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EU to Address Risks of Chemical Mixtures, Endocrine Disruptors, Nanosubstances

Wednesday, May 2, 2012

EU to Address Chemical Cocktails, Endocrine Disruptors, Nanosubstances

Key Development: The European Commission will take steps to more tightly control the risks of chemicals in areas seen as insufficiently regulated.

What's Next: Strategy paper on chemical combination effects will be published in May, followed by other initiatives in 2012 and 2013.

By Stephen Gardner  

BRUSSELS--The European Union is preparing to build on the REACH law and related legislation to address concerns about chemicals in three areas considered to be insufficiently regulated: endocrine disruptors, the combined effects of chemical mixtures, and nanosubstances.

A call for tighter regulation was contained in a European Parliament resolution, adopted April 20. It said “specific measures” to tackle risks in these areas should be included in the European Union’s seventh Environment Action Program (7EAP), which the European Commission, the bloc’s executive arm, is scheduled to publish in November.

7EAP will be the latest in a series of environment action programs, dating back to the 1970s, in which priority environmental objectives are identified. The plan will cover the period through 2020.

The Commission began taking public comments on the EAP, including possible measures to regulate chemicals, on March 12. The consultation is open through June 1 (35 INER 294, 3/28/12).

Mixtures Strategy in May.

The EAP will focus attention on the combination effects of chemicals, endocrine disruptors, and nanosubstances. However, even before finalization of the EAP, and independently of it, the Commission will start to propose measures.

A strategy document on chemical mixtures is scheduled to be published before the end of May.

Commission spokesman Joe Hennon said this will respond to issues raised in a study published by the Commission in 2010, which set out the scientific understanding of the cocktail effect of chemicals.

The study, State of the Art Report on Mixture Toxicity, found that combinations of chemicals could be more toxic “than the effects of each mixture component applied singly” and that the safe thresholds for individual substances set in regulations might not be appropriate when those substances are combined with others (33 INER 152, 2/17/10).

The mixture toxicity study also found that regulation of the effects of chemical mixtures in the European Union lagged behind that in the United States, where the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) authorizes the cleanup of badly contaminated sites, requiring assessment of the combination effects of the many chemicals that might be present at such sites.

Difficult Area to Regulate.

Andreas Kortenkamp of the United Kingdom’s Brunel University and lead author of the mixture toxicity study, told BNA that regulating chemical mixtures is difficult but “the science tells us that something can be done and should be implemented in regulatory practice.”

According to the study, the European Union should adopt guidelines that define “mixtures of concern” and provide for assessments of their effects on human health and on “ecosystem structure and function.”

The requirement to carry out assessments could be written into a range of EU legislation, including laws dealing with pesticides and biocidal products; laws such as the Industrial Emissions Directive (2010/75/EU) that deals with pollutants released from defined sources; and laws regulating environmental quality, such as the Water Framework Directive (2000/60/EC), which includes a requirement to identify priority pollutants in water and reduce their prevalence.

REACH, which deals with chemicals rather than processes or environmental media, is “not the tool to deal with mixtures necessarily,” Kortenkamp said. REACH (Regulation No. 1907/2006) stands for the registration, evaluation, and authorization of chemicals.

However, Christian Schaible, chemical policy officer at the European Environmental Bureau, a consortium of green groups, said the requirement under REACH that the most hazardous chemicals can only be used if specific authorizations are granted offers “an entry point to deal with cocktail effects.”

Assessment of combination effects could be included at the authorization stage, with authorizations allowed only if users of chemicals can demonstrate they adequately control the risks, Schaible said.

Strategy Updates.

Regarding endocrine disruptors, or substances that disrupt the hormone systems of humans or animals, Hennon said the Commission already is committed under several pieces of legislation to take steps toward tighter regulation.

Under REACH, the Commission is required to review by June 2013 how the rules on the authorization of endocrine disruptors are applied, while under both the Plant Protection Products Regulation ((EC) No. 1107/2009) and the Biocides Regulation (35 INER 96, 02/01/2012), the Commission must develop by December 2013 criteria for the identification of endocrine disruptors (35 INER 96, 2/1/12).

Hennon added that the Commission also will update its strategy on endocrine disruptors this year. That strategy has been in place since 1999 and is mainly aimed at listing suspected endocrine disruptors (35 INER 184, 2/29/12).

A Commission conference on June 11-12 will “provide input for the review” of the strategy, Hennon said.

One idea that has been proposed is that a regulatory class of endocrine disruptor should be created, allowing easier regulation of the substances under legislation such as REACH.

At present, endocrine disruptors can be proposed for bans under REACH if they are considered to be of “equivalent concern” to classes of chemicals slated for potential usage limitations under the legislation, such as substances classified as carcinogenic, mutagenic, or reprotoxic.

Nano Strategy Forthcoming.

Regarding nanosubstances, Hennon said a strategy paper “on the regulatory aspects of nanomaterials will come out in the coming months” but gave no further details.

The paper will follow a regulatory definition of a nanosubstance published by the Commission in October 2011, which is expected to open the way for nano-specific provisions in chemical legislation (34 INER 1000, 10/26/11).

Under REACH, nanosubstances are currently treated the same as the same substance at standard scale, and are subject to the REACH registration requirement if manufactured or imported in annual volumes of one metric ton or more.

The European Chemicals Agency April 30 published nanosubstance-specific appendices to guidance on information requirements and chemical safety assessments under REACH.

These contain nonbinding recommendations on the information on substance properties that should be included in REACH registration dossiers covering nanosubstances.

The European Parliament previously has called for nanosubstances to be more tightly regulated on the basis that they present more risks than the same substances at standard scale (32 INER 307, 4/15/09).


The European Commission web page on the combination effects of chemicals is available at http://ec.europa.eu/environment/chemicals/effects.htm.

The Commission endocrine disruptors web page is available at http://ec.europa.eu/environment/endocrine/index_en.htm.

European Chemicals Agency guidance on information requirements and chemical safety assessments under REACH is available at http://echa.europa.eu/web/guest/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment. Scroll down for nano-specific appendices.

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