1、PD CEN/TR15917:2009ICS 61.020; 71.100.70; 97.160NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWPUBLISHED DOCUMENTTextiles CosmetotextilesThis Published Documentwas published underthe authority of theStandards Policy andStrategy Committee on 30November 2009. BSI 2009ISBN 978 0
2、580 65117 5Amendments/corrigenda issued since publicationDate CommentsPD CEN/TR 15917:2009National forewordThis Published Document is the UK implementation of CEN/TR15917:2009.The UK participation in its preparation was entrusted to TechnicalCommittee TCI/80, Chemical testing of textiles.A list of o
3、rganizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligati
4、ons.PD CEN/TR 15917:2009TECHNICAL REPORT RAPPORT TECHNIQUE TECHNISCHER BERICHT CEN/TR 15917 September 2009 ICS 61.020; 71.100.70; 97.160 English Version Textiles - Cosmetotextiles Textiles - Cosmtotextiles Textilien - Cosmeto-Textilien This Technical Report was approved by CEN on 3 August 2009. It h
5、as been drawn up by the Technical Committee CEN/TC 248. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway
6、, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form an
7、d by any means reserved worldwide for CEN national Members. Ref. No. CEN/TR 15917:2009: EPD CEN/TR 15917:2009CEN/TR 15917:2009 (E) 2 Contents Page Foreword . 3Introduction . 41 Scope 52 Normative references 53 Terms and definitions . 54 Characteristics . 74.1 General . 74.2 General aspects . 74.2.1
8、Introduction 74.2.2 Recommendations 74.3 Safety evaluation . 84.3.1 Introduction 84.3.2 Risk in relation to the cosmetotextile 84.3.3 Requirements for a cosmetic dossier .114.3.4 Notification of the cosmetic product of cosmetotextiles to national poison centres 124.4 Claimed effects 124.4.1 Introduc
9、tion 124.4.2 Methodology 124.4.3 Examples (non-exhaustive list, without hierarchy in the listed methods) 144.5 Care resistance 164.5.1 Introduction 164.5.2 Methodology 164.5.3 Materials, reagents and apparatus 164.5.4 Calculation .174.5.5 Test report 174.5.6 Examples of extraction and chemical analy
10、ses .174.6 Labelling .174.6.1 Introduction 174.6.2 Product labelling .184.6.3 Marketing labelling requirements 18Annex A (informative) Regulations .19A.1 Cosmetics regulations 19A.2 Textile regulations .19Annex B (informative) Guidelines .20PD CEN/TR 15917:2009CEN/TR 15917:2009 (E) 3 Foreword This d
11、ocument (CEN/TR 15917:2009) has been prepared by Technical Committee CEN/TC 248 “Textiles and texile products”, the secretariat of which is held by BSI. PD CEN/TR 15917:2009CEN/TR 15917:2009 (E) 4 Introduction Recently, new textile products have appeared on the European market. They associate textil
12、e supports and cosmetic products, for example: slimming preparations: pantyhose, underwear, trousers; moisturizing preparations: pantyhose, underwear, T-shirts; refreshing preparations: houselinen (bedsheets.). CEN/TC 248 WG25 has worked on this combination between textiles and cosmetic products. Th
13、is new class of product has been given the name: cosmetotextiles. An indication that the European Commission will treat the cosmetic part of a cosmetotextile analogous to cosmetic products is given in the “Manual of the scope of application of the European Cosmetics Directive 76/768/EEC”. As a conse
14、quence, Article 2 of the European Cosmetics Directive 76/768/EEC gains also central importance for the cosmetic part of cosmetotextiles, stating that a cosmetic product should not cause damage to human health. European Cosmetics Directive 76/768/EEC, Article 2 states: “A cosmetic product put on the
15、market within the Community must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use, taking account, in particular, of the products presentation, its labelling, any instructions for its use and disposal as well as any other indication or informatio
16、n provided by the manufacturer or his authorized agent or by any other person responsible for placing the product on the Community market”. Cosmetic products are regulated within the European Cosmetics Directive (76/768/EEC) at present in accordance with the 7thamendment. Although the complete cosme
17、totextile product does not need to conform to the directive, the cosmetic products of a cosmetotextile will need to fulfil the terms of the European Cosmetics Directive if they are to be marketed in Europe. PD CEN/TR 15917:2009CEN/TR 15917:2009 (E) 5 1 Scope This Technical report specifies general c
18、haracteristics of cosmetotextiles and describes their recommended properties. Five parts have been established as follows: general aspects; safety evaluation; claimed effects; care resistance; labelling. These five characteristics are developed in Clause 4. 2 Normative references The following refer
19、enced documents are indispensable for the application 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. prEN ISO 3175-1, Textiles - Dry-cleaning and finishing - Part 1: Met
20、hod for assessing the cleanability of textiles and garments (ISO 3175-1:1998) EN ISO 3758, Textiles - Care labelling code using symbols (ISO 3758:2005) EN ISO 6330, Textiles - Domestic washing and drying procedures for textile testing (ISO 6330:2000) EN ISO 22716, Cosmetics - Good Manufacturing Prac
21、tices (GMP) - Guidelines on Good Manufacturing Practices (ISO 22716:2007) 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 textile flexible material comprising a network of natural, man-made fibres often referred to as yarn NOTE Yarn is produc
22、ed by spinning raw wool fibres, linen, cotton, or other material on a spinning machine. Textile fabrics are formed by weaving, knitting, or non-woven processes. 3.2 cosmetic product substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis
23、, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively, or mainly, to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition
24、”. In accordance with article 1 of the European Cosmetics Directive 76/768/EEC PD CEN/TR 15917:2009CEN/TR 15917:2009 (E) 6 3.3 cosmetotextile textile consumer article containing a durable cosmetic product which is released over time NOTE Disposable products (e.g. wipes) are not considered as cosmeto
25、textiles. 3.4 binder material used to bind together two or more other materials (for example textiles and microcapsules). Its two principal properties are adhesion and cohesion 3.5 microcapsule small particle with a wall that contains the cosmetic product. Most microcapsules have diameters of a few
26、micrometers 3.6 cosmetic effects effects that are in line with the general definition of a cosmetic product as mentioned in the European Cosmetics Directive (76/768/EEC) 3.7 cosmetic claim information, made available to the consumer and/or market, on the contents (properties, effects, etc.) of the c
27、osmetic product or its constituents as well as the cosmetotextile NOTE See also Guidelines for the Evaluation of the Efficacy of Cosmetic Products, COLIPA, Annex B. 3.8 claim substantiation process of proving the effects claimed to be generated by the cosmetotextile, e.g. via a scientifically sound
28、method, published data or consumer testing NOTE This is obligatory in accordance with various laws including the European Cosmetics Directive (76/768/EEC). 3.9 care resistance cosmetotextile property which characterizes the quantity of the cosmetic product remaining after a given number of care cycl
29、es NOTE “Care resistance“ should not be confused with “durability of the cosmetic effect“. 3.10 durability of the cosmetic effect number of care and use cycles during which this (these) effect(s) can be measured and/or noticed by the user NOTE 1 This information is relevant for marketing claims. It
30、should not be confused with the date of minimum durability of the cosmetic product (shelf life) which in accordance with the European Cosmetics Directive should be indicated by the words: “best used before the end of ”. NOTE 2 “Durability of the cosmetic effect“ should not be confused with “care res
31、istance“. 3.11 claimed effect ability of a cosmetotextile to produce the cosmetic effect claimed when using that specific cosmetotextile PD CEN/TR 15917:2009CEN/TR 15917:2009 (E) 7 3.12 product label label permanently attached to or printed onto a cosmetotextile 3.13 marketing label or hand tag labe
32、l which is not permanently attached to or printed onto a cosmetotextile 4 Characteristics 4.1 General Five characteristics are developed below: general aspects, safety evaluation, claimed effects, care resistances and labelling. 4.2 General aspects 4.2.1 Introduction A cosmetotextile is a product wh
33、ich combines a cosmetic product and a textile (with or without a binder). This cosmetic product may be contained in a microcapsule for example. The cosmetic product used in a cosmetotextile shall conform to European Cosmetics regulations. One condition for a substance or preparation to be a cosmetic
34、 is that it is intended to be released to the body. The present technical report focuses on some parts of the European Cosmetics Directive 76/768/EEC which apply mainly to the cosmetotextile. The textile of the cosmetotextile is only a “vehicle” to deliver a cosmetic product on different superficial
35、 parts of the human body. This textile should not be considered to be a cosmetic product. Substances which are part of the textile (dyestuffs, textile auxiliaries, binders, microcapsules) are not intended to be released to the body, and are therefore not considered to be cosmetic products. A textile
36、 with those substances, which are part of the textile, falls within the scope of application of European Textile regulations. Textiles which claim external biocide activity are excluded. They fall within the scope of the European Biocidal Products Directive 98/8/EC. 4.2.2 Recommendations 4.2.2.1 Gen
37、eral NOTE Special care should be given to the following points. 4.2.2.2 Quality control concerning textiles The quality of the textile should be well controlled. The following Table 1 proposes some suggestions: PD CEN/TR 15917:2009CEN/TR 15917:2009 (E) 8 Table 1 Quality control concerning textiles C
38、riteria Standard Colour fastness to water EN ISO 105-E01 Colour fastness to rubbing EN ISO 105-X12 Colour fastness to perspiration EN ISO 105-E04 Depending on care specifications: Colour fastness to domestic and commercial laundering EN ISO 105-C06 Colour fastness to dry cleaning EN ISO 105-D01 4.2.
39、2.3 Good manufacturing practices for cosmetotextiles (GMP) As far as the textile industry is concerned, cosmetotextiles should conform as closely as possible to the standard EN ISO 22716 relative to GMP for the cosmetic products. The requirements for cosmetotextiles are based on the main textile ref
40、erence frames used in the textile industry, such as European Ecolabel for textiles or other private labels. 4.3 Safety evaluation 4.3.1 Introduction A cosmetotextile placed on the European market is deemed to be in accordance with the General Product Safety Directive 2001/95/EC. The safety of a cosm
41、etic product placed on the market within the EU is, in accordance with the European Cosmetics Directive 76/768/EEC, the full responsibility of the manufacturer, the first importer into the EU market or the marketer. Information relating to the ingredients and undesirable effects should be made easil
42、y accessible to the public, (this is in accordance with article 7a (1) of the European Cosmetics Directive 76/768/EEC). 4.3.2 Risk in relation to the cosmetotextile 4.3.2.1 General The cosmetic product of a cosmetotextile usually consists of a complex composition of different ingredients. A toxicolo
43、gical profile is necessary for each ingredient. An overall toxicological evaluation for the cosmetic product is developed on the basis of these profiles. In accordance with the SCCP (Scientific Committee on Consumer Products) notes of guidance (see Annex B); a safety evaluation of a cosmetic product
44、 comprises the following steps: a) a hazard identification for all ingredients; b) a dose response assessment; c) an exposure assessment; PD CEN/TR 15917:2009CEN/TR 15917:2009 (E) 9 d) a risk characterization. The safety of binders and microcapsules, shell materials as well as other auxiliaries whic
45、h are generally used in the manufacture of cosmetotextiles should also be subjected to a risk assessment. The textile base fabrics used for cosmetotextiles should carry no substance at levels that are of toxicological concern. 4.3.2.2 Hazard identification for ingredients The hazard identification o
46、f the cosmetic ingredients is outlined in detail in the relevant SCCP notes of guidance (see annex B): “Based on the results of in vivo tests, in vitro tests, clinical studies, accidents, human epidemiological studies and, when available, Quantitative Structure Activity Relationship (QSAR) studies.
47、The intrinsic physical, chemical and toxicological properties of the molecule under consideration are studied to identify whether the substance has the potential to damage human health”. Within the toxicological evaluation process of chemical substances, several toxicological parameters and methods
48、are described. However, due to the application route of cosmetotextiles comparable to “leave-on” cosmetics (e.g. body lotion), the SCCP suggest, that as a minimum, the evaluation of a selected number of toxicological endpoints, described in the following. Acute toxicity The term “acute toxicity“ is
49、used to describe the adverse effects on health which may result from a single exposure to a substance via the oral, dermal or inhalation route. For acute oral or dermal toxicity testing, which are relevant in this context, the reader may be referred to the relevant SCCP notes of guidance (see Annex B). Skin irritation or dermal irritation Skin irritation or dermal irritation is defined as reversible damage of the skin following the app
