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 science. However, implementation presents challenges and has led to concerns about a potential loss of competitiveness if the administrative burden increases drastically. As such, FuelsEurope supports the inclusion of REACH in a future update of the Refining Fitness Check’s cumulative impact analysis of EU legislation.
EACH entered into force in 2007, with provisions being phased in over the coming decade. 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 have until 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.
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.
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. Concawe is developing ways improve the justification of read-across. Limitations on the applicability of data read-across should therefore not be excessive or premature.
Substances of Very High Concern
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. The approach for petroleum substances is being designed through the PetCo (Petroleum and Coal) Working Group. The focus is be on widespread consumer and professional uses of petroleum substances, and will serve as a guidance process for dealing with those whose risks have not yet been properly addressed. Where current risk management is deemed insufficient, alternatives to Authorisation should be considered, such as measures enhanced risk management measures.
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.