Sustainability Report 2014 Lek d.d.

27 Environment 31 GRI-G4-DMA Health, safety and environment systems Environmental permits and related amendments issued to Lek All our sites implement the Novartis Environmental Management System (EMS). Environmental permits issued to Lek, a Sandoz company, by the Slovenian Environment Agency, specify the limit values for all atmospheric and water emissions, waste management, measures to reduce light pollution, methods for safe storage of raw materials and products for the company’s sites. Our adher- ence to these values results in the safe operation of our production plants without excessive impact on the environment. In accordance with legal requirements, all Lek sites have acquired environmental permits with related amendments. 31 • Environmental permit for operation of a device with a high pollution potential (IPPC) for the Lendava site, Permit No. 35407-172/2006, dated 15. 4. 2010 • Decision amending the environmental permit for the Lendava site, No. 35407-37/2011-33, dated 12. 7. 2012 • Decision amending the environmental permit for the Lendava site, No. 35406-33/2012-4, dated 15. 3. 2013 • Decision amending the environmental permit for the Lendava site, No. 35406-53/2014-8, dated 23. 1. 2015 • Environmental permit for operation of a device with a high pollution potential (IPPC), for Menge‰ site, Permit No. 35407-171/2006, dated 14. 5. 2010 • Decision amending the environmental permit for the Menge‰ site, No. 35407-22/2010, dated 28. 12. 2010 • Decision amending the environmental permit for the Menge‰ site, No. 35407-54/2011, dated 16. 5. 2012 • Decision amending the environmental permit for the Menge‰ site, No. 35406-24/2012-3, dated 23. 8. 2012 • Decision amending the environmental permit for the Menge‰ site, No. 35406-25/2013-6, dated 11. 11. 2013 • Decision amending the environmental permit for the Menge‰ site, No. 35406-42/2014-4, dated 10. 9. 2014 • Environmental permit for operation of a device using VOCs, for Ljubljana site, Permit No. 35430-19/2006, dated 30. 1. 2008 • Decision amending the environmental permit for opera- tion of a device using VOCs, for the Ljubljana site, No. 35430-6/2010, dated 4. 3. 2011 • Decision amending the environmental permit for the Ljubljana site, No. 35430-9/2012-4, dated 11. 9. 2012 • Decision amending the environmental permit for the Ljubljana site, No. 35431-15/2012-2, dated 20. 11. 2012 – permit extension • Environmental permit for operation of a device with re- gard to emissions into waters for the Ljubljana site, Permit No. 35441-339/2006, dated 8. 11. 2010 • Decision amending the environmental permit with regard to emissions into waters for the Ljubljana site, Permit No. 35444-58/2013-2, dated 18. 3. 2014 • Decision amending the environmental permit with regard to emissions into waters for the Ljubljana site, Permit No. 35444-68/2014-2, dated 7. 10. 2014 • Environmental permit for operation of a device with re- gard to emissions into waters for the Prevalje site, Permit No. 35441-338/2006, dated 2. 2. 2011 • Environmental permit for operation of a device, using VOCs, for the Prevalje site, No. 35430-1/2013-6, dated 21. 8. 2013 • Partial water use permit for direct use of water for indu- strial purposes from the public water supply network, for Lek d.d. (all sites), Permit No. 35536-19/2011, dated 15. 7. 2011 • Decision amending the partial water use permit for di- rect use of water for industrial purposes from the pu- blic water supply network for Lek d.d. (all sites), Permit No. 35536-17/2013-2 (concerning 35536-19/2011) dated 17. 4. 2013 • Decision amending the partial water use permit for direct use of water for industrial purposes from the public water supply network for Lek d.d. (all sites), Permit No. 35536- 90/2014-2 (concerning 35536-17/2013-2 and 35536- 19/2011), dated 13. 1. 2015 • Water use permits for direct use of water No. 35536- 20/2008, 35536-45/2012-5 and 35536-65/2013-8 • Greenhouse gas emission permits No. 35485-53/2014 dated 22. 10. 2014 and No. 35485-54/2014 dated 15. 12. 2014. 2.1.1 Specifics of business operations and disparities in data collected When identifying our environmental impacts, certain factors have to be taken into account. They primarily refer to the efficiency of the use of materials, energy resources, water, waste, atmospheric emissions and wastewater per tonne of product. Namely, there are considerable differences in prod- uct and API weight. Compared to some self-medicati- on drugs, similar biological drugs, for example, have low weight, yet their manufacture requires larger quantities of water and energy resources, and their financial value is higher as well. These disparities become particularly noticeable when seeking a common basis for the preparation of data for Lek, a Sandoz company, and they are also apparent at the Ljubljana and Menge‰ sites, which have an extensive and versatile product portfolio. Our operations are also characterized by interim adjust- ments of the production program to changes in demand, which could again be observed in 2014. The manufacturing structure therefore varies from year to year. As a result of the above, year-on-year comparability of efficiency data and of individual production sites is compro- mised.