schadstoffinfo

Regulations on Harmful Substances in Textiles and Leather Products

Version: 01/2013

TV Rheinland LGA Products GmbH TV Rheinland Group Am Grauen Stein 29 D-51105 Kln

Tel. 0800 5888-770 Fax 0800 5888-807 [email protected] www.tuv.com

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Table of contents

Table of contents ..................................................................................................................................................2 1. Prohibited azo dyes ......................................................................................................................................4

1.1 Penologic consequences .................................................................................................................6 1.2 Test methods....................................................................................................................................6 1.3 Sources of / reasons for contaminations ..........................................................................................7 1.4 Critical components ..........................................................................................................................7 1.5 Health risks .......................................................................................................................................7 1.6 Regulations on prohibited azo dyes .................................................................................................7

2 Allergenic disperse dyes and carcinogenic dyes ..........................................................................................8 2.1 Critical components ..........................................................................................................................9 2.2 Regulation on allergenic disperse dyes and carcinogenic dyes ......................................................9

3 Pentachlorophenol (PCP) .......................................................................................................................... 11 3.1 Test methods................................................................................................................................. 11 3.2 Sources of / reasons for contamination ........................................................................................ 11 3.3 Critical components ....................................................................................................................... 11 3.4 Health risks .................................................................................................................................... 12 3.5 Regulations in other countries on PCP in products (exemplarily) ................................................. 12

4 Trichlorphenols(TriCP) and Tetrachlorphenols (TeCP) ............................................................................. 13 4.1 Regulations for TriCP and TeCP.................................................................................................. 13

5 Formaldehyde ............................................................................................................................................ 14 5.1 Test methods................................................................................................................................. 14 5.2 Sources of / reasons for contaminations ....................................................................................... 14 5.3 Critical components ....................................................................................................................... 14 5.4 Health risks .................................................................................................................................... 14 5.5 Regulations on formaldehyde ....................................................................................................... 15

6 Flame retardant substances ...................................................................................................................... 16 6.1 Regulations on flame retardents ................................................................................................... 17

7 Phthalates .................................................................................................................................................. 18 7.1 Critical components ....................................................................................................................... 20 7.2 Health risks .................................................................................................................................... 20 7.3 Regulations on phthalates ............................................................................................................. 21

8 Nickel in metallic components.................................................................................................................... 22 8.1 Test methods for nickel ................................................................................................................. 23 8.2 Health risks .................................................................................................................................... 24 1.3 Regulations on nickel .................................................................................................................... 24

9 Cadmium and its compounds .................................................................................................................... 25 9.1 Testing ........................................................................................................................................... 26 9.2 Sources of / reasons for contamination ........................................................................................ 26 9.3 Critical components ....................................................................................................................... 26 9.4 Health risks .................................................................................................................................... 26 9.5 Regulations on cadmium ............................................................................................................... 27

10 Lead ........................................................................................................................................................... 28 10.1 Critical components ....................................................................................................................... 28 10.2 Health risks .................................................................................................................................... 28 10.3 Regulations on lead ...................................................................................................................... 28

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11 Chromium (VI) compounds ........................................................................................................................ 29 11.1 Sources of / reasons for contamination ........................................................................................ 29 11.2 Critical components ....................................................................................................................... 29 11.3 Health Risks .................................................................................................................................. 29 11.4 Regulations on chromium (VI) ....................................................................................................... 30

12 Heavy metals, soluble ................................................................................................................................ 31 12.1 Regulations on soluble heavy metals in products ......................................................................... 31

13 TBT and other organotin compounds ........................................................................................................ 32 13.1 Health risks .................................................................................................................................... 33 13.2 Critical components ....................................................................................................................... 33 13.3 Regulations on organotin compounds .......................................................................................... 34

14 PAH Polycyclic aromatic hydrocarbons in rubber and plastic products ................................................. 35 14.1 Health risks .................................................................................................................................... 36 14.2 Regulations on PAH ...................................................................................................................... 37

15 NP, NPEs, OP and OPEO ......................................................................................................................... 39 15.1 Health risks .................................................................................................................................... 39 15.2 Regulations on NPEO and OPEO ................................................................................................ 40

16 Perfluorooctanesulfonic acid (PFOS) ........................................................................................................ 41 16.1 Health risks .................................................................................................................................... 41 16.2 Regulations on PFOS ................................................................................................................... 41

17 Dimethylfumarate (DMFU) ......................................................................................................................... 42 17.1 Health Risks .................................................................................................................................. 42 17.2 Regulations on Dimethylfumarate ................................................................................................. 42

18 Short-chained chlorinated paraffins ........................................................................................................... 43 18.1 Health risks .................................................................................................................................... 43 18.2 Regulations on short-chained chlorinated paraffins ...................................................................... 43

19 Food law regulations .................................................................................................................................. 44 20 Implementation of sampling, analysis, physical checks and inspections .................................................. 46 21 Disclaimer .................................................................................................................................................. 46

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1. Prohibited azo dyes

Azo dyes are synthetic dyes with a specific chemical composition and form the largest dyestuff class. Char-acteristic are the so called azo bridges (nitrogen double bonds). Azo dyes are used worldwide for colouring of textiles, leather, wax, straw, wood, paper and other things.

Some of these azo dyes can release toxic or carcinogenic amines and their use is therefore prohibited in Germany and other countries.

In Regulation (EC) 1907/2006 (so called REACh regulation), Annex XVII since June 1, 2009 (according to the amending Regulation (EC) No 552/2009 of 22 June 2009) restrictions on certain substances are regu-lated. Thus, the policy has been repealed and replaced 76/796/EWG and 2002/61/EC.

Under point 43 the restrictions on azo dyes are listed:

Azo dyes which by reductive separation of one or more azo groups, could release one or more aromatic amines (see page 4, table 1) in the finished product or in dyed parts of the finished product, are not allowed to be used

The limit for the detectable concentrations of the individual amines (tested according to the official test methods DIN EN 14362-1:2012-04 and DIN EN 14362-3:2010-05 for textiles and DIN EN ISO 17234-1:2010-06 and DIN EN ISO 17234-2:2011-06 - for leather) is 30 ppm per amine. Textiles with levels of> 30 ppm (mg / kg) publicly listed amine may not be used.

The EU-wide regulation applies to all products made of textiles and leather, which come into direct contact with the skin or the oral cavity for a prolonged period of time, but not those made of any other materials.

Affected are articles such as:

Clothing, bed sheets, towels, hairpieces, wigs, hats, diapers and other toiletries, sleeping bags

Shoes, gloves, watch straps, handbags, purses and wallets, brief cases, chair covers, money bags worn around the neck pouches

Textile and leather toys and also toys with textile or leather clothing

Yarns and fabrics for consumer use

The said textile and leather articles may not be placed on the market if they do not meet the requirements.

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Table 1: List of regulated aromatic amines

No. CAS-No. Substance name No. CAS-No. Substance name

1 92-67-1 Biphenyl-4-ylamine 4-Aminobiphenyl xenylamin

12 119-93-7 3,3-Dimethylbenzidine 4,4-Bi-o-toluidine

2 92-87-5 Benzidine 13 838-88-0 4,4-Methylendi-o-toluidine

3 95-69-2 4-Chlor-o-toluidine 14 120-71-8 6-Methoxy-m-toluidine

p-Cresidine

4 91-59-8 2-Naphthylamine 15 101-14-4 4,4-Methylen-bis-(2-chloraniline) 2,2-Dichlor-4,4-methylendianiline

5 97-56-3 o-Aminoazotoluene 4-Amino-23-dimethylazobenzene 4-o-Tolylazo-o-toluidine

16 101-80-4 4,4-Oxydianiline

6 99-55-8 5-Nitro-o-toluidine/2-Amino-4-nitrotoluene 17 139-65-1 4,4-Thiodianiline

7 106-47-8 4-Chloraniline 18 95-53-4 o-Toluidine 2-Aminotoluene

8 615-05-4 4-Methoxy-m-phenylandiamine 2,4-Diaminoanisole 19 95-80-7 4-Methyl-m-phenylendiamine 2,4-Toluylendiamine

9 101-77-9 4,4-Methylendianiline 4,4-Diaminodiphenylmethane 20 137-17-7 2,4,5-Trimethylaniline

10 91-94-1 3,3-Dichlorbenzidine

3,3-Dichlorbiphenyl-4,4-ylendiaminen

21 90-04-0 o-Anisidine

2-Methoxyaniline

11 119-90-4 3,3-Dimethoxybenzidine o-Dianisidine 22 60-09-3 4-Amino-azobenzene

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1.1 Penologic consequences

Offences against the aforementioned ordinance do not simply count as violations, but are rather handled as criminal offences that may result in severe criminal penalties.

Deliberate production and treatment of clothes with prohibited azo dyes can lead to sentences of up to three years imprisonment or fines. In case of negligence the penalty can be up to one year of imprison-ment or a fine in accordance with 58 Paragraph 1 No. 14. LFGB.

Deliberately circulating clothes containing prohibited azo dyes can lead to sentences of up to three years imprisonment or fines. In the case of negligence the penalty can be up to one year of imprisonment or fines in accordance with 58 Paragraph 1 No. 14. LFGB.

If a positive test result is established by a monitoring authority, the accused can only claim no negligence if he/she can prove that he/she has taken all the appropriate precautions.

Documented properly the following measures may serve this purpose:

Inclusion of the requirements of the Commodities Ordinance in the purchase conditions

Declaration from the primary suppliers that the goods do not contain prohibited azo dyes

Proof in the form of test reports from accredited test institutes

Product control during production and/or before shipping by internal or external inspectors

Analysis of pre-production samples

Analysis of randomly sampled specimen of the merchandise delivered.

1.2 Test methods

With the new edition of the standard DIN EN 14362-1: 2012-04 part 2 has now been incorporated in part 1. Part 3, which concerns the determination of 4-aminoazobenzene, has been revised in 2012 too.

The process applies for all coloured fabrics (e.g. dyed, printed and coated)

4-Aminoazobenzene: Azo dyes, which can form 4-aminoazobenzene, produce under the analytical condi-tions in accordance with DIN EN 14362-1: 2012-04 the substances p-phenylenediamine and aniline. If these substances are detected an additional test is necessary for 4-aminoazobenzene which is carried out according to DIN EN 14362-3: 2012-09.

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1.3 Sources of / reasons for contaminations

Dyes become mixed up when dyeing or at the tanners

Products become mixed up with those, that were not produced for the German or European market

Contamination during the change of dyes

Technical contamination of the dyes or contamination during nuancing with dyes containing prohibited azo dyes

Use of prohibited azo dyes in applications, pockets linings, cords, waist- bands, etc.

1.4 Critical components

Applications, linings, seam-bands, sewing threads etc.

Very colourful fashion articles that are produced in small numbers per colour-setting: e.g. headscarves, scarves, t-shirts

Carnival Clothing

Leather and furs, especially of black and red colour

Polyester and Cotton materials, prints

1.5 Health risks

Azo dyes containing releasable carcinogenic arylamines have a carcinogenic potential. The human body is able to reductively breakdown the absorbed azo dyes at the azo bridge into precursors. This can be done for example by intestinal bacteria or azo reductases in the liver.

1.6 Regulations on prohibited azo dyes

Table 2: Regulations on prohibited amines from azo dyes

Country Legal Regulation Limit value

EU Regulation (EG) 1907/2006, Annex XVII 30 mg/kg

Switzerland Adoption of the EU regulation 30 mg/kg

Turkey Prohibition of the 22 amines in accordance with the EU Directive and additionally prohibit the use of specific dyes that are individually listed

30 mg/kg

China

Chinese Standard GB 18401:2010 20 mg/kg

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2 Allergenic disperse dyes and carcinogenic dyes

In 1940 the first nylon stockings were sold in the USA. Soon afterwards the first cases of contact derma-titis were reported. Due to the correlation of women wearing the new stockings and the dermatitis, the skin reactions were incorrectly termed "nylon allergy".

However more detailed examinations indicated that these skin reactions were caused by the dyes and not by the nylon material itself. Today, the sensitizing effect of certain disperse dyes has been documented unequivocally by numerous findings recorded by skin specialists and clinical studies.

Due to the sensitizing potential, the Working Group Textiles at the Federal Institute for Risk Evaluation (Bundesinstitut fr Risikobewertung, BfR) demands total abdication of the following eight dyes in textiles that come into contact with the skin.

Table 3: List of dyes that should be avoided according to the BfR -Recommendations

Chemically it concerns two anthraquinone dyes (DB 1, DB 35), or for azo dyes (DB 106, DB 124, DG 3, DO 3, DO 37, DR 1).

For manufacturers and retailers we strongly recommended this requirement to which a broad consensus says it has to be incorporated into the conditions of purchase.

Despite these warnings, lab results from the last few years show that allergenic/sensitizing disperse dyes are still used in carnival articles, gloves, jackets and shoes. Most frequently the dye Disperse Orange 37/76 with content of 10 - 120 mg/kg was found in black synthetic materials.

The results were partially published in the media, with negative consequences for the image of the compa-ny and products.

30 Food and Feed Code (LFGB).

So far there are no specific legal regulations for allergenic/sensitizing disperse dyes in clothing. Neverthe-less, clothing on the market containing these dyes have been criticized by state surveillance authorities on the basis of 30 Food and Feed Code (LFGB).

Disperse dye CAS-No. Disperse dye CAS-No.

Disperse blue 1 569-61-9 Disperse yellow 3 2832-40-8

Disperse blue 35 56524-77-7 56524-76-7 Disperse orange 3 2581-69-3

Disperse blue 106 12223-01-7 Disperse orange 37/76 13301-61-6

Disperse blue 124 61951-51-7 Disperse red 1 2872-52-8

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The 30 LFGB states that it prohibits the manufacturing or the marketing that are suitable for intended or foreseeable use that damage health from their material composition, in particular by toxic substances or impurities.

Similar, basic rules exist in many countries.

Besides these 8 BfR named allergenic disperse dyes large trading houses ban in its Restricted Substances Lists also further dyes with allergenic and carcinogenic potential.


Due to the use of disperse dyes to colour textiles made of polyester and polyamide, problems have been encountered repeatedly with the following articles:

Carnival Articles (hats, clothing)

Linings

Trimmings such as Velcro, hatbands, woven ribbon, piping

2.2 Regulation on allergenic disperse dyes and carcinogenic dyes

Table 4: Regulations on allergenic disperse dyes and carcinogenic dyes


Germany No special prohibition of the substances, Complaints based on 30 LFGB

5 mg/l (extract) for 8 disperse dyes BfR-recommendations

Voluntary TOXPROOF criteria for tex-tiles and clothing (TV Rhein-land) 05/2010

5 mg/l (75 mg/l) (for the dyes in the following table, except the "requested further pro-hibited dyes" (indirectly included via 4-aminoazobenzene)

Voluntary kotex standard 100

50 mg/kg (approx. 3,5 mg/l) (all colours mentioned in the table below)

Note: The use of disperse dyes is detected, when a dye content of more than 5 mg/l (extract) can be deter-mined with a defined specific test method.

The test is performed according to DIN 54231: 2004-05

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Table 5: Categorization of carcinogenic and allergenic dyes

Allergenic Disperse dyes

Allergenic and carcinogenic dyes Carcinogenic dyes

Other prohibited dyes (p-Aminoazobenzene-

releasers, see forbidden Azo dyes

Disperse blue 3 Disperse blue 1 Acid red 26 Disperse yellow 23 Disperse blue 7 Disperse yellow 3 Basic red 9 Disperse orange 149 Disperse blue 26

Basic violet 14

Disperse blue 35

Direct black 38

Disperse blue 102

Direct blue 6

Disperse blue 106

Direct red 28

Disperse blue 124

Disperse orange 11

Disperse brown 1

Disperse orange 1

Disperse orange 3

Disperse orange 37/76

Disperse red 1

Disperse red 11

Disperse red 17

Disperse yellow 1

Disperse yellow 9

Disperse yellow 39

Disperse yellow 49

Bold: Dyes with sensitizing potential, which should no longer be used in clothing fabrics. (Introduction into the problems of clothing fabrics, Release No. 018/2007 from BfR on the 1 June 2007)

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3 Pentachlorophenol (PCP)

According to paragraph 15 of the Annex to 1 of the Ordinance on Banned Chemicals from the 13/06/2003 it is prohibited to put products with a PCP content of more than 5 mg/kg into circulation. This prohibition does therefore not only apply to textiles, leather articles, individual parts and components of textiles and leather articles and other commodities but also to all products traded on the market.

Furthermore throughout the EU, the Regulation (EG) 1907/2006 (the so called REACH Regulation, Annex XVII) still applies. Under section 22 the restrictions of PCP in substances and preparations are listed:

Section 22: PCP and its salts and esters

1. Shall not be used in a concentration equal to or greater than 0,1 % by mass (=1000 mg/kg, Authors note) in substances or prepa-rations placed on the market.

This regulation applies to any products, but shows clearly that PCP should not already be contained in substances and preparations that are used for manufacturing.

3.1 Test methods

For the detection of pentachlorophenol (PCP) the following test method is used:

LFGB B 82.02-8:2001-06 Analysis of commodity goods Detection and determination of pentachlorophe-nol in consumer articles, in particular from leather and textiles.

3.2 Sources of / reasons for contamination

PCP was used in the 1960s and the 1970s as a wood preservative. Although since 1989 the use of PCP has been prohibited. It can however be used for the treatment of textiles, leather and paper products such as:

Impregnation of textiles and leather

Used for storage/transport preservation against mould

Contamination of large batches of leather by single highly contaminated Wet Blues (wet chromium tanned leathers)

Preservation/transport preservation, also of upstream products, such as cotton, colour pastes (espe-cially for silk), wood, paper, cardboard, etc.


Leather fibres in shoes, e.g. front and heel caps

Simple leathers, e.g. work gloves, decorative bands, accessories

Printed silk scarves and blouses made of synthetic fibres

Latex coating

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3.4 Health risks

Pentachlorophenol is classified as carcinogenic (category 2 of MAK values list). Therefore it should be strictly minimised.

3.5 Regulations in other countries on PCP in products (exemplarily)

Table 6: PCP regulations


Germany Chemicals Act , Article 15, Annex to 1, dated 13.06.2003 Valid for all products and materials

5 mg/kg Voluntary limit TOXPROOF: 0.5 mg/kg 0.05mg/kg (baby products)

Austria

Ordinance of February 7, 1991 on the Prohibition of Pentachlorophenol (PCP), Federal Law Gazette No 58/1991. The regulation corresponds more or less with the German ordinance.

5 mg/kg

Denmark Statutory Order No. 420, April 1996 on limiting the sale and use of PCP 5 mg/kg

Netherlands Commodity goods act on pentachlorophenol, Sep-tember 1997 5 mg/kg

Norway Regulation relating to restrictions on the manufac-ture, import, export, sale and use of chemicals and other products hazardous to health and the envi-ronment

5 mg/kg

Poland Regulation on safety and textile marking; 2001 PCP shall not be used for certain products.

Switzerland Chemical Risk Reduction Ordinance, ChemRRV, last changed on the 10/12/2010.

PCP and TECP may not be used. Limit value for pieces of wood: 5 mg/kg PCP

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4 Trichlorphenols(TriCP) and Tetrachlorphenols (TeCP)

Trichlorphenols are classified as dangerous and harmful to the environment. It can for example be used as a degradation product from pentachlorinated fungicides.

Tetrachlorphenols may arise as an impurity in technical pentachlorophenol. They are classified as toxic.

4.1 Regulations for TriCP and TeCP

Table 7: TriCP and TeCP regulations


Germany No legal limit

Voluntary limit TOXPROOF: 0.5 mg/kg 0.05mg/kg (baby products)

Switzerland Chemical Risk Reduction Ordinance, ChemRRV, last changed on the 10/12/2010. TeCP must not be used

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5 Formaldehyde

According to Annex 9 (referring to 10 Paragraph 3) of the Commodity Ordinance from 1998 (last revised 13.12.2011) textiles containing more than 0.15 per cent (=1500 mg/kg) of free formaldehyde, which when used as intended will come into contact with the skin, must be marked with the following lab: "Contains formaldehyde; to avoid sensitive or allergic skin reactions, it is recommended that the garment should be washed before first wear").

5.1 Test methods

According to the TOXPROOF criteria (05/2010) from TV Rheinland for textiles, as well as delivery condi-tions for the trading companies, a limit has been set for formaldehyde of 300 mg/kg for outerwear, 75 mg/kg for clothing with direct skin contact and 20 mg/kg for baby clothing (test method DIN EN ISO 14181-1: 2011-12). For leather products the SG criteria (schadstoffgeprft = tested for harmful substances) require 150 mg/kg and 50 mg/kg for toddlers and infants (Textile: 64 LFGB, B 82.02-1: 1985-06 / leather: DIN EN ISO 17226-1: 2008-08, or DIN EN ISO 17226-2: 2009-09)

5.2 Sources of / reasons for contaminations

Preservatives e.g. for colourants, adhesives and other auxiliaries

Reaction components in resins, for example for nonwovens or equipment such as cotton, wood/paper fibre materials

Tanning additives


Baby clothing with coloured pigment prints, particularly in combination with binders, that contain formal-dehyde as preservative or binders (frequently exceed the limits of 20 mg/kg)

Textiles with special finishes like iron-free, or wrinkle-free, e.g. mens shirts

Fibre materials in stabilizing components e.g. nonwoven inserts, insoles

5.4 Health risks

Formaldehyde is a colourless, pungent smelling gas that is found very often in nature and is also used very often in the industry.

The harmful effect of Formaldehyde depends on its concentration. An incorrect use of Formaldehyde may cause allergies and skin, eye and respiratory irritations. Formaldehyde may also have carcinogenic effects. Construction products show the highest risk of harmful exposure, whereas textiles show nearly no harmful potential.

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5.5 Regulations on formaldehyde

Table 8: Regulations on formaldehyde in products


Germany

Commodity Ordinance Appendix 9 to 10 paragraph 3, serial No.2

From 1500 mg / (0.15%) labelling is required

Voluntary limit TOXPROOF: 300 mg / kg - tops, 75 mg / kg - clothing with direct skin contact and 20 mg / kg - Baby Clothing

Austria Formaldehyde regulations from 1990 from 1500 mg/kg (0,15%) labelling required

Finland Decree on maximum amounts of formalde-hyde in certain textile products (210/1988) Textiles for children under 2 years: 30 mg / kg, direct skin contact textiles and toys: 100 mg / kg without direct skin contact, also car-pets or home textiles: 300 mg / kg

Lithuania Lithuanian hygiene standard, H96:200 Baby clothes: 20 mg/kg Textiles with direct skin contact: 75 mg/kg, without direct skin contact: 300 mg/kg

Netherlands 178 Besluit van 22 maart 2001, houdende vaststelling van het Warenwetbesluit formaldehyde in textiel

Textiles with direct skin contact: 120 mg/kg, with levels higher than 120 mg/kg must be labelled levels higher than 120 mg / kg is to ensure that after the first wash, a value of 120 mg / kg is achieved

Norway

Regulations relating to restrictions on the manufacture import, export, sale and use of chemicals and other products, hazardous to health and the environment (product regulations)

Textiles for children under 2 years: 30 mg/kg Textiles with direct skin contact: 100 mg/kg Textiles without direct skin contact: 300 mg/kg

Poland Regulation on safety and textile marking

Products for children under 3 years: 20 mg/kg Products with direct skin contact: 150 mg/kg Products without direct skin contact: 300 mg/kg Decorative products such as wall coverings and eg. Tablecloths: 500 mg/kg

China National standard for textile products GB 18401-2010 national general safety tech-nical code for textile products

Limit values: Children 20 mg/kg Direct skin contact: 75 mg/kg No direct skin contact / home textiles: 300 mg/kg

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6 Flame retardant substances

In commodity goods*, in the sense of the Food and Feed Code (Lebensmittel- und Futtermittelgesetzbuch, LFGB), that have been manufactured using textiles (except for protective clothing, as well as for correspond-ingly manufactured plush toys and dolls), the following flame retardant substances TRIS, TEPA and PBB are prohibited (Commodities Ordinance, Annex 1 (to 3)). The prohibition is also regulated under the Regula-tion (EG) 1907/2006 throughout the EU.

These flame retardants are considered to be hazardous to your health and have been banned for use in clothing for the last 20 years.

According to Regulation (EC) 1907/2006 (so called REACH regulation) Annex XVII, products or parts of products which contain pentabromdiphenyl ether (pentaBDE) or octabromodiphenyl ether (OctaBDE) with a content of more than 0,1%, may not be placed on the market. As according to the European Directive 2003/11/EC.

PentaBDE and OctaBDE belong to the group PDBE (polybrominated diphenyl ethers), which are extremely resistant to any environmental degradation. As a result they accumulate in the food chain which then enters the human body. With the limitations on the regulations the risk to the environment posed by these sub-stances should be curbed and a preventive protection for nursed infants.

Textiles are normally not equipped with flame retardants, they will be only if this is desired or in certain cases prescribed for the intended use.

Critical components:

Articles equipped with flame retardants and components (if necessary).e.g.:

Soft toys Decorative textiles Home textiles

* Food and feed code (LFGB) (excerpt) - article 2 definitions

(6) Commodities are 1. Materials and articles referred to in Article 1, paragraph 2 of Regulation (EG) Nr. 1935/2004 of the European Parliament and Council

from 27th October 2004 on materials and articles that are intended to come in contact with food, 2. Packaging, containers or other wrappings that are intended to come into contact with cosmetics, 3. Articles which are intended to come into contact with the mucous membranes of the mouth, 4. Articles which are intended for personal care, 5. Toys and Novelties 6. Articles which are intended to, not only temporarily, come into contact with the human body such as articles of clothing,

bedding, masks, wigs, hair pieces, false eyelashes, bracelets, 7. Cleaning and maintenance products for domestic use or for commodities determined within the meaning of paragraph 1 8. Impregnation and other finishing agents which are used for articles defined in number 6, that are intended for domestic use, 9. Materials and objects that are used for improving the odour in rooms which are intended for human occupancy.

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6.1 Regulations on flame retardants

Table 9: Regulations on flame retardants

Country Legal regulation Description Limit value

Germany Commodities Regu-lation

Tri-(2,3-dibrompropyl)-phosphate (TRIS) (CAS.Nr. 126-72-7) Tris-(aziridinyl)-phosphine oxide (TEPA) (CAS.Nr. 5455-55-1) Polybromierted Biphenyle (PBB) (CAS.Nr. 59536-65-1)

Not used

EU Regulation (EC) 1907/2006 Annex XVII

Point 4:

Tri-(2,3-dibrompropyl)-phosphate (TRIS) Point 7

Tris-(aziridinyl)-phosphine oxid (TEPA) Punkt 8:

Polybromierted Biphenyle (PBB)

Must not be used in textile articles which are intended to come into contact with the skin such as clothing, knitted or crocheted and laundry.

Point 44:

Pentabromdiphenyle ether (PentaBDE) (CAS.Nr. 32534-81-9) Octabromdiphenyle ether (OctaBDE) (CAS.Nr. 32536-52-0)

0,1 %

(= 1000 mg/kg) In products or parts of products.

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7 Phthalates

Phthalic acid ester or phthalates are plasticizers that are used in plastics industrially on a large scale.

The REACH Regulation Regulation (EC) 1907/2006 (so called REACH regulation), Annex XVII, point 51 and 52 restricts certain phthalates in toys and childcare articles.

The content is summarized in Table 10.

Table 10: Regulations on plasticizers (Phthalates) in products

The following phthalates (or other CAS- and EINECS numbers covering the substance):

Di(2-ethylhexyl)phthalate (DEHP)CAS-Nr. 117-81-7 EINECS-Nr. 204-211-0 Dibutyl phthalate (DBP) CAS-Nr. 84-74-2 EINECS-Nr. 201-557-4 Benzyl butyl phthalate (BBP) CAS-Nr. 85-68-7 EINECS-Nr. 201-622-7

Shall not be used as substances or as con-stituents of preparations, at concentrations of greater than 0.1 % by mass of the plasti-cized material, in toys and childcare articles. Toys and childcare articles containing these phthalates in a concentration greater than the limit mentioned above shall not be placed on the market.

The following phthalates (or other CAS- and EINECS numbers covering the substance):

Di-"isononyl"phthalate (DINP) CAS-Nrn. 28553-12-0 und 68515-48-0 EINECS-Nrn. 249-079-5 und 271-090-9 Di-"isodecyl"phthalate (DIDP) CAS-Nrn. 26761-40-0 und 68515-49-1 EINECS-Nrn. 247-977-1 und 271-091-4 Dioctylphthalate (DNOP) CAS-Nr. 117-84-0 EINECS-Nr. 204-214-7

Shall not be used as substances or as con-stituents of preparations, at concentrations of greater than 0.1 % by mass of the plasti-cized material, in toys and childcare arti-cles which can be placed in the mouth by children. Toys and childcare articles containing these phthalates in a concentration greater than the limit mentioned above shall not be placed on the market.

The regulation applies to the sum of the three listed phthalates. I.e. as sum the three phthalates may not exceed the limit value of 0.1%.

For this purpose, you should know that to soften plastics in toys and childcare articles, a content of at least 10% of plasticizers is necessary.

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Toys and childcare articles are defined according to EU Directive 2005/84/EC as follows:

Toys: Articles which are intended to be played with by children up to 14 years of age..

Childcare products: "Any product intended for children to help facilitate sleep, relaxation, hygiene, feeding or sucking."

DINP, DIDP, DNOP are currently considered less critical and may be included in articles, that cannot be taken in the mouth by children.

An interpretation of the policy 2005/84/EG was submitted by the EUROPEAN COMMISSION with the title: Guidance Document on the interpretation of the concept which can be placed in the mouth' as laid down in the Annex to the 22nd amendment of Council Directive 76/769/EEC, which is quoted in the excerpts below.

Articles which exceed a size of 5 cm in all three dimensions can as a starting point not be placed in the mouth by children. If an article or a part of an article in one dimension is smaller than 5 cm, it can be taken into the mouth. However, the shape of the article, e.g. the existence of detachable or protruding parts and its resistance to compression or deformation also needs to be given consideration.

- Inaccessible parts of articles can also not be taken into the month. Articles or parts of articles should be considered inaccessible if, during proper use or reasonably foreseeable improper use by children, they cannot be reached. The definitions of accessible in EN 71 part 1 point 3.1 and detachable components in point 3.32 (as amended) can be used as decision-making criteria. Inaccessible plastic material, such as cables in toys, cannot be taken into the mouth under normal, foreseeable conditions. Cables made from plasticised material containing DINP, DIDP or DNOP should be safely enclosed inside the toy.

- Handheld toys are more likely to be placed into the mouth, but it cannot be excluded that toys which are not handheld also can be placed into the mouth. The guidance therefore also includes toys which are not handheld, but which can be taken into the mouth.

- Inflatable articles should be considered in an empty state. The mouthpiece, which is intended to be placed in the mouth, should not contain DINP, DIDP or DNOP.

After the above mentioned standard items such as childrens sleeping bags, baby blankets, baby carriers, covers for strollers and changing pads fall under this policy.

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Problems have been encountered again and again with the following products that contain phthalates:

Varnishes on painted toys made of wood, adhesives, plastic products

Small parts and add-on components, zipper pulls

Non-permanent tattoos

Coated textiles and prints

Low amounts of phthalates, due to carry over, are also noticed long after changeover of the production, especially when phthalate containing articles were manufactured on the machines.

PVC in gloves (e.g. single use gloves) represents a specific case. The amounts of phthalates absorbed by the skin are sometimes so high that the Ministry for Consumer Protection, Nutrition and Agriculture advises against their use.

7.2 Health risks

Plasticizers may emerge from the materials in which they were processed. This is how they enter the environment and the food chain.

Due to a number of negative evaluations such as fertility and reproductive problems, effects of certain plasticizers based on phthalates are a great concern against human health.

Therefore other plasticizers shall be used that are more favourably viewed in respect of their impacts on human health.

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7.3 Regulations on phthalates

Table 11: Regulations on phthalates in products (summary)

Country Legal regulation Limit value

EU Member States Regulation (EC) 1907/annex XVII, Points 51 and 52

0,1 % Phthalate in baby & childrens items (plastic): Di(2-ethylhexyl)phthalate (DEHP) Dibutyl phthalate (DBP) Benzyl butyl phthalate (BBP)

Phthalate in baby & childrens items (plastic), that can be taken in the mouth: Di-"isononyl" phthalate (DINP) Di-"isodecyl" phthalate (DIDP) Dioctylphthalate (DNOP)

Switzerland Toy regulations from March 2002 Regulations by the EU were adopted to the greatest possible extend

Canada Canadian environmental protection act

According to this act, phthalates are considered toxic; it can therefore be assumed, that corre-sponding legal measures will be taken. So far no explicit legal regulations are known.

Beyond the regulations, the big trading companies are demanding to waiver the (limit of 0.1% in total) on the following 11 phthalates, which are shown in part in the current SVHC candidate list of REACH: DIBP, DINP, DEHP, DNOP, DIDP, BBP, DBP, DHNUP, DIHP, BMEP, DHP

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8 Nickel in metallic components

In the Regulation (EC) 1907/2006 (so called REACH Regulation) Annex XVII, the restriction of nickel is regulated:

Under point 27 it states:

Nickel and its compounds

1. must not be used:

a) In all rods, which are inserted into pierced ears or other body parts, unless the rate of nickel release from these rods is less than 0,2 g/cm/week (migration limit).

b) In products that have direct and prolonged contact with the skin such as:

- earrings,

- necklaces, bracelets and chains, anklets and rings,

- wrist-watch cases, watch straps and clamps,

- Rivet buttons, clasps, rivets, zippers and metal markings, when they are used in clothing

- If the nickel release from these products, that have direct and prolonged contact with the skin, ex-ceeds 0,5 g/cm/week;

c) In articles such as those in point b) items that have a nickel-free coating that ensures the rate of nickel re-lease from those parts that come in direct and prolonged contact with the skin does not exceed 0.5 g/cm/week for a period of at least two years of normal use of the product.

2. Products used in paragraph 1, shall not be placed on the market unless they conform to the provisions of this paragraph.

3. For demonstrating the conformity of articles in paragraphs 1 and 2, the test methods of the European Committee for Standardization (CEN) will be used.

In paragraph 1 point c it is described in other words that products are excluded if the surface is coated with a nickel-free protective layer when the limit complies with the rate of nickel release of 0.5 g/cm/week for a period of at least two years of normal use of the product. That is why an examination of the release rate of coat-ed metals (e.g. painted metal parts) is done before and after the simulated wear and corrosion testing.

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8.1 Test methods for nickel

The release of nickel from metal surfaces can be tested by the following test method:

DIN EN 1811:2011-05 reference method to detect nickel release from all rods which are used for body piercings and that come into direct and prolonged skin contact; German Version of EN 1811:2011

Note: testing the amount of nickel release takes a minimum of 7 days because it must be stored in the test solution for 168 hours (=7 days).

The test method used for the testing of nickel release DIN EN 1811 has changed to the new version 2011-05. It replaces the previous version DIN EN 1811: 2008-06.

The main differences between the old and new test methods are:

- The composition of the test solution has changed.

- The correction factor of 0.1 was replaced by the introduction of a measurement uncertainty. (Thereby previously negative findings can now lead to positive results.)

- The standard incorporates a new normative Annex C for sample preparation

Uncoated products and products with nickel outer coating shall be tested in accordance with DIN EN 1811. Products with nickel-free coating firstly undergo testing according to the method DIN EN 12472: 2009-09 (simulation of wear and corrosion testing) and then to be considered. Seen as it is very difficult to know if a product has a nickel-free coating usually both tests, (the examination of nickel release before and after the abrasions) will be carried out.

There is also a so-called quick test or nickel rubbing test.

CR 12471: 2002-08 Nickel rubbing test: Quick test for nickel release from alloys and coatings on arti-cles that come into direct and prolonged skin contact (qualitative detection)

Negative result provides high surety that the material meets the legal requirements. However a weak posi-tive result may be an indication of a limit violation in accordance with DIN EN 1811.

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8.2 Health risks

Nickel is the most common contact allergy in Europe. Due to the absorption of nickel through the skin it can cause a sensitization. Renewed contact with nickel can then cause allergic reactions to the skin.

Approx. 10-20% of the female and 1-3% of the male population are currently allergic to nickel.

By the said regulations on the restriction of nickel this health problem shall be reduced.

1.3 Regulations on nickel

Table 12: Regulations on nickel in materials


EU Regulation (EG) 1907/2006, Annex XVII, point 27 0,5 g/cm/week release of nickel

USA No regulations on nickel in products with skin con-tact known. --

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9 Cadmium and its compounds

Prohibitions of the use of cadmium and its compounds exist based on the Ordinance on banned chemi-cals (Chemikalien-Verbotsverordnung) (ChemVerbotsV), in the Annex (to 1) paragraph. 18, last up-dated on 24.2.2012.

ChemVerbotsV Annex (to 1) paragraph 18: Cadmium (extract)

(1) Products coloured with cadmium or cadmium compounds consisting from 1. Polyvinyl chloride (PVC), 2. Polyurethane (PUR), 3. Low-density polyethylene (ld. PE), with the exception of low-density polyethylene used for the

production of coloured master batch

4. Cellulose acetate (CA), 5. Cellulose acetate butyrate (CAB), 6. Epoxy resins,

7. Melamine formaldehyde (MF), 8. Urea formaldehyde (UF), 9. Unsaturated polyesters (UP), 10. Polyethylene terephthalate (PET), 11. Polybutylene terephthalate (PBT), 12. Transparent/general-purpose Polystyrene,

13. Acrylonitrile methyl methacrylate (AMMA), 14. Cross linked polyethylene (VPE), 15. High impact polystyrene,

16. Polypropylene (PP) have been made, then they may not be placed on the market if the portion of cadmium or cadmium compounds (CD Metal) mass content of 0.01% (= 100 mg / kg) exceeds the plastic material. (3) The following products or their components consisting from vinyl chloride polymers and copoly-mers that have been stabilized with (cadmium and cadmium compounds), may not be placed on the market if the proportion of cadmium metal mass content exceeds 0.01% (=100 mg/kg) by weight of the polymer. .

4. Clothing and accessories (including gloves)

6. impregnated, coated, covered or laminated textile fabrics

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Throughout the EU the Regulation (EC) 1907/2006 (so-called REACH Regulation), Annex XVII, point 23, (the last variations to the cadmium regulation: Regulation (EU) No. 494/2011) applies, (excerpt):

Mixtures and products made from plastic may not be placed on the market if their cadmium content ex-ceeds 0,01 wt.- % (= 100 mg/kg) by mass of the plastic material.

The newest amendments to the restrictions for cadmium have been extended to jewellery metals (such as bracelets, brooches and cufflinks).

There are exceptions for special applications.

9.1 Testing

Testing is performed following DIN EN 1122:2002-02


Cadmium is used for example as

Stabilizer for plastic materials (especially PVC) e.g. impregnated, coated, coated and/or laminated tex-tiles, applique, shoes (soles and heels), borders on bags

Pigments for plastics, to a lesser extent for dyes and lacquers


Coatings on textiles e.g. rain-jackets, play-pants, belts

Labels, pendants, applications on textiles and shoes, accessories (including gloves)

Stabilizing components, inserts and closures on bags, backpacks, travelling bags and similar articles

Closures, selvages, feet on bags

Clear wrappings, sheet protectors, packaging materials

9.4 Health risks

Cadmium in all chemical compounds and forms is highly toxic. Inhalation from cadmium containing dust, ingesting or skin contact can endanger your health. In the environment cadmium is toxic to water organ-isms and is classified as "hazardous to water".

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9.5 Regulations on cadmium

Table 13: Regulations on cadmium in products


Germany Chemicals Ordinance (ChemVerbotsV) 100 mg/kg

EU-countries Regulation (EC) 1907/2006, annex XVII, point 23 100 mg/kg (0,01%) in all plastics

Sweden Amendment to ordinance (1998:944) on the prohibition etc. in connection with handling, importation an exportation of chemical products

Use of cadmium in products is in general prohibited. Very few exceptions exist. No limit value is set.

Switzerland Ordinance on the reduction of risks when han-dling certain especially hazardous substances and preparations and articles

0,01% for plastic materials in articles

Canada Hazardous products act Limit value for toys and childrens articles, 0,1% dissolved in 5%iger hydrochloric acid, 10 min., 20 C

USA Different regulations in the different states with regards to cadmium in packaging materials

100 mg/kg per packaging or part of the packaging

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10 Lead

Lead is a toxic heavy metal. In ancient times it was used for the drinking water pipelines. Until approxi-mately the1970s they were also still using lead in pipelines in Germany. Due to its properties and easy in processing, lead is extensively used in the industry e.g. for car batteries, radiation protection and in metal alloys. Lead may also be present in plastics.


Plastics, such as buttons (e.g. recycled plastics)

Paint coatings on plastics

Metals (accessories), pendants, lead chains in curtains

10.2 Health risks

Lead is one of the strong environmental toxins that accumulates in the body. Therefore constant absorp-tion, intake can lead to chronic lead poising. The symptoms are anemia, weakness, loss of appetite, nervousness or emaciation. Children are particularly at risk because their development is on-going and may lead to irreversible nerve damage.

Even a single intake of a relative high amount (e.g. ingestion of lead containing small parts) can lead to lead poisoning in children.

10.3 Regulations on lead

Table 14: Regulations on lead in Products

Country Legal regulations Limit value

Denmark Danish statutory order no 2012 (13.Nov. 2000) 100 ppm (mg/kg)

South Korea KC mark Textiles for children (0-12 years) 90 ppm

USA CPSIA 100 ppm

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11 Chromium (VI) compounds

Residues of chromium (VI) compounds may be found in chrome-tanned leather as a result of improper chromium tanning processes or treatment (coating, adhesives), but has also been found in textiles. Since chromium (VI) compounds are classified carcinogenic (EU C2), the amended 18th Commodities Regulation states that they must not be detectable in clothing and shoes.

According to the Consumer goods ordinance procedures are prohibited for causing chromium VI to be pre-sent in the following products: consumer products made of leather which are intended to come in contact with the body, especially clothing, watch bands, bags and backpacks, chair covers, neck pouches and leather toys.


Contamination of tanning agents based on chromium

Two-bath tanning procedure with incomplete reduction of chromium (VI) to chromium (III)

Oxidation of chromium (III) in chromium-tanned leathers by oxygen from the air in the presence of strong alkaline components e.g. latex adhesives, finishes and others


All chrome-tanned leather and leather fibre materials have shown to be critical with regards to chromium (VI) and its compounds especially:

Natural-coloured, light leather lining in shoes and clothes

Costume leathers, which contain higher amounts of fats and fish oils.

Leather bands, leather gloves

11.3 Health Risks

Chromium VI is toxic and can cause cancer, has an allergenic effect and can impair fertility. It exerts its negative effect already when it comes in contact with the skin and also by swallowing or inhaled.

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11.4 Regulations on chromium (VI)

Table 15: Regulations on chromium (VI) in products


Germany Commodities regulation (BedGgstVndV, annex 4, section 2. Last amended on 13.12.2011

Leather products that have skin contact:

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12 Heavy metals, soluble

Some heavy metals are harmful for the human body. They can be absorbed for example through the food chain. However, it is discussed that even sweat-soluble heavy metals in textiles have a potential health risk and therefore should not be included.

Heavy metals can be released though through certain dyes in textiles.

12.1 Regulations on soluble heavy metals in products

The limits below refer only to soluble heavy metals in artificial sweat. (the test is performed on a Migrate with artificial sweat solution.) The limits listed below are optional. These or similar limits are stipulated in the terms and conditions for many trading companies.

Table 16: Regulations to soluble heavy metals in products (voluntary)

Heavy metals (extractable)

Limit value

TOXPROOF

Away from the skin

Limit value

TOXPROOF

Away from the skin

Limit value

TOXPROOF

Small children

Research method TOXPROOF

Arsenic Antimony Lead Cadmium Chromium, whole Chromium (VI) Mercury Nickel Copper Cobalt

0,2 mg/kg 25,0 mg/kg 0,8 mg/kg 0,1 mg/kg 2,0 mg/kg n.n.

0,02 mg/kg 2,0 mg/kg 20 mg/kg 2,0 mg/kg





Extraction with acidic sweat solution accord-ing to DIN EN ISO 105-E04: Determination by ICP-OES, ICP-MS, AAS and Cr (VI) in Appen-dix. DIN EN ISO 17075, limit of usually 3 mg / kg)

Based on TUV Rheinland - TOXPROOF criteria for textiles and clothing (for textiles tested for harmful substances ) 05/2010

Table 17: Regulations to soluble heavy metals in China


China FZ/T 81014-2008 Test method GB/T 17593.1

Only for children's clothes (

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13 TBT and other organotin compounds

The following organotin compounds are the most important ones with regards to textiles/clothing:

TeBT Tetrabutyltin compounds DOT Dioctyltin compounds

TBT Tributyltin compounds MOT Monooctyltin compounds

DBT Dibutyltin compounds TCyT Tricyclohexyltin compounds

MBT Monobutyltin compounds TPhT Triphenyltin compounds

The tributyltin compounds (TBTs) are of special significance because of the vast applications (e.g. anti-fouling coating on ships). For these substances, adverse effects on the hormone system at trace concen-trations have been proven.

So far essentially four potential sources have been identified:

1. Anti-microbial finishing preventing the bacterial degradation of sweat and the corresponding unpleasant odour that goes with it.

2. PU (polyurethane) and TPU (thermoplastic polyurethane) are often produced by using organotin sub-stances as a catalyst. These catalysts are often DBT or/and MBT. It is known that DBT and MBT con-tain residues of TBT. It is possible to use catalysts that contain other organotin compounds (e.g. DOT) but that are free of TBT. It is safest to abdicate the use of any organotin compounds completely.

Please note that some release agents may contain catalysts like DBT and MBT.

3. To improve the grip, polysiloxane softeners were used for example for polyester fabric. Polysiloxanes may contain low amounts of organotin compounds as stabilisers.

4. PVC, which is used as binder for prints, sometimes contains DOT or other organotins as stabilisers. Among other reasons, this is necessary to prevent thermal degradation of the PVC at the temperatures of up to 180 C that may be reached during the transfer of the printing-foil.

With the "Commission Regulation (EU) No 276/2010 of 31 March 2010 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authori-sation and Restriction of Chemicals (REACH) as reference to Annex XVII (dichloromethane, lamp oils and grill lighter fluids and organotin compounds) " The following regulations have been adopted: Since the 1st July 2012, trisubstituted organotin compounds such as tributyltin (TBT) and triphenyl-tin

compounds (TPhT) may not be used in products where the concentration of tin in the article, or part thereof exceeds 0.1 wt. -%. Products which were already in use in the community are excepted from this regulation.

Since the 1st January 2012, dibutyltin compounds (DBT) cannot be used in mixtures and products which are intended to be released to the general public, when the concentration of tin in the mixture or the prod-uct or any part thereof exceeds 0,1 wt.-%. Products which were already in use in the community are ex-cepted from this regulation.

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Since the 1st January 2012, dioctylin compounds (DOT) may not be used in the following products which are intended to be released to the general public and to be used, when the concentration of tin in the product or in parts thereof exceed 0,1 wt.-%:

- Textile articles that are intended to come into contact with the skin - Gloves - Footwear or parts of the footwear intended to come into contact with the skin - Wall and floor coverings - Baby products - Feminine hygiene products - Diapers

Products which were already in use in the community are excepted from this regulation.

13.1 Health risks

Since 2008 BfR recommend limiting the use of organotin compounds.

TBT, TPhT, DBT, DOT:

For higher concentrations: These organotin compounds are classified as toxic and are considered damaging to the immune system. An addition of the effects is likely. Due to the variety of the use of organotin com-pounds in various consumer products from plastics and textiles, results in a high overall burden that needs to be minimized


Biocide treated materials, e.g. sole inserts, cycling pants, PES comforters

PVC and polyurethane coated textiles (rain clothes, childrens mud trousers)

PVC-materials

All plastics in shoes, sole materials and applications

Plastic accessories on textiles, synthetic leathers, coated textile components on shoes

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13.3 Regulations on organotin compounds

Table 18: Limits for organotin compounds


Germany Regulation (EC) No. 1907/2006 and Complaints according to 30 LFGB, prohibi-tion of ingredients that are harmful to health

DBT, DOT, TBT, TPHT: 0,1 %

Voluntary limits:

According different delivery condi-tions:

0,005 2,0 mg/kg per substance Test method: solvent solution extraction

South Korea

Self-Regulatory Confirmation Notice (Notice No. 2007-34)

Only baby clothing (0-24 months) DBT: 1ppm TBT: 0,05ppm

Japan

Law No. 112 TBT, TPhT: not detectable (0,05 ppm)

TBT concentrations of 0,025 0,1 mg/kg can be kept by most materials.

The TBT content in products is taken more and more into consideration in comparative product tests by con-sumer magazines. Positive test results usually result in a devaluation of the article. We therefore recommend for manufacturers and retailers to keep strictly avoiding TBT contamination in products, especially since there is no technical need for any TBT contamination in materials.

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14 PAH Polycyclic aromatic hydrocarbons in rubber and plastic products

Recently high PAH readings in every day products and commodity goods have repeatedly caused that the media recommended the return of the products.

Due to the carcinogenic effect a risk to human health can indeed not be excluded in case of high PAH con-tent and intensive skin contact. Though abrasion properties of the rubber are lowered, this is allowed for certain uses, e.g. in the case of a hammer handle.

In the manufacturing of rubber the addition of filling materials is profitable because the material is stretched and the costs for the rubber are reduced. If a lot of filling material (usually calcium sulphate) is used then the rubber turns hard. The material becomes softer again when mineral oils are added. Though abrasion properties of the rubber are lowered, this is allowed for certain uses, e.g. in the case of a hammer handle.

If however tar oils are used as plasticizers instead of clean mineral oils, these often contain high amounts of polycyclic aromatic hydrocarbons (PAH).

PAH can also come from soot which is used as black pigment in plastics.

A PAH risk is always present (which has been confirmed by many years of testing), in rubber materials, soft plastics or those in intensive or very dark colour.

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14.1 Health risks

Besides Benzo[a]pyrene, the best-known PAH which is often used as indicative component, several other PAH components, like e.g. Benz[a]anthracene, Chrysene, Benzo[b]fluoranthene, Benzo[k]fluoranthene and Dibenz[a,h]anthracene are classified K2 with regards to their carcinogenicity.

There are sufficient indications for a justified assumption that exposure to the substance can cause cancer in humans.

As tests on migration demonstrate, highly contaminated materials can transfer PAH in relatively large quan-tities to the skin. This transfer is further facilitated by greasy cosmetics, moisturizing creams and similar substances seen PAH are very fat-soluble.

PAHs fluoresce under UV-light. As shown in the picture below, it is already enough to touch a PAH-contaminated rubber handle of a hammer for a short time to make the transfer of PAHs to the skin visible under UV-light.

Picture 1: A hand, slightly moisturized with moisturizing cream, after touching a rubber-ized hammer handle only one time. At the points of contact the perforated pattern is clearly discernible under UV-light fluorescence.

Furthermore these substances are absorbed by the skin, so that parts are transferred to the skin and pene-trate the skin barrier. Depending on the concentration and kind of contact, a risk to health (e.g. cancer) by direct skin contact cannot be excluded. Since these contaminations are mostly technically avoidable - de-pending on the intended and foreseeable use - it is recommended, not to place products that are highly contaminated with PAHs on the market.

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14.2 Regulations on PAH

According to the provisions of 3 (2) Product Safety Act (ProdSG), a product may only be placed on the market if it is made in a way, that under normal or foreseeable conditions of use, the health and safety of individuals is not compromised.

As far as the extent for a particular use, a concrete threat to health through products containing PAH is not clarified without further toxicological reports.

According to Regulation (EC) No. 1907/2006, annex XVII No. 50 certain PAHs may not be used in extend-ed oils for tyres and parts. There is a limit for the sum of the listed PAHs from max. 10 mg/kg or max. 1 mg/kg for Benzo [a] pyrene for the extended oils.

The testing experience shows that not only rubber materials but also partially soft plastics such as PVC, ABS and butadiene can contain PAHs.

Given the versatility of soft fabrics and rubber materials in a wide variety of products and the lack of specific limits, a discussion was undertaken with experts from well-known companies and institutes e.g. TV Rheinland and representatives from the Stiftung Warentest and BfR (Federal Institute for Risk Assessment) and preliminary orientation values for PAH were agreed upon.

According to the expected contact time with the skin, for the materials used in products, must follow the following limits (under the GS testing which is mandatory according to ZEK 01-4-08 on 29/12/2011).

Table 19: Limits for PAH levels for materials (grip) surfaces after ZEK 01.4-08 Limit values for Category 1 Category 2 Category 3 Materials intended to be

put into the mouth or materials from toys for

children < 36 months with intended skin contact

Materials which are not covered in category 1 with foreseeable skin

contact for more than 30s (long term skin contact)

Materials which are not covered in category 1 or 2 with foreseeable skin

contact of up to 30s (short term skin contact)

Benzo[a]pyrene mg/kg Not detectable (

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*

List of individual substances:

1. Naphthalene 2. Acenaphthylene 3. Acenaphthene 4. Fluorene 5. Phenanthrene 6. Anthracene 7. Fluoranthene 8. Pyrene 9. Benzo [a] anthracene 10. Chrysene 11. Benzo [b] fluoranthene 12. Benzo [k] fluoranthene 13. Benzo [j] fluoranthene 14. Benzo [a] pyrene 15. Benzo [e] pyrene 16. Indeno [1,2,3-cd] pyrene 17. Anthracene dibenzo [a, h] 18. Benzo [g, h, i] perylene

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15 NP, NPEs, OP and OPEO

Nonylphenol (NP) and nonylphenol ethoxylates derived therefrom (NPEOs) and octylphenol (OP) and oc-tylphenol ethoxylates (OPEO) belong to the group of alkylphenols and alkylphenol ethoxylates.

The group of alkylphenol ethoxylates (APEO) comprises of various long-chain substances that are mainly used as washing and cleaning agents (detergents). The ecological relevance of the individual substances differs with the chain-length. Currently, especially the nonyl- and octyl-compounds are under suspicion to bio accumulate in the environment and thereby cause damaging effects.

According to the Regulation (EC) 1907/2006, annex XVII, point 46, is the marketing of preparations and substances, including textile and leather processing, which contain nonylphenol or nonylphenol ethoxylates are prohibited if it exceed 0,1 mass%.

The regulation of the European Chemicals Law is therefore not applicable to finished products such as textiles, clothing and other non-food articles. The use of these substances outside the EU and the import of such goods into the scope of application of this directive are permitted.

The use of these substances can only be controlled to a limited degree. According to our estimation nonyl- and octylphenol ethoxylates are meanwhile present ubiquitarily. Many commercial enterprises consider the use of NPEO and OPEO as proven, if residues of these substances of more than 50 mg/kg can be found in textiles and leather articles.

15.1 Health risks

NP and NPEs (which again breaks down to NP) are toxic to the aquatic environment and effect hormonally (classified as reproductively toxic) the aquatic organisms such as fish, mussels, crabs, water fleas etc.

Through many years of use these substances are now widely spread and therefore found in the environ-ment.

These risks should be reduced by the EU-wide ban.

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15.2 Regulations on NPEO and OPEO

It is problematic for commercial enterprises that NPEO and OPEO are still being used worldwide during the production of textiles and leather goods. This is contested by the media and non-governmental organiza-tions (ko-Test, Greenpeace etc.) repeatedly.

Therefore, and because of the questionable nature of the environment, many retailers demand that NPEO and OPEO should not be used in production.

In some conditions of the trade following limits were recorded for textiles and in recent years continuously revised downwards:

Table 20: Delivery of trading limits set for NPEO and OPEO in textiles

Country Substance Voluntary limit value

Germany

Alkylphenole (AP) > Nonylphenole (NP) > Octylphenole (OP)

Voluntary Limits: Total NP+OP:

undetectable (< 5mg/kg)

Alkylphenolethoxylate (APEO) > Nonylphenolethoxylate (NPEO) > Octylphenolethoxylate (OPEO)

Voluntary Limit:

Total NPEO+OPEO:

100 mg/kg 250 mg/kg

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16 Perfluorooctane sulfonate (PFOS)

The European Parliament has strongly regulated the use of PFOS since 2006.

PFOS in the past has mainly been used to make materials such as textiles, carpets and paper, grease, oil and water resistant. Similarly it has been used for fire-fighting foams but since 2011 it has been banned from use.

In addition it was and is used in chromium plating, in photography and in hydraulic fluids for aviation and aerospace. Use should, however, be eliminated step by step, when the available techniques allow it.

Perfluorooctane sulfonate (PFOS) chemical formula C8F12SO2X (X = OH, metal salts (O-M+), halogens, amides and other derivatives including polymers) may not be put into circulation in half-finished products or products, or parts of these, if the mass concentration of PFOS is 0,1 % or more (calculated in relation to the mass of the structurally or micro structurally different components, that contain PFOS) or for textiles or other coated materials with a PFOS-concentration of 1 g/m or more in the coating material.

16.1 Health risks

PFOS is environment-persistent, bio accumulative and toxic to mammals.

Persistent substances remain unchanged for a long time in the environment, accumulate in it and lead to uptake by organisms to further harm.

16.2 Regulations on PFOS

Table 21: Regulations on PFOS in products


EC Countries Regulation (EC) No 850/2004, Annex I (as amended by Regulation No 575/2010 of 24.08.2010)

Textiles: 1 g/m

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17 Dimethylfumarate (DMFU)

Pursuant to Directive 2001/95/EC producers are obliged to place only safe consumer products on the mar-ket.

The Commission Decision 2009/251/EC dated 17th March 2009 commits all Member States to ensure that products containing biocide dimethylfumarate are prohibited from being placed or made available on the market.

This Commission Decision was enacted by reason that furniture and footwear available on the market in several Member States have been identified as the cause of damage to the health of consumers in France, Poland, Finland, Sweden and the UK.

The health damage was caused by the chemical dimethylfumarate (DMFU), a biocide preventing moulds that may deteriorate leather furniture or footwear during storage or transport in a humid climate.

By Regulation (EU) No 412/2012 (dated 15th May, 2012) amending Annex XVII to Regulation (EC) No 1907/2006 of dimethylfumarate is regulated in articles.

Therefore dimethylfumarate may not be used in products or parts in concentrations of about 0.1 mg / kg. At levels above 0.1 mg / kg the products may not be put on the market. (Accordance with Section 61, (EC) No 1907/2006)

17.1 Health Risks

Strong allergic skin reactions can be triggered by dimethylfumarate.

These were confirmed by independent skin tests. In particular in the years 2008 / 2009 there were many cases of very bad allergies with severe skin damage caused from shoes and chairs (made of leather).

17.2 Regulations on Dimethylfumarate

Table 22: Regulations on dimethylfumarate in products


EU Regulation (EC) No 1907/2006, Annex XVII, Section 61 0,1 mg/kg* * Detection limit of the test method 0.05 mg/kg

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18 Short-chained chlorinated paraffins

Short-chained chlorinated paraffins, C10-C13 are used in plasticizers and as flame retardants for the production of plastics, rubber products, coatings for textiles, sealant, adhesives and paints.

The use of short-chained chlorinated paraffins in the metal processing industry and in the leather pro-cessing and finishing industry, was banned in the EU in 2002.

Regulation (EC) 1907/2006 annex XVII, point 42 concerning the limitations of the placing on the mar-ket and use of certain dangerous substances and preparations:

(Short-chained chlorinated paraffins) "may not be used as substances and constituents of other substances or preparations in concentrations higher than 1 % ... for oiling leather and may not be placed on the market.

Furthermore, the short-chained chlorinated paraffins are listed in the REACH Candidate List. After that there is a duty to inform the consumer if the content of short-chained chlorinated paraffins exceeds 0.1% by weight of the product.

The regulation amending Regulation (EU) No 519/2012 of 19.6.2012 amending Regulation (EC) No 850/2004, the limitation in the Union has been extended for manufacturing, placing on the market and the use of short-chained chlorinated paraffins which have now been banned (except for flame retardants in industrial conveyor belts and in sealants). The limit is 1% by weight.

18.1 Health risks

Short-chained chlorinated paraffins, C10-C13 are as dangerous for the environment and poisonous to fish. Acute toxicity does not exist.

18.2 Regulations on short-chained chlorinated paraffins

Table 23: Regulations on short-chained chlorinated paraffins in products


EU Regulation (EC) 1907/2006, Annex XVII, point 42 For substances or prepa-rations for oiling leather: 1% by weight

EU Regulation (EC) Nr. 850/2004 Substances and prepara-tions in general: 1% by weight

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19 Food law regulations

Within the harmonization process, the approach to the analysis and evaluation of materials and objects which come in contact with food (e.g. housewares and household appliances) the European reference la-boratory for this product group, situated in Italy, in co-operation with the national reference laboratories of the individual member states, has set harmonized test conditions. Germany is represented by the BfR (Federal Office for risk evaluation in Berlin) as national reference laboratory. Consumer protection

Materials or objects which come in contact with food, must only be manufactured in such a way, and made available to the general market, so that under normal and foreseeable circumstances of their use, no sub-stances will transfer to or onto the surface of the food, so that it: Could endanger your health

Could impair the composition, the smell, the taste or the appearance of the food

Intended purpose of use or worst case-view?

In the guidelines on testing objects which come in contact with foodstuffs from 09.09.2009, (Guidelines on testing conditions for articles in contact with foodstuffs (with a focus on kitchenware)) is for a range of house hold goods approach to simulate the substance transfer onto the foodstuffs, so called migration testing, has been harmonized Europe wide. The European reference laboratory focuses less on the intended use of the items, as rather to their worst case use (worst case).

Possible effects

Through the Europe wide harmonization of the test conditions for several objects being in contact with food, national control bodies will, in the near future, adapt their test regulations to the guidelines of the European reference laboratory.

As the TV Rheinland LGA Products GmbH, we examine and evaluate your products the same way it would be executed by an office body.

Since February 2010 we have adapted our approach, for all the products that are included, to the guide-lines of the European reference laboratory.

In individual cases, because of the change in the test conditions, a different result can occur.

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Which products are particularly affected?

In many cases of materials and objects that are in contact with foodstuffs, up to now regulated after the European reference laboratory guidelines, an intensification of the test conditions will occur. Particularly affected are:

Aprons, bibs

Hand towels, tea towels

Serviettes

Table cloths, place mats

Gloves

Legal classification

The guidelines of the European reference laboratory published now, still represents no legally binding de-faults.

However deviating from these guidelines is only advisable in individual cases with appropriate technical reasons, since these were published by the European institution and are supported by the respective Na-tional institutions. In the event of a dispute they can serve the courts to find make a decision.

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20 Implementation of sampling, analysis, physical checks and inspections

We offer to take samples and perform a very wide range of chemical, mechanical, physical, and microbio-logical tests and analysis for you.

This applies to both statutory and further requirements of a chemical nature, but also in the tests and exam-inations regarding fitness for use, claims, complaints, effectiveness studies etc.

In addition, we can carry out goods inspections, product testing and implement inspections of manufactur-ing facilities for you.

Through our numerous affiliates abroad we are able to take action, on site worldwide for you and your overseas suppliers and customers.

With our test reports and certificates you can document that we have fulfilled our duty of care and we have met all your requirements.

The DIN EN ISO/IEC 17025:2005 and ISO 9001:2008 accredited laboratory of TV Rheinland LGA Prod-ucts GmbH is involved in the development of many procedures and successfully take part in all relevant proficiency tests. All our laboratories abroad are also accredited in accordance with ISO/IEC 17025:2005 and ISO 9001:2008.

In addition we operate by the ZLS accredited testing laboratories for the complete range personal protec-tive equipment (PPE) and are under the number 0197 as Notified Body in the EU Commission.

21 Disclaimer

This document contains only general information without specific reference to certain natural or legal per-sons, objects or situations.

This documentation is not intended as legal advice and does not replace it in any case.

The TV Rheinland LGA Products GmbH (TRLP) cannot ensure that all formulations correspond exactly to the versions from the respective officials.

The TRLP strives for accuracy and actuality of the information provided. Nevertheless, errors and ambigui-ties cannot be completely ruled out. The TRLP assumes no responsibility for the actuality, correctness, completeness or quality of the information.

Liability claims against the TRLP which relate to damages of a material or immaterial nature caused by the use or disuse of the presented information or through the use of incorrect and incomplete information, are generally excluded.

The TRLP reserves the right to change parts of or the entire document, to add to, delete or cease publica-tion temporarily or permanently, without prior notice.

The copyright of this document lies with TRLP. Reproduction or publication in electronic or printed form is prohibited without the explicit permission from TRLP.

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Contact information

Location Germany / Cologne

Name Andreas Metzger Dr. Peter Withopf Sandra Schneich

Company TV Rheinland LGA Products GmbH

Address Am Grauen Stein 29 51105 Cologne

Tel.: +49/221/806-3371 +49/221/806-3486 +49/221/806-4055

Fax: +49/221/806-2882 +49/221/806-2882 +49/221/806-2882

email andreas.metzger @de.tuv.com peter.withopf @de.tuv.com

sandra.schoeneich @de.tuv.com

Location Germany / Leipzig

Name Dieter Knape Cornelia Albrecht

Company TV Rheinland LGA Products GmbH

Address Maximilianallee 2 04129 Leipzig

Tel.: +49/341/600369-12 +49/341/600369-17

Fax: +49/341/600369-10 +49/341/600369-10

email dieter.knape @de.tuv.com cornelia.albrecht

@de.tuv.com

Orderfax see: www.tuv.com/textilien, register Downloads

schadstoffinfo

Documents

carcinogenic dyes

prohibited azo dyes

test methods

critical components

sources of reasons

health risks

leather products version

tetrachlorphenols tecp