EU Reach Registration


EU REACH Registration - 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.

In the EU, disinfectant products are classified as biocides under which formulation having multiple intended use applications falls under Group I (Disinfectant) product types as below.

Table 1: Classification of Group I (Disinfectant) Product Types

PT1PT2PT3PT4PT5
Human hygieneDisinfectants and algaecides not intended for direct application to humans or animalsVeterinary hygiene

Food and feed area

 

Drinking water

Disinfectant regulation is dynamic and based on the active substance approval status in Europe, where the requirements/obligations are subject to the EU BPR 528/2012 regulation, which is managed by the EU member states/ECHA and the EU commission.

Detergent and household cleaning products in Europe are classified as general consumer products and subject to compliance checks as per the EU Detergent Regulation ((EC) No 648/2004) requirements and specifications.

Additionally, the chemicals in disinfectants and detergents are subject to Regulatory compliance with different chemical legislations such as the active substance approval program for disinfectants, EU REACH Regulation, CLP, etc.

Table 1: Chemical Regulations in the EU

Chemical RegulationBiocide/ Disinfectant

Detergents

/Cleaning products

General consumer ProductsChemicals
RegulationEU BPR 528/2012.EU Detergent Regulation – ((EC) No 648/2004).

General product safety regulation, Directive 2001/95/EC of the European Parliament.

 

Directive 2000/54/EC of the European Parliament” safety of workers exposing to the biological agents.

EU REACH, and CLP.
Registration RequirementYesNoNoYes
Process in Brief

Online and offline (Majorly online depending on EU 27 country).

 

The process could be at the local transitional level or harmonized level depending on the active substance approval status, where submission mode could be online or offline at the transitional level and online at the harmonized level.

 

N/AN/AOnline
Local RepresentativeYesN/AN/AYes
Key Data Requirements
  1. Proof of Compliance (Efficacy Studies, Safety Summary).
  2. Product Details and Product Characteristics.
  3. Manufacturer’s/Applicant’s Full Details.
  4. Full Ingredient Sheet.
  5. Safety Data Sheets (SDS).
  6. Product Labels & Artwork.
  7. Letter of Supply/Article 95 Declaration.
  8. Company Registration Letter.
  9. CLP Classification.
  10. Other R&D Documents as an Additional Requirement.
 

Requirements vary depending on the tonnage band:

  1. Phys/Chem Data and Information.
  2. Toxicological Data and Testing Information.
  3. Chemical Safety Report.

 

Classification, Labeling, and Packaging (CLP) ((EC) No 1272/2008) is legally binding across the Member States and directly applicable to all industrial sectors. It requires manufacturers, importers, or downstream users of substances or mixtures to classify, label, and pack their hazardous chemicals appropriately before placing them on the market, and since June 01, 2015, it has been the only legislation in force in the EU for classification and labeling of substances and mixtures.

Keeping abreast with the stringent and changing global chemical Regulatory dynamics, Freyr can extensively support and provide end-to-end scientific and EU REACH registration services in the Europe Union (EU).

Freyr Expertise

  • Product Classification and Regulatory Guidance.
  • Regulatory Strategies for Market Access/Product Launch.
  • Develop Product Notification/Registration Strategies.
  • Regulatory Applicability Review and Interpretation.
  • Prepare Technical Data Files (Specifications, MSDS, Etc.) Including Chemical Registration in ECHA/Notification Dossiers.
  • Application Preparation and Submission for Relevant Introductions and Renewals.
  • Sustainability and Packaging Solutions.
  • Regulatory Intelligence (RI) Services.
  • EU REACH Registration Only Representative (OR) Service.

Freyr Advantages

  • Local presence in the market with relevant expertise and experience.
  • End-to-end Regulatory consultation on EU REACH Registration.
  • Easily navigate the complexities of Regulatory Authorities.
  • Support for region-specific Regulatory complexities.
  • A structured and cost-effective approach to ensure Regulatory compliance in multi-market scenarios.
  • Quick turnarounds and faster time-to-market.
  • Expert advice on chemical Regulatory services in the European Union (EU).

Looking for Regulatory Support in European Union

Contact us now for Expert Guidance and Support

Send Us a Request