REACH – Applications for authorisation AFA017-01 – UV-328

Overview

Public consultation on alternatives

Reference: AFA017-01

Applicant: Becton, Dickinson U.K. Limited 

Application type: Initial

Substance name: 2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328)

EC number: 247-384-8

CAS number: 25973-55-1

Annex 14 entry number: 51

Proposed use: Use of an imported polymer containing UV-328 as an additive for UV stabilisation in the manufacture of a mechanical separator component used in Barricor^TM blood collection tubes.

Broad information on use applied for (conditions of use and function):

UV-328 is imported as a component (<1 wt %.) of a thermoplastic elastomer (TPE) which is used to manufacture a mechanical separator component for use in blood collection tubes at a single UK manufacturing site. UV-328 acts as a UV stabiliser to prevent degradation of the plastic separator.

When blood is being collected, the mechanical separator rests at the top of the tube. Its ring shape allows the collected whole blood to flow to the bottom of the tube. During centrifugation, the elastomer stretches as a result of the force applied and the separator detaches from the tube walls and drops into the blood. Throughout the centrifugation, the elastomer part remains stretched, thus allowing the blood cells to precipitate to the bottom of the tube through the plasma. At the same time, the difference in density between the top and the base of the mechanical separator keep it positioned properly in the tube. When the centrifuge slows and stops, the elastomer component returns to its original shape and forms a seal between the plasma and the blood cells.

If the physical properties of the mechanical separator such as density and elastic modulus are affected by UV light, it will not be able to perform its function of separating the blood samples properly. Change in elastic modulus means that the separator will be more rigid and even brittle, which can result in the separator not dropping during centrifugation or not providing a tight enough seal between plasma and blood cells. Any change in density means that the positioning of the separator during centrifugation is not the correct one, thus affecting effectiveness of the separation of blood cells from plasma.

During manufacture of the mechanical separator component highly controlled conditions are applied to minimise the potential for exposure to workers and releases to the environment of TPE resin containing UV-328. All waste generated during the use of the substance is collected and disposed of via incineration.

List of descriptors:

• Life cycle stage (LCS): Use at industrial site
• Sector of end Use (SU): 20 
• Product Category (PC): 0 (Other: Health care products)
• Process Category (PROC): 1, 8b, 10 14, 19 
• Environmental Release Category (ERC): ERC5, ERC12c
• Article Category related to subsequent service life: AC13g (Other plastic article)

Technical Function (TF): UV stabiliser

Annual tonnage used: 100-200 kg UV-328 

Review period requested: 4 years

How to submit comments

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The consultation lasts for 8 weeks (unless otherwise specified) and closes at 23:59 London time (BST).