(1)

On 15 July 2013 the Council authorised the Commission to open negotiations with certain other Members of the World Trade Organization under Article XXIV:6 of the General Agreement on Tariffs and Trade (GATT) 1994, in the course of the accession to the European Union of the Republic of Croatia.

(2)

Negotiations have been conducted by the Commission within the framework of the negotiating directives adopted by the Council.

(3)

Those negotiations have been concluded and an Agreement in the form of an Exchange of Letters between the European Union and the Eastern Republic of Uruguay pursuant to Article XXIV:6 and Article XXVIII of GATT 1994 relating to the modification of concessions in the schedule of the Republic of Croatia in the course of its accession to the European Union was initialled on 18 December 2015.

(4)

The Agreement should be signed,

(1)

Commission Regulation (EC) No 333/2007 (2) lays down the methods of sampling and analysis for the official control of levels of certain contaminants in foodstuffs.

(2)

The maximum levels for certain contaminants in food have been established by Commission Regulation (EC) No 1881/2006 (3). Commission Regulation (EU) 2015/1006 (4) amended Regulation (EC) No 1881/2006 to set maximum levels for inorganic arsenic, consequently it is appropriate to lay down specific procedures related to analysis for inorganic arsenic.

(3)

The EN standard 13804 related to the determination of elements and their chemical species has been updated, it is therefore appropriate to update the reference to that standard accordingly.

(4)

The maximum levels for polycyclic aromatic hydrocarbons (PAH) in cocoa beans and derived products have to be established on a fat basis. Proficiency tests performed by the European Union Reference Laboratory for PAH indicate divergences in the determination of the fat content. It is therefore appropriate to harmonise the approach for the determination of the fat content.

(5)

Following advice of the European Union Reference Laboratory for heavy metals in feed and food, it is appropriate to amend the definition of the limit of quantification and the performance criteria related to the limit of detection for the methods of analysis for lead, cadmium, mercury and inorganic tin.

(6)

It is appropriate that the provisions related to the methods of sampling and analysis also apply outside the frame of official controls.

(7)

Regulation (EC) No 333/2007 should therefore be amended accordingly.

(8)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(1)

the title is replaced by the following:

‘Commission Regulation (EC) No 333/2007 of 28 March 2007 laying down the methods of sampling and analysis for the control of the levels of trace elements and processing contaminants in foodstuffs’;

(2)

in Article 1, paragraph 1 is replaced by the following:

(3)

the Annex is amended in accordance with the Annex to this Regulation.

(1)

Commission Regulation (EU) No 1332/2011 (2) requires turbine-powered aeroplanes, with a maximum certificated take-off mass (MCTOM) of more than 5 700 kg or authorised to carry more than 19 passengers to be equipped with a new software version 7.1 of the airborne collision avoidance system (ACAS II) to avoid mid-air collision. This requirement also applies to operators of certain aeroplanes registered in a third country.

(2)

Regulation (EU) No 1332/2011 also requires Union air operators who are subject to Council Regulation (EEC) No 3922/91 (3) to install the new software version 7.1 of ACAS II on their aeroplanes. However, this provision is obsolete as Regulation (EEC) No 3922/91 no longer applies to those operators since its Annex III has been deleted. Commission Regulation (EU) No 965/2012 (4) now applies to those operators instead and contains the necessary rules in this regard. The obsolete provision of Regulation (EU) No 1332/2011 should therefore be deleted.

(3)

Regulation (EU) No 1332/2011 contains rules on operational procedures applicable in situations where ACAS II gives indication to the flight crew recommending a manoeuvre to ensure separation of the aeroplane from all threats or to maintain existing separation (resolution advisory). As those rules are safety-critical both for pilots and controllers, especially as regards the interface between them, they are better addressed in Commission Implementing Regulation (EU) No 923/2012 (5) instead. Therefore, the rules related to such operational procedures set out in Regulation (EU) No 1332/2011 should be deleted.

(4)

Regulation (EU) No 1332/2011 should therefore be amended accordingly.

(5)

The measures provided for in this Regulation are based on the opinion (6) issued by the European Aviation Safety Agency in accordance with Articles 17(2)(b) and 19(1) of Regulation (EC) No 216/2008.

(6)

The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 65 of Regulation (EC) No 216/2008,

(1)

Article 4 is deleted;

(2)

in Article 5, paragraphs 2 and 3 are replaced by the following:

(3)

the Annex is replaced by the text in the Annex to this Regulation.

(1)

Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.

(2)

The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,

(1)

Directive 2011/65/EU prohibits the use of lead, cadmium, hexavalent chromium, and polybrominated diphenyl ethers (PBDE) in electrical and electronic equipment placed on the market.

(2)

Refurbishment practices exists for imaging equipment such as magnetic resonance imaging devices, computer tomography devices, in vitro diagnostic devices, patient monitoring devices, and electron microscopes. Some of the recovered spare parts reused for refurbishment will contain small amounts of lead, cadmium, hexavalent chromium, or PBDE.

(3)

The exemption set out in point 31 of Annex IV to Directive 2011/65/EU does not allow for the use of spare parts recovered from used equipment which was not already placed on the Union market thus limiting the availability of recovered spare parts.

(4)

A comparison of the environmental impacts of using refurbished parts in such cases with the environmental impacts of substituting refurbished parts with new ones demonstrates that the total negative environmental, health and consumer safety impacts of substitution would outweigh the total benefits thereof.

(5)

Considering that the substance restriction will start to apply to the different equipment concerned on different dates as provided for in Article 4(3) of Directive 2011/65/EU, a different expiry date for the exemption should be set for each type of equipment.

(6)

Directive 2011/65/EU should therefore be amended accordingly.

(7)

In order to ensure a smooth transition for market operators from the existing provisions to those specified in this Directive and to prevent single market disruptions, it is appropriate to set a date for the simultaneous application by the Member States of their national provisions which also provides a reasonable period of time after the date of transposition,

(1)

Article 20(3)(g) of Directive 2014/40/EU requires Member States to ensure that electronic cigarettes and their refill containers have a mechanism that ensures refilling without leakage.

(2)

Article 20(13) of Directive 2014/40/EU empowers the Commission to lay down technical standards for the refill mechanism of electronic cigarettes by means of an implementing act.

(3)

In view of the toxicity of the nicotine-containing liquids used in electronic cigarettes and refill containers, it is appropriate to ensure that electronic cigarettes can be refilled in a manner that minimises the risk of dermal contact and accidental ingestion of such liquids.

(4)

On the basis of feedback received from stakeholders and work carried out by an external contractor, technical standards have been identified which are intended to ensure that compliant refill mechanisms provide sufficient protection against leakage.

(5)

The technical standards identified also comprise measures ensuring that consumers are properly informed of how to operate the refill mechanisms in order to ensure leakage-free refilling.

(6)

Stakeholders may wish to provide the Commission with information on alternative mechanisms they have developed to ensure leakage-free refilling, which may lead to this Decision being revised.

(7)

The measures provided for in this Decision are in accordance with the opinion of the Committee referred to in Article 25 of Directive 2014/40/EU,

(1)

The application submitted by the manufacturer Mazda Motor Europe GmbH on 7 July 2015 for the approval of light emitting diodes (LED) lighting, and the application submitted by Honda on 8 January 2016 for the approval of efficient exterior LED lighting have been assessed in accordance with Article 12 of Regulation (EC) No 443/2009, Commission Implementing Regulation (EU) No 725/2011 (2) and the Technical Guidelines for the preparation of applications for the approval of innovative technologies pursuant to Regulation (EC) No 443/2009.

(2)

The information provided in the Mazda and Honda applications demonstrates that the conditions and the criteria referred to in Article 12 of Regulation (EC) No 443/2009 and in Articles 2 and 4 of Implementing Regulation (EU) No 725/2011 have been met. As a consequence, the Mazda and Honda efficient exterior LED lighting should be approved as innovative technologies.

(3)

By Implementing Decisions 2014/128/EU (3), (EU) 2015/206 (4) and (EU) 2016/160 (5) the Commission has approved three applications concerning technologies that contribute to improving the efficiency of exterior lighting systems. Based on the experience gained from the assessment of those applications as well as the Mazdaand Honda applications, it has been satisfactorily and conclusively demonstrated that efficient exterior LED lighting including one or appropriate combinations of efficient exterior LED lights such as the low beam headlamp, high beam headlamp, front position, front fog, rear fog, front turn signal, rear turn signal, licence plate and reversing lamps meet the eligibility criteria referred to in Article 12 of Regulation (EC) No 443/2009 and Implementing Regulation (EU) No 725/2011 and provide a reduction in CO2 emissions of at least 1 g CO2/km as compared to a baseline exterior lighting package including the same combination of vehicle lights.

(4)

It is therefore appropriate to provide manufacturers with the possibility to certify the CO2 savings from efficient exterior LED lighting that satisfy those conditions. In order to ensure that only exterior LED lighting that are compliant with those conditions are proposed for certification, the manufacturer should provide a verification report from an independent verification body confirming the compliance together with the application for certification submitted to the type approval authority.

(5)

If the type approval authority finds that the LED lighting does not satisfy the conditions for certification the application for certification of the savings should be rejected.

(6)

It is appropriate to approve the testing methodology for determining the CO2 savings from exterior LED lighting.

(7)

In order to determine the CO2 savings from an exterior LED lighting, it is necessary to establish the baseline technology against which the efficiency of the LED lighting should be assessed. On the basis of the experience gained, it is appropriate to consider halogen lighting as a baseline technology.

(8)

The savings from an exterior LED lighting may be partially demonstrated by the test referred to in Annex XII to Commission Regulation (EC) No 692/2008 (6). It is therefore necessary to ensure that this partial coverage is taken into account in the testing methodology for CO2 savings from exterior LED lighting.

(9)

In order to facilitate a wider deployment of efficient exterior LED lighting in new vehicles, a manufacturer should also have the possibility to apply for the certification of the CO2 savings from several exterior LED lighting by a single certification application. It is however appropriate to ensure that where this possibility is used a mechanism is applied that incentivises the deployment of only those exterior LED lighting that offer the highest efficiency.

(10)

For the purposes of determining the general eco-innovation code to be used in the relevant type approval documents in accordance with Annexes I, VIII and IX to Directive 2007/46/EC of the European Parliament and of the Council (7), the individual code to be used for the innovative technology for exterior LED lighting should be specified,

(1)

The application submitted by the supplier Valeo Equipments Electriques Moteur on 3 November 2015 for the approval of the Valeo high efficient alternator with high efficiency diodes, and the application submitted by the supplier Robert Bosch GmbH on 10 June 2015 for the approval of the Bosch efficient alternator with MOS gated diodes (MGD) have been assessed in accordance with Article 12 of Regulation (EC) No 443/2009, Commission Implementing Regulation (EU) No 725/2011 (2) and the Technical Guidelines for the preparation of applications for the approval of innovative technologies pursuant to Regulation (EC) No 443/2009.

(2)

The information provided in the Valeo and Bosch applications demonstrates that the conditions and the criteria referred to in Article 12 of Regulation (EC) No 443/2009 and in Articles 2 and 4 of Implementing Regulation (EU) No 725/2011 have been met. As a consequence, the Valeo and Bosch efficient alternators should be approved as innovative technologies.

(3)

By Implementing Decisions 2013/341/EU (3), 2014/465/EU (4), (EU) 2015/158 (5), (EU) 2015/295 (6) and (EU) 2015/2280 (7) the Commission has approved six applications concerning technologies that contribute to improving the efficiency of alternators. Based on the experience gained from the assessment of those applications as well as the Valeo and Bosch applications, it has been satisfactorily and conclusively demonstrated that a 12 Volt (12 V) alternator with a minimum efficiency ranging from 73,4 % to 74,2 %, depending on the powertrain, and a mass not exceeding the mass of the baseline alternator by more than maximum 3 kg meets the eligibility criteria referred to in Article 12 of Regulation (EC) No 443/2009 and Implementing Regulation (EU) No 725/2011 and provides a reduction in CO2 emissions of at least 1 g CO2/km compared to a baseline alternator with an efficiency of 67 %.

(4)

It is therefore appropriate to provide manufacturers with the possibility to certify the CO2 savings from 12 V efficient alternators that meet those conditions. In order to ensure that only alternators that are compliant with those conditions are proposed for certification, the manufacturer should provide a verification report from an independent verification body confirming the compliance together with the application for certification submitted to the type approval authority.

(5)

If the type approval authority finds that the 12 V alternator does not satisfy the conditions for certification, the application for certification of the savings should be rejected.

(6)

It is appropriate to approve the testing methodology for determining the CO2 savings from 12 V efficient alternators.

(7)

In order to determine the CO2 savings from a 12 V efficient alternator, it is necessary to establish the baseline technology against which the efficiency of the alternator should be assessed. On the basis of the experience gained, it is appropriate to consider a 12 V alternator with 67 % efficiency as a baseline technology.

(8)

The savings from a 12 V efficient alternator may be partially demonstrated on the test referred to in Annex XII to Commission Regulation (EC) No 692/2008 (8). It is therefore necessary to ensure that this partial coverage is taken into account in the testing methodology for CO2 savings from 12 V efficient alternators.

(9)

In order to facilitate a wider deployment of 12 V efficient alternators in new vehicles, a manufacturer should also have the possibility to apply for the certification of the CO2 savings from several 12 V efficient alternators by a single certification application. It is however appropriate to ensure that where this possibility is used a mechanism is applied that incentivises the deployment of only those alternators that offer the highest efficiency.

(10)

For the purposes of determining the general eco-innovation code to be used in the relevant type approval documents in accordance with Annexes I, VIII and IX to Directive 2007/46/EC of the European Parliament and of the Council (9), the individual code to be used for the innovative technology for 12 V efficient alternators should be specified,