Proposal for a Council Regulation implementing Regulation (EC) No 853/2004 of the European Parliament and of the Council as regards the use of antimicrobial substances to remove surface contamination from poultry carcases
Date: 2008-10-29
Institutions: European Commission
Subjects: carcase, food inspection, foodstuff, health legislation, poultry

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 29.10.2008 
COM(2008) 430 final 

Proposal for a 

COUNCIL REGULATION 

implementing Regulation (EC) No 853/2004 of the European Parliament and of the 
Council as regards the use of antimicrobial substances to remove surface contamination 
from poultry carcases 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

Regulation  (EC)  No  853/2004  lays  down  specific  rules  on  the  hygiene  of  food  of  animal 
origin for food business operators. It provides that food business operators are not to use any 
substance other than water to remove surface contamination from products of animal origin, 
unless  the  use  of  the  substance  has  been  approved  in  accordance  with  that  Regulation.  It 
provides that the use of approved substances is not to affect the obligations of food business 
operators to comply with the requirements of that Regulation. 

In  October  1998  and  April  2003,  different  scientific  opinions  were  issued  by  the  Scientific 
Committee on Veterinary measures relating to Public Heath (SCVPH) and concluded that the 
use  of  antimicrobial  substances  can  contribute  to  the  decrease  of  pathogens  in  the  poultry 
provided  those  substances  are  used  in  the  framework  of  an  integrated control  system  of  the 
food chain. . 

In the framework of the EC-USA Veterinary Agreement, the USA submitted files concerning 
the use of four antimicrobial substances on poultry carcases. These files were transmitted to 
the European Food Safety Authority (EFSA), which adopted an opinion in December 2005. 
EFSA concluded that the use of these substances (chlorine dioxide, acidified sodium chlorite, 
trisodium phosphate and peroxyacids) in the described conditions does not present any risk to 
public  health  and  that  the  use  of  antimicrobial  solutions  does  not  replace  the  need  for  good 
hygienic  practices  during  processing  of  poultry  carcases,  particularly  during  handling.  In  a 
second  opinion  in  December  2005,  EFSA  nevertheless  pointed  out  that  the  information 
provided on peroxyacids indicated limited effectiveness, requiring specific conditions of use 
to be defined. 

On 6 March 2008, EFSA in its scientific opinion on the Assessment of the possible effect of 
the  four  antimicrobial  treatment  substances  on  the  emergence  of  antimicrobial  resistance 
concludes  that  there  are  currently  no  published  data  to  conclude  in  whatever  way  on  the 
occurrence  of  acquired  reduced  susceptibility  to  these  substances  when  applied  on  poultry 
carcases and to resistance to therapeutic antimicrobials. 

Finally  on  31  March  2008  ,  the  Scientific  Committee  on  Emerging  and  Newly  Identified 
Health Risks (SCENIHR) and the Scientific Committee on Health and Environmental Risks 
(SCHER)  in  their  joint  opinion  on  environmental  impact  and  effect  on  antimicrobial 
resistance of the four substances used for the removal of microbial surface contamination of 
poultry  carcases  conclude  that  there  is  not  enough  information  available  for  producing 
comprehensive  quantitative  assessments  that  there  is  an  environmental  concern  about  the 
possibility to disseminate or select more resistant strains and, finally, that a low environmental 
risk has been estimated in relation to the potential residues in the carcases. 

Against this background, a draft Commission Regulation approving the use of four substances 
to remove surface contamination from poultry carcases and setting down the conditions under 
which  the  substances  may  be  used  was  submitted  to  the  Standing  Committee  of  the  Food 
Chain  and  Animal  Health,  on  2  June  2008,  for  vote.  The  Committee  delivered  an  opinion 
against the proposal: 26 Member States voted against and one Member State abstained. 

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Consequently,  pursuant  to  Article  3(2)  of  Regulation  (EC)  No  853/2004  and  in  accordance 
with Article 5 of Council Decision 1999/468/EC modified by Council Decision 2006/512/EC, 
the Commission is submitting to the Council a proposal relating to the measures to be taken, 
the Council having three months in which to act by a qualified majority, and is informing the 
Parliament.  

This proposal has no financial implications for the Community budget. 

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Proposal for a 

COUNCIL REGULATION 

implementing Regulation (EC) No 853/2004 of the European Parliament and of the 
Council as regards the use of antimicrobial substances to remove surface contamination 
from poultry carcases 

(Text with EEA relevance) 

THE COUNCIL OF THE EUROPEAN UNION 

Having regard to the Treaty establishing the European Community, 

Having  regard  to  Regulation  (EC)  No  853/2004  of  the  European  Parliament  and  of  the 
Council  laying  down  specific  hygiene  rules  for  food  of  animal  origin1,  and  in  particular 
Article 3(2) thereof, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

Regulation  (EC)  No  853/2004  lays  down  specific  rules  on  the  hygiene  of  food  of 
animal origin for food business operators. It provides that food business operators are 
not  to  use  any  substance  other  than  water  to  remove  surface  contamination  from 
products  of  animal  origin,  unless  the  use  of  such  substance  has  been  approved  in 
accordance with that Regulation.  

Therefore  it  is  appropriate  to  approve  the  use  of  certain  antimicrobial  substances  for 
the removal of surface contamination from poultry carcases. 

Council  Directive  91/271/EEC  of  21  May  1991  concerning  urban  waste  water 
treatment2 lays down rules regarding the treatment and discharge of waste water from 
certain industrial sectors.  

Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety 
of  workers  from  the  risks  related  to  chemical  agents  at  work  (fourteenth  individual 
Directive  within  the  meaning  of  Article  16(1)  of  Directive  89/391/EEC)3  lays  down 
minimum  requirements  for  the  protection  of  workers  at  the  workplace  from  risks  to 
their safety or health arising due to the presence of chemical agents. 

(5) 

Regulation  (EC)  No  2160/2003  of  the  European  Parliament  and  of  the  Council  of 
17 November  2003  on  the  control  of  salmonella  and  other  specified  food-borne 

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OJ L 139, 30.4.2004, p. 55; corrected version (OJ L 226, 25.6.2004, p. 22). Regulation as last amended 
by Commission Regulation (EC) No 1243/2007 (OJ L 281, 25.10.2007, p. 8). 
OJ  L  135,  30.5.1991,  p.  40.  Directive  as  last  amended  by  Regulation  (EC)  No  1882/2003  of  the 
European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1). 
OJ L 131, 5.5.1998, p. 11. Directive as amended by Directive 2007/30/EC of the European Parliament 
and of the Council (OJ L 165, 27.6.2007, p. 21). 

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(6) 

(7) 

(8) 

zoonotic  agents4  provides  for  measures  to  be  taken  to  detect  and  control  salmonella 
and  other  zoonotic  agents  at  all  relevant  stages  of  production,  processing  and 
distribution. It provides for national control programmes for the detection of zoonoses 
and zoonotic agents at the primary production stage targeted at specific pathogens. 

Regulation  (EC)  No  882/2004  of  the  European  Parliament  and  of  the  Council  of 
29 April 2004 on official controls performed to ensure the verification of compliance 
with  feed  and  food  law,  animal  health  and  animal  welfare  rules5  lays  down  general 
rules  for  the  performance  of  official  controls  to  verify  compliance  with  rules 
concerning  preventing,  eliminating  or  reducing  to  acceptable  levels  risks  to  humans 
and animals.  

Those  acts  provide  for  certain  hygiene  and  other  obligations  on  food  business 
operators  and  controls  to  be  carried  out  by  the  competent  authority.  However,  it  is 
necessary to provide for additional conditions and requirements on the part of the food 
business operators and controls by the competent authority in addition to those already 
provided  for  in  the  existing  Community  legislation,  for  the  use  of  antimicrobial 
substances for the removal of surface contamination from poultry carcases.  

A  high  level  of  protection  of  human  health  is  assured  in  the  pursuit  of  Community 
policies. Measures adopted by the Community governing food and feed must be based 
on  an  appropriate  assessment  of  the  possible  risks  for  human  and  animal  health  and 
must,  taking  into  account  existing  scientific  evidence,  maintain,  or  if  scientifically 
justified  increase,  the  level  of  protection  of  human  and  animal  health  ensured  in  the 
Community.  It  is  impossible,  however,  to  consider  the  complete  elimination  of  any 
risk as a realistic objective for the risk management decision in the present matter. It is 
the role and responsibility for the risk manager to decide the acceptable level of risk, 
taking into account all the elements present in a scientific risk assessment. 

(9) 

In addition, a high level of protection of the environment is ensured in the pursuit of 
Community policies, both by acts of environmental policy itself and by the integration 
of environmental policy requirements into the definition and implementation of other 
Community policies and activities. 

(10)  The  Scientific  Committee  on  Veterinary  Measures  relating  to  Public  Health 
(“SCVPH”)  issued  a  report  on  30  October  1998  on  the  “benefits  and  limitations  of 
antimicrobial  treatments  for  poultry  carcases”  and  recommended  that  before  any 
decontamination  compound  or  decontamination  technique  is  authorised  for  use,  it 
should be fully assessed.  

(11)  The  SCVPH  also  issued  an  opinion  on  14  and  15  April  2003  on  “the  evaluation  of 
antimicrobial treatments for poultry carcases” and concluded that decontamination can 
constitute  a  useful  element in  further  reducing  the  number  of  pathogens  provided  an 
integrated  control  strategy  is  applied  throughout  the  entire  food  chain,  including 
hygienic measures applied at primary production, during transport and in the slaughter 
and processing plant. 

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OJ L 325, 12.12.2003, p. 1. Regulation as last amended by Commission Regulation (EC) No 1237/2007 
(OJ L 280, 24.10.2007, p. 5).  
OJ L 165, 30.4.2004, p. 1; corrected version (OJ L 191, 28.5.2004, p. 1). Regulation as last amended by 
Council Regulation (EC) No 301/2008 (OJ L 97, 9.4.2008, p. 85). 

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(12)  The  European  Food  Safety  Authority  (“EFSA”)  adopted  a  scientific  opinion  on 
6 December  2005,  in  which  it  concluded  that  the  treatment  of  poultry  carcases  with 
chlorine  dioxide,  acidified  sodium  chlorite,  trisodium  phosphate  or  peroxyacids  does 
not  constitute  a  safety  concern.  It  also  noted  that  by  comparison  to  dipping  and 
immersion in repeatedly used water in chiller baths, spraying reduces the exposure to 
residues and animal by-products that might arise from the application of antimicrobial 
substances. 

(13)  The toxicological effects of the application of more than one antimicrobial substance 
used simultaneously or consecutively for the removal of surface contamination of food 
of animal origin has not been properly evaluated. Therefore, combinations of several 
antimicrobial substances should not be used. 

(14)  The  EFSA  adopted  a  scientific  opinion  on  6 March  2008  "on  the  assessment  of 
possible  effect  of  the  four  antimicrobial  treatment  substances  on  the  emergence  of 
antimicrobial  resistance."  It  concluded  that  there  are  currently  no  published  data  to 
conclude  that  the  application  of  the  four  substances  referred  to  in  its  opinion  of 
6 December  2005  will  lead  to  the  occurrence  of  acquired  reduced  susceptibility  to 
these  substances  and  to  resistance  to  therapeutic  antimicrobials.  These  findings  lead 
the  EFSA  to  encourage  further  research  on  the  likelihood  of  the  emergence  of  such 
susceptibility  to  these  types  of  substances,  and  the  possibility  of  their  resistance  to 
therapeutic antibiotics and other antimicrobial agents. 

(15)  The  Scientific  Committee  on  Health  and  Environmental  Risks  (SCHER)  and  the 
Scientific  Committee  on  Emerging  and  Newly  Identified  Health  Risks  (SCENIHR) 
adopted  a  joint  scientific  opinion  on  18  March  2008  and  2  April  2008  on  the 
environmental impact and effect on the antimicrobial resistance of the four substances 
used for the removal of microbial surface contamination of poultry carcases in which 
they  stated  that  "there  is  currently  insufficient  knowledge  on  the  potential  negative 
effects of using different biocides." In response to the mandate of the Commission on 
the four substances, they concluded that there is not enough information available for 
producing comprehensive quantitative assessments. There is an environmental concern 
about the  possibility to disseminate or select more resistant strains and in relation to 
the  potential  residues  in  the  poultry  carcases.  However,  both  the  SCHER  and  the 
SCENHIR consider that the environmental risk is low. 

(16)  The Commission, in its role as risk manager responsible for the establishment of the 
acceptable  level  of  risk  to  public  and  animal  health  and  the  environment,  considers 
that the risk of a possible antimicrobial resistance effect and a possible environmental 
impact  of  the  four  antimicrobial  substances  cannot  be  excluded.  Consequently,  very 
strict  conditions  and  requirements  regarding  the  use  of  these  four  substances,  in 
particular regarding the time of exposure, the concentration of the substances and the 
limitation  of  the  application  to  only  one  substance,  should  be  laid  down  in  order  to 
further reduce any risks. 

(17)  Several antimicrobial substances that are used to remove surface contamination from 
poultry  carcasses  could  pose  a  risk  to  the  aquatic  environment,  the  health  of  staff 
working  in  waste  water  systems  and  the  operation  and  performance  of  sewerage 
systems  and/or  waste  water  treatment  plants.  The  use  of  antimicrobial  substances 
containing chlorine could lead to the formation of chloroorganic compounds, several 
of  which  are  persistent,  bioaccumulable  or  carcinogenic.  Phosphorus  compounds  are 

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also  one  of  the  sources  of  the  eutrophication  of  European  regional  seas,  leading  to 
mass  growth  algae  and  other  undesirable  disturbance  of  the  aquatic  environment. 
Accordingly, provision should make for appropriate controls for the disposal of such 
substances. 

(18)  The  use  of  antimicrobial  substances,  other  than  potable  water,  on  poultry  carcases 
should  be  indicated  on  the  labelling  of  poultry  carcasses,  and  on  cuts  and  meat 
preparations  derived  from  such  poultry  carcases,  in  order  to  inform  the  consumer. 
Accordingly,  it  is  appropriate  to  provide  for  such  labelling  requirements  in  this 
Regulation.  

(19)  Substances used for the removal of surface contamination from poultry carcases and 
not for conservation purposes do not affect the definition of 'fresh meat' in point 1.10 
of Annex I to Regulation (EC) No 853/2004.  

(20)  However, this Regulation should apply only after the definition of poultrymeat set out 
in  point  1  of  Part  B.II  of  Annex  XIV  to  Council  Regulation  (EC)  No  1234/2007  of 
22 October 2007 establishing a common organisation of agricultural markets and on specific 
provisions for certain agricultural products (Single CMO Regulation)6 has been amended. 
That  amendment  would  permit  the  placing  on the  market  and  the  marketing  of  meat 
which has been treated with antimicrobial substances as poultrymeat.  

(21) 

It  is  appropriate  to  approve  the  use  of  chlorine  dioxide,  acidified  sodium  chlorite, 
trisodium  phosphate  and  peroxyacids  for  the  removal  of  surface  contamination  from 
poultry  carcases  pending  further  scientific  data  to  be  provided  by  the  food  business 
operators  in  Member  States  regarding  the  use  of  such  substances.  That  information 
should  cover  the  possible  environmental  impact  and  the  possible  emergence  of 
antimicrobial  resistance.  Food  business  operators  in  Third  Countries  are  invited  to 
submit  the  data  to  the  latter.  These  data  will  be  the  basis  for  the  review  of  the 
authorisation as well as of the conditions of use of these substances. 

(22)  The  Standing  Committee  on  the  Food  Chain  and  Animal  Health  has  delivered  an 
unfavourable  opinion  on  the  Commission  proposed  measures  and  the  measures 
provided for in this Regulation must therefore be adopted by the Council , 

HAS ADOPTED THIS REGULATION: 

Article 1 
Approved substances  

The  antimicrobial  substances  listed  in  the  Annex  are  approved  for  the  removal  of  surface 
contamination from poultry carcases ('approved substances').  

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OJ L 299, 16.11.2007, p. 1. Regulation as last amended by Council Regulation (EC) No 248/2008 (OJ L 
76, 19.3.2008, p. 6). 

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Article 2  
Obligations of food business operators regarding the use of approved substances 

Food business operators shall only apply the approved substances to whole poultry carcases, 
and not to parts of carcases or poultry cuts. 

They shall only apply the approved substances to poultry carcases under the conditions set out 
in the Annex and in compliance with the following requirements:  

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

there must be no simultaneous or consecutive application of more than one approved 
substance to the poultry carcase; 

where an approved substance is used more than once during the production process, 
the total contact time must not exceed the periods set out in points 2, 3 and 4 of the 
Annex. 

where  an  approved  substance  is  used  in  a  pre-chiller  or  chiller  tank,  the  solution 
containing  that  substance  must  be  replaced  at regular intervals in  order to maintain 
the prescribed concentration of the approved substance; 

the poultry carcase must be rinsed with potable water, including an inside rinsing of 
the  eviscerated  poultry  carcase,  at  an  appropriate  point  in  the  production  process 
following the application of the approved substance, to ensure that the substance is 
intentionally removed to such an extent that it does not have a technological effect in 
the final product;  

the  efficacy  of  the  rinsing,  which  must  ensure  that  no  residues  of  the  approved 
substance  or  possible  derivatives  thereof  remain  in  the  final  product,  must  be 
scientifically demonstrated by an appropriate permanent monitoring. 

the  application  of  the  approved  substance  and  rinsing  must  be  performed  in  the 
slaughter room before the poultry carcases enter the chilling or refrigerating room; 

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Article 3 
Data collection obligations of food business operators 

1. 

Food business operators shall collect data for the following research purposes:  

(a) 

(b) 

(c) 

the  likelihood  of  the  emergence  of  acquired  reduced  susceptibility  to  the 
approved substances and resistance to therapeutic antimicrobials; 

the environmental impact of the disposal of the used solutions of the approved 
substances and leaching water; 

the  possibility  that  resistant  strains  are  disseminated  or  selected  in  the  waste 
water.  

2. 

Food business operators shall make the data provided for in paragraph 1 available to 
the  competent  authority  as  soon  as  the  Commission  will  define  the  technical 
specifications. 

Article 4 
Labelling 

Where an approved substance has been used for the removal of surface contamination from 
poultry carcases, the food business operator shall label the poultry carcases and any poultry 
cuts and poultrymeat preparations derived therefrom, in a conspicuous and clearly legible and 
indelible manner, as either: 

(a) 

(b) 

1. 

treated with antimicrobial substances; or 

decontaminated by chemicals. 

Article 5 
Waste water 

Food business operators shall comply with the following waste water effluent quality 
standards  where the  use  of approved substances is linked to the discharge  of waste 
water  to  an  urban  collection  and  treatment  system  or  to  the  discharge  of  industrial 
waste water into waters following treatment: 

(a) 

effluent quality for discharges into urban collection and treatment systems: 

total chlorine (expressed as Cl2): 

chloroorganic compounds, expressed as absorbable organic 
halogenated compounds (AOX) 

0.4 mg/l 

1.0 mg/l 

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(b) 

effluent quality for discharges into surface waters: 

total chlorine (expressed as Cl2): 

total phosphorus (expressed as P): 

chloroorganic compounds, expressed as absorbable organic 
halogenated compounds (AOX) 

0.4 mg/l 

2.0 mg/l 

0.1 mg/l 

2. 

Food business operators shall monitor compliance with the effluent quality standards 
provided  for  in  paragraph  1  at  least  once  a  month  based  on  flow-proportional 
24 hours sampling. 

The  monitoring  of  effluent  quality  shall  be  based  on  International  Standards  ISO 
7393-1:1985/2001,  ISO  7393-2:1985,  ISO  7393-3:1990,  ISO  6878:2004  and  ISO 
9562:2004. However, the competent authority may permit the use of other methods if 
it  can  be  demonstrated  that  the  results  obtained  are  equivalent  to  those  obtained 
through the ISO methods. 

Article 6 
Official controls 

1. 

Where an approved substance is used for the removal of surface contamination from 
poultry carcases, the competent authority: 

(a) 

shall increase the frequency of and/or extend the duration of official controls, 
in particular the official controls provided for in Article 10 of Regulation (EC) 
No  882/2004,  with  special  emphasis  on  the  obligations  of  food  business 
operators as provided for in Article 2 of this Regulation;  

(b)  may,  on  a  case-by-case  basis,  lay  down  additional  conditions  concerning  the 

use of that substance.  

2. 

The competent authority shall carry out official controls on the monitoring performed 
by food business operators as provided for in Article 5(2).  

Article 7 
Data collection obligations of the competent authority 

The competent authority shall transmit the data provided for in Article 3 to the Commission 
every six months from the date of application of this Regulation. 

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Article 8 
Entry into force, review, and application  

This Regulation shall enter into force on the third day following that of its publication in the 
Official Journal of the European Union. 

It shall apply from the date of application of the Council Regulation amending the definition 
of  poultry  meat  in  point  1  of  Part  B.II  of  Annex  XIV  to  Council  Regulation  (EC)  No 
1234/2007. 

Within 2 years from the date of application, the Commission shall review this Regulation in 
the light of further scientific data regarding the use of the substances listed in the Annex and, 
if necessary, will propose any necessary adaptations to the authorisation. 

This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Brussels, 

For the Council 
The President 

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ANNEX 

List of approved substances and the conditions for their application 

(as provided for in Article 2) 

1. 

Chlorine dioxide: 

(a) 

(b) 

at a maximum concentration of 3 mg/kg of residual chlorine dioxide in water at 
those points of the production process where the approved substance is used; 

in  the  case  of  continuous,  counter-flow,  immersion  chilling,  the  contact  time 
must be proportionate to the size of the poultry carcases and must be assessed 
in connection with the concentration of chlorine dioxide used. 

2. 

Acidified sodium chlorite: 

(a) 

(b) 

in  poultry  processing  waters  applied  as  pre-chiller  or  chiller  solutions  at 
concentrations  between  50  and  150  mg/kg  of  sodium  chlorite  combined  with 
an  acid  permitted  for  food  use  that  achieves  a  pH  between  2.8  –  3.2  in  the 
solution;  the  solution  shall  be  applied  as  an  immersion  dip  for  up  to  5 
to8 seconds in total; 

in  poultry  processing  waters  applied  as  spray  solutions  at  concentrations 
between  500  and  1200  mg/kg  of  sodium  chlorite  combined  with  an  acid 
permitted for food use that achieves a pH between 2.3 – 2.9 in the solution; the 
solution shall be applied as a spray for up to 15 seconds in total. 

3. 

Trisodium phosphate: 

in poultry processing waters at concentrations from 80 g/kg to 120 g/kg. The solution 
shall be applied by the dipping or spraying of poultry carcases, which have not been 
cooled, for up to 15 seconds in total. 

4. 

Peroxyacids: 

in  poultry  processing  waters  a  mixture  of  peroxyacetic  acid,  octanoic  acid,  acetic 
acid,  hydrogen  peroxide,  peroxyoctanoic  acid  and  1-hydroxyethylidene-1,  1-
diphosphonic acid (HEDP) may be used at a maximum concentration of 220 mg/kg 
peroxyacetic  acid,  110  mg/kg  hydrogen  peroxide  and  13  mg/kg  HEDP  for  up  to 
15 seconds in total when applied as a spray or dip. 

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