2022

REACH REGULATION: What’s new about polymers

by cyb2025

ANTONIO CONTO
Chemsafe, Colleretto Giacosa (TO), Italy

FOREWORD
People and the environment are widely exposed to polymers, the main constituents of plastics, as these chemicals continue to build up in terrestrial and ocean ecosystems and production is predicted to continue increasing, resulting in emissions to our waterways of up to 53 million metric tons (Mt) per year by 2030. Apart from plastics, polymeric substances are present in many other materials, products and applications, including but not limited to silicones, coatings, paints, detergents, household and personal care products, agricultural fertilizers and wastewater treatment, often leading to direct releases into the environment. Although polymers are manufactured and used in Europe in extremely high quantities (e.g. plastic production in Europe has been around 60 million tonnes per year over the last years as said in the PlasticsEurope report, 2020, not enough is known about their identity, uses, physical, chemical, and hazardous properties, particularly because polymers have so far been exempt from registration under the European chemicals regulations REACH. To finally initiate the polymer registration process, the European Commission (EC) developed a proposal on how and which polymers to register (Wood and PFA-Brussels, 2020), see later comments.

 

In order to ease the burden on industry, the approach followed by the EC seeks to limit registration obligations to a reduced number of polymers identified as “Polymers Requiring Registration (PRR)” based on a defined set of criteria. However, following the criteria outlined in the Wood/PFA report, only ca. 6% of the estimated 200’000 polymers on the EU market might require registration, while most of the polymers used in highest quantities and contributing majorly to the current plastic crisis and growing pollution with micro and nanoplastics would not require any registration process at all. This concerns, for example, polyolefins such as polyethylene (PE) and polypropylene (PP), as well as polystyrene (PS), polyvinyl chloride (PVC), polyethylene terephthalate (PET) and polyamide (PA) plastics. This omission also disregards the indications that a number of high production volume polymers (such as PS and PVC) can have negative impacts in human health, including carcinogenic effects, and impact organisms in the environment at levels of medium to high concern as reported in many literature sources.. To ensure a 2 high level of protection to human health and the environment, the EC should provide a framework for the registration of all polymers in a stepwise process, giving priority to those manufactured in highest volumes and thus likely to result in the highest exposures. In addition, while the registration of polymers under REACH concerns the polymers themselves, these materials cannot be considered as ‘pure’ in that plastic polymers typically contain not only the known, Intentionally Added Substances (IAS) but also Non-Intentionally Added substances (NIAS), which are often unknown and may include reaction side products and byproducts, degradation products, as well as other impurities and contaminants, some of which may be toxic. An example of hazardous IAS is antimony (Sb), which is commonly used to regulate polymerization in production of PET in the form of antimony oxides or antimony acetate. Many authors augue that Sb can leach from plastic products, like PET water bottles, at levels that exceed safety limits for chronic daily intake. One example of NIAS is Polycyclic Aromatic Hydrocarbons (PAHs) which have been found in virgin polystyrene (PS) and may be generated during its production. PAHs in PS can also be a result of contamination as described in some papers.

 

ABOUT THE AUTHOR

Antonio Conto is the founder of Chemsafe, an indipendent Regulatory Affairs company established in 2001. He has been working as Experimental Toxicologist in an Italian CRO for 13 years (1988-2001) before founding Chemsafe.
He manages a lot of REACH registration dossiers and related Risk Assessment at international level. In 2011 he was recognized as European Registered Toxicologist i within EUROTOX as well as RENTIC (the Italian Registry of Toxicologist). Antonio pubblished around 100 papers in the field of regulatory science and attended lots of regulatory/scientific events as invited speaker. He is active members of various associations both in the chemical and medical areas (pharma and Medical Devices).

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