Evaluation
EU/ Germany: Packaging materials
The migration of substances from packaging and other consumer goods into filling goods is strictly regulated by law. European regulations, directives and resolutions as well as national regulations and recommendations exist for this topic. For a more detailed explanation of the EU legislation, detailed guidelines are available in some cases.
For example, Regulation (EC) No 1935/2004 of the European Parliament and of the Council applies to all types of materials and articles intended to come into contact with food since 27 October 2004. Under Article 3 (1), the following general requirements are imposed on all food packaging:
Materials and articles, including active and intelligent materials and articles, shall be manufactured in compliance with good manufacturing practice so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities which could:
[a] endanger human health; or
[b] bring about an unacceptable change in the composition of the food; or
[c] bring about a deterioration in the organoleptic characteristics thereof.
Good manufacturing practice is regulated in a very general way by Commission Regulation (EC) No 2023/2006.
Article 5 of the Framework Regulation describes the groups defined under ANNEX I to which this shall apply. According to Article 6, this Regulation does not prevent Member States from maintaining or adopting national provisions in the absence of individual measures within the meaning of Article 5, provided that they are in conformity with the provisions of the Treaty. The recommendations of the Federal Institute for Risk Assessment (BfR) should be mentioned here as an example.
The best regulated food contact material is plastic materials, which must comply with the Commission’s Plastic Regulation (EU) No 10/2011.
In this Regulation, the following different possibilities of compliance check are mentioned:
- Determination of overall migration under special “OM” conditions for compliance with the overall migration limit (“OML”);
- Determination of specific migration in food simulants under “SML” conditions to verify the substance specific migration limit (“SML”);
- Determination of residual content of the substance;
- Replacement of specific migration by overall migration, whereby the migration conditions must be identical;
- Assumption of 100% migration of the substance, based on the residual content of the substance in the material;
- Mathematical modelling of migration using generally recognised diffusion models based on scientific evidence, based on the residual content of the substance in the material.
To check compliance, FABES examines migration from the packaging into the filling material. For this purpose, so-called food simulants are preferably used, simple test media that mimic food and, through their behaviour, the migration from food contact materials. Examples are acetic acid 3% for acidic foods and ethanol 50% for dairy products. The contact conditions (time/temperature) to be used in the test are specifically provided and represent quick tests with regard to the real contact conditions.
A test often includes the determination of total migrations, screenings for “NIAS” and, if necessary, specific migrations of substances. According to Regulation (EU) No 10/2011, NIAS, ‘non-intentionally added substances’, means an impurity in the substances used or a reaction intermediate formed during the production process or a decomposition or reaction product. Further analyses depend on the sample structure, the sample matrix or the objective of the investigation. An assessment is made on the basis of the analysed migration quantities and corresponding positive lists (plastic: Union list), which list substances whose use is partly only permitted with restrictions. Under certain circumstances, a further risk assessment is carried out.
The same procedure applies to other consumer goods such as cosmetic or pharmaceutical packaging, in addition to paper, cardboard and cardboard materials. It is important to know or have an idea of the worst case contact conditions of the packaging or contact material, as migration conditions depend on this.
FABES examines the above-mentioned materials with regard to the corresponding regulations and prepares the certificates of conformity with regard to migration behaviour.
If you have the objective of placing a substance on the Union list for plastic materials, FABES can determine the migration and the initial or residual content according to the specifications of the European “Note for Guidance”. All possible impurities and resulting degradation and reaction products of the substance are also taken into account. In addition, in close cooperation with you, it is possible to compile the complete dossier, which is made available e.g. to the European Food Safety Authority (EFSA) for evaluation. In addition to the above-mentioned analyses, the dossier also includes the unique identification of the substance, physicochemical properties of the substance, the use of the substance, information on the authorisation of the substance in other countries and toxicological studies.
If substances are to be authorised that are to be used e.g. in coatings or paper materials, a dossier corresponding to the EFSA dossier must be submitted to BfR.
Germany: Drinking water contact materials
In Germany, the Federal Environment Agency (UBA) is responsible for drinking water contact materials. For a compliance check of the materials, corresponding specifications of the UBA must be taken into account. For example, published evaluation criteria documents apply to plastics and other organic materials, enamel or ceramics, metal and cement, and corresponding recommendations or guidelines apply to elastomers or lubricants, silicones or TPE materials.
Of interest here is the De Minimis Guideline for the assessment of organic materials, according to which toxicological detection is no longer necessary for a migration of <0.1 µg/L drinking water if other defined specifications apply.
If a substance is not listed in a positive list of a document or recommendation, an application for inclusion is possible. In addition to toxicological tests, this application also consists of migration determinations or mathematical estimations (modellings) as well as initial or residual content determinations.
If a substance is listed in the European Plastics Regulation (EU) No 10/2011 or the 4MS “core list”, it has to be verified that the limit value is not exceeded.
FABES can provide you with comprehensive advice and analytical support on the above points. An application for inclusion is also possible.
USA: Packaging materials
For food contact materials that are to be tested for compliance, a differentiated approach applies in the USA. Depending on the question, an FDA investigation is based on formulation checks, above-mentioned migration examinations and/or extractions (“final tests”), which are to be carried out in accordance with the “Code of Federal Regulation (CFR) Title 21”. If a formulation ingredient is not listed under 21 CFR 174–186 or the GRAS “Notices” or is considered “prior sanctioned”, is not subject to a TOR exemption or does not have a valid FCN, there are in principle several possibilities:
- Consideration of the “functional barrier” principle or “generally recognised as safe” (GRAS) principle;
- Application of a “Threshold of Regulation” (TOR) to the American authority FDA;
- Preparation of a “Food Contact Notification” (FCN) for submission to the American authority FDA, describing the area of application of the substance, its analysis, migration and toxicity. The food simulants and migration conditions to be used are specifically described in the FDA’s “Guidance for Industry – Chemistry Recommendations”.
FABES can provide you with comprehensive advice on the above points, provide analytical support and confirm conformity where possible.
Other states
Other countries, such as Switzerland or China, lean on the EU or FDA specifications.
FABES will be happy to suggest a possible course of action with the aim of being able to confirm conformity.