FuelsEurope Position Paper – The petroleum industry’s human health workplan: a pragmatic approach to REACH delivery, avoiding excessive animal testing

This paper addresses the issue of the validity of the petroleum industry’s current datasets in its REACH Registrations dossiers regarding human health. The sector believes it is paramount regulators accept this dataset so further work can go on in increasing the understanding of its substances for the Evaluation phase of REACH according to a feasible and pragmatic approach.

The petroleum industry has been collecting data on its products and substances before REACH started as part of its long history and has now collected a large data set. Much of this historical data was used to meet the first Registration phase of REACH. This data shows that there are a large number of substance identities whose compositions overlap to such an extent it makes sense to group them in categories of products with similar chemical composition and chemical hazard. As a result of this substance grouping, using ‘read-across’ of certain data from one substance to another has been an effective way of reducing testing requirements.

The petroleum industry’s substances are widely used as a variety of different products by consumers and industry, across the economy. Our nearly 200 substances, across 18 categories, represent thousands of registrations and registrant companies. The industry works hard to support of all of REACH’s goals, including the safe use of substances and reducing animal testing. For example, we modified the standard test for mutagenicity, only testing an aromatic portion, to avoid false negatives which the standard test returns for our products.

For over a year now, the petroleum industry has been involved with the PetCo working group, collaborating with experts from ECHA, the European Commission and Member States, in order to develop a work plan to address dossier data gaps and set up the approach for the Evaluation phase of REACH. These discussions have been highly productive so far, and the petroleum industry wishes to keep on this positive and efficient collaboration to achieve the objectives of the SVHC Roadmap and REACH.

The issue and FuelsEurope’s position

FuelsEurope have been made aware that some stakeholders are questioning the historical data of human health provided in Registration dossiers, and that the sector could have to start from the beginning with data generation. This would mean that instead of an incremental work plan, an approach is enforced that entails extensive testing on all substances. We believe this approach is disproportionate and unnecessary. Indeed, such an approach could put delivery of REACH at risk; such testing may not be feasible in terms of required resources and time span.

Whilst there are some improvements needed, we strongly advise against throwing out the historical data from the basis for substance evaluation. The industry’s goal is to meet the REACH requirements, but we believe this can be done with a minimum of in vivo tests, by applying a number of strategies including use of historical data and read across between substances.

FuelsEurope firmly believes the industry approach is feasible, faster, involves fewer animals for testing, is more affordable for registrants, and consistent with the REACH text and process. The work plan is not set in stone, but setting out the right basis is fundamentally important. Such an approach will generate high quality and relevant data across all our categories of petroleum substances on a relatively short timeframe, while developing a more sustainable approach to human health risk assessment of petroleum substances for the short to long-term future. The industry approach will generate solid data in a way that:

• Takes less time, and puts less constraints on Europe’s laboratories, and delivers the REACH goals faster;
• Uses read across and looks at categories rather than examining every item in the long array of overlapping Petroleum Substances;
• Requires less animal testing, potentially saving thousands of animals from unnecessary tests;
• Is more affordable for registrants of petroleum substances (which are not all large multinationals), sharing REACH costs through the SIEF system.

For example, over 100 laboratory years and hundreds of thousands of animals would be required to fulfil ECHA’s requirements in the extreme case, if higher-tier testing were required for many substances. With the Industry approach, where weight of evidence, optimised in vivo tests, read across supported by CAT APP⁴ are proposed in the tiered approach, time can be reduced to 5 years testing for all categories and 10 times less animals would be killed.

Going forward, the industry also wants recognition within the REACH framework of data developed by innovative new approach methodologies, such as CAT-APP. Here, in vitro tests are used to show when certain substances are similar, so that data based on tests on one substances can be ‘read-across’ to other ones, avoiding the repetition of testing and the related additional animals required. There are several ways of accepting such new methods, eventually formalised through guidance or regulatory updates, to account for these developments, which could occur in the mid-term, according to REACH’s stated goals of innovation and avoiding unnecessary animal testing.