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Sophie the Giraffe – Just the Facts

Suzanne Price

There have been a lot of questions lately about why we do not have Sophie for sale in our stores at the moment. Though we believe Sophie is an excellent toy, we are still waiting for some answers from the manufacturer about the Sophies we currently have in stock and the ones you may have at home. I want to let you know what I know. So here it is, just the facts…

As documented recently 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. Recently, there have been a couple of blogs claiming that Sophie does not meet some European standards for toxicity. The company denies this. Here is what I found with some digging.

This is the European law for soothers (known here as pacifiers/teethers). It states:

Article 1
"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.
"

Article 2
"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 seem to be raising the question of Nitrosamine in Sophie, alarming consumers. The manufacturer has assured us that this is 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 would like to know if the Sophies we have 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 have pulled Sophie from the shelves at all 3 of our stores. We look forward to being able to offer the reformulated Sophie to our customers once this issue has been resolved.

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