Information to be provided to consumers medical personnel and member state competent authorities
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Dr. Dagmar Zaika A.I.S.E. / Henkel AG & Co. KGaA Workshop on the Implementation of the PowerPoint PPT Presentation


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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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Dr. Dagmar Zaika A.I.S.E. / Henkel AG & Co. KGaA Workshop on the Implementation of the

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Information to be provided to consumers medical personnel and member state competent authorities

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


Information to be provided to competent authorities art 9 1 2

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.


Hurdles for manufacturers of detergents

“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.


Guidance on implementation

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_guidelines_en.pdf


Process in case of inspection

Providing biodegradation

data to CA within 3 weeks

from the date of request

Surfactant Manufacturer

Immediately passing

request up the

supply chain

Surfactant Distributor

Immediately requesting

for biodegradation data

Inspection

Detergent Manufacturer

Competent Authority

Process in Case of Inspection

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


Recommendation to detergents manufacturers

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:

….

….


Recommendation to surfactant suppliers

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.


Recommendation to surfactant suppliers1

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

Recommendation to Surfactant Suppliers


Ingredient data sheet for medical personnel art 9 3 annex vii c

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.


A i s e recommendation

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.


Practical examples

Practical Examples

The address from which

ingredient datasheets for

medical personnel can be

obtained has to be provided

on the packaging of the

detergent.


Ingredient datasheet for medical personnel

Ingredient Datasheet for Medical Personnel


Publication of the list of ingredients annex vii d

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 > 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.


Practical examples dishwashing liquid

Practical ExamplesDishwashing Liquid


Pathway to list of ingredients 1 www henkel com

Pathway to List of Ingredients (1):www.henkel.com


Pathway to list of ingredients 2 laundry home care

Pathway to List of Ingredients (2):Laundry & Home Care


Pathway to list of ingredients 3 consumer information

Pathway to List of Ingredients (3):Consumer Information


Pathway to list of ingredients 4 product search

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.


List of ingredients dishwashing detergent

List of IngredientsDishwashing Detergent


List of ingredients laundry detergent

List of IngredientsLaundry Detergent


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