The European Commission has recently been reviewing whether to tighten up the way endocrine disrupting chemicals are considered under the ‘Authorization’ building block of REACH.
Senior Regulatory Consultant Pearl Nemeth explains what this decision means to your business, if your substance becomes listed on the Authorization List as an endocrine disruptor.
Endocrine disruptors – a type of chemicals we have blogged about before – have recently been receiving time and attention in the form of a European Commission assessment.
The Commission have assessed whether this group of substances should remain under their current REACH Authorization procedure, or instead be handled somewhat differently (explained below). And the Commission’s conclusion, published on 9 January, is that endocrine disruptors should remain as they are currently treated under the Authorization process. But what is the current approach, I hear you ask?
For an organization to undergo Authorization to use a chemical substance, there are two significantly different ways, or ‘Routes’ as they are called, to grant authorization for a use for a substance:
- The Adequate Control Route, i.e. the route to Authorization is to show that the risk to human health or the environment is being adequately controlled; or
- The Socio-Economic Route, in cases where the first Route is not feasible. This Route means that the socio-economic benefits of the continued use of the substance outweigh the risk to human health and the environment. This route to Authorization can only be granted if no suitable alternative substance or technology exists.
Some chemicals – such as carcinogenic, mutagenic and reproductive toxic (CMR) category 1A/1B substances – can go through either of the above routes, depending on whether a safe threshold can be determined for them. If it is not possible to determine a safe threshold for a CMR (and therefore allow the Adequate Control Route), the substance can only be authorized under the Socio-Economic Route.
However, other substances, such as those which are persistent, bioaccumulative and toxic, or very persistent, very bioaccumulative (PBT/vPvB), are always subjected to the Socio-Economic Route. This means the Regulator does not leave any space to show a safe threshold, as one cannot exist. Exactly as their names suggest, these chemicals have the potential to stick around for a long time, meaning their environmental concentration is expected to keep increasing, and eventually lead to harm to the environment.
Based on the REACH text currently adopted, endocrine disruptors, similar to CMRs, can go through either of the Routes to Authorization. The Commission was tasked to re-evaluate this and consider regrouping them instead with the PBTs and vPvBs. But, after assessment, it’s no change for the moment. The question of whether a safe threshold exists for particular endocrine disruptors, and therefore which Route companies can use to apply for Authorization, will have to be answered on a case-by-case basis.
So, it seems the Commission is still no closer to a universal conclusion on whether all endocrine disruptors have a safe threshold, or whether, in fact, none of them do; the final wording of the report leaves it completely open. (This conclusion would be crucial for defining the criteria for endocrine disruptors, which Chris Turner blogged about late last year, and which he’ll update on in his next blog). NGOs are disappointed with the final report, while companies still have a chance to prove a safe threshold exists for the endocrine disruptors they use. This will not be an easy task, and the final word as to whether the level determined by the applicant is acceptable will, of course, stay with ECHA’s Risk Assessment Committee.
It will be interesting to follow the developments. While there are no substances currently included for their endocrine disrupting properties on the Authorization List (Annex XIV), it continues to grow. 4-Nonylphenol, branched and linear, ethoxylated is already recommended for inclusion and DEHP, although already on Annex XIV for its reproductive properties, has been additionally identified in the Candidate List as an endocrine disruptor. The Member State Committee will discuss the draft 8th Recommendation during their next meeting 7-9 February, so watch out for our blog on Substances of High Concern after this meeting.
 6th Recommendation of priority substances to be included in Annex XIV