Little Pro on 2017-02-14
EU's definition of food contact materials is very broad. It includes both food package materials and any other materials and articles (i.e, coffee machine, some food processing machine) that are expected to come into contact with food under normal and foreseeable use conditions. Both chemical companies who supply food contact materials (including food contact additives) and food packaging or food companies need to comply EU's food contact regulation. In this article, we will give an introduction to how to comply with food contact regulations in EU with a focus on EU's regulation for plastic food contact materials. Sample declaration of compliance (DoC) for food contact materials is also given.
There are plenty of food contact regulations in EU. Luckily, you only need to comply with 2 main ones and some measures specific to your products (see table below).
Regulation | Description |
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Regulation (EC) No 1935/2004 |
It is EU's framework regulation and sets out general requirements for all food contact materials (FCMs):
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Regulation (EC) No 2023/2006 on GMP |
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Specific Measures for Materials
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Note: For FCMs with no specific EU measures, Member States may adopt their own national provisions on food contact materials. |
Specific Measures for Substances
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For some types of food contact materials (i.e, coatings, adhesives, and paper) for which there is no specific measures at EU level, a majority of EU Member States have set their own national provisions. You also need to comply with those national measures. More info can be found below.
In the rest of this article, we will use the Regulation (EU) No 10/2011(also known as plastics regulation) as an example to show you how to comply with specific measures.
The plastics regulation is the most comprehensive specific EU measure for plastic food contact materials. It sets out rules concerning the following aspects:
The annex I to the plastics regulation is a positive list of authorised substances that can be used in the manufacture of the plastic layers of food contact plastic materials and articles (see picture below). The list covers monomers, starting substances, additives, and polymer production aids.
Restriction, specification and specific migration limits are also listed if available. The complete list can be downloaded here.
Note 1: The Union list does not include authorized solvents and colorants, and substances only used to manufacture adhesives, coatings and printing inks. Substances on provisional list may also be used if compliant with national legislation.
Note 2: A listed substance must also comply with restriction and specification set out in column 10 (i.e, "not to be used for articles in contact with fatty foods"). A food contact material or article made from listed substances must comply with specific migration limits (SML) given in column 8 and 9.
Read more about the positive list of food contact substances and additives in EU
The migration of a hazardous substance into the food stuff is the main safety concern for food contact materials. The compliance of FCMs can be verified by migration testing. The plastics regulation requires that finished food contact materials and articles comply with both the specific migration limits (SML) and the overall migration limits (OML).
Migration testing is usually done by using various food simulants (for example, 10% ethanol for alcohols, 3% acetic acid for acidic food). Testing temperature and duration also vary depending on food package use conditions.
If you are a manufacturer or supplier of a food contact material (including additive), it is very important to reassure your customer that your product complies with the applicable EU and national legislation. The plastics regulation requires that a written declaration of compliance (DoC) be provided for finished plastic materials and articles, products from intermediate stages of their manufacturing as well as for the substances intended for the manufacturing of those materials and articles (excluding retail stage).
Each manufacturer has to declare their compliance under his responsibility depending on his role in the supply chain and communicate his DoC to customers (see below example).
The plastics regulation further requires that the written declaration of compliance for food contact materials contain the following information.
The picture below is a sample of declaration of compliance (DoC) for food contact materials given by the Food Safety Authority of Ireland and it has included all required info. Click here to download the sample DoC in pdf format. It can be easily modified for use for other types of food contact materials.
To demonstrate your compliance with EU food contact legislation, you need to do the following things:
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Tags: Topics - Food Contact, Food Contact Regulations