Worldwide Notification of New Chemical Substances
Harlan Laboratories has had experience in preparing and submitting notifications for ‘new’ chemical substances worldwide since 1991. Via Harlan personnel based in the EU, Japan and Korea, plus a network of local agents worldwide, Harlan Laboratories is able to test and notify new chemical substances in Australia, Canada, China, Japan, Korea, New Zealand, Philippines, USA, Taiwan and Turkey.
The EU, USA, Australia and Canada have developed sophisticated regulatory control schemes that require the industry to demonstrate the safe use of the chemical being manufactured or imported as part of a risk assessment, with any risks or hazards being communicated to users of the chemical. A minimum data set on which to base the risk assessment is required, often with provisions for additional data to be requested in order to refine the risks.
Other countries focus the evaluation of potential hazards on environmental effects (Japan) and/or potential effects on the workforce (Japan/ Korea), whilst protection of indigenous species requires some studies to be conducted on species native to individual countries (Japan and China).
In acknowledgement of the global regulation of chemicals, Australia, Canada and Korea recognize that chemicals may have undergone rigorous hazard assessment and are willing to accept toxicity evaluations from foreign regulatory bodies through programs of mutual agreement.
Southeast Asia (Taiwan, Malaysia) is developing regulations, basing its requirements on one or several other foreign regulatory schemes.
With a thorough knowledge of the country-specific requirements and cultural sensitivities, Harlan Laboratories is able to develop a testing program that maximizes full use of study data in order to optimize time to successful notification and minimize studies required.