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. 9 maart 2018 tot toelating van het middel Maxforce Quantum, toelatingnummer NL Evaluation Report Mutual Recognition Maxforce Quantum 9 maart 2018 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 Instructions for the use(s) Risk assessment for human health Risk assessment for the environment Substitution/exclusion criteria and comparative assessment Decision

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 NL Expiry date of the authorisation Trade name(s) Maxforce Quantum Evaluating member state UK Name of the product in RMS Maxforce Quantum Active substance Imidacloprid PT 18 User category Professionals and non-professionals 2 Summary of the product assessment 2.1 Classification and labelling For the classification and labelling we refer to the Summary of Product Characteristics. 2.2 Packaging and shelf-life Professional Packaging size and type Packaging authorised/ evaluated by RMS Plastic cartridge/syringe (PP cartridge with PE tip and plug), g Packaging applied for Plastic cartridge/syringe (PP cartridge with PE tip and plug), g Packaging authorised Plastic cartridge/syringe (PP cartridge with PE tip and plug), g Non professional use Packaging size and type Packaging authorised/ evaluated by RMS Plastic (PP or PE) polyfoil tubes (inner contact surface is PP/PE), 4 g Packaging applied for Plastic (PP or PE) polyfoil tubes (inner contact surface is PP/PE), 4 g Packaging authorised Plastic (PP or PE) polyfoil tubes (inner contact surface is PP/PE), 4 g The shelf life of the product is 36 months in PP of PE 1

4 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 the Product Assessment Report of the original authorization by the RMS UK (Maxforce Quantum, February 2017). The conclusions of the RMS are acceptable Instructions for the use(s) The applicant has provided a Dutch SPC. This has been adapted to our standards. 2.5 Risk assessment for human health For the risk assessment for human health we refer to the Product Assessment Report of the original authorisation. The Product Assessment Report (PAR) was prepared by the refms UK. The formulation Maxforce Quantum is as an insecticide (PT 18). It is a ready for use bait (viscous liquid) containing Imidacloprid at a concentration of 0.03% (w/w). The product is packaged in a cartridge containing 30 g of product (professionals) and a tube containing 4 g product (non- professionals).depending on the species to be treated either 1 spot per m 2 or 1 spot per linear metre of ant trail (one spot is equivalent to 200 mg of product). Outdoors users are also advised to inject 2g of product directly into the nest entrance. For non- professional use the application rate is expressed as drops of about 1 cm diameter (equivalent to 200 mg product). Indoors drops must be placed out of reach of children and not in areas subject to washing or food preparation. Outdoors bait must be placed in cracks or crevices away from children and pets. The hazard assessment of the product was made based on the calculation method in accordance to CLP. No classification is warranted for acute oral or acute dermal toxicity, for skin or eye irritation or for sensitising properties. The conclusions of UK on formulation toxicity is accepted by the Ctgb. No dermal absorption data has been submitted for this product. The applicant has proposed that the default dermal absorption value of 100% is used. UK has proposed, however, if the risk assessment needs to be refined a value of 75% can be used in line with the EFSA guidance (2012). The use of 75% is accepted by the Ctgb. Based on the low vapour pressure of imidacloprid ( Pa at 20 C), and given that the product is applied as a viscous liquid, inhalation exposure due to evaporation is considered to be negligible. For professional exposure, the most likely exposure scenario was considered to be to the hands when removing the gauge needle and sealing the partially used cartridge with the end cap. To assess the corresponding dermal exposure when removing the gauge needle and placing the end cap it was assumed that the total inner volume of the gauge needle is filled with product and this amount is transferred to the hand of the operator. Assuming inner diameter of 1 mm and length of 3.5 cm for the needle, and application frequency of once per day, total systemic exposure was estimated to be mg/kg bw, which is 3% of the long term systemic AEL without PPE. UK concluded that no adverse effects from exposure 2

5 to spinosad are expected for the unprotected professional user during the application of Maxforce Quantum. This is accepted by the Ctgb. For non-professional use, the product is packaged in a tube containing 4 g of product. Although some exposure could occur on removal and replacement of the cap given the smaller quantities applied this is expected to fall within that described for unprotected professionals. Therefore UK considered the exposure to be acceptable for unprotected non-professional users. The conclusion by UK is accepted by the Ctgb. Secondary exposure of the general public is possible if they accidentally come into contact with the bait. Risk assessment of the secondary exposure was performed using reverse reference scenario. First, dermal exposure by touching the treated surface was considered. The number of spots required to reach the AEL for adults, children and infants was calculated to be high (533 spots, 306 spots and 89 spots respectively). Subsequently, hand-to-mouth exposure was considered for infants. Taking 100% oral absorption rate, it was calculated that an infant would need to ingest 67 spots before reaching the long term AEL. Nevertheless, the formulate contains bittering agent to discourage ingestion. Lastly inhalation exposure was considered. Although imidacloprid is not considered to be volatile, respiratory exposure is still possible when the general public stays in enclosed unventilated spaces. Assuming the worst case (24 hour exposure, no ventilation), however, the inhalation exposure was calculated to be less than 1% of the AEL. Altogether, the UK concluded there is no concern for the secondary exposure of the general public to imidacloprid as a result of the use of Maxforce Quantum, noting also that users are instructed in accordance with the label phrases as indicated in SPC. The conclusion is accepted by the Ctgb. Furthermore, exposure of companion animals are evaluated, taking puppy (5 kg) and kitten (0.5 kg) as the worst case. Using reverse reference scenario, it was calculated that a puppy and kitten would need to eat, respectively 3 and 3 spots per day, to reach the acute AEL. Considering that the bait contains bittering agent and a risk mitigation measure instructs to prevent access of children or pets to bait, the UK concluded there is no concern for companion animals due to exposure to imidacloprid by using Maxforce Quantum. This is accepted by the Ctgb. Furthermore, UK did not identify any substance of concern. This accepted by the Ctgb. Based on this risk assessment, it was concluded that no adverse health effects are expected for the unprotected professional and non-professional user after dermal and respiratory exposure to imidacloprid as a result of the application of Maxforce Quantum, 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 imidacloprid as a result of the application of Maxforce Quantum. 2.6 Risk assessment for the environment For the risk assessment for the environment we refer to Product Assessment Report of the original authorisation. The product contains the active substance imidacloprid (0.03% w/w). None of the coformulants in the product were identified as a substance of concern for the environment. The active substance imidacloprid is highly toxic for aquatic invertebrates (NOEC μg/l) and relatively less toxic to soil organisms (NOEC mg/kg dw soil (0.157 mg/kg ww standard soil). 3

6 The degradation of imidacloprid in soil may result in the formation of metabolites, but the risk assessment for leaching to ground water was not assessed. Potential risks of the metabolite for the other compartments was covered by the active. Overall conclusion for the aspect environment: The conclusions in the risk assessment of the RMS are valid. 2.7 Substitution/exclusion criteria and comparative assessment The active substance imidacloprid shall be considered a candidate for substitution using the criteria in Article 10(1) of the BPR, therefore a comparative assessment of Maxforce Quantum has been performed by RMS UK. The RMS has considered all authorised products for the relevant uses, and concluded that the comparative assessment for Maxforce Quantum can be finalized at the screening stage and that the product Maxforce Quantum can be authorized for a period not exceeding 5 years in accordance with Article 23(6) of the BPR. As RMS UK has included in its assessment all products authorized according to the BPR in The Netherlands, an authorisation can be granted in The Netherlands as well. 3 Decision The authorisation of Maxforce Quantum is based on mutual recognition of the authorisation of RMS UK. 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 Maxforce Quantum 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. 4