HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

Transcription

1 HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE II bij het besluit d.d. 4 augustus 2017 tot toelating van het middel K-Othrine WG 250, toelatingnummer NL Evaluation Report Mutual Recognition K-Othrine WG 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 Packaging and shelf-life Physico/chemical properties and analytical methods Effectiveness against target organisms Risk assessment for human health Risk assessment for the environment Measures to protect man, animals and the environment Substitution/exclusion criteria and comparative assessment Proposal for decision... 6

3 1 General information about the product application Name and address of the authorisation holder Authorisation number Name Date of the authorisation Bayer CropScience SA-NV Address Energieweg 1, 3640 AE Mijdrecht NL Expiry date of the authorisation Trade name(s) K-Othrine WG 25 Evaluating member state Sweden Name of the product in RMS K-Othrine WG 250 Active substance Deltamethrin PT 18 User category Professional 2 Summary of the product assessment The proposed classification and labelling of the preparation is identical to that proposed in the Product Assessment Report by the competent authority Sweden. The identity of all substances in the mixture that contribute to the classification of the mixture *: Deltamethrin Pictogram: GHS09 Signal word: Warning H-statements: H332 H410 Harmful if inhaled. Very toxic to aquatic life with long lasting effects. P-statements: P273 P261 Avoid release to the environment. Avoid breathing dust and / or spray. P391 Collect spillage. P501 Dispose of contents/container to Supplemental Hazard information: - Child-resistant fastening obligatory? - Tactile warning of danger obligatory? - Explanation: Pictogram: - H-statements: -

4 P-statements: - Other: - * according to Reg. (EC) 1272/2008, Title III, article 18, 3 (b) 2.1 Packaging and shelf-life Packaging size and type Packaging size and type Packaging authorised/ Packaging applied for in evaluated by ECA NL HDPE bottles up to 1L HDPE bottles up to 1L Primary: 2.5g sachets (PE, Al or PET)* Secondary: cardboard box, up to 500g. Primary: 2.5g sachets (PE, Al or PET)* Secondary: cardboard box, up to 500g. Packaging authorised in NL HDPE bottles up to 1L Primary: 2.5g sachets (PE, Al or PET)* Secondary: cardboard box, up to 500g. * The commercial sachet material is an aluminium lined foil. In the stability studies, this material was adequately tested. The description in the PAR is PE, Al or PET, but the eca has confirmed only the aluminium lined foil is intended to be brought on the market, which is covered by the assessment. The shelf life of the product is 3 years, tested in HDPE and aluminium composite foil. 2.2 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. 2.3 Effectiveness against target organisms For the assessment of the effectiveness against target organisms we refer to the Product Assessment Report of the original authorization by the ECA Sweden (K-Othrine WG 250, ). The conclusions of the ECA are acceptable Authorised uses and use instructions The applicant has provided a Dutch SPC. This has been adapted to our standards. 2.4 Risk assessment for human health For the risk assessment for human health we refer to the Product Assessment Report of the original authorisation. K-Othrine WG250 is a water dispersible granule containing 25% w/w deltamethrin as active substance. K-Othrine WG250 is used to control crawling insects (e.g. ants, bedbugs, fleas, carpet beetles, cockroaches, stored product pests and booklice) and flying insects (flies and mosquitos) (PT18). K-Othrine WG250 is to be used in buildings including houses, blocks of flats, hotels, restaurants, hospitals, food factories, warehouses. The product is for hygiene use only and must not be used to protect plants and plant products from damage caused by insects. The product is intended for trained professional users and professional users. The product needs to be diluted in water and applied by spraying. For the control of bed bugs the worst case scenario 10 g of product with 5L water to

5 obtain a total amount of 5 liters of solution for 100 m² = 0.5 mg a.s./ml = 25 mg a.i. / m2 is used. For the control of crawling insects (except bed bugs) and flying insects 6.25 or 12.5 mg a.i. /m2 is used. The residual life of the deposit will last up to 4 weeks, depending upon the cleanliness and nature of the surface to which it is applied. Repeat treatment may be carried out as necessary, up to maximum of eleven applications per year. The Product Assessment Report (PAR) was prepared by the refms Sweden (SE). K-Othrine WG250 is sold in HDPE bottles in a range of sizes up to 1 L or in 2.5 g foil lined sachets (PE, Al or PET) contained in cardboard box (up to 500 g). Studies with the product have been submitted and based on the study outcome no classification is warranted for acute oral, dermal, skin or eye irritation or for sensitising properties. The acute inhalation LC50 (4 hrs, aerosol, rat) of >2.3 mg/l air determined in the form of a respirable aerosol is considered not relevant by SE because of low dust formation by K-Othrine WG250 as the formulation is nearly dust free. K-Othrine was one of the representative formulations submitted for EU review according to the biocide directive 98/8/EC. A value of 2% dermal absorption was considered appropriate for the concentrate as well as for the in use dilution of the product. The value was established based on data generated using an organic solvent based formulation, i.e. deltamethrin formulated as Deltamethrin EC25. In the calculations in this evaluation the worst case dermal absorption of 2% is used. Primary exposure to Deltamethrin WG250 was assessed following the approach proposed in Document II B2 Effects and Exposure Assessment for K-Othrine WG 250 of the non public CAR, final June Secondary exposure is assessed for persons (adult or child) re-entering a treated room as reasonable worst case. The corresponding transfer of residues to the skin is calculated taking into account the transfer rate proposed in the CAR for deltamethrin for hard surfaces. In addition exposure to persons laundering contaminated surfaces is assessed following the approach proposed in the CAR for deltamethrin. Finally as considered in the CAR combined exposure is evaluated. As stated by SE the estimated systemic exposure of the professional user amounts to 105% of the AEL (of mg/kg bw/day) if no PPE is worn. The estimated systemic primary exposure accounts for only 37% of the AEL if one layer of adequate work clothing and in addition protective gloves are worn during mixing and loading as well as during application (with 0.5 mg a.s./ml). In conclusion, based on these results no unacceptable risk is anticipated for the protected (gloves, suitable protective clothing) professional operator with the intended uses of K- Othrine WG 250. With the intended uses of K-Othrine WG250 respective scenarios that were considered relevant by the CAR in terms of secondary exposure, i.e. reflecting a reasonable worst case situation (using 25 mg a.i. per m2) are (the comparison with the AEL of mg/kg bw/day is presented): A. Exposure of a toddler to deltamethrin when re-entering a room after spot type treatment (19% of the AEL) and full surface treatment (47% of the AEL) B. Secondary inhalation exposure to deltamethrin residues dislodged from treated carpet during and after vacuuming of the carpet (infant (5.8% of the AEL), child (5% of the AEL) and adult (3.2 % of the AEL). C. Secondary dermal exposure from sleeping on a treated mattress (infant (38% of the AEL), child (21% of the AEL) and adult (21% of the AEL)). D. Secondary exposure to persons laundering contaminated work clothing (adult 1.4% of the AEL).

6 Based on these results no unacceptable risk is anticipated with the intended use of K- Othrine WG250 for persons being exposed to the product via secondary routes of exposure. Combined exposure of infants/ toddlers shows that for worst case scenario (bed bugs treatment) exposure via full surface treatment of carpet, during and after vacuuming and sleeping on a treated mattress results in a value of ^180% of AEL after re-treatment for 4 weeks, which is unacceptable. Thus the following condition for bedbugs treatment will be set Toddlers should not access treated rooms/ areas until all necessary treatment and cleaning have been finalised. Combined exposure due to primary exposure and re-entry into a room where a spot type application or full surface carpet treatment has been performed does not exceed the AEL. Based on these results no unacceptable risk is anticipated with the intended uses of K- Othrine WG 250 for persons being exposed to the product via primary and secondary routes of exposure. Exposure via food or feedstuff or pets will be excluded by handling with risk mitigation measures. The product is proposed to be labelled with the sentence The product should be applied so that children, food, feedstuffs and pets not come in to contact with the product. Also the following precautionary phrases on the product label are recommended (based on the elements to be taken into account in the AR): Do not apply directly to surfaces on which food or feed is stored, prepared or eaten, Cover food, food preparing equipment and eating utensils before application, Cover water storage tanks before application. The applicant also added the risk mitigation measures: Toddlers should not access treated rooms/ areas until all necessary treatment and cleaning have been finalised and the general public shall not be present in rooms during application. SE did not identify any substance of concern. The assessment is comparable to the assessment performed in the CAR. The whole risk assessment including the risk mitigation measures is accepted by the Ctgb. 2.5 Risk assessment for the environment Intended use K-Othrine WG 250 is a water dispersible granule containing 25 % w/w deltamethrin. The product is an insecticide (PT18) applied as a spray by (trained) professional users for the control of: 1. chronic infestations of crawling insects (including cockroaches) in domestic, commercial and industrial buildings, at an application rate of 12.5 mg/m 2 (5g of product in 5L of water for 100 m 2 ). 2. localised infestations of crawling insects (including cockroaches) in domestic, commercial and industrial buildings at an application rate of 6.25 mg/m 2 (2.5g of product in 5L of water for 100 m 2 ). 3. bed bugs in domestic, commercial and industrial buildings at a dose of 25 mg/m 2 (10g of product in 5L of water for 100m 2 ). 4. flies when at rest, in domestic, commercial and industrial buildings at a dose of 12.5 mg/m 2 (5g of product in 5L of water for 100 m 2 ).

7 K-Othrine WG 250 is one of the representative formulations submitted for EU review according to the biocide directive 98/8/EC. For the risk assessment for the environment we refer to the Product Assessment Report of the original authorisation. Exposure and risk assessment Relevant emission routes Treatments using K-Othrine WG 250 are carried out to control specific infestations. As a result, treatment areas will be dependent upon the location and severity of the infestation, as well as the characteristics of the affected premises. Treatments would take place according to a pattern characteristic of a typical crack and crevice treatment or a barrier treatment, as described in the Emission Scenario Document (ESD) for insecticides for household and professional uses (PT18; OECD, 2008) and potential revisions published within the Biocides Technical Meetings (in particular, TMII 10). Additionally, the product may be used for the treatment of bed bugs (application to mattresses, bed frames and other non-cleanable areas). The foreseeable routes of entry into the environment during the preparation, application and cleaning phase are listed in Table E.1. Table E.1. Foreseeable routes of entry into the environment on the basis of the use envisaged Environmental compartments and groups of organisms exposed STP Freshwater* Saltwater* Soil** Air Birds and mammals (-) + Compartment secondarily exposed (STP after preparation of the sprayer batch, washing of coveralls and wet cleaning of treated surfaces, surface water from STP discharge, vertebrates eating contaminated fish) - Compartment not exposed (-) Compartment potentially exposed (but unlikely significant concern due to a.s. hazard data and scale of exposure) * Including sediment ** Including groundwater, bees and non-target arthropods The environmental risk has been assessed for the active substance and the major metabolite Br 2 CA which is > 10% of the active substance. The risk assessment performed by the eca is in line with the CAR for deltamethrin and agreements made at TMs and WGs. These agreements are included in the document entitled Technical Agreements for Biocides which can be found on the ECHA website. After bilateral discussion with CMS NL considering the emission to the STP after cleaning of bed sheets and mattresses for the control of bed bugs, the RMS included a case by case risk assessment for washing of bedsheets in the PAR. The conclusion is that washing bedsheets may add to the wastewater exposure but the risk is acceptable, i.e. combined RCR is <1. The RMS also added restrictions regarding this use to the SPC. Substances of concern The product does not contain substances of concern. Endocrine disruption

8 Overall conclusion for the aspect environment: The conclusions in the risk assessment of the RMS are valid for indoor crack and crevice treatment. Using K-Othrine WG 250 for indoor barrier treatment in areas subject to wet cleaning leads to unacceptable risks for the aquatic compartment and it is also indicated that groundwater levels of the metabolite B22CA may exceed the acceptable threshold. Thus indoor barrier treatment shall not be authorised in areas subject to wet cleaning. At a late stage in the evaluation process, treatment of mattresses against bed bugs was specifically addressed and found to not cause unacceptable risk for the environment. 2.6 Measures to protect man, animals and the environment Based on this risk assessment, it was concluded that no adverse health effects are expected for the protected (gloves, suitable protective clothing) professional user after dermal and respiratory exposure to deltamethrin as a result of the application of K-Othrine WG250, when used in accordance to the SPC. Furthermore, when used according to the SPC, no adverse health effects are expected for the general public by indirect exposure to deltamethrin as a result of the application of K- Othrine WG250. Exposure via food or feedstuff or pets will be excluded by handling with risk mitigation measures. The product is proposed to be labelled with the sentence The product should be applied so that children, food, feedstuffs and pets not come in to contact with the product. Also the following precautionary phrases on the product label are recommended (based on the elements to be taken into account in the AR): Do not apply directly to surfaces on which food or feed is stored, prepared or eaten, Cover food, food preparing equipment and eating utensils before application, Cover water storage tanks before application. The applicant also added the risk mitigation measures: Toddlers should not access treated rooms/ areas until all necessary treatment and cleaning have been finalised and the general public shall not be present in rooms during application. For the measures to protect animals and the environment we refer to the Product Assessment Report of the original authorisation and the SPC of the CMS NL. 2.7 Substitution/exclusion criteria and comparative assessment K-Othrine WG 250 does not contain any active substances that are considered candidate for substitution. 3 Proposal for decision The authorisation of K-Othrine WG 250 is based on mutual recognition of the authorisation of RMS Sweden. For the evaluation we refer to the product assessment report which has been composed by the RMS conform the Common Principles.

9 It is concluded that the application of K-Othrine WG 250 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.