Document ID: 02016D1349-20201201
Language: ENG

02016D1349 — EN — 01.12.2020 — 001.001
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<table><col/><col/><tr><td><p><a>&#9658;B</a></p></td><td><p>                        COMMISSION DECISION (EU) 2016/1349</p><p>of 5 August 2016</p><p>establishing the ecological criteria for the award of the EU Ecolabel for footwear</p><p><span><span>(notified under document C(2016)&#160;5028)</span></span></p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 214 9.8.2016, p. 16)</p></td></tr></table>
Amended by:
<table><col/><col/><col/><col/><col/><tr><td><p>&#160;</p></td><td><p>&#160;</p></td><td><p>Official Journal</p></td></tr><tr><td><p>&#160;&#160;No</p></td><td><p>page</p></td><td><p>date</p></td></tr><tr><td><p><a>&#9658;M1</a></p></td><td><p><a>                              COMMISSION DECISION (EU) 2020/1805&#160;of 27 November 2020</a></p></td><td><p>&#160;&#160;L&#160;402</p></td><td><p>89</p></td><td><p>1.12.2020</p></td></tr></table>
COMMISSION DECISION (EU) 2016/1349
of 5 August 2016
establishing the ecological criteria for the award of the EU Ecolabel for footwear
(notified under document C(2016) 5028)
(Text with EEA relevance)
Article 1
1. The product group ‘footwear’ shall comprise all articles designed to protect or cover the foot, with an applied sole which comes into contact with the ground. Subject to the exemptions set out in paragraph 3, footwear covered by Annex II to Directive 94/11/EC of the European Parliament and of the Council ( 1 ) and protective footwear covered by Council Directive 89/686/EEC ( 2 ) are included in the scope.
2. Footwear may be composed of various natural and/or synthetic materials in line with Directive 94/11/EC.
3. The product group shall not comprise following products:
(a) footwear containing any electric or electronic components;
(b) footwear that is disposed of after a single use;
(c) socks with an applied sole;
(d) toy footwear.
Article 2
For the purpose of this Decision, the following definitions shall apply:
(1) ‘Shoe upper’ means the upper structural element, composed of one or more materials, which is attached to the shoe outer sole. The shoe upper includes lining and socks.
(2) ‘Lining and socks’ mean the lining of the shoe upper and the insole, constituting the inside of the footwear article.
(3) ‘Shoe outer sole’ means the bottom part of the footwear article which is attached to the shoe upper.
(4) ‘Footwear assembly’ means a series of operations that aim at joining together the shoe upper and shoe sole to form a final product. Final product packaging is included.
(5) ‘Footwear assembly site’ means the site where the final stages of the production (from material cutting or forming (for injection moulding production) to product packaging) that pertain to the licensed product and remain under management control of the applicant take place.
(6) ‘Volatile organic compounds (VOCs)’ are organic compounds that have, at 293,15 K, a vapour pressure of 0,01 KPa or more, or that have a corresponding volatility under the particular conditions of use, as defined in EN 14602.
(7) ‘Inherently biodegradable substance’ means a substance that shows 70 % degradation of dissolved organic carbon within 28 days or 60 % of theoretical maximum oxygen depletion or carbon dioxide generation within 28 days using one of the following test methods: ISO 14593, OECD 302 A, ISO 9887, OECD 302 B, ISO 9888, OECD 302 C.
(8) ‘Readily biodegradable substance’ means a substance that shows 70 % degradation of dissolved organic carbon within 28 days or 60 % of theoretical maximum oxygen depletion or carbon dioxide generation within 28 days using one of the following test methods: OECD 301 A, ISO 7827, OECD 301 B, ISO 9439, OECD 301 C, OECD 301 D, ISO 10708, OECD 301 E, OECD 301 F, ISO 9408.
Article 3
In order to be awarded the EU Ecolabel under Regulation (EC) No 66/2010, a product shall fall within the product group ‘footwear’ as defined in Article 1 of this Decision and shall comply with the ecological criteria and the related assessment and verification requirements set out in the Annex to this Decision.
Article 4
The ecological criteria for the product group ‘footwear’ and the related assessment and verification requirements shall be valid until 31 December 2025.
Article 5
For administrative purposes, the code number assigned to the product group ‘footwear’ shall be ‘017 ’.
Article 6
Decision 2009/563/EC is repealed.
Article 7
1. By derogation from Article 6, applications for the EU Ecolabel for products falling within the product group ‘footwear’ submitted before the date of adoption of this Decision shall be evaluated in accordance with the conditions laid down in Decision 2009/563/EC.
2. Applications for the EU Ecolabel for products falling within the product group ‘footwear’ submitted within two months of the date of adoption of this Decision may be based either on the criteria set out in Decision 2009/563/EC or on the criteria set out in this Decision. Applications shall be evaluated in accordance with the criteria on which they are based.
3. EU Ecolabel licences awarded in accordance with the criteria set out in Decision 2009/563/EC may be used for 12 months from the date of adoption of this Decision.
Article 8
This Decision is addressed to the Member States.
ANNEX
EU ECOLABEL CRITERIA AND ASSESSMENT AND VERIFICATION REQUIREMENTS
Criteria for awarding the EU Ecolabel to ‘footwear’:
1. Origin of hides and skins, cotton, wood and cork, and man-made cellulose fibres;
2. Reduction of water consumption and restriction on the tanning of hides and skins;
3. Emissions to water from the production of leather, textiles and rubber;
4. Volatile organic compounds (VOCs);
5. Hazardous substances in the product and shoe components;
6. Restricted Substances List (RSL);
7. Parameters contributing to durability;
8. Corporate Social Responsibility with regard to labour aspects
9. Packaging;
10. Information on the packaging.
Assessment and verification: The detailed assessment and verification requirements are indicated for each criterion.
Where the applicant is required to provide declarations, documentation, analyses, test reports, or other evidence to show compliance with the criteria, these may originate from the applicant or his or her supplier(s) or their suppliers, as appropriate.
Competent bodies shall preferentially recognise attestations which are issued by bodies accredited according to the relevant harmonised standard for testing and calibration laboratories and verifications by bodies that are accredited according to the relevant harmonised standard for bodies certifying products, processes and services.
Where appropriate, test methods other than those indicated for each criterion may be used if the competent body assessing the application accepts their equivalence.
Where appropriate, competent bodies may require supporting documentation and may carry out independent verifications or site visits.
The final product is one pair of shoes. Requirements are based on shoe size: 42 Paris point for men, 38 Paris point for women, 40 Paris point for unisex models, 32 Paris point for children (or the largest size in the case of sizes smaller than 32 Paris point), and 26 Paris point for children under three years of age.
Unless separately specified, the criteria apply to the final product which is composed of shoe uppers and outer soles that are made of homogeneous materials and articles that form the final product.
The applicant shall provide the bill of materials of the product, listing all homogeneous materials and articles used. The weight of each constituent material shall be expressed in grams and as a percentage of the shoe uppers and the shoe outer soles. The total final product unit weight shall be stated.
Criterion 6 refers to a Restricted Substances List which is provided in the Appendix. The list sets out the scope of restrictions and respective verification methods.
EU ECOLABEL CRITERIA
Criterion 1 — Origin of hides and skins, cotton, wood and cork, and man-made cellulose fibres, and plastics
1.1. Requirements on hides and skins
Raw hides and skins destined to be used in a final product shall be subject to the restrictions specified in criteria 1.1(a) and 1.1(b).
1.1(a) Hides and skins
Criterion 1.1(a) shall apply when the leather content in shoe uppers or shoe outer soles is greater than 10,0 % weight by weight of either component.
Only raw hides and skins from animals raised for milk or meat production are allowed to be used for the production of leather that is destined for use in the final product.
Assessment and verification: the applicant shall submit a declaration of compliance from the leather manufacturer or the hides or skins supplier. The declaration shall state that the leather manufacturing company conducts compliance verification checks on the raw materials used, and that the raw hides and skins destined to be used in the final product originate from animals raised for milk or meat production.
1.1(b) Prohibited hides and skins
Raw hides and skins originating from extinct, extinct in the wild, critically endangered, endangered, vulnerable, and near threatened species, according to the categories established by the International Union for Conservation of Nature (IUCN) Red List of Threatened Species ( 3 ), shall not be used in the final product.
Assessment and verification: the applicant shall provide a declaration of compliance from the leather manufacturer or leather supplier. The declaration shall identify the animal of origin and state that raw hides and skins destined to be used in a final product do not originate from extinct, extinct in the wild, critically endangered, endangered, vulnerable, or near threatened species according to the IUCN classification.
1.2. Cotton and other natural cellulosic seed fibres
Criterion 1.2 shall apply when the cotton content in shoe uppers or shoe outer soles is greater than 10,0 % weight by weight of either component.
Cotton that contains 70,0 % weight by weight or more of recycled content is exempted from the requirement of criterion 1.2.
Cotton and other natural cellulosic seed fibres (hereinafter referred to as cotton) that are not recycled fibres shall contain a minimum content of either organic cotton (see criterion 1.2(a) or integrated pest management (IPM) cotton (see criterion 1.2(b)).
Textiles that have been awarded the EU Ecolabel based on the ecological criteria of Commission Decision 2014/350/EU ( 4 ) are considered to comply with criterion 1.2.
Assessment and verification: the applicant or material supplier, as appropriate, shall provide a declaration of compliance.
Where EU Ecolabel textiles are used, the applicant shall provide a copy of the EU Ecolabel certificate showing that it was awarded in accordance with Decision 2014/350/EU.
Where applicable, recycled content shall be traceable back to the reprocessing of the feedstock. This shall be verified by independent third-party certification of the chain of custody or by documentation provided by feedstock suppliers and reprocessors.
1.2(a) Organic production standard
With the exception of footwear intended for children under three years of age, a minimum of 10 % weight by weight of the non-recycled cotton fibre used in the product shall be grown according to the requirements laid down in Council Regulation (EC) No 834/2007 ( 5 ), the US National Organic Programme (NOP) or equivalent legal obligations set by trading partners of the EU. The organic cotton content may include organically grown cotton and transitional organic cotton.
At least 95 % w/w of the non-recycled cotton fibre used in footwear intended for children under three years of age shall be organic cotton.
Where the organic cotton is to be blended with conventional or IPM cotton, cotton shall be from non-genetically modified varieties.
Organic content claims may only be made when the organic content is a minimum of 95 %.
Assessment and verification: the applicant or material supplier, as appropriate, shall provide a declaration of compliance for the organic content supported by evidence certified by an independent control body to have been produced in conformity with the production and inspection requirements laid down in Regulation (EC) No 834/2007, the US National Organic Programme (NOP) or those set by other trading partners. Verification shall be provided for each country of origin.
The applicant or material supplier, as appropriate, shall demonstrate compliance with the minimum organic cotton content requirement based on the annual volume of cotton purchased to manufacture the final product(s) and according to each product line. Transaction records and/or invoices shall be provided that document the quantity of certified cotton purchased.
For conventional or IPM cotton that is used in blends with organic cotton, a screening test for common genetic modifications shall be accepted as a proof of compliance of the cotton variety.
1.2(b) Cotton production according to Integrated Pest Management (IPM) principles and restriction on pesticides
With the exception of footwear intended for children under three years of age, a minimum of 20 % weight by weight of the non-recycled cotton fibre used in the product shall be grown according to IPM principles as defined by the UN Food and Agricultural Organisation (FAO) IPM programme or Integrated Crop Management (ICM) systems incorporating IPM principles.
At least 60 % of the non-recycled cotton fibre used in footwear intended for children under three years of age shall be grown according to IPM principles.
IPM cotton destined for use in the final product shall be grown without the use of any of the following substances: aldicarb, aldrin, camphechlor (toxaphene), captafol, chlordane, 2,4,5-T, chlordimeform, cypermethrin, DDT, dieldrin, dinoseb and its salts, endosulfan, endrin, heptachlor, hexachlorobenzene, hexachlorocyclohexane (total isomers), methamidophos, methylparathion, monocrotophos, neonicotinoids (clothianidine, imidacloprid, thiametoxam), parathion, pentachlorophenol.
Assessment and verification: the applicant or material supplier, as appropriate, shall provide a declaration of compliance with criterion 1.2(b), supported by evidence that at least 20 % weight by weight of the non-recycled cotton fibre contained in the product, or 60 % weight by weight in the case of footwear intended for children under three years of age, has been grown by farmers that have participated in formal training programmes of the UN FAO or Government IPM or ICM programmes and/or that have been audited as part of third-party-certified IPM schemes. Verification shall either be provided on an annual basis for each country of origin or on the basis of certifications for all IPM cotton purchased to manufacture the product.
The applicant or material supplier, as appropriate, shall also declare that the IPM cotton was not grown using any of the substances listed in criterion 1.2(b). IPM certification schemes that exclude the use of listed substances shall be accepted as proof of compliance.
1.3. Sustainable wood and cork
Criterion 1.3 shall apply when the wood or cork content used in shoe uppers or shoe outer soles is greater than 10,0 % weight by weight of either component.
All wood and cork shall be covered by chain of custody certificates issued by an independent third-party certification scheme such as the Forest Stewardship Council (FSC), the Programme for the Endorsement of Forest Certification (PEFC) or equivalent.
All virgin wood and cork shall not originate from GMO species and shall be covered by valid sustainable forest management and chain of custody certificates issued by an independent third-party certification scheme such as FSC, PEFC or equivalent.
Where a certification scheme allows the mixing of uncertified material with certified and/or recycled materials in a product or production line, a minimum of 70 % of the wood or cork material, as appropriate, shall be sustainable certified virgin material and/or recycled material.
Uncertified material shall be covered by a verification system which ensures that it is legally sourced and meets any other requirements of the certification scheme with respect to uncertified material.
The certification bodies issuing forest and/or chain of custody certificates shall be accredited or recognised by that certification scheme.
Assessment and verification: the applicant or material supplier, as appropriate, shall provide a declaration of compliance supported by valid, independently certified chain of custody certificate(s) for all wood and cork material used in the product or production line and demonstrate that at least 70 % of the wood or cork material originates from forests or areas managed according to sustainable forest management principles and/or from recycled sources that meet the requirements set out by the relevant independent chain of custody certification scheme. FSC, PEFC or equivalent schemes shall be accepted as independent third-party certification. In case the scheme does not specifically require that all virgin material is sourced from non-GMO species, additional evidence shall be provided to demonstrate this.
If the product or production line includes uncertified virgin material, proof shall be provided that the content of uncertified virgin material does not exceed 30 % and is covered by a verification system which ensures that it is legally sourced and meets any other requirements of the certification scheme with respect to uncertified material.
1.4. Man-made cellulose fibres (including viscose, modal and lyocell)
Criterion 1.4 shall apply when the man-made cellulose fibre content used in shoe uppers or shoe outer soles is greater than 10,0 % weight by weight of either component.
Man-made cellulose fibres that contain 70,0 % weight by weight or more of recycled content are exempted from the requirement of criterion 1.4.
A minimum of 25,0 % of the non-recycled pulp fibres shall be manufactured from wood that has been grown according to the principles of sustainable forest management as defined by the UN FAO. The remaining proportion of the non-recycled pulp fibres shall be from pulp that is sourced from legal forestry and plantations.
Textile products that have been awarded the EU Ecolabel based on the ecological criteria of Decision 2014/350/EU are considered to comply with criterion 1.4.
Assessment and verification: the applicant or material supplier, as appropriate, shall provide a declaration of compliance.
Where EU Ecolabel textile products are used, the applicant shall provide a copy of the EU Ecolabel certificate showing that it was awarded in accordance with Decision 2014/350/EU. Otherwise, the applicant shall obtain from the fibre manufacturer(s) valid, third-party certified chain of custody certificates demonstrating that the wood fibres have been grown according to sustainable forest management principles and/or are from legal sources. FSC, PEFC or equivalent schemes shall be accepted as independent certification.
The fibre manufacturer shall demonstrate that due diligence processes have been followed as specified in Regulation (EU) No 995/2010 of the European Parliament and of the Council ( 6 ) in order to ensure that timber has been legally harvested. Valid EU Forest Law Enforcement, Governance and Trade (FLEGT) or UN Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) licences and/or third-party certification shall be accepted as evidence of legal sourcing.
Where applicable, recycled content shall be traceable back to the reprocessing of the feedstock. That shall be verified by independent third-party certification of the chain of custody or by documentation provided by feedstock suppliers and reprocessors.
1.5. Plastics
PVC plastic shall not be used in any part of the product.
Assessment and verification: the applicant or material supplier, as appropriate, shall provide a declaration of compliance.
Criterion 2 — Reduction of water consumption and restriction on the tanning of hides and skins
Raw hides and skins that are destined to be used in the final product shall be subject to the limit on water consumption in the tanning process as specified under criterion 2.1.
Leather used in products intended for children under three years of age shall be subject to the restriction on chromium-based tanning as specified under criterion 2.2.
2.1. Water consumption
The criterion shall apply when the leather content used in shoe uppers or shoe outer soles is greater than 10,0 % weight by weight of either component.
Water consumption expressed as the annual average volume of water consumed per tonne of raw hides and skins shall not exceed the limits given in Table 1.
Table 1
Maximum permitted water consumption in tanning processes
<table><col/><col/><tbody><tr><td><p>Hides</p></td><td><p>28&#160;m<span>3</span>/t</p></td></tr><tr><td><p>Skins</p></td><td><p>45&#160;m<span>3</span>/t</p></td></tr><tr><td><p>Vegetable tanned leather</p></td><td><p>35&#160;m<span>3</span>/t</p></td></tr><tr><td><p>Pigskin</p></td><td><p>80&#160;m<span>3</span>/t</p></td></tr><tr><td><p>Sheepskins</p></td><td><p>180&#160;l/skin</p></td></tr></tbody></table>
Assessment and verification: the applicant shall provide a declaration of compliance from the leather supplier or leather manufacturing company, as appropriate. The declaration shall specify the annual amount of leather production and related water consumption based on the monthly average values of the last 12 months preceding the application, measured by the quantity of waste water discharged.
If the leather production process is conducted in different geographical locations, the applicant or supplier of semi-finished leather shall provide documentation that specifies the quantity of water discharged (m 3 ) for the quantity of semi-finished leather processed in tonnes (t) or number of skins for sheepskin, as appropriate, based on the monthly average values during the 12 months preceding the application.
2.2. Restriction on the tanning of hides and skins
For footwear intended for children under three years of age, raw hides and skins destined to be used in linings and socks, as defined in Article 2(2), shall be processed using chromium-free tanning technology.
Assessment and verification: for footwear intended for children under three years of age, the applicant shall submit a declaration of compliance from the leather manufacturer or leather supplier, as appropriate, with the information that the leather used in the interior parts of the footwear (lining and/or socks) is chromium-free tanned. The declaration shall specify the tanning agent used in the processing of raw hides and skins.
Criterion 3 — Emissions to water from the production of leather, textiles and rubber
Textiles, leather and rubber that are destined to be used in the final product shall be subject to the limit on emissions to water.
The criterion shall apply whenever the leather, textile or rubber content, as appropriate, is used in shoe uppers or shoe outer soles and is greater than 10,0 % weight by weight of either component.
3.1. Chemical Oxygen Demand (COD) in waste water from leather tanning sites
The COD value in waste water from leather tanning sites, when discharged to surface waters after treatment (whether on site or off site), shall not exceed 200,0 mg/l.
Assessment and verification: the applicant or material supplier, as appropriate, shall provide a declaration of compliance supported by detailed documentation and test reports in accordance with ISO 6060 showing compliance with this criterion on the basis of monthly averages for the six months preceding the application. The data shall demonstrate the compliance of the production site or, if the effluent is treated off site, of the waste water treatment operator.
3.2. Chemical Oxygen Demand (COD) in waste water from textile finishing processes
The COD value in waste water discharges from textile finishing processes shall not exceed 20,0 g/kg of textiles processed.
Finishing processes shall include the thermosetting, thermosoling, coating and impregnating of textiles. This requirement shall apply to wet processes used in the finishing of the textile fabric. The requirement shall be measured downstream of an on-site waste water treatment plant or a municipal waste water treatment plant receiving waste water from these processing sites.
Textile products that have been awarded the EU Ecolabel based on the ecological criteria of Decision 2014/350/EU are considered compliant with criterion 3.2.
Assessment and verification: the applicant or material supplier, as appropriate, shall provide a declaration of compliance.
Where EU Ecolabel textile products are used, the applicant shall provide a copy of the EU Ecolabel certificate showing that it was awarded in accordance with Decision 2014/350/EU.
Otherwise, the applicant or material supplier, as appropriate, shall provide detailed documentation and test reports in accordance with ISO 6060, showing compliance with this criterion on the basis of monthly averages for the six months preceding the application. The data shall demonstrate the compliance by the production site or, if the effluent is treated off site, by the waste water treatment operator.
3.3. Chemical Oxygen Demand (COD) in waste water from the processing of natural and synthetic rubber
The COD value in waste water from the processing of natural or synthetic rubber, as applicable, when discharged to surface waters after treatment (whether on site or off site), shall not exceed 150,0 mg/l. This requirement shall apply to wet processes used to manufacture the rubber.
Assessment and verification: the applicant or material supplier, as appropriate, shall provide a declaration of compliance supported by detailed documentation and test reports, based on ISO 6060 showing compliance with this criterion on the basis of monthly averages for the six months preceding the application The data shall demonstrate compliance by the production site or, if the effluent is treated off site, by the waste water treatment operator.
3.4. Chromium in tannery waste water after treatment
The total chromium concentration in tannery waste water after treatment shall not exceed 1,0 mg/l as specified in Commission Implementing Decision 2013/84/EU ( 7 ).
Assessment and verification: the applicant or material supplier, as appropriate, shall provide a declaration of compliance supported by a test report using one of the following test methods: ISO 9174, EN 1233 or EN ISO 11885 for chromium and showing compliance with this criterion on the basis of monthly averages for the six months preceding the application. The applicant shall provide a declaration of compliance with BAT 10 and either BAT 11 or 12, as appropriate, of Implementing Decision 2013/84/EU for the reduction of the chromium content of waste water discharges.
Criterion 4 — Volatile organic compounds (VOCs)
Unless otherwise specified, the total use of VOCs in the final footwear production shall not exceed, on average, 18,0 g VOC/pair.
For footwear classified as personal protective equipment in accordance with Directive 89/686/EEC, the total use of VOCs during final footwear production shall not exceed, on average, 20,0 g VOC/pair.
Assessment and verification: the applicant shall provide a declaration of compliance supported by a calculation of the total use of VOCs during final shoe production in accordance with EN 14602. The calculation shall be supported by test results and documentation (registration of purchased leather, adhesives, finishes and production of footwear) as appropriate.
Where applicable, a copy of certification issued by a certification body notified under Directive 89/686/EEC that proves that the product is classified as personal protective equipment shall be provided.
Criterion 5 — Hazardous substances in the product and shoe components
The presence in the final product, and any homogeneous materials or articles thereof, of substances and mixtures that meet the criteria for classification according to Article 57 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council ( 8 ) as substances of very high concern (SVHCs) or substances or mixtures that meet the criteria for classification, labelling and packaging (CLP) according to Regulation (EC) No 1272/2008 of the European Parliament and of the Council ( 9 ) for the hazards listed in Table 2 shall be restricted in accordance with criteria 5.1 and 5.2.
For the purposes of this criterion, the Candidate List of substances of very high concern (SVHCs) and CLP hazard classifications are grouped in Table 2 according to their hazardous properties.
The criterion does not apply to substances or mixtures which change their properties upon processing (in other words, substances which become no longer bioavailable or undergo chemical modification) such that the identified hazard no longer applies. This shall include chemical reactions where substances have been modified such as polymerisation where monomers or additives become covalently bonded.
Textile products that have been awarded the EU Ecolabel based on the ecological criteria of Decision 2014/350/EU are considered to comply with criterion 5.
Table 2
Grouping of restricted hazards
Group 1 hazards — Substances of very high concern (SVHC)
Hazards that identify a substance or mixture as being within Group 1:
— Substances that appear on the Candidate List for substances of very high concern (SVHC) by the European Chemical Agency (ECHA) ( 10 )
— Carcinogenic, Mutagenic and/or Toxic for Reproduction (CMR) Category 1A or 1B: H340, H350, H350i, H360, H360F, H360D, H360FD, H360Fd, H360Df
Group 2 hazards — CLP hazards
Hazards that identify a substance or mixture as being within Group 2:
— Category 2 CMR: H341, H351, H361f, H361d, H361fd, H362
— Category 1 aquatic toxicity: H400, H410
— Category 1 and 2 acute toxicity: H300, H310, H330,
— Category 1 aspiration toxicity: H304
— Category 1 Specific Target Organ Toxicity (STOT): H370, H372
— Category 1 Skin Sensitiser: H317
Group 3 hazards — CLP hazards
Hazards that identify a substance or mixture as being within Group 3:
— Category 2, 3 and 4 aquatic toxicity: H411, H412, H413
— Category 3 acute toxicity: H301, H311, H331, EUH070
— Category 2 STOT ( *1 ): H371, H373
5.1. Restriction of substances of very high concern
The final product, and any homogeneous materials or articles thereof, shall not contain substances that have been identified according to the procedure described in Article 59(1) of Regulation (EC) No 1907/2006 and included in the Candidate List for SVHCs in concentrations higher than 0,10 % weight by weight.
No derogation shall be given to Candidate List SVHCs if they are present in the final product, or to any homogeneous materials or articles that form part of the final product in concentrations higher than 0,10 % weight by weight.
The screening shall be based on the identification of the potential for presence of such substances in the product.
Assessment and verification: the applicant shall provide a declaration of compliance supported, where appropriate, by declarations from the material supplier regarding the absence of SVHCs at concentrations greater than 0,10 % (weight by weight) for the final product, and any homogeneous materials or articles that form part of the product. Declarations shall be referenced to the latest version of the Candidate List published by ECHA ( 11 ).
Where EU Ecolabel textile products are used, the applicant shall provide a copy of the EU Ecolabel certificate showing that it was awarded in accordance with Decision 2014/350/EU.
5.2. Restriction based on CLP classified substances and mixtures
With the exception of linings and socks, as defined in Article 2(2) of this Decision, the criterion shall apply when the content of any homogeneous material or article in shoe uppers or shoe outer soles is greater than 3,0 % (weight by weight) of either component. For linings and socks, any homogeneous material or article that is used for linings and socks shall be subject to the restriction as specified in the next paragraph.
Substances and mixtures falling within the groups identified in Table 3 that meet the criteria for classification with the CLP hazards in Table 2 shall not be present in any homogeneous materials or articles that form part of the final product in concentrations higher than 0,10 % (weight by weight).
Table 3
Substances and mixtures groups to which criterion 5.2 shall apply
— Active substances of biocidal products;
— Dyestuffs (including inks, pigments and varnishes);
— Auxiliary carriers, levelling, blowing and dispersing agents, surfactants;
— Fatliquoring agents;
— Solvents;
— Print thickeners, binders, stabilisers, and plasticisers;
— Flame retardants;
— Cross-linking agents, adhesives;
— Water, dirt, and stain repellents.
The use of certain substances and mixtures referred to in Table 3 is exempted from the requirements of criterion 5.2 subject to the conditions specified in Table 4.
Table 4
Derogation conditions that shall apply to the use of functional substances and mixtures
<table><col/><col/><col/><col/><tbody><tr><td><p>Substances and mixtures</p></td><td><p>Scope of derogation</p></td><td><p>Derogation conditions</p></td><td><p>Applicability to footwear</p></td></tr><tr><td><p>Nickel</p></td><td><p>H317, H351, H372</p></td><td><p>Nickel can only be contained in stainless steel.</p><p>A nickel release rate from the stainless steel shall be less than or equal to 0,5&#160;&#956;g/cm<span>2</span>/week as specified in criterion 6 (RSL).</p></td><td><p>Metal toecaps and footwear accessories</p></td></tr><tr><td><p>Dyestuffs for dyeing and non-pigment printing</p></td><td><p>H301, H311, H331, H317</p></td><td><p>Dust-free dye formulations or automatic dosing and dispensing of dyes shall be used by dye houses and printers to minimise worker exposure.</p></td><td><p>Dyestuffs</p></td></tr><tr><td><p>Dyestuffs for dyeing and non-pigment printing</p></td><td><p>H411, H412, H413</p></td><td><p>Dyeing processes using reactive, direct, vat, or sulphur dyes with these classifications shall meet a minimum of one of the following conditions:</p><p>1.&#160;&#160;Use of high affinity dyes;</p><p>2.&#160;&#160;Achievement of a reject rate of less than 3,0&#160;%;</p><p>3.&#160;&#160;Use of colour matching instrumentation;</p><p>4.&#160;&#160;Implementation of standard operating procedures for the dyeing process;</p><p>5.&#160;&#160;Use of colour removal to treat waste water.</p><p>The use of solution dyeing and/or digital printing is exempted from these conditions.</p></td><td><p>Dyestuffs</p></td></tr><tr><td><p>Water, dirt and stain repellents</p></td><td><p>H413</p></td><td><p>The repellent and its degradation products shall be readily and/or inherently biodegradable and non-bioaccumulative substances in the aquatic environment, including aquatic sediment.</p></td><td><p>Water repellence</p></td></tr><tr><td><p>Residual auxiliaries found in any homogeneous materials or articles that form part of the final product</p></td></tr><tr><td><p>Auxiliaries comprising: carriers, levelling agents, dispersing agents, surfactants, thickeners, binders</p></td><td><p>H301, H311, H331, H371, H373, H317 (1B), H411, H412, H413, EUH070,</p></td><td><p>Recipes shall be formulated using automatic dosing systems and processes shall follow standard operating procedures.</p><p>Substances classified with H311, H331, H317 (1B) shall not be present at concentrations greater than 1,0&#160;% w/w in any homogeneous material or article that forms part of the final product.</p></td><td><p>Auxiliaries</p></td></tr></tbody></table>
Assessment and verification: the applicant shall provide a declaration of compliance with criterion 5.2 supported, where appropriate, by declarations from the material supplier(s). The declaration shall be supported by a list of the substances and/or substances in mixtures as specified in Table 3 that are present in any homogeneous material or article that forms part of the final product, together with information about their hazard classification or non-classification.
The following information shall be provided to support declarations of the hazard classification or non-classification for each substance or mixture:
— the substance's CAS, EC or list number (where available for mixtures);
— the physical form and state in which the substance or mixture is used;
— harmonised CLP hazard classifications;
— self-classification entries in ECHA's REACH registered substance database if no harmonised classification is available ( 12 );
— mixture classifications according to the criteria laid down in the CLP Regulation.
When considering self-classification entries in the REACH registered substance database, priority shall be given to entries from joint submissions.
Where a classification is recorded as ‘data lacking’ or ‘inconclusive’ according to the REACH registered substance database, or where a substance has not yet been registered under the REACH regulation, toxicological data meeting the requirements in Annex VII to Regulation (EC) No 1907/2006 shall be provided that are sufficient to support conclusive self-classification in accordance with Annex I to Regulation (EC) No 1272/2008 and ECHA's supporting guidance. In the case of ‘data lacking’ or ‘inconclusive’ database entries, self-classifications shall be verified, with the following information sources being accepted:
— Toxicological studies and hazard assessments by ECHA peer regulatory agencies ( 13 ), Member State regulatory bodies or intergovernmental bodies.
— A Safety Data Sheet (SDS) fully completed in accordance with Annex II to Regulation (EC) No 1907/2006.
— A documented expert judgement provided by a professional toxicologist. This shall be based on a review of scientific literature and existing testing data, where necessary supported by results from new testing carried out by independent laboratories using methods recognised by ECHA.
— An attestation, where appropriate based on expert judgement, issued by an accredited conformity assessment body that carries out hazard assessments according to the Globally Harmonised System (GHS) of the classification and labelling of chemicals or CLP hazard classification systems.
Information on the hazardous properties of substances or mixtures may, in accordance with Annex XI to Regulation (EC) No 1907/2006, be generated by means other than tests, for instance through the use of alternative methods such as in vitro methods, by quantitative structure activity models or by the use of grouping or read-across.
For the derogated substances and mixtures listed in Table 4, the applicant shall provide proof that all the derogation conditions are met.
Where EU Ecolabel textile products are used, the applicant shall provide a copy of the EU Ecolabel certificate showing that it was awarded in accordance with Decision 2014/350/EU.
Criterion 6 — Restricted Substances List (RSL)
The criterion shall apply when any homogeneous material or article used in shoe uppers or shoe outer soles is greater than 3,0 % weight by weight of either component.
The final product, homogeneous materials or articles that form part of the final product, or production recipes used, as applicable, shall not contain substances specified under the Restricted Substances List (RSL). The applicability, scope of restrictions, verification and testing requirements are provided in the RSL for each substance or group of substances. The RSL can be found in the Appendix to this Decision.
The RSL shall be communicated by the applicant to all the suppliers of materials or articles that will be used as components of the EU Ecolabel product.
Textile products that have been awarded the EU Ecolabel based on the ecological criteria of Decision 2014/350/EU are considered to comply with criterion 6.
Assessment and verification: the applicant and their material supplier(s), as appropriate, shall provide a declaration of compliance with the RSL supported by evidence that is applicable to the substances and mixtures used to manufacture the final product or its materials. Verification shall be provided for each relevant requirement as indicated in the RSL, which may include:
— declarations obtained from those responsible for related production stages;
— declarations from chemical suppliers; or
— test results from laboratory analysis of samples of the final product.
Where required, Safety Data Sheets shall be completed in accordance with the guidance in Sections 10, 11 and 12 of Annex II to Regulation (EC) No 1907/2006 (Requirements for the Compilation of Safety Data Sheets). Incomplete Safety Data Sheets (SDS) will require supplemental declarations from chemical suppliers.
Where laboratory analysis of the final product is required, it shall be performed for specific product lines and based on random sampling. Where specified, it shall be carried out annually during the licence period in order to demonstrate ongoing compliance with the RSL criterion with results then communicated to the relevant competent body.
Test data obtained for the purposes of compliance with industry RSLs and other footwear certification schemes shall be accepted where the test methods are equivalent.
Where EU Ecolabel textile products are used, the applicant shall provide a copy of the EU Ecolabel certificate showing that it was awarded in accordance with Decision 2014/350/EU.
Criterion 7 — Parameters contributing to durability
Occupational and safety footwear shall carry the CE mark and shall meet the durability requirements specified in accordance with Directive 89/686/EEC. All other footwear shall meet the requirements indicated in Table 5.
Table 5
Durability parameters
<table><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Parameter/Standard test method</p></td><td><p>General sports</p></td><td><p>School footwear</p></td><td><p>Casual</p></td><td><p>Men's town</p></td><td><p>Cold weather footwear</p></td><td><p>Women's town</p></td><td><p>Fashion</p></td><td><p>Infants</p></td><td><p>Indoor</p></td></tr><tr><td><p>Uppers' flex resistant:</p><p>(kc without visible damage)/EN 13512</p></td><td><p>Dry&#160;= 100</p><p>Wet&#160;= 20</p></td><td><p>Dry&#160;= 100</p><p>Wet&#160;= 20</p></td><td><p>Dry&#160;= 80</p><p>Wet&#160;= 20</p></td><td><p>Dry&#160;= 80</p><p>Wet&#160;= 20</p></td><td><p>Dry&#160;= 100</p><p>Wet&#160;= 20</p><p>&#8211; 20&#176; = 30</p></td><td><p>Dry&#160;= 50</p><p>Wet&#160;= 10</p></td><td><p>Dry&#160;= 15</p></td><td><p>Dry&#160;= 15</p></td><td><p>Dry&#160;= 15</p></td></tr><tr><td><p>Uppers' tear strength</p><p>(Average tear force, N)/EN 13571</p></td><td><p>Leather</p></td><td><p>&#8805;&#160;80</p></td><td><p>&#8805;&#160;60</p></td><td><p>&#8805;&#160;60</p></td><td><p>&#8805;&#160;60</p></td><td><p>&#8805;&#160;60</p></td><td><p>&#8805;&#160;40</p></td><td><p>&#8805;&#160;30</p></td><td><p>&#8805;&#160;30</p></td><td><p>&#8805;&#160;30</p></td></tr><tr><td><p>Other materials</p></td><td><p>&#8805;&#160;40</p></td><td><p>&#8805;&#160;40</p></td><td><p>&#8805;&#160;40</p></td><td><p>&#8805;&#160;40</p></td><td><p>&#8805;&#160;40</p></td><td><p>&#8805;&#160;40</p></td><td><p>&#8805;&#160;30</p></td><td><p>&#8805;&#160;30</p></td><td><p>&#8805;&#160;30</p></td></tr><tr><td><p>Outsoles' flex resistance:</p><p>EN 17707</p></td><td><p>Cut growth (mm)</p><p>Nsc = no spontaneous crack</p></td><td><p>&#8804;&#160;4</p><p>Nsc</p></td><td><p>&#8804;&#160;4</p><p>Nsc</p></td><td><p>&#8804;&#160;4</p><p>Nsc</p></td><td><p>&#8804;&#160;4</p><p>Nsc</p></td><td><p>&#8804;&#160;4</p><p>Nsc at &#8211;&#160;10&#160;&#176;C</p></td><td><p>&#8804;&#160;4</p><p>Nsc</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Outsoles' abrasion resistance/EN 12770</p></td><td><p>D &#8805;&#160;0,9&#160;g/cm<span>3</span> (mm<span>3</span>)</p></td><td><p>&#8804;&#160;200</p></td><td><p>&#8804;&#160;200</p></td><td><p>&#8804;&#160;250</p></td><td><p>&#8804;&#160;350</p></td><td><p>&#8804;&#160;200</p></td><td><p>&#8804;&#160;400</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td><td><p>&#8804;&#160;450</p></td></tr><tr><td><p>D &lt;&#160;0,9&#160;g/cm<span>3</span> (mg)</p></td><td><p>&#8804;&#160;150</p></td><td><p>&#8804;&#160;150</p></td><td><p>&#8804;&#160;170</p></td><td><p>&#8804;&#160;200</p></td><td><p>&#8804;&#160;150</p></td><td><p>&#8804;&#160;250</p></td><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td><td><p>&#8804;&#160;300</p></td></tr><tr><td><p>Upper-sole adhesion (N/mm)/EN 17708</p></td><td><p>&#8805;&#160;4,0</p></td><td><p>&#8805;&#160;4,0</p></td><td><p>&#8805;&#160;3,0</p></td><td><p>&#8805;&#160;3,5</p></td><td><p>&#8805;&#160;3,5</p></td><td><p>&#8805;&#160;3,0</p></td><td><p>&#8805;&#160;2,5</p></td><td><p>&#8805;&#160;3,0</p></td><td><p>&#8805;&#160;2,5</p></td></tr><tr><td><p>Outsoles' tear strength</p><p>(Average strength, N/mm)/EN 12771</p></td><td><p>D &#8805;&#160;0,9&#160;g/cm<span>3</span></p></td><td><p>8</p></td><td><p>8</p></td><td><p>8</p></td><td><p>6</p></td><td><p>8</p></td><td><p>6</p></td><td><p>5</p></td><td><p>6</p></td><td><p>5</p></td></tr><tr><td><p>D &lt;&#160;0,9&#160;g/cm<span>3</span></p></td><td><p>6</p></td><td><p>6</p></td><td><p>6</p></td><td><p>4</p></td><td><p>6</p></td><td><p>4</p></td><td><p>4</p></td><td><p>5</p></td><td><p>4</p></td></tr><tr><td><p>Colour fastness of the inside of the footwear (lining or inner face of the upper). Grey scale on the felt after 50&#160;cycles wet/EN ISO 17700</p></td><td><p>&#8805;&#160;2/3</p></td><td><p>&#8805;&#160;2/3</p></td><td><p>&#8805;&#160;2/3</p></td><td><p>&#8805;&#160;2/3</p></td><td><p>&#8805;&#160;2/3</p></td><td><p>&#8805;&#160;2/3</p></td><td><p>&#160;</p><div/></td><td><p>&#8805;&#160;2/3</p></td><td><p>&#8805;&#160;2/3</p></td></tr><tr><td><p>Linings' and socks' abrasion cycles/EN 17704</p></td><td><p>&gt;&#160;25&#160;600  dry</p><p>&gt;&#160;12&#160;800  wet</p></td><td><p>&gt;&#160;25&#160;600  dry</p><p>&gt;&#160;12&#160;800  wet</p></td><td><p>&gt;&#160;25&#160;600  dry</p><p>&gt;&#160;12&#160;800  wet</p></td><td><p>&gt;&#160;25&#160;600  dry</p><p>&gt;&#160;6&#160;400  wet</p></td><td><p>&gt;&#160;25&#160;600  dry</p><p>&gt;&#160;12&#160;800  wet</p></td><td><p>&gt;&#160;25&#160;600  dry</p><p>&gt;&#160;6&#160;400  wet</p></td><td><p>&gt;&#160;25&#160;600  dry</p><p>&gt;&#160;3&#160;200  wet</p></td><td><p>&gt;= 25&#160;600  dry</p><p>&gt;= 12&#160;800  wet</p></td><td><p>&gt;&#160;8&#160;400  dry</p><p>&gt;&#160;1&#160;600  wet</p></td></tr></tbody></table>
Assessment and verification: the applicant shall provide a declaration of compliance supported by test reports as specified in Table 5.
Where applicable, a copy of the certification issued by a certification body notified under Directive 89/686/EEC that proves that the product is classified as personal protective equipment shall be provided.
Criterion 8 — Corporate Social Responsibility with regard to labour aspects
Requirements in this criterion shall apply to the final footwear assembly site.
Having regard to the International Labour Organisation's (ILO) Tripartite Declaration of Principles concerning Multinational Enterprises and Social Policy, the UN Global Compact (Pillar 2), the UN Guiding Principles on Business and Human Rights and the OECD Guidelines for Multinational Enterprises, the applicant shall obtain third-party verification supported by site audit(s) that the applicable principles included in the ILO's fundamental conventions and the supplementary provisions below have been respected at the final footwear assembly site for the product.
Fundamental conventions of the ILO:
(i) Child Labour:
— Minimum Age Convention, 1973 (No 138);
— Worst Forms of Child Labour Convention, 1999 (No 182).
(ii) Forced and Compulsory Labour:
— Forced Labour Convention, 1930 (No 29) and 2014 Protocol to the Forced Labour Convention;
— Abolition of Forced Labour Convention, 1957 (No 105).
(iii)
Freedom of Association and Right to Collective Bargaining:
— Freedom of Association and Protection of the Right to Organise Convention, 1948 (No 87);
— Right to Organise and Collective Bargaining Convention, 1949 (No 98).
(iv) Discrimination:
— Equal Remuneration Convention, 1951 (No 100);
— Discrimination (Employment and Occupation) Convention, 1958 (No 111).
Supplementary provisions:
(v) Working Hours:
— ILO Hours of Work (Industry) Convention, 1919 (No 1).
(vi) Remuneration:
— ILO Minimum Wage Fixing Convention, 1970 (No 131);
— Living wage: The applicant shall ensure that wages paid for a normal working week shall always meet at least legal or industry minimum standards, are sufficient to meet the basic needs of personnel and provide some discretionary income. Implementation shall be audited with reference to the SA8000 ( 14 ) guidance on ‘Remuneration’.
(vii)
Health & Safety:
— ILO Safety in the use of chemicals at work Convention, 1981 (No 170);
— ILO Occupational Safety and Health Convention, 1990 (No 155).
In locations where the right to freedom of association and collective bargaining are restricted under law, the company shall recognise legitimate employee associations with whom it can enter into dialogue about workplace issues.
The audit process shall include consultation with external stakeholders in local areas around sites, including trade unions, community organisations, NGOs and labour experts. The applicant shall publish the aggregated results and key findings from the audit online in order to provide evidence of their supplier's performance to interested consumers.
Assessment and verification: the applicant shall provide a declaration of compliance together with copies of certificates and a supporting audit reports for each final product assembly plant for the model(s) to be ecolabelled.
The third-party site audit shall be carried out by private auditors qualified to assess the compliance of the footwear industry supply chain with social standards or codes of conduct or, in countries where the ILO Labour Inspection Convention, 1947 (No 81) has been ratified and ILO supervision indicates that the national labour inspection system is effective ( 15 ) and where the scope of the inspection systems covers the areas listed above, by labour inspector(s) appointed by a national authority.
Certificate(s), not dated more than 12 months prior to the application, from schemes or processes that audit compliance with the applicable principles of the listed fundamental ILO conventions, together with the supplementary provisions on working hours, remuneration and health and safety, shall be accepted.
Criterion 9 — Packaging
This criterion applies only to primary packaging, as defined in European Parliament and Council Directive 94/62/EC ( 16 ).
9.1. Cardboard and paper
Cardboard and paper used for the final packaging of footwear shall be made of 100 % recycled material.
9.2. Plastic
Plastic used for the final packaging of footwear shall be made of at least 80 % recycled material.
Assessment and verification: the applicant or packaging supplier, as appropriate, shall provide a declaration of compliance specifying the material composition of the packaging and the shares of recycled and virgin material.
Criterion 10 — Information on the packaging
10.1. User Instructions
The following information shall be supplied with the product:
— Cleaning and care instructions specified for each product.
— ‘Repair your footwear rather than throw it away. This is less damaging to the environment.’
— ‘Please dispose of your footwear in the appropriate local collection point.’
Assessment and verification: the applicant shall provide a packaging sample or the proposed artwork of the packaging showing the user instructions that will be supplied with the product.
10.2. Information appearing on the EU Ecolabel
If the optional label with a text box is used, it shall contain, where relevant, three of the following statements:
(i) natural origin raw materials sustainably managed (in case criterion 1 applies);
(ii) reduced pollution in production processes;
(iii)
minimised use of hazardous substances;
(iv) tested for durability;
(v) xx % organic cotton used (this claim may be made only if, based on criterion 1.2(a), more than 95 % of the total cotton is organic).
The guidelines for the use of the optional label with a text box can be found in the ‘Guidelines for use of the Ecolabel logo’ on the website:
http://ec.europa.eu/environment/ecolabel/documents/logo_guidelines.pdf
Assessment and verification: the applicant shall provide a declaration of compliance together with a sample of the product label or the proposed artwork showing where the EU Ecolabel is placed.
APPENDIX
RESTRICTED SUBSTANCES LIST (RSL)
The list applies to substances that may be used during the production process or may be present in the final product. The EU Ecolabel RSL for Footwear compiles substances or groups of substances whose presence in the final product, materials or articles thereof, or production recipes, as applicable, shall be specifically restricted or verified. The restrictions apply to:
— production stages (for instance dyeing);
— recipes used in the footwear production stages (for instance auxiliaries);
— homogeneous materials or articles (for instance synthetic or natural rubber);
— final products.
The applicability, material(s) and/or production stage(s) where relevant, scope of restriction, verification and/or testing requirements are specified for each requirement.
The RSL shall be communicated by the applicant to all material suppliers.
Textile products that have been awarded the EU Ecolabel based on the ecological criteria of Decision 2014/350/EU are considered to comply with criterion 6.
Table 1
The following restrictions apply to specified production stages.
<table><col/><col/><col/><col/><tbody><tr><td><p>Applicability</p></td><td><p>Scope of restriction</p></td><td><p>Limit values</p></td><td><p>Verification</p></td></tr><tr><td><p>(a)&#160;&#160;Auxiliaries</p></td></tr><tr><td><p>Any mixture or formulation used in the production stages of leather, textiles, and coated leather and textiles</p></td><td><p>The following substances shall not be used in any mixtures or formulations used in production stages and are subject to the limit values for the presence of substances in the final product:</p><div><p>&#8212;&#160;Nonylphenol, mixed isomers CAS No 25154-52-3</p></div><div><p>&#8212;&#160;4-Nonylphenol CAS No 104-40-5</p></div><div><p>&#8212;&#160;4-Nonylphenol, branched CAS No 84852-15-3</p></div><div><p>&#8212;&#160;Octylphenol CAS No 27193-28-8</p></div><div><p>&#8212;&#160;4-Octylphenol CAS No 1806-26-4</p></div><div><p>&#8212;&#160;4-tert-Octylphenol CAS No 140-66-9</p></div><p>The following alkylphenolethoxylates (APEOs):</p><div><p>&#8212;&#160;Polyoxyethylated octyl phenol CAS No 9002-93-1</p></div><div><p>&#8212;&#160;Polyoxyethylated nonyl phenol CAS No 9016-45-9</p></div><div><p>&#8212;&#160;Polyoxyethylated p-nonyl phenol CAS No 26027-38-3</p></div></td><td><p>25&#160;mg/kg sum total for textiles</p><p>100&#160;mg/kg sum total for leather</p></td><td><p><span>Assessment and verification:</span> the applicant or material supplier(s) shall provide either a declaration that these substances have not been used, supported by a Safety Data Sheet or test results of the final product or of the leather, textiles, coated leather or textiles that make up the final product. Test method: leather: EN ISO 18218-2 (indirect method); textiles and coated textiles: EN ISO 18254 for alkylphenolethoxylates; for alkylphenols final product testing is to be carried out by solvent extraction followed by LC-MS or GC-MS.</p></td></tr><tr><td><p>Dyeing and finishing operations for leather, textiles, and coated leather and textiles</p></td><td><p>The following substances shall not be used in any mixtures or formulations for dyeing and finishing of leather, coated leather, and textiles:</p><div><p>&#8212;&#160;Bis(hydrogenated tallow alkyl) dimethyl ammonium chloride (DTDMAC)</p></div><div><p>&#8212;&#160;Distearyl dimethyl ammonium chloride (DSDMAC)</p></div><div><p>&#8212;&#160;Di(hardened tallow) dimethyl ammonium chloride (DHTDMAC)</p></div><div><p>&#8212;&#160;Ethylene diamine tetra acetate (EDTA),</p></div><div><p>&#8212;&#160;Diethylene triamine pentaacetate (DTPA)</p></div><div><p>&#8212;&#160;4-(1,1,3,3-tetramethylbutyl)phenol</p></div><div><p>&#8212;&#160;Nitrilotriacetic acid (NTA)</p></div></td><td><p>n/a</p></td><td><p><span>Assessment and verification:</span> the applicant or material supplier(s) shall provide a declaration of non-use.</p></td></tr><tr><td><p>(b)&#160;&#160;Colophony</p></td></tr><tr><td><p>Printing, varnishing and gluing</p></td><td><p>Colophony shall not be used as an ingredient in printing inks, varnishes or adhesives.</p></td><td><p>n/a</p></td><td><p><span>Assessment and verification:</span> the applicant or supplier(s) shall provide a declaration of non-use.</p></td></tr><tr><td><p>(c)&#160;&#160;Solvents</p></td></tr><tr><td><p>Auxiliaries used in mixtures, formulations and adhesives for leather, textiles coated leather and textiles, plastics and final products</p></td><td><p>The following substances shall not be used in any mixtures or formulations for the processing of component materials and in adhesives used during the final product assembly:</p><div><p>&#8212;&#160;2-Methoxyethanol</p></div><div><p>&#8212;&#160;N,N-dimethylformamide</p></div><div><p>&#8212;&#160;1-Methyl-2-pyrrolidone</p></div><div><p>&#8212;&#160;Bis(2-methoxyethyl) ether</p></div><div><p>&#8212;&#160;4,4&#8242;- Diaminodiphenylmethane</p></div><div><p>&#8212;&#160;1,2,3-trichloropropane</p></div><div><p>&#8212;&#160;1,2-Dichloroethane; ethylene dichloride</p></div><div><p>&#8212;&#160;2-Ethoxyethanol</p></div><div><p>&#8212;&#160;Benzene-1,4-diamine dihydrochloride</p></div><div><p>&#8212;&#160;Bis(2-methoxyethyl) ether</p></div><div><p>&#8212;&#160;Formamide</p></div><div><p>&#8212;&#160;N-methyl-2-pyrrolidone</p></div><div><p>&#8212;&#160;Trichloroethylene</p></div></td><td><p>n/a</p></td><td><p><span>Assessment and verification:</span> the applicant or material supplier(s) shall provide a declaration of non-use.</p></td></tr><tr><td><p>(d)&#160;&#160;Chlorinated paraffins</p></td></tr><tr><td><p>All production stages for leather, synthetic rubber, plastics, textiles and coatings</p></td><td><p>Short Chain Chlorinated Paraffins (SCCPs), C10-C13, shall not be used in the production and finishing of leather, synthetic rubber, plastics, textiles or coatings.</p></td><td><p>Not detectable</p></td><td><p><span>Assessment and verification:</span> the applicant or material supplier(s) shall provide a declaration that Short Chain Chlorinated Paraffins C10-C13 have not been used, supported by a Safety Data Sheet. Otherwise the applicant and/or material supplier(s) shall provide a declaration of compliance supported by the results of a test report according to EN ISO 18219.</p></td></tr><tr><td><p>Material processing for leather, synthetic rubber, plastics, textiles and coatings</p></td><td><p>Medium Chain Chlorinated Paraffins (MCCPs), C14-C17, shall be restricted in the production and finishing of leather, synthetic rubber, plastics, textiles or coatings.</p></td><td><p>1&#160;000 &#160;mg/kg</p></td><td><p><span>Assessment and verification:</span> the applicant or material supplier(s) shall provide a declaration that Medium Chain Chlorinated Paraffins C14-C17 have not been used, supported by a Safety Data Sheet. Otherwise, the applicant and/or material supplier(s) shall provide a declaration of compliance supported by the results of a test report according to EN ISO 18219.</p></td></tr><tr><td><p>(e)&#160;&#160;Biocidal products (within the meaning of Article 3(1)(a) of Regulation (EU) No 528/2012 of the European Parliament and of the Council&#160;<a>(<span>1</span>)</a></p></td></tr><tr><td><p>Used during transportation or storage of raw and semi-finished materials, final products or final product packaging</p></td><td><p>(i)&#160;&#160;Only the following active substances (within the meaning of Article&#160;3(1)(c) Regulation (EU) No 528/2012 shall be allowed:</p><div><p>&#8212;&#160;active substances included in the list drawn up in accordance with Article 9(2) of Regulation (EU) No 528/2012, for the relevant product type (i.e. fibre, leather, rubber and polymerised materials), provided the conditions or restrictions specified therein are met;</p></div><div><p>&#8212;&#160;active substances included in Annex I of that Regulation provided the conditions or restrictions specified therein are met;</p></div><div><p>&#8212;&#160;active substances under examination for the relevant product type in the work programme referred to in Article 89(1) of Regulation (EU) No 528/2012.</p></div></td><td><p>n/a</p></td><td><p><span>Assessment and verification:</span> the applicant and material supplier shall provide either declarations of non-use prior to transportation and storage, or evidence that the use of the biocidal active substance is allowed under Regulation (EU) No 528/2012.</p><p>If used, a list of active substances added during transportation or storage of raw, semi-finished materials or to final product packaging shall be provided, including the related H statements.</p></td></tr><tr><td><p>(ii)&#160;&#160;Biocidal products shall not be incorporated into final products or any part thereof during footwear assembly in order to impart biocidal properties to the final product.</p></td><td><p>n/a</p></td><td><p><span>Assessment and verification:</span> the applicant and material supplier shall provide declarations of non-use in the final product or any part thereof.</p></td></tr><tr><td><p>(iii)&#160;&#160;Chlorophenols (their salts and esters), organotin compounds (including TBT, TPhT, DBT and DOT), dimethyl fumarate (DMFu), triclosan and nanosilver shall not be used during the transportation or storage of the product, any article of it and any homogeneous part of it and shall not be incorporated into the final product or product packaging.</p></td><td><p>Not detectable</p></td><td><p><span>Assessment and verification:</span> the applicant or material supplier(s) shall provide a declaration of non-use. The declaration shall be supported by the results of final product testing for the presence of the following substances:</p><div><p><span>Chlorophenols:</span> leather, EN ISO 17070; textiles, XP G&#160;08-015 (detection limits: leather: 0,1&#160;ppm; textiles: 0,05&#160;ppm);</p></div><div><p><span>Dimethyl fumarate:</span> ISO/TS 16186.</p></div></td></tr><tr><td><p>(f)&#160;&#160;Other specific substances</p></td></tr><tr><td><p>Production recipes and adhesives used in the final product or any part thereof</p></td><td><p>The following substances shall not be intentionally added to any mixtures and formulations or to adhesives used during footwear assembly:</p><div><p>&#8212;&#160;Chlorinated or brominated dioxins or furans</p></div><div><p>&#8212;&#160;Chlorinated hydrocarbons (1,1,2,2-Tetrachloroethane, Pentachloroethane, 1,1,2-Trichloroethane, 1,1-Dichloroethylene)</p></div><div><p>&#8212;&#160;Hexachlorocyclohexane</p></div><div><p>&#8212;&#160;Monomethyldibromo&#8211;Diphenylmethane</p></div><div><p>&#8212;&#160;Monomethyldichloro-Diphenylmethane</p></div><div><p>&#8212;&#160;Nitrites</p></div><div><p>&#8212;&#160;Polybrominated Biphenyls (PBB)</p></div><div><p>&#8212;&#160;Pentabromodiphenyl Ether (PeBDE))</p></div><div><p>&#8212;&#160;Octabromodiphenyl Ether (OBDE)</p></div><div><p>&#8212;&#160;Polychlorinated Biphenyls (PCB)</p></div><div><p>&#8212;&#160;Polychlorinated Terphenyls (PCT))</p></div><div><p>&#8212;&#160;Tri-(2,3-dibromo-propyl)-phosphate (TRIS)</p></div><div><p>&#8212;&#160;Trimethylphosphate</p></div><div><p>&#8212;&#160;Tris-(aziridinyl)-phosphinoxide (TEPA)</p></div><div><p>&#8212;&#160;Tris(2-chloroethyl)-phosphate (TCEP))</p></div><div><p>&#8212;&#160;Dimethyl methylphosphonate (DMMP))</p></div></td><td><p>n/a</p></td><td><p><span>Assessment and verification:</span> the applicant or material supplier(s) shall provide a declaration of non-use.</p></td></tr><tr><td><div><a>(<span>1</span>)&#160;&#160;&#160;</a><p>Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1).</p></div></td></tr></tbody></table>
Table 2
The following restrictions apply to processes taking place in the dye house.
<table><col/><col/><col/><col/><tbody><tr><td><p>Applicability</p></td><td><p>Scope of restriction</p></td><td><p>Limit values</p></td><td><p>Verification</p></td></tr><tr><td><p>(a)&#160;&#160;Carriers</p></td></tr><tr><td><p>Carriers used in dyeing processes where disperse dyes are used</p></td><td><p>Halogenated dyeing accelerants (carriers) shall not be used (examples of carriers include: 1,2-dichlorobenzene, 1,2,4-trichlorobenzene, chlorophenoxyethanol).</p></td><td><p>n/a</p></td><td><p><span>Assessment and verification:</span> the applicant or material supplier(s) shall provide a declaration of compliance supported by a Safety Data Sheet.</p></td></tr><tr><td><p>Carriers used as blowing agents for plastics and foams</p></td><td><p>Halogenated organic compounds shall not be used as blowing agents or as auxiliary blowing agents.</p></td><td><p>n/a</p></td><td><p><span>Assessment and verification:</span> the applicant or material supplier(s) shall provide a declaration of compliance supported by a Safety Data Sheet.</p></td></tr><tr><td><p>(b)&#160;&#160;Restricted dyes</p></td></tr><tr><td><p>Azo dyes and azo colourants</p><p>Application in dyeing process</p></td><td><p>The following carcinogenic aromatic amines shall not be present in the final product.</p><br/><div><p><br/></p><table><col/><col/><tbody><tr><td><p>Arylamine</p></td><td><p>CAS number</p></td></tr><tr><td><p>4-aminodiphenyl</p></td><td><p>92-67-1</p></td></tr><tr><td><p>Benzidine</p></td><td><p>92-87-5</p></td></tr><tr><td><p>4-chloro-o-toluidine</p></td><td><p>95-69-2</p></td></tr><tr><td><p>2-naphtylamine</p></td><td><p>91-59-8</p></td></tr><tr><td><p>o-amino-azotoluene</p></td><td><p>97-56-3</p></td></tr><tr><td><p>2-amino-4-nitrotoluene</p></td><td><p>99-55-8</p></td></tr><tr><td><p>p-chloroaniline</p></td><td><p>106-47-8</p></td></tr><tr><td><p>2,4-diaminoanisol</p></td><td><p>615-05-4</p></td></tr><tr><td><p>4,4&#8242;-diaminodiphenylmethane</p></td><td><p>101-77-9</p></td></tr><tr><td><p>3,3&#8242;-dichlorobenzidine</p></td><td><p>91-94-1</p></td></tr><tr><td><p>3,3&#8242;-dimethoxybenzidine</p></td><td><p>119-90-4</p></td></tr><tr><td><p>3,3&#8242;-dimethylbenzidine</p></td><td><p>119-93-7</p></td></tr><tr><td><p>3,3&#8242;-dimethyl-4,4&#8242;-diaminodiphenylmethane</p></td><td><p>838-88-0</p></td></tr><tr><td><p>p-cresidine</p></td><td><p>120-71-8</p></td></tr><tr><td><p>4,4&#8242;-methylene-bis-(2-chloroaniline)</p></td><td><p>101-14-4</p></td></tr><tr><td><p>4,4&#8242;-oxydianiline</p></td><td><p>101-80-4</p></td></tr><tr><td><p>4,4&#8242;-thiodianiline</p></td><td><p>139-65-1</p></td></tr><tr><td><p>o-toluidine</p></td><td><p>95-53-4</p></td></tr><tr><td><p>2,4-diaminotoluene</p></td><td><p>95-80-7</p></td></tr><tr><td><p>2,4,5-trimethylaniline</p></td><td><p>137-17-7</p></td></tr><tr><td><p>o-anisidine (2-Methoxyanilin)</p></td><td><p>90-04-0</p></td></tr><tr><td><p>2,4-xylidine</p></td><td><p>95-68-1</p></td></tr><tr><td><p>2,6-xylidine</p></td><td><p>87-62-7</p></td></tr><tr><td><p>4-aminoazobenzene</p></td><td><p>60-09-3</p></td></tr></tbody></table></div></td><td><p>30&#160;mg/kg for each arylamine in the final product</p></td><td><p><span>Assessment and verification:</span> the applicant or material supplier(s) shall provide a declaration of compliance supported by the results of specific testing according to EN 14362-1:2012 and 3:2012 for textiles, and CEN ISO/TS 17234-1 and 2 for leather.</p><p>(<span>Note:</span> false positives may be possible with respect to the presence of 4-aminoazobenzene, and therefore shall be reported.)</p></td></tr><tr><td><p>CMR dyes</p></td><td><p>The following dyes that are carcinogenic, mutagenic or toxic to reproduction shall not be used.</p><br/><div><p><br/></p><table><col/><col/><tbody><tr><td><p>Dyes that are carcinogenic, mutagenic or toxic to reproduction</p></td><td><p>CAS number</p></td></tr><tr><td><p>C.I. Acid Red 26</p></td><td><p>3761-53-3</p></td></tr><tr><td><p>C.I. Basic Red 9</p></td><td><p>569-61-9</p></td></tr><tr><td><p>C.I. Basic Violet 14</p></td><td><p>632-99-5</p></td></tr><tr><td><p>C.I. Direct Black 38</p></td><td><p>1937-37-7</p></td></tr><tr><td><p>C.I. Direct Blue 6</p></td><td><p>2602-46-2</p></td></tr><tr><td><p>C.I. Direct Red 28</p></td><td><p>573-58-0</p></td></tr><tr><td><p>C.I. Disperse Blue 1</p></td><td><p>2475-45-8</p></td></tr><tr><td><p>C.I. Disperse Orange 11</p></td><td><p>82-28-0</p></td></tr><tr><td><p>C.I. Disperse Yellow 3</p></td><td><p>2832-40-8</p></td></tr></tbody></table></div></td><td><p>n/a</p></td><td><p><span>Assessment and verification:</span> the applicant or material supplier(s) shall provide a declaration of compliance supported by a Safety Data Sheet.</p></td></tr><tr><td><p>Potentially sensitising dyes</p></td><td><p>The following dyes that are potentially sensitising shall not be used.</p><br/><div><p><br/></p><table><col/><col/><tbody><tr><td><p>Disperse dyes that are potentially sensitising</p></td><td><p>CAS number</p></td></tr><tr><td><p>C.I. Disperse Blue 1</p></td><td><p>2475-45-8</p></td></tr><tr><td><p>C.I. Disperse Blue 3</p></td><td><p>2475-46-9</p></td></tr><tr><td><p>C.I. Disperse Blue 7</p></td><td><p>3179-90-6</p></td></tr><tr><td><p>C.I. Disperse Blue 26</p></td><td><p>3860-63-7</p></td></tr><tr><td><p>C.I. Disperse Blue 35</p></td><td><p>12222-75-2</p></td></tr><tr><td><p>C.I. Disperse Blue 102</p></td><td><p>12222-97-8</p></td></tr><tr><td><p>C.I. Disperse Blue 106</p></td><td><p>12223-01-7</p></td></tr><tr><td><p>C.I. Disperse Blue 124</p></td><td><p>61951-51-7</p></td></tr><tr><td><p>C.I. Disperse Brown 1</p></td><td><p>23355-64-8</p></td></tr><tr><td><p>C.I. Disperse Orange 1</p></td><td><p>2581-69-3</p></td></tr><tr><td><p>C.I. Disperse Orange 3</p></td><td><p>730-40-5</p></td></tr><tr><td><p>C.I. Disperse Orange 37</p></td><td><p>12223-33-5</p></td></tr><tr><td><p>C.I. Disperse Orange 76</p></td><td><p>13301-61-6</p></td></tr><tr><td><p>C.I. Disperse Red 1</p></td><td><p>2872-52-8</p></td></tr><tr><td><p>C.I. Disperse Red 11</p></td><td><p>2872-48-2</p></td></tr><tr><td><p>C.I. Disperse Red 17</p></td><td><p>3179-89-3</p></td></tr><tr><td><p>C.I. Disperse Yellow 1</p></td><td><p>119-15-3</p></td></tr><tr><td><p>C.I. Disperse Yellow 3</p></td><td><p>2832-40-8</p></td></tr><tr><td><p>C.I. Disperse Yellow 9</p></td><td><p>6373-73-5</p></td></tr><tr><td><p>C.I. Disperse Yellow 39</p></td><td><p>12236-29-2</p></td></tr><tr><td><p>C.I. Disperse Yellow 49</p></td><td><p>54824-37-2</p></td></tr></tbody></table></div></td><td><p>n/a</p></td><td><p><span>Assessment and verification:</span> the applicant or material supplier(s) shall provide a declaration of compliance supported by a Safety Data Sheet.</p></td></tr><tr><td><p>Chrome mordant dyes</p></td><td><p>Chrome mordant dyes shall not be used.</p></td><td><p>n/a</p></td><td><p><span>Assessment and verification:</span> the applicant or material supplier(s) shall provide a declaration of compliance supported by a Safety Data Sheet.</p></td></tr><tr><td><p>Metal complex dyes</p></td><td><p>Metal complex dyes based on copper, chromium and nickel shall only be permitted for leather, dyeing wool, polyamide or blends of these fibres with man-made cellulose fibres (for instance viscose).</p></td><td><p>n/a</p></td><td><p><span>Assessment and verification:</span> the applicant or material supplier(s) shall provide a declaration of compliance supported by a Safety Data Sheet.</p></td></tr><tr><td><p>Pigments</p></td><td><p>Pigments based on cadmium, lead, chromium (VI), mercury and/or antimony shall not be used.</p></td><td><p>n/a</p></td><td><p><span>Assessment and verification:</span> the applicant or material supplier(s) shall provide a declaration of compliance supported by a Safety Data Sheet.</p></td></tr></tbody></table>
Table 3
The following restrictions apply to the finishing process of the final product.
<table><col/><col/><col/><col/><tbody><tr><td><p>Applicability</p></td><td><p>Scope of restriction</p></td><td><p>Limit values</p></td><td><p>Verification</p></td></tr><tr><td><p>(a)&#160;&#160;Per- and polyfluorinated chemicals (PFCs)</p></td></tr><tr><td><p>Final product</p></td><td><p>(i)&#160;&#160;Fluorinated water, stain and oil repellent treatments shall not be used for footwear impregnation. These shall include perfluorinated and polyfluorinated treatments.</p><p>Non-fluorinated treatments shall use substances that are readily biodegradable and non-bioaccumulative substances in the aquatic environment including aquatic sediment.</p></td><td><p>n/a</p></td><td><p><span>Assessment and verification:</span> the applicant or material supplier shall provide a declaration of compliance supported by a Safety Data Sheet.</p></td></tr><tr><td><p>Footwear with declared integrated water repellence function</p></td><td><p>(ii)&#160;&#160;Fluoropolymer membranes and laminates may be used for footwear only if the required water penetration of the material is lower than 0,2&#160;g and the water absorption is lower than 30&#160;% according to ISO Standard 20347. Fluoropolymer membranes shall not be manufactured using PFOA or any of its higher homologues as defined by the OECD.</p></td><td><p>n/a</p></td><td><p><span>Assessment and verification:</span> the applicant shall provide a declaration of compliance from the membrane or laminate manufacturer with respect to the polymer production. The declaration shall be supported by technical test results for material water penetration according to ISO 20347.</p></td></tr><tr><td><p>(b)&#160;&#160;Flame retardants</p></td></tr><tr><td><p>Footwear with incorporated flame-retardant function</p></td><td><p>The use of flame retardants is allowed only for footwear classified and CE marked as Category III personal protective equipment with an incorporated flame-retardant function to ensure safety at work in line with the specifications laid down by Directive 89/686/EEC. The substance(s) used to achieve flame retardancy shall comply with criterion&#160;5.</p></td><td><p>n/a</p></td><td><p><span>Assessment and verification:</span> the applicant shall provide either a declaration of non-use of flame retardants or a declaration of compliance with criterion 5.</p><p>In both cases the declaration shall be supported by a Safety Data Sheet. When applicable, a list of flame retardants used in the product shall be provided together with the related H statements/R phrases. A copy of the certification issued by a certification body notified under Directive 89/686/EEC that proves the product is marketed as flameproof Category III personal protective equipment shall be provided.</p></td></tr></tbody></table>
Table 4
The following restrictions apply to the final product or specified parts thereof.
<table><col/><col/><col/><col/><tbody><tr><td><p>Applicability</p></td><td><p>Scope of restriction</p></td><td><p>Limit values</p></td><td><p>Verification</p></td></tr><tr><td><p>(a)&#160;&#160;PAHs</p></td></tr><tr><td><p>Plastics and synthetic rubber, textiles or leather coatings</p></td><td><p>The polycyclic aromatic hydrocarbons (PAHs) listed below shall not be present above the specified limits in the plastics, synthetic rubber, textiles or leather coatings.</p><p>The PAHs classified with Groups 1 and 2 hazards shall not be present at concentrations greater than or equal to individual and sum total concentration limits in plastics, synthetic rubber, textiles or leather coatings.</p><p>The presence and concentration of the following PAHs shall be verified.</p><p>PAHs restricted by Regulation (EC) No 1907/2006:</p><br/><div><p><br/></p><table><col/><col/><tbody><tr><td><p>Name</p></td><td><p>CAS</p></td></tr><tr><td><p>Chrysen</p></td><td><p>218-01-9</p></td></tr><tr><td><p>Benzo[a]anthracene</p></td><td><p>56-55-3</p></td></tr><tr><td><p>Benzo[k]fluoranthene</p></td><td><p>207-08-9</p></td></tr><tr><td><p>Benzo[a]pyrene</p></td><td><p>50-32-8</p></td></tr><tr><td><p>Dibenzo[a,h]anthracene</p></td><td><p>53-70-3</p></td></tr><tr><td><p>Benzo[j]fluoranthene</p></td><td><p>205-82-3</p></td></tr><tr><td><p>Benzo[b]fluoranthene</p></td><td><p>205-99-2</p></td></tr><tr><td><p>Benzo[e]pyrene</p></td><td><p>192-97-2</p></td></tr></tbody></table></div><p>Additional PAHs subject to restriction:</p><br/><div><p><br/></p><table><col/><col/><tbody><tr><td><p>Name</p></td><td><p>CAS</p></td></tr><tr><td><p>Naphthalene</p></td><td><p>91-20-3</p></td></tr><tr><td><p>Acenaphthylene</p></td><td><p>208-96-8</p></td></tr><tr><td><p>Acenaphthene</p></td><td><p>83-32-9</p></td></tr><tr><td><p>Fluorene</p></td><td><p>86-73-7</p></td></tr><tr><td><p>Phenanthrene</p></td><td><p>85-1-8</p></td></tr><tr><td><p>Anthracene</p></td><td><p>120-12-7</p></td></tr><tr><td><p>Fluoranthene</p></td><td><p>206-44-0</p></td></tr><tr><td><p>Pyrene</p></td><td><p>129-00-0</p></td></tr><tr><td><p>Indeno[1,2,3-c,d]pyrene</p></td><td><p>193-39-5</p></td></tr><tr><td><p>Benzo[g,h,i]perylene)</p></td><td><p>191-24-2</p></td></tr></tbody></table></div></td><td><p>For all footwear:</p><p>1.&#160;&#160;The individual concentration limits for PAHs restricted under Regulation (EC) No 1907/2006 shall be lower than 1&#160;mg/kg.</p><p>2.&#160;&#160;The sum total concentration limit for the 18&#160;PAHs listed shall be lower than 10&#160;mg/kg.</p><p>For footwear intended for children under three years of age:</p><p>1.&#160;&#160;The individual concentration limits for PAHs restricted under Regulation (EC) No 1907/2006 shall be lower than 0,5&#160;mg/kg.</p><p>2.&#160;&#160;The sum total concentration limit for the 18&#160;PAHs listed shall be lower than 1&#160;mg/kg.</p></td><td><p><span>Assessment and verification:</span> the applicant or material supplier(s) shall provide a declaration of compliance supported by the test report, using test method AfPS GS 2014:01 PAK.</p></td></tr><tr><td><p>(b)&#160;&#160;N-Nitrosamines</p></td></tr><tr><td><p>Natural and synthetic rubber</p></td><td><p>The following N-nitrosamines shall not be detected in synthetic and natural rubber.</p><br/><div><p><br/></p><table><col/><col/><tbody><tr><td><p>N-nitrosamine</p></td><td><p>CAS</p></td></tr><tr><td><p>N-nitrosodiethanolamine (NDELA)</p></td><td><p>1116-54-7</p></td></tr><tr><td><p>N-nitrosodimethylamine (NDMA)</p></td><td><p>62-75-9</p></td></tr><tr><td><p>N-nitrosodipropylamine (NDPA)</p></td><td><p>621-64-7</p></td></tr><tr><td><p>N-nitrosodiethylamine (NDEA)</p></td><td><p>55-18-5</p></td></tr><tr><td><p>N-nitrosodiisopropylamine (NDiPA)</p></td><td><p>601-77-4</p></td></tr><tr><td><p>N-nitrosodibutylamine (NDBA)</p></td><td><p>924-16-3</p></td></tr><tr><td><p>N-nitrosopiperidine (NPIP)</p></td><td><p>100-75-4</p></td></tr><tr><td><p>N-nitrosodiisobutylamine (NdiBA)</p></td><td><p>997-95-5</p></td></tr><tr><td><p>N-nitrosodiisononylamine (NdiNA)</p></td><td><p>1207995-62-7</p></td></tr><tr><td><p>N-nitrosomorpholine (NMOR)</p></td><td><p>59-89-2</p></td></tr><tr><td><p>N-nitroso N-methyl N-phenylamine (NMPhA)</p></td><td><p>614-00-6</p></td></tr><tr><td><p>N-nitroso N-ethyl N-phenylamine (NEPhA)</p></td><td><p>612-64-6</p></td></tr><tr><td><p>N-Nitrosopyrrolidine</p></td><td><p>930-55-2</p></td></tr></tbody></table></div></td><td><p>Not detectable</p></td><td><p><span>Assessment and verification:</span> the applicant or rubber supplier shall provide a declaration of compliance supported by the test report, using test method EN&#160;12868 or EN&#160;14602.</p></td></tr><tr><td><p>(c)&#160;&#160;Organotin substances</p></td></tr><tr><td><p>Final product</p></td><td><p>The organotin compounds listed below shall not be present in the final product above the specified limit concentrations.</p><br/><div><p><br/></p><table><col/><col/><tbody><tr><td><p>Tributyltin compounds (TBT)</p></td><td><p>0,025&#160;mg/kg</p></td></tr><tr><td><p>Dibutyltin compounds (DBT)</p></td><td><p>1&#160;mg/kg</p></td></tr><tr><td><p>Monobutyltin compounds (MBT)</p></td><td><p>1&#160;mg/kg</p></td></tr><tr><td><p>Dioctyltin compounds (DOT)</p></td><td><p>1&#160;mg/kg</p></td></tr><tr><td><p>Triphenyltin (TPT)</p></td><td><p>1&#160;mg/kg</p></td></tr></tbody></table></div></td><td><p>Limit values specified for each organotin compound</p></td><td><p><span>Assessment and verification:</span> the applicant shall provide a declaration of compliance supported by test results in accordance with test method ISO/TS 16179.</p></td></tr><tr><td><p>(d)&#160;&#160;Phthalates</p></td></tr><tr><td><p>Plastics, rubber, synthetic materials, coatings and printings of materials</p></td><td><p>(i)&#160;&#160;Only phthalates that at the time of application have been risk-assessed and fulfil the requirements of criterion 5 may be used in the product.</p></td><td><p>n/a</p></td><td><p><span>Assessment and verification:</span> the applicant shall provide a declaration of compliance supported by a Safety Data Sheet</p></td></tr><tr><td><p>(ii)&#160;&#160;The following plasticisers shall not be used in the product, any article of it or in any homogeneous part of it:</p><div><p>&#8212;&#160;1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich (DIHP) CAS: 71888-89-6</p></div><div><p>&#8212;&#160;1,2-Benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters ((DHNUP) CAS: 68515-42-4</p></div><div><p>&#8212;&#160;Bis(2-methoxyethyl) phthalate (DMEP) CAS: 117-82-8</p></div><div><p>&#8212;&#160;Diisobutyl phthalate (DIPB) CAS: 84-69-5</p></div><div><p>&#8212;&#160;Bis (2-ethylhexyl) phthalate (DEHP) CAS: 117-81-7</p></div><div><p>&#8212;&#160;Dibutyl phthalate (DBP) CAS: 84-74-2</p></div><div><p>&#8212;&#160;Benzyl butyl phthalate (BBP) CAS: 85-68-7</p></div><div><p>&#8212;&#160;Di-n-pentyl phthalate (DPP) CAS: 131-18-0</p></div><div><p>&#8212;&#160;1,2-Benzenedicarboxylic acid, dipentylester, branched and linear CAS: 84777-06-0</p></div><div><p>&#8212;&#160;Diisopentylphthalate (DIPP) CAS: 605-50-5</p></div><div><p>&#8212;&#160;Dihexyl phthalate (DnHP) CAS: 84-75-3</p></div><div><p>&#8212;&#160;N-pentyl-isopentylphthalate CAS: 607-426-00-1</p></div><p>(iii)&#160;&#160;The following phthalates shall not be used in footwear for children under three years of age:</p><div><p>&#8212;&#160;Di-iso-nonyl phthalate (DINP)*<span>CAS:</span> 28553-12-0; 68515-48-0</p></div><div><p>&#8212;&#160;Di-n-octylphthalate (DNOP)* CAS: 117-84-0</p></div><div><p>&#8212;&#160;Diisodecyl phthalate (DIDP)* CAS: 26761-40-0; 68515-49-1</p></div></td><td><p>The sum of the restricted plasticisers shall be lower than 0,10&#160;% weight by weight;</p><p>The sum of the restricted plasticisers for footwear intended for children under three years of age shall be lower than 0,05&#160;% weight by weight;</p></td><td><p><span>Assessment and verification:</span> the applicant shall provide either a declaration of non-use from the material manufacturer supported by a Safety Data Sheet for the plasticisers used in the formulation or the test results according to ISO/TS 16181.</p></td></tr><tr><td><p>(e)&#160;&#160;Extractable metals</p></td></tr><tr><td><p>Final product</p></td><td><p>For footwear intended for children under three years of age, the substances listed below shall not be present in the final product above the specified limit concentrations.</p><br/><div><p><br/></p><table><col/><col/><tbody><tr><td><p>Antimony (Sb)</p></td><td><p>30,0&#160;mg/kg</p></td></tr><tr><td><p>Arsenic (As)</p></td><td><p>0,2&#160;mg/kg</p></td></tr><tr><td><p>Cadmium (Cd)</p></td><td><p>0,1&#160;mg/kg</p></td></tr><tr><td><p>Chromium (Cr)</p></td><td><p>1,0&#160;mg/kg (for textiles)</p></td></tr><tr><td><p>Cobalt (Co)</p></td><td><p>1,0&#160;mg/kg</p></td></tr><tr><td><p>Copper (Cu)</p></td><td><p>25,0&#160;mg/kg</p></td></tr><tr><td><p>Lead (Pb)</p></td><td><p>0,2&#160;mg/kg</p></td></tr><tr><td><p>Nickel (Ni)</p></td><td><p>1,0&#160;mg/kg</p></td></tr><tr><td><p>Mercury (Hg)</p></td><td><p>0,02&#160;mg/kg</p></td></tr></tbody></table></div><p>The following limit values shall apply to footwear other than footwear intended for children under three years of age.</p><br/><div><p><br/></p><table><col/><col/><tbody><tr><td><p>Antimony (Sb)</p></td><td><p>30,0&#160;mg/kg</p></td></tr><tr><td><p>Arsenic (As)</p></td><td><p>1,0&#160;mg/kg</p></td></tr><tr><td><p>Cadmium (Cd)</p></td><td><p>0,1&#160;mg/kg</p></td></tr><tr><td><p>Chromium (Cr)</p></td><td><p>2,0&#160;mg/kg (for textiles)</p></td></tr><tr><td><p>Cobalt (Co)</p></td><td><p>4,0&#160;mg/kg</p></td></tr><tr><td><p>Copper (Cu)</p></td><td><p>50,0&#160;mg/kg</p></td></tr><tr><td><p>Lead (Pb)</p></td><td><p>1,0&#160;mg/kg</p></td></tr><tr><td><p>Nickel (Ni)</p></td><td><p>1,0&#160;mg/kg</p></td></tr><tr><td><p>Mercury (Hg)</p></td><td><p>0,02&#160;mg/kg</p></td></tr></tbody></table></div></td><td><p>Limit values specified for each substance</p></td><td><p><span>Assessment and verification:</span> the applicant or material supplier(s) shall provide a declaration of compliance supported by the test results in accordance with the&#160;following test methods: Extraction &#8212; EN ISO 105-E04-2013 (acid sweat solution). Detection: EN ISO&#160;17072-1 for leather, ICP-MS, ICP-OES (for textiles and plastic).</p><p>Testing shall be carried out annually during the licence period in order to demonstrate ongoing compliance with the criterion.</p></td></tr><tr><td><p>Metal components</p></td><td><p>The migration of nickel from nickel-containing metal alloys which are in direct and prolonged contact with skin shall be lower than 0,5&#160;&#956;g/cm<span>2</span>/week.</p></td><td><p>0,5&#160;&#956;g/cm<span>2</span>/week</p></td><td><p><span>Assessment and verification:</span> the applicant or material supplier(s) shall provide a declaration of the absence of nickel in footwear components, supported by the certification from the manufacturer of the metal parts, or a declaration of compliance supported by the results of test method EN 1811.</p></td></tr><tr><td><p>Chromium-tanned leather</p></td><td><p>For shoes containing chromium-tanned leather, there shall be no chromium (VI) in the final product.</p></td><td><p>Not detectable</p></td><td><p><span>Assessment and verification:</span> the applicant or material supplier(s) shall provide a declaration of compliance supported by the results of a test report, using test method EN ISO 17075 (detection limit: 3&#160;ppm). The sample preparation must follow the indications of EN ISO 4044.</p><p>Testing shall be carried out annually during the licence period in order to demonstrate ongoing compliance with the criterion. Non-chromium-tanned leather is exempted from the requirement.</p></td></tr><tr><td><p>For shoes containing chromium-tanned leather, the extractable chromium content in the final product shall be lower than 200&#160;mg/kg.</p></td><td><p>200&#160;mg/kg</p></td><td><p><span>Assessment and verification:</span> the applicant or material supplier(s) shall provide a declaration of compliance supported by the results of test report, using test method EN ISO 17072-1.</p><p>Testing shall be carried out annually during the licence period in order to demonstrate ongoing compliance with the criterion. Non-chromium-tanned leather is exempt from the requirement.</p></td></tr><tr><td><p>(f)&#160;&#160;TDA and MDA</p></td></tr><tr><td><p>PU</p></td><td><p>2,4-Toluenediamine (2,4-TDA, 95-80-7)</p><p>4,4&#8242;-Diaminodiphenylmethane (4,4&#8242;-MDA, 101-77-9)</p></td><td><p>Lower than 5&#160;mg/kg each</p></td><td><p><span>Assessment and verification:</span> the applicant shall provide a declaration of compliance supported by the results according to the following procedure: Extraction with 1&#160;% aqueous acetic acid solution. The sample must be a composite of six pieces to be taken from beneath each sample's face (to a maximum of 2&#160;cm from the surface). Four repeat extractions of the same foam sample must be performed, maintaining a sample weight to volume ratio of 1:5 in each case. The extracts are combined, made up to a known volume, filtered and analysed by HPLC-UV or HPLC-MS. If HPLC-UV is performed and interference is suspected, reanalysis with HPLC-MS shall be performed.</p></td></tr><tr><td><p>(g)&#160;&#160;Formaldehyde</p></td></tr><tr><td><p>Final product/leather, textile</p></td><td><p>The amount of free and hydrolysed formaldehyde of the components of the footwear shall not exceed the following limits:</p><div><p>&#8212;&#160;textiles: &lt;&#160;20&#160;mg/kg,</p></div><div><p>&#8212;&#160;leather: &lt;&#160;20&#160;mg/kg (children's footwear); 75&#160;mg/kg (linings and socks); 100&#160;mg/kg for other parts of the product.</p></div></td><td><p>Specified limit values</p></td><td><p><span>Assessment and verification:</span> the applicant or material supplier(s) shall provide a declaration of compliance supported by the results of a test report, using the following test methods: textiles: EN ISO 14184-1; leather: EN ISO 17226-1.</p></td></tr><tr><td><p>(h)&#160;&#160;Antimony</p></td></tr><tr><td><p>Raw polyester fibres</p></td><td><p>The level of antimony present in the raw polyester fibres shall not exceed 260&#160;ppm.</p></td><td><p>260&#160;mg/kg</p></td><td><p><span>Assessment and verification:</span> the applicant or fibre manufacturer shall either provide a declaration of non-use during the manufacturing process or a declaration of compliance supported by a test report using the following test methods: direct determination by Atomic Absorption Spectrometry or Inductively Coupled Plasma (ICP) Mass Spectrometry. The test shall be carried out on a composite sample of raw fibres prior to any wet processing.</p></td></tr></tbody></table>
<note>
( 1 ) Directive 94/11/EC of the European Parliament and of the Council of 23 March 1994 on the approximation of the laws, regulations and administrative provisions of the Member States relating to labelling of the materials used in the main components of footwear for sale to the consumer (OJ L 100, 19.4.1994, p. 37).
( 2 ) Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment (OJ L 399, 30.12.1989, p. 18).
( 3 ) http://www.iucnredlist.org/
( 4 ) Commission Decision 2014/350/EU of 5 June 2014 establishing the ecological criteria for the award of the EU Ecolabel for textile products (OJ L 174, 13.6.2014, p. 45).
( 5 ) Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91 (OJ L 189, 20.7.2007, p. 1).
( 6 ) Regulation (EU) No 995/2010 of the European Parliament and of the Council of 20 October 2010 laying down the obligations of operators who place timber and timber products on the market (OJ L 295, 12.11.2010, p. 23).
( 7 ) Commission Implementing Decision 2013/84/EU of 11 February 2013 establishing the best available techniques (BAT) conclusions under Directive 2010/75/EU of the European Parliament and of the Council on industrial emissions for the tanning of hides and skins (OJ L 45, 16.2.2013, p. 13).
( 8 ) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency (OJ L 136, 29.5.2007, p. 3).
( 9 ) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).
( 10 ) European Chemical Agency (ECHA), Candidate List of substances of very high concern for Authorisation, http://www.echa.europa.eu/candidate-list-table.
( *1 ) STOT = Specific target organ toxicity.
( 11 ) ECHA, Candidate List of substances of very high concern for Authorisation, http://www.echa.europa.eu/candidate-list-table
( 12 ) ECHA, REACH registered substances database, http://www.echa.europa.eu/information-on-chemicals/registered-substances
( 13 ) ECHA, Cooperation with peer regulatory agencies, http://echa.europa.eu/en/about-us/partners-and-networks/international-cooperation/cooperation-with-peer-regulatory-agencies
( 14 ) Social Accountability International, Social Accountability 8000 International Standard, http://www.sa-intl.org
( 15 ) See ILO NORMLEX (http://www.ilo.org/dyn/normlex/en) and supporting guidance.
( 16 ) European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste (OJ L 365, 31.12.1994, p. 10).
</note>