Streamlined EU REACH Registration Compliance
and Updates

REACH registrations are required when a Legal Entity either manufactures or imports on to the EU market, at or above 1T per calendar year of the substance. Registrations are not required for mixtures. However, the concentration of each substance within the mixture must be assessed to confirm the tonnage of each is less than 1T. There are exemptions from registration

• Substances listed in annex IV, which present minimum risk because of their intrinsic properties (i.e. water)
• Substances covered by annex V, for which registration is deemed inappropriate or unnecessary (such as substances occurring in nature)
• Polymers are exempted from the requirement to register, however the monomer substances or any other substances they consist of must be registered.
• Substances that are already registered and are either exported and re-imported, or recovered through a recovery process in the EU.
• Substances adequately regulated under other legislations, i.e. Food or feeding stuffs and Medicinal products
• Substances used in product and process orientated research and development (PPORD).  Although a PPORD dossier must be submitted in this case!
• Biocidal & Plant Protection Products are regarded as registered, therefore no further registration is required.

• Where a substance is not previously registered, the registrant must take the lead role, and obtain the required hazard data, (Physchem, Human health tox & EcoTox). The number of studies required is based on the tonnage band (Annex VII- 1-10T, Annex VIII- 10-100T, Annex IX- 100- 1000T and Annex X (>1000T). The exact time and cost cannot be determined until after a gap assessment is completed, to confirm if any studies exist either on the substance itself or a suitable read across candidate, or if a waiver may apply. If all studies are required, the generation of the required studies for annex VII & annex VIII is expected to take between 18- 24 months.
• If a substance is already registered in the EU by another legal entity, the registrant will instead join the existing registration by paying a Letter of access fee. In this case the member registrant will only need to gather analytical data to support their member registration. This data may be generated inhouse, however if using an external lab we would recommend to allow 3 months to gather the analytical data. Once the analytical data is available, registration is possible within 4-6 weeks.
• As intermediate registrations do not require hazard data, the timeframe is the same as a member registration.
• While PPORDs are exempt from registration, a PPORD dossier is required to be submitted before the 1Tonne threshold is exceeded. This is similar to the Member & Intermediate registration, however an inquiry is not required so the dossier can be submitted once the analytical data is available.

Updates are required in accordance with Article 22 of REACH​, the registrant is responsible for updating the registration without undue delay, with relevant new information​. In October 2020 the European Commission (ECHA/NR/20/33 EC) clarified when to update dossiers, with the requirement to update ‘without undue delay’ in most cases specified as 3 months, in more complex cases, up to 12 months.

• Administrative updates – 3 months​
  • • New identified uses​
    • Changes in registrant’s identity​ (following legal entity change etc.)
    • Tonnages if it results in change of tonnage band​
    • Manufacture or import of a substance has ceased.

• Complex updates – 6 months to 12 months​
  • • Any change in composition​
    • Changes in classification or risk that impacts SDS or Chemical Safety Report​
    • Testing proposals prior to conducting a test listed in Annex IX or Annex X​ (Lead Dossiers only)