F1The placing on the market of processed manure, derived products from processed manure and guano from bats shall be subject to the following conditions. In addition, in the case of guano from bats the consent of the Member State of destination is required as referred to in Article 48(1) of Regulation (EC) No 1069/2009:

1. (a)

   They must come from a plant for derived products for uses outside the feed chain or from a biogas or a composting plant or from a plant for the manufacturing of organic fertilisers or soil improvers.

2. (b)

   They shall have been subjected to a heat treatment process of at least 70 °C for at least 60 minutes and they shall have been subjected to reduction in spore-forming bacteria and toxin formation, where they are identified as a relevant hazard.

3. (c)

   However, the competent authority may authorise the use of other standardised process parameters than those referred to in point (b), provided an applicant demonstrates that such parameters ensure minimising of biological risks.

   That demonstration shall include a validation, which shall be carried out as follows:

   1. (i)

      Identification and analysis of possible hazards including the impact of input material, based on a full definition of the processing conditions, and a risk assessment, which evaluates how the specific processing conditions are achieved in practice under normal and atypical situations.

   2. (ii)

      Validation of the intended process

      1. (ii-1)

         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 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 confirm; or

      2. (ii-2)

         by measuring the reduction of viability/infectivity, during exposure, of a well-characterised test organism or virus introduced in a suitable test body into the starting material.

   3. (iii)

      The validation referred to in point (ii) must demonstrate that the process achieves the following overall risk reduction:

      • for thermal and chemical processes by reduction of Enterococcus faecalis by at least 5 log10 and by reduction of infectivity titre of thermoresistant viruses such as parvovirus, where they are identified as a relevant hazard, by at least 3 log10,

      • for chemical processes also by reduction of resistant parasites such as eggs of Ascaris sp. by at least 99,9 % (3 log10) of viable stages.

   4. (iv)

      Designing a complete control programme including procedures for monitoring the process.

   5. (v)

      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 plant as well as other critical control points shall be recorded and maintained so that the owner, operator or their representative and the competent authority can monitor the operation of the plant. Information relating to a process authorised under this point must be made available to the Commission on request;

4. (d)

   Representative samples of the manure taken during or immediately after processing at the plant in order to monitor the process must comply with the following standards:

   • Escherichia coli: n = 5, c = 5, m = 0, M = 1 000 in 1 g;

     or

   • Enterococcaceae: n = 5, c = 5, m = 0, M = 1 000 in 1 g;

     and

   • Representative samples of the manure taken during or on withdrawal from storage at the plant of production or 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.

   Processed manure or processed manure products not complying with the standards in this point shall be regarded as unprocessed;

5. (e)

   They must be stored in such a way that once processed contamination or secondary infection and dampness is minimised. They must therefore be stored in:

   1. (i)

      well-sealed and insulated silos or properly constructed storage sheds; or

   2. (ii)

      properly sealed packs, such as plastic bags or ‘big bags’.