New and updated test methods for assessing the safety of chemicals have been introduced by a recent Commission regulation. Many of the almost 100 included are new approach methods which explicitly avoid using animals in evaluating chemical hazards. This regulation bolsters both the wider EU commitment to phase out animal testing, as well as the testing toolkit with which REACH registrants are equipped to generate data on the chemicals they submit for consideration.
- The REACH Regulation (EC) 1907/2006 obliges industry to manufacture and use chemicals safely. The fulfillment of this obligation requires an immense amount of data on the hazard characteristics of chemicals. The creation of this information sometimes necessitates laboratory testing on live animals.
- There are several REACH provisions which seek to prevent an overreliance on animal testing as a means of meeting information requirements. Registrants are instructed to share data on substance properties where applicable, avoiding the duplicating of animal testing by multiple companies. Article 13 of REACH makes it clear that animal testing is to be seen as a last resort, with a clear preference for new approach methods (NAMs) which spare vertebrate animals from experimentation.
- The European Union’s commitment to reducing animal testing is also codified in Directive (EU) 2010/63 on the protection of animals used for scientific purposes. Article 13 of this legislation is similar to that found in REACH, creating a legal obligation to opt for a non-animal test method in instances where one exists and is acknowledged by any EU legislation.
New test methods
- An acknowledgement of non-animal test methods is exactly what Commission Regulation (EU) 2023/464 achieves. Adopted on March 3, 2023, it amends the longstanding Test Methods Regulation (TMR) (440/2008/EU) by adding and updating some 100 new and existing chemical safety test methods.
- The new regulation inserts three tables at the start of the TMR’s annex, consolidating all international chemical safety test methods recognized by the EU in one place. The first table contains methods for physicochemical properties, the second concerns toxicological properties, and the third encompasses tests of ecotoxicological properties. Most of the newly approved methods in table two are NAMs and therefore do not involve animals. Almost all the entries in the tables are sourced from the Organization for Economic Cooperation and Development (OECD), further harmonizing the EU with this international body in particular.
- While international test methods are included, the adopted regulation also deletes some of the now redundant ones which previously populated the TMR annex. Some of these methodologies represent an outdated testing technique and others are substituted with NAMs. The deleted test methods are listed at points 2-6 at the end of the regulation with a note referring readers to the equivalent entry in the new chart which is to be considered authoritative.
Streamlining the process
- In addition to adding new test methods, this new regulation also fundamentally renders the process for inserting future methods far less rigorous. Whereas additions to the TMR previously involved drafting an extensive section outlining testing methodology, future inclusions will simply entail referencing the appropriate international test guideline in the chart at the beginning of the annex. Significantly, this new procedure sidesteps labor-intensive requirements to translate chemical test method additions into all EU languages.
- Both the European Ombudsman and European Parliament (EP) have previously urged the Commission to simplify the process for introducing new test methods, easing the transition to non-animal testing. Through its decision in case 23/2018/SRS, the ombudsman explicitly advised the Commission to improve this process, identifying the burdensome language requirements as a clear bottleneck and endorsing harmonization with the OECD.
- The EP, in its resolution 2021/2784 (RSP) regarding the acceleration of research innovation without the use of animals, reasserted article 13 of REACH. Specifically, the EP noted that this article “requires that the test method requirements be updated as soon as non-animal methods become available,” a commitment considerably hampered by the red tape involved with integrating international test methods into the TMR.
- The use of consolidated charts whose entries endorse mostly OECD testing techniques in the EU represents a much faster way of including test methods. This heightened agility in updating the TMR to scientific progress regarding these techniques may make NAMs more mainstream while ushering in an influx of REACH data.
- Substantial funding has been earmarked to help industry transition away from animal testing in the EU. The Horizon Europe Framework Program for research and innovation runs from 2021 to 2027, allocating over EUR 200 million to this endeavor in 2022 alone.
- Regulation (EU) 2023/464 enters into force on March 26, 2023.
Key Documents and Dates
- Commission Regulation (EU) 2023/464 of 3 March 2023 amending, for the purpose of its adaptation to technical progress, the Annex to Regulation (EC) No 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorization and Restriction of Chemicals (March 3, 2023)