Transcript EU Feed Additive Legislation

Reducing Carry-Over of Coccidiostats
in Feed and Food
Dr. Peter Kubasa
Feed Safety Conference, Prague, March 3, 2009
Overview
• The Role of Coccidiostats
• Carry-Over
• Tolerances in non-target feed and food
List of Authorised
Coccidiostats for Broilers
Sponsor
Alpharma
Janssen
Eli Lilly
Phibro
Alpharma
Eli Lilly
Huveph.
Alpharma
Eli Lilly
Alpharma
Huveph.
Alpharma
Krka
Brand
Cygro
Clinacox
Maxiban
Aviax
Deccox
Elancoban
Coxidin
Avatec
Monteban
Robenidine
Sacox
Salinomax
Kokcisan
Substance
Maduramicin
Diclazuril
Narasin/ Nicarbazin
Semduramicin
Decoquinate
Monensin
Monensin
Lasalocid A
Narasin
Cycostat
Salinomycin
Salinomycin
Salinomycin
Validity Dose range
30.9.2009
5
30.9.2009
1
30.9.2009
80-100
29.09.2016
20-25
17.7.2014
20-40
30.7.2014
100-125
06.02.2017
100-125
20.8.2014
75-125
21.8.2014
60-70
29.10.2014
30-36
21.8.2014
60-70
22.04.2015
50-70
26.02.2018
60-70
Withdrawal
5
5
5
5
3
1
1
5
1
5
1
1
3
As Additives
of 20/10/2004
Community Register of Feed
pursusant to Regulation No. 1831/2003
Estimated EU 27 feed production –
use of coccidiostats by segment
Cross-Contamination / Carry-Over
• Transfer from one production batch to the following
batch due to manufacture of broad range of compound
feeding stuffs.
• Unavoidable traces of coccidiostats remain in
production line
 end up in following product batch
 can result in residues in feedingstuffs for
non target species
• Legal provisions for minimising the risk of carry-over
(Feed hygiene regulation 183/2005, HACCP)
At the Feed Mill
•
Level of cross-contamination depends on:
•
•
•
•
•
Quality control process (e.g.:new NIR online
technology)
Design of the dosage
Grinding and mixing equipment
Transport and storage facilities
…technical or organisational measures must be taken
to avoid or minimize, as necessary, any crosscontamination and errors…..
As of 3/10/2004
Contamination of Feed with a
Coccidiostat
Investigations in a feed mill:
A,B,C:
sampling
points
Ref.: McEvoy et al., 2003,Feed Additives and Contaminants, Vol 20
Contamination of Feed with a
Coccidiostat
•
•
Investigation of 3 feed batches (3x3t)
following coccidiostat-batch
Sampling before pelleting
( post mixer,  post elevator boot)



•
Steady decline of residues (mg/kg) in feed
batches
Only residues in first batch/3t would cause
violative residues in eggs
3t flush enough to minimize carry over!?
Sampling post press/pelleter ()


•
ppm
Residues in excess of limits causing
violative residues in tissues
Cause of prolonged contamination was
the mill‘s practice of recycling sieved
material back into pre-press bins
Corrective actions…
Ref.: McEvoy et al., 2003,Feed Additives and Contaminants, Vol 20
Corrective Actions
•
•
•
Step 1 – Extension of clean-out time to ensure that all medicated
material was re-pelleted before the next batch of drug-free feed
entered the pre-press bins
Step 2 – Pellet-overs were redirected back to cooler, reducing the
chances for contamination from the pre-press bin
Introduction of new production line for poultry rations
 New elevators with reduced dead-space at the boot (1kg)
 Two separate mixers for breeder rations and St/G/F/WD
 Three separate presses for breeder, St/G and F rations
 57 rations tested: 93% without any contamination; 7% all with
concentrations below the levels causing violative residues in
poultry tissues and eggs.
Multiple Potential Causes for
Residues in Tissues and Eggs
• Contamination of feed at the feed mill or during
transport
• Supply of incorrect feed bin
• Inadequate cleaning of feeding system on farm
prior to feed delivery and feed change over
• Inadequate withdrawal periods being obseved
• Poor management of feed on farm leading to
re-exposure of birds to drugs close to slaughter
• Recycling of drug by birds from litter
Tolerances for Residues in Feed
• Undesirable substances in animal feed
•
•
•
•
Directive 2002/32/EC
ALARA principle – ‘as low as reasonably achieveable’
Initially a carry-over range of 3 – 10% has been
considered achievable
Risk assessment of unavoidable carry-over of
coccidiostats for animal health and public health 
scientific assessment by EFSA/FEEDAP
Tolerance levels in feed can lead to residues in
products of animal origin  maximum limits for food of
non-target species have been established in parallel
Evaluation of Tolerances in Non
Target Species inFeed
hypothetical
carry-over
to non target feed
2% 5% 10%
11 coccidiostats
maximum dose
in feed
•Scientific opinions done by EFSA
•Decision by Standing Committe done on
tolerances in feed and food in Nov 08
•Application of Directive 2009/8/EC (feed)
and Regulation No.124/2009(food) by
July 09
•Risk for animals
•Residues in food
•Risk for consumer
Tolerances in Non-Target Feeds
Tolerance levels differentiated into two groups
Feed for
less-sensitive
non-target
species
Feed for
sensitive nontarget species,
WD feed
3%
1%
compared to authorised max. concentration
of coccidiostat in feed
compared to authorised max. concentration
of coccidiostat in feed
NICARBAZIN
1. Target feed
- Chickens for fattening (50 mg/kg) (in combination with narasin)
2. Non-target feed
a) sensitive species + withdrawal feed (finishing feed) + continuously food producing
animals for which transfer of feed into food is likely
- sensitive species : none
- withdrawal feed (finishing feed): chickens for fattening: 5 days;
- continuously food producing animals: laying birds
b) less sensitive species
- all other non target species
3. Tolerances non-target feed
Category
Animal species
General : 3 %
Sensitive : 1 %
Expressed in mg/kg
Sensitive species
--
Withdrawal feed
Chickens for fattening
0.5
Continuously food
producing animals
Laying birds
0.5
Less sensitive species
All other non target species
1.5
4. Established MRLs
None
5. Maximum Limits in food of animal origin – non-target species
(in function of the tolerances under point 3)
- eggs: 100 µg/kg
- liver and kidney from non-target species: 100 µg/kg
- milk: 5 µg/kg
- all other food of animal origin of non target species: 25 µg/kg
Tolerance Limits in Food & Feed
Substance
MRL Tissues
MLs eggs *)
Tolerances feed*)
=1% of max.dose
Narasin
yes
2 ppb
0,7 ppm
Lasalocid
yes, egg 150ppb
Salinomycin
yes
3 ppb
0,7 ppm
Monensin
yes
2 ppb
1,25 ppm
Semduramicin
no
2 ppb
0,25 ppm
Maduramicin
no
2 ppb
0,05 ppm
Robenidine
yes
25 ppb
0,7 ppm
Decoquinate
Annex II
20 ppb
0,4 ppm
Nicarbazin
JECFA 200 ppb
100 ppb
0,5 ppm
Halofuginon
bovine only
6 ppb
0,03 ppm
Diclazuril
Annex II
2 ppb
0,01 ppm
1,25 ppm
*) Layers =Non-target species
Residues in Eggs
at 5% carry-over
Ref.: Daeseleire et al.,SPSD II 2000-2006, Case study: coccidiostats
Open Questions to Tolerance
Levels
• 1% tolerance is too ambitious for many mixing plants
 Considerable investment needed for upgrades
 Regional supply of feed may be compromised
• How to detect substances at 1% inclusion
 e.g. diclazuril LOD is higher than 0,01 mg/kg feed
• Maximum Limits in food of non-target species
 MLs in „food“ are not considered MRLs in animal tissues
according to Reg. 2377/1990 and residue complaints
may still be raised by residue inspection.
Summary
• Coccidiostats will continue to play a significant
role as zootechnical additives in poultry feeds
beyond 2012
• Unavoidable carry-over into non-target feeds
will continue despite GMP, but tolerance limits
are set now for feed and food
• It is a great achievement to get away from the
0-tolerance approach in feeding stuffs but 1%
tolerance is challenging for a number of feed
compounders