HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

Transcription

1 HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE II (NL) bij het besluit d.d. 2 februari 2018 tot toelating van het biocide Valtti Plus Base, toelatingsnummer NL Evaluation Report Mutual Recognition Valtti Plus Base 2 February 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 Measures to protect man, animals and the environment Substitution/exclusion criteria and comparative assessment Proposal for decision

3 1 General information about the product application Name and address of the authorisation holder Authorisation number Name Tikkurila Oyj Address Kuninkaalantie 1, P.O. Box 53 FI Vantaa Finland NL Date of the authorisation 2 February 2018 Expiry date of the authorisation 31 March 2020 Trade name(s) Evaluating member state Name of the product in RMS Active substance PT 8 User category Valtti Plus Base United Kingdom WOCOSEN WF 3-iodo-2-propynylbutylcarbamate (IPBC) 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3- dioxolan-2-yl]methyl]-1h-1,2,4-triazole (Propiconazole) Professional and non-professional 2 Summary of the product assessment 2.1 Classification and labelling The following CLP proposal has been made by the RMS UK, according to the CLP regulation (Reg (EC) 1272/2008). The proposal is accepted by the Ctgb. For professional and non-professional use: The identity of all substances in the mixture that contribute to the classification of the mixture *: Pictogram: - Signal word: - H-statements: H412 Harmful to aquatic life with long lasting effects. P-statements: P273 Avoid release to the environment. P501 Dispose of contents/container to 1

4 Supplemental Hazard information: Child-resistant fastening obligatory? Tactile warning of danger obligatory? EUH208 Contains 3-Iodo-2-propynyl butylcarbamate (IPBC), propiconazole and 1,2- benzisothiozool-3(2h)-on. May produce an allergic reaction. No No 2.2 Packaging and shelf-life Industrial use Packaging size and type Packaging authorised/ evaluated by RMS Up to 1000 L Lined metal or HDPE Packaging applied for in NL Up to 1000 L Lined metal or HDPE Packaging authorised in NL Up to 1000 L Lined metal or HDPE Non-professional use Packaging size and type Packaging authorised/ evaluated by RMS Up to 5L Lined metal or HDPE Packaging applied for in NL Up to 5L Lined metal or HDPE Packaging authorised in NL Up to 5L Lined metal or HDPE The storage stability studies are performed using a metallic box as packaging. The results are extrapolated to lined metal and HDPE based on the composition of the product. The shelf life of the product is 18 months in lined metal and HDPE. 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 authorisation by the RMS United Kingdom (WOCOSEN WF, April 2012). 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 2.5 Risk assessment for human health For the risk assessment for human health we refer to the Product Assessment Report (PAR) of the original authorisation. The PAR was prepared by the RMS UK. Valtti Plus Base is a water based ready-to-use formulation for use as a wood preservative (PT8). The product contains 0.30% w/w IPBC (3-iodo-2-propynyl butyl carbamate) and 0.90% w/w propiconazole. Industrial application is conducted via dipping (automated and manual), automated spraying, flow coating and vacuum pressure. Professional users may apply the product both indoors and outdoors via brush/roller, spraying, manual dipping and surface injection. Non-professionals may apply the product both indoors and outdoors via brush/roller and spraying. The applicant has requested up to and including Use Class 3. The use rate of application is ml/m 2, equates to a maximum rate of 0.48 g IPBC/ m2 and 1.44 g propiconazole/m 2. No studies with the product have been submitted and this was accepted by UK. Based on the calculation rules no classification is warranted for acute toxicity, for skin or eye irritation or for sensitising properties. Based on the sensitising properties of both active substances the following sentence shall be stated on the label: Contains IPBC and Propiconazole: May produce an allergic reaction. A new RAC opinion became available for propiconazole after the authorisation in UK. According to the RAC opinion, propiconazole is categorised to be Repr. 1B (H360D: May damage the unborn child). Because the concentration of propiconazole is higher than the threshold of 0.3%, Valtti Plus Base will be classified to be Repr. 1B based on the RAC opinion. However, as under the Mutual recognition rules the CLP proposals of the RMS are not re-evaluated by cms, the RAC opinion will be reflected at the time of product renewal or when it will be mandatory based on a ATP update of the CLP Regulation. The conclusions of UK on formulation toxicity is therefore accepted by the Ctgb. No dermal absorption of the product has been submitted. The applicant has proposed the use of 2% for exposure to treating (ready-to-use) formulations for propiconazole, and 30% for IPBC representing a reasonable worst case assumption for a water based formulation based on their respective CARs. These proposals were accepted by the UK, and are accepted by the Ctgb. The exposure assessment and risk characterisation for professional and non-professional use was performed by applying a risk envelope approach by reference to the related product Wocosen PWF. Wocosen PWF is a water based ready to use wood preservative, and has been assessed under BPD. Where uses are the same, the related product Wocosen PWF is considered to represent a worse case than Valtti Plus Base in the risk assessment because the concentrations of the active substances (0.60% w/w IPBC and 1.2% w/w propiconazole), and the maximum application rate (0.84 g IPBC/m 2 and 1.68 g propiconazole/m 2 ) are higher. Additional exposure assessment for Valtti Plus Base was performed for non-professional users by using brush and roller (indoor) for IPBC, as this scenario did not result in a safe use for Wocosen PWF. The exposure was calculated using Consumer product painting Model 1 described in TNsG The calculated level exceeded the short term AEL for IPBC (108%). It is noted in the PAR that the AEL was derived from a 90 day rat study in which critical effects of decreased bodyweight increased organ weight occurred over the duration of the study and not after one or two exposure events as anticipated for this application scenario. In the absence of an acute AEL, exposure arising from Valtti Plus Base was considered to be sufficiently close to the short term AEL and was considered acceptable by UK. 3

6 For the calculation for non-professionals, the UK has applied 50% protection factor by clothing assuming them wearing long-sleeved shirt and trousers or skirt with shoes. According to the HEEG opinion no.9, however, the protection factor of 50% may be applied only for a dry substance, or liquid formulation where contamination is judged to be relatively light (e.g. from using an aerosol canister or application by a trigger spray). There is no data to support that contamination caused by application of liquid by using brush/roller is light, and therefore the Ctgb does not agree with the application of 50% safety factor in this case. Without the protection factor, the exposure level of the non-professional use by using brush or roller increases from 108% to 120% AEL (0.4183/0.35) for IPBC. To refine the calculation, the model for professional brush treatment (PT8) described in HEAd hoc recommendation no.6 (ver 3, page 20) may be used instead of Consumer product painting Model 1. The model in HEAd hoc recommendation no.6 is for professional users, and it is reasonable to assume that it also covers exposure of non-professionals, who usually treat less area than professional users per day. The exposure level is calculated to be 3.72E-2 mg/kg bw, which corresponds to 10.6% of the short term AEL of IPBC. Based on this refined calculation, the Ctgb agrees with the UK that no adverse health effects are expected from primary exposure to either IPBC or propiconazole from the use of Valtti Plus Base. With regard to the secondary exposure, the following exposure scenarios have already been assessed for Wocosen PWF. Adult non-professional sanding treated wood (acute) Infant chewing wood (acute) Adult professional sanding treated wood (chronic) Adult cleaning work clothes at home (chronic) Adult, child and infant inhalation of volatised residue indoors (chronic) Children playing on weathered playground structure and mouthing (chronic) The exposure levels did not exceed relevant AELs for each active substance. No additional scenario was considered for Valtti Plus Base. Combined exposure Valtti Plus Base contains two active substances. UK has not performed the assessment of combined exposure to both substances. However, the guidance on the evaluation of combined toxicity proposed by France has already been endorsed at the TM IV 2012 and included in the current ECHA guidance. Therefore the risk assessment for combined toxicity is performed by the Ctgb. As the first tier, the adverse toxicological effects of both compounds are considered to be additive by default. If the sum of %AEL per exposure scenario for both substance is <100%, no risk of adverse toxicological effects from combined exposure is expected. The sum of %AELs as calculated by UK exceeded 100 for three scenarios: For the industrial application by flow coating and non-professional use by spraying, the risk of combinational effects the sum are just above 100 (105% and 106%, respectively), and the calculation is based on Wocosen PWF, which contains higher concentration of the active substances. Therefore risk from combinational exposure is considered acceptable for these two uses. The sum of %AELs was 146% for the application using brush and roller by non-professionals (108% IPBC (Vlattie Plus Base)+38% Propiconazole (Wocosen PWF)). However, by using the refined exposure value for IPBC using the model described in HEAd hoc recommendation 6, the sum is lowered to 49%AEL (10.6% IPBC (Vlattie Plus Base, refined)+38% Propiconazole (Wocosen PWF)). Based on this the Ctgb concludes that there is no adverse health effects expected from the combined exposure to IPBC and propiconazole. UK did not identify any substance of concern. This is accepted by the Ctgb. 4

7 Based on these calculations, no adverse health effects are expected for the unprotected non-professional users due to exposure to IPBC and propiconazole as a result of application of Valtti Plus Base. No adverse effects are expected for the protected (coverall, gloves and shoes) industrial and professional users when used in accordance with the SPC. Furthermore, no adverse effects are expected for the general public from indirect exposure as a result of the application of Valtti Plus Base, when used in accordance with the SPC. 2.6 Risk assessment for the environment Valtti Plus Base is a wood preservative (PT08) based on the active substances IPBC (0.3%) and propiconazole (0.9%). The product is intended to preserve wood meant for wood applied indoors and outdoors, but not permanently exposed to soil and water, i.e. intended for use classes 1, 2, and 3, and applied by professionals, non-professionals, and industry. For the risk assessment of IPBC reference was made to the assessment report in which no unacceptable risks were concluded for the foreseen uses. The RMS (UK) has renewed the risk assessment for propiconazole due to the submission of leaching data for superficially treated wood and new insights regarding groundwater simulations for the metabolite 1,2,4-triazole.For the risk assessment for the environment we refer to the Product Assessment Report of the original authorisation. Unacceptable risks were identified for surface water and soils during industrial application and storage, as well as for groundwater for preserved wood in service. However, risks were reduced to acceptable levels (below any threshold value) when a non-propiconazole containing topcoat (e.g. a paint, coating, or lacquers) is applied. The effect of a topcoat was experimentally determined in a semi-field leaching test. In conclusion, the risks for the environment are acceptable if the following risk mitigation measures are enforced: The product is for use on timbers not in ground contact, either continually exposed to the weather or protected from the weather but subject to frequent wetting; Treated timber must not be used in external situations where it is in contact with the ground and permanently exposed to wetting, or in permanent contact with fresh or salt water; application processes must be carried out within a contained area, situated on impermeable hard standing with bunding to prevent run-off and a recovery system in place (e.g. sump); storage of freshly treated wood must be either undercover with a recovery system in place (e.g. sump) or on impermeable hard standing and bunded to prevent run-off with a recovery system in place (e.g. sump); preserved wood permanently exposed to weather must have a top-coat applied (minimum total volume of 240 ml/m²), achieved by 1-3 applications or minimum dry film thickness in total of 100 μm, achieved by 1-3 applications). The topcoat should either be applied prior to the use of the treated timber in situations exposed to weathering, or in the case of new build scenarios or in situ applications of this product, prior to the weathering events themselves (e.g. rainfall). The top-coat should not contain a triazole fungicide. This information will be included on the product label. The use of a specific top-coat is not required at this stage. Use of the product by penetrative means (vacuum-pressure impregnation) is considered unacceptable by the UK CA. Overall conclusion for the aspect environment: The conclusions in the risk assessment of the RMS are valid. 5

8 2.7 Measures to protect man, animals and the environment For the measures to protect man, animals and the environment we refer to Product Assessment Report of the original authorisation and the SPC of the CMS NL. 2.8 Substitution/exclusion criteria and comparative assessment Valtti Plus Base does not contain any active substances that are considered candidate for substitution. 3 Proposal for decision The authorisation of Valtti Plus Base 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 Valtti Plus Base 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