The term Food Contact Materials (FCM) includes all materials and commodities which food products come in contact with during their production (harvest, transportation, preparation, and storage), their trade (packaging), and their usage (final preparation, garnishing, and consumption). This broad term can include a multitude of varying materials such as plastic, rubber, paper, and metal.
Components of these materials can, through migration for example, be transferred to the food products when these contact one another. It is therefore the objective of the general legislation to exclude the chance of resulting health hazards from such a migration where possible. In the USA, this is mainly controlled by the FDA in chapter 21 CFR, while in Europe there is a complex mix of harmonized EU regulations, national regulations, and recommendations.
General Rules and Regulations:
European Union (EU)
For EU standards, general conditions regarding the safety of food commodities are stated in the so-called framework regulation (EG) Nr. 1935/2004. Under this, the manufacturer of the materials holds the responsibility that end products conform to the requirements in article 3.
Article 3 states that materials and objects which come in contact with food must not, under normal or predictable usage, give off substances to food products which:
- are a threat to human health,
- cause an undesirable change in the composition of foods, or
- bring about damage or interference to the smell, taste, texture, or appearance of the food (so-called organoleptic characteristics).
The manufacturer of commodities has to comply to many more requirements alongside those of the parent EU-framework regulations. Examples include requirements of good manufacturing practices (GMP) (regulation (EG) Nr. 2023/2006), or individual measures of material-specifics, such as the regulation (EU) Nr. 10/2011 for plastics.
The European requirements have largely been integrated into the national regulations. The German counterpart to the EU-framework regulations is the “Food, commodities, and animal feed code (LFGB- Lebensmittel-, Bedarfsgegenstände- und Futtermittelgesetzbuch)”, which eliminated the old food and commodities law (LMBG- Lebensmittel- und Bedarfsgegenständegesetz) in the year of 2005 and has become the umbrella law of German food product rights. Article 3 of the EU-framework regulations for example, has been incorporated into section 31, §1 of this new law.
The federal institute for risk assessment (BfR- Bundesinstitut für Risikobewertung) gives recommendations to the German “Food, commodities, and animal feed code (LFGB)”. These can be found in the database “BfR recommendations for materials in contact with food products” (formerly known as “Plastic recommendations”).
The BfR recommendations for materials in contact with food products do not lay out legal norms. They do however orient themselves towards the European legal system and its implementation on national law and are based on the current status of science and technology. The federal institute for risk assessment is therefore an important and accepted guide to determine if a product in contact with food fulfills the legal conditions of the EU-framework regulations (EG) Nr. 1935/2004 or that of the LFGB. The BfR recommendations are significant in that, up to this point, there have not been any regulations on an EU level regarding specific materials such as silicone, paper, or rubber coming in contact with food products.
USA / FDA
The goal of the US-American “Food and Drug Administration (FDA)” is to ensure safe food products. All substances that US authorities have determined as being acceptable to come in contact with food have been listed in Title 21 of the “Code of Federal Regulation (CFR)”. These lists of acceptable materials and conditions are very material specific, contrary to the EU. It is assumed that all components of materials can in principle migrate to food products and therefore all materials and ingredients are labelled as “Indirect Food Additives”. Title 21 is organized into parts, where Parts 170-190 are relevant to food contact materials and are further split up into paragraphs. These paragraphs lay out the conditions for the respective material coming in contact with food. These requirements are based on what the contents of the material are, and then still have additional conditions. Furthermore, materials from the GRAS lists (“Generally Recognized as Safe”; Part 182-184) or the so-called “Prior-Sanctioned Food Ingredients” (Part 181) can at any time be incorporated as additives into materials in contact with food products.
There are numerous individual measures for certain materials that exist within the framework regulation (EG) Nr. 1935/2004. One of these individual measures is the regulation (EU) Nr. 10/2011 regarding plastic materials and objects that are destined to come in contact with food products. This regulation, which replaced the previous “Plastics Directive” (2002/72/EG), is also known as PIM (Plastic Implementation Measure) and has had a series of corrections and changes made to it in over time.
Plastic components can transfer to food products through a process of migration when coming in contact with one another. The ultimate goal is to exclude any health hazards created from such a migration process, where possible. To achieve this, a positive list (union list) of monomers and additives has been laid out in the regulation (EU) Nr. 10/2011. This list clearly states what is permitted to be used in the production of plastic materials and objects that will be in contact with food. No components of the union list are, amongst other things, polymerization aids (catalysts, accelerators, initiators, etc.) or dyes. This list does not fully include all polymer production aids (PPA). Those substances not mentioned on the union list are subject of national legislation and recommendations (e.g. the BfR recommendations).
Before being admitted onto the unions list, all substances have to be tested for their toxicological properties and any possible transitions to food products. Based on the results of these tests, an upper limit, known as “Specific Migration Limits (SML)”, of acceptable transition to food products is set for certain substances. For a long period of time, all substances that did not receive a specific established SML had a “General SML” of 60 mg/kg which was then abolished with the amendment Regulation (EU) 2016/1416 at the end of the year 2016. Substances, for which a specific SML cannot be tested, have quantitative restrictions (maximum concentrations) within the material instead (QM). This in advance, limits or brings the migration of substances to food products out of question. There is also an overall limit for the sum of all migrating material into food products, known as “Overall Migration Limit (OML)”. The OML is defined as 10 mg per dm2 of the surface area of the material coming in contact with food, or with 60 mg per kg of food. Substances that were not evaluated are not permitted to be present in food products. A generally accepted and practical detection limit of 10 ppb (0.01 mg/kg) applies for a substance as being “not detected”. This limit value is also recognized and stated in article 11, paragraph 4 in the amendment Regulation (EU).
In general, polymers and substances with a molecular mass greater than 1.000 Dalton have a minimal to non- existent potential of migration. Furthermore, these materials cannot be reabsorbed from the gastrointestinal tract and therefore pose little to no toxicological threat according to the European Food Safety Authority (EFSA). Based on this theory, polymers and substances > 1.000 Dalton play no role in regards to the EU regulations and the national laws and recommendations.
The German Consumer Goods Ordinance (BedGgstV- Bedarfsgegenständeverordnung) can be seen as the national counterpart to the EU regulation Nr. 10/2011. The BedGgstV lists substances that are not permitted to be used by commercial manufacturers and commodity dealers (§3, recital 1), or that are only allowed to be present to a certain maximum in food commodities (§6, recital 5). The transfer of substances to food products out of materials is also controlled by the BedGgstV (§6).
The main emphasis of this recommendation was originally focused on materials coming in contact with food products. In the meantime though, there have been numerous harmonized legislations created on a European level regarding plastics, with the regulation (EU) Nr. 10-2011 being an especially important one for regulating in this field. Gradually, substances originally listed in the plastics recommendations were accepted onto the Consumer Goods Ordinance (BedGgstV) or the union list and were subsequently taken out of the BfR recommendations.
Due to this, the BfR recommendations now only consider those substances in the plastics field which are not already thoroughly recorded and listed in the unions list of the EU recommendations Nr. 10/2011. These are amongst others, the aids to polymerization to which the components of catalytic systems (catalysts and initiators) belong to, as well as the “Polymer Production Aids (PPA)”, including emulsifiers, which are needed in the manufacturing process.
Parts 177 and 178 in Title 21 of the “Code of Federal Regulation (CFR)” are especially relevant to plastics. Part 177, “Indirect Food Additives: Polymers”, lists and explains the varying polymer types in individual paragraphs. The conditions for polyolefin for example are explained in §177.1520 and those of polyurethane in §177.1680. Part 178, “Indirect Food Additives: Adjuvants, Productions Aids, and Sanitizers”, describes various additives and aiding materials in corresponding paragraphs. Paragraph 178.2010 is relevant to antioxidants for example, while dyes are thoroughly discussed in §178.3297. Furthermore, substances listed in the GRAS paragraphs (Part 182-184) and the “Prior-Sanctioned Food Ingredients” (Part 181) can be incorporated into products at any time.
If an additive is not listed in the paragraphs relating to that in which the additive is planned to be used in, then it is still possible to use this substance based on the “no-migration” principle. If FDA acknowledged migration studies for the desired application have found that substance concentrations in food products lie below 50ppb, then this product is permitted to be used on the producers own responsibility. The FDA recommends a limit of 10 ppb for packaging materials that have a high market share and are resultantly largely exposed to consumers (“Consumption Factor”).
Why we cannot provide a guarantee for the final conformity of our additives when used in food contact materials…
The migration potential of certain substances can depend on many varying factors, and also on:
- the type of plastic /polymer,
- the characteristics of the food products (e.g. dry, watery, acidic, greasy),
- interactions with other plastic additives,
- the relationship between packaging surface area and volume.
It is therefore the duty of the final product manufacturer of the food contact materials/articles to follow the statutory requirements regarding the usage and specific conditions of use. Due to this, we recommend that tests and confirmation of the conformity, relating to migration tests, should be carried out on final products. Testing of the final product can be exempt, supposing that the migration of substances in relation to the ratio of packaging material to food mass can be fully excluded (worst case). If you need more details on our products in this regard you are welcome to contact us. We would be glad to further assist you.
What we do for you…
We typically check that our products, or better said their components, are present on the union list of the regulation (EU) Nr. 10/2011. We will specify if there are polymers or substances present in our products with molecular weights of exclusively >1.000 Dalton. Additionally, we also test the FDA status of our products. We will gladly send you “Regulatory Information Sheets” upon request on which you can find relative information. We are also willing to test the conformity of our products if requested, in relation to further national- or industry-specific regulations. We will gladly advise you in the selection of products suitable for food contact- Solutions that work.
Lubricants can, amongst other things, be used as lubricants or releasing agents in various building components or machinery (e.g. conveyor belts, seals, sealants), which may be applied in locations where the lubricated component can come in contact with food products. As the occurrence of occasional and unintentional contact between lubricants and food products cannot be excluded, it is important that certain conditions are acknowledged and fulfilled. General rules and regulations, such as the EU framework regulation Nr. 1935/2004 or the LFGB (§31), are valid for lubricants in the EU and on a national level.
There are no specific EU regulations or specific national rules regarding food-grade lubricants, as is the case with plastics. It is therefore common to utilise the widely recognized US-American standards. No other country has as strict of legal provision regarding the usage of lubricants and lubricant additives as the USA.
The FDA clearly states in Title 21 of the “Code of Federal Regulation (CFR)” which components are permitted to be used as food-grade lubricants. In this regard, Title 21 §178.3570 (Lubricants with incidental food contact) is particularly relevant, where additives to lubricants that will be in contact with food products must meet the conditions stated in this paragraph. Furthermore, substances listed in the GRAS paragraphs (Part 182-184) are, as is the case with plastics, permitted to be used without question.
NSF certification as per H1 / HX-1
The United States Department of Agriculture (USDA) was responsible for the registration of food compatible lubricants until 1998. Since 1999, “NSF International” (National Sanitary Foundation) and “InS Services Ltd” have taken on this task. In order to be authorized as an acceptable lubricant for the food industry, the requirements of the FDA first have to be met. Lubricants are organized into varying categories depending on conditions and requirements. In this case, H1 lubricants (“Lubricants- General incident contact”) are particularly important as they relate to the food industry.
The highest requirements are set on H1 lubricants. In all situations relating to the food, pharmaceutical, and animal feed industry, where an occasional but technically unavoidable contact can occur between lubricants and products, only H1 certified lubricants are permitted to be used. The ingredients in H1 lubricants have to be HX-1 (“Ingredients for use in H1 lubricants - incidental contact”) certified. In order to be HX-1 certified, substances must either be listed in 21 CFR §178.3570 or have a GRAS notification (Part 182 and 184). Otherwise, a very intense notification process is required.
We are pleased to inform you that our product LUBIO® EP 3 has successfully been HX-1 certified following NSF standards. Further information on this can be found in the NSF - White Book™ or the “Regulatory Information Sheet”. Our goal is to have more LUBIO® products certified in the future. We are willing to answer any questions you may have.
What we do for you…
We regularly test the FDA status of our products and their ingredients. The appropriate information can be found on our “Regulatory Information Sheets”, which we will gladly send to you if desired.
Upon request and where possible, we are willing to certify more of our products through “NSF International” or with “InS Services Ltd.”, such as with HX-1 for example. We gladly support you!
Upon request, we are also willing to test the conformity of our products in relation to further national- or industry-specific regulations, if this is required for you to use our products. We will gladly advise you in the selection of products suitable for food contact- Solutions that work.