authorisation under (EU) Regulation 528/2012

2 Contents 1 General information about the product application Summary of the product assessment Classification and labelling Packaging and shelf-life Physico/chemical properties and analytical methods Effectiveness against target organisms Exposure to humans Risk assessment for human health Risk assessment for the environment Proposal for decision

3 1 General information about the product application Naam en adres van de toelatinghouder Toelatingsnummer Naam Detia Freyberg GmbH Adres Dr.-Werner-Freyberg-Str. 11 D Laudenbach 13182N Datum van toelating 3 oktober 2014 Expiratie datum 31 oktober 2022 Trade names Evaluating member state Name of the product in RMS Active substance PT 18 User category Mirazyl Box Mierenlokdoos Natria Edialux Mierenlokdoos Luxan Mierenlokdoos DE Ameisen-Köderdose Spinosad Professional users Non-professional users 2 Summary of the product assessment 2.1 Classification and labelling The classification and labelling of the preparation according to Reg (EC) 1272/2008 as proposed by the competent authority of Germany is acceptable for Ctgb. For details we refer to the SPC. 2.2 Packaging and shelf-life Professional and non professional use Packaging authorised/ evaluated by RMS Packaging size and type Box (aluminium) containing a cotton pad impregnated with a spinosad liquid formulation. The cover and the bottom part of the bait Packaging applied for in NL Box (aluminium) containing a cotton pad impregnated with a spinosad liquid formulation. The cover and the bottom part of Packaging authorised in NL Box (aluminium) containing a cotton pad impregnated with a spinosad liquid formulation. The cover and the bottom part of 1

4 are sealed with a rubber sealant. Ant bait 5 g Cover: diameter 78.8 ± 0.3 mm Bottom: diameter ± 0.2 mm Height: 20.5 ± 0.3 mm the bait are sealed with a rubber sealant. Ant bait 5 g Cover: diameter 78.8 ± 0.3 mm Bottom: diameter ± 0.2 mm Height: 20.5 ± 0.3 mm the bait are sealed with a rubber sealant. Ant bait 5 g Cover: diameter 78.8 ± 0.3 mm Bottom: diameter ± 0.2 mm Height: 20.5 ± 0.3 mm The shelf life of the product is 24 months in aluminium. 2.3 Physico/chemical properties and analytical methods For the assessment of the physical and chemical properties, analytical methods and risk assessment regarding physical and chemical properties we refer to the Product Assessment Report of the original authorisation. 2.4 Effectiveness against target organisms For the assessment of the effectiveness against target organisms we refer to Product Assessment Report of the original authorisation by RMS DE (Ameisenkoederdose,June 2014). The conclusions of the RMS are acceptable. Due to Dutch regulations on administration of biocides for professional use (art. 25 Bgb), professional use and non-professional use cannot be placed on one label. Therefore, two uses were separated in the SPC, one for professional use and one for non-professional use. On the product label only one of these uses should be mentioned The label claim The applicant has provided a Dutch SPC. This has been adapted to our standards. Target species According to the PAR, the organisms claimed to be controlled are ants. In NL a differentiation between ants and tropical ants is always made on the label. The NL SPC will state that efficacy against tropical ants has not been tested. 2.5 Exposure to humans For the assessment of the exposure to humans we refer further to Product Assessment Report of the original authorisation. The biocidal product consists of a cylindrical metal tin marketed in size of 5g containing a cotton pad impregnated with an aqueous solution of the a.s. spinosad (0.08%). The cover and the bottom part are sealed with a rubber sealant. `Ameisen-Köderdose (the name of the product in Germany) is a ready-to-use product; no refilling occurs. For application, the tin has to be opened on two small areas on the side of the metal container with the help of a screwdriver and is then positioned on the travel path of ants. After successful eradication of the target organisms the boxes are collected and disposed. The intended use of the biocidal product is not covered by the CAR for spinosad (RMS NL). In the TNsG Human Exposure (2002 and 2007) no suitable model is available to assess the described exposure situation. The RMS has based the exposure assessment on a worst case assumption. 2

5 For Annex I inclusion a dermal absorption study with an aqueous spray dilution was submitted. The dermal absorption value from this study (2 %) is considered applicable by the RMS-DE for the biocidal product as a worst case value. The composition of the biocidal product and the tested dilution differs significantly. However, the main components of these mixtures are water (for the test dilution) and water, sugar and cotton pad (for the biocidal product). These components are not expected to influence dermal absorption significantly. The concentrations of other components, which may have an effect due to their irritating properties, are strongly diluted far below of any concentration limit for classification. Thus, significant effects on dermal absorption are not expected. The concentration of the active substance in the biocidal product is significantly higher than in the tested dilution particularly since the biocidal product dried after impregnation of the cotton pad. Based on the dermal absorption studies submitted for Annex I inclusion of spinosad it can be assumed that dermal absorption values for this active substance decrease with higher concentrations. Thus, the value of 2 % represents worst case conditions for the active substance spinosad in this biocidal product. The RMS-DE used the oral absorption factor of 50% based on the final CAR. The applicant has submitted no acute oral and acute dermal toxicity, skin and eye irritation and sensibilisation studies with the formulation. Moreover, no other repeated dose studies are submitted. Professional users Dermal exposure According to the applicant, the design of the bait box prevents professional users to come into contact with the cotton pad containing spinosad. However, photos of the biocidal product provided by the applicant, suggest a possibility of dermal exposure since the holes may be as wide as a fingertip. Therefore, the scenario of fingertips entering the hole of the bait box is assessed as a worst case assumption. Due to the lack of a suitable model for professional operators applying these bait boxes, the RMS estimated that parts of two fingertips are contaminated by contact to the impregnated pad via two holes in the container (skin area: 10 cm2); a transfer coefficient of 20% for dried fluids on cotton is assumed. Furthermore, during opening of tin, contamination of the screwdriver is possible since it may come into contact with the cotton pad and, subsequently, may lead to dermal exposure to hands. However, this scenario is covered by the worst case assessment performed for the fingertips entering the holes of the tin. Since the biocidal product is a ready-to-use product, no mixing and loading phase is calculated. Potential dermal exposure is focused on sections of fingertips during application of bait boxes and post-application phase (collection of boxes after treatment). After calculation the potential dermal exposure resulted in 0.2 mg/person/dag (based on 0.1 mg/cm2 spinosad impregnation of the coton pad, a skin area contact of 10 cm2 and a transfer coefficient of 20%). Exposure by inhalation According to the CAR of spinosad, experimental data indicate that the vapour pressure for both isomers (spinosyn A and spinosyn D) is less than 10-5 Pa at 20 C. Therefore, exposure via inhalation of vapour is not considered to occur. The described exposure assessment is valid for professional users (e.g. housekeepers) or specialised professional users (e.g. pest control operators). No secondary exposure of professionals is expected in view of the anticipated use patterns. 3

6 Non-professional users and secondary exposure The secondary exposure covers the primary exposure of the non-professional users. Taking into account a dermal absorption of 2 % and a body weight of 10 kg for infants a systemic dermal exposure of (0.2 mg/dag x 0.02=) mg/kg bw can be calculated. For oral exposure it is assumed that 50 % of the external dermal dose (0.2 mg) is ingested orally. 50 % was used as a worst case assumption, further refinement was not considered necessary. A factor of 10% is based on the assumption that the hands account for appr. 10 % of the body surface of an infant. However, in this case exposure is restricted to the fingers. Thus, a higher factor is required. Taking into account an oral absorption of 50 % and a body weight of 10 kg the systemic oral exposure is mg/kg. Due to the low vapour pressure of less than 3.0 x 10-8 (25 C, spinosad A) a significant influence of inhalation exposure on the total systemic exposure is not expected. The estimated total systemic exposure is mg/kg bw. Residues in food and feed The intended use descriptions of the spinosad-containing biocidal product for which authorisation is sought indicate that these uses are not relevant in terms of residues in food and feed. The product is to be used for control of ant pests by applying bait that does not come in direct contact with food, feed stuff or livestock animals. No further data are required concerning the residue behaviour. The intended uses are not relevant in terms of consumer health protection. RMS-DE described that the biocidal product contains no substance of concern. 2.6 Risk assessment for human health For the risk assessment for human health we refer to Product Assessment Report of the original authorisation. The RMS-DE used the threshold values as AELmedium-term (=0.012 mg/kg bw/day) and AELlong-term (=0.024 mg/kg bw/day) based on the final CAR. The quantitative risk characterisation for professional users which is presented in the PAR takes into account dermal exposure to spinosad resulting from use of the biocidal product Ameisen-Köderdose. The internal reference value mg/kg bw/d (AEL long-term) is used and converted to an external reference value in order to allow for a comparison with external exposure concentrations of spinosad. By comparing the 0.2 mg/person (= mg/kg bw/day) with the external AEL long-term of mg/kg bw/day/0.02 (based on 2% dermal absorption described in the CAR), the resulting risk index of (0.0033/0.6=)0.006 is derived. The quantitative risk characterisation for secondary exposure of infants (also covering the exposure to non-professionals) which is presented in the PAR takes into account dermal exposure to spinosad resulting from use of the biocidal product Ameisen- Köderdose. Exposure of infants is expected to be an incidental event occurring only occasionally and which would be considered as acute exposure. However, since an AELacute has not been derived, exposure is compared to the AELmedium-term. By comparing the estimated total systemic exposure of mg/kg bw. with the systemic AEL medium-term of mg/kg bw/day the resulting risk index of (0.0054/0.024=) is derived. The intended uses are unlikely to lead to residues in food. Regarding consumer health protection, there are no objections against the intended uses if the instruction for use with the sentence Keep away from food, drink and animal feedingstuffs is followed. 4

7 Based on the overall risk assessment, no adverse effects from exposure to spinosad are expected for the professional and the non-professional users resulting from the intended use with the biocidal product Ameisen-Köderdose and from secondary exposure. The following instructions for use are added to the product label: Avoid any unnecessary contact to the preparation. Misuse may cause health damage. Do not force open the bait tin. Keep away from food, drink and animal RMS-DE described that the biocidal product contains no substance of concern. Thus the risk assessment is geared to the risk assessment of the active substance. However, CMS- NL is on the opinion that the risk characterisation for this substance should be included in the PAR. RMS-DE confirmed this in the commenting table for agreement on the SPC. However, there was no risk assessment for the substance of concern in the final PAR. Therefore, CMS-NL made an exposure assessment and a risk characterisation for the substance of concern. Based on this risk assessment, no adverse effects from exposure to the substance of concern are expected for the professional and the non-professional users resulting from the intended use with the biocidal product Ameisen-Köderdose and from secondary exposure. Regarding occupational safety, there are no objections against the intended use taking into account the provisions described. 2.6 Risk assessment for the environment Intended use The environmental exposure to spinosad was assessed for the use of the active substance integrated in a liquid formulation of a watery bait solution absorbed on a cellulose pad which is tightly sealed in a metal tin (Mirazyl Box) for use as bait against ants (product type 18). Target organisms are ants, e.g. Black Ants (Lasius niger). One trap per 12 m 2 is deployed at low and two at heavy infestation rates DE proposes that the product is for indoors use only,.i.e. for the control of garden ants that nest indoors, including on balconies and terraces. This type of application is usually referred to as home perimeter application, indoor application and/or application in and/or around homes. The product can be applied by both professional and non-professional users. For the risk assessment for the environment we refer to Product Assessment Report of the original authorisation. Conclusion CMS NL: For the environmental risk assessment as part of the national authorisation of Mirazyl Box, the conclusions of the RMS are acceptable. Substances of concern For the product in the current authorisation assessment, no substances of concern were identified, as none of the co-formulants triggered the classification of the product according to Regulation EC 1272/2008. Major metabolites 5

8 Spinosad is a mixture of two structurally similar molecules which have both insecticidal properties and are designated as spinosyn A and spinosyn D. Spinosad typically contains spinosyn A and D in a ratio of approximately 85% A : 15% D. Under aerobic conditions, no degradation products were detected in the water phase or in sediment at a level > 10%. Spinosyn B was the major degradation product of spinosyn A in soils, amounting to 67% AR at maximum. The main degradation product of spinosyn D was N-demethylated spinosyn D, representing 68% AR at maximum. No other metabolites were detected at levels of > 10% of AR. Conclusion CMS NL: The major metabolites spinosyn B and N-demethylated spinosyn were included in the risk assessments for the terrestrial compartment of the CAR for spinosad and the PAR for Mirazyl Box. Environmental exposure and risk assessment The product Mirazyl Box containing spinosad is used for the control of ants in buildings, in close proximity to gardens and buildings, e.g. on terraces and balconies. According to the OECD ESD PT18 No. 18 (2008), chapter 2.4.9, insecticides in sealed bait boxes (bait stations) are usually ready-to-use products (i.e. neither mixing nor loading steps) and for these products emissions to the environment during handling are negligible. Furthermore, it is assumed that no release will occur during the service life stage for solid baits and gels deployed in bait stations and used for indoor treatments (ref. to Table in OECD ESD PT 18 No. 18). According to the use, soil is the main potential receiving compartment for emission of spinosad from the bait station. Such releases from bait stations or boxes may occur from the transport of the product by contaminated insects or following flooding from a rain event. Risk characterisation was done for the terrestrial compartment and no risks were identified for soil and groundwater. As a risk of primary poisoning of non-target animals is not relevant due to the intended use of the product, a risk characterisation was only conducted for secondary poisoning of bird and mammals. All risk quotients were below 1 and therefore the biocidal product Mirazyl Box poses no risk to non-target animals. For the aquatic and air compartment, exposure is negligible and therefore no risk characterisation was done. Overall conclusion for the aspect environment: With the risk mitigations included in the SPC, the use of the product Mirazyl Box for the professional and non-professional control of ants in and around homes will not cause unacceptable risks to the environment. 3 Proposal for decision The authorisation of Mirazyl Box, Mierenlokdoos Natria, Edialux Mierenlokdoos, Luxan Mierenlokdoos is based on mutual recognition of the authorisation of RMS DE. For the evaluation we refer to the product assessment report which has been composed by the RMS conform the Common Principles. It is concluded that the application of Mirazyl Box, Mierenlokdoos Natria, Edialux Mierenlokdoos, Luxan Mierenlokdoos according to the use instructions as stated in the SPC, will be effective and that there will be no harm for the health of humans and for the environment. 6