Figure 1 - REACH revision timeline
uses , exposure routes and pathways of substances . As such , it may fall short of taking into account all of the relevant facts and circumstances of each case or substance . Second , the grouping of substances would depart from the ‘ one substance , one registration ’ ( OSOR ) principle , which is the main principle underpinning REACH . OSOR means that all EU-based importers , manufacturers and only representatives of the same substance need to submit a joint registration for it , which ECHA will then evaluate . Third , the more substances are included within the group , the more challenging their assessment is likely to be , especially when they present different hazard and risk profiles . There are currently no specific limits as to the number of substances that can be grouped together under a restriction proposal , but each proposal will need to be evaluated individually , on a case-by-case basis . By way of example , the tattoo inks restriction dealt with nearly 4,000 substances , which had many different hazard profiles because of the specificity of the related exposure scenario . It is indeed important to assess the profiles of all substances included in the group . If these profiles have not been ( fully ) established because , for example , the scope of the restriction covers substances for which data is not available , the justification of the grouping scope may be more challenging . This may also be scientifically uncertain as the authorities may only rely on assumptions to draw conclusions on the concerned substances . Fourth , as set out in Annex XV , a restriction should meet three criteria : 1 . Effectiveness ( i . e . it must be targetted at the effects or exposures that cause the risk identified , capable of reducing these risks to an acceptable level within a reasonable period of time and proportional to the risk )
2 . Practicality ( i . e . it must be implementable , enforceable and manageable )
3 . Monitorability ( i . e . it must be possible to monitor the results of the implementation of the proposed restriction ) In that respect , the grouping of substances may not comply with these three criteria since the restriction will not necessarily be targeted to the appropriate substances , it may be difficult to enforce and the outcome may be difficult to monitor . Furthermore , if the EC considers that the conditions laid down in Article 68 of REACH are fulfilled and prepares a proposal to restrict a substance , the proposal should necessarily be
in conformity with the provisions of REACH and with the principles of EU law , such as the principle of proportionality , which requires that each specific use be analysed and the benefits of the restriction be compared with the risks that such specific use represents , thus requiring a case by-case , use-by-use analysis of the substances . In addition , the assessment must take account of the specificity of each chemical substance being considered in order to be proportionate . A generic restriction that would rely on the characteristics of one substance to extrapolate it to all other substances in a group without positive demonstration of their harmful criteria would be contrary to the principle of proportionality . The grouping of substances may also raise issues of due process , especially when many substances are included in a same group . Manufacturers would indeed be de facto unable to defend their position on these substances adequately . The grouping approach may constitute a shortcut to group all substances based on a structural similarity .
Conclusion
From a legal standpoint , grouping substances is not per se unlawful under REACH . Indeed , it is routinely used to fill data gaps during the
74 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981