Exemptions Under UK REACH

While UK REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals) applies to most substances manufactured, imported, distributed, or used in Great Britain (England, Scotland, and Wales), certain substances and uses are exempt from all or some of its requirements.

1. Full Exemptions from UK REACH

Some substances are completely outside the scope of UK REACH and do not require registration, evaluation, authorisation, or restriction. These include:

A. Radioactive Substances

  • Regulated under separate nuclear and radiation protection laws.

B. Waste Materials

  • Waste is not considered a substance, mixture, or article under UK REACH.
  • Instead, waste is regulated under environmental and waste management laws.

C. Non-Isolated Intermediates

  • Substances that are never intentionally removed from a reaction process and remain within a controlled environment.

D. Defense and National Security Exemptions

  • The UK government may grant specific exemptions for substances used in national defense and military applications.

2. Partial Exemptions from UK REACH

Some substances are covered by sector-specific legislation and only need to comply with parts of UK REACH. These include:

A. Medicines and Pharmaceuticals

  • Regulated by the Medicines and Healthcare Products Regulatory Agency (MHRA).
  • Covers human and veterinary medicines, including active pharmaceutical ingredients.

B. Food and Animal Feed Additives

  • Regulated under food safety and hygiene laws.
  • Includes food flavorings, preservatives, colorants, and nutritional additives.

C. Plant Protection Products (Pesticides and Herbicides)

  • Regulated under Plant Protection Products (PPP) regulations.
  • Includes agricultural pesticides, herbicides, and insecticides.

D. Biocidal Products (Disinfectants, Preservatives, etc.)

  • Regulated under the Biocidal Products Regulation (BPR).
  • Covers antibacterial sprays, preservatives, insect repellents, and antifouling agents.

E. Cosmetics and Personal Care Products

  • Ingredients used exclusively in cosmetic products are regulated under UK Cosmetic Product Regulations.
  • Cosmetic substances do not need UK REACH registration but must comply with safety assessments.

F. Medical Devices

  • Materials used in medical equipment, prosthetics, and implants are regulated by UK medical device laws.

G. Polymers (But with Monomer Registration Requirement)

  • Polymers themselves are exempt from UK REACH registration.
  • However, manufacturers/importers must register monomers or other raw materials used in polymer production.

3. Exemptions Based on Tonnage or Specific Uses

A. Substances Manufactured or Imported Below 1 Tonne Per Year

  • UK REACH registration is only required for substances ≥1 tonne per year.
  • Small-scale manufacturers or importers below this threshold are exempt from registration but must still comply with safety requirements.

B. Substances Used in Product Development and Research (PPORD Exemption)

  • Companies can apply for a Product and Process Oriented Research and Development (PPORD) exemption, which allows:
    • The use of unregistered substances for up to 5 years for research purposes.
    • Possible extensions if justified by research needs.

4. UK REACH vs. Northern Ireland (EU REACH Exemptions)

  • Northern Ireland follows EU REACH under the Northern Ireland Protocol.
  • Companies trading between Great Britain and Northern Ireland must comply with both UK and EU REACH regulations.
  • Some substances exempt in UK REACH may still be regulated under EU REACH in Northern Ireland.

Conclusion

While UK REACH applies broadly, various full and partial exemptions reduce regulatory burdens on certain substances and industries. Companies should carefully assess whether their substances qualify for exemptions while ensuring compliance with alternative regulations.