Masterbatch is a mixture where a high concentration of pigment and/or additives are dispersed in a carrier medium which can then be used directly by the processor in small quantities to pigment or modify the virgin polymer material. Therefore the masterbatch producer shall be assimilated to an “Ingredient supplier”.

His responsibilities are mentioned in slides 32 and 36 of the presentation "Food Plastic Packaging Regulations: How to Easily Comply with EU Directive 2002/72/EC". He can rely on his supplier' documents unless there are chemical reactions between the various components. If this is the case he should perform some tests. Of course the masterbatch producer can obtain the needed information on the individual pigment/additive from the substances suppliers to perform tests . In principle, he should give an indication of the concentration of the additives in the masterbatch or a dilution factor of the masterbatch in the final plastic. The problem of the confidentiality of data should be taken into account (see also question N° 2 of the DoC(s) & Supporting Documents part and the answer)

I am unable to give a general answer to this “practical” case. I can just recommend to compile all the data available for the materials and substances and look out for the worst cases, perhaps by using modelling programs, such as migrapass, migratest, multiwise etc. Literature research and consultation of FDA data bank on migration data could be also useful.

The Directive 85/572 specifies the simulants to be used in correspondence of the foodstuffs. For dry foods there is no specific obligation to carry out the migration testing.

However the draft of Super-Regulation (future EU Regulation in 2006-2007?) modifies this exemption and provides the following (probable) rules:

Dry foods: “Food for which no test with simulants A, B, C and D is prescribed by Directive 85/572”.
Where necessary, special simulant in accordance with point 2.2.2 which states:

In accordance with Directive 82/711 and 85/572. Guidance for your specific cases may be found in Chapter IV of “Note for Guidance" pages 72-77.

In my presentation ingredients mean the monomers used in the manufacture of resins and the additives added to the resin to manufacture the finished plastics. By resin I intend the product obtained by the polymerisation of a monomer.

First question: Yes but note that this is not valuable for some types of substances (see slide 46 of the presentation "Food Plastic Packaging Regulations: How to Easily Comply with EU Directive 2002/72/EC").

Second question: by carrying out migration tests or other alternative strategies described in slides 23-26 of the presentation "Food Plastic Packaging Regulations: How to Easily Comply with EU Directive 2002/72/EC".

Yes. You should collect all the data available and send them to Ms Simoneau charged to update Annex I of Practical Guide. To obtain the experimentally needed data, see Annex B of Annex I of the Practical Guide, page 88. Further guidance may be obtained by Ms Simoneau catherine.simoneau@jrc.it.

Pigments cannot be listed, since they are not harmonised yet. You can only add monomers and additives to EU lists. The procedure for the introduction of a monomer or additive into the EU lists is explained in "Note for Guidance".

MigraPass™ is a mathematical model based on the well established model of FABES, MIGRATEST © Lite 2001. The mathematical model used in the software MIGRATEST © Lite describes a one-dimensional migration process from a finite homogenous plane plastic sample of constant thickness into a well-mixed liquid food or food simulant of finite volume.

The differential equation - also known as Fick's 2 nd diffusion equation - describes this migration process. With initial and boundary conditions, this equation can be solved analytically and the amount of migrant found in the foodstuff at the end of the migration period can be calculated.

Another Fick equation can be rearranged to give an equation which can be used to estimate the Maximum Initial Concentration of migrant ( MIC ) in the food contact material or article.

These equations are used in the software MIGRATEST © Lite to estimate both the amount of migrant released in a timeframe from a plastic food contact material into a certain food simulant as well as the MIC corresponding in a given application to a SML.

The European Commissions supported recently an international group of experts, coordinated by the FABES GmbH, from Munich, Germany and CEFIC/FCA, from Brussels, Belgium, to demonstrate that the theoretical estimation of migration processes can be regarded as a valid and reliable method to calculate “worst-case” migration rates from the most important food contact plastics into the EU official food simulants. The result of this contract was published in:

K. Hinrichs and O. Piringer (editors), 2002, “Evaluation of migration models to used under Directive 90/128/EEC”, Final report to SMT4-CT98-7513 contract, European Commission, Directorate General for Research, Report-EUR 20604EN, Brussels.

The evidence demonstrated by this Contract was sanctioned by the European Commission who recently passed the theoretical migration estimation as a conformity and quality assurance instrument in the framework of the:

EU Plastics Directive 2002/72/EC, Article 8, § 4:

The verification of compliance with the specific migration limits provided for in §1 may be ensured by the determination of the quantity of a substance in the finished material or article, provided that a relationship between that quantity and the value of the specific migration of the substance has been established either by an adequate experimentation or by the application of generally recognised diffusion models based on scientific evidence. To demonstrate the non-compliance of a material or article, confirmation of the estimated migration value by experimental testing is obligatory.

The mathematical model and algorithms used to be used for this purpose are given in the:

Practical Guide for Users of EU-Directives, 2004, in “Food Contact Materials”,
EU-Commission SANCO-DGIII/LR

MigraPass™, based on the software MIGRATEST © Lite developed by FABES GmbH, from Munich, Germany, works with the very same mathematical models and algorithms as the ones given in this Practical Guide. Here is an abstract of the Practical Guide concerning migration modelling software:

For conveniency reasons, it should be noted that a specifically tailored and user friendly computer program is available on the market (MIGRATEST Lite 2001, FABES GmbH Munich , Germany )

Moreover MigraPass™ also relies on a series of other information, algorithms and data banks found in the following EU documents:

- EC Directive 97 / 48 / EC
- EEC Directive 85 / 572 / EEC
- Synoptic Document - provisional list of monomers and additives not defied to EU Commissions as substances which may be used in the manufacture of plastic intended to come into contact with foodstuffs.

as well as the one used in MigraPass™ describes a one-dimensional migration process from a mono-layer homogenous plastic sample of constant thickness into a well-mixed liquid food or food simulant of finite volume.

For such a system, provided some specific initial and boundary conditions are fulfilled, the differential equation describing the migration process can be solved analytically and the amount of migration can be calculated with a relatively simple analytical algorithm.

The migration process from a multi-layer plastic food contact article into a food or food simulant is a much more complex process (especially when the multi-layer structure is made of a series of very different plastics!). The differential equation describing the migration process in such a case can be solved only with advanced numerical algorithms .

At the level of the EU Commission, the estimation, for compliance purposes, of migration from multi-layer plastic food contact article into a food or food simulant is an actual but not yet finalised topic.

Issues with (experimental) migration testing conditions recommended by the EU Directives for compliance testing of plastic food contact materials must be answered case-by-case. That means that the petitioner must first know/define the real conditions (duration and temperature) under which the plastic food contact material is intended to be used in contact with a certain food. Based on this data the petitioner must then use the information and data banks given in the:

EC Directive 97 / 48 / EC
EEC Directive 85 / 572 / EEC

to find out the corresponding food simulant, migration time, t ,and temperature, T , to be used in a migration experiment.

For migration estimations using a user-friendly software, for example MigraPass™ developed by the FABES GmbH , the petitioner can use either the very same input data (recommended food simulant, migration time and temperature) as the ones derived for the migration experiment or the EU "worst case" contact conditions : 40°C during 10 days.