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installations for monitoring that the temperature of 70 °C is reached during the time of one hour;
recording devices to record continuously the results of the monitoring measurements referred to in point (a); and
an adequate system to prevent insufficient heating.
Category 2 material that has been processed in accordance with processing method 1 as set out in Chapter III of Annex IV;
Category 3 material that has been processed in accordance with any of the processing methods 1 to 5 or processing method 7, or in the case of material originating from aquatic animals, any of the processing methods 1 to 7, as set out in Chapter III of Annex IV;
Category 3 material that has undergone pasteurisation/hygienisation in another approved plant;
animal by-products which may be used as raw material without processing in accordance with Article 13(e)(ii) of Regulation (EC) No 1069/2009 and with this Regulation;
animal by-products which have been subject to the alkaline hydrolysis process set out in point A of Section 2 of Chapter IV of Annex IV;
the following animal by-products, if authorised by the competent authority:
the animal by-products referred to in Article 10(f) of Regulation (EC) No 1069/2009, which have undergone processing as defined in Article 2(1)(m) of Regulation (EC) No 852/2004 at the time when they are destined for purposes other than human consumption;
the animal by-products referred to in Article 10(g) of Regulation (EC) No 1069/2009; or
animal by-products which are transformed into biogas, where the digestion residues are subsequently composted or processed or disposed of in accordance with this Regulation.
That distance shall be determined in a manner which ensures that there is no unacceptable risk for the transmission of a disease communicable to humans or animals from the biogas plant.
In all cases, there must be total physical separation between that biogas plant and the animals and their feed and bedding, with fencing where necessary.
installations for monitoring temperature against time;
recording devices to record, where appropriate continuously, the results of the monitoring measurements referred to in point (a);
an adequate safety system to prevent insufficient heating.
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; or
transform only materials referred to in point 2 of Section 1; and
comply with all other relevant requirements of this Regulation.
That distance shall be determined in a manner which ensures that there is no unacceptable risk for the transmission of a disease communicable to humans or animals from the composting plant.
In all cases, there must be total physical separation between that composting plant and the animals and their feed and bedding, with fencing where necessary.
That area must be situated or designed so as to prevent risk of contamination of treated products.
A documented pest-control programme must be used for that purpose.
maximum particle size before entering the unit: 12 mm;
minimum temperature in all material in the unit: 70 °C; and
minimum time in the unit without interruption: 60 minutes.
However, Category 3 milk, milk-based products, milk-derived products, colostrum and colostrum 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 to humans or animals.
The minimum requirements set out in points (b) and (c) of this point shall also apply to Category 2 material which is introduced into a biogas plant without prior processing in accordance with Article 13(e)(ii) of Regulation (EC) No 1069/2009.
maximum particle size before entering the composting reactor: 12 mm;
minimum temperature in all material in the reactor: 70 °C; and
minimum time without interruption: 60 minutes.
The minimum requirements set out in points (b) and (c) of this point shall also apply to Category 2 material which is composted without prior processing in accordance with Article 13(e)(ii) of Regulation (EC) No 1069/2009.
Identification and analysis of possible hazards, including the impact of input material, based on a full description of the transformation conditions and parameters;
A risk assessment, which evaluates how the specific transformation conditions referred to in point (a) are achieved in practice under normal and atypical situations;
Validation of the intended process by measuring the reduction of viability/infectivity of:
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 transformation process, but also not significantly more resistant than the pathogens for which it is being used to monitor,
relatively easy to quantify and to identify and to confirm; or
a well-characterised test organism or virus, during exposure, introduced in a suitable test body into the starting material.
The validation of the intended process referred to in point (c) must demonstrate that the process achieves the following overall risk reduction:
for thermal and chemical processes by:
a reduction of 5 log10 of Enterococcus faecalis or Salmonella Senftenberg (775W, H2S negative),
reduction of infectivity titre of thermoresistant viruses such as parvovirus by at least 3 log10, whenever they are identified as a relevant hazard; and
as regards chemical processes also by:
a reduction of resistant parasites such as eggs of Ascaris sp. by at least 99,9 % (3 log10) of viable stages;
Designing a complete control programme including procedures for monitoring the functioning of the process referred to in point (c);
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 by the operator to the competent authority on request. Information relating to a process authorised under this point must be made available to the Commission on request.
catering waste used as the only animal by-product in a biogas or composting plant; and
mixtures of catering waste with the following materials:
manure;
digestive tract content separated from the digestive tract;
milk;
milk-based products;
milk-derived products;
colostrum;
colostrum products;
eggs;
egg products;
animal by-products referred to in Article 10(f) of Regulation (EC) No 1069/2009, which have undergone processing as defined in Article 2(1)(m) of Regulation (EC) No 852/2004.
does not consider that those materials present a risk of spreading any serious transmissible disease to humans or animals;
considers that the digestion residues or compost are unprocessed material and obliges operators to handle them in accordance with Regulation (EC) No 1069/2009 and with this Regulation.
in accordance with point 1;
in accordance with points 2 and 3, only within the Member State where those parameters have been authorised.
Representative samples of the digestion residues or compost taken during or immediately after transformation at the biogas plant or composting at the 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
Enterococcaceae: 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 must comply with the following standards:
Salmonella: absence in 25 g: n = 5; c = 0; m = 0; M = 0
Where in the case of point (a) or (b):
=
number of samples to be tested;
=
threshold value for the number of bacteria; the result is considered satisfactory if the number of bacteria in all samples does not exceed 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
=
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.