(1)

In its Communication to the Council and the European Parliament on a Community Strategy Concerning Mercury (2) the Commission outlined that it is necessary to reduce mercury levels in the environment and human exposure and proposed as objectives, among others, the reduction of entry into circulation of mercury in society by cutting supply and demand, the reduction of mercury emissions and the protection against mercury emissions.

(2)

The strategy was reviewed in 2010 in the Communication from the Commission to the European Parliament and the Council on the review of the community strategy concerning mercury (3), in which the Commission acknowledged that work will continue on the extension of the existing marketing restrictions for certain measuring devices containing mercury to additional devices used in the healthcare sector, in particular sphygmomanometers and for other professional and industrial uses.

(3)

The Council has reaffirmed several times its commitment to the overall objective of protecting human health and the environment from the release of mercury and its compounds by minimising and, where feasible, ultimately eliminating global anthropogenic mercury releases to air, water and land. In this context, the Council underlined that mercury-added products, where viable alternatives exist, should be phased out as rapidly and as completely as possible, with the ultimate goal that all mercury-added products should be phased-out, taking into due account technical and economic circumstances and the needs for scientific research and development (4).

(4)

Mercury and its compounds are highly toxic to humans, ecosystems and wildlife. High doses can be fatal to humans, but even relatively low doses can have serious adverse neurodevelopmental impacts and have also been linked with possible harmful effects on the cardiovascular, immune and reproductive systems. Mercury is considered as a global persistent pollutant, circulating between air, water, sediments, soil and biota in various forms. It can change in the environment into methylmercury, its most toxic form. Methylmercury biomagnifies especially in the aquatic food chain, making the human population and wildlife with a high intake of fish and seafood particularly vulnerable. Methylmercury readily passes both the placental barrier and the blood-brain barrier, inhibiting potential mental development even before birth, making the exposure of women of child-bearing age and children of greatest concern. Mercury and its degradation products, mainly methylmercury, present an equivalent level of concern to persistent, bioaccumulative and toxic substances (PBTs) and have long range transport properties.

(5)

Mercury measuring devices are used widely across Europe, leading to a possible release of mercury to the environment during all the stages of their lifecycle and contributing to the overall emissions of mercury, and thereby also to the exposure of human population and other species via the environment.

(6)

Regulation (EC) No 1907/2006, in entry 18a of Annex XVII, provides for a ban on the placing on the market of fever thermometers containing mercury, as well as other mercury containing measuring devices intended for sale to the general public, and requests the Commission to carry out a review of the availability of reliable safer alternatives that are technically and economically feasible for mercury containing sphygmomanometers and other measuring devices in healthcare and in other professional and industrial uses. On the basis of that review, or as soon as new information on reliable safer alternatives for sphygmomanometers and other measuring devices containing mercury becomes available, the Commission is requested, if appropriate, to present a legislative proposal to extend the restrictions already provided in that entry to sphygmomanometers and other measuring devices in healthcare and in other professional and industrial uses, so that mercury in measuring devices is phased out whenever technically and economically feasible.

(7)

Based on the significant amount of new information collected, the Commission sent the European Chemicals Agency (hereinafter ‘the Agency’) its review report and requested the Agency to prepare a dossier conforming to the requirements of Annex XV to Regulation (EC) No 1907/2006 in accordance with Article 69 of that Regulation.

(8)

The Agency has prepared a dossier proposing to restrict mercury in the following measuring devices used in industrial and professional (including healthcare) applications: mercury containing barometers, hygrometers, manometers, sphygmomanometers, strain gauges used with plethysmographs, tensiometers, thermometers and other non-electrical thermometric applications, mercury metering devices for the determination of softening point and mercury pycnometers. The dossier demonstrates that action on a Union-wide basis is necessary to address the risk to human health and environment posed by the use of mercury in these measuring devices.

(9)

Alternative measuring devices without mercury have become available and show significantly lower associated risks than the health and environmental risks posed by mercury measuring devices.

(10)

For ongoing epidemiological studies using mercury sphygmomanometers the method of measurement should not be changed, therefore a derogation should be granted until these studies are completed. For sphygmomanometers used as reference standard for validation of mercury free devices it was not possible to establish the time needed to develop and recognise as reference standard mercury-free alternatives, therefore the derogation for these devices should be without time limit.

(11)

For thermometers exclusively intended to perform tests according to standards that require the use of mercury thermometers a time period is needed to amend those standards, therefore derogation should be granted for a period of five years. Given that mercury is needed as a reference point in the 1990 International Temperature Scale a derogation should also be granted, without time limit, for mercury triple point cells which are used for the calibration of platinum resistance thermometers.

(12)

For porosimeters, mercury electrodes used in voltammetry and mercury probes used for capacitance voltage determination, feasible alternatives are not yet available, therefore no restriction is proposed for these measuring devices.

(13)

A derogation should be granted to allow the general selling and buying of old, historically valuable mercury measuring devices which can be regarded as antiques or cultural goods. Regulation (EC) No 1907/2006, in entry 18a of Annex XVII, allows the placing on the market of mercury containing measuring devices intended for sale to the general public, other than fever thermometers, if they were more than 50 years old on 3 October 2007. For reasons of clarity, the same age determinants should apply for the exception concerning the old measuring devices used in industrial and professional (including healthcare) applications.

(14)

A derogation should also be granted for measuring devices displayed in exhibitions for cultural and historical purposes, including those that were less than 50 years old on 3 October 2007 but have nevertheless historical and cultural value.

(15)

On 8 June 2011, the Committee for Risk Assessment of the Agency adopted its opinion on the proposed restriction, which it considered as the most appropriate Union-wide measure to address the identified risks in terms of the effectiveness in reducing the risks.

(16)

On 15 September 2011 the Committee for Socioeconomic Analysis of the Agency adopted its opinion on the proposed restriction, which it considered as the most appropriate Union-wide measure to address the identified risks in terms of the proportionality of its socioeconomic benefits to its socioeconomic costs.

(17)

The Agency has submitted to the Commission the opinions of the Committees for Risk Assessment and Socioeconomic Analysis.

(18)

Regulation (EC) No 1907/2006 should therefore be amended accordingly.

(19)

It is appropriate to provide for a reasonable period of time for the stakeholders concerned to take the measures that may be required to comply with the measures set out in this Regulation.

(20)

The measures provided for in this Regulation are in accordance with the opinion of the Committee established under Article 133 of Regulation (EC) No 1907/2006,

(1)

In its Communication to the Council and the European Parliament on a Community Strategy Concerning Mercury (2) the Commission outlined that it is necessary to reduce mercury levels in the environment and human exposure and proposed as objectives, among others, the reduction of entry into circulation of mercury in society, by cutting supply and demand, the reduction of mercury emissions and the protection against mercury emissions. That Communication was reviewed in 2010 (3).

(2)

The Council has reaffirmed several times its commitment to the overall objective of protecting human health and the environment from the release of mercury and its compounds by minimising and, where feasible, ultimately eliminating global anthropogenic mercury releases to air, water and land. In this context, the Council underlined that mercury-added products, where viable alternatives exist, should be phased out as rapidly and as completely as possible, with the ultimate goal that all mercury-added products should be phased-out, taking into due account technical and economic circumstances and the needs for scientific research and development (4).

(3)

Mercury and its compounds are highly toxic to humans, ecosystems and wildlife. High doses can be fatal to humans, but even relatively low doses can have serious adverse neurodevelopmental impacts and have also been linked with possible harmful effects on the cardiovascular, immune and reproductive systems. Mercury is considered as a global persistent pollutant, circulating between air, water, sediments, soil and biota in various forms and can change in the environment into methylmercury, its most toxic form.

(4)

Regulation (EC) No 1907/2006 provides that, if a Member State considers that the manufacture, placing on the market or use of a substance on its own, in a mixture or in an article poses a risk to human health or the environment that is not adequately controlled and needs to be addressed, it shall prepare a dossier after notifying that intention to the European Chemicals Agency (hereinafter ‘the Agency’).

(5)

Pursuant to Decision of the EEA Joint Committee No 25/2008 of 14 March 2008 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement (5), Regulation (EC) No 1907/2006 was incorporated into the Agreement on the European Economic Area.

(6)

Norway has prepared a dossier concerning five phenylmercury compounds, namely phenylmercury acetate, phenylmercury propionate, phenylmercury 2-ethylhexanoate, phenylmercury octanoate and phenylmercury neodecanoate, which demonstrates that action on a Union-wide basis is necessary to address the risk to human health and the environment posed by the manufacture, use and placing on the market of those substances, on their own, in mixtures and articles. That dossier was submitted to the Agency in order to initiate the restriction process.

(7)

The five phenylmercury compounds are known to be used especially as catalysts in polyurethane systems used for coatings, adhesives, sealants and elastomer applications. The mercury catalysts are incorporated into the polymer structure and remain in the final article from which mercury or phenylmercury compounds are not released intentionally. Other phenylmercury compounds are not known to be used as catalysts in polyurethane systems and therefore they were not included in the assessment performed in the dossier.

(8)

The life-cycle of the phenylmercury compounds leads to a significant release of mercury to the environment and adds to the overall emissions of mercury. In particular, the phenylmercury compounds are degraded in the environment and give degradation products, including methylmercury, with equivalent level of concern to persistent, bioaccumulative and toxic substances (PBTs). The interconversion of metabolites of phenylmercury compounds allows for long range transport properties. Therefore as transformation/degradation products with PBT-properties are being generated, the phenylmercury compounds themselves must be treated like PBT-substances with regard to emission and exposure control. To this end, the exposures and emissions to humans and the environment should be minimised as much as possible.

(9)

The main exposure to humans via the environment may be through food, in which the phenylmercury compounds degradation products, including methylmercury, may be found. Methylmercury biomagnifies especially in the aquatic food chain, making human population and wildlife with a high intake of fish and seafood particularly vulnerable. Methylmercury readily passes both the placental barrier and the blood-brain barrier, inhibiting potential mental development even before birth, making the exposure of women of child-bearing age and children of greatest concern.

(10)

On 10 June 2011, the Committee for Risk Assessment of the Agency (RAC) adopted its opinion on the proposed restriction, taking into account its effectiveness in reducing the risks to human health and the environment. Moreover, RAC identified that other organomercury compounds might be used as catalysts in the polymer production. However, these substances were not included in the assessment performed in the dossier.

(11)

On 15 September 2011 the Committee for Socioeconomic Analysis of the Agency adopted its opinion on the proposed restriction, taking into account its effectiveness in addressing the identified risks in terms of the proportionality of its socioeconomic benefits to its socioeconomic costs.

(12)

The Agency has submitted to the Commission the opinions of the Committees for Risk Assessment and Socioeconomic Analysis.

(13)

It is appropriate to provide for a reasonable period of time for the stakeholders concerned to take the measures that may be required to comply with the measures set out in this Regulation.

(14)

The measures provided for in this Regulation are in accordance with the opinion of the Committee established under Article 133 of Regulation (EC) No 1907/2006,

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.

(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of citric acid, sorbic acid, thymol and vanillin. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(3)

The application concerns the authorisation of a preparation of citric acid, sorbic acid, thymol and vanillin as a feed additive for chickens for fattening, chickens reared for laying, all minor avian species for fattening and reared for laying and all minor porcine species (weaned), to be classified in the additive category ‘zootechnical additives’.

(4)

The use of a preparation of citric acid, sorbic acid, thymol and vanillin was authorised for 10 years as a feed additive for use in weaned piglets by Commission Regulation (EU) No 1117/2010 (2).

(5)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 25 May 2012 (3) that under the proposed conditions of use, the preparation of citric acid, sorbic acid, thymol and vanillin set out in the Annex does not have an adverse effect on animal health, human health or the environment, and that this additive has the potential to improve performance of the target species. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(6)

The assessment of that preparation shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this preparation should be authorised as specified in the Annex to this Regulation.

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

(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)

Regulation (EC) No 533/2007 opened tariff quotas for imports of poultrymeat products.

(2)

The applications for import licences lodged during the first seven days of September 2012 for the subperiod from 1 October to 31 December 2012 relate, for some quotas, to quantities exceeding those available. The extent to which import licences may be issued should therefore be determined by establishing the allocation coefficient to be applied to the quantities requested,

(1)

Regulation (EC) No 539/2007 opened tariff quotas for imports of egg products and egg albumin.

(2)

The applications for import licences lodged during the first seven days of September 2012 for the subperiod from 1 October to 31 December 2012 relate, for some quotas, to quantities exceeding those available. The extent to which import licences may be issued should therefore be determined by establishing the allocation coefficient to be applied to the quantities requested,

(1)

On 16 September 2010 the European Central Bank (ECB) adopted Decision ECB/2010/14 on the authenticity and fitness checking and recirculation of euro banknotes (1), which lays down common rules and procedures protecting the integrity of euro banknotes as a means of payment.

(2)

In particular, the scope of Decision ECB/2010/14 needs to be amended to cover current and future series of euro banknotes thereby ensuring that the euro banknotes in circulation are genuine and fit and that suspect counterfeit euro banknotes are detected and handed over to the competent national authorities. To this end, a number of technical amendments to the annexes to Decision ECB/2010/14 should be made.

(3)

The minimum standards for automated fitness checking of euro banknotes, as set out in Annex IIIa to Decision ECB/2010/14, constitute requirements applying to the functionalities of banknote handling machines. They are therefore only of interest to manufacturers of banknote handling machines and have no impact on the authenticity and fitness checking procedures laid down in Decision ECB/2010/14, with which cash handlers have to comply. As they are outside the scope of Decision ECB/2010/14, the minimum standards for automated fitness checking should be integrated into the rules and procedures for the testing of banknote handling machines, data collection and monitoring.

(4)

In the light of experience gained in relation to Decision ECB/2010/14 it is necessary to improve some of the rules and procedures for reasons of clarity and efficiency.

(5)

Decision ECB/2010/14 should therefore be amended accordingly,

(1)

in Article 2, the following definition is added:

(*1)   OJ L 78, 25.3.2003, p. 16.’;"

(2)

in Article 3, paragraph 5 is replaced by the following:

(3)

Article 6 is replaced by the following:

(4)

in Article 8, paragraph 4 is replaced by the following:

(5)

in Article 9, paragraph 3 is replaced by the following:

(6)

in Article 10, paragraph 3 is replaced by the following:

(7)

Article 13 is replaced by the following:

(8)

Annexes I, IIa, IIb, IIIa, IIIb and IV are amended in accordance with the Annex to this Decision.