kSIST FprEN 17487:2022
(Main)Protective clothing - Protective garments treated with permethrin for the protection against tick bites
Protective clothing - Protective garments treated with permethrin for the protection against tick bites
This document formulates requirements for garments that support the protection against tick bites. The document applies to all types of garments where protection against tick bites, which is provided by garments as physical barriers, is reinforced by industrial treatment with the biocide permethrin prior to confection
NOTE Untreated garments covering the torso, arms and legs and feet offer some protection against tick bites but are insufficient under high exposure to ticks, which can crawl over the fabric to reach bare skin and bite. Garments that comply with this document and cover at least torso, arms and legs counter ticks from crawling over the fabric to reach bare skin and bite; such garments thereby provide substantial additional protection.
Schutzkleidung - Mit Permethrin behandelte Schutzkleidungsstücke zum Schutz gegen Zeckenbisse
Dieses Dokument formuliert Anforderungen für Kleidungsstücke, die den Schutz gegen Zeckenbisse unter-stützen. Das Dokument gilt für alle Kleidungsstückarten, bei denen der von den Kleidungsstücken als physikalische Barriere gewährleistete Schutz gegen Zeckenbisse durch eine industrielle Behandlung mit dem Biozid Permethrin vor der Konfektionierung verstärkt wird.
ANMERKUNG Unbehandelte Kleidungsstücke, die Torso, Arme, Beine und Füße bedecken, bieten einen gewissen Schutz gegen Zeckenbisse, sind aber bei hoher Exposition gegenüber Zecken, die auf dem Textil umherwandern können, um zur bloßen Haut zu gelangen und zu beißen, nicht ausreichend. Kleidungsstücke, die diesem Dokument entsprechen und mindestens Torso, Arme und Beine bedecken, vereiteln, dass Zecken auf dem Textil bis zur bloßen Haut umherwandern und beißen können; derartige Kleidungsstücke bieten damit umfangreichen zusätzlichen Schutz.
Habillement de protection - Vêtements de protection traités à la perméthrine pour la protection contre les morsures de tiques
Le présent document formule des exigences relatives aux vêtements qui contribuent à la protection contre les morsures de tiques. Le présent document s’applique à tous les types de vêtements où la protection contre les morsures de tiques, qui est assurée par les vêtements en tant que barrières physiques, est renforcée par un traitement industriel au moyen d'un biocide, la perméthrine, avant la confection.
NOTE Les vêtements non traités couvrant le torse, les bras, les jambes et les pieds offrent une certaine protection contre les morsures de tiques, mais sont insuffisants en cas d’exposition élevée aux tiques, qui peuvent se déplacer sur l’étoffe afin d’atteindre la peau nue, et la mordre. Les vêtements qui sont conformes au présent document et qui couvrent au moins le torse, les bras et les jambes empêchent les tiques de se déplacer sur l’étoffe afin d’atteindre la peau nue et la mordre ; ces vêtements fournissent par conséquent une protection supplémentaire conséquente.
Varovalna obleka - S permetrinom obdelana varovalna oblačila za zaščito pred klopi
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN 17487:2020
01-april-2020
Varovalna obleka - S permetrinom obdelana varovalna oblačila za zaščito pred
klopi
Protective clothing - Protective garments treated with permethrin for the protection
against tick bites
Schutzkleidung - Mit Permethrin behandelte Schutzkleidungsstücke zum Schutz gegen
Zeckenbisse
Habillement de protection - Vêtements de protection traités à la perméthrine pour la
protection contre les morsures de tiques
Ta slovenski standard je istoveten z: prEN 17487
ICS:
13.340.10 Varovalna obleka Protective clothing
61.020 Oblačila Clothes
oSIST prEN 17487:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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DRAFT
EUROPEAN STANDARD
prEN 17487
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2020
ICS 61.020; 13.340.10
English Version
Protective clothing - Protective garments treated with
permethrin for the protection against tick bites
Habillement de protection - Vêtements de protection Schutzkleidung - Mit Permethrin behandelte
traités à la perméthrine pour la protection contre les Schutzkleidungsstücke zum Schutz gegen Zeckenbisse
morsures de tiques
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 162.
If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations
which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 17487:2020 E
worldwide for CEN national Members.
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Contents Page
European foreword . 4
Introduction . 5
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 7
4 Performance requirements . 9
4.1 General . 9
4.2 Innocuousness . 10
4.3 Design . 10
4.4 General technical requirements . 10
4.5 Permethrin requirements. 10
4.6 Requirements for biological activity (bio-activity) against ticks . 11
4.7 Mechanical properties considering fabric strength . 11
4.8 Sampling and pre-treatment . 11
4.8.1 Sampling for permethrin content . 11
4.8.2 Sampling for bio-activity . 11
5 Ageing . 11
5.1 General . 11
5.2 Washing and cleaning . 11
6 Marking in garments . 12
7 Information supplied by the manufacturer . 12
Annex A (normative) Performance level . 14
A.1 Requirements for permethrin content in treated fabrics . 14
A.2 Requirements for safeguarding user health . 14
A.3 Bio-activity . 15
Annex B (normative) Laundering for testing purposes. 16
B.1 Washing for preparation of fabrics for testing . 16
B.2 Drying conditions for preparation of fabrics for testing . 16
Annex C (normative) Test for permethrin content in fabric . 17
C.1 Measuring permethrin content before and after 100x laundering . 17
C.2 Test for permethrin homogeneity . 17
Annex D (normative) Bio-activity testing . 19
D.1 Testing activity of the permethrin in the fabric against ticks . 19
Annex E (informative) Rationale . 20
E.1 Why permethrin? . 20
E.2 Why use body covering clothing that is industrially treated with permethrin? . 20
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E.3 Why is standardization need for body covering clothing that is industrially treated
with permethrin? . 21
E.4 What is known about the uptake of permethrin in the bdy and the effects of
permethrin on human health? . 21
E.4.1 General . 21
E.4.2 How does the body absorb permethrin? . 22
E.4.3 Is permethrin a CMR (carcinogenic, mutagenic or reprotoxic) substance? Is it, for
example, carcinogenic?. 22
E.4.4 Can allergic reactions occur? Are any allergic reactions known? . 23
E.4.5 Can other chemicals in the textile be hazardous to health? . 23
E.4.6 Have the health of wearers of the clothing and the possible long-term effects on their
health been studied? . 23
E.4.7 Are there any high-risk groups for permethrin? . 23
E.5 Risks other than permethrin . 24
E.6 Why 100 standardized launderings are required . 24
E.7 How to achieve optimal protection? . 24
E.8 Washing and drying conditions for users of the garments . 24
E.9 Additional remarks on labelling . 25
E.10 Justification of test choices . 25
E.10.1 General . 25
E.10.2 Tests on permethrin content . 25
E.10.3 Tests on bio-activity against ticks . 25
E.10.4 User safety . 26
Annex ZA Annex ZA (informative) Relationship between this European Standard and the
essential requirements of Regulation (EU) 2016/425 aimed to be covered . 27
Bibliography . 29
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European foreword
This document (prEN 17487:2020) has been prepared by Technical Committee CEN/TC 162 “Protective
clothing including hand and arm protection and lifejackets”, the secretariat of which is held by DIN.
This document is currently submitted to the CEN Enquiry.
This document has been prepared under a standardization request given to CEN by the European
Commission and the European Free Trade Association, and supports essential requirements of
Regulation (EU) 2016/425 and Regulation (EU) No 528/2012.
For relationship with EU Regulation, see informative Annex ZA, which is an integral part of this
document.
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Introduction
By preventing tick bites, a range of tick-borne infectious diseases can be prevented. This document
refers to protection against all biting stages of the tick Ixodes ricinus, hereafter named wood tick, the
tick species with the largest occupational and public health relevance in Europe.
The most prevalent disease transmitted by the wood tick is Lyme borreliosis, which can affect the skin,
nervous system, joints and heart. In some EU countries, Lyme borreliosis is regarded as an occupational
disease. Employers are then obliged to make the best possible effort to prevent occupational diseases
among employees. Employees are also obliged to reasonably abide by the measures offered.
The garments help protect people who can come into contact with ticks during their work. Wood ticks
lay in ambush in the lower vegetation and cling on to passers-by with whom they come in to contact.
They then crawl over skin or clothing to find a site where they can consume a blood meal. The
protective effect of the garment against tick bites is primarily determined by the extent to which the
garment covers the skin, and this effect will increase as a larger part of the body is covered. It is
important here that those body parts (legs, waist, torso and arms) are covered that have contact with
vegetation in which ticks can be present (up to a height of 1,5 m). With usual untreated covering
garments, ticks are able to crawl over the fabric for minutes up to several hours and reach bare skin to
bite. In addition to the protective effect of covering the body, the permethrin on or in the fabric offers
extra protection. Ticks that come in contact with permethrin are immobilized, and as a result they are
no longer able to reach bare skin and transfer pathogens through a bite. Protection against tick bites
may be one of the functions of a garment. Examples of other functions may be maintaining body heat,
preventing exposure to UV light, camouflage, preventing skin irritation or injury by plants or working
conditions, or representation and recognizability.
The body covering garment can also help other target groups such as volunteers and recreationists
(such as hunters) to offer protection against tick bites. However, the choice of using the garments is
ideally based on a professional risk assessment which includes exposure to ticks, and factors such as
age and pregnancy. Instructions for use and warnings for tick bite risks also apply to these users and it
is important that these are provided to these groups by manufacturers of these garments.
The body covering garment industrially treated with permethrin can also help to protect against other
arthropods that can transmit diseases, such as different tick and mosquito species [6]. However, this
document only applies to the protection against bites by the wood tick, and specifically the most
relevant developmental stage (nymphs).
Some general statements for the development of the protective clothing according to this document are:
— this document applies to body covering garments (with long trouser legs and/or sleeves) where the
protection against ticks provided by covering the body is reinforced by industrial treatment with
the biocide permethrin;
— the WHO states limits to the daily uptake of permethrin by the human body. This document states
requirements to ensure that these limits will not be exceeded by wearing the protective garment;
— this document states requirements that safeguard the health of the user and at the same time
safeguard that the additional protective effect of the permethrin treatment is maintained as long as
possible during use. These two factors are, with the current state of technology, inseparable, as
permethrin release rate from the garment determines uptake of permethrin by the user;
— the standard formulates requirements that ensure that the health of the wearer will not be
burdened by other agents which are used as additives to, for example, bind permethrin to the fabric
or other as a result of manufacturing processes;
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— the biological activity (bioactivity) against ticks is decisive for the protective effect of the
permethrin-treated garments. Bioactivity is determined by the degree of contact between the tick
and the permethrin (and to lesser extent by the level of the permethrin content);
— the number of standardized launderings that are required to reach the minimal permethrin content
stated in this document may differ from the number of launderings under practical use including
conditions during domestic laundering.
A detailed description of the requirements is given in Clause 4 of this document.
Garments can be treated with permethrin to prevent tick bites. In accordance with the Biocidal
Products Regulation (EU) 528/2012, such garments can be regarded either as ‘treated articles’ (if
protection against ticks is part of a set of functionalities such as protection against weather conditions,
camouflage, company representation, protection against stinging plants etc.) or as ‘biocides’ (if the
primary function of the clothing is protection against tick bites). This document is applicable to
garments that might be considered as biocides and garments that might be considered as treated
articles. If a specific product is regarded as biocide, EU member states could require specific
registration or legislation before the product can be made available on the market.
This document describes requirements and the tests to which clothing that is treated with permethrin
complies in order to provide sufficient assistance in protection against tick bites, and to be durable and
safe for the user. Optimal laundering conditions, which are determinative for a sustainable effect of
permethrin treatment, are also referred to.
The following regulations were observed in composing this document:
— 2016/425 regarding personal protective equipment;
— 528/2012 EU regarding biocidal products regulation.
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1 Scope
This document formulates requirements for garments that support the protection against tick bites. The
document applies to all types of garments where protection against tick bites, which is provided by
garments as physical barriers, is reinforced by industrial treatment with the biocide permethrin prior to
confection
NOTE Untreated garments covering the torso, arms and legs and feet offer some protection against tick bites
but are insufficient under high exposure to ticks, which can crawl over the fabric to reach bare skin and bite.
Garments that comply with this document and cover at least torso, arms and legs counter ticks from crawling over
the fabric to reach bare skin and bite; such garments thereby provide substantial additional protection.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
EN ISO 6330:2012, Textiles — Domestic washing and drying procedures for textile testing
(ISO 6330:2012)
EN ISO 13688:2013, Protective clothing — General requirements (ISO 13688:2013)
EN ISO 13934-1:2013, Textiles — Tensile properties of fabrics — Part 1: Determination of maximum force
and elongation at maximum force using the strip method (ISO 13934-1:2013)
EN ISO 13937-2:2000, Textiles — Tear properties of fabrics — Part 2: Determination of tear force of
trouser-shaped test specimens (Single tear method) (ISO 13937-2:2000)
EN ISO 13935-2:2014, Textiles — Seam tensile properties of fabrics and made-up textile articles — Part 2:
Determination of maximum force to seam rupture using the grab method (ISO 13935-2:2014)
EN 13921:2007, Personal protective equipment — Ergonomic principles
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at http://www.iso.org/obp
3.1
accepted daily intake
ADI
maximal allowed daily body intake of a substance (100%) before adverse health effects can be expected
Note 1 to entry: In this document, the substance is permethrin.
Note 2 to entry: Based on definition of the World Health Organization (WHO).
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3.2
bio-activity
degree to which permethrin in the test fabric affects the test animals that came into contact with the
fabric in the test assay
Note 1 to entry: This value is determined by the degree to which the animal comes into contact with
permethrin.
Note 2 to entry: Bio-activity is not by definition determined by the permethrin concentration in a fabric. It is
determined by the availability of permethrin on contact surfaces of the fabric.
3.3
biocidal product
any substance or mixture which, in the form in which it is supplied to the user, consists of, contains or
generates one or more active substances, with the purpose of destroying, deterring, rendering
harmless, preventing the action of, or otherwise exerting a controlling effect on a harmful organism by
any means other than mere physical or mechanical action
Note 1 to entry: Manufacturers, suppliers and users of biocidal products can find information about the
authorization of biocides to the market, rules for labelling, use and monitoring within the EU on the websites of
ECHA and the European Commission [1].
Note 2 to entry: According to the definitions set by the EU, products treated with permethrin can be considered
as biocidal products or treated articles. This consideration could differ per product and depends on the primary
function of the product. If the product is primarily intended to control harmful organisms or to prevent harmful
effects, then the product is considered a biocide. If the biocidal effect through treatment with permethrin is only
an additional property to the basic function(s) of the product, such product / object can be regarded as treated
article [2].
[SOURCE: 528/2012 EU regarding biocidal products regulation, 2018-06-15]
3.4
cytotoxicity
effect of one or more components in a substance on growth of living cells in a cell culture
3.5
sensitization
effect of one or more components in a substance on expression of specific membrane proteins of cells in
a cell culture
3.6
cut-off value
minimal effective concentration of permethrin per square meter that is required to support protection
against tick bites sufficiently
Note 1 to entry: Concentrations below the cut-off value have adverse effects such as:
— the required contact time between the tick and the fabric is too long, which enables ticks to bite;
— a short immobilisation followed by recovery of the tick;
— insufficiently exposed ticks could show increased bite frequency before taking a blood meal (this was
observed in tick species other than the wood tick).
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3.7
knock-down time
time between first contact of the test animal with the permethrin-treated fabric, until the inability of the
test animal to move (immobilisation)
3.8
permethrin
active ingredient based on synthetic pyrethroïd variant 25:75 cis:trans isomere ratio, non-racemic
Note 1 to entry: Permethrin is EU-registered under the biocide legislation and described by CAS number
52645–53–1.
Note 2 to entry: Permethrin is categorized as products used for the control of arthropods (e.g. insects,
arachnids and crustaceans), by means other than repulsion or attraction in 528/2012 EU [3] (cat. PT18). This
means that it does not have attractant or repellent properties (cat. PT19) to target animals without contact with
the treated fabric.
3.9
permethrin migration rate
velocity of permethrin molecules migrating through a substrate
3.10
biocide treated article
treated article
any substance, mixture or article that has been treated with, or intentionally incorporates, one or more
biocides
[SOURCE: EU 528/2012 regarding biocidal products regulation, Article 3, sub Clause 1.a]
3.11
industrially treated
treatment procedure by which fibres, yarns and /or fabrics are treated during production with
permethrin on a large and mechanised scale before confection
Note 1 to entry: Retreatment of used garments is not included.
Note 2 to entry: A treated article that has a primary biocidal function is considered a biocidal product.
4 Performance requirements
4.1 General
This clause covers the health, technical and maintenance requirements for garments that help to
protect against tick bites, are industrially treated with permethrin and are marketed as a treated article
or biocide.
If the garments are to be placed on the market as a biocide, an authorization procedure could be
required according to the Biocides Regulation.
This document is to be applied in conjunction with EN ISO 13688:2013 and EN 13921:2007 for general
ergonomic principles to be used in designing and specifying personal protective equipment. For general
ergonomic requirements involving design and comfort, EN ISO 13688:2013 (4.3.1, 4.3.2, 4.3.3 and 4.4)
shall be followed.
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4.2 Innocuousness
Protective clothing shall not adversely affect the health or hygiene of the user [source:
EN ISO 13688:2013]. Permethrin per se may in certain concentrations pose a risk to human health.
Several requirements stated in Annex A safeguard the users health and justify the application of
permethrin in protective clothing in accordance with EN ISO 13688:2013 Annex B, Figure B.1 (flow
chart acceptability of materials in protective clothing). If the requirements in these documents are met,
the health benefits of preventing tick-borne disease outweigh potential health risks of for example
minor temporal skin impairments that may occur.
Specific requirements and tests for permethrin incorporated in fibres or fabrics during the industrial
treatment are described in Annex A.
4.3 Design
For general ergonomic requirements involving design and comfort, EN ISO 13688 (4.3.1, 4.3.2, 4.3.3 and
4.4 and Annex C) shall be followed.
Specifically regarding the protective effect of permethrin in preventing ticks to reach bare skin to bite,
the following requirements are formulated:
1) The permethrin-free surface (for example, applications such as reflective striping in accordance
with EN ISO 20471:2013, name badges etc.) shall comprise no more than 12 % of the outer surface
of the garment.
2) The non-treated applications or fabric shall not be placed within 5 cm around the openings of a
garment
3) Trousers shall have long trouser legs, where coverage of underlying skin or other garments at the
openings at the end of the trouser-legs and the waist shall be retained during movement as
described in EN ISO 13688:2013, Annex C.
4) The upper body garment shall have long sleeves. Coverage of the underlying skin or other garment
at sleeve and waist openings shall be retained during movement as described in
EN ISO 13688:2013, Annex C.
4.4 General technical requirements
1) The garment shall be made from materials industrially treated with permethrin.
2) Other treatments, for example to enhance fire resistance or water repellency, can be applied to the
garment treated with permethrin. These applications shall not deteriorate or reduce the protective
effect against ticks beyond the requirements stated in this document.
4.5 Permethrin requirements
1) The active ingredient with biocidal effects on ticks shall be: permethrin (m-phenoxylbenzyl-3-(2,2-
dichloorvinyl)-2-dimethyl-cyclopropanecarboxylate), CAS No. 52645-53-1.
The cis:trans isomere ratio of the permethrin shall be 25:75.
The biocide containing the permethrin needs to be registered according to the EU regulation in one of
the member states.
2) Detailed requirements regarding permethrin content are described in A.1.
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4.6 Requirements for biological activity (bio-activity) against ticks
In order to ensure the additional protect
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