8. Current chemical regulation distinguishes between
"new" and "existing" (pre-1981) chemicals.
Existing substances are regulated by Regulation (EEC) 793/93 and
represent 99% of chemicals on the market. New substances are regulated
under Directive 67/548/EEC; there are approximately 3,000 which
have been tested and assessed for possible risks to human health
and the environment before being marketed in volumes starting
at 10 kg per year.
9. Existing substances are not subject to the same
testing requirements that apply to new substances. Approximately
140 of the 30,000 substances manufactured in volumes over 1 tonne
have been identified as priority substances and are subject to
comprehensive risk assessment carried out by Member State authorities
under Regulation (EC) 793/93.[8]
Under Directive 76/769/EEC restrictions on the marketing and use
of certain dangerous substances and preparations are applied where
necessary. Risk assessments and adequate analyses of the costs
and the benefits are required prior to any proposal or adoption
of a regulatory measure controlling the marketing and use of chemicals.
The proposed legislation will replace over 40 pieces of existing
legislation, including these three.[9]
10. The Commission identified the following problems
with the current legislation:
a) There is a general lack of knowledge about
the properties and the uses of existing substances;
b) The risk assessment process is slow and resource-intensive
and does not allow the system to work efficiently and effectively;
c) The allocation of responsibilities is inappropriate
because authorities are responsible for the assessment rather
than the enterprises which produce, import or use the substances;
d) Current legislation only requires the manufacturers
and importers of substances to provide information, but not the
downstream users (industrial users and formulators). Thus information
on uses of substances is difficult to obtain and information about
the exposure arising from downstream uses is generally scarce;
and
e) Decisions on further testing of substances
can only be taken via a lengthy committee procedure and can only
be requested from industry after authorities have proven that
a substance may present a serious risk. Without test results,
however, it is almost impossible to provide such proof. Final
risk assessments have therefore only been completed for a small
number of substances.
