(1)

By virtue of the first subparagraph of Article 9(1) of Regulation (EC) No 510/2006, the Commission has examined France's application for the approval of amendments to the specification for the name ‘Langres’ registered under Commission Regulation (EC) No 1107/1996 (2).

(2)

Since the amendment in question is not minor within the meaning of Article 9 of Regulation (EC) No 510/2006, the Commission published the amendment application in the Official Journal of the European Union (3) as required by the first subparagraph of Article 6(2) of that Regulation. As no statement of objection within the meaning of Article 7 of Regulation (EC) No 510/2006 has been sent to the Commission, the amendment should be approved,

(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 representative prices and additional duties applicable to imports of white sugar, raw sugar and certain syrups for the 2011/12 marketing year are fixed by Commission Implementing Regulation (EU) No 971/2011 (3). Those prices and duties were last amended by Commission Implementing Regulation (EU) No 759/2012 (4).

(2)

The data currently available to the Commission indicate that those amounts should be amended in accordance with Article 36 of Regulation (EC) No 951/2006.

(3)

Given the need to ensure that this measure applies as soon as possible after the updated data have been made available, this Regulation should enter into force on the day of its publication,

(1)

The United Kingdom received on 17 January 2007 an application from Lonza, in accordance with Article 11(1) of Directive 98/8/EC, for the inclusion of the active substance DDACarbonate in Annex I to that Directive for use in product type 8, wood preservatives, as defined in Annex V to Directive 98/8/EC. DDACarbonate was not on the market on the date referred to in Article 34(1) of Directive 98/8/EC as an active substance of a biocidal product.

(2)

After carrying out an evaluation, the United Kingdom submitted its report, together with a recommendation, to the Commission on 11 November 2010.

(3)

The report was reviewed by the Member States and the Commission within the Standing Committee on Biocidal Products on 2 March 2012, and the findings of the review were incorporated in an assessment report.

(4)

It appears from the evaluations that biocidal products used as wood preservatives and containing DDACarbonate may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include DDACarbonate for use in product type 8 in Annex I to that Directive.

(5)

Not all potential uses have been evaluated at Union level. For example, use by non-professional users was not assessed. It is therefore appropriate to require that Member States assess those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels.

(6)

In view of the risks identified for human health, for industrial users it is appropriate to require that safe operational procedures are established, and that products are used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks can be reduced to an acceptable level by other means.

(7)

In view of the risks identified for the aquatic and terrestrial compartments, it is appropriate to require that industrial application is conducted within a contained area or on impermeable hard standing with bunding, that freshly treated timber is stored after treatment under shelter or on impermeable hard standing, or both, and that any losses from the application of products used as wood preservatives and containing DDACarbonate are collected for reuse or disposal.

(8)

Unacceptable risks for the environment were identified for situations where wood treated by dipping with DDACarbonate was continually exposed to the weather or subject to frequent wetting (use class 3 as defined by OECD (2)), and where wood treated with DDACarbonate was used for outdoor constructions near or above water (the ‘bridge’ scenario in use class 3, as defined by OECD (3)) or was in contact with fresh water (use class 4b as defined by OECD (4)). It is therefore appropriate to require that products are not authorised for the treatment of wood intended for those uses, unless data is submitted demonstrating that the product will meet the requirements of both Article 5 of and Annex VI to Directive 98/8/EC, if necessary by the application of appropriate risk mitigation measures.

(9)

The provisions of this Directive should be applied simultaneously in all Member States in order to ensure equal treatment on the Union market of biocidal products of product type 8 containing the active substance DDACarbonate and also to facilitate the proper operation of the biocidal products market in general.

(10)

A reasonable period should be allowed to elapse before an active substance is included in Annex I to Directive 98/8/EC in order to permit Member States to bring into force the laws, regulations and administrative provisions necessary to comply with this Directive.

(11)

Directive 98/8/EC should therefore be amended accordingly.

(12)

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

(1)

Pursuant to Directive 95/46/EC, Member States are required to provide that the transfer of personal data to a third country may take place only if the third country in question ensures an adequate level of protection and if the Member States’ laws implementing other provisions of the Directive are complied with prior to the transfer.

(2)

The Commission may find that a third country ensures an adequate level of protection. In that case, personal data may be transferred from the Member States without additional guarantees being necessary.

(3)

Pursuant to Directive 95/46/EC the level of data protection should be assessed in the light of all the circumstances surrounding a data transfer operation or a set of data transfer operations and giving particular consideration to a number of elements relevant for the transfer and listed in Article 25 thereof.

(4)

Given the different approaches to data protection in third countries, the adequacy assessment should be carried out, and any decision based on Article 25(6) of Directive 95/46/EC should be made and enforced in a way that does not arbitrarily or unjustifiably discriminate against or between third countries where like conditions prevail, nor constitute a disguised barrier to trade, regard being had to the European Union’s present international commitments.

(5)

The Political Constitution of the Eastern Republic of Uruguay, passed in 1967, does not expressly recognise the rights to privacy and the protection of personal data. However, the catalogue of fundamental rights is not a closed list since Article 72 of the Constitution provides that the listing of rights, obligations and guarantees made by the Constitution does not exclude others that are inherent to the human personality or that derive from the republican form of government. Article 1 of Act No 18.331 on the Protection of Personal Data and ‘Habeas Data’ Action of 11 August 2008 (Ley No 18.331 de Protección de Datos Personales y Acción de ‘Habeas Data’) expressly sets out that ‘the right to the protection of personal data is inherent to the human being and it is therefore included in Article 72 of the Constitution of the Republic’. Article 332 of the Constitution provides that the application of the provisions of this Constitution that acknowledge individuals’ rights as well as those awarding rights and imposing obligations on public authorities, shall not be impaired by of the lack of specific regulation; rather, it shall be based, through recourse to the underlying principles of similar laws, on the general principles of the law and generally accepted doctrines.

(6)

The legal standards for the protection of personal data in the Eastern Republic of Uruguay are largely based on the standards set out in Directive 95/46/EC and are laid down in Act No 18.331 on the Protection of Personal Data and ‘Habeas Data’ Action (Ley No 18.331 de Protección de Datos Personales y de Acción de ‘Habeas Data’) of 11 August 2008. It covers natural persons and legal persons.

(7)

This Act is further complemented by Decree No 414/009 of 31 August 2009, adopted in order to clarify several aspects of the Act and to lay down the detailed regulation of the organisation, powers and functioning of the data protection supervisory authority; The Preamble of the Decree sets out that it is appropriate to adjust the national legal system on this matter to the most accepted comparable legal regime, essentially that established by European countries through Directive 95/46/EC.

(8)

Data protection provisions are also contained in a number of special acts that create and regulate databases, namely, acts regulating certain public registries (public deeds, industrial property and trade marks, personal acts, real estate, mining or credit reporting). Act No 18.331 applies additionally to these acts in relation to those issues that are not governed by these specific legal instruments, pursuant to Article 332 of the Constitution.

(9)

The legal data protection standards applicable in the Eastern Republic of Uruguay cover all the basic principles necessary for an adequate level of protection for natural persons, and also provide for exceptions and limitations in order to safeguard important public interests. These legal data protection standards and the exceptions reflect the principles laid down by Directive 95/46/EC.

(10)

The application of the legal data protection standards is guaranteed by administrative and judicial remedies, in particular, by the ‘habeas data’ action, which enables a data subject to take a data controller to court in order to enforce his right of access, rectification and deletion, and by independent supervision carried out by the supervisory authority, the Unit for the Regulation and Control of Personal Data (Unidad Reguladora y de Control de Datos Personales (URCDP)), which is invested with powers of investigation, intervention and sanction in line with Article 28 of Directive 95/46/EC, and which acts completely independently. Moreover, any interested party is entitled to seek judicial redress for compensation for damages suffered as a result of the unlawful processing of his personal data.

(11)

Uruguayan data protection authorities have provided explanations and assurances as to how the Uruguayan law is to be interpreted, and have given assurances that the Uruguayan data protection legislation is implemented in accordance with such interpretation. In particular, Uruguayan data protection authorities have explained that, pursuant to Article 332 of the Constitution, Act No 18.331 applies additionally to special acts that create and regulate specific databases in relation to those issues that are not governed by these specific legal instruments. They have also clarified that, regarding the lists referred to in Article 9 C) of Act No 18.331, and which do not require the consent of the data subject for the processing, the Act also applies, namely the principles of proportionality and finality, the rights of data subjects and that they are subject to the supervision by the data protection authority. With regard to the transparency principle, the Uruguayan data protection authorities have informed that the obligation to provide the data subject with the necessary information applies in all cases. Regarding the right of access, the data protection authority has clarified that it is sufficient for a data subject to prove its identity when making a request. The Uruguayan data protection authorities have clarified that the exceptions relating to the principle on international transfers laid down in Article 23(1) of Act No 18.331 cannot be understood as having a broader application than that of Article 26(1) of Directive 95/46/EC.

(12)

This Decision takes into account these explanations and assurances and it is based upon them.

(13)

The Eastern Republic of Uruguay is also party to the American Convention of Human Rights (‘Pact of San José de Costa Rica) of 22 November 1969, and in force since 18 July 1978 (3). Article 11 of this Convention lays down the right to privacy and Article 30 sets out that restrictions that, pursuant to this Convention, may be placed on the enjoyment or exercise of the rights or freedoms recognised by the Convention may not be applied except in accordance with laws enacted for reasons of general interest and in accordance with the purpose for which such restrictions have been established (Article 30). Moreover the Eastern Republic of Uruguay has accepted the jurisdiction of the Inter-American Court of Human Rights. Furthermore at the 1118th meeting of the Ministers’ Deputies of the Council of Europe held on 6 July 2011, the Deputies invited the Eastern Republic of Uruguay to accede the Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data (ETS No 108) and to its Additional Protocol (ETS No 118), after a favourable opinion of the relevant Consultative Committee (4).

(14)

The Eastern Republic of Uruguay should therefore be regarded as providing an adequate level of protection for personal data as referred to in Directive 95/46/EC.

(15)

This Decision should concern the adequacy of protection provided in the Eastern Republic of Uruguay with a view to meeting the requirements of Article 25(1) of Directive 95/46/EC. It should not affect other conditions or restrictions implementing other provisions of that Directive that pertain to the processing of personal data within the Member States.

(16)

In the interest of transparency and in order to safeguard the ability of the competent authorities in the Member States to ensure the protection of individuals as regards the processing of their personal data, it is necessary to specify the exceptional circumstances in which the suspension of specific data flows may be justified, notwithstanding the finding of adequate protection.

(17)

The Commission should monitor the functioning of the Decision and report any pertinent findings to the Committee established under Article 31 of Directive 95/46/EC. Such monitoring should cover, inter alia, the Eastern Republic of Uruguay’s regime applicable to transfers in the framework of international treaties.

(18)

The Working Party on the protection of individuals with regard to the processing of personal data established under Article 29 of Directive 95/46/EC has delivered a favourable opinion on the level of adequacy as regards protection of personal data which has been taken into account in the preparation of this Decision (5).

(19)

The measures provided for in this Decision are in accordance with the opinion of the Committee established under Article 31(1) of Directive 95/46/EC,