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Appendix - Decision 2014/312/EU

Appendix

HAZARDOUS SUBSTANCE RESTRICTION AND DEROGATION LIST



Substance group

Scope of restriction and/or derogation

Concentration limits (where applicable)

Assessment and verification

1.  Preservatives added to colourants, binders and the final product

 
(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 (1) 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.
(ii)  Permitted sum totals of in-can and dry film preservatives in the ready to use product
In-can and dry film preservatives may be used in indoor and outdoor products according to the sum total concentrations detailed in the following table.


Sum total preservatives permitted in paint and varnish products

Preservation type

Indoor products

Outdoor products

In-can preservatives

0,060 %

0,060 %

Dry film preservatives

Not permitted

0,30 %

Derogated exceptions:

 

 

(i)  Paints for use in high humidity areas

0,10 %

n/a

(ii)  IPBC combinations for outdoor protection

n/a

0,65 %

Sum total preservatives

0,060 %

0,360 %

With derogated exceptions (i) or (ii) for dry film preservation

0,160 %

0,710 %


(iii)  Permitted sum totals of isothiazolinone substances and compounds in the ready to use product
The sum total of isothiazolinone compounds in any paint or varnish product shall not exceed 0,050 % (500 ppm) with the exception of outdoor wood paints and varnishes which shall not exceed 0,20 %. The following preservatives are derogated for use subject to specific limits on their contribution to the sum total of isothiazolinone compounds in the final ready to use product.
 

2-methyl-2H-isothiazol-3-one: 0,0015 %

1,2-Benzisothiazol-2(2H)-one: 0,0500 %


 

2-octyl-2H-isothiazol-3-one: 0,0500 % (until 28 February 2022); 0,0015 % (from 1 March 2022 onwards)

5-chloro-2-methyl-4-isothiazolin-3-one/2- methyl-4-isothiazolin-3-one: 0,0015 %

(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)  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)  Preservative stabiliser

Zinc oxide is derogated for use as a stabiliser for:

 

Verification: Declaration by the applicant and their raw material suppliers.

in-can preservative combinations and tinting paste preservative combinations that require zinc pyrithione with or without 1,2 Benzisothiazol-3(2H)-one (BIT).

0,030 %

in-can preservative combinations and tinting paste preservative combinations that require 1,2 Benzisothiazol-3(2H)-one (BIT).

0,040 %

dry film preservative combinations that require zinc pyrithione.

0,050 %

2.  Drying and anti-skinning agents

(a)  Driers

Applicability:

All paints products unless specified otherwise.

Derogated classifications: H301 (R24), H317 (R43), H373 (H48/20-22), H412 (R52/53), H413 (R53)

Cobalt driers in alkyd paints, which are additionally classified with H400 (R50) and H410, are derogated for white and light coloured paints only up to the following concentration limit:

Sum total drier content

0,10 % w/w

Cobalt drier content limit

0,050 %

Verification:

Declaration shall be provided by the applicant and their raw material suppliers supported by CAS numbers and classifications.

(b)  Anti-skinning agents

Applicability:

All paints products

Derogated classifications: H412 (R52/53), H413 (R53), H317 (R43)

0,40 % w/w

Verification:

Declaration shall be provided by the applicant and their raw material suppliers supported by CAS numbers and classifications.

3.  Corrosion inhibitors

(a)  Anti- corrosion pigments

Applicability:

Where required

Derogated classifications: H410 (R50/53), H411 (R51/53), H412 (R52/53), H413 (R53)

Concentration limits that shall apply:

(i)  Paints Directive 2004/42/EC classes d, i, j

8,0 % w/w

Verification:

Declaration shall be provided by the applicant and their raw material suppliers supported by SDS.

(ii)  All other products

2,0 % w/w

(b)  Verdigris prevention

Applicability:

Where required

Derogated classifications: H412 (R52/53), H413 (R53)

0,50 % w/w

Verification:

Declaration shall be provided by the applicant and their raw material suppliers supported by CAS numbers and classifications.

4.  Surfactants

(a)  General purpose surfactants

Applicability:

Surfactants used in all products.

Derogated classifications: H411 (R51/53), H412 (R52/53), H413 (R53)

The following sum total values apply to the ready to use final product:

— White and light coloured products

— All other colours

The derogation applies to the surfactant formulation supplied to the paint manufacturer. Specific restrictions apply to Alkylphenolethoxylates (APEOs) and Perfluorinated surfactants.

Sum total surfactants in the ready to use product:

1,0 % w/w

3,0 % w/w

Verification:

Declaration shall be provided by the applicant, raw material suppliers and/or their surfactant supplier supported by CAS No's and classifications for the surfactants used.

(b)  Alkylphenolethoxylates (APEOs)

Applicability:

Surfactants used in all products.

Alkylphenolethoxylates (APEOs) and their derivatives shall not be used in any paint or varnish preparations or formulations.

n/a

Verification:

A declaration of non-use shall be provided by the applicant and their raw material suppliers supported by CAS No's and classifications for the surfactants used.

(c)  Perfluorinated surfactants

Applicability:

Surfactants used in specific products.

Long chain perfluorinated surfactants, as specified in the OECD definition below, shall not be used:

(i)  Perfluorocarboxylic acids with carbon chain lengths ≥ C8, including perfluorooctanoic acid (PFOA);

(ii)  Perfluoroalkyl sulfonates with carbon chain lengths ≥ C6, including perfluorohexane sulfonic acid (PFHxS) and perfluorooctane sulfonate (PFOS); and

(iii)  Related compounds that may degrade to the substances identified in (i) or (ii) shall not be present in the surfactant or as a residue in the paint or varnish product.

Perfluorinated surfactants that do not meet (i),(ii) or (iii) may only be used in paint that is required to be resistant or repellent to water (see efficiency of use criteria 3(b) and 3(g) respectively) and to have a spreading rate of greater than 8 m2/l (see efficiency of use criteria 3(a).

n/a

Verification:

A declaration of non-use shall be provided by the applicant and their raw material suppliers supported by CAS numbers and identification of chain length for the surfactants used.

5.  Miscellaneous functional substances with general application

(a)  Silicon resin emulsion in white paints, colourant and tinting bases

Applicability:

All paints products

Derogated classifications: H412 (R52/53), H413 (R53)

2,0 % w/w

Verification:

Declaration shall be provided by the applicant and their raw material suppliers supported by CAS numbers and classifications.

(b)  Metals and their compounds

Applicability:

All products

The following metals or their compounds shall not be present in the product or the ingredients used in the product above the specified cut-off limit:

Cadmium, lead, chromium VI, mercury, arsenic, barium, selenium, antimony and cobalt.

The following derogations apply:

— Barium, antimony and cobalt in pigments (see restriction 5(f))

— Cobalt in driers (see restriction 2(a))

0,010 % cut-off per listed metal

Verification:

Declaration by the applicant and their raw material suppliers.

(c)  Mineral raw materials including fillers

Applicability:

All paints products

Mineral raw materials including crystalline silica and leucophyllite minerals containing crystalline silica are derogated for H373 (R48/20).

Mineral raw materials containing metals referred to in restriction 5(b) may be used if laboratory testing shows that the metal is bonded within a crystal lattice and is insoluble (see test method applicable).

The following fillers are derogated on this basis:

Nepheline syenite, containing barium

 

Verification:

Declaration shall be provided by the applicant and their raw material suppliers supported by CAS numbers and classifications.

Applicants wishing to use binders containing restricted metals shall submit test reports carried out in accordance with the listed standard.

Test method:

DIN 53770-1 or equivalent

(d)  Neutralising agents

Applicability:

All paints products unless specified

Derogated classifications: H311 (R24), H331 (R23), H400 (R50), H410 (R50/53), H411 (R51/53), H412 (R52/53), H413 (R53)

The following concentration limits shall apply:

 

Verification:

Declaration shall be provided by the applicant and their raw material suppliers supported by CAS numbers and classifications.

—  Varnishes and floor paints

1,0 % w/w

—  All other products

0,50 % w/w

(e)  Optical brighteners

Applicability:

All paints products

Derogated classifications: H413 (R53)

0,10 % w/w

Verification:

Declaration shall be provided by the applicant and their raw material suppliers supported by CAS numbers and classifications.

(f)  Pigments

Applicability:

All products

Restriction: Pigments containing metals shall only be used where laboratory testing of the pigment shows that the metal chromophore is bonded within a crystal lattice and is insoluble.

Derogation: The following metal containing pigments are derogated for use without the need for testing:

— Barium sulphate

— Antimony nickel within an insoluble TiO2 lattice

— Cobalt aluminate blue spinel

— Cobalt chromite blue-green spinel

n/a

Verification: Test results demonstrating that the pigment chromophore is bonded within a crystal lattice and is insoluble.

Test method:

DIN 53770-1 or equivalent

Derogation to criterion 5(a): Carc. Cat. 2, H351 (inhalation):

— For titanium dioxide (TiO2) only, and only in cases where the presence of TiO2 does not trigger Carc. 2, H351 classification of the paint or varnish product to be licensed

n/a

Verification: The applicant shall demonstrate that both they and the TiO2 supplier have systems in place to minimise worker exposure to dry TiO2 powder in the workplace (e.g. closed dosing systems, ventilated dosing and mixing areas, personal protective equipment).

Derogation to criterion 5(a): Repr. Cat. 2, H361fd:

— For trimethylolpropane (TMP), and only when used as an additive in pigments

0,50  %

Verification: The pigment supplier shall declare that the TMP content does not exceed 0,50  % w/w of the pigment.

6.  Miscellaneous functional substances with specialist applications

(a)  UV protectors and stabilising agents for outdoor paints

Applicability:

Outdoor paints

Derogated classifications: H317 (R43), H411 (R51/53), H412 (R52/53), H413 (R53),

0,60 % w/w

Verification:

Declaration shall be provided by the applicant and their raw material suppliers supported by CAS numbers and classifications.

(b)  Plasticisers in paint and varnish.

Applicability:

Where included in the formulation

The following phthalates shall not be intentionally added as plasticisers:

DEHP (Bis-(2-ethylhexyl)-phthalate)

BBP (Butylbenzylphthalate)

DBP (Dibutylphthalate)

DMEP (Bis2-methoxyethyl) phthalate

DIBP (Diisobutylphthalate)

DIHP (Di-C6-8-branched alkyphthalates)

DHNUP (Di-C7-11-branched alkylphthalates)

DHP (Di-n-hexylphthalate)

Concentration limit for any individual phthalate:

0,010 %

Verification:

Declaration shall be provided by the applicant and their raw material suppliers supported by CAS numbers and classifications.

7.  Residual substances that may be present in the final product

(a)  Formaldehyde

Applicability:

All products.

Free formaldehyde shall not be intentionally added to the final product. The final product shall be tested in order to determine its free formaldehyde content. The sampling requirements for testing shall reflect the product range.

The following sum total limit value shall apply:

The following derogations are made from the requirement set out in the first paragraph:

(i)  Where preservatives that are formaldehyde donors are required as an in-can preservative to protect a specific type of paint or varnish and where the formaldehyde donor is used in the place of isothiazolinone preservatives.

(ii)  Where polymer dispersions (binders) provide, through residual levels of formaldehyde, the function of formaldehyde donors instead of in-can preservatives.

In both points (i) and (ii) the sum total shall not exceed the following limit value:

 

Verification:

The free formaldehyde content shall be determined for the white base or transparent tinting base predicted to contain the highest theoretical amount of formaldehyde. The content of the colour tint which is predicted to contain the highest theoretical amount of formaldehyde shall also be determined.

Test method:

0,0010 % limit value:

Determination of the in-can concentration using the Merckoquant method. If the outcome is not definitive according to this method then high-performance liquid chromatography (HPLC) shall be used to confirm the in-can concentration.

0,010 % limit value:

(1)  All paints: Determination of the in-can formaldehyde concentration by means of analysis using VdL-RL 03 or high-performance liquid chromatography (HPLC)

(2)  Indoor paints and varnishes: Determination by means of analysis according to ISO 16000-3. Emissions must not exceed 0,25 ppm upon first application and they must be less than 0,05 ppm after 24 hours from the first application.

0,0010 %

0,010 %

(b)  Solvents

Applicability:

All products.

Derogated classifications: H304 (R65)

2,0 % w/w

Verification:

Declaration shall be provided by the applicant and their raw material suppliers supported by CAS numbers and classifications.

(c)  Unreacted monomers

Applicability:

Polymer binder systems

Unreacted monomers present from binders including acrylic acid may be present in the final product up to a sum total limit.

0,050 % w/w

Verification:

Declaration shall be provided by the applicant and their raw material suppliers supported by CAS numbers and classifications.

(d)  Volatile Aromatic Hydrocarbons and halogenated solvents

Applicability:

All products.

Volatile Aromatic Hydrocarbons and halogenated solvents shall not be present in the final product.

residual limit value of 0,01 %

Verification:

A declaration of non-use shall be provided by the applicant and their raw material suppliers supported by CAS numbers and classifications.

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

 (1)   

ECHA, Biocidal active substances — list of approved active substances, http://www.echa.europa.eu/web/guest/information-on-chemicals/biocidal-active-substances.