Azeco Cosmeceuticals

AZECO COSMECEUTICALS BV - MUSSENBERG 1, 6049 GZ Herten, The Netherlands – Phone: +31 475 206070

Contributing Scenario 11 : Production of preparations or articles by tabletting, compression, extrusion, pelletisation

PROC 14

9.2. C ONDITIONS OF USE AFFECTING EXPOSURE

9.2.1. C ONTROL OF ENVIRONMENTAL EXPOSURE : U SE AS A RUBBER ADDITIVE (ERC 4, ERC 5, ERC 6 b , ERC 6 d )

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

9.2.2. C ONTROL OF WORKER EXPOSURE : U SE IN CLOSED BATCH PROCESS ( SYNTHESIS OR FORMULATION ) (PROC 3)

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 batch process (synthesis or formulation) Advanced (industrial) exposure controls assumed O THER CONDITIONS AFFECTING WORKERS EXPOSURE Indoor use Assumes elevated process temperature up to 40.0 °C

9.2.3. C ONTROL OF WORKER EXPOSURE : U SE IN BATCH AND OTHER PROCESSES ( SYNTHESIS ) WHERE OPPORTUNITY FOR EXPOSURE ARISES (PROC 4)

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 semi-closed process with opportunity for exposure Local exhaust ventilation - efficiency of at least 90.0 % Advanced (industrial) exposure controls assumed O THER CONDITIONS AFFECTING WORKERS EXPOSURE Indoor use Assumes elevated process temperature up to 40.0 °C

9.2.4. C ONTROL OF WORKER EXPOSURE : M IXING OR BLENDING IN BATCH PROCESSES FOR FORMULATION OF PREPARATIONS AND ARTICLES (PROC 5) 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

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

Page 45 of 58

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