Progress in regulating substances under REACH and CLP (Indicator)

Key messages: The number of chemicals registered under the REACH Regulation and under assessment by EU authorities has increased substantially since 2010, from around 50 to over 2,000. Authorities requested additional data for many of these chemicals, which led to improved knowledge of their hazardous properties. The number of chemicals registered under REACH deemed to need EU-wide risk management measures has increased moderately since 2010. This rising trend is expected to continue as more substances are assessed.

Number of substances in different regulatory pools, 2010-2021

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^{Note: Substances registered under REACH Article 10 according to their regulatory status: (a) REACH-registered substances at 100 t/y or more; (b) REACH-registered substances at less than 100 t/y.}^{Substances for which EU-wide risk management action (such as a REACH restriction) is in place or proposed (orange). Substances for which authorities are still considering the need for EU-wide risk management action (yellow). Substances for which an assessment has found that no further EU-wide actions are warranted (green). Substances for which no regulatory action has been initiated (grey).}

The number of substances registered above 100 tonnes per year (t/y) or more that have been assessed as needing EU-wide risk management measures steadily increased between 2010 and 2021. EU-wide risk management measures may be for instance harmonised classification under the Classification, Labelling and Packaging of Substances (CLP) Regulation or restriction and authorisation under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation. This moderate increase is expected to continue (orange area, Figure (a)). The number of substances registered below 100 t/y assessed as needing EU-wide risk management measures has also been rising, especially from 2017.

A clear and substantial increase has been found in substances registered above 100 t/y or more for which an assessment has concluded that no further EU-wide risk management action is needed (green area, Figure (a)). The number of substances in this pool is expected to rise as more assessments confirm their low hazard and/or low potential for exposure of human health and environment. A similar increase is visible for substances registered at less than 100 t/y.

The number of substances under assessment has increased substantially since 2010 (yellow area, Figure (a)). These substances are under examination for risk management action by EU authorities, including evaluating whether they are actually hazardous. Most substances in this pool require some generation of hazard data by industry before a conclusion can be reached. The number will continue to rise for some years due to EU authorities’ continuous effort to assess all REACH registered substances, in particular clarifying their hazardous properties. This pool has expanded due to the time required to generate long-term toxicity data, in particular. Ultimately, the number of substances under assessment is expected to decrease as they are reallocated to green or orange pools.

Knowledge of the hazardous properties and exposure potential for all REACH registered substances on the EU market continues to grow. This is represented by the dramatic fall in substances not yet assigned since 2010 since 2010 (grey area, Figure (a)). These substances have not yet been assessed.

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

This indicator tracks progress in regulating substances under REACHand CLP. It provides an understanding on how the European Commission, EU Agencies and Member States are working together to minimise and control risks of substances by continuously considering and implementing EU-wide risk management measures for hazardous substances.

EU-wide risk management measures include restrictions under REACH or a harmonised classification under CLP. These can be a pre-requisite to other downstream EU legislations, leading to minimisation of exposure of humans or the environment. Authorities prioritise substances with higher potential of exposure of humans and the environment.

The indicator provides information on substances fully registered at more than 100 t/y and less than 100 t/y. For several years, authorities have focused on substances registered at high tonnage (above 100 t/y) which explains the differences observed between Figure (a) and Figure (b).

The indicator includes substances that as of December 2021 have at least one active full registration (according to REACH Article 10) at 100 t/y or more (Figure (a) or below (Figure (b)). It is assumed that the registration status remained the same at all points in time. The indicator therefore only tracks the movement of substances in different regulatory pools over time and not the movement across tonnage bands or activity status. The tonnage band of substances can change over time. This simplified workflow does not significantly change the observed indicator trends.

Not all substances for which risk management has been implemented are visible in the indicator. Establishing EU-wide risk management measures may lead to substances being taken out of the EU market or produced at lower quantities than the tonnage per year threshold of this indicator.

The European Chemicals Agency Universe of registered substances is available here.

References and footnotes

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, 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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Progress in regulating substances under REACH and CLP (Indicator)

Number of substances in different regulatory pools, 2010-2021

Relevant objectives under the Chemicals Strategy for Sustainability

Other relevant indicators and signals

References and footnotes