Classify hazardous substances according to GHS and CLP: classification, labelling, evidence

The classification of hazardous substances has been mandatory for mixtures since June 1, 2015 according to the Globally Harmonized System (GHS), implemented in the EU by the CLP Regulation (EC) No. 1272/2008. Manufacturers, importers and downstream users are obliged to classify, label and document their substances and mixtures in safety data sheets in accordance with Annex II of the REACH Regulation (EC) No. 1907/2006. According to Section 11 ChemG, violations are punished with administrative offenses of up to 50,000 euros; intentional violations that endanger health are punishable by imprisonment. Trade association regulations and sector-specific requirements such as the Biological Substances Ordinance can also be added as soon as the substances are used in the respective industry.

This article explains the classification system, the five mandatory elements of CLP labelling, the role of the safety data sheet and the interface to the Hazardous Substances Ordinance (GefStoffV). It is aimed at hazardous materials officers, safety specialists, warehouse management and management of manufacturing companies, chemical dealers and importers with around 25 employees. At the end, you will know the central obligations, the most common audit findings, how they are linked to risk assessment and instruction, the interface to dangerous goods and environmental law compliance, and how a compliance platform and officer-as-a-service like CIVAC accelerates the maintenance of the hazardous substances list and audit preparation.

The CLP Regulation (EC) No. 1272/2008 implements the United Nations Globally Harmonized System (GHS) in the EU. It differentiates between three hazard classes: physical hazards (17 classes, such as explosive, flammable, oxidizing), health hazards (10 classes, such as acute toxicity, carcinogenicity, reproductive toxicity), environmental hazards (2 classes, such as hazardous to water, damaging to the ozone layer). Each class is divided into categories that describe severity. With the CLP revision (Delegated Regulation 2023/707), new hazard classes for endocrine disruptors, PBT, vPvB, PMT and vPvM were introduced.

The classification follows a fixed procedure. First: Identification of the ingredients and their harmonised classifications from Part 3 of Annex VI to the CLP Regulation. Second: For mixtures, use the calculation methods (additivity formula, concentration limits, bridging principles) in accordance with Annex I. Third: Determination of the final hazard class and category. Fourth: Derivation of the labelling elements according to Annex IV (H statements) and Annex V (pictograms). Fifth: inclusion in the safety data sheet and the list of hazardous substances as well as distribution to customers.

In practice, many users rely on the ECHA database (Classification and Labeling Inventory), but this is not legally binding, but rather a collection of self- and manufacturer classifications. Only the harmonised classifications in Annex VI are binding. Anyone who makes their own classification must justify and document this in the safety data sheet. CIVAC provides a template for the classification documentation that is coordinated with the audit requirements of the Federal Office of Economics and Export Control (BAFA) and the state offices. The template contains fields for data source, method, concentration limits and justification, so that follow-up tests or requests from authorities can be handled without research. The appointment certificate, signed, filed, verifiable.

Art. 17 CLP Regulation 1272/2008 lists the mandatory elements of hazardous substance labelling. Each label must contain five components, otherwise it cannot be marketed. These five obligations apply equally to substances and mixtures; additional regulations apply to special containers, aerosols and bulk deliveries, for example from the Aerosol Regulation 75/324/EEC or the ADR rules for the transport of dangerous goods.

1. Product identifier: chemical name, for substances the IUPAC name or another unique name, for mixtures the trade name plus at least the identity of the substances that contributed to the classification.
2. Supplier information: name, address, telephone number of the person placing the product on the market in the EU.
3. Nominal quantity (for packaging on Consumers).
4. Danger pictograms according to Annex V, black symbol on a white background with a red frame.
5. Signal word (danger or caution), hazard statements (H-phrases) and safety statements (P-phrases).

Additionally, additional information (EUH phrases) may be required, such as EUH 208 for sensitizing ingredients or EUH 210 (safety data sheet available upon request). The labelling must be in German if the product is placed on the market in Germany. The minimum font size and the minimum sizes of the pictograms are regulated in Articles 18 and 31 CLP-VO. For small containers under 125 ml, simplified rules apply, which are described in Annex I, Section 1.5. Foldable labels are also permitted if the full labelling remains legible despite the small container area.

If you create the label internally in Word, you risk errors every time you change the recipe. CIVAC bundles the classification, the generated labelling elements and the safety data sheet in the workspace, so that a recipe change automatically updates all derived documents. The auditor calls, the evidence is ready. You can find out more about the role of the representative at Hazardous Substances Officer.

The hazard statements (H phrases, hazard statements) are listed in Annex III of the CLP Regulation and describe the type and severity of the hazard in a standardised manner. The safety instructions (P-phrases, precautionary statements) are listed in Appendix IV and provide instructions for safe handling. For substances and mixtures with a harmonised classification, the H-statements are necessarily derived from Annex VI Part 3. When classifying themselves, the person placing them on the market derives them from the tables in Annex I. Translation errors or outdated sentence codes are a common finding in audit practice and very quickly lead to formal notifications of defects.

The P-sentence selection is not rigid, but requires prioritization. Annex IV contains around 120 P-phrases, of which six to eight are generally useful for each product. The ECHA guideline Guidance on Labeling and Packaging recommends a selection along four categories: general, prevention, response, storage, disposal. If you choose too many P-phrases, you will make the label illegible, if you choose too few, you will violate the duty of completeness.

The justification for the selection is relevant to the audit. In the case of a random sample, the food control or trade inspection office requires an explanation as to why P210 (Keep away from heat) was chosen and P211 (Do not spray against an open flame) was not. This justification belongs in the internal classification dossier. CIVAC offers a guided P-phrase selection in the workspace that reflects the ECHA methodology and saves the justification. Anyone who orders the hazardous substances officer externally will receive the selection as an ongoing service with a 2 working day SLA. Others run compliance like a filing cabinet. We run it like software.

The safety data sheet (SDS) according to Article 31 REACH and Annex II is mandatory for all substances and mixtures classified as dangerous. Before the first delivery to commercial customers, it must be sent free of charge in the national language (in Germany: German), in electronic form (PDF) or on paper. The structure follows 16 mandatory sections, the order is non-negotiable. Even for mixtures not classified as dangerous, an SDS can be requested at the customer's request, provided they contain certain ingredients in relevant concentrations.

The 16 sections include: Identification, possible hazards, composition, first aid measures, fire fighting, accidental release measures, handling and storage, exposure limitation and monitoring, physical and chemical properties, stability and reactivity, toxicological information, environmental information, disposal information, transport information, legal regulations, other information. For substances with a chemical safety report, an exposure scenario must also be included. An extended SDB (eSDS) is also common in such cases.

The SDB must be current. According to Article 31 Paragraph 9 REACH, there is an obligation to update in the event of new findings on hazards or risk management measures, if an authorisation is granted or refused, if there are restrictions or new harmonised classifications. The latest update is noted in Section 16. In practice, major customers and regulatory authorities require an SDS age of less than 24 months. Licence the workspace for your internal representatives, or have our representatives order it. In both models, the SDS remains current and distribution to customers is logged. Anyone who maintains the SDB as a pure PDF file loses the version history and, in the event of a dispute, cannot prove which version was received by which customer and when. Audit-proof, documented, Art. 31-firm.

§ 6 Paragraph 12 GefStoffV obliges every employer to keep a list of the hazardous substances used in the company. The list is a prerequisite for the risk assessment in accordance with Section 6 Paragraph 1 GefStoffV and is therefore a central audit document for the occupational safety authorities. The requirements are clear and the error rate is high in practice. Cleaning agents and maintenance materials must also be included, not just production raw materials, because they can also have significant risk potential and are regularly randomly checked in audits.

Minimum content per entry: name of the hazardous substance, classification according to CLP or reference to dangerous properties, quantities used, work areas with use, reference to the current safety data sheet. If the substance is subject to a harmonised classification, the index number from Annex VI Part 3 CLP should be given. If there are multiple locations, one directory per location makes sense, but can be consolidated centrally. For CMR substances (carcinogenic, mutagenic, toxic to reproduction), additional documentation requirements apply according to TRGS 905, including a separate exposure list for employees.

Frequent errors: stocks not updated after changing substance suppliers, missing quantities for substances under 1 kg, incorrect or outdated H statements, no reference to the SDB. Supervisory authorities check the register during every routine inspection. Fines of up to 25,000 euros according to Section 22 ChemG are possible. CIVAC maintains the list of hazardous substances as a linked data record in the workspace: Anyone who uploads a new SDS automatically updates the classification and quantities from the warehouse management system (if connected). Licence the workspace for your internal representatives, or have our representatives order it. This makes the directory not only suitable for audits, but also a database for risk assessment. The appointment certificate, signed, filed, verifiable.

Classification and labelling are just the beginning. Section 6 (1) GefStoffV requires a risk assessment before starting work, which must be carried out professionally and documented in writing. It assesses inhalative, dermal and oral exposure, determines occupational limit values ​​(TRGS 900), examines technical, organisational and personal protective measures (TOP principle) and defines procedures. For particularly dangerous activities, a substitution test report is mandatory in accordance with Section 7 (3) GefStoffV, i.e. checking whether a less dangerous substance can be used. This test must be documented in writing and repeated regularly as soon as new alternatives are available on the market or the application changes significantly.

Instruction in accordance with Section 14 GefStoffV is mandatory for all employees who handle hazardous substances at least annually. The content includes designation, hazards, protective measures, what to do in the event of an accident and first aid. It must be activity-related, documented in writing and signed by the employee. Industry-specific technical rules (TRGS) further specify the obligations, such as TRGS 555 for operating instructions or TRGS 510 for storage in portable containers.

Anyone who manages classification, lists, risk assessments and instructions in four separate systems will lose consistency after two personnel changes. CIVAC connects the four documents in the workspace: a new substance intake triggers a risk assessment, a changed risk assessment triggers an instruction task. If you have an occupational safety specialist, you can include them as a second reporting line. More about the integration with occupational safety at Occupational safety specialist. Depending on the material portfolio, the company doctor and the works council must also be involved; the reporting line is technically mapped in the workspace. The auditor calls, the evidence is ready. Deadline expires as soon as we become aware of it.

From the annual reports of the state trade supervisory authorities and the Federal Institute for Occupational Safety and Health (BAuA), patterns can be derived that regularly cause compliance with hazardous substances to fail. Six findings are particularly common and avoidable in practice. Experience shows that they account for around 80 percent of complaints in controls relevant to hazardous substances and, if repeated, lead to formal orders or the prohibition of individual activities. Experienced inspectors regularly start their sample with the list of hazardous substances and from there work their way through the SDB, labels and operating instructions right up to proof of training at the workplace.

Firstly: the list of hazardous substances is outdated or incomplete (most common finding). Second: safety data sheets older than 24 months or in English. Third: Labels without supplier information or with illegible pictograms. Fourth: risk assessment across the board instead of specific to the workplace. Fifth: Instructions not annually or without activity-related content. Sixth: Operating instructions according to TRGS 555 are missing or not up to date. Each of these gaps leads to reports of defects, to fines if repeated and, in extreme cases, to the shutdown of individual systems or areas.

Each finding can be specifically remedied. CIVAC provides 490 audit templates, ten of which relate to hazardous substances: classification dossier, label template CLP, safety data sheet master, list of hazardous substances, risk assessment GefStoffV, operating instructions TRGS 555, proof of training, PPE list, storage class overview, emergency plan. The templates are provided with § and article references so that every statement can be verified. Anyone who carries out the self-check with the platform will have a clear prioritization for the next 90 days in around 4 hours. Audit-proof, documented, § 6-GefStoffV-proof. This means that the preparation for the next trade inspection procedure can be planned instead of being reactive and the main burden is spread over the whole year.

§ 13 ChemG and additionally TRGS 400 provide for the appointment of a hazardous substances officer if the complexity of the use of hazardous substances requires this. There is no hard employee limit; in practice, the function is common for around 50 employees or for several warehouse classes. Larger companies with in-house production actually need the function from the first dangerous ingredient in the recipe.

An internal hazardous substances officer means training effort (at least 32 hours of basic training according to TRGS 400, annual training), time quota (estimated 4 to 10 hours per week depending on the substance portfolio) and personnel risk in the event of fluctuation. An external hazardous materials officer through CIVAC brings the qualifications, classification knowledge and audit experience. The costs are calculable, usually well below an internal full-time equivalent. SLA: 2 working days instead of the classic 2 to 6 weeks.

Which model fits depends on the fabric portfolio. Individual locations with 5 to 15 hazardous substances typically benefit from the external model. Production companies with their own recipe and more than 50 substances often need a hybrid form: internal coordinator with production knowledge, external officer for classification and audit preparation. Licence the workspace for your internal representatives, or have our representatives order it. CIVAC supports both models with the same platform and the same 490 audit templates. Added to this is scalability: the function grows with new recipes or locations without having to look for personnel. Anyone considering switching from the internal to the external model should plan for a 3-month handover in which existing SDBs are digitized and responsibilities are realigned. This means that ongoing operations can be monitored without any gaps. Audit-proof, documented, § 6-firm.

The classification and labelling of hazardous substances is a network of CLP-VO, REACH, GefStoffV, ChemG and TRGS. Anyone who manages the duties in separate systems loses time in maintenance and points in control. CIVAC sees itself as a compliance platform and officer-as-a-service: The workspace bundles classification dossier, safety data sheet, list of hazardous substances, risk assessment, operating instructions and proof of training in an EU data residence, operated under an ISO/IEC 27001:2022 ISMS. 25 representative roles are live in the platform, the hazardous substances representative is one of them.

There are two clear reference models for manufacturing companies. Licence the workspace for your internal representatives if you have appointed your own person as a hazardous materials representative and want to provide them with tools. Or let our representatives appoint you if you would like to hand over the function completely. In both models you get 490 ready-to-use audit templates, a maintenance reminder mechanism and a reporting line that holds up in trade inspections. If you combine several officer roles (hazardous substances, dangerous goods, environment, fire protection), you noticeably reduce the overall effort of the compliance function.

If you want to audit or re-create existing hazardous substances documentation, the next step is a structural discussion. We review your current directory and your safety data sheets, identify the gaps according to the six findings fields and provide an implementation plan with specific deadlines. A structural discussion lasts 45 minutes; the gap analysis is available after 5 working days. Turn reading into an assignment. Write to info@civac.de or use the contact form at civac.de/faq. The auditor calls, the evidence is ready.