CELEX: 32022R0114
Language: en
Date: 2022-01-26 00:00:00
Title: Commission Implementing Regulation (EU) 2022/114 of 26 January 2022 granting a Union authorisation for the single biocidal product ‘SchwabEX-Guard’ (Text with EEA relevance)

28.1.2022   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 19/11
               
            
         COMMISSION IMPLEMENTING REGULATION (EU) 2022/114
         of 26 January 2022
         granting a Union authorisation for the single biocidal product ‘SchwabEX-Guard’
         (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 Article 44(5), first subparagraph, thereof,
         Whereas:
         
                     (1)
                  
                  
                     On 24 March 2017, Sumitomo Chemical Agro Europe SAS submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013 (2) for authorisation of the same single biocidal product, as referred to in Article 1 of Implementing Regulation (EU) No 414/2013, named ‘SchwabEX-Guard’, of product-type 18, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-PP031247-26 in the Register for Biocidal Products (‘the Register’). The application also indicated the application number of the related reference single product ‘Pesguard® Gel’, recorded in the Register under case number BC-HS027052-37.
                  
               
                     (2)
                  
                  
                     The same single biocidal product ‘SchwabEX-Guard’ contains pyriproxyfen and clothianidin, as the active substances, which are included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012.
                  
               
                     (3)
                  
                  
                     On 17 December 2020, the Agency submitted to the Commission an opinion (3) and the draft summary of the biocidal product characteristics (‘SPC’) of ‘SchwabEX-Guard’ in accordance with Article 6(1) and (2) of Implementing Regulation (EU) No 414/2013.
                  
               
                     (4)
                  
                  
                     The opinion concludes that ‘SchwabEX-Guard’ is a biocidal product, that it is eligible for Union authorisation in accordance with Article 42(1) of Regulation (EU) No 528/2012, that the proposed differences between the same single biocidal product and the related reference biocidal product are limited to information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013 (4), and that based on the assessment of the related reference ‘Pesguard® Gel’ single product and subject to compliance with the draft SPC, the same single biocidal product meets the conditions laid down in Article 19(1) of Regulation (EU) No 528/2012.
                  
               
                     (5)
                  
                  
                     On 17 December 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.
                  
               
                     (6)
                  
                  
                     The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the same single biocidal product ‘SchwabEX-Guard’.
                  
               
                     (7)
                  
                  
                     The same single biocidal product ‘SchwabEX-Guard’ contains the non-active substances cis CTAC and dichloromethane, for which it was not possible to conclude whether they meet the scientific criteria for the determination of endocrine-disrupting properties set out in Commission Delegated Regulation (EU) 2017/2100 (5) within the period for the evaluation of the application for the related reference single biocidal product. Further examination of cis CTAC and dichloromethane should therefore take place. If it is concluded that either cis CTAC or dichloromethane or both are considered as having endocrine-disrupting properties, the Commission will consider whether to cancel or amend the Union authorisation for ‘SchwabEX-Guard’ in accordance with Article 48 of Regulation (EU) No 528/2012.
                  
               
                     (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-0025436-0000 is granted to Sumitomo Chemical Agro Europe SAS for the making available on the market and use of the same single biocidal product ‘SchwabEX-Guard’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
            The Union authorisation is valid from 17 February 2022 until 30 June 2026.
         
         
            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, 26 January 2022.
            
               
                  For the Commission
               
               
                  The President
               
               Ursula VON DER LEYEN
            
         
         
            (1)  OJ L 167, 27.6.2012, p. 1.
         
            (2)  Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 125, 7.5.2013, p. 4).
         
            (3)  ECHA opinion of 17 December 2020 on the Union authorisation of the same biocidal product ‘SchwabEX-Guard’, https://echa.europa.eu/opinions-on-union-authorisation/echa
         
            (4)  Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4).
         
            (5)  Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament and Council (OJ L 301, 17.11.2017, p. 1).
      
      
         
            ANNEX
            
               Summary of product characteristics for a biocidal product
            
            SchwabEX-Guard
            Product type 18 – Insecticides, acaricides and products to control other arthropods (Pest control)
            Authorisation number: EU-0025436-0000
            R4BP asset number: EU-0025436-0000
            1.   ADMINISTRATIVE INFORMATION
            
            1.1.   Trade name(s) of the product
            
            
                        Trade name(s)
                     
                     
                        SchwabEX-Guard
                     
                  1.2.   Authorisation holder
            
            
                        Name and address of the authorisation holder
                     
                     
                        Name
                     
                     
                        Sumitomo Chemical Agro Europe SAS
                     
                  
                        Address
                     
                     
                        Parc d’ Affaires de Crécy 10A, rue de la Voie Lactée, 69370, Saint Didier au Mont d’Or, France
                     
                  
                        Authorisation number
                     
                     
                        EU-0025436-0000
                     
                  
                        
                           R4BP asset number
                        
                     
                     
                        EU-0025436-0000
                     
                  
                        Date of the authorisation
                     
                     
                        17 February 2022
                     
                  
                        Expiry date of the authorisation
                     
                     
                        30 June 2026
                     
                  1.3.   Manufacturer(s) of the product
            
            
                        Name of manufacturer
                     
                     
                        McLaughlin Gormley King Company (MGK)
                     
                  
                        Address of manufacturer
                     
                     
                        8810 10th Avenue North, MN 55427 Minneapolis United States
                     
                  
                        Location of manufacturing sites
                     
                     
                        McLaughlin Gormley King Company, 4001 Peavey Road, MN 55318 Chaska United States
                     
                  1.4.   Manufacturer(s) of the active substance(s)
            
            
                        Active substance
                     
                     
                        (E)-1-(2-Chloro-1,3-thiazol-5-ylmethyl)-3- methyl-2-nitroguanidine (Clothianidin)
                     
                  
                        Name of manufacturer
                     
                     
                        Sumitomo Chemical Co. Ltd
                     
                  
                        Address of manufacturer
                     
                     
                        27-1, Shinkawa 2-chome, Chuo-ku, 104-8260 Tokyo Japan
                     
                  
                        Location of manufacturing sites
                     
                     
                        Sumitomo Chemical Company LTD, Oita Works, 2200, Tsurusaki, Oita City„ 870-0106 Oita Japan
                     
                  
               
            
                        Active substance
                     
                     
                        pyriproxyfen
                     
                  
                        Name of manufacturer
                     
                     
                        Sumitomo Chemical Co. Ltd
                     
                  
                        Address of manufacturer
                     
                     
                        27-1, Shinkawa 2-chome, Chuo-ku, 104-8260 Tokyo Japan
                     
                  
                        Location of manufacturing sites
                     
                     
                        Sumitomo Chemical Company LTD, Misawa Works, Aza-Sabishirotaira, Oaza-Misawa, Misawa„ 033-0022 Aomori Japan
                     
                  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 (%)
                     
                  
                        (E)-1-(2-Chloro-1,3-thiazol-5-ylmethyl)-3- methyl-2-nitroguanidine (Clothianidin)
                     
                     
                         
                     
                     
                        Active Substance
                     
                     
                        210880-92-5
                     
                     
                        433-460-1
                     
                     
                        0,526 
                     
                  
                        Pyriproxyfen
                     
                     
                        4-phenoxyphenyl (RS)-2-(2- pyridyloxy)propyl ether
                     
                     
                        Active Substance
                     
                     
                        95737-68-1
                     
                     
                        429-800-1
                     
                     
                        0,515 
                     
                  
                        Acetic acid
                     
                     
                        Ethanoic acid
                     
                     
                        Non-active substance
                     
                     
                        64-19-7
                     
                     
                        200-580-7
                     
                     
                        0,3 
                     
                  
                        Potassium sorbate
                     
                     
                        potassium (E,E)-hexa-2,4-dienoate
                     
                     
                        Non-active substance
                     
                     
                        24634-61-5
                     
                     
                        246-376-1
                     
                     
                        0,5 
                     
                  2.2.   Type of formulation
            
            RB – Bait (ready for use)
            3.   HAZARD AND PRECAUTIONARY STATEMENTS
            
            
                        Hazard statements
                     
                     
                        May cause an allergic skin reaction.
                        Very toxic to aquatic life with long lasting effects.
                     
                  
                        Precautionary statements
                     
                     
                        IF ON SKIN: Wash with plenty of water.
                        If skin irritation or rash occurs: Get medical advice.
                        Wear protective gloves.
                        Avoid release to the environment.
                        Dispose of container in accordance with local regulations.
                        Collect spillage.
                     
                  4.   AUTHORISED USE(S)
            
            4.1.   Use description
            
            
               Table 1
            
            
               Use # 1 – Professional Use – RTU Bait
            
            
                        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: Blattella germanica
                        Common name: German cockroach
                        Development stage: Nymphs
                        Scientific name: Blattella germanica
                        Common name: German cockroach
                        Development stage: Adults
                        Scientific name: Supella longipalpa
                        Common name: Brown-banded cockroach
                        Development stage: Nymphs
                        Scientific name: Supella longipalpa
                        Common name: Brown-banded cockroach
                        Development stage: Adults
                        Scientific name: Blatta orientalis
                        Common name: Oriental Cockroach
                        Development stage: Nymphs
                        Scientific name: Blatta orientalis
                        Common name: Oriental Cockroach
                        Development stage: Adults
                        Scientific name: Periplaneta americana
                        Common name: American Cockroach
                        Development stage: Nymphs
                        Scientific name: Periplaneta americana
                        Common name: American Cockroach
                        Development stage: Adults
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                        In cracks and crevices, or in concealed locations inaccessible to humans or domestic animals: behind refrigerators cupboards and shelves, under kitchen appliances, in electrical control boxes, voids and ducting and under bathroom fixtures etc.
                     
                  
                        Application method(s)
                     
                     
                        Method: Bait application
                        Detailed description:
                        A ready to use (RTU) insecticidal gel bait for the control of cockroaches in public hygiene
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Application Rate: SchwabEX-Guard should be applied as a number of spots of approximately 4 mm diameter (each spot comprising approximately 0,032 g of bait).
                        In cases of severe infestation, where larger cockroach species are present (B. orientalis or P. americana), in areas that are particularly dirty or cluttered or where alternative sources of food cannot be entirely eliminated the higher application rate (e.g. 2 instead of 1 spot per m2 in case of a light infestation) should be used.
                        Dilution (%): 0
                        Number and timing of application:
                        
                                    —
                                 
                                 
                                    Light infestation 1 – 2 (0,032 – 0,064 g) spots per m2
                                    
                                 
                              
                                    —
                                 
                                 
                                    Medium infestation 3 – 6 (0,096 – 0,192 g) spots per m2
                                    
                                 
                              
                                    —
                                 
                                 
                                    Heavy infestation 6 – 10 (0,192 – 0,320 g) spots per m2
                                    
                                 
                              The maximum number of annual applications is 11.
                     
                  
                        Category(ies) of users
                     
                     
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        30 g Polypropylene (PP) syringe
                        Screw top cap High Density Poly Ethylene (HDPE)
                     
                  4.1.1.   Use-specific instructions for use
            
            See the general directions for use
            4.1.2.   Use-specific risk mitigation measures
            
            See the general directions for use
            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
            
            See the general directions for use
            4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See the general directions for use
            4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See the general directions for use
            5.   GENERAL DIRECTIONS FOR USE (1)
            
            5.1.   Instructions for use
            
            Always read the label or leaflet before use and respect/follow all the instructions provided.
            Do not expose bait drops to sunlight or heat (e.g. radiator).
            The pre-filled plastic reservoir containing SchwabEX-Guard is intended for use with the plunger provided or a specific bait application device common to the pest control industry. Refer to the manufacturer’s instructions for directions on the use of the applicator.
            Inject the bait into cracks and crevices, void spaces, or in concealed locations inaccessible to humans or domestic animals where insects may live, feed and breed. Such areas are generally warm/damp and dark (behind refrigerators, cupboards and shelves, under kitchen appliances, in electrical control boxes, voids and ducting and under bathroom fixtures etc.). Inspection or trapping to confirm infestation is recommended prior to treatment. Ensure that any alternative food sources are removed and concentrate the bait placements as individual spots at cockroach activity sites. The product should only be applied to areas inaccessible to children and pets.
            Do not apply SchwabEX-Guard where it will come into contact with water or in areas that are routinely cleaned. Typically cockroaches will die a few hours after a single feed on SchwabEX-Guard. In infested premises, dead cockroaches will normally be seen within 24 hours of treatment.
            Remove the cap from the nozzle, touch the top to the surface to be treated, and push down on the plunger. Replace the cap on the dispenser after treatment is completed.
            The bait will adhere to non-greasy or non-dusty surfaces and will remain pliable and palatable to cockroaches as long as it is visibly present.
            Treated area’s should be visually inspected after 1–2 weeks. Where initial infestation was heavy a second SchwabEX-Guard application may be required if the first treatment has been consumed and live cockroaches are still present.
            A second visual inspection of bait placements is recommended 2-4 weeks after the initial treatment. Reapply when bait is no longer visibly present, according to the level of infestation (light, medium or heavy). Replace bait before it is completely consumed to keep cockroaches from returning.
            Inform the registration holder if the treatment is ineffective.
            Spills and residues containing the product need to be removed as chemical waste.
            Care should be taken to avoid depositing gel onto exposed surfaces. If gel contacts an exposed surface, remove gel with a paper towel and clean the area with disposable wet wipes.
            During follow-up visits, inspect bait placements and re-apply when necessary.
            Do not place bait in locations that are routinely washed, as bait will be removed by washing. Do not use this product in or on electrical equipment where a possibility of shock hazard exists. Avoid contact with textiles and clothing, as bait may stain.
            5.2.   Risk mitigation measures
            
            Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information).
            Do not apply bait in area’s where repellent insecticides have been used without thoroughly cleaning the surface with disposable wet tissue. Do not apply repellent insecticides after application of the bait.
            Do not apply directly on or near food, feed or drinks, or on surfaces or utensils likely to be in direct contact with food, feed, drinks and animals.
            Spills and residues containing the product must be removed as chemical waste.
            Avoid placing gel on fabrics or carpets since it may stain some absorbent materials. To prevent staining, exposed bait should be cleaned up immediately with disposable wet wipes.
            Cleaning materials must be disposed of as solid waste.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            This biocidal product contains clothianidin, which is dangerous to bees
            Description of first aid measures
            Skin contact: Remove contaminated clothing immediately and wash skin with soap and water. Get medical attention if irritation persists after washing.
            Eye contact: If symptoms occur; rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor.
            Ingestion: If swallowed: If symptons occur call a POISON CENTRE or a doctor.
            If inhaled: not applicable.
            Most important symptoms and effects, both acute and delayed
            Eyes: May cause temporary eye irritation.
            Emergency measures to protect the environment
            Avoid release of the product to the environment.
            5.4.   Instructions for safe disposal of the product and its packaging
            
            Only pass on empty containers/packaging for recycling.
            Disposal of this packaging should at all times comply with the waste disposal legislation and any regional local authority requirements.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage
            
            Protect from frost. Store away from direct sunlight.
            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 any authorised uses.