What is a Safety Data Sheet (SDS)?

A Safety Data Sheet is a standardized document that compiles all safety-relevant information about a chemical substance or mixture — from composition and hazards to handling, storage, and disposal guidance. It is aimed primarily at professional recipients in the supply chain, not end consumers, and exists to protect workers and downstream users from risks associated with the product. Its structure follows the UN's Globally Harmonized System (GHS) worldwide, implemented in the EU through the REACH and CLP Regulations.

In the EU, the obligation to provide a Safety Data Sheet stems from Article 31 of the REACH Regulation (EC) No 1907/2006. Classification of a substance or mixture as hazardous follows the criteria set out in the CLP Regulation (EC) No 1272/2008 ("Classification, Labelling and Packaging"), which transposes GHS into European law. The exact content and structure of the SDS is defined in Annex II of the REACH Regulation and is updated periodically to reflect new scientific and regulatory developments.

Every Safety Data Sheet must contain exactly 16 sections in a fixed order: (1) identification of the substance/mixture and of the company, (2) hazards identification, (3) composition/information on ingredients, (4) first-aid measures, (5) firefighting measures, (6) accidental release measures, (7) handling and storage, (8) exposure controls/personal protection, (9) physical and chemical properties, (10) stability and reactivity, (11) toxicological information, (12) ecological information, (13) disposal considerations, (14) transport information, (15) regulatory information, and (16) other information. This fixed structure ensures that users in every EU member state find the same information in the same place.

E-liquids typically contain propylene glycol, vegetable glycerin, flavoring agents, and often nicotine. Nicotine is classified as acutely toxic under the CLP Regulation, which means nicotine-containing e-liquids generally qualify as hazardous mixtures and are therefore subject to the SDS obligation. Certain flavoring compounds can also carry sensitizing or irritant properties that feed into the classification. Beyond the REACH/CLP SDS requirement, nicotine-containing products carry additional notification duties, such as product notification under the Tobacco Products Directive (TPD, 2014/40/EU) and poison centre notification under Annex VIII of the CLP Regulation.

The obligation to prepare and supply a Safety Data Sheet falls on whoever manufactures, imports, or first places a hazardous substance or mixture on the EU market — typically manufacturers, importers, and in some cases downstream formulators. The SDS must be provided to the professional recipient free of charge, on first supply, and in the official language of the member state where the product is placed on the market. The document must be updated and re-issued whenever the formulation changes, new toxicological data emerges, or the relevant legislation is amended.

In practice, e-liquid manufacturers tend to run into the same recurring issues: Safety Data Sheets that are not translated into the target market's language, outdated templates that omit the mandatory 16-section structure, or a CLP classification that isn't updated after a formulation change. Another common gap is a missing Unique Formula Identifier (UFI) on the label, which is required for poison centre notification. Failing to review and update the document regularly is also a frequent cause of market surveillance objections.

EINS Labor supports manufacturers and importers of e-liquids and e-cigarette products in preparing compliant Safety Data Sheets under CLP and REACH requirements — from classifying the formulation to structuring the document according to the mandatory 16-section format. As a point of contact for regulatory compliance in the e-cigarette industry, EINS Labor helps companies position their products securely and lawfully on the European market.

Commission Regulation (EU) 2020/878 of 18 June 2020 amended Annex II of the REACH Regulation (EC) No 1907/2006, which sets out the mandatory structure of the Safety Data Sheet, and was published in Official Journal L 203 on 26 June 2020. In substance, it aligned Section 9 (physical and chemical properties) and Section 14 (transport information) in particular with the sixth and seventh revisions of the UN GHS. For substances listed under Section 3, specific concentration limits, M-factors, and acute toxicity estimates (ATE) under the CLP Regulation must now be stated where available. The amendment also introduced new disclosure requirements for nanoforms of substances and for endocrine-disrupting (hormonal) properties, for example for substances on the Candidate List under Article 59(1) REACH. In addition, the Unique Formula Identifier (UFI) must now be stated in sub-section 1.1. The regulation entered into force on 16 July 2020 and has applied since 1 January 2021; after a transition period, all Safety Data Sheets had to be updated by 31 December 2022 at the latest. Since 1 January 2023, every Safety Data Sheet must comply with the format aligned to Regulation (EU) 2020/878 — for e-liquid manufacturers, this particularly affects the UFI entry and the updated toxicity information in Section 11.

Annex VIII of the CLP Regulation (EC) No 1272/2008 governs the harmonized notification of hazardous mixtures to the poison centres designated by EU member states (Poison Centre Notification, PCN) and has applied uniformly across the EU since 1 January 2021. Importers and other entities placing health- or physically-hazardous mixtures on the market must notify them, using the standardized PCN format submitted through ECHA's central submission portal. The core element is the Unique Formula Identifier (UFI), a 16-character alphanumeric code arranged in four blocks of four characters with the prefix "UFI:" (e.g. UFI: N1QV-R02N-J00M-WQD5), generated from the notifying company's tax/VAT ID and an internal formulation number. It allows poison centres to instantly match a product to its exact formulation in a poisoning incident, without disclosing the confidential composition on the label. The phase-in schedule required notification with UFI labeling for consumer and professional products from 1 January 2021, and for mixtures used exclusively industrially from 1 January 2024; mixtures previously notified under old national schemes had a transition period ending 1 January 2025 at the latest. For nicotine-containing e-liquids, generally classified as hazardous mixtures, PCN notification with UFI labeling on the pack is therefore just as mandatory as the Safety Data Sheet itself.

The Safety Data Sheet and the CLP label are frequently confused in practice, yet they rest on different legal bases and address different audiences. The Safety Data Sheet is based on Article 31 and Annex II of the REACH Regulation (EC) No 1907/2006 and is aimed at professional recipients in the supply chain, who need it to identify appropriate risk management measures; for products classified as hazardous, it must be supplied to the commercial recipient without being requested. The label, by contrast, is based on Title III (Article 17 et seq.) of the CLP Regulation (EC) No 1272/2008 and is permanently affixed to the packaging, making it visible to every user — including end consumers — regardless of whether an SDS exists. Under Article 17 CLP, it must include the product identifier, supplier details, hazard pictograms, signal word, hazard and precautionary statements, and, where applicable, the UFI code. Both documents must be consistent: the precautionary statements listed in SDS Section 2.2 must match those on the label exactly. While the label delivers the essential hazard information compactly on the product itself, the Safety Data Sheet is the comprehensive technical document intended for the professional supply chain.

Does every e-liquid need a Safety Data Sheet?

Not strictly every one, but most. As soon as an e-liquid is classified as a hazardous mixture under the CLP Regulation — typically the case for nicotine-containing liquids — an SDS is required. Depending on composition, nicotine-free liquids can be affected too.

Who issues the Safety Data Sheet — the manufacturer or the retailer?

The obligation generally falls on the manufacturer or importer who first places the product on the EU market. Pure retailers who resell the product unchanged simply pass on the existing SDS.

How long is a Safety Data Sheet valid?

There is no fixed expiry date, but the document must be updated without delay whenever relevant information changes — for example, a new formulation, an updated classification, or new toxicological findings.

What language does the Safety Data Sheet need to be in?

The official language of the member state where the product is placed on the market. Selling in multiple EU countries requires the corresponding language versions.

Does the UFI code also have to appear on e-liquid labels?

Yes, if the e-liquid is classified as a hazardous mixture — generally the case for nicotine-containing liquids. Under Annex VIII of the CLP Regulation, the 16-character UFI code must be prominently displayed on the label, a requirement in force for consumer products since 1 January 2021. Stating it only in the Safety Data Sheet is sufficient solely for mixtures used exclusively at industrial sites.

Do existing Safety Data Sheets need updating because of Regulation (EU) 2020/878?

Yes. Since 1 January 2023, every Safety Data Sheet must comply with Annex II as amended by Regulation (EU) 2020/878. Older templates lacking the UFI entry in sub-section 1.1 and the updated toxicity and transport information required under Sections 9 and 14 are no longer considered compliant and must be revised.