BAKGRUNN (fra kommisjonsforordningen)

(1) On 12 January 2021, the Commission received an application from Roullier for the approval of magnesium hydroxide E528 as a basic substance to be used in plant protection as a fungicide on grapevines, olives, banana, oat, rye, triticale, wheat, tomatoes, aubergine, sweet pepper, chili, Physalis sp. and pepino, potatoes, rosebush, ornamental plants, peach, apricot, cherry, plum, nectarine, mirabelle and rice crops. 

(2) After the admissibility checks, revised applications were received in May 2021, April 2022 and in January 2023. The application, as revised in January 2023, was accompanied by the information required under Article 23(3), second subparagraph, of Regulation (EC) No 1107/2009. 

(3) The Commission asked the European Food Safety Authority (ʽthe Authorityʼ) for scientific assistance pursuant to Article 23(4) of Regulation (EC) No 1107/2009. The Authority provided the Commission with a technical report on magnesium hydroxide E528 on 6 March 2023.

(4) The Commission presented the review report and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed, on 12 October 2023 and 11 December 2023, respectively. 

(5) The information provided by the applicant shows that magnesium hydroxide E528 is used as food and feed additive, as an osmotic laxative and antacid for the stomach in medicine, as body deodorant in cosmetics, as fertiliser in agriculture and in several industrial uses. Moreover, it is not predominantly used for plant protection purposes, but the substance is useful in plant protection in a product consisting of the substance. Based on the information provided in the application and the Technical Report from the Authority, it can also be concluded that is not a substance of concern; it does not have an inherent capacity to cause endocrine disrupting, neurotoxic or immunotoxic effects; and it is not placed on the market as a plant protection product. Consequently, magnesium hydroxide E528 meets the conditions set out in Article 23(1) of Regulation (EC) No 1107/2009. 

(6) A Commission Regulation laying down specifications for magnesium hydroxide E528 as an approved food additive was available. This information has been taken into account by the Authority as well as by the Commission in the framework of Article 23(2) of Regulation (EC) No 1107/2009. 

(7) The Commission invited the applicant to submit its comments on the Technical Report of the Authority and on the Commission’s draft review report. The applicant submitted its comments, which have been carefully examined. 

(8) After examination of the application and all related documents, it may be expected that magnesium hydroxide E528 satisfies, in general, the requirements laid down in Article 23 of Regulation (EC) No 1107/2009, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve magnesium hydroxide E528 as a basic substance. 

(9) In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions for the approval. 

(10) In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 should be amended accordingly. 

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