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- Original (As adopted by EU)
Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (Text with EEA relevance)
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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 [F1appropriate authority] on request.
Textual Amendments
F1Words in Annex 5 Ch. 3 Section 2 point 1 substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(39)(a)
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;
[F2animal 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;]
[F3mixture of animal by-products referred to in point 2(b) with non-animal by-product materials.]
Textual Amendments
F2Substituted by Commission Regulation (EU) 2015/9 of 6 January 2015 amending Regulation (EU) No 142/2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (Text with EEA relevance).
F3Inserted by Commission Regulation (EU) 2015/9 of 6 January 2015 amending Regulation (EU) No 142/2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (Text with EEA relevance).
does not consider that those materials present a risk of spreading any serious transmissible disease to humans or animals;
[F2considers that the digestion residues or compost are unprocessed material and obliges operators to handle them in accordance with Regulation (EC) No 1069/2009, with this Regulation or, in the case of compost or digestion residues derived from catering waste, to recover or dispose of in accordance with the environmental legislation.]
Textual Amendments
F4Words in Annex 5 Ch. 3 Section 2 point 4(a) substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(39)(b)(i)
F5Annex 5 Ch. 3 Section 2 point 4(b) omitted (E.W.S.) (31.12.2020) by virtue of The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(39)(b)(ii)
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