The planned REACH revision is one of the actions announced in the Chemicals Strategy for Sustainability
We have already spoken about the new discussion about polymers’ registration. Of course, this is “THE” massive change in the REACH, however it is not the only one.
As some of you have noticed, the European Commission has launched a public consultation on the revision of the REACH, with the deadline scheduled for 15th April 2022.
As part of the EU’s zero pollution ambition, which is a key commitment of the European Green Deal, the European Commission published the “Chemicals Strategy for Sustainability” the preceding on 14 October 2020.
- Increased information on critical hazards
To better protect human health and the environment, the Chemical Strategy for Sustainability has committed to increase the information requirements under REACH for all chemicals, especially for so-called critical hazards such as carcinogenicity, mutagenicity and reproductive toxicity, endocrine disruption. This may imply the need for companies (registrants of substances, i.e. manufacturers and importers of substances) to test more chemicals for more hazardous properties.
- Information on substances marketed at the lowest tonnage level
The REACH regulation seeks to address information deficits on chemicals by requiring manufacturers and importers to provide toxicological and ecotoxicological information on substances placed on the market in quantities of more than 1 tonne per year.
Article 138 of REACH requires the Commission to undertake reviews of the requirements for 1-10 tonnes substances and the Chemicals Strategy for Sustainability notes that information required for substances in the low and medium tonnages under REACH does not fully allow substances with critical hazard properties to be identified and their risks managed.
- Information requirements to provide information on endocrine disruption
As part of the impact assessment on the revision of the REACH Regulation, the Commission is assessing options for introducing standard information requirements at each tonnage level that will allow EDs to be identified.
- Information on environmental footprint
The Chemicals Strategy for Sustainability concludes that the EU is still lacking a comprehensive information base on all substances placed on the market and on their overall environmental footprint, including their impact on climate, and that this hinders the proper management of chemicals and products and does not allow for a full sustainability assessment. Therefore, to improve the availability of chemical data, the Chemicals Strategy for Sustainability asks for an assessment of how to best introduce information requirements under REACH on the overall environmental footprint of chemicals, including on emissions of greenhouse gases.
- Information requirements on use and exposure
Information on uses and exposures is one of the key building blocks of REACH, allowing registrants to implement and/or recommend operational conditions and risk management measures to downstream users (end users) that ensure the safe use of chemicals.
However, shortcomings in the currently available use and exposure data have been identified which impact regulatory management of chemical risk including the above-mentioned processes under REACH. The European Commission is therefore considering a potential revision of the registration requirements and downstream user obligations as regards the provision of information on uses and exposures.
- Introduction of a Mixture Assessment Factor
Various studies have shown that ‘unintentional’ co-exposure to substances can lead to adverse effects on people and the environment. Exposures at concentrations that are regarded as safe for individual substances (i.e., where no effects are expected) can still result in adverse (eco)toxicological effects when humans or other organisms are exposed to several substances together or subsequently.
Under REACH, registrants are required to document the safety of their substances, but they are not required to take into account the possibility of co-exposure to other substances. Indeed, they are seldom in a position to do so, as they usually do not have information on how other substances are used.
Assessment factors are already widely used in REACH to account for uncertainties in data: a mixture assessment factor (MAF) is a pragmatic approach to manage the unknown unintentional co-exposures.
When applying a MAF, exposure levels that are considered sufficiently safe for single chemicals are reduced by a certain factor (i.e., by MAF) to safeguard against risk from combined exposure to multiple chemicals.
The maximum risk ratio (RCR) demonstrating “safe use” for the substance is then equal to 1/MAF to account for unintentional co-exposures of substances.
- Changes to the provisions on the evaluation process
Companies must ensure that the information contained in their registration dossiers is correct at the time of registration and that any changes to this information are reported without delay. The REACH evaluation provisions give ECHA the responsibility to check whether registrations are in compliance.
However, update of registration dossiers by companies is still a weak point: most dossier owners do not routinely review their REACH data and most dossier updates only take place after prompting by the authorities.
The REACH review from 2018 identified specific weaknesses and opportunities to further increase the effectiveness of some of the evaluation provisions. Moreover, in relation to the announced zero tolerance approach to non-compliance, EU-wide measures are being considered to address persisting non-compliance established during an evaluation process.
- Including the concept of essential use in authorisations and restrictions
The Commission’s Chemicals Strategy for Sustainability outlines a number of commitments to tackle chemical pollution.
One of the commitments is to “define criteria for essential uses to ensure that the most harmful chemicals are only allowed if their use is necessary for health, safety or is critical for the functioning of society and if there are no alternatives that are acceptable from the standpoint of environment and health”.
At present, there is no common definition of “essential use of a chemical substance”.
Defining the criteria will be the first step. This will allow the adoption of criteria to be used in policy, ultimately to prevent the non-essential use of the most harmful chemicals, speeding up the authorization and restriction processes.
- Generic risk management approach
The Chemicals Strategy for Sustainability announced extending the generic risk management approach to further hazard classes and uses. This generic approach means that the existing mandate to the Commission to prohibit substances that may cause cancer (carcinogenic), gene mutations (mutagenic) or affect the reproductive system (reprotoxic), based on their hazard and on generic exposure considerations (e.g. used by consumers, used by children), will be extended to additional very harmful chemical substances and to professional uses (e.g. use by construction, equipment maintenance or cleaning workers), while allowing limited exemptions for essential uses.
This differs from a specific approach to risk management requiring proof of an unacceptable risk for each use before introducing a restriction.
(not exhaustive) Summary of “Chemicals Strategy for Sustainability”
Promoting safe and sustainable-by-design chemicals
The strategy promotes the transition to safe and sustainable by design chemicals and materials, which is a societal urgency as well as an economic opportunity. As a first step, the Commission is developing a framework defining the concept of ‘safe and sustainable by design’ and a set of criteria.
Achieving safe products and non-toxic material cycles
In a clean circular economy, it is essential to boost the production and uptake of secondary raw materials and ensure that both primary and secondary materials and products are always safe. the creation of a well-functioning market for secondary raw materials and the transition to safer materials and products is being slowed down by a number of issues, in particular the lack of adequate information on the chemical content of products.
To move towards toxic-free material cycles and clean recycling it is necessary to ensure that substances of concern in products and recycled materials are minimized.
As a principle, the same limit value for hazardous substances should apply for virgin and recycled material. However, there may be exceptional circumstances where a derogation to this principle may be necessary. This would be under the condition that the use of the recycled material is limited to clearly defined applications where there is no negative impact on consumer health and the environment, and where the use of recycled material compared to virgin material is justified on the basis of a case by case analysis.
Protect consumers, vulnerable groups and workers from the most harmful chemicals
One of the biggest health benefits of the EU chemicals legislation in the past decades has been the reduction in the exposure of citizens to carcinogenic substances. This has been possible in particular thanks to a preventive approach across legislation which has led to generally ban of carcinogenic substances from most consumer products.
Ample evidence and citizens’ worries justify that for the most harmful chemicals the generic approach to risk management becomes the default option.
· Tier I: extend the generic approach to risk management to ensure that consumer products do not contain chemicals that cause cancers, gene mutations, affect the reproductive or the endocrine system, or are persistent and bioaccumulative
· Tier II: extend to further harmful chemicals, including those affecting the immune, neurological or respiratory systems and chemicals toxic to a specific organ
· Tier III: extend to professional users under REACH the level of protection granted to consumers.
A zero-tolerance approach to non-compliance
Enforcement and compliance of EU chemicals legislation must be stepped up. These are priorities to ensure the highest level of protection of health and the environment from hazardous chemicals as well as to ensure a level playing field. The Strategy announces a set of actions for all relevant players to work together – to step up enforcement of EU rules on chemicals nationally and at the EU borders, and to promote compliance.