What does the food contact label mean?
The vast majority of single-use, so-called "disposable" gloves are used in sensitive environments such as catering and medical and hospital settings. Sometimes the glove must even be able to meet both environments and different constraints in order to limit the number of references and simplify use for agents in community or professional settings.
The purpose of this article is to clarify the term "Food Contact" within the meaning of the latest regulations in force in France, particularly for nitrile gloves , which remain one of the most widely used. This term, which you may see indicated on glove packaging or claimed differently from one product to another, is in the form of a pictogram incorporating the symbol of a glass of wine and a fork side by side.
It is necessary to clarify the regulatory aspect to better understand certain price differences, in particular...
Why is the food contact label useful and necessary?
It is an approval which ensures the health safety of materials and objects intended to come into contact with foodstuffs .
This mention is therefore a prerequisite for all professionals wishing to use this glove in the context of food preparation, table service, handling of foodstuffs, service in shops or on market stalls, etc.
We will see later that total compliance with European regulations and now French regulations since 2020 is not sufficient on its own to clearly determine the scope of use of the glove, particularly with the problem of "migration" on a series of foods.
It is therefore necessary to pay particular attention to the restrictions and framework of use of the glove, whether in terms of food or time of use ...
The three mandatory regulations on single-use gloves
To be suitable for food contact, a single-use glove must meet three different regulations:
1 - EC Regulation 1935/2004 General requirements
It defines the principles of inertia and safety:
The single-use glove must not be susceptible to:
- Represent a danger to human health
- Unacceptably alter the composition of foodstuffs.
- Modify the organoleptic characteristics of foodstuffs (taste, appearance, color, consistency).
2- EU Regulation 2023/2006 Commission GMP requirements of 22 December 2006
Good manufacturing practices indicating:
- Quality assurance system
- Quality control system
- Documentation demonstrating product compliance and safety
3 - Regulations according to the type of material of the single-use glove
3 a - Plastic or Vinyl EU Regulation 10/2011
Or
3 b - Latex or Nitrile Rubber French Decree 05/08/2020
PLASTIC (vinyl, PE & TPE gloves) Regulation (EU) No 10/20011 | RUBBER (nitrile and latex gloves) National Regulation applies: French decree of August 5, 2020 |
1 - Positive composition list: list of substances that can be used in the composition; it is strictly forbidden to incorporate a substance that is not on the positive list. The manufacturer must check that all the components of the glove are listed. 2 - Global (stability) and specific (dangerous substances) migration tests. 3 - Additional tests in accordance with Regulation (EC) 1935/2004 (organoleptic tests and migration of substances with restrictions). |
Restriction of food contact with fatty foods
In addition to these food contact compliances, there may be a restriction on the handling of certain foodstuffs and/or a maximum contact time of the glove with these foodstuffs.
This means that a glove with food contact approval and meeting the 3 regulations mentioned above may nevertheless be subject to this restriction, which must be clearly indicated.
In fact, you can find the mention " Food Quality with restrictions on fatty foods" such as:
- Whole fat and oil or food swimming in oil
- Butter and margarine
- Fish, cheese, mayonnaise and pasta made with nuts or cocoa
- Meat
- Chocolate, cocoa powder, pastries and cakes with greasy surfaces
In this specific case, this means that there is a risk of "migration" towards the aforementioned foodstuffs.
On the other hand, you will find the words "suitable for food contact without restriction".
The restriction can also be indicated with a duration of use in contact with these foodstuffs (generally fatty bodies).
As you can see, the only thing that is missing is the "food contact" logo, not the ALPHA and OMEGA. A careful study of the product's use framework in your usage protocols is important.
New food contact regulations for rubber gloves
| BEFORE | TODAY |
FRENCH DECREE
November 9, 1994 | FRENCH DECREE
August 5, 2020 |
| COMPOSITION (positive list) |
| Composition in accordance with the positive list, including color pigments |
| GLOBAL MIGRATIONS 5 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 5 conditions: 2h -40°c) - No restrictions authorized
NON-COMPLIANCE = NO FOOD CONTACT QUALIFICATION |
| (Conditions: 4h - 105°C) Volatile organic substances: < 0.5% |
| N-nitrosamines: < 1 ug/dm2 |
| N-nirosable substances: < 10 ug/dm2 |
| / | Primary aromatic amines: not detectable |
| Primary and secondary aromatic amines: < 1 mg/kg |
| Formaldehyde: < 3 mg/kg |
| / | Formaldehyde + Hexamethylenetetramine: < 15 mg/kg |
| Peroxides: 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 |
| / | Aluminum: 1mg/kg |
| / | Residues of lead, cadmium, antimony, mercury and arsenic: < 1 mg/kg |
Failure to comply with legal requirements and risks
Article L441-1 of the Consumer Code: the offense of deception
It is prohibited for any person, whether or not a party to the contract, to deceive or attempt to deceive the contractor, by any means or process whatsoever, even through a third party.
Article L454-1 to 7 of the Consumer Code: penalties incurred
Deception or attempted deception is punishable by.
1 - Imprisonment of 2 years and a fine of 300,000 euros.
2 - The fine may be increased to 750,000 euros and imprisonment to 7 years if there is deception, or attempted deception.
_UK_