Refined petroleum products come under the scope of REACH, the EC Regulation 1907/2006 on Registration, Evaluation, Authorisation and Restriction of Chemicals, the EU’s instrument for managing the risks presented by chemical substances for human health and the environment. Refining companies have been very active in the registration phase, and the sector supports REACH’s approach to risk management based on sound science. However, implementation presents challenges and has led to concerns about a potential loss of competitiveness if the administrative burden increases drastically and unjustified restrictions are imposed on petroleum products. As such, FuelsEurope supports the inclusion of REACH in a future update of the Refining Fitness Check’s cumulative impact analysis of EU legislation.
REACH entered into force in 2007, with provisions being phased in over the coming years. The Regulation addresses the production and use of chemical substances, requiring all companies manufacturing or importing chemical substances in quantities of more than one tonne per year to register them with the European Chemicals Agency (ECHA). Registration deadlines depend on the volumes produced or imported. Those used in quantities of more than 1,000 tonnes a year had to be registered by 2010, as did chemicals of higher concern or toxicity. Those used in quantities of less than 100 tonnes a year were registered in 2018.
Petroleum products are characterised in REACH as UVCBs: substances of Unknown or Variable composition, Complex reaction products or Biological material. They are complex and variable because they are derived from crude oil and their exact composition varies across different streams of the same product, reflecting specific refining processes and crude oil sources.
The REACH Regulation is generally designed for mono-constituents. However, most petroleum substances and many other natural products have multiple constituents. Petroleum substances are archetypal UVCBs or substances of Unknown or Variable composition, Complex reaction products or Biological materials.
The biggest challenge in applying REACH to petroleum substances is to account for their UVCB nature. The complexity of UVCB substances means it is impossible to determine the precise chemical composition to the level of each constituent. The variability in detailed composition and the large number of constituents which could reach over a million molecules makes it difficult to represent the composition of petroleum substances at such a detailed level.
Traditionally, petroleum substances have been grouped in categories based on process and carbon length or distillation range. REACH challenges this traditional approach but still the Regulation allows for grouping and read cross when justified. The 200 petroleum substances currently registered have been placed in 18 categories. The approach allows hazard data for a substance to be applied to other substances in the same category. Using ‘read across’ within the same categories and between ones is used to reduce unnecessary animal testing.
The category approach is a long-established method. Using the worst-case approach ensures the hazard level – and consequently the risks – are not underestimated. This approach needs to be retained, but further developed, explained and justified in response to the challenges of REACH.
REACH implementation has its challenges, especially for complex petroleum substances. FuelsEurope therefore calls for an improved collaborative approach between ECHA, Member States, the European Commission and industry, based upon a shared appreciation of both the key principles of REACH and the scientific, technical and economic challenges of its application. This should include an improved dialogue throughout the process over screening and evaluation. It is important to remember that, as well as managing risks, REACH is supposed to enhance competitiveness and innovation in both methodology and products. As such, Member States will play a critical role in avoiding fragmentation of the EU internal market and disruption of the level playing field. They also need to consider international competitiveness, particularly regarding the differing treatment of imported articles using SVHCs in their production processes.
Concawe has instigated a number of programmes to develop new information to ensure continuing compliance with the requirements of REACH. These programmes need time to develop the science and for the implications to be understood. FuelsEurope supports a collaborative approach between ECHA, Member States, Commission and other key stakeholders to propose a suitable timeline for overhauling the registration dossiers and better understand how to apply REACH to UVCB substances.
FuelsEurope calls for support for innovative testing methods in areas such as data generation, experimental design and analysis leading to a better understanding of the relationship between chemical properties and biological responses, as well as reduce animal testing. For example, data read-across – where endpoint information from one chemical is used to predict the same endpoint for a similar chemical – can reduce unnecessary data proliferation and the need for animal testing. Limitations on the applicability of data read-across should therefore not be excessive or premature Concawe is developing ways improve the justification of read-across with its Cat-App project..
The Cat-App project tackles these challenges by investigating practical strategies for grouping and read across approaches with the aim of providing a cost-effective integrative approach to solving the similarity challenges of UVCBs. The concept is to develop a framework based on chemical-biological read-across, a novel direction in regulatory decision making regarding. The approach is to integrate innovations in (i) in vitro testing, (ii) high-throughput genomics and (iii) integrative data analyses and visualisation into a transparent workflow for read-across assessment of UVCBs in regulatory programmes.
SVHC (Substances of Very High Concern) Roadmap
Data proliferation from overly-conservative screening could lead to a number of substances being unnecessarily identified as Substances of Very High Concern, even when current risk management measures are sufficient. . Proportional and well-grounded assessment of risk management options scientific criteria should therefore be applied. These should consider uses and hazards in a way that avoids unnecessary testing. The SVHC Roadmap should not become a political target, leading to unjustified additions of substances to the candidate list.
PetCo (Petroleum and Coal Working Group)
In 2016, ECHA formed the Petroleum and Coal Stream Substances Working Group (PetCo WG) with representatives from ECHA, European Commission, Member States and industry stakeholders including Concawe, with a mandate to develop the approach for assessment of petroleum substances for potential Substances of Very High Concern (SVHC) status.
The SVHC roadmap agreed highest priority should be given to screening petroleum substances with widespread uses (professional and consumer uses and use in articles) for SVHC properties. Industrial uses are in scope of the SVHC roadmap, but the current view of ECHA is that appropriate risk management measures are correctly applied in industry. Petroleum substances which are only used as a fuel or as an intermediate or for industrial uses were assigned a lower priority and it was confirmed that substances which only had fuels uses were outside the scope for authorisation.
For 2017, PetCo WG agreed a new mandate for the prioritisation of substances and coordination of assessment activities. This will focus on the 44 petroleum substances with widespread uses and a total volume of 38 million tpa (2013 basis)