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Commission Implementing Regulation (EU) 2021/1044 of 22 June 2021 granting a Union authorisation for the single biocidal product Pesguard® Gel (Text with EEA relevance)

Commission Implementing Regulation (EU) 2021/1044 of 22 June 2021 granting a Union authorisation for the single biocidal product Pesguard® Gel (Text with EEA relevance)

Article 1

A Union authorisation with authorisation number EU-0024951-0000 is granted to Sumitomo Chemical Agro Europe SAS for the making available on the market and use of the single biocidal product ‘Pesguard® Gel’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 15 July 2021 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.

ANNEX

SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT

Pesguard® Gel

Product type(s)

PT18: Insecticides, acaricides and products to control other arthropods

Authorisation number: EU-0024951-0000

R4BP asset number: EU-0024951-0000

1. ADMINISTRATIVE INFORMATION

1.1. Trade name(s) of the product

Trade name(s)

Pesguard® Gel

GOLIATH®GEL NEW

1.2. Authorisation holder

Name and address of the authorisation holder

Name

Sumitomo Chemical Agro Europe SAS

Address

10A, rue de la Voie Lactée, 69370 Saint Didier au Mont d’Or, France

Authorisation number

EU-0024951-0000

R4BP asset number

EU-0024951-0000

Date of the authorisation

25 September 2024

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 (the)

Location of manufacturing sites

McLaughlin Gormley King Company, 4001 Peavey Road, MN 55318, Chaska, United States (the)

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

7-1, Nihonbashi 2-chome, Chuo-ku 103-6020 Tokyo, Japan

Location of manufacturing sites

Sumitomo Chemical Company LTD, Oita Works, 2200, Tsurusaki, Oita City, 870-0106 Oita, Japan

Jiangsu Flag Chemical Industry Co., Ltd., No. 309, Changfenghe Road, Nanjing Chemical, Industry Park 210047 Nanjing, China

Active substance

pyriproxyfen

Name of manufacturer

Sumitomo Chemical Co. Ltd.

Address of manufacturer

7-1, Nihonbashi 2-chome, Chuo-ku 103-6020 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(s) of formulation

RB Bait (ready for use)

3. HAZARD AND PRECAUTIONARY STATEMENTS

Hazard statements

H317: May cause an allergic skin reaction.

H410: Very toxic to aquatic life with long lasting effects.

Precautionary statements

P302 + P352: IF ON SKIN: Wash with plenty of water.

P333 + P313: If skin irritation or rash occurs: Get medical advice.

P280: Wear protective gloves.

P273: Avoid release to the environment.

P501: Dispose of container to ..... in accordance with local regulations.

P391: Collect spillage.

4. AUTHORISED USE(S)

4.1. Use description

Table 1

Professional Use – RTU Bait

Product type

PT18: Insecticides, acaricides and products to control other arthropods

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 use

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: Pesguard® Gel should be applied as a number of spots of approximately 4 mm diameter (each spot comprising approximately 0,032 g of bait).

Dilution (%): 0

Number and timing of application:

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.

  • 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 Pesguard® Gel 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 Pesguard® Gel 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 Pesguard Gel. 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 areas should be visually inspected after 1–2 weeks. Where initial infestation was heavy a second Pesguard® Gel 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 areas 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.

Likely direct or indirect effects

No adverse effects expected when used as directed.

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