Mheas an Fhrainc go bhfuil gá le tástáil chéim 2 chéim 1 agus tástáil úsáide ionsamhlaithe araon, de réir Threoir na Gníomhaireachta Eorpaí Ceimiceán (ECHA) maidir le Rialachán na dTáirgí Bithicídeacha.
France considered that, according to the European Chemicals Agency (ECHA) Guidance on the Biocidal Products Regulation, both a phase 2 step 1 test and a simulated-use test are required.
Treoir ECHA maidir le Rialachán na dTáirgí Bithicídeacha, Imleabhar II, Éifeachtúlacht - Measúnú agus Meastóireacht (Codanna B+C), leagan 3.0 ó mhí Aibreán 2018950efefa-f2bf-0b4a-a3fd-41c86daae468 (europa.eu)
ECHA Guidance on the Biocidal Products Regulation, Volume II, Efficacy – Assessment and Evaluation (Parts B+C), version 3.0 of April 2018950efefa-f2bf-0b4a-a3fd-41c86daae468 (europa.eu)
Assessment and Evaluation, Version 5.0, November 2022 [Treoraíocht na Gníomhaireachta Eorpaí Ceimiceán maidir le Rialachán na dTáirgí Bithicídeacha, Imleabhar II: Éifeachtúlacht, Ranna B + C: Measúnú agus Meastóireacht, Leagan 5,0, Samhain 2022].
Efficacy, Parts B+C: Assessment and Evaluation, Version 5.0, November 2022.
gníomhaíochtaí tacaíochta le haghaidh chur chun feidhme Rialachán (CE) Uimh. 1907/2006 ó Pharlaimint na hEorpa agus ón gComhairle [2] (REACH) agus Rialachán (AE) Uimh. 528/2012 ó Pharlaimint na hEorpa agus ón gComhairle [3] (Rialachán na dTáirgí Bithicídeacha) chun úsáid níos sábháilte, níos inbhuanaithe nó níos tíosaí de cheimiceáin a áirithiú (lena n-áirítear nana-ábhair);
support activities for the implementation of Regulation (EC) No 1907/2006 of the European Parliament and of the Council [2] (REACH) and Regulation (EU) No 528/2012 of the European Parliament and of the Council [3] (Biocidal Products Regulation) to ensure a safer, more sustainable or economical use of chemicals (including nanomaterials);
Sa tástáil um chobhsaíocht stórála comhthimpeallaí fadtéarmaí, tabharfar aghaidh ar airíonna ábhartha fisiceacha, ceimiceacha agus teicniúla an táirge sin idir roimh an stóráil agus ina diaidh, i gcomhréir le roinn 2.6.4 de Guidance on the Biocidal Products Regulation Volume I: Identity of the active substance/physico-chemical properties/analytical methodology – Information Requirements, Evaluation and Assessment (ECHA, March 2022) [Treoraíocht maidir le Rialachán na dTáirgí Bithicídeacha Imleabhar I: Aitheantas na substainte gníomhaí/na n-airíonna fisiciceimiceacha/na modheolaíochta anailísí (ECHA, Márta 2022)], chun seilfré 24 mhí a dheimhniú.
The long-term ambient storage stability test shall address the relevant physical, chemical and technical properties of that product both prior to and after storage in accordance with section 2.6.4 of the Guidance on the Biocidal Products Regulation Volume I: Identity of the active substance/physico-chemical properties/analytical methodology – Information Requirements, Evaluation and Assessment (ECHA, March 2022), in order to confirm a shelf life of 24 months.
Sa tástáil um chobhsaíocht stórála comhthimpeallaí fadtéarmaí, tabharfar aghaidh ar airíonna ábhartha fisiceacha, ceimiceacha agus teicniúla na dtáirgí sin idir roimh an stóráil agus ina diaidh, i gcomhréir le roinn 2.6.4 de Guidance on the Biocidal Products Regulation Volume I: Identity of the active substance/physico-chemical properties/analytical methodology – Information Requirements, Evaluation and Assessment (ECHA, March 2022) [Treoraíocht maidir le Rialachán na dTáirgí Bithicídeacha Imleabhar I: Aitheantas na substainte gníomhaí/na n-airíonna fisiciceimiceacha/na modheolaíochta anailísí (ECHA, Márta 2022)], chun seilfré 24 mhí a dheimhniú.
The long-term ambient storage stability test shall address the relevant physical, chemical and technical properties of the products both prior to and after storage in accordance with section 2.6.4 of the Guidance on the Biocidal Products Regulation Volume I: Identity of the active substance/physico-chemical properties/analytical methodology – Information Requirements, Evaluation and Assessment (ECHA, March 2022), in order to confirm a shelf life of 24 months.
An Ghníomhaireacht Eorpach Ceimiceán, Guidance on the Biocidal Products Regulation, Volume II Efficacy — Assessment and Evaluation (Parts B+C) [Treoraíocht maidir le Rialachán na dTáirgí Bithicídeacha, Imleabhar II Éifeachtúlacht - Measúnú agus Meastóireacht (Codanna B+C)], Leagan 3.0, Aibreán 2018 https://echa.europa.eu/documents/10162/23036412/bpr_guidance_assessment_evaluation_part_vol_ii_part_bc_en.pdf/950efefa-f2bf-0b4a-a3fd-41c86daae468
European Chemicals Agency, Guidance on the Biocidal Products Regulation, Volume II Efficacy - Assessment and Evaluation (Parts B+C), Version 3.0, April 2018 https://echa.europa.eu/documents/10162/23036412/bpr_guidance_assessment_evaluation_part_vol_ii_part_bc_en.pdf/950efefa-f2bf-0b4a-a3fd-41c86daae468
An Ghníomhaireacht Eorpach Ceimiceán, Guidance on the Biocidal Products Regulation, Volume II Efficacy - Assessment and Evaluation (Parts B+C) [Treoraíocht maidir le Rialachán na dTáirgí Bithicídeacha Imleabhar II Éifeachtúlacht - Measúnú agus Meastóireacht (Codanna B+C)], Leagan 5.0, Samhain 2022 https://echa.europa.eu/documents/10162/2324906/bpr_guidance_assessment_evaluation_part_vol_ii_part_bc_en.pdf/ae2e9a18-82ee-2340-9354-d82913543fb9?t=1667389376408
European Chemicals Agency, Guidance on the Biocidal Products Regulation, Volume II Efficacy - Assessment and Evaluation (Parts B+C), Version 5.0, November 2022 https://echa.europa.eu/documents/10162/2324906/bpr_guidance_assessment_evaluation_part_vol_ii_part_bc_en.pdf/ae2e9a18-82ee-2340-9354-d82913543fb9?t=1667389376408
Sainmhínítear na haicmí úsáide a dtugtar tuairisc orthu in EN 335:2013 i dtéarmaí coinníollacha seirbhíse, agus tagairt á déanamh do chion taise ghinearálaithe agus na hoibreáin bhitheolaíocha mheathlaithe a bhíonn ann de ghnáth (ECHA Guidance on the Biocidal Products Regulation, Volume II: Efficacy, Parts B+C: Assessment and Evaluation, Version 5.0, November 2022 [Treoraíocht na Gníomhaireachta Eorpaí Ceimiceán maidir le Rialachán na dTáirgí Bithicídeacha, Imleabhar II: Éifeachtúlacht, Ranna B + C: Measúnú agus Meastóireacht, Leagan 5.0, Samhain 2022]).
The use classes described in EN 335:2013 are defined in terms of service conditions, with reference to the generalised moisture content and the prevailing biological agents of deterioration (ECHA Guidance on the Biocidal Products Regulation, Volume II: Efficacy, Parts B+C: Assessment and Evaluation, Version 5.0, November 2022).
Chun críoch na gceisteanna sin, liostaítear i dtábla 1 na húsáidí sainaitheanta a shonraítear maidir leis an iarratas dá dtagraítear in Airteagal 23(3), pointe (a), de Rialachán (AE) Uimh. 528/2012 (‘Rialachán na dTáirgí Bithicídeacha’).
For the purpose of those questions, the identified uses specified for the application referred to in Article 23(3), point (a), of Regulation (EU) No 528/2012 (‘the BPR’) are listed in Table 1.
Níl éifeachtaí do-ghlactha ag baint leis na substaintí gníomhacha malartacha a shainaithnítear i gceist (a) ar sprioc-orgánaigh dhíobhálacha, go háirithe friotaíocht nó trasfhriotaíocht dho-ghlactha, toisc gur critéar é sin chun substaint ghníomhach a fhormheas, dá bhforáiltear in Airteagal 4(1) agus in Airteagal 19(1), pointe (b)(ii), de Rialachán na dTáirgí Bithicídeacha.
The alternative active substances identified in question (a) do not have unacceptable effects on target harmful organisms, in particular unacceptable resistance or cross-resistance, as this is a criterion for approving an active substance, as provided by Article 4(1) and Article 19(1), point (b)(ii), of the BPR.
Sna táirgí údaraithe a shainaithnítear faoi cheist (b) tá substaintí gníomhacha formheasta a mheastar a bheith éifeachtach le haghaidh na n-úsáidí sonraithe, ós rud é gur gá iad a bheith éifeachtach go leor mar chritéar chun údarú a dheonú in Airteagal 19(1), pointe (b)(i) de Rialachán na dTáirgí Bithicídeacha.
The authorised products identified under question (b) contain approved active substances that are considered effective for the specified uses, as being sufficiently effective is a criterion for granting an authorisation in Article 19(1), point (b)(i), of the BPR.
UmweltbundesamtAn 1 Nollaig 2021 ghlac an Coiste um Tháirgí Bithicídeacha tuairim lena gcinntear gurb ionann na critéir chun éifeachtúlacht creimiricídí antaithéachtacha a chinneadh, mar a thuairiscítear sa treoraíocht ó Rialachán na dTáirgí Bithicídeacha a bhaineann le Rialachán (AE) Uimh. 528/2012, agus na critéir a luaitear i dtreoraíocht NoCheRo, Le fáil ag: ECHA opinion on questions regarding the guidance on rodent traps [Tuairim ón nGníomhaireacht Eorpach Ceimiceán maidir le ceisteanna faoin treoraíocht i ndáil le gaistí creimirí]
UmweltbundesamtOn 1 December 2021, the Biocidal Products Committee adopted an opinion concluding that the criteria for determining the efficacy of anticoagulant rodenticides as described in the BPR guidance related to Regulation (EU) No 528/2012 are the same as the ones mentioned in the NoCheRo-Guidance.
Chun tacú lena seasamh, rinne an Ísiltír tagairt don Guidance on the Biocidal Products Regulation Volume II Efficacy — Assessment and Evaluation (Parts B+C) [Treoraíocht maidir le Rialachán na dTáirgí Bithicídeacha Imleabhar II Éifeachtúlacht - Measúnú agus Meastóireacht (Codanna B+C)] (‘an treoraíocht éifeachtúlachta’) ón nGníomhaireacht Eorpach Ceimiceán, leagan Aibreán 2018, ina dtugtar le fios i gcaibidil 5.4.3.1 di maidir le táirgí bithicídeacha a úsáidtear le haghaidh díghalrú ginearálta dromchlaí i réimse na míochaine (cleachtais leighis, ospidéil) agus le haghaidh díghalrú dromchlaí i gcleachtais tréidliachta a bhaineann le scrúdú agus obráid/cóireáil a dhéanamh ar na hainmhithe, go sanntar na táirgí sin do chineál táirge 2, ach maidir le táirgí chun críoch sonrach sláinteachais tréidliachta (e.g. táirgí a ndéantar maíomh sonrach ina leith maidir le spriocorgánach nach bhfuil ábhartha ach i réimse na tréidliachta), go meastar go mbaineann na táirgí sin le cineál táirge 3.
To support their position, the Netherlands referred to the Guidance on the Biocidal Products Regulation Volume II Efficacy - Assessment and Evaluation (Parts B+C) (‘the efficacy guidance’) of the European Chemicals Agency, version of April 2018, which indicates in its chapter 5.4.3.1 that biocidal products applied for general disinfection of surfaces in the medical area (medical practices, hospitals) as well as of surfaces in veterinary practices associated with examination and operation/treatment of the animals are assigned to product-type 2, whereas products for specific veterinary hygiene purposes (e.g. products with specific claims against a target organism only relevant in the veterinary area) are considered to be in product-type 3.