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DoH Interested Parties Letter, 28 February 2014
You will wish to be aware that the Infant Formula and Follow-on Formula (England) (Amendment) Regulations 2014 (SI No. 3243) has been published and enters into force today, as will separate, parallel, regulations in Scotland, Wales and Northern Ireland.
A copy of the Regulations is available from the Her Majesty’s Stationery Office (HMSO) website at: www.legislation.gov.uk. [See: http://www.legislation.gov.uk/uksi/2013/3243/made/data.pdf]
The amendment makes two technical changes to the compositional criteria following positive assessment by the European Food Safety Authority (EFSA). These are:
Placing products on the market
Any business wishing to place new products on the market conforming to the new criteria, is kindly reminded that products must comply with all the requirements of the Infant Formula and Infant Formula Regulations (England) 2007, and in the case of infant formula, must notify the Department with a copy of the label. Further information and copies of the notification forms are available on the Department’s website.
Goats’ milk based formula and food allergy
Since this amendment will for the first time allow for the use of goats’ milk based formulas on the UK market, it was necessary for the Government to review existing advice on the suitability of such products for infants diagnosed with an allergy to cows’ milk protein. Clinical studies have shown a high risk of cross-reactivity between the proteins in cows’ milk and in other mammalian milk, including goats’ milk [See Notes 1 and 2 below] and cases have been reported of cows’ milk allergic infants developing anaphylaxis after the ingestion of goats’ milk [See Note 3 below].
There is high homology between the amino acid composition of the six major proteins of cows’ and goats’ milk [?See Note 4 below]. As a result there is a high risk of cross reactivity between cows’ and goats’ milk proteins which could lead to life-threatening reactions in cows’ milk allergic infants if goats’ milk is consumed.
There are 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 on a case by case basis.
Given the high risk of cross reactivity between cows’ and goats’ milk proteins, the Government advises the following:
Should you require any further information or clarification on these issues please e-mail the Department at firstname.lastname@example.org
1 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.
2 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.
3 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.
4 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 formulae and in follow-on formulae. The EFSA Journal 10 (3):2603.