Post-Brexit chemicals regulation: Royal Society of Chemistry – Written evidence (CRB002)

 

The Royal Society of Chemistry welcomes the opportunity to provide written evidence to the House of Lords EU Environment sub-committee.

 

This submission covers our ‘asks’ on the future EU-UK partnership in respect of chemicals regulation and the importance of a UK REACH scheme, and other UK chemicals regulation, being strongly informed by independent, expert scientific advice and of establishing a strong, independent UK chemicals regulator.

 

UK-EU future partnership

During the Brexit process, we have called for a close UK-EU partnership on chemicals – not just on regulation, but also solutions for the sharing of data and scientific knowledge. We have argued for continued and uninterrupted close cooperation with the European Chemicals Agency (ECHA) and for regulatory harmonisation. However, we recognise that the Government started from a point of no dynamic alignment of regulations in a UK-EU trade deal, which is likely to lead to regulatory divergence between the UK and EU over time, with consequences for trade and for businesses. Should this situation arise, we call on the Government to:

a) Maintain harmonisation of the chemicals evidence-base between the UK and the EU

b) Put chemicals safety science at the heart of regulatory decision-making

c) Look at regulation in the context of a longer-term UK chemicals strategy

d) Make regulatory decisions based on a set of defined and transparent principles

e) Ensure decision-making frameworks are transparent and have clear accountability.

 

We set this out in more detail in our Briefing on regulatory divergence in chemicals regulation

 

In A Chemicals Strategy for a Sustainable Chemicals Revolution we argue that the UK Chemicals Framework, which the Government is developing, should be based around high standards and global leadership, with world leading education, research & innovation, circular economy infrastructures and regulation. In a UK chemicals framework, the government should seek maximum cooperation and consistency with the evolving EU Chemicals Strategy for Sustainability and the EU Green Deal, and be a leading player in the United Nations Strategic Approach to International Chemicals Management (SAICM).

 

UK REACH

From the 1 January 2020, the UK will have its own UK-REACH system and will be open to changing other chemicals regulations transposed across into UK law from the EU. The Secretary of State will be responsible for making authorisation and restriction decisions for chemicals evaluated within UK REACH and as included in product regulations.

The RSC’s view is that the drivers for a UK chemicals framework that is fit for the future of the UK and international trade ambitions are economic prosperity, wellbeing and quality of life improvements for citizens and wildlife, and are related to ‘trust in chemicals’ for the purposes of business and trade.

In view of the political direction and the need for a chemicals framework, we have three main asks of the Government:

1)    Regarding Schedule 19 of the Environment Bill on UK-REACH: We call for Secretary of State (SoS) decisions to always be taken in full knowledge of the recommendations from the scientific evidence that exists on human and environmental chemical safety. We recognise that there is a discussion to be had about whether the requirement to take account of scientific evidence and advice resides in the legislation or in accompanying statutory/non-statutory guidance. But we make the point here that scientific evidence must be considered in an open and transparent way in decisions that are taken about chemicals safety by the Secretary of State.

We call for the following amendments to Schedule 19 of the Environment Bill, regarding UK REACH:

Amendment: Schedule 19, page 231, line 22, at end insert “and take account of all relevant scientific evidence and advice through the ‘Agency’s’ science advice mechanisms”

Amendment: Schedule 19, page 231, line 30, at end insert “take account of all relevant scientific evidence and advice through the Agency’s science advice mechanisms, and”

Amendment: Schedule 19, page 231, line 31, at end insert “(4) The Secretary of State, or any relevant devolved authority, shall make transparent the reasons for all decisions taken under this regulation by publishing this information in the public domain”

 

2)    We call for the establishment of a dedicated UK Chemicals Standards Agency:
In order for the evidence to be considered and for citizens to trust that UK decision making for chemicals is performed using credible processes, we support the establishment of a dedicated UK Chemicals Standards Agency, that puts chemicals on a par with foods and medicines, and works on the basis of scientific and regulatory excellence.

Building on the current strong regulatory framework, this new UK agency must be adequately resourced to lead and act as the primary national point of cooperation and collaboration with other chemicals agencies in the world (eg the European Chemicals Agency (ECHA) and the US EPA’s Office of Chemical Safety and Pollution Prevention (OSCPP)).

 

For foods, for example, citizens rely on the work of the Foods Standards Agency in all devolved nations to keep them safe and assure food quality; similarly for medicines the UK has the Medicines and Healthcare Regulatory Agency (MHRA). These agencies have high reputations and standing in UK society and internationally. Citizens’ trust in chemicals will be maintained through a visible, high profile, credible and sufficiently resourced UK Chemicals Standards Agency working consistently on a strong foundation of science.

 

We understand that the Health & Safety Executive’s (HSE) Chemicals Regulation Division (CRD) is set to be the new ‘Agency’ for chemicals in the UK. This provides a practical legislative solution in difficult times, however it may not currently have the status and credibility for chemicals in the environment and products that a dedicated UK Chemicals Standards Agency would provide at the global level.


We recognise the HSE employs some excellent scientists and experts in chemicals regulation, who have worked highly effectively at European level, and that recruitment is underway for further scientists (who will likely require training) that is set to increase staff numbers at the CRD by approximately 50 before the end of the year. Nevertheless, we have concerns over the current lack of capacity of fully scientifically trained staff at the necessary levels to be able to fully operate a UK REACH. Also to manage possible alignment or divergence – and the consequences of divergence for the sector - in other regulations such as Classification, Labelling and Packaging (CLP) regulation, Prior Informed Consent (PIC), biocidal product regulation (BPR) and plant protection product regulations (PPPR). It is expected that CRD will have to deal with a high workload for UK REACH from 1 January 2021. This workload could be in managing processes, but it will also involve highly technical work of a complex scientific nature reviewing data on chemical exposure, toxicology and risk assessment. For this, independent experts will be required for committee work and in the provision of new guidance and scientific advice.

 

3)    Establish a new independent government-funded UK Institute for Chemicals Safety Assessment to lead on areas of new science for assessing exposures, hazards and risks of chemicals to humans and wildlife. It should be a central institute or science hub independent of industry that can liaise with other scientific bodies such as the EC Joint Research Centre (JRC) and EU Science Hub and science divisions of the US EPA. The new hub/institute could for instance, help to manage the provision of independent scientific advice in the UK by connecting to the world’s best scientists and scientific networks, keeping abreast of all latest developments and leading in priority science areas.

Chemicals safety science is progressing rapidly in areas such as exposure assessment, kinetic modelling, data on hazard characterisation (ideally from new approach methodologies (NAMs) wherever possible without using new animal data) as brought together in adverse outcome pathways (AOPs) and risk assessment frameworks. It is possible for the UK to develop a world leading reputation in developing new risk assessment approaches that use NAMs and AOPs to inform decision-making. By pushing the boundaries of science and drawing on the world’s best talent, new scientific methods can be developed to enable safe and sustainable chemical innovation in the UK.

The independence of scientific advice is paramount in securing the trust of citizens. The UK regulator will need to foster future regulatory cooperation with new international trading partners. If the UK is visibly using independent world-leading scientific evidence in a high profile way to underpin its chemicals policy it will help to engender trust. Building harmonised approaches for chemicals safety assessment can be achieved at global level through international science diplomacy, where the UK should be world-leading. Having an excellent UK independent specialist science hub for chemicals regulation, focused on the most challenging areas of relevant science, as defined and requested by the UK ‘Agency’, would be a visible commitment to high quality independent science advice to support regulatory cooperation. 

 

These points are elaborated in the RSC’s new document  ‘Drivers and Scope for a UK Chemicals Framework.