Date: 2022-09-08Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2022/1489 of 7 September 2022 postponing the expiry date of the approval of spinosad for use in biocidal products of product-type 18 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
This Commission Implementing Decision (EU) 2022/1489 postpones the expiry date of the approval of spinosad for use in biocidal products of product-type 18. The original expiry date was October 31, 2022, and the new expiry date is April 30, 2025. This postponement is due to pending applications for renewal and the time required for evaluation and opinion.
Key Points / Main Content:
* **Subject of the Decision:** Postponement of the expiry date for the approval of spinosad.
* **Active Substance:** Spinosad, approved for use in biocidal products of product-type 18.
* **Original Approval Context:** Annex I to Directive 98/8/EC.
* **New Expiry Date:** April 30, 2025.
* **Reason for Postponement:**
* Renewal applications were submitted under Article 13(1) of Regulation (EU) No 528/2012.
* A full evaluation of the applications is necessary, according to Article 14(1) of Regulation (EU) No 528/2012.
* The evaluation process requires time for data provision, evaluation by the competent authority, and an opinion from the European Chemicals Agency.
* **Continued Approval:** Spinosad remains approved under the conditions set out in Annex I to Directive 98/8/EC until the new expiry date.
* **Entry into Force:** The decision takes effect twenty days after its publication in the Official Journal of the European Union.
Impact Analysis:
**Applicants for Renewal:**
* Impact: Benefits from extended approval period allowing completion of the renewal process.
* Action Required: Continue to cooperate with the evaluating competent authority by providing any necessary data.
**Evaluating Competent Authority (Netherlands):**
* Impact: Responsible for the full evaluation of the renewal applications.
* Action Required: Perform the full evaluation of the applications within the stipulated timeframe, potentially requesting additional data from the applicants.
**European Chemicals Agency:**
* Impact: Required to prepare and submit an opinion on the renewal of the approval of spinosad to the Commission.
* Action Required: Prepare and submit the opinion within 270 days of receiving a recommendation from the evaluating competent authority.
**European Commission:**
* Impact: Responsible for making a decision on the renewal of the approval of spinosad.
* Action Required: Examine the applications and the opinion from the European Chemicals Agency to decide on the renewal.
**Manufacturers and Distributors of Biocidal Products Containing Spinosad:**
* Impact: Can continue to market and use products containing spinosad for product-type 18 until April 30, 2025, subject to existing conditions.
* Action Required: Ensure continued compliance with the conditions set out in Annex I to Directive 98/8/EC.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: An executive branch of the European Union responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU.
Regulation (EU) No 528/2012: A regulation of the European Parliament and of the Council concerning the making available on the market and use of biocidal products.
European Parliament: The directly elected parliamentary assembly of the European Union.
Council of the European Union: One of two legislative bodies of the European Union and representing the governments of the EU member states.
spinosad: An active substance used in biocidal products of product-type 18, the approval of which is being discussed in the document.
Directive 98/8/EC: A directive of the European Parliament and of the Council concerning the placing of biocidal products on the market.
Brussels: The de facto capital city of the European Union, located in Belgium, where the decision was adopted.
8.9.2022 EN Official Journal of the European Union L 233/89
COMMISSION IMPLEMENTING DECISION (EU) 2022/1489
of 7 September 2022
postponing the expiry date of the approval of spinosad for use in biocidal products of product-type
18 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012concerning
the making available on the market and use of biocidal products(1), and in particular Article 14(5) thereof,
After consulting the Standing Committee on Biocidal Products,
Whereas:
(1) Spinosad was included in Annex I to Directive 98/8/EC of the European Parliament and of the Council(2) as an
active substance for use in biocidal products of product-type 18. Pursuant to Article 86 of Regulation (EU)
No 528/2012, it is therefore considered approved under that Regulation subject to the conditions set out in Annex
I to Directive 98/8/EC.
(2) The approval of spinosad for use in biocidal products of product-type 18 (‘the approval’) is to expire on 31 October
2022. On 27 April 2021and 28 April 2021, two applications were submitted in accordance with Article 13(1) of
Regulation (EU) No 528/2012 for the renewal of the approval (‘the applications’).
(3) On 13 September 2021, the evaluating competent authority of the Netherlands informed the Commission that it
had decided, pursuant to Article 14(1) of Regulation (EU) No 528/2012, that a full evaluation of the applications
was necessary. Pursuant to Article 8(1) of that Regulation, the evaluating competent authority is to perform a full
evaluation of the applications within 365 days of their validation.
(4) The evaluating competent authority may, as appropriate, require the applicants to provide sufficient data to carry out
the evaluation, in accordance with Article 8(2) of Regulation (EU) No 528/2012. In that event, the 365-day period is
suspended for a period that may not exceed 180 days in total unless a longer suspension is justified by the nature of
the data requested or by exceptional circumstances.
(5) Within 270 days of receipt of a recommendation from the evaluating competent authority, the European Chemicals
Agency is to prepare and submit to the Commission an opinion on renewal of the approval of the active substance in
accordance with Article 14(3) of Regulation (EU) No 528/2012.
(6) Consequently, for reasons beyond the control of the applicants, the approval is likely to expire before a decision has
been taken on its renewal. It is therefore appropriate to postpone the expiry date of the approval for a period of time
sufficient to enable the examination of the applications. Taking into account the time-limits for the evaluation by the
evaluating competent authority and for preparation and submission by the European Chemicals Agency of its
opinion, and the time needed to decide whether the approval of spinosad for use in biocidal products for product-
type 18 may be renewed, the expiry date should be postponed to 30 April 2025.
(7) After the postponement of the expiry date of the approval, spinosad remains approved for use in biocidal products
of product-type 18 subject to the conditions set out in Annex I to Directive 98/8/EC,
(1) OJ L 167, 27.6.2012, p. 1.
(2) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on
the market (OJ L 123, 24.4.1998, p. 1).L 233/90 EN Official Journal of the European Union 8.9.2022
HAS ADOPTED THIS DECISION:
Article 1
The expiry date of the approval of spinosad for use in biocidal products of product-type 18 set out in Annex I to Directive
98/8/EC is postponed to 30 April 2025.
Article 2
This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.
Done at Brussels, 7 September 2022.
For the Commission
The President
Ursula VON DER LEYEN