New EU Regulation: Shell Powder Removed from List of Plant Protection Products, New Regulation to Take Effect in 2024!

In accordance with Regulation (EU) 2024/2197 of the European Parliament and of the Council (EC) No 1107/2009 on market access for plant protection products, the Commission Implementing Regulation (EU) was promulgated on 4 September 2024. The regulation makes it clear that eggshell powder cannot be approved for use as an essential substance according to regulations.

Commission Implementing Regulation (EU) 2024/2197, published on 4 September 2024, concerning Regulation (EC) No 1107/2009 of the European Parliament and of the Council on Market access for plant protection products, clearly states that eggshell powder is not approved as an essential substance (text relating to the European Economic Area). The Commission, in accordance with the Treaty on the Functioning of the European Union and in the light of Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 on market access for plant protection products and repealing Council Directives 79/117/EEC and 91/414/EEC, In particular the provisions of Articles 13(2) and 23(5).

On 25 June 2020, the European Commission received an application from SAMO (the "Applicant") for approval of eggshell powder as a grapevine bactericide, an essential substance for plant protection. The European Commission received the first revision of the application on 12 September 2021. After a final admissibility check, the application was received on March 4, 2022, with the information required by paragraph 2 of Article 23(3) of Regulation (EC) No 1107/2009.

In accordance with Article 23(2) of Regulation (EC) No 1107/2009, the relevant assessment of other EU legislation has been carried out. The European Food Safety Authority (" the Authority ") peer review of the risk assessment of pesticides has reached a number of conclusions, combined with the different scientific opinions of the ANS, CEP, CONTAM, FAF and NDA Panels of the Authority. These assessments have been taken into account by the Authority and the Board.

In accordance with Article 23(4) of Regulation (EC) No 1107/2009, the Commission requires the Authority to provide scientific assistance. The Authority submitted a technical report on eggshell powder to the Commission on October 31, 2023.

With regard to the characteristics of the products, the Administration noted that the exact parameters of the production process were not yet clear. The Authority states that depending on the temperature applied and the heating time, materials with different compositions and properties (such as pH) will be produced. The main component of the base material (about 50%) is expected to be calcium carbonate/calcium oxide (CaCO3/CaO), in varying proportions depending on the manufacturing process conditions. CaCO3 is an active substance approved under Regulation (EU) No 1107/2009. Based on pH, CaO is classified as category 1 that causes serious injury to the eyes, causes skin irritation, and may cause respiratory irritation.

With regard to human health, the Authority concluded that, based on the specifications provided by the applicant, there may be neurodevelopmental effects, given the lead content in eggshell powder, based on estimates of dietary exposure to consumers (consumers with higher consumption of grapes (children) and consumers of wine grapes (adults). Accordingly, the Authority declared that the intended use of eggshell powder with the proposed lead content specification could not be concluded to be safe. Moreover, according to the Authority, residues of eggshell powder are likely to show up on the berries because the last time eggshell powder was used was when the berries were ripe. The Authority also notes that under EU food Law (5), eggs and their derivatives are required to be labelled with allergens. This will eventually lead to mandatory labelling of food products.

With regard to the environmental impact of eggshell powder, the Authority noted that there was little data in the dossier on exposure to non-target organisms and hazard assessments. Furthermore, for any group of non-target organisms, there is neither a quantitative risk assessment nor a risk assessment based on a reliable evidence weighting approach.

The European Commission presented the review report (6) and the draft Implementing Regulation to the Standing Committee on Plants, Animals, Food and Feed on 22 May 2024 and 10 July 2024 respectively.

The Committee invites the applicant to provide comments on the technical report of the Authority and the review report of the Committee. The applicant submitted comments, which were duly considered.

However, despite the arguments put forward by the applicant, concerns regarding the safety of the use of the substance cannot be eliminated in terms of the protection of human health and the environment.

Therefore, it has not been determined whether the conditions laid down in Article 23 of Regulation (EC) No 1107/2009 have been met. Therefore, it can be properly determined that eggshell powder is not approved as an essential substance.

This Regulation does not prevent the submission of an application for further approval of eggshell powder as an essential substance under Article 23(3) of Regulation (EC) No 1107/2009.

The measures provided for in this Ordinance are based on the advice of the Standing Committee on Plants, Animals, Food and Feed, which has passed this Regulation: Article 1 The substance eggshell powder is not approved as an essential substance. Article 2 This Regulation shall enter into force on the 20th day after its publication in the Official Journal of the European Union.

This Regulation is binding in its entirety and directly applies to all Member States. Brussels, 4 September 2024.