AMERICAN REGULATION: TSCA & HazCom 2012
The Toxic Substance Control Act (TSCA) is the chemical control law in the United States of America and which gives the Environmental Protection Agency (EPA) the authority to take regulatory action for new and existing chemicals.
This “industrial chemicals” law does not apply to certain products such as tobacco, nuclear materials, ammunition, food, food additives, drugs, cosmetics and substances used exclusively as pesticides.
The Toxic Substances Control Act (TSCA) requires the EPA to compile, maintain and publish a list, called the “TSCA Inventory”, of every chemical produced or processed, including imports, in the United States.
For the purposes of regulation under the TSCA, if a chemical is on the Inventory, the substance is considered an “existing” chemical, if it is not on the inventory it is considered a “new chemical”.
In addition to defining whether a specific substance is “new” or “existing”, the inventory also contains information for existing chemicals that are subject to production or use restrictions.
Anyone intending to manufacture (and export) a new chemical for commercial purposes in the United States must determine if a chemical is listed on the inventory. If not, you will need to provide the EPA with a Manufacturing Notice (PMN) at least 90 days prior to starting the business.
Possible findings from the EPA’s PMN review include:
- Release or approval: no further regulatory action;
- Withdrawal;
- Request additional data;
- Approval with some kind of restrictions (consent orders);
- Approved with Significant Usage Regulations (SNUR) which establish certain types of restrictions. The restrictions apply both to the shipper and to other producers and exporters of the same substance.
The exporter to the US will then have to certify that the chemicals comply with the TSCA (a “positive certification”) or that the chemicals are not subject to the TSCA (a “negative certification”).
What we offer
TECHNICAL SUPPORT AND REGULATORY CONSULTING
We identify which products you market fall within the scope of the TSCA and help you interpret and comply with the obligations. We evaluate the compliance status of the products and what procedures to take to place products on the American market.
CHECK FOR THE PURPOSE OF TSCA CERTIFICATION FOR EXPORT
Control of the components of a mixture in order to verify if the component substances are listed in the TSCA inventory and comply with any restrictions imposed.
PREPARATION AND SENDING OF PMN
Compilation and submission of PMN. Our service includes consulting on your behalf with the EPA prior to submitting the PMN and while reviewing the notice.
IDENTIFICATION OF SUBSTANCES EXCLUDED FROM NOTIFICATION
We determine if the substance is exempt from the PMN notification, advising you if it falls into one of the following categories: materials excluded from the law, research and development substances (marketing trial exemption (TME), low volume exemption (LVE), polymer exemption and / or low release and exposure exemption (LoREX).
DRAFTING OF SAFETY DATA SHEETS AND LABELS
We draw up SDSs and labels for your products in language and in compliance with the requirements of HazCom 2012 (American GHS).
TRAINING
Our courses cover the main obligations deriving from the TSCA. Trained individuals will have the means to recognize the elements necessary to undertake procedures for exporting chemicals to the United States.