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					Objectives and Scope of the
Detergents Regulation
Stephen Pickering
 Stephen Pickering
  Objectives: legal basis
Legal basis is Article 95 of the EC Treaty


4Article 95(1): Free movement of goods (detergents)
 in the internal market

4Article 95(3): Protection of the environment and
 human health
 Scope: products covered
   All detergents and surfactants for detergents
Detergent means preparation intended for cleaning
   Cleaning means removal of soil (EN ISO 862)
Soil means undesirable deposits in or on a substrate
     that affect the appearance or feel of a clean
  Scope: products covered
    All detergents and surfactants for detergents
  Surfactant means organic substance capable of
   forming emulsions and of reducing the surface
                 tension of water
reducing the surface tension of water means reducing
   to below 45mN/m (International trade tariff value)
  Scope: product requirements

4Biodegradability of surfactants
4Restrictions on non-biodegradable surfactants
  • bans
  • derogations (restricted use)
4Labelling of detergents
4Information to be provided by manufacturers to
  Product requirements:
  legal responsibilities

      The legal liability resides with the manufacturer.
     manufacturer means person placing on the market
   (import, change of composition, change of packaging)
placing on the market means making available to third parties
making available to third parties means change of ownership
   Product requirements:

4 Ultimate biodegradability
   § Ultimate biodegradatation = breakdown to CO2, H2O, mineral salts
     and increased biomass
   § (Primary biodegradatation = loss of surfactant characteristics)
4 Criterion for ultimate biodegradability: 60% in 28 days
4 Same criterion applies to all types of surfactant i.e. ionic,
  anionic, cationic and amphoteric
 Product requirements:
 labelling for constituents
4Constituents by class (concentrations > 0.2%)
    Phosphates, phosphonates, anionic surfactants, cationic
    surfactants, amphoteric surfactants, non-ionic surfactants, oxygen
    -based bleaching agents, chlorine-based bleaching agents,
    EDTA, NTA, phenols, parachlorobenzene, aromatic
    hydrocarbons, aliphatic hydrocarbons, halogenated
    hydrocarbons, soap, zeolites, polycarboxylates (18 classes)
    Weight percentage ranges: <5%, 5 - 15%, 15 – 30%, >30%
4Constituents by class (if deliberately added)
    enzymes, disinfectants, optical brighteners, perfumes,
    preservation agents
4Constituents in concentrations > 0.01%
    allergenic fragrances (26 listed in the Cosmetics Directive)
  Product requirements:
  DPD labelling
Labelling rules of the Dangerous Preparations Directive (DPD)
apply in addition to the rules specific to Detergents
Example: A detergent contains a substance classified as R41
under the DSD, i.e. “Risk of serious damage to eyes”.
Under the DPD the detergent is classified:
either according to the concentration of the substance, i.e.
4<5%: no classification, no risk phrase, no symbol.       Xi
45-10%: classified R36, “Irritating to eyes”, symbol:
or “according to its effects on man” Art 6(3).
 Product requirements:
 labelling (manufacturer)

The packaging of detergents must be labelled for:
4Name and trade mark of the product
4Name or trade name or trade mark and full
 address and telephone number of manufacturer
4Address, email address and telephone number
 from which the ingredient datasheet may be
 Product requirements:
 labelling (dosage)

The packaging of laundry detergents must be labelled for:
4 Recommended dosage for a standard washing machine
  load (4.5kg or 2.5kg) for soft, medium and hard water,
  taking into account one or two wash cycles.
4 The number of standard washes contained in the
  package for medium water hardness.
4 The capacity of any measuring cup in ml or grams, and
  markings to indicate appropriate dosage.
   Product requirements: information

4Manufacturers shall make available the ingredient
 datasheet to health care professionals on demand.
4Manufacturers shall make available on a website a
 list of ingredients.
4Manufacturers shall hold at the disposal of the
 competent authorities a technical file with the
 results for the test for ultimate biodegradability.
 Product requirements:
 information (datasheet)
The manufacturer shall make available to medical personnel
  on demand an ingredients datasheet containing:
4 The name of the detergent and the manufacturer.
4 All ingredients in order of decreasing abundance
  subdivided into weight percentage ranges of:
   a) <0.1%, b) 0.1% - 1%, c) 1% - 10%, d) > 10%
   (Impurities are not considered to be ingredients)
4 The IUPAC, INCI and European pharmacopoeia names
  of the ingredients, and their CAS number.
 Product requirements:
 information (list of ingredients)

  Manufactures shall make available on a website
  a list of ingredients containing:
4All ingredients in order of decreasing abundance.
4The INCI names of the ingredients where

  This is information to be available to the general
   Scope: which products are
4Contact lens care solutions: Not covered.
  The solutions are some times advertised as
  cleaning solutions, but they act only to reduce the
  build up of deposits on contact lenses.
4Polishes: Some covered, others not covered
  Polishes that have a combined cleaning and
  coating action are covered.
  Polishes that do not clean but have only a coating
  action are not covered.
   Scope: which products are
4Window cleaners without surfactant: Covered.
  Alcohol-based window cleaners must comply with
  the labelling requirements.
4Fuel additives: Not covered
  Manufacturer claimed that fuel additives clean
  engine valves. However, they only act to shift the
  equilibrium between the rate of soil deposition and
  rate of removal through combustion.
4Fruit and vegetable cleaners: Covered
   Guidelines for interpreting the
   Detergents Regulation
4A.I.S.E. Guideline on Implementation of the
 Detergent Regulation Biodegradability of
 Surfactants and Annex VII (Labelling and Ingredient
4CESIO Tiered Approach Guidance Document:
 Methodology for the Tiered Approach to Testing in
 the Context of Annex IV of Regulation (EC) No
4CESIO "Read Across Rules" in the context of
 Annex III of Regulation (EC) No 648/2004
 Future Perspectives
Three issues identified for possible future action in
the Detergents Regulation (Article 16)

4Anaerobic biodegradation of surfactants
4 Biodegradation of non-surfactant organic
4The use of phosphates in detergents

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