EU-IN_VITRO_MEDICAL_DEVICE_REG-ART_5_2_ANX_1

In Vitro Diagnostic Medical Devices Regulation - Hazardous Substances

EU. Hazardous Substances for Purposes of Art. 5(2) and Annex I of Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices, 5 May 2017, as corrected 27 December 2019

This list contains a non-exhaustive inventory of hazardous substances for purposes of Regulation (EU) 2017/746, including Chap. 2 (Placing on the market and putting into service) and Annex I (General Safety and Performance Requirements). It is derived from: Table 3 of Annex VI to CLP, REACH Candidate List of SVHCs, and Directive 2000/54/EC's Annex III (Biological Agents list).

Last updated 23 April 2024. Database contains 4917 unique substances/entries.

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Showing 1 - 50 of 4,917 results.

Substance Name	EC No.	CAS No.	EU CLP (1272/2008)	EU_BA Directive 2000/54/EC	EU REACH: List of SVHC
(1R,2S,5R)-2-[(4-chlorophenyl)methyl]-5-propan-2-yl-1-(1,2,4-triazol-1-ylmethyl)cyclopentan-1-ol	-	115850-69-6	Repr. 1B; Acute Tox. 4; STOT RE 2			Details
(1R,2S,5S)-2-[(4-chlorophenyl)methyl]-5-propan-2-yl-1-(1,2,4-triazol-1-ylmethyl)cyclopentan-1-ol	-	115937-89-8	Repr. 1B; Acute Tox. 4; STOT RE 2			Details
(1R,3E,4S)-1,7,7-trimethyl-3-(4- methylbenzylidene)bicyclo[2.2.1]heptan-2-one	-	95342-41-9			END Endocrine disrupting properties (Article 57(f) - human health)	Details
(1R,3Z,4S)-1,7,7-trimethyl-3-(4- methylbenzylidene)bicyclo[2.2.1]heptan-2-one	-	852541-21-0			END Endocrine disrupting properties (Article 57(f) - human health)	Details
(1R,4S)-1,7,7-trimethyl-3-(4-methylbenzylidene)bicyclo[2.2.1]heptan-2-one	-	741687-98-9			END Endocrine disrupting properties (Article 57(f) - human health)	Details
(1S,2S,5R,6R,9S,10S,13R,14R)-1,6,7,8,9,14,15,16,17,17,18,18-Dodecachloropentacyclo[12.2.1.1⁶,⁹.0²,¹³.0⁵,¹⁰]octadeca-7,15-diene	-	135821-03-3			VPVB very Persistent and very Bioaccumulative (article 57e)	Details
(1S,2S,5S,6S,9R,10R,13R,14R)-1,6,7,8,9,14,15,16,17,17,18,18-Dodecachloropentacyclo[12.2.1.1⁶,⁹.0²,¹³.0⁵,¹⁰]octadeca-7,15-diene	-	135821-74-8			VPVB very Persistent and very Bioaccumulative (article 57e)	Details
(1S,3E,4R)-1,7,7-trimethyl-3-(4- methylbenzylidene)bicyclo[2.2.1]heptan-2-one	-	852541-30-1			END Endocrine disrupting properties (Article 57(f) - human health)	Details
(1S,3Z,4R)-1,7,7-trimethyl-3-(4-methylbenzylidene)bicyclo[2.2.1]heptan-2-one	-	852541-25-4			END Endocrine disrupting properties (Article 57(f) - human health)	Details
(2E)-2-cyano-N-[(ethylamino)carbonyl]-2-(methoxyimino) acetamide	-	166900-80-7	Repr. 2; Acute Tox. 4; STOT RE 2; Skin Sens. 1			Details
(2R)-3-(4-tert-Butylphenyl)-2-methylpropanal	-	75166-31-3			R Toxic for reproduction (article 57c)	Details
(2S)-3-(4-tert-Butylphenyl)-2-methylpropanal	-	75166-30-2			R Toxic for reproduction (article 57c)	Details
(R)-2-chloro-N-(2-ethyl-6-methyl-phenyl)-N-(2-methoxy-1-methyl-ethyl)-acetamide (0-20 %)	-	178961-20-1	Skin Sens. 1			Details
1,1',1''-[(3Z)-2,6-Dimethylhept-3-ene-2,4,6-triyl]tribenzene	-	957070-06-3			VPVB very Persistent and very Bioaccumulative (article 57e)	Details
1,1-dimethyl-3-phenyluronium trichloroacetate; fenuron-TCA	-	4482-55-7	Skin Irrit. 2			Details
1,2,3,4-tetranitrocarbazole	-	6202-15-9	Expl. 1.1; Acute Tox. 4			Details
1,2-dimethylhydrazine	-	540-73-8	Carc. 1B; Acute Tox. 3			Details
1,6,7,8,9,14,15,16,17,17,18,18-Dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15-diene (''Dechlorane Plus''™) including any of its individual anti- and syn-isomers or any combination thereof	-	-			VPVB very Persistent and very Bioaccumulative (article 57e)	Details
1-(3,4-dichlorophenylimino); thiosemicarbazide	-	5836-73-7	Acute Tox. 2			Details
2,2-dichlorovinyl 2-ethylsulphinylethyl methyl phosphate	-	7076-53-1	Acute Tox. 3			Details
2,3,5,6-tetrafluoro-4-(methoxymethyl)benzyl (1R,3R)-2,2-dimethyl-3-[(1Z)-prop-1-en-1-yl]cyclopropanecarboxylate; epsilon-metofluthrin	-	240494-71-7	Acute Tox. 4; Acute Tox. 3; STOT SE 1; STOT RE 2			Details
2,3,5,6-tetrafluoro-4-(methoxymethyl)benzyl (Z)-(1R,3R)-3-(2-cyanoprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate; epsilon-momfluorothrin	-	1065124-65-3	Acute Tox. 4; STOT SE 2			Details
2,3-epoxypropyl-2-ethylcyclohexyl ether; ethylcyclohexylglycidyl ether	-	130014-35-6	Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1			Details
2,4,5-trimethylaniline hydrochloride	-	21436-97-5	Carc. 1B; Acute Tox. 3			Details
2,7-naphthalenedisulfonic acid, nickel(II) salt	-	72319-19-8	Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1			Details
2-ethylhexanoic acid and its salts, with the exception of those specified elsewhere in this Annex show/hide Metal salts of 2-ethylhexanoic acid EC / List no: - \| CAS no: - 2-ethylhexanoic acid EC / List no: 205-743-6 \| CAS no: 149-57-5	-	-	Repr. 1B			Details
3-chloro-6-cyano-bicyclo(2,2,1)heptan-2-one-O-(N-methylcarbamoyl)oxime; triamid	-	15271-41-7	Acute Tox. 2; Acute Tox. 3			Details
3-methylpyrazol-5-yl-dimethylcarbamate; monometilan	-	2532-43-6	Acute Tox. 3			Details
4,4'-oxydianiline and its salts show/hide 4,4'-oxydianiline EC / List no: 202-977-0 \| CAS no: 101-80-4	-	-	Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3			Details
4-(1,1,3,3-Tetramethylbutyl)phenol, ethoxylated	-	-			ENDE Endocrine disrupting properties (Article 57(f) - environment)	Details
4-(3,4,5,6-tetramethyloctan-2-yl)phenol	-	-			R Toxic for reproduction (article 57c) ENDE Endocrine disrupting properties (Article 57(f) - environment) END Endocrine disrupting properties (Article 57(f) - human health)	Details
4-Heptylphenol, branched and linear	-	-			ENDE Endocrine disrupting properties (Article 57(f) - environment)	Details
4-Nonylphenol, branched and linear	-	-			ENDE Endocrine disrupting properties (Article 57(f) - environment)	Details
4-Nonylphenol, branched and linear, ethoxylated	-	-			ENDE Endocrine disrupting properties (Article 57(f) - environment)	Details
5-(3,6,9-trioxa-2-undecy loxy)benzo(d)-1,3-dioxolane; sesamex	-	51-14-9	Acute Tox. 4			Details
5-sec-Butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane	-	-			VPVB very Persistent and very Bioaccumulative (article 57e)	Details
5-sec-Butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [2] [covering any of the individual stereoisomers of [1] and [2] or any combination thereof]	-	-			VPVB very Persistent and very Bioaccumulative (article 57e)	Details
5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane	-	-			VPVB very Persistent and very Bioaccumulative (article 57e)	Details
8,9,10-trinorborn-2-yl acrylate	-	10027-06-2	Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1			Details
Absettarov	-	-		V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.		Details
Acanthamoeba castellani	-	-		P Parasites		Details
Actinomadura madurae	-	-		B Bacteria and similar species		Details
Actinomadura pelletieri	-	-		B Bacteria and similar species		Details
Actinomyces gerencseriae	-	-		B Bacteria and similar species		Details
Actinomyces israelii	-	-		B Bacteria and similar species		Details
Actinomyces pyogenes	-	-		B Bacteria and similar species		Details
Actinomyces spp.	-	-		B Bacteria and similar species		Details
Acute haemorrhagic conjunctivitis virus	-	-		V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.		Details
Acyl Halides of 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionic acid	-	-			E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment) HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health)	Details
Adenoviridae	-	-		V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.		Details

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EU-IN_VITRO_MEDICAL_DEVICE_REG-ART_5_2_ANX_1

EU-IN_VITRO_MEDICAL_DEVICE_REG-ART_5_2_ANX_1

In Vitro Diagnostic Medical Devices Regulation - Hazardous Substances

EU. Hazardous Substances for Purposes of Art. 5(2) and Annex I of Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices, 5 May 2017, as corrected 27 December 2019

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Last updated 23 April 2024. Database contains 4917 unique substances/entries.

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