Document Sample




1.     Enquiries from the food industry and local authorities have brought to
the FSA’s attention that a new type of food product is being produced and
sold in the UK, aimed at babies from 4–12 months old. Concerns have been
raised that these products, which are chilled or frozen purees, have not been
heat processed sufficiently to destroy Clostridium botulinum spores. There is
therefore a potential risk that they may give rise to cases of infant botulism, a
very rare disease in the UK.

2.     The FSA would like to seek the views of members on the risk
associated with these types of product, specifically in relation to C. botulinum
and infant botulism.

Baby food market

3.       Commercially produced infant weaning foods come in two main types :-

     •   ambient pre-cooked pureed meals packaged in jars, cans or pots and
         chilled yoghurts or fromage frais specifically designed for babies,

     •   dry foods which need rehydrating.

These foods are generally aimed at infants aged from 4 or 7 months,
depending on their consistency. Wet foods make up around three quarters of
the sector, and jars are more popular than cans. Rusks, rice cakes,
breadsticks and similar finger foods are also available but only make up a
small percentage of sales.

4.     A handful of manufacturers dominate the UK market for the two main
types of foods - Heinz/Farleys being the largest with 48% of sales. Other
major manufacturers are Cow and Gate 18%, HiPP 18%, Baby Organix 7%
and Boots 4%.1 HiPP and Baby Organix are both organic ranges, highlighting
the increasing popularity of organic food in this sector. Sales of all baby foods
increased by an estimated 10% between 1997 and 2002, reflecting the
general move towards convenience food.

5.     The FSA is aware of three companies in the UK currently producing
chilled or frozen baby food, and two others who are considering production in
the near future. Current levels of production are generally small scale and
only represent a tiny proportion of the market as a whole. No products of this
type are known to be imported into the UK. Ranges include simple fruit or

vegetable purees for the first stages of weaning, ranging up to more
complicated ‘meals’ such as Lancashire Hotpot.

6.     Marketing tends to centre on them being a fresher, more nutritious
alternative to the traditional jars or cans of pureed baby food, and the
emphasis is placed on them being ‘as good as home made’. Convenience
and lack of waste are also highlighted as, if frozen, only the required amount
needs be de-frosted at each meal.

Incidence of Infant botulism

7.     Infant botulism was first recognised in 1976, since when over 1,500
cases have been reported in 15 countries. Although the vast majority of
cases have been reported in the USA,2 49 cases have been reported in
Europe,3 of which only 6 have occurred in the UK. Illness generally occurs
between 1 and 6 months of age but can occur in babies up to 12 months old.
Ingestion of C. botulinum spores leads to subsequent growth/colonisation and
toxin production in the gastrointestinal tract. Most cases are caused by
proteolytic strains of Type A or B, and the minimum infectious dose has been
estimated at 10–100 spores. There is an incubation period of between 3 and
30 days.

8.    Symptoms include constipation, weak cry, feeding difficulty and muscle
weakness. Treatment involves supportive and respiratory care, and recovery
generally occurs in weeks or months. Mortality rates are low (around 5%),
and there are usually no long term effects.

Source of Infection

9.     In approximately 85% of cases, the source of infection is unknown and
may be food or environmental. The only food directly linked with infant
botulism is honey which is known to occasionally contain high levels of C.
botulinum spores (103–104 spores/kg).        The FSA and many honey
manufacturers therefore advise that honey should not be fed to infants under
12 months. Although cases of infant botulism have been associated with
honey, in 2001 a case in the UK was linked to infant formula, leading to a
product recall.

10.      Given the ubiquitous nature of C. botulinum spores in the environment
(eg. soil, dust), occasional ingestion of spores by infants is likely to occur, and
it is difficult to rule this out as a source of infection. The incidence and toxin
types of infant botulism have been found to closely mirror the geography of
spores in the environment. They are also reported to mirror the density of
spores occurring in soil from these regions, although there are few studies
describing the level of spores found. Epidemiological studies have shown
organisms producing the same toxin type as that causing illness to be present
in the immediate environment of the infant (eg. soil or dust).

11.      The potential presence of C. botulinum spores on fruit and vegetables
is well established. Contamination occurs during growing and harvesting, and
although good agricultural practices may help to reduce the level of
contamination, they cannot prevent it. Washing is unlikely to lower numbers
significantly. It can therefore be assumed that spores will at times be present
on raw materials used in production of the baby food, although the levels are
difficult to estimate due to lack of information.

12.    Manufacturers of jars and cans destroy C. botulinum spores (and
therefore the risk of infant as well as foodborne botulism) by heat processing
to a minimum of Fo 3 or Fo 6, thereby effecting a theoretical 12 log or 24 log
reduction in the numbers of C.botulinum spores. A full investigation of the
heat treatments applied to other forms of baby food, such as dried foods and
yoghurts or fromage frais, has not been carried out. However, where
information has been provided, one manufacturer of dried products reported
that their products do not receive this level of heat treatment.

13.    Similarly, information on the heat processing of all the chilled or frozen
baby food ranges currently on sale has not been sought. However, the FSA is
aware that one range is cooked to 90°C for 10 minutes which will destroy non-
proteolytic C. botulinum spores. A company developing a product range was
also planning to adopt this time/temperature regime.

14.    It should be noted that many parents produce their own baby foods -
cooking, pureeing and often freezing them for use as required. Enquiries are
regularly received by the FSA on the safe production, storage and re-heating
of such foods, which it may be assumed would on occasions contain C.
botulinum spores.


15.    Exposure to C. botulinum spores during the first year of life is likely to
occur due to either their presence in food or the environment. However, the
incidence of infant botulism is extremely low in the UK and world wide it is a
rare disease.

16.    Exposure via food may be arising through consumption of commercial
baby foods which do not receive sufficient heat treatment to destroy all C.
botulinum spores. It may also occur via consumption of home made baby
foods and other foods not aimed at children, which may contain spores. It
should also be recognised that opened foods may become contaminated with
spores from the environment, particularly when there is prolonged use.

17.    There appears to be an increasing move towards the development and
sale of chilled or frozen baby foods as a ‘fresher’ and more nutritious
alternative to traditional jars, cans or dried foods. These products only receive
a moderate cooking process and may therefore contain C. botulinum spores.
18.    Local authorities and the food industry have been seeking FSA
guidance on the safety of these new products in relation to the risk of infant
botulism, as they have been receiving mixed views from food safety experts.
The FSA is therefore considering what advice to provide to Environmental
Health Officers and would appreciate the views of the Committee.


19.    The Agency would like the Committee’s views on the risk of infant
botulism in relation to chilled and frozen weaning foods. To enable a full
discussion of the issues, the Committee may wish to set up an ad hoc group
to consider this issue further.


1. Mintel Report on Baby Food, Drinks and Milk. October 2002.

2. Dodds K L. 1992. Worldwide incidence and ecology of infant botulism. In
   Hauschild A H W, Dodds K L (eds) Clostridium botulinum : ecology and
   control in foods. Dekker, New York.

3. Aureli P, Franciosa G, Fenicia L 2002. Infant botulism and honey in
   Europe: a commentary. Pediatric Infectious Disease Journal 21, 866–968.

September 2003