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The EU Eco-label and Health

4 Principles for evaluation of chemicals

• 4.1 Hazard assessment
  • 4.1.1 Hazard identification
  • 4.1.2 Classification and labelling of substances and preparations
• 4.2 Exposure

In the following, the principles for health hazard and risk assessment of chemicals are outlined. Environmental aspects are not covered.

4.1 Hazard assessment

4.1.1 Hazard identification

Health hazardous properties may be divided into acute and chronic effects. Acute effects are effects that may be seen immediately after exposure such as corrosion, damage from contact with skin or narcotic effects from inhalation. Chronic effects are lasting effects appearing after prolonged exposure, e.g. central nervous system damages after long-term inhalation of organic solvents or cancer. Other health hazards include the development of allergy or hormone disruptive effects.

A general list of potential hazards are outlined in Table 1.

Table 1: Parameters included in health hazard identification of substances:

Other properties having indirect health aspects are ozone layer degrading properties (leading to increased frequency of skin cancer), green house impact, persistence and bioaccumulation leading to increased contamination of food stuff.

4.1.2 Classification and labelling of substances and preparations

The EU classification regulations are based on hazard assessment of substances and preparations (chemical products).

The classification of substances and preparations is carried out by comparing information on the properties of the substance (toxicological data, eco-toxicological data, and physical-chemical data) with a number of hazard criteria described in the relevant chemical legislation /3, 4/.

The purpose of classifying substances (and preparations) is to identify all hazardous properties of the substance in the state in which it is marketed in order to inform the (professional) user of the hazardous properties through labelling with hazard symbols, risk and safety phrases. The information is provided for the user in Safety Data Sheets according to the EU directive /5/ and any national implementation requirements. The final hazard labelling of the product helps the consumer to take necessary precautions.

All suppliers of chemical substances are obliged to classify and label the substances in accordance with the Council Directive 67/548/EEC /3/ before they place them on the market (self-classification). This obligation is independent of the quantity manufactured or imported. Presently Community harmonised self-classifications are included in Annex 1 to the Directive. Once REACH has been implemented, manufactures’ and importers’ self-classifications together with the substance registration numbers will appear on the Agency website (Classification and Labelling Inventory).

Member States will decide the need for harmonizing the various classifications appearing.

For products, the classification is determined on the basis of the classification of the individual ingredients based on calculation rules established by the EU /4/.

Chemicals to be classified as hazardous must be appropriately labelled. The labelling is prepared based on the classification of the chemicals and consists of hazard symbol(s), hazards designation(s) as well as risk and safety phrases (R- and S-phrases) (Table 2 and Annex 2).

Table 2 Overview of hazard classes and the letter designation of the hazard symbol:

The R-phrases gives information on the inherent properties of the substance or product, i.e. the effects that the substance or product may cause, e.g. ”Harmful if swallowed” or ”Irritating to eyes and skin”.

The S-phrases indicate precautions during use of the product (Risk Management Measures, RRM), e.g. ”Use only in well-ventilated areas”, or instructions for what should be done in case of accidents, e.g. ”In case of contact with eyes, rinse immediately with plenty of water and seek medical advice”.

4.2 Exposure

The risk of health impact of a product does not only depend on the hazardous properties of the substances contained in the product but also on the actual exposure of the substances.

If the hazardous substances in the product are not released from the product or are contained in the product in such a way that the user does not come in contact with the substances, i.e. is not exposed, the substances will not have any harmful effects.

The exposure of the user and thus the potential health impacts of the product is influenced by the physical state of the product (fluid, liquid, or gas), the state in which it is marketed (powder, aerosols, tablets, etc.) together with the way it is used.

Products containing volatile substances may lead to a risk of inhaling the substances during use. Products marketed in a packaging with a spray device or in an aerosol may be harmful to the consumer when inhaling the aerosols (atomized liquid). The risk of inhaling harmful substances will be greater for products applied as a spray than if the similar product is applied as a liquid using a cloth, sponge or brush paint for application (paint, lacquer). Finally, there may be a risk of inhaling dust when using a powder product.

Exposure in the working environment may be reduced via planning of work routines or through technical precautionary measures, such as establishment of ventilation or encapsulation of processes. If it is not possible to reduce the risk of exposure to the employees, appropriate personal protection equipment may be used such as gloves, respirator equipment, etc.

Assessment of exposure includes an evaluation of the duration of the exposure (e.g. hours per day) as well as an evaluation of the concentration of the exposure.

The dosage to which the consumer of the product is exposed may vary a great deal as different consumers have different behaviour, and an exact determination is often almost impossible. However, realistic worst-case estimates may be made based on its various uses.

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Version 1.0 August 2006, © Danish Environmental Protection Agency