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. 26 april 2018 tot toelating van het middel Uragan D2 / BLUEFUME toelatingnummer NL Evaluation Report Mutual Recognition URAGAN D2 / BLUEFUME 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 Risk assessment for human health Risk assessment for the environment Measures to protect man, animals and the environment Substitution/exclusion criteria and comparative assessment Decision... 5

3 1 General information about the product application Name and address of the authorisation holder Authorisation number Name Lučební závody Draslovka a.s. Kolín Address Havlíčkova Kolín IV NL Date of the authorisation Expiry date of the authorisation Trade name(s) Evaluating member state Name of the product in RMS Active substance PT User category URAGAN D2 Czech Republic URAGAN D2 hydrogen cyanide PT8, PT14, PT18 Professional 2 Summary of the product assessment 2.1 Classification and labelling Based on the profile of the substance, the provided toxicology of the preparation, the characteristics of the co-formulants, the method of application and the risk assessment for the operator, as mentioned above, the following labeling of the preparation is proposed: Based on Reg. (EC) 1272/2008: Hazard statement codes H224 Extremely flammable liquid and vapour. H300+H310+H330 Fatal if swallowed, in contact with skin or if inhaled H315 Causes skin irritation H319 Causes severe eye irritation H373 May cause damage to organs (thyroid gland) through prolonged or repeated exposure; oral, dermal, inhalation. H410 Very toxic to aquatic life with long lasting effects.

4 Hazard statement codes P210 Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P243 Take precautionary measures against static discharge P260 Do not breathe gas. P273 Avoid release to the environment. P280 Wear protective nitrile gloves, protective clothing and eye protection. P304+P340 IF INHALED: Remove person to fresh air and keep comfortable for breathing. P310 Immediately call a doctor. 2.2 Packaging and shelf-life Professional use Packaging size and type Packaging size and type Packaging authorised/ evaluated by RMS Can/tin, metal: 1.5kg Cylinder, metal: 27.5kg Packaging applied for in NL Can/tin, metal: 1.5kg Cylinder, metal: 27.5kg Packaging authorised in NL Can/tin, metal: 1.5kg Cylinder, metal: 27.5kg The shelf life of the product is 12 months in the proposed packaging. 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 three Product Assessment Reports of the original authorization by the RMS Czech Republic (URAGAN D2, PT8, PT14 and PT18, ). The conclusions of the RMS are acceptable Authorised uses and use instructions The applicant has provided a Dutch SPC. This has been adapted to our standards. In NL there are national specific requirements on the training and certification of the professional users and risk mitigation measures to be taken, therefore, some additional lines were added to the SPC. 2.5 Risk assessment for human health For the risk assessment for human health we refer to the Product Assessment Reports for PT8, PT14 and PT18 of the original authorisation. The formulation URAGAN D2 / BLUEFUME is a ready-to-use product for PT8 containing stabilized hydrogen cyanide for use as a wood preservative by trained professionals only. The fumigation may be performed only by specifically trained professional personnel. All

5 employees shall be annually retrained and tested in fumigation procedures, as well as in first aid and resuscitation procedures. Only specially trained personnel at least 18 years old may handle hydrogen cyanide. Personnel handling the substance must use the approved protective equipment: gastight chemical protective clothing, cap or hat, rubber gloves and rubber boots. Respiratory equipment must be worn by operators (SCBA) independently of the temperature of the room. During fumigation, special, in detail specified methods are used, both for the preparation process and after-fumigation treatment. Dosage: 20 g/m 3, i.e. 2 kg per 100 m 3 in field conditions. The formulation Uragan D2 is a ready-to-use product for PT14 containing stabilized hydrogen cyanide for use as a rodenticide by trained professionals only. The fumigation may be performed only by specifically trained professional personnel. All employees shall be annually retrained and tested in fumigation procedures, as well as in first aid and resuscitation procedures. Only specially trained personnel at least 18 years old may handle hydrogen cyanide. Personnel handling the substance must use the approved protective equipment: gastight chemical protective clothing, cap or hat, rubber gloves and rubber boots. Respiratory equipment must be worn by operators (SCBA) independently of the temperature of the room. During fumigation, special, in detail-specified methods are used, both for the preparation process and after-fumigation treatment. Description of the fumigation process with hydrogen cyanide in empty spaces: Dosage: 10 g/m 3, i.e. 1 kg per 100 m 3 in field conditions CZ CA notes that the text also applies to the fumigation of planes and structures where no leakage or dilution due to accumulation in the upper parts is possible, where dose of 1g/m3 is sufficient to ensure the required efficacy. This has been specified in the SPC. The formulation Uragan D2 is a ready-to-use product for PT18 containing stabilized hydrogen cyanide for use as a rodenticide by trained professionals only. The fumigation may be performed only by specifically trained professional personnel. All employees shall be annually retrained and tested in fumigation procedures, as well as in first aid and resuscitation procedures. Only specially trained personnel at least 18 years old may handle hydrogen cyanide. Personnel handling the substance must use the approved protective equipment: gastight chemical protective clothing, cap or hat, rubber gloves and rubber boots. Respiratory equipment must be worn by operators (SCBA) independently of the temperature of the room. During fumigation, special, in detail specified methods are used, both for the preparation process and after-fumigation treatment. Description of the fumigation process with hydrogen cyanide in empty spaces: Dosage: 10 g/m 3, i.e. 1 kg per 100 m 3 in field conditions. The Product Assessment Reports (PARs) were prepared by the refms Czech Republic (CZ). Studies with the product have not been submitted, since the biocidal product is the same as the technical grade active substance. The conclusions of CZ on formulation toxicity is accepted by the Ctgb. For the exposure, application concentrations of hydrogen cyanide is 1-20 g/m 3. Operators handling Uragan D2 for fumigation must use personal protective equipment (gastight

6 chemical clothing (including face mask), self contained breathing apparatus (SCBA), rubber gloves and rubber boots). Professionals during ventilation phase for PT8, PT14 and PT18 Value of threshold HCN air concentration for re-entering the treated structure should be 0.6 mg/m3, as it corresponds to an acceptable level for both by-standers (acute exposure) and operators (long term exposure). Therefore, after the treatment with hydrogen cyanide is completed, the treated buildings are ventilated to remove the gas and only after residual concentrations of hydrogen cyanide drop below the long-term exposure limit (= TWA = average airborne concentration over the 8 hour shift) of 0.6 mg/m3, unprotected persons are allowed to enter the building. So, during ventilation phase the exclusion zone is determined so that the airborne HCN concentration at its border is 0.6 mg/m 3. An operator wearing prescribed PPE (gastight chemical clothing (including face mask), self contained breathing apparatus (SCBA), rubber gloves and rubber boots) is responsible for shifting the border if need be e.g. due to a change in weather conditions. This operator is not exposed to HCN while wearing the PPE. For some applications such as airplane fumigation the operators are assumed to be without a mask for most of their 8 hour shift. In such a case the operator must find a place where airborne HCN concentration does not exceed 0.6 mg/m 3. Non-professional exposure for PT8, PT14 and PT18 There will be an exclusion zone for exposure of residents exceeding 24 hours where the HCN concentration must not exceed mg/m3. This zone is primarily determined to ensure the safety of the residents in the close neighbourhood of the fumigated structures that may be exposed throughout the fumigation to low levels of HCN. Ctgb accepted the risk assessment. CZ did not identify any substance of concern. This is accepted by the Ctgb. 2.6 Risk assessment for the environment URAGAN D2 / BLUEFUME is intended to be used by professionals for the hygienic fumigation of : wood and wooden furniture, pallets placed in a structure or special container (PT8); a) Storehouses, depositories, museums, temples, and other buildings (PT14); b) Agro-food industry deratization of empty buildings (PT14); c) Transport facilities (PT14); d) Structures where no leakage and no significant dilution due to accumulation in the upper parts is possible i.e. planes (PT14); a) Storehouses, depositories, museums, temples, and other buildings (PT18); b) Agro-food industry deratization of empty buildings (PT18); c) Transport facilities (PT18) The product contains the active substance hydrogen cyanide (HCN ; 97.6%). The active substance functions as a respiratory poison, killing pests by damaging their metabolism. It is absorbed through airways, digestive tract and body surface. It causes asphyxiation directly in tissues: all of the pharmacological actions of cyanide result from cyanide's reversible complex with the ferric (+3) state of mitochondrial cytochrome c oxidase, the terminal oxidase in aerobic metabolism of all animals, plants, yeasts, and some bacteria. Cessation of the mitochondrial electron transport results in inhibition of oxygen utilization and causes hypoxia and cellular destruction.

7 Uragan D2 is produced and filled into a cylinder as liquid. Due to fumigation conditions (application by spraying nozzles, temperature, pressure), the liquid evaporates (and does not condense back) and so the active substance is gas. After the fumigation is finished, HCN is vented to the atmosphere. It may enter surface waters in a minimal quantity through precipitation. Due to HCN properties, these amounts are negligible. Theoretical max. concentration: 400 µg /L (PNECwater). The same applies to ground waters and sediments. Fumigation scenarios used for hydrogen cyanide do not consider HCN reaching wastewater treatment plants or entering soil. For the risk assessment for the environment we refer to Product Assessment Report of the original authorisation. Uragan D2 is the representative product in the assessment reports (AR) for hydrogen cyanide in PT8, P14 and PT18. HCN does not fulfil the PBT or vpvb criteria and is no candidate for substitution or exclusion. Overall conclusion for the aspect environment: The conclusions in the risk assessment of the RMS are valid for the intended uses of Uragan D2 in PT8, 14 and 18 applications. 2.7 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 (gastight chemical clothing (including facemask), self contained breathing apparatus (SCBA), rubber gloves and boots)) professional user after exposure to HCN as a result of the application of Uragan D2, 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 HCN as a result of the application of Uragan D2. Value of threshold HCN air concentration for re-entering the treated structure should be 0.6 mg/m3, as it corresponds to an acceptable level for both by-standers (acute exposure) and operators (long term exposure). There will be an exclusion zone for exposure of residents exceeding 24 hours where the HCN concentration must not exceed mg/m3. For the measures to protect 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 Uragan D2 does not contain any active substances that are considered candidate for substitution. 3 Decision The authorisation of URAGAN D2/BLUEFUME is based on mutual recognition of the authorisation of RMS Czech Republic. 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 the product 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.

8