040824_miljouppdraget-rapport

Summary
Introduction
As part of the work of achieving national environmental goals, the Swedish Government commissioned an
official report from the Medical Products Agency on the environmental effects of pharmaceuticals, cosmetics
and hygiene products, including their packaging. The report was to include a risk assessment of environmental
effects based on the occurrence of the products in the environment in relation to their current
sales volumes. The report was also to submit proposals on measures to reduce environmental effects of the
products and on how information on the qualitative and quantitative composition of the products could be
improved and made more easily available. A study of the possibilities to introduce environmental classification
of pharmaceutical products was also part of the commission.
Pharmaceuticals
Selection of active substances and excipients in pharmaceutical products
There are about 7 600 pharmaceutical products on the Swedish market containing about 1 200 active substances
and 1 300 excipients. About 7 200 products are intended for human use and about 400 for veterinary
use. It has not been possible to investigate the environmental effects of all active substances and excipients,
mainly due to deficient or non-existent data necessary for environmental risk assessments and partly
due to the time limit of the commission.
By considering half-lives/biodegradability, literature data on occurrence in the environment, and Swedish
retail sales statistics for pharmaceutical products, 27 active pharmaceutical substances were selected for
environmental risk assessments. Documentation submitted by the pharmaceutical industry and published
literature was used to identify additional substances that should be studied with respect to environmental
effects. A number of excipients were also selected for environmental risk assessment on the basis of Swedish
sales statistics and their environmental classification.
Environmental hazard assessments
Environmental hazard assessments according to the Swedish National Chemicals Inspectorate’s guidelines
on classification and labelling of chemical products do not consider the amounts or concentrations of chemicals
expected to reach the environment. The tests used for environmental hazard assessments include
short-term (acute) toxicity, biodegradability and bioaccumulation. Classification of a chemical substance as
“environmentally hazardous” does not mean that it, with certainty, causes deleterious environmental effects.
The amount released into the environment and how the substance is used are of decisive importance
for whether its labelling as “environmentally hazardous” also implies a risk to the environment.
The environmental hazard assessment of the selected active substances and excipients in pharmaceutical
products was hampered by lack of data. Environmental hazard assessments were possible for only 12 of 30
active substances and 31 of 55 preservatives. Nine active substances and 13 preservatives were assessed to
be hazardous to the aquatic environment.
Environmental risk assessments
In an environmental risk assessment an assessment is made of the risk of negative environmental effects
considering the magnitude of the discharge of the chemical and the effects that this discharge may have on
the structure and the functions of an ecosystem. In this report, concentrations in the environment were estimated
on the basis of the total retail sales volumes of individual active substances in human pharmaceutical
products. Two of the 27 active substances selected for environmental risk assessments were found to be
13