West Europe: European Union (EU) & UK SDS Services

REACH Annex II, CLP, and Mandatory National Language Compliance

By Zoesoe Exports Pvt Ltd – Your Trusted Regulatory Partner for the EU/EEA and UK Markets

Zoesoe Exports Pvt Ltd provides specialized SDS services compliant with the strict European Union (EU) REACH Regulation and the CLP Regulation (Classification, Labelling, and Packaging). Our service ensures compliance with the most recent updates to REACH Annex II (Regulation (EU) 2020/878), including requirements for Poison Centre Notification (PCN) and the Unique Formula Identifier (UFI).

Why SDS is Critical in Western Europe

The SDS is the central hazard communication tool and a key component of the REACH/CLP framework. Compliance is mandatory for:

1. Legal Mandate (REACH Annex II): SDS must adhere to the 16-section format and content requirements detailed in the latest REACH Annex II amendments (e.g., specific requirements for nanoforms, endocrine disruptors, and the UFI).

2. Mandatory Language: The SDS must be provided in the official language of every single EU Member State where the chemical is sold (up to 23 languages).

3. Unique Identifiers: Hazardous mixtures require a UFI to be listed in Section 1.1 of the SDS, linking the product to the central PCN system managed by ECHA.

4. Extended SDS (eSDS): For registered substances ($\ge 10$ TPA), the Chemical Safety Report's Exposure Scenarios must be appended to the SDS, forming an eSDS.

A Compliant EU SDS must be:

• Format: The 16-section format, adhering to REACH Annex II (EU) 2020/878.

• Language: Translated and localized into the official national languages of the destination countries.

• Content: Classified according to the current CLP Regulation (including the latest ATPs).

Our SDS Services for the EU/UK (REACH/CLP Compliant)

ServiceDescription & Key Compliance Point1. SDS Preparation (EU/GB)Complete 16-section SDS for the EU and a separate document for the UK (GB CLP), including relevant DNELs/PNECs in Section 8 and correct regulatory references.2. Multi-Language TranslationExpert translation into all required European languages (German, French, Italian, Spanish, etc.), ensuring technical and regulatory phraseology is accurate (H- and P-phrases).3. UFI/PCN IntegrationIntegration of the Unique Formula Identifier (UFI) into SDS Section 1.1 and support for aligning the SDS data with your Poison Centre Notification (PCN) submission.4. Extended SDS (eSDS)Review and appending of Exposure Scenarios for registered substances to create a compliant eSDS.

Industries We Serve: Chemical Manufacturers, Importers, Distributors, Formulators, and Downstream Users in the EU, EEA, and UK.

🇷🇺🇰🇿🇧🇾 East Europe: Eurasian Economic Union (EAEU) SDS Services

GOST 30333, TR EAEU 041/2017, and Mandatory Registration

By Zoesoe Exports Pvt Ltd – Your Trusted Regulatory Partner for the EAEU Market (Russia, Kazakhstan, Belarus, Armenia, Kyrgyzstan)

Zoesoe Exports Pvt Ltd offers specialized services for the Eurasian Economic Union (EAEU) market, focusing on the mandatory Russian Safety Passport (Passport Bezopasnosti). Compliance is based on the specific requirements of GOST 30333-2022 and the forthcoming TR EAEU 041/2017 (Eurasian REACH).

Why SDS is Critical in the EAEU

The EAEU's "Safety Passport" is a registered, official document required for chemical circulation and is fundamental to the new Eurasian REACH regime. It is mandatory for:

1. Legal Mandate (GOST 30333): The SDS must strictly adhere to the 16-section GOST 30333-2022 standard, which dictates format, content, and classification criteria (GHS Rev. 7 alignment).

2. Mandatory Registration: Unlike the EU, the Safety Passport must be officially registered by the Russian Institute of Standardization (Rosstandart/CIS Center) to be legally valid across the EAEU.

3. Eurasian REACH Precursor: The Safety Passport is a mandatory submission document for chemical notification and registration under the delayed, but imminent, TR EAEU 041/2017.

A Compliant EAEU SDS must be:

• Format: The 16-section format, strictly adhering to GOST 30333-2022 (Safety Passport).

• Language: Entirely in the Russian language.

• Registration: Must include a registration number or accompanying documents showing official registration status.

Our SDS Services for the EAEU (GOST Compliant)

ServiceDescription & Key Compliance Point1. SDS Preparation (Safety Passport)Complete Russian Safety Passport authored according to GOST 30333-2022 (GHS Rev. 7). Includes specific mandatory data and terminology required for the EAEU market.2. Russian LocalizationExpert technical translation into the Russian language, ensuring compliance with GOST's specific requirements for H- and P-phrase terminology.3. SDS Registration SupportFull support for the mandatory registration process of the Safety Passport with the relevant EAEU body, which makes the document legally valid.4. TR EAEU AlignmentEnsuring the SDS data meets the requirements for notification and registration under the new TR EAEU 041/2017 system.