Language of the Safety Data Sheet in the EU

MSDS-EUropeSafety Data Sheet Knowledge Base – Language of the Safety Data Sheet in the EU

Language of the Safety Data Sheet in the EU – In which language is the SDS mandatory?

The Safety Data Sheet (SDS) is the key document containing information on chemical substances and mixtures: among other things, users learn from it about hazards and the requirements for handling, storage and transport. In the European Union, the language of the document is determined by strict legislation, primarily Article 31 of the REACH Regulation and its Annex II.

Below we summarize in which language the SDS must be provided on each market, what applies to hazard codes and exposure scenarios, and which specific rules govern exports outside the EU.

 

Regulatory background – REACH, CLP, PIC

 

The basic principle of Article 31 of REACH

According to Article 31(5) of the REACH Regulation, the safety data sheet must be made available in the official language(s) of the Member State in which the substance or mixture is placed on the market, unless the Member State concerned provides otherwise.

The same rule applies to the format of the safety data sheet: the 16-section structure is defined in Annex II of REACH and must be applied uniformly throughout the EU.

 

CLP – consistency between the label and the SDS

The CLP Regulation (EC) No 1272/2008 lays down the labelling and packaging requirements. The language(s) used on the label must generally match the language of the safety data sheet: the label must be prepared in the official language of the Member State concerned, unless that country lays down different rules.

Since the label and the SDS refer to the same product, the languages, classifications and hazard indications of the two documents must always be consistent.

 

PIC Regulation – export outside the EU

For exports outside the EU, the PIC Regulation (EU) No 649/2012 provides that the information appearing on the label and on the safety data sheet accompanying exported hazardous chemicals must, where possible, be given in the official or main languages of the country of destination.

In practice, this means that partners outside the EU generally require at least an English SDS, and in many cases also an SDS in the local language.

 

Language of the Safety Data Sheet in the EEA Member States

 

Basic rule: language of the recipient Member State

The safety data sheet must always be supplied in the language(s) of the Member State in which the product is placed on the market – regardless of the country of origin of the manufacturer or distributor.

It is important to note that:

  • The fact that a manufacturer benefits from an exemption in one Member State does not automatically grant an exemption in other Member States.
  • A Member State may also lay down stricter requirements (e.g. only the national language is accepted, or several official languages are mandatory).

ECHA publishes a summary table showing in which languages each EEA country requires the label and the SDS; for a number of countries this table also indicates when the annex to the SDS (e.g. the exposure scenario) may, under certain conditions, be accepted in English.

 

Several official languages in one country

Some countries have more than one official language (e.g. Belgium, Finland, Luxembourg). In such cases, national rules determine:

  • in which languages the SDS and the label must be provided,
  • and whether it is acceptable for certain annexes to the SDS (e.g. exposure scenario) to remain in English.

Switzerland (although not an EU Member State, it is often a relevant market at EEA level) requires that labelling be provided in at least two official languages.

 

Language agreement with the customer

Some countries allow, in the case of professional users, the parties to reach an agreement in writing on the use of a different language (e.g. English). Even in such cases, the basic principle is that the recipient must fully understand the information contained in the SDS.

 

Language of the attached exposure scenario

In the case of an extended Safety Data Sheet (eSDS), exposure scenarios (ES) are attached as annexes to the SDS. According to ECHA guidance, the ES is an integral part of the safety data sheet, and is therefore subject to the same translation requirements as the SDS itself.

This means that:

  • where the Member State requires the safety data sheet to be provided in its own official language, the exposure scenario must also be made available in that language;
  • some countries may allow the ES to remain in English, but this is a Member State decision and not a general rule.

 

What do we translate and what not? – codes, abbreviations, H-statements

 

Hazard classes and category codes

In Section 2 of the safety data sheet, the hazard classification may be presented in several ways:

  • in full text, including the hazard class and category as well as the description of the hazard (H) statements,
  • or in the form of codes, e.g. “Flam. Liq. 1, H224”.

Important rules:

  • Codes such as Flam. Liq. 1, Eye Irrit. 2, etc. must not be translated, as they are harmonised, language-independent codes set out in Annex VI to CLP.
  • If the SDS provides only the codes, the full text explanation of the codes must be given in Section 16 in the language of the safety data sheet.
  • If the hazard classification is already given in full text in Section 2 (e.g. “Flammable liquid, Category 1”) together with the full wording of the H-statements, a separate explanation of the codes in Section 16 is not mandatory.

 

Translation of H- and P-statements

The standard wording of the H-statements and P-statements is laid down in EU legislation and exists in all official EU languages. In the SDS they must be used in the official translation in the language of the relevant Member State.

 

Language of the SDS in the case of exports (outside the EU)

For exports outside the EU, the SDS is subject to both EU requirements and the specific rules of the destination country:

  • on the basis of the PIC Regulation, the information provided on the label and in the SDS must, where possible, be given in the official or main language(s) of the country of destination;
  • many countries – in particular outside Europe – have their own GHS-based requirements, so the SDS often has to be prepared in a completely new format, adapted to the local legislation.

In such cases, instead of mere linguistic translation, a complex compilation and restructuring of the SDS is required.

 

Practical advice for manufacturers, importers and distributors

 

Check the requirements of the destination country

  • Review the ECHA language table on the languages required for labels and SDSs.
  • Consult the information provided by the national authority (e.g. the occupational safety authority or the national chemicals authority).

 

Do not settle for a word-for-word translation

An SDS that is faithful in wording but technically incorrect or outdated entails serious risks: incorrect classification, missing national requirements, fines or objections from the authorities. Both REACH and national legislation draw attention to this risk.

It is therefore advisable to choose a service provider who:

  • is familiar with REACH/CLP and the national requirements of the destination country,
  • where necessary, will also re-edit the SDS, not only translate it,
  • takes into account the most recent amendments.

 

Lifecycle of the safety data sheet – typical tasks

The following tasks are most commonly associated with safety data sheets:

  • Preparation of an SDS for new products or in the case of imports where no suitable starting document is available.
  • SDS translation and regulatory adaptation into the official language(s) of the destination country (taking into account any regulatory differences that may also affect the content requirements of the SDS).
  • SDS review and update where the classification, the formulation or the regulatory framework changes.
  • Preparation of CLP label layouts to ensure that the label is consistent with the SDS both linguistically and in terms of content.
  • PCN notification (Poison Centre Notification) for hazardous mixtures, which is closely linked to the data included in the SDS and to the identifiers of the mixture (e.g. UFI).

All of the above tasks are directly linked to the language and content of the safety data sheet – therefore it is advisable to manage them in a coordinated way and under one roof.

 

How can MSDS-Europe help?

The expert team behind MSDS-Europe covers the entire lifecycle of the SDS:

 

Quick questions and answers

In which language must the safety data sheet be provided in the EU?
The safety data sheet must be supplied at least in the official language of the Member State in which the substance or mixture is placed on the market – unless that Member State lays down different rules (e.g. requires several languages or accepts English).

Is an English-only SDS acceptable in the EEA?
This is only possible if the legislation or the administrative practice of the Member State concerned explicitly allows it, or if a clear language agreement has been concluded with professional users. Otherwise, an SDS in the national language is mandatory.

Does the exposure scenario also need to be translated?
Yes. The exposure scenario is an integral part of the SDS and must therefore, as a rule, be available in the same language as the safety data sheet – unless the Member State concerned allows the annex in English under certain conditions.

Do codes such as Flam. Liq. 1 or Eye Irrit. 2 need to be translated?
No. These are language-independent codes, based on English abbreviations and laid down in Annex VI to CLP, and they must be used unchanged in all languages. The full meaning of the codes must be explained in the SDS – typically in Section 16 – in the language of the document.

In which language must the SDS be issued for exports outside the EU?
In addition to the EU requirements, the PIC Regulation provides that the information on the label and in the SDS must be given, as far as practically feasible, in the official or main language(s) of the country of destination. In practice, this usually means an English + local language SDS.

Can the translation of the SDS be entrusted to a general translation agency?
This is not recommended. The safety data sheet is not merely a linguistic document but a technical and legal document whose errors can have direct legal and safety consequences. During translation, regulatory adaptation in line with local legislation must also be carried out – a task that can only be responsibly performed by experts with sound REACH/CLP knowledge.

 

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