NEW FOOD CONTACT REGULATION ON RUBBER FOR SINGLE-USE GLOVES

What are the differences?

Before

Today

FRENCH DECREE

November 9th 1994

FRENCH DECREE

August 5th 2020
M A N D A T O R Y

 

COMPOSITION - Positive list     ?

 

Composition in accordance with the positive list, including colour pigments

 

GLOBAL AND SPECIFIC MIGRATIONS   ?

 

 

Global migrations (Conditions : 2h - 40°C) - Restrictions allowed     ?

 

Ethanol 10%: ≤ 10 mg/dm²

Ethanol 20%: ≤ 10 mg/dm²

Ethanol 50%: ≤ 10 mg/dm²

Acetic acid 3%: ≤ 10 mg/dm²

Vegetable oil (olive oil) or ethanol 95% + Isooctane: ≤ 10 mg/dm²

Poly (2,6-diphenyl-p-phenylene) oxide: ≤ 10 mg/dm²

 

Specific migrations (Conditions : 2h - 40°C) - No restrictions allowed    ?

 

(Conditions: 4h - 105°C) Free organic volatile substances: ≤ 0,5%

N-nitrosamines : ≤ 1 µg/dm²
N-nitrosable substances: ≤ 10 µg/dm²
/

Primary aromatic amines: not detectable

Primary & secondary aromatic amines: ≤ 1 mg/kg

Formaldehyde : ≤ 3 mg/kg

/

Formaldehyde + Hexamethylenetetramine :
≤ 15mg/kg

Peroxydes : negative reaction

/

For natural latex:
Hydroxylamine : not detectable

/

For natural latex:
P-nitrophenol, boric acid and sodium salts: not allowed in natural rubber

Metals: Metals: 

Zinc : 10 mg/kg

Zinc : 5 mg/kg

/

Barium : 1,2 mg/kg

/

Copper: 4 mg/kg

/

Aluminium : 1 mg/kg

/

Lead, cadmium, antimony, mercury and arsenic residues:
≤ 1 mg/kg