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2024/2492

24.9.2024

RIALACHÁN (AE) 2024/2492 ÓN gCOIMISIÚN

an 23 Meán Fómhair 2024

lena leasaítear Rialachán (CE) Uimh. 440/2008 a mhéid a bhaineann leis na modhanna tástála, chun iad a chur in oiriúint don dul chun cinn teicniúil

(Téacs atá ábhartha maidir le LEE)

TÁ AN COIMISIÚN EORPACH,

Ag féachaint don Chonradh ar Fheidhmiú an Aontais Eorpaigh,

Ag féachaint do Rialachán (CE) Uimh. 1907/2006 ó Pharlaimint na hEorpa agus ón gComhairle an 18 Nollaig 2006 maidir le Clárú, Meastóireacht, Údarú agus Srianadh Ceimiceán (REACH), lena mbunaítear Gníomhaireacht Eorpach Ceimiceán, lena leasaítear Treoir 1999/45/CE agus lena n-aisghairtear Rialachán (CEE) Uimh. 793/93 ón gComhairle agus Rialachán (CE) Uimh. 1488/94 ón gCoimisiún, chomh maith le Treoir 76/769/CEE ón gComhairle agus Treoracha 91/155/CEE, 93/67/CEE, 93/105/CE agus 2000/21/CE (1) ón gCoimisiún, agus go háirithe Airteagal 13(2) de,

De bharr an mhéid seo a leanas:

(1)

San Iarscríbhinn a ghabhann le Rialachán (CE) Uimh. 440/2008 (2) ón gCoimisiún, tá modhanna tástála a aithnítear mar mhodhanna iomchuí chun faisnéis a ghiniúint maidir le hairíonna fisiciceimiceacha, tocsaineolaíocha agus éiceathocsaineolaíocha substaintí chun críocha Rialachán (CE) Uimh. 1907/2006.

(2)

Forbraíonn an Eagraíocht um Chomhar agus Forbairt Eacnamaíochta (ECFE) treoirlínte tástála comhchuibhithe a chomhaontaítear go hidirnáisiúnta le haghaidh ceimiceáin a thástáil chun críoch rialála. Eisíonn ECFE treoirlínte tástála nua leasaithe go rialta, ag cur dul chun cinn eolaíoch sa réimse sin san áireamh.

(3)

D’fhonn Rialachán (CE) Uimh. 440/2008 a choinneáil cothrom le dáta leis an dul chun cinn teicniúil agus chun líon na n-ainmhithe a úsáidtear chun críoch turgnaimh a laghdú, rud atá i gcomhréir freisin le Treoir 2010/63/AE ó Pharlaimint na hEorpa agus ón gComhairle (3), ba cheart seacht modh tástála a chur leis an Iarscríbhinn ar Rialachán (CE) Uimh. 440/2008: aon mhodh tástála nua maidir le hairíonna fisiciceimiceacha bunúsacha (4), aon mhodh tástála nua mar aon le dhá mhodh tástála nuashonraithe chun éifeachtaí ar shláinte an duine a chinneadh, mar atá éifeachtaí a bhaineann le tástálacha in vitro maidir le tocsaineacht imdhíonachta agus íogrú craicinn (5), agus trí mhodh tástála nuashonraithe le haghaidh éiceatocsaineacht a mheasúnú (6).

(4)

Ina theannta sin, d’eisigh ECFE leaganacha ceartaithe nua in 2023 ar na modhanna tástála a leanas a cuireadh san áireamh i Rialachán (CE) Uimh. 440/2008: OECD Test Guideline 125 (7); OECD Test Guideline 316 (8); OECD Test Guideline405 (9); OECD Test Guideline 437 (10); OECD Test Guideline 438 (11); OECD Test Guideline 456 (12); OECD Test Guideline 458 (13); OECD Test Guideline 460 (14); OECD Test Guideline 487 (15); OECD Test Guideline 491 (16); OECD Test Guideline 492 (17); OECD Test Guideline 496 (18); OECD Test Guideline 497 (19); OECD Test Guideline 498 (20). Dá bhrí sin, is iomchuí na leaganacha as dáta de na tuairiscí iomlána ar na modhanna tástála sin a scriosadh ó Chodanna B agus C den Iarscríbhinn ar Rialachán (CE) Uimh. 440/2008.

(5)

Chun ailíniú níos fearr leis an reachtaíocht lena mbaineann a bhaint amach, go háirithe Rialachán (CE) 1272/2008 ó Pharlaimint na hEorpa agus ón gComhairle (21), ba cheart liostú na modhanna tástála ábhartha le haghaidh airíonna fisiciceimiceacha i gCuid 0, Tábla 1, den Iarscríbhinn a ghabhann le Rialachán (CE) Uimh. 440/2008 a athstruchtúrú agus ba cheart na modhanna tástála ábhartha a chur leis: ASTM D4359-90: Standard Test Method for Determining whether a Material Is a Liquid or a Solid; Test for determining fluidity according to section 2.3.4 of Annex A of the Agreement concerning the International Carriage of Dangerous Goods by Road (ADR); Calorimetric test methods according to section 20.3.3.3 of Part II of the UN Manual of Tests and Criteria; DIN 66137-2 – Determination of solid state density – Part 2: Gas pycnometry; ISO 12154 – Determination of density by volumetric displacement – Skeleton density by gas pycnometry; ISO/TR 14187:2020 – Surface chemical analysis –Characterization of nanostructured materials; EN 17199-1:2019 – Workplace exposure - Measurement of dustiness of bulk materials that contain or release respirable NOAA and other respirable particles; EN 15051-1: Workplace exposure – Measurement of the dustiness of bulk materials – Part 1: Requirements and choice of test methods; EN 15051-2: Workplace exposure – Measurement of the dustiness of bulk materials – Part 2: Rotating drum method; EN 15051-3: Workplace exposure – Measurement of the dustiness of bulk materials - Part 3: Continuous drop method; na modhanna tástála a leanas, dá bhforáiltear in Iarscríbhinn I, Cuid 2, de Rialachán (CE) Uimh. 1272/2008 ó Pharlaimint na hEorpa agus ón gComhairle: modh tástála le haghaidh gáis phireafóracha (22); modh tástála le haghaidh éagobhsaíocht cheimiceach (23); modhanna tástála le haghaidh fiuchphointe tosaigh ar leachtanna inadhainte a chinneadh (24); modhanna tástála le haghaidh splancphointe leachtanna inadhainte a chinneadh (25); modh tástála le haghaidh substaintí féin-imoibríocha (26); modhanna tástála le haghaidh sárocsaídí orgánacha (27); modh tástála le haghaidh substaintí atá creimneach do mhiotail (28), agus modhanna tástála le haghaidh pléascáin dhí-íograithe (29).

(6)

Dá bhrí sin, ba cheart Rialachán (CE) Uimh. 440/2008 a leasú dá réir sin.

(7)

Chuathas i gcomhairle leis na páirtithe leasmhara ábhartha maidir leis an leasú atá beartaithe.

(8)

Na bearta dá bhforáiltear sa Rialachán seo, tá siad i gcomhréir leis an tuairim ón gCoiste arna bhunú faoi Airteagal 133(1) de Rialachán (CE) Uimh. 1907/2006,

TAR ÉIS AN RIALACHÁN SEO A GHLACADH:

Airteagal 1

Leasaítear an Iarscríbhinn a ghabhann le Rialachán (CE) Uimh. 440/2008 i gcomhréir leis an Iarscríbhinn a ghabhann leis an Rialachán seo.

Airteagal 2

Tiocfaidh an Rialachán seo i bhfeidhm an fichiú lá tar éis lá a fhoilsithe in Iris Oifigiúil an Aontais Eorpaigh.

Beidh an Rialachán seo ina cheangal go huile agus go hiomlán agus beidh sé infheidhme go díreach i ngach Ballstát.

Arna dhéanamh sa Bhruiséil, an 23 Meán Fómhair 2024.

Thar ceann an Choimisiúin

An tUachtarán

Ursula VON DER LEYEN


(1)   IO L 396, 30.12.2006, lch. 1, ELI: http://data.europa.eu/eli/reg/2006/1907/oj.

(2)  Rialachán (CE) Uimh. 440/2008 ón gCoimisiún an 30 Bealtaine 2008 lena leagtar síos modhanna tástála de bhun Rialachán (CE) Uimh. 1907/2006 ó Pharlaimint na hEorpa agus ón gComhairle maidir le Clárú, Meastóireacht, Údarú agus Srianadh Ceimiceán (REACH) (IO L 142, 31.5.2008, lch. 1, ELI: http://data.europa.eu/eli/reg/2008/440/oj).

(3)  Treoir 2010/63/AE ó Pharlaimint na hEorpa agus ón gComhairle an 22 Meán Fómhair 2010 maidir le cosaint ainmhithe a úsáidtear chun críoch eolaíoch (IO L 276, 20.10.2010, lch. 33, ELI: http://data.europa.eu/eli/dir/2010/63/oj).

(4)  OECD Test Guideline 126: Determination of the Hydrophobicity Index of Nanomaterials Through an Affinity Measurement (2023), https://doi.org/10.1787/ae9c0fd1-en.

(5)  OECD Test Guideline 444A: In Vitro Immunotoxicity: IL-2 Luc Assay (2023) https://doi.org/10.1787/27b10ba3-en; OECD Test Guideline 442C: In Chemico Skin Sensitisation: Assays addressing the Adverse Outcome Pathway key event on covalent binding to proteins (2023) https://doi.org/10.1787/9789264229709-en; OECD Test Guideline 442E: In Vitro Skin Sensitisation: In Vitro Skin Sensitisation assays addressing the Key Event on activation of dendritic cells on the Adverse Outcome Pathway for Skin Sensitisation (2023), https://doi.org/10.1787/9789264264359-en.

(6)  OECD Test Guideline No. 240: Medaka Extended One Generation Reproduction Test (MEOGRT) (2023) https://doi.org/10.1787/9789264242258-en; Sediment-Water Chironomid Toxicity Using Spiked Sediment (2023), https://doi.org/10.1787/9789264070264-en; OECD Test Guideline 219: Sediment-Water Chironomid Toxicity Using Spiked Water (2023) https://doi.org/10.1787/9789264070288-en.

(7)  OECD Test Guideline 125: Nanomaterial Particle Size and Size Distribution of Nanomaterials (2023), https://doi.org/10.1787/af5f9bda-en.

(8)  OECD Test Guideline 316: Phototransformation of Chemicals in Water – Direct Photolysis (2023), https://doi.org/10.1787/9789264067585-en.

(9)  OECD Test Guideline 405: Acute Eye Irritation/Corrosion (2023), https://doi.org/10.1787/9789264185333-en.

(10)  OECD Test Guideline 437: Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage (2023), https://doi.org/10.1787/9789264203846-en.

(11)  OECD Test Guideline 438: Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage (2023), https://doi.org/10.1787/9789264203860-en.

(12)  OECD Test Guideline 456: H295R Steroidogenesis Assay (2023), https://doi.org/10.1787/9789264122642-en.

(13)  OECD Test Guideline 458: Stably Transfected Human Androgen Receptor Transcriptional Activation Assay for Detection of Androgenic Agonist and Antagonist Activity of Chemicals (2023), https://doi.org/10.1787/9789264264366-en.

(14)  OECD, Test Guideline 460: Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe Irritants (2023), https://doi.org/10.1787/9789264185401-en.

(15)  OECD Test Guideline 487: In Vitro Mammalian Cell Micronucleus Test (2023), https://doi.org/10.1787/9789264264861-en.

(16)  OECD Test Guideline 491: Short Time Exposure In Vitro Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage (2023), https://doi.org/10.1787/9789264242432-en.

(17)  OECD Test Guideline 492: Reconstructed human Cornea-like Epithelium (RhCE) test method for identifying chemicals not requiring classification and labelling for eye irritation or serious eye damage (2023), https://doi.org/10.1787/9789264242548-en.

(18)  OECD Test Guideline 496: In vitro Macromolecular Test Method for Identifying Chemicals Inducing Serious Eye Damage and Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage (2023), https://doi.org/10.1787/970e5cd9-en.

(19)  OECD Test Guideline 497: Defined Approaches on Skin Sensitisation (2023), https://doi.org/10.1787/b92879a4-en.

(20)  OECD Test Guideline 498: In vitro Phototoxicity – Reconstructed Human Epidermis Phototoxicity test method (2023), https://doi.org/10.1787/7b2f9ea0-en.

(21)  Rialachán (CE) Uimh. 1272/2008 ó Pharlaimint na hEorpa agus ón gComhairle an 16 Nollaig 2008 maidir le haicmiú, lipéadú agus pacáistiú substaintí agus meascán, agus lena leasaítear agus lena n-aisghairtear Treoir 67/548/CEE agus Treoir 1999/45/CE, agus lena leasaítear Rialachán (CE) Uimh. 1907/2006 (IO L 353, 31.12.2008, lch. 1, ELI: http://data.europa.eu/eli/reg/2008/1272/oj).

(22)  Roinn 2.2.4.2. d’Iarscríbhinn I, Cuid 2, de Rialachán (CE) Uimh. 1272/2008.

(23)  Roinn 2.2.4.4. d’Iarscríbhinn I, Cuid 2, de Rialachán (CE) Uimh. 1272/2008.

(24)  Tábla 2.6.4 d’Iarscríbhinn I, Cuid 2, de Rialachán (CE) Uimh. 1272/2008.

(25)  Roinn 2.6.4.4. d’Iarscríbhinn I, Cuid 2, de Rialachán (CE) Uimh. 1272/2008.

(26)  Roinn 2.8.4.1. d’Iarscríbhinn I, Cuid 2, de Rialachán (CE) Uimh. 1272/2008.

(27)  Roinn 2.15.4.1. d’Iarscríbhinn I, Cuid 2, de Rialachán (CE) Uimh. 1272/2008.

(28)  Roinn 2.16.2.1. d’Iarscríbhinn I, Cuid 2, de Rialachán (CE) Uimh. 1272/2008.

(29)  Roinn 2.17.2.1., pointí (b) agus (c), agus Roinn 2.17.2.2. d’Iarscríbhinn I, Cuid 2, de Rialachán (CE) Uimh. 1272/2008.


IARSCRÍBHINN

Leasaítear an Iarscríbhinn a ghabhann le Rialachán (CE) Uimh. 440/2008 mar a leanas:

(1)

Leasaítear Cuid 0 mar a leanas:

(a)

Cuirtear an méid seo a leanas in ionad Thábla 1:

‘TÁBLA 1: MODHANNA TÁSTÁLA LE hAGHAIDH AIRÍONNA FISICEIMICEACHA NA SUBSTAINTE

Airíonna fisiceimiceacha bunúsacha

Críochphointe

Modh tástála

Caibidil chomhfhreagrach i gCuid A den Iarscríbhinn seo, ina bhfuil tuairisc iomlán ar an modh tástála (léirítear leis na huimhreacha atá idir lúibíní gur scriosadh tuairisc iomlán an mhodha tástála ó Chuid A; cill fholamh: gan modh tástála comhfhreagrach i gCuid A den Iarscríbhinn seo)

Leáphointe/reophointe

OECD Test Guideline 102: Melting Point/Melting Range (1995)

A.1.

ASTM D4359-90: Standard Test Method for Determining whether a Material Is a Liquid or a Solid

 

Test for determining fluidity according to section 2.3.4 of Annex A of the Agreement concerning the International Carriage of Dangerous Goods by Road (ADR)

 

Fiuchphointe

OECD Test Guideline 103: Boiling point (1995)

A.2.

Test methods according to Table 2.6.4 of Annex I, Part 2 of Regulation (EC) No 1272/2008

 

Inadhainteacht

EN 15188:2020 – Determination of the spontaneous ignition behaviour of dust accumulations

 

Íosteorainn agus uasteorainn sophléascachta

Test methods according to section 2.2.4.1. of Annex I, Part 2 of Regulation (EC) No 1272/2008 (ISO 10156 and EN 1839)

 

Splancphointe

Test methods according to table 2.6.3 of Annex I, Part 2 of Regulation (EC) No 1272/2008

 

Teocht uathadhainte (leachtanna, gáis)

ISO/IEC 80079-20-1:2017 – Explosive atmospheres – Part 20-1: Material characteristics for gas and vapour classification – Test methods and data

 

Teocht dianscaoilte

Calorimetric test methods according to section 20.3.3.3 of Part II of the UN Manual of Tests and Criteria

 

Test Series H, part II, section 28, of the UN Manual of Tests and Criteria for the self-accelerating decomposition temperature (SADT) (with reference to a specific package)

 

pH

OECD Test Guideline 122: Determination of pH, Acidity and Alkalinity (2013)

 

Slaodacht Chinéimiteach

OECD Test Guideline 114: Viscosity of Liquids (2012)

 

Tuaslagthacht an uisce

OECD Test Guideline 105: Water Solubility (1995)

A.6.

Comhéifeacht rannach

n-ochtánól/uisce

OECD Test Guideline 107: Partition Coefficient (n-octanol/water): Shake-Flask Method (1995)

(A.8.)

OECD Test Guideline 123: Partition Coefficient (1-Octanol/Water): Slow-Stirring Method (2022)

A.23.

OECD Test Guideline 117: Partition Coefficient (n-octanol/water): HPLC Method (2022)

A.24.

Galbhrú

OECD Test Guideline 104: Vapour Pressure (2006)

(A.4)

Dlús/Dlús coibhneasta

OECD Test Guideline 109: Density of Liquids and Solids (2012)

(A.3.)

DIN 66137-2 – Determination of solid state density - Part 2: Gas pycnometry

ISO 12154 – Determination of density by volumetric displacement - Skeleton density by gas pycnometry

Saintréithe na gcáithníní

EU test method A.22. Length Weighted Geometric Mean Diameter of Fibres

A.22.

ISO 21501 – Determination of Particle Size Distribution – Single Particle Light Interaction Methods

 

OECD Test Guideline 124: Determination of the Volume Specific Surface Area of Manufactured Nanomaterials (2022)

 

OECD Test Guideline 125: Particle Size and Particle Size Distribution of Nanomaterials (2023)

 

ISO/TR 14187:2020 – Surface chemical analysis –Characterization of nanostructured materials

Deannacht (i gcás nanafhoirmeacha substainte)

EN 17199-1:2019 – Workplace exposure – Measurement of dustiness of bulk materials that contain or release respirable NOAA and other respirable particles

 

EN 15051-1: Workplace exposure – Measurement of the dustiness of bulk materials – Part 1: Requirements and choice of test methods

EN 15051-2: Workplace exposure – Measurement of the dustiness of bulk materials – Part 2: Rotating drum method

EN 15051-3: Workplace exposure – Measurement of the dustiness of bulk materials – Part 3: Continuous drop method

Teannas dromchla

OECD Test Guideline 115: Surface Tension of Aqueous Solutions (1995)

A.5.

Tairiseach díthiomsúcháin

OECD Test Guideline 112: Dissociation Constants in Water (1981)

A.25.

Hidreafóbacht

OECD Test Guideline 126: Determination of the Hydrophobicity Index of Manufactured Nanomaterials Through an Affinity Measurement (2023)

 

Airíonna guaiseacha fisiciceimiceacha

Pléascáin

Test methods for explosives according to section 2.1.2.1. and 2.1.2.3. of Annex I, Part 2 of Regulation (EC) No 1272/2008

 

EU Test method A.14 Explosive Properties

A.14

Gáis inadhainte

Test method for the fundamental burning velocity according to section 2.2.4.1. of Annex I, Part 2 of Regulation (EC) No 1272/2008

 

Test method for pyrophoric gases according to section 2.2.4.2. of Annex I, Part 2 of Regulation (EC) No 1272/2008

 

Test method for the chemical instability according to section 2.2.4.4. of Annex I, Part 2 of Regulation (EC) No 1272/2008

 

Gáis ocsaídeacha

Test method for oxidising gases according to section 2.4.4. of Annex I, Part 2 of Regulation (EC) No 1272/2008

 

Leachtanna inadhainte

Test method for the sustained combustibility according to section 2.6.4.5. of Annex I, Part 2 of Regulation (EC) No 1272/2008

 

Test methods for determining the flash point of flammable liquids according to section 2.6.4.4. of Annex I, Part 2 of Regulation (EC) No 1272/2008

Solaid inadhainte

Test method for flammable solids according to section 2.7.2.3. of Annex I, Part 2 of Regulation (EC) No 1272/2008

 

Substaintí féin-imoibríocha

Test method for self-reactive substances according to section 2.8.4.1. of Annex I, Part 2 of Regulation (EC) No 1272/2008

 

Leachtanna pireafóracha

Test method for pyrophoric liquids according to section 2.9.2.1. of Annex I, Part 2 of Regulation (EC) No 1272/2008

 

Solaid phireafóracha

Test method for pyrophoric solids according to section 2.10.2.1. of Annex I, Part 2 of Regulation (EC) No 1272/2008,

 

Substaintí féintéimh

Test method for self-heating substances according to section 2.11.2.2 of Annex I, Part 2 of Regulation (EC) No 1272/2008

 

Substaintí a astaíonn gáis inadhainte nuair a thagann siad i dteagmháil le huisce

Test method for substances which in contact with water emit flammable gases according to section 2.12.2.1. of Annex I, Part 2 of Regulation (EC) No 1272/2008

 

Leachtanna ocsaídeacha

Test method for oxidising liquids according to section 2.13.2.1. of Annex I, Part 2 of Regulation (EC) No 1272/2008

 

Solaid ocsaídeacha

Test method for oxidising solids according to section 2.14.2.1. of Annex I, Part 2 of Regulation (EC) No 1272/2008

 

Sárocsaídí orgánacha

Test methods according to section 2.15.4.1 of Annex I, Part 2 of Regulation (EC) No 1272/2008

 

Creimneach do mhiotail

Test method for substances corrosive to metals according to section 2.16.2.1. of Annex I, Part 2 of Regulation (EC) No 1272/2008

 

Pléascáin dhí-íograithe

Test methods according to section 2.17.2.1 (b) and (c) and according to section 2.17.2.2 of Annex I, Part 2 of Regulation (EC) No 1272/2008

 

Airíonna polaiméirí

OECD Test Guideline 118: Determination of the Number-Average Molecular Weight and the Molecular Weight Distribution of Polymers using Gel Permeation Chromatography (1996)

A.18.

OECD Test Guideline 119: Determination of the Low Molecular Weight Content of a Polymer Using Gel Permeation Chromatography (1996)

A.19.

OECD Test Guideline 120: Solution/Extraction Behaviour of Polymers in Water (2000)

(A.20.)’

(b)

Leasaítear Tábla 2 mar a leanas:

(i)

cuirtear an méid seo a leanas in ionad na hiontrála ‘Damáiste/greannú tromchúiseach súile’:

‘Damáiste/greannú tromchúiseach súile

In vitro:

OECD Test Guideline 437: Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage (2023)

(B.47.)

OECD Test Guideline 438: Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage (2023)

(B.48.)

OECD Test Guideline 460: Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe Irritants (2023)

(B.61.)

OECD Test Guideline 491: Short Time Exposure In Vitro Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage (2023)

(B.68.)

OECD Test Guideline 492: Reconstructed human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage (2023)

(B.69.)

OECD Test Guideline 492B: Reconstructed Human Cornea-like Epithelium (RHCE) Test Method for Eye Hazard Identification (2022)

 

OECD Test Guideline 494: Vitrigel-Eye Irritancy Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage (2021)

 

OECD Test Guideline 496: In vitro Macromolecular Test Method for Identifying Chemicals Inducing Serious Eye Damage and Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage (2023)

 

OECD Test Guideline 467: Defined Approaches for Serious Eye Damage and Eye Irritation (2022)

 

In vivo:

OECD Test Guideline 405: Acute Eye Irritation/Corrosion (2023)

(B.5.)’

(ii)

san iontráil ‘Íogrú craicinn’, cuirtear an méid seo a leanas in ionad na roinne ‘In vitro’:

‘In vitro:

OECD Test Guideline 442C: In Chemico Skin Sensitisation Assays addressing the Adverse Outcome Pathway key event on covalent binding to proteins (2023)

(B.59.)

OECD Test Guideline 442D: In Vitro Skin Sensitisation Assays Addressing the AOP Key Event on Keratinocyte Activation (2022)

(B.60.)

OECD Test Guideline 442E: In Vitro Skin Sensitisation: In Vitro Skin Sensitisation Assays Addressing the Key Event on Activation of Dendritic Cells on the Adverse Outcome Pathway for Skin Sensitisation (2023)

(B.71.)’

OECD Test Guideline 497: Defined Approaches on Skin Sensitisation (2023)’

 

(iii)

san iontráil ‘Só-ghineacht’, i gcás an ró:

 

 

‘OECD Test Guideline 487. In vitro Mammalian Cell Micronucleus Test (2016)

B.49.’

cuirtear an méid seo a leanas ina ionad:

 

 

‘OECD Test Guideline 487. In vitro Mammalian Cell Micronucleus Test (2023)

(B.49.)’;

(iv)

san iontráil ‘Airíonna suaite inchrínigh’, i gcás na rónna:

 

 

‘OECD Test Guideline 456: H295R Steroidogenesis Assay (2022)

B.57.’

OECD Test Guideline 458: Stably Transfected Human Androgen Receptor Transcriptional Activation Assay for Detection of Androgenic Agonist and Antagonist Activity of Chemicals (2020)’

 

cuirtear an méid seo a leanas ina n-ionad:

 

 

‘OECD Test Guideline 456: H295R Steroidogenesis Assay (2023)

(B.57.)’

OECD Test Guideline 458: Stably Transfected Human Androgen Receptor Transcriptional Activation Assay for Detection of Androgenic Agonist and Antagonist Activity of Chemicals (2023)’;

 

(v)

san iontráil ‘Fótatocsaineacht’, i gcás an ró:

 

‘OECD Test Guideline 498: In Vitro Phototoxicity Test Method Using the Reconstructed Human Epidermis (RhE) (2021)’

 

cuirtear an méid seo a leanas ina ionad:

 

‘OECD Test Guideline 498: In Vitro Phototoxicity Reconstructed Human Epidermis Phototoxicity test method (2023)’

 

(vi)

cuirtear an iontráil seo a leanas isteach i ndiaidh na roinne ‘Fótatocsaineacht’:

‘Tocsaineacht imdhíonachta

OECD Test Guideline 444A: In vitro immunotoxicity IL-2 Luc assay (2023)’

 

(c)

Leasaítear Tábla 3 mar a leanas:

(i)

san iontráil ‘Díghrádú’, i gcás an ró:

 

‘OECD Test Guideline 316: Phototransformation of Chemicals in Water – Direct Photolysis (2008)’

 

cuirtear an méid seo a leanas ina ionad:

 

‘OECD Test Guideline 316: Phototransformation of Chemicals in Water – Direct Photolysis (2023)’

 

(ii)

san iontráil ‘Éifeachtaí ar orgánaigh dhríodair’, i gcás na rónna:

 

‘OECD Test Guideline 218: Sediment-Water Chironomid Toxicity Using Spiked Sediment (2004)

C.27.

OECD Test Guideline 219: Sediment-Water Chironomid Toxicity Using Spiked Water (2004)

C.28.’

cuirtear an méid seo a leanas ina n-ionad:

 

‘OECD Test Guideline 218: Sediment-Water Chironomid Toxicity Test Using Spiked Sediment (2023)

(C.27.)

OECD Test Guideline 219: Sediment-Water Chironomid Toxicity Test Using Spiked Water (2023)

(C.28.)’;

(iii)

san iontráil ‘Airíonna suaite inchrínigh’, i gcás an ró:

 

‘OECD Test Guideline 240: Medaka Extended OneGeneration Reproduction Test (MEOGRT) (2015)

C.52.’

cuirtear an méid seo a leanas ina ionad:

 

‘OECD Test Guideline 240: Medaka Extended One Generation Reproduction Test (MEOGRT) (2023)

(C.52.)’;

(2)

i gcuid B, cuirtear an méid seo a leanas in ionad an téacs atá faoi bhun na dteideal ar gach ceann de na Caibidlí B.49 agus B.57: ‘Scriosadh an tuairisc iomlán ar an modh tástála seo. Tá an modh tástála idirnáisiúnta coibhéiseach i gCuid 0, Tábla 2.’;

(3)

i gcuid C, cuirtear an méid seo a leanas in ionad an téacs atá faoi bhun na dteideal ar gach ceann de Chaibidlí C.27., C.28. agus C.52: ‘Scriosadh an tuairisc iomlán ar an modh tástála seo. Tá an modh tástála idirnáisiúnta coibhéiseach i gCuid 0, Tábla 3.’


ELI: http://data.europa.eu/eli/reg/2024/2492/oj

ISSN 1977-0839 (electronic edition)