Challenges of the EU´s Chemical Strategy
The Opening Keynote at the 2022 HCF Forum featured the head of one of the core departments within the European Commission responsible for the revision of REACH, DG GROW. Mrs. Kristin Schreiber shared her views on the EU´s progress and path forward: “while the EU has come a long way in the management of chemicals, procedures need to be more generic, effective and efficient”. This core need has been translated into priority initiatives such as the revision of CLP, and REACH, the development of Mixture Assessment Factors to address the combined exposure to multiple substances, an “Essential Use Concept”, and the One Substance One Assessment (OSOA) approach, among others. The development of a Generic Risk Assessment (GRA), aimed to speed up restriction for the most harmful chemicals or particularly hazardous substances in consumer and some professional uses, was said to have so far enjoyed success with CMR substances in cosmetics. The EU is now expected to expand the GRA approach to endocrine disruptors, and persistent substances, as well as to “specific” professional uses, always allowing for derogations in specific cases. All these issues are currently in the midst of consultation processes, so enterprises are recommended to follow closely to better understand how the assessment of substances will be defined. With regards to substances coming from outside the EU bloc, illicit chemical products and how they are marketed was highlighted as a relevant challenge, expressing the EU Commission would step up its efforts on the enforcement and combating of illegal online sales.
Frameworks to Move Ahead to Safer and More Sustainable Chemicals
Among the key issues proposed by CSS with global implications is the Safe and Sustainable by Design (SSbD) approach. On Day 1 the panel led by the EU Commission shared some ideas on why a framework is key to the future of the chemicals industry and of consumers in Europe and globally: The objective behind the SSbD initiative is to help innovators bringing safety and sustainability considerations forward from the design phase, also relevant to respond to consumer demands for quality and safety standards for goods produced and/or marketed in the EU. Frida Hök, Deputy Director of ChemSec, described it as a driver, to help set the direction for companies to move towards safer, more sustainable chemicals and to ensure more transparency for consumers. A label or certification for companies that push for chemical innovation was suggested, ultimately aimed at increasing the competitiveness of the industry. As regards the Ukraine crisis, an issue that deserved multiple mentions throughout the forum, previous indications on the potential postponement of the overall chemicals regulatory review were discouraged by the EU Commission. Mrs. Schreiber from DG GROW explained that stopping the ongoing review process would not help tackling the consequences of the crisis and nor would it help the industry move towards the production and use of safe and sustainable chemicals, a key goal for the EU and globally.
Animal Testing: the Elephant in the Room
A topic that received a panel of its own, with the presence of regulators from Canada, NGOs, and the industry was animal testing. Addressed as the “elephant in the room” due to its controversial and high impact in the future of chemical safety, Peter van der Zandt, Director within ECHA, shared that, to reach a tradeoff between human health and testing, the grouping of chemicals based on their similarities for assessing and managing them could be the answer.
“What we need is information, the right information or the chemicals to fulfill as agency our regulatory obligations” explained van der Zandt. The management of chemicals in groups can allow for a holistic look at chemicals to save testing on animals. This is especially relevant in light of the tighter scrutiny of chemicals that is expected from the implementation of the CSS. Having more chemicals under the radar for regulatory actions could lead to increasing needs for data and thus, testing.
One of the challenges is building knowledge. Moving to alternative test methods would not necessarily imply a lower level of protection or a higher uncertainty around chemical toxicity. Actually, animal tests do not ensure full certainty, which is what often leads to the need for safety assessment factors.
“Now is the time” was the overall agreement on the panel led by Patience Browne from OECD. New approach methods (NAMs) are becoming more available, but their implementation has remained a relatively slow process. It is necessary to better align NAMs with regulatory objectives, as well as a need for more standardization, as “there are many methods, but not enough integration to satisfy regulatory needs”, shared Maurice Whelan from JRC. Case studies were mentioned an important approach to demonstrate the effectiveness of NAMs and how they can actually meet these regulatory needs.
There is light ahead. Tara Barton-Maclaren from Heart Canada explained that identifying near-term opportunities for the use of currently available NAMs in terms of prioritisation and risk assessment activities could provide a good starting point. Nonetheless, the flexibility afforded by regulatory acts would be a relevant determinant, a point further addressed by NGO Humane Society International (HSI) speaker Marina Pereira. In Canada, certain Acts offered more flexible assessment approaches to be applied to certain chemicals, which had brought good opportunities to use NAMs, explained Barton-Maclaren.
“We need collaborative science with impact”, claimed Ms.Pereira, further sharing examples such as the work achieved by APCRA, OECD and PARC initiative. This focus on cooperation was also set forward by the European Partnership for Alternative Approaches to Animal Testing (EPAA), represented in the panel by Gavin Maxwell, and by Ofelia Bercaru from ECHA who called for collaboration between the regulators, researchers and industry to develop short and long-term goals in relation to replacement. On this point, Ms.Barton-Maclaren Health Canada further claimed the need for data shared generation and accessibility once the methods are established to apply them in an internationally aligned manner.
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Over the last two years, the Helsinki Chemicals Forum worked alongside REACH24H annual CRAC (the Chemicals Annual Regulatory Conference), delivering the Joint CRAC-HCF Virtual Forums (for more details, here). This 2022, the Forum was able to have a hybrid format, with many joining in person and others virtually, with ChemLinked present as Official Press.
By Julia Pochat (for ChemLinked) and Ainhoa Fernandez Perez (co-author- Fipra International)
Reprinted from: ChemLinked
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