(1)

Annex III to Regulation (EC) No 1210/2003 lists public bodies, corporations and agencies and natural and legal persons, bodies and entities of the previous government of Iraq covered by the freezing of funds and economic resources that were located outside Iraq on the date of 22 May 2003 under that Regulation.

(2)

On 28 September 2018, the Sanctions Committee of the United Nations Security Council decided to remove one entry from the list of persons or entities to whom the freezing of funds and economic resources should apply.

(3)

Annex III to Regulation (EC) No 1210/2003 should therefore be amended accordingly,

(1)

On 16 December 2014, the company Merck KGaA (‘the applicant’) submitted an application for mutual recognition in parallel of two insect repellents applied on humans against mosquitoes and ticks containing the active substance ethyl butylacetylaminopropionate in the form of a pump spray and an aerosol, respectively (‘the contested products’) to the competent authority of Belgium (‘the reference Member State’) in accordance with Article 34(1) of Regulation (EU) No 528/2012. At the same time, the applicant submitted applications for mutual recognition of the contested products to a number of Member States, including the United Kingdom, in accordance with Article 34(2) of that Regulation.

(2)

Pursuant to Article 35(2) of Regulation (EU) No 528/2012, the United Kingdom referred objections to the coordination group on 14 February 2017 and to the applicant, indicating that the contested products do not meet the conditions laid down in Article 19(1)(b) of that Regulation.

(3)

The United Kingdom considers that the assessment of the applications has not been correctly carried out by the reference Member State, since there is a discrepancy between the application rate used in the efficacy studies and the application rate used in the exposure assessment, which is lower (‘the discrepancy’).

(4)

The coordination group secretariat invited the other Member States concerned and the applicant to submit written comments about the referral. Denmark, Germany, Latvia and the applicant submitted comments. The referral was also discussed in the coordination group's meetings of 14 March 2017 and 10 May 2017.

(5)

As no agreement was reached in the coordination group, the reference Member State referred the unresolved objection to the Commission pursuant to Article 36(1) of Regulation (EU) No 528/2012 on 18 July 2017. It hereby 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.

(6)

The reference Member State, Austria, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, Latvia, Lithuania, Malta, The Netherlands, Spain and Sweden authorised the relevant contested product in the period from 16 May 2017 to 6 March 2018, pursuant to Article 34(7) of Regulation (EU) No 528/2012.

(7)

On 7 September 2017, 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 discrepancy.

(8)

The Agency (the Biocidal Products Committee) adopted its opinion (2) on 12 December 2017.

(9)

According to the Agency, the approach followed by the reference Member State, namely to accept the discrepancy, is not appropriate when verifying whether the conditions in Article 19(1)(b) of Regulation (EU) No 528/2012 are satisfied. The Agency considers that either the available information is not sufficient to demonstrate that the contested products, when used at the lower application rates, are sufficiently effective or unacceptable effects on the health of humans are identified, when the contested products are used at the higher application rates derived from the efficacy studies.

(10)

The Agency emphasises in its opinion the general principle that the application rate proven efficacious should be considered for the exposure assessment. Using the application rate derived from the efficacy studies in the exposure assessment for the contested products results in an unacceptable risk for human health with regard to a number of the intended uses.

(11)

In light of the opinion of the Agency, the condition laid down in Article 19(1)(b)(iii) of Regulation (EU) No 528/2012 cannot be considered to be met for any of the intended uses of the aerosol contested product, nor for the intended use of the pump spray contested product for infants under one year of age. Such uses can therefore only be authorised in accordance with Article 19(5) of that Regulation in those Member States in which the condition laid down in the first subparagraph of Article 19(5) is met.

(12)

However, pursuant to point 77 of Annex VI to Regulation (EU) No 528/2012, the recommended application rate should be the minimum necessary to achieve the desired effect. An unnecessarily high application rate would be inconsistent with the principle of proper use referred to in the second subparagraph of Article 17(5) of that Regulation.

(13)

The Agency also points out in its opinion that there is no precise agreed Union guidance on how to generate efficacy data for insect repellents when using the recommended application rates. Work on developing such Union guidance has already started but time to conclude is needed in order to enable applicants to generate data to demonstrate the efficacy of a product in a predictable manner.

(14)

The Agency refers in its opinion to an agreement reached by the coordination group in accordance with Article 35(3) of Regulation (EU) No 528/2012 on certain other insect repellents containing a different active substance (3). For those products, the discrepancy was accepted by all Member States concerned under the condition that it would be addressed when the product authorisations are renewed and new Union guidance is available. It is also mentioned in the opinion that this precedent may have led to a misunderstanding by the applicant and the reference Member State regarding the efficacy data requirements for insect repellents.

(15)

Pursuant to Article 22(1) of Regulation (EU) No 528/2012, an authorisation of a biocidal product shall stipulate the terms and conditions relating to the making available on the market and use of the product. Those terms and conditions may include a requirement for the authorisation holder to provide additional information and, where relevant, to submit an application for a change of the authorisation in accordance with Commission Implementing Regulation (EU) No 354/2013 (4) within a given deadline.

(16)

It is necessary to maintain sufficient availability of insect repellents containing different active substances to minimise the occurrence of resistance in the target harmful organisms and a level playing field with regard to the generation of efficacy data at the recommended application rate should apply for all applicants and/or authorisation holders, irrespective of the involved active substances in their products. The recommended application rate should be the minimum necessary to achieve the desired effect of the insect repellent in accordance with the principle of proper use.

(17)

Consequently, authorisations of the contested products should include a condition that the authorisation holder provides new data to confirm the efficacy of the products at the proposed application rate when Union guidance on how to generate efficacy data at the recommended application rates has been published by the Agency. The authorisation holder should be allowed sufficient time to generate the new data in accordance with that guidance.

(18)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products,

(1)

The European List of ship recycling facilities (‘the European List’) was established by Commission Implementing Decision (EU) 2016/2323 (2) and has been amended by Commission Implementing Decision (EU) 2018/684 (3).

(2)

The United Kingdom has informed the Commission that a ship recycling facility located in its territory has been authorised by the competent authority in accordance with Article 14 of Regulation (EU) No 1257/2013 and has provided the Commission with all information necessary for that facility to be included in the European List.

(3)

The authorisation of two ship recycling facilities located in Poland expired on 28 April 2018 and the Commission has not received information from Poland that the authorisations granted to those facilities to conduct ship recycling have been, or would be, renewed. Therefore, the two facilities no longer meet the requirements set out in Article 13(1)(a) of Regulation (EU) No 1257/2013 and should be removed from the European List in accordance with point (ii) of Article 16(4)(b) of Regulation (EU) No 1257/2013.

(4)

It is therefore appropriate to amend Implementing Decision (EU) 2016/2323.

(5)

As regards ship recycling facilities located in a third country for which an application for inclusion in the European List has been submitted to the Commission in accordance with Article 15 of Regulation (EU) No 1257/2013, the assessment of the relevant information and supporting evidence provided or gathered is still ongoing. The Commission is to adopt implementing acts pertaining to those ship recycling facilities located outside the Union once the assessment is finalised.

(6)

The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 25 of Regulation (EU) No 1257/2013,

(1)

The active substance sulfuryl fluoride was included into Annex I to Directive 98/8/EC of the European Parliament and of the Council (2) for use in biocidal products of product-type 8, and pursuant to Article 86 of Regulation (EU) No 528/2012 is therefore considered approved under that Regulation subject to the specifications and conditions set out in Annex I to that Directive.

(2)

The approval of sulfuryl fluoride for use in biocidal products of product-type 8 will expire on 31 December 2018. In accordance with Article 13(1) of Regulation (EU) No 528/2012, an application has been submitted for the renewal of the approval of this active substance on 28 June 2017.

(3)

The evaluating competent authority of Sweden has informed the Commission services on 14 February 2018 on its decision pursuant to Article 14(2) of Regulation (EU) No 528/2012 that a full evaluation will have to be performed. A 365-day period is allowed to perform a full evaluation pursuant to Article 8(1) of that Regulation. During the evaluation, the evaluating competent authority may, as appropriate, request the applicant to provide sufficient data to carry out the evaluation, in accordance with Article 8(2) of that Regulation. In such case, the 365-day period is suspended for a period that may not exceed 180 days in total unless it is justified by the nature of the data requested or by exceptional circumstances.

(4)

Within 270 days of receipt of a recommendation from the evaluating competent authority, the European Chemicals Agency (‘the 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.

(5)

Consequently, for reasons beyond the control of the applicant, the approval of sulfuryl fluoride for use in biocidal products of product-type 8 is likely to expire before a decision has been taken on its renewal. It is therefore appropriate to postpone the expiry date of approval of sulfuryl fluoride for use in biocidal products of product-type 8 for a period of time sufficient to enable the examination of the application. Considering the periods of time allowed for the evaluation by the evaluating competent authority and for the preparation and submission of the opinion by the Agency, it is appropriate to postpone the expiry date of approval to 30 June 2021.

(6)

Except for the expiry date of the approval, sulfuryl fluoride should remain approved for use in biocidal products of product-type 8 subject to the specifications and conditions set out in Annex I to Directive 98/8/EC,