1. Spanish Royal Decree for the statement of polluted soils Real Decreto 9/2005 (B.O.E nº15, 18 of January, 2005) JRC Meeting, 3-4 February, 2005 The criteria to declare a site as polluted, as well as the possible restoration measures, are based on the potential unacceptable risks associated to the presence of contaminants. (Regulation (CE) nº 1488/94 and Regulation (CEE) nº 793/93). Human Health Environment

2. Requested information: 1.General information about the activity 2.Hazardous substances used 3.Hazardous sub-products generated 4.Hazardous by-products generated 5.Storage 6.Existence of mechanisms/structures to preclude soil pollution 7.Historical uses/activities supported by the site Who has to present a declaration? * The land owner of an potential polluting activity (Annex I). * Those companies: which produce, use or storage hazardous substances (> 10 tn/year) average store of combustibles of 50.000 l and average consumption of combustible > 300.000 l JRC Meeting, 3-4 February, 2005

3. Concentration of contaminants in soil POTENTIALLY CONTAMINATED SOILS ? E(L)C50 / HIGH VALUES YES NO GENREIC VALUES YES CONTAMINATED SOILS NON-CONTAMINATED SOILS TIERED SITE SPECIFIC RISK ASSESSMENT ACEPTABLE UNACEPTABLE General approach (HH and Env) JRC Meeting, 3-4 February, 2005

4. HH CRITERIA NON-CONTAMINATED SOILS Risk Assessment: acceptable risks for the Human Health Priority in Human Health protection: below the Generic values (I,R,AU) Identification and definition of: Exposure routes Characteristics of the most sensitive target individuals Maximum Tolerable Concentrations (MTC) carcinogenic substances: frequency 10 -5 systemic substances: ratio: long-term exposure/MTC 0.05 pesticides 0.2 organochlorinated substances 0.05 PAHs 0.1 MAHs Soil Uses: Industrial (I) Residential (R) Any use (AU) JRC Meeting, 3-4 February, 2005

5. Risk Assessment: acceptable risks for the Environment Priority in Environmental protection: below the Generic values (EU approach) ENV. CRITERIA NON-CONTAMINATED SOILS JRC Meeting, 3-4 February, 2005

6. HH / ENV. CRITERIA CONTAMINATED SOILS Risk Assessment: Unacceptable risks for HH and/or Env Priority in HH protection: if soil concentration > 100 * Generic values (I,R,AU) Priority in Environmental protection: If E(L)C50, for most sensitive organism, is lower than 10mg of sampled soil/g soil test If E(L)C50, for most sensitive organism, is lower than 10 mg of leacheate/l medium test JRC Meeting, 3-4 February, 2005

7. Regulation (CE) nº 1488/94 and Regulation (CEE) nº 793/93. When is required a risk assessment? If the concentration of hydrocarbons in soil is higher than 50 mg/L If concentrations of any substance in soil is higher than the Generic Values. Requirements for the Environmental Risk Assessment: Description of the sources of pollution Description of soil characteristics Identification of the potential target receptors Environmental exposure and routes of Risk characterization Analysis of uncertainties JRC Meeting, 3-4 February, 2005