The European Commission is proposing for the first time to regulate pharmaceutical pollutants in surface water, citing their potential health hazards to humans and aquatic life.
Three pharmaceutical substances – including those found in oral contraceptives and hormone medications – are among the 15 chemicals the Commission is proposing to add to those regulated in EU countries. There are currently 33 aquatic pollutants covered under the EU’s Directive on Priority Substances.
“These 15 additional chemicals need to be monitored and controlled to ensure they don't pose a risk to the environment or human health", Environment Commissioner Janez Poto?nik said in a statement after the release of the proposal on Tuesday (31 January).
The decision followed review of some 2,000 insecticides, herbicides, drug products and industrial chemicals considered potentially harmful to humans or water life.
The products used in drug manufacturing are 17 alpha-ethinylestradiol (EE2) and 17 beta-estradiol (E2), which the Commission says can disrupt the endocrine system in humans and harm fish reproduction; and Diclofenac, which has been shown to kill fish.
The pharmaceuticals industry condemned the proposals that still face scrutiny by national representatives and the European Parliament.
Philomène Bouchon, spokesperson for the European Federation of Pharmaceutical Industries and Associations, called the action “premature and inappropriate”.
Bouchon noted that a Commission report on the environmental impact of pharmaceutics is not due before the start of 2012, while the Commission’s Joint Research Centre is also developing a watch list that includes chemicals and drug products.
But the European Environmental Bureau, a pressure group, welcomed the addition of pharmaceutical substances in the Commission’s proposals, but said the EU executive did not go far enough.
“From a list of 2,000 substances initially considered as potentially dangerous, it is worrying to see that the Commission has decided to target only 15 of these for pollution reduction,” Sarolta Tripolszky, the conservation group’s water policy officer, said in a statement.
“Considering they are supposed to take a precautionary approach to these matters, this seems reckless.”
Pressure on Commission
The Commission is under mounting pressure to expand regulations of chemicals and substances that are deemed toxic – substances contained not just in manufacturing but in home products and cleaning supplies. Commissioners are also considering changes to the 2007 law on Registration, Evaluation, Authorisation and Restriction of Chemical substances, or REACH Directive.
The Standing Committee for European Doctors has urged the EU to require the substitution of hazardous chemicals whenever safer alternatives are available. And the Göteborg, Sweden-based International Chemical Secretariat has identified 378 chemicals used in consumer product it says are “substances of very high concern” that should be replaced with safer alternatives under European chemicals regulations.
One widely used chemical that advocacy groups want put under greater scrutiny is formaldehyde – a compound widely used in disinfectants, cosmetics, textiles, wood products and paint. It is also released into the air from burning organic matter and wood stoves that are growing in popularity in Central and Northern Europe.
The Commission has proposed adding 15 additional priority substances to the 33 pollutants regulated under the EU’s Directive on Priority Substances are. They are:
- Aclonifen, Bifenox, Cypermethrin, Dicofol, Heptachlor and Quinoxyfen - used for crop and plant protection.
- Cybutryne, Dichlorvos and Terbutryn - biocides used for coastings and surface protection.
- Perfluorooctane sulfonic acid (PFOS) and Hexabromocyclododecane (HBCDD) - industrial chemicals.
- Dioxin and Dioxin-Like PCBs – used in the past in electronic equipment and now produced from combustion.
- 17 alpha-ethinylestradiol (EE2), 17 beta-estradiol (E2) and Diclofenac – used in drug manufacturing. EE2 is an ingredient in contraceptive drugs, while E2 is used in hormone replacement medications.
EU official documents
- European Environment AgencyHazardous substances in Europe’s fresh and marine waters
- European Commission:Proposal for a revised directive of the European Parliament and of the Council on Priority Substances in the field of water quality
- European Commission:Priority substances under the Water Framework Directive
NGOs and Think-Tanks
- European Environmental BureauWebsite
- European Federation of Pharmaceutical Industries and Associations:Website