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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 08 listopada 2024. Database contains 4821 unique substances/entries.
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203-449-2
106-98-9
Flam. Gas 1; Press. Gas
203-448-7
106-97-8
Flam. Gas 1; Press. Gas
203-448-7
106-97-8
Flam. Gas 1; Press. Gas; Carc. 1A; Muta. 1B
203-445-0
106-94-5
Flam. Liq. 2; Repr. 1B; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
yes
203-444-5
106-93-4
Carc. 1B; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
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
203-441-9
106-91-2
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; STOT RE 1; Eye Dam. 1; Skin Corr. 1C; Skin Sens. 1
203-440-3
106-90-1
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
203-439-8
106-89-8
Flam. Liq. 3; Carc. 1B; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
203-438-2
106-88-7
Flam. Liq. 2; Carc. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Irrit. 2
203-437-7
106-87-6
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4
203-430-9
106-75-2
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
203-417-8
106-63-8
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
203-405-2
106-51-4
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
203-404-7
106-50-3
Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
203-403-1
106-49-0
Carc. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
203-402-6
106-48-9
Acute Tox. 4
203-401-0
106-47-8
Carc. 1B; Acute Tox. 3; Skin Sens. 1
203-400-5
106-46-7
Carc. 2; Eye Irrit. 2
203-398-6
106-44-5
Acute Tox. 3; Skin Corr. 1B
203-397-0
106-43-4
Acute Tox. 4
203-396-5
106-42-3
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
203-389-7
106-36-5
Flam. Liq. 3; Acute Tox. 4
203-388-1
106-35-4
Flam. Liq. 3; Acute Tox. 4; Eye Irrit. 2
203-377-1
106-24-1
Skin Sens. 1
203-336-8
105-83-9
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
203-326-3
105-74-8
Org. Perox. D
203-322-1
105-68-0
Flam. Liq. 3
203-321-6
105-67-9
Acute Tox. 3; Skin Corr. 1B
203-313-2
105-60-2
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
203-312-7
105-59-9
Eye Irrit. 2
203-310-6
105-57-7
Flam. Liq. 2; Eye Irrit. 2; Skin Irrit. 2
203-301-7
105-48-6
Flam. Liq. 3; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
203-300-1
105-46-4
Flam. Liq. 2
203-299-8
105-45-3
Eye Irrit. 2
203-294-0
105-39-5
Acute Tox. 3
203-291-4
105-37-3
Flam. Liq. 2
203-290-9
105-36-2
Acute Tox. 2; Acute Tox. 1
203-275-7
105-16-8
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
203-254-2
104-94-9
Acute Tox. 2; Acute Tox. 1; STOT RE 2
203-251-6
104-91-6
Muta. 2; Acute Tox. 4; Eye Dam. 1
203-239-0
104-80-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
203-236-4
104-78-9
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
203-199-4
104-40-5
yes
203-180-0
104-15-4
Skin Corr. 1B
203-180-0
104-15-4
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
203-176-9
104-12-1
Acute Tox. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1
203-149-1
103-83-3
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
203-135-5
103-69-5
Acute Tox. 3; STOT RE 2
203-132-9
103-65-1
Flam. Liq. 3; Asp. Tox. 1; STOT SE 3
203-102-5
103-33-3
Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2
203-083-3
103-16-2
Eye Irrit. 2; Skin Sens. 1
203-080-7
103-11-7
STOT SE 3; Skin Irrit. 2; Skin Sens. 1
203-052-4
102-77-2
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
203-002-1
102-06-7
Repr. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
202-987-5
101-90-6
Carc. 1B; Muta. 2; Acute Tox. 3; Acute Tox. 4; Skin Irrit. 2; Eye Irrit. 2; Skin Sens. 1
202-980-7
101-83-7
Acute Tox. 4; Skin Corr. 1B
202-977-0
101-80-4
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3
yes
202-974-4
101-77-9
Carc. 1B; Muta. 2; STOT SE 1; STOT RE 2; Skin Sens. 1
yes
202-969-7
101-72-4
Acute Tox. 4; Skin Sens. 1
202-966-0
101-68-8
Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
202-959-2
101-61-1
Carc. 1B
yes
202-933-0
101-31-5
Acute Tox. 2
202-930-4
101-27-9
Acute Tox. 4; Skin Sens. 1
202-925-7
101-21-3
Carc. 2; STOT RE 2
202-918-9
101-14-4
Carc. 1B; Acute Tox. 4
yes
202-910-5
101-05-3
Eye Irrit. 2; Skin Irrit. 2
202-908-4
101-02-0
Eye Irrit. 2; Skin Irrit. 2
202-905-8
100-97-0
Flam. Sol. 2; Skin Sens. 1
202-873-5
100-63-0
Carc. 1B; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
202-870-9
100-61-8
Acute Tox. 3; STOT RE 2
202-866-7
100-57-2
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
202-860-4
100-52-7
Acute Tox. 4
202-859-9
100-51-6
Acute Tox. 4
202-855-7
100-47-0
Acute Tox. 4
202-854-1
100-46-9
Acute Tox. 4; Skin Corr. 1B
202-853-6
100-44-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
202-851-5
100-42-5
Flam. Liq. 3; Repr. 2; Acute Tox. 4; STOT RE 1; Skin Irrit. 2; Eye Irrit. 2
202-849-4
100-41-4
Flam. Liq. 2; Acute Tox. 4; STOT RE 2; Asp. Tox. 1
202-848-9
100-40-3
Carc. 2
202-847-3
100-39-0
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
202-845-2
100-37-8
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
202-833-7
100-25-4
Acute Tox. 2; Acute Tox. 1; STOT RE 2
202-831-6
100-22-1
Acute Tox. 4
202-811-7
100-02-7
Acute Tox. 4; STOT RE 2
202-810-1
100-01-6
Acute Tox. 3; STOT RE 2
202-809-6
100-00-5
Carc. 2; Muta. 2; Acute Tox. 3; STOT RE 2
202-808-0
99-99-0
Acute Tox. 3; STOT RE 2
202-807-5
99-98-9
Acute Tox. 3
202-805-4
99-97-8
Acute Tox. 3; STOT RE 2
202-796-7
99-87-6
Flam. Liq. 3; Acute Tox. 3; Asp. Tox. 1
202-795-1
99-86-5
Flam. Liq. 3; Acute Tox. 4; Skin Sens. 1; Asp. Tox. 1
202-776-8
99-65-0
Acute Tox. 2; Acute Tox. 1; STOT RE 2
202-765-8
99-55-8
Carc. 2; Acute Tox. 3
202-759-5
99-49-0
Skin Sens. 1
202-752-7
99-35-4
Expl. 1.1; Acute Tox. 2; Acute Tox. 1; STOT RE 2
202-729-1
99-09-2
Acute Tox. 3; STOT RE 2
202-716-0
98-95-3
Carc. 2; Repr. 1B; Acute Tox. 3; STOT RE 1
yes
202-710-8
98-88-4
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
202-709-2
98-87-3
Carc. 2; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1

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