How do the nanomaterials produced by Evonik have to be labeled and registered?

Worldwide there are many definitions of what constitutes a nanomaterial. Consequently, the provisions whether a product is a nanomaterial differ depending on the country and areas of application.  Many definitions relate only to the particle size, while with others, various properties are decisive as regards labeling or registration obligations. For example, in France and Belgium, silica must be registered in the respective national register before being sold as a nanomaterial. In Europe, products containing nanomaterials must be labeled for use in cosmetics and food to inform consumers. But this does not apply to silica from Evonik and it does not have to be labeled as a nanomaterial in food or cosmetics.

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Currently, in the EU there are different nanomaterial definitions for different law sectors. In the European Cosmetics Regulation (EC) 1223/2009 a nanomaterial is defined as “an insoluble or biopersistent and intentionally manufactured material with one or more dimensions, or an internal structure, on the scale from 1 to 100 nanometers.” The properties “insoluble” and “biopersistent” do not apply to synthetic amorphous silica (SAS), which is why silica products are not nanomaterials in terms of the cosmetics regulation and, therefore, do not have to be registered or labeled as such.
 
The relevant definition for “engineered nanomaterials” for food can be found in the Regulation on Novel Foods (EU) 2015/2283, which comes into force on January 1, 2018. The silica used in food as additive E 551 and approved in Regulation (EC) 1333/2008 has been produced and used for many decades with the same production processes and with the same product specifications. E 551 is not produced to show novel nano properties in food. Rather, silica acts as a spacer between the particles of the powdered food and is therefore approved as an anti-caking agent in Regulation (EC) 1333/2008. Unbound silica primary particles would be too small to act as an anti-caking agent. It is aggregates that fulfill this function. Aggregates normally have dimensions in the micrometer range. No individual primary particles of E 551 have been found in commercially available silica products. Therefore, according to the Food Information to Consumers Regulation (EU) 1169/2011, E 551 does not have to be labeled with the affix “(nano)”.


As opposed to the described definitions of nanomaterials, the Commission Recommendation for the definition of nanomaterials (2011/696/EU) contains the parameters aggregates/agglomerates, number size distribution, and specific surface area per volume. In particular, the volume-specific surface area of silica is greater than 60 m2/cm3. Therefore, silica is defined as a nanomaterial according to the Commission Recommendation.


The definition of nanomaterials in French Decree N° 2012-232 is similar to that in the Commission Recommendation. According to the French Decree, silica is to be considered a nanomaterial.