What Does Chemical Compliance Mean?
Compliance encompasses all regulatory requirements for the manufacture, labeling, documentation, and transport of chemical products in the EU. Relevant regulations are REACH, CLP/GHS, ADR, and since 2024 the Digital Product Passport (DPP).
The 4 Pillars of Chemical Compliance
| Regulation | Focus | Core Obligation |
|---|---|---|
| REACH | Registration & Authorization | Substance registration, Safety Data Sheets |
| CLP/GHS | Classification & Labeling | Hazard pictograms, H/P statements |
| ADR | Dangerous Goods Transport | UN numbers, transport documents |
| DPP | Digital Documentation | Product passport from 2027 (EU 2024/1781) |
Who is Affected?
- Manufacturers: Produce chemical substances in the EU
- Importers: Bring substances from non-EU countries
- Downstream Users: Use substances in industrial processes
- Distributors: Store and distribute without modifying substances
Why Compliance Matters
Violations of REACH or CLP can result in fines up to €50,000 per violation. Additionally, there are reputational damages, delivery stops, and personal liability of management.
REACH – Background & Obligations
REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. The goal is to protect human health and the environment through the safe use of chemical substances. Mandatory content includes: SDS, exposure scenarios, substance information.
Key Topics
- Registration Dossier: Technical documentation for substances >1 t/year at ECHA
- SVHCs: Substances of Very High Concern with information and authorization obligations
- Substance Information Exchange: Data sharing between registrants (SIEF)
Registration Requirement
Substances >1 tonne/year per manufacturer/importer must be registered with ECHA. Without registration: "No data, no market" – the substance cannot be placed on the market.
Key REACH Obligations
| Obligation | For Whom? | Article |
|---|---|---|
| Registration | Manufacturers, Importers | Art. 5-24 |
| Safety Data Sheet | All in supply chain | Art. 31 |
| SVHC Communication | Article manufacturers | Art. 33 |
| Authorization | Users of Annex XIV substances | Art. 55-66 |
Safety Data Sheets (SDS)
The Safety Data Sheet is the central communication tool in the chemical supply chain. It must be provided in the official language of the recipient country and contains 16 mandatory sections:
- Identification of the substance/mixture and company
- Hazards identification
- Composition/information on ingredients
- First-aid measures
- Fire-fighting measures
- Accidental release measures
- Handling and storage
- Exposure controls/personal protection
- Physical and chemical properties
- Stability and reactivity
- Toxicological information
- Ecological information
- Disposal considerations
- Transport information
- Regulatory information
- Other information
Attention: Update Obligation
SDS must be updated "without delay" when: new hazard information emerges, authorization/restriction decisions are made, classification changes occur. The updated SDS must be sent to all recipients of the last 12 months.
SVHC & Candidate List
SVHCs (Substances of Very High Concern) are substances of very high concern according to Art. 57 REACH:
- CMR substances Category 1A/1B (carcinogenic, mutagenic, toxic for reproduction)
- PBT substances (persistent, bioaccumulative, toxic)
- vPvB substances (very persistent, very bioaccumulative)
- Substances with equivalent level of concern (e.g., endocrine disruptors)
As of February 2026: The Candidate List contains over 230 substances. If an article contains >0.1% of an SVHC, information obligations (Art. 33) and SCIP notification requirements apply.
Exposure Scenarios
Exposure Scenarios (ES) are extended SDS annexes for REACH-registered hazardous substances (>10 t/year). They describe safe use conditions, operational conditions (OC), and risk management measures (RMM).
CLP & GHS Labeling
CLP regulates the classification, labeling, and packaging of chemical substances according to the GHS standard. It is mandatory for SDS, packaging labels, and safety communication.
Key Focus Areas
- Signal Words & Hazard Pictograms: Visual warning symbols for quick hazard identification
- H & P Statements: Standardized hazard and precautionary statements
- Exposure Scenarios: Link to REACH for safe use conditions
Labeling Elements
- Hazard Pictograms: 9 standardized symbols (e.g., skull, flame, environment)
- Signal Words: "Danger" (severe) or "Warning" (less severe)
- H-Statements: Hazard Statements – describe the nature of the hazard
- P-Statements: Precautionary Statements – safety advice
- UFI: Unique Formula Identifier for mixtures (mandatory since 2021)
The 9 GHS Pictograms
| Symbol | Meaning |
|---|---|
| GHS01 | Exploding Bomb – Explosives |
| GHS02 | Flame – Flammable |
| GHS03 | Flame over Circle – Oxidizing |
| GHS04 | Gas Cylinder – Gases under Pressure |
| GHS05 | Corrosion – Corrosive |
| GHS06 | Skull and Crossbones – Acute Toxicity |
| GHS07 | Exclamation Mark – Irritant, Sensitizing |
| GHS08 | Health Hazard – CMR, STOT |
| GHS09 | Environment – Hazardous to Aquatic Environment |
ADR & Dangerous Goods
ADR is the EU-wide agreement on the international transport of dangerous goods. Compliance requires: transport documents, classification, packaging, training certificates.
Dangerous Goods Classes
| Class | Description |
|---|---|
| 1 | Explosive substances and articles |
| 2 | Gases |
| 3 | Flammable liquids |
| 4.1/4.2/4.3 | Flammable solids |
| 5.1/5.2 | Oxidizing substances, Organic peroxides |
| 6.1/6.2 | Toxic/Infectious substances |
| 7 | Radioactive material |
| 8 | Corrosive substances |
| 9 | Miscellaneous dangerous goods |
Transport Document – Mandatory Information
UN number, proper shipping name, class, packing group, tunnel restriction code, consignor/consignee, quantity.
Dangerous Goods Safety Adviser
Companies that consign, pack, or transport dangerous goods must appoint a Dangerous Goods Safety Adviser (except for small quantities under ADR 1.1.3.6).
Digital Product Passport – EU 2024/1781
The Digital Product Passport makes product information permanently available. For chemicals: SDS data, labeling, exposure scenarios, data structure.
DPP for Chemicals – Required Content
- Product identity and manufacturer
- Safety and sustainability data
- Batch traceability
- REACH/CLP compliance status
- Recycling and disposal instructions
- Carbon footprint (for certain product categories)
Timeline
The first DPP obligations will apply from 2027 for batteries, followed by textiles and other product categories. Chemicals are expected to be covered from 2028/2029.
Practical Checklist: REACH Compliance 2026
Use this checklist to systematically verify your company's compliance status. Each item corresponds to a specific regulatory requirement:
REACH Registration & Documentation
- ☑ All substances >1 t/year registered with ECHA
- ☑ Registration dossiers up to date
- ☑ SVHC screening completed for all articles (>0.1% threshold)
- ☑ SCIP notification submitted for SVHC-containing articles
- ☑ Only Representative appointed (if importing from non-EU)
Safety Data Sheets (SDS)
- ☑ SDS available for all classified substances/mixtures
- ☑ All 16 mandatory sections completed
- ☑ SDS in official language of recipient country
- ☑ Exposure scenarios attached (for >10 t/year)
- ☑ Update obligation checked (new hazard data, CLP changes)
CLP/GHS Labelling
- ☑ Classification per CLP correct (hazard classes, categories)
- ☑ Labels with pictograms, signal word, H/P statements
- ☑ UFI (Unique Formula Identifier) assigned for mixtures
- ☑ Poison centre notified (Annex VIII CLP)
ADR Dangerous Goods Transport
- ☑ Dangerous goods classification correct (UN number, packing group)
- ☑ Transport documents complete
- ☑ Dangerous Goods Safety Adviser appointed (or small quantity exemption 1.1.3.6 verified)
- ☑ Training certificates of involved personnel current
Digital Product Passport (DPP)
- ☑ DPP data structure prepared (EU 2024/1781)
- ☑ Product identity, safety and sustainability data structured
- ☑ Batch traceability implemented
- ☑ Timeline for DPP introduction defined (batteries 2027, chemicals ~2028/2029)
Tip: Free Initial Assessment
Unsure about your current compliance status? Request a free initial assessment -- confidential and non-binding by an expert with over 30 years of chemical industry experience.
Frequently Asked Questions about REACH, GHS & Compliance
What is REACH?
REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is EU Regulation (EC) No 1907/2006 for the registration, evaluation, and authorization of chemical substances. It requires manufacturers and importers to register substances with ECHA and provide Safety Data Sheets.
When do I need a Digital Product Passport?
The Digital Product Passport (DPP) becomes mandatory from 2027 for batteries and progressively for other product categories. For chemicals, the requirement is expected to come into force in 2028/2029. Starting early secures competitive advantages. Learn more on our DPP page.
What does ADR mean for my shipping?
ADR is the European Agreement concerning the International Carriage of Dangerous Goods by Road. It regulates classification, packaging, labeling, and documentation. For dangerous goods shipping, you need UN numbers, hazard labels, and correct transport documents.
What is the SVHC Candidate List?
The ECHA SVHC Candidate List contains over 230 Substances of Very High Concern (as of 2026). If an article contains more than 0.1% of an SVHC, information obligations under Art. 33 REACH and SCIP notification requirements apply. CMR substances, PBT substances, vPvB substances, and endocrine disruptors can be identified as SVHCs. SVHC substances are flagged in our chemistry database.
How much does a REACH registration cost?
ECHA fees for REACH registration vary by tonnage band: 1-10 t/year from EUR 1,600, 10-100 t/year from EUR 4,300, 100-1,000 t/year from EUR 11,500, over 1,000 t/year from EUR 31,000. SMEs receive up to 90% reduction. Additional costs for substance data and potentially studies apply.
How often must a Safety Data Sheet be updated?
A Safety Data Sheet must be updated without delay when new hazard information emerges, authorization or restriction decisions are made, or CLP classification changes occur. The updated SDS must be sent to all recipients of the last 12 months. A routine review every 3-5 years is recommended.
What is the difference between GHS and CLP?
GHS (Globally Harmonized System) is the international UN system for classification and labelling of chemicals. CLP (Classification, Labelling and Packaging, Regulation (EC) No 1272/2008) is the EU implementation of GHS. CLP is legally binding in the EU, while GHS serves as the global framework. The core elements -- pictograms, H-statements, P-statements -- are identical.
Further Resources
Our public chemical lexicon on oysi.eu provides detailed safety data for over 3,800 substances:
Compliance Questions? We Can Help.
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