Certificate of compliance for materials intended for food contact
and product technical specifications for Vitop taps and glands*

2010

We supply taps and glands in 1,000 or 1,120 unit boxes to container manufacturers. Filling centers are provided with containers with the taps partially inserted in the gland. The taps may be placed in a preset position (the height being determined by the position of the Vitop gland's inner groove) and then fully inserted into the gland by the filling centre.

Our identification code present on each cardboard box for taps and glands must be registered by container manufacturers in their production records and our code must correspond with their own code that identifies a specific batch of containers.

We recommend that the period between delivery of the taps by Vitop and their installation on the container by the manufacturer does not exceed one year. Also, the period between delivery of the taps by Vitop to the container manufacturer and their use by the end consumer must not exceed two and a half years.

Vitop tap and gland materials:
Part Resin Colorant Lubricant
Body Polypropylene (PP) Black No
Capsule Polypropylene (PP) Red No
Piston High-Density Polyethylene (HDPE) Red No
Valve Elastomer Natural Yes
Gland Linear Low-Density Polyethylene (LLDPE) Natural Yes

Notes: Food Contact

The Vitop tap and gland unit fully meets FDA and European Union global migration requirements and is therefore suitable for contact with foodstuffs.

The Migration analysis during 10 days at 40°C with the following simulants:
  • Distilled water
  • Acid simulant (acetic acid at 3% in aqueous solution)
  • Alcoholic simulant (ethanol at 50% v/v in aqueous solution)
  • Olive oil
The following certificates * for food contact were attributed to all the above materials (including colorants and lubricants):
  • FDA Regulations (paragraphs 21 CFR 177.1520, 178.1520)
  • Directive 2002/72, specific directive plastics materials, (2004/1, 2004/19, 2005/79, 2007/19, 2008/39) and others amendments.
  • Regulation 1935/2004, regulation for materials in contact with foodstuffs.
  • 2023/2006 : guide of good practices for materials in contact with foodstuffs.
  • Directive 82/711/CEE (85/572, 93/8, 97/48) , and others amendments.
  • Regulation 1895/2005 (badge)
  • Heavy metals: Materials used in the production of Vitop taps and glands do not contain any heavy metal
  • Environment: Materials used in the production of Vitop taps and glands are in conformity with the ECC regulation 94/62 (2005/20/CE and 2004/12/CE) and others amendments.
  • Identification: Each cardboard box is identified by its label (Vitop tap: “standard 28mm tap”, Vitop gland: “standard 28mm gland”) and with an identification code.
  • Storage: The taps and glands must be stored at room temperature (over 4° C and less than 30° C).
  • Transport and packaging: Deliveries on pallets of 24 cardboard boxes with 1,000 or 1,120 units / box with protective adhesive tape (Quality Seal).
  • Hygiene: The assembly area of the taps is kept very clean, meeting the standards of production of packaging materials intended for food contact.
  • Leak Proof: Each tap must undergo a tightness test at a pressure of 0.4 bars.
  • Oxygen permeability: The Vitop tap has a permeability rate of oxygen of approximately 0.1 cm3 (24-hour period, 21% oxygen rate, 50% relative humidity, 23°C) measured according to ASTM D3985-81 standard.
  • Insertion of the tap inside the gland: The Vitop tap’s barrel has an outer diameter (measured on the second outer ring) of 28.9 millimeters to 29.1 millimeters. The Vitop gland has an inner diameter (measured above the inner groove) of 28.2 mm to 28.4 mm. On inserting the tap inside the gland, the tap must be centralized to prevent any damage to either part. The taps must not be inserted inside the glands if the temperature is below 10° C.
  • Thermal resistance of the gland manufacturing material: The filling temperature must not exceed 45° C. In case of hot filling, we recommend storing the recipients with the taps facing upwards to reduce to the maximum the pressure on the glands.
  • Quality and Hazards certification:Vitop is ISO 9001:2000, HACCP as well as NSF certified.

Vitop taps, glands and connectors are appropriate for contact with alcoholic solutions, as defined below *:

  • “EC Commission Directive 2002/72/EC” dated August 6, 2002 and successive amendments.
  • “Code of Federal Regulations”, issued by the Food and Drug Administrations (FDA), paragraph 21 CFR 177.1520 and 178.2021 (“OLEFIN POLYMERS for BODY and Gland”)
  • “Code of Federal Regulations”, issued by the Food and Drug Administrations (FDA), paragraph 21 CFR 177.2600 (“Rubber articles for repeated use for Valve”)
Vitop acts with diligence to obtain food contact certificates and to manufacture its products, however, it does not guarantee that all these materials or products are suitable for a certain use, for certain conditions of transformation, storage or distribution, or still, their compliance with local regulations. Before any commercial use, Vitop invites its clients to conduct their own tests on their own products to determine their applicability. The nature of these tests and the research protocol must be determined by the client and may include, among others, parameters like temperature, chemical and environmental resistance, resistance to cracks, permeability to gases, flow rate, suitability for machinery for manufacture of the recipient, filling and distribution, etc. Vitop does not assume any liability for any loss, damage, injury or death resulting from failure to follow the abovementioned precautions.