At the end of December, the CBA wrote to DEFRA seeking clarification on key components of the annexe relating to chemicals in the EU trade agreement.
The following month, the organisation, which represents the independent chemical supply chain, published its proposed solution to the impasse bedevilling the formation of UK REACH.
Here, we publish the letter and the proposal.
Rebecca Pow MP
Parliamentary Under Secretary of State
Department of the Environment, Food, and Rural Affairs
cc Alok Sharma MP, BEIS
29 December 2020
CHEMICALS ANNEXE: UK-EU TRADE AND CO-OPERATION AGREEMENT
CBA welcomes the conclusion of the Trade and Co-operation Agreement with the European Union (EU). But considerable uncertainty remains concerning the content and precise meaning of the final terms of the chemicals’ annexe.
This letter requests the urgent clarification of a number of key issues some of which, in our opinion, are leading to the scope and content of the chemicals’ annexe being widely misinterpreted.
Industry needs a definition of the term ‘non-confidential information’ that will be exchanged between the UK and EU authorities. We assume this information (a) will not be shared with industry; and (b) does not extend to the EU REACH registration data held by the European Chemicals Agency (ECHA) as ownership of this information is held by individual mainly European-based companies and consortia.
There is a widespread belief in UK industry that this provision of the chemicals annexe will facilitate free data access for UK companies to the testing data held on the ECHA database enabling its use for registration to UK REACH.
We think this belief is mistaken, but it is easy to understand why it has gained currency.
The UK’s negotiating position contained several additional phrases referring to ‘removing technical barriers to trade’ and UK/EU co-operation ‘including through sharing information on chemicals.’ These phrases are not in the final version of the chemicals’ annexe and we believe the situation needs urgent clarification by DEFRA to remove any further misunderstandings.
The importance of sharing the data held by ECHA cannot be under-estimated. The industry estimates the full cost of UK REACH could be up to £1billion, with the cost of testing data representing up to £800 million of this total.
The UK industry has already invested millions in EU REACH. It is now facing the prospect of multiple registrations for exactly the same substance, the wasteful duplication of databases, and an unjustified and disproportionate fee regime to be imposed by the Health and Safety Executive (HSE). Sharing data supports continuing high safety, health, and environmental standards as well as avoiding the prospect of increased levels of animal testing.
The last-minute nature of the agreement with the EU and the absence of official guidance on the new rules and regulations means a period of pragmatic enforcement is essential. Industry must be given time to adjust and comply with the new regime.
CBA has set dates for a series of regulatory and trade workshops to help its member companies to come to terms with the emerging post-Brexit framework.
To perform this function effectively, we need detailed guidance from both your department and the Health and Safety Executive.
Despite many requests for this guidance relatively little has been provided to date on how compliance should be achieved.
As you can see, there is a need for your department to issue clarification and guidance on the meaning and practical impact of the chemicals’ annexe.
It is not an exaggeration to say that the profitability and growth of the UK’s strategic chemical sector depends on an effective, functioning and affordable regulatory framework which allows it to continue to deliver key chemical components to thousands of downstream manufacturing and process companies.
This proposal offers an innovative solution to the provision of testing data to support registrations under UK REACH, an issue that is central to the workability of the new regime.
This is a revised version of the document first submitted to DEFRA in February 2020 and now updated for the content of the subsequent UK/EU Trade and Co-operation Agreement.
DEFRA has confirmed the UK cannot gain continued access to the substance database of the European Chemicals Agency (ECHA) for use in registering substances to UK REACH.
The implementation of the UK REACH legislation will therefore require the submission of a large volume of chemical test data to the UK REACH IT system operated by the Health and Safety Executive (HSE).
When EU REACH was formulated the principle of ‘One substance, One Registration’ was enshrined in the regulatory text following a joint industry (CBA) and UK government (DEFRA) campaign to reduce duplicative and animal testing.
The resulting Substance Information Exchange Fora (SIEFs) allowed entities to pre-register substance(s) under (EC) 1907/2006 Articles 29 and 30. Articles 29 and 30 are not legally applicable post-Brexit as EU REACH states “Each SIEF shall be operational until 1 June 2018.”
In reality, this does not mirror the real-world situation. SIEFs and their equivalents are still operating within EU REACH: sharing new data, handling new registrants through the enquiry system, and arranging for new testing to be undertaken as part of the EU evaluation process.
EU SIEFs allow competing organisations to share sensitive information without risking a breach of competition law.
As UK companies are unable to form UK SIEFs to share data, a novel solution is needed to ensure that UK REACH does not result in an excessive regulatory burden on the UK and EU industry and avoids duplicative substance testing, especially tests involving animals.
This is further complicated because other articles in the EU regulation, such as Article 11, require data sharing and the joint submission of data by lead registrants, with these being adopted within the UK REACH system with no amendment.
A solution which would accelerate the development of UK REACH, is to allow European SIEF data holders to submit the full registration dossier already lodged with ECHA to UK HSE, regardless of whether or not they are based in the UK.
The provisions of UK REACH mean that the EU SIEF must appoint a UK Based Only Representative (OR) to be responsible for the submission of any subsequent changes within the data package.
CBA proposes that the HSE registration fee should be waived for these types of registrants as an incentive for data owners to populate the UK REACH database rapidly.
This ensures that the same data currently held by ECHA would also be held by the HSE IT system – an important step for chemical safety and security.
EU REACH participants based in the UK with valid EU joint registrations obtained via a Letter of Access (LoA), would be able to negotiate through the EU REACH SIEF, an LoA extension covering the UK REACH registration.
This process would be free of charge or involve a small administration cost, as recommended by CIA & Cefic.
Any new registrants for existing EU registered substances would contact HSE via a notification and would be directed to the European SIEF to obtain access to the relevant data package accordingly, as per the current system within EU REACH.
This proposal allows the UK to complete the registrations for the substances within the published timescales and means that the UK HSE has the same data as ECHA, thus reducing the possibility of diverging data sets.
The interpretation of data would be a matter for the HSE/HMG and any differences of interpretation and their application within the sovereign territories of each party could be discussed under the provisions of the UK/EU chemicals’ annexe.
If the European SIEF undertakes new tests or gathers further data, it would then update both ECHA (for EU REACH) and HSE (for UK REACH), so ensuring continuity.
Registrants to UK REACH of substances not previously registered to EU REACH would undertake notifications to HSE, submit data to the appropriate revised deadlines under UK REACH, and pay fees to HSE for each registration.