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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 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 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 • 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 • 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
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 • 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 • 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.
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 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 • 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 The address from which ingredient datasheets for medical personnel can be obtained has to be provided on the packaging of the detergent.
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.
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.
