Azeco Cosmeceuticals

AZECO COSMECEUTICALS BV - MUSSENBERG 1, 6049 GZ Herten, The Netherlands – Phone: +31 475 782540

1. ES 1: M ANUFACTURE OF THE SUBSTANCE

1.1. T ITLE SECTION E NVIRONMENT Contributing Scenario 1: Manufacture

ERC 1

W ORKER Contributing Scenario 2 : Use in closed process, no likelihood of exposure Contributing Scenario 3 : Use in closed, continuous process with occasional controlled exposure Contributing Scenario 5 : Control of worker exposure: Use in batch and other processes (synthesis) where opportunity for exposure arises Contributing Scenario 6 : Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities Contributing Scenario 4 : Use in closed batch process (synthesis or formulation)

PROC 1

PROC 2

PROC 3

PROC 4

PROC 8b

Contributing Scenario 7 : Use a laboratory reagent

PROC 15

1.2. C ONDITIONS OF USE AFFECTING EXPOSURE

1.2.1. C ONTRIBUTING S CENARIO 1 - C ONTROL OF ENVIRONMENTAL EXPOSURE (ERC 1) In consideration of the chemical safety assessment, performed for this substance according to Article 14 (3) of the REACH regulation, all identified uses of azelaic acid are assessed as safe for the environment. 1.2.2. C ONTRIBUTING S CENARIO 2 - C ONTROL OF WORKER EXPOSURE : U SE IN CLOSED PROCESS , NO LIKELIHOOD OF EXPOSURE (PROC 1) P RODUCT ( ARTICLE ) CHARACTERISTICS Covers percentage substance in the product up to 100 % A MOUNT USED ( OR CONTAINED IN ARTICLES ), FREQUENCY AND DURATION OF USE / EXPOSURE Covers daily exposures up to 8 hours T ECHNICAL AND ORGANISATIONAL CONDITIONS AND MEASURES Provide a basic standard of general ventilation (1 to 3 air changes per hour)

Use in closed process, no likelihood of exposure Advanced (industrial) exposure controls assumed O THER CONDITIONS AFFECTING WORKERS EXPOSURE Indoor use Assumes elevated process temperature up to 40.0 °C

1.2.3. C ONTRIBUTING S CENARIO 3 - C ONTROL OF WORKER EXPOSURE : U SE IN CLOSED , CONTINUOUS PROCESS WITH OCCASIONAL CONTROLLED EXPOSURE (PROC 2) P RODUCT ( ARTICLE ) CHARACTERISTICS Covers percentage substance in the product up to 100 % A MOUNT USED ( OR CONTAINED IN ARTICLES ), FREQUENCY AND DURATION OF USE / EXPOSURE Covers daily exposures up to 8 hours T ECHNICAL AND ORGANISATIONAL CONDITIONS AND MEASURES

Provide a basic standard of general ventilation (1 to 3 air changes per hour) Use in closed, continuous process with occasional controlled exposure

REGULATION (EC) No 1907/2006 Date of Issue: 02/01/2020

Page 15 of 56

Date of Revision: - AZCO99 Revision Nr.: - Version Nr.: 1