(2)

Part II is amended as follows: (a) in CMC 1, point 1 is amended as follows: (i) at the end of sub-point (j),the word ‘or’ is deleted; (ii) in sub-point (k), ‘.’ is replaced by ‘, or’; (iii) the following sub-point (l) is added: ‘(l) ammonium salts, sulphate salts, phosphate salts, elemental sulphur, calcium carbonate or calcium oxide, which are recovered from waste within the meaning of Article 3, point 1, of Directive 2008/98/EC.’; (b) in CMC 11, point 1 is amended as follows: (i) at the end of sub-point (f), the word ‘or’ is deleted; (ii) in sub-point (g), ‘.’ is replaced by ‘, or’; (iii) the following sub-point (h) is added: ‘(h) ammonium salts, sulphate salts, phosphate salts, elemental sulphur, calcium carbonate or calcium oxide, which are recovered from waste within the meaning of Article 3, point 1, of Directive 2008/98/EC.’; (c) the following CMC 15 is added: ‘CMC 15: RECOVERED HIGH PURITY MATERIALS (1) An EU fertilising product may contain a recovered high purity material, which is ammonium salt, sulphate salt, phosphate salt, elemental sulphur, calcium carbonate or calcium oxide, or mixtures thereof, of a purity of at least 95 % dry matter of the material. (2) The high purity material shall be recovered from waste generated from: (a) a production process that uses as input materials substances and mixtures other than animal by-products or derived products within the scope of Regulation (EC) No 1069/2009 (1), or (b) a gas purification or emission control process designed to remove nutrients from off-gases derived from one or more of the following input materials and facilities: (i) substances and mixtures, other than waste within the meaning of Article 3, point 1, of Directive 2008/98/EC; (ii) plants or plant parts; (iii) bio-waste within the meaning of Article 3, point 4, of Directive 2008/98/EC, resulting from separate bio-waste collection at source; (iv) urban and domestic waste waters within the meaning of Article 2, points 1 and 2, respectively, of Directive 91/271/EEC (2); (v) sludge within the meaning of Article 2, point (a), of Directive 86/278/EEC (3), which displays no hazardous properties listed in Annex III to Directive 2008/98/EC; (vi) waste within the meaning of Article 3, point 1, of Directive 2008/98/EC, and fuels input to a waste co-incineration plant as defined in Directive 2010/75/EU of the European Parliament and of the Council (4) and operated according to the conditions of that Directive, on condition that these inputs display no hazardous properties listed in Annex III to Directive 2008/98/EC; (vii) Category 2 or Category 3 materials or derived products thereof, in accordance with the conditions set out in Article 32(1) and (2) and in the measures referred to in Article 32(3) of Regulation (EC) No 1069/2009, provided that the off-gases are derived from a composting or digestion process in accordance with CMCs 3 and 5, respectively, in Annex II to this Regulation; (viii) manure within the meaning of Article 3, point 20, of Regulation (EC) No 1069/2009 or derived products thereof; or (ix) livestock housing facilities. The input materials referred to in points (i) to (vi) shall not contain animal by-products or derived products within the scope of Regulation (EC) No 1069/2009. (3) The high purity material shall have an organic carbon (C org ) content of no more than 0,5 % dry matter of the material. (4) The high purity material shall contain no more than: (a) 6 mg/kg dry matter of polycyclic aromatic hydrocarbons (PAH16) (5); (b) 20 ng WHO toxicity equivalents (6)/kg dry matter of the polychlorinated dibenzo-para-dioxins and dibenzofurans (PCDD/PCDF) (7). (5) An EU fertilising product containing or consisting of high purity materials shall contain no more than: (a) 400 mg/kg dry matter of total chromium (Cr); and (b) 2 mg/kg dry matter of thallium (Tl). (6) Where compliance with a given requirement laid down in points 4 and 5 (such as absence of a given contaminant) follows certainly and uncontestably from the nature or the recovery process of the high purity material or the manufacturing process of the EU fertilising product, that compliance may be presumed in the conformity assessment procedure without verification (such as testing), under the responsibility of the manufacturer. (7) Where for the product function category of an EU fertilising product containing or consisting of high purity materials referred to in point 2(b) no requirements regarding Salmonella spp., Escherichia coli or Enterococcaceae have been laid down in Annex I, those pathogens in the EU fertilising product shall not exceed the limits set out in the following table: Micro-organisms to be tested Sampling plans Limit n c m M Salmonella spp. 5 0 0 Absence in 25 g or 25 ml Escherichia coli or Enterococcaceae 5 5 0 1 000 in 1 g or 1 ml Where: n = number of samples to be tested, c = number of samples where the number of bacteria expressed in colony forming units (CFU) is between m and M, m = threshold value for the number of bacteria expressed in CFU that is considered satisfactory, M = maximum value of the number of bacteria expressed in CFU. (8) The compliance of an EU fertilising product containing or consisting of high purity materials referred to in point 2(b) with requirements in point (7), or with the requirements for Salmonella spp., Escherichia coli or Enterococcaceae set out in Annex I for the corresponding PFC of the EU fertilising product shall be verified via testing, in accordance with point 5.1.3.1 in Module D1 – quality assurance of the production process in Part II of Annex IV. The requirements in point (7) and the requirements for Salmonella spp., Escherichia coli or Enterococcaceae set out in Annex I for the corresponding PFC of an EU fertilising product consisting only of high purity materials referred to in point 2(b) shall not apply, when the high purity materials or all of the biogenic input materials used have undergone one of the following processes: (a) pressure sterilisation through the heating to a core temperature of more than 133 °C for at least 20 minutes at an absolute pressure of at least 3 bars, whereby the pressure must be produced by the evacuation of all air in the sterilisation chamber and the replacement of the air by steam (‘saturated steam’); (b) processing in a pasteurisation or hygienisation unit that reaches a temperature of 70 °C for at least one hour. The requirements in point (7) and the requirements for Salmonella spp., Escherichia coli or Enterococcaceae set out in Annex I for the corresponding PFC of an EU fertilising product consisting only of high purity materials referred to in point 2(b) shall not apply, where the off-gases derive from an incineration process as defined in Directive 2010/75/EU. (9) High purity materials that are stored in a way that does not protect them against precipitation and direct sunlight may be added to an EU fertilising product only if they have been manufactured maximum 36 months before signing the EU declaration of conformity for the respective EU fertilising product. (10) The high purity material shall have been registered pursuant to Regulation (EC) No 1907/2006, with a dossier containing: (a) the information provided for by Annexes VI, VII and VIII to Regulation (EC) No 1907/2006, and (b) a chemical safety report pursuant to Article 14 of Regulation (EC) No 1907/2006 covering the use as a fertilising product, unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to Regulation (EC) No 1907/2006 or by points 6, 7, 8, or 9 of Annex V to that Regulation. (1) Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) (OJ L 300, 14.11.2009, p. 1)." (2) Council Directive 91/271/EEC of 21 May 1991 concerning urban waste-water treatment (OJ L 135, 30.5.1991, p. 40)." (3) Council Directive 86/278/EEC of 12 June 1986 on the protection of the environment, and in particular of the soil, when sewage sludge is used in agriculture (OJ L 181, 4.7.1986, p. 6)." (4) Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (OJ L 334, 17.12.2010, p. 17)." (5) Sum of naphthalene, acenaphthylene, acenaphthene, fluorene, phenanthrene, anthracene, fluoranthene, pyrene, benzo[a]anthracene, chrysene, benzo[b]fluoranthene, benzo[k]fluoranthene, benzo[a]pyrene, indeno[1,2,3-cd]pyrene, dibenzo[a,h]anthracene and benzo[ghi]perylene." (6) van den Berg M., L.S. Birnbaum, M. Denison, M. De Vito, W. Farland, et al. (2006) The 2005 World Health Organization Re-evaluation of Human and Mammalian Toxic Equivalency Factors for Dioxins and Dioxin-like Compounds. Toxicological sciences: an official journal of the Society of Toxicology 93:223-241. doi:10.1093/toxsci/kfl055." (7) Sum of 2,3,7,8-TCDD, 1,2,3,7,8-PeCDD; 1,2,3,4,7,8-HxCDD; 1,2,3,6,7,8-HxCDD; 1,2,3,7,8,9-HxCDD; 1,2,3,4,6,7,8-HpCDD; OCDD; 2,3,7,8-TCDF; 1,2,3,7,8-PeCDF; 2,3,4,7,8-PeCDF; 1,2,3,4,7,8-HxCDF; 1,2,3,6,7,8-HxCDF; 1,2,3,7,8,9-HxCDF; 2,3,4,6,7,8-HxCDF; 1,2,3,4,6,7,8-HpCDF; 1,2,3,4,7,8,9-HpCDF; and OCDF.’."