Document ID: 02021R1044-20221229
Language: ENG

02021R1044 — EN — 29.12.2022 — 001.001
This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document
<table><col/><col/><tr><td><p><a>&#9658;B</a></p></td><td><p>                        COMMISSION IMPLEMENTING REGULATION (EU) 2021/1044</p><p>of 22&#160;June 2021</p><p>granting a Union authorisation for the single biocidal product &#8216;Pesguard&#174; Gel&#8217;</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 225 25.6.2021, p. 54)</p></td></tr></table>
Amended by:
<table><col/><col/><col/><col/><col/><tr><td><p>&#160;</p></td><td><p>&#160;</p></td><td><p>Official Journal</p></td></tr><tr><td><p>&#160;&#160;No</p></td><td><p>page</p></td><td><p>date</p></td></tr><tr><td><p><a>&#9658;M1</a></p></td><td><p><a>                              COMMISSION IMPLEMENTING REGULATION (EU) 2022/2405&#160;of 7&#160;December 2022</a></p></td><td><p>&#160;&#160;L&#160;317</p></td><td><p>54</p></td><td><p>9.12.2022</p></td></tr></table>
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 18 – Insecticides, acaricides and products to control other arthropods (Pest control)
Authorisation number: EU-0024951-0000
R4BP asset number: EU-0024951-0000
1. ADMINISTRATIVE INFORMATION
1.1. Trade name(s) of the product
<table><col/><col/><tbody><tr><td><p>Trade name(s)</p></td><td><p>Pesguard&#174; Gel</p></td></tr></tbody></table>
1.2. Authorisation holder
<table><col/><col/><col/><tbody><tr><td><p>Name and address of the authorisation holder</p></td><td><p>Name</p></td><td><p>Sumitomo Chemical Agro Europe SAS</p></td></tr><tr><td><p>Address</p></td><td><p>Parc d&#8217;Affaires de Cr&#233;cy 10A, rue de la Voie Lact&#233;e, 69370 Saint Didier au Mont d&#8217;Or, France</p></td></tr><tr><td><p>Authorisation number</p></td><td><p>EU-0024951-0000</p></td></tr><tr><td><p><span>R4BP asset number</span></p></td><td><p>EU-0024951-0000</p></td></tr><tr><td><p>Date of the authorisation</p></td><td><p>15&#160;July 2021</p></td></tr><tr><td><p>Expiry date of the authorisation</p></td><td><p><span><a><span>&#9658;M1</span></a></span>&#160;30&#160;June 2026<span>&#160;&#9668;</span></p></td></tr></tbody></table>
1.3. Manufacturer(s) of the product
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>McLaughlin Gormley King Company (MGK)</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>8810 10th Avenue North, MN 55427 Minneapolis United States</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>McLaughlin Gormley King Company, 4001  Peavey Road, MN 55318 Chaska United States</p></td></tr></tbody></table>
1.4. Manufacturer(s) of the active substance(s)
<table><col/><col/><tbody><tr><td><p>Active substance</p></td><td><p>(E)-1-(2-Chloro-1,3-thiazol-5-ylmethyl)-3- methyl-2-nitroguanidine (Clothianidin)</p></td></tr><tr><td><p>Name of manufacturer</p></td><td><p>Sumitomo Chemical Co. Ltd</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>27-1, Shinkawa 2-chome, Chuo-ku, 104-8260 Tokyo Japan</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Sumitomo Chemical Company LTD, Oita Works, 2200, Tsurusaki, Oita City&#8222; 870-0106 Oita Japan</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Active substance</p></td><td><p>pyriproxyfen</p></td></tr><tr><td><p>Name of manufacturer</p></td><td><p>Sumitomo Chemical Co. Ltd</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>27-1, Shinkawa 2-chome, Chuo-ku, 104-8260 Tokyo Japan</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Sumitomo Chemical Company LTD, Misawa Works, Aza-Sabishirotaira, Oaza-Misawa, Misawa&#8222; 033-0022 Aomori Japan</p></td></tr></tbody></table>
2. PRODUCT COMPOSITION AND FORMULATION
2.1. Qualitative and quantitative information on the composition of the product
<table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Clothianidin</p></td><td><p>(E)-1-(2-Chloro-1,3-thiazol-5-ylmethyl)-3- methyl-2-nitroguanidine</p></td><td><p>Active Substance</p></td><td><p>210880-92-5</p></td><td><p>433-460-1</p></td><td><p>0,526</p></td></tr><tr><td><p>pyriproxyfen</p></td><td><p>4-phenoxyphenyl (RS)-2-(2- pyridyloxy)propyl ether</p></td><td><p>Active Substance</p></td><td><p>95737-68-1</p></td><td><p>429-800-1</p></td><td><p>0,515</p></td></tr><tr><td><p>Acetic acid</p></td><td><p>Ethanoic acid</p></td><td><p>Non-active substance</p></td><td><p>64-19-7</p></td><td><p>200-580-7</p></td><td><p>0,3</p></td></tr><tr><td><p>Potassium sorbate</p></td><td><p>potassium (E,E)-hexa-2,4-dienoate</p></td><td><p>Non-active substance</p></td><td><p>24634-61-5</p></td><td><p>246-376-1</p></td><td><p>0,5</p></td></tr></tbody></table>
2.2. Type of formulation
RB – Bait (ready for use)
3. HAZARD AND PRECAUTIONARY STATEMENTS
<table><col/><col/><tbody><tr><td><p>Hazard statements</p></td><td><p>May cause an allergic skin reaction.</p><p>Very toxic to aquatic life with long lasting effects.</p></td></tr><tr><td><p>Precautionary statements</p></td><td><p>IF ON SKIN:Wash with plenty of water.</p><p>If skin irritation or rash occurs: Get medical advice.</p><p>Wear protective gloves.</p><p>Avoid release to the environment.</p><p>Dispose of container in accordance with local regulations.</p><p>Collect spillage.</p></td></tr></tbody></table>
4. AUTHORISED USE(S)
4.1. Use description
Table 1. Use # 1 – Professional Use – RTU Bait
<table><col/><col/><tbody><tr><td><p>Product type</p></td><td><p>PT18 &#8211; Insecticides, acaricides and products to control other arthropods (Pest control)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>Insecticide</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Scientific name: Blattella germanica</p><p>Common name: German cockroach</p><p>Development stage: Nymphs</p><p>Scientific name: Blattella germanica</p><p>Common name: German cockroach</p><p>Development stage: Adults</p><p>Scientific name: Supella longipalpa</p><p>Common name: Brown-banded cockroach</p><p>Development stage: Nymphs</p><p>Scientific name: Supella longipalpa</p><p>Common name: Brown-banded cockroach</p><p>Development stage: Adults</p><p>Scientific name: Blatta orientalis</p><p>Common name: Oriental Cockroach</p><p>Development stage: Nymphs</p><p>Scientific name: Blatta orientalis</p><p>Common name: Oriental Cockroach</p><p>Development stage: Adults</p><p>Scientific name: Periplaneta americana</p><p>Common name: American Cockroach</p><p>Development stage: Nymphs</p><p>Scientific name: Periplaneta americana</p><p>Common name: American Cockroach</p><p>Development stage: Adults</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>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.</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Bait application</p><p>A ready to use (RTU) insecticidal gel bait for the control of cockroaches in public hygiene</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>Pesguard&#174; Gel should be applied as a number of spots of approximately 4 mm diameter (each spot comprising approximately 0,032&#160;g of bait).</p><p>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 m<span>2</span> in case of a light infestation) should be used.</p><div>Light infestation 1 &#8211; 2 (0,032 &#8211; 0,064&#160;g) spots per m<span>2</span></div><div>Medium infestation 3 &#8211; 6 (0,096 &#8211; 0,192&#160;g) spots per m<span>2</span></div><div>Heavy infestation 6 &#8211; 10 (0,192 &#8211; 0,320&#160;g) spots per m<span>2</span></div><p>The maximum number of annual applications is 11.</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Professional</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>30 g Polypropylene (PP) syringe</p><p>Screw top cap High Density Poly Ethylene (HDPE)</p></td></tr></tbody></table>
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 not be applied to areas accessible 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 area’s 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 to 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
<note>
( 1 ) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.
</note>