Substitution testing for hazardous substances: obligation, procedure, evidence

According to Section 6 Paragraph 1 Sentence 2 Number 4 of the Hazardous Substances Ordinance (GefStoffV) in the version dated November 26, 2010, every employer must, as part of the risk assessment, check whether a hazardous substance can be replaced by a substance, a mixture or a process with a lower risk potential. This so-called substitution test is not a recommendation, but rather a requirement. Anyone who fails to do so or documents them incompletely is acting improperly in accordance with Section 22 GefStoffV in conjunction with Section 25 ArbSchG and risks fines of up to 25,000 euros per violation. In the recent supervisory practice of the state trade supervisory authorities, the missing or formulaic substitution test is one of the three most common complaints during on-site inspections.

The Technical Rule for Hazardous Substances TRGS 600 in the August 2008 version specifies the procedure. It requires a six-stage evaluation matrix, a written comparison of the alternatives and a reasoned decision. This article shows when the audit is triggered, how the process works operationally, which tools the professional associations recognise and what evidence the supervisory authorities, especially the state trade regulator and the BG, specifically want to see in the audit. The clock starts on awareness.

The obligation to test for substitution is rooted in Section 6 Paragraph 1 Sentence 2 Number 4 of the Hazardous Substances Ordinance. The employer must determine and evaluate “the possibilities of substitution” as part of the risk assessment. The regulation applies to all activities with hazardous substances, regardless of whether they involve pure substances, mixtures or processes. Section 7 paragraph 3 GefStoffV tightens the obligation for carcinogenic, mutagenic or reprotoxic substances (CMR) of category 1A or 1B: Substitution must generally be carried out here, as long as this is technically possible. An economic consideration alone does not justify sticking to the CMR substance.

The current version of TRGS 600 specifies the procedure. It defines substitution as “the replacement of a hazardous substance or a process by a substance, a mixture, a process or an article that poses a lower risk to the health and safety of employees under the respective conditions of use”. The TRGS provides the hazardous substances officer with a column matrix in which properties such as acute toxicity, sensitizing effects, flammability, environmental hazards and route of exposure are weighted. Anyone who works as an appointed hazardous substances officer can find the operational tasks in the profile of the Hazardous Substances Officer: Substitution testing is one of the core duties alongside the list of hazardous substances, training and operating instructions. TRGS 555 supplements the picture with specifications for the appointment and the professional suitability of the representative.

The classification also includes the relationship to the EU Occupational Safety and Health Framework Directive 89/391/EEC and the Chemicals Directive 98/24/EC. The German GefStoffV is the national implementation of these European requirements. When it comes to controversial questions of interpretation, supervisory authorities often rely on EU guidelines such as the ECHA Guidance on REACH Annex XIV or the methodology of the Scientific Committee on Occupational Exposure Limits (SCOEL). A clean appointment certificate, signed, filed, verifiable, belongs in every audit folder and closes the circle between standard, person and process.

The substitution test is not a one-time process, but rather an ongoing process. Four triggers set them in motion according to TRGS 400 and TRGS 600. First: the first use of a hazardous substance in the company. Before a substance is purchased and used, the test must be documented, not after the fact. Secondly: a significant change in working conditions, such as a higher use rate, new process temperature, changed ventilation situation or a switch from manual to automated application. Third: new findings on the risk, for example an ECHA classification according to Annex VI of the CLP Regulation, a change in the MAK value of the DFG Senate Commission or an entry in the SVHC candidate list. Fourth: regular review of the risk assessment at least every three years in accordance with TRGS 400 Section 7.

In practice, we recommend linking every procurement process to a formal release workflow. Purchasing presents the planned product, the hazardous substances officer checks the data sheet, H and P statements, searches for alternatives in official databases such as GESTIS, ChemInfo NRW or the IFA column model and only releases the product once the check has been completed. This workflow can be stored in the CIVAC workspace as a standard process, with task routing, deadline monitor and audit-proof storage. The appointment certificate, signed, filed, verifiable: Whoever formally appoints the representative has also clearly regulated responsibility for the substitution decision.

A second operational lever is the supplier update workflow. As soon as a safety data sheet changes in accordance with Article 31 REACH, a substitution resubmission is automatically generated. In this way you avoid the classic mistake of a recipe change by the supplier going unnoticed and the check being formally outdated. Thirdly, it is worth linking it to investment planning: every purchase of new systems or machines that interact with hazardous substances should have a substitution review as a gate before orders are released. In this way, the audit moves from an audit reflex to a real decision-making tool in the company.

The TRGS 600 structures the test in six steps. Step one: Description of the activity, the hazardous substance and the conditions of use. A precise definition of activity is important here, as substitution is context-dependent. Step two: Research possible substitute materials or replacement processes. Sources include supplier catalogues, the GESTIS substance database, the IFA column model, the SUBSPORT database, BG rules and industry publications such as DGUV information 213-091. Step three: Assessment of the alternatives based on the hazard characteristics of acute and chronic health hazards, physico-chemical hazards, environmental hazards as well as availability and technical suitability.

Step four: Comparison of the alternatives with the starting material in an evaluation matrix. The TRGS 600 provides the column model for this, which classifies each property into five levels, from “very high” to “negligible”. Step five: reasoned decision. The decision must be clearly documented, even if no substitution is possible. The justification “technically not possible” is not enough; it must be specifically proven, for example by the customer’s product requirements, regulatory requirements of the downstream market or evidence of failed attempts on a pilot scale. Step six: Documentation and inclusion in the risk assessment. The substitution test is part of the risk assessment according to Section 7 Paragraph 8 GefStoffV and is subject to the general documentation requirements. The inspector calls and the proof is ready if the six steps are clearly documented. In the CIVAC platform, each of these six steps is stored as a mandatory field in the examination template, so that an incomplete process cannot be completed at all. This creates the data basis for 490 ready-to-use audit templates that are available in the workspace. If you follow steps one to six consistently, you can have the process checked by external parties and, if in doubt, defend it before the authorities without having to submit it later.

The column model of the Institute for Occupational Safety of the German Statutory Accident Insurance (IFA) is the assessment tool expressly recommended in TRGS 600. It compares source material and alternatives in seven columns: acute health hazard, chronic health hazard, environmental hazard, fire and explosion hazard, process hazard, release behaviour and additional information. Each column is divided into five risk levels: very high, high, medium, low, negligible. The direct comparison makes it clear whether the alternative actually reduces the overall risk or whether risks just shift.

Example from practice: A cleaning company uses dichloromethane (CMR substance category 2, H351) to remove paint. The substitution test compares dichloromethane with benzyl alcohol-based paint strippers and a mechanical process (dry ice blasting). Column model result: Benzyl alcohol has lower acute toxicity, no CMR classification, lower environmental hazard, but has a higher flash point. Dry ice blasting completely eliminates the chemical hazard, but requires high investment costs and longer processing times.

The reasoned decision must weigh all three options, make a recommendation and provide a deadline and responsibility for implementation. The column model is stored as a template in the CIVAC workspace; The weighting can be saved for each activity and exported in an audit-proof manner. Anyone who runs the column model as a pure Excel solution risks version breaks and audit deficiencies as soon as several areas of activity or locations come into play. Platform-based care is the resilient alternative. In addition, structured column model data sets allow subsequent aggregation across locations, which is regularly requested during group audits or insurance reviews. This also makes it possible to compare several suppliers of the same substitute. This shifts the substitution decision from an individual case assessment to a systematic method that remains comprehensible in the audit and becomes economically defensible.

For carcinogenic, mutagenic and reproductively toxic substances in category 1A or 1B according to the CLP Regulation, a stricter obligation applies according to Section 7 Paragraph 3 GefStoffV. The employer must “replace the hazardous substance or process with a substance, mixture or process that is not or less dangerous to the health and safety of employees under the conditions of use.” Substitution is the rule, sticking to the CMR substance is the exception that requires justification. Anyone who deviates from substitution bears the full burden of justification and must be able to present this in detail in the audit.

In concrete terms, this means: The justification against substitution must be available in writing, the technical impossibility or lack of economic viability must be specifically proven, and the justification must be checked at least every three years. Examples of CMR substances category 1A or 1B are benzene, vinyl chloride, cadmium compounds, hexavalent chromium compounds and some wood preservatives. If substitution is not possible, stricter protective measures according to § 10 GefStoffV apply: closed system, minimization requirement, exposure list according to § 14 paragraph 3 GefStoffV with a 40-year retention requirement and occupational health precautions according to ArbMedVV.

The appointment certificate of the hazardous substances officer must cover these expanded tasks, ideally coupled with a constant reporting line to the management and the responsible person Professional association. Audit-proof, documented, Section 7-proof: This is the standard for CMR substitution. An additional difficulty: The EU Carcinogens and Mutagens Directive (Directive 2004/37/EC) is constantly being expanded to include limit values, which can make substitution decisions earlier than the three-year resubmission. Anyone who works proactively here avoids the typical situation in which a new limit value reduction suddenly overtakes the previous technical standard and forces expensive investments under time pressure. In the CIVAC workspace, regulatory triggers from EUR-Lex and ECHA can be subscribed to as a watchlist, so that relevant changes automatically trigger a resubmission of the substitution decision.

According to Section 7 Paragraph 8 GefStoffV, the substitution test is part of the risk assessment and therefore requires documentation. TRGS 400 Section 8 specifies the requirements. The documentation must contain: the description of the activity, the identification of the hazardous substance including CAS number and H and P phrases, the alternatives tested, the evaluation matrix, the decision, the justification and the date. If a decision is made against substitution, additional reasons must be given as to why the alternative is unsuitable. A general phrase can be attacked in an audit and regularly leads to additional demands or fines.

In practice, supervisory authorities require the following documents in the audit: List of hazardous substances in accordance with Section 6 Paragraph 12 GefStoffV as of the last twelve months, safety data sheets for all substances used in accordance with Article 31 of the REACH Regulation, the risk assessment with substitution test for each activity, the operating instructions in accordance with Section 14 GefStoffV, proof of training and the appointment certificate from the hazardous substances officer. If you store these documents in a structured system, you can survive any audit without any hassle.

The CIVAC workspace offers 490 ready-to-use audit templates, including substitution matrix, hazardous substance inventory and operating instruction templates, plus an integrated reporting line to management. Licence the workspace for your internal representatives or have our representatives order it. Both models comply with Section 6 GefStoffV and work with the same templates, so that a later switch between the models is possible without data disruption. The EU data residency of all documents is standard, a point that is increasingly being asked about in group audits and insurance reviews. In addition, the workspace logs every change with a time stamp and user ID, so that the chain of evidence remains unbroken even after staff changes. This means that the platform not only meets Section 6 GefStoffV, but also the requirements for electronic file management in Art.

Five typical deficiencies occur in audit practice. First: lack of documentation. The substitution test was discussed orally but not recorded in writing. Consequence: The obligation is deemed not to have been fulfilled, regardless of whether the decision was made correctly. Second: general justifications. “Substitution is not technically possible” without concrete evidence is insufficient. Regulatory authorities require a product-related or process-related declaration with reference to specific tests, product requirements or regulatory requirements of the end market. Third: outdated testing. The last substitution test was more than three years ago and a new assessment was not carried out, although new replacement processes have now become established on the market.

Fourth: lack of update on metabolism. A supplier changes the recipe, the H statements change, but the testing is not adjusted. A supplier update workflow that automatically compares safety data sheet versions helps here. Fifth: no connection to the risk assessment. The substitution test exists as an isolated solution without the protective measures being adapted accordingly. This contradicts Section 7 Paragraph 8 GefStoffV and is particularly expensive in the audit because it regularly leads to a review of the entire hazard dossier.

Avoiding these errors begins with a closed process: procurement release linked to substitution testing, automatic resubmission after three years, supplier update workflow for safety data sheets, clear appointment certificate from the hazardous substances officer with reporting line to management. The Hazardous Substances Officer as a Service takes on this process responsibility externally, including an appointment certificate, templates and an SLA of 2 working days for substitution questions instead of the 2 to 6 weeks of classic consultations. This turns the substitution test from a reactive mandatory appointment into an ongoing process. In conjunction with the reporting line to management, an early warning system for regulatory tightening is also created, which also supports strategic purchasing planning.

The substitution test according to GefStoffV is not isolated. It dovetails with other regulatory obligations. Title VII of the REACH Regulation (EC) No. 1907/2006 contains authorisation requirements for substances of very high concern (SVHC). The ECHA candidate list currently includes around 240 substances. Anyone who uses an SVHC substance must demonstrate in the approval decision that no suitable alternatives are available. This REACH substitution obligation overrides the GefStoffV obligation and requires additional documentation, usually a separate alternative assessment in English according to the ECHA format.

The CLP Regulation (EC) No. 1272/2008 provides the classification and labelling system. Without correct H and P phrases, no serious substitution test is possible, as the comparison of the hazard characteristics is based on the data sheet. The Biological Substances Ordinance with its own substitution logic in accordance with Section 9 BioStoffV also applies to biological agents. In companies that carry out both chemical and biological activities (e.g. laboratories, biotechnology, food industry), both tests must run in parallel and come together in an integrated risk assessment.

This requires a representative who masters both worlds, or a platform that brings both processes together. Others run compliance like a filing cabinet. We run it like software. In addition, there is the EU Chemicals Strategy for Sustainability from October 2020, which introduces the “essential use” concept: In the long term, certain substances should only be approved where their use is socially essential. Substitution pressure will therefore increase over the next few years. Anyone who keeps clean substitution dossiers today will be able to act more quickly in the next wave of restrictions and avoid delivery bottlenecks, which regularly occur when EU-wide bans come into force and unprepared market participants look for alternatives at short notice.

The substitution test requires three things: specialist knowledge, process discipline and audit-proof documentation. CIVAC’s compliance platform and officer-as-a-service delivers all three in one package. The workspace contains the TRGS 600 assessment matrix as a template, an integrated list of hazardous substances in accordance with Section 6 GefStoffV, automatic follow-ups for the three-year test, a supplier module for safety data sheet updates and 490 ready-to-use audit templates. The reporting line to the management is standardised, the appointment certificate for the hazardous substances officer is generated in the system, versioned and stored in an audit-proof manner. The EU data residency at ISO/IEC 27001:2022 level is fixed in the contract, with 93 controls and traceable access history.

Licence the workspace for your internal representatives or have our representatives order it. With Officer-as-a-Service, an externally appointed hazardous materials officer from the CIVAC team assumes full operational responsibility with an SLA of 2 working days instead of the 2 to 6 weeks that classic consultations require. Both models comply with Section 6 GefStoffV and are documented for audit purposes. You can switch between the models at any time, for example if an internal representative leaves and you want to ensure short-term continuity. Turn reading into a mandate.: Write to info@civac.de or use the contact form on civac.de. An initial assessment of which substitution tests are open in your company takes 30 minutes and ends with a concrete priority plan that you can continue to use regardless of whether you have commissioned it. We will name the three most critical substances or activities where substitution must begin immediately and specifically identify the associated supervisory risks. If you wish, you will then receive a written recommendation with which you can continue working internally or trigger a procurement process in your organisation without having to start all over again.