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Chemical and pharmaceutical translations - English German translator for safety data sheets and approvals

Professional translation › Chemicals & pharmaceuticals

German translators for chemicals, pharma and safety data sheets

A UK, US, Irish or Australian chemical or pharmaceutical company needs its safety data sheets, GHS/CLP labels and marketing-authorisation documents in precise, REACH/CLP-compliant German before it can legally place products on the German, Austrian or Swiss market.

Customer serviceDocument types Germany +49 30 2023 5227 0 Austria +43 1 3050 647 Switzerland +41 44 586 82 97

Professional German translators for chemistry & pharma · English ⇄ German, both directions · GHS/CLP and regulatory terminology · confidential

DIN EN ISO 17100registered · Reg. 7U517
German and Englishnative-speaker professional translators
Price up fronttransparently calculated
ConfidentialGDPR-compliant · NDA available

In short

In life sciences, the exact designation is the safety measure.

Reviewed by specialists · termbase editorial team

One mistranslated H or P statement, one inaccurate hazard label — in either direction — and a formality turns into a safety risk. Chemical and pharmaceutical texts demand exact, standardised terminology. That is why at termbase they are translated by professional German translators for chemistry and pharmaceuticals who know both the subject and the regulations — the same regulatory discipline behind our medical-device (MDR/IVDR) translation.

We render safety data sheets to GHS/CLP with correct H/P statements, keep terminology stable through glossaries, and treat formulations and studies as confidential. As a neighbouring discipline of our medical translation and technical translation, this field covers life sciences and process engineering alike.

Document types

Data sheets, dossiers and labels we render into German and English.

Safety data sheets, labels, H and P statements

  • Safety data sheets (SDS)
  • GHS/CLP labelling
  • H & P statements

Certificates of analysis, batch records, SOPs

  • Certificates of analysis (CoA)
  • Test & manufacturing records
  • SOPs

Marketing-authorisation dossiers and SmPCs

  • Marketing-authorisation dossiers
  • Summaries of product characteristics
  • Study documents

Catalogues, product data sheets, websites

  • Product catalogues
  • Data sheets
  • Websites

Decision aid

Four documents, four language rules: REACH, CLP, EMA QRD, GLP.

In chemistry and pharma it is not the text but the regulatory framework that governs the translation. Four common cases – and the rules we follow for each.

If: safety data sheet

Then the national language of every supply state, a fixed structure of 16 sections, H and P statements word-for-word – under REACH (Art. 31, Annex II) and CLP.

If: labelling & label

Then the signal word (Danger or Warning), pictograms and H/P statements in the national language – standardised under CLP (Reg. (EC) 1272/2008).

If: package leaflet & SmPC

Then to the EMA's QRD templates and Section 11 AMG – wording and structure are prescribed, not free to reword.

If: study & testing documents

Then professional translation to GCP/GLP; unpublished data is treated strictly confidentially, under an NDA on request.

Why German — and what decides it

Who sets the language of your label: REACH Art. 8, CLP Art. 17, Swiss law.

REACH Art. 8

REACH Art. 8: non-EU makers need an EU Only Representative

Non-EU manufacturers must appoint an EU Only Representative (REACH Art. 8); SDS must be supplied in the official language of every EU state of sale (Art. 31, Annex II).

CLP Reg. (EC) 1272/2008

CLP Art. 17: H and P statements in the prescribed wording

Hazard and precautionary statements must appear in the officially prescribed wording of the target Member State's language, per CLP Art. 17 and Annex II — not freely translated.

Swiss chemicals regulation

Swiss chemicals law is a separate regime, CLP-aligned

Switzerland runs its own chemicals regulation, not EU law — CLP-aligned but a separate compliance and labelling regime in Switzerland's national languages.

One H statement wrong, and the labelling no longer holds — before an authority, that is not a nuance.

Two decades. Millions of translated words of safety and regulatory documentation. A network of German ⇄ English specialists that chemical and pharma companies trust to keep GHS/CLP labelling compliant — in Germany, Austria and Switzerland.

Regulation & confidentiality

Compliant labelling, consistent terminology, confidential formulations.

Chemical and pharmaceutical texts move within a dense regulatory framework – from REACH-driven labelling through GHS/CLP to marketing-authorisation requirements. We translate safety data sheets, certificates and dossiers into German and English for the German-speaking market and keep specialist terminology constant through recognised references and your glossaries.

Formulations, active substances and study data we treat strictly confidentially – for the agreed purpose only, in line with the GDPR, under an NDA on request, always with qualified human specialists. For medicinal products and medical devices we additionally draw on the terminology of our medical translation.

Expert perspective

One substance is raw material, active ingredient and dangerous good at once.

termbase field team for chemistry, pharmacy & toxicologyReviewed by specialists

The chemical industry is one of the most research-intensive sectors – from plastics through fertilisers, crop protection and industrial adhesives to cosmetics, coatings, paints and medicinal products. Only around 15 per cent of output goes directly to consumers; the bulk moves across borders as an intermediate between businesses – every shipment with its own documentation obligation.

That is why termbase couples the chemistry field closely to medical translation: a substance is raw material, active ingredient and dangerous good at once. In these texts it is not the elegant sentence that matters, but the unambiguous designation – an H statement, a CAS number, an INN active-substance name. Reword any of them freely and a translation turns into a liability and authorisation risk.

Our professional translators work to the standards: safety data sheets under REACH and CLP, product information to the EMA's QRD templates, analytics to the conventions of the target market. Adjacent to this, we translate medical-device documentation, technical instructions for use and documents from agrochemistry.

Pitfalls

Eight errors that make a safety data sheet or an SmPC unusable.

In chemistry and pharma it is often not the translator who dictates the wording, but an EU regulation, a register or a template. These eight details decide legal certainty – and are routinely missed in non-professional translation.

Typical sources of error in chemical and pharmaceutical translations and termbase rule against each
Source of errorWhat happens with free translationtermbase rule
Safety data sheet (SDS)Sections reordered or shortened – the SDS is no longer REACH-compliant and placing on the market becomes challengeable.Fixed structure of 16 sections under REACH Annex II (Art. 31); the national language of every supply state.
H and P statementsHazard and precautionary statements are paraphrased – and lose their legal validity.H/P statements in the official wording from CLP (Reg. (EC) 1272/2008) – never translated freely.
Hazard vs. precautionary statements & signal word"Danger" and "Warning" swapped, or H mixed with P statements – hazard communication breaks down.Signal word, H statements (Hazard) and P statements (Precautionary) kept cleanly separate and standardised.
INN active-substance namesBrand name instead of the active substance, or mistranscribed – the substance is no longer uniquely identifiable.INN per WHO unchanged; language variants (e.g. -in/-ine) set correctly.
CAS/EC numbersDigits "translated along", reordered or separators changed – the substance is no longer traceable in any register.CAS, EC (EINECS/ELINCS) and index numbers carried over character-for-character.
EMA QRD templates (SmPC/package leaflet)Freely worded instead of standard sentences – submission is delayed or rejected.Wording and structure to the EMA's QRD template; standard phrasing carried over.
Units, concentrations, decimal separatorsGerman comma and English point swapped (1,5 ↔ 1.5) – a dose turns into a dosing error.Target convention checked; mg/kg, %, ppm and dilutions kept consistent.
IUPAC nomenclatureTrivial name instead of the systematic name, locants or stereodescriptors slipped – a different substance.Systematic IUPAC names; locants and (R/S, E/Z) descriptors preserved.

Use cases

Three regulatory jobs: an SDS, a package leaflet, a certificate of analysis.

Case 01

Safety data sheet for an EU import

An importer places a mixture on the market in several EU states and needs the SDS in every official language of the supply states.

We translate the 16 sections to REACH true to structure, set H/P statements in the CLP wording and keep CAS/EC numbers character-for-character.

Result: a compliant SDS per target market – terminology identical across every language version.

Case 02

Package leaflet and SmPC to the EMA QRD template

For a medicinal-product authorisation, the package leaflet and summary of product characteristics (SmPC) must be submitted in further EU languages.

We work to the EMA's QRD template, carry over standard phrasing and INN active-substance names, and align the labelling.

Result: submission-ready product information, consistent with the label and earlier versions.

Case 03

Certificate of analysis for a batch export

A batch goes to export or audit – the certificate of analysis / CoA with specifications and methods has to go with it.

We translate test parameters, methods (e.g. HPLC) and limit values faithfully and leave figures, units and batch numbers unchanged.

Result: a verifiable certificate – measured values and units stay reliable.

Quote & price

What a regulatory translation costs — quoted before the work starts.

The price depends on volume, language direction, terminology requirements and deadline. After a review we name a binding fixed price – with standing terms for ongoing needs.

Binding fixed price
from € 0.89per standard line · professional translation
everything included
Professional translation✓included
Terminology & TM✓included
Four-eyes review✓included
Binding fixed price✓included

As a guide, translations start from € 0.89 per standard line (55 characters incl. spaces); we name the exact amount after a brief review. How the price is made up →

Request a quote

FAQ

What regulatory affairs teams ask before commissioning a job.

Do you translate safety data sheets to GHS/CLP?

Yes. We translate SDSs with correct H and P statements and compliant hazard labelling to GHS/CLP – terminologically exact and into German and English for the German-speaking market.

Which translators handle chemical and pharmaceutical texts?

Professional translators with a chemical or pharmaceutical background who know both the subject matter and the regulations; with a four-eyes review on request.

Do formulations and studies stay confidential?

Yes. Sensitive data is processed for the agreed purpose only, in line with the GDPR; on request under an NDA, with qualified human specialists.

Do you keep terminology consistent across product lines?

Yes. Through glossaries and translation memories, technical terms stay consistent across data sheets, batches and product lines.

Do you also translate marketing-authorisation documents?

Yes. We translate marketing-authorisation dossiers, summaries of product characteristics and study documents accurately; for medical devices and medicinal products see also our medical translation page.

Do you translate H and P statements freely or in the official wording?

In the official wording. Hazard statements (H statements) and precautionary statements (P statements) are laid down in the CLP Regulation (EC) No 1272/2008 and are not translated freely, but taken from the applicable official language version.

Do CAS numbers, EC numbers and INN active-substance names stay unchanged?

Yes. CAS, EC (EINECS/ELINCS) and index numbers are carried over character-for-character; INN active-substance names follow the WHO list. That way every substance remains uniquely traceable in the registers.

What does a chemical/pharmaceutical translation cost?

The price depends on volume, language direction and terminology requirements. After a review we name a binding fixed price.
Safety data sheets have a fixed structure and a fixed vocabulary; a creative synonym in section two is a finding at the next audit. termbase worked from our existing German sheets, so the new products read like the rest of the catalogue instead of like a separate document.
★★★★★

Karim Fahmy · regulatory affairs manager, Giza (Egypt) · safety data sheets → German customers

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REACH & EMA language obligations

REACH Art. 31 and the EMA QRD templates fix the language, not the writer.

Under REACH (Article 31, Annex II) the safety data sheet must be provided in an official language of every Member State in which the substance or mixture is placed on the market. The GHS/CLP hazard and precautionary statements (H and P statements) must be used in their officially prescribed wording – not translated freely.

For centrally authorised medicinal products, the EMA's QRD templates prescribe the SmPC, package leaflet and labelling in all EU languages. We work from these reference specifications and align the terminology with adjacent medical-device documentation, instructions for use and our medical professional translation.

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