CELEX: 52012PC0578
Language: en
Date: 2012-10-03
Title: Proposal for a COUNCIL REGULATION concerning the use of lactic acid to reduce microbiological surface contamination on bovine carcases

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		52012PC0578
		
			Proposal for a COUNCIL REGULATION concerning the use of lactic acid to reduce microbiological surface contamination on bovine carcases /* COM/2012/0578 final - 2012/0280 (NLE) */
			
				
		
		
			
			   	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 the evaluation of the safety
and efficacy of lactic acid for decontamination purposes. The Commission
therefore proposed measures concerning the use of lactic acid to reduce surface
contamination on bovine carcases.
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. 
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.
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 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
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. 
(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 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.
(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 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[5]
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 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.
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, 
                                                                       For
the Council
                                                                       The
President
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. 
[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.
[5]               OJ
L 83, 22.3.2012, p. 1.