II 
(Non-legislative acts)  
REGULATIONS  
COMMISSION REGULATION (EU) No 101/2013  
of 4 February 2013  
concerning the use of lactic acid to reduce microbiological surface contamination on bovine 
carcases  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European 
Union,  
Having regard to Regulation (EC) No 853/2004 of 29 April 
2004 of the European Parliament and of the Council laying 
down specific hygiene rules for food of animal origin (  1 ), and 
in particular Article 3(2) thereof,  
Whereas:  
(1) Regulation (EC) No 852/2004 of the European 
Parliament and of the Council of 29 April 2004 on 
the hygiene of foodstuffs (  2 ) 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).  
(2) 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.  
(3) In addition, Commission Regulation (EC) No 2073/2005 
of 15 November 2005 on microbiological criteria for 
foodstuffs (  3 ) lays down the microbiological criteria for 
certain microorganisms and the implementing rules to be 
complied with by food business operators when imple ­
menting 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.  
(5) 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 trimmings (  4 ). 
(6) In its Opinion, EFSA concludes that the treatments using 
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.  
(7) 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.  
(8) 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 tech ­
nological effect in the final product. In addition, theEN 5.2.2013 Official Journal of the European Union L 34/1  
( 1 ) OJ L 139, 30.4.2004, p. 55.  
( 2 ) OJ L 139, 30.4.2004, p. 1.  
( 3 ) OJ L 338, 22.12.2005, p. 1.  (  4 ) EFSA Journal  2011; 9(7):2317.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.  
(9) 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 of 9 March 
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 Council (  1 ) 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.  (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 legis ­
lation on food hygiene, as laid down in Regulations (EC) 
No 852/2004, (EC) No 853/2004 and (EC) 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 did not deliver an opinion within the time limit 
laid down by its Chairman. The Commission therefore 
submitted to the Council a proposal relating to this 
measure and forwarded it to the European Parliament 
at the same time.  
(14) In view of the fact that the Council did not act and the 
European Parliament did not oppose the measure within 
the applicable time-periods, the Commission should 
adopt the measure,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Food business operators may use lactic acid to reduce microbi ­
ological 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.  
Article 2  
This Regulation shall enter into force on the twentieth day 
following that of its publication in the  Official Journal of the 
European Union . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels, 4 February 2013.  
For the Commission  
The President  
José Manuel BARROSOEN L 34/2 Official Journal of the European Union 5.2.2013  
( 1 ) OJ L 83, 22.3.2012, p. 1.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. Lactic acid solutions must only be prepared from lactic acid which complies with the specifications set out in 
Regulation (EU) No 231/2012.  
2. 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.  
3. Lactic acid solutions must not be applied to carcases with visible faecal contamination.  
4. 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. 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.  
2. Lactic acid concentration during treatment must be, as part of the HACCP plan, verified by periodic monitoring, 
documented and recorded.  
3. 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.EN 5.2.2013 Official Journal of the European Union L 34/3