This article is part of our special report Chemicals management: What’s at stake.
Authorising or banning potentially hazardous substances in the European Union can drag on for years and the current rules allow separate regulators to run their own assessments, sometimes leading to different outcomes. A planned new regime aims to change that.
As part of the European Commission’s proposal to revamp chemical management principles, published earlier this year, the EU executive intends to explore the idea of a ‘one substance, one assessment’ method.
“The complexity of assessment procedures represents a specific challenge for authorities and stakeholders. It can lead to inconsistencies, slow procedures, inefficient use of resources and unnecessary burdens,” the chemicals strategy explains.
In order to make the process simpler and more transparent, the Commission suggests that the assessment should involve grouping chemicals, instead of scrutinising them on a ‘substance-by-substance’ basis.
Currently, any number of agencies, authorities and regulatory bodies can initiate an assessment procedure, which ups the complexity of what is already a murky process that stakeholders need to keep track of.
Two of those authorities – the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA) – released a joint position paper earlier this year that backs the idea of a streamlined system.
“Currently, risk assessment and risk management of the same chemical is carried out at different times for different uses by different bodies, under different legislation, often using different data and potentially leading to seemingly different outcomes,” the paper warns.
It points out that ECHA has the lead when the chemicals in question are classed as for industrial use, while EFSA takes the baton when they are used in things like food packaging and utensils.
When it comes to products like cosmetics, toys and electronic devices, the issue of who is in charge becomes more complex and has in the past led to problems, due to the use of different datasets, competing timeframes and diverse marketing frameworks.
The paper lists bisphenol A, a substance used to make plastics, resins and plastic coatings, and phthalates, which soften or ‘plasticise’ plastics such as PVC, as examples of assessments that “may have created uncertainty for decision-makers and the public”.
ECHA and EFSA acknowledge that a new system has to be built around better coordination between EU bodies. They agree with the Commission’s proposal to build on the ‘Public Activities Coordination Tool’ that is already established under the REACH chemicals law.
“To avoid duplication of work, early agreement on the problem definition will be key, favouring the assessment by groups of substances with structural or functional similarities,” the Commission’s chemicals plan suggests.
Violaine Verougstraete, a chemicals expert with trade body Eurometaux, likes the idea of a simpler process, citing “its potential to improve efficiencies”. She added that “a step-by-step approach is needed to roll the concept out and make sure it works in practice.”
To that end, the Commission has pledged to set up working groups made up of representatives from the EU member states, relevant agencies and the EU executive itself to “discuss initiatives on hazard/risk assessment on chemicals across chemical legislation”.
It will also establish a coordination mechanism in-house, publish plans to boost ECHA governance and financing resilience, and reform REACH’s authorisation and restriction processes.
According to estimates, clarifying concerns about specific chemicals under REACH takes on average seven to nine years to complete, and many more years to control the risks if proved to be hazardous.
“‘One substance, one assessment’ will also build greater trust in the scientific underpinning of the EU decision-making process for chemicals, building on the important steps taken regarding transparency in the EU food safety sector,” the Commission strategy adds.
The ECHA-EFSA paper also backs increased transparency and proposes a “fully connected and interoperable EU chemical safety platform to facilitate seamless sharing of data between authorities and provide public access to researchers, regulators, industry and citizens.”
Tatiana Santos of the European Environmental Bureau warned that ‘one substance, one assessment’ “is just a title of a commitment without real content yet, so it could be anything at this point”.
The new regime, she told EURACTIV, should be used as a tool to help the Commission’s chemical plan “radically accelerate and scale up action to effectively reduce cumulative exposures to chemicals of concern”.
Santos insisted that the system should be “based on the toxic-free hierarchy and generic risk considerations. Unfortunately, some industry laggards are more focused on continuing paralysis by analysis.”
[Edited by Zoran Radosavljevic]