Report from the Sub-comittee on the environment and health

Authorisation of
coformulants
7 Coformulants and o<strong>the</strong>r chemical substances,
including substances occurring naturally in
agriculture
7.1 Coformulants in pesticides
A number of chemical coformulants are added to pesticide formulations.
They include carriers, solvents, surfactants, dispersants, spreading
products, adhesives, absorption-improving products, antioxidants,
bactericides, colouring products, fillers and perfume. In 1997, around
69% of pesticides sold in Denmark consisted of coformulants,
corresponding to about 10,000 tonnes. Part of <strong>the</strong> quantity of
coformulants is water. Coformulants are also called inert ingredients
(Danish Environmental Protection Agency 1998a). The coformulants
comprise a motley collection of chemicals, some of which are more
acutely toxic than <strong>the</strong> active ingredients, e.g. organic solvents
(information <strong>from</strong> <strong>the</strong> Danish Working Environment Authority).
Isophoron is a commonly used solvent in a number of products, and <strong>the</strong>
total quantity used is large. The substance has recently been classified as
Carcinogenic Cat3. Some of <strong>the</strong> substances feature in DEPA’s list of
undesirable compounds. The coformulants have been in focus because
<strong>the</strong>y include organic solvents and because it was found in 1997 that <strong>the</strong>y
included alkylphenols and alkylphenolethoxylates, which, in
experimental studies, show hormonal effects on mammals. These
coformulants are now being phased out, which means that many products
are being reformulated, using substitute coformulants whose known
properties are deemed to be less harmful.
Coformulants (or additives) in pesticides are not in <strong>the</strong>mselves subject to
authorisation. The various substances are subject to <strong>the</strong> regulation as
described for chemicals in <strong>the</strong> Act on Chemical <strong>Sub</strong>stances and Products.
For pesticides <strong>the</strong>re are <strong>the</strong>refore no actual requirements concerning
analyses of <strong>the</strong> individual ingredients. However, <strong>the</strong> authorities must
know <strong>the</strong> precise composition of <strong>the</strong> products, so that all <strong>the</strong> ingredients
can be identified. DEPA can also demand so-called data sheets for <strong>the</strong>
individual coformulants. These data sheets contain brief information
about <strong>the</strong> substances’ physical, chemical and toxicological properties,
where <strong>the</strong>se have been determined. When assessing coformulants, DEPA
also consults <strong>the</strong> list of dangerous substances, which gives <strong>the</strong>
classification of a number of chemicals (including some pesticides).
The toxicological properties of coformulants can also to some extent be
seen <strong>from</strong> <strong>the</strong> tests required on <strong>the</strong> formulated product. These tests
include tests for acute toxicity with oral intake, intake through <strong>the</strong> skin
and inhalation, skin and eye irritation and, in some cases,
ecotoxicological tests on aquatic organisms, bees, worms, microflora,
etc. If a coformulant has a serious long-term effect and is included in <strong>the</strong>
product in a sufficiently high concentration, <strong>the</strong> product is classified
accordingly and has to undergo an exposure and risk analysis, even if <strong>the</strong>
active ingredient does not have serious effects. DEPA can withdraw
authorisation of a product simply on grounds of a coformulant. In
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