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Standards and directives

We operate in a regulated global market in many countries. Thus, we must manage requirements that may vary greatly between countries or regions.
The common goal of our product managers and services is to offer reliable, sustainable, high-performance products in compliance with the regulations and/or standards of each territory where they are used.
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Standards and certifications

All you need to know about PPE standards

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EN ISO 13688 GENERAL REQUIREMENTS

Reference standard, not for use alone, but only in association with another standard containing the protection performance requirements. This standard specifies general performance requirements for ergonomics, innocuousness, size designation, durability, ageing, compatibility and marking of protective clothing and the information to be supplied by the manufacturer with the protective clothing.

FOOD COMPATIBILITY

FOOD COMPATIBILITY IS GOVERNED BY: Regulation (EC) N° 1935/2004 of the European Parliament and of the Council of 27th October 2004 on materials and articles intended to come into contact with foodstuffs.
Materials and articles must be manufactured in compliance with good manufacturing practice so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities which could:

• Endanger human health ;

• Bring about an unacceptable change in the composition of the food or a deterioration in the organoleptic characteristics thereof.

Food contact of plastic materials is governed by Regulation (EU) No 10/2011 and the related requirements. Materials PVC/Vinyl or even Latex/Nitrile gloves (unless local legislation exists) are directly subject to these regulations. They define:

• Positives lists of authorized constituents;

• The purity criteria applicable to some of these constituents;

• Special migration limits in foodstuffs for certain constituents;

• Maximum residual quantities of some constituents in the material;

• An overall migration limit in foods.

• A limit of metal content for plastic materials and objects.

Annex III of Regulation (EU) 10/2011 provides the list of stimulants to be used for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs:

• Aqueous foods (pH > 4.5): Simulants A, B and C.

• Acid food (pH ≤ 4.5): Simulant B;

• Alcoholic foods (≤ 20%): Simulant C;

• Alcoholic foods (> 20%): Simulant D1.

• Fatty foods: Simulants D1 and D2.

• Foods containing free surface fats: Simulant D2.

• Dry foods: Stimulant E.

Regulatory directives