Information to be provided to Consumers, Medical Personnel and Member State Competent Authorities

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Information to be provided to Consumers,
Medical Personnel and Member State Competent
Authorities

• Dr. Dagmar Zaika A.I.S.E. / Henkel AG Co.
  KGaA
• Workshop on the Implementation of the
• Regulation (EC) 648/2004 Detergents Regulation
• INFRA 32637
• Bucharest, Sept. 21 22, 2009

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Information to be provided to Competent
AuthoritiesArt. 9 (1, 2)

• The following information has to be provided to
  Competent Authorities by manufacturers of
  surfactants and detergents upon request
• Documentation on the tests carried out to
  demonstrate ultimate biodegradability (Annex
  III).
• Documentation on the tests of primary
  biodegradability (Annex II) and on complimentary
  risk assessments (Annex IV) in case of derogation
  requested for surfactants in detergents used in
  industrial or institutional sectors.
• In case the manufacturer is not owner of the test
  results, evidence that he can benefit from the
  property rights.

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Hurdles for Manufacturers of Detergents

• In case of inspection at a detergent
  manufacturer, he himself has ultimate
  responsibility to provide data proving the
  biodegradability of the surfactants used in his
  products.
• Data on biodegradability of surfactants are
  typically generated and owned by the surfactant
  manufacturer.
• Close and prompt cooperation between the
  detergent manufacturer and his suppliers is
  required to ensure that the Competent Authorities
  receive the requested documentation in time.

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Guidance on Implementation

• AISE / CESIO / ECOSOL / FECC Guideline
• describes process to be followed within the
  supply chain to ensure a swift submission of
  biodegradability data to authorities
• published on the website of the European
  Commission http//ec.europa.eu/enterprise/sectors
  /chemicals/files/studies/cesio_aise_ecosol_fecc_gu
  idelines_en.pdf

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Process in Case of Inspection

• E-mail address should be provided by inspector
  to ensure speedy process.

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Recommendation to Detergents Manufacturers

• A.I.S.E. recommends to always request from
  surfactant suppliers (EU and non-EU) written
  compliance confirmations on the SDS or on a
  specific document.
• Example

.
.
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Recommendation to Surfactant Suppliers

• CESIO recommends to employ Safety Data Sheet
  (section 12 and /or 15) to report compliance with
  biodegradability criteria
• Additionally required information in the SDS
• Name, phone number and e-mail address to be
  contacted for requesting the data.

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Recommendation to Surfactant Suppliers

• Statement to be indicated in the Safety Data
  Sheet for surfactants being evaluated for
  derogation or listed in Annex V (derogated
  surfactants)

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Ingredient Data Sheet for Medical PersonnelArt.
9 (3), Annex VII C

• Ingredient data sheet (for medical purposes only)
  have to be provided without delay and free of
  charge to any medical personnel upon request. The
  following provisions apply
• All ingredients (except impurities) must be
  listed in order of decreasing concentration
  subdivided in the following weight percentage
  ranges
• - 10 or more
• - 1 or over, but less than 10
• - 0,1 or over, but less than 1
• - less than 0,1
• Common chemical or IUPAC name, and where
  available CAS number, INCI name and European
  Pharmacopoeia name must be given for each
  ingredient.

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A.I.S.E. Recommendation

• Information from where to obtain ingredients
  datasheets should appear on the packaging of
  detergents sold to the general public as well as
  of Institutional Industrial products.
• All ingredients added by the manufacturer to
  produce the final product should be listed. In
  case chemical reactions between ingredients, the
  resulting chemicals should be identified in the
  list as ingredients.
• The presence of perfume and colour should be
  indicated by the terms perfume and
  colorant(s). Allergenic fragrance ingredients
  exceeding 0,01 by weight should also be listed.

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Practical Examples
The address from which ingredient datasheets
for medical personnel can be obtained has to be
provided on the packaging of the detergent.
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Ingredient Datasheet for Medical Personnel
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Publication of the List of IngredientsAnnex VII D

• Manufacturer of detergents have to provide to
  consumers on a website simplified ingredient
  datasheets containing the following information
• INCI names of all ingredients in order of
  decreasing concentration.
• The word parfum when the product contains
  perfume. Allergenic fragrances gt 0,01 have to be
  listed additionally.
• The word colorant when the product contains
  colouring agents.
• This obligation applies only to detergents for
  the general public.

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Practical ExamplesDishwashing Liquid
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Pathway to List of Ingredients (1)
www.henkel.com
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Pathway to List of Ingredients (2)Laundry
Home Care
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Pathway to List of Ingredients (3)Consumer
Information
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Pathway to List of Ingredients (4)Product Search
A link to a website providing correspondence
between INCI, European Pharmacopoeia names, and
CAS numbers (e.g. Commission Pharmacos website)
is required.
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List of IngredientsDishwashing Detergent
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List of IngredientsLaundry Detergent
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