SDS (Safety Data Sheet) Romania 🇷🇴
SDS (Safety Data Sheet) Preparation & PCN Services for Romania
By Zoesoe Exports Pvt Ltd – Your Trusted Partner for EU REACH/CLP Compliance
Romania, as a full member state of the European Union (EU), operates under the chemical safety framework established by the REACH and CLP Regulations. To legally place a chemical substance or mixture on the Romanian market, your documentation must meet these stringent, harmonized EU standards.
Why SDS Is Mandatory in Romania (EU REACH/CLP Framework)
The legal basis for the Safety Data Sheet (SDS) requirement in Romania is derived directly from EU law, which is implemented and enforced by national authorities, primarily the Ministry of Environment, Water and Forests.
REACH Regulation (EC) No 1907/2006: This regulation mandates the provision of an SDS for all substances and mixtures classified as hazardous, defining the general content requirements (Article 31).
CLP Regulation (EC) No 1272/2008: This regulation governs the classification, labelling, and packaging of chemicals. The SDS must be entirely consistent with the CLP classification.
Commission Regulation (EU) 2020/878: This updates Annex II of REACH and sets the latest mandatory format and content requirements for all SDSs placed on the EU market.
A compliant SDS for Romania must be:
Format: The mandatory 16-section SDS format defined by REACH Annex II, as updated by Regulation (EU) 2020/878.
Language Specific: The SDS must be supplied entirely in Romanian (Limba Română), the official language of Romania, as mandated by the EU for the country where the product is placed on the market.
Content: For all hazardous mixtures (consumer, professional, and industrial use), it must include the Unique Formula Identifier (UFI) code in Section 1.1, linked to a successful Poison Centre Notification (PCN).
Our SDS Services for Romania (EU 2020/878 & PCN Compliant)
1. SDS Preparation (EU 2020/878 Compliant)
We create a complete, 16-section GHS-compliant SDS, ensuring full technical and regulatory adherence to the latest EU standards, for:
Substances and hazardous mixtures.
Extended SDS (eSDS) incorporating Exposure Scenarios for registered substances.
Our SDS includes:
Classification according to the latest CLP ATPs (Adaptations to Technical Progress).
Compliance with Regulation (EU) 2020/878 requirements.
UFI code readiness and inclusion in Section 1.1.
2. SDS Review & Localisation
We review your existing international SDS (e.g., US OSHA) for technical gaps against the strict EU requirements, perform all necessary technical modifications, and provide the mandatory, accurate Romanian translation.
3. Poison Centre Notification (PCN) Support
For hazardous mixtures, we assist with the entire PCN compliance process, which involves:
Generating the Unique Formula Identifier (UFI) code.
Preparing the data dossier (including full mixture composition and toxicological information) in the harmonized PCN format.
Submitting the notification to the Toxicology Information Center (part of the Emergency Clinic Hospital of Bucharest) via the ECHA Submission Portal (the harmonized submission method).
Industries We Serve
Industrial Chemicals and Manufacturing
Agriculture and Agrochemicals
Consumer Cleaning Products and Detergents
Paints, Coatings, and Adhesives
Why Choose Zoesoe Exports Pvt Ltd?
EU REACH/CLP Expertise: Ensures immediate compliance with the general EU framework.
PCN Submission: Expertise in generating the UFI and submitting the notification through the ECHA Portal to the appointed Romanian body.
Mandatory Romanian Translation: Accurate, specialized translation of chemical and regulatory terminology, including H/P statements and Exposure Scenarios.
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