Polyco Main Catalogue

Food Contact Articles intended for food contact must comply with the requirements of the framework Regulation (EC) No. 1935/2004, which outlines general requirements for all food contact materials (FCMs), including, but not limited to, that FCMs must be manufactured in compliance with good manufacturing practice regulations, and that chemicals migrating from the FCM into food must not endanger human health (evidenced by laboratory testing). Certain materials also have further mandatory requirements, such as those for plastic materials included in Regulation (EU) No. 10/2011. Articles which are not obviously intended for food contact (such as gloves) must be labelled with the words ‘for food contact’ or the fork and goblet symbol (pictured right) on the product or packaging, and a declaration of compliance must be made available for all FCMs. Standards Explained All PPE gloves must comply with the EN ISO 21420 / EN 420 standards which specify general requirements for protective gloves, including tests for properties such as innocuousness and sizing. Other available standards, some of which are explained below, relate to protective gloves for specific use cases including • Food contact • Chemicals and micro-organisms • Medical

Technical Standards Explained

Migration testing – OML and SML Both overall and specific migration testing must be performed. Both tests involve placing chemical food simulants into contact with the test item under set conditions (30 minutes at 40°C for gloves, with one extraction for disposable gloves, and 3 extractions for reusable gloves); the differences between OML and SML are below: • Overall migration limit (OML): determines the total amount of non-volatile substances extracted. Tested according to EN 1186 series of standards. Each required simulant must result in <10 mg/dm² of migration to pass. • Specific migration limit (SML): determines the individual amount of migration of specific restricted substances (mostly metals), which each have their own maximum permissible limits. Tested according to EN 13130 standard.

Migration testing – food simulants For both overall and specific migration, the type of food the product is intended for determines which simulants must be tested (for ‘all food types’, which is used for gloves, A, B, and D2 are required): Simulant A 10% ethanol: aqueous foods Simulant B 3% acetic acid: acidic foods Simulant C 20% ethanol: alcoholic foods (up to 20% alcohol content) Simulant D1 50% ethanol: oil in water emulsions and alcoholic foods with >20% alcohol content Simulant D2 Vegetable oil (or substitute simulants 95% ethanol and iso-octane, both of which must pass): foods with free surface fats Simulant E Poly(2,6-diphenyl-p-phenylene oxide): dry foods

EN ISO 374-1:2016+A1:2018 EN 374-1 is the standard for protective gloves against dangerous chemicals and micro-organisms. Gloves are tested in the palm (unless over 400mm in which case the cuff is also tested) for permeation resistance against any of 18 specified chemicals. There are 3 types of chemical resistant gloves; Type A, Type B and Type C as detailed. The permeation performance levels are from 1-6, with 6 being the highest.

EN ISO 374-1:2016 +A1:2018 Type A

EN ISO 374-1:2016 +A1:2018 Type C

EN ISO 374-5:201 6

EN ISO 374-1:2016 +A1:2018 Type B

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T o claim chemical resistance (and micro-organism resistance) EN374-5 must also be passed which ensures the gloves do not leak when tested with air or water. Virus resistance can also be tested under EN374-5 and if passed the word Virus can be shown under the EN374-5 pictogram. Chemical resistant gloves are also tested against EN374-4 which gives an indication of the degradation of the glove material in contact with the chemicals claimed under EN374-1.

Type A Passing a minimum level 2 permeation resistance against at least 6 chemicals. Code letters for chemicals shown under the pictogram.

Type B Passing a minimum level 2 permeation resistance against at least 3 chemicals. Code letters for chemicals shown under the pictogram.

Type C Passing a minimum level 1 permeation resistance against at least 1 chemical. No letters under the pictogram.

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