EU-IN_VITRO_MEDICAL_DEVICE_REG-ART_5_2_ANX_1

In Vitro Diagnostic Medical Devices Regulation - Hazardous Substances

EU. Hazardous Substances for Purposes of Art. 5(2) and Annex I of Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices, 5 May 2017, as corrected 27 December 2019

This list contains a non-exhaustive inventory of hazardous substances for purposes of Regulation (EU) 2017/746, including Chap. 2 (Placing on the market and putting into service) and Annex I (General Safety and Performance Requirements). 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).

RELEVANT LEGISLATION
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EU CLP (1272/2008)
Carc. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1

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Group members
This group of substance has the following member substances:
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Name EC / List no. CAS no. Association
Nitric acid, beryllium salt, tetrahydrate 690-699-4 13510-48-0 Expert judgement
Beryllium dibromide 232-115-9 7787-46-4 Expert judgement
Beryllium sulphate 236-842-2 13510-49-1 Expert judgement
Bis(pentane-2,4-dionato-O,O')beryllium 233-513-5 10210-64-7 Expert judgement
Beryllium diboride 235-443-0 12228-40-9 Expert judgement
Beryllium, bis(carbonato(2-))dihydroxytri- - 66104-24-3 Expert judgement
Beryllium selenide 235-450-9 12232-25-6 Expert judgement
Beryllium chloride 232-116-4 7787-47-5 Expert judgement
Tetraberyllium boride 235-695-1 12536-52-6 Expert judgement
Silicic acid, beryllium salt 261-293-0 58500-38-2 Expert judgement
Beryllium hydroxide 236-368-6 13327-32-7 Expert judgement
Disodium tetrafluoroberyllate 237-630-2 13871-27-7 Expert judgement
Beryllium phosphide 261-137-1 58127-61-0 Expert judgement
Beryllium oxyfluoride - 63990-88-5 Expert judgement
Steel manufacture, chemicals
This category includes the chemical substances which are manufactured as part of steel and alloy steels. The following list identifies those elements which may exist in steel or which may comprise compounds present in steel or alloy steels. Aluminum, beryllium, boron, calcium, carbon, cerium, chromium, cobalt, copper, hafnium, iron, lanthanum, lead, magnesium, manganese, molybdenum, nickel, niobium, nitrogen, oxygen, phosphorus, selenium, silicon, sulfur, tantalum, tin, titanium, tungsten, vanadium, yttrium, zinc, zirconium.
 266-048-1 65997-19-5 Expert judgement
Copper alloy, Cu 96, Be 2.2-2.8, Ni 1.1 (CDA 827) - 11108-64-8 Expert judgement
Beryllium 231-150-7 7440-41-7 Expert judgement
Aluminium alloy, Al,Be 603-236-8 12770-50-2 Expert judgement
Hexakis[μ-(acetato-O:O')]-μ4-oxotetraberyllium 242-785-4 19049-40-2 Expert judgement
Beryllium phosphide (BeP2) - 1268721-56-7 Expert judgement
Phosphoric acid, beryllium salt (2:3) - 13598-26-0 Expert judgement
Beryllium acetylide 208-050-7 506-66-1 Expert judgement
Bertrandite (Be4(OH)2O(SiO3)2) 235-299-9 12161-82-9 Expert judgement
Zinc beryllium silicate - 39413-47-3 Expert judgement
Beryllium di(acetate) 208-850-6 543-81-7 Expert judgement
Triberyllium nitride 215-132-6 1304-54-7 Expert judgement
Octadecanoic acid, beryllium salt - 16687-38-0 Expert judgement
Beryllium orthosilicate 239-251-8 15191-85-2 Expert judgement
Beryllium sulphide 237-064-6 13598-22-6 Expert judgement
Phosphoric acid, beryllium salt 252-356-3 35089-00-0 Expert judgement
Diethylberyllium 208-823-9 542-63-2 Expert judgement
Beryllium sulfate tetrahydrate 629-461-1 7787-56-6 Expert judgement
Beryllium zinc silicate 247-151-0 25638-88-4 Expert judgement
Beryllium telluride 235-451-4 12232-27-8 Expert judgement
Beryllium nitrate trihydrate - 7787-55-5 Expert judgement
Beryllium hexaboride 235-657-4 12429-94-6 Expert judgement
Beryllium diboride 235-694-6 12536-51-5 Expert judgement
Beryllium hydrogen phosphate (1:1) - 13598-15-7 Expert judgement
Beryllium fluoride 232-118-5 7787-49-7 Expert judgement
Beryllium diiodide 232-119-0 7787-53-3 Expert judgement
Beryllium nitrate 237-062-5 13597-99-4 Expert judgement
Beryllium diammonium tetrafluoride 238-948-4 14874-86-3 Expert judgement
Beryllium carbonate 236-030-8 13106-47-3 Expert judgement