As the date set for the United Kingdom’s exit from the European Union fast approaches, with just over four months to go, preparations for a scenario in which there will be no trade deal struck between the EU and the UK before that time are being expedited. Although the UK government insists that it is unlikely that no agreement will be reached in the meantime regarding Hazardous Substances, they are being prudent in preparing for such an eventuality, given the amount of uncertainty surrounding the issue to date.
A number of crucial areas are in need of an alternative structure, if there is no trade deal by next Spring, including the regulation of biocidal products which are categorised as hazardous substances. At present, biocidal product market in the EU is regulated under the Biocidal Products Regulation (EU) No 528/2012 (BPR). Biocidal products are active chemical or biological substances that control harmful organisms. The BPR, which currently applies to the UK, sets out a two-stage process for authorising biocidal products. First the active ingredients contained in a biocidal product must be approved at EU level, at which point companies can then apply for the authorisation of that biocidal product to be authorised in individual countries. In the case they want to trade in more than one EU country, they can apply for a ‘Union’ authorisation, which is EU wide or authorisation in a ‘lead’ EU country which would then be authorised in other EU countries by a ‘mutual recognition’ process.
What the UK government has proposed to put in place, post March 29th, 2019, is an independent framework which essentially retains the BPR in almost all way; with changes only being made in areas that are needed to make it work at a national level. In this regard, the system and processes as they apply to the authorisation of biocidal products remains largely unchanged. Companies wishing to apply for an active substance to be approved or for a biocidal product to be authorised in the UK would apply to HSE, instead of European Chemicals Agency. While the HSE is already acting as the competent authority for applications, the Register for Biocidal Products is facilitated by the European Chemicals Agency, which would no longer be the case if there is no deal in place. Furthermore, all authorisations processed and approved by the HSE would be UK specific.
For companies that hold biocidal product authorisation that is valid in the UK on March 29th, 2019, it would remain valid in the UK until its natural expiry date, as would active substance approvals.
For more information on the regulation of biocidal products in a no-deal Brexit, click here.
The UK government has also issued a notice regarding the regulation of businesses producing, registering, importing or exporting chemicals considered as hazardous substances, in a no-deal situation. At present there is a large body of European legislation regulating chemicals in the UK, with the main piece of legislation being REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals). REACH requires companies operating in EU member states to register chemicals with European Chemicals Agency before placing them on the market. It also sets more rigorous controls on hazardous chemicals.
Much like the proposed replacement for the BPR, the UK government have proposed a new legislative structure that would align closely with REACH, which, it says, will ensure the continued protection and safety of any chemicals, hazardous or otherwise, being produced, entering or trading within the UK. Again, the Health and Safety Executive (HSE) would act as the lead UK regulatory authority “building on its existing capacity and capability”.
However, the implications for chemical businesses are somewhat more impactful from exit day, than those regulated under BPR. Companies currently registered under REACH will no longer be able to sell into the EU market without transferring their registrations to an EEA-based organisation. This requires action on the part of these companies, in order to preserve their registration under REACH. There would also be a number of new requirements required from downstream users of chemicals, when they apply for register.
The government has set out a number of proposals they would implement in a no-deal scenario that would ensure the smoothest possible transition out of the EU for the relevant chemical companies, with the aim of maintaining the current standards and ensuring continued access to the EU market.
For more information on the regulation of chemicals in a no-deal Brexit, click here.
Import and Export of Hazardous Substances or Chemicals
The UK government has outlined the systems that would come into force to regulate chemicals relating to the Export and Import of Hazardous Chemicals Regulation (known as the PIC Regulation). At present, the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade is implemented by the PIC Regulation and the UK is proposing to continue the implementation of the Rotterdam Convention in a no-deal Brexit, but through its own established independent UK PIC Regulation.
This will mean that, while much of the existing systems will continue to operate, there will be some changes to processes, such as UK based companies no longer being able to access PIC and instead moving to the new UK PIC system, which will be operated by the HSE, etc.
For more information on the import and export of chemicals in a no-deal Brexit, click here.
Other Areas for Change in the Manufacturing and Trading of Hazardous Substances
In line with the above plans for relevant businesses, the UK government has also issued notices of its plans for regulation in relation to pesticides, the control of mercury, and the control of persistent organic pollutants if there is no trade deal agreed by the Spring. UK companies are advised to be prepared for a no-deal exit and to get their affairs in order. While all parties to the deal agree that there is a long road ahead in terms to getting a solid agreement in place and what that will look like, the proposed plans above should offer some structure to the companies which they impact for making arrangements in the worst-case scenario.