CELEX: 32021R0368
Language: en
Date: 2021-03-01 00:00:00
Title: Commission Implementing Regulation (EU) 2021/368 of 1 March 2021 granting a Union authorisation for the single biocidal product ‘Aero-Sense Aircraft Insecticide ASD’ (Text with EEA relevance)

2.3.2021   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 71/4
               
            
         COMMISSION IMPLEMENTING REGULATION (EU) 2021/368
         of 1 March 2021
         granting a Union authorisation for the single biocidal product ‘Aero-Sense Aircraft Insecticide ASD’
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular the first subparagraph of Article 44(5) thereof,
         Whereas:
         
                     (1)
                  
                  
                     On 2 February 2018, Aero-Sense NV submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a single biocidal product named ‘Aero-Sense Aircraft Insecticide ASD’ of product-type 18, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Belgium had agreed to evaluate the application. The application was recorded under case number BC-DX037393-17 in the Register for Biocidal Products.
                  
               
                     (2)
                  
                  
                     ‘Aero-Sense Aircraft Insecticide ASD’ contains 1R-trans phenothrin, as the active substance, which is included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012.
                  
               
                     (3)
                  
                  
                     On 7 May 2020, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).
                  
               
                     (4)
                  
                  
                     On 2 July 2020, the Agency submitted to the Commission an opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘Aero-Sense Aircraft Insecticide ASD’ and the final assessment report on the single biocidal product in accordance with Article 44(3) of Regulation (EU) No 528/2012.
                  
               
                     (5)
                  
                  
                     The opinion concludes that ‘Aero-Sense Aircraft Insecticide ASD’ is a biocidal product, that it is eligible for Union authorisation in accordance with Article 42(1) of Regulation (EU) No 528/2012 and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) of that Regulation.
                  
               
                     (6)
                  
                  
                     On 4 August 2020, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.
                  
               
                     (7)
                  
                  
                     The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘Aero-Sense Aircraft Insecticide ASD’.
                  
               
                     (8)
                  
                  
                     The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,
                  
               HAS ADOPTED THIS REGULATION:
         
            Article 1
            A Union authorisation with authorisation number EU-0024297-0000 is granted to Aero-Sense NV for the making available on the market and use of the single biocidal product ‘Aero-Sense Aircraft Insecticide ASD’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
            The Union authorisation is valid from 22 March 2021 until 28 February 2031.
         
         
            Article 2
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
         
         
            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 1 March 2021.
            
               
                  For the Commission
               
               
                  The President
               
               Ursula VON DER LEYEN
            
         
         
            (1)  OJ L 167, 27.6.2012, p. 1.
         
            (2)  ECHA opinion of 17 June 2020 on the Union authorisation of the biocidal product ‘Aero-Sense Aircraft Insecticide ASD’ (ECHA/BPC/262/2020), https://echa.europa.eu/bpc-opinions-on-union-authorisation
      
      
         
            ANNEX
            Summary of product characteristics for a biocidal product
            Aero-Sense Aircraft Insecticide ASD
            Product type 18 – Insecticides, acaricides and products to control other arthropods (Pest control)
            Authorisation number: EU-0024297-0000
            R4BP asset number: EU-0024297-0000
            1.   ADMINISTRATIVE INFORMATION
            
            1.1.   Trade name(s) of the product
            
            
                        Trade name(s)
                     
                     
                        Aero-Sense Aircraft Insecticide ASD
                     
                  1.2.   Authorisation holder
            
            
                        Name and address of the authorisation holder
                     
                     
                        Name
                     
                     
                        Aero-Sense NV
                     
                  
                        Address
                     
                     
                        Schaapbruggestraat 50, 8800 Roeselare, Belgium
                     
                  
                        Authorisation number
                     
                     
                        EU-0024297-0000
                     
                  
                        
                           R4BP asset number
                        
                     
                     
                        EU-0024297-0000
                     
                  
                        Date of the authorisation
                     
                     
                        22 March 2021
                     
                  
                        Expiry date of the authorisation
                     
                     
                        28 February 2031
                     
                  1.3.   Manufacturer(s) of the product
            
            
                        Name of manufacturer
                     
                     
                        Volcke Aerosol Connection
                     
                  
                        Address of manufacturer
                     
                     
                        Industrielaan 15, 8520 Kuurne Belgium
                     
                  
                        Location of manufacturing sites
                     
                     
                        Industrielaan 15, 8520 Kuurne Belgium
                     
                  
               
            
                        Name of manufacturer
                     
                     
                        Envasado Xiomara, S.L.
                     
                  
                        Address of manufacturer
                     
                     
                        Polígono Industrial La Torrecilla Chica, 6, 45220 Yeles – Toledo Spain
                     
                  
                        Location of manufacturing sites
                     
                     
                        Polígono Industrial La Torrecilla Chica, 6, 45220 Yeles – Toledo Spain
                     
                  
               
            
                        Name of manufacturer
                     
                     
                        Aero-Sense NV
                     
                  
                        Address of manufacturer
                     
                     
                        Kachtemsestraat 289, 8800 Roeselare Belgium
                     
                  
                        Location of manufacturing sites
                     
                     
                        Kachtemsestraat 289, 8800 Roeselare Belgium
                     
                  1.4.   Manufacturer(s) of the active substance(s)
            
            
                        Active substance
                     
                     
                        1R-trans phenothrin
                     
                  
                        Name of manufacturer
                     
                     
                        Endura S.p.A
                     
                  
                        Address of manufacturer
                     
                     
                        Viale Pietro Pietramellara 5, 40121 Bologna Italy
                     
                  
                        Location of manufacturing sites
                     
                     
                        39 Wenfeng Road, 225009 Yangzhou, Jiangsu China
                     
                  2.   PRODUCT COMPOSITION AND FORMULATION
            
            2.1.   Qualitative and quantitative information on the composition of the product
            
            
                        Common name
                     
                     
                        IUPAC name
                     
                     
                        Function
                     
                     
                        CAS number
                     
                     
                        EC number
                     
                     
                        Content (%)
                     
                  
                        1R-trans phenothrin
                     
                     
                        3-phenoxybenzyl (1R,3R)-2,2-dimethyl- 3-(2-methylprop-1- enyl)cyclopropanecarboxylate
                     
                     
                        Active Substance
                     
                     
                        26046-85-5
                     
                     
                        247-431-2
                     
                     
                        2,0
                     
                  2.2.   Type of formulation
            
            AE – Aerosol dispenser
            3.   HAZARD AND PRECAUTIONARY STATEMENTS
            
            
                        Hazard statements
                     
                     
                        Pressurised container: May burst if heated
                        Very toxic to aquatic life.
                        Very toxic to aquatic life with long lasting effects.
                     
                  
                        Precautionary statements
                     
                     
                        Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
                        Do not pierce or burn, even after use.
                        Avoid release to the environment.
                        Collect spillage.
                        Protect from sunlight. Do not expose to temperatures exceeding 50 °C/122 °F.
                        Dispose of contents/container to hazardous or special waste collection point.
                     
                  4.   AUTHORISED USE(S)
            
            4.1.   Use description
            
            
               Table 1. Use # 1 – Mosquitoes – Aircraft treatment – Professionals
            
            
                        Product type
                     
                     
                        PT18 – Insecticides, acaricides and products to control other arthropods (Pest control)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        Insecticide
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Scientific name: Culex spp.
                        Common name: Culex mosquitoes
                        Development stage: Adults
                        Scientific name: Aedes spp.
                        Common name: Aedes mosquitoes
                        Development stage: Adults
                        Scientific name: Anopheles spp.
                        Common name: Anopheles mosquitoes
                        Development stage: Adults
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                        Application in cockpit and cabin for aircraft disinsection.
                     
                  
                        Application method(s)
                     
                     
                        Aerosol spray
                        Spraying
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Recommended application rate: 35 g/100 m3 (i.e. 0,7 g a.i./100 m3).
                        Ready-to-use product.
                        Treatment should be repeated on each flight for which a disinsection treatment is required.
                        One application per flight only.
                     
                  
                        Category(ies) of users
                     
                     
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Aluminium (ALU) printed can 18 bar – Full colour printed
                        White cap (One Shot actuator) or Blue cap (Multi Shot actuator)
                        Packed in cardboard packaging per 24 pieces
                        Available in different can sizes:
                        
                                    •
                                 
                                 
                                    40 g (34 mL)
                                 
                              
                                    •
                                 
                                 
                                    60 g (52 mL)
                                 
                              
                                    •
                                 
                                 
                                    100 g (86 mL)
                                 
                              
                  4.1.1.   Use-specific instructions for use
            
            
                        —
                     
                     
                        Please refer to the onboard manual for the number of cans required for a disinsection treatment for each specific aircraft type.
                     
                  
                        —
                     
                     
                        The disinsection procedure should be announced to passengers prior to the application of the product in the aircraft. Passengers should be advised to close their eyes and cover their faces whilst the procedure is carried out.
                     
                  
                        —
                     
                     
                        Do not spray directly on skin or in eyes.
                     
                  
                        —
                     
                     
                        Do not spray on or near food, food preparation areas or food utensils.
                     
                  
                        —
                     
                     
                        Wash hands after handling.
                     
                  
                        —
                     
                     
                        Prevent use by unauthorised personnel.
                     
                  
                        —
                     
                     
                        Remove the cap.
                     
                  
                        —
                     
                     
                        Hold can(s) vertically at arm’s length.
                     
                  
                        —
                     
                     
                        ‘One shot’ white cap: depress tab on spray nozzle until it locks down. The aerosol product is released in one continuous spray.
                     
                  
                        —
                     
                     
                        ‘Multi shot’ blue cap: depress tab on spray nozzle until sufficient quantity is released or until product is completely discharged.
                     
                  
                        —
                     
                     
                        The insecticide aerosol should be sprayed by directing the nozzle of the aerosol dispenser at an angle of approximately 45° towards the ceiling throughout the aircraft.
                     
                  
                        —
                     
                     
                        The spray should be directed slightly behind the user.
                     
                  
                        —
                     
                     
                        Spray evenly throughout the whole area.
                     
                  
                         
                     
                     
                        40 g (34 mL) – One can effectively treats 114 m3 of air volume;
                     
                  
                         
                     
                     
                        60 g (52 mL) – One can effectively treats 171 m3 of air volume;
                     
                  
                         
                     
                     
                        100 g (86 mL) – One can effectively treats 285 m3 of air volume.
                     
                  
               ‘Blocks away’ disinsection
            
            This procedure takes place prior to take off, after passengers have boarded and the doors have been closed.
            The flight deck is sprayed prior to boarding by the cabin crew.
            For disinsection to be effective, the aircraft air conditioning system must be switched off whilst spraying. The cabin crew must treat all possible insect harbourages including toilets, galleys and wardrobes, unless these areas have been sprayed together with the flight-deck prior to boarding.
            
               ‘Top-of-descent’ (in-flight spraying)
            
            According to WHO guidance: pre-flight and top-of-descent spraying is a two-part disinsection method. ‘Top-of-descent’ (in-flight spraying) is the second technique of this method and is carried out at ‘top-of-descent’, as the aircraft starts its descent to the destination airport. Air re-circulation shall be set at normal flow.
            No residual efficacy has been demonstrated.
            Products containing 1R-trans phenothrin should not be used for both pre-flight and in-flight treatment in the same aircraft.
            4.1.2.   Use-specific risk mitigation measures
            
            
                        —
                     
                     
                        The product should be applied only once per flight.
                     
                  
                        —
                     
                     
                        A member of the cabin crew shall perform no more than one application per day.
                     
                  
                        —
                     
                     
                        Do not use/apply the product directly on or near food, feed or drinks, or on surfaces or utensils likely to be in direct contact with food and drinks.
                     
                  
                        —
                     
                     
                        Contains 1R-trans phenothrin (pyrethroids), may be dangerous to cats. Care must be taken in using the product when cats are present in the aircraft. Cats must be kept away during treatment.
                     
                  
                        —
                     
                     
                        Cleaning of treated aircraft must only be undertaken using specialised products that do not require discharge of liquid waste to drains and local sewage treatment plants.
                     
                  
                        —
                     
                     
                        Cleaning equipment (brushes, cloths, etc.) used on an aircraft after application of the product must be disposed of as solid waste and must not be re-used.
                     
                  4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            First Aid instructions:
            
               General
            
            
                        —
                     
                     
                        IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.
                     
                  
                        —
                     
                     
                        IF SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor.
                     
                  
                        —
                     
                     
                        IF ON SKIN: Wash with soap and water. If symptoms occur call a POISON CENTRE or a doctor.
                     
                  
                        —
                     
                     
                        IF IN EYES: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If symptoms occur call a POISON CENTRE or a doctor.
                     
                  
                        —
                     
                     
                        Pyrethroids may cause paresthesia (burning and prickling of the skin without irritation). If symptoms persist: seek medical advice.
                     
                  
               Emergency measures to protect the environment in case of accident
            
            
                        —
                     
                     
                        Contain and control any leaks or spills with non-combustible absorbent materials such as sand, earth, vermiculite, or diatomaceous earth in drums for waste disposal.
                     
                  
                        —
                     
                     
                        Prevent any material from entering drains or waterways.
                     
                  
                        —
                     
                     
                        Do not direct water spray at the point of leakage or of spillage.
                     
                  
                        —
                     
                     
                        Allow any product remaining as a result of the leak or spill to evaporate.
                     
                  4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            
                        —
                     
                     
                        An appropriate entry should be made in the Aircraft General Declaration, giving details of the disinsection procedure together with the serial numbers of the spray cans used.
                     
                  
                        —
                     
                     
                        The empty spray cans are to be retained for inspection by the Port Health Authority.
                     
                  
                        —
                     
                     
                        Do not pour the product into drains or waterways.
                     
                  
                        —
                     
                     
                        Ensure that waste management is carried out without endangering human health, without harming the environment and, in particular, without risk to water, air, soil, plants or animals.
                     
                  
                        —
                     
                     
                        Recycle or dispose of waste product in compliance with applicable legislation, preferably via a certified collector or company.
                     
                  
                        —
                     
                     
                        Do not contaminate the ground or water with waste product.
                     
                  
                        —
                     
                     
                        Do not dispose of waste product into the environment.
                     
                  4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See directions for use
            5.   GENERAL DIRECTIONS FOR USE (1)
            
            5.1.   Instructions for use
            
            See section 4.1.1
            5.2.   Risk mitigation measures
            
            See section 4.1.2
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See section 4.1.3
            5.4.   Instructions for safe disposal of the product and its packaging
            
            See section 4.1.4
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage
            
            
                        —
                     
                     
                        Store in original packagingin a cool (below 40 °C), dry and well-ventilated place. Protect from frost.
                     
                  
                        —
                     
                     
                        Store out of direct sunlight, even when empty.
                     
                  Shelf life: 2 years
            6.   OTHER INFORMATION
            
            
               (1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for all authorised uses.