| On 24 September 2003 Directive 2003/83/EG on adapting to technical progress Annexes II, III and VI to Council Directive 76/768/EEC (EU Cosmetic Directive) was adopted. On 25 September 2003 this Directive was published in the Official Journal of the European Union.
With regards to the transitional periods, from 24 March 2005 MDGN-containing leave-on products shall not be placed on the market and shall not be sold or disposed to the final consumer after 24 September 2005.
Annex VI of the EU Cosmetic Directive has been changed as follows:
Ref. No. a „36
Substance b 1,2-Dibromo-2,4-dicyanobutane (methyldibromo glutaronitrile)
Maximum authorised concentration c 0.1 %
Other limitations and requirements d Rinse-off products only“
Conditions of use and warnings which must be printed on the label e
What consequences result from this?
The use of MDGN in leave-on products is prohibited. Use in rinse-off products is not affected at all, and is still safe in the permitted concentrations (up to 0.1 % MDGN active).
Although legally MDGN can continue to be used in leave-on products during the transitional periods, we recommend that you start with the reformulation of your MDGN-containing leave-on products without delay. There are already numerous alternatives available to you from the extensive S&M product range for the preservation of cosmetics. We shall support you in the reformulation of MDGN-containing leave-on products. Our advisers in the field force will continue to contact you about this situation.
Schülke & Mayr will also continue to invest in the safety of MDGN and carry out an extensive study with the collaboration of COLIPA (the umbrella organisation of the European cosmetic industry) in order to improve the data situation regarding evaluation of the safety of MDGN in leave-on products. Due to ongoing discussions relating to the test protocol to be used it is anticipated that this study will commence by beginning of 2004. We have informed the European Commission accordingly.
If you have any further questions, please do not hesitate to contact us.
Schülke & Mayr GmbH Special Additives International Silke Wüstermann Product Manager
Tel.: +49-40-521 00 215 ; Fax: +49-40-521 00 244, e-mail: silke.wuestermann@schulke-mayr.com
|