Suitability of goats milk infant formula and follow-on formula

for infants who are allergic to cows milk

Issue

On 28 February 2014 an amendment to the infant formula and follow-on formula Directive
2006/141/EC will enter into force. This will permit goats milk infant formula and follow-on formula
to be sold on the UK market.
It is expected that one company will be placing a goats milk based formula on the UK market in May
2014; however, other companies may also provide such products in future.
The FSA will be advising that goats milk infant formula and follow-on formula is not suitable for
infants with a cows milk protein allergy, unless directed by a healthcare professional.

Background

Cows milk protein allergy is the most frequent food allergy in the first years of life. A review paper
by the World Allergy Organization estimates that 1.9% to 4.9% of children suffer from cows milk
protein allergy 1. Milk from other mammalian species has been suggested as a possible nutritional
alternative to cows milk for these infants.
However, clinical studies have shown a high risk of cross-reactivity between the proteins in cows
milk and in other mammalian milk, including goats milk 2,3. In addition cases have been reported of
cows milk allergic infants developing anaphylaxis after the ingestion of goat's milk 4.
Milk contains around 3.5% protein. The major proteins in cows milk are caseins (~ 80% of the
protein and include s1, s2, , and ) and whey proteins (~20% of proteins and include -lactalbumin
and -lactoglobulin). Individuals with a cows milk allergy, can be allergic to one or more of these
proteins.
There is a difference between goats and cows milk particularly in the composition of caseins 5.
However, goats milk proteins are similar to the major milk proteins present in cows milk in their

Fiocchi A, Brozek J, Schunemann H, Bahna SL, von BA, Beyer K, et al. World Allergy organization (WAO) diagnosis
and rationale for action against Cow's milk allergy (DRACMA) guidelines. World Allergy Organ J, 2010, 3(4):57-161.
2
Ballabio C, Chessa S, Rignanese D, Gigliotti C, Pagnacco G, Terracciano L, Fiocchi A, Restani P and Caroli AM, 2011. Goat
milk allergenicity as a function of alphas-casein genetic polymorphism. Journal of Dairy Science, 94, 998-1004.
3
Infante Pina D, Tormo Carnice R and Conde Zandueta M, 2003. [Use of goat's milk in patients with cow's milk allergy].
Anales de Pediatria, 59, 138-142.
4
Pessler F, Nejat M. Anaphylactic reaction to goat's milk in a cow's milk-allergic infant. Pediatr Allergy Immuno,
2004,15(2):183-5.
5
EFSA (European Food Safety Authority), 2004. Opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies
on a request from the Commission relating to the evaluation of goats milk protein as a protein source for infant
formulaand follow-on formula. The EFSA Journal 30, 1-15.

general classification and there is high homology (84-95 %) between the amino acid composition of
the six major proteins of cows and goats milk, resulting in a high risk of cross reactivity 6.
Although there is little published literature in this area, it is estimated that the majority of infants
with a cows milk protein allergy will also react to goats milk. There will be a small percentage of
infants with a cows milk protein allergy who may tolerate goats milk, however, the suitability of this
product for such infants would need to be advised by a healthcare professional.
It should also be noted that selective allergy to goats milk proteins only has been reported 7.

EFSA findings

In 2012 EFSA published an opinion on the suitability of goats milk protein as a source of protein in
infant formula and follow-on formula5. Regarding allergenicity, they concluded that there are
insufficient data on the allergenicity of goats milk protein and there were no convincing data to
support the conclusion that the incidence of allergic reactions is lower when feeding goats milkbased infant formula when compared with cows milk-based infant formula. They also concluded
that substituting goats milk protein for cows milk protein in infant formula intended for cows milk
allergic infants cannot be considered safe, unless proven to be so in clinical and in vitro studies.
Taking all of these points into consideration, it can be concluded that the risk of cross-reactivity
between cows and goats milk proteins in cows milk allergic infants is high and can lead to lifethreatening reactions. Therefore infants allergic to cows milk protein should avoid goat's milk infant
formula and follow-on formula.

Recommendation
Given the high risk of cross reactivity between cows and goats milk proteins, the Government will
be advising the following: Goats milk infant formula and follow-on formula is not suitable for
infants with a cows milk protein allergy unless directed by a healthcare professional.

EFSA (European Food Safety Authority), 2012. Opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies
on a request from the Commission relating to the suitability of goat milk protein as a source of protein in infant formula
and in follow-on formula. The EFSA Journal 10 (3):2603.
7
Muoz Martn T, de la Hoz Caballer B, Maran Lizana F, Gonzlez Mendiola R, Prieto Montao P and Snchez Cano M.
Selective allergy to sheep's and goat's milk proteins. Allergologia et Immunopathologia, 2004, 32, 39-41.