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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 18 April 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
Alkanes, chloro
263-004-3
61788-76-9
yes
alkenes, C12-14, hydroformylation products, distn. residues, C-(hydrogen sulfobutanedioates), disodium salts
435-660-2
243662-67-1
Skin Irrit. 2; Skin Sens. 1
alkyl(rapeseed oil), bis(2-hydroxyethyl)ammonium fluoride
435-650-8
-
Acute Tox. 4; Skin Corr. 1A
allethrin; (RS)-3-allyl-2-methyl-4-oxocyclopent-2-enyl (1RS,3RS;1RS,3SR)-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate; bioallethrin; (RS)-3-allyl-2-methyl-4-oxocyclopent-2-enyl (1R,3R)-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate;esbiothrin; (RS)-3-allyl-2-methyl-4-oxocyclopent-2-enyl(1R,3R)-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate
209-542-4
584-79-2;84030-86-4
Acute Tox. 4
allethrin; (RS)-3-allyl-2-methyl-4-oxocyclopent-2-enyl (1RS,3RS;1RS,3SR)-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate; bioallethrin; (RS)-3-allyl-2-methyl-4-oxocyclopent-2-enyl (1R,3R)-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate;esbiothrin; (RS)-3-allyl-2-methyl-4-oxocyclopent-2-enyl(1R,3R)-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate
209-542-4
584-79-2;84030-86-4
Acute Tox. 4
allidochlor (ISO); N,N-diallylchloroacetamide
202-270-7
93-71-0
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
allyl alcohol
203-470-7
107-18-6
Flam. Liq. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
allyl glycidyl ether; allyl 2,3-epoxypropyl ether; prop-2-en-1-yl 2,3-epoxypropyl ether
203-442-4
106-92-3
Flam. Liq. 3; Carc. 2; Muta. 2; Repr. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
allyl methacrylate; 2-methyl-2-propenoic acid 2-propenyl ester
202-473-0
96-05-9
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4
allylamine
203-463-9
107-11-9
Flam. Liq. 2; Acute Tox. 3
Alpha-hexabromocyclododecane
603-801-9
134237-50-6
yes
aluminium alkyls
-
-
Pyr. Liq. 1; Water-react. 1; Skin Corr. 1B
aluminium chloride, anhydrous
231-208-1
7446-70-0
Skin Corr. 1B
aluminium lithium hydride
240-877-9
16853-85-3
Water-react. 1; Skin Corr. 1A
aluminium phosphide
244-088-0
20859-73-8
Water-react. 1; Acute Tox. 2; Acute Tox. 3; Acute Tox. 1
aluminium powder (pyrophoric);aluminium powder (stabilised)
231-072-3
7429-90-5
Water-react. 2; Flam. Sol. 1
aluminium powder (pyrophoric);aluminium powder (stabilised)
231-072-3
7429-90-5
Water-react. 2; Pyr. Sol. 1
aluminium-tri-isopropoxide
209-090-8
555-31-7
Flam. Sol. 1
Aluminosilicate Refractory Ceramic Fibres
604-314-4
142844-00-6
yes
ametryn (ISO);N-ethyl-N'-isopropyl-6-(methyl-thio)-1,3,5-triazine-2,4-diamine
212-634-7
834-12-8
Acute Tox. 4
amidithion (ISO); 2-methoxyethylcarbamoylmethyl O,O-dimethyl phosphorodithioate
-
919-76-6
Acute Tox. 4
amines, coco alkyl
262-977-1
61788-46-3
Acute Tox. 4; Asp. Tox. 1; STOT SE 3; STOT RE 2; Skin Corr. 1B
amines, hydrogenated tallow alkyl
262-976-6
61788-45-2
Asp. Tox. 1; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
amines, polyethylenepoly-; HEPA;polyethlyenepolyamines with the exception of those specified elsewhere in this Annex
268-626-9
68131-73-7
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
amines, polyethylenepoly-; HEPA;polyethlyenepolyamines with the exception of those specified elsewhere in this Annex
268-626-9
68131-73-7
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
amines, tallow alkyl
263-125-1
61790-33-8
Acute Tox. 4; Asp. Tox. 1; STOT RE 2; Skin Corr. 1B
aminocarb (ISO); 4-dimethylamino-3-tolyl methylcarbamate
217-990-7
2032-59-9
Acute Tox. 3
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
amitraz (ISO); N,N-bis(2,4-xylyliminomethyl); methylamine
251-375-4
33089-61-1
Acute Tox. 4; STOT RE 2; Skin Sens. 1
amitrole (ISO);1,2,4-triazol-3-ylamine
200-521-5
61-82-5
Repr. 2; STOT RE 2
ammonia ....%
215-647-6
1336-21-6
Skin Corr. 1B
ammonia, anhydrous
231-635-3
7664-41-7
Flam. Gas 2; Press. Gas; Acute Tox. 3; Skin Corr. 1B
ammonium (Z)-α-methoxyimino-2-furylacetate
640 AMMONIUM SALT; KSMIA; S-102; SMIA
405-990-1
97148-39-5
Flam. Sol. 1
Ammonium 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propanoate
700-242-3
62037-80-3
yes
ammonium 2-cocoyloxyethanesulfonate
441-050-7
223705-57-5
Skin Irrit. 2; Eye Dam. 1
ammonium bifluoride; ammonium hydrogen difluoride
215-676-4
1341-49-7
Acute Tox. 3; Skin Corr. 1B
ammonium bis(1-(3,5-dinitro-2-oxidophenylazo)-3-(N-phenylcarbamoyl)-2-naphtholato)chromate(1-)
AIZEN SPILON BLACK TRH; AIZEN SPILON SCHWARZ TRH; THR-1; TRH
400-110-2
109125-51-1
Self-react. C
ammonium chloride
235-186-4
12125-02-9
Acute Tox. 4; Eye Irrit. 2
ammonium dichromate
232-143-1
7789-09-5
Ox. Sol. 2; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
ammonium fluoride
235-185-9
12125-01-8
Acute Tox. 3
ammonium nonadecafluorodecanoate
221-470-5
3108-42-7
Carc. 2; Repr. 1B; Lact.
yes
ammonium perchlorate
232-235-1
7790-98-9
Expl. 1.1; Ox. Sol. 1
Ammonium perfluorohexane-1-sulphonate
269-511-6
68259-08-5
yes
ammonium perfluorooctanesulfonate; ammonium heptadecafluorooctanesulfonate
249-415-0
29081-56-9
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
ammonium polysulphides
232-989-1
9080-17-5
Skin Corr. 1B
ammonium salt of DNOC; ammonium 4,6-dinitro-o-tolyl oxide
221-037-0
2980-64-5
Acute Tox. 2; Acute Tox. 1; STOT RE 2
Ammonium salts of perfluorononan-1-oic-acid
-
4149-60-4
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
yes
ammoniumpentadeca-fluorooctanoate
223-320-4
3825-26-1
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
yes
amylase, α-
232-565-6
9000-90-2
Resp. Sens. 1
amylases with the exception of those specified elsewhere in this Annex
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Amylase, α-, Aspergillus oryzae EC / List no: 232-588-1 | CAS no: 9001-19-8
Amylase EC / List no: 232-567-7 | CAS no: 9000-92-4
Amylase, mixed with proteinase, Bacillus thuringiensis-fermented EC / List no: - | CAS no: 68909-36-4
Amylase, alpha-, Bacillus amyloliquefaciens EC / List no: - | CAS no: 152923-48-3
Amylase, bacterial EC / List no: 232-560-9 | CAS no: 9000-85-5
Amylase, gluco- EC / List no: 232-877-2 | CAS no: 9032-08-0
Amylase, α- EC / List no: 232-565-6 | CAS no: 9000-90-2
Amylase, fungal EC / List no: 232-742-8 | CAS no: 9013-01-8
Amylase, mixture with proteinase EC / List no: 685-079-5 | CAS no: 9001-11-0
Bacteria, complex with amylase and proteinase EC / List no: - | CAS no: 68920-42-3
Amylase, gluco-, Rhizopus oryzae EC / List no: - | CAS no: 152923-55-2
Amylase, β- EC / List no: 232-566-1 | CAS no: 9000-91-3
Amylase, mixed with proteinase, Bacillus cereus-fermented EC / List no: - | CAS no: 68909-35-3
Amylase, iso- EC / List no: 232-956-1 | CAS no: 9067-73-6
-
-
Resp. Sens. 1
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