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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

Last updated 12 srpnja 2024. Database contains 4821 unique substances/entries.
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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.
(R)-EPICHLOROHYDRIN
424-280-2
51594-55-9
Flam. Liq. 3; Carc. 1B; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
SCH.19927 DIBENZOYLTARTRATE
404-390-7
88976-55-0
Flam. Sol. 1; Skin Sens. 1
PANTERA; QUIZALOFOP-P-TEFURYL
414-200-4
119738-06-6
Carc. 2; Repr. 2; Acute Tox. 4; STOT RE 2
201-435-0
82-68-8
Skin Sens. 1
602-997-3
124495-18-7
Skin Sens. 1
219-455-3
2439-01-2
Repr. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
202-051-6
91-22-5
Carc. 1B; Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
205-711-1
148-24-3
Repr. 1B; Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
BAS 514 H
402-780-1
84087-01-4
Skin Sens. 1
237-031-6
13593-03-8
Acute Tox. 3; Acute Tox. 4
264-151-6
63449-41-2
Acute Tox. 4; Skin Corr. 1B
610-007-6
422556-08-9
Skin Sens. 1
611-516-6
57369-32-1
Acute Tox. 4
201-762-9
87-66-1
Muta. 2; Acute Tox. 4
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77588.
232-382-1
8012-00-8
yes
236-671-3
13463-41-7
Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Dam. 1
The complex combination of polyalkylated pyridines derived from coal tar distillation or as high-boiling distillates approximately above 150°C (302°F) from the reaction of ammonia with acetaldehyde, formaldehyde or paraformaldehyde.
269-929-9
68391-11-7
Carc. 1B; Muta. 1B
203-809-9
110-86-1
Flam. Liq. 2; Acute Tox. 4
259-686-7
55512-33-9
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
PYRIDABEN
405-700-3
96489-71-3
Acute Tox. 3
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Acute Tox. 4
204-927-3
129-00-0
yes
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108-34-9
Acute Tox. 2; Acute Tox. 1
236-656-1
13457-18-6
Acute Tox. 4

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