Regulatory Services for Chemical Products & Mixtures in the UK

Overview

Cleaning and disinfectant products are called/identified and regulated differently across countries and regions, making it very challenging for the industry to place these products in different markets.

After Brexit, the UK has framed a separate individual set of chemical/product legislation, which is an amended version of the EU’s existing legislation.

In the UK, disinfectant products are classified as biocides in a similar way as in Europe. After Brexit, the UK framed its own disinfectant regulation like Europe, which is referred to as GB BPR. Biocides under the GB BPR are categorized in the same way as in Europe as Group I Disinfectants having below PT types.

PT1

PT2

PT3

PT4

PT5

Human hygiene

Disinfectants and algaecides not intended for direct application to humans or animals

Veterinary hygiene

Food and feed area

 

Drinking water

 

Disinfectant regulation is dynamic and is based on the active substance approval status in the UK, where the requirements/obligations are subject to compliance with the GB BPR regulation, which is managed by the Health Safety & Executive (HSE) Agency in the UK.

Further, Detergents regulation is the retained EU law on detergents that applies in Great Britain, which is Regulation (EC) No 648/2004 

Additionally, the chemicals in disinfectants and detergents are subject to compliance with different chemical legislation like the EU. For e.g., the active substance approval program for disinfectant (GB active substance review program), UK REACH regulation, GB CLP, etc.

Further, the EU CLP Regulation, as amended, is retained in GB law. These arrangements mean that Great Britain continues to adopt GHS, independently of the European Union, as GB CLP. HSE becomes the relevant GB CLP Agency overseeing GB CLP functions for substances and mixtures placed on the GB market.

Keeping abreast with the stringent and changing global Regulatory dynamics for chemical products, Freyr can extensively support and provide the end-to-end scientific and chemical Regulatory services in the UK.

Categories

Biocide/ Disinfectant

Detergents

/Cleaning products

General consumer Products

Chemicals

Regulation

GB BPR (Similar to EU BPR 528/2012

EU Detergent regulation – ((EC) No 648/2004)

General Product Safety Regulations 2005 (GPSR) 

UK REACH, GB CLP

Registration Requirement

Yes

No

No

Yes

Process in Brief

Online

N/A

N/A

Online

Local Representative

Yes

N/A

N/A

Yes

Key Data Requirements

  1. Proof of compliance (Efficacy studies, safety
  2. summary)
  3. Product details & product characteristics
  4. Manufacturer/ applicant full details
  5. Full ingredient sheet
  6. Safety data sheets
  7. Product labels artwork
  8. Letter of Supply/Article 95 declaration
  9. Company registration letter
  10. CLP classification
  11. Other R&D documents

 

Requirements vary depending on the tonnage band

 

  1. Phys/chem data and information
  2. Toxicological data and testing information
  3. Chemical safety report

 

 

 

Expertise

Freyr Expertise

  • Product classification and Regulatory guidance
  • Regulatory strategies for market access/product launch
  • Product notification/registration strategies
  • Regulatory applicability review and interpretation
  • Preparation of technical data files (specifications, MSDS, etc.), including chemical product registration in the UK/notification dossiers
  • Application preparation & submission for relevant introductions and renewals
  • Sustainability & packaging solutions
  • Regulatory intelligence
  • GB-based Only Representative service (OR service)
  • Biocide Regulatory services in the UK
Freyr Advantages
Advantages

Freyr Advantages

  • Local presence in the market with relevant expertise and experience
  • End-to-end Regulatory consultation
  • Easily navigate complexities of Regulatory Authorities
  • Support for region-specific Regulatory complexities
  • A structured and cost-effective approach to ensure compliance in a multi-market scenario
  • Quick turnaround and faster time-to-market
  • Expert advice on Regulatory services for Chemicals in the UK