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5.2.2013 Official
Journal
of
the
European
Union L
34/1
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,
provides that food business operators are to ensure that
foodstuffs are to comply with those microbiological
criteria.
Having regard to the Treaty on the Functioning of the European
Union,
(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
Having regard to Regulation (EC) No 853/2004 of 29 April
meat.
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,
(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
Whereas:
microbial surface contamination from beef carcases, cuts

and trimmings ( 4 ).
(1) Regulation
(EC)
No
852/2004
of
the
European (6)
In its Opinion, EFSA concludes that the treatments using
Parliament and of the Council of 29 April 2004 on
lactic acid for decontamination are of no safety concern,
the hygiene of foodstuffs ( 2 ) lays down general rules for
provided that the substance used complies with Union
food business operators on the hygiene of foodstuffs,
specifications for food additives. In addition, EFSA
taking particular account of the principle concerning
concludes that treatments with lactic acid provide a
the general implementation of procedures based on
significant reduction of microbiological contamination
hazard analysis and critical control point (HACCP).
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.
(2) Regulation
(EC)
No
853/2004
lays
down
specific
rules
on the hygiene of food of animal origin for food
(7) EFSA
recommends
that
food
business
operators
validate
business operators. It provides that food business
the antimicrobial efficacy of such treatments under their
operators are not to use any substance other than
specific processing conditions and verify lactic acid
potable water to remove surface contamination from
concentration, temperature of application and other
products of animal origin, unless use of the substance
factors affecting its efficacy as a decontaminating agent.
has been approved in accordance with that Regulation.
The EFSA Opinion also concluded that there are no
negative implications resulting from this use of lactic
acid on the environment.
(3) In
addition,
Commission
Regulation
(EC)
No
2073/2005
of 15 November 2005 on microbiological criteria for
foodstuffs (
(8)
According to the EFSA Opinion, the residual amount

3 ) lays down the microbiological criteria for
certain microorganisms and the implementing rules to be
absorbed in the beef meat from lactic acid treatment
complied with by food business operators when imple
will not be higher than 190 mg/kg. Such amount is
menting the general and specific hygiene measures
considered residual compared to the active amount
referred to in Regulation (EC) No 852/2004. It
necessary for the purpose of reducing microbial surface
contamination. Furthermore, it does not have any tech
nological effect in the final product. In addition, the
( 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.

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L 34/2
EN
Official Journal of the European Union
5.2.2013
residual amount of lactic acid used for reducing microbial
(12) The use of lactic acid to reduce microbiological surface
surface contamination is negligible compared to the
contamination on bovine carcases or half carcases or
amount of lactic acid naturally present in beef and it is
quarters must not affect the food business operator’s
of no safety concern. In certain meat preparations, lactic
duty to comply with the requirements of Union legis
acid salts are authorised as food additives for the purpose
lation on food hygiene, as laid down in Regulations (EC)
of preservation. For this purpose, levels of 20 000 mg/kg
No 852/2004, (EC) No 853/2004 and (EC) No
are commonly used. Therefore, the use of lactic acid for
2073/2005 and should in no way be considered as a
the purpose of reducing microbial surface contamination
substitution for good hygienic slaughtering practices
is clearly distinct from its use as a food additive.
and operating procedures or as an alternative to
comply with the requirements of those Regulations.
(9)
In view of the EFSA Opinion, taking into account that
lactic acid can provide a significant reduction of possible
(13) The
Standing
Committee
on
the
Food
Chain
and
Animal
Health did not deliver an opinion within the time limit
microbiological contamination, it is appropriate to
laid down by its Chairman. The Commission therefore
approve its use to reduce surface contamination. Such
use should however be subjected to certain conditions.
submitted to the Council a proposal relating to this
Its use should be limited to the use on carcases or half
measure and forwarded it to the European Parliament
carcases or quarters at the level of the slaughterhouse and
at the same time.
it should be integrated into good hygienic practices and
HACCP-based systems.
(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
(10) Commission
Regulation
(EU)
No
231/2012
of
9
March
adopt the measure,
2012 laying down specifications for food additives listed
in Annexes II and III to Regulation (EC) No 1333/2008
HAS ADOPTED THIS REGULATION:
of the European Parliament and of the Council ( 1 ) lays
down specifications for food additives relating, in
Article 1
particular, to origin, purity criteria and any other
necessary information.
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
(11) In
accordance
with
the
EFSA
Opinion,
lactic
acid
used
to
compliance with the conditions set out in the Annex to this
reduce surface contamination in bovine carcases should
Regulation.
comply with the specifications for lactic acid laid down
in Union legislation. Consequently, where lactic acid is
Article 2
used to reduce microbiological surface contamination
pursuant to this Regulation, it is appropriate that such
This Regulation shall enter into force on the twentieth day
lactic acid complies with the specifications laid down in
following that of its publication in the Official Journal of the
Regulation (EU) No 231/2012.
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 BARROSO
( 1 ) OJ L 83, 22.3.2012, p. 1.

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EN
5.2.2013 Official
Journal
of
the
European
Union L
34/3
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.

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