UK REACH ONAY Chemical Regulations Consulting Ltd

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UK REACH services

We do the regulatory work, not just the regulatory advice. Every engagement starts with the same question — what is the shortest lawful route to market for this substance — and often the answer costs you nothing but a scoping call.

01 — Position and scope

Before anything is built, we establish what you actually owe. This is the cheapest work in the project and it changes the answer more often than any other stage.

Role determination

Manufacturer, importer, downstream user, distributor or Only Representative — assessed against your real contractual and customs arrangements, not the org chart.

Tonnage confirmation

Aggregating the same substance across every product line and entity, to establish the band and therefore the data set.

Exemption assessment

Annex IV and V, polymers, intermediates, PPORD, recovered substances and re-import — with the reasoning written down so you can hand it to an auditor. Detail →

02 — Data

The expensive part of UK REACH is not the paperwork, it is the evidence. Our objective is to satisfy the information requirement with the least new testing the law permits.

Data gap analysis

What Annexes VII–X demand for your band, mapped against what you already hold, with a costed route to closing the difference.

Literature review

Systematic search of published and grey literature, assessed for reliability against Klimisch criteria, delivered per endpoint.

QSAR modelling

Validated computational prediction with an applicability domain assessment and a written adequacy justification — the part regulators actually scrutinise.

Read-across

Analogue and category approaches with a similarity hypothesis that explains the toxicological reasoning, not just the structural resemblance.

Data waivers

Technical justification that a study is scientifically unnecessary or technically impossible for this substance and these uses.

Testing strategy

Where new studies are unavoidable: designing the minimum programme, drafting the testing proposal, and managing the laboratory.

03 — Dossier and submission

Registration dossier

Full IUCLID construction: substance identity and analytical characterisation, classification, identified uses, robust study summaries, and submission through the HSE Comply with UK REACH service — including completeness failures and follow-up correspondence.

Chemical safety report

Required at ten tonnes a year. Hazard assessment, DNEL and PNEC derivation, PBT/vPvB assessment, exposure scenarios across the lifecycle, and risk characterisation.

Transitional submissions

Grandfathered registrations and DUIN holders whose full data is now due, including bringing an existing EU dossier across where the data rights allow. DUIN and NRES →

Intermediate registrations

On-site and transported isolated intermediates on reduced requirements, with the strictly controlled conditions documented to the standard HSE expects.

04 — Only Representative

For manufacturers established outside Great Britain. We hold the GB registration so your customers do not have to, and we maintain the volume records and customer notifications the role requires.

Our mandate states that the dossier, the study data and any letters of access acquired on your behalf remain your property and transfer to you or a successor on termination. Ask any prospective OR — including us — for that in writing before you sign. How appointment works →

05 — After registration

Dossier maintenance

Tonnage band upgrades, new identified uses, composition changes and new hazard information.

GB safety data sheets

Authoring and conversion of EU documents to GB requirements — classification, legislation references, exposure limits and emergency contact.

GB CLP

Classification against GB criteria and the GB mandatory classification list, with notification where required.

Evaluation responses

Responses to HSE compliance checks and substance evaluation decisions, to the deadline stated.

List monitoring

Watching the GB candidate, authorisation and restriction lists against your portfolio — separately from the EU lists, because they diverge. Why →

Compliance review

An annual check across tonnage, lists, safety data sheets, identified uses and exemption bases.

Working with other consultancies

We take white-label instructions from consultancies and laboratories on the technical layer — data gap analysis, QSAR, read-across, literature review, robust study summaries and dossier construction. Your client relationship stays yours; we do not approach your clients.

Multi-jurisdiction work

Most substances that need UK REACH also need EU REACH, and for our clients frequently Turkish KKDIK as well. Sequencing the science once and submitting three times is materially cheaper than commissioning three projects. Our sister practice ONAY Mühendislik covers the EU and Turkish regimes, with KKDIK.AI and KKDIK Market handling Turkish submissions.