Objectives and Scope of the Detergents Regulation

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Objectives and Scope of the Detergents Regulation
Stephen Pickering
Stephen Pickering
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Objectives legal basis

• Legal basis is Article 95 of the EC Treaty
• Objectives
• Article 95(1) Free movement of goods
  (detergents) in the internal market
• Article 95(3) Protection of the environment and
  human health

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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 surface

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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)

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Scope product requirements

• Biodegradability of surfactants
• Restrictions on non-biodegradable surfactants
• bans
• derogations (restricted use)
• Labelling of detergents
• Information to be provided by manufacturers to
  authorities

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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

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Product requirements biodegradability

• Ultimate biodegradability
• Ultimate biodegradatation breakdown to CO2,
  H2O, mineral salts and increased biomass
• (Primary biodegradatation loss of surfactant
  characteristics)
• Criterion for ultimate biodegradability 60 in
  28 days
• Same criterion applies to all types of surfactant
  i.e. ionic, anionic, cationic and amphoteric

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Product requirements labelling for constituents

• Constituents by class (concentrations gt 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 lt5, 5 - 15, 15
  30, gt30
• Constituents by class (if deliberately added)
• enzymes, disinfectants, optical brighteners,
  perfumes, preservation agents
• Constituents in concentrations gt 0.01
• allergenic fragrances (26 listed in the
  Cosmetics Directive)

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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.
• lt5 no classification, no risk phrase, no
  symbol. Xi
• 5-10 classified R36, Irritating to eyes,
  symbol
• or according to its effects on man Art 6(3).

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Product requirements labelling (manufacturer)

• The packaging of detergents must be labelled for
• Name and trade mark of the product
• Name or trade name or trade mark and full address
  and telephone number of manufacturer
• Address, email address and telephone number from
  which the ingredient datasheet may be obtained.

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Product requirements labelling (dosage)

• The packaging of laundry detergents must be
  labelled for
• 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.
• The number of standard washes contained in the
  package for medium water hardness.
• The capacity of any measuring cup in ml or grams,
  and markings to indicate appropriate dosage.

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Product requirements information

• Manufacturers shall make available the ingredient
  datasheet to health care professionals on demand.
• Manufacturers shall make available on a website a
  list of ingredients.
• Manufacturers shall hold at the disposal of the
  competent authorities a technical file with the
  results for the test for ultimate
  biodegradability.

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Product requirements information (datasheet)

• The manufacturer shall make available to medical
  personnel on demand an ingredients datasheet
  containing
• The name of the detergent and the manufacturer.
• All ingredients in order of decreasing abundance
  subdivided into weight percentage ranges of
• a) ?0.1, b) 0.1 - 1, c) 1 - 10, d) gt 10
• (Impurities are not considered to be ingredients)
• The IUPAC, INCI and European pharmacopoeia names
  of the ingredients, and their CAS number.

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Product requirements information (list of
ingredients)

• Manufactures shall make available on a website a
  list of ingredients containing
• All ingredients in order of decreasing abundance.
• The INCI names of the ingredients where possible.
• This is information to be available to the
  general public

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Scope which products are covered?

• Contact 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.
• Polishes 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.

16
Scope which products are covered?

• Window cleaners without surfactant Covered.
• Alcohol-based window cleaners must comply with
  the labelling requirements.
• Fuel 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.
• Fruit and vegetable cleaners Covered

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Guidelines for interpreting the Detergents
Regulation

• A.I.S.E. Guideline on Implementation of the
  Detergent Regulation Biodegradability of
  Surfactants and Annex VII (Labelling and
  Ingredient Datasheet)
• CESIO Tiered Approach Guidance Document
  Methodology for the Tiered Approach to Testing in
  the Context of Annex IV of Regulation (EC) No
  648/2004
• CESIO "Read Across Rules" in the context of Annex
  III of Regulation (EC) No 648/2004
• http//europa.eu.int/comm/enterprise/chemicals/leg
  islation/detergents/index_en.htm

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Future Perspectives

• Three issues identified for possible future
  action in the Detergents Regulation (Article 16)
• Anaerobic biodegradation of surfactants
• Biodegradation of non-surfactant organic
  ingredients
• The use of phosphates in detergents