The EU’s REACH system for regulating chemicals was supposed to bring with it a significant improvement in protection of people and the environment from toxic chemicals. But is it delivering? The latest developments in the debate over alternatives to the phthalate DEHP, used in PVC products, suggest that there are some serious problems.
One particular concern is the part of REACH that deals with chemicals with particularly problematic properties – defined as “Chemicals of Very High Concern”, for example because they have been shown to be cancer causing (carcinogenic), or to accumulate in our bodies.
The REACH text is pretty clear about what is supposed to happen with these chemicals, as they pass through the ‘Authorisation’ process:
The aim of this Title [Authorisation] is to ensure the good functioning of the internal market while assuring that the risks from substances of very high concern are properly controlled and that these substances are progressively replaced by suitable alternative substances or technologies where these are economically and technically viable
That sounds fine – but now chemicals are starting to make their way through this system, and what is actually happening is that chemicals of very high concern are being authorised for continued use, even when safer alternatives are already widely available.
The essence of authorisation is that a deadline is set by which companies must apply if they wish to continue to use a chemical that has entered the Authorisation system. The EU Chemical Agency (ECHA) receives this application, and it is examined by two committees – a Risk Assessment Committee (RAC) which looks at how safe the use of the chemicals is, and a Socioeconomic Assessment Committee (SEAC) that looks at the availability of alternatives.
The first test is whether RAC decides that risks from the use of the chemical is ‘adequately controlled’ – if it is, then the use will be authorised, though this will be reviewed after several years.
If RAC decides that the risk from the use of the chemical is not ‘adequately controlled’ then SEAC must look at the availability of alternatives, and it can recommend that the application for authorisation can be denied if alternatives are available.
The two agency committees then send their opinions to the European Commission, who will take the draft decision on the authorisation within 3 months.
The DEHP case
The phthalate DEHP – accepted under REACH to be a reproductive toxin – is currently going through the authorisation process, with Rolls Royce having been granted authorisation for use in manufacture of aircraft engine blades. In this case RAC decided that the risk of DEHP would be adequately controlled in this use.
However, there are much more wide-ranging applications for use of DEHP in many PVC articles & in recycled PVC articles; here’s an extract from a press release from the relevant trade association, listing essentially the full range of possible uses of PVC, many of them in consumer products.
Significantly, in these cases RAC concluded that the risk to workers was not adequately controlled; this meant that an authorisation could only be given if SEAC decided that substitutes were not available. SEAC concluded:
“that there appear not to be suitable alternatives in terms of their technical and economic feasibility for the applicant.”
This conclusion is very surprising, given that there are many substitutes available and in use for both PVC and DEHP, and that research by CIEL has found a link between the listing of DEHP as a Chemical of Very High Concern and the patenting of DEHP alternatives.
SEAC therefore recommended that an authorisation for the continued use of DEHP in many PVC and recycled PVC articles be given for four years. It is now up to the Commission to decide on the final outcome of the application for authorisation; EU Member States also have a chance to block the Commission’s proposal. The Commission should be publishing a draft decision within the next few weeks.
A large group of civil society organisations – including CHEM Trust – have written a letter to the European Commission to object to the proposal to grant this authorisation, and we’ve also signed up to a more detailed position paper on this proposed decision. Chemical Watch has reported on this letter – their article also outlines legal actions underway regarding confidentiality of important information relevant to this decision.
Conclusions and next steps
- CHEM Trust and many other civil society organisations are concerned that Authorisation is not working properly, with the issue of socioeconomic assessment being of particular concern.
- The example of the proposed authorisation of DEHP for wide-ranging uses where substitutes are readily available has brought these concerns to a head, and we have called on the Commission to deny this authorisation.
- We and others will be continuing to investigate this issue; it is vital that authorisation does its job in ensuring that the worst chemicals are replaced with safer alternatives wherever they are available.
Update, 29th January 2015
- CHEM Trust and other NGOs have now sent a second letter regarding this proposed authorisation, focussing on procedural and substantive flaws in ECHA’s opinion in this area. The letter can be downloaded here. This new letter has been reported on by ENDS Europe and by Chemical Watch.
Update, 19th July 2016
- At the end of June 2016 the European Commission published its decision to authorise the use of DEHP in recycled PVC products, with some exceptions, and with a review period ending on February 2019 (i.e. another application for authorisation would be needed to continue use after this date). CHEM Trust is very disappointed with this outcome, and we had joined with other NGOs in writing to Member State officials to ask for them to reject this authorisation at their meeting in April 2016.
