Stakeholders are being encouraged to weigh in on the European Chemicals Agency (ECHA) 60-day public consultation period related to a planned ban on per-and-polyfluoroalkyl (PFAS) substances, also known as forever chemicals.
The widely used substances are sometimes used in the production of pharmaceuticals, including being found in some active pharmaceutical ingredients (APIs), raw materials used for chemical synthesis, as well as in reagents and manufacturing equipment.
ECHA is accepting public comment from 26 March-25 May on a recent draft opinion by its Socio-Economic Analysis Committee (SEAC) about the feasibility, benefits and costs of proposed EU-wide Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) restrictions on PFAS..
As part of the process for getting a REACH restriction on a substance that harms human health or the environment, authorities in EU member countries explain the background and risks in a dossier, which is then reviewed by the SEAC and RAC. Both committees recommended a ban on PFAS across the EU, allowing for targeted derogations.
In its final opinion, published 10 March, the RAC noted the growing and highly persistent health risks of PFAS, including cancer and reproductive harm. It called for EU-wide regulatory action to protect people and the environment as well as risk management requirements if derogations for specific uses are allowed, including emissions monitoring and reporting of PFAS emissions from manufacturing and industrial sites.
The restrictions can also apply to packaging materials using fluoropolymers, or combination products such as pre-filled syringes.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) said that it was “deeply concerned” about the ECHA opinions in a 26 March statement. It will take time to find alternatives to PFAS and the pharma industry needs a time-unlimited derogation, in EFPIA’s view.
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As a result of the amendment of the CLP Regulation (Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures), new hazard classes have entered into force.
Tris(2,4-di-tert-butylphenyl) phosphite (TDPP) often recognized commercially as Irgafos 168 is a high-performance organophosphorus compound primarily utilized as secondary antioxidant and processing stabilizer. Its characteristic to undergo metallation reaction and provide a cost-effective synthetic processes allows it to be useful in biaryl coupling reactions.
Undecylenic acid is an unsaturated fatty acid naturally derived from castor oil. It is a colorless to pale yellow liquid with antifungal and antimicrobial properties. Chemically known as 10-undecenoic acid, it contains an 11-carbon chain with one double bond and is widely used in pharmaceuticals