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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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
Borate(2-), tetrahydroxybis[μ-(peroxy-κO1:κO2)]di-, sodium, hydrate (1:2:6)
-
125022-34-6
yes
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), sodium salt (1:1)
-
14890-53-0
yes
Boric acid, sodium salt
215-604-1
1333-73-9
yes
boron tribromide
233-657-9
10294-33-4
Acute Tox. 2; Skin Corr. 1A
boron trichloride
233-658-4
10294-34-5
Press. Gas; Acute Tox. 2; Skin Corr. 1B
bromobenzene
203-623-8
108-86-1
Flam. Liq. 3; Skin Irrit. 2
bromofenoxim (ISO); 3,5-dibromo-4-hydroxybenzaldehyde-O-(2,4-dinitrophenyl)-oxime
236-129-6
13181-17-4
Acute Tox. 4
bromoxynil (ISO) 3,5-dibromo-4-hydroxybenzonitrile; bromoxynil phenol
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3,5-dibromo-4-hydroxybenzonitrile EC / List no: 216-882-7 | CAS no: 1689-84-5
2,6-dibromo-4-cyanophenyl octanoate EC / List no: 216-885-3 | CAS no: 1689-99-2
2,6-dibromo-4-cyanophenyl heptanoate EC / List no: 260-300-4 | CAS no: 56634-95-8
2,6-dibromo-4-cyanophenyl butyrate EC / List no: 223-374-9 | CAS no: 3861-41-4
216-882-7
1689-84-5
Repr. 2; Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
bromoxynil octanoate (ISO); 2,6-dibromo-4-cyanophenyl octanoate
216-885-3
1689-99-2
Repr. 2; Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
but-1-ene
203-449-2
106-98-9
Flam. Gas 1; Press. Gas
but-2-yne-1,4-diol; 2-butyne-1,4-diol
203-788-6
110-65-6
Skin Corr. 1B; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Sens. 1
butane;butane (containing ≥ 0,1 % butadiene (203-450-8))
203-448-7
106-97-8
Flam. Gas 1; Press. Gas
butane;butane (containing ≥ 0,1 % butadiene (203-450-8))
203-448-7
106-97-8
Flam. Gas 1; Press. Gas; Carc. 1A; Muta. 1B
butene, mixed-1-and-2-isomers
203-452-9
107-01-7
Flam. Gas 1; Press. Gas
butroxydim (ISO); 5-(3-butyryl-2,4,6-trimethylphenyl)-2-[1-(ethoxyimino)propyl]-3-hydroxycyclohex-2-en-1-one
BUTROXYDIM; ICIA0500
414-790-3
138164-12-2
Repr. 2; Acute Tox. 4; Skin Irrit. 2
butyl (dialkyloxy(dibutoxyphosphoryloxy))titanium (trialkyloxy)titanium phosphate
TILCOM CA35; TILCOM IA10; TYTAN AP 100; TYTAN CA 100; TYTAN CX 35; TYZOR IAM
401-100-0
109037-78-7
Flam. Liq. 2; Eye Irrit. 2
butyl butyrate
203-656-8
109-21-7
Flam. Liq. 3
butylamine
203-699-2
109-73-9
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
butyraldehyde
204-646-6
123-72-8
Flam. Liq. 2
butyraldehyde oxime
203-792-8
110-69-0
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2
butyric acid
203-532-3
107-92-6
Skin Corr. 1B
butyryl chloride
205-498-5
141-75-3
Flam. Liq. 2; Skin Corr. 1B
C,C'-azodi(formamide)
204-650-8
123-77-3
Resp. Sens. 1
yes
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