Sustainability Report 2010 Lek d.d.

33 Active Environmental Policy 3.7 Storage Storage of hazardous chemicals, including chemical waste, complies with the legal requirements and Novartis guide- lines. Storage compatibility is considered in view of individu- al chemicals’ properties. In 2010, the Globally Harmonized System (GHS) of classifi- cation and labelling of chemicals for manufacture and stor- age purposes was implemented in accordance with the legal requirements. 3.8 Distribution Accidents related to product distribution 33 From Lek, 4731 consignments of finished products and APIs were dispatched to 85 countries around the world either by road, air or sea. During the transport of both non-hazardous and hazardous goods, no accidents occurred and neither did in the dispatching process (fatality - injury, spill - discharge, damage to property, civil commotion, or media coverage). 3.9 Indirect environmental impacts As most of the indirect environmental impact is potentially caused by suppliers, these are bound by Novartis to commit to the Novartis Corporate Citizenship Policy. By signing a supply agreement, the supplier guarantees to execute the contractual obligations in accordance with all applicable laws and regulations associated with HSE, fair work practices and unlawful discrimination. For waste management, we only select suppliers having all authorizations needed and those recorded as contracting providers with the respective Ministry. 33 POR OI22 Table 6: Abstract from the report on hazardous goods transport issued by the Safety Advisor 3 3,144,171 4.1 256,764 4.2 405 4.3 12 5.2 16 6.1 5,550 6.2 987 8 4,710 9 1,555 TOTAL 3,414,170 Class Quantity in kg Environmental impact of transport is limited by more extensive use of teleconferencing and videoconferencing which replace long-distance business travel. 3.10 Biological safety Lek deals exclusively with biological agents from Risk Groups 1 and 2 which are defined as follows: • Group 1: biological agents with minimum risk of caus- ing disease in humans, and negligible risk of spreading into the environment; • Group 2: biological agents with a potential to cause dis- ease in humans, and potentially hazardous to workers; the risk of spreading into the environment is minimal; in most of the cases, effective prevention or treatment is available. Lek’s manufacture involves exclusively biological agents of Risk Group 1. All the genetically modified organisms (GMO) belong to this group as well. For the biological agents, risk assessments were made. The basic task of those responsible for biological safety is to diminish potential risk in the handling of biological agents, and to ensure compliance with the Slovenian legislation and Novartis guidelines. The persons responsible for biological safety at Lek include: • Person authorized for biological safety of Lek d.d., and persons authorized for biological safety at the Menge‰, Ljubljana and Lendava sites; • Persons responsible for control and safety of the areas where work with GMOs is performed; • Persons responsible for the implementation of meas- ures planned for accidents associated with GMOs, and • Heads of projects related to working with GMOs. At Lek, a nine-member Biological Safety Committee has been operating since 2005. Its tasks include: • Reviewing the lists of biological agents of Lek d.d.; • Checking the accuracy of biological agents’ classifica- tion into risk groups and, consequently, the adequacy of proposed containment measures; • Approving individual projects in accordance with the risk assessment, taking into account workplace safety and potential risk to the environment and to human health. 3.11 Efficiency of water and energy resource use In 2010, the efficiency of water, electricity and natural gas use per unit of product was improved once again, which was the result of many years of systematic implementation of measures aimed at decreasing the use of natural resources. A comparison of efficiency by year provides a true picture of trends at the sites where a single product or a small number of products are manufactured (Lendava, Prevalje). At the

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