Food Contact – What Does 'Food Safe' Actually Mean?

The framework: EC 1935/2004

EC 1935/2004 is the EU framework regulation for materials and articles in contact with food. It applies to everything that touches food – packaging, utensils, machinery and gloves.

Two fundamental prohibitions:

1. The material must not transfer substances to food in quantities that could damage human health

2. The material must not alter the food's composition, taste or odour in an unacceptable manner

These requirements are principle-based – they cannot be met simply by holding one certificate. They require systematic testing and documentation.

EU 10/2011 – plastic-specific rules

For plastic materials (including vinyl/PVC and polyethylene gloves), EU 10/2011 applies, supplementing EC 1935/2004 with:

• A positive list of approved monomers and additives
• Migration limits (SML – Specific Migration Limit and OML – Overall Migration Limit)
• Requirements for migration testing with simulants

Nitrile (NBR) and latex are rubber materials – they are not fully harmonised under EU 10/2011, but are assessed under EC 1935/2004's general principles and possibly national rules.

Migration – what is it, and when does it occur?

Migration is the chemical transfer of substances from the glove material to the food the glove touches. The risk depends on:

Migration simulants (test methods)

EU standards use simulants that represent food categories:

Practical risk assessment

Low risk: Glove used briefly to place bread on a plate – dry contact, low temperature, short time.

High risk: Glove used to marinate meat in oil and acid at elevated temperature – fat, acid, heat and time combined.

As a sales person, always ask: "What will the glove specifically be used for?"

REACH and chemicals in gloves

REACH (EC 1907/2006) regulates chemicals in the EU generally. For gloves this is relevant because:

• Plasticisers in vinyl: Historic phthalates (DEHP, DBP, BBP) are SVHC (Substances of Very High Concern) and prohibited in medical use. Modern vinyl uses DINP, DIDP, DOTP – under ongoing REACH assessment.
• Accelerators in rubber gloves: Thiurams and dithiocarbamates are under REACH attention, and regulation is continuously being discussed.
• Antioxidants and stabilisers: Various chemicals are added during manufacturing and can migrate.

For buyers: A REACH declaration (REACH Declaration of Compliance) is not the same as a food contact DoC. They cover partially overlapping, but not identical, requirements.

Declaration of Compliance (DoC) for food contact

A Declaration of Compliance is the primary documentation requirement under EC 1935/2004. It is a declaration from the manufacturer (or someone in the supply chain) that the material is suitable for the stated use.

What a valid DoC must contain

Per EU 10/2011 (Article 15) – similar principle for other materials:

1. Identification of the material/article (name, type)

2. Identification of the manufacturer issuing the DoC

3. Date of the declaration

4. Confirmation of conformity with relevant EU legislation

5. Statement of restricted use – which conditions, temperatures, contact times the DoC covers

6. Specifications enabling verification (test results, standard references)

7. Information on SVHC substances above 0.1 % w/w

What a DoC is NOT

• A DoC is not a certificate from a third-party laboratory (although it should be supported by test reports)
• A DoC is not valid for all uses – it specifies the conditions
• A DoC does not replace the supplier's own product safety responsibility

National rules

In addition to EU regulations, national food safety authorities (such as the UK FSA, German BfR or Danish Fødevarestyrelsen) issue guidance for businesses. Typically:

• The business has a duty to ensure that gloves for food use are suitable
• A DoC from the supplier is necessary – but the business bears ultimate responsibility
• Control occurs through rule-based surveillance and sampling

Fatty, acidic and alcoholic foods – migration risk

These three categories carry particularly high migration risk and require more careful material assessment:

Fatty foods (meat, cheese, oil):

• Fat dissolves fat-soluble substances from the material (plasticisers, antioxidants)
• Vinyl gloves with plasticisers are under particular scrutiny
• Recommendation: Use nitrile or latex with documented low migration for fat contact

Acidic foods (fruit, vinegar, pickled products):

• Acid can attack rubber materials and accelerate migration
• Verify that the DoC covers acidic conditions (simulant B)

Alcoholic foods and hand sanitiser:

• Alcohol is a good solvent and can extract substances from the glove
• A glove suitable for aqueous foods is not necessarily suitable for alcoholic ones

What you can and cannot say as a sales person

You CAN say:

• "The glove is produced to meet the requirements of EC 1935/2004"
• "The manufacturer has issued a Declaration of Compliance for [specified use]"
• "The glove is suitable for [specified use under specified conditions] per the enclosed DoC"

You CANNOT say:

• "The glove is approved for all food contact" (no universal certification exists)
• "Food safe means it is safe regardless of use"
• "Our gloves comply with all EU rules" (this requires active testing and documentation work)

Practical documentation checklist for food contact gloves

Use this list when a customer buys gloves for food use:

• [ ] Declaration of Compliance (DoC) from the manufacturer – updated and signed
• [ ] Statement of which conditions the DoC covers (temperature, contact time, food type)
• [ ] Test report with migration data (which simulants, which conditions)
• [ ] REACH compliance declaration (SVHC substances)
• [ ] Information on plasticisers (vinyl) or accelerators (nitrile/latex)
• [ ] Information on correct use and limitations

A supplier who cannot provide these documents should not be selling to regulated food businesses.