TSCA Regulations

TSCA and EINECS Regulations

Norquay’s core business is the development of new products and commercialization to meet customer expectations. A number of products we offer at research, development and commercialization scale may not be on the EPA TSCA Registry or the European Union’s EINECS Registration system. To address these government regulations Norquay manufactures a number of products under EPA TSCA exemptions.

1.Research and Development Applications

(Click on Part 721.47, Conditions for research and development exemption.)

2.Pharmaceutical Applications

Pharmaceutical Applications are regulated by the FDA, and are therefore exempt from EPA TSCA regulations.

For products that are sold under the TSCA exemptions, Norquay will label the product and documentation to meet the customer’s notification standards per the TSCA regulations. For product sales on the non-TSCA listed materials above research and development volumes, Norquay will request a TSCA statement from the customer prior to accepting any commercial order for domestic or export sales. For non-pharmaceutical applications, Norquay will work with the customer to file the appropriate TSCA documentation for Low Volume Exemptions (LVE) [under 10,000kg/year] or Pre-Manufacturing Notice (PMN) [above 10,000kg/year]. Norquay can also support the customer EINEC Registration process.

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