(1)

Commission Regulation (EU) No 10/2011 (2) lays down specific rules as regards plastic materials and articles intended to come into contact with foods. In particular, Annex I to that Regulation establishes a Union list of substances that may be used in the manufacture of plastic food contact materials and articles.

(2)

Commission Regulation (EU) 2023/1442 (3) revoked the authorisations for the substances ‘wood flour and fibers, untreated’ (FCM No 96) and ‘salicylic acid’ (FCM No 121) as of 1 August 2023. A transitional measure was provided to allow that plastic materials and articles complying with Regulation (EU) No 10/2011 as applicable before the entry into force of Commission Regulation (EU) 2023/1442, which were first placed on the market before 1 February 2025 may remain on the market until the exhaustion of stocks. Furthermore, a transitional measure was also provided to allow the placing on the market of plastic materials and articles manufactured with those substances after 1 February 2025, provided that certain conditions are met. Those conditions include the requirement that an application for authorisation was submitted before 1 August 2024, and that the European Food Safety Authority (‘the Authority’) considered the application valid before 1 February 2025.

(3)

The only application submitted for the authorisation of ‘salicylic acid’ was declared valid by the Authority before 1 February 2025. However, with respect to ‘untreated wood flour or fibers’ from a specific wood species, none of the applicants was able to submit the information that the Authority considers necessary for its risk assessment in accordance with its administrative guidance for the preparation of applications on substances to be used in plastic food contact materials (4).

(4)

After the entry into force of Regulation (EU) 2023/1442, the Authority published a technical report (5) that broadly describes principles that could be applicable to the safety assessment of the use of mixtures of natural origin, such as wood. The timing and nature of the report caused uncertainty regarding the information that the Authority considers necessary for its assessment of ‘untreated wood flour and fibers’. In addition, the report specified that in certain situations analytical tests may be required which, due to their duration, were difficult to complete in time to allow the Authority to consider the applications valid by 1 February 2025, as required by Article 2(3) of Regulation (EU) 2023/1442.

(5)

In the light of the difficulties to submit the information that the Authority considers necessary for its risk assessment in time and given the absence of immediate safety concerns resulting from the use of the ‘untreated wood flour and fibers’ in plastic materials and articles as described in the applications, it is appropriate to amend the date by which the Authority must have considered the application valid for the transitional period to apply, so that applicants have a reasonable, although limited, time to complete their application and that, as intended by Article 2(3) of Regulation (EU) 2023/1442, plastic materials and articles manufactured with ‘untreated wood flour or fibers’ for which an application has been submitted pursuant to that provision may continue to be first placed on the market until a decision is taken on their application.

(6)

It is also appropriate to clarify that plastic materials and articles benefiting from the transitional period may continue to be first placed on the market and remain on the market until the applicant withdraws its application or a decision on that application is taken.

(7)

Regulation (EU) 2023/1442 should therefore be amended accordingly.

(8)

Since the transitional measure amended by this Regulation allows for the first placing on the market of plastic materials and articles manufactured with ‘salicylic acid’ or ‘untreated wood flour or fibers’ after 1 February 2025, this Regulation should apply as of that date in order to ensure the smooth transition sought by that transitional measure.

(9)

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

(1)

paragraph 3 is replaced by the following:

(2)

paragraph 4 is replaced by the following: