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Objectives and Scope of the Detergents Regulation

Objectives and Scope of the Detergents Regulation. Stephen Pickering. Stephen Pickering. 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

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Objectives and Scope of the Detergents Regulation

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  1. Objectives and Scope of the Detergents Regulation Stephen Pickering Stephen Pickering

  2. 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

  3. 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

  4. Scope: products covered All detergents and surfactants for detergents  Surfactant means organic substance capable of forming emulsions and of reducing thesurface tension of water  reducing the surface tension of water means reducing to below 45mN/m (International trade tariff value)

  5. 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

  6. 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

  7. 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

  8. Product requirements: labelling for constituents • Constituents 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% • Constituents by class (if deliberately added) enzymes, disinfectants, optical brighteners, perfumes, preservation agents • Constituents in concentrations > 0.01% allergenic fragrances (26 listed in the Cosmetics Directive)

  9. 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. • <5%: 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).

  10. 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.

  11. 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.

  12. 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.

  13. 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) > 10% (Impurities are not considered to be ingredients) • The IUPAC, INCI and European pharmacopoeia names of the ingredients, and their CAS number.

  14. 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

  15. 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

  17. 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/legislation/detergents/index_en.htm

  18. 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

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