Key messages: Use volumes of substances for which there is scientific evidence that they are carcinogenic, mutagenic or reprotoxic (CMR category 1) grew by less than 10% across the EU over the last decade. This compares to use of other (non-CMR) substances which grew by nearly 40%. Over the last decade, the growth in use volumes of CMR substances was about 20% slower than that for less hazardous substances.  

Growth of use volumes of REACH-registered substances of different levels of concern, relative to use volumes in 2010,  2010-2022

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This indicator tracks how use volumes of CMR category 1 substances registered under the Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation (REACH) have developed in the EU since 2010, compared to other REACH-registered substances.   

As shown in Figure 1, use of substances in the two pools has grown over the last decade (by 8% and 37%, respectively). However, growth in the use of substances classified as CMR category 1 has been 20% slower than that of other substances (see red line). This trend has accentuated since 2015. Given that CMR substances are highly regulated, it may be concluded that EU chemicals regulations has dampened growth in use volumes of such substances. 

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

Definition 

The indicator tracks how the use volumes of substances of varying concern have developed in the EU. Use volumes are calculated by adding production and imported volumes, and subtracting volumes exported or used as intermediates. It indicates whether the use of substances of a particular level of concern has grown faster than that of other substance classes. To this end, use volumes for each REACH registration submitted since the first REACH registration deadline in 2010 were normalised against their maximum use volume in any given year between 2005 and 2022 (excluding registrations whose annual use volume never reached 1 tonne/year).  

In a second step, the normalised volumes were aggregated by year and level of concern, then normalised again with respect to the baseline year 2010 (when the first REACH registration deadline occurred). It should be stressed that every registration contributes equally to the indicator, regardless of the absolute use volumes recorded.   

Hence, the curves can measure economic growth, i.e. the growth in the market that is using substances belonging to the respective hazard pool. The indicator does not convey information on absolute use volumes. If a registration showed a 50% decline in business, this will be cancelled out by another registration that saw a 50% increase in business, even though the absolute use volumes may differ by several orders of magnitude. The methodology is tailored to particularities of the volume data received in the REACH registration dossiers, as summarised in the paragraphs below.  

Conventions  

Registrations are assigned to the two pools based on harmonised classifications rather than the self-classifications contained in the registration dossiers. Assignment of substances to the pool of CMR substances is based on the current hazard classes and categories in Annex VI of the Classification, Labelling and Packaging of Chemical Substances and Mixtures (CLP) Regulation.   

In the future this might be adjusted to include substances that are persistent, bioaccumulative and toxic (PBT); very persistent and very bioaccumulative (vPvB); endocrine-disrupting as well as persistent, mobile and toxic (PMT); or very persistent and very mobile (vPvM). Conditional classification for carcinogenicity and mutagenicity, as reflected in the notes of the affected index entries, is not applicable. However, the indicator algorithm applies a harmonised classification for group entries in Annex VI of the CLP Regulation to the extent available data and knowledge allow doing so. It is important to note that substances are assigned to the CMR pool according to Annex VI of the CLP Regulation regardless of the time their corresponding index number was first introduced or updated. Hence, use volume is time-dependent, whilst the hazard classification is not. This convention was adopted primarily because the inherent properties of a substance are time invariant, even though they might not have been fully known when the substance was originally identified.  

Data source 

The indicator is based on use volume data from REACH registration dossiers. Subject to the constraints explained below, it considers all submitted registrations and their updates. It is important to note that registrants are not required to report volume information for every calendar year. The indicator algorithm attempts to complete the time series of use volumes for each registration using linear interpolation for missing time points. As many registrations are not regularly updated, it is necessary to project the last reported volume figures into the future and into the past to fill gaps before the first update and after the latest update. Events like cease of manufacture and import are taken into account.  

Limitations 

The large volume of reported data prevents manually checking their accuracy. While data-quality challenges hamper meaningful interpretation of raw use volumes, it is still possible to produce a robust indicator by normalising the data in such a way that inaccuracies in reported volumes do not dominate. The proposed indicator achieves this by normalising the time series of use volumes for each registration (dividing the use volumes by the maximum use volume ever reported for that registration).  

In this way, the use volume of each registration is limited to the unit interval. Normalised volumes of a registration are then totalled for all registrations for substances in the same hazard pool. The pool sum as of 2010 is used as a baseline. Registrations that never reach 1 tonne/year in their lifetime are ignored as commercially not important. This means that the indicator does not track absolute use volumes and does not convey information about human exposure to substances or emissions to the environment.   

Instead, it tracks the growth of businesses based on the hazard level of the substances they use. Moreover, it is important to keep in mind that overall economic growth affects the increase in use volumes of all chemicals. Chemicals regulations contribute to the observed differences between CMR substances and other substances, either because it restricts the use of certain substances or because it encourages the substitution of less hazardous alternatives. However, the available data cannot determine how much the observed differences result from chemicals regulation versus economic churn.  

For further information please contact the European Chemicals Agency from here.

References and footnotes

  1. EU, 2010, Commission Regulation (EU) No 276/2010 of 31 March 2010 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII (dichloromethane, lamp oils and grill lighter fluids and organostannic compounds) (Text with EEA relevance) (OJ L 86, 1.4.2010, pp. 7-12). 
  2. 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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