RULES CONCERNING VALIDATION OF
PROCESSING METHODS, APPLICATION OF
ALTERNATIVE METHODS
N. LEACH, A. LEBOUCHER
Health and
Consumers
Aims and programme
Aims of the presentation
Identify the differences
between:
 process/treatment,
 method/parameters and
 validation/approval/authorisation
Health and
Consumers
Aims and programme
•Scope of alternative methods
•Scope of alternative parameters
Health and
Consumers
Alternative methods
Use and disposal of ABPs
• Articles 12, 13 and 14 of regulation (EC) No 1069/2009
define possible destinations for ABPs and ways for disposal or
use
• Annexes III, IV, V, IX, X, XI and XIII of regulation (EU) No
142/2011 lay down implementing rules for defined uses
and/or disposal called « treatments »
• A « treatment » (use/disposal) is defined:
– if it is listed as a possible way of use or disposal of ABPs or
derived products, and
– if conditions are described to ensure safety of derived products
remark : disposal through waste water is always prohibited (annex IV, chapt I, section 2,
point 6 of regulation (EU) No 142/2011)
Health and
Consumers
Alternative methods
Use and disposal of ABP : focus on
combustion
• Combustion or use ABP as fuel for combustion is a way of
using ABPs rather than disposal
• It is defined for all categories of ABP in Articles 12 (e), 13
(h) and 14 (i) of regulation (EC) No 1069/2009
• Plant where combustion is carried out has to be approved
according to Article 24 1.(d) of regulation (EC) No 1069/2009
• Article 15 1. (e) lays down that implementing measures
may defined conditions for the combustion of ABP and
derived products
Remark : no conditions, no authorisation available yet
Health and
Consumers
Alternative methods
Use and disposal of ABP : focus on
combustion
• Few requirements for use as fuel for combustion are laid down in
regulation (EU) No 142/2011
• Annex IV of regulation (EU) No 142/2011 defines rules only as
–alternative method : combustion of animal fat in a thermal boiler process
• Concern only rendered fat (no adipose tissue or other ABP such as Used Cooking Oils)
• taking notice of % of impurities (ruminant rendered fat)
• Requiring standard processing methods depending on categories, species of origin, location of boiler
• Define standard temperature parameters or equivalent authorized parameters for combustion :
> 1 100°C, >0.2 sec
–alternative method : combustion of poultry manure as fuel on the
production breeding farm and
–other combustion of ABPs/derived products as fuel is not yet authorised
Health and
Consumers
Alternative methods
Use and disposal of ABP : focus on
combustion
• Annex IV (or III if in future it is named « incineration, coincineration and combustion »)
– could add requirements for ABPs/derived products used as fuel for
combustion in relation to rules for combustion not within the scope of EU
environmental rules
– could be
• methods (standard –III- or alternative –IV-) or
• only parameters, fixing specific temperature to be obtained for the
material used as fuel during combustion or other (alternative) parameters
to be validated by operators and authorised or approved by CA
Health and
Consumers
Alternative methods
Use/Disposal and processing
• Among several authorised treatments, processing is
especially noted and processing methods are defined
• Annex IV defines standard processing methods*
• Standard processing methods are listed as methods 1 to 7
• Each method is defined through precise parameters
including temperature, time, pressure, size of particules
* For use as feed material, processing methods using other methods are defined
(hydrolysation of proteins, processing collagen, gelatine, blood products, milk products,
etc..) which are not necessarily complying with standard M1 to 7.
Health and
Consumers
Alternative methods
Use/Disposal and processing
CASE STUDY
Method 1 named sterilisation
under pressure
133°C, 20 min, 3 bars, 50mm
• Only M7 used for PAP, OF/SI (art
10 n, o and p or else) has to be
authorised by CA, may be placed
on EU market
• M7 will use parameters chosen
and validated by operators
Health and
Consumers
Alternative methods
Using M1 to 7 in ABP plants
• M1 to 7 take place in plants approved according to article 24 1 (a)
of regulation (EC) No 1069/2009 for processing
• Annex XVI of regulation (EU) No 142/2011 requires validation of
procedures used in approved plants
• As a result, in a processing plant
– official controls must validate a procedure related to a specific
processing method used on one category of ABP processed on a
single processing line
– several methods may be used and approved in the same plant on
different lines
CASE STUDY
a CAT 3 processing plant using M1 and 7 : blood may be
processed according to M7 for blood meal whereas a mix of
Cat 3 (Article 10, (a) to (m)) may be processed using M1 for
PAP used as OF/SI and feathers may be processed through
M7 for feather meal
Health and
Consumers
Alternative methods
New processing methods or new
treatment
• Article 20 of regulation (EC) No 1069/2009 allows to propose new
processing method (« alternative ») for use, containment and
disposal
• Article 16 and Annex VII of regulation (EU) No 142/2011 provides a
form to submit the application to EFSA
• EFSA will ensure that risks to public and animal health are
controlled before disposal and reduced to an equivalent degree to
standard methods (and treatment)
• Commission may then propose authorising the new method as
« alternative processing method » by amendment to regulation (EU)
No 142/2011 (annex IV)
CASE STUDY
since 2011, new methods to be authorised are : « bunker
system » disposed by incineration, mixing manure with special
component
Health and
Consumers
Alternative methods
New processing methods or new
treatment
• MSs are not allowed to authorise a new method of use or disposal if
it is not already authorised by EU regulation
• Once authorised, method is to be approved in approved plants by
MSs
• Processing parameters (critical limits including other measures than
temperature) are described in the annex IV
CASE STUDY
Biodiesel production process is described as an alternative
method which may use rendered fat; processed using M1 for
Cat 1 or 2 and M1 to 7 for Cat 3
Fat fraction from ruminant mus be submitted to purification,
followed by esterification and transesterification and
distillation.
During esterification and transesterification, a reduction of pH and
heating are required according to specific parameters
Process using equivalent parameters may be authorised by CA
Health and
Consumers
Aims and programme
•Scope of alternative methods
•Scope of alternative parameters
Health and
Consumers
Alternative parameters
Existing standard parameters
• Conditions required for certain treaments, parameters may be fixed
by EU rules
• Standard parameters have been described while describing
standard processing methods (133°C, etc..) or combustion...
• Apart from processing, treatments such as
– transformation into biogas and compost, and
– processing manure or manure derived products to be put on the market as
OF/SI are described according to standard parameters
CASE STUDY
For the 3 treatments cited above, standard parameters are
about the same in nature (time/temperature) and value
70 degrees celsius for 60 minutes
Only particle size may be required for transformation. For
processing manure, may be added a treatment for
reducing spore-forming bacteria and toxin formation
Health and
Consumers
Alternative parameters
Validation of alternative parameters
• If operator wants to use other parameters for the treatments listed
• Operator has to validate the parameters proposed according to
– Identification of hazards from ABP entering the plant
– Hazard analysis
– Demonstration that chosen parameters are equivalent to 70°C-60 min
• Demonstration is linked to sampling and analysis showing that
– S. Senftenberg (Enterococcus faecalis) and parvovirus or
– endogenous indicators showing the same resistance have been reduced (5
log)
Health and
Consumers
Alternative parameters
Validation of alternative parameters
• Once demonstration is validated by operator on-the-spot and with
results and hazard analysis approved by CA,
• The parameters are authorised by CA and are part of the
characteristics of the approved plant
• They can be implemented in the approved plant where validation
has been conducted
• OF/SI may be put on the EU market without any restrictions
CASE STUDY
Biogas plant aims to pasteurise CAT 2 (dead fish) and 3 (former
foodstuffs, milk, former petfood,) using 55°C during 14 days.
To get an authorisation, a validated program is sent to CA. It is
mostly composed of results of 2 analysis in 5 samples for
Salmonella sp. and E. coli.
Health and
Consumers
Alternative methods and parameters
Validation, authorisation & approval
• For methods and parameters, operators who want to use other
than standard ones have to validate the alternatives
– through specific EFSA form for method of ABP use/disposal
– through specific form for parameters to be authorised by CA during certain
use/disposal such as transformation into biogas or compost or manufacturing
processed manure for OF/SI
• Authorised process resulting from the validated demonstration
– may be used in the EU (or in certain MSs), if it is recognised as a method
of use/disposal. Approved plants carrying out alternative methods must
follow fixed parameters as laid down in alternative method description. May
be used in the plant where demonstration has been run.
• In every case, except new method of disposal, EU market is
available for the finished products without restrictions
Health and
Consumers
Alternative methods and parameters
Validation, authorisation & approval
• Alternative method or parameters which have issued
from validated demonstrations are carried out
– In plants approved for using alternative methods according to
Article 24 1. (a) of regulation (EC) No 1069/2009. Fixed parameters
are to be controlled through HACCP plan as critical limits of a CCP
step
– In the plant where demonstration has been run and which is
approved according to one of the activities listed in Article 24 1. of
regulation (EC) No 1069/2009 ((f) and (g) mostly*). Operator must
control the critical limits identified as « alternative » parameters
through the implementation of HACCP plan.
*Method 7, standard processing method could be considered developing and demonstrating the
efficacy of « alternative » parameters (mostly temperature, size of particles, etc..) and authorised
by CA for one unit. Just procedure of demonstration is different (30 days of sampling and analysis).
Health and
Consumers
Alternative methods and parameters
Validation, authorisation and approval
To conclude:
1.EFSA validates alternative method ; DGSANCO authorises it with
precise parameters to be followed by approved operators
2. Operator validates alternative parameters ; CA authorises them
with precise procedures to be followed by the approved operator
• Most activites involved must follow HACCP principles.
- Fixed parameters of alternative (or standard) methods and also
-alternative parameters
must be considered as critical limits of a CCP.
• CCP is defined through its critical limits
• In ABP chain, one of the CCP is often fixed by regulation as soon as
method/parameters are linked to temperature rising to the required
minimum
Health and
Consumers
Alternative methods and parameters
•Questions?
Thanks for your attention
Health and
Consumers