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Regulatory Information

European Food Contact Regulations

EU Commission Regulation 1935/2004/EU

Commission Regulation1, “1935/2004/EC: Materials and articles intended to come into contact with food” is known as the “Framework Regulation” and covers all materials which might come into contact with food. It states that “food contact materials shall be safe. They shall not transfer their components into the food in quantities that could endanger human health, change the composition of the food in an unacceptable way or deteriorate the taste and odour of foodstuffs.”

The regulation establishes 17 groups of materials and articles which may be covered by specific measures, three of which could apply to nonstick coatings: silicones, textiles, varnishes and coatings.

As with the US FDA, there is no formal authority approving food-contact coatings but coating manufacturers have specific requirements:

  • Follow “Commission Regulation 2023/2006/EC: Good manufacturing practice for materials and articles intended to come into contact with food”.
  • Use “approved substances.”
  • Meet requirements of Council Directive “82/711/EEC, as amended, laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs” for Specific overall migration using appropriate stimulants, time, temperature and method.

Sol-gel coatings are expected to be regulated as part of the coatings and varnishes group.

Note:

  • A regulation is automatically law in all EU countries without having to go through each country’s legislative body.
  • A directive has to be passed by each country’s legislative body before becoming law.
  • Minor amendments/changes/correction to regulations/directives are made regularly but by quoting "as amended" all such adaptations are included without having to list numerous other numbers.

Council of Europe Food Contact Framework Resolutions

The Council of Europe consists of 47 member states, of which 28 are also EU members. The Council provides a mechanism for creating common standards across the member states through the publication of common standards, known as Resolutions. Once a resolution is adopted, the individual member states must pass national legislation to implement the resolutions in that country.

One important aspect of the resolutions is that the member states cannot adopt limits that differ from those in the resolution. Consequently, Council of Europe Resolutions are used as guidelines for determining compliance in member states, including the EU, even if no regulations have been adopted within those countries.

For coatings, several Framework Resolutions (Res Aps) have been published that have applicability to nonstick coatings.

  • Res Ap 2004 covers food-contact materials, establishing categories that include two relevant to nonstick coatings: Coatings intended to come in contact with foodstuffs; and Silicones used for food contact applications.
  • Res AP (89) 1 covers colorants used in plastic materials coming in contact with food.

National Legislation LFBG (Germany) and DGCCRF (France)

While many European countries have adopted legislation governing food contact articles, the most commonly known are those from Germany and France. Under the provisions of mutual recognition, however, once a substance is approved and marketed in one country, it is accepted for use in all other EU member states.

The LFBG (Lebensmittel-, Bedarfsgegenstände-und Futtermittelgesetzbuch, or “Foods, Consumer Goods and Feedstuffs Code”) is sometimes thought to be the European equivalent of the FDA. This is not quite correct. The LFGB is the German enactment of European law as operated by the Bundesinstitut für Risikobewertung (BfR). The BfR recommendations for food-contact materials are some of the more comprehensive in the EU.

The Directorate General for Competition Policy, Consumer Affairs and Fraud Control (DGCCRF) published regulations governing food contact materials under the French Décret no 92-631 of 08/07/1992. These regulations also include extraction test methods that are based on, but more extensive than those identified in the EU Directive (EC) 82/711.

Standard Setting Bodies – TÜV (EU/Asia)

The TÜV (Technischen Überwachungsverein or “Technical Inspections Group”) Group is a global leader in independent testing and assessment services. These include testing of consumer products, household appliances, machinery, RoHS/WEEE (see below) compliance, and certification to many other standards. TÜV consists of three separate operating entities: TÜV Nord, TÜV Rheinland, and TÜV Süd. Each entity has specific focus areas, and only TÜV Rheinland and TÜV Süd perform consumer product testing and certification.

TÜV also has the capability to issue a “certificate of compliance” similar to the BSI mark. This applies to the complete item including electrics, dimensions, etc.

The LGA (Landesgewerbeanstalt Bayern) was formerly a competitor of TÜV; however it is now part of TÜV Süd.

 

 
 
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