Nanotechnology Registration: What to do in Asian-Pacific Countries (APAC)
The Asian-Pacific countries (APAC) are among the emerging markets in which companies have taken interest. A number of those countries have existing chemical regulations and chemical inventory lists, but they’re also routinely amended with new regulations. One question for product stewards is how nanotechnology fits into these markets. Are they covered by existing regulations, or will they be incorporated into new regulations?
Kerrie Canavan, environmental consultant at Environmental Resources Management, spoke about trends in nanotechnology registration in APAC during a presentation at Product Stewardship 2017. She broke down the challenges of registering nanotechnology into four categories: Legislative differences, language barriers, composition disclosure, and communication with authorities.
To illustrate how these challenges come into play, Canavan presented the following real-life scenario: A manufacturer comes up with a nanomaterial used to coat electronics. Say they want to register the material globally, even in countries where they haven’t identified users or a market. Their solution was a phased approach, meaning they started with countries that had more developed regulations and worked outward from there.
The U.S. and EU have more developed regulations, so they provided a baseline. One difference is that in the U.S., nanomaterials are treated like their larger counterparts, so read-across data is okay to use, while the EU uses a stricter definition. “The approach in the EU, because the nanomaterial is considered its own entity, you can only use read-across data when it’s appropriate,” said Canavan.
In Japan, the chemical control law that provides the basis for regulating nano substances includes small-volume exemptions and low-volume exemptions. So ERM hired a Japanese speaker and a regulatory specialist to determine whether the chemical already existed. They found that it was, so the requirements for notification were reduced.
In China, regulations deal with nanomaterials at the substance and product levels. Depending on where your product is in the supply chain, various orders from the State Administration of Work Safety may apply. Canavan pointed out that China has a complex system of chemical management because so many ministries have a hand in regulation. In this case, the manufacturer had a choice to register as a solution (high-volumes but less likely to require inhalation data) or ship as powder (less volume but greater likelihood they would have to provide inhalation data).
In Taiwan, you have to be a local importer or manufacturer to perform registration activities. If the chemical is on their inventory, however, it’s considered existing. Canavan noted that nanomaterials in Taiwan are not identified as separate until someone in the supply chain designates them that way, and then regulations kick in, especially related to food packaging, cosmetics and worker exposure.
In South Korea, there are many types of registrations, depending on the use and tonnage of the chemicals. “Korea was by far the most difficult country we had to deal with,” said Canavan. The manufacturer wanted to register in the category R&D for a year and then move into commercial import. To register as a R&D, you have to describe the project. On the other hand, to take a low-volume commercial registration requires you to map your entire supply chain and explain the uses of the product.
Canavan said the experience reinforced the importance of keeping up with regulations and predicting how they might evolve. There are no universal definitions of nanotechnology, so knowing your substances at the granular level is key, along with studying the differences in jurisdictions. To do this well, use local experts and staff to assist with compliance activities.