(1)

Council Directive 2009/117/EC (2) included paraffin oil (CAS 8042-47-5) as an active substance in Annex I to Council Directive 91/414/EEC (3).

(2)

Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

(3)

The approval of the active substance paraffin oil (CAS 8042-47-5), as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 30 November 2026.

(4)

An application for the renewal of the approval of the active substance paraffin oil (CAS 8042-47-5) was submitted to Greece, the rapporteur Member State, and France, the co-rapporteur Member State, in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) and within the time period provided for in that Article.

(5)

The applicant submitted the supplementary dossier required to the rapporteur Member State, the co-rapporteur Member State, the Commission and the European Food Safety Authority (‘the Authority’) in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be admissible by the rapporteur Member State.

(6)

The rapporteur Member State prepared a draft renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the Authority and the Commission on 1 February 2021. In its draft renewal assessment report, the rapporteur Member State proposed to renew the approval of paraffin oil (CAS 8042-47-5).

(7)

The Authority made the supplementary summary dossier available to the public. The Authority also circulated the draft renewal assessment report to the applicant and to the Member States for comments and launched a public consultation on it. The Authority forwarded the comments received to the Commission.

(8)

On 1 July 2024, the Authority communicated to the Commission its conclusion. An updated version of this conclusion was communicated on 17 June 2025 (6). The Authority indicated that, taking into account the approval criteria laid down in Annex II to Regulation (EC) No 1107/2009, plant protection products containing paraffin oil (CAS 8042-47-5) can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

(9)

The Commission presented a renewal report on 1 October 2025 and a draft of this Regulation on 20 January 2026 to the Standing Committee on Plants, Animals, Food and Feed.

(10)

The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with Article 14(1), third subparagraph, of Implementing Regulation (EU) No 844/2012, on the renewal report. The applicant submitted its comments, which have been carefully examined and taken into consideration.

(11)

It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance paraffin oil (CAS 8042-47-5) that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

(12)

Although the risk assessment for the renewal of the approval of the active substance paraffin oil (CAS 8042-47-5) is based on a limited number of representative uses, this does not restrict the uses for which plant protection products containing paraffin oil (CAS 8042-47-5) may be authorised. It is therefore appropriate not to maintain its restriction for use as insecticide and acaricide.

(13)

In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge and the outcome of the risk assessment, it is, however, necessary to provide for certain conditions. It is, in particular, appropriate to require further confirmatory information on the contents of the impurity polycyclic aromatic hydrocarbons (PAHs), in order to address the new technical developments regarding the limit for PAHs in the European Pharmacopoeia and to increase confidence in the conclusion that the potential exposure from PAH is low and that there is no indication of consumer concern.

(14)

Implementing Regulation (EU) No 540/2011 should be amended accordingly.

(15)

Commission Implementing Regulation (EU) 2025/787 (7) extended the approval period of paraffin oil (CAS 8042-47-5) to 30 November 2026 in order to allow the renewal process to be completed before the expiry of the approval period of that active substance. However, given that a decision on renewal has been taken ahead of that extended expiry date, this Regulation should apply earlier than that date.

(16)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,