Differentiated view of "risk versus hazard"

According to which principles should substances used in the chemical industry be regulated today and in the future? The concept of "hazard" and "risk" is of central importance here. The fundamental understanding of these two terms and the resulting approaches to the safety assessment of chemical substances or entire chemical substance classes form the basis for regulatory provisions and thus determine how chemicals are handled in the industry today.

A matter of perspective
The distinction between the two terms "risk" and "hazard" is very important for the chemical industry. While "hazard" describes the inherent danger of a substance, "risk" refers to the extent of the potential damage. Under the risk-based approach, it is not only the hazard potential of a substance that is relevant, but the actual risk potential if the substance is used in a certain way and quantity.

This approach thus offers the possibility of implementing further factors, such as exposure, in the assessment of the hazard potential. For example, a substance can have a high hazard classification but pose a low risk if it is used in a targeted manner and under controlled conditions (see comparative example " mobility and transport" below).

Reducing risks without sacrificing benefits
With regard to the regulation of chemical substances, this means risks must be reduced as far as possible without having to forego the benefits of using substances and processes. This includes technical measures, such as encapsulating processes in closed systems or controlled exhaust air purification, if substitution with other, less hazardous substances is not available. Furthermore, organisational measures such as access restrictions and, ultimately, equipping employees with personal protective equipment are also elements of risk reduction.

Such elements have long been standard in our industry's risk management processes. With regard to regulation, it is always necessary to carefully weigh up the advantages and disadvantages of using a substance, refraining from using a substance and, if available, assessing alternatives. This is time-consuming for individual substances, but hardly feasible for entire groups of substances due to their complexity - neither for industry nor for authorities.

EU: original regulatory plan postponed
In terms of opportunities and risks, perfluorinated and polyfluorinated alkyl substances (PFAS) pose a particular challenge. This group of different classes of chemicals is used in industry due to a variety of positive properties: Water-, grease- and dirt-repellent properties as well as high chemical and thermal stability make these chemicals fundamental in industrial products and processes (e.g. in the manufacture of solar cells and photovoltaic systems, in medicines for humans and animals and in the production of computer chips). However, it is precisely these inert properties that also make them highly resistant to natural degradation processes.

The EU has therefore taken extensive measures to minimise the risks of PFAS, including the introduction of strict limits for certain PFAS compounds and a planned large-scale ban on PFAS compounds. The problem with the EU's publicised intention to ban PFAS is that the disruption for industry and commerce, but above all for the general public, would be extremely high. The European authorities therefore had to abandon the original timetable and face the challenge of an actual risk assessment.

Switzerland: more pragmatic chemicals regulation to date
Switzerland pursues a similar approach to regulation. These include, in particular, restrictions and bans from the European chemicals legislation REACH, which are implemented almost one-to-one autonomously with the argument of the "same level of protection". To date, Switzerland has taken a somewhat more pragmatic approach to the use of substances in Switzerland than the EU.

With the chemicals regulation currently in force in Switzerland, local companies can work with substances for longer (plus 10 years compared to the EU). In order for companies to benefit from the extension, they must fulfil a number of criteria. For example, Switzerland relies on the S-T-O-P principle (substitution - technical measures - organisational measures - personal protective equipment) - a classic risk management strategy.

Regulatory developments in the EU and Switzerland
The European Union has taken significant steps in recent years to increase chemical safety. With the introduction of the REACH Regulation, a comprehensive system for the assessment and control of chemicals has been established. This regulation emphasises the importance of a differentiated risk assessment. However, REACH favours the hazard approach over the more sensible risk approach.

The Chemicals Act, the Chemicals Ordinance and the Chemical Risk Reduction Ordinance enable Switzerland to independently adopt the main restrictions on the handling of chemicals introduced at European level by REACH, in addition to its own considerations. Harmonisation of regulation can be implemented quickly and pragmatically at the ordinance level.

Balanced and pragmatic approach necessary
The revision of the EU's REACH regulation as part of the European Green Deal and the foreseeable update of Swiss chemicals legislation show that the chemical and pharmaceutical industry in Switzerland will have to expect a more strictly regulated approach to chemicals in the future. It faces the challenge of finding a balance between innovation and safety. In other words, a differentiated and knowledge-based view of the risk and danger of chemicals is essential.

In order to realise the full benefits of chemicals in the various areas of application, a holistic approach is necessary. The interests of society, the substance- and application-related risks, the damage potential of a ban and the availability of alternatives and their relevance in terms of safety for humans and the environment must be carefully weighed up. The proven cooperation between the Swiss authorities and industry and commerce forms the foundation for the safe handling of chemicals and thus enables innovation and progress for people and the environment - now and in the future.