We get a lot of questions about why we do not have Sophie for sale in our stores. Though we believed Sophie to be an excellent toy, we pulled the toy from our shelves in 2012 while waiting for some answers from the manufacturer about the Sophies we currently had in stock at the time. This is why…
As documented in the NY Times, Sophie the Giraffe is one of the most popular children’s toys in the world and commonly regarded as one of the safest. In 2012, there were a couple of blogs claiming that Sophie did not meet some European standards for toxicity. The company denied this. Here is what I found with some digging.
The European law for soothers (known here as pacifiers or teethers) states:
“It concerns the release of N-nitrosamines and of substances capable of being converted into N-nitrosamines, hereinafter called ‘N-nitrosatable substances`, from teats and soothers, made of elastomer or rubber.”
“The teats and soothers referred to in Article 1 must not pass on to release-test liquid (saliva test solution) under the conditions specified in Annex I any N-nitrosamine and N-nitrosatable substance detectable by a validated method which complies with the criteria laid down in Annex II and which can detect the following quantities:
– 0,01 mg in total of N-nitrosamines released/kg (of the parts of teat or soother made of elastomer or rubber),
– 0,1 mg in total of N-nitrosatable substances/kg (of the parts of teat or soother made of elastomer or rubber).”
To clarify, Nitrosamines, a known carcinogen, cannot be present in greater than 0.01mg/kg and Nitrosatables, which can convert to Nitrosamine inside the stomach, cannot be present in greater than 0.1 mg/kg. A few blogs seemed to be raising the question of Nitrosamine in Sophie, alarming consumers. The manufacturer assured us that this was not a concern. When I inquired, I got the following response.
The U.S. distributor of Sophie, a company called Calisson, sent me lab testing data dated January 2011. This test shows that Sophie tests below the maximum levels of Nitrosamine, proving it safe in this regard. The levels are basically undetectable, under 0.01 mg/kg. The Nitrosamine levels are not in question here. This test however showed a level of Nitrosatables at 0.5 mg/kg, above today’s EU legal limit for a soother.
When I expressed my concern, the French manufacturer, Vulli, sent me new testing data from April of 2012 that shows a level of Nitosatables at 0.05 mg/kg. This would satisfy the EU requirement. The Vulli representative informed me that the formulation had changed. I do not believe that consumers are aware of this. I have asked when exactly the formulation has changed. I am still awaiting a response. I wanted to know if the Sophies we had in our stores would pass the law today and I am sure our customers would want to know if the Sophies they have at home are safe. In the meantime, we pulled Sophie from the shelves at all of our stores. We look forward to being able to offer the reformulated Sophie to our customers once this issue has been resolved.
UPDATE (August 2015):
The above article was written in 2012. We never were able to receive a response from the manufacturer about whether or not the bar codes on the boxes we had in stock represented inventory from the new or old formulation. Customers often ask us, “Don’t you think by now that all of their products are made in the new formulation?” I think that it would be logical to assume that, but we have no way to really know, as we have no idea how much of the old inventory the company would have had to sell through in the U.S. before changing over to the new formula. We stand behind all the products we sell & our criteria is reliant on complete & up-to-date test results on products. Without these facts, we can’t give a product our approval. Given this, we cannot continue selling products made by Vulli.
We are thrilled to now have a great alternative to Sophie. Mia the Lamb meets all criteria to be “Sprout Approved”!