1.

In Annex VI, Chapter II is amended as follows: (a) Points A(1) and (2) are replaced by the following: ‘1. A biogas plant must be equipped with: (a) a pasteurisation/hygienisation unit, which cannot be by-passed, with: (i) installations for monitoring temperature against time; (ii) recording devices to record continuously the results of the monitoring measurements referred to in (i); and (iii) an adequate safety system to prevent insufficient heating; (b) adequate facilities for the cleaning and disinfecting of vehicles and containers upon leaving the biogas plant. However, a pasteurisation/hygienisation unit shall not be mandatory for biogas plants that transform only: (i) animal by-products that have undergone processing Method 1; (ii) Category 3 material that has undergone pasteurisation/hygienisation elsewhere; or (iii) animal by-products which may be used as raw material without processing. If the biogas plant is located on premises where farmed animals are kept and does not only use manure which accrues from those animals, the plant shall be located at an adequate distance from the area where such animals are kept and there must be, in any case, total physical separation between that plant and those animals and their feed and bedding, with fencing where necessary. 2. A composting plant must be equipped with: (a) a closed composting reactor, which cannot be by-passed, with: (i) installations for monitoring temperature against time; (ii) recording devices to record, where appropriate continuously, the results of the monitoring measurements referred to in (i); and (iii) an adequate safety system to prevent insufficient heating; (b) adequate facilities for cleaning and disinfecting of vehicles and containers transporting untreated animal by-products. However, other types of composting systems may be allowed provided they: (i) ensure adequate measures to control vermin; (ii) are managed in such a way that all the material in the system achieves the required time and temperature parameters, including, where appropriate, continuous monitoring of the parameters; (iii) comply with all other requirements of this Regulation. If the composting plant is located on premises where farmed animals are kept and does not only use manure which accrues from those animals, the composting plant shall be located at an adequate distance from the area where animals are kept and there must, in any case, be total physical separation between that composting plant and the animals and their feed and bedding, with fencing where necessary.’ (b) Point B(11) is replaced by the following: ‘11. Digestion residues and compost must be handled and stored at the biogas respective composting plant in such way as to prevent recontamination.’ (c) Point C(12) is replaced by the following: ‘12. Category 3 material used as raw material in a biogas plant equipped with a pasteurisation/hygienisation unit must be submitted to the following minimum requirements: (a) maximum particle size before entering the unit: 12 mm; (b) minimum temperature in all material in the unit: 70 °C; and (c) minimum time in the unit without interruption: 60 minutes. However, category 3 milk, colostrums and milk products may be used without pasteurisation/hygienisation as raw material in a biogas plant, if the competent authority does not consider them to present a risk of spreading any serious transmissible disease.’ (d) Point C(13) is replaced by the following: ‘13. Category 3 material used as raw material in a composting plant must be submitted to the following minimum requirements: (a) maximum particle size before entering the composting reactor: 12 mm; (b) minimum temperature in all material in the reactor: 70 °C; and (c) minimum time in the reactor at 70 °C (all material): 60 minutes.’ (e) The following Point C(13a) is inserted: ‘13a. However, the competent authority may authorise the use of other standardised process parameters provided an applicant demonstrates that such parameters ensure minimising of biological risks. That demonstration shall include a validation, which shall be carried out in accordance with points (a) to (f): (a) Identification and analysis of possible hazards, including the impact of input material, based on a full definition of the processing conditions. (b) A risk assessment, which evaluates how the specific processing conditions referred to in (a) are achieved in practice under normal and atypical situations. (c) Validation of the intended process by measuring the reduction of viability/infectivity of: (i) endogenous indicator organisms during the process, where the indicator is: — consistently present in the raw material in high numbers, — not less heat resistant to the lethal aspects of the treatment process, but also not significantly more resistant than the pathogens for which it is being used to monitor, — relatively easy to quantify and relatively easy to identify and to confirm; or (ii) a well-characterised test organism or virus, during exposure, introduced in a suitable test body into the starting material. (d) The validation of the intended process referred to in (c) must demonstrate that the process achieves the following overall risk reduction: (i) for thermal and chemical processes by: — reduction of 5 log10 of Enterococcus faecalis or Salmonella Senftenberg (775W, H2S negative), — reduction of infectivity titre of thermo resistant viruses such as parvovirus by at least 3 log10, whenever they are identified as a relevant hazard; and (ii) as regards chemical processes also by: — reduction of resistant parasites such as eggs of ascaris sp. by at least 99,9 % (3 log10) of viable stages. (e) Designing a complete control programme including procedures for monitoring the functioning of the process referred to in (c). (f) Measures ensuring continuous monitoring and supervision of the relevant process parameters fixed in the control programme when operating the plant. Details on the relevant process parameters used in a biogas or composting plant as well as other critical control points must be recorded and maintained so that the owner, operator or their representative and the competent authority can monitor the operation of the plant. Records must be made available to the competent authority on request. Information relating to a process authorised under this point must be made available to the Commission on request.’ (f) In point C(14), point (b) shall be replaced by the following: ‘(b) considers that the residues or compost are unprocessed material.’ (g) Point D(15) is replaced by the following: ‘15. Representative samples of the digestion residues or compost taken during or immediately after processing at the biogas or composting plant in order to monitor the process must comply with the following standards: Escherichia coli: n = 5, c = 1, m = 1 000, M = 5 000 in 1 g; or Enterococaceae: n = 5, c = 1, m = 1 000, M = 5 000 in 1 g; and Representative samples of the digestion residues or compost taken during or on withdrawal from storage at the biogas or composting plant must comply with the following standards: Salmonella: absence in 25 g: n = 5; c = 0; m = 0; M = 0 where: n = number of samples to be tested; m = threshold value for the number of bacteria; the result is considered satisfactory if the number of bacteria in all samples does not exceed m; M = maximum value for the number of bacteria; the result is considered unsatisfactory if the number of bacteria in one or more samples is M or more; and c = number of samples the bacterial count of which may be between m and M, the sample still being considered acceptable if the bacterial count of the other samples is m or less. Digestion residues or compost, which does not comply with the requirements set out in this Chapter shall be reprocessed, in the case of Salmonella handled or disposed of in accordance with the instructions of the competent authority.’