(1)

Council Regulation (EU) No 40/2013 of 21 January 2013 fixing for 2013 the fishing opportunities available in EU waters and, to EU vessels, in certain non-EU waters for certain fish stocks and groups of fish stocks which are subject to international negotiations or agreements (2), lays down quotas for 2013.

(2)

According to the information received by the Commission, catches of the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein have exhausted the quota allocated for 2013.

(3)

It is therefore necessary to prohibit fishing activities for that stock,

(1)

Council Regulation (EU) No 39/2013 of 21 January 2013 fixing for 2013 the fishing opportunities available to EU vessels for certain fish stocks and groups of fish stocks which are not subject to international negotiations or agreements (2), lays down quotas for 2013.

(2)

According to the information received by the Commission, catches of the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein have exhausted the quota allocated for 2013.

(3)

It is therefore necessary to prohibit fishing activities for that stock,

(1)

Council Regulation (EU) No 39/2013 of 21 January 2013 fixing for 2013 the fishing opportunities available to EU vessels for certain fish stocks and groups of fish stocks which are not subject to international negotiations or agreements (2), lays down quotas for 2013.

(2)

According to the information received by the Commission, catches of the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein have exhausted the quota allocated for 2013.

(3)

It is therefore necessary to prohibit fishing activities for that stock,

(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. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

(2)

The feed additives cobaltous chloride hexahydrate, cobaltous nitrate hexahydrate and cobaltous sulphate monohydrate were authorised without a time limit by Directive 70/524/EEC as compounds of the trace element Cobalt and the conditions for their authorisation were last set out in Commission Regulation (EC) No 1334/2003 (3). Those feed additives were subsequently entered in the Community Register of Feed Additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

(3)

No applications for authorisation in accordance with Article 10(2) of Regulation (EC) No 1831/2003 were submitted before the deadline provided for in that provision for the use of those feed additives belonging to the group of trace elements.

(4)

Those feed additives should therefore be withdrawn from the market.

(5)

As a consequence of the withdrawal of those feed additives, it is necessary to delete them from the ‘E3 Cobalt-Co’ entry of the Annex to Regulation (EC) No 1334/2003. Regulation (EC) No 1334/2003 should therefore be amended accordingly.

(6)

It is appropriate to allow a transitional period for interested parties within which existing stocks of the additives to be withdrawn from the market, premixtures, compound feed and feed materials which have been produced with those additives may be used up.

(7)

The withdrawal from the market of the three products is without prejudice to the granting of an authorisation concerning them or to the adoption of a measure concerning their status in accordance with Regulation (EC) No 1831/2003.

(8)

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)

In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For potassium thiocyanate the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2005/751/EC (3).

(2)

In accordance with Article 6(2) of Directive 91/414/EEC the Netherlands received on 6 September 2004 an application from Koppert Beheer B.V. for the inclusion of the active substance potassium thiocyanate in Annex I to Directive 91/414/EEC. Decision 2005/751/EC confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

(3)

For that active substance, the effects on human and animal health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 27 July 2007. In accordance with Article 11(6) of Commission Regulation (EU) No 188/2011 (4) additional information was requested from the applicant. The applicant informed on 30 May 2011 that no additional information was available.

(4)

The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’). The Authority presented to the Commission its conclusion on the pesticide risk assessment of the active substance potassium thiocyanate (5) on 22 October 2012. The Authority identified several data gaps that would have required further contributions from the applicant. By letter of 27 September 2013 Koppert B.V. withdrew its application for the approval of potassium thiocyanate.

(5)

In accordance with Article 8(1)(b) of Directive 91/414/EEC, Member States were given the possibility to grant provisional authorisations for plant protection products containing potassium thiocyanate for an initial period of three years. Commission Decision 2010/457/EU (6) allowed Member States to extend provisional authorisations for potassium thiocyanate for a period ending on 31 August 2012 at the latest. Commission Implementing Decision 2012/363/EU (7) allowed Member States to extend provisional authorisations for potassium thiocyanate for a period ending on 31 July 2014 at the latest.

(6)

Due to the withdrawal of the application, potassium thiocyanate should therefore not be approved pursuant to Article 13(2) of Regulation (EC) No 1107/2009.

(7)

Existing provisional authorisations should, consequently, be withdrawn and no new authorisations be granted.

(8)

Member States should be provided with time to withdraw authorisations for plant protection products containing potassium thiocyanate.

(9)

For plant protection products containing potassium thiocyanate, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, this period should expire at the latest 18 months after the entry into force of this Regulation.

(10)

This Regulation does not prejudice the submission of a further application for potassium thiocyanate pursuant to Article 7 of Regulation (EC) No 1107/2009.

(11)

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)

According to Article 126 of the Treaty on the Functioning of the European Union (TFEU) Member States are to avoid excessive government deficits.

(2)

The Stability and Growth Pact (SGP) is based on the objective of sound government finances as a means of strengthening the conditions for price stability and for strong sustainable growth conducive to employment creation.

(3)

The excessive deficit procedure (EDP) under Article 126 TFEU, as clarified by Council Regulation (EC) No 1467/97 (1), which is part of the SGP, provides for a Council decision on the existence of an excessive deficit. The Protocol No 12 on the excessive deficit procedure, annexed to the Treaty on European Union and TFEU sets out further provisions relating to the implementation of the EDP. Council Regulation (EC) No 479/2009 (2) lays down detailed rules and definitions for the application of those provisions.

(4)

According to Article 126(5) TFEU, if the Commission considers that an excessive deficit in a Member State exists or may occur, it is to address an opinion to the Member State concerned and is to inform the Council accordingly.

(5)

Having taken into account its report under Article 126(3) TFEU and having regard to the opinion of the Economic and Financial Committee in accordance with Article 126(4) TFEU, the Commission concluded that an excessive deficit existed in Croatia. The Commission therefore addressed such an opinion to Croatia and informed the Council on 10 December 2013 (3) accordingly.

(6)

Article 126(6) TFEU provides that the Council is to consider any observations which the Member State concerned may wish to make before deciding, after an overall assessment, whether an excessive deficit exists. In the case of Croatia, this overall assessment leads to the following conclusions.

(7)

According to the revision of the 2013 budget and the draft 2014 budget (4) adopted by the Croatian Government and sent to the Croatian Parliament on 14 November 2013, the Croatian authorities envisage a general government deficit of 5,5 % of GDP for 2013, after 5 % of GDP in 2012, and expect the ratio to remain unchanged in 2014 and to decrease only gradually in 2015 and 2016. The Commission services’ 2013 autumn forecast, released on 5 November 2013, projects the general government deficit to be significantly above the 3 % of GDP Treaty reference value already in 2013, rising to above 6 % of GDP in the 2013-2015 period in the absence of countervailing measures. As indicated in the Commission report prepared pursuant to Article 126(3) TFEU, the planned and forecast deficits are above, and not close to, the Treaty reference value. The excess over the reference value can be considered as exceptional within the meaning of the SGP. In particular, it results in part from a severe economic downturn in the sense of the SGP. Economic activity is estimated to have contracted by almost 12 % since the peak in 2008. Real GDP is projected to contract further in 2013, with a slight recovery expected only in 2014. Potential output growth, as estimated by the Commission services according to the commonly agreed method, stagnated in 2009, turned negative in 2010, and has been negative since then. The calculated output gap, which has been negative since 2009, is expected to narrow gradually over the forecast period and yet remain negative through 2015, confirming the depth and the extension of the recession. However, the planned excess over the reference value cannot be considered temporary in the sense of the SGP. According to the projections of the Croatian authorities and the Commission services’ 2013 autumn forecast, the general government deficit will remain significantly above the reference value also in 2014 and 2015. The requirement concerning the deficit criterion in the TFEU is therefore not fulfilled.

(8)

In the draft 2014 budget, the government foresees an increase in the general government debt ratio from 58,1 % in 2013 to 62 % in 2014 and further to 64,1 % in 2015 and 64,7 % in 2016. These figures are slightly higher than those in Croatia’s Economic and Fiscal Policy Guidelines of September 2013, in which the government forecast the general government debt ratio to reach 56,6 % in 2013, and 60,6 %, 63,4 % and 65,3 % in 2014, 2015 and 2016 respectively. In the Commission services’ 2013 autumn forecast, the projection for the general government debt ratio is 59,7 % for 2013. On unchanged policies, the general government debt ratio is expected to rise above 60 % in 2014, thus exceeding the 60 % of GDP Treaty reference value. According to currently available information, a USD-denominated bond issuance in November 2013 would bring the general government debt ratio above the 60 % threshold already by the end of 2013. Article 2(1a) of Regulation (EC) 1467/97 stipulates that the requirement under the debt criterion is also to be considered to be fulfilled if the budgetary forecasts of the Commission indicate that the required reduction in the differential with respect to the reference value will occur over the three-year period encompassing the two years following the final year for which the data is available. The forecasts of the Croatian authorities and of the Commission services show that the general government debt ratio is on an upward trend on account of continuing high deficits and weak economic activity and it is expected to remain so over the forecast horizon. Hence the debt benchmark and thus the debt criterion in the TFEU are not fulfilled.

(9)

In line with the provisions of the TFEU, the Commission also analysed the ‘relevant factors’ in its report under Article 126(3) TFEU. As specified in Article 2(4) of Regulation (EC) No 1467/97, for countries with a general government debt ratio above the reference value, those factors are to be taken into account in the steps leading to the decision on the compliance with the deficit criterion if the general government deficit remains close to the reference value and if its excess over the reference value is temporary, which is not the case for Croatia. The relevant factors, in particular the deep and protracted recession, against the backdrop of unsupportive external conditions, have been taken into account in the assessment of compliance with the debt criterion. However, the relevant factors do not modify the conclusion that the debt criterion in the TFEU is not fulfilled,

(1)

In accordance with Article 32(5) first subparagraph of Directive 2010/75/EU, Hungary submitted to the Commission its transitional national plan (TNP) by letter dated 18 December 2012, received by the Commission by e-mail on 28 December 2012 (2).

(2)

During the assessment of the completeness of the TNP, the Commission found that for several plants included in the TNP essential data were missing, such as the date on which the first permit was granted, the amount of fuel used, the average annual waste gas flow rate and the reference oxygen content used in the calculations. In addition, some of the plants included in the TNP did not match with those reported by Hungary in its emission inventory submitted in 2010 under Directive 2001/80/EC of the European Parliament and of the Council (3).

(3)

By letter of 12 June 2013 (4), the Commission requested the Hungarian authorities to provide the missing data at individual plant level, to clarify the grounds for including one particular plant in the TNP and to resolve the discrepancies between the TNP and the emission inventory under Directive 2001/80/EC.

(4)

By e-mail of 25 June 2013 (5), Hungary submitted the requested additional information and clarifications.

(5)

After further assessment of the TNP and the additional information, the Commission sent a second letter to Hungary on 13 September 2013 (6) with a request to confirm the correct implementation of the aggregation rules set out in Article 29 of Directive 2010/75/EU and to clarify how the average annual waste gas flow rate was determined and how the contribution to the TNP ceilings was calculated for the plants which had undergone an extension during the reference period 2001-2010. The Commission also asked for clarification of the grounds for applying certain emission limit values for two plants.

(6)

By e-mail of 23 September 2013 (7), Hungary informed the Commission that one plant had been removed from the TNP and confirmed the correct application of the aggregation rules set out in Article 29 of Directive 2010/75/EU to the remaining plants. Hungary also clarified the method used for calculating the waste gas flow rate per fuel type, provided justification for applying specific emission limit values and corrected certain erroneous data.

(7)

By letter of 4 October 2013 (8), the Commission requested further clarification of the data and methodology used for calculating the average annual waste gas flow rate for five plants, and Hungary provided such information by letter of 10 October 2013 (9). After assessing the data provided and finding remaining inconsistencies for two plants, the Commission, by letter of 15 October 2013 (10), requested the Hungarian authorities to further verify the calculations for those plants.

(8)

By letter of 18 October 2013 (11), Hungary provided the corrected data for the average annual waste gas flow rate for the two plants concerned, as well as an explanation thereon, in conformity with Commission Implementing Decision 2012/115/EU (12).

(9)

The TNP has therefore been assessed by the Commission in accordance with Article 32(1), (3) and (4) of Directive 2010/75/EU and with Implementing Decision 2012/115/EU.

(10)

In particular, the Commission has examined the consistency and correctness of the data, the assumptions and calculations used for determining the contributions of each of the combustion plants covered by the TNP to the emission ceilings set out in the TNP, and has analysed whether the TNP contains objectives and related targets, measures and timetables for reaching these objectives and a monitoring mechanism to assess future compliance.

(11)

Further to the additional information submitted, the Commission found that the emission ceilings for the years 2016 and 2019 were calculated using the appropriate data and formulae and that the calculations were correct. Hungary has provided sufficient information regarding the measures that will be implemented in order to achieve the emission ceilings, the monitoring and the reporting to the Commission on the implementation of the TNP.

(12)

The Commission is satisfied that the Hungarian authorities have taken into consideration the provisions listed in Article 32(1), (3) and (4) of Directive 2010/75/EU and in Implementing Decision 2012/115/EU.

(13)

The implementation of the TNP should be without prejudice to other applicable national and Union law. In particular, by setting individual permit conditions for the combustion plants covered by the TNP, Hungary should ensure that compliance with the requirements set out in, inter alia, Directive 2010/75/EU, Directive 2008/50/EC of the European Parliament and of the Council (13) and Directive 2001/81/EC of the European Parliament and of the Council (14) is not jeopardised.

(14)

Article 32(6) of Directive 2010/75/EU requires Hungary to inform the Commission of any subsequent changes to the TNP. The Commission should assess whether those changes comply with the provisions laid down in Article 32(1), (3) and (4) of Directive 2010/75/EU and in Implementing Decision 2012/115/EU,

(1)

Annex I to Directive 98/8/EC contains the list of active substances approved at Union level for inclusion in biocidal products. Commission Directive 2008/81/EC (2) added the active substance difenacoum for use in products belonging to product-type 14, Rodenticides, as defined in Annex V to Directive 98/8/EC.

(2)

Difenacoum is an anticoagulant rodenticide known to pose risks of accidental incidents with children, as well as risks for non-target animals and the environment. It has been identified as potentially persistent, liable to bioaccumulate and toxic (‘PBT’), or very persistent and very liable to bioaccumulate (‘vPvB’).

(3)

For reasons of public health and hygiene, it was nevertheless found to be justified to include difenacoum and other anticoagulant rodenticides in Annex I to Directive 98/8/EC, thus allowing Member States to authorise difenacoum-based products. However, Member States were obliged to ensure, when granting authorisation of products containing difenacoum, that primary as well as secondary exposure of humans, non-target animals and the environment is minimised, by considering and applying all appropriate and available risk mitigation measures. The risk mitigation measures mentioned in Directive 2008/81/EC therefore include, amongst others, restriction to professional use only.

(4)

The company VEBI Istituto Biochimico S.r.l. (‘the applicant’) has, in accordance with Article 8 of Directive 98/8/EC, submitted one application to Italy for authorisation of one rodenticide containing difenacoum (‘the product’).

(5)

Italy granted the authorisation of the product on 20 December 2012. The product was authorised with restrictions to ensure that the conditions of Article 5 of Directive 98/8/EC were met in Italy. Those restrictions did not include restriction to trained or licensed professional users.

(6)

On 18 February 2013, the applicant submitted a complete application to Germany for mutual recognition of the first authorisation in respect of the product.

(7)

On 12 June 2013, Germany notified the Commission, the other Member States and the applicant of its proposal to restrict the first authorisation in accordance with Article 4(4) of Directive 98/8/EC. Germany proposed to impose a restriction on the product to use by trained or licensed professionals.

(8)

The Commission invited the other Member States and the applicant to submit comments to the notification in writing within 90 days in accordance with Article 27(1) of Directive 98/8/EC. No comments were submitted within that deadline. The notification was also discussed between the Commission and Member States’ Competent Authorities for biocidal products in the meeting of the Product Authorisation and Mutual Recognition Facilitation Group of 9 July 2013.

(9)

In accordance with Directive 98/8/EC, authorisations of biocidal products containing difenacoum are to be subject to all appropriate and available risk mitigation measures, including the restriction to professional use only. The scientific evaluation leading to the inclusion of difenacoum in Directive 98/8/EC concluded that only professional users could be expected to follow the instructions minimising the risk of secondary poisoning of non-target animals, and to use products in a way that prevents the selection and spreading of resistance. A restriction to professional users should therefore in principle be considered to be an appropriate risk mitigation measure, in particular in Member States where resistance to difenacoum occurs.

(10)

In the absence of any indication to the contrary, restriction to professional users is therefore an appropriate and available risk mitigation measure for the authorisation of products containing difenacoum in Germany. This conclusion is reinforced by the arguments put forward by Germany that resistance against difenacoum in rats has been found and is thought to be developing in the country. Furthermore, Germany has a well-functioning infrastructure of trained pest control operators and licensed professionals, such as farmers, gardeners and foresters who received professional training, which means that the proposed restriction does not hinder infection prevention.

(11)

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

(1)

Products covered by Directive 2001/95/EC which conform to national standards transposing European standards drawn up under that Directive benefit from a presumption of safety as far as the risks covered by the standards are concerned.

(2)

European standards are to be drawn up on the basis of safety requirements intended to ensure that products which conform to the standards satisfy the general safety requirement set out in Article 3 of Directive 2001/95/EC.

(3)

Laser products, in particular hand-held, battery-powered laser pointers, that pose a risk of damage to sight and to the skin have become widely available to consumers.

(4)

The current European standard for laser products (EN 60825-1:2007 ‘Safety of laser products – Part 1: Equipment classification and requirements’) provides that the hazard of laser products has to be assessed and that laser products have to carry appropriate warning labels and be supplied with user instructions that contain all relevant safety information. However, compliance with that standard does not ensure that a laser product is safe to be used by consumers.

(5)

Currently there is a widespread consensus that laser products corresponding to classes 1, 1M, 2 and 2M of the classification put in place by the standard referred to in recital 4 can be considered safe when used by consumers (provided that exposure to laser radiation does not take place with optical viewing instruments in case of products corresponding to classes 1M and 2M). This is not the case however for laser products of other laser classes.

(6)

European standards should be drawn up in such a way as not to hamper technical innovation. For this reason, any standard for consumer laser products should not ban completely any products as far as the products can be used safely, bearing in mind that any damage to the eyes or unintended damage to the skin, whether reversible or irreversible, is incompatible with a high level of consumer health and safety protection.

(7)

It is therefore appropriate to determine the safety requirements for consumer laser products in order to be able to submit a request to the European standardisation bodies to develop a new European standard or amend the current European standard.

(8)

The measures provided for in this Decision are in accordance with the opinion of the Committee on General Product Safety,

(1)

‘consumer laser product’ means any product or assembly of components that:

(2)

‘child appealing consumer laser product’ means a consumer laser product that:

(3)

‘damage to the eyes or the skin’ means any effect of laser radiation detrimental to the structure or function of the eyes or the skin, whether reversible or irreversible.

(1)

child appealing consumer laser products shall not cause damage to the eyes or the skin in case of any exposure to laser radiation that could occur under any conditions of use, including deliberate long-term exposure with optical viewing instruments;

(2)

all other consumer laser products shall not cause damage to the eyes or unintended damage to the skin in case of any exposure to laser radiation that could occur under normal or reasonably foreseeable conditions of use, including momentary accidental or unintentional exposure; any intended damage to the skin caused by consumer laser products shall be compatible with a high level of consumer health and safety protection;

(3)

conformity with points 1 and 2 shall be achieved by technical means;

(4)

in the case of products that conform with point 2, if exposure to laser radiation that would cause damage to the eyes or the skin could occur under conditions of use other than those referred to in point 2, those products shall carry appropriate warning labels and shall be supplied with user instructions that contain all relevant safety information.