(3)

the Appendix is amended as follows: (a) in the Hazardous Substance Restriction and Derogation List the entry ‘1. Preservatives added to colourants, binders and the final product’ the section ‘(i) Rules relating to biocide authorisation status’ is replaced by the following: ‘(i) Rules relating to the approval status of preservatives The paint formulation shall only contain active substances (within the meaning of Article 3(1)(c) of Regulation (EU) No 528/2012) that meet the requirements of 1a, 1b and 1c (as applicable) and are approved in accordance with Article 9(2) of Regulation (EU) No 528/2012 for use in product-type 6 in the case of 1a and 1b or product–type 7 in the case of 1c, or are included in Annex I to that Regulation. Furthermore, a risk assessment for professional and consumer (non-professional) use shall have been provided in the Assessment Report. Applicants should consult the most current approved active substance list of the EU (*) and Annex I to that Regulation. Paint formulations may contain preservatives for which a dossier has been submitted and which are under examination pending a decision on approval in the interim period up until the adoption of a positive decision to approve the active substance or to include it in Annex I to that Regulation. (*) ECHA, Biocidal active substances — list of approved active substances, http://www.echa.europa.eu/web/guest/information-on-chemicals/biocidal-active-substances’;" (b) in the Hazardous Substance Restriction and Derogation List the entries ‘1(a) In-can preservatives’ and ‘1(b) Tinting (colourant) machine preservatives’ are replaced by the following: ‘(a) In-can preservatives Applicability: All products unless specified otherwise In-can preservatives classified with the following derogated hazard classifications may be used in ecolabelled products: Derogated classifications: H331 (R23), H400 (R50), H410 (R50/53), H411 (R51/53), H412 (R52/53), H317 (R43) In-can preservatives classified with these derogated classifications shall also meet the following derogation conditions: — The sum total concentration shall not exceed 0,060 % w/w — Substances classified with H400 (R50) and/or H410 (R50/53) shall be non-bioaccumulative. Non-bioaccumulative substances shall have a Log Kow ≤ 3,2 or a Bioconcentration Factor (BCF) ≤ 100. — For those substances that are approved for use or are included in Annex I to Regulation (EU) No 528/2012 evidence shall be provided that the approval conditions are respected for the paint product. — Where preservatives that are formaldehyde donors are used then formaldehyde content and emissions from the final product must meet the requirements in substance restriction 7(a) In-can preservatives Sum total in the final product: 0,060 % w/w Verification: Declaration by the applicant and their binder supplier supported by CAS numbers and classifications for the active substance in the final product and its binder. This shall include calculation by the applicant of the concentration of the active substance in the final product. All manufactured active substances for which 50 % or more of the particles in the number size distribution have one or more external dimensions in the size range 1 nm-100 nm shall be identified. Specific concentration limits applies to the following preservatives: Concentration limit (i) Zinc pyrithione 0,050 % (ii) N-(3-aminopropyl)-N-dodecylpropane-1, 3-diamine 0,050 % (b) Tinting (colourant) machine preservatives The derogated hazard classifications and the derogation conditions listed under 1(a) shall apply also to preservatives used to protect colour tints whilst stored in machines prior to mixing with base paints. Preservatives added to protect tints that will be dispensed from machines shall not exceed a sum total of 0,20 % w/w. The following preservatives are subject to specific maximum concentration limits contributing to the sum total of preservatives in the colourant: Sum total preservatives in the colourant: 0,20 % w/w Verification: Declaration by the applicant and/or their tint supplier supported by CAS numbers and classifications for the active substance in the final product and its binder. This shall include calculation of the concentration of the active substance in the final tint product. All manufactured active substances for which 50 % or more of the particles in the number size distribution have one or more external dimensions in the size range 1 nm-100 nm shall be identified.’ (i) 3-iodo-2-propynyl butylcarbamate (IPBC) 0,10 % (ii) Zinc pyrithione 0,050 % (iii) N-(3-aminopropyl)-N-dodecylpropane-1, 3-diamine 0,050 % (c) in the Hazardous Substance Restriction and Derogation List the entry ‘1(c) Dry film preservatives’ is replaced by the following: ‘(c) Dry film preservatives Applicability: Outdoor paints, indoor paints for specific applications Dry film preservatives and their stabilisers classified with the following derogated hazard classifications may be used in all outdoor products and only specific indoor products: Derogated classifications: H400 (R50), H410 (R50/53), H411 (R51/53), H412 (R52/53), H317 (R43) Dry film preservatives classified with these derogated classifications must also meet the following derogation conditions: — The sum total concentration shall not exceed 0,10 % w/w or 0,30 % w/w (as relevant). — Substances classified with H400 (R50) and/or H410 (R50/53) shall be non-bioaccumulative. Non-bioaccumulative substances shall have a Log Kow ≤ 3,2 or a Bioconcentration Factor (BCF) ≤ 100. — For those substances that are approved for use or are included in Annex I to Regulation (EU) No 528/2012 evidence shall be provided that the approval conditions are respected for the paint product. A higher sum total and a derogation from the requirements in criterion 5a which shall allow for the final product to become classified as hazardous for the aquatic environment (Chronic Category 3) and to carry the hazard statement H412 applies to the use of the following dry film preservative for the specified applications only: Dry film preservatives Sum total in the final product: Indoor paints intended for use in areas with high humidity, including kitchens and bathrooms 0,10 % w/w All outdoor paint applications 0,30 % w/w Verification: Declaration by the applicant and their binder supplier supported by CAS numbers and classifications for the active substances in the final product and its binder. This shall include calculation by the applicant of the concentration of the active substances in the final product. All manufactured active substances for which 50 % or more of the particles in the number size distribution have one or more external dimensions in the size range 1 nm-100 nm shall be identified.’ 3-iodo-2-propynyl butylcarbamate (IPBC) combinations Outdoor paints and varnishes Outdoor paints sum total for IPBC combinations: 0,650 % Specific concentration limits applies to the following preservative: Zinc pyrithione 0,050 % (d) in the Hazardous Substance Restriction and Derogation List an entry ‘8. Substances in binders and polymer dispersions’ is added as follows: ‘8. Substances in binders and polymer dispersions (a) Binders and cross linking agents Applicability: — Interior/exterior trim — Decoration, protection and coating of wood — Metal coatings — Floor coating — High gloss coating — Architectural and decorative coating Adipic acid dihydrazide (ADH) used as adhesion promoter or as a cross linking agent 1,0 % w/w Verification: A declaration shall be provided by the applicant and their raw material suppliers supported by calculations or by an analytical test report. (b) Reaction products and residues Applicability: Products with polymer binder systems The presence of residual methanol is restricted depending on the content of binder in the final product. Verification: A declaration shall be provided by the applicant and their raw material suppliers supported by calculations or by an analytical test report.’ — more than 10 % and up to 20 % binder content in the final product 0,02 % w/w — more than 20 % and up to 40 % binder content in the final product 0,03 % w/w — more than 40 % binder content in the final product 0,05 % w/w