Przewidywane zmiany w przepisach UE i polskich dotyczące przemysłu

utylizacyjnego

Warszawa 26 września 2011r.dr Jerzy Dowgiałło

Zmiany w przepisach UEna 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 andtesting of ruminants for thepresence of transmissible

spongiform encephalopathies(TSEs) in the EU in 2010

Total tests performed in the period 2001–2010 in the EU27

Dane DG SANCO

Evolution of the number of BSE positive cases in the EUsince 2001

Dane DG SANCO

Evolution of BSE cases detected by passive surveillanceand active monitoring in the EU-27, from 2000 to 2010

Dane DG SANCO

Total BSE positive cases per number of cattle tested orpresent in the adult cattle population (> 24 months of age) in 2010

Dane DG SANCO

European countries where BSE positive cases were detectedin 2010

Dane DG SANCO

Average age (in months) of BSE positive cases detected inthe 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 2002to 2010

Dane DG SANCO

EU Member States (+ Norway) where TSE in small ruminantswas reported in 2010

Dane DG SANCO

Distribution of TSE cases detected in 2010

Dane DG SANCO

Distribution of TSE cases detected in 2010

Dane DG SANCO

DraftCOMMISSION 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 non-ruminant 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 non-ruminants 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 2This 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 DETERMINESPECIES ORIGIN OF PROCESSED ANIMAL PROTEINS

Working Group TSE - Brussels, 26th September 2011

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.

2) DISCUSSION ON A DRAFT PROPOSAL AMENDING ANNEX VI OF REGULATION (EC) 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 N°152/2009 LAYING DOWN THE METHODS OF SAMPLING AND ANALYSIS FOR THE OFFICIAL CONTROL OF FEEDOFFICIAL CONTROL OF FEED

• 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 feedValidated during the SAFEED-PAP project.

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

PCR training : status

DVD on PCR stepsA 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

Operational schemes (I)

Light microscopy (LM)

Detection ofterrestrial material ?

FEED/ INGREDIENT intended for

A – B - C

Presence of DNA (*)?

FIT (for intended final use)

PCR

NO

YES

Detection ofterrestrial material ?

+ ++

A = Pigs then (*) = from ruminant and/or porcine targetsB = Poultry, then (*) = from ruminant and/or poultry targetsC = Fishes , then (*) = from ruminant target

REJECTED

2nd PCR on sediment

Presence of DNA (*)?

+

Free choice of method for first test (LM or PCR)

Label mention of authorized

animal products ?

LM on sediment

Dane DG SANCO

Operational schemes (II)

Light microscopy (LM)

Detection ofPAP material ?

FEED for RUMINANTS

FIT (for intended final use)

+ Is the feed a MILK REPLACER ?

REJECTED

Detection of terrestrial material?

+

YES

NO

Presence of animal DNA?

PCR

+

Free choice of method for first test (LM or PCR)

Dane DG SANCO

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 : PCRThe 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 criterionThere must be a clear interpretation criterion of the results (e.g. a cut-off)

Acceptance criteria:

SpecificitySensitivityPCR efficiencyRobustness

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