The EU’s REACH Regulation requires the Commission to review the adequacy of criteria for identifying persistent, bioaccumulative and toxic (PBT) and very persistent, bioaccumulative and toxic (vPvB) substances that are set out in Annex XIII. But the Commission’s proposals, issued in a paper in December, have provoked an outcry from NGOs, several EU member states, the European Parliament’s Environment Committee and the European Chemical Agency (ECHA).
The criteria in Annex XIII were agreed as part of the REACH package as a matter of political expediency amid the heated negotiations that led to its adoption in December 2006. They allow little room for manoeuvre as they set numerical thresholds for the outcome of laboratory tests to assess persistent, bioaccumulative or toxic properties.
The Commission’s paper accepts that other information might be valuable in identifying PBT/vPvB substances but essentially maintains the Annex XIII criteria unchanged as the legal basis for decision-making.
Under REACH, substances that are classified as PBT or vPvB are regarded as being "of very high concern" (SVHCs). If firms want to continue to manufacture, import or sell them in the EU, they will need authorisation from the Commission for each and every application of the substance. Moreover, the REACH Regulation makes an assumption there are no safe exposure thresholds for PBT and vPvB substances and as a consequence, substances are only likely to be authorised if companies successfully argue that there is a socio-economic need for them.
As the authorisation process is unprecedented under EU chemicals law, it is predicted to be long, difficult and resource-intensive. Firms will want to avoid going through it if at all possible.
Industry groups and the UK government say that strict Annex XIII criteria provide legal clarity in making judgments. They argue that if substances do not meet the Annex XIII criteria but there is still concern about them, then member states and companies have recourse to Article 57(f) of the Regulation, which allows them to identify substances of "equivalent concern".
But in a paper issued at the REACH competent authorities meeting, ECHA disagrees. It says the criteria are too narrow: "The identification criteria in the current Annex XIII do not allow sufficient flexibility in determining whether a substance has the potential to persist, bioaccumulate and eventually cause toxic effects in the environment."
It argues: "The problems relating to PBT/vPvB substances relate to low concentration levels over long time periods in large areas often far away from emission sources, ending up in high but unpredictable levels in wildlife or man over extended time periods, which is not reflected in the laboratory testing methods. Consequently, extrapolation of results from such tests will introduce large uncertainties."
ECHA notes the acknowledgement in the Commission’s review paper that other evidence may be useful in identifying PBT/vPvB, but it points out "there is no derogation possibility mentioned in the actual criteria". It has asked the Commission to clarify where this leaves ECHA and member states if they have evidence pointing to persistence, bioaccumulative or toxic properties for a substance that does not strictly meet the criteria.
Conversely, ECHA says it is possible that some substances may meet the criteria, but other data from environmental monitoring could demonstrate they are not actually persistent or bioaccumulating in the real environment. ECHA and member states could thus find their decisions open to legal challenge unless such scenarios are thought through, it warns.
Nine member states are thought to have indicated, during a written consultation on the Commission paper, they do not agree with its approach and would prefer to see more flexibility built into the criteria to use other available evidence. They argue that recourse to Article 57(f) is far from ideal because this imposes a higher burden of proof to show "there is serious scientific evidence of probable serious effects to human health or the environment" before a substance can be proposed for authorisation.
The Commission’s paper is thought to reflect a battle between its Enterprise and Environment Directorates. The Commission is expected to circulate a further proposal for the review of Annex XIII in the coming weeks in advance of a Committee vote, likely to happen in March.
A coalition of seven European NGOs including ChemTrust, Greenpeace, Friends of the Earth and WWF Europe wrote to Commissioners Günter Verheugen and Stavros Dimas in December, accusing them of failing in their duty - as stated in the REACH Regulation - to ensure a high level of protection for human health and the environment.
They point out that applying the current Annex XIII criteria would mean that half of the 27 chemicals already accepted as PBT by the former EU PBT working group would lose their classification. Some substances in the pipeline for control under the UN Stockholm Convention would also lose their PBT status.
In a subsequent legal analysis of the Commission proposal, WWF demands that either additional, more qualitative criteria are added to Annex XIII or that there is a clear statement allowing derogations from the criteria if certain conditions are fulfilled.
The Chairman of the European Parliament’s Environment Committee Miroslav Ouzky also wrote an open letter to Commissioners Verheugen and Dimas warning that his committee would not look favourably on their proposal without changes. Under the ‘regulatory procedure with scrutiny’ that applies in comitology decisions, MEPs have the right to veto any regulatory proposal that they feel exceeds the Commission’s implementing powers. MEPs last year effectively used the threat to secure changes to the EU test methods Regulation.
Mamta Patel is editor of Chemical Watch