Who can honestly say that they haven’t, now and then, bitten into a tasty apple or pear only to discover they’ve accidentally munched on a fruit label. You and I will probably (if not distracted) remove and discard said offending item. But young children and compromised adults might ingest a label on occasion.

Multi-component items

How do we know that swallowing the odd label is not a significant health risk? It’s a multi-component item, perhaps containing paper/plastic as well as complex printing inks and adhesives; perhaps also a coating. Adhesives and coatings are often made from highly-reactive chemicals, and ink components often possess novel chemical structures and poorly-studied toxicity profiles. Any plastic components might contain residues of starting monomers, reaction catalysts and other additives. We are talking complex chemical formulations here.

But not to worry, the label supplier will have evaluated the health risk of ingesting such labels, right? Well, not necessarily. A responsible label supplier will do their best to assess “safety” but faces a significant challenge. Commonly, their direct upstream suppliers will be unwilling to fully disclose the chemical composition of their materials. Indeed, they might not even know them, if these components have been generated from subcomponents obtained from further upstream suppliers. Chemical materials are often identified only as trade names; the buyer knows they perform a desired technical function, but not what is in them. SDSs generally tell you very little about composition, if they are obliged only to identify chemicals classified as “dangerous” (which anyway has very specific meanings in law and is far from the full story as far as chemical health risk is concerned). The full composition of most products distributed in industry is considered confidential, a feature accepted as having significant commercial value.

How can bibra help?

Since 1961, bibra has been providing a solution to this dilemma. We obtain full chemical disclosure under an NDA from each supplier, all the way back up the chains, until we have a full understanding of the chemical profile of the final product. A health risk conclusion can then be drawn from the toxicological literature (and other hazard assessment tools as necessary) and an exposure estimate. The client then receives a Formal Opinion from bibra, stating simply that the expert toxicologists have reviewed the relevant data on the disclosed chemicals and concluded that the described exposure would not (all being well) pose any significant health risks to consumers. No chemicals are identified in this Opinion. Comprehensive details of the health risk assessment are retained in bibra’s secure files, in case of a future regulatory submission or audit.

The upstream suppliers are happy because their chemical composition data are kept confidential and the Opinion means they have a strengthened bond with a satisfied customer. The ultimate label supplier is happy because they have a bibra Opinion that reassures them over safety and can be added as a valuable item to their own marketing offering. The consumer is happy that the industry is ensuring they are not at significant risk.

Everyone is happy. Especially our short-sighted fruit eaters.

[This example focuses on fruit labels but the same principles and process can apply to any multi-component product. Contact bibra for further information.]

Contact us