Proposal for a COUNCIL REGULATION concerning the use of lactic acid to reduce microbiological surface contamination on bovine carcases
Date: 2012-10-03
Institutions: European Commission
Subjects: beef, biology, carcase, food industry, food standard

EUROPEAN 
COMMISSION 

Brussels, 3.10.2012  
COM(2012) 578 final 

2012/0280 (NLE) 

Proposal for a 

COUNCIL REGULATION 

concerning the use of lactic acid to reduce microbiological surface contamination on 
bovine carcases 

(Text with EEA relevance) 

EN 

   EN 

 
 
 
  
 
EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

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. 

On 14 December 2010, the Commission received an application for approval of the 
use of lactic acid to reduce surface contamination of bovine carcases and meat. 

On 26 July 2011, the European Food Safety Authority (EFSA) adopted a favourable 
opinion  on 
lactic  acid  for 
the  evaluation  of 
decontamination  purposes.  The  Commission 
therefore  proposed  measures 
concerning the use of lactic acid to reduce surface contamination on bovine carcases. 

the  safety  and  efficacy  of 

2. 

RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND 
IMPACT ASSESSMENTS 

A  draft  Commission  Regulation  approving  the  use  of  lactic  acid  to  reduce  surface 
contamination  on  bovine  carcases  was  submitted  to  the  Standing  Committee  of  the 
Food  Chain  and  Animal  Health,  on  21  September  2012,  for  an  opinion.  The 
Committee  did  not  deliver  an  opinion  on  the  draft  Commission  Regulation,  as  a 
qualified majority was not reached neither for nor against the proposed measures. 

Consequently,  pursuant  to  Article  3(2)  of  Regulation  (EC)  No  853/2004  and  in 
accordance  with  Article  5a  of  Council  Decision  1999/468/EC,  the  Commission  is 
submitting to the Council and the Parliament a draft Council Regulation relating to 
the  measures  to  be  taken,  the  Council  having  two  months  in  which  to  give  its 
position following which the Parliament would also have an additional two months 
to  give  its  position.  In  the  absence  of  an  opinion  of  the  Council,  the  Regulation  is 
sent back to the Commission and the Commission has the legal obligation to adopt 
the measures. 

No impact assessment was foreseen for this implementing Regulation. 

3. 

LEGAL ELEMENTS OF THE PROPOSAL 

Following  the  positive  EFSA  Scientific  Opinion  and  taking  into  account  that  lactic 
acid can provide a significant reduction of possible microbiological contamination, it 
is deemed appropriate to approve its use to reduce surface contamination of bovine 
carcases. Such use should however be subjected to certain conditions (concentration, 
temperature, etc.) as reported in Part I of the Annex to this Regulation.  

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The  use  of  lactic  acid  for  surface  decontamination  should  be  limited  to  the  use  on 
carcases or half carcases or quarters at the level of the slaughterhouse and it should 
be integrated into good hygienic practices and HACCP-based systems. Furthermore, 
its  use  must  not  affect  the  food  business  operator's  duty  to  comply  with  the 
requirements of Union legislation on food hygiene -as laid down in Regulations (EC) 
No 852/2004, No 853/2004 and No 2073/2005- and should in no way be considered 
as a substitution for good hygienic slaughtering practices and operating procedures. 

EN 

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2012/0280 (NLE) 

Proposal for a 

COUNCIL REGULATION 

concerning the use of lactic acid to reduce microbiological surface contamination on 
bovine carcases 

(Text with EEA relevance) 

THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty on the Functioning of the European Union, 

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) 

Regulation  (EC)  No  852/2004  of  the  European  Parliament  and  of  the  Council  of 
29 April 2004 on the hygiene of foodstuffs2 lays down general rules for food business 
operators  on  the  hygiene  of  foodstuffs,  taking  particular  account  of  the  principle 
concerning  the  general  implementation  of  procedures  based  on  hazard  analysis  and 
critical control point (HACCP). 

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  potable  water  to  remove  surface  contamination 
from  products  of  animal  origin,  unless  use  of  the  substance  has  been  approved  in 
accordance with that Regulation. 

In  addition,  Commission  Regulation  (EC)  No  2073/2005  of  15  November  2005  on 
microbiological  criteria  for  foodstuffs3  lays  down  the  microbiological  criteria  for 
certain  microorganisms  and  the  implementing  rules  to  be  complied  with  by  food 
business  operators  when  implementing  the  general  and  specific  hygiene  measures 
referred to in Regulation (EC) No 852/2004. It provides that food business operators 
are to ensure that foodstuffs are to comply with those microbiological criteria. 

(4) 

On  14  December  2010,  the  Commission  received  an  application  for  approval  of  the 
use of lactic acid to reduce surface contamination of bovine carcases and meat.  

1 
2 
3 

OJ L 139, 30.4.2004, p. 55. 
OJ L 139, 30.4.2004, p. 1. 
OJ L 338, 22.12.2005, p. 1. 

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(5) 

(6) 

(7) 

(8) 

(9) 

On 26 July 2011, the European Food Safety Authority ("EFSA") adopted a Scientific 
Opinion on the evaluation of the safety and efficacy of lactic acid for the removal of 
microbial surface contamination from beef carcases, cuts and trimmings4.  

the 

that 

treatments  using 

its  Opinion,  EFSA  concludes 

In 
lactic  acid  for 
decontamination are of no safety concern, provided that the substance used complies 
with  Union  specifications  for  food  additives.  In  addition,  EFSA  concludes  that 
treatments  with  lactic  acid  provide  a  significant  reduction  of  microbiological 
contamination compared to no treatment or to treatment with potable water and that it 
is  unlikely  that  such  treatments  would  contribute  to  the  development  of  microbial 
resistance. 

EFSA recommends that food business operators validate the antimicrobial efficacy of 
such  treatments  under  their  specific  processing  conditions  and  verify  lactic  acid 
concentration,  temperature  of  application  and  other  factors  affecting  its  efficacy  as  a 
decontaminating agent. The EFSA Opinion also concluded that there are no negative 
implications resulting from this use of lactic acid on the environment.  

According to the EFSA Opinion, the residual amount absorbed in the beef meat from 
lactic  acid  treatment  will  not  be  higher  than  190  mg/kg.  Such  amount  is  considered 
residual  compared  to  the  active  amount  necessary  for  the  purpose  of  reducing 
microbial  surface  contamination.  Furthermore,  it  does  not  have  any  technological 
effect  in  the  final  product.  In  addition,  the  residual  amount  of  lactic  acid  used  for 
reducing  microbial  surface  contamination  is  negligible  compared  to  the  amount  of 
lactic  acid  naturally  present  in  beef  and  it  is  of  no  safety  concern.  In  certain  meat 
preparations,  lactic  acid  salts  are  authorised  as  food  additives  for  the  purpose  of 
preservation. For this purpose, levels of 20.000 mg/kg are commonly used. Therefore, 
the  use  of  lactic  acid  for  the  purpose  of reducing  microbial  surface  contamination  is 
clearly distinct from its use as a food additive. 

In  view  of  the  EFSA  Opinion,  taking  into  account  that  lactic  acid  can  provide  a 
significant  reduction  of  possible  microbiological  contamination,  it  is  appropriate  to 
approve  its  use  to  reduce  surface  contamination.  Such  use  should  however  be 
subjected to certain conditions. Its use should be limited to the use on carcases or half 
carcases or quarters at the level of the slaughterhouse and it should be integrated into 
good hygienic practices and HACCP-based systems. 

(10)  Commission  Regulation  (EU)  No  231/2012  laying  down  specifications  for  food 
additives  listed  in  Annexes  II  and  III  to  Regulation  (EC)  No  1333/2008  of  the 
European Parliament and of the Council5 lays down specifications for food additives 
relating, in particular, to origin, purity criteria and any other necessary information.  

(11) 

In  accordance  with  the  EFSA  Opinion,  lactic  acid  used  to  reduce  surface 
contamination in bovine carcases should comply with the specifications for lactic acid 
laid  down  in  Union  legislation.  Consequently,  where  lactic  acid  is  used  to  reduce 
microbiological  surface  contamination  pursuant  to  this  Regulation,  it  is  appropriate 
that such lactic acid complies with the specifications laid down in Regulation (EU) No 
231/2012. 

4 
5 

EFSA Journal 2011;9(7):2317. 
OJ L 83, 22.3.2012, p. 1. 

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(12)  The  use  of  lactic  acid  to  reduce  microbiological  surface  contamination  on  bovine 
carcases or half carcases or quarters must not affect the food business operator's duty 
to comply with the requirements of Union legislation on food hygiene, as laid down in 
Regulations (EC) No 852/2004, No 853/2004 and No 2073/2005 and should in no way 
be considered as a substitution for good hygienic slaughtering practices and operating 
procedures or as an alternative to comply with the requirements of those Regulations. 

(13)  The Standing Committee on the Food Chain and Animal Health has not delivered an 
opinion within the time limit laid down by its Chairman. The measures provided for in 
this Regulation should therefore be adopted by the Council, 

HAS ADOPTED THIS REGULATION: 

Article 1 

Food business operators may use lactic acid to reduce microbiological surface contamination 
on  bovine  carcases  or  half  carcases  or  quarters  at  the  level  of  the  slaughterhouse  in 
compliance with the conditions set out in the Annex to this Regulation. 

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

Article 2 

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  

Part I – Conditions of use of lactic acid to reduce microbiological surface contamination 
of bovine carcases or half carcases or quarters at the level of the slaughterhouse 

1. 

2. 

3. 

4. 

Lactic acid solutions must only be prepared from lactic acid which complies with the 
specifications set out in Regulation (EU) No 231/2012.  

Lactic acid solutions must: 

(a) 

only  be  applied  on  entire  carcases  or  half-carcases  or  quarters  of  meat  from 
domestic bovine animals (including Bubalus and Bison species) at the level of 
the slaughterhouse; 

(b)  only be applied either by spraying or misting using from 2% to 5% lactic acid 

solution in potable water at temperatures of up to a maximum of 55°C; 

(c) 

be applied under controlled and verifiable conditions integrated in a HACCP-
based management system including, at least, the criteria set out in Part II. 

Lactic  acid  solutions  must  not  be  applied  to  carcases  with  visible  faecal 
contamination. 

The  application  of  lactic  acid  solutions  must  not  result  in  any  irreversible  physical 
modification of the meat. 

Part II – Minimum HACCP criteria and control parameters 

1. 

2. 

3. 

Sampling of carcases for the purposes of assessing compliance with microbiological 
criteria  within  the  meaning  of  Regulation  (EC)  No  2073/2005  must  be  carried  out 
before  the  application  of  lactic  acid  solutions  on  the  carcases  or  half-carcases  or 
quarters. 

Lactic  acid  concentration  during  treatment  must  be,  as  part  of  the  HACCP  plan, 
verified by periodic monitoring, documented and recorded. 

The  temperature  of  the  lactic  acid  solution  during  treatment  must,  as  part  of  the 
HACCP  plan,  be  continuously  monitored  by 
instrumental  measurements, 
documented and recorded. 

Part III – Information on the treatment 

Food business operators operating slaughterhouses in which lactic acid solutions are used to 
reduce  microbial  surface  contamination  of  entire  carcases  or  half-carcases  or  quarters  must 
inform the food business operator receiving the treated carcases or half-carcases or quarters of 
such use. This information should be documented.  

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