fbig-logo-2016EU reviews of the use of biocides impact on the availability of effective disinfectants that are vital to assure food hygiene through the food chain.

In response, some 20 UK trade and professional organisations (see membership list at the bottom of this page) have been working together since 2012 primarily as the Food & Biocides Industry Group (FBIG).

FBIG is leading lobbying in the UK and engagement with the European Commission, the latter having recognised the need to assure food hygiene and safety through the appropriate use of hygiene biocides, some of which my be regulated as Plant Prtotection Products (PPPs), e.g. Quaternary Ammonium Compounds (QACs), and chlorate (which can arise from use of certain hygiene biocides).

FBOs are referred by HSE to FBIG’s various guidance on the use of biocides in cleaning and disinfection and also on the minimisation of biocides’ traces in food (see below for documents).

As a result of lobbying to protect food hygiene and safety, the EU agreed new MRLs for chlorate that came into force on 20 June 2020, which include a footnote referring specifically to taking account of the use of biocides during processing in addition to the MRLs for food as harvested or initially produced. The footnote exceptionally specifies that for considering compliance with chlorate MRLs, simple types of processing that do not affect the other residue levels, (such as packing, washing, chopping and freezing), can be taken into account. This goes beyond the definition of ‘processing’ in EU Reg 852/2004.

The responsibility for providing evidence showing that residues from processing can be taken into account lies with the FBO.

This is what FBIG’s guidance addresses.

HSE and defra are not advising that food companies change their existing practices. Note that HSE’s Chemical Residues Directorate (CRD) specifically excludes chlorate results from some year-on-year pesticide residue trend analyses (see pp12-13 of linked document).

The positions of the food and biocide industries on the issue are aligned, including at EU level. The main aim is now for the EC to recognise in law that it is not appropriate to apply MRLs to hygiene biocides used for disinfection (of water and equipment etc) as they are not being used as PPPs (i.e. pesticides). Contaminants legal instruments should instead be used, balancing risk, recognising the need for microbiological food safety assurance with potential traces in the diet.

See:

 

Good Practice for Use of Hygiene Biocides

In its regular reports from the CRD HSE specifically points FBOs to use of FBIG’s hygiene biocides’ traces minimisation guidance, e.g. “The Food and Biocides Industry Group have produced more detailed information and guidance on this topic which is available on the Chilled Food Association’s website”.

FBIG (via Karin Goodburn of the Chilled Food Association), also contributed to the development of parallel GFSI guidance on the use of biocides published in 2019:

A GFSI technical review of the Relationship of Sanitizers, Disinfectants, and Cleaning Agents with Antimicrobial Resistance, led by Karin Goodburn, was published in the Journal of Food Protection in April 2019.

 

Chlorate MRLs

FBIG and its partners has secured:

FBIG’s focus regarding chlorate is now on assuring awareness by FBOs of its guidance on demonstration of compliance. 

The HSE has advised FBIG that ‘companies should issue a statement confirming that, with respect to the practical interpretation of the Regulation in the UK, goods identified as processed foods may legitimately exceed statutory MRLs set for unprocessed foods (with no enforcement or restriction on sale/supply arising), with the following provisos’:

  • That these special rules will only apply where businesses provide proof that there have been legitimate chlorate trace inputs at the processing stage, such as through the use of potable water or other sources in processed food production, or through legitimate disinfection practices to maintain hygiene.
  • That each food business generates a full description of its production practices to serve as proof that these are legitimate additional inputs leading to the MRL being exceeded.
  • Where exceedance results solely from a concentration of the residue through actions such as drying, and not because of additional chlorate inputs at the processing stage. In those cases, information on the process and calculated processing factors should be generated.
  • It is also expected that the above arrangements will run alongside continuing industry efforts to minimise uses and traces arising from those uses, provided standards of food hygiene remain high.
  • Any steps taken to comply with the MRLs Regulation should not undermine appropriate food hygiene controls.

FBIG suggests that FBOs prepare such a statement of compliance with its various guidance (see below) where there is any likelihood of an MRL exceedance so that they can provide this statement to CRD should it be requested in the event of an exceedance arising.

 

Quaternary Ammonium Compounds (QACs)

QACs such as Benzalkonium chloride (BAC) and Didecyldimethylammonium chloride (DDAC) are highly effective and extremely low toxicity biocides used to control food hygiene and maintain safety, and in wider healthcare applications. They are not regulated under EU law as hygiene biocides, which is their usage.

FBIG worked to secure QAC rational limits for multicomponent/composite and other foods where traces of QACs may arise from their use as hygiene biocides. The minimisation techniques and approaches are the same as set out in FBIG’s various chlorate-related guidance in relation to food contact surface application.

EC Reg (EU) 2023/377 of 15 Feb 2023 amending Annexes II, III, IV and V to Reg (EC) No 396/2005,whch came into effect on 14/3/2023 recognised that both BAC and DDAC “are used as biocides for disinfection. That use may lead to detectable residues [traces] in food. For both substances, temporary MRLs [0.1 mg/kg] were therefore set by Commission Regulation (EU) No 1119/2014 for all products, since FBOs showed that residues of those substances are present in food products at levels that frequently exceed the default MRL of 0.01 mg/kg due to their use as a biocide. Those MRLs were to be revised based on monitoring data after 5 years.”

Traces monitoring data analysed by the EC resulted in 2023 of lowering of the existing temporary MRLs for DDAC in plant products [to 0.05 mg/kg], but the MRL was not changed for products of animal origin.

The MRLs for BAC and DDAC are due to be reviewed by 22 February 2030 (7 years from the publication of 2023/377) to evaluate new data and information that will become available.

 

FBIG Best Practice Chlorate MRLs Compliance Guidance – NOTE THESE PRINCIPLES ALSO APPLY TO QACs USED FOR NON-FOOD SURFACES

FBIG has issued a series of guidance documents developed by its members for different sectors of the food industry, published below, the principles set out also applying minimisation of QAC traces in food:

 

Supporting Produce-Related Guidance:

 

FBIG Articles:

 

FURTHER BACKGROUND
Concerns raised

Biocides in disinfectants and sanitisers are used routinely both in food production and in the home to prevent microbiological contamination of our food. They are used throughout the supply chain and are very important in the production of high quality safe food, contributing to food safety assurance and helping to protect the consumer. Concerns have been expressed repeatedly in UK official reports that clear guidance on cleaning and disinfection needs to be made available to enforcers and smaller businesses to ensure that it is being carried out properly.

The European Commission in March 2017 recognised that positive benefits of using biocides to prevent microbiological contamination need to be balanced with the need to set practicable levels, this was reiterated by the EC to industry in the context of QAC MRLs on 29 April 20 after industry contact in the context of both food hygiene and safety, and wider healthcare.

 

Biocides essential to maintain food hygiene standards

Food poisoning outbreaks are rare in the UK. The UK food industry places an absolute priority on food safety. Good Agricultural Practices, hygienic preparation and packaging minimise the potential for contamination, and the use of biocides and cleaning agents play an essential role in maintaining high standards of food hygiene.

FBIG has stressed to both UK authorities and the European Commission the need to maintain an adequate range of effective biocides and cleaning agents in order not to compromise food safety through increased microbiological risk.

The safety and quality of food is paramount to the industry which is working with the UK authorities and participating in discussions with the European Commission to ensure that food safety remains the key driver for any recommendations to set Maximum Residue Levels (MRLs), or as, FBIG believes, to regulate traces of hygiene biocides and their derivatives under contaminants legislation.

 

Desired end-points

What FBIG is seeking and has achieved:

  1. Continued ability to responsibly use effective biocides – achieved
  2. Rational basis for regulation – improved, but still need hygiene biocides not to be regulated as PPP
  3. Recognise FBOs’ need to be able to protect hygiene for public health – achieved
  4. Full risk assessment of impacts of biocide regulation review on hygiene including water – being pursued
  5. Non-pesticide use should not be regulated under 396/2005, but under contaminants legislation – being pursued
  6. No ‘gold plating’, e.g. going beyond scope of legislation applying to end products not listed in 396/2005 – greater clarity achieved
  7. Clear enforcement guidance and rationale – processed foods special rules achieved, but legislative basis remains inappropriate
FBIG member organisations:

British Beer & Pub Association
British Frozen Food Association
British Meat Processors Association
British Retail Consortium
The British Sandwich & Snacks Association
British Soft Drinks Association
British Specialist Nutrition Association
British Association for Chemical Specialities
Chilled Food Association
Dairy UK
Food & Drink Federation
Fresh Produce Consortium
International Meat Trade Association
International Scientific Forum on Home Hygiene
National Craft Butchers
National Farmers Union
Provision Trade Federation
Society for Food Hygiene Technology
UK Cleaning Products Industry Association
UK Hospitality

 

Updated 13/10/23