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What is the existing approach in the European Community?


Under the existing legislation within the EU, the assessment of the toxic potential of a chemical is dependent on the type of chemical. For example, pesticides and biocides have separate legislation governing their testing and assessment.

In general, chemicals, prior to marketing, are required to undergo a very specific programme of testing and assessment in order to ensure that once in use or released into the environment, they pose no danger to people or wildlife. Under this approach, chemicals would undergo testing (hazard identification), the results of which would be used in a risk assessment. The third level determines whether restrictions are needed on the chemical's usage (risk management).

This existing legislation, while accounting for detrimental endocrine related effects on reproduction or disease states such as cancer, does not use disruption to the endocrine system as an endpoint per se.

Hazard identification The potential of a chemical to cause harm, resulting in detrimental health effects in people or wildlife.

Risk assessment The probability that a chemical will cause harm, resulting in a detrimental health risk to people or wildlife.

Risk management The identification of any necessary restrictions regarding transportation, usage and disposal.

Hazard identification

The potential hazard of chemicals are identified using a set battery of tests. Prior to adoption by the Commission into Directives, these tests are validated at the international level by the OECD.

Under the existing EU legislation,

  • Directive 67/548/EEC on the classification, packaging and labelling of dangerous substances requires that:
    • Dangerous substances must be classified into one or several of 15 defined categories of adverse effects
    • The packaging must be adequate to protect people and the environment from the known dangers
    • The substance must be labelled with the dangers and with safety information

Currently, there are 15 categories of danger under which chemicals can be classed. A battery of tests that are specified under this Directive define these categories and include tests for carcinogenicity, reproduction and ecotoxicity.

However, endocrine disruption is not addressed under the classification system, nor are there (yet) any agreed test methods to detect whether a chemical has endocrine disrupting properties.

  • Directive 1999/45/EC addresses for various groups of chemicals, the classification, packaging and labelling of dangerous preparations. This has now been amended to include pesticides. Such preparations must be labelled using risk phrases, which denote a range of biological effects such as irritation, cancer and effects on reproduction.

Risk assessment

The Risk Assessment process assesses the probability that a chemical may cause harm to the health of people or the environment. Data from tests carried out in the hazard identification exercise together with calculated environmental levels of the chemical are used to find whether the proposed use of the chemical will pose a threat to human health or the environment.

The Commission has several regulations and Directives in place that govern the risk assessment of specific types of chemicals and provide a framework by which all chemicals are assessed to a similar standard, for example the following regulations and directives :

  • Risk assessment of existing substances (Regulation (EEC) No. 793/93)
  • Restrictions on marketing and use of certain dangerous substances and preparations (Directive 76/769/EEC).
  • Placing of plant protection products on the market (Directive 91/414/EEC)
  • Marketing of Biocidal products (Directive 98/8/EC)
  • Materials and articles intended to come into contact with food stuffs (Directive 89/109/EEC and its specific directives)
  • On 1 June 2007 Community Regulation (EC) No 1907/2006 REACH will enter into force and will supersede the risk assessment for existing substances within one year after entry into force.

Risk management

The management of risks posed by substances or chemicals are also regulated under EU Directive and regulations. If potential for harm is likely, then the use of the chemical may have to be restricted or reviewed. For example, if a pesticide poses a threat to fish, then its use near to water bodies is restricted.

Risk management within the EU is legislated under the following Directives:

  • Prohibition of placing on the market and use of Plant Protection Products (Directive 79/117/EEC)
  • Placing of plant protection products on the market (Directive 91/414/EEC)
  • Maximum residue limits in agricultural products and foodstuffs (Directives 86/362/EEC, 86/363/EEC and 90/642/EEC)
  • Materials and articles intended to come into contact with food stuffs (Directive 89/109/EEC and its specific directives)
  • Restrictions on marketing and use of certain dangerous substances and preparations (Directive 76/769/EEC)
  • Prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta agonists (Directive 96/22/EC)
  • Measures to monitor certain substances and residues thereof in live animals and animal products (Directive 96/23/EC)
  • Integrated pollution prevention and control (Directive 96/61/EC)
  • Water Framework Directive (Directive 2000/60/EC)