(1)

On 19 January 2012, the Kingdom of Denmark submitted to the European Chemicals Agency (hereinafter ‘Agency’) a dossier pursuant to Article 69(4) of Regulation (EC) No 1907/2006, in order to initiate the restrictions process in accordance with Articles 69 to 73 of that Regulation (hereinafter ‘Annex XV dossier’). In that dossier, it was demonstrated that exposure to chromium VI, when contained in leather articles or leather parts of articles coming into contact with the skin, poses a risk to human health. Chromium VI compounds can induce new cases of sensitisation and elicit allergic response. The dossier demonstrates that action on a Union-wide basis is necessary.

(2)

Chromium VI compounds can be formed in leather through the oxidation of chromium III compounds, which are added in some tanning processes to cross-link the collagen subunits in order to increase leather’s dimensional stability, as well as its resistance to mechanical action and heat. According to the Annex XV dossier, the mechanisms of and conditions under which chromium VI is formed are known and most tanneries in the Union have already developed and widely implemented measures in order to control and minimise its formation.

(3)

On 28 November 2012 the Committee for Risk Assessment (hereinafter ‘RAC’) adopted by consensus the opinion on the restriction proposed in the Annex XV dossier. According to the RAC opinion, the restriction is the most appropriate Union-wide measure to address the identified risks posed by chromium VI compounds in leather, both in terms of effectiveness and practicability. However, in its opinion RAC proposed to modify the restriction by deleting the notion of direct and prolonged contact with the skin, originally included in the Annex XV dossier.

(4)

The proposed restriction focuses on the risk of induction of skin sensitisation related to direct or indirect skin contact with leather articles or leather parts of articles containing chromium VI. In already sensitised people, such contacts may also elicit allergic response at lower concentrations than those needed for the induction of sensitisation.

(5)

The proposed restriction should cover leather articles and articles containing leather parts used by consumers or workers, that under normal or reasonably foreseeable conditions of use come into contact with the skin.

(6)

The EN ISO 17075 standard method is the only internationally recognised analytical method currently available to detect chromium VI in leather, including leather in articles. The determination limit of the EN ISO 17075 standard method is 3 mg/kg (0,0003 % by weight) of chromium VI content in the total dry weight of the leather. Fixing such threshold for the restriction of the placing on the market of leather articles or articles containing leather parts is therefore justified for monitorability and enforceability purposes.

(7)

According to the RAC opinion, the threshold of 3 mg/kg (0,0003 % by weight) of chromium VI content in the total dry weight of the leather corresponds to exposures higher than the Lowest-Observed Adverse Effect Level for elicitation. According to the opinion of RAC, that threshold is expected to be 80 % effective in reducing the occurrence of new chromium VI-related allergic dermatitis cases due to chromium VI in leather articles.

(8)

The effectiveness of the restriction on the number of cases of chromium allergy can be determined by monitoring cases of chromium VI-related allergic dermatitis. Should the prevalence of the allergy not decrease, or should an analytical method to detect lower content of chromium VI become available and be recognised as reliable, this restriction should be reviewed.

(9)

On 6 March 2013 the Committee for Socio-Economic Analysis (hereinafter ‘SEAC’) adopted by consensus the opinion on the restriction proposed in the Annex XV dossier. According to the SEAC opinion, the restriction, as modified by RAC, is the most appropriate Union-wide measure to address the identified risks in terms of the proportionality of its socioeconomic benefits to its socioeconomic costs.

(10)

The Forum for Exchange of Information on Enforcement was consulted during the restrictions process.

(11)

On 8 April 2013 the Agency submitted to the Commission the opinions of RAC and SEAC based on which the Commission concluded that an unacceptable risk to human health arose where chromium VI compounds were present in leather articles and articles containing leather parts, coming into contact with the skin, which needs to be addressed on a Union-wide basis. The socioeconomic impacts of this restriction, including the availability of alternatives, have been taken into account.

(12)

The restriction on the placing on the market of second-hand articles would impose a disproportionate burden on the consumers re-selling these articles. Furthermore, due to the nature of those transactions, such restriction would be difficult to enforce. Therefore, this restriction should not apply to leather articles or articles containing leather parts which were in end-use in the Union before this Regulation applies.

(13)

It is appropriate to provide for a period of 12 months after the entry into force of this Regulation for the stakeholders concerned to take measures to comply with this Regulation, including addressing articles that are already in the supply chain, including in stocks.

(14)

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

(15)

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 endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (CBS 126896). 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 endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (CBS 126896) as a feed additive for chickens for fattening and weaned piglets, to be classified in the additive category ‘zootechnical additives’.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 9 October 2013 (2) that, under the proposed conditions of use, the preparation of endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (CBS 126896) does not have an adverse effect on animal health, human health or the environment. It also concluded that the additive improves significantly the performance of the animals. 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 endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (CBS 126896) 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,

(1)

As a result of the United States’ failure to bring the Continued Dumping and Subsidy Offset Act (CDSOA) in compliance with its obligations under the World Trade Organization (WTO) agreements, Regulation (EC) No 673/2005 imposed a 15 % ad valorem additional customs duty on imports of certain products originating in the United States of America as from 1 May 2005. In conformity with the WTO authorisation to suspend the application of concessions to the United States, the Commission is to adjust the level of suspension annually to the level of nullification or impairment caused by the CDSOA to the European Union at that time.

(2)

The CDSOA disbursements for the most recent year for which data are available relate to the distribution of anti-dumping and countervailing duties collected during the Fiscal Year 2013 (1 October 2012-30 September 2013). On the basis of the data published by the United States’ Customs and Border Protection, the level of nullification or impairment caused to the Union is calculated at USD 872685.

(3)

The level of nullification or impairment and consequently of suspension has decreased. However, the level of suspension cannot be adjusted to the level of nullification or impairment by adding or removing products from the list in Annex I to Regulation (EC) No 673/2005. As a consequence, in accordance with Article 3(1)(e) of that Regulation, the Commission should keep the list of products in Annex I unchanged and amend the rate of the additional duty in order to adjust the level of suspension to the level of nullification or impairment. The three products listed in Annex I should therefore be maintained on the list and the rate of additional import duty should be amended and set at 0,35 %.

(4)

The effect of a 0,35 % ad valorem additional import duty on imports from the United States of the products in Annex I represents, over one year, a value of trade that does not exceed USD 872 685.

(5)

To make sure that there are no delays in the application of the amended rate of additional import duty, this Regulation should enter into force on the day of its publication.

(6)

Regulation (EC) No 673/2005 should therefore be amended accordingly.

(7)

The measures provided for in this Regulation are in accordance with the opinion delivered by the Committee on Trade Retaliation,

(1)

Article 2 is replaced by the following:

(*1)   OJ L 302, 19.10.1992, p. 1.’;"

(2)

Annex I is replaced by the text set out in the Annex to this Regulation.

(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(7) of Regulation (EC) No 1831/2003 in conjunction with Article 10(1) to (4) thereof sets out specific provisions for the evaluation of products used in the Union as silage additives at the date that Regulation became applicable.

(2)

In accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003, the preparations of Enterococcus faecium NCIMB 10415, Enterococcus faecium DSM 22502 and Pediococcus acidilactici CNCM I-3237 were entered in the Register of Feed Additives as existing products belonging to the functional group of silage additives, for all animal species.

(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, applications were submitted for the authorisation of those preparations as feed additives for all animal species, requesting those additives to be classified in the category ‘technological additives’ and in the functional group ‘silage additives’. Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinions of 23 May 2012 (2), 10 September 2013 (3) and 10 October 2013 (4) that, under the proposed conditions of use, the preparations concerned do not have an adverse effect on animal health, human health or the environment. The Authority also concluded that the preparations of Enterococcus faecium NCIMB 10415, Enterococcus faecium DSM 22502 and Pediococcus acidilactici CNCM I-3237 have the potential to improve the production of silage. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the methods of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(5)

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

(6)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

(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)

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 propionic acid, sodium propionate and ammonium propionate. 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 propionic acid, sodium propionate and ammonium propionate as feed additives for all animal species to be classified in the additive category ‘technological additives’, functional group ‘silage additives’. The application includes also other uses of the same substances for which no decision has yet been taken. The additive was authorised for 10 years by Commission Implementing Regulation (EU) No 1222/2013 (2) for ruminants, pigs and poultry.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 16 November 2011 (3) that, under the proposed conditions of use, propionic acid, sodium propionate and ammonium propionate do not have an adverse effect on animal health, human health or the environment. It was also concluded that the substances improve the aerobic stability of easy to ensile materials. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the methods of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(5)

The assessment of the substances concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those substances 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,

(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)

The European Globalisation Adjustment Fund (EGF) was established to provide additional support for workers made redundant as a result of major structural changes in world trade patterns due to globalisation and to assist them with their reintegration into the labour market.

(2)

Regulation (EU, Euratom) No 1311/2013 allows the mobilisation of the EGF within the annual ceiling of EUR 150 million.

(3)

Spain submitted an application to mobilise the EGF on 8 October 2013 in respect of redundancies in 198 enterprises operating in the NACE Revision 2 Division 13 (Manufacture of textiles) in the NUTS II region of Comunidad Valenciana (ES52), and supplemented it by additional information up to 5 November 2013. This application complies with the requirements for determining the financial contributions as laid down in Article 10 of Regulation (EC) No 1927/2006. The Commission, therefore, proposes to mobilise an amount of EUR 840 000.

(4)

The EGF should, therefore, be mobilised in order to provide a financial contribution for the application submitted by Spain,

(1)

On 13 September 2010 the Council adopted Decision 2010/570/EU, Euratom appointing the members of the European Economic and Social Committee for the period from 21 September 2010 to 20 September 2015 (1).

(2)

A member’s seat on the European Economic and Social Committee has become vacant following the end of the term of office of Mr Dušan BARČIK,