Frequently Asked Questions

  1. I mixed two or more chemicals together. I have all the base material SDSs; do I really need a new mixture SDS?
  2. I need to transport an experimental chemical from one lab to another using public roads. Do I need to meet DOT requirements?
  3. What is the difference between hazard and risk?
  4. Why does my article require an SDS?
  5. My business uses a chemical that is ordered from multiple suppliers. Is it necessary to have multiple supplier-specific SDSs on file?
  6. Do all hazardous components of my chemical mixture need to be disclosed?
  7. My product contains components that are trade secret. Can I withhold disclosing them?
  8. My company is selling a product in the European Union. Does the product need to be registered under REACH?
  9. My product contains a chemical that my company produces. Does the product need to be registered under REACH?
  10. What is TSCA and how does it affect me?
  11. What is the TSCA Inventory? What if my chemical substance is not on the TSCA Inventory?
  12. What are the possible outcomes after submitting a Premanufacturing Notice (PMN)?
  13. Which categories of chemicals are exempt from TSCA?
  14. What are the Premanufacturing Notification (PMN) exemptions under TSCA?

Q: I mixed two or more chemicals together. I have all the base material SDSs; do I really need a new mixture SDS?

A: SDSs are required and regulated by OSHA for all hazardous chemicals. If the mixture of the mixed components has the same hazards as described on the original SDSs, then a new SDS is not needed. However, if the mixture created a new chemical with different hazards, you are required to create a new SDS for the mixture.

Q: I need to transport an experimental chemical from one lab to another using public roads. Do I need to meet DOT requirements?

A: If any hazardous chemical is transported on public roads, DOT requirements apply. However, depending on the hazards of the chemical and the size of the chemical being transported, you may qualify for certain exemptions.

Q: What is the difference between hazard and risk?

A: The formula for risk is hazard multiplied by exposure. This means that greater hazard or greater exposure will result in greater risk. Risk is the probability that a hazard can lead to harm.

Q: Why does my article require an SDS?

A: The definition of an article under OSHA is "a manufactured item other than a fluid or particle: (i) which is formed to a specific shape or design during manufacture; (ii) which has end use function(s) dependent in whole or in part upon its shape or design during end use; and (iii) which under normal conditions of use does not release more than very small quantities, e.g., minute or trace amounts of a hazardous chemical (as determined under paragraph (d) of this section), and does not pose a physical hazard or health risk to employees." If an article does not meet all three of those OSHA requirements, then it is not considered an article per OSHA standards. OSHA is the regulators for SDSs, so it would then be required to have an SDS if it was hazardous.

Q: My business uses a chemical that is ordered from multiple suppliers. Is it necessary to have multiple supplier-specific SDSs on file?

A: A generic SDS can be used for situations where the same chemical is being provided by multiple suppliers. However, the generic SDS must be clear to the employees. Also, OSHA clearly states that the name on the label and the SDS must match.

Q: Do all hazardous components of my chemical mixture need to be disclosed?

A: All hazardous components within a chemical mixture in excess of 1% must be disclosed on the SDS. Certain chemicals including carcinogens must also be disclosed on the SDS if they are in excess of 0.1% of the total mixture.

Q: My product contains components that are trade secret. Can I withhold disclosing them?

A: The manufacturer may withhold the specific chemical identity, including the chemical name or the exact percentage (concentration) of the substance in a mixture from the Safety Data Sheet provided that

  1. the claim of a trade secret can be supported,
  2. information concerning the properties and effects of the hazardous chemical is disclosed,
  3. the SDS indicates that the specific identity and/or percentage is being withheld as a trade secret, and
  4. the specific identity and percentage is made available to health professionals, employees, and designated representatives.

Chemical ingredients of public/general knowledge cannot be claimed as a trade secret. If a trade secret claim is made, the permissible exposure limit (PEL), threshold limit value (TLV), or other designated exposure limits, as well as properties and effects of the hazardous ingredients, must be included on the SDS.

Q: My company is selling a product in the European Union. Does the product need to be registered under REACH?

A: Intentional mixtures are not registered under REACH. You will need to be sure that all of the components of your company's product are registered, and you will need to provide your importer with a REACH-compliant SDS and label. Hazard classifications on the SDS and label must follow the EU's Classification, Labelling & Packaging (CLP) legislation requirements. If your product has a hazard classification, its SDS will need to contain an Annex with the relevant exposure scenarios to be in compliance with CLP.

Q: My product contains a chemical that my company produces. Does the product need to be registered under REACH?

A: Individual chemical substances, whether pure substances or substances that are inherently a mixture, must be registered under REACH if manufactured or imported to the EU at more than one ton per year. If your company is the sole supplier of the substance, much of the burden of registration will be on your company. If other companies also produce or import the substance to the EU, your company may be able to enter a joint registration and share costs. Registrants can only reside in the EU. If your company does not have a legal presence in the EU, your EU importer may be interested in filing the registration dossier on your company's behalf. If they do not want to handle the registration, then you must engage an "only representative" in the EU to file the dossier. However, you may prepare the dossier yourself or hire a consultant to prepare it for you.

Q: What is TSCA and how does it affect me?

A: The Toxic Substances Control Act is a United States risk management statute allowing the Environmental Protection Agency (EPA) to assess chemical risk to the environment or human health and to take action to control unreasonable risks. Any entity who manufactures, processes, or distributes in commerce a chemical substance or mixture must report under TSCA.

Q: What is the TSCA Inventory? What if my chemical substance is not on the TSCA Inventory?

A: The TSCA Chemical Substance Inventory is a list of over 80,000 chemical substances approved for use in commerce in the United States. If your chemical substance is not on the TSCA Inventory and you would like to sell it in the Unites States, you must submit a PMN (Premanufacturing Notice) to the EPA.

Q: What are the possible outcomes after submitting a Premanufacturing Notice (PMN)?

A: Possible outcomes after submitting a Premanufacturing Notice (PMN) include:

  1. the new chemical being added to the TSCA Inventory list,
  2. a Consent Order being issued or negotiated that prohibits or limits activities associated with that chemical, or
  3. a Significant New Use Rule (SNUR) being issued, binding all other manufacturers to the terms of the Consent Order.

Q: Which categories of chemicals are exempt from TSCA?

A: Pesticides, nuclear or radioactive material, food/cosmetics/devices, tobacco and tobacco products, and ammunition are categories of chemicals exempt from TSCA.

Q: What are the Premanufacturing Notification (PMN) exemptions under TSCA?

A: Generally speaking, several categories still fall under TSCA, but are exempt from PMN submissions. It is important to note that they each have specific criteria that must be met in order to be categorized as PMN exempt. The categories are: Polymers, Research & Development (R&D) chemicals, Low Volume (LVE), Low Release and Low Exposure (LoRex) chemicals as well as Test Market products.

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