Glossary

Preparation means a mixture or solution composed of two or more substances;

Producer of a product means any natural or legal person who makes or assembles an product within the Community;

Product and process orientated research and development means any scientific development related to product development or the further development of a substance, on its own, in preparations or in products in the course of which pilot plant or production trials are used to develop the production process and/or to test the fields of application of the substance;

Product means an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition;

Reasonably foreseeable conditions of use means conditions of use outside the use originally intended by the product producer (normal use) but which may be foreseen because of the form, shape or function of that product .
The following conditions are considered reasonably foreseeable:

  • “Accidents” of high likelihood, e.g. breakage of a fragile container releasing all of the content (wording is dependent on the product definition). These are to be considered as worst-case situations.
  • Uses not in accordance with the function but which can be anticipated because function and appearance of the product also suggests other uses than the intended ones
  • Extremely intensive use (e.g. ‘a consumer' working with a tool 12 hours a day for three months when building his own house)
    Excluded from reasonably foreseeable conditions in situations of professional and industrial uses are:
  • Uses, which are clearly and noticeably excluded by the product producer or importer. These uses are to be regarded as use deliberately against the intention
  • Uses, which have been clearly advised to be avoided by means of product design or warning labels 
  • Clear misuse. Children are a good example to illustrate how reasonably foreseeable conditions of use can be identified: It is commonly known that children do not always know the function of an product but still use it for any of their purposes and in a way that suits them best. Especially small children put any-thing into their mouth or, if the object is too big, bite it or lick it.
    Therefore, when defining conditions of reasonable foreseeable uses of an product, children's access to the product should be assessed.

The assessment of reasonably foreseeable conditions of use for products solely used by industrial or professional users can mainly focus on evaluating the likelihood of breakage/accidents as uses not foreseen by the product function can normally (but not al-ways) be excluded.

The assessment of reasonably foreseeable conditions of ‘use' should be targeted only to those situations where an increased exposure or an exposure via different pathways (inhalation, dermal contact or ingestion) as compared to the normal conditions of use occurs.