Date: 2020-01-15Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2020/29 of 14 January 2020 concerning the non-approval of Vitis vinifera cane tannins as a basic substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Implementing Regulation (EU) 2020/29 of 14 January 2020, concerns the non-approval of Vitis vinifera cane tannins as a basic substance, according to Regulation (EC) No 1107/2009. The decision follows a review and technical report from the European Food Safety Authority (EFSA). The regulation takes effect twenty days after its publication in the Official Journal of the European Union.
Key Points / Main Content:
* **Non-Approval:**
* Vitis vinifera cane tannins is not approved as a basic substance.
* **Basis for Non-Approval:**
* The application did not demonstrate that Vitis vinifera cane tannins meets the criteria of a foodstuff.
* Concerns were identified regarding the lack of toxicological assessment, especially concerning the protection of children and environmental risk.
* No relevant evaluation was available as required by Union legislation.
* Applicants did not submit comments on the technical report or the draft review report.
* **Future Applications:**
* The regulation does not prevent the submission of further applications for approval, in accordance with Article 23(3) of Regulation (EC) No 1107/2009.
* **Enforcement:**
* The regulation is binding and directly applicable in all Member States.
* **Effective Date:**
* The regulation enters into force on the twentieth day following its publication in the Official Journal of the European Union.
Impact Analysis:
* **Applicants (Biomolcules et Biotechnologies Vgtales BBV EA2106 and Institut Technique de l'Agriculture Biologique ITAB):**
* Impact: Their application for approval of Vitis vinifera cane tannins as a basic substance has been rejected.
* Action Required: They must cease any activities relying on the approval of Vitis vinifera cane tannins as a basic substance under the specified regulations. They may submit a new application with additional data addressing the identified concerns.
* **European Commission:**
* Impact: The Commission's initial assessment led to the non-approval, reinforcing regulatory standards for plant protection products.
* Action Required: The Commission must enforce the regulation across all member states and process any potential future applications related to Vitis vinifera cane tannins, should they arise.
* **Member States:**
* Impact: Must adhere to the regulation and ensure that Vitis vinifera cane tannins is not used as a basic substance in plant protection products within their jurisdiction.
* Action Required: Incorporate the regulation into national law and enforce its provisions.
* **Plant Protection Product Manufacturers/Distributors:**
* Impact: They are prohibited from using Vitis vinifera cane tannins as a basic substance in plant protection products.
* Action Required: Reformulate products to comply with the regulation.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: An institution 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 (EC) No 1107/2009: Regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market.
Vitis vinifera cane tannins: A substance derived from grapevine canes, considered for use as a basic substance in plant protection products.
European Food Safety Authority: An agency of the European Union that provides independent scientific advice and communicates on risks associated with the food chain.
Regulation (EC) No 178/2002: Regulation of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety.
Standing Committee on Plants, Animals, Food and Feed: A committee of the European Union that provides opinions on measures related to plant health, animal health, food and feed safety.
Brussels: The de facto capital city of the European Union, where the regulation was adopted.
15.1.2020 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n U nion L 9/1
II
(Non-legislative acts)
REGULATIONS
COMMISSION IMPLEMENTING REGULATION (EU) 2020/29
of 14 January 2020
concerning the non-approval of Vitis vinifera cane tannins as a basic substance in accordance with
Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the
placing of plant protection products on the market
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009
concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and
91/414/EEC(1), and in particular Article 23(5) in conjunction with Article 13(2) thereof,
Whereas:
(1) On 30 June 2017, the Commission received an application from Biomolécules et Biotechnologies Végétales (BBV)
EA2106 and Institut Technique de l’Agriculture Biologique (ITAB) for the approval of Vitis vinifera cane tannins as a
basic substance. That application was accompanied by the information required under the second subparagraph of
Article 23(3) of Regulation (EC) No 1107/2009.
(2) The Commission asked the European Food Safety Authority (‘the Authority’) for scientific assistance. The Authority
provided the Commission with a technical report on Vitis vinifera cane tannins on 2 May 2018(1). The Commission
presented the review report(2) and the draft of this Regulation on the non-approval of Vitis vinifera cane tannins to
the Standing Committee on Plants, Animals, Food and Feed on 24 June 2019 and finalised them for the meeting of
that Committee on 22 October 2019.
(3) The documentation provided by the applicants do not show that Vitis vinifera cane tannins fulfils the criteria of a
foodstuff as defined in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council(3).
(4) Specific concerns were identified, in the technical report of the Authority, regarding Vitis vinifera cane tannins. No
toxicological assessment was available for Vitis vinifera cane tannins used as a plant protection product, especially as
regards the protection of children. This applies to the estimation of the non-dietary exposure risk assessment, in
particular bystanders and residents. Furthermore, there was insufficient information for performing an
environmental risk assessment for the substance.
(5) No relevant evaluation, carried out in accordance with other Union legislation as referred to in Article 23(2) of
Regulation (EC) No 1107/2009, was available.
(1) OJ L 309, 24.11.2009, p. 1.
(1) EFSA (European Food Safety Authority), 2017. Technical report on the outcome of the consultation with Member States and EFSA on
the basic substance application for Vitis vinifera cane tannins for use in plant protection as protectant and repellent. EFSA supporting
publication 2018:EN-1414. 46 pp. doi: 10.2903/sp.efsa.2018.EN-1414.
(2) http://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=activesubstance.selection&language=EN
(3) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles
and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety
(OJ L 31, 1.2.2002, p. 1).L 9/2 E N O f f i c i a l J o u r n a l o f t h e E u r o p e an Union 15.1.2020
(6) The Commission invited the applicants to submit their comments on the technical report of the Authority and on
the Commission’s draft review report. The applicants did not submit comments.
(7) Consequently, as laid down in the Commission’s review report, it has not been established that the requirements laid
down in Article 23 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not to approve Vitis
vinifera cane tannins as a basic substance.
(8) This Regulation does not prejudice the submission of a further application for the approval of Vitis vinifera cane
tannins as a basic substance in accordance with Article 23(3) of Regulation (EC) No 1107/2009.
(9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1
Vitis vinifera cane tannins is not approved as a basic substance.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 14 January 2020.
For the Commission
The President
Ursula VON DER LEYEN