Guest post by Principal Toxicologist Richard Young and Toxicologist Daniel Threlfall from Bibra, specialists in assessing the hazards and risks posed by chemicals and assisting chemical companies with REACH obligations.
What is REACH?
REACH is a European Regulation concerning the safe use of chemicals, with the aim of improving the protection of human health and the environment through a system of
- Authorisation and
- Restriction of Chemicals
At around 1,000 pages, and described by some as the most complex legislation in the history of the European Union, it certainly isn’t the easiest of reads, but REACH is hugely important if you’re a manufacturer or importer of chemical substances in the EU (primarily in quantities of ≥1 tonne/year). REACH requires that industry has certain knowledge regarding the properties of its substances and that it manages and communicates potential risks appropriately. Read on for your brief introduction to REACH and why it’s so important.
What Does REACH Mean for Chemical Companies?
In short, chemical manufacturers/importers are required to prepare a registration dossier in order to assess whether their substance may cause adverse effects to human health and/or the environment, either based on test results or alternative (scientifically justified) information. The REACH Standard Information Requirements (SIRs) are those data which are required as a minimum to meet the registration obligations; these vary between substances (e.g. dependant on tonnages manufactured/imported, use and properties), but include a series of physicochemical, (eco)toxicological and environmental fate “endpoints”.
The Key Principles of REACH
Characterisation of the substance in question is an important initial step in the Registration process, to understand exactly what chemical (e.g. constituent quantification) is being produced/imported. This has facilitated the formation of a substance information exchange forum (SIEF) amongst legal entities (such as manufacturers, importers, and data holders) who are dealing with the same substance, with the aim of sharing information and costs as well as limiting vertebrate animal testing where possible (which is a key principle of REACH, in line with the wider regulatory drive in this area). Although SIEFs are no longer an “official” part of REACH, the function that they perform remains key to REACH compliance.
Literature searches and company data gathering exercises are essential steps in the identification of existing REACH-relevant data on a particular substance; such data can be used (possibly as part of a Weight-of-Evidence argument) to negate the need for conducting new experimental studies, to demonstrate where data-gaps exist in the available information, and where new testing and/or alternative approaches might be needed.
Common alternatives to in vivo laboratory animal testing include: the read-across concept (use of data on a closely-related (source) substance to predict the potential (eco)toxicity of the target substance); in vitro methods (involving isolated tissues, organs or cells rather than whole organisms); and (Quantitative) Structure-Activity Relationships ((Q)SAR; computational methods for predicting the characteristics of untested compounds based on knowledge of the activity of others). The regulation encourages the use of such alternative methods where appropriate; it’s worth noting that there are high expectations as to the robustness, reliability and detailed supporting data/documentation accompanying such alternative approaches.
How REACH Uses Data
Many aspects of a REACH registration (e.g. data capture and management) are handled by a specifically designed software application (IUCLID) which is maintained by the European Chemicals Agency (ECHA). The key features of a REACH registration include the following: summarising pertinent data on a particular chemical as outlined by the SIRs; interpretation of hazard information on classification and labelling (according to the EU CLP criteria); and calculation of DNELs/PNECs for characterisation of the human health/environmental dose response. Certain substances (>10 tonnes/year) require the conduct of a chemical safety assessment (CSA) and the inclusion of a chemical safety report (CSR), the ultimate goal of which is to demonstrate safe use of the substance throughout its lifecycle.
Submission of IUCLID dossiers to ECHA is accomplished via the web-based software REACH-IT, at which stage a large portion of the REACH registration data is publicly disseminated on the ECHA website.
This is all well and good, with the registration process running relatively smoothly and well over 50,000 registration dossiers having been submitted to date, though the elephant in the room is what will happen to REACH in relation to the UK’s exit from the EU.
How Will Brexit Affect REACH?
As is to be expected, there is still a lot of uncertainty in this area and much will depend on the precise nature of the UK’s withdrawal agreement on (at the time of writing) 31 October 2019. However, significant changes will be needed for UK- and EU-based registrants, and those companies importing into these areas in the future. It is currently anticipated that the EU REACH regulation will essentially be incorporated into UK law to create a separate regulatory system (referred to as UK REACH) which is recognised by the EU, and that the UK Health and Safety Executive (HSE) will manage registrations.
Although there will inevitably be a certain degree of confusion on the part of registrants and other stakeholders, and much work to be done (e.g. establishing a legal presence in the UK or mainland Europe; i.e. a Legal Entity), it’s worth highlighting that support and guidance is presently available from both ECHA and the UK HSE. Whatever the outcome of the ongoing negotiations, the priority from a chemical perspective is to ensure the continued effective and safe management of substances to safeguard human health and the environment.
Chemical Companies’ Compliance with REACH
Turning back to the overall REACH process, as the name suggests, it isn’t all about registration. Following the most recent registration deadline (31 May 2018), the attention is shifting more towards substance evaluation. ECHA makes a point of assessing certain key aspects of the information submitted by companies, to ensure compliance with the specific requirements and essence of REACH, and to clarify whether a given substance constitutes a risk to human health and/or the environment.
In the past, only a relatively small proportion of dossiers were checked at random, though this has shifted over time to more targeted investigations (e.g. for specific endpoints of concern). In the eyes of ECHA, registration dossiers are to be viewed as “living documents” which should be regularly updated whenever new information is made available or a need to improve data quality is identified. It is therefore critical that all registrants endeavour to ensure that the information provided in their dossiers is robust and up-to-date, and that human health and the environment are adequately protected.
Bibra specialises in assessing the hazards and risks posed by chemicals and assisting companies with their REACH obligations, notably the preparation of registration dossiers and more recently in dealing with toxicological issues following ECHA Evaluations.
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