Date: 2019-08-07Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2019/1331 of 5 August 2019 on the terms and conditions of the authorisation of a biocidal product containing peppermint oil and citronellal referred by the United Kingdom in accordance with Article 36(1) of Regulation (EU) No 528/2012 of the European Parliament and Council (notified under document C(2019) 5691) (Text with EEA relevance.)
Issued by European Commission
· Directorate-General for Health and Food Safety
**Executive Summary:**
This Commission Implementing Decision (EU) 2019/1331 addresses objections raised by France and Germany regarding the authorization of the biocidal product "Bird Free," a bird repellent containing peppermint oil and citronellal, initially authorized in the United Kingdom. The European Chemicals Agency (ECHA) issued an opinion on March 1, 2019, regarding these objections. The decision concludes that Bird Free meets the conditions for authorization under Regulation (EU) No 528/2012. The decision was adopted on August 5, 2019, and is addressed to the Member States.
**Key Points / Main Content:**
* **Background:**
* Bird Free, a product to deter feral pigeons, was authorized in the UK, containing peppermint oil and citronellal, which are in Annex I of Regulation EU No 528/2012.
* France and Germany raised objections, stating that the product does not meet the requirements of Article 25 of Regulation (EU) No 528/2012.
* The United Kingdom referred unresolved objections to the Commission on October 31, 2018.
* **Objections:**
* France questioned the product's efficacy and suggested the repellent effect might be due to UV light emission, requiring further testing with a negative control.
* Germany considered the efficacy data unacceptable due to the absence of a control group without active substances, making it unclear if the active substances had a repellent effect on pigeons.
* **ECHA Opinion and Commission Decision:**
* ECHA issued an opinion on March 1, 2019, stating that Bird Free is sufficiently effective.
* The Commission concluded that Bird Free meets the conditions for authorization under Article 25d of Regulation (EU) No 528/2012.
* The decision, BCRG03539731, was adopted on August 5, 2019.
**Impact Analysis:**
* **Member States**
* Impact: The decision is addressed to the Member States, which must acknowledge the decision regarding the authorization of Bird Free.
* Action Required: No specific action outlined.
* **Bird Free Ltd (Applicant)**
* Impact: Confirmation that "Bird Free" meets authorization conditions.
* Action Required: No specific action outlined.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
Commission Implementing Decision EU 2019/1331: An implementing decision of the European Commission regarding the authorization of a biocidal product.
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.
United Kingdom: The Member State that initially authorised the biocidal product 'Bird Free'.
Bird Free: A biocidal product containing peppermint oil and citronellal used to deter feral pigeons.
France: A Member State that raised objections to the authorization of the biocidal product 'Bird Free'.
Germany: A Member State that raised objections to the authorization of the biocidal product 'Bird Free'.
European Chemicals Agency: An agency requested by the Commission to provide an opinion on the unresolved objections regarding the biocidal product 'Bird Free'.
7.8.2019 EN Official Journal of the European Union L 207/37
COMMISSION IMPLEMENTING DECISION (EU) 2019/1331
of 5 August 2019
on the terms and conditions of the authorisation of a biocidal product containing peppermint oil
and citronellal referred by the United Kingdom in accordance with Article 36(1) of Regulation
(EU) No 528/2012 of the European Parliament and Council
(notified under document C(2019) 5691)
(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 2012
concerning the making available on the market and use of biocidal products (1), and in particular Article 36(3) thereof,
Whereas:
(1) On 24 November 2017, the company Bird Free Ltd (‘the applicant’) submitted an application for authorisation of
the biocidal product ‘Bird Free’ under the simplified authorisation procedure to the competent authority of the
United Kingdom. The product was authorised in the United Kingdom on 5 June 2018. ‘Bird Free’ is a bird-
repellent of product-type 19 and the two active substances contained in it, peppermint oil and citronellal, are
included in Annex I of Regulation (EU) No 528/2012 without restrictions.
(2) ‘Bird Free’ is a gel which may be used to deter feral pigeons from roosting on buildings and other structures. In
accordance with Article 27(1) of Regulation (EU) No 528/2012 the authorisation holder notified the Member
States on whose territory it intended to place the product on the market on 12 June 2018.
(3) Pursuant to the first subparagraph of Article 27(2) of Regulation (EU) No 528/2012, France and Germany
referred objections to the coordination group on 12 July 2018, indicating that the contested biocidal product
does not meet the requirements laid down in Article 25 of that Regulation.
(4) In its objection France considers that ‘Bird Free’ seems to repel birds by visual aversion due to UV light emission
and considers that this effect should have been reported in the application. It also considers that an additional
negative control, i.e. testing of a formulation of the product without the active substances is required in order to
ensure that the biocidal effect is caused by the active substances. France questions the efficacy of the active
substances in ‘Bird Free’ because of the low quantities thereof present in the product and the decrease of concen
tration of citronellal during storage of the product. Therefore France considers that new tests should be carried
out in order to demonstrate that the efficacy of ‘Bird Free’ is the result of an olfactory aversion due to the
presence of the active substances.
(5) In its objection Germany considers the efficacy data provided by the applicant not acceptable as the biocidal
product without the active substances was not used in the control groups. Germany considers that without such
a control it cannot be confirmed that the active substances have a repellent effect on pigeons. It also considers
that it is unclear which mode of action is causing the repellent effect.
(6) The coordination group secretariat invited the Member States and the applicant to submit written comments
about the referral. The referral was discussed in the meeting of the coordination group on 25 September 2018
and a teleconference on 12 October 2018.
(7) As no agreement was reached in the coordination group, the United Kingdom referred the unresolved objections
to the Commission pursuant to Article 36(1) of Regulation (EU) No 528/2012 on 31 October 2018. The United
Kingdom thereby provided the Commission with a detailed statement of the matters on which Member States
were unable to reach agreement and the reasons for their disagreement. A copy of that statement was forwarded
to the Member States concerned and the applicant.
(1) OJ L 167, 27.6.2012, p. 1.L 207/38 EN Official Journal of the European Union 7.8.2019
(8) On 27 November 2018, the Commission requested an opinion from the European Chemicals Agency (‘the
Agency’) pursuant to Article 36(2) of Regulation (EU) No 528/2012 on a number of questions concerning the
unresolved objections.
(9) The Agency adopted its opinion (2) on 1 March 2019 after having given the opportunity to the applicant to
provide written comments pursuant to Article 38(2) of Regulation (EU) No 528/2012.
(10) According to the Agency, the biocidal product ‘Bird Free’ is sufficiently effective and therefore meets the
condition for granting an authorisation in accordance with the simplified authorisation procedure laid down in
Article 25(d) of Regulation (EU) No 528/2012.
(11) In light of the opinion of the Agency, the contested biocidal product is considered as sufficiently effective as
required under Article 25(d) of Regulation (EU) No 528/2012.
(12) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on
Biocidal Products,
HAS ADOPTED THIS DECISION:
Article 1
The biocidal product ‘Bird Free’, identified by the case number BC-RG035397-31 in the Register for Biocidal Products,
meets the condition laid down in Article 25(d) of Regulation (EU) No 528/2012.
Article 2
This Decision is addressed to the Member States.
Done at Brussels, 5 August 2019.
For the Commission
Vytenis ANDRIUKAITIS
Member of the Commission
(2) ECHA opinion of 1 March 2019 on a request according to Article 36(2) and 38 of Regulation (EU) No 528/2012 on ‘Questions on
unresolved objection during the notification in accordance with Article 27(1) of the Biocidal Products Regulation of a product type 19
biocidal product “Bird Free” containing peppermint oil and citronellal used to deter feral pigeons’ (ECHA/BPC/224/2019).