CEFIC HSPA welcomes the opportunity to provide comments on the workability of the Commission’s consultation document concerning the Registration, Evaluation, Authorization and Restrictions of Chemicals.

 

CEFIC HSPA  member companies will be impacted by REACH both as manufacturers of hydrocarbon solvents as well as downstream users of other substances.  In their capacity as manufacturers, they will be responsible for the preparation of Chemical Safety Reports on hydrocarbon solvents. These products, which generally have a complex and variable composition, belong to the category of complex substances. The concept of a complex substance is well established and accepted by many regulatory authorities, including the EU.  We are puzzled why the Commission’s consultation document for REACH makes no reference to complex substances as such. We suggest that the Commission clarify its intention for the scope of REACH as it applies to complex substances.

 

CEFIC HSPA supports the goal of simplifying the procedures for risk assessment and welcomes the consideration of risk management measures in the risk assessment process. However, the risk assessment methodology described in the Annex I is overly complex, yet incomplete. The process that is described for the environmental risk assessment is applicable only to single component substances, not to complex substances. Moreover, the methodology described for human health risk assessment suggests it is possible to derive safe exposure levels for multiple human populations and sub-populations and assumes exposure data are available for all these populations. The approach appears to be a box-ticking exercise and is based on the assumption that for all substances to be registered, a complete set of human health and environmental data are, or will be, made available for all endpoints.

In contrast to the several hundred pages of accepted test methods, there is limited guidance for the risk assessment process itself. Apart from a textbook description of how to perform risk assessments for single component chemicals, there is a marked absence of any reference to any accepted risk assessment tools or methodologies that industry would be expected to use and which, in turn, would be accepted by the authorities.

For risk assessments of high tonnage volume chemicals for which there is widespread human exposure, no reference is made to existing risk assessment procedures described in the Technical Guidance Document (TGD).  Further, there is no guidance on a tiered and targeted approach to risk assessment driven by intended uses and their exposure potential, or, for procedures for substances that are complex chemical mixtures. 

We suggest deleting reference for the need to consider broad and complex environmental issues such as ozone depletion or ozone formation "on a case by case basis" within REACH.  These broad environmental issues are best addressed under other EU-wide programs and certainly cannot be addressed in any logical fashion through the filing of chemical safety reports for individual chemicals or groups of chemicals under REACH.  For example, the Clean Air for Europe program was designed to be an all-encompassing program to address broad air quality objectives such as ozone depletion or control of ground level ozone.

Concerning use of existing toxicology data, in our view, when multiple studies of the same type are available for the same toxicological enpdoint, it is not acceptable to consider only the study showing the highest concern.  Rather, we suggest studies of highest quality, validity, and relevance to the exposure situation encountered should be the basis for the safety report.

Concerning the assessment of exposure, we encourage the use of generic exposure scenarios that encompass common uses that address the frequency, duration, and major routes of exposure for broad population groups (industrial worker, professional, consumer).  It is unrealistic and unworkable to address exposure for all of the potential subsets of individuals as suggested in the draft legislation.  Similarly, it is unrealistic and unworkable to expect manufactures to know the activities and control equipment for each downstream user in detail.  

We are disappointed that the Commission still appears not to fully appreciate the complexity of the supply chain and the time required for information to flow up and down the supply chain. We suggest that the Commission reflect on the recent Member State experiences in the implementation of the revised SDS Directive, which also required the transmittal of information throughout the supply chain, as a basis for setting realistic timeframes.

While we support the proposed deadlines for phased-in substances as a pragmatic and realistic approach to implement REACH, we are alarmed of the requirement for manufacturers/importers and downstream users to prepare and issue Chemical Safety Reports (CSR) for all substances, even for those substances not to be registered, a mere 12 months after adoption of the legislation. This is neither realistic, nor pragmatic, nor workable but rather a recipe for failure. We suggest that the same deadlines proposed for the registration of phased-in substances should also apply to the transmittal of CSRs up/down the supply chain.

We are concerned with the definition that is proposed for isolated intermediate transported that limits the supply to no more than two sites. In the context of the petroleum/petrochemicals material flow, and the critical cost advantages that the European supply network presents for the industry, this effectively precludes any exemption for any petroleum/petrochemicals intermediates. This is irrational and has no bearing on the risks to either man or the environment that the supply and use of these materials present.

We support the Commission’s acknowledgement of grouping as a pragmatic approach to handling a number of substances having similar physico-chemical, toxicological or eco-toxicological properties as outlined in Annex IX. We encourage the Commission to acknowledge the utility of the grouping approach in all phases of REACH and not limited only to classification and labeling.