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    Substitution of hazardous chemical agents

    The substitution of hazardous chemical agents is the preventive measure that consists of replacing a hazardous substance, mixture, or process with another that eliminates or reduces the risk to human safety and health. This can be achieved by using a less hazardous product, changing its physical form (for example, from powder to granules or solution), modifying the process or technology, or eliminating the need to use it altogether. It is the first option in the hierarchy of measures for addressing chemical risk: Article 15 of Law 31/1995 mandates avoiding risks and replacing hazardous substances with those that pose little or no danger; Article 5 of Royal Decree 374/2001 requires eliminating or minimizing the risk of chemical agents, preferably through substitution; and Article 4 of Royal Decree 665/1997 mandates replacing carcinogenic and mutagenic agents to the extent technically possible, documenting the results of the investigation when substitution is not feasible. The REACH Regulation reinforces this obligation through the authorization regime for substances of very high concern, which encourages the search for alternatives. Substitution requires a method: identifying priority substances, searching for alternatives, comparing their hazards using tools such as the column model included in INSST Technical Prevention Note 1216, assessing new risks and technical and economic feasibility, testing the alternative, and verifying that exposure is effectively reduced, avoiding substitutions that simply transfer the risk to another agent, another group, or the environment.

    In short

    Replacing a hazardous substance, mixture, physical form, process, or technology with others that eliminate or reduce the chemical risk is the first option in the prevention hierarchy. Law 31/1995 mandates replacing hazardous substances with those that pose little or no danger, Royal Decree 374/2001 requires it as the preferred option over other measures, and Royal Decree 665/1997 mandates replacing carcinogens and mutagens whenever technically possible, documenting the research if it is not. REACH promotes this approach by authorizing substances of very high concern. It requires a methodical approach: prioritizing, searching for alternatives, comparing them with tools such as the column model (NTP 1216 of the INSST), assessing new risks and feasibility, testing, verifying the reduction in exposure, and documenting the results.

    Content
    1. Regulatory framework for replacement
    2. Types of substitution and comparison criteria
    3. Conditions for an effective replacement
    4. Organizational application: how to approach a replacement program
    5. Limits and common mistakes
    6. Practical example
    7. Regulatory and reference framework
    8. Related concepts
    9. References

    A–Z dictionary →

    Regulatory framework for replacement

    • Law 31/1995. Article 15 establishes the principles of preventive action: avoid risks, combat them at their source and replace what is dangerous with what entails little or no danger.
    • Royal Decree 374/2001. Article 5 requires eliminating or minimizing the risks of chemical agents, preferably by replacing the agent or process with others that are not dangerous or are less dangerous, before resorting to other measures.
    • Royal Decree 665/1997. Article 4 requires avoiding the use of carcinogenic and mutagenic agents by replacing them, whenever technically possible, with non-hazardous or less hazardous substances, mixtures or procedures, and documenting the research carried out when this is not possible.
    • REACH Regulation. The authorization regime in Annex XIV requires applicants to analyze alternatives and submit substitution plans, and the candidate list identifies priority substances.
    • CLP Regulation . Harmonised classification and labelling are the basis for comparing the hazard of alternatives.
    • Technical Prevention Notes. NTP 673 describes the general aspects of substitution and NTP 1216 the column model for comparing alternatives.

    Types of substitution and comparison criteria

    The substitution can affect the substance (a chlorinated solvent for a water-based one, a pigment with hexavalent chromium for one without), the physical form or packaging (powder for granules or paste, containers with closed dosing), the process (application by immersion instead of spraying, welding with lower emissions, mechanical cleaning instead of chemical cleaning), or the technology (closed systems, automation). The comparison of alternatives must encompass all hazards: acute and chronic health effects, physicochemical risks (flammability, reactivity), environmental risks, release potential (volatility, dustiness), and process risks (temperature, pressure, quantities), in addition to technical properties and cost.

    The column model, developed by the German Accident Insurance Institute for Occupational Safety and Health and adapted by the INSST in NTP 1216, organizes these criteria into columns and assigns each substance a risk level per column based on its classification according to the CLP Regulation, allowing a quick and transparent comparison between the substance used and the candidates without the need for expert analysis in the preliminary phase; the final decision requires assessing aspects not covered by the model, such as endocrine disruptors and the actual conditions of use.

    Conditions for an effective replacement

    • Complete information. Updated safety data sheets and supplier information on the alternative, including impurities and nanoforms.
    • Analysis of new risks. Verification that the alternative does not introduce fire, reactivity, sensitization or environmental risks that did not exist before.
    • Technical feasibility. Performance testing, compatibility with equipment and materials, and final product quality.
    • Participation. Consultation with workers and their representatives and training in the use of the alternative.
    • Verification. Risk reassessment and exposure measurements after the change to confirm the effective reduction.
    • Documentation. Record of the analysis process and the decision, mandatory when the substitution of carcinogens is not possible.

    Organizational application: how to approach a replacement program

    1. Inventory the chemical agents and prioritize substitutions according to hazard (carcinogens, mutagens, reproductive toxins, sensitizers, substances on the candidate list), exposure, and the number of people affected.
    2. Gather information on the function of each substance in the process and look for alternatives in suppliers, databases, industry associations and publications of the INSST and ECHA.
    3. Compare the alternatives with the column model or other methods, considering all hazards, release potential and process risks, and discard those that transfer the risk.
    4. Evaluate the technical and economic feasibility with pilot tests, consult with workers and their representatives, and decide with the participation of production, quality, purchasing, and prevention.
    5. Implement the alternative with training, updating of procedures, data sheets and labeling, and adjustment of control measures.
    6. Verify effectiveness with risk reassessment and exposure measurements, and document the entire process, including discarded substitutions and their reasons.
    7. Periodically review the inventory and replacement opportunities in light of regulatory, technical and market developments.

    Preventive management software allows maintaining the inventory of chemical agents with their classification and priority for substitution, documenting the analysis of alternatives and decisions, recording tests, training and verification measurements, and making traceable compliance with the obligation to investigate the substitution of carcinogens and mutagens.

    Limits and common mistakes

    1. Replacing with a lesser-known alternative that is equally or more dangerous, or that shifts the risk to another group or to the environment.
    2. Compare only toxicity and forget flammability, reactivity, volatility and process risks.
    3. Making decisions without technical testing or input from the people who use the product leads to rejection or incorrect use.
    4. Do not verify with measurements that exposure has been reduced after the change.
    5. Failure to document research into alternatives when substitution of a carcinogen is not possible.
    6. Abandoning the search for alternatives after a first failed attempt, without periodically reviewing the market and regulations.

    The replacement should be analyzed on a case-by-case basis with complete technical information; this sheet is for informational purposes only.

    Practical example

    Situation: A machinery repair shop uses a degreaser with a chlorinated solvent classified as carcinogenic for cleaning parts.

    • Prioritization. The prevention service identifies the solvent as a priority for replacement based on its classification and the number of people exposed, and gathers information on the required cleaning function.
    • Alternatives. Three options are identified: an aqueous-based degreaser in a closed washing machine, a non-chlorinated solvent of lower volatility, and mechanical cleaning by ultrasound; they are compared with the column model of NTP 1216.
    • Decision and tests. The non-chlorinated solvent is discarded due to its flammability, the water-based washing machine is tested with the participation of the mechanics, and the quality of the cleaning is verified.
    • Verification. After implementation, reassessment and measurements confirm the elimination of exposure to the carcinogen, procedures and training are updated, and the process is documented in the management system.

    Regulatory and reference framework

    NTP 1216 replaces NTP 712 on criteria and practical models for substitution; ECHA publishes guidelines and examples of alternative analysis within the framework of REACH authorization.

    Related concepts

    References

    1. Official State Gazette. Law 31/1995, of November 8, on Occupational Risk Prevention. 1995, current consolidated text. Official source
    2. Official State Gazette. Royal Decree 374/2001, of April 6, on the protection of the health and safety of workers against risks related to chemical agents at work. 2001, current consolidated text. Official source
    3. Official State Gazette. Royal Decree 665/1997, of May 12, on the protection of workers against risks related to exposure to carcinogenic agents at work. 1997, current consolidated text. Official source
    4. European Union. Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). 2006. Official source
    5. National Institute for Occupational Safety and Health. NTP 1216: Substitution of hazardous chemical agents (III): column model (2020 version). 2025. Official source
    6. National Institute for Occupational Safety and Health. NTP 673: The substitution of hazardous chemical agents: general aspects. 2004. Official source
    7. European Union. Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures. 2008. Official source

    Editorial information

    Publication date: August 30, 2026 .

    Editorial Manager: Sabentis Editorial Team .

    Editorial review by Pablo Rodríguez LinkedIn

    Executive Vice President of the ORP International Foundation and Chief Financial Officer of Sabentis.

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