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On September 7, 2005 the new German law (Lebensmittel- und Futtermittelrechts - `LFGB' ) became effective. This law replaces the Act on food and commodities (Lebensmittel- und Bedarfsgegenständegesetz - `LMBG'). Recent events involving animal feeds for animals destined for human consumption have prompted officials to replace LMBG with the new law, LFGB. In addition to the animal feeds issues, LFGB includes some changes for commodities and cosmetics as well. The changes for commodities and cosmetics are noted below: A Commodities

In the definition what is classified as commodities there is no change. Articles in contact with food Packaging materials for cosmetics and tobacco products Articles for contact with mucous membranes of the month Articles for body care (i. e. brush, sponge, comb, ...) Toys and joke articles Articles which will have more than only short term contact with the skin (clothes, bed linen, ...) These commodities have to meet the requirements of § 30 and food contact items must meet the requirements of § 31 of the LFGB. LFGB § 30 has no changes from the last version of LMBG In general it is forbidden to provide articles in a way that they can endanger human health in their intended or foreseeable use by their composition, neither by substances added intentionally, nor by impurities. It is forbidden to bring articles which endanger human health as commodities on the market. It is forbidden to use the commodities in professional production and treatments of food in a way that it is possible that the commodities will endanger human health by eating the food LFGB § 31 change: in this § the EC-regulation 1935/2004 is fully implemented now It is forbidden to bring materials and products (§ 2 Abs. 6, Satz 1, Nr. 1) on the market which do not meet the requirements of Article 3, Abs. 1 of the EC-regulation 1935/2004. It is also forbidden to use them. Materials/Products must be produced in a way that ­ under the conditions of intended and foreseeable use ­ no substances will be released to the food or food contact surface in quantities in which they can Endanger human's health Influence composition, odour, taste or appearance of the food It is forbidden to bring articles for food contact on the market which does not meet these requirements.

So in general before you bring an article on the market you have to make sure the articles meet the legal requirements. To prove the requirements are met, all relevant tests have to be done and especially for food contact: Check of material composition against lists of approved substances Testing (Sensory test, Overall migration, Specific migration) either for 1 contact (single use) or for 3 Contacts (repeated use). B. Cosmetics According to § 4 (1) No. 3 of LFGB the regulations for cosmetics products have been expanded to tattoos and comparable ingredients or formulations, which are intended to improve the appearance of the consumer and which will stay permanently or temporarily on skin. Due to the fact that this definition is not completely clear which products are included and which not, the German Health Authorities have pointed out that not only tattoos and permanent make-up but also products which are injected under skin (e.g. Botox) will be covered by this regulation. It can be expected that this will be regulated under additional and separate decrees. According to this definition the product group of tattoos (including temporary tattoos e.g. stickers etc) and permanent make up have to follow the requirements of Cosmetic Directive 76/768/EEC and its amendments. SGS and SGS Institute Fresenius can offer a broad range of services for this product groups e.g.: Skin Tolerance Tests (e.g. Human Patch Test) Analysis of contaminants (NDELA, Formaldehyde, PAHs, aromatic amine, etc.) and heavy metals (sweat soluble nickel, soluble chromium, cadmium, lead, etc.) Compilation of technical information file according to Article 7a of Directive 76/768/EEC

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© 2005 SGS SA. All rights reserved. This technical bulletin is a publication of SGS SA although certain contents have been submitted by third parties or have otherwise been licensed for use by SGS SA and all copyrights in such third party contents remain vested in such third parties. Contents identified as being from third parties reflect solely the positions of such third parties and SGS SA neither endorses nor disapproves of said contents. This technical bulletin is intended to provide technical information on a particular subject or subjects and is not an exhaustive treatment of such subject(s). Accordingly, the information provided herein is strictly educational and does not replace any legal requirements or applicable regulations. It is not intended to constitute consulting or other professional advice or services. This technical bulletin is provided "as is" and SGS SA does not warrant that the information contained therein will be error-free or will meet any particular criteria of performance or quality. The information may not be quoted or referred to in any other publication or proceeding without the prior written consent of SGS SA.


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