European Union: Food Safety and the Conditions of a Withdrawal of Unsafe Food and Notification of Such to the Relevant Authority

Last Updated: 1 June 2005
Article by Richard Welfare


You will not have escaped the recent press attention received by a large number of food products on sale in the EU, particularly the UK, contaminated with Sudan I. Sudan I is a dye that should not be added to food and is banned across the EU. Sudan I may have a genotoxic effect and Sudan I to IV have potential carcinogenic effects according to the International Agency for Research on Cancer. Given the low levels present in the contaminated food products, it is understood the risk to health is likely to be very small but the authorities across the EU have advised that consumers avoid any food known to be contaminated. There is no indication that the contamination creates an immediate threat to human health.


European Parliament and Council Directive 94/36/EC lays down detailed rules on colours. This Directive establishes a positive list of colours authorised for use in food to the exclusion of all others in the EU. As Sudan dyes are not included in this list, the presence of these dyes in food contravenes EU legislation. Sudan I is fraudulently used to enhance the colour of the food. The presence of Sudan 1 in food in the EU came to light when information was provided to the Commission, on 9 May 2003 by France, that the presence of the chemical had been found in some Indian spice imports.

After the discovery in May 2003 in France, the Commission initiated procedures to test for the banned substance. On 20 June 2003, the Commission adopted Decision 2003/460 on emergency measures regarding the presence of Sudan I in chilli and chilli products. This Decision aimed at avoiding up stream the contamination of food products by testing the raw materials. It also requested Member States to carry out testing of products on the market in order to assess the extent of the problem and give orientations for review of the Decision. The current incident centred in the UK, derives from a batch of chilli powder purchased in 2002.

This most recent food scare has once again exposed the vulnerability of consumers in the very ordinary activity of purchasing food. In an attempt to create the safest food system in the world (according to the ex-Commissioner Byrne) the cornerstone Regulation 178/2002 which sets out the general principles of food law, the food safety requirements and establishes the European Food Safety Authority was adopted. Its requirements became applicable 1 January 2005. The Regulation imposes a heavy burden on food and feed business operators with regard to food safety requirements. This article briefly summaries two of the obligations relating to the situation where a business operator believes standards have not been met1.


Article 19(1) imposes the specific obligation on food business operators to withdraw (or recall) from the market a food that does not meet the food safety requirements if they have left the operator's immediate control and inform the competent authorities thereof. Withdrawal (or recall) can be costly and time consuming for affected businesses. In the case of Sudan I, 474 products have been withdrawn or recalled at the time of writing.

There are two cumulative criteria triggering the obligations under 19(1):

  1. The food in question is considered by the operator as not being in compliance with the food safety requirements, and
  2. The food is on the market and has left the control of the initial operator.

The withdrawal obligations under Article 19(1) only apply when the food has left the immediate control of the initial operator. In other words, when there is the possibility for the food business operator to remedy the non-compliance by their own means, without the need to require co-operation from other operators, the obligations of Article 19(1) do not apply.

Only when a withdrawal takes place in accordance with Article 19(1), is the operator required to notify the authorities. Therefore, there is no mandatory obligation to notify the authorities where the food has been removed from the food chain at a point when it is still under the immediate control of the operator.

If the contaminated product has reached the consumer then the operator is obliged by Article 19(1) to provide adequate information to the consumer as to the reasons for withdrawal and how to deal with the product.


Article 19(3) imposes on food business operators an obligation to inform the authorities when they consider or have reason to believe that a food product that they have ‘placed on the market’ may be ‘injurious to health’. In this case, they shall immediately inform the competent authorities and detail the action taken to prevent the risk. Article 19 (3) does not necessarily impose systematic withdrawal but provides for immediate information of the competent authorities of a potential risk and the action taken to prevent it. Article 19(3) will apply where:

  1. The food in question has been placed on the market. Note that there is a wide definition of 'placed on the market'. It can cover food that has been produced or imported that is being held with a view to sell or supply free of charge to customers.
  2. The food in question may be injurious to health. The definition of "injurious to health" will include long term cumulative harm. Thus, with Sudan 1 the effects to the consumer would not have been immediate, but rather harm may be caused by consistent and continued consumption of contaminated food.


The Sudan I scare has, once again, shown that recalls are costly and can prove damaging to consumer and trading partners confidence in the businesses affected. Companies should act swiftly on discovering that products emanating from their business are either injurious to health or otherwise fail to meet the legal requirements for food and feed safety in order to minimise any risk to health, comply with the legislative requirements and limit damage to market confidence.


1 See article "Commission Issues Guidance on the Implementation of Regulation 178/2002 on General Food Law - Including Guidance on Traceability", relating to the Commission's recent guidance on these obligations by clicking on the 'Next Page' link at the bottom of this article.

Please click on 'Next Page' link below to view "Commission Issues Guidance on the Implementation of Regulation 178/2002 on General Food Law - Including Guidance on Traceability"

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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