Detailed explanation: BfRshort forGerman Federal Institute for Risk Assessment recommendations on food contact materials

The term “consumer articles” is defined in § 2 of the German Food, Consumer Articles and Feed Act (LFGB). It includes consumer products such as toys and garments, but also materials which come into contact with foods.

In Article 1 of the European Regulation (EC) No 1935/2004, food contact materials and articles are defined as materials and articles which are intended to come into contact with food or are already in contact with food or which can reasonably be expected to come into contact with food.

Contact with articles made of various materials can occur during, for example, manufacturing, transport, storage or consumption of foods. Practical examples of food contact materials include plastic, paper and cardboard packaging, cutlery and crockery and cups made of ceramics, cookware and frying pans with and without enamel or polymer coating, and food vessels and pipes used on food production sites.

According to EU legislation, food contact materials must be manufactured in such a way that they do not release substances into food in amounts which may be hazardous to human health under intended or foreseeable use conditions. Additionally, the materials may not unacceptably change the composition of the food being contacted and are also not permitted to impair the smell or taste.

There is no authorisation required for food contact materials and articles. Therefore, the BfRshort forGerman Federal Institute for Risk Assessment does not have a list of materials and articles authorised for food contact.

However, the European Commission can declare what are termed specific measures. These are legal requirements including specific regulations for certain materials. Although the measures already adopted also do not provide for an authorisation requirement for the material or the article itself, Commission Regulation (EU) No 10/2011 includes, among other things, a list of substances which are permitted for use in the manufacture of plastics for food contact as well as any related restrictions such as migration limits or use conditions. In order for a new substance to be added to this list, an authorisation process must be completed, which includes demonstration that the substance does not pose a health risk in its intended use.

National regulations exist in some European countries for other materials. In Germany, for example, substances intended for use in printing inks that come into contact with food are regulated under the Commodities Regulation (“Bedarfsgegenständeverordnung”).

For many other materials such as paper, silicone or rubber, neither the EU Commission nor the German Federal Government has yet issued specific measures. For many years, the BfRshort forGerman Federal Institute for Risk Assessment has developed recommendations on several of these materials, which include substance lists and use conditions and which are consistently updated. For new substances to be added to the BfRshort forGerman Federal Institute for Risk Assessment recommendations on food contact materials, an assessment process must be completed. The scientific basis and required data for this assessment correspond to those of the European authorisation process.

The BfRshort forGerman Federal Institute for Risk Assessment recommendations on food contact materials are material-specific lists of substances, use conditions, and restrictions. The recommendations are based on lists of substances that the BfRshort forGerman Federal Institute for Risk Assessment and its predecessors have assessed since 1958. The substances on these lists can, when used for the mentioned purpose, in compliance with the specified restrictions, be considered as non-hazardous for consumer health in accordance with the current state of science and technology. Specifically, this means that no substances migrate from the materials into foods in amounts which would pose a health risk for consumers.

Each recommendation refers to a specific material, such as silicone or paper. Originally, the recommendations dealt primarily with substances for the production of plastics with food contact. For that reason, they were termed “Plastics recommendations” for a long time. Now, however, this domain is almost entirely regulated at the European level.

The BfRshort forGerman Federal Institute for Risk Assessment recommendations on food contact materials are not legal norms (see below, “What legal status do the BfRshort forGerman Federal Institute for Risk Assessment recommendations have?”).

The BfRshort forGerman Federal Institute for Risk Assessment publishes recommendations for areas which are not yet legally regulated. This applies to high polymers, such as plastics, silicones, natural and synthetic rubber as well as papers, cartons and cardboards. Furthermore, the Institute makes recommendations which refer to the intended use of the materials. This includes recommendations on artificial casings, plastic dispersions for the coating of articles for food contact or temperature resistant coatings for cooking, frying and baking equipment.

The further development of legal provisions is taken into account by corresponding updates of the recommendations. For plastics, for which harmonised regulations are already available on an EU level, the BfRshort forGerman Federal Institute for Risk Assessment recommendations are restricted to components of catalytic systems (catalysts and initiators) and polymerisation auxiliaries, which have not yet been taken into account by the EU provisions or have not yet been finally considered.

The BfRshort forGerman Federal Institute for Risk Assessment recommendations on food contact materials are not legal norms. However, they reflect the current state of science and technology for the conditions under which consumer products of high polymer materials meet the requirements of § 31.1 of the Food, Consumer Articles and Feed Act (LFGB) and Article 3.1.a of Regulation (EC) No 1935/2004 in terms of their non-hazardousness for human health. Accordingly, food contact materials and articles must be manufactured in such a way that they do not release substances into food in quantities which may be hazardous to human health under intended or foreseeable use conditions. Additionally, in some cases the recommendations include requirements corresponding to good manufacturing practice for compliance with the stipulations of Article 3.1.b and c of Regulation (EC) No 1935/2004.

To add a new substance or mixture of substances to the BfRshort forGerman Federal Institute for Risk Assessment recommendations on food contact materials, an application must be made to the BfRshort forGerman Federal Institute for Risk Assessment. The application must formally correspond to the “Note for Guidance” of the European Food Safety Authority (External Link:http://www.efsa.europa.eu/en/efsajournal/doc/21r.pdf). Furthermore, applicants are asked to complete a substance overview defined by the BfRshort forGerman Federal Institute for Risk Assessment and submit it together with the application documents.

The applications must be submitted by 1 December of the previous year or by 1 July so that the BfRshort forGerman Federal Institute for Risk Assessment can process the documents in order to enable the discussion at the meetings of the BfRshort forGerman Federal Institute for Risk Assessment Commission for Consumer Products in its April and November meetings. A digital version must also be submitted (e.g. by uploading it to a BfRshort forGerman Federal Institute for Risk Assessment server) which includes the full data set in a searchable format, e.g. as a Word or PDF document. If applications include data which applicants consider to be sensitive, one analogue and one digital version without the sensitive data must be additionally submitted.

Further information can be found on the website “BfR Recommendations on Food Contact Materials”: External Link:https://www.bfr.bund.de/en/service/databases/bfr-recommendations-on-food-contact-materials/.

The BfRshort forGerman Federal Institute for Risk Assessment database “BfR Recommendations on Materials for Food Contact” is available for free on the following page: External Link:https://empfehlungen.bfr.bund.de/recommendations?locale=en.

Any commercial use of the recommendations is not permitted without expressed consent of the BfRshort forGerman Federal Institute for Risk Assessment.

The BfRshort forGerman Federal Institute for Risk Assessment Commission for Consumer Products (BeKo) is made up of relevant experts and advises the BfRshort forGerman Federal Institute for Risk Assessment, including on the assessment of applications for addition of substances to the BfRshort forGerman Federal Institute for Risk Assessment recommendations on food contact materials, especially in the Commission Working Groups “Toxicology” and “Applications”. The BfRshort forGerman Federal Institute for Risk Assessment conducts the assessments and takes the decisions regarding possible addition of new substances to the BfRshort forGerman Federal Institute for Risk Assessment recommendations. The Committee and both Working Groups meet twice per year.

The BfRshort forGerman Federal Institute for Risk Assessment is not in charge of the authorisation of substances to produce food contact materials. Responsibility for existing authorisation procedures lies with the EU Commission (for European regulations) or with the German Federal Government for the addition of new substances into the positive list of the German Printing Ink Regulation (see above, “Do food contact materials have to complete an authorisation process?”).

The inclusion of a substance into the BfRshort forGerman Federal Institute for Risk Assessment recommendations is not an authorisation from a legal point of view.

Regulation (EC) No 1935/2004 requires an application process for substances and procedures for manufacturing food contact materials and articles. Following a positive assessment by the European Food Safety Authority (EFSAshort forEuropean Food Safety Authority), the substances must be authorised by the European Commission and listed in the annexes of the relevant EU Directives or Regulations. 

The current state of regulations provides for such directories in the following cases:

1. Plastics: Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food.
2. Recycled plastics: Commission Regulation (EU) 2022/1616 on recycled plastic materials and articles intended to come into contact with foods.
3. Active and intelligent packaging: Commission Regulation (EC) No 450/2009 on active and intelligent materials and articles intended to come into contact with food.
4. Regenerated cellulose films: Commission Directive 2007/42/EC of 29 June 2007 relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs.

The corresponding applications have to be submitted to the national contact points which are published under the following link: External Link:https://food.ec.europa.eu/document/download/ddbe2c89-487c-4346-9a62-f21eb01872ee_en

For Germany, the German Federal Office of Consumer Protection and Food Safety (BVLshort forGerman Federal Office of Consumer Protection and Food Safety) is the contact partner for these authorisation procedures. The BVLshort forGerman Federal Office of Consumer Protection and Food Safety transmits the applications to the European Food Safety Agency (EFSAshort forEuropean Food Safety Authority).

Materials and articles which come into contact with drinking water (for instance plastic pipes) do not fall within the scope of responsibility of the BfRshort forGerman Federal Institute for Risk Assessment, but are covered by the German Federal Environmental Agency (UBAshort forGerman Environment Agency) as well as by the European Chemicals Agency (ECHAshort forEuropean Chemicals Agency).

The BfRshort forGerman Federal Institute for Risk Assessment is not in charge of answering legal questions. Enforcing the legal provisions of the LFGB is the task of the German federal states ("Laender").

The BfRshort forGerman Federal Institute for Risk Assessment can be reached for questions regarding the interpretation of the BfRshort forGerman Federal Institute for Risk Assessment recommendations on food contact materials.

The enforcement of provisions laid down in the German Food, Consumer Articles and Feed Act (LFGB) is the responsibility of the German federal states ("Laender"). The monitoring on site is normally carried out by the municipal regulatory agency which also inspects business operators and collects samples. The BfRshort forGerman Federal Institute for Risk Assessment is not the appropriate contact for questions relating to the monitoring of consumer articles.

In principle, all materials that comply with the applicable food law provisions are suitable for food contact. The non-hazardousness of the materials must be ensured by the manufacturer or user. The BfRshort forGerman Federal Institute for Risk Assessment does not have any information as to whether commercial materials meet the statutory requirements. Corresponding information can be provided by the manufacturer. If corresponding enquiries are made, the intended use conditions should be taken into account.

The BfRshort forGerman Federal Institute for Risk Assessment does not carry out any contract tests for companies or private individuals. Tests carried out by the BfRshort forGerman Federal Institute for Risk Assessment exclusively serve the work of the National Reference Laboratory for Food Contact Materials, to support other public authorities or the institute’s own scientific research.

The BfRshort forGerman Federal Institute for Risk Assessment does not issue certificates of this kind. Testing and determination of compliance with the BfRshort forGerman Federal Institute for Risk Assessment recommendations can be performed by testing institutes with competence in the monitoring of food contact materials.

The BfRshort forGerman Federal Institute for Risk Assessment is often asked by manufacturers for contact data of test institutes, e.g. for testing the legal compliance of food contact materials or for inclusion of substances in the BfRshort forGerman Federal Institute for Risk Assessment recommendations in connection with a corresponding application. However, as a public authority the BfRshort forGerman Federal Institute for Risk Assessment is not permitted to recommend test institutes.

Manufacturers may, however, contact the appropriate trade associations, which represent the individual materials or consumer articles. Chambers of Industry and Commerce may also provide information on test laboratories. Furthermore, the Expert Group of Self-employed Chemists within the German Chemical Society has a list of laboratories on its website. The website of the German Accreditation Body (DAkkS) may also provide suitable testing institutes. 

With this information the BfRshort forGerman Federal Institute for Risk Assessment does not make any assessment of the quality of the mentioned institutions.

Analytical methods conforming with the requirements for food contact materials can be found in the scientific literature and the following collections of procedures: 

Official Collection of Test Procedures under § 64 of the LFGB, see: External Link:http://www.methodensammlung-bvl.de/

BfRshort forGerman Federal Institute for Risk Assessment database “Method collection for studying paper, carton, and cardboard for food contact” (in German): External Link:https://www.bfr.bund.de/service/datenbanken/bfr-empfehlungen-zu-materialien-fuer-den-lebensmittelkontakt/methodensammlung-papier-karton-und-pappe/

Website of the EU Reference Laboratory for Food Contact Materials: External Link:https://joint-research-centre.ec.europa.eu/eurl-food-contact-materials_en