D7: authorisation to use different standardised process parameters for processed manure, derived products from processed manure and guano from bats to be placed on the market, provided it is demonstrated they minimise biological risks
Dated: 27 April 2011
Authorisation D7
The Scottish Ministers for the Scottish Government, acting as the Competent Authority for Scotland in respect of the following EU Regulations:
- Regulation (EC) No 1069/2009* of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal byproducts and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002
- Commission Regulation (EU) No 142/2011* of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council
Authorisation to use different standardised process parameters for processed manure, derived products from processed manure and guano from bats to be placed on the market, provided it is demonstrated they minimise biological risks
In accordance with Article 15(1)(i) of Regulation (EC) 1069/2009 and Article 22(1) and Section 2(c), Chapter I, Annex XI of Commission Regulation (EU) No 142/2011 the Scottish Ministers authorises the use of different standardised process parameters, as laid down in Annex A, to those in Section 2(b), Chapter I of Annex XI for processed manure, derived products from processed manure and guano from bats other than those imported from third countries to be placed on the market provided this complies with the requirements of Section 2(a), (c), (d) and (e), Chapter I, Annex XI of Regulation (EU) No 142/2011.
*Enforced in Scotland by the Animal By-Products (Enforcement) (Scotland) Regulations 2013
Annex A
The Scottish Ministers authorises the use of other standardised process parameters than those referred to in point (b) of Section 2, Chapter I of Annex XI, provided the operator demonstrates that such parameters ensure minimising of biological risks.
That demonstration shall include a validation, which shall be carried out as follows:
1. 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. Validation of the intended process:
a) by measuring the reduction of viability/infectivity of endogenous indicator organisms during the process, where the indicator is:
i) consistently present in the raw material in high numbers
ii) 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
iii) relatively easy to quantify and relatively easy to identify and confirm; or
b) by measuring the reduction of viability/infectivity, during exposure, of a wellcharacterised test organism or virus introduced in a suitable test body into the starting material
3. 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. EN 26.2.2011 Official Journal of the European Union L 54/77
4. Designing a complete control programme including procedures for monitoring the process
5. 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.