In Europe the pharmaceutical field imposes no special restrictions on the inclusion of polyols in medicines for newborn babies, and this for the quite simple and valid reason that all aspects of the medicine will be assessed via the AMM file.
The only known regulatory constraints are those of the European guidelines relating to excipients with well-known effects (EU guideline, July 2003).
When polyols are used in a medicine, the guidelines require certain information to be included in the instruction leaflet.
This dose is of course 10 g per day for an adult (Average body weight =70 kg) in good health. Special care must to be taken should polyols be administered to infants and children under 3.
There are already products containing polyols on the market for small children and infants, notably syrups and solutions.
Overall a prudent approach is appropriate, but as indicated in one communication, “Children, more than younger or older adults, are likely to consume larger amounts of freely available polyols; there is, however, no evidence that children are less able to tolerate polyols than are adults in terms of the weight of polyols per meal or day” (Spengler et al., 1987; Paige et al., 1992; A Lee, Salford University, personal communication)
In Europe in the food field our polyols (Mannitol, Maltitol, Sorbitol and Xylitol) are additives. They are therefore subject to the regulations laid down in Directive 95/2/EC and in its amended versions which concern the conditions under which food additives can be used.
Annex IV of this directive applies more especially to the food additives for baby food (0 - 12 months) and food for young children (12 months - 36 months). In this annex it is stated that:
""preparations and cereal-based preparations and food for infants and young children may contain the substance E 421 (mannitol) when it is used as a support for vitamin B12 (not less than 1 part of B12 for 1000 parts of mannitol).""
In other words, with the exception of mannitol as a support for vitamin B12, it is not possible to use our polyols in baby food.
Again in the food field, the preparations for infants and follow-on preparations (children aged between 1 and 3 years) aremore especiallyregulated by Directive 2006/141/CE.
Annex I of this directive gives the ESSENTIAL COMPOSITION OF INFANT FORMULAE.
In these preparations only a few carbohydrates can be used. These are:
Lactose / Maltose / Sucrose / Glucose / Maltodextrins / Glucose syrup or dried glucose syrup / Pre-cooked starch / Gelatinised starch.
Annex II of this directive gives the ESSENTIAL COMPOSITION OF FOLLOW-ON FORMULAE.
In these preparations:
- Carbohydrates containing gluten are prohibited.
- Minimum or maximum contents are laid down for certain carbohydrates (lactose, sucrose, glucose)
- A minimum and maximum content of g/kcal is also laid down.
With the exception of polyols, carbohydrates in compliance with the above conditions can be used in these Follow-on Formulae.
