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(Kommissionens forordning (EU) 2025/2573 af 18. december 2025 om ændring af forordning (EF) nr. 440/2008 for så vidt angår forsøgsmetoderne med henblik på tilpasning til den tekniske udvikling)
Bilaget til forordning (EF) nr. 440/2008 ændres som angivet i bilaget til denne forordning.
Denne forordning træder i kraft på tyvendedagen efter offentliggørelsen i Den Europæiske Unions Tidende.
Denne forordning er bindende i alle enkeltheder og gælder umiddelbart i hver medlemsstat.
Udfærdiget i Bruxelles, den 18. december 2025.
EUT L 396 af 30.12.2006, s. 1, ELI: http://data.europa.eu/eli/reg/2006/1907/oj.
Kommissionens forordning (EF) nr. 440/2008 af 30. maj 2008 om fastlæggelse af forsøgsmetoder i henhold til Europa-Parlamentets og Rådets forordning (EF) nr. 1907/2006 om registrering, vurdering og godkendelse af samt begrænsninger for kemikalier (REACH) (EUT L 142 af 31.5.2008, s. 1, ELI: http://data.europa.eu/eli/reg/2008/440/oj).
Europa-Parlamentets og Rådets direktiv 2010/63/EU af 22. september 2010 om beskyttelse af dyr, der anvendes til videnskabelige formål (EUT L 276 af 20.10.2010, s. 33, ELI: http://data.europa.eu/eli/dir/2010/63/oj).
OECD Test Guideline 442D: In Vitro Skin Sensitisation: Assays addressing the Adverse Outcome Pathway Key Event on Keratinocyte activation (2024) https://doi.org/10.1787/9789264229822-en; OECD Test Guideline 467: Defined Approaches for Serious Eye Damage and Eye Irritation (2024) https://doi.org/10.1787/28fe2841-en; 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 (2024) https://doi.org/10.1787/970e5cd9-en.
OECD Test Guideline 252: Rapid Estrogen Activity In Vivo (REACTIV) assay (2024) https://doi.org/10.1787/54066090-en; OECD Test Guideline 253: Short-term Juvenile Hormone Activity Screening Assay using Daphnia magna (JHASA) (2024) https://doi.org/10.1787/03cb5c08-en; OECD Test Guideline 321: Hyallela azteca Bioconcentration Test (HYBIT) (2024) https://doi.org/10.1787/8ac30c4e-en.
OECD Test Guideline 403: Acute Inhalation Toxicity (2024) https://doi.org/10.1787/9789264070608-en.
OECD Test Guideline 442B: Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA or –FCM (2024) https://doi.org/10.1787/9789264090996-en.
OECD Test Guideline 442C: In Chemico Skin Sensitisation: Assays addressing the Adverse Outcome Pathway key event on covalent binding to proteins (2024) 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 (2024) https://doi.org/10.1787/9789264264359-en.
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 (2024) https://doi.org/10.1787/9789264242548-en.
OECD Test Guideline 492B: Reconstructed Human Cornea-like Epithelium (RHCE) Test Method for Eye Hazard Identification (2024) https://doi.org/10.1787/0d603916-en.
OECD Test Guideline 493: Performance-Based Test Guideline for Human Recombinant Estrogen Receptor (hrER) In Vitro Assays to Detect Chemicals with ER Binding Affinity (2024) https://doi.org/10.1787/9789264242623-en.
I bilaget til forordning (EF) nr. 440/2008 foretages følgende ændringer:
1) Del 0 ændres således:
a) I tabel 1 affattes posten »Støvholdighed (i nanoformer af et stof)« således:
| »Støvholdighed (i nanoformer af et stof) | EN 17199-1:2019 — Workplace exposure — Measurement of dustiness of bulk materials that contain or release respirable NOAA and other respirable particles — Part 1: Requirements and choice of test methods | | | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | | | EN 17199-2:2019 — Workplace exposure — Measurement of dustiness of bulk materials that contain or release respirable NOAA and other respirable particles — Part 2: Rotating drum method | | | | EN 17199-3:2019 — Workplace exposure — Measurement of dustiness of bulk materials that contain or release respirable NOAA and other respirable particles — Part 3: Continuous drop method | | | | EN 17199-4:2019 — Workplace exposure — Measurement of dustiness of bulk materials that contain or release respirable NOAA and other respirable particles — Part 4: Small rotating drum method | | | | EN 17199-5:2019 — Workplace exposure — Measurement of dustiness of bulk materials that contain or release respirable NOAA and other respirable particles — Part 5: Vortex shaker method | | | | EN 15051-1:2013 — Workplace exposure — Measurement of the dustiness of bulk materials — Part 1: Requirements and choice of test methods | | | | EN 15051-2:2016 — Workplace exposure — Measurement of the dustiness of bulk materials — Part 2: Rotating drum method | | | | EN 15051-3:2013 — Workplace exposure — Measurement of the dustiness of bulk materials — Part 3: Continuous drop method« | | |
2) I del A affattes teksten under overskriften for kapitel A.13. således: »Den komplette beskrivelse af denne forsøgsmetode er blevet slettet. Den ækvivalente internationale forsøgsmetode eller andre relevante forsøgsmetoder for det pågældende endepunkt fremgår af tabel 1 i del 0«.
3) I del B affattes teksten under overskriften for kapitel B.2. således: »Den komplette beskrivelse af denne forsøgsmetode er blevet slettet. Den ækvivalente internationale forsøgsmetode fremgår af del 0, tabel 2«.
4) I del B affattes teksten under overskriften for kapitel B.70. således: »Den komplette beskrivelse af denne forsøgsmetode er blevet slettet. Den ækvivalente internationale forsøgsmetode fremgår af del 0, tabel 2«.
ELI: http://data.europa.eu/eli/reg/2025/2573/oj
ISSN 1977-0634 (electronic edition)
b) I tabel 2 foretages følgende ændringer:
i) I posten »Alvorlig øjenskade/øjenirritation« erstattes afsnittet »In vitro« af følgende:
Alvorlig øjenskade/øjenirritation »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 (2024) (B.69.)« OECD Test Guideline 492B: Reconstructed Human Cornea-like Epithelium (RHCE) Test Method for Eye Hazard Identification (2024) 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 (2024) OECD Test Guideline 467: Defined Approaches for Serious Eye Damage and Eye Irritation (2024) ii) I posten »Hudsensibilisering« erstattes afsnittet »In vitro« af følgende:
Hudsensibilisering »In vitro: OECD Test Guideline 442C: In Chemico Skin Sensitisation: Assays addressing the Adverse Outcome Pathway key event on covalent binding to proteins (2024) (B.59.) OECD Test Guideline 442D: In Vitro Skin Sensitisation: Assays addressing the Adverse Outcome Pathway Key Event on Keratinocyte activation (2024) (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 (2024) (B.71.)« OECD Test Guideline 497: Defined Approaches on Skin Sensitisation (2023) iii) I afsnittet »In vivo« i posten »Hudsensibilisering« affattes den række, der svarer til OECD Test Guideline 442B, således:
| | »OECD Test Guideline 442B: Skin Sensitisation — Local Lymph Node Assay: BrdU-ELISA or –FCM (2024) | (B.51.)« | | | ------------------------------------------------------------------------------------------------- | -------- |
iv) I afsnittet »Inhalation« i posten »Akut toksicitet« affattes den række, der svarer til OECD Test Guideline 403, således:
| | »OECD Test Guideline 403: Acute Inhalation Toxicity (2024) | (B.2.)« | | | ---------------------------------------------------------- | ------- |
v) I afsnittet »In vitro« i posten »Hormonforstyrrende egenskaber« affattes den række, der svarer til OECD Test Guideline 493, således:
| | »OECD Test Guideline 493: Performance-Based Test Guideline for Human Recombinant Estrogen Receptor (hrER) In Vitro Assays to Detect Chemicals with ER Binding Affinity (2024) | (B.70.)« | | | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------- |
c) I tabel 3 foretages følgende ændringer:
i) I posten »Skæbne og opførsel i miljøet« indsættes følgende række:
| | »OECD Test Guideline 321: Hyalella azteca Bioconcentration Test (HYBIT) (2024)« | | | | ------------------------------------------------------------------------------- | |
ii) I posten »Hormonforstyrrende egenskaber« indsættes følgende rækker:
| | »OECD Test Guideline 252: Rapid Estrogen Activity In Vivo (REACTIV) assay (2024) | | | | ----------------------------------------------------------------------------------------------------------------- | | | | OECD Test Guideline 253: Short-term Juvenile Hormone Activity Screening Assay using Daphnia magna (JHASA) (2024)« | |
