According to Article 14 of Regulation (EC) No. 1907/2006 (REACH), the chemical safety report on substances must not take into account the risks to human health arising from their use "in materials intended to come into contact with foodstuffs, falling within the scope of Regulation (EC) No. 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with foodstuffs".

Are substances used to manufacture materials and articles intended to come into contact with food exempt from REACH requirements?

The main REACH requirements

Coming into force on June 1, 2007, Regulation (EC) no. 1907/2006, known by its acronym REACH ("Registration, Evaluation and Authorization of CHemicals"), established a single system for the registration, evaluation and authorization of chemical substances. Any substance produced or imported into the European Union in quantities exceeding one tonne per year must be registered with a European agency located in Helsinki (ECHA: European Chemicals Agency). In addition, an authorization procedure is mandatory for all substances considered to be of "very high concern" (SVHC: "Substances of Very High Concern"), with no tonnage limit, with the aim of promoting the eventual substitution of these substances.

How are companies that manufacture, import or use food contact materials affected by REACH?

For substances used in the manufacture of food contact materials, they are subject to the REACH registration procedure if the materials concerned are manufactured in the European Union. However, when a chemical safety report is drawn up, it is not necessary to cover risks to human health, which are already covered by EC Regulation no. 1935/2004. Instead, the report must take into account the risks to the environment as well as the risks to human health from other uses of the substances. SVHC substances listed in Annex XIV of the REACH regulation, which have been authorized for use in food contact materials, are exempt from the authorization procedure. However, in the context of the use of these substances in the manufacture of materials, authorization may be necessary, since the regulation of food-contact materials aims to ensure the protection of people as consumers, but not as workers. Finally, all these substances are subject to the restrictions set out in Annex XVII of the REACH regulation.

Food-contact materials used in packaging, consumer products or equipment in the food industry are considered under REACH as articles whose manufacturers and importers are subject, with certain exceptions, to the following obligations:

  • registration of substances present in articles when these substances are intended to be released from the constituent material during normal and reasonably foreseeable use and in quantities exceeding one tonne per year;
  • notification to ECHA of any substance that appears on the SVHC candidate list where the concentration is greater than 0.1% w/w and the substance is present in all articles manufactured or imported in quantities greater than one tonne per year, and this from June 1, 2011.

Finally, any supplier of articles intended to come into contact with food, containing substances from the SVHC candidate list at more than 0.1% mass/mass, must communicate downstream sufficient information to allow safe use.

Update date: August 2010

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