An application for authorisation has been lodged to use endocrine disruptor OPEO, which has applications in the medical industry and in manufacturing laminated safety glass. An extension to an authorisation for another subtance of very high concern (SVHC), the phthalate DEHP, is also being sought.
The programme was published by the Health and Safety Executive (HSE) last week, detailing what it plans to do alongside the Environment Agency (EA) to implement the new regime over 2021/22.
It says that the following substances have been earmarked to be considered as SVHCs:
- A series of tin fatty acid derivatives,
- High temperature solvent bis(2-(2-methoxyethoxy)ethyl) ether (known as tetraglyme)
- Industrial intermediate resorcinol
- Brominated flame retardants BMP, TBNPA and 2,3-DBPA
- Disinfectant, wart medication, preservative, and fixative glutaral
- Fragrance 2-(4-Tert-butylbenzyl)propionaldehyde
- 1,4-dioxane, a possibly carcinogenic solvent
- Sodium orthoborate, thought to be toxic to reproduction
- Suspected endocrine disruptor Dodecylphenol (PDDP)
- Bisphenol B, closely related to the widely-used endocrine disruptor bisphenol A.
HSE and staff working on the new regime are expected to spend only 72% of their time delivering it, the rest taken up by training. The figure is equivalent to ten of an anticipated 35 staff being in training all of their time and illustrates how much the joint regulators need to gear up to implement UK REACH.
As of 15 April, there nine vacancies were unfilled in the HSE’s REACH teams, five of them toxicologists.
The document says that the HSE’s Chemicals Regulation Division’s workforce has tripled compared to last year, while the Environment Agency’s Chemical Assessment Unit is expected to almost double its technical capacity this year.
The training, aimed particularly at the new recruits, includes understanding the legislation and associated guidance, learning processes and procedures and developing knowledge of regulatory science, particularly in the area of toxicology.
Helpdesk and engagement work will take up about 15% of HSE staff time, with other day-to-day tasks such as authorisations, dossier evaluation, registration and restrictions adding up to around half of the regulator’s activity. The EA’s time will be taken up largely by technical support to the government, considering proposals for restrictions and SVHC status and ‘preparatory work for substance evaluation’.
No time at all has been allocated for substance evaluation itself. In the EU system, this is how member state authorities assess a chemical’s risks and propose measures to control them. Instead, time will be devoted to establishing a priority list, to be drafted by the end of the year and finalised by the end of March 2022.
The plan says that there are five ‘key delivery objectives’ for 2021/22:
- Complete the processing of UK REACH authorisation applications within the statutory deadline.
- Complete the processing of UK REACH registrations for previously unregistered substances within 3 weeks of submission (i.e. technical completeness check).
- Produce two UK REACH Annex 15 restriction dossiers (tattoo inks and lead ammunition) by the end of the year.
- Answer 90% of helpdesk queries within 10 working days. As the UK Competent Authority for EU REACH, the “great majority” were answered within three working days.
- Produce a draft annual report for 2021/22 and a draft work programme for 2022/23 by 31 March 2022.
Another major priority is the recruitment of the ‘RISEP’ panel of scientific expertise, from which the HSE and EA can draw up on an ad-hoc basis. “It is not intended for RISEP to function as a scientific advisory committee. Rather, it will provide a source of individual experts who will support us in the preparation of scientific opinions by providing independent challenge and supplementary experience, knowledge and skills,” says the plan.
The regulators aim to check at least 20% of new dossiers in each tonnage band for compliance with information requirements. The focus over this financial year will be on novel substances, those not registered previously under EU REACH.
However, this is less a choice than a consequence of UK REACH’s transitional provisions. As the plan says, “It is possible that many UK registrations will have little data in them before the submission deadlines in November 2023, November 2025 or November 2027”.