UK: FSA consultation on its approach to regulatory decision making

Last Updated: 21 April 2005
Article by Mark Tyler and Jessica Burt

On 1 April, the Food Standards Agency (FSA) launched a consultation on its approach to regulatory decision making. The Policy Statement considers stakeholder engagement in consultations generally and sets out the objectives and principles of regulatory decision making, the evidence base underpinning any decision as well as its approach to deciding the most appropriate action in each case and the factors that are taken into account.

FSA has invited comments by 30 June 2005.

For further information on this consultation and some of the main points for industry as well as a consideration of the FSA's decision making process with reference to the recent Sudan 1 recall, please view the article in full below:

Full Article

On 1 April, the Food Standards Agency (FSA) launched a consultation on its approach to regulatory decision making. Click here for more information.

To view the FSA draft Policy Statement please click here.

The Policy Statement considers stakeholder engagement in consultations generally, and sets out the objectives and principles of regulatory decision making, the evidence base underpinning any decision as well as its approach to deciding the most appropriate action in each case and the factors that are taken into account.

Key Consultation Questions


The FSA focuses on whether or not they are accessing "hard to hear" consumer groups as well as small and medium sized food enterprises.

One aspect which is not covered however is any aspect of 'weighting' given to responses to consultations. For instance the response from a fringe consumer group should not be commensurate with the response from a global company that has consulted with employees and suppliers before providing their response.

Protecting consumer' "other interests" generally

Aspects to take into account are stated to include consumer choice and cost repercussions of any action, the heterogeneity or otherwise of consumer perceptions and protection of the most vulnerable consumers. The question is asked if these aspects should be taken into account and what additional issues should be considered.

Whether or not any action will have a significant impact on achieving the aimed protection and the provision of a 'level playing field' for industry and freedom of commercial expression are not considered as options under this heading.

Costs and benefits

There is some reference to assessing the costs and benefits of any decision, which includes administrative costs for industry. However, the wider implications of the costs of any restrictions on the market against any limited perceived social good is not considered.

regulation and alternatives to regulation

The various options for intervention are listed ranging from doing nothing to direct regulation and encouraging enforcement action. The question raised if there are any other possible steps not listed.

The intervention of publishing survey result showing the extent to which individual companies follow best practice guidance is stated in the consultation summary to be reasonable as it allows consumers to be informed about the extent to which best practice is being followed. The argument against this position is that this publication amounts to "regulatory creep". The FSA raises questions as to whether stakeholders agree with these publications and if it is felt that this information is useful to consumers.

One response may be that it will depend upon whether or not any of the best practice issues coincide with those issues that consumers feel strongly about as to whether or not this practice may be deemed at all useful to them.

when to take action

Different factors influence the approach in each case, this includes; different types of risk (eg if there is an immediate and acute threat,) speed of implementation, and in the event where there are possible rather than actual risks it may be the FSA will inform consumers, provide advice and still allow the consumers to make their own choices. The aim is stated not to reduce all risks, but to take action to reduce risks to the level that would be acceptable to the 'reasonable consumer'.

Lord Phillips in his 16-volume, £30m inquiry into BSE drew the conclusion that 'The Government does not set out to achieve zero risk, but to reduce risk to a level, which should be acceptable to the reasonable consumer.' This of course begs the question of what is acceptable and what is reasonable.

It has been presented by the FSA (Sir John Krebs, Chair of the Food Standards Agency at Queen's University, Belfast, on 5 November 2003) that the notion of assessing risks on the basis of scientific facts, coming to a conclusion about risk management, and then telling the public, should be blended with public attitudes towards the acceptability of risks and the costs and feasibility of actions to manage risks.

However, the legislative requirements under Regulation 178/2002 (Article 19) state that where a product not in compliance with the food safety requirements may have reached the consumer, consumers must be effectively and accurately informed of the reason for the withdrawal. If necessary products must be recalled when other measures are not sufficient to achieve a high level of health protection. i.e. recall is only required where other measures are insufficient to achieve a high level of health protection. It is therefore clear that the FSA by referring to the 'reasonable consumer' in its consultation is going much further than European legislation in factors governing a potential recall decision.

It is likely that the FSA's position on the Sudan 1 recall followed their own factors in making the decision for recall with an emphasis on public opinion as opposed to any consideration of if other measures would be sufficient to achieve a high level of health protection as part of a risk assessment. The FSA alert itself considered the level of risk to be "very small". (The FSA alert that was circulated on 18 February 2005 stated "Sudan I could contribute to an increased risk of cancer and it is not possible to identify a safe level or to quantify the risk. However, at the levels present in these food products the risk is likely to be very small.")

The FSA has invited comments to this consultation by 30 June 2005.

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 18/04/2005.

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