misc offerings

From localized classification & labeling to trade, business development...

product stewardship

The responsible management of a product throughout its lifecycle is at the forefront ...

global test plan, notification &

risk assessment

Regulatory audits

Regulatory audits play a crucial role in promoting and ensuring responsible chemical management...

Being at the forefront of many of the chemical control regulations enables the M8 team to provide in-depth knowledge of existing and developing regulatory requirements and strategies to obtain a successful registration regardless of the country.

When a local agent may be required, we offer these services via our strategic partnerships of which we have a long-standing relationship and have been fully vetted. Our local partnerships allow us to offer our clients real-time access to the ever-evolving regulatory requirements or in-country trends that is necessary to navigate a successful registration, particularly for priority chemicals, i.e.

• Substance of very high concern (SVHC) 
  
• Persistent bio-accumulative toxic (PBT)
  
• And/or Endocrine disruptors
  

New and Existing substances areas of expertise include:

• United States’ Toxic Substance Control Act (TSCA); 
• Australia’s Industrial Chemicals Introduction Scheme (AICIS); 
• Canada’s Environmental Protection Act (CEPA);
• China’s Environmental Management of New Chemical Substances Decree No. 12 (formerly Decree No. 7) and Regulations on Safe Management of Chemicals (Decree No. 591); 
• European Union's (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH);
• Japan’s Chemical Substance Control Law (CSCL) and Industrial Safety and Health Law (ISHL);
• Korea’s The Act on Registration and Evaluation of Chemicals, etc. (K-REACH) and Ministry of Employment and Labor requirements (MoEL);
• Thailand inventory nominations under List 5.6 notifications;
• Vietnam inventory nominations;
• Taiwan’s Toxic Chemical Substance Control Act (TCSCA);
• Turkey’s Inventory of the Control of Chemicals (CICR) and REACH (KKDIK); and 
• Additional countries and regulatory programs available upon request. 

In each of the above areas, when data are required to be gathered, M8 evaluates various approaches to fulfill those data gaps depending upon the substance type in lieu of testing. When testing is required, M8 assists our clients in contract research organization (CRO) selection, test plan design and implementation, and technical study monitor.