Many doubts usually raise around Safety Data Sheets, or SDS; so let’s look at the 5 most frequently questions addressed to our regulatory affairs experts.
A Safety Data Sheet (SDS) or Material Safety Data Sheet (MSDS) is a legal document intended to provide complete details for the correct handling and storage of hazardous substances or mixtures; it is addressed to professional users, in production and distribution chains.
Is the SDS mandatory?
Yes, it is. When a substance/mixture is dangerous according to CLP Regulation the SDS must be provided to the distributor/retailer. No need for an explicit request.
If the mixture is not dangerous but it contains hazardous substances a SDS must be provided on request.
Which vaping products require a mandatory SDS?
- Nicotine/zero nicotine e-liquids if, as a result of a CLP classification, are considered hazardous;
- concentrates/flavours if, as a result of a CLP classification, are considered hazardous;
- prefilled POD or devices, if the contained e-liquid requires the SDS .
If I import a product/substance from an extra EU Country, can I use the SDS my supplier provides me?
No, you can’t; SDS have different formats in different parts of the world, defined by specific regulations. Also the hazardous classification systems, are not globally aligned.
In the European Union, for example, the REACH regulation forsees a SDS format consisting of 16 sections, each one containing specific information. Moreover, the hazardousness of the mixture is defined on the basis of CLP regulation criteria and its amendments.
The SDS must be written in the official language of the Member State in which the product is placed on the market, for an immediate understanding by professional users; since some Member States has specific requests, a simple translation is not sufficient, but a State-specific adaptation is needed.
So, imported products require the authoring of a specific SDS for the Country.
Does a SDS have to be consistent with other documents?
Yes, it has to. For instance, Section 2 of the European SDS format contains the classification of the mixture/substance: it lists the hazard identification and labelling elements (pictograms, signal words and hazard and precautionary statements). It’s mandatory to have consistency among SDS, labels and data transmitted in the TPD notification: this is a highly investigated aspect by the competent Authorities during inspections.
Is it necessary to know the full composition of the finished product to prepare its SDS?
Yes, it is. It is necessary to know the full composition of the finished product together with the SDS of the single substances contained in it to properly classify a product.
Any doubt? More questions? Ask us for a prompt reply!
