Chemical Registrations & Notifications Overview
Experien Health Sciences can help you navigate this maze of regulations in ways that will maximize the benefits to your business, or we can simply work alongside your internal experts as another trusted resource to help you meet your business goals with Chemical Registrations & Notifications. Click on the region/country below to find out more:
U.S. TSCA Section 5 Notices (PMNs, SNUNs, LVEs, & LoREX)
Experien Health Sciences staff have more than 50 years of combined experience preparing and filing TSCA Pre-Manufacture Notices (PMNs), Significant New Use Notices (SNUNs), Low Volume Exemptions (LVEs), and Low Environmental Release and Human Exposure (LoREX) exemptions for Class I and Class II chemical substances and for polymers that don’t qualify under EPA’s polymer exemption. Under TSCA, the U.S. EPA regulates all chemicals in commerce, regardless of volume and with few exceptions, and importers are held to the same standards as domestic manufacturers. But much has changed since congress passed The Frank R. Lautenberg Chemical Safety for the 21st Century Act. No longer can the R&D chemist just fill-in the PMN form, submit it to EPA, and hope for the best. Now, EPA is required to make an affirmative finding on every PMN that the new chemical either is “not likely to present an unreasonable risk” or “presents and unreasonable risk” or “may present an unreasonable risk” and, although EPA has specific deadlines for reaching their conclusion, they effectively have unlimited ability to extend those deadlines to complete a thorough review of your case. It’s just too risky and potentially costly to your business to leave anything to chance. You need a partner who understands exactly how EPA will evaluate your new substance and a partner who can devise a submission strategy that helps to ensure your PMN will pass through with the least amount of resistance possible. While submissions with no data are still possible and are still sometimes successful, that decision can only be made by trying to anticipate and address EPA’s concerns before the notice is filed. Failure to do so can result in costly delays and overly burdensome Consent Orders and/or Significant New Use Rules (SNUR).
Trust our team to help with the following:
- Name your Class I or Class II chemical substance or polymer using EPA’s preferred method of submitting it for review by Chemical Abstract Services (CAS) Inventory Expert Services (IES) and obtain a CAS No. if so desired.
- Determine the status of your chemical substance or polymer as either a new or existing substance.
- File a Bona fide Intent to Manufacture to EPA to determine if your substance is on the confidential portion of the TSCA Inventory.
- Determine if EPA’s polymer exemption rules or Significant New Use Rules (SNUR) apply., and determine if your business would benefit by filing a PMN, SNUN, LVE, or LoREx is required before you can begin to manufacture or import the substance.
- Evaluate your substance and its uses to determine what test data, if any, will yield the best value for a successful submission. This often involves the use of the same QSAR and exposure modeling software that EPA uses and will help to anticipate what EPA’s concerns will be when they perform their evaluation.
- Assist with securing the necessary physical-chemical, toxicological, eco-toxicological, and environmental fate data to support your notice, whether through testing using qualified laboratories or by identifying analog or read-across data to include in your submission.
- Prepare and file the notice using EPA’s CDX system and ensure your Confidential Business Information (CBI) is protected under EPA’s complex CBI rules.
- File the required Notice of Commencement to get your chemical substance or polymer listed on the TSCA Inventory.
Work with EPA to resolve questions/concerns that may arise during the review of your notification.
EU REACH Regulation
Experien Health Sciences staff, along with the staff of our EU partner Experien Chemical Services (Ireland) Limited based in Cork Ireland, have been involved with the registration of chemical substances in EU member countries from the very beginning of the EU’s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation, but also long before that under what was known as the Notification of New Substances (NONS) process which formed the basis for REACH. Unlike the U.S. and many other countries, there is no free pass for so-called “existing” chemicals. With few exceptions, such as R&D and volumes less than 1 metric tonne per year, every molecule of every chemical placed on the EU market, either on its own or in a formulated mixture, must be covered by a unique registration held by each EU-manufacturer, each EU-importer, or by an “Only Representative” who has been [voluntarily] appointed by each non-EU manufacturer or formulator exporting to the EU. To secure registration, EU REACH requires specific data to be submitted depending on the volume being placed on the market. This data must be reliable, must be submitted to the European Chemicals Agency (ECHA) through the REACH-IT system, and the submitter must have a legal right to use the data in their submission. Fortunately, there are several ways to fulfill ECHA’s data requirements and we can help you find the most economical path forward.
We have technically qualified personnel on both sides of the Atlantic with many years of experience who can:
- Help you understand how EU REACH impacts you and help you devise a compliance strategy that maximizes the benefits to your business.
- Help you understand the cost and timing of filing a REACH registration for your substances, and help you identify any cost-saving data waivers that can be applied.
- Serve as your Only Representative or Third-Party Representative.
- Help secure access to the physical-chemical, toxicological, eco-toxicological, and environmental fate data that may be required to support your registration, whether by sponsoring your own testing using qualified laboratories, by identifying analog or read-across data to include in your submission, or by purchasing access to the data you need from other manufacturers of the same substance through the Substance Information Exchange Forum (SIEF).
- Complete any required exposure assessments and risk characterisations and prepare the Chemical Safety Report (CSR).
- Prepare your registrations dossiers, as Lead Registrant or Joint Registrant, and submit them to ECHA.
- Help you maintain compliance by updating the dossiers as required and by responding to ECHA if your substance is chosen for evaluation, restriction, or authorisation.
- Help you to properly communicate your REACH registration status to customers and explain the duties they retain under the regulation.
Canadian New Substance Notifications (NSNs)
Experien Health Sciences staff, along with the staff our long-time strategic partner and NSN expert in Ottawa Ontario Canada, have been notifying new substances in Canada since the Canadian Environmental Protection Act (CEPA) NSN regulations were first introduced in 1994 and we have kept up with the many changes that have occurred in the years since.
The agency that regulates the manufacture and import of chemicals placed on the Canadian market is Environment and Climate Change Canada (ECCC) and while there are many similarities with the processes in place in other countries, Canada’s NSN process also has some important differences. For example, there are multiple notification Schedules, each of which apply to specific circumstances depending on the status of your chemical or polymer under the regulations and each Schedule grants a different status under the rules, and not all paths lead to a listing on Canada’s Domestic Substances List (DSL).
Unlike many countries, Canada doesn’t have a polymer exemption category and instead regulates all polymers but allowing some polymers to qualify under their Reduced Regulatory Requirements (RRR). Therefore, choosing the right Schedule to notify under can make the difference between a successful business strategy and a failed one.
Our team here in the U.S., with support from our expert in Canada, is well positioned and has the necessary experience to:
- Help you understand the impact Canada’s NSN regulations have on your business, and help you decide which role in the notification process best fits your strategic plans.
- Determine the status of your chemical substance or polymer as either a new or existing substance on the Domestic Substance List (DSL) or non-Domestic Substance List (NDSL). New substances require a notification to ECCC before manufacture in Canada or import into Canada in excess of 100 kg unless the business activity qualifies under an R&D or other exemption.
- File a Confidential Search Request with ECCC to see if your chemical substance or polymer is on the confidential portion of the DSL or NDSL.
- Determine if any Significant New Activity (SNAc) determinations apply to your chemical substance or polymer that might require you to submit a Significant New Activity Notification (SNAN).
- Help you understand the data requirements, cost, and timing of filing an NSN for your substance, and help you identify any cost-saving data waivers that can be applied.
- Help you obtain the physical-chemical, toxicological, eco-toxicological, environmental fate, and exposure data that may be required to support your notification, whether through testing using qualified laboratories or by identifying analog or read-across data to include in your submission.
- Complete the required documentation and submit it to ECCC electronically through their Single Window system.
- Help protect your confidential business information (CBI) by ensuring ECCC’s CBI rules are followed and, if necessary, proposing a masked name for your chemical substance or polymer.
- File the required Notice of Manufacture or Import to add the chemical substance or polymer to the DSL.
- Nominate substances on the NDSL to the DSL.
- Serve as your Canadian Agent.
UK REACH Regulation
Experien Health Sciences, along with our UK-based partner Experien Chemical Services (Europe) Limited, brings all our EU REACH experience to the table to help clients navigate the changes to chemical regulations in the UK brought about by BREXIT. While the UK has largely kept the EU REACH requirements intact, there are important differences and no longer are your EU REACH registrations automatically applicable to chemicals placed on the market in the UK. Likewise, the “Letters of Access” that you purchased for data for your EU REACH registrations may not apply to a UK REACH registration.
We have technically qualified personnel on both sides of the Atlantic with many years of experience who can:
- Help you understand how UK REACH impacts you and help you devise a compliance strategy that maximizes the benefits to your business.
- File your UK legal entity’s Downstream User Import Notification (DUIN) to extend your registration deadlines until the end of the transition period or help your UK customers take advantage of this important provision of the regulation.
- Help you understand the cost and timing of filing a UK REACH registration for your substances, and help you identify any cost-saving data waivers that can be applied.
- Serve as your Only Representative or Third-Party Representative.
- Help secure access to the physical-chemical, toxicological, eco-toxicological, and environmental fate data that may be required to support your registration, whether by sponsoring your own testing using qualified laboratories, by identifying analog or read-across data to include in your submission, or by purchasing access to the data you need from other manufacturers of the same substance through the Substance Information Exchange Forum (SIEF).
- Complete any required exposure assessments and risk characterisations and prepare the Chemical Safety Report (CSR).
- Prepare your registrations dossiers, as Lead Registrant or Joint Registrant, and submit them to the UK Health and Safety Executive (HSE), in the required IUCLID format, through the Comply with UK REACH system (UK REACH-IT).
- Help you maintain compliance by updating the dossiers as required and by responding to HSE if your substance is chosen for evaluation, restriction, or authorisation.
- Help you to properly communicate your UK REACH registration status to customers and explain the duties they retain under the regulation.
Turkey REACH, Korea REACH (K-REACH), China REACH, Taiwan TCCSCA/OSHA, and Japan CSCL
Experien Health Sciences staff understand the chemical regulations in place in each of these countries, but we do not have strategic partners on the ground in these countries like we do in Canada, the EU, and the UK. Nonetheless, we can still add value to your business in several ways:
- We can help you understand your options for compliance, the impact these regulations can have on your business plans, and help you choose a compliance strategy that best fits within your plans.
- If registration makes sense for your business, we can help you choose a consulting firm with staff in that country capable of delivering the services you need without breaking the bank, and we can serve as your technical expert to assist with the work while being your eyes and ears looking out for your financial and business interests.
- If new study data needs to be generated to support your registration, we can solicit quotes from several qualified labs and choose those who will deliver the best value and avoid the potential for under-the-table deals that can sometimes be made between entities in foreign countries.
Chemical Registrations & Notifications