It’s what’s inside that matter when it comes to substances.
The most important part of building a compliant Safety Data Sheet (SDS) is appropriately assessing the hazards associated with the substances within the product mixture. A solid scientific background and experience in Environmental Health & Safety regulations is a prerequisite for the preparation of compliant safety documents.
Evaluating a substance is challenging. It may sound elementary, but we must first consider the physical state of a substance when assessing its hazards. Is the substance a liquid, gas or solid? If it is a solid, is it in a powder form or a massive solid? If it is a powder, what is the particle size? This apparent simple question on physical form matters as these variations could have an impact on the substance’s hazards.
Once the physical form is established, substance data-gathering starts, but it is not a simple matter of Googling around because information gleaned must be assessed for reliability.
Here are relevant sources of substance data worth considering:
- Data gathering from suppliers’ disclosures through Safety Data Sheets or others
- Regulatory data for classifying substances, imposing bans or restrictions on use
- Governmental databases such as:
- European Chemical Agency (ECHA) information on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) registered substances
- The Hazardous Substances Database, a toxicology data file on the National Library of Medicine’s (NLM) Toxicology Data Network (TOXNET)
- Quebec Province Répertoire Toxicologique from the Commission for Standards, Equity, Health and Safety at Work, better known as CNESST
- Data maintained for common substances produced or used by specific industries such as Concawe (petrol products), the Research Institute for Fragrance Materials and the European Committee of Organic Surfactants and their Intermediaries (CESIO)
- End-point data resulting from tests (toxicological, ecotoxicological or physical hazards)
- Knowledge of the substance’s chemical group
The data-gathering part is usually straightforward, but if there is insufficient data on a substance itself, we may need to base the evaluation on the substance’s nature and our knowledge of its chemical group. Here are a few examples:
- Volatile organic solvents are likely to cause narcotic effects.
- Organic powders are likely to cause a combustible dust hazards.
- Compounds containing metals such as lead have very specific hazards to take into consideration.
- Fluoride compounds, especially salts, target teeth and bones.
- Nitrite and nitrate salts may cause methemoglobinemia.
- Melamine compounds may release formaldehyde.
- Acrylates may polymerize.
Picking the Right Information
There are a few guiding principles when setting a hierarchy for considering substance data sources.
First, we will consider as primary data:
- The substance or raw material information from suppliers Safety Data Sheets and product Declarations.
- Test results characterizing the mixture’s properties.
- Information published by governments imposing mandatory classification and restrictions.
The variation in regulatory requirements from one country to another must be considered since the differences might be enough to cause a substance to be nonhazardous in one country and hazardous in another.
Mind the Gap
When primary data are not enough to fully characterize substances, we refer to data from industrial and governmental databases (ECHA, CNESST, TOXNET, Concawe, etc.) to complete the assessment.
In this day and age, one can drown in the sea of information while surfing the web for chemical substance data. It is of prime importance to define specifically trusted sources of information relevant to your business and then stay focused on those fewer sources.
When we author Safety Data Sheets as a consultancy service, we keep a close dialogue with our customers to advise them of classification changes resulting from the data sources we recommend as well as additional requirements affecting their products, such as notifications and registrations. Very often, we need to also communicate flaws and missing information that our team finds in Safety Data Sheets from our customers suppliers.
The Globally Harmonized System is not. This is a running gag now in EH&S. But we do apply a systematic approach and procedure for harmonizing (as much as possible) the hazards across the jurisdictions. This is essential for consistency for global coverage, and this approach consists of leveraging the official classification of substances per one jurisdiction and applying it to countries that do not publish an inventory of classified substances. Also, the typical hazards not otherwise classified must be covered and are globally applicable. Finally, organizations commonly have internal requirements to test and assess product properties or content that requires supplementary information to be disclosed on Safety Data Sheets and labels.
About Sphera Managed Regulatory Services
This brief article touches only one aspect of Sphera Managed Regulatory Services coverage. In addition to substances evaluation and SDS and label authoring, Sphera MRS can also help clients:
- Determine hazards during their product research and development phase.
- Advise on country-specific requirements, such as chemical inventories and negative lists.
- Orient clients on regulatory and best practice for protecting intellectual property.
Over the years, many have used our expertise to adapt their formulations to the best possible outcome in terms of hazards, transport classification, packaging costs and even import considerations (for substances on negative lists). The outcome of these Product Stewardship best practices is risk reduction, processing efficiency and cost reduction.
Contact us to learn more about Sphera Manged Regulatory Services.