The European commission has launched the world’s first system for classifying and banning endocrine-disrupting chemicals (EDCs), against a barrage of criticism from scientists, NGOs, industry and consumer groups.
Endocrines are hormone-altering chemicals common in everyday substances from paint to pesticides that have been linked to an array of illnesses including cancer, infertility, obesity, diabetes, birth defects and reproductive problems.
Attempts to regulate them have been plagued by missed deadlines, buried official papers, censure from EU courts, and US pressure within the TTIP (Transatlantic Trade and Investment Partnership) negotiations.
Hailing the release of the long-delayed endocrines policy, the EU’s president, Jean-Claude Juncker, said that it showed that the commission was: “committed to ensuring the highest level of protection of both human health and the environment.”
But the proposal triggered an immediate backlash from endocrine scientists and green groups who said that it set an impossibly high burden for proof of public harm, when the onus should have been on chemicals manufacturers to show their products were safe.
The proposal put on the table on Wednesday takes its cue from a World Health Organisation definition of substances that have an endocrinal mode of action causally linked to an adverse health effect on humans.
Professor Andreas Kortenkamp, a human toxicologist who has authored past endocrine studies for the European commission, said: “The WHO definition is not a criteria, it is just a definition. In effect, the commission has decided to place the burden of deciding how to regulate endocrine-disrupting chemicals onto the assessors on a case-by-case basis.
“So you will probably have total variance in how high the bar is set in order to declare something an endocrine-disrupting chemical, with all the regulatory consequences that has in terms of a lack of consistency.”
Kortenkamp’s position was supported by the Endocrine Society of scientists.
Commission officials insist that the new rules are in line with the bloc’s precautionary principle which takes a “hazard-based” approach to regulation, erring towards public safety.
Even so, existing legislation on biocides and pesticides will now be amended to allow exemptions from the laws, where there is a “negligible risk of exposure”. An annex to the new proposal suggests that this be done in the form of a risk assessment.
“It is a total reversal of the intention of the regulation,” Kortenberg said, “the worst of all the possible outcomes. Risk assessments are precisely what industry has lobbied for, and the commission has given it to them.”
Trade associations representing the agriculture and chemical sectors said that the new proposals were highly disappointing, despite the risk-based exemptions.
“Regulation by derogation is not acceptable, nor is it predictable and expanding the derogations is essentially signalling a flaw in the criteria,” a statement by the European Crop Protection Agency said.
Jean-Charles Bocquet, the group’s director, added that the legislation failed to distinguish between safe and harmful substances. “In our view, this could lead to bans of crop protection products with the same endocrine-disrupting properties found in every day products like coffee.”
The plastics and chemicals sector also criticised the new proposals for not applying a potency-based approach to identify EDCs of regulatory concern, which could allow innovation elsewhere in the industry.
In its proposal, the commission accepted a consensus among environmental scientists against potency-based measurements for EDCs because their adverse health effects may not be dose-specific.
Some companies including Ikea, H&M, Co-op and Skanska have written to the commission calling for tough EDC criteria that will increase consumer confidence.
Sylvia Maurer, the sustainability chief of European consumer group BEUC, said that the proposal would not protect consumers from harmful cosmetics, clothes and food packaging.
“Sadly today’s package seems to confirm our concerns that the commission has lowered its ambition concerning strong EDC criteria so as not to jeopardise the TTIP talks with the US,” she said.
Before passing into law, the proposal will need the assent of the EU’s 28 nations – and of the European parliament, where it is likely to face strong opposition.
The Green party spokesman Bas Eickhout branded the proposal “shameful” and said that work would begin immediately to craft a majority to veto the new rules.
Lisette van Vliet, a spokeswoman for the Health and Environmental Alliance said she was “flabbergasted” by the new proposals, which “would cripple the use of accumulated (and future) knowledge about effects on animals, that should be used to prevent harm to human health.”
The criteria will apply to imported products as well as those domestically manufactured, and Brussels will have to inform the World Trade Organisation about the new rules.
Green groups such as the Pesticides Action Network said that the new rules violated EU law and would not result in the banning of a single endocrine disrupting pesticide.
But it is unclear how exactly the new classification will be applied and the commission stressed that it would take place in parallel with the “evolving science” in this area.
One EU source said: “We do foresee that there will surely be long term product prohibitions over time because of these criteria.”
The European Food Safety Authority and European Chemicals Agency will now be asked to begin reviewing products on the market to see whether they contain endocrine-disrupting compounds.