Przewidywane zmiany w przepisach
UE i polskich dotyczące przemysłu
utylizacyjnego
Warszawa 26 września 2011r.
dr Jerzy Dowgiałło
Zmiany w przepisach UE
na podstawie materiałów na posiedzenie
Grupy Roboczej ekspertów ds. TSE
DG SANCO
w Brukseli w dniu 26 września 2011 roku
- Projekt raportu w sprawie TSE w krajach UE
- Załącznik IV do rozporządzenia WE 999/2001
- Załącznik VI do rozporządzenia WE 152/2009
Draft report on the monitoring and
testing of ruminants for the
presence of transmissible
spongiform encephalopathies
(TSEs) in the EU in 2010
Dane DG SANCO
Total tests performed in the period 2001–2010 in the EU27
Dane DG SANCO
Evolution of the number of BSE positive cases in the EU
since 2001
Dane DG SANCO
Evolution of BSE cases detected by passive surveillance
and active monitoring in the EU-27, from 2000 to 2010
Dane DG SANCO
Total BSE positive cases per number of cattle tested or
present in the adult cattle population (> 24 months of age) in 2010
Dane DG SANCO
European countries where BSE positive cases were detected
in 2010
Dane DG SANCO
Average age (in months) of BSE positive cases detected in
the EU from 2001 to 2010
Dane DG SANCO
No BSE case was detected in cattle
younger than 60 months in 2010.
Dane DG SANCO
Evolution of TSE testing in sheep in the EU 27 from 2002
to 2010
Dane DG SANCO
EU Member States (+ Norway) where TSE in small ruminants
was reported in 2010
Dane DG SANCO
Distribution of TSE cases detected in 2010
Dane DG SANCO
Distribution of TSE cases detected in 2010
SANCO/10843/2011 rev.23
Draft
COMMISSION REGULATION
of
amending Annex IV to Regulation (EC) No
999/2001 of the European Parliament and of
the Council as regards prohibitions
concerning animal feeding of processed
animal protein derived from non-ruminant
animals
On 17 November 2007, the Panel on Biological Hazards
(BIOHAZ) of the European Food Safety Authority (EFSA)
adopted a scientific opinion on certain aspects related to the
feeding of animal proteins to farmed animals. This opinion
concluded that to date, no TSEs have been identified as
occurring in pigs or poultry under natural conditions. Taking
account of the epidemiological situation of BSE in cattle in
the EU, which indicates a decreasing trend, together with
the current control measures in place to avoid exposure of
pigs and poultry to BSE contaminated material, the BIOHAZ
Panel of EFSA concluded that the risk of transmitting BSE
to pigs utilizing poultry PAP and vice versa is negligible and
that, in this scenario, any increase in the exposure risk of
BSE to humans would be negligible.
Opinion of the Scientific Panel on Biological Hazards on a request from the European Parliament on
Certain Aspects related to the Feeding of Animal Proteins to Farm Animals, The EFSA Journal (2007)
Journal number 576, 1-41
On 29 November 2010, the Council (AGRIFISH)
adopted conclusions on the TSE Roadmap 2
recognising the fundamental importance of the
ban on using PAP in feed for farmed animals in
preventing the circulation of BSE via the feed chain
and thus playing a key role in the reduction of the
incidence of this disease in the bovine population.
Furthermore, the Council conclusions consider it a
prerequisite of any possible re-introduction of the
use of non-ruminant PAPs to feed for other nonruminant species that effective and validated tests
are available to distinguish between PAP originating
from different species and that there has been a
careful analysis of the risks of relaxation, regarding
animal and public health.
http://register.consilium.europa.eu/pdf/en/11/st05/st05455-re02.en11.pdf
Considering that the transmission risk of BSE
from non ruminants to non-ruminants is very
unlikely, the Communication acknowledges that
a lifting of the ban on the use of PAP from nonruminants in non-ruminant feed could be
considered, but without lifting the existing
prohibition
on
intra-species
recycling
("cannibalism") and only if validated analytical
techniques to determine the species origin of
PAP are available and a correct channelling of
PAP from different species is in place
On 9 December 2010, the BIOHAZ of EFSA adopted a
scientific opinion on the revision of the quantitative risk
assessment (QRA) of the BSE risk posed by PAP. This
opinion concluded that on the basis of 2009 BSE
surveillance data in the EU, assuming a 0.1%
contamination (the limit of detection for PAP in feed)
with non-ruminant PAP and according to EFSA’s QRA PAP
model, the estimated mean total BSE infectivity load
that could enter in cattle feed per year in the EU would
be equivalent to 0.2 cattle oral ID50. This would mean
that less than one additional BSE infected animal could
be expected in the EU cattle population per year with
an upper 95% confidence.
Opinion of the Scientific Panel on Biological Hazards on a revision of the quantitative risk
assessment (QRA) of the BSE risk posed by processed animal protein (PAPs), EFSA Journal
2011;9(1):1947
Article 2
This Regulation shall enter into force on the 20th
day following its publication in the Official
Journal of the European Union.
It shall apply as from 1st July 2012.
1) PRESENTATION BY THE EUROPEAN UNION REFERENCE LABORATORY ON ANIMAL
PROTEINS OF THE CURRENT SITUATION AND THE REMAINING WORK SCHEDULE AS
REGARDS VALIDATION/DEVELOPMENT OF ANALYTICAL TECHNIQUES ABLE TO DETERMINE
SPECIES ORIGIN OF PROCESSED ANIMAL PROTEINS
2) DISCUSSION ON A DRAFT PROPOSAL AMENDING ANNEX VI OF REGULATION (EC)
N°152/2009 LAYING DOWN THE METHODS OF SAMPLING AND ANALYSIS FOR THE
OFFICIAL CONTROL OF FEED
Dr. Vincent Baeten, Dr Gilbert Berben, Dr Pascal Veys, Dr Olivier Fumière
Abbas O., Belinchón Crespo C., Doms K., Fernández Pierna J.A.,
Hulin J., Marien A., Mouteau A., Pire A., Quoitot A., Scaut B.
Working Group TSE - Brussels, 26th September 2011
• Status of the development and
validation of PCR
What is already validated?
1.
Transfer protocol
Determination of a cut-off value specific of a PCR platform thanks to
calibration with plasmids
2.
CRA-W cattle target
Detection of cattle DNA in feed
Validated during the SAFEED-PAP project.
PCR training : status
Participants choosen by the EURL-AP:
- Enquiry in 2010
- Priority given to the NRLs having the least experience
- Voluntary basis for the 2 last sessions
•
7-9 December 2010 (2.5 days)
6 participants : Belgium, Cyprus, Greece, Portugal, Romania, Slovakia
•
15-17 February 2011 (2.5 days)
5 participants : Bulgaria, Czech Republic, France, Hungary, Ireland
•
13-15 September 2011 (2.5 days)
4 participants : Austria, Lithuania, Poland, Spain
•
4-6 October 2011 (2.5 days)
4 participants : Estonia, Finland, Latvia, Slovenia
 Actual status : 19 of 26 NRLs participated to a training
DVD on PCR steps
A DVD ready to be provided to the NRLs:
©
details all steps of the PCR method from the laboratory sample up to the
interpretation of results
 there might be no need of training for all NRLs but some reminders can be
helpful
Amendment of Annex VI of
EC/152/2009
Combination of LM - PCR
Objectives
–
–
–
–
Keep detection ability at highest level
Species identification
Cost effectiveness (time, HR, money)
Flexibility
Proposed solution = basic investigation LM, when species (or genus) detection
is needed PCR
Variations of operational scheme according the type of feed or ingredient as
well as its final destination of use (e.g fish feed, pet food,...)
Further information on public Website EURL.CRAW.EU
Structure of amended Annex VI
•
OBJECTIVES and PRINCIPLES
•
OPERATIONAL SCHEMES
- Decision diagrams
•
METHODS
• Part A : Light microscopy
• Part B : Polymerase Chain Reaction
Dane DG SANCO
Operational schemes (I)
FEED/ INGREDIENT
intended for
A–B-C
Light microscopy (LM)
Free choice of method for
first test (LM or PCR)
A = Pigs then (*) = from ruminant and/or porcine targets
B = Poultry, then (*) = from ruminant and/or poultry targets
C = Fishes , then (*) = from ruminant target
PCR
LM on sediment
YES
Detection of
terrestrial material ?
+
Presence of DNA (*)?
+
Label
mention of authorized
animal products ?
Detection of
terrestrial material ?
+
NO
2nd PCR
on sediment
Presence of DNA (*)?
+
FIT
(for intended final use)
REJECTED
Dane DG SANCO
Operational schemes (II)
FEED for RUMINANTS
Free choice of method for
first test (LM or PCR)
PCR
Presence of
animal DNA?
Light microscopy (LM)
+
Detection of
PAP material ?
+
Is the feed a
MILK REPLACER ?
NO
FIT
(for intended final use)
REJECTED
YES
Detection of
terrestrial material?
+
Part A : Light microscopy
• Revised protocol
yet validated by EURL-AP Interlaboratory Study Microscopy 2010
(available from eurl.craw.eu/img/page/interlaboratory/EURL_AP_ILS_2010_final.pdf )
• Modifications
–
–
–
–
–
Standardisation : only separation funnels
Fixed nr. of slides to analyse
Repetition of analysis in case ≤ 5 particles detected from first analysis
Decision diagrams
Open options :
–
–
–
–
sieving,
stereomicroscopic observations,
3g in case of fish meal
Observations sediment + flotate OR raw material
Part
B
:
PCR
The Annex will provide minimum performance requirements for the PCR methods.
This means that NRLs and their network are not obliged to use the PCR methods
provided by the EURL-AP if the PCR method used can comply with these
requirements.
Parameters considered
Target size : guidance, no mandatory criterion
There must be a clear interpretation criterion of the results (e.g. a cut-off)
Acceptance criteria:
Specificity
Sensitivity
PCR efficiency
Robustness
A guidance document for determination of the parameters will be provided by the
EURL-AP
Zmiany w przepisach krajowych
Rozporządzenie Ministra Rolnictwa i Rozwoju Wsi w
sprawie wymagań weterynaryjnych dla nawozów
organicznych i polepszaczy gleby, wytworzonych z
produktów ubocznych pochodzenia zwierzęcego,
produktów pochodnych lub z udziałem tych produktów