Of all the chemicals in the world… Understanding the REACH prioritisation process

July 3, 2009 at 8:29 am | Posted in Briefing | Leave a comment

By Paul Whaley

This post is based on detailed email discussion with EU policy experts Lisette van Vliet and Genon Jenson of the Health and Environment Alliance (HEAL). Any errors are those of the author.

The European Chemicals Agency recently prioritised seven chemicals, out of an initial list of 15, to be the first to go through the process of being authorised under the new European REACH regulations.

Under REACH the most harmful chemicals (called ‘substances of very high concern’) must obtain specific permission in order to be put on the European market. [For more information on REACH, there is a reasonable explanation on Wikipedia.]

The initial list, and prioritised choices, are not entirely uncontentious: for example, there are notable absences (such as bisphenol-A) which could certainly be argued to be at least as hazardous as the chemicals on the list (such as the phthalate DBP).

Here, we hope to shed some light on why chemicals are being prioritised as they are, what it means for a chemical to be prioritised, and what (for our medical audience) this means for the use in medical devices of controversial chemicals such as DEHP.

As HEAL say, some REACH ‘translation’ might be helpful:

In October 2008, the first version of the list of chemicals considered to be the most harmful was published as a Candidate List, and more chemicals will be added as they are identified and agreed upon by EU member states. DEHP and two other phthalates were put on at that time. The list consisted of 15 chemicals. [As to why only 15, there is more information at the Chemicals Health Monitor site, here and here.]

Genon Jenson, Executive Director of HEAL, explains that once the 15 were agreed upon, the next step was to decide which were the highest priority for going through the authorisation process. This was largely determined by an article in the REACH legal text, which says: “Priority shall normally be given to substances with Persistent, Bioaccumulative and Toxic or very Persistent, very Bioaccumulative properties, or wide dispersive use, or high [production] volumes.”

A bright spark at the European Chemicals Agency noted that this information, particularly when assessed in combination, could be seen as a proxy for potential risk to human health or the environment (i.e. the higher the harmful nature of the chemical or ‘hazard’, the volume used and the potential for release of a substance, the higher its potential risk and thereby its priority).

What has happened now is that after a public consultation and a meeting of European Union Member States, the European Chemicals Agency has recommended that DEHP and two other phthalates (DBP and BBP) be “prioritised”, along with five other chemicals.

“Prioritised” means to go first through the Authorisation procedure of REACH, which is where it becomes illegal to use a chemical of high concern unless the user obtains authorisation for a specific use.

The recommendation process is described in more detail in another article at the Chemicals Health Monitor website, here.

This “prioritisation” recommendation of ECHA must now be confirmed by the European Commission and European Union member states in a process called “Commitology”. If confirmed by Commitology, due around December 2009, companies which have registered and use these chemicals must make an application to get an authorisation for their uses.

Lisette van Vliet, Toxics Policy Advisor for HEAL, says: “To get permission to use the phthalates on the priority list, companies must apply by a certain date (possibly June-July 2012) and will no longer be allowed to put their application of these chemicals on the European market approximately 1.5 years after that (unless they have an application still going through authorisation at that time, or have obtained an authorisation).

“It is worth noting that DEHP is presumed to be the sort of chemical for which a toxicological threshold can be identified.  Unfortunately according to the REACH legal text, this means if the companies can prove the risks are ‘adequately controlled’, they must be granted authorisation to use it.”

HEAL, WWF, and ChemTrust disagree with this assessment and have put in a submission to the public consultation arguing for the need to have “cumulative risk assessment”, which involves looking at how chemicals interact with each other to affect health, rather than treating them as if they act independently of one another. [A good guide to CRA is here.]

Medical devices are “exempted” from the authorisation process. The risks to human health from the use of substances of very high concern such as DEHP in medical devices cannot be taken into account when making authorisation decisions – those risks are supposed to be covered by the revised Medical Devices Directive, which (unfortunately) mostly just gave a new labelling requirement.  Any medical device which contains a phthalate that is a recognised carcinogen, mutagen or is toxic to reproduction must be labelled by March 2010.

For each chemical and/or chemical group prioritised, there is a separate Agency paper justifying its draft recommendation for inclusion in the priority list.

Lisette says these papers are worth looking at because they include interesting details on how the chemical is used, describe the complexity of the supply chain in Europe, and the availability of alternatives. To obtain the ‘justification’ files that the Agency has put together on these substances, go here.

There are also long supporting documents on each substance adopted to the candidate list, these may also be useful sources of information.

Please feel free to post any questions in the comments.

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