Substitution principles in EU chemical regulations : History & future uses
Max Moseley and Damon Waterworth of Yordas Group look at a key challenge in REACH and other EU regulations in practice
The challenge of substituting hazardous chemicals is becoming an increasingly prevalent activity in a number of different industries . Within this , research into , the development of and the ultimate choice of alternatives can be a highly contentious and complex affair .
This is a widespread issue , affecting numerous existing products , processes and services . However , in the future , can we design new products , processes and services in a way that negates the need for eventual substitution ?
Substitution principle
The substitution principle refers to the practice of replacing hazardous substances with safer alternatives . The principle is based on the idea that chemicals that pose a significant risk to human health or the environment should be replaced with a safer alternative whenever feasible . 1 Historically , the substitution principle has been central to the development of many global chemical regulations , including REACH and the Biocidal Product Regulation ( BPR ).
The implementation of the substitution principle by industry has its challenges . Firstly , there is no
Figure 1 – The substitution principle
consensus on how to approach the substitution problem : this can lead to a number of different interpretations of its use . Common applications include the use of chemical screening and assessment tools , alternatives assessment and Green Chemistry metrics , which can help determine potential impacts to human health and the environment and identify suitable alternatives .
In addition , the process of performing chemical substitution is prolonged by the need for a multidisciplinary approach . Contributions from chemists , engineers , product designers , environmental scientists and so on , are required to ensure substitution is performed correctly .
Challenges for direct substitution
When there is a requirement for the replacement of one substance for another , there are a number of hurdles in the path ahead . These include , but are not limited to :
• The spectrum of substitution
• Data availability / quality
• Problems for small businesses
When considering alternatives that have proven performance , there are a number of different options available ( Figure 1 ). The ‘ next best ’ alternative may be a substance that is similar to the existing substance in structure . Care should be taken for this alternative due to potential issues around similar hazard profiles .
A ‘ green ’ option can be considered an alternative with a superior hazard profile , but it may not be feasible due to difficulties around sourcing or changes in infrastructure needed prior to adoption . The ‘ perfect ’ solution is a substance that presents no hazards , is not regulated and is readily available .
It is unlikely that all of these factors will be satisfied when investigating for alternatives and will require significant amounts of R & D . It is important to consider that different stakeholders involved in the substitution project may desire different alternatives from this spectrum , and those different options will require different efforts to achieve .
In terms of data availability , a considerable amount of novel research is typically required when investigating potential substitutions . The generation of this data is timeconsuming and requires investment . There are a number of independent databases available containing information on sustainable options for alternatives , but there is no recognised central database .
Substitution is a particularly difficult challenge for small businesses . Less human resource , more limited innovation funds and issues around a lack of internal knowledge can all contribute to difficulties for substitution projects . Consequently , small businesses are sometimes forced into joint ventures on substitution projects , which then raises issues around confidential business information .
42 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981