The EU Eco-label and Health

5 Health aspects presently covered by the EU eco-label

In the following, the extent of the coverage of health aspect is analysed in:

  • the Regulation
  • the method basis for establishment of criteria
  • the criteria for selected product groups
  • the demands for the final design of the label for selected product groups.

5.1 Coverage of health aspects in the Regulation

The scope of the regulation contains provisions regarding protection of the consumer and also regarding occupational health:

Regulation EC No 1980/2000 of 17. July 2000:

Article 2, sec. 4:
”The eco-label may not be awarded to substances or preparations classified as very toxic, toxic  (...) carcinogenic, toxic for reproduction, or mutagenic (...) nor to goods manufactured by processes which are likely to significantly harm man and/or the environment, or in their normal application could be harmful to the consumer.”

Article 3, sec. 2:
”(...) in evaluating the comparative improvements, consideration shall be given to (...) health and safety aspects (...)”



The scope of the regulation may be interpreted as follows:

  • Preparations containing CMR substances (Carcinogenic. Mutagenic and Repro-toxic) or substances characterised to be toxic and very toxic according to directive 99/45/EEC cannot be labelled with the EU eco-label.
  • Eco-labelled goods may not be manufactured in a way that significantly harms man or environment. In practice, a company producing eco-labelled goods should comply with relevant occupational health and environmental legislation. In REACH terminology, the text may read: “The production processes should be in compliance with the identified uses and the risk management measures identified in SDS and attached exposure scenarios”.
  • An eco-labelled product may not harm the user in its normal application, i.e. the existing legislation should be complied with. An interpretation in REACH regulation terminology would be that there should be no unacceptable risk to man (and environment) by its intended use.
  • Health and safety should be considered whenever appropriate, but the main focus is environmental issues.

While the first provision above is clear as it refers to an EU directive, the other three should be more clearly defined. The proposal for a new EU chemical policy (REACH) may be consulted to improve definition of item two and three above.

As a whole the scope may be interpreted as “minimum requirements”, i.e. all criteria documents should as a minimum be in compliance with the scope. There are no indications anywhere in the Regulation that these should be interpreted as maximum requirements.

5.2 Method basis

Annex II of the Regulation describes the methodological requirements for establishment of the Eco-label criteria.

Extract from Regulation EC No 1980/2000 of 17. July 2000, Annex II:

Life cycle considerations (LCC)
Key environmental aspects, for which criteria will need to be developed, will be defined through the use of life cycle considerations and will be performed in accordance with internationally recognized methods and standards. The principles laid down in EN ISO 14040 and ISO 14042 will be duly taken into account, where appropriate.


Annex I of the Regulation contains an indicative assessment matrix regarding environmental load assessment in the life cycle of the product.

Environmental conditions Goods
Pre-production/raw materials Production Distribution (including packaging) Use Recycling/ reclamation/ removal
Air quality          
Water quality          
Soil protection          
Waste reduction          
Energy conservation          
Administration of natural resources          
Prevention of global warming          
Protection of the ozone layer          
Environmental safety          
Noise          
Biodiversity          

Table 3. Indicative assessment matrix for environmental loads of goods.

As may be seen, ”noise” is the only condition that is directly related to health although also protection of the ozone layer and prevention of global warming indirectly include considerations regarding health. It may be concluded that “health load” from chemicals is not appropriately considered . Article 3, sec. 2 of the Regulation states that the comparative improvements must consider the positive net effects for the environment and the environmental advantages and disadvantages, including health aspects. A transparent assessment in relation to the scope of the regulation would require a description of a method or a guideline to cover health aspects in line with the form in annex I (Table 3 above).

5.3 Analysis of selected criteria document

Six criteria sets have been analysed regarding the health aspects covered. Five of these cover chemical products (preparations). In addition, the criteria document for textiles has been selected as representative for an article in which chemicals play a major role regarding environmental aspects.

The selected criteria documents are identified below:

The EU Eco-label Product groups analysed for health coverage
  Adopted Next revision
Dish washers detergents /6/ Nov 2002 Dec 2007
Indoor paints and varnishes /7/ Sept 2002 -
Hand dish washing detergents /8/ Mar 2005 2008
Textile products /9/ Feb 2002 May 2007
Laundry detergents /10/ Feb 2003 Feb 2008
All purpose cleaners and cleaners for sanitary facilities /11/ Mar 2005 Dec 2008

Only the health aspects as they appear in the final criteria documents have been analysed. It is outside the scope of the present project to analyse how the health aspects have been dealt with in the preparatory life cycle considerations.

The following aspects have been covered:

  • Health considerations in relation to scope of the regulation
  • Demands regarding classification of the preparations
  • The level of stringency regarding use limitation of ingredients with health concern, e.g. sensitizing substances, and whether relevant official lists and regulations have been applied.
  • Demands for declaration of certain ingredients/substance groups
  • Demands for measures to reduce exposure of the consumer during use.

A short summary of the results of the analysis is given below. Reference is made to annex 1 for a more detailed description of the analysis.

5.3.1 Health as part of the scope of the criteria document

Health considerations are only explicitly mentioned in criteria set for all purpose cleaners and for hand dish washing detergents.

5.3.2 Scope of the regulation regarding health reflected in criteria documents

Although it is not a prerequisite that the non-supported hazard classes listed in the Regulation under Article 2, sec. 4 should be explicitly mentioned in all criteria documents, there is limited information in many of the documents that these restrictions have actually been part of the technical analysis background documentation or are part of the assessment of compliance of applications with the criteria. This could be part of a checklist used during the application procedure

The criteria document for indoor paints and varnishes support the overall demands in the Regulation to the effect that the preparation may not be classified as acutely toxic (”Very toxic”, ”Toxic”) or with regard to CMR effects (carcinogenic, mutagenic or reprotoxic). For the remaining criteria the demands are limited to restrictions regarding the hazard classes ”Very toxic” or ”Toxic”.

The criteria set for laundry detergents, all purpose cleaners, as well as for hand

dish washing detergents go further than the scope of the regulation, as the criteria do not allow products to be classified with R43  ”May cause sensitisation by skin contact”. The last two mentioned documents also include a ban regarding products classified with R42 ”May cause sensitisation by inhalation”, Xn (harmful) and C (corrosive).

5.3.3 Criteria regarding health aspects of ingredients

All criteria have restricted the use of certain chemicals dangerous to health. These demands include for example limitation in the use of specified fragrance, dyes and/or sensitizing substances. They are all more stringent than the relevant chemical legislation. Various criteria documents require that the products may not contain, or there is a fixed limitation in the content of, substances classified with specific R-phrases. Annex 2 contains an overview of the R-phrases restricted in the selected criteria set.

For some criteria the demand has been formulated as a general ban against or limitation in the use of substances with a specific classification (e.g. substances classified with R48), while for other criteria it has been formulated as a ban against the use of specific substances or substance groups that are otherwise frequently applied in the product groups. Some of the criteria documents contain criteria formulated in both ways. All nitro musk and polycyclic musk compounds considered to be sensitizing and known to occur in washing and cleaning agents are examples of substance groups that are restricted in specific product groups.

No direct reference is made to IARC evaluations of carcinogenic substances in any of the criteria sets, but some criteria include a regulation of substances evaluated by IARC.

5.3.4 Declaration of ingredients hazardous to health in the products

For textile detergents and dish washer detergents criteria regarding declaration of fragrances have been included. The declaration demands refer to Commission Recommendation 89/542/EEC of 13 September 1989 on labelling of detergents.

For hand dish washing detergents and all-purpose cleaners this demand has been omitted in the recent updated criteria of 2005 and instead a reference to the new detergent regulation (648/2004/EC) has been made. The detergent regulation requires that fragrances listed in the Cosmetic Directive (2003/15/EC amending the Council Directive 76/768/EEC) should be declared if the concentration of any of the 26 fragrances listed appears in concentrations above 0.01% (w/w).

The former criteria document for these two product groups contained a list of fragrances along with a demand that it must be clearly stated on the package if the product contains one or more of these substances along with the name or names of the fragrances in question.

Therefore, the two criteria documents are no longer more stringent than the existing regulation regarding these aspects, although presumably it would be possible for products on the market to fulfil more stringent requirements.

5.3.5 Criteria regarding workers environment

To some extent occupational health is indirectly covered through the restrictions on raw materials applied in the production of the eco-labelled product. The exclusion of all fragrances in eco-labelled professional hand dish washing detergent criteria may also be taken as a protection of occupational health. There are no other demands regarding occupational health in any of the criteria documents reviewed.

5.3.6 Criteria regarding exposure to the consumer

None of the criteria documents include demands on reduction of the exposure risk of the consumer, e.g. restrictions of the physical form of the product. The risk of inhalation of certain volatile substances may for example be reduced by requesting that the product may not be sold with a spray device, thus reducing the formation of aerosols.

5.3.7 Summary

The results of the evaluation of the criteria are summarized in table 4.

Table 4 Schematic overview of the result of the evaluation of selected criteria set

Product group Indoor paints and varnishes Textile products Laundry detergents All purpose cleaners Dish washers detergents Hand dish washing detergents
Parameters
Description of purpose
- Health considerations - - - + - +
Tightened demands for the classification of the product
- Ban on classification with R42 and/or R43 - - + (R43) + (R42,R43) - + (R42,R43)
Regulation of specific ingredients
- Acutely toxic substances + - - - - -
- Substances with CMR-effects (category) 1,2 (1,2,3) 1,2,3 1,2,3 1,2,3 1,2,3
- Health hazardous substances + (R48) - - - - -
- Heavy metals + + - - - -
- VOC’s + + - + - -
- Negative lists ++ ++ + + + +
- Enzymes n.r. n.r. + - + -
Declaration demands[2] - - + - + -
EU’s recommendation on detergents - - + + + +
Fragrances - - - + - +
Exposure to the consumer - - - - - -
Exposure during production - - + + + +

+ : The parameter is included in the criteria

- : The parameter is not included in the criteria

n.r.: not relevant for the current product type

The relevance of health and environmentally related limit requirements for chemicals may vary for different product groups. It is interesting, however, to note that around 75% of the specific limit requirements in the 6 criteria documents relate to environmental aspects, while around half of the requirements relate to health aspects. Therefore, in practice there is a relatively high coverage of health aspects, although variations between the criteria are significant.

Based on the evaluation of selected criteria, it may be concluded that:

  • Where health-related criteria are present, the criteria are in general more stringent than the demands in relevant chemicals legislation.
  • Although not required only one of the selected criteria set (indoor paints and varnishes) lists the requirements of the Regulation that products cannot obtain the Eco-label if they are classified as very toxic (Tx), toxic (T) or with regard to CMR effects.
  • Workers environment is only indirectly covered by the restriction of substances used as raw materials. The physical environment and auxiliary substances are not covered.
  • Exposure of the consumer via the physical application of the products is only indirectly reflected in the criteria.

5.4 Information phrases on the product label

The introduction to the Regulation states that ”the eco-label should contain simple, precise, non-misleading and scientifically based information on essential environmental conditions, that should be taken into consideration in connection with the assignment of the label, so that the consumer can make their choice on a well-informed basis”.

In addition to the logo (the Flower), the label must contain information on the reasons for awarding the Eco-label. The information must include at least one and no more than 3 environmental impact phrases.

Table 5 shows the phrases selected for 6 criteria documents.

Criteria set Information on the label (box 2)
Indoor paints and varnishes Suitable for indoor use
Restrictions on use of hazardous substances
Low solvent content
Textile products Reduced water pollution
Restrictions on use of hazardous substances
The entire product chain is included
Laundry detergents Contributes to reduced water pollution
Contributes to reduced resource consumption
All-purpose cleaners and cleaners for sanitary facilities Reduced impact on aquatic life
Reduced use of hazardous substances
Clear user instructions
Detergents for dishwashers Contributes to reduced water pollution
Contributes to reduced packaging
Hand dish washing detergents Reduced impact on aquatic life
Reduced use of hazardous substances
Clear user instructions

Table 5 Information to be given in label box 2 for selected criteria documents.

It would probably help the consumer to understand the message if the wording of the phrases was more direct and less academic. The problem of formulating the phrases is that they should be clear, use positively loaded words and at the same time be legally valid.

Health is a good example of the problem of phrasing a valid line on health protection. Very few phrases refer to health aspects even though health aspects are an important issue in some of the criteria, e.g. the criteria document for indoor paint and varnishes.


Fodnoter

[2] Declaration demands going beyond the present detergent regulation regarding fragrances

 



Version 1.0 August 2006, © Danish Environmental Protection Agency