The Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation puts a high importance on identifying persistent, bio-accumulative and toxic (PBT) or very persistent and very bio-accumulative (vPvB) substances on the EU market. These substances tend to be slow to degrade in the environment once released and to bioaccumulate in tissues of organisms. As such, they can pose a high risk to human health and the environment. Under REACH, they are considered as Substances of Very High Concern (SVHC).
PBT and vPvB substances might be added to the Candidate List of SVHCs in accordance with REACH Article 59.
This generally results in significant restrictions being applied to how products containing these substances at concentrations of 0.1% (w/w) or greater can be produced and used. For example, it is a legal requirement to minimise emissions of PBT and vPvB substances and their exposure to humans and the environment, and these substances are prioritised over other SVHCs to be moved from the Candidate List onto the REACH Authorisation List. Once on the Authorisation List, a substance will be given a ‘sunset date’, after which its use will be forbidden unless subject to a specific authorisation or exemption. In general, the inclusion of PBT and vPvB substances on the Candidate List is likely to lead to severe disruption for businesses with an interest in using them.
The European Chemicals Agency (ECHA) continuously screens the substances registered under REACH for potential PBT and vPvBs. Substances that are suspected to be PBT and vPvB are evaluated by ECHA and the Member States under a Community rolling action plan (CoRAP). Therefore, identifying PBT and vPvBs under REACH is not static, but a continuous process. In addition, the implementation of REACH continues to evolve in response to new scientific developments and public pressure to ‘speed up’ the SVHC identification process. Some of the things this has led to include:
- New proposed SVHC criteria, such as persistent, mobile and toxic (PMT), and very persistent, very mobile (vPvM) substances.
- Procedural changes, such as increasing the ECHA compliance check target for registration dossiers from 5% to 20%.
- A renewed focus on grouping multiple substances for assessment.
Developments such as these mean that the pace and the complexity at which the REACH process is evolving is changing rapidly, and it is critical for businesses to understand and develop strategies to manage these risks.
As well as being aware of the process, it is crucial for companies to have access to expertise to achieve optimal outcomes under REACH. For example, where substances are being evaluated for their PBT or vPvB properties, it is the registrant who is tasked with generating the data that will be used for the assessment. Normally, an organisation will not have the capabilities in-house to perform these studies and will use a third-party contract research organisation (CRO). This means a lot of trust is placed in the chosen CRO and if the organisation doesn’t have any expertise, it will have to take the results of the studies at face value rather than being in a position to have input or question them at any level. There are some high-quality CROs, but it cannot be assumed that they will always get everything right or that their interests are fully aligned with the organisation’s. For the commercially focused industry of the CRO, the priority is normally to deliver the study as efficiently as possible, while meeting the narrow validity criteria of the study guideline. This often leaves limited room for customisation to suit specific substance properties or circumstances.
Performing regulatory tests on chemicals is far from straightforward, particularly for suspected PBT and vPvB substances, which are notoriously difficult to test. This is especially the case in biodegradability testing for persistence assessments (common to PBT, vPvB, PMT and vPvM substances) because there is a lot of potential for things to ‘go wrong’, and the difference between a test passing and failing can have far-reaching consequences. It is essential to have expert input during the study planning, monitoring and report review stages if the resulting data is to be both acceptable to regulators and a realistic representation of a substance’s properties. Expert input is also invaluable during communications with the authorities about the study and can often make the difference to the ultimate decision on the regulatory status of a substance.
In addition to identifying and addressing potential substances of concern, environmental testing and assessment of products can also help to deliver significant value for businesses.
For example, with proper design and execution, a positive result in a ready biodegradability study can unlock further benefits such as improved Globally Harmonized System of Classification and Labelling of Chemicals (GHS) and dangerous goods classifications for the products, and the potential to apply for ecolabels. Many of these studies deliver negative results simply because they have not been set up in the proper way to account for the specific properties of the substance. Another example is in product development, where early screening and assessment of environmental properties can significantly enhance the safety and sustainability of new products and enable businesses to avoid potentially costly regulatory issues further down the road. Furthermore, an appropriately designed testing and assessment strategy can significantly reduce the costs of meeting regulatory requirements for new substances or keeping existing substance registration dossiers compliant and on the market.
At NCEC we have considerable experience in evaluating and assessing chemicals. We are leading experts in PBT assessments and evaluating complex and difficult test substances. Our highly skilled team of specialists has a track record of helping clients to address the challenges of REACH – from understanding the regulatory status of substances and developing strategies to mitigate the associated business risks, through supporting companies in performing ecotoxicology and environmental fate tests, to engaging in technical discussions with regulatory authorities. We can also support you in the search for alternatives to SVHCs and enable you to make informed decisions that enhance the sustainability of your products and your organisation.
The uniqueness of our offering is in applying a combination of scientific expertise and regulatory insight to deliver superior outcomes, resilience and value for our customers.
If you need technical expertise in environmental hazard and risk assessment of chemical substances, please do not hesitate to contact us at [email protected].