UK: D is for Due Diligence

Last Updated: 19 May 2010
Article by Jessica Burt and Dana Coey

Due Diligence is a defence that every company active in the food and drink sector should be able to utilise and already have in operation as part of its quality control and risk management processes.

It provides a defence to the main offences under the Food Safety Act of rendering food injurious to health (section 7); selling, to the purchaser's prejudice, food which is not of the nature or substance or quality demanded (section 14); and falsely or misleadingly describing or presenting food (section 15). Furthermore, it is also relevant to offences under the General Food Regulations 2004 (Regulation (EC) 178/2002) and the Food Hygiene Regulations 2006.

The "due diligence" defence is as follows:

" a defence for the person charged to prove that he took all reasonable precautions and exercised all due diligence to avoid the commission of the offence by himself or by a person under his control."

(S.21 Food Safety Act 1990)

Those who don't have direct control over the food product, such as traders who neither manufactured nor imported the food, can rely on the defence that the commission of the offence (e.g. false labelling,) was due to an act or default of another person who was not under his control, or to reliance on information supplied by such a person.

Crucially, the burden of proof lies with the accused person or company. The level required is the civil basis of balance of probabilities and not beyond all reasonable doubt. It is important to be aware that the requirement is for the defendant to prove that he took all reasonable precautions AND exercised all due diligence. These are cumulative matters, not alternatives.

What is reasonable depends very much on the facts of each case. What is reasonable for a large multinational is very different to what may be deemed reasonable for a small or medium sized business. Equally this may also depend on the respective specialist knowledge of each party, as well as their resources.

It is therefore important for a company to have a regular audit of their systems, to include:

  • Suppliers - what questions are being asked to ascertain and, where necessary, actually check or test, the source of ingredients of and quality of the products provided? Are these up to date? Are full traceability documents provided and kept up to date for all products? Are those who carry out checks appropriately experienced and equipped? Are there specific labeling requirements due to the source of supply?
  • Manufacturing - Are risk assessments carried out and recommendations complied with? Are Hazard Analysis Control Points complied with? Is quality testing regularly carried out and records kept? Are those who carry out checks appropriately experienced and equipped?
  • Packaging & Storage - Are these regularly inspected and checked? Are those who carry out checks appropriately experienced and equipped?
  • Carriage - what are the conditions of transportation and carriage? Are these tested? Are quality checks utilized? Are those who carry out checks appropriately experienced and equipped?
  • Labelling & Advertising - is appropriate legal advice obtained in respect of all new packaging, advertising and product lines, as well as of revisions to old labeling? Are recommendations carried out, for example re supporting data, and all legal regulations complied with? Are new legal and technical developments kept abreast of?
  • Personnel & Out-sourcing - Are staff properly experienced and/or equipped to carry out required checks? Is training kept up to date and properly documented? Are there the resources to request external expertise? If out-sourcing of checks takes place, is it to an appropriately experienced and equipped entity? What checks have been done of their credentials and those of their insurers? Are these checks kept up to date? Are references confirmed?
  • "Post-Marketing Surveillance" / Customer Complaints Department (This is likely to depend on the size of the entity/sensitivity of the product concerned) - Is there a system in place? Is it responsive? This system should, in addition to forwarding more serious claims to insurers, be aware of key issues such as emerging patterns, malicious damage, health risks that appear genuine and these should be forwarded to legal and the risk assessment, technical, QA part of the crisis team for assessment/follow up/monitoring.

The due diligence defence has a fluid identity. Once a company becomes aware of an issue or problem it has a responsibility to deal with it, what the defence may have covered one week may not be covered the next week. It is important as part of a companies' due diligence process that as well as auditing and keeping up to date on their processes, they have in place a crisis management plan in case things go wrong.

It is important that companies always put customer safety first and not only do this but are perceived to do this by the regulatory authorities and the consumer. A detailed and regularly updated due diligence process combined with a crisis plan should allow the company to act responsibly, decisively and with transparency.

The FSA's Nov 2009 Guidance on the Food Safety Act 1990, which refers to the Due Diligence Defence, is available here .

This article was written for Law-Now, CMS Cameron McKenna's free online information service. To register for Law-Now, please go to

Law-Now information is for general purposes and guidance only. The information and opinions expressed in all Law-Now articles are not necessarily comprehensive and do not purport to give professional or legal advice. All Law-Now information relates to circumstances prevailing at the date of its original publication and may not have been updated to reflect subsequent developments.

The original publication date for this article was 17/05/2010.

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