14-07-19 MRL Implications of QACs

Technical Guide
MRL Implications of QACs
Quaternary Ammonium Compound (QAC) Maximum Residue Levels (MRLs) and their implications.
What is the background to the QAC MRL issue?
In Europe, disinfectants (biocides) used in the food industry are controlled by a range of legislation but two are key in
determining the level of disinfectant that can be taken up by foodstuffs after the disinfectant’s legitimate use.
REGULATION (EC) No 396/2005 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 23 February 2005 on
maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council
Directive 91/414/EEC, governs the use of pesticide residues.
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2005:070:0001:0016:en:PDF
Among the pesticides used in Europe, are didecyldimethylammonium chloride (DDAC) with alkyl chain lengths of C8,
C10 and C12 and benzalkonium chloride (BAC) with alkyl chain lengths of C8, C10, C12, C14, C16 and C18. Table 1
shows the Holchem products that do, and do not, contain QAC’s.
Table 1 - Distribution of QAC Disinfectants in Holchem Products.
Disinfectant containing QACs
HOLQUAT
M2
OPTIMUM K2
TRADELINE KITCHEN SANITISER CLEANER
ALCOSAN
HOLQUAT LF
COLD SHIELD
TERMINOL
DUAL
IMPACT
BACTI BLUE
FOOTBATH
TRADELINE CLEANER SANITISER
BIOACTIVE
Disinfectants not containing QACs
ACTIVE
PERBAC OPD
PERBAC
PERBAC 15
CRYSTAL
HANDSAN
M8
DYRSAN
LUXSAN
FOAMSAN
PROTECT WIPES
M11 WIPES
TERMINOL FARM
TURBO KILL
FARMCLEAR
PERBAC FARM
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All pesticides have an MRL set by this legislation and for these QACs, the EU agreed in 2012 on an enforcement level
of 0.5 mg/kg foodstuffs, for all foodstuffs mention in Annex 1 of EC 396/2005. This includes fresh fruit and nuts;
vegetables; pulses; oilseeds and oilfruits; cereals; teas, coffee, herbal infusions and cocoa; hops; spices; sugar plants;
products of animal origin – terrestrial animals; fish, fish products, shell fish, molluscs and other marine and freshwater
food products; and crops exclusively used for animal feed.
REGULATION (EU) No 528/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 May 2012 concerning
the making available on the market and use of biocidal products, governs the use of biocides for the purpose of
disinfection in the food hygiene sector. http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:167:0001:0123:EN:PDF
Article 19(1)(e) of the Biocidal Product Regulation (EU) No 528/2012 requires the setting of MRLs, where appropriate,
for active substances contained in a biocidal products. Ultimately, when formulated biocide products are considered
for approval under 528/2012, MRLs may then be set for all disinfectants used in food hygiene. This is unlikely to be
before 2016 at the earliest.
Following potential misuse of QAC based pesticides in foodstuffs, resulting in unacceptably high residues, the
European Food Safety Authority (EFSA) were asked to provide a reasoned opinion as to whether the MRL of 0.5 mg/kg
could be lowered to 0.1mg/kg. The following document was published determining EFSA’s views.
Reasoned opinion on the dietary risk assessment for proposed temporary maximum residue levels (MRLs) of
didecyldimethylammonium chloride (DDAC) and benzalkonium chloride (BAC)
http://www.efsa.europa.eu/en/efsajournal/pub/3675.htm
After having surveyed food products across the EU, this document proposed that a move to the lower limit of
0.1mg/kg was both possible and advocated on a health based risk assessment.
A last minute effort was made by chemical suppliers, BACS and the Chilled Food Association (CFA) in the UK to oppose
any reduction of QAC MRL based on the fact that the UK was unusual in the EU in that QACs were not rinsed off food
contact surfaces prior to production recommencing. This would most likely result in high QAC MRLs in UK food
products.
In June 2014, set statutory MRLs of 0.1 mg/kg for DDAC and BAC were voted through at the EU Standing Committee
on The Food Chain and Animal Health (Residues). The EU Commission will be issuing a statement confirming that the
current guideline levels of 0.5 mg/kg will continue to be applied for 9 months after the publication of the voted
Regulation. Taking into account the standard period of EU Parliament and Council scrutiny prior to any Regulation
publication, this means that the 0.5 level will be maintained for around a year– taking us to mid-2015 before the
lower statutory MRL takes effect.
How does this all affect Holchem and the food industry?
QACs are the largest class of disinfectants sold into the UK food industry. They are found in many Holchem products
(and also our competitors) because they are:•
Effective.
•
Non-tainting.
•
When used correctly they are safe to operatives and consumers (It would be necessary to consume 111ltrs of a
1% Holquat Solution to exceed the LD50 value for the QAC).
•
They do not cause corrosion of common materials of construction used in food processing equipment.
•
They are relatively inexpensive
QACs are not rinsed off surfaces for 3 key reasons.
Copyright Holchem. Issue Date: 19 July 2014. Page 2 of 5
•
Firstly, QAC residues are believed to provide a protective challenge to food contact surfaces such that if the
surface is subsequently cross-contaminated by pathogenic or spoilage microorganisms, the QAC residue will
provide a biocidal action. This is particularly important in the chilled ready-to-eat (RTE) food sector where
Listeria monocytogenes is a major pathogen of concern and is able to survive/grow in typically unpreserved RTE
products. The Chilled ready to eat market in the UK is far greater than in the rest of the EU.
•
Secondly, there is often insufficient time for process lines to dry prior to production commencing.
•
Thirdly, holding cleaned utensils and small items of equipment in QAC soak baths allows penetration of
disinfectant into surface features and preserves their low microbial surface count prior to subsequent reuse.
A group of disinfectant manufacturers (Holchem, SealedAir, Ecolab, CCL, Byotrol and Klenzan) commissioned
Campden BRI to assess the uptake of QACs into a number of foodstuffs. A mixture of 500ppm BAC (C14), 500ppm BAC
(C16) and 1000ppm DDAC (total 2000ppm) was coated onto stainless steel surfaces, dried for 20 min or overnight,
following which a number of food products (salmon, minced beef, sliced bread and lettuce) were placed onto the
stainless steel, with and without prior surface rinsing. 2000ppm represents a worst case scenario if the QAC was
made up at too high a concentration.
Following rinsing of the BAC/DDAC mixture, uptake into the foodstuffs was below the proposed MRL of 0.1mg/kg. If
rinsing was not undertaken, however, uptake of the BAC/DDAC mixture into the foodstuffs was higher than the
proposed MRL of 0.1mg/kg in the products and at the QAC concentrations tested.
This would suggest that many food manufacturers could be at risk of exceeding the proposed MRL in their food
products, particularly if they do not rinse QAC based disinfectants from food contact surfaces.
What are the alternatives for the food industry?
Fortunately there are many options available to the industry. These are listed below with a brief discussion of the
pros and cons.
Option One:- Food manufacturers currently using QAC products could undertake their existing cleaning and
disinfection programme without rinsing and then assess their food products for MRL levels. If they were below
0.1mg/kg, their product would be deemed safe. Analysis requires very sophisticated equipment. Holchem could not
undertake this analysis on behalf of customers: independent testing organisations such as Campden BRI could. There
are some potentially confusing issues relating to food types however, relative to Annex 1 of EC 396/2005. For
example, if a BLT sandwich was manufactured, the lettuce and tomato would be covered under Annex 1, but the
bread, margarine and dressing may not.
Option Two:- Food manufacturers could assess if, following the first product down the line, later product was below
the MRL limit, on the basis that the first product down the line had absorbed all QAC residues. If this was proven, the
first product down the line could be discarded, though clearly at a cost!
Option Three:- Food manufacturers’ currently using QAC products but not rinsing prior to subsequent production
could simply rinse food contact surfaces following an appropriate disinfectant contact time. Rinsing (subject to the
necessity for surface drying), could also occur immediately prior to production recommencing. However, if rinsing
was required, this would result in additional water costs and cleaning operative’s time, together with higher energy
use (increased room temperature for a time period sufficient to dry surfaces) or cleaning operative’s time in manual
drying with cloths or paper. There may also be food safety issues with respect to Listeria monocytogenes. It would be
sensible if this approach were followed, to use an independent testing organisation to validate that food was below
the MRL level, then put in place a subsequent monitoring process to demonstrate that surfaces were after rinsing free
of QAC. Use of QAC test strips, or available hand held instruments would be applicable possible options.
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Option Four:- Food manufacturers currently using QAC products but not rinsing prior to subsequent production could
potentially remove QAC residues from food contact surfaces by wiping them down immediately prior to production
recommencing. Wiping could either be dry or wet paper or cloth towels (chemical free) or alcohol impregnated
cloths. Initial trials at Holchem have shown that QAC residues can be removed by some wiping actions. Holchem
have commissioned further work to validate this approach which is intending to conclude in September/October.
Option Five:- There are disinfectants designed for the food industry that are not based on QAC’s and are not used in
Pesticides (see Table 2 for Holchem products). These are not covered by regulation (EC) No 396/2005. Changing to a
QAC alternative will have implications with respect to cost, but also potentially to food equipment materials of
construction (corrosion).
For some chemical disinfectant applications such as in Tray Washers and Soak Tanks, unless subsequent manually
rinsing or wiping is possible, a move to a non-QAC disinfectant may be the only solution.
Holchem commissioned Campden BRI to undertake Marks & Spencer approval of Active in June so that food
manufacturers could use a non-oxidative disinfectant alternative to Terminol where M&S approval is required. . It is
expected that Active product will be approved in October.
Following wiping and M&S Approval trials, Holchem should be in a position to fully inform customers and/or provide
alternative chemical choices by the end of October this year.
Does this apply to hand bactericidal soaps and rubs?
The following two hand rubs contain QAC.
•
Handsan
•
Drysan
There is the potential for QAC rubbed into the hands to transfer to food products during food handling. This would
not occur if the hands were subsequently gloved, by may occur if the gloves were decontaminated via Handsan or
Drysan.
Some theoretical calculations have been made based on information supplied in Handsan’s and Drysan’s Cosmetic
Product Safety Assessment sheets. These sheets have defined the average dose of product being added to the hands,
the average size of hands and an estimate of the percentage of product transferred from the hands to food products.
Knowing the level of QAC in each of these products, it has been calculated that for the first food product touched by
hands to which Handsan or Drysan has been applied, would have MRLs of 0.099 and 0.13 mg/kg respectively. The
second and third products touched will have lower MRLs. There is a chance, therefore, that a tiny number of food
products produced in the working day will contain QAC at or around the 0.1mg/kg level.
Holchem, however, do not perceive the use of a Handsan and Drysan as a risk to food manufacturers at this time.
Tests have been commissioned to undertake real transfer tests from hands to a range of foodstuffs which will allow a
more detailed assessment of the risk of exceeding QAC MRLs.
Future issues
It is likely that following the approval of biocidal products under the Biocidal Product Regulation (EU) No 528/2012, all
disinfectants will have an MRL imposed (other than those biocides that break down into chemicals already noted as
food safe, e.g. acetic acid (vinegar) the breakdown product of PAA.
When formulated products containing QACs have been approved, there may well be a case where there are different
MRLs set for the use of these actives in pesticides and in food hygiene disinfectants. This, clearly, will need to be
resolved by the EU in the future.
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Many disinfect products used in the interim as QAC replacements, e.g. amphoterics, may well have MRLs set at a
higher level than the generically ‘safer’ QACs. Such biocides will thus only have a temporary window of increased use
until (EU) No 528/2012 product formulation approval.
Prior to the approval of formulated biocidal products, however, BACS, CEFIC and AISE will lobby the EU to ascertain
within Article 19(1)(e) of the Biocidal Product Regulation (EU) No 528/2012, how and where appropriate, will MRLs be
set. It may be, therefore, that MRLs of biocides approved under 528/2012 may not have MRLs set.
BACS, CEFIC and AISE will also lobby the EU to seek urgent clarification on the scope and means of enforcement of
both EC 396/200) and EU 528/2012 in the case of foodstuffs and biocidal actives which potentially fall under both
regulations.
John Holah / Jim Taylour
th
19 July 2014
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