REACH

Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is regarded as the EU’s flagship piece of chemical regulation, applicable across the European Economic Area (EEA), plus Iceland, Liechtenstein and Norway. It aims to ensure the adequate protection of human health and the environment from the risks presented by chemicals. To date, more than 22,000 substances have been registered, including chemicals used in industrial processes and those used regularly by the public. This vast scope means REACH has far-reaching implications for many industries using chemicals. Manufacturers, importers or downstream users of these chemicals may have obligations to comply with it.

The regulation places obligations on companies manufacturing or importing substances into the EEA to collect and assess information on their properties and hazards to identify and manage associated risks. Companies must demonstrate that chemicals can be used safely and communicate risk management measures to users. The regulations ensures several mechanisms to support managing the chemicals. The core pillars for its implementation include

  • Registration: companies manufacturing or importing substances into the EEA in quantities over 1 tonne per year must register their substances under REACH with the European Chemicals Agency (ECHA). The registration process requires companies to collect and report information about the properties and hazards of the substance in a registration dossier for ECHA. The accompanying information depends on the annual manufactured or imported quantities. The regulation operates on a one-substance, one-registration principle, meaning companies manufacturing or importing the same substance must submit a joint registration.
  • Evaluation: a registered substance may later be chosen for evaluation by ECHA or a Member State’s competent authority. The evaluation process can involve checking a registration dossier contains the information legally required by the regulation and reviewing the substance that poses concerns about specific hazards and risks. An evaluation’s outcome may include no further action or may necessitate additional substance data or the substance being proposed for inclusion on the candidate list as a substance of very high concern (SVHC).
  • Authorisation: an SVHC on the candidate list may be placed on the REACH authorisation list, with an accompanying sunset date. After this sunset date, it will become illegal to use or sell it in the EEA unless an authorisation has been applied for and granted for specific uses of the substance.
  • Restriction of chemicals: restricting the use of certain chemicals that may pose a risk to human health or the environment can fall under REACH. Where a restriction is enforced, all supply chain actors (e.g., manufacturers, importers, downstream users, distributors and retailers) must comply with the conditions.

Safety data sheets

Concerning communicating the hazards and risk management measures for chemicals, REACH also lays out the requirements for the format and supply of safety data sheets (SDS) for substances and mixtures.

Only representatives for non-EU manufacturers

It is a requirement under REACH that its registrations and the associated obligations are held by a legal entity that is located in the EEA. However, non-EEA companies looking to supply chemicals into the EU can still do so by appointing an ‘only representative’ (OR) based within the EEA who can submit and hold REACH substance registrations on their behalf and fulfil all other relevant obligations that arise under REACH. Enviresearch are able to offer:

  • OR services for non-EU manufacturers via our Portuguese office.
  • OR services for non-UK manufactures via our UK office.

Enviresearch’s REACH support

Enviresearch’s team of regulatory consultants will support you with achieving REACH compliance. We can help you to identify and understand your obligations and work with you to create a custom-built support plan to ensure you can meet these obligations on an ongoing basis.

Support package activities and services

  • Ad hoc regulatory advice to support you with maintaining ongoing REACH compliance
  • Substance registration strategy development
  • Inquiry dossier support
  • Registration dossier support
  • REACH authorisation dossier support and OR service
  • Representation in SIEF/consortia
  • SDS compliance reviews and authoring
  • Regulation of substances under UK REACH in Great Britain

Following the UK’s exit from the EU in January 2021, an independent UK REACH regulation has been in operation. It is referred to as UK REACH, but it does not include Northern Ireland, which continues to be subject to EU laws including the EU REACH regulation, owing to the NI Protocol established under the final Brexit agreement. UK REACH was established via a ‘lift and shift’ of Regulation (EC) No 1907/2006 (EU REACH) 528/2012 into UK law with amendments made where necessary to the text to make it operable in a GB-only context. The GB regulatory framework broadly continues to mirror the principles laid down by EU REACH but operates entirely independently and separately. An obvious implication is that businesses wishing to manufacture or import substances to both the EU and Great Britain will need separate EU and UK REACH registrations for each region. Since Brexit, Enviresearch has been closely working with clients to manage the transition to UK REACH and ensure continued market access to the GB market. Our consultants are proactively engaging with the adoption of the UK REACH in parallel with our continuing work to support our clients with meeting their obligations. Enviresearch can provide regulatory support services relevant to both UK and EU REACH regions to help you achieve compliance in parallel across both regions in the most cost-effective way.

Regulations

PPP
BPR
REACH
CLP
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