LegalizeCommission 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)
| Applicability | Scope of restriction | Limit values | Verification |
|---|---|---|---|
| (a) PAHs | (a) PAHs | (a) PAHs | (a) PAHs |
| Plastics and synthetic rubber, textiles or leather coatings | The polycyclic aromatic hydrocarbons (PAHs) listed below shall not be present above the specified limits in the plastics, synthetic rubber, textiles or leather coatings. 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. The presence and concentration of the following PAHs shall be verified. PAHs restricted by Regulation (EC) No 1907/2006: Name CAS Chrysen 218-01-9 Benzo[a]anthracene 56-55-3 Benzo[k]fluoranthene 207-08-9 Benzo[a]pyrene 50-32-8 Dibenzo[a,h]anthracene 53-70-3 Benzo[j]fluoranthene 205-82-3 Benzo[b]fluoranthene 205-99-2 Benzo[e]pyrene 192-97-2 Additional PAHs subject to restriction: Name CAS Naphthalene 91-20-3 Acenaphthylene 208-96-8 Acenaphthene 83-32-9 Fluorene 86-73-7 Phenanthrene 85-1-8 Anthracene 120-12-7 Fluoranthene 206-44-0 Pyrene 129-00-0 Indeno[1,2,3-c,d]pyrene 193-39-5 Benzo[g,h,i]perylene) 191-24-2 | For all footwear: 1. The individual concentration limits for PAHs restricted under Regulation (EC) No 1907/2006 shall be lower than 1 mg/kg. 2. The sum total concentration limit for the 18 PAHs listed shall be lower than 10 mg/kg. For footwear intended for children under three years of age: 1. The individual concentration limits for PAHs restricted under Regulation (EC) No 1907/2006 shall be lower than 0,5 mg/kg. 2. The sum total concentration limit for the 18 PAHs listed shall be lower than 1 mg/kg. | Assessment and verification: 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. |
| (b) N-Nitrosamines | (b) N-Nitrosamines | (b) N-Nitrosamines | (b) N-Nitrosamines |
| Natural and synthetic rubber | The following N-nitrosamines shall not be detected in synthetic and natural rubber. N-nitrosamine CAS N-nitrosodiethanolamine (NDELA) 1116-54-7 N-nitrosodimethylamine (NDMA) 62-75-9 N-nitrosodipropylamine (NDPA) 621-64-7 N-nitrosodiethylamine (NDEA) 55-18-5 N-nitrosodiisopropylamine (NDiPA) 601-77-4 N-nitrosodibutylamine (NDBA) 924-16-3 N-nitrosopiperidine (NPIP) 100-75-4 N-nitrosodiisobutylamine (NdiBA) 997-95-5 N-nitrosodiisononylamine (NdiNA) 1207995-62-7 N-nitrosomorpholine (NMOR) 59-89-2 N-nitroso N-methyl N-phenylamine (NMPhA) 614-00-6 N-nitroso N-ethyl N-phenylamine (NEPhA) 612-64-6 N-Nitrosopyrrolidine 930-55-2 | Not detectable | Assessment and verification: the applicant or rubber supplier shall provide a declaration of compliance supported by the test report, using test method EN 12868 or EN 14602. |
| (c) Organotin substances | (c) Organotin substances | (c) Organotin substances | (c) Organotin substances |
| Final product | The organotin compounds listed below shall not be present in the final product above the specified limit concentrations. Tributyltin compounds (TBT) 0,025 mg/kg Dibutyltin compounds (DBT) 1 mg/kg Monobutyltin compounds (MBT) 1 mg/kg Dioctyltin compounds (DOT) 1 mg/kg Triphenyltin (TPT) 1 mg/kg | Limit values specified for each organotin compound | Assessment and verification: the applicant shall provide a declaration of compliance supported by test results in accordance with test method ISO/TS 16179. |
| (d) Phthalates | (d) Phthalates | (d) Phthalates | (d) Phthalates |
| Plastics, rubber, synthetic materials, coatings and printings of materials | (i) 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. | n/a | Assessment and verification: the applicant shall provide a declaration of compliance supported by a Safety Data Sheet |
| Plastics, rubber, synthetic materials, coatings and printings of materials | (ii) The following plasticisers shall not be used in the product, any article of it or in any homogeneous part of it: — 1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich (DIHP) CAS: 71888-89-6 — 1,2-Benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters ((DHNUP) CAS: 68515-42-4 — Bis(2-methoxyethyl) phthalate (DMEP) CAS: 117-82-8 — Diisobutyl phthalate (DIPB) CAS: 84-69-5 — Bis (2-ethylhexyl) phthalate (DEHP) CAS: 117-81-7 — Dibutyl phthalate (DBP) CAS: 84-74-2 — Benzyl butyl phthalate (BBP) CAS: 85-68-7 — Di-n-pentyl phthalate (DPP) CAS: 131-18-0 — 1,2-Benzenedicarboxylic acid, dipentylester, branched and linear CAS: 84777-06-0 — Diisopentylphthalate (DIPP) CAS: 605-50-5 — Dihexyl phthalate (DnHP) CAS: 84-75-3 — N-pentyl-isopentylphthalate CAS: 607-426-00-1 (iii) The following phthalates shall not be used in footwear for children under three years of age: — Di-iso-nonyl phthalate (DINP) CAS: 28553-12-0; 68515-48-0 — Di-n-octylphthalate (DNOP) CAS: 117-84-0 — Diisodecyl phthalate (DIDP)* CAS: 26761-40-0; 68515-49-1 | The sum of the restricted plasticisers shall be lower than 0,10 % weight by weight; The sum of the restricted plasticisers for footwear intended for children under three years of age shall be lower than 0,05 % weight by weight; | Assessment and verification: 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. |
| (e) Extractable metals | (e) Extractable metals | (e) Extractable metals | (e) Extractable metals |
| Final product | 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. Antimony (Sb) 30,0 mg/kg Arsenic (As) 0,2 mg/kg Cadmium (Cd) 0,1 mg/kg Chromium (Cr) 1,0 mg/kg (for textiles) Cobalt (Co) 1,0 mg/kg Copper (Cu) 25,0 mg/kg Lead (Pb) 0,2 mg/kg Nickel (Ni) 1,0 mg/kg Mercury (Hg) 0,02 mg/kg The following limit values shall apply to footwear other than footwear intended for children under three years of age. Antimony (Sb) 30,0 mg/kg Arsenic (As) 1,0 mg/kg Cadmium (Cd) 0,1 mg/kg Chromium (Cr) 2,0 mg/kg (for textiles) Cobalt (Co) 4,0 mg/kg Copper (Cu) 50,0 mg/kg Lead (Pb) 1,0 mg/kg Nickel (Ni) 1,0 mg/kg Mercury (Hg) 0,02 mg/kg | Limit values specified for each substance | Assessment and verification: the applicant or material supplier(s) shall provide a declaration of compliance supported by the test results in accordance with the following test methods: Extraction — EN ISO 105-E04-2013 (acid sweat solution). Detection: EN ISO 17072-1 for leather, ICP-MS, ICP-OES (for textiles and plastic). Testing shall be carried out annually during the licence period in order to demonstrate ongoing compliance with the criterion. |
| Metal components | The migration of nickel from nickel-containing metal alloys which are in direct and prolonged contact with skin shall be lower than 0,5 μg/cm2/week. | 0,5 μg/cm2/week | Assessment and verification: 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. |
| Chromium-tanned leather | For shoes containing chromium-tanned leather, there shall be no chromium (VI) in the final product. | Not detectable | Assessment and verification: 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 ppm). The sample preparation must follow the indications of EN ISO 4044. 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. |
| Chromium-tanned leather | For shoes containing chromium-tanned leather, the extractable chromium content in the final product shall be lower than 200 mg/kg. | 200 mg/kg | Assessment and verification: 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. 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. |
| (f) TDA and MDA | (f) TDA and MDA | (f) TDA and MDA | (f) TDA and MDA |
| PU | 2,4-Toluenediamine (2,4-TDA, 95-80-7) 4,4′-Diaminodiphenylmethane (4,4′-MDA, 101-77-9) | Lower than 5 mg/kg each | Assessment and verification: the applicant shall provide a declaration of compliance supported by the results according to the following procedure: Extraction with 1 % 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 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. |
| (g) Formaldehyde | (g) Formaldehyde | (g) Formaldehyde | (g) Formaldehyde |
| Final product/leather, textile | The amount of free and hydrolysed formaldehyde of the components of the footwear shall not exceed the following limits: — textiles: < 20 mg/kg, — leather: < 20 mg/kg (children's footwear); 75 mg/kg (linings and socks); 100 mg/kg for other parts of the product. | Specified limit values | Assessment and verification: 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. |
| (h) Antimony | (h) Antimony | (h) Antimony | (h) Antimony |
| Raw polyester fibres | The level of antimony present in the raw polyester fibres shall not exceed 260 ppm. | 260 mg/kg | Assessment and verification: 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. |
[^E0001]: 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).
[^E0002]: 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).
[^E0004]: 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).
[^E0005]: 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).
[^E0006]: 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).
[^E0007]: 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).
[^E0008]: 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).
[^E0009]: 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).
[^E0010]: European Chemical Agency (ECHA), Candidate List of substances of very high concern for Authorisation, http://www.echa.europa.eu/candidate-list-table.
[^E0011]: STOT = Specific target organ toxicity.
[^E0012]: ECHA, Candidate List of substances of very high concern for Authorisation, http://www.echa.europa.eu/candidate-list-table
[^E0013]: ECHA, REACH registered substances database, http://www.echa.europa.eu/information-on-chemicals/registered-substances
[^E0014]: ECHA, Cooperation with peer regulatory agencies, http://echa.europa.eu/en/about-us/partners-and-networks/international-cooperation/cooperation-with-peer-regulatory-agencies
[^E0015]: Social Accountability International, Social Accountability 8000 International Standard, http://www.sa-intl.org
[^E0016]: See ILO NORMLEX (http://www.ilo.org/dyn/normlex/en) and supporting guidance.
[^E0017]: 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).
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