Astroflex-A029_en_food_declaration

Marigold Astroflex-A029_en_food_declaration

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1. FOOD DECLARATION OF PRODUCT COMPLIANCE the Authorised Representative, established in the European Community: ANSELL HEALTHCARE EUROPE N.V. RIVERSIDE BUSINESS PARK, BLOCK J BOULEVARD INTERNATIONAL 55 B-1070 BRUSSELS declares that the glove described hereafter: Astroflex A029 belonging to the "Elastomers and Rubber" category (for more detailed information on product composition please consult the Ansell Technical Datasheet) is in conformity with the following provisions: the EC-regulation 1935/2004 and the EC-regulation 2023/2006 related to Good Manufacturing Practices (GMP) for Materials and Articles intended to come in contact with Foodstuffs (for more detailed information please also consult Ansell GMP Food Declaration). All ingredients, starting monomers, additives used in manufacturing this glove comply with: - any positive list - any relevant SML(Specific Migration Limit) or restrictions as specified in the applicable EU-28 food legislations. France: Arrêté du 9 novembre 1994, relatif aux matériaux et objets en caoutchouc au contact des denrées, produits et boissons alimentaires Italy: D.M. 21/03/1973 Disciplina igienica degli imballaggi, recipienti, utensili, destinati a venire in contatto con le sostanze alimentari o con sostanze d'uso personale Germany: BfR Empfehlung XXI (2011) Bedarfsgegenstände auf Basis von Natur- und Synthesekautschuk Netherlands: Regeling Verpakkingen en Gebruiksartikelen (Warenwet), Hoofdstuk III, Rubberproducten Verpakkingen Czech Republic: Vyhláška č. 38/2001 Sb. (Consolidated 2009-5-15) Annex 07: Elastomers and rubber products - list of materials Slovakia: Výnos MPSR a MZSR z 9. júna 2003 č. 1799/2003 - 100, Annex 10 United Kingdom: FDA Code of Federal Regulations, Title 21, Part 177, section 2600 (21 CFR 177.2600) - Rubber articles intended for repeated use Ri v erside Busine s s P ark, Block J Boul e v a r d In t ern a tional 55, 1 0 7 0 Bru s sels, Belgium T el. +32 (0) 2 5 28 7 4 00 • F ax +32 (0) 2 5 28 7 4 0 1 http: / / w w w .ansell . eu • E-mail info.europe@ansell.com

2. For compliance in countries outside of the EU-28 or for more information, please contact Ansell at: info@eu.ansell.com Global migration data: Type of foodstuffs - Testing conditions Aqueous food Alcoholic food Acidic food Fatty food correction factor 1 Fatty food correction factor 2 Fatty food correction factor 3 Fatty food correction factor 4 Fatty food correction factor 5 2 hours/temp. 40°C <10 mg/dm2 <10 mg/dm2 <10 mg/dm2 >10 mg/dm2 >10 mg/dm2 >10 mg/dm2 <10 mg/dm2 <10 mg/dm2 10min/40°C <10 mg/dm2 <10 mg/dm2 <50 mg/dm2 Analytical tolerance for aqueous, alcoholic and acidic food simulant is 2mg/dm2 and for fatty food simulant is 3mg/dm2. Conclusions: As per French & Italian legislation: not suitable for contact with fatty food with a correction factor 1, 2 and 3 • No other restrictions apply • Guido Van Duren Director – Regulatory Affairs PPE Products Ansell Date 05-12-2018 Ri v erside Busine s s P ark, Block J Boul e v a r d In t ern a tional 55, 1 0 7 0 Bru s sels, Belgium T el. +32 (0) 2 5 28 7 4 00 • F ax +32 (0) 2 5 28 7 4 0 1 http: / / w w w .ansell . eu • E-mail info.europe@ansell.com

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