REGULATORY ASSISTANCE

HAZARDOUS SUBSTANCES AND MIXTURES

HAZARDOUS SUBSTANCES AND MIXTURES, are governed by the CLP Regulation (EC) no. 1272/2008, entered into force on 20 January 2009, and which progressively replaced the directive on the classification and labelling of dangerous substances (67/548/EEC) and the directive on dangerous preparations (1999/45/EC).

Annex 1 of the CLP Regulation defines hazardous substances and mixtures as:

  • Explosives
  • Flammable gases
  • Flammable aerosols
  • Oxidising and pressurized gases
  • Flammable liquids and solids
  • Self-reactive substances and mixtures
  • Pyrophoric liquids and solids
  • Self-heating substances and mixtures
  • Substances and mixtures which, in contact with water, develop flammable gases
  • Fluid liquids and solids
  • Organic peroxides
  • Substances or mixtures corrosive to metals
The Hazardous Substances and Mixture Technical-Regulatory Area of Bio Basic Europe assists the client by offering consulting services and producing the necessary documentation for the trading of the products, in line with the current regulations concerning safety and protection of public health.

Below is a list of the main technical-regulatory services offered by Bio Basic Europe for producers and manufacturers of hazardous substances and mixtures:

  • Identification of the category to which a product belongs in borderline cases (dangerous mixture according to the CLP Regulation or treated article according to the REACH Regulation)
  • Substitute declarations to meet the requests of other suppliers
  • Evaluation of the product documentation in compliance with regulatory requirements
  • Formal examination of safety data sheets provided by non-EU producers
  • Drafting of safety data sheets for dangerous and non-hazardous mixtures (e.g. air fresheners, liquids for electronic cigarettes, perfumed candles, perfume papers, etc.), bulk cosmetic products, detergents
  • Translation of safety data sheets in different languages
  • Advice on the labelling of hazardous mixtures/scented candles
  • Consultancy regarding the labelling of detergents and technical data drafting intended for consumers and authorities
  • National (ISS-hazardous preparations archive) and European registration of companies and hazardous mixtures (home fragrances, scented candles, detergents, etc.)
  • Advice on VOCs for export purposes
  • Contacts with national and international competent Authorities to meet the legal obligations for export/import of dangerous mixtures (registration, drafting of safety data sheets, labelling, etc.)
  • ADR transport advice
  • Suggestion of the most suitable tests necessary for the declassification of the danger of mixtures
  • Evaluation of formulas and safety data sheets of detergent and softening formulations, to extend previous safety tests and drafting of equivalence declarations
  • Documentation audit, concerning tests performed on scented candles
Bio Basic Europe is also expert in performing clinical monitoring and laboratory tests to substantiate the safety and efficacy of hazardous substances and mixtures.

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