L_202402492HR.000101.fmx.xml

UREDBA KOMISIJE (EU) 2024/2492

оd 23. rujna 2024.

o izmjeni Uredbe (EZ) br. 440/2008 u pogledu prilagodbe ispitnih metoda tehničkom napretku

(Tekst značajan za EGP)

EUROPSKA KOMISIJA,

uzimajući u obzir Ugovor o funkcioniranju Europske unije,

uzimajući u obzir Uredbu (EZ) br. 1907/2006 Europskog parlamenta i Vijeća od 18. prosinca 2006. o registraciji, evaluaciji, autorizaciji i ograničavanju kemikalija (REACH) i osnivanju Europske agencije za kemikalije te o izmjeni Direktive 1999/45/EZ i stavljanju izvan snage Uredbe Vijeća (EEZ) br. 793/93 i Uredbe Komisije (EZ) br. 1488/94 kao i Direktive Vijeća 76/769/EEZ i direktiva Komisije 91/155/EEZ, 93/67/EEZ, 93/105/EZ i 2000/21/EZ (1), a posebno njezin članak 13. stavak 2.,

budući da:

(1)	U Prilogu Uredbi Komisije (EZ) br. 440/2008 (2) navode se ispitne metode koje su priznate kao primjerene za dobivanje informacija o fizikalno-kemijskim, toksikološkim i ekotoksikološkim svojstvima tvari za potrebe Uredbe (EZ) br. 1907/2006.

(2)	Organizacija za gospodarsku suradnju i razvoj (OECD) razvija usklađene i na međunarodnoj razini dogovorene smjernice za ispitivanje kemikalija u regulatorne svrhe. OECD redovito izdaje nove i revidirane smjernice za ispitivanje uzimajući u obzir znanstveni napredak u tom području.

(3)

Kako bi Uredba (EZ) br. 440/2008 bila ažurirana u pogledu tehničkog napretka i kako bi se smanjio broj životinja koje se koriste u pokusne svrhe, u skladu s Direktivom 2010/63/EU Europskog parlamenta i Vijeća (3), u Prilog Uredbi (EZ) br. 440/2008 trebalo bi dodati sedam ispitnih metoda: jednu novu ispitnu metodu za osnovna fizikalno-kemijska svojstva (4), jednu novu i dvije ažurirane ispitne metode za određivanje učinaka na zdravlje ljudi, koje se odnose na in vitro ispitivanja imunotoksičnosti i preosjetljivosti kože (5) te tri ažurirane ispitne metode za procjenu ekotoksičnosti (6).

(4)

Osim toga, OECD je 2023. objavio nove, ispravljene verzije sljedećih ispitnih metoda, koje su uključene u Uredbu (EZ) br. 440/2008: OECD Test Guideline 125 (7); OECD Test Guideline 316 (8); OECD Test Guideline 405 (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). Stoga je primjereno izbrisati zastarjele verzije potpunih opisa tih ispitnih metoda iz dijelova B i C Priloga Uredbi (EZ) br. 440/2008.

(5)

Kako bi se postigla bolja usklađenost s povezanim zakonodavstvom, posebno s Uredbom (EZ) br. 1272/2008 Europskog parlamenta i Vijeća (21), popis ispitnih metoda za fizikalno-kemijska svojstva u tablici 1. u dijelu 0. Priloga Uredbi (EZ) br. 440/2008 trebalo bi restrukturirati i trebalo bi dodati relevantne ispitne metode: 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; sljedeće ispitne metode, kako je predviđeno u dijelu 2. Priloga I. Uredbi (EZ) br. 1272/2008 Europskog parlamenta i Vijeća: ispitnu metodu za piroforne plinove (22); ispitnu metodu za kemijsku nestabilnost (23); ispitne metode za određivanje početnog vrelišta zapaljivih tekućina (24); ispitne metode za određivanje plamišta zapaljivih tekućina (25); ispitnu metodu za samoreagirajuće tvari (26); ispitne metode za organske perokside (27); ispitnu metodu za tvari nagrizajuće za metale (28) i ispitne metode za desenzitirane eksplozive (29).

(6)	Uredbu (EZ) br. 440/2008 trebalo bi stoga na odgovarajući način izmijeniti.

(7)	S relevantnim dionicima provedeno je savjetovanje o predloženoj izmjeni.

(8)	Mjere predviđene u ovoj Uredbi u skladu su s mišljenjem odbora osnovanog člankom 133. stavkom 1.Uredbe (EZ) br. 1907/2006,

DONIJELA JE OVU UREDBU:

Članak 1.

Prilog Uredbi (EZ) br. 440/2008 mijenja se u skladu s Prilogom ovoj Uredbi.

Članak 2.

Ova Uredba stupa na snagu dvadesetog dana od dana objave u Službenom listu Europske unije.

Ova je Uredba u cijelosti obvezujuća i izravno se primjenjuje u svim državama članicama.

Sastavljeno u Bruxellesu 23. rujna 2024.

Za Komisiju

Predsjednica

Ursula VON DER LEYEN

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

(2) Uredba Vijeća (EZ) br. 440/2008 od 30. svibnja 2008. o utvrđivanju ispitnih metoda u skladu s Uredbom (EZ) br. 1907/2006 Europskog parlamenta i Vijeća o registraciji, evaluaciji, autorizaciji i ograničavanju kemikalija (REACH) (SL L 142, 31.5.2008., str. 1., ELI: http://data.europa.eu/eli/reg/2008/440/oj).

(3) Direktiva 2010/63/EU Europskog parlamenta i Vijeća od 22. rujna 2010. o zaštiti životinja koje se koriste u znanstvene svrhe (SL L 276, 20.10.2010., str. 33., ELI: http://data.europa.eu/eli/dir/2010/63/oj).

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

(5) OECD Test Guideline 444 A: 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 br. 240: Medaka Extended One Generation Reproduction Test (MEOGRT) (2023) https://doi.org/10.1787/9789264242258-en; OECD Test Guideline 218: 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) Uredba (EZ) br. 1272/2008 Europskog parlamenta i Vijeća od 16. prosinca 2008. o razvrstavanju, označivanju i pakiranju tvari i smjesa, o izmjeni i stavljanju izvan snage Direktive 67/548/EEZ i Direktive 1999/45/EZ i o izmjeni Uredbe (EZ) br. 1907/2006 (SL L 353, 31.12.2008., str. 1. ELI: http://data.europa.eu/eli/reg/2008/1272/oj).

(22) Odjeljak 2.2.4.2. dijela 2. Priloga I. Uredbi (EZ) br. 1272/2008.

(23) Odjeljak 2.2.4.4. dijela 2. Priloga I. Uredbi (EZ) br. 1272/2008.

(24) Tablica 2.6.4. u dijelu 2. Priloga I. Uredbi (EZ) br. 1272/2008.

(25) Odjeljak 2.6.4.4. dijela 2. Priloga I. Uredbi (EZ) br. 1272/2008.

(26) Odjeljak 2.8.4.1. dijela 2. Priloga I. Uredbi (EZ) br. 1272/2008.

(27) Odjeljak 2.15.4.1. dijela 2. Priloga I. Uredbi (EZ) br. 1272/2008.

(28) Odjeljak 2.16.2.1. dijela 2. Priloga I. Uredbi (EZ) br. 1272/2008.

(29) Odjeljak 2.17.2.1. točke (b) i (c) i odjeljak 2.17.2.2. dijela 2. Priloga I. Uredbi (EZ) br. 1272/2008.

PRILOG

Prilog Uredbi (EZ) br. 440/2008 mijenja se kako slijedi:

(1)

Dio 0. mijenja se kako slijedi:

(a)

tablica 1. zamjenjuje se sljedećim:

„TABLICA 1.: ISPITNE METODE ZA FIZIKALNO-KEMIJSKA SVOJSTVA TVARI

Osnovna fizikalno-kemijska svojstva
Krajnja točka	Ispitna metoda	Odgovarajuće poglavlje u dijelu A ovog Priloga koje sadržava potpuni opis ispitne metode (brojevi u zagradama znače da je potpuni opis ispitne metode izbrisan iz dijela A, a prazno polje znači da u dijelu A ovog Priloga nema odgovarajuće ispitne metode)
Talište/ledište	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)
Vrelište	OECD Test Guideline 103: Boiling point (1995)	A.2.
Vrelište	Test methods according to table 2.6.4 of Annex I, Part 2 of Regulation (EC) No 1272/2008
Zapaljivost	EN 15188:2020 – Determination of the spontaneous ignition behaviour of dust accumulations
Donja i gornja granica eksplozivnosti	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)
Plamište	Test methods according to table 2.6.3 of Annex I, Part 2 of Regulation (EC) No 1272/2008
Temperatura samozapaljenja (tekućine, plinovi)	ISO/IEC 80079-20-1:2017 – Explosive atmospheres – Part 20-1: Material characteristics for gas and vapour classification – Test methods and data
Temperatura razgradnje	Calorimetric test methods according to section 20.3.3.3 of Part II of the UN Manual of Tests and Criteria
Temperatura razgradnje	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)
Kinematička viskoznost	OECD Test Guideline 114: Viscosity of Liquids (2012)
Topljivost u vodi	OECD Test Guideline 105: Water Solubility (1995)	A.6.
Koeficijent razdjeljenja n-octanol/voda	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.
Tlak pare	OECD Test Guideline 104: Vapour Pressure (2006)	(A.4.)
Gustoća / relativna gustoća	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
Svojstva čestica	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
Prašenje (za nanooblike tvari)	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
Površinska napetost	OECD Test Guideline 115: Surface Tension of Aqueous Solutions (1995)	A.5.
Konstanta disocijacije	OECD Test Guideline 112: Dissociation Constants in Water. (1981)	A.25.
Hidrofobnost	OECD Test Guideline 126: Determination of the Hydrophobicity Index of Manufactured Nanomaterials Through an Affinity Measurement (2023)
Opasna fizikalno-kemijska svojstva
Eksplozivi	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
Eksplozivi	EU Test method A.14 Explosive Properties	A.14.
Zapaljivi plinovi	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
Oksidirajući plinovi	Test method for oxidising gases according to section 2.4.4. of Annex I, Part 2 of Regulation (EC) No 1272/2008
Zapaljive tekućine	Test method for the sustained combustibility according to section 2.6.4.5. of Annex I, Part 2 of Regulation (EC) No 1272/2008
Zapaljive tekućine	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
Zapaljive krute tvari	Test method for flammable solids according to section 2.7.2.3. of Annex I, Part 2 of Regulation (EC) No 1272/2008
Samoreagirajuće tvari	Test method for self-reactive substances according to section 2.8.4.1. of Annex I, Part 2 of Regulation (EC) No 1272/2008
Piroforne tekućine	Test method for pyrophoric liquids according to section 2.9.2.1. of Annex I, Part 2 of Regulation (EC) No 1272/2008
Piroforne krute tvari	Test method for pyrophoric solids according to section 2.10.2.1. of Annex I, Part 2 of Regulation (EC) No 1272/2008,
Samozagrijavajuće tvari	Test method for self-heating substances according to section 2.11.2.2 of Annex I, Part 2 of Regulation (EC) No 1272/2008
Tvari koje u dodiru s vodom proizvode otrovne plinove	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
Oksidirajuće tekućine	Test method for oxidising liquids according to section 2.13.2.1. of Annex I, Part 2 of Regulation (EC) No 1272/2008
Oksidirajuće krute tvari	Test method for oxidising solids according to section 2.14.2.1. of Annex I, Part 2 of Regulation (EC) No 1272/2008
Organski peroksidi	Test methods according to section 2.15.4.1 of Annex I, Part 2 of Regulation (EC) No 1272/2008
Tvari nagrizajuće za metale	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
Desenzitirani eksplozivi	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
Svojstva polimera	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)

tablica 2. mijenja se kako slijedi:

unos „Teška ozljeda oka/nadraživanje oka” zamjenjuje se sljedećim:

„Teška ozljeda oka / nadraživanje oka	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.

u unosu „Preosjetljivost kože” odjeljak „In vitro” zamjenjuje se sljedećim:

„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.

u unosu „Mutagenost” redak:


	„OECD Test Guideline 487. In vitro Mammalian Cell Micronucleus Test (2016)	B.49.”

zamjenjuje se sljedećim:


	„OECD Test Guideline 487. In vitro Mammalian Cell Micronucleus Test (2023)	(B.49.)”

iv.

u unosu „Svojstva endokrine disrupcije” redci:


	„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)

zamjenjuju se sljedećim:


	„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)

u unosu „Fototoksičnost” redak:

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

zamjenjuje se sljedećim:

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

vi.

nakon odjeljka „Fotoksičnost” umeće se sljedeći unos:

„Imunotoksičnost

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

(c)

tablica 3. mijenja se kako slijedi:

u unosu „Razgradnja” redak:

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

zamjenjuje se sljedećim:

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

ii.

u unosu „Učinci na organizme koji žive u sedimentu”, redci:

	„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.”

zamjenjuju se sljedećim:

	„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.

u unosu „Svojstva endokrine disrupcije” redak:

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

C.52.”

zamjenjuje se sljedećim:

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

(C.52.)”

(2)	u dijelu B tekst ispod naslova poglavlja B.49. i B.57. zamjenjuje se sljedećim: „Potpuni opis ove ispitne metode izbrisan je. Ekvivalentna međunarodna ispitna metoda navedena je u tablici 2. u dijelu 0.”;

(3)	u dijelu C tekst ispod naslova poglavlja C.27., C.28. i C.52. zamjenjuje se sljedećim: „Potpuni opis ove ispitne metode izbrisan je. Ekvivalentna međunarodna ispitna metoda navedena je u tablici 3. u dijelu 0.”