The European Commission wants to measure the benefits of chemical regulation
The Commission is studying the results of REACH and CLP
As part of the regulatory compliance program (REFIT), the European Commission studied the benefits of chemical regulations on health and the environment such as REACH regulation.
Three types of indicators were set up in order to measure the benefits of European regulations between 2004 and 2013:
- Realization
- Result
- Impact
Indicators of achievement
This type of indicator refers to the objectives pursued by legislation. They measure the specific actions of the REACH and CLP regulatory mechanisms that are likely to cause changes in terms of population exposure (measured by the result indicators) and/or the reduction of negative effects on health and the environment (measured by the impact indicators).
The regulatory mechanisms targeted by these indicators are harmonized classification and labelling (CLH), self-classification (classification according to the internal regulations of the Member States), authorizations and restrictions. More specifically, the indicators put forward by the study are:
- Substances whose CHL was implemented after the entry into force of REACH and CLP, organized by risk class
- Self-classification changes (according to their risk class) since the entry into force of REACH and CLP
- Restriction decisions taken after the entry into force of REACH and CLP according to the hazard class, the PBT/vPvB profile and the endocrine activity of the substances, and the groups of substances covered by these legislations
- SVHCs included in Annex XIV according to their risk class, possessing a PBT/vPvB profile or clear evidence of endocrine activity
Outcome indicators
The result indicators proposed by the study measure the immediate effects of regulation on direct beneficiaries. They are defined according to changes in exposure to chemical substances:
- Changes in the concentration levels of selected substances in the tissues of the human body
- Changes in the concentration levels of selected substances in animal and plant tissues
- Changes in concentration levels of selected substances in air, water, and soil samples
- Changes in emissions of selected substances into air, water and land
- Changes in the volume of production of selected substances
Impact indicators
Impact indicators measure the “final” consequences of regulations, beyond direct interactions with their beneficiaries. The study interprets this as moving from changes in exposure to changes in reality. The indicators proposed are:
- Changes in incidence, prevalence and mortality, following a change in exposure to chemicals due to regulatory requirements of chemical legislation, by disease group
- Changes in environmental impacts (defined by ecosystem service or number of species) following a decrease in human exposure due to regulatory requirements of chemical legislation
Lack of data and measurement difficulties
The lack of information to quantify human exposure
However, the authors of the study warn of the difficulties that the Commission will have in quantifying the benefits provided by chemical legislation. Indeed, there is little historical data on trends in human exposure to chemical substances, as well as on the impacts that can be attributed to these exposures.
According to the study, “the most appropriate indicator of current human exposure is the biological measure of body burden, but currently only 200 chemical substances can be measured using data from human biomonitoring.” To solve this problem, the Commission has invested 50 million to develop human biomonitoring on a European scale.
The difficulty of monetizing disease benefits
The statistics that feed the impact indicators only make it possible to measure the monetary value provided by regulatory requirements for diseases with a short latency period, such as occupational skin diseases or occupational asthma.
However, according to the report, “the systematic collection of data on the incidence and prevalence of diseases related to exposure to chemical substances, coupled with the improvement and increase of toxicological and epidemiological studies, should allow for a future expansion of the evaluation of the benefits of chemical regulations to diseases with a long latent period, with stronger associations to exposure to specific chemical substances.”
The tenuous link between changing impacts and regulatory requirements
The report states that it will be difficult for the Commission to prove that the reduction in harmful effects on human health and the environment is in fact due to the new requirements brought about by the implementation of REACH, CLP and other chemical regulations. At present, it is difficult to attribute changes in trends to regulatory changes rather than to technical or economic factors.
The Commission is studying the results of REACH and CLP
As part of the regulatory compliance program (REFIT), the European Commission studied the benefits of chemical regulations on health and the environment such as REACH regulation.
Three types of indicators were set up in order to measure the benefits of European regulations between 2004 and 2013:
- Realization
- Result
- Impact
Indicators of achievement
This type of indicator refers to the objectives pursued by legislation. They measure the specific actions of the REACH and CLP regulatory mechanisms that are likely to cause changes in terms of population exposure (measured by the result indicators) and/or the reduction of negative effects on health and the environment (measured by the impact indicators).
The regulatory mechanisms targeted by these indicators are harmonized classification and labelling (CLH), self-classification (classification according to the internal regulations of the Member States), authorizations and restrictions. More specifically, the indicators put forward by the study are:
- Substances whose CHL was implemented after the entry into force of REACH and CLP, organized by risk class
- Self-classification changes (according to their risk class) since the entry into force of REACH and CLP
- Restriction decisions taken after the entry into force of REACH and CLP according to the hazard class, the PBT/vPvB profile and the endocrine activity of the substances, and the groups of substances covered by these legislations
- SVHCs included in Annex XIV according to their risk class, possessing a PBT/vPvB profile or clear evidence of endocrine activity
Outcome indicators
The result indicators proposed by the study measure the immediate effects of regulation on direct beneficiaries. They are defined according to changes in exposure to chemical substances:
- Changes in the concentration levels of selected substances in the tissues of the human body
- Changes in the concentration levels of selected substances in animal and plant tissues
- Changes in concentration levels of selected substances in air, water, and soil samples
- Changes in emissions of selected substances into air, water and land
- Changes in the volume of production of selected substances
Impact indicators
Impact indicators measure the “final” consequences of regulations, beyond direct interactions with their beneficiaries. The study interprets this as moving from changes in exposure to changes in reality. The indicators proposed are:
- Changes in incidence, prevalence and mortality, following a change in exposure to chemicals due to regulatory requirements of chemical legislation, by disease group
- Changes in environmental impacts (defined by ecosystem service or number of species) following a decrease in human exposure due to regulatory requirements of chemical legislation
Lack of data and measurement difficulties
The lack of information to quantify human exposure
However, the authors of the study warn of the difficulties that the Commission will have in quantifying the benefits provided by chemical legislation. Indeed, there is little historical data on trends in human exposure to chemical substances, as well as on the impacts that can be attributed to these exposures.
According to the study, “the most appropriate indicator of current human exposure is the biological measure of body burden, but currently only 200 chemical substances can be measured using data from human biomonitoring.” To solve this problem, the Commission has invested 50 million to develop human biomonitoring on a European scale.
The difficulty of monetizing disease benefits
The statistics that feed the impact indicators only make it possible to measure the monetary value provided by regulatory requirements for diseases with a short latency period, such as occupational skin diseases or occupational asthma.
However, according to the report, “the systematic collection of data on the incidence and prevalence of diseases related to exposure to chemical substances, coupled with the improvement and increase of toxicological and epidemiological studies, should allow for a future expansion of the evaluation of the benefits of chemical regulations to diseases with a long latent period, with stronger associations to exposure to specific chemical substances.”
The tenuous link between changing impacts and regulatory requirements
The report states that it will be difficult for the Commission to prove that the reduction in harmful effects on human health and the environment is in fact due to the new requirements brought about by the implementation of REACH, CLP and other chemical regulations. At present, it is difficult to attribute changes in trends to regulatory changes rather than to technical or economic factors.
