07 October 2024

Who should supply the Safety Data Sheet?

One of the most important questions in the world of Safety Data Sheets is who should provide the SDS. Will the distributor of the product or manufacturer be responsible for providing the Safety Data Sheet? Can this obligation be imposed on an entity outside of the European Union? Can I use the Safety Data Sheet from my supplier? Let's take a look at what ECHA's guidance on preparing Safety Data Sheets stipulates:

"Where there is a chain of supply, the requirements of REACH in relation to the provision of safety data sheets apply at each stage of the supply chain. The initial responsibility for drawing up the safety data sheet falls on the first supplier of the substance onto the EU market. (...) Actors further down the supply chain should also provide a safety data sheet, drawing on, checking the adequacy of, and adding to, the information provided by their suppliers to cater for the specific needs of their customers. In all cases, suppliers of a substance or a mixture which requires a safety data sheet have the responsibility for its contents, even though they may not have prepared the safety data sheet themselves. (...) However, they will remain responsible for the accuracy of the information on the safety data sheets they provide (this also applies to SDSs distributed in languages other than the original language of compilation). It should be noted that the supplier always needs to add their contact details in Section 1.3 of the SDS, even when they use the SDS from their supplier without changing any content."

Guidance is therefore firm and clear that this obligation basically sits with every actor along the supply chain.

How is the supplier defined?

We intuitively know who the supplier is, but it is worth understanding how the supplier is defined by applicable regulations, and thus:

supplier: of a substance or a mixture: means any manufacturer, importer, downstream user or distributor placing on the market a substance, on its own or in a mixture, or a mixture.

The definitions of manufacturer and importer are also quite intuitive:

manufacturer: means any natural or legal person established within the Community who manufactures a substance within the Community

importer: means any natural or legal person established within the Community who is responsible for import

The next two definitions, especially the one for downstream users, are very specific to the REACH and CLP regulations, but it is necessary to quote them as well to recognize the requirements:

downstream user: means any natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a mixture, in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user.

distributor: means any natural or legal person established within the Community, including a retailer, who only stores and places on the market a substance, on its own or in a mixture, for third parties.

As can be spotted in the example above, regardless of our role in the supply chain (unless we are consumers), we will have an obligation to provide a Safety Data Sheet.

Liability of the supplier from outside the European Union

If we take a closer look at the definitions of individual roles in the supply chain from the previous paragraph, we will see that they have one thing in common. All of them indicate that it must be a natural or legal person establishedwithin the Community. This means that the obligation to provide a Safety Data Sheet will always sit with the entity from the European Union. If we buy our product outside the EU (for example in the United States or even closer, in the UK), we, as the Importer, will be responsible for preparing and delivering the Safety Data Sheet. An entity from outside the European Union, in accordance with our regulations, is not responsible for the Safety Data Sheet.

It is worth being aware of this if we decide to purchase goods from a third country, especially since, for example, in the United States, regulations regarding Safety Data Sheets are different from those in the EU and a document from a US supplier will rarely be sufficient for the EU market. Additionally, there are often issues of data confidentiality, which American companies are reluctant to share with their European customers (and it must be remembered that they have no such obligation - there is no law that would indicate that they must provide this information to the product recipient in the European Union).

Using the Safety Data Sheet from the supplier

In the scenario where our supplier provided us with a Product Safety Data Sheet, as per the previously quoted excerpt from the guide, we could use it to fulfill our obligations. This is absolutely possible as long as the following several basic assumptions are met:

  • As a supplier, we do not modify the product in any way that could affect the content of the Safety Data Sheet
  • We do not change product packaging We do not change its trade name
  • We do not change the use of the product
  • The Safety Data Sheet was provided to us in the language of the country in which we want to sell our products (the issue of translating the Safety Data Sheets is a separate topic)
  • We are convinced that our supplier has provided us with a correct and compliant
  • Safety Data Sheet (it is worth noting that responsibility is borne by all entities at every stage of the supply chain)
  • We know that our supplier will not mind if we add our data to the Safety Data Sheet

 

Of course, there are also purely business issues, for example:

  • Do we want our recipient to know our supplier's data - these will be visible in the Safety Data Sheet prepared by him?
  • Wouldn't it be better to have a Safety Data Sheet with your own logo and company details?

 

The above considerations usually lead to the conclusion that the most effective and safest course of action is to develop your own Safety Data Sheet, verified and checked by an experienced team of specialists.