(1)

In accordance with Article 97(2) and (3) of Regulation (EU) No 1308/2013, the Commission has examined the application to register the name ‘Ambt Delden’ as a Protected Designation of Origin (PDO) sent by the Netherlands on 12 February 2016, and has published it in the Official Journal of the European Union (2).

(2)

An objection was received from the Italian Ministry of Agriculture in line with Articles 98 of Regulation (EU) No 1308/2013 and 14 of Commission Regulation (EC) No 607/2009 (3), on 8 May 2018. The Commission deemed the objection admissible according to Article 15 of Regulation (EC) No 607/2009.

(3)

By letter dated 5 July 2018, the Commission forwarded this objection to the Dutch authorities and invited them to submit their related observations within two months, in line with Article 16(1) of Regulation (EC) No 607/2009. The Netherlands sent its observations within the required deadline, on 4 September 2018.

(4)

As provided for in Article 16(1) of Regulation (EC) No 607/2009, the Commission communicated the observations from the Dutch authorities by letter of 2 October 2018 to the objector, the Italian Ministry of Agriculture, who was given two months for possible comments. The Commission received no further reaction from the Italian Ministry of Agriculture.

(5)

In accordance with Article 16(3) of Regulation (EC) No 607/2009, the Commission should take a decision on the basis of the evidence available to it.

(6)

The objector claims that certain vine varieties used for the production of ‘Ambt Delden’, namely ‘Souvignier Gris B’, ‘Pinotin N’, ‘Solaris B’, ‘Regent N’ and ‘Johanniter B’, are obtained from cross-breeding the species Vitis vinifera with other species of the genus Vitis. The objector is of the opinion that this is in clear contradiction with Article 93(1)(a)(iv) of Regulation (EU) No 1308/2013 which lays down that PDO wines must be produced from vine varieties belonging to Vitis vinifera. It also claims that all Member States, like Italy, can classify their wine grape varieties (both those belonging to the species Vitis vinifera and cross-bred varieties) on the basis of precise scientific evidence and data and that in no case a variety obtained from an interspecies cross could be considered as belonging to the species Vitis vinifera.

(7)

The Commission has assessed the arguments provided by the objector and the applicant, and concluded that the name ‘Ambt Delden’ should be registered as Protected Designation of Origin for the following reasons.

(8)

As regards the allegations that the product is not obtained from vine varieties belonging to Vitis vinifera, several elements have to be taken into account. Firstly, there is no harmonised classification of vine varieties belonging to Vitis vinifera at EU level. In addition, there is no reference list or scientific document available from any official competent body, such as the International Organisation of Vine and Wine (OIV), which currently would allow to clearly categorize Vitis vinifera species or a cross between the Vitis vinifera species and other species of the genus Vitis, or to distinguish between them. Against this background, the issue of scientific definition should primarily be addressed in the preliminary national assessment conducted by the Member States in accordance with Article 96 of Regulation (EU) No 1308/2013. For this, the Netherlands rely on the classification included in the Vitis International Variety Catalogue (VIVC) (4), where all five wine grape varieties in question are classified as belonging to Vitis vinifera. Secondly, pursuant to Article 16(3) of Regulation (EC) No 607/2009 regarding the scrutiny of an objection, the Commission shall take any decision to reject or register the designation of origin on the basis of the evidence available to it. In the case at hand the objector refers to the German national register of vine varieties kept by the Bundessortenamt (German Federal Plant Variety Office) and to the information in the VIVC which indicates that all five varieties used for the production of ‘Ambt Delden’ wine were created using a certain degree of crossing between different species of the genus Vitis. Nevertheless, this does not prevent the VIVC website from classifying these five varieties as Vitis vinifera. Lastly, when taking its decisions the Commission has to take into account the principle of non-discrimination. In this regard the Commission notes that currently the wine grape varieties in question are used in production of wines with Protected Designation of Origin in several Member States.

(9)

For the above reasons, it is not possible to conclude that the product referred to by the name ‘Ambt Delden’ is obtained from vine varieties not belonging to Vitis vinifera. The objections made on that ground therefore have to be rejected.

(10)

In the light of the above and in accordance with Article 99 of Regulation (EU) No 1308/2013, the Commission considers that the name ‘Ambt Delden’ should be protected and entered in the register referred to in Article 104 of that Regulation.

(11)

The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets,

(1)

The Danish language version of Commission Implementing Regulation (EU) No 873/2011 (2) contains errors in the table of the Annex as regards a category of products and thus changes the scope of the Regulation.

(2)

The Danish language version of Implementing Regulation (EU) No 873/2011 should therefore be corrected accordingly. The other language versions are not affected.

(3)

The measures provided for in this Regulation are in accordance with the opinion of the Customs Code Committee,

(1)

Directive 2009/48/EC lays down migration limits for aluminium from toys or components of toys. Currently, the limits for aluminium are 5 625 mg/kg for dry, brittle, powder-like or pliable toy material, 1 406 mg/kg for liquid or sticky toy material and 70 000 mg/kg for scraped-off toy material.

(2)

The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) has reviewed the available data on the toxicity of aluminium, taking into account the different tolerable intake levels for aluminium established by the European Food Safety Authority in 2008 (2) and by the Joint FAO/WHO Expert Committee on Food Additives in 2011 (3). The SCHEER considered, in its ‘Final opinion on tolerable intake of aluminium with regard to adapting the migration limits for aluminium in toys’, adopted on 28 September 2017, a tolerable daily intake (TDI) of 0,3 mg/kg body weight per day as an appropriate base for revising the migration limits for aluminium from toys.

(3)

Since children are exposed to aluminium also through sources other than toys, only a certain percentage of the TDI should be allocated to the exposure from toys when calculating the limits. The maximum contribution from toys to the daily intake recommended by the Scientific Committee on Toxicity, Ecotoxicity and the Environment in its 2004 opinion (4) is 10 %. In 2010, this percentage was confirmed by the Scientific Committee on Health and Environmental Risks in its opinion on ‘Risk from organic CMR substances in toys’ (5) and in its opinion on ‘Evaluation of the migration limits for chemical elements in toys’ (6).

(4)

The SCHEER applied 10 % of the TDI, multiplied by the average weight of a child under three years of age (estimated at 7,5 kg) and divided by the daily quantity of toy material ingested. That quantity was estimated at 100 mg/day for dry, brittle, powder-like or pliable toy material, 400 mg/day for liquid or sticky toy material and 8 mg/day for scraped-off toy material. On the basis of that calculation, the SCHEER proposed revised migration limits for aluminium from toys of 2 250 mg/kg for dry, brittle, powder-like or pliable toy material, 560 mg/kg for liquid or sticky toy material and 28 130 mg/kg for scraped-off toy material (‘the proposed migration limits’).

(5)

Compliance with the proposed migration limits can be verified with the test method set out in European standard EN 71-3:2013+A3:2018, the reference of which has been published in the Official Journal of the European Union (7). The proposed migration limits can be easily enforced, since they are several thousand times higher than the lowest concentration that can be reliably quantified with the test method set out in the standard (8).

(6)

In order to advise the Commission in the preparation of legislative proposals and policy initiatives in the area of toy safety, the Commission established the Expert Group on Toys Safety (9). The mission of its subgroup Working Group on chemicals in toys (subgroup Chemicals) is to provide advice to the Expert Group on Toys Safety with regard to chemical substances that may be used in toys.

(7)

The subgroup Chemicals considered, at its meeting on 26 September 2017, that the migration limits proposed by SCHEER were appropriate.

(8)

Market surveillance data on aluminium in toys (10) (11) (12) (13) from approximately 5 800 tests has showed compliance with the proposed migration limits in almost all cases. Data from writing instrument manufacturers on approximately 250 samples (14) has suggested that a substantial part of the writing materials are already compliant with those limits.

(9)

The Expert Group on Toys Safety agreed, at its meeting on 19 December 2017, that the migration limits for aluminium should be amended as proposed.

(10)

In light of the available scientific evidence, the opinion of the SCHEER, the data provided by the Member States and the writing materials industry and the recommendations from the Expert Group on Toys Safety and its subgroup chemicals, it is necessary to adapt the current migration limits for aluminium from toys or components of toys to technical and scientific developments by replacing them with the proposed migration limits.

(11)

Directive 2009/48/EC should therefore be amended accordingly.

(12)

The measures provided for in this Directive are in accordance with the opinion of the Toy Safety Committee,

(1)

In accordance with Article 17 of Regulation (EU) 2016/424 of the European Parliament and of the Council (2), subsystems and safety components for cableway installations which are in conformity with harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, are to be presumed to be in conformity with the essential requirements set out in Annex II to that Regulation covered by those standards or parts thereof.

(2)

By letter M/300 of 15 February 2000 the Commission made a request to the CEN, Cenelec and ETSI for drafting standards for the safety components of installations designed to carry persons in support of Directive 2000/9/EC of the European Parliament and of the Council (3). That Directive was replaced by Regulation (EU) 2016/424 without making amendments to the essential safety requirements.

(3)

On the basis of the request M/300 CEN drafted several harmonised standards related to the safety requirements for cableway installations designed to carry persons. In particular, CEN drafted EN 17064:2018 and revised standards EN 1709:2004, EN 12927-1:2004, EN 12927-3:2004, EN 12927-4:2004, EN 12927-5:2004 and EN 12927-8:2004, replacing them with standards EN 1709:2019 and EN 12927:2019.

(4)

The Commission together with the CEN has assessed whether the standards EN 17064:2018, EN 1709:2019 and EN 12927:2019 drafted by CEN comply with the mandate M/300.

(5)

The standards EN 17064:2018, EN 1709:2019 and EN 12927:2019 satisfy the requirements which they aim to cover and which are set out in Annex II to Regulation (EU) 2016/424. It is therefore appropriate to publish the references of those standards in the Official Journal of the European Union.

(6)

Standard EN 1709:2019 replaces standard EN 1709:2004 and standard EN 12927:2019 replaces standards EN 12927-1:2004, EN 12927-3:2004, EN 12927-4:2004, EN 12927-5:2004 and EN 12927-8:2004. It is therefore necessary to withdraw the references of those standards from the Official Journal of the European Union. In order to give manufacturers sufficient time to prepare for application of standards EN 1709:2019 and EN 12927:2019, it is necessary to defer the withdrawal of the references of the standards that are replaced.

(7)

Compliance with a harmonised standard confers a presumption of conformity with the corresponding essential requirements set out in Union harmonisation legislation from the date of publication of the reference of such standard in the Official Journal of the European Union. This Decision should therefore enter into force on the date of its publication,