Pharmaceutical Business review

Preliminary ruling: REACh regulation of monomers in polymers required

On March 10, a preliminary ruling by the European Court of Justice would require registration under REACh of reacted monomers in polymers. Juliane Kokott one of the Advocate Generals at the European Court of Justice (ECJ) issued an opinion rejecting the claim made by four companies that such a registration requirement is unlawful. “The proceedings are aimed at removing doubts as to the interpretation of Article 6(3) of the REACh regulation or clarifying whether that provision should be declared invalid,” said Kokott.

In her opinion statement, Kokott made the important conclusion that, “[t]he term monomer substances … refers only to reacted monomers, that is, monomers which have reacted together in such a way that they are bound in the polymer of which they are components.” This was the court’s first interpretation of the REACh regulation since its implementation. It is important to note that this opinion is non-binding and could be overturned. Stay tuned for a final judgment towards the end of the year.