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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 10 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
boric acid
233-139-2
10043-35-3
Repr. 1B
yes
boric acid
234-343-4
11113-50-1
Repr. 1B
yes
Boric acid (H3BO3), disodium salt
-
22454-04-2
yes
Boric acid (H3BO3), sodium salt (1:1)
-
14890-53-0
yes
Boric acid (H3BO3), sodium salt, hydrate
-
25747-83-5
yes
Boric acid, sodium salt
215-604-1
1333-73-9
yes
Butyl 4-hydroxybenzoate
202-318-7
94-26-8
yes
C,C'-azodi(formamide)
204-650-8
123-77-3
Resp. Sens. 1
yes
C.I. Basic Violet 3 with ≥ 0,1 % of Michler's ketone (EC no.202-027-5);C.I. Basic Violet 3; 4-[4,4'-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride;[4-[4,4'-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride; C.I. Basic Violet 3
208-953-6
548-62-9
yes
cadmium carbonate
208-168-9
513-78-0
Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 1
yes
cadmium chloride
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cadmium chloride (CdCl2), hydrate (2:5) EC / List no: 640-998-0 | CAS no: 7790-78-5
233-296-7
10108-64-2
Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
yes
Cadmium chloride, hydrate (2:5)
640-998-0
7790-78-5
yes
cadmium fluoride
232-222-0
7790-79-6
Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
yes
cadmium hydroxide; cadmium dihydroxide
244-168-5
21041-95-2
Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 1
yes
Cadmium nitrate
-
-
yes
cadmium oxide (non-pyrophoric)
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Monteponite (CdO) EC / List no: - | CAS no: 12139-21-8
215-146-2
1306-19-0
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 2; STOT RE 1
yes
Cadmium sulphate;cadmium sulphate
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Sulfuric acid, cadmium salt, hydrate (3:3:8) EC / List no: 616-572-5 | CAS no: 7790-84-3
Sulfuric acid, cadmium salt (1:1), hydrate EC / List no: 626-360-4 | CAS no: 15244-35-6
233-331-6
10124-36-4;31119-53-6
yes
Cadmium sulphate;cadmium sulphate
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Sulfuric acid, cadmium salt, hydrate (3:3:8) EC / List no: 616-572-5 | CAS no: 7790-84-3
Sulfuric acid, cadmium salt (1:1), hydrate EC / List no: 626-360-4 | CAS no: 15244-35-6
233-331-6
10124-36-4;31119-53-6
Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
yes
cadmium sulphide
215-147-8
1306-23-6
Carc. 1B; Muta. 2; Repr. 2; STOT RE 1; Acute Tox. 4
yes
Cadmium;cadmium (non-pyrophoric);cadmium (pyrophoric)
231-152-8
7440-43-9
yes
Calcium arsenate
231-904-5
7778-44-1
yes
Chromic acid
231-801-5
7738-94-5
yes
chromium (VI) trioxide
215-607-8
1333-82-0
Ox. Sol. 1; Carc. 1A; Muta. 1B; Repr. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Skin Corr. 1A; Resp. Sens. 1; Skin Sens. 1
yes
chrysene
205-923-4
218-01-9
Carc. 1B; Muta. 2
yes
cis-cyclohexane-1,2-dicarboxylicanhydride
236-086-3
13149-00-3
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
cobalt carbonate
208-169-4
513-79-1
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
cobalt di(acetate)
200-755-8
71-48-7
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
cobalt dichloride
231-589-4
7646-79-9
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
yes
cobalt dinitrate
233-402-1
10141-05-6
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
cobalt sulfate
233-334-2
10124-43-3
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
yes
cyclohexane-1,2-dicarboxylic anhydride
201-604-9
85-42-7
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
Decamethylcyclopentasiloxane; D5
208-764-9
541-02-6
yes
Di-, tri- and tetrachlorotetradecane
950-299-5
-
yes
di-n-pentyl phthalate
205-017-9
131-18-0
Repr. 1B
yes
diarsenic pentaoxide; arsenic pentoxide; arsenic oxide
215-116-9
1303-28-2
Carc. 1A; Acute Tox. 3
yes
diarsenic trioxide; arsenic trioxide
215-481-4
1327-53-3
Carc. 1A; Acute Tox. 2; Skin Corr. 1B
yes
diboron trioxide
215-125-8
1303-86-2
Repr. 1B
yes
dibutyl phthalate; DBP
201-557-4
84-74-2
Repr. 1B
yes
dibutylbis(pentane-2,4-dionato-O,O')tin
245-152-0
22673-19-4
Repr. 1B; STOT RE 1
yes
dibutyltin dichloride; (DBTC)
211-670-0
683-18-1
Muta. 2; Repr. 1B; Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Corr. 1B
yes
Dichromic acid
236-881-5
13530-68-2
yes
dichromium tris(chromate); chromium III chromate; chromic chromate
246-356-2
24613-89-6
Ox. Sol. 1; Carc. 1B; Skin Corr. 1A; Skin Sens. 1
yes
dicyclohexyl phthalate
201-545-9
84-61-7
Repr. 1B; Skin Sens. 1
yes
diethyl sulphate
200-589-6
64-67-5
Carc. 1B; Muta. 1B; Acute Tox. 4; Skin Corr. 1B
yes
dihexyl phthalate
201-559-5
84-75-3
Repr. 1B
yes
diisobutyl phthalate
201-553-2
84-69-5
Repr. 1B
yes
diisohexyl phthalate
276-090-2
71850-09-4
Repr. 1B
yes
diisopentylphthalate
210-088-4
605-50-5
Repr. 1B
yes
dimethyl sulphate
201-058-1
77-78-1
Carc. 1B; Muta. 2; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
yes
dinoseb (ISO); 6-sec-butyl-2,4-dinitrophenol
201-861-7
88-85-7
Repr. 1B; Acute Tox. 3; Eye Irrit. 2
yes
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