REACh – Chemical substances

REACH Strategic advice and Compliance Audit

Our service can be adapted to suit your requirements, but typically involves a review of your substance inventory and position in the supply chain, to determine your obligations under REACH. We will advise on the available options for achieving compliance with Regulation (EC) No.1907/2006. This service is available to different actors in the supply chain, including manufacturers, importers, and downstream users.

Our service also extends to REACH Compliance in the context of Brexit. Our experts can advise on how your REACH obligations may evolve as the transitional ‘implementation’ period of the Brexit negotiations comes to an end. We can also advise on the anticipated implementation of a separate ‘UK REACH’ regime, which is currently expected to come into force in January 2021.

REACH ‘Lead’ Registration Dossiers

Our lead registration service includes strategic advice on the most efficient way to achieve compliance. Typically, a lead registration project will involve preparation and submission of an Inquiry dossier to ECHA. A detailed data gap analysis will be conducted, alongside a targeted literature search. The strategy for addressing any data gaps will be agreed with the Client (including commissioning new testing, or securing access to read across ‘source’ data, if required). Study monitoring services can be incorporated into the project if needed. The IUCLID dataset, and (if required) accompanying read across justification (in accordance with the RAAF) and Chemical Safety Report, will then be prepared by our technical specialists, prior to submitting the peer-reviewed dossier via ECHA’s REACH-IT system.

REACH Joint Submission (non-lead) Registration

For joint submission registrations (sometimes referred to as ‘non-lead’ registrations), our regulatory specialists will prepare and submit the initial inquiry dossier to ECHA. Once ECHA have confirmed substance identity, we will facilitate letter of access discussions, and once complete, join the joint submission via REACH-IT. We will work with you in capturing use and tonnage data appropriately, and submit the completed dossier once this has been peer-reviewed.

REACH ‘Only Representative’ Services

Staphyt can fulfil the role of ‘Only Representative’ for non-EU manufacturers and formulators. Without an appointed Only Representative, sales (> 1 tonne per annum) into the EU are restricted to only those customers who have already put in place their own REACH registrations. By appointing an Only Representative, non-EU manufacturers and formulators can achieve greater access to the European market. Staphyt’s Only Representative services include dossier preparation and submission, set up and monitoring of the required REACH-IT account, assembling and maintaining records in accordance with the regulations, and liaison with downstream users.

With legal entities based in both mainland Europe and the United Kingdom, we are able to support clients who require access to the EU market, and also clients who wish to retain access to the UK market following the end of the current implementation period in the Brexit negotiations.

REACH Dossier Updates

We can support you with updates to existing dossiers, for example in response to ECHA compliance checks, tonnage band increases, or changes to requirements such as the recent introduction of additional information requirements for nanomaterials. Though dependent on the nature of the upgrade required, tasks may include data gap work, strategic advice, responding to ECHA draft compliance check decisions; updating the IUCLID dataset and CSR, and commissioning new testing if required.

Exposure Assessment

In addition to the preparation of Chemical Safety Reports (see our “REACH ‘Lead’ Registration Dossiers” service), exposure assessment for additional uses which are not covered by the REACH joint submission can be prepared. Our specialists will work with clients to define uses in detail, before conducting the exposure assessment using ECHA’s Chesar tool.

Related Services

We also have extensive experience in providing the following services:

• Reviewing and authoring Safety Data Sheets (including extended SDS) in accordance with European regulations and specific national provisions.
• Poison Centre Notifications (and UFI code generation), across a range of EU Member States. Note that our PCN service has recently been extended, to ensure that information is submitted in accordance with the harmonised PCN format (as required from 2021), and to support submissions via ECHA’s PCN portal.
• REACH Consortium Management and SIEF facilitation.
• Study placement, generation and monitoring.
• Classification and labelling (CLP compliance) advice.

Our team can assist you with any regulatory issue. Please do contact us if you need our support or if you would like to find out more.