Environmental Project, 1109 – The EU Eco-label and Health – Annex 1 Analysis of selected criteria sets

The EU Eco-label and Health

Annex 1 Analysis of selected criteria sets

1A Indoor paints and varnishes

Purpose

to promote efficient product use and to reduce the amount of waste to a minimum
to limit the environmental risk and other risks (such as tropospheric ozone degradation) by reducing the emissions from solvents
to reduce discharges of toxic and in other way polluting substances to aquatic environments.

Area

The product group ”indoor paints and varnishes” includes indoor decorative paints, varnishes, stain and similar products meant for consumers or professional users, and that primarily have been developed for indoor use and are marketed as such.

Corrosion protection agents, anti-fouling paints, wood preservatives and special surface coatings for special industrial uses (e.g. thick-film paints and two-component products) are not included in the product group.

Health-related criteria

Classification:

The product may not be classified as toxic (T), very toxic (Tx) and/or carcinogenic, mutagenic or repro-toxic (CMR).

Regulation of specific ingredients:

The product may not contain substances that are classified as

acutely toxic (R23, R24, R25; R26, R27, R28, R39^[6]) unless the substance is a preservative and is found in a concentration of ≤ 0.1%.^[7]
CMR^[8] in categories 1 and 2 (R45, R46, R60, R61)
R48 (Danger of serious damage to health by prolonged exposure)

The product may only contain traces from raw materials of Cd, Pb, Cr(VI) and As, but a more accurate limit has not been specified.

Some of the regulated substances have been evaluated by IARC /12/. Cd, Cr(VI) and As have been evaluated by IARC as belonging to group 1, formaldehyde has been categorised in group 2A and Pb is in group 2B^[9].

Exposure:

Exposure during use has only been regulated indirectly through the demands for ingredients. There are no special demands for physical state of the product (liquid, aerosol) or for application method (brush, spraying).

The effect of the product during the application phase and through the indoor climate has been indirectly regulated through the criteria for volatile organic compounds (VOC’s), volatile aromatic hydrocarbons (VAH’s) and free formaldehyde. There are limit values for the content of VOC’s with a boiling point of < 250^oC at normal pressure and VAH’s with a boiling point of < 250^oC at normal pressure and at least one aromatic ring. In addition, there is a limit value for the content of free formaldehyde.

There are no special criteria for the working environment during production apart from the indirect benefit appearing from the criteria for the substances that may be used as raw materials. For products containing the white pigment TiO₂, limit values have been established for the discharge of SOx for air, sulphate and chloride waste.

Summary

The point of origin for all the criteria are environmental considerations, but several of the criteria also cover health aspects (table A).

Criteria	Environment	Health
1. White pigments	x
2. Volatile organic compounds	x	x
3. Volatile aromatic hydrocarbons	x	x
4. Heavy metals	x	x
5. Dangerous substances	x	x
6. Fitness for use	x

Table A. Indoor paints and varnishes. Environment and health coverage.

	Ban	Limitation	Declaration
Product level	T, Tx and CMR	-	-
Substance level	CMR cat. 1 and 2 R48	≤ 0.1% preservatives with T or Tx VOC VAH Free formaldehyde Cd, Cr(VI), As, Pb Isothiazolinons	-

The criteria establishes requirements regarding the content of toxic and very toxic substances as well as certain carcinogenic, repro-toxic and mutagenic substances in categories 1 and 2. The demands for the content of VOC’s, VAH’s and formaldehyde will benefit the indoor climate properties of the products.

There are no direct limits for the content of substances that may cause cancer or allergy through inhalation(R49: may cause cancer by inhalation). No demands have been established for the content of substances with R68 (possible risk of irreversible effects).

1B Textile products

Purpose

to limit the water pollution in connection with the central processes of the textile production chain including fibre production, spinning, weaving, knitting, bleaching, dying and aftercare
to promote labelling of textile products with a lower environmental load.

Area

The product group ”textile products” includes furnishing fabrics, accessories (such as bags) and clothing fabrics including fibres, yarn and fabrics sold by the metre.

Wall and floor coverings are not included in the product group.

Health-related criteria

The criteria document covers 40 different specific requirements in 3 areas: textile fibres, processes and chemicals and usability. Most of the requirements are environmentally based but a considerable number of the requirements also cover health considerations (Table B).

Regulation of specific ingredients:

The product may not contain dyes, flame retardants and aftercare agents that may be classified as

CMR in categories 1, 2 and 3 (R40, R45, R46, R49, R60, R61, R63, R68) unless the substance/mixture/agent is found in a concentration of ≤ 0.1%

Limit values have been established for the content of the metals Ag, As, Ba, Cd, Co, Cr, Cu, Fe, Hg, Mn, Ni, Pb, Se, Sb, Sn, Zn when they are found as impurities in dyes and pigments. When the metals are included as an integrated part of a metal-complex dye or a reactive dye, there is no limit value. A limit value has been established for the content of formaldehyde in the product and the product may not contain a number of specified dyes – including azo-compounds that are carcinogenic, or that may split off carcinogenic amines.

Some of the regulated substances are found on the IARC list of carcinogenic substances. Chlordane, DDT, toxaphene, hexachlorobenzene, certain organic tin compounds and PCB are furthermore on the EU list of hormone-disrupting substances.

Biocides are only to be used as a preservative of the product.

Exposure:

The product’s influence on the indoor climate is only regulated through the criteria for formaldehyde.

For the manufacturing of various fibre types there are demands for emissions to the air for the substances acrylnitril, aromatic diisocyanates, S, N₂O, VOC

Criteria	Environment	Health
Textile fibre criteria:
1. Acrylic	x	x
2. Cotton and other natural cellulosic seed fibres	x	x
3. Elastane	x	x
4. Flax and other bast fibres	x
5. Greasy wool and other keratin fibres	x	x
6. Man-made cellulose fibres	x
7. Polyamide	x
8. Polyester	x	x
9. Polypropylene	x	x
Processes and chemical criteria
10. Auxiliaries and finishing agents for fibres and yarns	x	x
11. Biocidal or biostatic products	x	x
12. Stripping or depigmentation	x	x
13. Weighting	x	x
14. Auxiliary chemicals	x
15. Detergents, fabric softeners and complexing agents	x
16. Bleaching agents	x
17. Impurities in dyes	x	x
18. Impurities in pigments	x	x
19. Chrome mordant dyeing	x	x
20. Metal complex dyes	x
21. Azo dyes	x	x
22. Dyes that are carcinogenic, mutagenic or toxic to reproduction		x
23. Potentially sensitising dyes		x
24. Halogenated carriers for polyester	x	x
25. Printing	x	x
26. Formaldehyde		x
27. Waste water discharges from wet-processing	x
28. Flame retardants	x	x
29. Shrink resistant finishes	x	x
30. Finishes	x	x
31. Fillings	x	x
32. Coatings, laminates and membranes	x	x
33. Energy and water use	x

Table B. Textile products. Environment and health coverage.

	Ban	Limitation	Declaration
Product level	-	-	-
Substance level	Azo-compounds 9 dyes Aromatic diisocyanates* Heavy metals (minus Fe)* Formaldehyde* Ce*	< 0.1% CMR* Ag* As* Ba* Cd* Co* Cr* Cu* Fe* Hg* Mn* Ni* Pb* Se* Sb* Sn* Zn* Formaldehyde Pesticides Acrylnitril* Aromatic diisocyanates* VOC* Chlorphenoles* PCB* Organic tin compounds* 18 dyes	-

*: Only certain ingredients or processes

The criteria document includes a high number of very specific criteria. The demands are related to specific substance groups instead of substances with specific properties. A number of substances applied for textile production have been banned – including certain azo-dyes.

Chronic health effects have been considered through the ban against content of dyes, flame retardants and aftercare products classified as CMR in categories 1, 2 and 3. However, there is no demand that the product may not contain other types of substances classified regarding CMR effects. Polyester for example may contain up to 260 ppm Sb – SbO₃, which is used as catalyst in polyester manufacturing, and classified as carcinogenic in category 3.

Sensitizing substances and substances classified as R48 have not been restricted and the content of toxic, very toxic and irritating substances is not considered.

1C Laundry detergents

Purpose

to reduce the transport and energy consumption by favouring compact textile detergents
to reduce contamination of water by reducing the amount of chemicals used in the product and by limiting the use of potentially harmful ingredients
to minimize the production of waste by limiting the amount of packaging.

Area

Detergents primarily intended for use in household. The detergent may be powder, liquid or any other physical form for washing of textiles.

Health-related criteria

Classification:

The product may not be classified as R43 (may cause sensitisation by skin contact).

The product may not contain substances classified as

CMR in categories 1, 2 and 3 (R40, R45, R46, R49, R60, R61, R62, R63, R68) unless the substance is found in a preparation in a concentration of ≤ 0.01% of the final product
R64: ”May cause harm to breastfed babies” unless the substance is found in a preparation in a concentration of ≤ 0.01% of the final product.

All criteria are based on environmental considerations, but a few criteria also include health aspects (table C).

Criteria	Environment	Health
1. Total chemicals	x	x
2. Insoluble inorganic ingredients	x
3. Toxicity to aquatic organisms	x
4. Phosphates	x
5. Biodegradability of surfactants	x
6. Dangerous, hazardous or toxic substances or preparations	x	x
7. Purity of enzymes	x	x
8. Packaging requirements	x

Table C. Laundry detergents. Environment and health coverage.

	Ban	Limitation	Declaration
Product level	R43	-	-
Substance level	Nitromoskus and polycyclic musk compounds NTA Micro-organisms	≤ 0.01% CMR and R64	Enzymes Preservatives Disinfectants Perfume (unspecified, but shall fulfil detergent regulation)

The restrictions regarding the total amount of chemicals will also be a benefit to health. The criteria also lists demands the content of carcinogenic, repro-toxic and mutagenic substances.

There are no criteria for the content of toxic, very toxic, irritating and sensitizing substances. There are no considerations regarding the physical state of the product – e.g. a recommendation for tablets and liquid instead of powder.

Chronic health effects have been considered as the product may not contain substances classified as CMR in categories 1, 2 and 3. However, the Eco-label may be awarded to products classified with R42 (may cause sensitisation by inhalation) and products with a content of allergens as well as substances with R48. Content of the allergenic nitromusk and polycyclic musk compounds as well as NTA suspected of being carcinogenic is, however, not allowed.

1D All purpose cleaners and cleaners for sanitary facilities

Purpose

to reduce the environmental impact by limiting the amount of harmful ingredients, detergents used and the amounts of packaging
to reduce or prevent environmental or health risks related to the use of hazardous substances
to provide information enabling the consumer to use the product efficiently to minimize the environmental impact.

Area

The product group ”all-purpose cleaners & cleaners for sanitary facilities” is divided into 2 parts – all-purpose cleaners and cleaners for sanitary facilities. The criteria include products for both private and professional use.

All-purpose cleaners include products that are dissolved or diluted in water for regular cleaning of floors, walls, ceilings and other solid surfaces. Also window cleaners are included.

Cleaners for sanitary facilities include products for regular removal of dirt or deposits in sanitary facilities such as washrooms, bathrooms, shower rooms and toilets as well as kitchens.

Health-related criteria

Classification:

The product may not be classified as R42 (may cause sensitisation by inhalation) and R43 (may cause sensitisation by skin contact).

The product may not contain substances classified as

CMR in categories 1, 2 and 3 (R40, R45, R46, R49, R60, R61, R62, R63)
R68 “Possible risk of irreversible effects”
R64 ”May cause harm to breastfed babies”
R31 ”Contact with acids liberates toxic gas”
R42 and R43

The requirements apply to ingredients that exceeds 0.01% by weight of the final product (0.1% regarding substances classified by R42 and R43)

Regulation of specific ingredients:

The use of the nitromusk and polycyclic musk compounds as well as NTA suspected of being carcinogenic is not allowed. The overall content of other allergens and substances classified with R48 ”Danger of serious damage to health by prolonged exposure” are not regulated.

A limit on the content of VOC’s with a boiling point of < 150^oC has been established. Biocides may only be used for preservation of the product.

All fragrances must be manufactured and handled according to the International Fragrance Association guidelines. The criteria require the compliance with the Detergent regulation (648/2004/EC) where requirements regarding fragrances are included. The criteria is thus reduced in relative stringency related to the regulation compared to the former criteria document.

Dyes and colouring agents must comply with the cosmetic and food stuff regulation.

The majority of the criteria is motivated by environmental concern, but a significant part are also relevant for health (table D).

Criteria	Environment	Health
1. Eco-toxicity and biodegradability	x
2. Phosphorus and phosphonates	x
3. Anaerobic biodegradability of surfactants	x
4. Hazardous substances or preparations	x	x
5. Volatile organic compounds	x	x
6. Dyes or colouring agents		x
7. Fragrances		x
8. Sensitizing substances		x
9. Biocides	x	x
10. Packaging requirements	x

Table D. All-purpose cleaners and cleaners for sanitary facilities. Environment and health coverage.

	Ban	Limitation	Declaration
Product level	R42 and R43	-	-
Substance level	Nitromusks and polycyclic musks NTA Glutaraldehyde	≤ 0, 01% CMR, R64 and R31 VOC Biocides	-

There are no direct demands for absence of toxic, very toxic and allergenic substances. The product may not be classified as sensitizing, but this does not exclude a content of allergenic substances as the general limit for substances with R43 is 0.1%.

Acute health effects have not been taken into account based on the classification criteria.

Chronic health effects have been taken into account as products are not allowed to contain substances classified as CMR in categories 1, 2 and 3.

There are no considerations regarding the physical form of the product such as a recommendation of paste and liquid instead of powder and spray.

As for laundry detergents no requirements have been included, that a product awarded the Eco-label may not belong to hazard classes T and Tx /8/. A reason may be that products belonging to these classes do not appear at the market.

1E Dish washers detergents

Purpose

to reduce water pollution by both limiting the amount of detergent used as well as its content of harmful substances
to reduce energy consumption by promoting detergents working at low temperatures
to minimize the production of waste by limiting the amount of packaging.

Area

All detergents for automatic dishwashers in the household along with all detergents for automatic dishwashers for professional use. For professional use only as long as the dishwasher is similar to those used in private households.

Health-related criteria

Classification:

There are no demands for the classifications of the product.

The product may not contain substances classified as

CMR in categories 1, 2 and 3 (R40, R45, R46, R49, R60, R61, R62, R63, R68) unless the substance is found in a preparation in a concentration of ≤ 0.01% of the final product
R64 unless the substance is found in a preparation in a concentration of ≤ 0.01% of the final product

Acute health effects:

Acute health effects have not been considered based on the classification criteria.

Chronic health effects:

Chronic health effects have been considered as the product is not allowed to contain substances classified as CMR in categories 1, 2 and 3.

There are no demands regarding substances classified as sensitizing, allergenic substances or substances classified with R48.

Regulated ingredients:

The allergenic nitromusk and polycyclic musk compounds as well as NTA, which is suspected of being carcinogenic, are not allowed.

	Ban	Limitation	Declaration
Product level	-	-	-
Substance level	Nitromusk and polycyclic musk compounds NTA Micro-organisms	≤ 0.01% CMR and R64	Enzymes Preservatives Perfume (unspecific)

The majority of the criteria is motivated by environmental considerations but a minor part also relate to health considerations (table E).

Criteria	Environment	Health
1. Environmental scoring matrix	x
2. Biodegradability of surfactants	x
3. Dangerous, hazardous or toxic substances or preparations	x	x
4. Fragrances		x
5. Packaging	x
7. Purity of enzymes	x	x

Table E. Detergents for dishwashers. Environment and health coverage.

1F Hand dishwashing detergents

Purpose

to reduce the discharge of toxic and otherwise polluting substances to the aquatic environment
to reduce or prevent risks to health and environment related to the use of hazardous substances
to minimize packaging waste
information enabling the consumer to use the product efficiently to minimize environmental impact.

Area

The product group include all detergents intended to be used for hand dish washing and cover products for both private and professional use.

Health-related criteria

Classification:

The product may not be classified as R42 and R43.

The product may not contain substances classified as

CMR in categories 1, 2 and 3 (R40, R45, R46, R49, R60, R61, R62, R63)
R68 “Possible risk of irreversible effects”
R64 ”May cause harm to breastfed babies”
R31 ”Contact with acids liberates toxic gas”
R42 and R43

The requirements apply to ingredients that exceeds 0.01% by weight of the final product (0.1% regarding substances classified by R42 and R43)

Regulation of specific ingredients:

A limit on the content of VOC’s with a boiling point of < 150^oC has been established. Biocides may only be used for preservation of the product.

Dyes and colouring agents must comply with the cosmetic and food stuff regulation.

The majority of the criteria is motivated by environmental concern, but a significant part are also relevant for health (table F).

Criteria	Environment	Health
1. Toxicity to aquatic organisms	x
2. Biodegradability of surfactants	x
3. Dangerous, hazardous or toxic substances or preparations	x	X
4. Fragrances		X
5. Dyes or colouring agents		X
6. Biocides	x	X
7. Sensitising substances		X
8. Limitations of surfactants per wash	x
9. Packaging requirements	x

Table F. Hand dishwashing detergents. Environment and health coverage.

	Ban	Limitation	Declaration
Product level	R42 and R43 Any fragrances in professional products	-	-
Substance level	Nitromusk and polycyclic musk compounds NTA	≤ 0.01% CMR and R64 Biocides	13 fragrances

There are no direct demands regarding the content of toxic, very toxic and allergenic substances.

Fodnoter

^[6] See annex 3 for the wording of the R-phrases.

^[7] R68 ” Possible risk of irreversible effects” is not regulated R68 is included in Directive 1999/45/EC /5/, but in the previous Directive 88/379/EEC R40 had this wording (Possible risk of irreversible effects). However, R40 (in its previous meaning) has neither been regulated in the criteria for indoor paints and varnishes.

^[8] Carcinogenic, Mutagenic, Repro-toxic

^[9] See the meaning of the IARC groups in annex 5.