Azeco Cosmeceuticals

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

ANNEX TO THE EXTENTED SAFETY DATA SHEET ( E SDS)

G ENERAL I NFORMATION The most prominent effect of the substance towards workers is skin/eye irritation. According to the 1272/2008 EC regulation, azelaic acid is classified as Skin Irritation 2, H315 (Causes Skin irritation) and Eye Irritation 2, H319 (causes serious eye irritation) and the exposure to such irritant substances should be well controlled and the following measures are advised: 1) W ORKERS According to the individual identified uses, the worker may be exposed to inhalation of certain vapors or aerosols and, in case of skin contact, also via the dermal route. Both routes of exposure were taken into account in the exposure scenarios listed in this Annex. The implementation of the listed Operational Conditions and Risk Management Measures (RMMs / OCs) will ensure that worker exposure to azelaic acid, for the two considered routes, is negligible. However, the use of the Personal Protective Equipment (PPE) to prevent the occurrence of skin irritation and / or eyes, is also required. 2) G ENERAL POPULATION Since it is not expected consumer exposure to the substance azelaic acid (except for use in cosmetic products and in drugs, which, being these products already regulated by the EC 1223/2009 and the by EC 2001/83, are exempt from the verification of the safety assessment to man under REACH), the exposure estimation was not done in this case. 3) ENVIRONMENT In the chemical safety assessment, performed for this substance according to Article 14 (3) in connection with Annex I section 3 (Environmental Hazard Assessment) and section 4 (PBT/ vPvB Assessment), no hazard was identified. Therefore according to REACH Annex I (5.0), an exposure estimation and the subsequent step of risk characterisation is not necessary. Consequently, all identified uses of azelaic acid are assessed as safe for the environment..

P ERSONAL PROTECTIVE EQUIPMENT :

- Substance/task appropriate gloves; - Eye protection.

F URTHER TECHNICAL AND ORGANIZATIONAL MEASURES : - Containment as appropriate;

- Minimise number of staff exposed; - Segregation of the emitting process; - Effective contaminant extraction; - Good standard of general ventilation; - Minimisation of manual phases; - Avoidance of contact with contaminated tools and objects; - Regular cleaning of equipment and work area; - Management/supervision in place to check that the RMMs in place are being used correctly and OCs followed;

- Training for staff on good practice; - Good standard of personal hygiene.

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

Page 14 of 56

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