New Approaches & Sustainable Innovation

With constant innovation in chemical science, new potential safety concerns regularly emerge and become regulatory priorities. In addition, the public demand for greener products means chemicals must be both safe and sustainable. Such drivers are promoting more and more innovation in chemical development and 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.

New Priorities Impacting Chemical Regulation

Microplastics regulation in the EU

ECHA has 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 <5 mm, 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. 

We are, 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

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  January 1, 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, characterization of nanoforms is the biggest challenge. There is currently no single recommended approach appropriate for every chemical, so chemistry expertise is essential to select the right approach for your chemical. Under the new regulation, similar nanoforms should be categorized into sets to simplify regulatory assessment. QSARs and read-across are essential for categorization, as these and are the building blocks for assessment of hazard and risk. 

We have strengthened our physico-chemical capabilities to better support nanoform characterization. Collaboration between analytical chemists, QSAR modelers 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.