Suntheanine meets the stringent ecological and human health assessments.
Generic theanine not in compliance is limited to 100 kilos per year.
Taiyo International and its Canadian partner Mitsubishi International Food Canada want to raise awareness of long-standing Environment and Climate Change Canada regulations under the New Substances Program, to help food and dietary supplement industry companies avoid costly repercussions.
“Taiyo has strong and enduring commitments to regulatory compliance and our environment,” states Taiyo International Vice President Scott Smith. “We want to help clear up confusion that the New Substances Program only applies to chemicals, when in fact it also applies to a wide range of substances and finished products ranging from cosmetics and natural health products to food additives and novel foods.”
He adds, “We are happy to confirm that Suntheanine is covered under Schedule 5 with Environment and Climate Change Canada (ECCC). This enables Mitsubishi to import and sell up to 10,000 kilos per year of Suntheanine; whereas all other unregistered theanine is limited to 100 kg/per importer per year.”
The New Substances Program limits importation of unregistered substances
The New Substances Program, part of the Canadian Environmental Protection Act, 1999, is a complex series of regulations to ensure that no new substances are introduced into the Canadian marketplace until they have undergone ecological and human health risk assessments, and any appropriate control measures have been taken.
The program is jointly administered by the ECCC and Health Canada. The regulations cover any raw materials and substances in finished goods that would have an impact on the environment and/or human health.
“Companies often don’t know that their industry is subject to these regulations and that they can’t exceed the limits identified in the Regulations,” comments Dan Bastien, associate director of Intertek Health Sciences, Inc. Bastien, who was formerly with the ECCC, helped administer the original regulations. He now assists companies with achieving regulatory compliance.
Bastien cautions: “If you are making a substance available on the Canadian marketplace, you need to be certain that you are in compliance. The ECCC’s mission is to protect the environment and human health by ensuring everyone is compliant. If not, and you exceed the 100 kg limitation, you could face significant fines and other ramifications.”
Substances on Canada’s Domestic Substances List (DSL) are not subject to these regulations. However substances, including food and supplement ingredients that are not on the DSL, would be subject to the New Substances Program and are limited to 100 kg per year.
“Compliance with the New Substances Notification Regulations can be time-consuming and expensive. The solution is to source from someone whose ingredients are already compliant,” observes Smith. “Taiyo has done the work for you and, through Mitsubishi, can provide you with the confidence that with Suntheanine you are compliant with the current Environment and Climate Change Canada regulations.”
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