December 16, 2022

EU updates FAQs on the application of EU sanctions to chemicals legislation

The European Commission recently published updated Frequently Asked Questions on the application of EU sanctions on the EU’s legislation on chemicals and, in particular, Regulation (EC) No 1907/2006 (REACH Regulation). 

According to the FAQs, which were updated on December 9, 2022, individuals and entities in the EU are not required to comply with the mandatory data sharing obligations in the REACH Regulations for potential registrants with whom transactions would be prohibited under letter (a)-(c) of Article 5aa Council Regulation (EU) No 833/2014 (concerning restrictive measures related to Russia’s actions destabilizing the situation in Ukraine). More specifically, the prohibitions include transactions with (a) Russian persons or entities which are publicly controlled in Russia or in which Russia, its Government or Central Bank have the right to participate in profits or have some other substantial economic relationship; (b) persons or entities outside of the EU who proprietary rights are owned more than 50 percent by any entity listed in Annex XIX; or (c) any person or entity acting on behalf or at the direction of any party described in point (a) or (b).  While granting a letter of access in exchange for cost sharing would be a prohibited transaction under the criteria in Article 5aa, the European Chemicals Agency (“ECHA”) should grant access to data, but exceptions may apply. 

In addition, data sharing should not be permitted after the submission of a registration dossier under Article 3 of Council Regulation 2019/1692, if a company that has been granted a letter of access, becomes designated, owned/controlled by a designated persons, or the company meets the criteria under letters (a)-(c) of Article 5aa of Council Regulation (EU) No 833/2014.  Exceptions may however apply.

The FAQs also state that EU persons or entities should not represent a designated company or, for example, submit an updated registration dossier pursuant to the REACH Regulation on their behalf, because to do so would be tantamount to making resources available to a designated persons or engaging in a prohibited transaction.  Furthermore, any submission made with a co-registrant that meets the criteria under letters (a)-(c) of Article 5aa of Council Regulation (EU) No 833/2014, would also be prohibited, but exceptions may apply.

The FAQs also confirm that there is an exemption that will allow EU persons or entities to import substances from a person/entity that meets the criteria under letters (a)-(c) of Article 5aa(1) of Council Regulation (EU) No 833/2014 if the transaction is necessary for the purchase, import or transport of pharmaceutical, medical, agricultural and food products, including wheat and fertilizers. Such transactions are allowed as long as the underlying trade in goods is not otherwise restricted under Council Regulation (EU) No 833/2014.  However, the European Commission reiterates that purchasing substances from companies that are designated or owned/controlled under Council Regulation (EU) No 269/2014 (concerning restrictive measures against those who threaten or undermine the territorial integrity or sovereignty of Ukraine) or persons or entities that meet the criteria under letters (a)-(c) of Article 5aa of Council Regulation (EU) No 833/2014, is prohibited even if the company holds a REACH Registration.  However, exceptions may apply.

Frequently Asked Questions – Regulation (EC) No 1907/2009 (REACH Regulation)