Evaluation Report Mutual Recognition

Transcription

1 HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE II bij het besluit d.d. 10 oktober 2014 tot toelating van het middel Racumin Foam, toelatingnummer 14585N Evaluation Report Mutual Recognition Racumin Foam 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 Measures to protect man, animals and the environment Proposal for decision... 5

3 1 General information about the product application Naam en adres van de toelatinghouder Toelatingsnummer Naam Bayer CropScience SA-NV Adres Energieweg RT Mijdrecht Nederland 14585N Datum van toelating Expiratie datum Trade name Racumin Foam Evaluating member state DE Name of the product in RMS Racumin Schaum Active substance Coumatetralyl PT 14 User category Professional users 2 Summary of the product assessment 2.1 Classification and labelling Classification required based on the physical-chemical, toxicological and environmental properties of the product based on both 1999/45/EC and Reg (EC) 1272/2008. The identity of all substances in the mixture that contribute to the classification of the mixture *: coumatetralyl Pictogram: GSH02 GSH07 Signal word: Warning H-statements: H222 Extremely flammable aerosol H319 Causes serious eye irritation. H412 Harmful to aquatic life with long lasting effects P-statements: P210 Keep away from heat/sparks/open flames/hot surfaces. No smoking. P211 Do not spray on open flame or other ignition source. P251 Pressurized container: Do not pierce or burn, even after use. P264 Wash hands thoroughly after handling. P280 Wear eye/face protection

4 Supplemental Hazard information: Child-resistant fastening obligatory? Tactile warning of danger obligatory? P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P337+P313 If eye irritation persists: Get medical advice/attention. P410+P412 Protect from sunlight. Do not expose to temperatures exceeding 50º C / 122º F. P501 Dispose of contents/container to hazardous or special waste collection point EUH401 To avoid risks to human health and the environment, comply with the instructions for use. Not applicable Not applicable Explanation: Pictogram: - H-statements: - P-statements: - Other: EUH401 is normally only assigned to PPP products. However, as DE includes this in their C&L for Racumin Foam, we consider this acceptable. * according to Reg. (EC) 1272/2008, Title III, article 18, 3 (b) 2.2 Packaging and shelf-life Professional use Packaging size and type Packaging authorised/ evaluated by RMS 500 ml spray can with 450g solution and 41g propellant Packaging applied Packaging for in NL authorised in NL 500 ml spuitbus 500 ml spuitbus, per 2 spuitbussen verpakt The shelf life of the product is 24 months in spray can. 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 the RMS DE (Racumin Schaum, ).

5 2.4.1 Instructions for the use(s) The applicant has provided a Dutch label (WG/GA). This has been adapted to a Dutch SPC by our standards. Target species According to the PAR, the organisms claimed to be controlled are brown rats and mice. However, authorisation for this product in NL was only given for use against house mice, because of widespread resistance development in brown rats in the Netherlands. Therefore, this product in NL is only authorised for use against house mice. 2.5 Risk assessment for human health For the risk assessment for human health we refer to Product Assessment Report of the original authorisation. The formulation Racumin Foam is a ready to use foam containing 0.04% coumatetralyl as an active substance and is intended for the use against mice (PT14) for professional use only. Racumin Foam is applied indoors as foam to the entrances of air canal systems, to cracks in walls and holes. The foam is normally replaced after two weeks. If the foam has been applied to often-frequented sites, it could be necessary to apply the product again within a shorter time-frame than two weeks. Any traces of foam left should be wiped away with a dry cloth before the next application is made. At the end of the pest control measure all sites where foam was applied are checked and any remaining foam will be removed. The Product Assessment Report (PAR) was prepared by the eca Germany (DE). No studies with the product have been submitted and the classification and labelling of the formulation has been prepared based on the calculation method described in Annex I of Regulation 1272/2008/EC. As worst case approach for the farmer, DE performed a risk assessment for the pest operator. And as the product is to be used in a very specific way, the eca has considered medium term exposure for the operator. Which is accepted by the Ctgb. Inhalation exposure to coumatetralyl for the professional user is not included as the active substance is not volatile and aerosols are not formed by the application. Furthermore, for the dermal exposure by application of the foam the ConsExpo model: Do-it-yourselfproducts, insulation foam is used. Also post-application, wiping of traces of foam, is considered by DE. For the exposure calculations for wiping the ConsExpo model: Disinfectant products, disinfectant to use indoors, exposure during wiping was used. As a refinement, as a foam is less transferrable than a liquid, the transfer factor of 0.1% of ConsExpo was lowered to 0.01%. The assumptions and calculations are accepted by the Ctgb. For the risk assessment the limit values and labelling of the active substance as during inclusion of the active substance were considered for the risk assessment of Racumin Foam by DE. This is accepted by the Ctgb. A new dermal absorption study was submitted with a unfoamed Racumin Foam formulations to be used for the risk assessment of Racumin Foam (Odin, 2013). This is accepted by the Ctgb. Based on the risk assessment (risk index 0.71), DE concluded that no adverse effects from exposure to coumatetralyl are expected for protected (gloves) professional user during the application of Racumin Foam for the control of mice. This is accepted by the Ctgb.

6 DE also considered a secondary exposure of children due to accidental swallowing of bait. Two scenario s were considered: 1) swallowing 5000 mg of bait (TNsG 2007) or 2) transient mouthing of 10 mg of bait (TNsG 2002). The resulting risk indices were 1300 and 2.7 for swallowing 5000 mg and mouthing of 10 mg respectively. Based on the risk assessment a concern for adverse effects due to secondary exposure of an infant that swallowed the bait exists. Therefore, DE concluded that the product should contain an aversive agent and a dye. Furthermore the following precautionary phrases should be added to the SPC: - Keep out of the reach of children (P102) - Prevent access to bait by children, domesticated animals and pets, (particularly cats, dogs and pigs). When these risk management measures are taken into consideration, the risk of secondary exposure for children is considered to be mitigated. This is acceptable by the Ctgb. Furthermore, a substance of concern was identified, etoxylated isotridecanol, which is present in the formulation at 1.8% w/w. A quantitative risk assessment was not performed. However, it was concluded by DE that the safety advise as laid down for the classification and labelling of the product and the measures to protect man and environment in which eye protection is included, were sufficient to exclude human health effects after exposure to the substance by using Racumin Foam. Although normally eye protection is not prescribed when a product is classified for eye irritation, this approach of DE is acceptable by the Ctgb. 2.6 Risk assessment for the environment Racumin Foam is a first generation foam rodenticide, which is applied into rat holes or passageways. The product is for professional use indoors. In the Netherlands, however, these first generation rodenticides are only allowed for indoor use for the control of house mice by professionals as rats have shown resistance for first generation rodenticides. For the risk assessment for the environment we refer to the Product Assessment Report of the original authorisation. The product contains the active substance coumatetralyl (0.3981% w/w). No substances of concern were identified in the product, as none of the co-formulants triggered the classification of the product according to Regulation EC 1272/2008. Therefore, the risk assessment for the product is based on the active substance coumatetralyl. Coumatetralyl does not fulfil the PBT- or vpvb criteria. In addition, according to the CAR, this active substance is not considered as an endocrine disruptor. Metabolites of coumatetralyl found in rat metabolism are hydroxy and dihydroxy coumatetralyl, which were assumed to have a lower ecotoxicity towards aquatic organisms in surface water and in sewage treatment (Position Paper, P. Suteau, 2004). However, as there are no available data on their potential toxicity and to keep a very conservative approach, a first theoretical risk calculation can be done assuming the metabolite is as toxic as the parent compound coumatetralyl. The risk assessment still indicates acceptable risks under these very worst case conditions and therefore there is no need for testing the metabolites. The intended use concerns indoor use of the product for the professional control of brown rats. As the product is a first generation rodenticide based on the active substance

7 coumatetralyl and resistance of rats is observed in the Netherlands, the product can only be authorized for professional use for control of mice indoors. Further restrictions are necessary to prevent access of non-target animals to the product, see SPC. Overall conclusion for the aspect environment: The conclusions in the risk assessment of the RMS are valid for indoor use of the product by professionals for the control of house mice. 2.7 Measures to protect man, animals and the environment Based on the risk assessment no adverse effects from exposure to coumatetralyl are expected for protected (gloves) professional user during the application of Racumin Foam for the control of mice. Based on the risk assessment adverse effects from secondary exposure to coumatetralyl cannot be excluded for an infant incidentally swallowing the bait. Therefore the following precautionary phrases should be added to the instructions for use: - Keep out of the reach of children (P102) - Prevent access to bait by children, domesticated animals and pets, (particularly cats, dogs and pigs). When these risk management measures are taken into consideration, the risk of secondary exposure for children is considered to be mitigated. Furthermore, based on this risk assessment no adverse effects from exposure to the substance of concern is expected for the protected (eye protection) professional user during the application of Racumin Foam. 3 Proposal for decision The authorisation of Racumin Foam 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 Racumin Foam 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.