Commission Decision (EU) 2019/70Show full title

Criterion 4 — Restricted hazardous substances and mixtures

The basis for demonstrating compliance with each of the sub-criteria under criterion 4 shall be the applicant providing a list of all the relevant chemicals used together with appropriate documentation (safety data sheet or a declaration from the chemical supplier).

Criterion 4(a) Restrictions on Substances of Very High Concern (SVHC)

Note: All process and functional chemicals used in the paper mill and, where relevant, during the tissue paper conversion process must be screened. This criterion does not apply to chemicals used for wastewater treatment unless the treated wastewater is recirculated back into the paper production process.

The paper product 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 Substances of Very High Concern in concentrations greater than 0,10 % (weight by weight). No derogation from this requirement shall be granted.

Assessment and verification: The applicant shall provide a declaration that the paper product does not contain any SVHC in concentrations greater than 0,10 % (weight by weight). The declaration shall be supported by safety data sheets or appropriate declarations from chemical suppliers of all process and functional chemicals used in the paper mill that show that none of the chemicals contain SVHC in concentrations greater than 0,10 % (weight by weight).

The list of substances identified as SVHC and included in the candidate list in accordance with Article 59(1) of Regulation (EC) No 1907/2006 can be found here:

http://echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp

Reference to the list shall be made on the date of application.

Criterion 4(b) Classification, Labelling and Packaging (CLP) restrictions

Note: All process and functional chemicals used in the paper mill and, where relevant, during the tissue paper conversion process must be screened. This criterion does not apply to chemicals used for wastewater treatment unless the treated wastewater is recirculated back into the paper production process.

Unless derogated in Table 3, the paper product shall not contain substances or mixtures in concentrations greater than 0,10 % (weight by weight) that are classified with any of the following hazard statements in accordance with Regulation (EC) No 1272/2008:

• Group 1 hazards: Category 1A or 1B carcinogenic, mutagenic and/or toxic for reproduction (CMR): H340, H350, H350i, H360, H360F, H360D, H360FD, H360Fd, H360Df.

• Group 2 hazards: Category 2 CMR: H341, H351, H361, 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(1): H317.

• Group 3 hazards: Category 2, 3 and 4 aquatic toxicity: H411, H412, H413; Category 3 acute toxicity: H301, H311, H331; Category 2 STOT: H371, H373.

The use of substances or mixtures that are chemically modified during the paper production process (e.g. inorganic flocculating agents, cross-linking agents, inorganic oxidising and reducing agents) so that any relevant restricted CLP hazard no longer applies shall be exempted from the above requirement.

Table 3

Derogations to the CLP hazard restrictions and applicable conditions

Substance/mixture type	Applicability	Derogated classification(s)	Derogation conditions
Dyes and pigments	Used in wet end or surface application during the production of coloured paper.	H411, H412, H413	The chemical supplier shall declare that a fixation rate of 98 % can be achieved on the paper and provide instructions about how this can be ensured. The paper producer shall provide a declaration of compliance with any relevant instructions.
Polyamidoamine-epichlorohydrin (PAE)-based wet strength agents	Used as retention agents to improve runnability or to impart wet strength to the product.	H411, H412, H413	The combined residual monomer content of epichlorohydrin (ECH, CAS No 106-89-8) and its breakdown products 1,3-dichloro-2-propanol (DCP, CAS No 96-23-1) and 3-monochloro-1,2-propanediol (MCPD, CAS No 96-24-2) must not exceed 0,35 % (w/w) of the active solids content of the formulation.
Glyoxal (recycled fibre)	Impurity in recycled fibres.	H341, H317	Only permitted in concentrations exceeding 0,10 % (w/w) if due to contaminants from recycled materials used in the papermaking process. In such cases, compliance with the limit defined in criterion 6c) must be demonstrated.
Polyamidoamine-epichlorohydrin (PAE)-based Yankee auxiliary chemicals	Used as creping aids.	H411, H412, H413	The combined residual monomer content of epichlorohydrin (ECH, CAS No 106-89-8) and its breakdown products 1,3-dichloro-2-propanol (DCP, CAS No 96-23-1) and 3-monochloro-1,2-propanediol (MCPD, CAS No 96-24-2) must not exceed 0,05 % (w/w) of the active solids content of the formulation.
Cationic polymers (including polyethyleneimines, polyamides and polyamines)	Various uses possible, which include use as retention aids, improve wet-web strength, dry strength and wet strength.	H411, H412, H413	The paper producer shall provide a declaration of compliance with any relevant instructions for safe handling and dosing specified in the safety data sheet.

Assessment and verification: The applicant shall provide a list of all relevant chemicals used together with the relevant safety data sheet or supplier declaration.

Any chemicals containing substances or mixtures with restricted CLP classifications shall be highlighted. The approximate dosing rate of the chemical, together with the concentration of the restricted substance or mixture in that chemical (as provided in the safety data sheet or supplier declaration) and an assumed retention factor of 100 %, shall be used to estimate the quantity of the restricted substance or mixture remaining in the final product.

Justifications for any deviation from a retention factor of 100 % or for chemical modification of a restricted hazardous substance or mixture must be provided in writing to the competent body.

For any restricted substances or mixtures that exceed 0,10 % (weight by weight) of the final paper product but are derogated, proof of compliance with the relevant derogation conditions must be provided.

Criterion 4(c) Chlorine

Note: This requirement shall apply to pulp and paper producers. While it also applies to the bleaching of recycled fibres, it is accepted that the fibres in their previous life cycle may have been bleached with chlorine gas.

Chlorine gas shall not be used as a bleaching agent. This requirement does not apply to chlorine gas related to the production and use of chlorine dioxide.

Assessment and verification: The applicant shall provide a declaration that chlorine gas has not been used as a bleaching agent in the paper production process, together with declarations from any relevant pulp suppliers.

Criterion 4(d) Alkylphenol ethoxylates (APEOs)

Note: This requirement shall apply to pulp and paper producers.

APEOs or other alkylphenol derivatives shall not be added to cleaning chemicals, de-inking chemicals, foam inhibitors or dispersants. Alkylphenol derivatives are defined as substances that upon degradation produce alkylphenols.

Assessment and verification: The applicant shall provide a declaration(s) from its chemical supplier(s) that APEOs or other alkylphenol derivatives have not been added to these products.

Criterion 4(e) Surfactants used in de-inking

Note: This requirement shall apply to the producer(s) of de-inked pulp.

All surfactants used in de-inking processes shall demonstrate ready biodegradability or inherent ultimate biodegradability (see test methods and pass levels below). The only exemption to this requirement shall be the use of surfactants based on silicone derivatives provided that paper sludge from the de-inking process is incinerated.

Assessment and verification: The applicant shall provide a declaration of compliance with this criterion together with the relevant safety data sheets or test reports for each surfactant. These shall indicate the test method, threshold and conclusion reached using one of the following test methods and pass levels:

• For ready biodegradability: OECD No 301 A-F (or equivalent ISO standards) with a percentage degradation (including absorption) within 28 days of at least 70 % for 301 A and E, and of at least 60 % for 301 B, C, D and F.

• For inherent ultimate biodegradability: OECD 302 A-C (or equivalent ISO standards), with a percentage degradation (including adsorption) within 28 days of at least 70 % for 302 A and B, and of at least 60 % for 302 C.

In cases where silicone-based surfactants are used, the applicant shall provide a safety data sheet for the chemicals used and a declaration that paper sludge from the de-inking process is incinerated, including details of the destination incineration facility or facilities.

Criterion 4(f) Biocidal product restrictions for slime control

Note: This requirement shall apply to the paper producer.

The active substances in biocidal products used to counter slime-forming organisms in circulation water systems containing fibres shall have been approved for this purpose, or be under examination pending a decision on approval, under Regulation (EU) No 528/2012 and shall not be potentially bio-accumulative.

For the purposes of this criterion, the potential to bio-accumulate shall be characterised by log Kow (log octanol/water partition coefficient) ≤ 3,0 or an experimentally determined bioconcentration factor ≤ 100.

Assessment and verification: The applicant shall provide a declaration of compliance with this criterion together with the relevant material safety data sheet or test report. This shall indicate the test method, threshold and conclusion reached, using one of the following test methods: OECD 107, 117 or 305 A-E.

Criterion 4(g) Azo dye restrictions

Note: This requirement shall apply to the paper producer.

Azo dyes, which by reductive cleavage of one or more azo groups may release one or more of the aromatic amines listed in Directive 2002/61/EC or Regulation (EC) No 1907/2006 Annex XVII, Appendix 8, shall not be used in the production of EU Ecolabel tissue paper.

Assessment and verification: The applicant shall provide a declaration of compliance with this criterion from the supplier(s) of all colourants used in the production process for EU Ecolabel tissue paper and tissue products. The colourant supplier declaration should be supported by test reports according to the appropriate methods described in Appendix 10 to Annex XVII to Regulation (EC) No 1907/2006 or equivalent methods.

Criterion 4(h) Metal-based pigments and dyes

Note: This requirement shall apply to the paper producer or, where relevant, to the tissue paper converter. See definition of metal-based pigments and dyes in the preamble of this Annex.

Dyes or pigments based on aluminium(2), silver, arsenic, barium, cadmium, cobalt, chromium, mercury, manganese, nickel, lead, selenium, antimony, tin or zinc shall not be used.

Assessment and verification: The applicant shall provide a declaration of compliance with the requirements of this criterion from the supplier(s) of all colourants used in the production process for EU Ecolabel tissue products. The supplier declaration(s) shall be supported by safety data sheets or other relevant documentation.

Criterion 4(i) Ionic impurities in dye-stuffs

Note: This requirement shall apply to the paper producer or, where relevant, to the tissue paper converter.

The levels of ionic impurities in the dyestuffs used shall not exceed the following limits: silver 100 ppm; arsenic 50 ppm; barium 100 ppm; cadmium 20 ppm; cobalt 500 ppm; chromium 100 ppm; mercury 4 ppm; nickel 200 ppm; lead 100 ppm; selenium 20 ppm; antimony 50 ppm; tin 250 ppm; zinc 1 500 ppm.

Assessment and verification: The applicant shall provide a declaration of compliance with the requirements of this criterion from the supplier(s) of all colourants used in the production process for EU Ecolabel tissue paper. The supplier declaration(s) shall be supported by safety data sheets or other relevant documentation.

Criterion 4(j) Lotions

No substances that are classified as H317, H334, CMR or listed on the Candidate List for Substances of Very High Concern shall be added to lotion formulations used during the conversion of EU Ecolabel tissue products. Furthermore, no parabens, triclosan, formaldehyde, formaldehyde releasers or methylisothiazolinone shall be added to lotion formulations.

Furthermore, no lotion formulation used shall be dosed in quantities that result in any individual substances with the CLP restricted classifications listed in criterion 4(b) being present in quantities exceeding 0,010 % (w/w) of the final tissue product. The sum of substances with any particular restricted CLP classifications shall not exceed 0,070 % (w/w) of the tissue product.

Assessment and verification: The applicant shall provide a list of any relevant lotion formulations used in the production of EU Ecolabel tissue products together with declarations of compliance from the respective suppliers of those lotion formulations, relevant safety data sheets and, for demonstrating compliance with the limits in the final product, calculations based on dosing rates used by the applicant that estimate the concentrations of any restricted CLP substances in the formulation that would remain in the final EU Ecolabel tissue product.

(1)

H317 restrictions shall only apply to commercial dye formulations, surface finishing agents and coating materials applied to paper.

(2)

The restriction for aluminium shall not apply to aluminosilicates.