Although the REACH law has been in force for two and a half years, there have been some parts of its implementation that have been stalled due to disagreements between the EU Member States, the European Commission, and other entities, as well as between different sections of the European Commission itself.
In late March, the new Environment Commissioner Janez Potocnik and Vice President and Commissioner of Industry and Entrepreneurship Antonio Tajani announced their approach to resolving three issues affecting the implementation of REACH during their visit to the European Chemicals Agency. These issues concern 1) Persistent, bioaccumulative, and toxic substances, and how companies must identify whether they are these chemicals and how to control their risks; 2) how the most harmful chemicals are put on REACH’s most harmful, or candidate list; and 3) whether all companies applying for an authorization must do a substitution plan or an assessment of alternatives only in some cases.
Persistent, bioaccumulative, and toxic substances (PBTs): The newly agreed-upon criteria for identifying PBT substances requires the consideration of all available information through a weight-of-evidence approach. However, a collection of eight NGOs, including HEAL, have noted that the information utilized will still only be lab tests following GLP (Good Laboratory Practice) protocol and will not consider, for example, epidemiologic and exposure studies (see the Joint NGO letter below). The Commissioners’ agreement stipulates that companies will have a two-year transition before using the full ‘all available evidence’ approach. As a result, the first registrations done for high volume and certain other chemicals this coming December will follow the previous method, and may miss identifying some chemicals as PBTs or vPvBs.
Substances of very high concern: the Commission has called for 106 new substances to be added to the candidate list by 2012, requesting that ECHA take on a certain number of the dossiers (possibly 15) and for the Member States to complete the remaining (possibly 91) dossiers for review. However, these 8 NGOs note that this is still much lower than the number of substances identified by a group of member states as meeting the REACH criteria (a quasi pre-candidate list of 478 substances); the 356 substances on the S.I.N. list 1.1, and the Trade Union priority list of 306 chemicals. The NGOs call for a faster pace of addition of substances to the candidate list. Having more substances on the candidate list as quickly as possible will allow European consumers to get full answers when they utilize the Chemical Health Monitor’s Right-to-Know model letters to learn about the presence of any harmful chemicals in the products they buy.
Authorization: the ‘technical guidance document’ on Authorization that companies use to understand how to operationalise the REACH legal text had been delayed by a review. But the Commissioners were able to resolve the remaining issues, and have agreed that any application for authorization must include an assessment of possible alternatives to the hazardous chemical in question. However, the analysis of alternatives will likely only influence the decision to grant an authorization for those chemicals (PBTs and non-threshold CMRs) which undergo the ‘socio-economic’ route: the social and economic advantages must outweigh the risks to human health and the environment and alternatives must be unavailable for the chemicals to be authorized. The NGO letter calls for authorization to commence without any further delay.
Written on 12 April 2010.