Introduction

The European Union being considered as Party to the two international instruments for persistent organic pollutants, the POP Convention and the POP Protocol, had published the POP regulation (Regulation (EU) 2019/1021) in order to implement these two international instruments in the Union.

In order to be able to relevantly  manage the substances subject to the POP convention (and protocol) in European legislation, the European Commission has prepared an understanding document on the link between the POP convention and protocol and the REACH regulation (Regulation (EC) 1907/2006). The understanding document thus represents the interaction between the two European regulations POP and REACH, in particular concerning restrictions and authorisations under REACH.

Depending on the substances’ situation regarding the restriction or authorisation procedures REACH and the POP Regulation, this can have various consequences on how to deal with them. The information below presents a summary of the situations and consequences mentioned in the understanding document prepared by the European Commission.

Restriction procedure under REACH

In this first case, several situations can arise:

  • Any change in the annexes of the POP Convention must be reproduced in the annexes of the POP Regulation.
  • When a substance is listed in the POP Regulation, REACH can no longer be used to modify the measures taken under the POP Regulation.
  • A total ban of a substance in the POP Convention, followed by the amendment of the annexes of the POP Regulation, means that the preparation of a restriction proposal under REACH (article 69 REACH) is no longer possible. Risks to human health and/or the environment will be adequately controlled by the measures of the POP Convention, and thus by the POP Regulation. Further measures under REACH are therefore no longer necessary.
  • In case that exemptions are set out by the POP Convention, the EU can implement the Convention more strictly under the POP Regulation. This is done on the basis of a risk analysis under REACH following the submission of an Annex XV dossier which must be confirmed by the opinions of the Risk Assessment Committee (RAC) and the Socio-economic Analysis Committee (SEAC).

Once a substance is listed in the annexes of the POP Regulation, it is removed from the list of restrictions of the REACH Regulation (annex XVII).

Examples of substances: Perfluorooctane sulfonic acid and its derivatives (PFOS), Pentabromodiphenyl ether, Alkanes, C10-13, chloro (short chain chlorinated paraffins).

The action to be taken will depend on whether the substance is listed in the POP Convention and whether it is listed there before or immediately after the initiation of a restriction procedure under REACH. But as soon as the substance is listed in the annexes of the POP convention, the REACH restriction must be removed.

Note:  Listing a substance in one of the annexes to the POP Convention takes a minimum of three and a half years or more. A REACH restriction can be concluded in less than three years with an amendment to Annex XVII. Even if a proposal for inclusion in the POP Convention has been submitted, at the same time initiating a restriction procedure under REACH may be beneficial in order to lead more quickly to measures to protect human health and/or environment within the EU.

Authorisation procedure under REACH

In this first case, several situations can arise:

  • If all uses of a substance have been prohibited in accordance with the Title VIII (restrictions) of REACH Regulation or by other European legislation, such as the POP Regulation for example, this substance will not be included in the Authorisation list of REACH or will be withdrawn (Article 58(7) of REACH).
  • The POP Convention and the POP Regulation do not prohibit all uses of a substance and certain exemptions exist. If a substance, already regulated by the POP Regulation, is on the REACH authorisation list, the authorisations that can be granted under REACH must be aligned to the uses exempted under the POP Regulation.
  • The risks of uses exempted under the POP Regulation must be taken into account during the preparation of an application for authorisation.

The REACH authorisation requirements should not be superimposed on the provisions of the POP Regulation. A fair balance must therefore be found between rapid implementation by the EU of the inclusion of a new substance in the POP Convention and safeguarding the legitimate interests of applicants and holders of an authorisation for the substances concerned.

A. If the inclusion of a new substance in the POP Convention is adopted before the sunset date appearing in the Authorisation list, thereof:

  • In accordance with article 61(6) REACH, the Commission withdraws an authorisation for the use of this substance if this use is subsequently prohibited in the POP Regulation. REACH therefore gives priority to decisions taken within the framework of the POP Convention and implemented by the POP Regulation.
  • Once the use is prohibited in the POP Regulation, not only all existing authorisations are withdrawn, but all applications for authorisation must also be refused.

B. The inclusion in the POP Convention is adopted after the expiration date and the decision to grant or refuse authorisation requests has already been taken. With regard to the authorisations granted, there are two possibilities:

  • The POP Convention does not exempt any use.
  • The POP Convention creates exemptions for certain uses.

The procedure for including a substance from the Candidate list to the REACH Authorisation list takes approximately two years with a transition period of at least three additional years. The procedure for including a substance in the POP Convention, on the other hand, takes at least three and a half years.

Since the procedure for inclusion of a substance in the POP Convention is shorter than the REACH authorisation procedure, there is a low probability that a substance will be recommended for inclusion in the Authorisation list if a proposal for its inclusion in the POP Convention has already been initiated.