(2)

Part II is amended as follows: (a) In CMC 1, point 1, the following sub-point (k) is added: ‘(k) pyrolysis and gasification materials, which are recovered from waste or are by-products within the meaning of Directive 2008/98/EC.’; (b) In CMC 11, point 1, the following sub-point (g) is added: ‘(g) pyrolysis and gasification materials, which are recovered from waste or are by-products within the meaning of Directive 2008/98/EC.’; (c) The following CMC 14 is added: ‘CMC 14: PYROLYSIS AND GASIFICATION MATERIALS 1. An EU fertilising product may contain pyrolysis or gasification materials obtained through the thermochemical conversion under oxygen-limiting conditions of exclusively one or more of the following input materials: (a) living or dead organisms or parts thereof, which are unprocessed or processed only by manual, mechanical or gravitational means, by dissolution in water, by flotation, extraction with water, by steam distillation or by heating solely to remove water, or which are extracted from air by any means, except (*1): — materials originating from mixed municipal waste, — sewage sludge, industrial sludge or dredging sludge, and — animal by-products or derived products within the scope of Regulation (EC) No 1069/2009; (b) vegetable waste from the food processing industry and fibrous vegetable waste from virgin pulp production and from production of paper from virgin pulp, if not chemically modified; (c) processing residues within the meaning of Article 2, point (t) of Directive 2009/28/EC from the production of bioethanol and biodiesel, derived from materials referred to in sub-points (a), (b) and (d); (d) bio-waste within the meaning of Article 3, point 4 of Directive 2008/98/EC resulting from separate bio-waste collection at source, other than animal by-products or derived products within the scope of Regulation (EC) No 1069/2009 or (e) pyrolysis or gasification additives which are necessary to improve the process performance or the environmental performance of the pyrolysis or gasification process, provided that those additives are consumed in chemical processing or used for such processing and that total concentration of all additives do not exceed 25 % of the fresh matter of the total input material, with the exception (*1) of: — input materials referred to in sub-points (a) to (d), — waste within the meaning of Article 3, point 1 of Directive 2008/98/EC, — substances or mixtures which have ceased to be waste in one or more Member States by virtue of the national measures transposing Article 6 of Directive 2008/98/EC, — substances formed from precursors which have ceased to be waste in one or more Member States by virtue of the national measures transposing Article 6 of Directive 2008/98/EC, or mixtures containing such substances, — non-biodegradable polymers, and — animal by-products or derived products within the scope of Regulation (EC) No 1069/2009. An EU fertilising product may contain pyrolysis or gasification materials obtained through thermochemical conversion under oxygen-limiting conditions of any input material referred to in sub-points (a) to (e), or combination thereof, processed by manual, mechanical or gravitational means, by solid-liquid fractionation using biodegradable polymers, by dissolution in water, by flotation, by extraction with water, by steam distillation or by heating solely to remove water, by composting or by anaerobic digestion. 2. The thermochemical conversion process shall take place under oxygen-limiting conditions in such a way that a temperature of at least 180 °C for at least two seconds is reached in the reactor. The pyrolysis or gasification reactor may only process input materials, which are not contaminated with other material streams, or input materials, other than animal by-products or derived products within the scope of Regulation (EC) No 1069/2009, which have been contaminated with other material streams unintentionally in a one-off incident resulting only in trace levels of exogenous compounds. In the plant where the pyrolysis or gasification takes place, physical contacts between input and output materials shall be avoided after the thermochemical process, including during storage. 3. The pyrolysis and gasification materials shall have a molar ratio of hydrogen (H) to organic carbon (H/C org ) of less than 0,7, with testing to be performed in the dry and ash-free fraction for materials that have an organic carbon (C org ) content of less than 50 %. They shall have no more than: (a) 6 mg/kg dry matter of PAH16 (*2), (b) 20 ng WHO toxicity equivalents (*3) of PCDD/F (*4)/kg dry matter, (c) 0,8 mg/kg dry matter of ndl-PCB (*5), 4. Notwithstanding point 1, an EU fertilising product may contain pyrolysis or gasification materials obtained through the thermochemical conversion under oxygen-limiting conditions of Category 2 or Category 3 materials or derived products thereof, in accordance with the conditions set out in Article 32(1) and (2) of Regulation (EC) No 1069/2009 and in the measures referred to in Article 32(3) of that Regulation, alone or mixed with input materials referred to in point 1, provided that both of the following conditions are fulfilled: (a) the end point in the manufacturing chain has been determined in accordance with Article 5(2), third subparagraph of Regulation (EC) No 1069/2009; (b) the conditions in points 2 and 3 are met. 5. In the plant where the pyrolysis or gasification takes place, the production lines for the processing of input materials referred to in points 1 and 4 shall be clearly separated from production lines for the processing of other input materials. 6. In an EU fertilising product containing or consisting of pyrolysis and gasification materials: (a) the chlorine (Cl-) content shall not be higher than 30 g/kg dry matter and (b) the thallium (Tl) content shall not be higher than 2 mg/kg dry matter, in case more than 5 % of pyrolysis or gasification additives relative to the fresh weight of total input material have been applied. 7. The pyrolysis and gasification material shall have been registered pursuant to Regulation (EC) No 1907/2006, in a dossier containing: (a) the information provided for by Annex VI, VII and VIII of 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) The exclusion of an input material from a sub-point does not prevent it from being an eligible input material by virtue of another sub-point." (*1) The exclusion of an input material from a sub-point does not prevent it from being an eligible input material by virtue of another sub-point." (*2) 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." (*3) 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." (*4) Polychlorinated dibenzo-p-dioxins and dibenzofurans." (*5) Sum of congeners PCB 28, 52, 101, 138, 153, 180.’"