Changes are vague, unclear and risk countless products from SMEs across Europe being caught in unnecessary regulation
24 Sept 2015, Brussels –In October, the European Union Parliament is expected to vote on legislation that repeals Regulation No 258/97 and replaces it with ‘Regulation on Novel Foods 2013/045(COD)’, which will fundamentally change how nanomaterials in food are regulated. The Nanotechnology Industries Association has issued the following statement (PDF version here) on the upcoming vote:
After reviewing the draft European legislation updating the ‘Regulation on Novel Foods 2013/045(COD)’, it has become clear to the Nanotechnology Industries Association and within the nanotech supply chain that the proposed changes are unworkable. It is vague, unclear and contradicts firmly established nanomaterial regulations that have been effectively used by European institutions for years. Implementing it will create new, unnecessary challenges for SMEs, the drivers of economic growth, aiming to use nanotechnology to improve the daily lives of Europeans.
To include materials that are “composed of discrete functional parts….which have one or more dimensions of the order of 100 nm or less” fundamentally changes the accepted definition of engineered nanomaterials and risks countless products being caught in disproportional regulation. The term “discrete functional parts” adds further complexity as it has little scientific basis, opening it up to a wide range of interpretation when put into practice. This will drive innovators to avoid any products that could possibly be caught in this broad, unclear definition and, ultimately, consumers will miss out on the benefits.
Innovators that can overcome this uncertainty and continue to utilize cutting-edge nanomaterials, will then face a new requirement that their safety tests be ‘the most up-to-date’ – a vague term with no formal definition. This leaves companies subject to unpredictable changes in testing requirements with little notice, a burden no other industry faces.
Finally, if implemented, the text would require the European commission to change the definition of ‘engineered nanomaterial’ in the Food Information to Consumers Regulation. However, regulations cannot be updated overnight, which means companies will be faced with two parallel and competing definitions for an indeterminate period of time.
The Council claims that this regulation will ‘reduce administrative burdens,’ however, we believe it will achieve the opposite. Industry and innovators need regulation that is clear and grounded in science. It ensures they know when they are subject to nanomaterial regulations and are prepared to meet all the requirements. This approach provides them with predictability in regulations and assures the public that the nanomaterials used are safe. A conclusion all parties can welcome.
NIA urges Members of the European Parliament not to create uncertainty in a sector that is a leader in European innovation, and to engage in direct discussions with the European Commission, which is already working on a review of the European Commission Recommendation for a Definition of a Nanomaterial with the Joint Research Centre.
For further inquires, please contact:
Nanotechnology Industries Association
Phone: +32 28 50 61 97
Email: Alex.Rinkus at nanotechia.org
About the Nanotechnology Industries Association:
The Nanotechnology Industries Association (NIA) is the sector-independent, responsible voice for the industrial nanotechnologies supply chains. NIA supports the ongoing innovation and commercialisation of the next generation of technologies and promotes their safe and reliable advancement. Globally the only industry-focused trade association in nanotechnology, NIA provides a uniquely consolidated perspective derived from a multi-disciplinary membership which operates across a wide range of markets and industrial sectors.
NIA Membership is made up of many varied companies, all of which at different stages of their commercial existence and with a variety of interests in the large range of technologies that derive their benefit from the nanoscale.