Rubber and plastics gloves for food services -- Limits for extractable substances

ISO 14285:2014 specifies limits for extractable chemical substances for single-use gloves made from natural rubber, synthetic rubber, or plastic materials that are intended for use in food preparation, food handling, and related application in food service industry. ISO 14285:2014 does not cover the specification for extractable biological substances and physical requirements of the gloves. It is not applicable to gloves used under extreme conditions such as those having pH less than 4,5 and/or temperature above 40 °C. It does not cover gloves being exposed to fat and oil foods.

Gants en caoutchouc et en plastique pour les services alimentaires -- Limites pour les substances extractibles

General Information

Status
Published
Publication Date
06-Feb-2014
Current Stage
6060 - International Standard published
Start Date
09-Jan-2014
Completion Date
07-Feb-2014
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ISO 14285:2014 - Rubber and plastics gloves for food services -- Limits for extractable substances
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INTERNATIONAL ISO
STANDARD 14285
First edition
2014-02-15
Rubber and plastics gloves for food
services — Limits for extractable
substances
Gants en caoutchouc et en plastique pour les services alimentaires —
Limites pour les substances extractibles
Reference number
ISO 14285:2014(E)
ISO 2014
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ISO 14285:2014(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2014

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form

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Published in Switzerland
ii © ISO 2014 – All rights reserved
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ISO 14285:2014(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Types ................................................................................................................................................................................................................................. 1

4 Requirements .......................................................................................................................................................................................................... 2

4.1 Allowable limits of extractable substances from the gloves ............................................................................ 2

4.2 Heavy metals ............................................................................................................................................................................................. 2

4.3 Phthalate content .................................................................................................................................................................................. 2

5 Sample preparation ........................................................................................................................................................................................... 2

5.1 Determination of heavy metals ................................................................................................................................................. 2

5.2 Determination of potassium permanganate consumption and the evaporation residue ...... 3

5.3 Determination of the phthalate content............................................................................................................................ 3

6 Provision for use ................................................................................................................................................................................................... 3

7 Labelling and marking ................................................................................................................................................................................... 3

Annex A (normative) Determination of heavy metals ........................................................................................................................ 4

Annex B (normative) Determination of potassium permanganate consumption ................................................8

Annex C (normative) Determination of evaporated residue ....................................................................................................10

Annex D (normative) Determination of phthalate content ........................................................................................................12

Annex E (informative) Precision ............................................................................................................................................................................16

Bibliography .............................................................................................................................................................................................................................18

© ISO 2014 – All rights reserved iii
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ISO 14285:2014(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation on the meaning of ISO specific terms and expressions related to conformity

assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers

to Trade (TBT) see the following URL: Foreword - Supplementary information

The committee responsible for this document is ISO/TC 45, Rubber and rubber products, Subcommittee

SC 4, Products (other than hoses).
iv © ISO 2014 – All rights reserved
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INTERNATIONAL STANDARD ISO 14285:2014(E)
Rubber and plastics gloves for food services — Limits for
extractable substances

WARNING — Persons using this International Standard should be familiar with normal laboratory

practice. This International Standard does not purport to address all of the safety problems, if

any, associated with its use. It is the responsibility of the user to establish appropriate safety and

health practices and to ensure compliance with any national regulatory conditions.

1 Scope

This International Standard specifies limits for extractable chemical substances for single-use gloves

made from natural rubber, synthetic rubber, or plastic materials that are intended for use in food

preparation, food handling, and related application in food service industry.

This International Standard does not cover the specification for extractable biological substances and

physical requirements of the gloves. It is not applicable to gloves used under extreme conditions such

as those having pH less than 4,5 and/or temperature above 40 °C. This International Standard does not

cover gloves being exposed to fat and oil foods.

NOTE The physical requirements specified for gloves could be found in related International Standards, for

example, ISO 11193-1 and ISO 11193-2.

This International Standard does not cover safe and proper application of the gloves with subsequent

handling, packaging, and storage procedures.
2 Normative references

The following documents, in whole or in part, are normatively referenced in this document and are

indispensable for its application. For dated references, only the edition cited applies. For undated

references, the latest edition of the referenced document (including any amendments) applies.

EN 14372:2004, Child use and care articles – Cutlery and feeding utensils – Safety requirements and tests

3 Types
Gloves are classified into the following types:
a) type 1: natural rubber latex;
b) type 2: synthetic latex;
c) type 3: polyvinyl chloride (PVC);
d) type 4: polyethylene (PE);
e) type 5: polypropylene (PP).

NOTE Gloves made from blend polymer are not covered in this International Standard.

© ISO 2014 – All rights reserved 1
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ISO 14285:2014(E)
4 Requirements
4.1 Allowable limits of extractable substances from the gloves

The allowable extractable substances for all types of glove shall not exceed the limits presented in

Table 1.

Determination of the extractable substances shall be carried out according to the test methods given in

Table 1.

Table 1 — Maximum limits for allowable extractable substances from food-contact gloves

Parameters Maximum limit Test methods
Heavy metals, μg/ml See Table 2 Annex A
Potassium permanganate
≤10 Annex B
consumption, µg/ml
Evaporation residue, µg/ml
Distilled water ≤100 Annex C
10 % ethanol ≤100
4.2 Heavy metals

The heavy metals shall not exceed the limits given in Table 2 when tested in accordance with Annex A.

Table 2 — Limits of heavy metals
Maximum limit
Element
μg/ml
Arsenic, As 0,05
Cadmium, Cd 0,05
Chromium, Cr 0,5
Lead, Pb 0,5
Zinc, Zn 15,0
4.3 Phthalate content

The total content of phthalate for Type 3 glove shall not exceed 0,1 % (m/m). The determination of

phthalate content shall be carried out as described in Annex D, or in 6.3.2 of EN 14372.

5 Sample preparation
5.1 Determination of heavy metals

Cut one piece of 5 cm × 5 cm test sample to provide a surface area of 50 cm taken from the palm or the

back of a glove.

The extraction is done by immersing the test piece in a container of 100 ml of the recommended extraction

medium. Use water bath to control the temperature, according to the condition given in Table 3.

After extraction, remove the test piece from the container and keep the solution for the determination

of heavy metals.
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ISO 14285:2014(E)
Table 3 — Conditions for sample preparation
Parameters Extraction medium Conditions
Heavy metals 4 % acetic acid (40 ± 1) °C for (10 ± 1) min
Potassium permanganate consumption Distilled water (40 ± 1) °C for (10 ± 1) min
Distilled water
Evaporation residue (40 ± 1) °C for (10 ± 1) min
10 % ethanol

5.2 Determination of potassium permanganate consumption and the evaporation resi-

due

Cut two pieces of 5 cm × 5 cm from the palm or the back of gloves to provide a total surface area of

100 cm . Wash the test samples with distilled water to remove any lubricant or powder used to prevent

the gloves from sticking together.

The extraction is done by immersing the test pieces in a container of 200 ml of the recommended

extraction medium. Use water bath to control the temperature, according to the condition given in

Table 3.

After extraction, remove the test pieces from the container and keep the solution for the determination

of potassium permanganate consumption and the evaporation residue.
5.3 Determination of the phthalate content
The extraction procedure is as described in Annex D, or in EN 14372.
6 Provision for use

6.1 The manufacturer shall provide information on the provision of the gloves for application in wet or

dry conditions.

6.2 The glove should remain intact after exposure to wet surfaces throughout the food preparation or

handling processes as recommended by the manufacturer.
6.3 The glove shall be used only once.
7 Labelling and marking

7.1 The language used for labelling and marking shall be as agreed upon between the interested parties.

7.2 Information provided shall be at the box or packaging container.

7.3 Appropriate labelling for food service gloves shall include instructions for use that identify materials

or conditions with which contact should be avoided.

7.4 Gloves made of natural rubber latex shall be provided with the following label: “Natural rubber

latex, which may cause an allergic reaction has been used in the manufacturing of this product”, or words

to that effect.
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ISO 14285:2014(E)
Annex A
(normative)
Determination of heavy metals
A.1 Principle

This test procedure describes the method for the determination of an individual heavy metal element

extracted from gloves using inductively coupled plasma optical emission spectroscopy (ICP-OES). The

basis of the method is the measurement of emission of light by an optical spectroscopic technique. The

sample solutions are nebulized and the aerosol that is produced is transported to the plasma torch where

the excitation occurs. Characteristic emission spectra are produced by radio frequency inductively

coupled plasma (ICP). The spectra are dispersed by a grating spectrometer and the intensities of the

lines are monitored by a detector. The signals from the detector(s) are processed and controlled by

a computer system. A suitable background correction technique is used to compensate for variable

background contributions to the determination of trace elements.
A.2 Apparatus
Use usual laboratory apparatus and, in particular, the following.

A.2.1 ICP-OES, equipment consisting of sample holder, plasma torch, spray chamber, nebulizer, optical

unit, detector, system control, and data output device.

NOTE Detailed operating instructions is not provided due to the differences between various makers and

models.
A.2.2 Analytical balance, capable of measuring accurately up to 0,0001 g.
A.2.3 Containers, for storage of standard solution and calibrant.
NOTE All containers shall be cleaned with 10 % (v/v) nitric acid before use.

A.2.4 Glassware, all glassware shall be soaked with 10 % (v/v) nitric acid at least 24 h before use.

A.2.4.1 Glass beakers, of suitable capacity.
A.2.4.2 Volumetric flasks, of suitable size.
A.2.4.3 Erlenmeyer flask.
A.2.4.4 Pipette.
A.2.4.5 Funnel.
A.2.5 Micropipettes.
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ISO 14285:2014(E)
A.3 Reagents
A.3.1 Argon gas, gas with purity of over 99,99 % (v/v).
A.3.2 Nitrogen gas, gas with purity of over 99,99 % (v/v).
A.3.3 Nitric acid, ρ(HNO ) = 1,4 g/ml [w(HNO ) = 650 g/kg].
3 3
A.3.4 Deionised water.

A.3.5 Nitric acid solution 5 % (v/v), prepare by adding 50 ml of nitric acid (A.3.3) to deionised water

(A.3.4) and bring the volume to 1 000 ml of volumetric flask (A.2.4.2).

A.3.6 Standard stock solutions, 100 mg/l of arsenic (As), cadmium (Cd), chromium (Cr), lead (Pb),

and zinc (Zn).

NOTE Standard stock solutions of other concentrations can be used. The standard stock solutions can be

purchased or prepared from high purity grade chemicals or metals. Traceable standard solutions might be

preferred.
A.4 Standard solutions

The following standard solutions for the five elements, i.e. arsenic (As), cadmium (Cd), chromium (Cr),

lead (Pb), and zinc (Zn) shall be prepared.
A.4.1 Standard solution of 100 μg/l

Pipette 50 μl of standard stock solution of the element standard (A.3.6) in a 50 ml volumetric flask. Add

5 % nitric acid solution (A.3.5) to bring the total volume of 50 ml.
A.4.2 Standard solution of 500 μg/l

Pipette 250 μl of standard stock solution of the element standard (A.3.6) in a 50 ml volumetric flask. Add

5 % nitric acid solution (A.3.5) to bring the total volume of 50 ml.
A.4.3 Standard solution of 1 000 μg/l

Pipette 500 μl of standard stock solution of the element standard (A.3.6) in a 50 ml volumetric flask. Add

5 % nitric acid solution (A.3.5) to bring the total volume of 50 ml.
A.5 Laboratory reagent blank

The procedure is identical to that of sample solution preparation and is carried out concurrently but

without the sample.
A.6 Determination
A.6.1 General

A.6.1.1 Set up the instrument with proper operating parameters established from the manufacturer’s

instruction manual. Allow the instrument to achieve thermal stability before beginning. Instructions

provided by the manufacturer should be followed.
A.6.1.2 Initiate the appropriate operating configuration of the computer.
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ISO 14285:2014(E)

A.6.1.3 Profile and calibrate the instrument according to the manufacturer’s recommended proce-

dures using the standard solutions (A.4).

A.6.1.4 Begin the sample run by flushing the system with the reagent blank (A.5) between each sam-

ple.
A.6.2 Recommended wavelengths and important spectral interferences

Table A.1 lists the recommended wavelengths and the important spectral interferences.

Table A.1 — Recommended wavelengths and the important spectral interferences
Element Wavelength Interfering elements
As 188,979 Al, Cr, Fe, Ti
193,696 Al, Co, Fe, W, V
197,197 Al, Co, Fe, Pb, Ti
Cd 214,441 As, Cr, Fe, Sc, Sb
226,502 As, Co, Fe, Ni
228,802 As, Co, Sc
Cr 205,559 Be, Fe, Mo, Ni, Ti
267,719 Mn, P, V
283,563 Fe, Mo, V, W
...

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