Never has there been more legislative change impacting on the food industry at one time. And in all the thousands of pages of legislation that need to be digested, and the not always complementary pieces of legislation that require managing, not to mention the exceptional costs likely to hit the industry, it’s easy to see how efficacy may be a casualty of legislation.
CLP, BPR, MRLs are all impacting the food manufacturing industry with an overarching agenda to protect man and the environment alongside a pressing need to reduce the chemicals used in everyday life. It’s fair to say most manufacturers and industry bodies understand the need for these changes whilst striving to ensure there is greater clarity around chemicals and their use alongside continuing to operate to the same high standards.
But the legislation, as often is, is a minefield and in some cases seems to consider the very real risk of food poisoning less important than the broader discussion around the use of chemicals.
We asked Byotrol’s CTO, Dr Trevor Francis, to give us his views on each of the regulations and the impact these are likely to have on the future of the food manufacturing industry.
Classification, Labelling & Packaging Regulations
Background: CLP – Classification, labelling and packaging – first tabled in 1992 at the Rio Earth Summit seeks to harmonise the classification, labelling and packaging of chemicals globally. There are exceptions of course with some countries selecting and rejecting some parts of the legislation. The system is a hazard based system with the 12 categories of danger under DSD/DPD being replaced by 28 hazard categories. In practical terms, the labelling system moves from a maximum of 2 orange and black symbols to a maximum of 5 red and black pictograms. Mixtures sold into the supply chain from 1st June 2015 will adhere to these new regulations, with industry having two years to move already existing stock through the supply chain.
Dr Francis: “Some biocides that are regularly used in industry will now be labelled as corrosive, carcinogenic or damaging to respiratory systems at higher concentrations although while in use, the labelling and risk to the user is unchanged. There continues to be great debate by experts about applying the precautionary principle which has led to these classifications by the EU in opposition to other global regulatory bodies and in some cases is based on new interpretations of historic studies. Should a concentrate that will be never used in its concentrated form, will always be handled with PPE to dilute to ready to use, be banned from a factory yard by Health & Safety purely as the label identifies a hazard from misuse as opposed to the risk from correct use?”
Biocidal Product Regulations
Then there is the implementation of Biocidal Product Regulations. The biocides themselves have been or are being reviewed and in some cases are no longer supported for use. The number of available biocides for use across all of the different 22 Product Types (including Food – PT4) has decreased from well over 750 to now less than 250, and it becomes apparent that the selection of the right biocide to meet all of these challenges is becoming increasingly difficult.
“As the actives are added to the European Register, so-called Article 95, manufacturers will be required to move from the current system of ensuring compliance to producing dossiers for all the formulations they place for sale. As with many implementations of legislation, timings, cost and even process are still a moving feast, but conservative estimates suggest investment in resource to prepare the dossier, generating additional data and the fees to be paid could set a manufacturer back hundreds of thousands of pounds per formulation/ dossier. This is likely to have a dramatic impact on the number of biocides and formulations available to industry and the dossier costs, which will be passed on in some ways to consumers. Many small businesses who are integral to the chemical industry are likely to fall as their pockets won’t be deep enough nor do they have the luxury of armies of regulatory experts at the disposal of the larger players.”
Maximum Residue Levels (MRL)
One of the preferred biocides in industry are Quaternary Ammonium Compounds (QAC). They are broad spectrum biocides and allow for a lower quantity of the biocides to be present in solution for the performance required. They remain one of the most efficacious biocides readily available and easy to handle. Ubiquitous, they’re also cost-effective for users and with the reduced availability of other biocides; increasingly the Industry has become dependent upon QAC.
Recently though, QAC have themselves become embroiled in restrictions on use due to their dual use historically as a Pesticide. And as a pesticide, QUAT have had a Maximum Residue Level imposed for the use of Food Produce of 0.1 mg/Kg (from 12th August 2015). In most Food Produce factories, it is possible that such a MRL will be exceeded and belatedly lobbying attempts to relax this limit are ongoing. Even with potential challenges that are being mounted with the UK Regulatory Authority, in the very short term, it seems very unlikely that this level will be changed. Indeed the EU Commission is now discussing whether MRL’s should also be imposed on all biocides that are used in Food Disinfection.
“While such a stance is in many ways understandable, as no one can imagine that consumers want to digest biocides with their Food, equally this fails to recognise the low toxicity of QAC, for which long term dietary studies fail to lead to significant systematic toxicity and following the standard risk assessment approach by applying the default safety factors on the lowest available No Observed Adverse Effect Level (NOAEL) from a very extensive database of performed studies with these compounds, levels up to 16 mg/kg in foodstuffs can be considered safe.
For many users, moving away from QAC on food contact surfaces will likely increase factory costs, training time and potentially efficacy. With all other biocides poised to follow suit, the UK food industry may find themselves moving backwards to introducing more water back in to the environment to negate the risk of being named and shamed for MRLs by the Chemicals Regulation Directorate and therefore increasing risk to public health.
To a food manufacturer, the financial and PR impact of a recall of product that has become contaminated by micro-organisms is huge, not to mention the time off for sickness or even loss of life for the individual that consumes contaminated products. Without the right biocides for the job, the food manufacturers and industry itself are in a no-win situation.”
The future of biocides
“What is normally said in such times is that such changes and restrictions will lead to new innovation with industry leading the way. Certainly one can see that some time in the distant future alternative technical solutions will emerge, such as antimicrobial surfaces deployed in all plants, or the use of fixed bacteriophages to manage bacterial contamination. Indeed many of these solutions are now being worked on, but they are still probably a long time to implementation. Equally given the financial demands and conservative nature of registering a new technology within the European framework, the process is expected to be both lengthy and challenging.
In the short term, we in industry need to pull together to champion our biocides and our successes in keeping consumers protected from food pathogens. We need to ensure we’re as well educated as we can collectively be to ensure that we chemical manufacturers, food manufacturers, processers and retailers, aren’t required to muddle through the legislation taking uncalculated risks with food safety, jeopardising public health or risking business closure. It’s incumbent on us to be a voice for good food hygiene which after all is all about controlling harmful bacteria, the very thing biocides are designed to do.”
This interview was also published as an article in the recent issue of SOFHT FOCUS which can be read here