ECHA

Jack de Bruijn, Head of ECHA's Risk Management Unit, leads on the effective implementation of the two risk management processes under REACH: restriction and authorisation. He stresses that the key to successful management of these processes is a good analysis of the best option for each chemical.

Mr de Bruijn got involved with REACH from the very beginning. After completing his studies in chemistry and PhD in computational toxicology at the University of Utrecht, The Netherlands, Mr de Bruijn joined the Dutch Ministry of the Environment and dealt with national and international chemicals policy development.

"Then after about ten years, I had the opportunity to join the European Chemical Bureau in Ispra, Italy. There, we soon got very involved in discussions on REACH, providing scientific and technical advice to the Commission," explains Mr de Bruijn. As the European Chemicals Agency (ECHA) was established in Helsinki to implement REACH, Mr de Bruijn convinced his family to leave Italy for the cold North. "It was not an easy task," he says. "Working in ECHA is a great opportunity for implementing the ideas that we had when developing the draft legislation, trying to learn from the past as well as avoid making the same mistakes. That is the big challenge and also the great privilege to see ten years of discussion, interaction and negotiation now finally being really implemented."

Crucial choice

Mr de Bruijn explains that there are several options for managing the risks of hazardous chemicals. The correct choice of the measure is important, and authorities which submit proposals should carefully analyse which is the best risk management option. Mr de Bruijn stresses that once the authorities decide to send a substance into the restriction or authorisation process, it has consequences and may also limit the choices later on.

"As regards the Candidate List of Substances of Very High Concern, I would like to refer to a useful discussion we had in January 2009 in a workshop between the Member States, the Commission and us about what the Candidate List is actually for. We focussed on why a substance should or should not be on the Candidate List, and not so much on whether this list should be long or not" Mr de Bruijn explains.

Jack de Bruijn - involved with REACH from the very beginning.

"There can be various reasons for adding a substance to the Candidate list, the most obvious one being that you want to identify the substance as a substance of very high concern (SVHC) to prioritise it further in the authorisation process. Once it goes there, then the whole machinery starts and industry has to send in applications. If they do not, then after a certain deadline, the sunset day, they cannot use the substance any more."

"Another reason to put a substance on the Candidate List is the link with REACH Articles 33 and 7. These articles contain specific requirements for manufacturers to provide information to people buying products if they contain substances of very high concern. "For PBTs* and vPvBs**, identification as a substance of very high concern is practically the only way of getting their PBT status formally recognised. There is no other mechanism at present. Whereas for CMRs*** there is the normal harmonised classification system which identifies them, and that is what normally is done before they enter the list of substances of very high concern," underlines Mr de Bruijn.

"We agreed with the Member States that the most relevant aspect is to know whether you have the right substances on the list and whether the Candidate List is the best way to address concerns on these substances. This question is not easy to answer." ECHA has worked on a framework to support the authorities in identifying the best risk management option. The target is that before a dossier is sent in, an exchange of views between the Member States, the Commission and ECHA will take place on the reasons and arguments for selecting a certain route.

A lot on the agenda

ECHA and the EU Member States and EEA/ EFTA countries have agreed that the Candidate List will be updated twice per year.

On 1 June 2009, ECHA sent the Commission its first recommendation for substances that should be added in Annex XIV of REACH (List of substances subject to authorisation) and not to be used without prior authorisation. The Commission is developing the Annex XIV proposal but has not come up with it as of yet. "In theory, the day after the Annex XIV is published, we could receive an application for authorisation," says Mr de Bruijn. "And then the whole opinion making process starts. We have responsibility to make the information available on our website, and also to request further information for instance on alternatives for those substances. And of course we then have to manage the opinion-making process for the RAC and SEAC in a very short timeline with the aim of providing the Commission with the best possible support for their final decisionmaking."

The restrictions process has also started. Annex XVII, which lists all restrictions agreed in the past, was updated and published again in a new version. ECHA is expecting proposals for new restrictions from the Member States in the first half of 2010.

"In addition, our unit is working on a restriction dossier on mercury in blood pressure measuring devices which was requested by the Commission. It is basically a revision of an already existing restriction in Annex XVII. We are looking at whether there is a need for further restrictions on the use of mercury devices such as blood-pressure meters. In addition, the Commission has asked us to look whether there is a need to review the current restrictions on phthalates, taking into account all new scientific information. We have collected all the new information and are evaluating it. And that we will communicate to the Commission very soon and decide on the next steps," says Mr de Bruijn.

A key element of REACH

The Risk Management Unit also provides work on developing exposure scenarios. Mr de Bruijn considers them to be one of the key new elements of REACH and very important for industry in risk management and communicating to the downstream users proper advice on how their substances can be handled safely. "I believe particularly that if we get the exposure scenario concept working well in the companies, and there is appropriate communication down the supply chain to all the relevant people using chemicals, that is the area where we will ultimately see the greatest impact of REACH."

* PBT=persistent, bioaccumulative, toxic,
** vPvB=very persistent, very bioaccumulative,
*** CMR=carcinogenic, mutagenic, toxic for reproduction