Explanations

Declarations for the food industry

Regulation (EC) No. 1935/2004

Regulation (EC) No. 1935/2004 is an outline regulation concerning materials intended to come into contact with food such as plastics, metal, rubber and adhesives.

Regulation (EC) No. 2023/2006

Regulation (EC) No. 2023/2006 refers to good manufacturing practice (GMP) for materials and objects intended to come into contact with food. Similar to the previous regulation, it contains precise directions on how to handle products, processes and documents in order to ensure safety and traceability.

Regulation (EU) No. 10/2011

Regulation (EU) No. 10/2011 refers to materials and objects made of plastic intended to come into contact with food. Regulation (EU) No. 10/2011, also known as PIM (Plastics Implementation Measure), is a replacement for (EC) No. 2002/72, which has now been declared invalid, along with the associated regulations. Regulation (EU) No. 10/2011 contains a positive list of monomers and additives which may be used in manufacturing materials and objects made of plastic. The regulation also defines test conditions, simulants and migration test procedures to prove the suitability of products which come into contact with different types of food.

Declaration for the food industry in the USA

FDA

According to FDA stipulations (in accordance with CFR Title 21 - Food and Drugs) various materials suitable for food contact are recorded in a positive list. In particular, part 177 contains the list of standard polymers which are suitable for single or multiple contact with foods and part 178 lists relevant additives, production aids and dyes. The positive lists contain information regarding the requirements imposed on physical and chemical composition as well as on approved application conditions.

NSF 51

The NSF/ANSI standard 51 "Food Equipment Materials" is a generally recognised standard which requires a check of the formulation on the basis of FDA regulations, laboratory testing and an audit of the manufacturing location. This certification needs to be extended annually. The NSF International (National Sanitation Foundation), a not-for-profit organisation, maintains lists of products and manufacturers which comply with their requirements. To be listed, the material must be tested and the producing location must be audited.

20-25 3-A Sanitary Standard

The 20-25 3-A Sanitary Standard refers to multiple-use plastic materials in the dairy industry, which aims to define sanitary standards and practices for equipment and systems used. The standard describes the cleanability of a material and defines that the material must not lose its functional characteristics or surface quality, even under tough environmental conditions, following regular treatment with bactericides. This area is not covered by the FDA regulations. Although the 20-25 3-A Sanitary Standard is not legally binding, it is generally acknowledged.

Drinking water declaration

Germany - Plastics in contact with drinking water (KTW)

Germany – Plastics which come into contact with drinking water (KTW): testing in accordance with DVGW (German Technical and Scientific Association for Gas and Water) regulations and the 2001 Drinking Water Ordinance 2001, using a microbial growth test in accordance with work sheet W 270. Migration values in accordance with DIN EN 12873-1: 2004 and -2: 2005 in accordance with the updated guidelines of the German Environmental Protection Agency (dated 08/10/2008).

UK - WRAS (Water Regulations Advisory Scheme)

UK – Testing in accordance with WRAS (Water Regulations Advisory Scheme), certifications from WRc-NSF (cooperation between the Water Research Council and the NSF). Certificate valid for five years.

USA - NSF 61 (National Sanitation Foundation)

USA – Testing in accordance with NSF 61 (National Sanitation Foundation) with approvals specific to the manufacturer, specific production locations, material types and temperature specifications.

Biocompatibility declarations

ISO 10993

ISO 10993 is of particular relevance to manufacturers of medical products and test laboratories, and is now the acknowledged guideline for medical products. In addition to describing biological-toxicological tests, the ISO 10993 standard also includes physical-chemical tests for the identification of potentially toxic and allergenic materials or substances.

USP class VI

USP class VI: the United States Pharmacopeia Convention (USP) can be can be consulted for the assessment of components/products made of plastic. USP describes the cytotoxicity test and classifies products into categories I-VI, where the products in category VI have to comply with the most stringent requirements and consequently have to undergo extensive testing.

Declarations for the oil & gas industry

EN ISO 23936

EN ISO 23936 contains general principles and gives requirements and recommendations for selection and qualification, and gives guidance for quality assurance of non-metallic materials for use in equipment used in the oil and gas production environment. Part 1 is intended to define requirements and recommendations for the selection and qualification of thermoplastic materials for use in equipment used in oil and gas production. The technical requirements for qualification of thermoplastic materials in oil and gas environments are described in Annex B.

NORSOK standard M-710, Edition 3

The NORSOK standards are developed by the Norwegian petroleum industry to ensure adequate safety, added value and cost-effectiveness for petroleum industry developments and operations. The NORSOK standard M-710, Edition 3, September 2014 covers elastomers and thermoplastics used for offshore oil and gas production.

Aerospace declarations

Material Data Sheets (for instance WL 5.2206.3)

Material Data Sheets (for instance WL 5.2206.3) list the physical properties of materials. In most cases, properties of injection-moulded test bodies are used as a basis. However, these are not directly comparable with values of the semi-finished product.

Aviation Standards (for example LN 9388)

Aviation Standards (for example LN 9388) describe the dimensions and tolerances for semi-finished products and are comparable to the semi-finished products standard (DIN 15860).

ASTM (USA)

ASTM (USA): American standard encompassing test methods and so-called material codes which characterise the properties of the raw material:

ASTM D-6778 (POM)

ASTM D-4066 (PA 6 and PA 66)

ASTM D-3965 (PC)

Mil Spec (Military Specification/USA)

Mil Spec (Military Specification/USA): encompasses American test methods in accordance with the ASTM described above.

For example: MIL P-46183 (PEEK)

LP (USA – Federal Specification)

For example: L-P-410a for polyamides.

Maybe more info on this one?

FAR 25.853

FAR 25.853 is a typical fire test specification for aerospace applications. In addition to pure combustibility using the vertical test, it also contains tests to determine smoke density and toxicity under the influence of radiant heat and flames.

UL 94 -V0

UL 94 -V0: inherent flame resistance of high-performance plastics

ESA ECSS-Q-70-02

Tests in compliance with the ESA ECSS-Q-70-02 on outgassing, indicate no condensable impurities in TECASINT. The products tested can thus be used in high vacuum/space applications.