Sustainability Report 2012 Lek d.d.

Sustainability Report 2012 – Lek d.d. Environment 22 Lek HSE systems Compliance with HSE laws and standards We operate in adherence with the legal and other requirements. The Environmental Protection Act, the key environmental management regulation, dictates the contents of other im- plementing regulations in the field of water, noise, waste, packaging materials, emissions to the air, light pollution, storage of hazardous liquids, and other areas related to environmental protection. Our waters are regulated by the Decree on the Emission of Substances and Heat in the Discharge of Wastewater from Installations for the Production of Pharmaceutical Products and Active Substances, which applies particu- larly to the pharmaceutical industry. Being an IPPC certified company, our Lendava and Menge‰ sites operate in compliance with the Decree on the Type of Activities and Installations with a High Large-Scale Polluti- on Potential. The two IPPC permits also cover greenhouse gas emissions from the two cooling devices, whereas this type of emissions at the Ljubljana and Prevalje sites are included in the permits dealing with atmospheric emissions. All Lek sites comply with the Decree on Limit Values for Atmospheric Emissions of Volatile Organic Compounds from Installations Using Organic Solvents. As a low-risk source, the Menge‰ site is obligated to adhe- re to the Decree on the Prevention of Major Accidents and Mitigation of their Consequences. We focus on timely and effective application of new legal and other requirements in our work processes and prac- tice. The individuals authorized for specific areas keep track of and identify them, ensuring appropriate internal publication after a GAP analysis. Responsibility for effec- tive application in practice lies with the site heads / repre- sentatives of HSE units. In 2012, a total of 13 inspections were carried out at all of the four sites, revealing our overall compliance with the ap- plicable regulations. The majority of the inspections cove- red the environmental aspect of our operations, and one fo- cused on the company’s fire safety and occupational safety. All our sites implement the Novartis Environmental Management System. Environmental permits issued to Lek by the Slovenian Environment Agency specify the limit values for all atmo- spheric and water emissions, waste management, mea- sures to reducelight pollution, methods for safe storage of raw materials and products for the company’s sites. Our adherence to these values results in safe operation of ourproduction plants without excessive impact on the environment. In accordance with legal requirements, all Lek sites have acquired environmental permits with related amendments. • Environmental permit for operation of a device with a high pollution potential (IPPC) for the Lendava site, Permit No. 35407-172/2006 dated 15 April 2010 • Decision amending the environmental permit for the Lendava site, No. 35407-37/2011-33, dated 12 July 2012 • Decision amending the environmental permit for the Lendava site, No. 35406-33/2012-4, dated 15 March 2013 • Environmental permit for operation of a device with a high pollution potential (IPPC), for Menge‰ site, Per- mit No. 35407-171/2006, dated 14 May 2010 • Decision amending the environmental permit for the Menge‰ site, No. 35407-22/2010, dated 28 December 2010 • Decision amending the environmental permit for the Menge‰ site, No. 35407-54/2011, dated 16 May 2012 • Decision amending the environmental permit for the Menge‰ site, No. 35406-24/2012-3, dated 23 August 2012 • Environmental permit for operation of a device using VOCs, for Ljubljana site, Permit No. 35430-19/2006, dated 30 January 2008 • Decision amending the environmental permit for operation of a device using VOCs, for the Ljubljana site, No. 35430-6/2010, dated 4 March 2011 • Decision amending the environmental permit for the Ljubljana site, No. 35430-9/2012-4, dated 11 Sep- tember 2012 • Decision amending the environmental permit for the Ljubljana site, No. 35431-15/2012-2, dated 20 No- vember 2012 – permit extension • Environmental permit for operation of a device with regard to emissions into waters for the Ljubljana site, Permit No. 35441-339/2006, dated 8 November 2010 • Environmental permit for operation of a device using VOCs, for the Prevalje site, Permit No. 35413- 23/2007, dated 26 October 2007 • Decision amending the environmental permit for operation of a device using VOCs, for the Prevalje site, No. 35412-17/2012-2, dated 4 October 2012 – permit extension • Environmental permit for operation of a device with regard to emissions into waters for the Prevalje site, Permit No. 35441-338/2006, issued on 2 February 2011 • • Water use permit for direct use of water for industri- al purposes from the public water supply network, for Lek d.d. (all sites), Permit No. 35536-19/2011, issued on 15 July 2011 • Water use permits for direct use of water (Nos. 35507-248/2003, 35504-143/2003, 35536-20/2008 and 35536-45/2012-5) • Greenhouse gas emission permits No. 35433- 88/2009 dated 19 August 2009, and No. 35433- 87/2009 dated 18 August 2009 • Decision extending the permit granting the status of a manufacturer exempt from pollution charge for the CO 2 emissions resulting from the burning of fu- els at the Menge‰ and Lendava sites, No.DT 4231- 77/2011 dated 30 November 2011