Applying for a UK REACH Authorisation

The process for applying for an authorisation under UK REACH is very similar to the EU process and much of the ECHA guidance and templates can be used.

ECHA information on how to apply for REACH authorisation.^[33]

Who needs to apply

Applications for authorisation may be made by the manufacturers, importers and/or downstream users of the substance listed on Annex XIV. Applications may be made by one or several persons.

• in a downstream user application, it is the end user or a group of end users who are applying for their own use. If authorisation is granted, then they can obtain the substance from any source.
• in an upstream application, a single manufacturer, importer or a group of manufactures/importers apply for authorisations to cover uses performed by their downstream users. Downstream users outside of these supply chains will not be covered. An upstream authorisation can also cover the uses of the manufacturer or importer themselves.

Under UK REACH, a substance subject to authorisation (included in the Authorisation List) cannot be used or placed on the market for a use in Great Britain (England, Scotland and Wales) unless an authorisation has been granted.

Distributors who only store the substance are not considered downstream users  as the substance is not ‘used’ and  authorisation under UK REACH will not be required. This means that distributors are essentially ‘invisible’ in authorisation supply chains.

How to apply

If after you have checked the status of your substance, you think you will need to apply for UK REACH authorisation, you should first contact HSE by email.

You should provide:

• the intended submission date
• the Substance(s) and use(s)for which the application will be made
• the applicant(s) and role(s) in the supply chain
• contact details

HSE will then advise you of the next steps to take.

Preparing your application

 Authorisation may be granted under 2 circumstances.

Adequate control route

Granted by demonstrating that the risk from using the substance is adequately controlled, such as that the exposure is below the derived no-effect level (DNEL) or the predicted no-effect concentration (PNEC).

Socioeconomic route

Granted by demonstrating that the socio-economic benefits of using the substance outweigh the risks and that there are no suitable alternative substances or technologies for the applicant. For non-threshold substances (such as substances for which a no-effect cannot be established) or when uses of threshold substance result the exposure in exposures above the DNEL/PNEC, this is the only possible route.

However, this does not exclude situations where suitable alternatives for the uses applied for might exist in the EU. In this situation an authorisation might still be granted if these alternatives are not feasible for the applicant and the applicant submits a credible Substitution Plan as part of the authorisation application.

Application information

When you are submitting an application for authorisation you must include the information as described in Article 62 of UK REACH.

Authorisations are time limited, the decision will include a review period and the date the authorisation will expire. If the use needs to continue beyond that date a review report should be submitted.

When you are submitting a review report you must include the information as described in Article 61.

The key documentation includes:

• a chemical safety report (CSR)
• an analysis of the alternatives (AoA)
• a substitution plan - where the AoA shows that suitable alternatives are available, taking into account the elements in Article 60(5)
• a socioeconomic analysis (SEA) - required for the socioeconomic route (not mandatory for the adequate control route but highly recommended)
• for a review report an explanatory note should be included summarising any elements of the original application that have changed

The Agency must hold a public consultation on alternatives during the process and will publish the application documents on the website for information. If an applicant considers their documents contain confidential information, a public version with redactions can be provided in addition to the confidential versions. Justifications as to why the information should be kept confidential should be included.

Fees and how to pay

The fees for an application for authorisation depend on the size of the company applying and how many uses or substances they apply for.

More information on fees^[34]

Timelines for the authorisation process

The Agency has 10 months from the receipt of the application (taken as the date of payment) to produce its draft Opinion and send it to the applicant for comment. Below is an overview of the general timeframe:

Pre-submission – Before submitting, the applicant can have one or more pre-submission meetings with the Agency.

Once the applicant has submitted the documents, the Agency checks that all elements are present and any confidentiality claims are justified then raises an invoice.

Day 0 – The 10-month Agency deadline is calculated from the date of receipt of application which is the day the invoice paid.

Months 1-3 – Agency will commence drafting the Opinion. The applicant may receive clarification questions on their application from the Agency. Within this time period an 8-week public consultation on alternatives will be launched.

Months 4-6 – If comments are submitted via the public consultation the Agency may hold a stakeholder consultation meeting (SCM). This is an opportunity for the applicant to respond to any comments on possible alternatives raised in the public consultation. Third parties that have submitted comments during the consultation may also be invited, as well as accredited stakeholder observers.

Months 7-9 – A challenge panel is normally held for each application. The purpose of this is to allow for independent scrutiny and advice on the scientific and technical quality of the Agency’s Opinions.

This is provided by our UK REACH: REACH Independent Scientific Expert Pool (RISEP) (hse.gov.uk)^[35]

Months 10-12– The draft Opinion is sent to the applicant. The applicant will then have an opportunity to provide comments on the draft Opinion  before it is sent to the appropriate authorities. The applicant has 2 months to  comment.

Months 12-14 Taking into account the applicants comments the Agency has 2 months to amend the draft Opinion before sending the final Opinion to the appropriate authorities who then have 6-months to make a decision granting or refusing the authorisation.

The whole process from submission of the application documents to the issue of the decision takes around 20-22 months.