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Belgium: The New Royal Decree on Food Contact Metals and Alloys

MARCH 2021 - ELECTRICAL AND ELECTRONICS, HARDLINES

On 15 March 2021, the Belgian Official Journal announced a New Royal Decree1 on metal and alloy materials and articles intended to come into contact with food. This Decree ensures a higher degree of consumer health protection by laying down specific release limits for metals and alloys in contact with food, as well as specific release limits for metal pollutants and impurities in the metals and alloys.

The New Decree is based on the Council of Europe Resolution CM/Res(2013)92. Before its publication, the general rules for metals and allows are set out only for tin and tin alloys in Annex 2 of the Royal Decree of 11 May 19923. The lack of specific European legislation on metal and alloy materials and articles that come into contact with food poses a serious problem of uncertainty for both governments and industry. Belgium, therefore, has decided to convert that resolution into her legislation.

The details of the New Decree are summarized as follows:

Scope (Article 2)
Should apply on materials and articles in their finished stage which are fully or partly made of metals or alloys and/or whether or not covered with surface coating, which:

  1. are intended to be brought into contact with food; or
  2. are already in contact with food and intended for this purpose; or
  3. can be reasonably expected to contact with food or transfer their constituents to food during their normal or foreseeable use.

General requirement (Article 3)
The metal and alloy materials and articles must be manufactured in accordance with:

  1. EU Framework Regulation (EC) No. 1935/20044;
  2. EU Regulation (EC) No. 2023/20065 on good manufacturing practices;
  3. Belgian Royal Decree of 11 May 1992.

Specific release of metal ions (Article 4 & 5 )
The materials and articles should comply with the specific release limits in Annex Chapter 1 - Table 1 & 2 (see below) which are adopted from Resolution ResAP (2013)9. Substances in nano form should be assessed individually according to their characteristics, intended uses and exposure levels in case of release into the food. The conformity with specific release limit should be verified by national or European methods and should apply the worst-case test conditions under reasonable circumstances for the test. For this, Federal Public Service Health, Food Chain Safety and Environment has published a guideline6 for implementation of testing.  

Declaration of conformity (DoC) (Article 6)
A written DoC should be readily prepared with the information in Annex - Chapter 2 - point 1 to 7 included. For products that are not yet considered as a final product, points 1, 2, 3 and 5 in Chapter 2 of the DoC must be completed.
If no modification occurs in the raw materials, in their treatment, in the use, in the production process and others, a DoC can remain valid for a maximum period of 5 years.

Annex Chapter 1 - Table 1 - Specific Release Limit applicable to metals and alloy components

Name Specific Release Limit (mg/kg of food)
Aluminium  5
Antimony 0.04
Silver 0.08
Chromium 0.25
Cobalt 0.02
Copper 4
Tin* 100
Iron 40
Magnesium  -
Manganese  1.8
Molybdenum 0.12
Nickel 0.14
Titanium -
Vanadium 0.01
Zinc 5

*except in field of application under Regulation (EC) No. 1881/2006

Annex Chapter 1 - Table 2 - Specific Release Limits applicable to metals as contaminants and impurities

Name Specific Release Limit (mg/kg of food)
Arsenic 0.002
Barium 1.2
Beryllium 0.01
Cadmium 0.005
Lithium 0.048
Mercury 0.003
Lead 0.01
Thallium 0.0001

Annex Chapter 2:

  1. The identity and address of the operator who manufactures or imports the materials and articles or the substances intended for the manufacture of those materials and articles;
  2. The identity of metals and alloys used for the manufacture of such materials and articles;
  3. Date of the declaration;
  4. Confirmation of the materials and articles that are in conformity with the relevant provisions of this decree or other specific legislation concerning metals and alloys published by another EU Member State or Turkey or an EFTA State which is a contracting party to the EEA agreement, and Regulation (EC) No. 1935/2004;
  5. Adequate information is in place to allow downstream operators to ensure compliance with restrictions;
  6. Adequate information on the restricted metals in food, obtained by experimental data or theoretical calculations of their specific release level;
  7. Specifications regarding the use of materials or articles, such as:
  • the type(s) of food intended to come into contact with them;
  • the duration and temperature of processing and storage in contact with the food;
  • the surface area/volume ratio in contact with food used to establish compliance of materials or articles

 

[1]  Royal Decree of 17 February 2021

[2]  Resolution CM/Res(2013)9

[3]  Royal Decree of 11 May 1992

[4]  Commission Regulation (EC) No. 1935/2004

[5]  Commission Regulation (EC) No. 2023/2006

[6]  Commission Regulation (EC) No. 2023/2006

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