SDS According to European Union Requirements (REACH & CLP)

The Safety Data Sheet (SDS) is one of the key documents required for the legal placement of chemical products on the European Union market It forms the basis for classification, labelling, poison centre notification (PCN), and risk assessment throughout the supply chain.

SDS requirements in the EU are established by the REACH Regulation (EC) No. 1907/2006, Article 31 and Annex II. The currently applicable structure and content are defined by Regulation (EU) 2020/878, mandatory since 1 January 2023.

The SDS is the first and fundamental document from which any entry to the European market begins.

Standard SDS Structure: 16 Mandatory Sections

An SDS has no fixed length, but it must always contain 16 standardized sections — from product identification to regulatory and environmental information. Any omission or merely formal completion of these sections automatically makes the document unacceptable for regulators.

These 16 sections form the basis for:

• verification of CLP labelling compliance

• preparation of the PCN dossier

• assessment of the legal responsibility of the EU Responsible Person

Language and Supply Obligation

The SDS must be provided in the official language of the EU Member State where the product is placed on the market. An English version is not universally acceptable — France requires French, Poland Polish, Italy Italian, etc.

The document must be supplied free of charge, in paper or electronic form, no later than the date of the first supply of the product.

Key New Requirements (Regulation 2020/878)

Many foreign suppliers still use outdated SDS formats that are no longer accepted in the EU. The most critical errors include:

• absence of the UFI code

• ignoring nanoforms

• lack of SCLs, M-factors and ATE values

• incomplete classification data

Data Consistency — the Most Critical Issue

In practice, inconsistencies between the SDS and the product label are the number one reason for border detention of products in the EU.

Who Is Responsible for the SDS

Legal responsibility always lies with:

• the manufacturer (if located in the EU), or

• the importer / Responsible Person (for non-EU manufacturers)

Even if the SDS was prepared by a consultant or laboratory, legal liability remains with the supplier.

The SDS must be prepared by a competent person with documented training in chemical regulations.

Typical Mistakes of Foreign Suppliers

Based on KRP CG practice, the most common issues are:

• use of SDS from Asia or the USA without REACH adaptation

• missing UFI for mixtures

• no nanoform information

• discrepancies between SDS and labelling

• incorrect or underestimated classifications

• label translations without regulatory terminology

• use of outdated templates

In reality, most “ready-made” SDSs from third countries are not suitable for the EU without complete revision.

Developing a proper SDS is not a formality — it is a strategic step for entering the EU market.

How KRP CG Helps

KRP CG supports non-EU manufacturers in the EU and provides:

• SDS preparation according to REACH 2020/878

• adaptation into all EU languages

• CLP and PCN alignment

• EU Responsible Person services

• full support from formulation to legal sales

KRP CG approach: building a complete regulatory support system for your product in the EU, ensuring full compliance.