REGULATION & COMPLIANCE
substance-level only but at the level of substance-use-combinations.
The Department of Environmental Science at Stockholm University published an interesting study, in which 100 actual applications for REACH authorisation were assessed according to the EUC criteria. 4 About 10 % of the uses were identified as non-essential, while around 55 % were essential. The rest were considered as complex cases and would need a more in-depth assessment.
Given that we have approximately 11,500 MHCs in the CLI, if we assume that each MHC has only one use and 35 % of these substance-usecombinations need to be assessed regarding essentially, we would end up with 4,025 assessments. If we limit the MHC, for example by excluding some properties and / or to substances with a harmonised classification according to the CLP Regulation, the number of assessments would fall.
How can we enforce the‘ essentiality’ parameter?
The enforcement of chemical and product legislation is one of the EU’ s weak points. We have difficulties enforcing relatively clear and simple rules, like a standard restriction setting a concentration limit for a substance in a product. Enforcement officers in the field need clear criteria, which they should check.
Essentiality is the opposite of it. In principle, this should not play a role, if a substance is banned due to an MHC property, since an enforcer can always assume that such a substance is banned until proven otherwise. However, we do not look at substances, but at substanceuse-combinations.
Recalling the basic idea of the EUC as a kind of filter( Figure 2), we will probably need a huge inventory that enforcers can go back to. This will have to include all substance-uses that are:
• Generically essential
• Generically non-essential
• Assessed as essential and eventually for whom this finding is valid
• Assessed as non-essential and eventually for whom this finding is valid
• Non-assessed In principle, enforcement could work with such an overview, though we do not know if the necessary resources are available in the Member States, which are responsible for the enforcement activities. What clearly will not work is enforcers performing their own essentiality assessments.
What are the risks related to the EUC?
The largest risk is a wrong categorisation of an essential use as non-essential. This can happen simply because information is lacking or if the situation changes over time. A good example is two phenolates, NPE and OPNEO. They were not considered important years ago, but later proved to be highly important in the analysis and combat of influenza and corona viruses and so are included in Annex XIV of REACH and subject to authorisation.
Another risk is resources. Today ECHA can process around 60 applications / year for authorisation. The number of essentiality assessments would come on top of this and exceed this number significantly. The approval system would probably collapse and cause a high level of legal uncertainty on the market. Such consequences would not make the EU’ s chemicals legislation an attractive blueprint globally.
In general, the EUC is very theoretical and works under idealised conditions. In practice,
small administrative changes, like renaming a use, can already cause confusion. For example, one and the same use can be called either functional or decorative and both can be correct. The surface of an oven is chromated to protect it from constant heat but also to make it appear attractive, for example.
Final thoughts
It is hard to understand how we could manage the practical enforcement of such a system. Without it, we risk our global competitiveness by losing ourselves in an unprecedented micromanagement exercise that will melt our resources down and suppress our entrepreneurial spirit to a degree that we only know from rigidly planned economies.
Like so many other aspects in chemistry, the EUC follows Paracelsus’ s dictum. At too high a dose it is highly toxic; at a suitably low dose and wisely applied where needed, it can be helpful. Consequently, a regulation should never have the EUC as a main pillar, but only as an auxiliary tool in combination with classical tools like risk and exposure management that have proven to be effective and adjustable. ●
Marko Sušnik
CHEMICALS EXPERT
References: 1: European Commission, EU Chemicals Strategy for Sustainability – Towards a Toxic-Free Environment, COM( 2020) 667 final. 2: European Commission, Guiding Criteria & Principles for the Essential Use Concept in EU Legislation Dealing with Chemicals, C( 2024) 1995 final. 3: European Chemicals Agency( ECHA), Homepage. https:// www. echa. europa. eu / 4: F. Borchert et al., Frontiers in Toxicology, 1 November 2024, 6. https:// doi. org / 10.3389 / ftox. 2024.1488336
J j
SMEUNITED marko. susnik @ wko. at www. wko. at
56 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981