Infant Formula For Pesach

HaModia, March 29, 2006

Once, not long ago, executives of a global health-nutritional manufacturing company met with representatives of a kosher certifying agency. One of the topics the certifying agency was keen on raising was the Jewish community’s need for Passover certified infant formulas. Outside of Israel few, if any, infant formulas are produced and certified specifically for Passover. Would the health nutrition company, already certified kosher for its infant formulas year-round by the agency, be interested in producing a Passover certified product? After discussing the measures that would need to be taken to certify the product for Pesach, the executives were not willing to commit to the project. The economic incentive for producing a special Passover infant formula did not, apparently, justify the disruption in standard production nor the limitations on ingredients suppliers the manufacturer would have to accommodate.

Thus this year, like every other year, infant formula certified for Passover is, for most people in chutz l’aretz, prohibitively difficult to get (even if a person can get Pesach certified formulas, it may not be advisable in every circumstance to switch to another formula). Nor should one make one’s own formula without specific medical consent and advice. And therefore parents around the world ask rabbanim about the Pesach acceptability of infant formulas: is there a dispensation to continue to feed infants formula despite the fact that they are not specifically certified for Pesach? Because infants who are fed formulas cannot, in many cases, eat anything other than formulas, rabbanim often find themselves obliged to find a basis to permit them. Since the minhag prohibiting kitneous is generally not considered applicable to infants, typically the question turns on whether the infant formulas can be considered chametz-free.

Their answer must be based, of course, on information about how formulas are made. Gathering that information is not easy, because infant formulas contain a dizzying number of ingredients. Formulas try to simulate the extraordinary spectrum of nutritional ingredients present in mother’s milk; the complexity of a formula is a reflection of (though not a perfect parallel to) mother’s milk’s rich nutritional content.

A typical ingredients label provides some meaningful facts regarding its Pesach status. The first thing to notice about a label is simply is that it breaks down for the consumer the percentages of different ingredients. The ingredients present in highest proportion are listed first, and the ones that are present in smaller proportions are listed second.

43.2% Corn syrup solids, 14.6% soy protein isolate, 11.5% high oleic safflower oil, 10.3% sugar (sucrose), 8.4% soy oil, 8.1% coconut oil; Less than 2% of: calcium phosphate, potassium citrate, potassium chloride, magnesium chloride, sodium chloride, ascorbic acid, choline chloride, L-methionine, taurine, ascorbyl palmitate, ferrous sulfate, m-inositol, mixed tocopherols, zinc sulfate, d-alpha-tocopheryl acetate, L-carnitine, niacinamide, calcium pantothenate, cupric sulfate, thiamine chloride hydrochloride, vitamin A palmitate, riboflavin, pyridoxine hydrochloride, folic acid, potassium iodide, phylloquinone, biotin, sodium selenate, beta-carotene, vitamin D3 and cyanocobalamin.
The label is structured this way because in the United States (this label was taken from a U.S.-distributed product) food labels are required to identify the ingredient present in greatest proportion to lowest proportion, in that order, until the ingredients are present at less than two percent. At that point, the ingredients must be identified, but are not required to be listed in any particular order.

The second point to notice about the label is that ingredients present at higher percentages, the first group, are readily identifiable as not being from chametz: this group consists of vegetable oils, corn syrup, and soy protein (in a dairy version milk or whey would replace soy). These ingredients are present in large quantities because babies need lots of fats (represented here in the form of vegetable oils), something called linoleic acid (also in vegetable oil) lots of carbohydrates (corn syrups), and protein (soy protein isolate, or milk in a dairy version) for all the energy they need to grow.

The remaining ingredients – those in the “Less than 2%” group, are vitamins, minerals and other ingredients that are crucial to the development of a baby’s health but need to be present only in miniscule amounts in order to be effective. There are no less than thirty-one ingredients in this particular formula and collectively they make up less than four percent of the entire formula. Each of them is present at far less than 2% (for a rough idea of how much of each ingredient is required to be in a formula according to U.S. guidelines, see CFR (Code of Federal Regulations) 21, 107, D “Infant Formula – Nutrient Requirements”).

This discussion is worthwhile because it is helps us determine whether or not the ingredients in this second group, the ones that are present in miniscule proportions, are even relevant to an evaluation of the Pesach-status of an infant formula. Chametz that is mixed into a food before Pesach is subject to standard rules of bittel, and is nullified in one sixtieth, or 1.6% of the volume of the food. (Shulchan Aruch, OC 447: 2). Only when Pesach enters on seder night is chametz considered an aissur ma’shu. Since these ingredients are present at below bittel proportions and because people buy infant formulas that have been prepared before Pesach, these ingredients are considered halachically insignificant.

However, there is a less well known, but distinct, mesoras ha’psak, based on a teshuvas haRashba that holds that the standard rules of bittel do not apply to cases in which an ingredient was added deliberately to a food (see Responsa Harashba, III, 214, cited at the end of Beis Yosef Y.D. 134. ; see also Mishnah Breruah 447,14 in the name of Rabbenu Yerucham. Nodah B’yehuda, Y.D. II:56, cited in Pischei Teshuva,134:8 specifically rejects the position of the Rashba). Even within this mesorah there are various opinions about which circumstances this ruling applies (for example; Chelkas Binyamin, biurim,Y.D. 114,4 s.v. ad sh’aino buttel b’shishim ). The Magen Avraham rules that the position of the Rashba applies to hilchos Pesach and, if an essential ingredient would be deliberately added to a formula and it would be less than one sixtieth, it would not be considered bittel. However, this din, he writes, is only m’drabbanan (O.C. 447 1, see Mechtzis HaShekel at this location and on Magen Avraham 447,45). According to this line of reasoning, one could argue that the presence of a vitamin or mineral, were it to be from chametz, would, perhaps, not be considered bittel, since its presence is not accidental but essential (however, see Mechtzis Hashekel O.C. 447, 45 s.v. u’lifi mah shakasuv ). Therefore, this position would consider it important to investigate whether or not any of the vitamins or other ingredients may be derived from chametz to clarify whether a product would be rabbinically prohibited.

To satisfy the interest of this position, one is obligated to clarify how each of the ingredients is made and determine whether there may be any chametz used in the process. Such a project is not as straightforward as it may seem.

If infant formulas were made from rudimentary raw materials all in one factory, it would be relatively easy to know what ingredients are being used as they relate to Pesach. But that is not the case. Even the hashgacha agency that certifies the product year-round faces concrete challenges when trying to determine whether any of the ingredients used in the year-round formula may contain chametz. Tracing the entire web of production, from scratch to final blend, is virtually undoable.

The hashgacha agency must, of course, be in command of the ingredients sources of every component in a formula. Every supplier has to be evaluated and approved by the agency, and mashgichim visit the infant formula blending sites to confirm that only approved ingredients are being used. But the considerations involved in year-round certification are distinct from the considerations used for Pesach. The potential presence of a grain ingredient in one step in the chain of production of one of the ingredients does not send up a red flag to a hashgacha agency – why should it? It’s hetter. Undertaking that kind of review after such a complex product has already been certified is not so simple.

An infant formula company purchases the dozens of ingredients it needs from different places, and blends them together at the blending site. Corn syrup is purchased from a corn syrup vendor, vegetable oil from a vegetable oil vendor, and so on. Many of these ingredients are not made entirely by the supplier, who may be a broker, or who may be a manufacturer that is simply finishing off the product.

Furthermore, these ingredients are purchased from multiple suppliers. Just as a cookie company may be buying chocolate chips from one of three different suppliers, an infants formula company may be buying its ascorbyl palmitate from one of three suppliers. The health nutritional company may operate five blending sites, each of which may be using a supplier different from its sister plant.

An illustration of the hurdles involved in clarifying the status of each of the ingredients is Vitamin C, or ascorbic acid, which is the most sensitive, from a Pesach perspective, of the ingredients in an infant formula. Vitamin C is required by law to be present in infant formulas, and thus is present in every formula on the market (this ingredient is also present in many geriatric health nutritional products and other vitamin-boosting products, so this discussion is pertinent, in this regard, to these products as well).

Briefly, to produce Vitamin C: starch is converted to glucose (step one at, let’s say, Company One), which in turn is converted to sorbitol (step two, Company Two), which in turn becomes Vitamin C (step three, Company Three).

Now starch, which is the raw material for glucose, can be made from various raw materials. Different parts of the world, depending on what crop is most bountiful, have different sources of starch. In Indonesia, tapioca is a staple starch. Glucose from that part of the world would most likely be tapioca based. In the United States, starch is generally from corn. In Japan or China starches may be from corn, wheat, tapioca, or some other source. And in Europe, about fifty percent of the starch is from wheat (chametz) and the rest is from corn or other starches.

Now, the hashgacha agency that certifies Company Three (the Vitamin C company) year round approves sorbitol from Company Two. The glucose, which is the raw material used to make sorbitol, comes from Company One. Now, the certifying agency for Company Two (the sorbitol manufacturer) may be – and probably is — approving glucose from Company One regardless of what kind of starch is used to make the glucose – whether it is from chametz, tapioca, corn, or another starch.

Theoretically, if there were only one Vitamin C company, and it was purchasing its sorbitol from only one sorbitol company, and the sorbitol company was purchasing its glucose from only one glucose company, it may be worthwhile for the hashgacha agency doing the Pesach review to try to determine the nature of the starch that is being produced at Company One. But in fact the Vitamin C company is approved to purchase sorbitol from multiple sources. And the sorbitol company (Company Two) is approved to purchase its glucose from multiple sources. And the glucose company (Company One) is likely purchasing starch from multiple sources.

And, finally, the infant formula company is purchasing Vitamin C from multiple producers of Vitamin C. So each one of them would have to be investigated with an eye to this question.

Each year this effort is expended. But each year it becomes evident, even to someone trying to make a conscientious and thorough effort, that determining, for certain, what the Vitamin C (or other similar ingredient) in a given sample of infant formula came from is essentially unfeasible.

Halacha provides guidelines to make presumptions when not all of the facts are obtainable. In the case of Vitamin C production, for example, when starch is used to make glucose and it is not feasible to have perfect knowledge about which starch is used and, in cases in which the glucose is being sourced from diverse global locations, we can rely on the fact that the majority of starch in global glucose production comes from non-chametz sources. Even, however, if there were not a majority, there is a distinct safek about whether Vitamin C, in any given part of the world, is made from chametz or not. And since this entire stringency is only d’rabbanan one can, it appears, be lenient. Additional reasons why the position of the Rashba may not be applicable to infant formula are beyond the scope of this article.

Infant formulas are complex blends of many ingredients. As long as Pesach certified is not easily available on the market, consumers must continue to seek guidance from their rabbanim as to its acceptability.

OU Kosher Staff