New Approaches and Sustainable Innovation
With constant innovation in chemical science, new potential safety concerns regularly emerge and become regulatory priorities. In addition, the pubic demand for greener products means chemicals must be both safe and sustainable. Such drivers are promoting more and more innovation in chemical development, use and in testing techniques and regulatory science.
Keeping ahead of the regulatory curve for innovations is vital for business success in the chemical sector. You need to anticipate forthcoming changes in the regulatory environment and build robust strategic plans to address them.
- Regulatory scientists who understand the impact of potential regulatory changes and engage proactively in thought leadership in this arena.
- Access to the latest regulatory thinking and innovative regulatory science to future-proof your chemical portfolio.
New priorities impacting chemical regulation
Microplastics regulation in the EU
ECHA have proposed restrictions on the intentional use of microplastics in products used in the EEA due to concerns about their potential impact on animal and human health. Microplastics are tiny solid polymer particles, typically <5mm, used in many products across a range of industries. Unfortunately, some 70% of intentionally used microplastics are released into the environment where their stability and small size make them a potential risk. In fact, ECHA recommends microplastics are treated like PBT/vPvB (persistent, bioaccumulative, toxic/very persistent, very bioaccumulative) substances. The proposed restriction on microplastics states under paragraph 1 of Annex XV of REACH:
“Polymers within the meaning of Article 3(5) of Regulation (EC) No 1907/2006 shall not, from [entry into force (EiF)], be placed on the market as a substance on its own or in a mixture as a microplastic in a concentration equal to or greater than [0.01]% w/w.”
Some sectors may find it challenging to comply, so transition periods and derogations are in place to give industry time to develop alternatives. The ECHA restriction on microplastics will likely enter into force (EiF) in 2022 so industries need to start planning now for the consequences.
The biggest challenge in establishing microplastic safety is estimating biodegradability. ECHA recommends tiered testing using standard biodegradability studies but many higher tier studies are difficult to perform without modification.
Covance is therefore focusing considerable effort on optimizing study designs to effectively and robustly assess microplastic biodegradability. This will ensure we can continue to support you in creating high-quality scientific dossiers fully characterizing the environmental behavior and fate of microplastics in your products.
Nanomaterials have been a regulatory concern for many worldwide regulators for some time. ECHA introduced an update on the REACH requirements for nanomaterials that came into force on 1 January 2020. The regulation applies to currently registered and new substances. Crucially, this includes substances intentionally developed as nanomaterials, as well as those that may unintentionally contain nanomaterials by virtue of their formulation. The update specifies requirements for nanoform characterization (Annex VI), chemical safety assessments (Annex I), registration information requirements (Annexes III, VII-XI) and downstream user obligations (Annex XII).
Effective nanoform identification and characterization requires assessment of particle size distribution, particle shape and surface chemistry. For many registrants, characterisation of nanoforms is the biggest challenge. There is currently no single recommended approach appropriate for every chemical, so chemistry expertise is essential to selecting the right approach for your chemical. Under the new regulation, similar nanoforms should be categorized into sets to simplify regulatory assessment. The use of QSARs and read-across are essential categorization and are the building blocks for assessment of hazard and risk.
Covance have strengthened their physico chemical capabilities to better support nanoform characterization. Collaboration between analytical chemists, QSAR modellers and regulatory scientists allows us to leverage expertise and insight to support your chemical through the new regulation.
You can find out more about EU REACH nanoform regulation and its impact on you in our ebook.