EU Regulations

We can help you to devise cost-effective test programmes to demonstrate compliance with EU regulations, and carry out a comprehensive range of overall migration and specific migration tests using EU standard methods.

The European Framework EC Regulation 1935 (2004) sets out some general rules that should be met by all classes of food packaging materials, namely that they do not - under normal or forseeable conditions of use - transfer constituents to foodstuffs in quantities which could: 

  • endanger human health; or
  • bring about an unacceptable change in the composition of the food; or
  • bring about a deterioration in the organoleptic characteristics (taste, smell, texture, etc) thereof. 

Whilst sensible, these goals do not offer any specific advice on how to demonstrate that they have been met, so that Framework regulation also states that the EU will bring forward 'specific measures' for various types of food packaging materials, for example plastics, paper, ceramics, regenerated cellulose, active and intelligent packaging, etc. These 'measures' could either be in the form of EU Directives or Regulations. 

Using Specific Measures to Demonstrate Compliance

Currently, the extent of specific EU legislation in Food Contact is limited to plastics, regnerated cellulose, ceramics and some classes of coatings. Of these, the best-known set of legislation is in the area of plastics (see below). This is outlined in EU Regulation 10/2011 and its amendments. In general, for a material covered by the scope of the plastics Directive, compliance with the requirements of EU Regulation 10/2011 will go most of the way towards demonstrating compliance with the Framework Regulation. The same applies to cellophane, ceramics, etc, provided they comply with their own specific Directives. 


How we can help:
Smithers Pira can help you devise programmes to demonstrate compliance with these various requirements. 
Contact our featured expert to find out more

 

What happens for materials with no specific EU Legislation? 

For paper, adhesives and other materials without their own specific legislation, it can be more complicated to demonstrate compliance with the general requirements of the Framework Regulation. However, there are a number of acceptable options including: 

  • use of National Rules of EU member states (provided they have not been superseded by EU Directives or Regulations)
  • Safety Assessment using the EU's Synoptic Document
  • General Industry Codes of Practice and Council of Europe Resolutions


How we can help: 
We can guide you through the various options. 

 
What else is in the EC Regulation 1935 (2004)?

The Framework Regulation also contains a number of other important clauses, which apply even if you already comply with a specific directive for your type of food packaging material: 

  • Article 4 sets out special requirements for active and intelligent materials and articles
  • Articles 8 and 9 define the rules for authorisation of new substances such as monomers and plastics additives
  • Article 15 gives labelling rules for Food Contact materials 
  • Article 16 sets out the requirements for the declaration of compliance that should accompany Food Contact materials throughout the food packaging chain
  • Article 17 lays out traceability requirements for food packaging materials 

It's also worth remembering that Food Contact articles should not introduce any off-flavours or odours to foods - as specified in the general terms of this regulation. 

How we can help:
We will help you understand how the requirements of the Framework Regulation could affect your products. 

Plastics

EC Regulation 10/2011 and its amendments (which are sometimes known as the Plastics Implementing Measure or PIM) lay out in great detail what you need to do to ensure that plastics are safe for use in contact with foods. In particular, these Directives contain the following requirements: 

  • A limit on the total amount of material that can be transferred to food from plastic packaging. This is known as the overall migration limit.
  • A positive list for monomers which can be used in Food Contact plastics. Some of these monomers have their own specific migration limits.
  • A partial positive list for additives which can be used in Food Contact plastics. Again some of these have their own specific migration limits.

contact usHow we can help: 
We can 
help you demonstrate compliance with these regulations and carry out appropriate test methods (such as EN 1186 parts 1 to 15, and EN 13130 parts 1 to 28)
We can advise on the status of Food Contact materials and the use of diffusion-based models to demonstrate compliance with additive restrictions.