The new EU sustainability strategy for chemicals
This quarter, the EU Commission presents its sustainability strategy for chemicals. This is part of the Green Deal presented by EU Commission President Ursula von der Leyen in December 2019. The main objectives of the new chemicals strategy are:
- ensure an environment free of toxic substances (zero pollution),
- avoid undesirable combination effects
- simplify the legal framework for chemicals policy,
- create more transparency in the evaluation of chemicals and to advance the process in the sense of "one substance - one assessment",
- strengthen the production capacity of the chemical industry in a sustainable and competitive way.
What the new initiative means in practice
This EU strategy is the first of its kind since the REACH Regulation came into force in 2007. It will have a serious impact on the effort chemical companies have to make to ensure their substances meet all regulatory requirements, possibly leading to changes in their product range. The reasons for this are:
- Stricter requirements will be imposed on certain products, up to a possible complete ban.
- For many substances, a complete re-evaluation will be necessary to take account of so-called "unintentional mixtures".
- The introduction of a hazard class for the EU-wide classification of endocrine disruptors under the CLP Regulation.
"A detailed risk assessment is already in place for all our substances," says Teresa Bernheim, Manager Chemicals Policy at LANXESS (see also interview below). "We would like to see every further step in EU chemicals policy continue to be based on this risk-based approach, rather than undermining it. Substances should not be banned because of their hazardous properties only. These substances can also be handled safely. It is important to look at the benefits of the substance and the risk that has been recorded and documented, as well as the proven risk management. Looking at real-world operational practice is important."
Politicians are called upon to act with a sense of proportion
- LANXESS welcomes the initiative to simplify the legal framework for chemicals policy. Especially the "one substance - one assessment" approach creates transparency and is helpful to avoid double assessments or contradictory assessments depending on the member state, authority or field of application.
- It is expedient to harmonize the assessment of endocrine disruptors. However, this must be done within an appropriate legal framework. The CLP Regulation* is the wrong instrument for this.
- Introducing the so-called Mixture Assessment Factor** (MAF) as an additional safety mechanism would exceed the cost-benefit ratio. This is because the required handling of substances already serves to avoid unintended combination effects. LANXESS therefore rejects the MAF.
** In order to incorporate the risk of undesirable combination effects into the REACH chemical assessment, a Mixture Assessment Factor is under discussion. This is a number by which a key risk calculation value is multiplied to include the risk of unintended mixtures of chemicals.
What are endocrine disruptors?
- damage growth, development and reproduction, or
- increase susceptibility to specific diseases.
Identifying these effects is difficult because
- the function of hormone systems and species-specific sensitivity differences is not known well enough - resulting in a lack of testing methods.
- effects occur with a time lag and
- there may be additive effects with endocrine disrupting chemicals already present in the environment.
Interview with Teresa Bernheim, Manager Chemicals Policy at LANXESS
Which substances are affected by the EU sustainability strategy for chemicals?
The strategy comprises many possible measures. Some measures apply to groups of substances with certain properties, for example endocrine disruptors or substances that do not degrade in the environment. However, the Mixture Assessment Factor**, which is intended to prevent the negative effects of so-called chemical cocktails, would affect all our substances.
And what does this mean for LANXESS?
We are already performing risk assessments for all our substances. How great the risk is depends not only on the substance, but also on how it is used, in what quantities it is used and whether people come into contact with it at all. We record these data on a scientific basis, document it and, among other things, prepare detailed safety data sheets for safe handling on our premises and by subsequent users, right through to disposal.
How dangerous are adverse chemical cocktails?
Avoiding them, for example through incorrect disposal, is a key aspect of chemical safety, to which companies are already obliged by a number of laws. Additional safety factors are built into the assessment of each individual substance to protect particularly sensitive population groups such as pregnant women or children. We and our customers handle substances competently and safely. The idea of re-evaluating every substance is not based on new scientific findings or observations. That's why we reject the Mixture Assessment Factor**.
How should endocrine disruptors be handled?
We do not want people or the environment to be harmed by endocrine disruptors. That's why we are working on proposals for how endocrine disruptors can be effectively regulated without the need for complete bans.
