EU-IN_VITRO_MEDICAL_DEVICES-ART_3_ANX_1

In Vitro Diagnostic Medical Devices Directive - Hazardous Substances

EU. Hazardous Substances for Purposes of Article 3 & Annex I (Essential Requirements), Directive 98/79/EC on In Vitro Diagnostic Medical Devices, 7 December 1998

This list contains a non-exhaustive inventory of hazardous substances for purposes of essential requirements (Article 3 and Annex I) for general safety, design, manufacture and hazard communication of in vitro diagnostic medical devices. 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). Note that Regulation 2017/746/EU on in vitro diagnostic medical devices was published in the EU Official Journal on 5 May 2017. With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

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Last updated 03 May 2024. Database contains 4821 unique substances/entries.
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Substance Name
EC No.
CAS No.
EU CLP (1272/2008)
EU_BA Directive 2000/54/EC
EU REACH: List of SVHC
Di-, tri- and tetrachlorotetradecane
950-299-5
-
yes
Nonylphenol, ethoxylated (EO = 10)
939-993-9
-
yes
Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP)
939-460-0
1471311-26-8
yes
Nonylphenol, ethoxylated (polymer)
938-618-6
-
yes
Zirconia Aluminosilicate Refractory Ceramic Fibres
936-037-2
-
yes
proteases with the exception of those specified elsewhere in this Annex
show/hide
Proteinase, serine (Tritirachium album) EC / List no: 686-165-5 | CAS no: 102925-54-2
Proteinase, Aspergillus alkaline EC / List no: 232-977-6 | CAS no: 9074-07-1
Myxobacteralphalyticproteinase EC / List no: - | CAS no: 12585-31-8
Proteinase, Agkistrodon serine EC / List no: 232-933-6 | CAS no: 9046-56-4
Proteinase, Bacillus subtilis serine EC / List no: 266-557-9 | CAS no: 67051-83-6
Proteinase, serine EC / List no: 253-431-3 | CAS no: 37259-58-8
Proteinase, Bacillus subtilis metallo- EC / List no: 232-991-2 | CAS no: 9080-56-2
Proteinase, Staphylococcus aureus serine EC / List no: 259-611-8 | CAS no: 55354-32-0
Aspergillin M EC / List no: - | CAS no: 42615-60-1
Proteinase, Mucor aspartic EC / List no: 232-975-5 | CAS no: 9073-79-4
Bacteria, complex with amylase and proteinase EC / List no: - | CAS no: 68920-42-3
Proteinase, Aspergillus neutral EC / List no: 278-588-5 | CAS no: 77000-13-6
Proteinase, Bacillus neutral EC / List no: 278-547-1 | CAS no: 76774-43-1
Proteinase, Aspergillus parasiticus neutral EC / List no: 254-418-5 | CAS no: 39335-09-6
Proteinase, bacterial E 30 serine EC / List no: - | CAS no: 39369-34-1
Proteinase, Tritirachium album serine EC / List no: 254-457-8 | CAS no: 39450-01-6
Proteinase, Bacillus alkaline EC / List no: 232-972-9 | CAS no: 9073-77-2
Proteinase, Myxobacter AL-1, II EC / List no: 276-716-4 | CAS no: 72561-05-8
Proteinase, Streptomyces griseus EC / List no: 232-909-5 | CAS no: 9036-06-0
Proteinase, Endothia aspartic EC / List no: 253-395-9 | CAS no: 37205-60-0
Proteinase, Serratia extracellular EC / List no: 253-457-5 | CAS no: 37312-62-2
Proteinase, Bacillus subtilis EC / List no: 257-520-8 | CAS no: 51931-23-8
Amylase, mixed with proteinase, Bacillus cereus-fermented EC / List no: - | CAS no: 68909-35-3
Amylase, mixed with proteinase, Bacillus thuringiensis-fermented EC / List no: - | CAS no: 68909-36-4
Proteinase, pancreatic EC / List no: 232-626-7 | CAS no: 9001-72-3
Proteinase, Bothrops atrox serine EC / List no: 232-918-4 | CAS no: 9039-61-6
Proteinase, Myxobacter α-lytic EC / List no: 253-448-6 | CAS no: 37288-76-9
Proteinase, microbial acid EC / List no: 256-862-5 | CAS no: 50936-52-2
Amylase, mixture with proteinase EC / List no: 685-079-5 | CAS no: 9001-11-0
Proteinase, rhizopus acid EC / List no: 812-486-9 | CAS no: 9074-09-3
Proteinase, aspartic EC / List no: 278-856-1 | CAS no: 78169-47-8
Proteinase, microbial alkaline EC / List no: 256-863-0 | CAS no: 50936-53-3
Thrombin EC / List no: 232-648-7 | CAS no: 9002-04-4
Proteinase, Bacillus alcalophilus serine EC / List no: 306-090-0 | CAS no: 95979-76-3
Proteinase, Bacillus polymyxa neutral EC / List no: 255-914-4 | CAS no: 42613-33-2
Proteinase, oryzin EC / List no: 232-992-8 | CAS no: 9081-30-5
Proteinase, microbial neutral EC / List no: 232-966-6 | CAS no: 9068-59-1
Proteinase, Aspergillus niger neutral EC / List no: 254-422-7 | CAS no: 39346-39-9
Proteinase, Aspergillus melleus, semialkaline EC / List no: - | CAS no: 76106-83-7
Proteinase, Bacillus licheniformis serine EC / List no: 279-361-3 | CAS no: 79986-26-8
Proteinase, Aspergillus oryzae neutral EC / List no: 232-990-7 | CAS no: 9080-55-1
Proteinase, Bacillus subtilis, sutilain EC / List no: 235-390-3 | CAS no: 12211-28-8
Bacillus megaterium protease fermentation product EC / List no: - | CAS no: 68909-17-1
Proteinase, submandibular gland serine, A EC / List no: 279-893-6 | CAS no: 82047-85-6
Proteinase, Aspergillus acid EC / List no: 232-796-2 | CAS no: 9025-49-4
934-013-6
39450-01-6
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
Nonylphenolpolyglycolether
932-998-7
-
yes
Nonylphenol, ethoxylated (15-EO) (9016-45-9)
931-756-8
-
yes
Nonylphenol, ethoxylated (10-EO) (9016-45-9)
931-755-2
-
yes
Nonylphenol, ethoxylated (8-EO) (9016-45-9)
931-754-7
-
yes
Nonylphenol, ethoxylated (6,5-EO) (9016-45-9)
931-753-1
-
yes
Reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate; reaction mass of DOTE and MOTE
915-270-3
-
yes
(2RS)-2-[4-(4-chlorophenoxy)-2-(trifluoromethyl)phenyl]-1-(1H-1,2,4-triazol-1-yl)propan-2-ol; mefentrifluconazole
822-682-6
1417782-03-6
Skin Sens. 1
N-methoxy-N-[1-methyl-2-(2,4,6-trichlorophenyl)-ethyl]-3-(difluoromethyl)- 1-methylpyrazole-4-carboxamide; pydiflumetofen
817-852-1
1228284-64-7
Carc. 2; Repr. 2
(RS)-4-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole; medetomidine
811-718-6
86347-14-0
Acute Tox. 2; STOT SE 3; STOT SE 1; STOT RE 1
sulfoxaflor (ISO); [methyl(oxo) {1-[6-(trifluoromethyl)-3-pyridyl]ethyl}-λ6-sulfanylidene]cyanamide
807-366-8
946578-00-3
Acute Tox. 4
4-{[(6-chloropyridin-3-yl)methyl](2,2-difluoroethyl)amino}furan-2(5H)-one; flupyradifurone
804-373-8
951659-40-8
Acute Tox. 4; STOT RE 2
Tris(4-nonylphenyl, branched) phosphite
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Phenol, p-isononyl-, phosphite (3:1) EC / List no: - | CAS no: 31631-13-7
Phenol, 4-nonyl-, phosphite (3:1) EC / List no: 608-492-4 | CAS no: 3050-88-2
Tris(nonylphenyl) phosphite EC / List no: 247-759-6 | CAS no: 26523-78-4
Phenol, p-sec-nonyl-, phosphite EC / List no: - | CAS no: 106599-06-8
tris(4-nonylphenyl, branched) phosphite EC / List no: 701-028-2 | CAS no: -
799-976-5
-
yes
Dioctyltin dilaurate, stannane, dioctyl-, bis(coco acyloxy) derivs., and any other stannane, dioctyl-, bis(fatty acyloxy) derivs. wherein C12 is the predominant carbon number of the fatty acyloxy moiety
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Stannane, dioctyl-, bis(coco acyloxy) derivs. EC / List no: 293-901-5 | CAS no: 91648-39-4
dioctyltin dilaurate; stannane, dioctyl-, bis(coco acyloxy) derivs. EC / List no: - | CAS no: -
Dioctyltin dilaurate EC / List no: 222-883-3 | CAS no: 3648-18-8
799-973-9
-
yes
Phenol, alkylation products (mainly in para position) with C12-rich branched alkyl chains from oligomerisation, covering any individual isomers and/ or combinations thereof (PDDP)
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Phenol, dodecyl-, branched EC / List no: 310-154-3 | CAS no: 121158-58-5
Phenol, 4-dodecyl, branched EC / List no: 640-104-9 | CAS no: 210555-94-5
[No public or meaningful name is available] EC / List no: - | CAS no: 27459-10-5
Phenol, (tetrapropenyl) derivatives EC / List no: 616-100-8 | CAS no: 74499-35-7
Phenol, tetrapropylene- EC / List no: - | CAS no: 57427-55-1
Phenol, 4-isododecyl- EC / List no: 608-055-8 | CAS no: 27147-75-7
799-972-3
-
yes
Medium-chain chlorinated paraffins (MCCP)
UVCB substances consisting of more than or equal to 80% linear chloroalkanes with carbon chain lengths within the range from C14 to C17
show/hide
Tetradecane, chloro derivs. EC / List no: - | CAS no: 198840-65-2
di-, tri- and tetrachlorotetradecane EC / List no: 950-299-5 | CAS no: -
Alkanes, C14-16, chloro EC / List no: 701-376-5 | CAS no: 1372804-76-6
Alkanes, C14-17, chloro EC / List no: 287-477-0 | CAS no: 85535-85-9
799-971-8
-
yes
2-(4-tert-Butylbenzyl)propionaldehyde and its individual stereoisomers
show/hide
(2S)-3-(4-tert-butylphenyl)-2-methylpropanal EC / List no: - | CAS no: 75166-30-2
(2R)-3-(4-tert-butylphenyl)-2-methylpropanal EC / List no: - | CAS no: 75166-31-3
2-(4-tert-butylbenzyl)propionaldehyde EC / List no: 201-289-8 | CAS no: 80-54-6
799-970-2
-
yes
metaflumizone (ISO); (EZ)-2-[2-(4-cyanophe-nyl)-1-(a,a,a -trifluoro-m-tolyl)ethylidene]-[4-(tri-fluoromethoxy)phenyl] carbanilohydrazide [E-iso-mer > 90 %, Z-isomer <10 % relative content]; [1] (E)-2-[2-(4-cyanophenyl)-1-(a,a,a -trifluoro-m-tolyl) ethylidene]-[4-(trifluoro-methoxy)phenyl]carbani-lohydrazide [2]
701-454-9
852403-68-0
Repr. 2; Lact.; STOT RE 2
(3E)-1,7,7-trimethyl-3-(4-methylbenzylidene)bicyclo[2.2.1]heptan-2-one
701-394-3
1782069-81-1
yes
Alkanes, C14-16, chloro
701-376-5
1372804-76-6
yes
(RS)-1-{1-ethyl-4-[4-mesyl-3-(2-methoxyethoxy)-o-toluoyl]pyrazol-5-yloxy} ethyl methyl carbonate; tolpyralate
701-225-3
1101132-67-5
Carc. 2; Repr. 2; STOT RE 2
phenol, 3-dodecyl-, branched
701-107-1
1801269-77-1
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
phenol, 2-dodecyl-, branched
701-105-0
1801269-80-6
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
Ammonium 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propanoate
700-242-3
62037-80-3
yes
2-methyl-1,2-benzothiazol-3(2H)-one; [MBIT]
695-989-4
2527-66-4
Acute Tox. 4; Acute Tox. 3; Skin Corr. 1C; Eye Dam. 1; Skin Sens. 1A
(5-chloro-2-methoxy-4-methyl-3-pyridyl) (4,5,6-trimethoxy-o-tolyl)methanone; pyriofenone
692-456-8
688046-61-9
Carc. 2
benzovindiflupyr (ISO); N-[9-(dichloromethylene)-1,2,3,4-tetrahydro-1,4-methanonaphthalen-5-yl]-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide
691-719-4
1072957-71-1
Acute Tox. 3
N-{2-[[1,1'-bi (cyclopropyl)]-2-yl] phenyl}-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide; sedaxane
688-331-2
874967-67-6
Carc. 2
2-{2-[4-(3,6-dimethylheptan-3-yl)phenoxy]ethoxy}ethanol
687-833-9
1119449-38-5
yes
2-[4-(3,6-dimethylheptan-3-yl)phenoxy]ethanol
687-832-3
1119449-37-4
yes
di-L-para-menthene
686-814-2
34363-01-4
Skin Irrit. 2; Skin Sens. 1
tetracopper hexahydroxide sulphate hydrate
682-362-5
12527-76-3
Acute Tox. 4
trinexapac-ethyl (ISO); ethyl 4-[cyclopropyl (hydroxy) methylene]-3,5-dioxocyclohexanecarboxylate
680-302-2
95266-40-3
STOT RE 2; Skin Sens. 1B
amisulbrom (ISO); 3-(3-bromo-6-fluoro-2-methylindol-1-ylsulfonyl)-N,N-dimethyl-1H-1,2,4-triazole-1-sulfonamide
672-776-4
348635-87-0
Carc. 2; Eye Irrit. 2
cyflumetofen (ISO); 2-methoxyethyl (RS)-2-(4-tert-butylphenyl)-2-cyano-3-oxo-3-(α,α,α-trifluoro-o-tolyl)propionate
642-974-5
400882-07-7
Carc. 2; Skin Sens. 1A
hydroxyisohexyl 3-cyclohexene carboxaldehyde (INCI); reaction mass of 4-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde and 3-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde
641-410-5
130066-44-3
Skin Sens. 1A
Cadmium chloride, hydrate (2:5)
640-998-0
7790-78-5
yes
phenol, 4-dodecyl-, branched
640-104-9
210555-94-5
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
yes
α-hydroxypoly(methyl-(3-(2,2,6,6-tetramethylpiperidin-4-yloxy)propyl)siloxane)
639-478-6
182635-99-0
Acute Tox. 4; Skin Corr. 1B
4-(3-ethylheptan-2-yl)phenol
635-696-0
186825-39-8
yes
4-(3,6-dimethylheptan-3-yl)phenol
635-391-2
142731-63-3
yes
4-(3,5-dimethylheptan-3-yl)phenol
635-389-1
186825-36-5
yes
4-(2,6-dimethylheptan-2-yl)phenol
635-388-6
521947-27-3
yes
pinoxaden (ISO); 8-(2,6-diethyl-4-methylphenyl)-7-oxo-1,2,4,5-tetrahydro-7H-pyrazolo[1,2-d][1,4,5]oxadiazepin-9-yl 2,2-dimethylpropanoate
635-361-9
243973-20-8
Repr. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Sens. 1A
methacrifos (ISO); methyl (E)-3-[(dimethoxyphosphinothioyl)oxy]methacrylate
630-448-8
62610-77-9
Acute Tox. 4; Skin Sens. 1
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