Operating instructions for hazardous substances in accordance with Section 14 GefStoffV: Sample, mandatory content and testing in the audit

§ 14 Paragraph 1 of the Hazardous Substances Ordinance (GefStoffV) obliges the employer to create written operating instructions for activities involving hazardous substances, in which the hazards occurring in the company as well as the necessary protective measures and rules of conduct must be communicated in a form and language that employees can understand. The instruction must be work area and activity-related; it is not identical to the safety data sheet according to Article 31 of the REACH Regulation. This separation generates the most complaints in everyday life because safety data sheets are chemical-related, but operating instructions are activity-related. Anyone who replaces one with the other misses the protective purpose and the audit at the same time.

This article provides a model structure according to the seven mandatory sections of TRGS 555 (Technical Rules for Hazardous Substances 555), explains the connection with the obligation to provide instruction according to Section 14 Paragraph 2 GefStoffV and shows how a growing number of hazardous substances can be maintained without version chaos. At the end, he describes how CIVAC, as a compliance platform and officer-as-a-service, connects the operating instructions with the hazardous substances officer, the hazardous substances register and the instruction documentation in a verifiable workspace. We address industry, laboratories, trades and logistics equally because the GefStoffV has a sector-neutral effect and triggers the same set of obligations in all four areas. The article is suitable as a briefing for management, hazardous substances officers and occupational safety specialists who want to consolidate their inventory of operating instructions before an official inspection or an internal audit.

§ 14 GefStoffV is the central legal basis, TRGS 555 specifies it. TRGS 555 in the January 2024 version requires written operating instructions for every activity in which employees handle hazardous substances or may be exposed to danger from hazardous substances. The instructions must be formulated in the language of the employees, meaning in several versions in multilingual companies. It must be displayed in a suitable place in the workplace or made digitally accessible; the employer must also ensure that the employees know the content.

The interfaces are important in everyday life. Firstly: the risk assessment according to Section 6 GefStoffV is the analytical basis, the operating instructions are the communicative implementation. Secondly: the safety data sheet according to Article 31 REACH provides the chemical-related data, the operating instructions translate them into activity-related instructions. Thirdly: the instruction according to Section 14 Paragraph 2 GefStoffV is the oral communication of the content. Anyone who interrupts one of these three interfaces risks complaints. Violations of § 14 GefStoffV can be punished according to § 23 GefStoffV in conjunction with § 25 ArbSchG with a fine of up to 25,000 euros per individual case; in serious cases, criminal proceedings are possible according to § 26 ArbSchG. The supervisory authorities of the federal states, often the state offices for occupational safety or the professional associations, regularly carry out random checks to ensure that the instructions are complete and up-to-date. The appointment certificate, signed, filed, verifiable. In supervisory practice we often experience that the instructions are available, but the bridge to the risk assessment is missing. Anyone who does not interlink both documents risks a complaint due to insufficient derivation of the protective measures, even if the instructions are formally complete.

TRGS 555 prescribes seven mandatory sections that must appear in every operating instruction. First: work area and activity. This describes in which part of the company and for which specific activities the instruction applies (e.g. paint shop, acid laboratory, cleaning work with solvent cleaners). Second: hazardous substance or group of hazardous substances. With designation according to the safety data sheet, index number of the CLP Regulation (EC) 1272/2008 and, if applicable, H and P phrases. Third: Dangers for people and the environment. Specific dangers such as skin absorption, eye irritation, fire or explosion risk.

Fourth: protective measures and rules of conduct. Technical, organisational and personal protective measures (TOP principle) are described here, with specific PPE requirements such as chemical protection gloves according to DIN EN ISO 374-1 Type B or respiratory protection with filter class A2P3. Fifth: behaviour in case of danger. Specific instructions for leaks, fires, accidental releases, including notification of the factory fire department or external fire department. Sixth: first aid. Measures in the event of skin contact, eye contact, swallowing, inhalation, with reference to the emergency number and, if necessary, the nearest eye wash. Seventh: proper disposal. With reference to the waste code number according to AVV and the responsible disposal route in the company. The sample structure is not optional; it is requested in audits. Audit-proof, documented, § 14 GefStoffV-proof. Anyone who combines sections risks being criticized for incompleteness. A proven practice is the DIN A4 instruction with a clear column structure, pictograms at the top and signature field at the bottom for the annual confirmation of currentness. Multi-page instructions are possible, but in industrial companies with high activity frequency they should be limited to a maximum of two pages so that employees can actually read the content. In laboratories with a lot of special activities, three pages are often unavoidable; the most important information should always be on page one.

The most common mistake among first-time users is to write separate operating instructions for each hazardous substance in the company rather than for each activity. This confusion leads to unusable instructions because a cleaning employee can use 15 substances but only performs one activity, surface cleaning. A sensible operating instruction describes this activity as a whole and references the materials used. If the activity changes, for example by switching to an alternative cleaning system, the instructions are adapted, not rewritten.

TRGS 555 Section 4.2 distinguishes between individual substance operating instructions and group-related instructions. Both are permitted if the substances have comparable hazard potential. For example, a group statement for aliphatic solvents groups hexane, heptane and pentane together when the protective measures are identical. In the case of significantly different risks, such as the combination of a carcinogenic and a non-carcinogenic substance, separation is mandatory. During ongoing operations, the approach of maintaining master operating instructions for each work area with the usual activities and creating separate instructions for special tasks (e.g. maintenance, cleaning of the system) has proven successful. You can find an overview of the role obligations at Hazardous Substances Officer. Anyone who consistently takes the activity perspective typically reduces the number of instructions by 40 to 60 percent compared to material-by-substance recording and thus also gains significantly in care. This consolidation is often the most effective individual measure when initially consolidating the instruction portfolio. We recommend placing it at the beginning of every consolidation project because it significantly simplifies all subsequent steps (versioning, translation, integration with instruction) and permanently reduces maintenance costs. An experienced specialist can complete this consolidation per work area in two to four hours.

Three mandatory elements are often under-specified. First: GHS pictograms according to CLP Regulation (EC) 1272/2008. The nine pictograms (GHS01 explosive, GHS02 flammable, GHS03 oxidizing, GHS04 compressed gas, GHS05 corrosive, GHS06 toxic, GHS07 harmful, GHS08 hazardous to health, GHS09 hazardous to the environment) must be visible in the instructions. A pure text description is not sufficient because the majority of employees are informed more quickly visually. The pictograms must be at least 1 cm² in size; TRGS 555 recommends 2 to 4 cm² for DIN A4 instructions.

Secondly: H-phrases (Hazard Statements) and P-phrases (Precautionary Statements). At least the most important H and P phrases of the main substance must be reproduced in the instructions, in full (e.g. H315 'Causes skin irritation' and P280 'Wear protective gloves and eye protection'). A mere reference to the safety data sheet is not sufficient because the instructions must be understandable in the workplace. Third: PPE specification. A phrase like 'wear suitable protective gloves' is not enough. The instructions must specify the specific material, the protection class and, if applicable, the maximum wearing time, for example 'Nitrile chemical protection gloves according to DIN EN ISO 374-1 Type B, layer thickness at least 0.4 mm, maximum wearing time 30 minutes in the event of hexane contact'. Anyone who avoids these specifics loses the effectiveness of the measure and thus the protective purpose. The auditor calls, the evidence is ready. TRGS 401 (hazards due to skin contact) provides the basis for assessment and is the source most frequently used in practice for the specification of hand and skin protection. Anyone who formulates superficially here not only loses the protective purpose, but also the control effect over purchasing, because the procurement of the correct PPE depends on precise instructions.

The written operating instructions alone do not fulfil Section 14 GefStoffV. Paragraph 2 requires oral instruction, which is carried out based on the operating instructions at least once a year and before starting work with hazardous substances. The instruction must be workplace and activity-related, i.e. not in a collective training course for different areas. The content includes the hazards listed in the operating instructions, the protective measures and what to do in the event of danger. In the case of particularly dangerous substances, such as carcinogenic or reproductively toxic hazardous substances in category 1A or 1B, the instruction must be carried out every six months.

Proof is provided in writing or electronically. Required are the date, content, duration, name of the instructor, list of participants and signature or digital signature of the participants. In the case of electronic instruction with a knowledge test on the screen, the identity of the person taking part must also be clearly established; a simple click on a check mark is not enough. According to general practice, the retention period is two years, in special cases longer. For carcinogenic substances in category 1A or 1B, there is also an obligation to provide occupational health care in accordance with Section 14 Paragraph 3 GefStoffV in conjunction with the Ordinance on Occupational Health Care (ArbMedVV). Licence the workspace for your internal representatives, or have our representatives order it. CIVAC interlinks operating instructions, instruction and occupational health care in a workflow so that the three-pillar logic of the GefStoffV becomes operationally viable. A consolidated file is created for each employee consisting of an instruction version, proof of instruction and occupational health certificate, which can be accessed within seconds in the event of an audit. This file is GDPR-compliant with access restricted to supervisors, hazardous materials officers and company doctors, so that neither uninvolved colleagues nor external auditors have access to health data.

A medium-sized production company quickly maintains 80 to 200 operating instructions. Without a system, they end up in version chaos: outdated H phrases after CLP changes, expired PSA specifications, forgotten adjustments after substance substitution. TRGS 555 requires regular review, at least annually, as well as immediate adjustment in the event of significant changes, such as new substance classification according to the CLP-ATP regulation, substitution or change of activity. The topicality is checked randomly in audits, often by comparing the safety data sheet date with the status of the operating instructions.

Four organisational measures have proven successful. First: a central instruction database instead of distributed Word documents. Second: a versioning scheme with revision number, date of last check, date of next check and responsible person. Third: Link to the hazardous substances register in accordance with Section 6 Paragraph 12 GefStoffV. Anyone who purchases a substance automatically triggers a check to see whether an instruction exists. Fourth: a defined workflow for changes with reviewers and approvers. CIVAC provides these four measures as a preconfigured process in the workspace. Others run compliance like a filing cabinet. We run it like software. The reporting line to the Hazardous Substances Officer is stored in the system so that every change is clearly documented. If the supplier updates the safety data sheet, the system triggers a mandatory review of the associated operating instructions within 30 days. This automatic interlinking with the supplier data flow prevents the typical documentation gap after a material change at the supplier, which in practice often only becomes apparent months later during the next internal self-audit. In industrial companies with high supplier fluctuation, this is one of the most common triggers for audit findings because a new safety data sheet sometimes contains changed H phrases or PPE requirements without the job description in the company having been adjusted.

Three groups of people and substance categories create a special documentation effort. First: carcinogenic, germ cell mutagenic and reproductive toxic substances of category 1A or 1B (KMR substances). For them, Section 14 Paragraph 2 GefStoffV requires six-monthly training, and the employer must explicitly point out in the instructions that the minimization requirement according to Section 7 Paragraph 4 GefStoffV applies. The TRGS 905 lists the relevant substances, the TRGS 906 records carcinogenic activities without a clear individual substance allocation.

Secondly: pregnant and breastfeeding women. Section 11 of the Maternity Protection Act in conjunction with Section 9 of the GefStoffV prohibits certain activities with hazardous substances during pregnancy and breastfeeding. The operating instructions must explicitly state these employment bans and contain a note that pregnant or breastfeeding employees must report immediately. Deadline begins as soon as we become aware of it. Third: young people under 18 years of age. Section 22 of the Youth Labour Protection Act prohibits certain dangerous work. Exceptions for trainees are possible, but must be documented in the instructions. In laboratories, workshops and production areas with trainees, a separate instruction variant with clear marking of the activities permitted for young people is therefore mandatory. Anyone who does not differentiate between these groups of people not only risks fines, but also personal liability of their superiors according to Section 130 OWiG because supervisory duties have been violated. The annual self-assessment should explicitly query all three special cases and document in a matrix which instructions address special cases and which do not. This matrix is ​​a central proof requirement in the audit and protects management from accusations of inadequate supervision. CIVAC supplies the matrix as a template and updates it automatically when a new instruction or a new substance is entered, so that the overview is always up to date and can be presented if necessary without any preparation effort.

Trade associations and state offices for occupational safety check operating instructions as part of their routine inspections using a recurring scheme. Seven checkpoints are particularly common. First: Are there written instructions for every activity involving hazardous substances? Second: Are the seven mandatory sections of TRGS 555 complete? Third: Are GHS pictograms depicted correctly and in sufficient size? Fourth: Is the instruction accessible in the workplace, without going through superiors? Fifth: Is the annual timeliness documented?

Sixth: Are proofs of training available for each employee, with date, content and signature, and has the frequency been maintained? Seventh: Does the language of the instruction match the language of the employees? In companies with foreign skilled workers without German language skills, this point is regularly complained about because the instruction is then practically ineffective. For each of these checkpoints, CIVAC provides a workspace report that summarizes the status per workspace on one page. The 490 audit templates include, among other things, a self-audit checklist that asks exactly these seven points and is reported to management on a quarterly basis. Anyone expecting a routine check should go through the checklist 14 days in advance and close any gaps. The auditor calls, the evidence is ready. The appointment certificate for the external hazardous substances officer is available in the CIVAC-SLA in 2 working days, instead of the classic 2 to 6 weeks, so that responsibility does not remain unclear in the event of an acute audit announcement. This speed is the decisive point of differentiation compared to classic consulting models in the run-up to the audit, because a missing appointment certificate is viewed in the audit as a breach of supervision and thus leads to a separate complaint. Anyone who only initiates the assignment after an examination has been announced will often not be able to fill the formal gap in time.

A sample according to TRGS 555 is a good starting point, but the real effort comes from maintenance, the integration with the risk assessment, the hazardous substances register and the annual training. CIVAC is a compliance platform and officer-as-a-service that translates exactly this interlinking into an auditable process: 25 officer roles are live, 490 audit templates are ready for use, and the reporting line between the hazardous substances officer, occupational safety specialist and management is clearly documented. The ISO 27001:2022-certified ISMS and the EU data residence secure the personal data of the training certificates in a GDPR-compliant manner.

You have two options. First: You licence the Workspace and carry out the operating instructions with your own internal hazardous substances officer and occupational safety specialist. CIVAC supplies templates for the seven TRGS mandatory sections, GHS library, versioning and audit reports. Second: You appoint an external hazardous materials officer who prepares the instructions, updates them annually and carries out oral training with your workforce. If you would like to know how your company is set up with 50, 200 or 2,000 employees and 30 to 300 hazardous substances, write to info@civac.de or use the contact form on civac.de. We check your instruction files against TRGS 555 and provide a written migration plan with milestones for the first 30, 60 and 90 days. The migration plan identifies responsible roles, technical steps for importing existing instructions and a date for the first consolidated wave of instructions in the new system. If requested, we can also accompany the next routine inspection on site as an external representative and take over correspondence with the employers' liability insurance association or the responsible state office for occupational safety, including the subsequent submission of documents within the set deadlines. Turn reading into an assignment.