Number of substances identified as carcinogenic, mutagenic or toxic for reproduction (Indicator)

Key messages: Between 2009 and 1 January 2023, the number of substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMR category 1A or 1B) has increased by 88. Substances that are carcinogenic, mutagenic or toxic for reproduction require risk management measures in the workplace and under sector specific legislation. They also need regulatory actions under Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). This increases pressure on industry to replace these chemicals with less hazardous alternatives.

Cumulative change in the number of substances identified as CMR category 1, 2009-2023

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To protect human health and the environment, manufacturers, importers and downstream users of chemicals must classify and label the hazardous substances and mixtures they place on the market.

For substances with CMR properties classification and labelling should be harmonised throughout the EU on a case-by-case basis. Details of harmonised classification and labelling (CLH) are listed in Annex VI of the Classification, Labelling and Packaging (CLP) Regulation. These should be applied by all manufacturers, importers or downstream users of such substances — and mixtures containing such substances — to ensure adequate risk management.

Classifying a substance as carcinogenic, mutagenic or toxic to reproduction (CMR 1A/B) triggers mandatory risk management measures under the legislation for workers and regulatory actions under REACH and various EU sectorial regulations. These include for instance the Cosmetics Products Regulation, Biocidal Product Regulation, Plant Protection Regulation and Toy Safety Directive. For this reason, harmonised classification of CMR 1A/B substances pressures industry to substitute with less hazardous alternatives. For instance, under REACH, placing CMR 1A/B substances (including as constituents of other substances and in mixtures) on the market for supply to the general public is restricted when the concentration exceeds a certain limit.

The Figure shows the cumulative number of substances identified as CMR 1A/B each year since CLP Regulation entered into force. When first introduced, approximately 1,100 CMR 1 substances were transferred from the older legislative framework, but those are not tracked by the current indicator.

The graph demonstrates continued and steady progress in identifying substances as CMR 1. Notably, between 1 January 2022 and 1 January 2023, approximately 20 new substances were added to Annex VI of CLP, which should put additional pressure on industry to substitute with less hazardous substances.

Please consult the relevant indicators and signals below for a more comprehensive overview on the topic.

For the current indicator, in anticipation of changes stipulated by the CSS, the evolution of harmonised CMR 1 classifications in Annex VI to the CLP Regulation is used as an initial proxy measure in identifying most harmful substances by authorities. Expanding the indicator’s scope will require further analysis and will be carried out in subsequent iterations once more hazard classes are added.

The European Chemicals Agency (ECHA) created a database that retrospectively recorded the development of Annex VI of the CLP Regulation over time. The database also links to the REACH registration database so that newly-registered substances can be identified. The indicator tracks the cumulative number of substances present in Annex VI over time since the beginning of the CLP regulation implementation.

No new substances were added to Annex VI between 2010 and 2012 due to the time needed to adapt to the change of regulation. Note also that substances may be removed from Annex VI or have their hazard classes changed. The indicator tracks the addition, removal and modification of harmonised classifications over time.

It is important to note that the current indicator only tracks substances with their EC or CAS number explicitly included in Annex VI of CLP, without attempting to account for the substances affected by group entries. The quality of the substance identifiers is critical in developing this indicator as it allows us to identify and track the substances. The results presented are the most accurate we can produce today, but we would expect the quality to improve as ECHA continues its work on substance identifier management.

This indicator is recommended by the European Commission's study on key performance indicators (KPIs) to measure the industrial transition towards producing safer and more sustainable chemicals.

For more information on harmonised classification under CLP, please visit ECHA's dedicated webpage.

References and footnotes

EU, 2008, 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, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance) (OJ L 353, 31.12.2008, pp. 1–1355).
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EU, 2006, 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), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, pp. 1–849).
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EU, 2009c, Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) (Text with EEA relevance) (OJ L 342, 22.12.2009, pp. 59–209).
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EU, 2012, Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products Text with EEA relevance (OJ L 167, 27.6.2012, pp. 1–123).
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EU, 2009, Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, pp. 1–50).
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EU, 2009, Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (Text with EEA relevance) (OJ L 170, 30.6.2009, pp. 1-37).
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EC, 2020, COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Chemicals Strategy for Sustainability Towards a Toxic-Free Environment, (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52020DC0667) accessed 26 April 2023, European Commission.
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Number of substances identified as carcinogenic, mutagenic or toxic for reproduction (Indicator)

Cumulative change in the number of substances identified as CMR category 1, 2009-2023

Relevant objectives under the Chemicals Strategy for Sustainability

Other relevant indicators and signals

References and footnotes