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Harmonized EU Food Law

HARMONIZED EU FOOD LAW

There is no European Directive specifically applicable to rubber gloves meant for food contact applications. Therefore, (EC) No.1935/2004- Council Directive of October 27, 2004, on materials and articles intended to come into contact with food (repealing Directive 80/590/EEC and 89/109/EEC) is normally used for evaluating the suitability of a glove in food contact applications.

Parent Directive (EC) No,1935/2004 stipulates that any material or article intended to come into contact directly or indirectly with food must be sufficiently inert to preclude substances from being transferred to food in quantities large enough to endanger human health or to bring about an unacceptable change in the composition of the food or a deterioration in its organoleptic properties.

Specific Directives supplement the Parent Directive and apply to groups of materials. There are seventeen categories in total and gloves are governed by the Directive specific to the Plastics category.

2002/72/EC-Commission Directive of August 4, 2002, relating to plastic materials and articles intended to come into contact with foodstuffs (repealing Directive 90/128/EEC and its seven amendments) is used as a guideline for evaluating rubber gloves in the absence of a Specific Directive for Rubber.

Gloves must be manufactured using ingredients from the authorized list in the Directive.

In order to evaluate the transfer of components of plastic materials in contact with the foodstuff, migration tests are carried out.

The Directive defines:

 
 

Global Migration

Any ingredient of the gloves that may endanger health or unacceptably modify the content of the foodstuff or their organoleptic characteristics should not transfer to the food stuff handled.

The limit of global (total) migration is fixed at 10mg/drn of glove surface in contact with the foodstuff.

Specific Migration

Specific migration testing is carried out to ensure that the migration of ingredients that maybe hazardous to health is within a stated limit.

The foodstuff are divided into four classes, viz. aqueous food, acidic food, alcohols and fatty food. The gloves can be tested for all four of the food classes or for an individual food class, according to their final use. If the glove is only suitable for certain classes of food, this must be clearly indicated.

The test stimulants used for both global and specific migration are:

Distilled water = for water based food
Dilute acetic acid = for acidic food
Dilute ethanol = for alcoholic food
Rectified olive oil = for fatty food

Food Contact

Gloves tested and found to be suitable for food contact should carry the following pictogram.