Official Approvals

Here at JIOrings the ongoing improvement both of our products and of our services is our prime objective. To meet the current market requirements, we must be able to verify the quality and reliability of our materials, from raw materials to the end product delivered to the Client.

The official approvals themselves as well as the supplier official approvals we rely on reflect the quality of our materials. At present we have more than 600 compounds available, many of them officially approved by our suppliers at certified laboratories or compliant with the more common international standards. As we are unable to thoroughly detail all of these compounds, below we have set out a representative sample of the most highly rated ones.

Here at JIOrings we propose a vast range of internationally approved compounds for food and pharmaceutical applications, for contact with drinking water, gas or flame. These official approvals mainly apply to the manufacture of O-rings though they are also valid for quad-rings, customized gaskets, aseptic seals and washers.

International official approvals

Here at JIOrings we propose a vast range of internationally approved compounds for food and pharmaceutical applications, for contact with drinking water, gas or flame. These official approvals mainly apply to the manufacture of O-rings though they are also valid for quad-rings, customized gaskets, aseptic seals and washers.

FOOD CONTACT NOTIFICATION (FCN) of the FDA

The Food and Drug Administration is the US federal authority that oversees and ensures food safety, human and animal drugs, biological products and medical devices.  It also controls the harmless nature of the rays emitted by electronic devices.

Although the FDA’s competence is limited to the US, it rules and requirements are usually adopted as international monitoring standards. By means of its codes of federal regulations (CFR) the FDA sets out a list of the chemical products and materials officially approved for contact with food. CFR 21.177.2600 describes the rules which apply to the “rubber items intended for repeated use”. The FDA also sets out a list of the ingredients and their quantitative limits which may be used for elastomer moulding intended for repeated use at all stages of the manufacturing process (from the preparation of food products to final transport). Rule CFR 21.177.2600 also stipulates the limits that apply to extractable products if the elastomer has to come into contact with aqueous or fatty foods.

The FDA does not officially approve itself the products in accordance with the CFR rule 21.177.2600. It is the manufacturer of elastomers itself who has to test that it respects the requirements laid down by the FDA.

• Materials available: NBR, FPM, EPDM, VMQ, HNBR, CR, FFKM

Seals compliant with the FOOD CONTACT NOTIFICATION (FCN) of the FDA

The FDA has monitoring power over the substances added to food products. It monitors, inter alia, the harmless nature of their use. Furthermore, according to article 309 of the modernisation act of the Food and Drug Administration of 1997 (FDAMA), the FCN procedure (Food Contact Notification) constitutes the main way of regulating the food quality substances which may be used as the main ingredients for the manufacture, packaging, transport or storage of foods but which are not an additive incorporated in said foods.

During the course of the FCN official approval procedure, the watertightness material and each of its ingredients are subject to numerous investigations and to analysis and testing intended to evaluate the potential for food contamination.

The FDA modernisation act foresees a system whereby a manufacturer or a supplier of materials for contact with foods can submit to it an official approval document called a Food Contact Notification (FCN). This document sets out the identification and use of a new substance for contact with foods as well as the data required, demonstrating that said substance is harmless within the context of the usage for which it has been developed.

The FCN document constitutes an official approval of a material provided by the FDA. It is thus essentially different from “self-certification” CFR 21.177.2600.

• Materials available: on request

The FDA rules constitute the reference code for the applications of the pharmaceutical and biotechnological industries. However, clients frequently require elastomers compliant with the United States Pharmacopeia standards – Class VI (USP Class VI).

It is an independent organisation which does not belong to the US government and which monitors public health, setting out strict standards with a view to ensuring the quality of the drugs and other medical technologies.

The standards are published by the USP and the National Formulary. Users frequently request compliance with USP Class VI requirements. The tests which allow the validation of this compliance include an evaluation of the influence of the material and of the extractable substances in animal tissues.

• Materials available: EPDM, FPM, VMQ, FFKM

3-A Sanitary Standards Inc. derives from the US agro-food and dairy industry. It defines specifications and good practices in the design, manufacture, installation and use of hygiene equipment.

Standard 3-A-18-03 pertaining to “rubber materials for repeated use” deployed for the surfaces of products in contact with dairy machinery, details the requirements in terms of food quality materials which must also respect cleanliness and disinfection.

In order to comply with the requirements of this standard, the elastomer materials must comply with the standard FDA CFR 21.177.2600, resist autoclave sterilization, the fatty content of milk, acidic and alkaline cleaning solutions and chlorine-based disinfectant solutions.

• Materials available: FPM, VMQ, EPDM, NBR

Official approvals by the German Gas and Water Association (Deutscher Verein des Gas und Wasserfaches – DVGW) of the parts in contact with gas for appliances and machinery for household use as well as for fittings and gas transport conduits.

• Materials available: NBR, FPM, VMQ, FVMQ, HNBR

The National Sanitary Foundation (NSF) is a US organisation for inspecting and certifying products and materials intended to come into contact with foods and drinking water.

Standard NSF/ANSI 51 is specifically applicable to the materials and coatings used in the manufacture of products which come into contact with solid or liquid foods. The standard NSF/ANSI 61 refers to the certification of systems and components deployed in the supply of drinking water.

• Materials available: NBR, VMQ, EPDM

Numerosos países exigen que los materiales con contacto con agua potable, bien sea fría o caliente, sean homologados por institutos autorizados.

The Water Research Council in the UK, for example, lays down demanding tests for official approval which are different from the FDA ones: it must be demonstrated that the elastomers do not promote the propagation of bacteria nor alter water quality.

Kunstoffe und TrinkWasser (KTW) in Germany applies the requirements stipulated by the Deutscher Verein des Gas und Wasserfaches (DVGW) in a directive called “Arbeitsblatt W270”. The KTW specifications also require test son the finished product to prevent it from having influence on the odour, taste and colour of the water, the propagation of components in the water and to stipulate chlorine contamination limits.

GERMANY: KTW / W270.>

FRANCE: Attestation de Conformité Sanitaire à la liste positive (ACS) + migration tests for parts whose diameter is greater than 63mm. for parts whose diameter is less, the CLP is valid.

UNITED KINGDOM: WRAS / WRC.

THE NETHERLANDS: KIWA.

Furthermore, the standard EN 681-1 is used for the watertightness joints deployed on water pipes and conduits:

WA: for cold drinking water (+50 ºC maximum).

WB: for hot drinking water (continuous up to +110 ºC).

Finally, standard W534 is used for the joints deployed on the connectors and fittings deployed in drinking water systems.

• Materials available: NBR, VMQ, EPDM, HNBR

The certifications issued by the US Underwriters Laboratories. UL has drawn up more than 1,000 safety standards. These standards prove essential for public safety and trust, cost-cutting, improving quality and the commercialisation of products and services. Millions of products and components are tested in accordance with the strict UL safety standards so that consumers can enjoy a safer environment.

• Materials available: NBR, EPDM

Each material is intended for a specific use: