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The Datacor Blog

Regulatory Compliance Update for Chemical Manufacturers & Distributors

August 3, 2023 by Sharon Brody

The chemical distribution and manufacturing industry is constantly changing, and keeping up with regulatory requirements can be challenging. We're here to help. We're introducing a new series where each quarter, we'll share some of the most relevant changes concerning the classification, labeling, and packaging of hazardous substances and mixtures.

In this post, we’ll cover the following:

US OSHA Proposes Update to GHS Revision 7

On February 5, 2021, the United States Occupational Safety and Health Administration (OSHA) issued a proposed rule to update the Hazard Communication Standard (HCS) to align with Revision 7 of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). HCS 2012 is the current governing regulation in the U.S. and follows Revision 3 of GHS. The move to Revision 7 will harmonize regulations with Canada, who recently announced that Revision 7 will be adopted.

Although we don't know exactly when the update in the U.S. will happen, we can, however, speculate that the following changes will be incorporated.

The key changes include:

  • New hazard categories and classes for:
    • desensitized explosives
    • pyrophoric gases
    • chemically unstable gases
    • non-flammable aerosols
  • Updated test methods for several physical hazard classes, including Flammable Gases, Oxidizing Gases, and Oxidizing Solids.
  • Updated precautionary statements. 
  • Additional information to be included in section 9 of the SDS, as well as changes in wording and the order of information
  • Changes to small container labeling
  • New CBI requirements for trade secret components.

Some aspects of GHS Revision 8, namely revised medical response statements, are also being considered. OSHA is currently accepting comments on the proposed modifications. A two-year transition period to the modified HCS is proposed, with the revisions being effective 60 days after official publication.

The full proposal can be found here.

Canada Publishes Amendments to Adopt GHS Revision 7

After many months of meetings between the U.S. and Canadian working groups, Canada published the amendments to the Hazardous Products Regulations (HPR) in the Canada Gazette, Part II, to align with the 7th revised edition, along with certain provisions of the 8.

Key changes adopted by Canada are similar to those planned by the U.S. and are noted below:

  • Adoption of a new physical hazard class, Chemicals Under Pressure.
  • Change of hazard class name to Aerosols and adoption of a new category: Aerosols – Category 3 (non-flammable aerosol products).
  • Adoption of subcategories for Flammable Gases for Category 1.
  • Repeal of the Pyrophoric Gases hazard class as the adoption of new subcategories for Flammable Gases include these gases under a subcategory of Flammable Gases – Category 1A.
  • Updates to Acute Toxicity (Inhalation) classification criteria for water-activated toxicants.
  • New information elements required on safety data sheets (SDSs) and/or labels.
  • Modification of information to be disclosed on an SDS and/or label.
  • Suppliers have until December 15th 2025 to bring product classification, safety data sheets and labels into compliance with the updated amendments.

Learn more: Regulations Amending the Hazardous Products Regulations (GHS, Seventh Revised Edition): SOR/2022-272, Order Amending Schedule 2 to the Hazardous Products Act: SOR/2022-273

ECHA Provides Advice on New Hazard Classes for Substances and Mixtures

New Hazard Classes 2023

The European Commission has published a Delegated Regulation amending the CLP Regulation, which sets out new hazard classes and criteria for the classification, labelling and packaging of substances and mixtures.

It applies to all chemical substances and mixtures placed on the EU market under REACH. It also applies to active substances in biocidal products and plant protection products, which are normally prioritized for harmonized classification in the EU.

This EU legislation applies to manufacturers, importers, downstream users and distributors placing substances on the European Union market. Member States will also refer to the new hazard classes and criteria when making proposals for harmonized classification and labelling.

The new hazard classes are:

  • ED HH in Category 1 and Category 2 (Endocrine disruption for human health)
  • ED ENV in Category 1 and Category 2 (Endocrine disruption for the environment)
  • PBT (persistent, bioaccumulative, toxic), vPvB (very persistent, very bioaccumulative)
  • PMT (persistent, mobile, toxic), vPvM (very persistent, very mobile)

Learn more: ECHA | New Hazard Classes 2023

EPA Submits Significant New Use Rules on Certain Chemical Substances

On June 20, 2023, the U.S. Environmental Protection Agency (EPA) submitted a proposal for an update to the significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for certain chemical substances that were the subject of premanufacture notices (PMNs) and are also subject to an Order issued by the EPA pursuant to TSCA.

The SNURs require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is proposed as a significant new use by this rule to notify the EPA at least 90 days before commencing that activity.

The required notification initiates the EPA’s evaluation of the use, under the conditions of use for that chemical substance, within the applicable review period. Persons may not commence manufacture or processing for the significant new use until the EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required by that determination.

The proposed rule is open for comments until July 20, 2023 and the full proposal can be found at here.

US EPA New Rule: Diisononyl Phthalate Added to Toxic Chemical Reporting Requirements for Community Right-to-Know

The U.S. Environmental Protection Agency (EPA) has proposed a final rule, effective from September 12, 2023, to add the diisononyl phthalate (DINP) category to the list of toxic chemicals requiring reporting under the Toxics Release Inventory (TRI) reporting requirements under the Emergency Planning and Community Right-to-Know Act and the Pollution Prevention Act. This addition is based on the potential for serious or irreversible reproductive dysfunctions, as well as other chronic health effects such as developmental, kidney, and liver toxicity.

Diisononyl phthalate is a phthalate used as a plasticizer. DINP is typically a mixture of chemical compounds consisting of various isononyl esters of phthalic acid, and is commonly used in a large variety of plastic items.

The European Union has set a maximum specific migration limit (SML) from food contact materials of 9 mg/kg food for the sum of diisononyl phthalates and diisodecyl phthalates.

DINP is listed as a substance "known to the State of California to cause cancer" under Proposition 65 legislation.

Learn more: EPA | Toxic Release Inventory Program Overview

Have questions?

Contact the Datacor Regulatory Services team today to request a free consultation. Whether you have queries regarding the latest regulations, want assistance updating existing Safety Data Sheets, or need a complete overhaul of your compliance and reporting procedures, we're here to help.

Topics: Datacor ERP, Regulatory Compliance, Regulatory Services

Sharon Brody

Written by Sharon Brody

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