The European Commission Issues Guidelines on Essential Uses: Internal Pushback Has Been Successful?
On April 22, 2024, the European Commission (‘Commission’) issued its long-awaited Guiding Criteria and Principles for the EU Essential Use Concept (‘Guidelines’). The concept of essentiality will be a driving element for granting derogations from future substance restrictions of the ‘most harmful substances.’
The key feature is that the concept does not include any risk element: the only relevant question is whether the use is essential. The concept will be used horizontally: not only in REACH (restriction/authorization), but also in cosmetics, food contact materials, toys, eco-design requirements, etc.
In the past months, media reported some internal pushback (mainly from Commission’s DG GROW) related to this concept. In fact, it comes as a surprise that the Guidelines were issued at this point in time, i.e., shortly before the nomination of the new Commission. In our view, this was only possible at the price of important concessions: the Guidelines seem to be less restrictive than anticipated.
Concept of ‘Most Harmful Substances’
First, the Guidelines provide that the essential use concept will only apply to the ‘most harmful substances’ that are as follows:
- CMR, Cat. 1A and 1B
- Endocrine disruption Cat. 1 (human health + environment)
- Respiratory sensitisation Cat. 1
- Specific target organ toxicity – repeated exposure (STOT-RE) Cat. 1, including immunotoxicity and neurotoxicity
- Persistent, bioaccumulative, and toxic/very persistent and very bioaccumulative (PBT/vPvB)
- Persistent, mobile, and toxic/very persistent and mobile (PMT/vPvM)
- Hazardous to the ozone layer
With respect to the PMT and vPvM category, the Guidelines provide that the inclusion of ‘all’ PMT and vPvM will be subject to ‘further assessment.’
The definition of ‘most harmful substances’ is slightly narrower than ‘substances of concern’ as defined in the eco-design criteria for sustainable products (for example, CMR Cat. 2 not covered, ecotox categories, and STOT-RE single exp. not included). It is very similar to categories that will be subject to generic REACH restrictions (except for the ozone layer hazard). This said, the note related to the PMT/vPvM category is interesting: it may suggest that after all, these categories are not that critical and may not even be included in the future of the generic REACH restriction concept.
The Criteria for Demonstrating Essential Use
The basic criteria are the same as included in the March 2023 WSP Report, i.e., the use must be:
- Necessary for health and safety AND/OR critical for the functioning of society, AND
- There are no alternatives that are acceptable from the standpoint of environment and health
The Guidelines include a number of subcategories and examples. The ‘necessary for health and safety’ element will likely be applied quite narrowly to applications that are strictly related to health (medical devices, etc.) and safety (personal protection, elements crucial for safety, such as breaks or fire and corrosion protection).
On the other hand, the ‘critical for the functioning of society’ element is broader. For example, the Guidelines include the following subcategories of uses:
- Securing sufficient and safe food and feed chain (all stages, including distribution and thus arguably food packaging)
- Providing resources or services that must remain in service for society to function
- Includes: renewable energy, electricity, oil, gas, mobility and transport, water treatment and water supply, waste treatment, critical raw materials, etc.
- Enabling the functioning of indispensable digital infrastructures, technologies and services, such as data processing, navigation, and sensing
- Enabling the manufacture, supply, maintenance, and recycling of key equipment and components for those resources and services that are critical for society
- Here, the Guidelines make a direct link to the recent EU Chips Act (Regulation (EU) 2023/1781)
- Reducing and mitigating greenhouse gas emissions, such as use for renewable energy technologies and zero-emission transport technologies
- Research and development under controlled conditions
Acceptable Alternatives
The Guidelines provide that ‘acceptable alternatives’ must be ‘capable of providing the function and the level of performance that society can accept as sufficiently delivering the expected service.’ This is quite vague, but it can be interpreted as meaning that the performance should be quasi-equivalent (as the society is rather demanding).
The Guidelines make an indirect link to technical and economic feasibility assessment under REACH authorization and restriction. In addition, the Guidelines recall the case law under REACH, according to which the term ‘suitable’ means that the alternative must be ‘economically and technically viable.’ Thus, the Guidelines seem to concede that the economical element is also relevant (this said, we note that whereas REACH uses the term ‘suitable’ alternative, the essential use concept uses the term ‘acceptable’ alternative, which may be less strict).
All in all, it seems that an alternative must be available, viable, and sufficiently performant in order to justify a ban.
Concluding Remarks
The concept of essential uses is not truly new. Derogations from substance restrictions under REACH or Biocidal Products Regulation have already been subject to socio-economic analysis to prove that the use is (de-facto) essential. In our view, the Guidelines do not restrict the continued use of this concept. The subcategories in the Guidelines are sufficiently broad to cover e.g., environmental applications. They even seem to cover digital technologies, including semiconductors. Thus, the scope seems to be broader as compared to the essential use concept outlined in the 2020 EU Chemicals Strategy for Sustainability. So, DG GROW can be satisfied as the concept facilitates derogations for essential uses thus far to continue, which has reportedly been one of DG GROW’s main concerns.
The only restrictive element in the essential use concept is the lack of the risk element in the essentiality assessment. But here, the battle is not lost. The risk element can still be built in the specific legislative amendments that will introduce the essential use concept for each of the product categories.
In other words: the applicability of the (non-binding) Guidelines is only limited to the definition of essential uses as such. But the Guidelines do not preclude any additional criterions to be added in the future pieces of legislation, including a sort of ‘low-risk’ derogation.