CELEX: 32021R2109
Language: en
Date: 2021-11-30 00:00:00
Title: Commission Implementing Regulation (EU) 2021/2109 of 30 November 2021 amending Implementing Regulation (EU) 2020/704 to make administrative changes to the Union authorisation of the biocidal product family ‘INSECTICIDES FOR HOME USE’ (Text with EEA relevance)

1.12.2021   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 429/99
               
            
         COMMISSION IMPLEMENTING REGULATION (EU) 2021/2109
         of 30 November 2021
         amending Implementing Regulation (EU) 2020/704 to make administrative changes to the Union authorisation of the biocidal product family ‘INSECTICIDES FOR HOME USE’
         (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) and Article 50(2) thereof,
         Whereas:
         
                     (1)
                  
                  
                     On 26 May 2020, Commission Implementing Regulation (EU) 2020/704 (2) granted a Union authorisation with authorisation number EU-0021035-0000 to Agrobiothers Laboratoire for the making available on the market and use of the biocidal product family ‘INSECTICIDES FOR HOME USE’.
                  
               
                     (2)
                  
                  
                     On 8 September 2020, Agrobiothers Laboratoire submitted a notification to the European Chemicals Agency (‘the Agency’), in accordance with Article 11(1) of Commission Implementing Regulation (EU) No 354/2013 (3), regarding the administrative changes to the Union authorisation for the biocidal product family ‘INSECTICIDES FOR HOME USE’ referred to in Section 1 of Title 1 of the Annex to that Regulation.
                  
               
                     (3)
                  
                  
                     Agrobiothers Laboratoire proposed the addition of trade names in the third information level: individual products in the meta SPC 1, of the summary of the product characteristics for the biocidal product family ‘INSECTICIDES FOR HOME USE’ as set out in Annex II to Implementing Regulation (EU) 2020/704. The notification was recorded under the case number BC-DR061688-14 in the Register for Biocidal Products.
                  
               
                     (4)
                  
                  
                     On 12 October 2020, the Agency submitted an opinion (4) on the proposed changes to the Commission, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013. The opinion concludes that the amendments to the existing authorisation sought by the authorisation holder fall under Article 50(3)(a) of Regulation (EU) No 528/2012, and that after the implementation of the changes the conditions of Article 19 of that Regulation are still met. On the same date, the Agency transmitted to the Commission the revised summary of the biocidal product characteristics in all the official languages of the Union in accordance with Article 11(6) of Implementing Regulation (EU) No 354/2013.
                  
               
                     (5)
                  
                  
                     The Commission concurs with the opinion of the Agency and therefore considers it appropriate to amend the Union authorisation of the biocidal product family ‘INSECTICIDES FOR HOME USE’.
                  
               
                     (6)
                  
                  
                     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
            Annex II to Implementing Regulation (EU) 2020/704 is replaced by the text in the Annex to this Regulation.
         
         
            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, 30 November 2021.
            
               
                  For the Commission
               
               
                  The President
               
               Ursula VON DER LEYEN
            
         
         
            (1)  OJ L 167, 27.6.2012, p. 1.
         
            (2)  Commission Implementing Regulation (EU) 2020/704 of 26 May 2020 granting a Union authorisation for the biocidal product family ‘INSECTICIDES FOR HOME USE’ (OJ L 164, 27.5.2020, p. 19).
         
            (3)  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).
         
            (4)  ECHA opinion of 9 October 2020 on the administrative change of the Union authorisation of the biocidal product family ‘INSECTICIDES FOR HOME USE’, https://echa.europa.eu/documents/10162/22836226/opinion_for_ua-admin_change_bc-dr061688-14_en.pdf/90bc7c1f-ed8e-a127-982c-4f08b3af513f
      
      
         
            ANNEX
            
               
                  
                     ‘ANNEX II
                     
                        Summary of product characteristics for a biocidal product family
                     
                     INSECTICIDES FOR HOME USE
                     Product type 18 – Insecticides, acaricides and products to control other arthropods (Pest control)
                     Authorisation number: EU-0021035-0000
                     R4BP asset number: EU-0021035-0000
                     PART I
                     
                        FIRST INFORMATION LEVEL
                     
                     1.   ADMINISTRATIVE INFORMATION
                     
                     1.1.   Family name
                     
                     
                                 Name
                              
                              
                                 INSECTICIDES FOR HOME USE
                              
                           1.2.   Product type(s)
                     
                     
                                 Product type(s)
                              
                              
                                 PT18 – Insecticides, acaricides and products to control other arthropods (Pest control)
                              
                           1.3.   Authorisation holder
                     
                     
                                 Name and address of the authorisation holder
                              
                              
                                 Name
                              
                              
                                 Agrobiothers Laboratoire
                              
                           
                                 Address
                              
                              
                                 ZI Route des Platières, 71290 CUISERY, France
                              
                           
                                 Authorisation number
                              
                              
                                 EU-0021035-0000
                              
                           
                                 
                                    R4BP asset number
                                 
                              
                              
                                 EU-0021035-0000
                              
                           
                                 Date of the authorisation
                              
                              
                                 16 June 2020
                              
                           
                                 Expiry date of the authorisation
                              
                              
                                 31 May 2030
                              
                           1.4.   Manufacturer(s) of the biocidal products
                     
                     
                                 Name of manufacturer
                              
                              
                                 Agrobiothers Laboratoire
                              
                           
                                 Address of manufacturer
                              
                              
                                 ZI Route des Platières, 71290 CUISERY France
                              
                           
                                 Location of manufacturing sites
                              
                              
                                 AF3 16 rue de l’Oberwald, 68360 Soultz France
                              
                           1.5.   Manufacturer(s) of the active substance(s)
                     
                     
                                 Active substance
                              
                              
                                 Permethrin
                              
                           
                                 Name of manufacturer
                              
                              
                                 Tagros Chemicals India Ltd. (Art.95 List: LIMARU NV (Acting for Tagros Chemicals India Private Limited)
                              
                           
                                 Address of manufacturer
                              
                              
                                 Jhaver Centre, Rajah Annamalai Bldg., IV floor 72 Marshal’s road Egmore, 600008 Chennai India
                              
                           
                                 Location of manufacturing sites
                              
                              
                                 A-4/1&2, Sipcot Industrial Complex, Pachayankuppam Cuddalore, 607 005  Tamilnadu India
                              
                           
                        
                     
                                 Active substance
                              
                              
                                 S-Methoprene
                              
                           
                                 Name of manufacturer
                              
                              
                                 Babolna bio Ltd.
                              
                           
                                 Address of manufacturer
                              
                              
                                 Szallas u.6 H-, 1107 Budapest Hungary
                              
                           
                                 Location of manufacturing sites
                              
                              
                                 Szallas u.6 H-, 1107 Budapest Hungary
                              
                           2.   PRODUCT FAMILY COMPOSITION AND FORMULATION
                     
                     2.1.   Qualitative and quantitative information on the composition of the family
                     
                     
                                 Common name
                              
                              
                                 IUPAC name
                              
                              
                                 Function
                              
                              
                                 CAS number
                              
                              
                                 EC number
                              
                              
                                 Content (%)
                              
                           
                                 Min
                              
                              
                                 Max
                              
                           
                                 Permethrin
                              
                              
                                  
                              
                              
                                 Active Substance
                              
                              
                                 52645-53-1
                              
                              
                                 258-067-9
                              
                              
                                 0,177 
                              
                              
                                 0,177 
                              
                           
                                 S-Methoprene
                              
                              
                                  
                              
                              
                                 Active Substance
                              
                              
                                 65733-16-6
                              
                              
                                  
                              
                              
                                 0,00225 
                              
                              
                                 0,00225 
                              
                           
                                 Propan-2-ol
                              
                              
                                 Propan-2-ol
                              
                              
                                 Non-active substance
                              
                              
                                 67-63-0
                              
                              
                                 200-661-7
                              
                              
                                 3,33475 
                              
                              
                                 3,33475 
                              
                           
                                 n-butane
                              
                              
                                 n-butane
                              
                              
                                 Non-active substance
                              
                              
                                 106-97-8
                              
                              
                                 203-448-7
                              
                              
                                 63,458 
                              
                              
                                 63,458 
                              
                           
                                 propane
                              
                              
                                 propane
                              
                              
                                 Non-active substance
                              
                              
                                 74-98-6
                              
                              
                                 200-827-9
                              
                              
                                 16,271 
                              
                              
                                 16,271 
                              
                           
                                 isobutane
                              
                              
                                 isobutane
                              
                              
                                 Non-active substance
                              
                              
                                 75-28-5
                              
                              
                                 200-857-2
                              
                              
                                 4,068 
                              
                              
                                 4,068 
                              
                           2.2.   Type(s) of formulation
                     
                     
                                 Formulation(s)
                              
                              
                                 AE – Aerosol dispenser
                              
                           PART II
                     
                        SECOND INFORMATION LEVEL – META SPC(S)
                     
                     
                        Meta SPC 1
                     
                     1.   META SPC 1 ADMINISTRATIVE INFORMATION
                     
                     1.1.   Meta SPC 1 identifier
                     
                     
                                 Identifier
                              
                              
                                 Meta-SPC1: INSECTICIDE HOUSEHOLD SPRAY
                              
                           1.2.   Suffix to the authorisation number
                     
                     
                                 Number
                              
                              
                                 1-1
                              
                           1.3.   Product type(s)
                     
                     
                                 Product type(s)
                              
                              
                                 PT18 – Insecticides, acaricides and products to control other arthropods (Pest control)
                              
                           2.   META SPC 1 COMPOSITION
                     
                     2.1.   Qualitative and quantitative information on the composition of the meta SPC 1
                     
                     
                                 Common name
                              
                              
                                 IUPAC name
                              
                              
                                 Function
                              
                              
                                 CAS number
                              
                              
                                 EC number
                              
                              
                                 Content (%)
                              
                           
                                 Min
                              
                              
                                 Max
                              
                           
                                 Permethrin
                              
                              
                                  
                              
                              
                                 Active Substance
                              
                              
                                 52645-53-1
                              
                              
                                 258-067-9
                              
                              
                                 0,177 
                              
                              
                                 0,177 
                              
                           
                                 S-Methoprene
                              
                              
                                  
                              
                              
                                 Active Substance
                              
                              
                                 65733-16-6
                              
                              
                                  
                              
                              
                                 0,00225 
                              
                              
                                 0,00225 
                              
                           
                                 Propan-2-ol
                              
                              
                                 Propan-2-ol
                              
                              
                                 Non-active substance
                              
                              
                                 67-63-0
                              
                              
                                 200-661-7
                              
                              
                                 3,33475 
                              
                              
                                 3,33475 
                              
                           
                                 n-butane
                              
                              
                                 n-butane
                              
                              
                                 Non-active substance
                              
                              
                                 106-97-8
                              
                              
                                 203-448-7
                              
                              
                                 63,458 
                              
                              
                                 63,458 
                              
                           
                                 propane
                              
                              
                                 propane
                              
                              
                                 Non-active substance
                              
                              
                                 74-98-6
                              
                              
                                 200-827-9
                              
                              
                                 16,271 
                              
                              
                                 16,271 
                              
                           
                                 isobutane
                              
                              
                                 isobutane
                              
                              
                                 Non-active substance
                              
                              
                                 75-28-5
                              
                              
                                 200-857-2
                              
                              
                                 4,068 
                              
                              
                                 4,068 
                              
                           2.2.   Type(s) of formulation of the meta SPC 1
                     
                     
                                 Formulation(s)
                              
                              
                                 AE – Aerosol dispenser
                              
                           3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
                     
                     
                                 Hazard statements
                              
                              
                                 Extremely flammable aerosol.
                                 Pressurised container: May burst if heated
                                 May be fatal if swallowed and enters airways.
                                 Causes serious eye irritation.
                                 Very toxic to aquatic life with long lasting effects.
                                 Contains PERMETHRIN. May produce an allergic reaction.
                              
                           
                                 Precautionary statements
                              
                              
                                 If medical advice is needed, have product container or label at hand.
                                 Keep out of reach of children.
                                 Read carefully and follow all instructions.
                                 Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.
                                 Do not spray on an open flame or other ignition source.
                                 Do not pierce or burn, even after use.
                                 Wash hands thoroughly after handling.
                                 IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
                                 If eye irritation persists:Get medical advice.
                                 Protect from sunlight.Do not expose at temperatures exceeding 50 °C/122 °F.
                                 Store at temperatures not exceeding 40 °C/104 °F.
                                 Avoid release to the environment.
                                 Collect spillage.
                                 Dispose of contents/container in accordance with local regulation
                              
                           4.   AUTHORISED USE(S) OF THE META SPC 1
                     
                     4.1.   Use description
                     
                     
                        Table 1. Use # 1 – Insecticide household spray
                     
                     
                                 Product type
                              
                              
                                 PT18 – Insecticides, acaricides and products to control other arthropods (Pest control)
                              
                           
                                 Where relevant, an exact description of the authorised use
                              
                              
                                 -
                              
                           
                                 Target organism(s) (including development stage)
                              
                              
                                 Fleas (larvae and adults):
                                 e.g. Ctenocephalides felis
                                 
                                 Ticks:
                                 Ixodes ricinus
                                 Rhipicephalus sanguineus
                              
                           
                                 Field(s) of use
                              
                              
                                 Indoor
                                 Targeted treatment of non-washable furniture and home textile such as carpets, mats, arm chairs
                              
                           
                                 Application method(s)
                              
                              
                                 Spraying
                                 After vacuuming the surface to be treated, the product is sprayed at a distance of 30 cm.
                              
                           
                                 Application rate(s) and frequency
                              
                              
                                 1,3 second spray treat for approximately 1 m2 (2,1 g/m2)
                                 The minimum time interval between two treatments is 6 months.
                              
                           
                                 Category(ies) of users
                              
                              
                                 General public (non-professional)
                              
                           
                                 Pack sizes and packaging material
                              
                              
                                 Tin plate aerosol can with internal coating made of epoxy phenolic protective lacquer (250mL or 500mL)
                                 Tin plate aerosol can without internal coating (300 mL)
                              
                           4.1.1.   Use-specific instructions for use
                     
                     See general directions for use
                     4.1.2.   Use-specific risk mitigation measures
                     
                     See 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 general directions for use
                     4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
                     
                     See general direction 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 general directions for use
                     5.   GENERAL DIRECTIONS FOR USE (1)
                        OF THE META SPC 1
                     
                     5.1.   Instructions for use
                     
                     
                                 —
                              
                              
                                 The product is to be used for targeted treatment of non-washable furniture and home textile as carpets, mats, arm chairs.
                              
                           
                                 —
                              
                              
                                 Always read the label or leaflet before use and respect all the instructions provided.
                              
                           
                                 —
                              
                              
                                 Respect the recommended application doses.
                              
                           
                                 —
                              
                              
                                 Residual efficacy until up to 6 months that can be lowered in case of normal cleaning (e.g. vacuum on carpets) or extensive use of the surfaces (e.g., walking, friction).
                              
                           
                                 —
                              
                              
                                 In case of continuous infestation, use alternate products containing active substances with a different mode of action in order to avoid the occurance of resistance.This is to remove the resistant individuals from the population.
                              
                           
                                 —
                              
                              
                                 If the infestation persists despite following the instructions of the label/leaflet, contact a pest control professional.
                              
                           
                                 —
                              
                              
                                 Do not use on cats and other animals or pet baskets for cats.
                              
                           
                                 —
                              
                              
                                 Inform the authorisation holder if the treatment is ineffective.
                              
                           5.2.   Risk mitigation measures
                     
                     
                                 —
                              
                              
                                 Do not use on wet washable surfaces and textile.
                              
                           
                                 —
                              
                              
                                 Do not wash furniture with wet wiping clothes and do not wet clean carpets or mats to avoid discharges into the sewer system.
                              
                           
                                 —
                              
                              
                                 Remove all food, feed and drinks prior treatment.
                              
                           
                                 —
                              
                              
                                 Do no use on surfaces and facilities in the vicinity or likely to be in contact with food, feed and drinks.
                              
                           
                                 —
                              
                              
                                 Avoid contact with eyes.
                              
                           
                                 —
                              
                              
                                 After spraying, leave the room and let act for 1 hour before airing.
                              
                           
                                 —
                              
                              
                                 Remove or cover terrariums, aquariums and animal cages before application.
                              
                           
                                 —
                              
                              
                                 Turn off aquarium air-filter while spraying.
                              
                           
                                 —
                              
                              
                                 Keep cats away from treated surfaces. Due to their particular sensitivity to permethrin, the product can cause severe adverse reactions in cats.
                              
                           
                                 —
                              
                              
                                 Keep children and pets away during treatment.
                              
                           5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
                     
                     
                                 —
                              
                              
                                 Inhalation: Remove victim to fresh air and keep at rest in a half-sitting position. Seek medical advice immediately if symptoms occur and/or large quantities have been inhaled.
                              
                           
                                 —
                              
                              
                                 Eye contact: Immediately flush with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses if easy to do. Continue to rinse with tepid water for at least 10 minutes. Get medical attention if irritation or vision impairment occurs.
                              
                           
                                 —
                              
                              
                                 Skin contact: Remove contaminated clothing and shoes. Wash contaminated skin with water. Contact poison treatment specialist if symptoms occur.
                              
                           
                                 —
                              
                              
                                 Mouth contact: Wash out mouth with water. Contact poison treatment specialist immediately if symptoms occur and/or in case of mouth contact with large quantities.
                              
                           
                                 —
                              
                              
                                 Do not give fluids or induce vomiting in case of impaired consciousness; place in recovery position and seek medical advice immediately.
                              
                           
                                 —
                              
                              
                                 Keep the container or label available.
                              
                           
                                 —
                              
                              
                                 Permethrin may be dangerous for cats. If signs of poisoning occur, seek veterinary advice immediately and show the package to a veterinarian.
                              
                           
                                 —
                              
                              
                                 Pyrethroids may cause paresthesia (burning and prickling of the skin without irritation). If symptoms persist: Get medical advice.
                              
                           5.4.   Instructions for safe disposal of the product and its packaging
                     
                     
                                 —
                              
                              
                                 Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains.
                              
                           
                                 —
                              
                              
                                 Dispose of unused product, its packaging and all other waste, in accordance with local regulations.
                              
                           5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage
                     
                     
                                 —
                              
                              
                                 Shelf-life: 24 months
                              
                           
                                 —
                              
                              
                                 Do not store at a temperature higher than 40 °C
                              
                           
                                 —
                              
                              
                                 Do not expose to direct sunlight
                              
                           
                                 —
                              
                              
                                 Protect from frost
                              
                           6.   OTHER INFORMATION
                     
                     7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1
                     
                     7.1.   Trade name(s), authorisation number and specific composition of each individual product
                     
                     
                                 Trade name(s)
                              
                              
                                 FRONTLINE PET CARE SPRAY INSECTICIDE ET ACARICIDE POUR L’HABITAT
                                 SPRAY ANTIPARASITAIRE POUR L’HABITAT 300 ML FRISKIES
                                 INSECTICIDE HABITAT/HOME VETOCANIS
                                 FRONTLINE HOMEGARD SPRAY INSECTICIDE ET ACARICIDE POUR L’HABITAT
                                 INSECTICIDE HABITAT/HOME VITALVETO
                                 SPRAY INSECTICIDE POUR L’HABITAT VITALVETO/INSECTICIDE HOUSEHOLD
                                 SPRAY VITALVETO
                                 SPRAY INSECTICIDE POUR L’HABITAT VETOCANIS/INSECTICIDE HOUSEHOLD
                                 SPRAY VETOCANIS
                                 FRONTLINE HOMEGARD Husholdningsspray med insekticid og acaricid
                                 FRONTLINE HOMEGARD Insecticide and acaricide household spray
                                 FRONTLINE HOMEGARD Hyönteisten ja punkkien torjuntasuihke kotitalouksille
                                 FRONTLINE HOMEGARD insektizides und akarizides Haushaltsspray
                                 FRONTLINE HOMEGARD Spray Εντομοκτόνο και ακαρεοκτόνο σπρέι οικιακής χρήσης
                                 FRONTLINE HOMEGARD Spray insetticida e acaricida per l’ambiente domestico
                                 FRONTLINE HOMEGARD Insecticide en acaricidespray voor huishoudelijk gebruik
                                 FRONTLINE HOMEGARD Husholdningsspray med insekticid og acaricid
                                 FRONTLINE HOMEGARD INSETICIDA E ACARICIDA EM SPRAY PARA USO DOMÉSTICO
                                 FRONTLINE HOMEGARD Hushållspray med insekticid och akaricid
                              
                           
                                 Authorisation number
                              
                              
                                 EU-0021035-0001 1-1
                              
                           
                                 Common name
                              
                              
                                 IUPAC name
                              
                              
                                 Function
                              
                              
                                 CAS number
                              
                              
                                 EC number
                              
                              
                                 Content (%)
                              
                           
                                 Permethrin
                              
                              
                                  
                              
                              
                                 Active Substance
                              
                              
                                 52645-53-1
                              
                              
                                 258-067-9
                              
                              
                                 0,177 
                              
                           
                                 S-Methoprene
                              
                              
                                  
                              
                              
                                 Active Substance
                              
                              
                                 65733-16-6
                              
                              
                                  
                              
                              
                                 0,00225 
                              
                           
                                 Propan-2-ol
                              
                              
                                 Propan-2-ol
                              
                              
                                 Non-active substance
                              
                              
                                 67-63-0
                              
                              
                                 200-661-7
                              
                              
                                 3,33475 
                              
                           
                                 n-butane
                              
                              
                                 n-butane
                              
                              
                                 Non-active substance
                              
                              
                                 106-97-8
                              
                              
                                 203-448-7
                              
                              
                                 63,458 
                              
                           
                                 propane
                              
                              
                                 propane
                              
                              
                                 Non-active substance
                              
                              
                                 74-98-6
                              
                              
                                 200-827-9
                              
                              
                                 16,271 
                              
                           
                                 isobutane
                              
                              
                                 isobutane
                              
                              
                                 Non-active substance
                              
                              
                                 75-28-5
                              
                              
                                 200-857-2
                              
                              
                                 4,068 
                              
                           
               ’
            
               (1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1.