hyflex-11-840_fødevare

1. FOOD DECLARATION OF PRODUCT COMPLIANCE declares that the glove described hereafter: HyFlex 11-840 The Business Operator, established in the European Community: ANSELL HEALTHCARE EUROPE N.V. RIVERSIDE BUSINESS PARK, BLOCK J BOULEVARD INTERNATIONAL 55 B-1070 BRUSSELS ® belonging to the "Elastomers & Rubber" category 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 food legislations. France: Arrêté du 5 août 2020, relatif aux matériaux et objets en caoutchouc destines à entrer en contact avec des denrées 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 ( 01.02.2023 ) 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 FDA Code of Federal Regulations, Title 21, Part 177, section 2600 (21 CFR 177.2600) - Rubber articles intended for repeated use Ansell Healthcare Europe N.V. Riverside Business Park, Block J Boulevard International 55, 1070 Brussels, Belgium Tel. +32 (0) 2 528 74 00 • Fax +32 (0) 2 528 74 01 http://www.ansell.eu • E-mail info.europe@ansell.com

2. Storage instruction: Keep away from direct sunlight; store in a cool dry place and keep in the original packaging. Keep away from ozone sources. If gloves are properly stored, as indicated above, they won’t lose their performances and won’t change the glove characteristics significantly. If gloves could be affected by ageing or storage, the expiry date is mentioned on the packaging materials. Global migration data: Type of foodstuffs - Testing conditions 2 hours/temp. 40°C > 8 mg/dm² > 8 mg/dm² > 8 mg/dm² > 8 mg/dm² > 8 mg/dm² > 8 mg/dm² > 8 mg/dm² > 8 mg/dm² 10min/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 Aqueous food Simulant used: Distilled Water Alcoholic food Simulant used: Ethanol 15% Acidic food Simulant used: Acetic acid 3% Fatty food correction factor 1 Simulant used: Ethanol 95%/Isooctane Fatty food correction factor 2 Simulant used: Ethanol 95%/Isooctane Fatty food correction factor 3 Simulant used: Ethanol 95%/Isooctane Fatty food correction factor 4 Simulant used: Ethanol 95%/Isooctane Fatty food correction factor 5 Simulant used: Ethanol 95%/Isooctane Analytical tolerance for aqueous, alcoholic and acidic food simulant is 1mg/dm² and for fatty food simulant is 3mg/dm² as per EN 1186. Guido Van Duren Director - Regulatory affairs Ansell Date 06/11/2023 Ansell Healthcare Europe N.V. Riverside Business Park, Block J Boulevard International 55, 1070 Brussels, Belgium Tel. +32 (0) 2 528 74 00 • Fax +32 (0) 2 528 74 01 http://www.ansell.eu • E-mail info.europe@ansell.com