The gulf between identification of endocrine disruptors and regulatory restrictions being placed on their use

April 16, 2013 at 12:52 pm | Posted in Feature Articles | 2 Comments
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Obstacles - JPPI - Morguefile

By Yannick Vicaire. Chemicals Policy Officer, Réseau Environnement Santé.

It is often presented as though a chemical being identified as an EDC means being banned systematically. For example, industry environmental risk assessment think-tank and lobby group ECETOC describes the consequences of identifying a substance as an endocrine disruptor as “severe” (Fegert 2013).

In fact, there is a lengthy and complex process between something being identified as presenting a certain type of hazard, and something being banned (or in REACH vocabulary, the chemical not being authorised for a proposed use) because it is deemed to pose too great a threat to health.

Firstly, under REACH it is only chemicals which are produced in volumes of greater than 100 tons which have comprehensive testing and data requirements. The data requirements for these high-production volume chemicals are already insufficiently stringent (for example, there is no mandated test which is equivalent to a lifetime’s exposure, even for chemicals classified as Carcinogenic, Mutagenic or Reprotoxic [CMR]). Manufacturers and users of chemicals in volumes of less than 100 tons have to present the regulators with even less data to prove safety in the process of their being authorised for use.

Authorisation can theoretically apply to any chemical, even those which do not have to be registered (i.e. those manufactured and imported under 1 ton per year). However, since registration is the principle process by which data is generated and fed to the EU authorities for the authorisation process, reduced or absent data requirements greatly reduce the chance that a chemical would be targeted for authorisation, unless a huge and obvious environmental or health impact occurs.

The second obstacle is that authorisation is a process driven and conducted by EU Member States and the European Chemicals Agency. Member States can only process as many chemicals as they are willing to commit resources to do so. Some countries such as France involve industry and other stakeholders in the process of selecting chemicals for the authorisation process, which can slow the process down even more. So it could be a very long time before a chemical which is identified as an EDC becomes restricted under REACH, even if the chemical presents a substantial threat to health.

Thirdly, even hazardous chemicals can be authorised for use if the user can demonstrate “adequate control” over the potential threat it presents to health. Although this is only possible for substances for which a threshold of effect can be determined (UK HSE 2012), even the majority of chemicals which are classified as CMRs end up subjected to adequate control rather than restriction and substitution.

The only chemicals which are forced down the regulatory route which may ultimately result in their restriction and substitution are those which are CMRs without threshold of effect and chemicals which are persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB).

Fourthly, however, even for chemicals which have neither thresholds of effect nor for which adequate control can be demonstrated, there is a further mechanism under which authorisation rather than restriction is possible. This is via the process of socio-economic analysis (SEA) in which risks to environment and health are weighed against benefit to society, in deciding if the use of a chemical should be restricted or not. There is no chance that the European Chemicals Agency would ban a “useful” chemical without a sound alternative offering the same service to society. An EDC without a readily-available switch-in alternative will remain on the market until the alternative exists.

As things stand, it is not yet decided if EDC classification will push chemicals down a PBT-like route where they will be subject to substitution or SEA, or if EDCs will be subject to the softer “adequate control” route. This is why we are seeing arguments about whether or not EDCs have a threshold of effect: if regulators decide they do have effect thresholds, then the adequate control route is open for the authorisation of EDCs.

The many questions raised by scientific uncertainty around which chemicals are endocrine disruptors and how much of a threat they pose to health have to be answered by scientists. In the meantime, the role of advocates of environmental interests is to push legislation towards environmental and health protection.

Given the obstacles to restrictions on use of hazardous substances being imposed in REACH, this means at the very least that the regulatory definition of EDC should be broad enough to capture all chemicals which exhibit a plausible endocrine hazard. What happens next will remain to be seen, but we will at least have regulatory recognition of all the potential endocrine disruptors.


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  1. “This is why we are seeing arguments about whether or not EDCs have a threshold of effect”… nail on the head.. same happened with intermediates definition, panic to authorisatin process…

  2. […] month, Yannick Vicaire, Chemicals Policy Officer at Réseau Environnement Santé described the gulf between the identification and actual regulation of endocrine disrupting chemical… (EDCs). To follow up, this month we examine how the definition of EDC ultimately adopted by the EU […]

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