21.6.2014   

EN

Official Journal of the European Union

L 182/1

(1)

Council Decision 2009/831/EC (1), adopted on the basis of Article 299(2) of the EC Treaty (now Article 349 of the Treaty on the Functioning of the European Union (TFEU)), authorised Portugal to apply a reduced rate of excise duty in the autonomous region of Madeira on locally produced and consumed rum and liqueurs and in the autonomous region of the Azores on locally produced and consumed liqueurs and eaux-de-vie which may be lower than the minimum rate of excise duty set by Council Directive 92/84/EEC (2), but not more than 75 % lower than the standard national excise duty on alcohol.

(2)

On 30 July 2013, the Portuguese authorities asked the Commission to submit a proposal for a Council Decision extending Decision 2009/831/EC, under the same conditions, until 31 December 2020. This request was modified on 19 November 2013, when Portugal requested an extension of Decision 2009/831/EC for six months, until 30 June 2014, to coincide with the current regional aid guidelines that would be followed by a new extension covering the period from 1 July 2014 to 31 December 2020.

(3)

The granting of the new authorisation is justified in order to avoid endangering the development of those outermost regions. Faced with difficulties in exporting outside the regions, the regional markets are the only possible outlets to sell those products.

(4)

In the autonomous regions of the Azores and Madeira, raw materials of agricultural origin are more expensive than under normal conditions of production, due to the small size, fragmented nature and low mechanisation of agricultural holdings. In the case of Madeira, in addition, output from the processing of sugar cane is lower than in other outermost regions, due to the topography, climate, soil and artisanal production. The transport to the islands of certain raw and packaging materials not produced locally leads to additional cost, as compared to the transport of only the finished product. In the case of the Azores, the insularity is twofold, since the islands are widely spread. Transport and the installation of equipment in those remote and insular regions further increase the additional costs. The same applies to certain necessary travels and shipments to the mainland. Additional costs are also required for the storage of finished products as local consumption does not absorb output as it materialises, but stretches throughout the year. The small size of the regional market increases per unit costs in various ways, notably through the unfavourable relationship between fixed costs and output, both as regards equipment and costs necessary to meet environmental norms. Moreover, rum producers in Madeira have to treat waste from the processing of sugar cane, whereas producers in other regions can recycle those products. Finally, the producers concerned also bear extra costs generally borne by the local economies, in particular increased labour and energy costs.

(5)

The detailed calculations provided in the reports referred to in Article 4 of Decision 2009/831/EC confirm that the reduction of 75 % of the rate of excise duty does not offset completely the competitive disadvantage which distilled alcoholic beverages produced in Madeira and the Azores face as a result of higher production and marketing costs. Therefore, a reduction of the rate of excise duty should continue to be authorised at the level requested.

(6)

A careful examination of the situation confirms that it is necessary to grant Portugal's request in order to ensure that the alcohol industry is maintained in the outermost regions concerned.

(7)

Since the tax advantage does not go beyond what is necessary to offset additional costs, and since the volumes at stake remain modest and the tax advantage limited to consumption in the regions concerned, the measure does not undermine the integrity and coherence of the Union legal order.

(8)

The submission of a mid-term report should be required, so that the Commission can assess whether the conditions justifying the granting of such derogation continue to be fulfilled.

(9)

This Decision is without prejudice to the possible application of Articles 107 and 108 TFEU,

1.

in Madeira

2.

in the Azores

21.6.2014   

EN

Official Journal of the European Union

L 182/4

(1)

Pursuant to Article 349 of the Treaty on the Functioning of the European Union (TFEU), the Council, taking into account the structural social and economic situation of the outermost regions, which is compounded by their remoteness, insularity, small size, difficult topography and climate, and economic dependence on a few products, adopts specific measures aimed, in particular, at laying down the conditions of application of the Treaties to those regions, including common policies.

(2)

Specific measures should therefore be adopted in order to establish the conditions for applying the TFEU to those regions. Such measures are to take account of the special characteristics and constraints of those regions, without undermining the integrity and coherence of the Union legal order, including the internal market and common policies.

(3)

The most significant handicap identified in the Canary Islands is the high dependence of their economy on the services sector, in particular tourism, together with the small share of industry in the Canary Islands' GDP.

(4)

Second to that is the isolation inherent in an archipelago which hinders the free movement of persons, goods and services. Dependence on certain modes of transport, air transport and maritime transport is increased, since those are modes of transport which have not yet been fully liberalised. Furthermore, production costs are greater because those modes of transport are less efficient and are more expensive than road or rail.

(5)

As a further consequence of this isolation, higher production costs result from dependence in terms of raw materials and energy, from the obligation to build up stocks and from difficulties affecting the supply of production equipment.

(6)

The small size of the market and the low level of export activity, the geographical fragmentation of the archipelago, and the obligation to maintain diversified but small production lines in order to meet the requirements of a small market restrict the opportunities for economies of scale.

(7)

It is in many cases more difficult or more expensive to obtain specialised and maintenance services, and training for managers and technicians, or to subcontract or promote business expansion beyond the Canary Islands' market. The narrow range of distribution methods also results in overstocking.

(8)

As regards the environment, the disposal of industrial waste and the treatment of toxic waste give rise to higher environmental costs. Those costs are higher because there are no recycling plants, other than for certain products, and waste has to be transported to the mainland and toxic waste has to be treated outside the Canary Islands.

(9)

On the basis of the above and of the notification from the Spanish authorities to the Commission on 4 March 2013, the authorisation concerning the application of a tax to a list of products for which exemptions for local products may be allowed should be renewed.

(10)

Council Decision 2002/546/EC (1), adopted on the basis of Article 299 of the EC Treaty, initially authorised Spain, up to 31 December 2011, to apply exemptions from or reductions in the tax known as ‘Arbitrio sobre Importaciones y Entregas de Mercancías en las Islas Canarias’ (‘AIEM’) to certain products produced locally in the Canary Islands. The Annex to that Decision contains a list of products to which tax exemptions and reductions may be applied. The difference between the taxation of locally manufactured products and the taxation of other products may not exceed 5, 15 or 25 percentage points, depending on the product.

(11)

Council Decision No 895/2011/EU (2) amended Decision 2002/546/EC, extending its period of application to 31 December 2013.

(12)

Council Decision No 1413/2013/EU (3) further amended Decision 2002/546/EC, extending its period of application to 30 June 2014.

(13)

The AIEM tax serves the objectives of autonomous development of the Canary Islands' industrial production sectors and of diversifying the Canary Islands' economy.

(14)

The maximum exemptions which may be applied to the industrial products in question vary from 5 % to 15 %, depending on sector and product.

(15)

The maximum exemption applicable to finished tobacco products is nevertheless higher, as the tobacco sector is an exceptional case. The tobacco industry, which had greatly expanded in the Canary Islands, has been declining markedly for a number of years. The traditional handicaps of insularity described above are at the root of the decline in local tobacco production in the Canary Islands. There are grounds for keeping a substantial exemption for tobacco. Exemption from taxation is directly related to the objective of maintaining production in the Canary Islands.

(16)

The objectives of promoting the socioeconomic development of the Canary Islands are reflected at national level in the purpose of the tax and the allocation of the revenue it generates. The incorporation of the revenue from this tax in the resources of the Canary Islands' economic and tax system and its use for an economic and social development strategy involving the promotion of local activities is a legal obligation.

(17)

The exemptions from or reductions in the AIEM tax should apply for 6,5 years. It will, nevertheless, be necessary to evaluate the results of such exemptions or reductions. Therefore, the Spanish authorities should present to the Commission by 30 September 2017 at the latest a report on the application of the AIEM tax exemptions or reductions, in order to check the impact of the measures taken and their contribution to promoting or maintaining local economic activities, account being taken of the handicaps affecting the outermost regions. On this basis, the scope and the exemptions authorised under Union rules will be revised, if necessary.

(18)

The fiscal advantage granted by the AIEM needs to remain proportionate so as not to undermine the integrity and the coherence of the Union legal order, including safeguarding undistorted competition in the internal market and State aid policies.

(19)

This Decision is without prejudice to the possible application of Articles 107 and 108 TFEU,

(a)

5 % for the products listed in Section A of the Annex;

(b)

10 % for the products listed in Section B of the Annex;

(c)

15 % for the products listed in Section C of the Annex;

(d)

25 % for the products listed in Section D of the Annex. Nevertheless, the Spanish authorities may establish a minimum tax on cigarettes of not more than EUR 18 per 1 000 cigarettes, applicable only if the AIEM tax resulting from the application of general types of taxation is below this figure.

21.6.2014   

EN

Official Journal of the European Union

L 182/9

(1)

Council Decision 2004/162/EC (1) authorises France to apply exemptions or reductions to dock dues for products produced locally in the French overseas departments and listed in the Annex to that Decision. The difference between the taxation of locally manufactured products and that of other products may not exceed 10, 20 or 30 percentage points, depending on the product. Those exemptions or reductions constitute specific measures designed to offset the specific constraints facing the outermost regions provided for in Article 349 of the Treaty on the Functioning of the European Union (TFEU) which increase production costs for local companies and make it difficult for their products to compete with the same products imported from metropolitan France and other Member States or non-Member States. The exemptions from or reductions in the dues applicable to local products support the creation, maintenance and development of local production. Pursuant to Decision 2004/162/EC, the French authorities are authorised until 1 July 2014 to apply those exemptions and reductions.

(2)

France is of the view that the handicaps suffered by the French outermost regions persist, and has submitted a request to the Commission that a system of differentiated taxation similar to the current system be maintained after 1 July 2014, until 31 December 2020.

(3)

Analysing the lists of the products to which France has requested the application of differentiated taxation is a lengthy process requiring verification, for each product, of the reasons for differential taxation and its proportionality, so as to ensure that such differentiated taxation does not undermine the integrity and the coherence of the Union legal order, including the internal market and common policies.

(4)

Such analysis has not yet been completed, due to the large number of products involved and the quantity of information to be collected, in particular the quantification of the higher production costs that handicap local products and the structure of the product markets concerned.

(5)

Failure to adopt a proposal before 1 July 2014 could create a legal vacuum, as the application of any differentiated taxation in the French outermost regions after 1 July 2014 would not be possible.

(6)

An additional period of six months is required to complete the analysis of the products to which France requests the application of differentiated taxation, and to give the Commission time to present a balanced proposal that takes account of the various interests at stake.

(7)

Decision 2004/162/EC should therefore be amended accordingly,

21.6.2014   

EN

Official Journal of the European Union

L 182/11

(1)

The maximum residue limit (hereinafter ‘MRL’) for pharmacologically active substances intended for use in the Union in veterinary medicinal products for food-producing animals or in biocidal products used in animal husbandry is to be established in accordance with Regulation (EC) No 470/2009.

(2)

Pharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin are set out in the Annex to Commission Regulation (EU) No 37/2010 (2).

(3)

Rafoxanide is currently included in Table 1 of the Annex to Regulation (EU) No 37/2010 as an allowed substance, for bovine and ovine species, applicable to muscle, fat, liver and kidney, excluding animals producing milk for human consumption.

(4)

A request for an opinion on the extrapolation of the existing entry for rafoxanide applicable to bovine milk has been submitted to the European Medicines Agency.

(5)

The Committee for Medicinal Products for Veterinary Use has recommended the establishment of a provisional MRL for rafoxanide for bovine and ovine milk and the removal of the prohibition to use that substance in animals from which milk is produced for human consumption.

(6)

The entry for rafoxanide in Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended to include the recommended provisional MRL for bovine and ovine milk and to remove the prohibition to use that substance from animals from which milk is produced for human consumption.

(7)

The provisional MRL for rafoxanide set out in that Table should expire on 31 December 2015.

(8)

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

(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,

21.6.2014   

EN

Official Journal of the European Union

L 182/14

(1)

The maximum residue limit (hereinafter ‘MRL’) for pharmacologically active substances intended for use in the Union in veterinary medicinal products for food-producing animals or in biocidal products used in animal husbandry is to be established in accordance with Regulation (EC) No 470/2009.

(2)

Pharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin are set out in the Annex to Commission Regulation (EU) No 37/2010 (2).

(3)

Closantel is currently included in Table 1 of the Annex to Regulation (EU) No 37/2010 as an allowed substance, for bovine and ovine species, applicable to muscle, fat, liver, kidney and milk. The provisional maximum residue limits for that substance set out for bovine and ovine milk expired on 1 January 2014.

(4)

Additional data were provided and assessed by the Committee for Medicinal Products for Veterinary Use who recommended that the provisional MRLs for closantel for bovine and ovine milk should be set as definitive.

(5)

The entry for closantel in Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended accordingly.

(6)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,

21.6.2014   

EN

Official Journal of the European Union

L 182/17

(1)

The maximum residue limit (hereinafter ‘MRL’) for pharmacologically active substances intended for use in the Union in veterinary medicinal products for food-producing animals or in biocidal products used in animal husbandry is to be established in accordance with Regulation (EC) No 470/2009.

(2)

Pharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin are set out in the Annex to Commission Regulation (EU) No 37/2010 (2).

(3)

Clorsulon is currently included in Table 1 of the Annex to Regulation (EU) No 37/2010 as an allowed substance, for bovine species, applicable to muscle, liver, kidney and milk. The provisional maximum residue limits for that substance set out for bovine milk expired on 1 January 2014.

(4)

Additional data were provided and assessed by the Committee for Medicinal Products for Veterinary Use who recommended that the provisional MRLs for clorsulon for bovine milk should be set as definitive.

(5)

The entry for clorsulon in Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended accordingly.

(6)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,

21.6.2014   

EN

Official Journal of the European Union

L 182/20

(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 canthaxanthin. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(3)

That application concerns the authorisation of a preparation of canthaxanthin as a feed additive for breeder hens to be classified in the additive category ‘zootechnical additives’.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 12 December 2012 (2) that, under the proposed conditions of use, the preparation of canthaxanthin does not have an adverse effect on animal health, human health or the environment, and that it has a potential to stabilise the reproductive performance of breeder hens. 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.

(5)

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

(6)

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

21.6.2014   

EN

Official Journal of the European Union

L 182/23

(1)

Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in foods and their conditions of use.

(2)

Commission Regulation (EU) No 231/2012 (3) lays down specifications for food additives that are listed in Annexes II and III to Regulation (EC) No 1333/2008.

(3)

Those lists may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008, either on the initiative of the Commission or following an application.

(4)

On 13 September 2011, an application was submitted for authorisation of the use of polyvinyl alcohol-polyethylene glycol-graft-co-polymer (PVA-PEG graft co-polymer) in aqueous instant-release film coatings for food supplements. The application was made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008.

(5)

The European Food Safety Authority evaluated the safety of PVA-PEG graft co-polymer when used as a food additive and concluded that its use in food supplements as film coating is of no safety concern for the proposed uses (4).

(6)

PVA-PEG graft co-polymer is intended for use in aqueous instant-release film coatings for food supplements. It protects against unpleasant tastes or odours, improves appearance, makes tablets easier to swallow, gives a distinctive appearance, and protects sensitive active ingredients. A specific property of the substance is that it is extremely flexible, has low viscosity, and dissolves rapidly in acidic, neutral, and alkaline aqueous media. It is therefore appropriate to authorise the use of PVA-PEG graft co-polymer as a glazing agent in solid food supplements and to assign E 1209 as E-number to that additive.

(7)

The specifications for PVA-PEG graft co-polymer should be included in Regulation (EU) No 231/2012 when it is included in the Union lists of food additives laid down in Annex II to Regulation (EC) No 1333/2008 for the first time.

(8)

Regulations (EC) No 1333/2008 and (EU) No 231/2012 should therefore be amended accordingly.

(9)

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

21.6.2014   

EN

Official Journal of the European Union

L 182/27

(1)

Regulation (EC) No 1924/2006 provides that applications for authorisations of health claims are to be sent to the national competent authority of the respective Member State. The national competent authority is to forward those applications to the European Food Safety Authority (EFSA), hereinafter referred to as ‘the Authority’. The Authority is to give an opinion on the health claim and to forward it to the Commission who is to decide on the authorisation of the health claim taking into account the opinion delivered by the Authority.

(2)

Pursuant to Article 16(4) of Regulation (EC) No 1924/2006, an opinion of the Authority in favour of authorising a health claim may include specific conditions of use of the claim.

(3)

The authorisation of health claims may be amended following a request by the applicant or user according to Article 19(1) of Regulation (EC) No 1924/2006 or following an opinion of the Authority issued on its own initiative or following a request from a Member State or from the Commission according to Article 19(2) of Regulation (EC) No 1924/2006.

(4)

Following the opinion of the Authority, based on a request of the Commission and a similar request from France, regarding the possibility to indicate a quantitative effect in health claims related to the lowering effects of plant sterols/plant stanol esters on blood LDL-cholesterol (Question No EFSA-Q-2009-00530 and Q-2009-00718) (2), the Commission amended, by Regulation (EU) No 376/2010 (3), the conditions of use of two health claims related to the lowering effects of plant sterols and plant stanol esters on blood cholesterol, as laid down in Commission Regulation (EC) No 983/2009 (4), by indicating a quantitative effect. Moreover, based on the same opinion of the Authority, the Commission authorised, by Regulation (EU) No 384/2010 (5), a health claim related to the lowering effects of plant sterols/plant stanol esters on blood LDL-cholesterol, establishing conditions of use related to the indication of a quantitative effect.

(5)

Following an application from Raisio Nutrition Ltd, submitted pursuant to Article 14(1)(a) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to the lowering effects of plant stanols as plant stanol esters on blood LDL-cholesterol concentrations (Question No EFSA-Q-2011-00851) (6). The claim proposed by the applicant was worded as follows: ‘The daily consumption of 3 g plant stanols in ester form has been shown to reduce blood cholesterol by 12 %. High cholesterol is a risk factor in the development of coronary heart disease’. The applicant further requested that the minimum duration to obtain the effect be stated to be one to two weeks, and that an authorisation be given for claims for an extended range of foods, including yellow fat spreads, dairy products, cheese, rye bread, oatmeal, fermented soy milk based products (drinkable and spoonable yoghurt-type products), and oat-based milk drinks.

(6)

On the basis of the data presented, the Authority concluded in its opinion, received by the Commission and the Member States on 16 May 2012, that plant stanol esters at a daily intake of 3 g (range 2,7-3,3 g) lower blood LDL-cholesterol by 11,4 % (95 % Confidence Interval (CI): 9,8-13,0), and that the minimum duration required to achieve the maximum effect of plant stanol esters on blood LDL-cholesterol lowering is two to three weeks. Moreover, the Authority concluded that while plant stanol esters added to foods such as margarine-type spreads, mayonnaise, salad dressings and to dairy products such as milk, yoghurts including low-fat yoghurts, and cheese have been shown consistently to lower blood LDL-cholesterol levels, the extent of the cholesterol-lowering effect of plant stanols added to other food formats is less well established.

(7)

Unilever PLC and Unilever NV submitted an application pursuant to Article 19 of Regulation (EC) No 1924/2006, for the modification of the conditions of use of the health claims related to the lowering effects of plant sterols and plant stanols on blood LDL-cholesterol (Question No EFSA-Q-2011-01241) (7). The modification concerns the magnitude of the lowering effect on blood LDL-cholesterol (7-12 %) for a daily intake of plant sterols and plant stanols between 1,5 and 3 g. The applicant further requested that the minimum duration to obtain the effect be stated to be one to two weeks.

(8)

On the basis of the data presented, the Authority concluded in its opinion, received by the Commission and the Member States on 16 May 2012, that plant sterols and plant stanol esters at a daily intake of 3 g (range 2,6-3,4 g) lower blood LDL-cholesterol by 11,3 % (95 % Confidence Interval (CI): 10,0-12,5), and that the minimum duration required to achieve the maximum effect of plant sterols and plant stanols on LDL-cholesterol is two to three weeks. The Authority also noted in its assessment that plant sterols and plant stanols at daily intakes ranging from 1,5 to 3 g have a similar efficacy on lowering blood LDL-cholesterol.

(9)

The conditions of use of the authorised health claims on plant sterols, plant stanol esters and plant sterols/plant stanol esters, as laid down in Regulations (EC) No 983/2009 and (EU) No 384/2010, provide that reference to the magnitude of the cholesterol-lowering effect of those substances may be made for foods falling within certain categories. According to those conditions, when reference is made to the magnitude of the cholesterol-lowering effect, consumers are to be informed that plant sterols and/or plant stanol esters at daily intakes ranging from 1,5 to 2,4 g lower blood LDL-cholesterol by 7 % to 10 % within two to three weeks. Since new evidence has shown that an additional effect is achieved with higher intakes of those substances of up to 3 g per day, it is necessary to amend those conditions of use as regards the consumer information on the magnitude of the effect and the required daily intake, taking into account the scientific opinions of the Authority.

(10)

In order to ensure that the claims authorised by Regulations (EC) No 983/2009 and (EU) No 384/2010 do not confuse or mislead the consumer, the conditions of use concerning consumer information on the magnitude of the cholesterol-lowering effect should be set in a coherent way. Since plant sterols and plant stanols at daily intakes ranging from 1,5 to 3 g have a similar efficacy, it is appropriate to indicate the same magnitude of the effect for plant sterols, plant stanol esters and plant sterols/plant stanol esters. Commission Regulation (EC) No 608/2004 (8) provides that the consumption of more than 3 g of plant sterols and plant stanols should be avoided. It is therefore appropriate to only provide ranges of intakes up to 3 g in the conditions of use.

(11)

Regulations (EC) No 983/2009 and (EU) No 384/2010 should therefore be amended accordingly.

(12)

The comments from the applicants and the members of the public received by the Commission pursuant to Article 16(6) of Regulation (EC) No 1924/2006 have been considered when setting the measures provided for in this Regulation.

(13)

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)

the first entry (concerning the health claim: ‘Plant sterols have been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease’), is amended as follows:

(2)

the second entry (concerning the health claim: ‘Plant stanol esters have been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease’) is amended as follows:

(a)

the text in the fifth column (conditions of use of the claim) is replaced by the following:

‘Information to the consumer that the beneficial effect is obtained with a daily intake of 1,5-3 g plant sterols/stanols. Reference to the magnitude of the effect may only be made for foods within the following categories: yellow fat spreads, dairy products, mayonnaise and salad dressings. When referring to the magnitude of the effect, the range “7 % to 10 %” for foods that provide a daily intake of 1,5-2,4 g plant sterols/stanols or the range “10 % to 12,5 %” for foods that provide a daily intake of 2,5-3 g plant sterols/stanols and the duration to obtain the effect “in 2 to 3 weeks” must be communicated to the consumer.’;

(b)

the text in the seventh column (EFSA opinion reference) is replaced by the following:

‘Q-2008-779

Q-2009-00530 and Q-2009-00718

Q-2011-01241.’

21.6.2014   

EN

Official Journal of the European Union

L 182/31

(1)

Experience with the implementation of Commission Regulation (EU) No 185/2010 (2) has shown the need for amendments to the implementing modalities of certain common basic standards.

(2)

Certain specific aviation security measures should be clarified, harmonised or simplified in order to improve legal clarity, so as to avoid diverging interpretations of the legislation and further ensure the best implementation of the common basic standards on aviation security.

(3)

The amendments concern the implementation of a limited number of measures in relation to prohibited articles, aircraft security, security controls for cargo, mail, in-flight and airport supplies and security equipment.

(4)

In accordance with Commission Regulation (EC) No 272/2009 (3), the Commission should recognise the equivalence of aviation security standards of third countries and other countries and territories to which Title VI of the TFEU does not apply under the condition that the criteria set out in that Regulation are met.

(5)

The Commission has verified that airports located in Guernsey, Isle of Man and Jersey fulfil the criteria set out in Part E of the Annex to Regulation (EC) No 272/2009.

(6)

Regulation (EU) No 185/2010 lists in its Annex the third countries and other countries and territories to which Title VI of the TFEU does not apply recognised as applying security standards equivalent to the common basic standards that Regulation (EC) No 272/2009 establishes.

(7)

Commission Regulation (EEC) No 2454/93 (4) and Regulation (EU) No 185/2010 both lay down similar security requirements for entities operating in the cargo and mail supply chain.

(8)

The security requirements for the aviation security regulated agent and known consignor programme defined in Regulation (EU) No 185/2010 and for the customs Authorized Economic Operator programme defined in Regulation (EEC) No 2454/93 should be further aligned in order to allow for mutual recognition to facilitate the concerned industry and government authorities while at the same time maintaining current security levels.

(9)

Regulation (EU) No 185/2010 should therefore be amended accordingly.

(10)

The measures provided for in this Regulation are in accordance with the opinion of the Committee on Civil Aviation Security,

21.6.2014   

EN

Official Journal of the European Union

L 182/47

(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,

21.6.2014   

EN

Official Journal of the European Union

L 182/49

(1)

The substance tris(2-chloroethyl) phosphate (TCEP), CAS No 115-96-8, is a phosphate ester used as a flame-retardant plasticiser in polymers. The main industrial branches in which TCEP has been used are the building industry, the furniture and the textile industry. TCEP is classified under Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (2) as carcinogenic category 2 and toxic for reproduction category 1B.

(2)

Directive 2009/48/EC establishes general requirements for substances which are classified as carcinogenic, mutagenic or toxic for reproduction (CMR) under Regulation (EC) No 1272/2008. Such substances may not be used in toys, in components of toys or in micro-structurally distinct parts of toys, except if inaccessible to children, permitted by a Commission decision or contained in individual concentrations equal to or smaller than the relevant concentrations established for the classification of mixtures containing them as CMRs. In the absence of any specific requirements, TCEP can thus be contained in toys in concentrations equal to or smaller than the relevant concentration established for the classification of mixtures containing it as CMRs, namely 0,5 % as from 20 July 2013 and 0,3 % as from 1 June 2015 respectively.

(3)

TCEP was comprehensively evaluated in 2009 under Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances (3). The risk assessment report, entitled ‘European Union Risk assessment on TCEP’, shows that TCEP easily migrates, and, when ingested, results in toxicity in the kidney, liver and brain, causing health damages and potentially cancer.

(4)

The risk assessment report also shows that since 2001 there is no EU TCEP production. Its use in the EU had also declined, TCEP being replaced progressively by other flame retardants. Nevertheless, the presence of TCEP in toys cannot be excluded, as most toys available on the EU market are imported, thus manufactured outside the EU.

(5)

To assess the health effects of TCEP in toys and the appropriateness of Directive 2009/48/EC's generic limits for TCEP as a CMR substance, the Commission sent a request for an opinion to the Scientific Committee on Health and Environmental Risks (SCHER). In its opinion, adopted on 22 March 2012 and entitled ‘Opinion on tris(2-chloroethyl) phosphate (TCEP) in toys’, SCHER notes that health effects (in particular kidney effects) have been observed after repeated exposure to 12 mg of TCEP/kg body weight per day. SCHER also notes that the TCEP content found by the Danish Environmental Protection Agency (Danish EPA) in toys (0,5-0,6 %), as reported in the Danish EPA's ‘Survey and risk assessment of perfume and flavours in toys and childcare articles. Survey of chemical substances in consumer products’, corresponds to a risk for children, even without considering other exposures. When considering TCEP exposure from other sources than toys (e.g. air, dust), SCHER concludes that no additional exposure from toys can be considered as safe, and recommends setting the limit for TCEP in toys at the detection limit of a sufficiently sensitive analytical method.

(6)

In the light of the above, the generic limit values of 0,5 % and 0,3 % referred to by Directive 2009/48/EC appear to be inappropriate for protecting children's health. Following a stakeholder consultation, the ‘detection limit of a sufficiently sensitive analytical method’ for TCEP was set at 5 mg/kg. As this limit refers to a detection level, it is not based on a toxicological approach.

(7)

In addition to TCEP, SCHER also assessed TCEP's halogenated alternatives, namely tris[2-chloro-1-(chloromethyl)ethyl] phosphate (TDCP), CAS No 13674-87-8, and tris(2-chloro-1-methylethyl) phosphate (TCPP), CAS No 13674-84-5, in the above-mentioned opinion of 22 March 2012. These alternatives were assessed in 2008 under Regulation (EEC) No 793/93.

(8)

In its opinion SCHER agrees with the conclusion of the alternatives' risk assessments that there is sufficient information from the structures, physical-chemical properties, toxicokinetics and mutagenic profiles of TCEP, TDCP and TCPP to support a qualitative read-across, indicating a potential concern for carcinogenicity for TCPP by a non-genotoxic mechanism. The read-across implies, according to SCHER, that considerations given for TCEP could be applied to its halogenated alternatives as well, if used in toy manufacturing.

(9)

TDCP is classified under Regulation (EC) No 1272/2008 as carcinogenic category 2, and for TCPP, although not classified, SCHER identified a potential concern for carcinogenicity. In line with the above considerations for TCEP and the SCHER opinion, limit values for TDCP and TCPP should therefore also be set at 5 mg/kg.

(10)

Directive 2009/48/EC foresees that, to further protect children's health, specific limit values for chemicals can be set out, when appropriate, for toys intended for use by children under three years old or other toys intended to be placed in the mouth.

(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 Committee established in Article 47 of Directive 2009/48/EC,

21.6.2014   

EN

Official Journal of the European Union

L 182/52

(1)

Based on the first review under Article 10 of Directive 2006/118/EC, not enough information is available to set new groundwater quality standards in Annex I to that Directive for any pollutants, but technical adaptations in accordance with Article 8 of that Directive are necessary in its Annex II.

(2)

Common principles for the determination of background levels need to be applied in order to improve the comparability of threshold values.

(3)

There is considerable potential for nitrogen and phosphorus in groundwater to present a eutrophication risk to associated surface waters and to directly dependent terrestrial ecosystems. Besides nitrates, already included in Annex I to Directive 2006/118/EC, and ammonium, included in Annex II to that Directive, nitrites, as a contributor to total nitrogen, and total phosphorus, either as such or as phosphates, should also be considered by Member States when establishing threshold values.

(4)

The need to obtain and respond to new information on other substances posing a potential risk should be acknowledged. Therefore, a watch list for pollutants of groundwater should be established under the Common Implementation Strategy for Directive 2000/60/EC of the European Parliament and of the Council (2) to increase the availability of monitoring data on substances posing a risk or potential risk to bodies of groundwater, and thereby facilitate the identification of substances, including emerging pollutants, for which groundwater quality standards or threshold values should be set.

(5)

The information provided by Member States on the pollutants and indicators for which threshold values have been established, in particular as regards the methodologies related to groundwater chemical status assessment, proved insufficient in the first river basin management plans to enable proper understanding and comparison of the results. The relevant requirements regarding the information to be provided should be clarified and complemented in order to ensure the transparency of that assessment. The information provided would also facilitate comparison of the chemical status assessment results across the Member States and contribute to a potential future harmonisation of methodologies for establishing groundwater threshold values.

(6)

Directive 2006/118/EC should therefore be amended accordingly.

(7)

The measures provided for in this Directive are in accordance with the opinion of the Committee under Article 9 of Directive 2006/118/EC,

21.6.2014   

EN

Official Journal of the European Union

L 182/56

21.6.2014   

EN

Official Journal of the European Union

L 182/61

(1)

The European Union has adopted a new Directive on the transportable pressure equipment (1) and Switzerland has amended its legislative, regulatory and administrative provisions deemed equivalent under Article 1(2) of the Agreement to the above mentioned European Union legislation;

(2)

Chapter 6, Pressure vessels, of Annex 1 should be amended to reflect these developments;

(3)

The European Union has adopted a new Regulation on construction products (2) (hereinafter the ‘Construction Products Regulation’);

(4)

The Swiss legislation on construction products (Federal Law and Ordinance on construction products) is in the process of being amended; however, the Swiss ordinance on Accreditation and Designation (3), establishing the relevant framework requirements for the accreditation and designation of Swiss conformity assessment bodies is already in force;

(5)

Chapter 16, Construction products, of Annex 1 should be amended, in a first step, to reflect the adoption of the Construction Products Regulation by the European Union, and, until the adoption of Swiss equivalent legislation, to enable the Parties during an interim period to grant mutual acceptance of conformity assessment results showing compliance with the Construction Products Regulation; once Swiss legislation equivalent with the Construction Products Regulation is adopted, the Parties shall replace this amendment with a subsequent one reflecting the adoption of both the Construction Products Regulation and the revised equivalent Swiss legislation. It is understood that this decision is meant to ensure continuity in the activities of conformity assessment bodies during this interim period, and is without prejudice to the application of the principles of Article 1 of the Agreement;

(6)

Article 10(5) of the Agreement provides that the Committee may, on a proposal from one of the Parties, modify the Annexes to the Agreement,

1.

Chapter 6, Pressure vessels, of Annex 1 to the Agreement is amended in accordance with the provisions set out in Attachment A annexed to this Decision.

2.

The Swiss Confederation shall accept conformity assessment results of EU recognised conformity assessment bodies assessing conformity in accordance with the requirements of the Construction Products Regulation. The European Union shall accept conformity assessment results of Swiss recognised conformity assessment bodies assessing conformity in accordance with the requirements of the Construction Products Regulation until the amendment of Chapter 16 following the adoption of equivalent Swiss legislation.

Chapter 16, Construction products, of Annex 1 to the Agreement is amended in accordance with the provisions set out in Attachment B annexed to this Decision and shall apply during the interim period until such amendment.

3.

Annex 1 to the Agreement is amended in accordance with the provisions set out in Attachment C annexed to this Decision.

4.

This Decision, done in duplicate, shall be signed by representatives of the Parties in the Committee who are authorized to act on behalf of the Parties. This Decision shall be effective from the date of the later of these signatures.