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Dokument 02020R0704-20211221
Commission Implementing Regulation (EU) 2020/704 of 26 May 2020 granting a Union authorisation for the biocidal product family INSECTICIDES FOR HOME USE (Text with EEA relevance)
Konsolidierter Text: Commission Implementing Regulation (EU) 2020/704 of 26 May 2020 granting a Union authorisation for the biocidal product family INSECTICIDES FOR HOME USE (Text with EEA relevance)
Commission Implementing Regulation (EU) 2020/704 of 26 May 2020 granting a Union authorisation for the biocidal product family INSECTICIDES FOR HOME USE (Text with EEA relevance)
02020R0704 — EN — 21.12.2021 — 001.001
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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) |
Amended by:
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Official Journal |
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No |
page |
date |
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COMMISSION IMPLEMENTING REGULATION (EU) 2021/2109 of 30 November 2021 |
L 429 |
99 |
1.12.2021 |
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COMMISSION IMPLEMENTING REGULATION (EU) 2020/704
of 26 May 2020
granting a Union authorisation for the biocidal product family ‘INSECTICIDES FOR HOME USE’
(Text with EEA relevance)
Article 1
A Union authorisation with authorisation number EU-0021035-0000 is granted to Agrobiothers Laboratoire for the making available on the market and use of the biocidal product family ‘INSECTICIDES FOR HOME USE’ subject to compliance with the terms and conditions set out in Annex I and in accordance with the summary of the biocidal product characteristics set out in Annex II.
The Union authorisation is valid from 16 June 2020 until 31 May 2030.
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.
ANNEX I
Terms and conditions (EU-0021035-0000)
The authorisation holder shall conduct a shelf life study of INSECTICIDE HOUSEHOLD SPRAY in packagings in which the product will be made available on the market. The study shall determine the active substance contents, the cis/trans ratio of permethrin, the spray pattern, the functioning of the trigger device, the discharge rate and the mass median aerodynamic diameter, before and after storage.
By 16 December 2022 the authorisation holder shall submit the results of the study to the Agency.
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
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Name |
INSECTICIDES FOR HOME USE |
1.2. Product type(s)
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Product type(s) |
PT18 – Insecticides, acaricides and products to control other arthropods (Pest control) |
1.3. Authorisation holder
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Name and address of the authorisation holder |
Name |
Agrobiothers Laboratoire |
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Address |
ZI Route des Platières, 71290 CUISERY, France |
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Authorisation number |
EU-0021035-0000 |
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R4BP asset number |
EU-0021035-0000 |
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Date of the authorisation |
16 June 2020 |
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Expiry date of the authorisation |
31 May 2030 |
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1.4. Manufacturer(s) of the biocidal products
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Name of manufacturer |
Agrobiothers Laboratoire |
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Address of manufacturer |
ZI Route des Platières, 71290 CUISERY France |
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Location of manufacturing sites |
AF3 16 rue de l’Oberwald, 68360 Soultz France |
1.5. Manufacturer(s) of the active substance(s)
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Active substance |
Permethrin |
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Name of manufacturer |
Tagros Chemicals India Ltd. (Art.95 List: LIMARU NV (Acting for Tagros Chemicals India Private Limited) |
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Address of manufacturer |
Jhaver Centre, Rajah Annamalai Bldg., IV floor 72 Marshal’s road Egmore, 600008 Chennai India |
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Location of manufacturing sites |
A-4/1&2, Sipcot Industrial Complex, Pachayankuppam Cuddalore, 607 005 Tamilnadu India |
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Active substance |
S-Methoprene |
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Name of manufacturer |
Babolna bio Ltd. |
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Address of manufacturer |
Szallas u.6 H-, 1107 Budapest Hungary |
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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
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Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
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Min |
Max |
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Permethrin |
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Active Substance |
52645-53-1 |
258-067-9 |
0,177 |
0,177 |
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S-Methoprene |
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Active Substance |
65733-16-6 |
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0,00225 |
0,00225 |
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Propan-2-ol |
Propan-2-ol |
Non-active substance |
67-63-0 |
200-661-7 |
3,33475 |
3,33475 |
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n-butane |
n-butane |
Non-active substance |
106-97-8 |
203-448-7 |
63,458 |
63,458 |
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propane |
propane |
Non-active substance |
74-98-6 |
200-827-9 |
16,271 |
16,271 |
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isobutane |
isobutane |
Non-active substance |
75-28-5 |
200-857-2 |
4,068 |
4,068 |
2.2. Type(s) of formulation
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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
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Identifier |
Meta-SPC1: INSECTICIDE HOUSEHOLD SPRAY |
1.2. Suffix to the authorisation number
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Number |
1-1 |
1.3. Product type(s)
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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
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Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
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Min |
Max |
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Permethrin |
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Active Substance |
52645-53-1 |
258-067-9 |
0,177 |
0,177 |
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S-Methoprene |
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Active Substance |
65733-16-6 |
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0,00225 |
0,00225 |
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Propan-2-ol |
Propan-2-ol |
Non-active substance |
67-63-0 |
200-661-7 |
3,33475 |
3,33475 |
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n-butane |
n-butane |
Non-active substance |
106-97-8 |
203-448-7 |
63,458 |
63,458 |
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propane |
propane |
Non-active substance |
74-98-6 |
200-827-9 |
16,271 |
16,271 |
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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
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Formulation(s) |
AE – Aerosol dispenser |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
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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. |
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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
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Product type |
PT18 – Insecticides, acaricides and products to control other arthropods (Pest control) |
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Where relevant, an exact description of the authorised use |
- |
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Target organism(s) (including development stage) |
Fleas (larvae and adults): e.g. Ctenocephalides felis Ticks: Ixodes ricinus Rhipicephalus sanguineus |
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Field(s) of use |
Indoor Targeted treatment of non-washable furniture and home textile such as carpets, mats, arm chairs |
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Application method(s) |
Spraying After vacuuming the surface to be treated, the product is sprayed at a distance of 30 cm. |
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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. |
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Category(ies) of users |
General public (non-professional) |
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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
5.2. Risk mitigation measures
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
5.4. Instructions for safe disposal of the product and its packaging
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
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
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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 |
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Authorisation number |
EU-0021035-0001 1-1 |
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Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
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Permethrin |
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Active Substance |
52645-53-1 |
258-067-9 |
0,177 |
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S-Methoprene |
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Active Substance |
65733-16-6 |
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0,00225 |
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Propan-2-ol |
Propan-2-ol |
Non-active substance |
67-63-0 |
200-661-7 |
3,33475 |
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n-butane |
n-butane |
Non-active substance |
106-97-8 |
203-448-7 |
63,458 |
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propane |
propane |
Non-active substance |
74-98-6 |
200-827-9 |
16,271 |
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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.