Safety Data Sheets (SDS) for Imported Products: Compliance Requirements Under REACH

As a US importer, you might not think about chemical regulations until your shipment gets held at customs. I've seen countless delays because suppliers didn't provide a proper Safety Data Sheet (SDS) for products containing hazardous substances. Understanding SDS requirements upfront can save you from costly penalties and ensure smooth entry into the US market.

What does the Safety Data Sheet include?

The document provides information to the user, such as the manufacturer, description of the product, the product’s model, and chemical and physical properties. It also contains safety instructions: fire extinguishing methods, how the material reacts to damage, ways of secure packing and shipping, dangers and risks of use, a toxicity report, and information on utilizing the product.

What is the purpose of SDS?

Safety Data Sheet (SDS):

• informs about potential hazards of a given substance (mixture)
• provides safe ways to use the product
• contains methods of minimalizing the risk and appropriate practices in case of contamination or any other dangerous situation.

This way, it protects both human health and the environment.

Who has to provide the Safety Data Sheet?

The manufacturer, their representative, importer, or supplier of a given chemical product are responsible for the proper preparation and eventual introduction of the SDS. It includes the technical background, so classification, and hazard description, as well as formal procedures.

REACH Regulation

The SDS document is regulated by the European REACH regulation, which was adopted in the EU to protect the environment and human health from hazards related to the usage of chemical substances. These actions are also intended to increase the competitiveness of the EU chemical industry. Because of the efforts to limit animal testing, the regulation also propagates alternative methods of safety assessment.

According to Art. 31 no. 8, a safety data sheet should be provided free of charge on paper or electronically no later than the date on which the substance or mixture is first supplied:

• where a substance or mixture meets the criteria for classification as hazardous in accordance with regulation (EC) No 1272/2008
• where a substance is persistent, bioaccumulation, and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII
• where a substance is included in the list established in accordance with article 59(1) for reasons other than stated earlier.

SDS provision requirements

Don't leave your chemical imports to chance. Always request the SDS from your supplier before production begins, and verify it meets US standards like ANSI Z400.1. At China-Check, we specialize in supplier verification and can help you confirm your supplier's documentation is compliant—so you can import with confidence.

• in an individual concentration of at least 1% by weight for non-gaseous mixtures and at least 0,2% by volume for gaseous mixtures at least one substance posing human health or environmental hazards
• in an individual concentration of at least 0,1% by weight for non-gaseous mixtures of at least one substance that is carcinogenic category 2 or toxic to reproduction category 1A, 1B and 2, skin sensitizer category 1, respiratory sensitizer category 1, or has effects on or via lactation or is persistent, bioaccumulative and toxic (PBT) in accordance with the criteria set out in Annex XIII or very persistent and very bioaccumulative (vPvB) in accordance with the criteria set out in Annex XIII or has been included for reasons other than those referred above
• a substance for which there are Community workplace exposure limits.

Safety Data Sheet – what should you remember?

• It should be updated and completed following directions included in the chemical substances and their mixtures directive. At each legal change, in line with guidelines set in the directive on chemical substances and their mixtures, as well as community regulations.)
• When it comes to products intended for foreign markets, SDS should be prepared and issued in the given country’s language by those with relevant qualifications. The translator should have relevant subject matter expertise, including chemistry, law, toxicology, etc.
• It should take into account the specific needs and knowledge of its users
• SDS should comply with EU legislation and the legislation of the country in which the substance or formulation is placed on the market. The nomenclature used for hazard descriptions is strictly defined in each country. A literal translation is no guarantee of compliance with legislation)
• NAFTA countries (United States, Canada, and Mexico) have regulations similar to the SDS. According to the regulations, a business owner from the EU is obliged to deliver two safety data sheets together with the products when exporting substances to the NAFTA area. The first must comply with EU requirements. The second must be in accordance with ANSI Z.400.1-2004.