Regulatory Services for Chemical Products & Mixtures in the EU

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

 

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 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 compliance with different chemical legislations like the active substance approval program for disinfectants, REACH regulation, CLP, etc.

Categories

Biocide/ Disinfectant

Detergents

/Cleaning products

General consumer Products

Chemicals

Regulation

EU 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

REACH, CLP

Registration Requirement

Yes

No

N

Yes

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/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 and product characteristics
  4. Manufacturer’s/applicant’s full details
  5. Full Ingredient sheet
  6. Safety Datasheets
  7. Product labels artwork
  8. Letter of Supply/Article 95 declaration
  9. Company registration letter
  10. CLP classification
  11. 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 Regulatory dynamics for chemical products, Freyr can extensively support and provide the end-to-end scientific and Chemical Regulatory services in the Europe Union (EU).

Expertise

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 registration/notification dossiers
  • Application preparation and submission for relevant introductions and renewals
  • Sustainability and packaging solutions
  • Regulatory intelligence
  • EU REACH Only Representative service (OR)
Freyr Advantages
Advantages

Freyr Advantages

  • Local presence in the market with relevant expertise and experience
  • End-to-end Regulatory consultation in the EU
  • 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 European Union (EU)