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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 26 April 2024. Database contains 4821 unique substances/entries.
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237-411-1
13775-54-7
Carc. 1A; STOT RE 1; Skin Sens. 1
234-828-0
12035-64-2
Carc. 1A; STOT RE 1; Skin Sens. 1
235-033-1
12059-14-2
Carc. 1A; STOT RE 1; Skin Sens. 1
215-217-8
1314-06-3
Carc. 1A; STOT RE 1; Skin Sens. 1
620-400-4
12031-65-1
Carc. 1A; STOT RE 1; Skin Sens. 1
-
12673-58-4
Carc. 1A; STOT RE 1; Skin Sens. 1
238-034-5
14177-55-0
Carc. 1A; STOT RE 1; Skin Sens. 1
248-169-1
27016-75-7
Carc. 1A; STOT RE 1; Skin Sens. 1
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77900.
271-853-6
68610-24-2
Carc. 1A; STOT RE 1; Skin Sens. 1
235-723-2
12619-90-8
Carc. 1A; STOT RE 1; Skin Sens. 1
234-493-0
12007-00-0
Carc. 1A; STOT RE 1; Skin Sens. 1
-
65229-23-4
Carc. 1A; STOT RE 1; Skin Sens. 1
235-103-1
12068-61-0
Carc. 1A; STOT RE 1; Skin Sens. 1
234-823-3
12035-36-8
Carc. 1A; STOT RE 1; Skin Sens. 1
235-379-3
12201-89-7
Carc. 1A; STOT RE 1; Skin Sens. 1
257-970-5
52502-12-2
Carc. 1A; STOT RE 1; Skin Sens. 1
Product of blowing smelted nickel ore in a converter to lower the iron content.
273-749-6
69012-50-6
Carc. 1A; STOT RE 1; Skin Sens. 1
215-215-7
1313-99-1
Carc. 1A; STOT RE 1; Skin Sens. 1
208-933-7
547-67-1
Carc. 1A; STOT RE 1; Skin Sens. 1
234-323-5
11099-02-8
Carc. 1A; STOT RE 1; Skin Sens. 1
215-216-2
1314-05-2
Carc. 1A; STOT RE 1; Skin Sens. 1
250-788-7
31748-25-1
Carc. 1A; STOT RE 1; Skin Sens. 1
235-260-6
12142-88-0
Carc. 1A; STOT RE 1; Skin Sens. 1
234-824-9
12035-38-0
Carc. 1A; STOT RE 1; Skin Sens. 1
235-752-0
12653-76-8
Carc. 1A; STOT RE 1; Skin Sens. 1
234-825-4
12035-39-1
Carc. 1A; STOT RE 1; Skin Sens. 1
239-876-6
15780-33-3
Carc. 1A; STOT RE 1; Skin Sens. 1
238-032-4
14177-51-6
Carc. 1A; STOT RE 1; Skin Sens. 1
274-755-1
70692-93-2
Carc. 1A; STOT RE 1; Skin Sens. 1
244-578-4
21784-78-1
Carc. 1A; STOT RE 1; Skin Sens. 1
An inorganic pigment that is the reaction product of high temperature calcination in which nickel (II) oxide and silicon oxide in varying amounts are homogeneously and ionically interdiffused to form a crystalline matrix of olivine. Its composition may include any one or a combination of the modifiers alkali or alkaline earth halides.
271-112-7
68515-84-4
Carc. 1A; STOT RE 1; Skin Sens. 1
243-867-2
20543-06-0
Carc. 1A; STOT RE 1; Skin Sens. 1
253-461-7
37321-15-6
Carc. 1A; STOT RE 1; Skin Sens. 1
235-688-3
12519-85-6
Carc. 1A; STOT RE 1; Skin Sens. 1
236-771-7
13477-70-8
Carc. 1A; STOT RE 1; Skin Sens. 1
-
74646-29-0
Carc. 1A; STOT RE 1; Skin Sens. 1
234-495-1
12007-02-2
Carc. 1A; STOT RE 1; Skin Sens. 1
-
12137-12-1
Carc. 1A; STOT RE 1; Skin Sens. 1
CARTASOL GEEL M-GL CONC.; CARTASOL GELB M-GL FLÜSSIG (ZUBEREITUNG); CARTASOL GELB M-GL KONZ.; CARTASOL YELLOW M-GL CONC.; HM 2580
401-500-5
118658-99-4
Carc. 1B
214-237-4
1116-54-7
Carc. 1B
209-474-5
581-89-5
Carc. 1B
205-057-7
132-32-1
Carc. 1B
209-321-2
569-61-9
Carc. 1B
200-453-6
60-09-3
Carc. 1B
yes
202-204-7
92-93-3
Carc. 1B
210-025-0
602-87-9
Carc. 1B
ARANCIO DISPERSO 149; C.I. DISPERSE ORANGE 149; DISPERS ORANGE 149; DISPERSE ORANGE 149; ORANGE DISPERSE 149; TERASIL GOLDGELB 2RS
400-340-3
85136-74-9
Carc. 1B
A complex combination of hydrocarbons obtained as a redistillate from the distillation of wash oil. It consists predominantly of 2-ringed aromatic and heterocyclic hydrocarbons boiling in the range of approximately 260°C to 290°C (500°F to 554°F).
309-851-5
101316-45-4
Carc. 1B
292-454-3
90622-53-0
Carc. 1B
A complex combination of hydrocarbons from the base-freed fraction obtained from the distillation of coal tar and boiling in the range of approximately 325°C to 365°C (617°F to 689°F). It contains predominantly anthracene and phenanthrene and their alkyl derivatives.
295-274-3
91995-14-1
Carc. 1B

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