Sustainability Report 2012 Lek d.d.

Sustainability Report 2012 – Lek d.d. Environment 42 2.9.3 Providing storage and distribution safety 2.9.3.1 Storage Handling and storage of hazardous chemicals are carried out in accordance with both statutory requirements and Novartis' guidelines. All of our warehouses for hazardous liquids were declared with the Ministry of Health, whereas specific sites have plans for the management of hazardous liquids in place in accordance with the legal requirements. In above-ground tank storage of hazardous liquids, we pro- vide appropriate retarding catchment systems preventing liquid spillage into the environment. In addition, the tanks are fitted in a way to enable detection of any spillage at any time. In 2012, we further upgraded the classification and labelling of chemicals according to the GHS (Globally Harmonized System) for manufacture and storage purposes, and in the field of waste management. 2.9.3.2 Distribution 57 From Lek production sites, 5857 consignments of finished products and APIs were dispatched to 93 countries. During the transport of both non-hazardous and hazardous goods, no accidents occurred. In the organization of international road transport, we conti- nued with the implementation of the "Control Tower" business model organized by DHL Belgium. The project proved to be successful and cost efficient. A global tender was launched for the selection of an air freight forwarder, and a local call for bids was put out for sea freight forwarding services. In 2012, the volume of distributed goods remained at the level of 2011, amounting to 17,816 tons. Major changes took place in the distribution of goods for the Russian Federation, where the goods in stock at the Ljubljana site intended for that mar- ket were relocated to the Hoãe location, freeing the capacity of the Ljubljana site, and increasing the volume of operation in Hoãe. In the distribution of goods to Asian countries, the model of dispatch and transport organization was changed, which also resulted in cost savings. 2.9.4 Chemical safety With its chemical safety system, Lek ensures safe handling of chemicals in laboratories as well as in the API and finished products manufacturing process. In accordance with the le- gal requirements for handling of chemicals and the Novartis' guidelines, we keep our employees informed of their hazar- dous properties. By taking into account the type of techno- logy used in the manufacture, and the procedures for using chemicals in laboratories, we assess the risks and determine technical and organizational measures to ensure safety in their use. We have established a system for collecting data on manipulation of chemicals subject to statutory reporting, a system for the preparation of registration dossiers for the registration of strategic raw materials (intermediates) pur- suant to the REACH Regulations (Registration, Evaluation, Authorization and Restriction of Chemical Substances), and the Globally Harmonized System (GHS) of labelling to meet the requirements of the manufacturing process and of the buyers of our APIs. In the area of toxicology and pharmacology, we determine exposure limit values for APIs and strategic intermediates. By determining the exposure limit values and performing measurements in the working environment, we determine appropriate technical and organizational measures. 57 RC KPI 22 Lek HSE systems HSE function The HSE function employs the HSE Director and persons responsible for individual fields of expertise. By authori- ty of the Management Board, these are responsible for the compliance of the professional area with Slovenian laws and Novartis’/Sandoz’ standards, for representation of Lek in the professional area, conducting inspections, conducting periodic internal audits, and monitoring the implementation of corrective measures, consulting and professional assistance in the implementation of preven- tive measures at specific sites as well as communication of identified risks to the management team. HSE department The HSE system has been established at all the four si- tes of Lek d.d. in Slovenia. HSE roles, responsibilities and authorities are determined on the basis of the organiza- tional structure and functional organization. At multi-unit sites, activities are performed following the Host-Guest principle, whereby uniformity of HSE standards is ensured within each individual location. The same principle applies to our contract partners.The largest unit having a suitable HSE organization in place is the Host. Host sets internal standards for individual sites that also apply to the Guests. HSE organization, human resources and training