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)

• CELEX: Implementing Regulation (EU) 2020/704
• Articles: 4

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 .

Schedules & Appendices

ANNEX I

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

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 m 2 (2,1 g/m 2 )

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 (250 mL or 500 mL)

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 occurrence 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 one 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

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.