12.4.2011   

EN

Official Journal of the European Union

L 97/1

(1)

On 12 April 2005, the Council adopted Regulation (EC) No 560/2005.

(2)

In view of the developments in Côte d’Ivoire, the list of persons and entities subject to restrictive measures set out in Annex IA to Regulation (EC) No 560/2005 should be amended,

12.4.2011   

EN

Official Journal of the European Union

L 97/3

(1)

Regulation (EC) No 1338/2008 established a common framework for the systematic production of European statistics on public health and health and safety at work.

(2)

Pursuant to Article 9(1) of Regulation (EC) No 1338/2008, implementing measures are necessary to determine the data and metadata to be supplied on accidents at work covered in Annex IV to that Regulation as well as to determine the reference periods, intervals and time limits for data provision.

(3)

Confidential data sent by Member States to the Commission (Eurostat) should be handled in accordance with the principle of statistical confidentiality as laid down in Regulation (EC) No 223/2009 of the European Parliament and of the Council of 11 March 2009 on European statistics (2) and with Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (3).

(4)

A cost-benefit analysis has been carried out and evaluated in accordance with Article 6 of Regulation (EC) No 1338/2008.

(5)

The measures provided for in this Regulation are in accordance with the opinion of the European Statistical System Committee,

(a)

‘accident at work’ means a discrete occurrence in the course of work which leads to physical or mental harm. The phrase ‘in the course of work’ means whilst engaged in an occupational activity or during the time spent at work. This includes road traffic accidents that occur in the course of work but excludes commuting accidents, i.e. road accidents that occur during the journey between home and the workplace;

(b)

‘a fatal accident’ means an accident which leads to the death of a victim within 1 year of the accident;

(c)

‘economic activity of the employer’ covers the main ‘economic’ activity of the local unit of the enterprise of the victim;

(d)

‘age’ means the age of the victim at the time of the accident;

(e)

‘type of injury’ means the physical consequences for the victim;

(f)

‘geographical location’ means the territorial unit where the accident has occurred;

(g)

‘size of the enterprise’ means the number of employees (full-time equivalent) working at the local unit of the enterprise of the victim;

(h)

‘nationality of the victim’ means the country of citizenship;

(i)

‘days lost’ means the number of calendar days during which the victim is unfit for work as a result of an accident at work;

(j)

‘workstation’ means the usual or, alternatively, occasional nature of the place/post occupied by the victim at the time of the accident;

(k)

‘working environment’ means the workplace, work premises or general environment where the accident happened;

(l)

‘working process’ means the main type of work or task (general activity) being performed by the victim at the time of the accident;

(m)

‘specific physical activity’ means the victim’s exact physical activity at the instant of the accident;

(n)

‘material agent associated with the specific physical activity’ means the tool, object or instrument being used by the victim when the accident happened;

(o)

‘deviation’ means the last event deviating from normality and leading to the accident;

(p)

‘material agent associated with the deviation’ means the tool, object or instrument involved in the abnormal event;

(q)

‘contact — mode of injury’ means how the victim was hurt (physical or mental trauma) by the material agent that caused the injury;

(r)

‘material agent associated with the contact — mode of injury’ means the object, tool or instrument with which the victim came into contact or the psychological mode of injury.

12.4.2011   

EN

Official Journal of the European Union

L 97/9

(1)

Commission Regulation (EC) No 1251/2008 of 12 December 2008 implementing Council Directive 2006/88/EC as regards conditions and certification requirements for the placing on the market and the import into the Community of aquaculture animals and products thereof and laying down a list of vector species (2) lays down placing on the market requirements, including animal health certification requirements, for movements of aquaculture animals into areas covered by national measures approved by Commission Decision 2010/221/EU of 15 April 2010 approving national measures for limiting the impact of certain diseases in aquaculture animals and wild aquatic animals in accordance with Article 43 of Council Directive 2006/88/EC (3).

(2)

Since 2008, increased mortality in Pacific oysters (Crassostrea gigas) has occurred in several areas in Ireland, France and the United Kingdom. The epidemiological investigations undertaken in 2009 suggested that a newly described strain of ostreid herpesvirus-1 (OsHV-1), namely OsHV-1 μνar, played a major role in the increased mortality.

(3)

Commission Regulation (EU) No 175/2010 of 2 March 2010 implementing Council Directive 2006/88/EC as regards measures to control increased mortality in oysters of the species Crassostrea gigas in connection with the detection of Ostreid herpesvirus 1 μνar (OsHV-1 μνar) (4) was adopted with the aim of preventing the further spread of OsHV-1 μνar. It introduced measures to control the spread of that disease and it applies until 30 April 2011.

(4)

Decision 2010/221/EU, as recently amended by Commission Decision 2011/187/EU (5), allows the Member States listed in Annex III thereto to impose placing on the market requirements on the movement of Pacific oysters into areas covered by approved surveillance programmes, in order to prevent the introduction of OsHV-1 μνar into those areas. In the interests of clarity and simplification of Union legislation, the respective placing on the market requirements should be laid down in Regulation (EC) No 1251/2008.

(5)

In order to prevent the introduction of OsHV-1 μνar into Member States or parts thereof listed in Annex III to Decision 2010/221/EU, consignments of Pacific oysters intended for farming or relaying areas, and for dispatch centres, purification centres or similar businesses before human consumption, introduced into such Member States or parts thereof, should originate from an area with an equivalent health status.

(6)

To ensure that those requirements are complied with, such consignments should be accompanied by an animal health certificate providing the necessary attestations.

(7)

Regulation (EC) No 1251/2008 should therefore be amended accordingly.

(8)

It is appropriate to provide for transitional measures to allow Member States and the industry to take the necessary measures to comply with the requirements laid down in this Regulation.

(9)

To avoid the further spread of OsHV-1 μνar, this Regulation should apply immediately following the date of expiry of Regulation (EU) No 175/2010.

(10)

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 Article 1, point (b)(ii) is replaced by the following:

(2)

in Article 8a(1)(a), the following point (iii) is added:

(3)

the following Article 8b is inserted:

‘Article 8b

Live molluscs intended for dispatch centres, purification centres or similar businesses before human consumption in Member States and parts thereof with national measures approved by Decision 2010/221/EU

1.   Consignments of live molluscs intended for dispatch centres, purification centres or similar businesses before human consumption shall be accompanied by an animal health certificate completed in accordance with the model set out in Part B of Annex II and the explanatory notes set out in Annex V, where the animals:

2.   Consignments of live molluscs referred to in paragraph 1 shall comply with the animal health requirements set out in the model animal health certificate and explanatory notes as referred to in that paragraph.

3.   This Article shall not apply to consignments intended for dispatch centres, purification centres or similar businesses which are equipped with an effluent treatment system validated by the competent authority that:

(4)

Annex II is replaced by the text in the Annex to this Regulation.

12.4.2011   

EN

Official Journal of the European Union

L 97/20

(1)

Article 53 of Regulation (EC) No 178/2002 provides for the possibility to adopt appropriate Union emergency measures for food and feed imported from a third country in order to protect public health, animal health or the environment, where the risk cannot be contained satisfactorily by means of measures taken by the Member States individually.

(2)

Following the accident at the Fukushima nuclear power station on 11 March 2011, the Commission was informed that radionuclide levels in certain food products originating in Japan such as milk and spinach exceeded the action levels in food applicable in Japan. Such contamination may constitute a threat to public and animal health within the Union and therefore Commission Implementing Regulation (EU) No 297/2011 imposing special conditions governing the import of feed and food originating in or consigned from Japan following the accident at the Fukushima nuclear power station (2) was adopted on 25 March 2011.

(3)

Regulation (EU) No 297/2011 provides for the requirement for pre-export control by the competent authorities of Japan. Action levels for iodine, caesium and plutonium in food have been established by the competent authorities of Japan. The Commission was informed on 17 March 2011 of these action levels applicable in Japan but it was indicated that these action levels were adopted for the time being as provisional regulation values. The authorities from Japan also informed the Commission that products that are not allowed to be placed on the Japanese market, are also not allowed to be exported. It becomes now evident that these action levels will be applied in Japan for a longer term. It is therefore appropriate in order to provide consistency between the pre-export controls performed by the Japanese authorities and the controls on the level of radionuclides performed on feed and food originating in or consigned from Japan at the entry into the EU, to apply on a provisional basis the same maximum levels in the EU for radionuclides in feed and food from Japan as the action levels applicable in Japan as long as these are lower than the EU values.

(4)

This Regulation is without prejudice to the scientifically established levels laid down in Council Regulation (Euratom) No 3954/87 and Commission Regulations (Euratom) No 944/89 and (Euratom) No 770/90 for application in case of a future nuclear accident or any other case of radiological emergency affecting the EU territory. This Regulation applies for isotopes of strontium the values established in Regulation (Euratom) No 3954/87, since there are no such values laid down in Japan.

(5)

Given that for the time being, there is evidence that feed and food from certain regions from Japan is contaminated by the radionuclides iodine-131, caesium-134 and caesium 137 and that there is no indication that feed and food originating in or consigned from Japan is contaminated with other radionuclides, it is appropriate to restrict the obligatory controls to iodine-131, caesium-134 and caesium-137. Member States may also perform analysis on a voluntary basis for the presence of other radionuclides in view of gathering information on the possible presence of these other radionuclides. It is therefore appropriate to mention the existing maximum levels in EU legislation or action levels applied in Japan for the radionuclides strontium, plutonium and trans-plutonium elements in Annex II to this Regulation.

(6)

It is therefore appropriate to amend Regulation (EU) 297/2011 accordingly.

(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)

Article 2 is amended as follows:

(2)

Article 7 is replaced by the following:

‘Article 7

Non-compliant products

Feed and food originating in or consigned from Japan which do not comply with the maximum levels referred to in Annex II, shall not be placed on the market. Such non-compliant feed and food shall be safely disposed of or returned to the country of origin.’

(3)

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

(4)

A new Annex II, the text of which is set out in Annex II to this Regulation, is added.

12.4.2011   

EN

Official Journal of the European Union

L 97/24

12.4.2011   

EN

Official Journal of the European Union

L 97/26

(1)

The representative prices and additional duties applicable to imports of white sugar, raw sugar and certain syrups for the 2010/11 marketing year are fixed by Commission Regulation (EU) No 867/2010 (3). These prices and duties have been last amended by Commission Regulation (EU) No 347/2011 (4).

(2)

The data currently available to the Commission indicate that those amounts should be amended in accordance with the rules and procedures laid down in Regulation (EC) No 951/2006,

12.4.2011   

EN

Official Journal of the European Union

L 97/28

(1)

Point 2.4 of Annex V to Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components (2) sets minimum (6,4) and maximum (7,4) pH levels for units of platelets at the end of the shelf life. Therefore, platelet units that do not meet these minimum or maximum values have to be discarded.

(2)

Recent scientific evidence and field practice experience has demonstrated that values higher than pH 7,4 do not affect the quality and safety of stored platelets, contrary to pH levels below 6,4 that systematically result in damaging the platelets, and that a maximum pH value for platelet concentrates is thus not necessary.

(3)

Discarding platelets that exceed the maximum pH value as set out in Annex V to Directive 2004/33/EC leads to considerable losses. These losses may increase in the future due to new collection methods and storage bags, which both generate higher pH values at the end of the shelf life.

(4)

Therefore the maximum (7,4) pH value for all platelet concentrates listed in Annex V to Directive 2004/33/EC should be removed.

(5)

The measures provided for in this Directive are in accordance with the opinion of the Committee set up by Article 28 of Directive 2002/98/EC,

12.4.2011   

EN

Official Journal of the European Union

L 97/30

(1)

Commission Regulations (EC) No 451/2000 (2) and (EC) No 1490/2002 (3) lay down the detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list included fenazaquin.

(2)

In accordance with Article 11e of Regulation (EC) No 1490/2002 the notifier withdrew its support of the inclusion of that active substance in Annex I to Directive 91/414/EEC within 2 months from receipt of the draft assessment report. Consequently, Commission Decision 2008/934/EC of 5 December 2008 concerning the non-inclusion of certain active substances in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing these substances (4) was adopted on the non-inclusion of fenazaquin.

(3)

Pursuant to Article 6(2) of Directive 91/414/EEC the original notifier (hereinafter ‘the applicant’) submitted a new application requesting the accelerated procedure to be applied, as provided for in Articles 14 to 19 of Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I (5).

(4)

The application was submitted to Greece, which had been designated rapporteur Member State by Regulation (EC) No 1490/2002. The time period for the accelerated procedure was respected. The specification of the active substance and the supported uses are the same as were the subject of Decision 2008/934/EC. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008.

(5)

Greece evaluated the additional data submitted by the applicant and prepared an additional report. It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 28 January 2010. The Authority communicated the additional report to the other Member States and the applicant for comments and forwarded the comments it had received to the Commission. In accordance with Article 20(1) of Regulation (EC) No 33/2008 and at the request of the Commission, the Authority presented its conclusion on fenazaquin to the Commission on 28 October 2010 (6). The draft assessment report, the additional report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 11 March 2011 in the format of the Commission review report for fenazaquin.

(6)

It has appeared from the various examinations made that plant protection products containing fenazaquin may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which have been examined and detailed in the Commission review report. It is therefore appropriate to include fenazaquin in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive.

(7)

A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion.

(8)

Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of 6 months after inclusion to review existing authorisations of plant protection products containing fenazaquin to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

(9)

The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (7) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the Directives which have been adopted until now amending Annex I.

(10)

It is therefore appropriate to amend Directive 91/414/EEC accordingly.

(11)

Decision 2008/934/EC provides for the non-inclusion of fenazaquin and the withdrawal of authorisations for plant protection products containing that substance by 31 December 2011. It is necessary to delete the line concerning fenazaquin in the Annex to that Decision.

(12)

It is therefore appropriate to amend Decision 2008/934/EC accordingly.

(13)

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

(a)

in the case of a product containing fenazaquin as the only active substance, where necessary, amend or withdraw the authorisation by 31 May 2015 at the latest; or

(b)

in the case of a product containing fenazaquin as one of several active substances, where necessary, amend or withdraw the authorisation by 31 May 2015 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

12.4.2011   

EN

Official Journal of the European Union

L 97/34

(1)

Commission Regulations (EC) No 451/2000 (2) and (EC) No 1490/2002 (3) lay down the detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list included sintofen.

(2)

In accordance with Article 11e of Regulation (EC) No 1490/2002 the notifier withdrew its support of the inclusion of that active substance in Annex I to Directive 91/414/EEC within 2 months from receipt of the draft assessment report. Consequently, Commission Decision 2008/934/EC of 5 December 2008 concerning the non-inclusion of certain active substances in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing these substances (4) was adopted on the non-inclusion of sintofen.

(3)

Pursuant to Article 6(2) of Directive 91/414/EEC the original notifier (hereinafter ‘the applicant’) submitted a new application requesting the accelerated procedure to be applied, as provided for in Articles 14 to 19 of Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I (5).

(4)

The application was submitted to France, which had been designated rapporteur Member State by Regulation (EC) No 1490/2002. The time period for the accelerated procedure was respected. The specification of the active substance and the supported uses are the same as were the subject of Decision 2008/934/EC. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008.

(5)

France evaluated the additional data submitted by the applicant and prepared an additional report. It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 14 January 2010. The Authority communicated the additional report to the other Member States and the applicant for comments and forwarded the comments it had received to the Commission. In accordance with Article 20(1) of Regulation (EC) No 33/2008 and at the request of the Commission, the Authority presented its conclusion on sintofen to the Commission on 26 November 2010 (6). The draft assessment report, the additional report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 11 March 2011 in the format of the Commission review report for sintofen.

(6)

It has appeared from the various examinations made that plant protection products containing sintofen may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which have been examined and detailed in the Commission review report. It is therefore appropriate to include sintofen in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive.

(7)

Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EEC provides that inclusion of a substance in Annex I may be subject to conditions. Therefore, it is appropriate to require that the applicant submit further information confirming: the specification of the technical material, the relevance of the impurities present in the technical specifications, the relevance of the test material used in the toxicity and ecotoxicity dossiers and the metabolic profile of sintofen in rotational crops.

(8)

A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion.

(9)

Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of 6 months after inclusion to review existing authorisations of plant protection products containing sintofen to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

(10)

The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (7) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the Directives which have been adopted until now amending Annex I.

(11)

It is therefore appropriate to amend Directive 91/414/EEC accordingly.

(12)

Decision 2008/934/EC provides for the non-inclusion of sintofen and the withdrawal of authorisations for plant protection products containing that substance by 31 December 2011. It is necessary to delete the line concerning sintofen in the Annex to that Decision.

(13)

It is therefore appropriate to amend Decision 2008/934/EC accordingly.

(14)

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

(a)

in the case of a product containing sintofen as the only active substance, where necessary, amend or withdraw the authorisation by 31 May 2015 at the latest; or

(b)

in the case of a product containing sintofen as one of several active substances, where necessary, amend or withdraw the authorisation by 31 May 2015 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

12.4.2011   

EN

Official Journal of the European Union

L 97/38

(1)

Commission Regulations (EC) No 451/2000 (2) and (EC) No 1490/2002 (3) lay down the detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list included dithianon.

(2)

In accordance with Article 11e of Regulation (EC) No 1490/2002 the notifier withdrew its support of the inclusion of that active substance in Annex I to Directive 91/414/EEC within 2 months from receipt of the draft assessment report. Consequently, Commission Decision 2008/934/EC of 5 December 2008 concerning the non-inclusion of certain active substances in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing these substances (4) was adopted on the non-inclusion of dithianon.

(3)

Pursuant to Article 6(2) of Directive 91/414/EEC the original notifier (hereinafter ‘the applicant’) submitted a new application requesting the accelerated procedure to be applied, as provided for in Articles 14 to 19 of Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I (5).

(4)

The application was submitted to Greece, which had been designated rapporteur Member State by Regulation (EC) No 1490/2002. The time period for the accelerated procedure was respected. The specification of the active substance and the supported uses are the same as were the subject of Decision 2008/934/EC. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008.

(5)

Greece evaluated the additional data submitted by the applicant and prepared an additional report. It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 27 January 2010. The Authority communicated the additional report to the other Member States and the applicant for comments and forwarded the comments it had received to the Commission. In accordance with Article 20(1) of Regulation (EC) No 33/2008 and at the request of the Commission, the Authority presented its conclusion on dithianon to the Commission on 15 November 2010 (6). The draft assessment report, the additional report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 11 March 2011 in the format of the Commission review report for dithianon.

(6)

It has appeared from the various examinations made that plant protection products containing dithianon may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which have been examined and detailed in the Commission review report. It is therefore appropriate to include dithianon in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive.

(7)

Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EC provides that inclusion of a substance in Annex I may be subject to conditions. Therefore, it is appropriate to require that the applicant submit information confirming the storage stability and the nature of residues in processed products, the aquatic and groundwater exposure assessment for phthalic acid and the risk assessment for aquatic organisms with respect to phthalic acid, phthalaldehyde and 1,2 benzenedimethanol.

(8)

A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion.

(9)

Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of 6 months after inclusion to review existing authorisations of plant protection products containing dithianon to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

(10)

The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (7) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties, it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the Directives which have been adopted until now amending Annex I.

(11)

It is therefore appropriate to amend Directive 91/414/EEC accordingly.

(12)

Decision 2008/934/EC provides for the non-inclusion of dithianon and the withdrawal of authorisations for plant protection products containing that substance by 31 December 2011. It is necessary to delete the line concerning dithianon in the Annex to that Decision.

(13)

It is therefore appropriate to amend Decision 2008/934/EC accordingly.

(14)

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

(a)

in the case of a product containing dithianon as the only active substance, where necessary, amend or withdraw the authorisation by 31 May 2015 at the latest; or

(b)

in the case of a product containing dithianon as one of several active substances, where necessary, amend or withdraw the authorisation by 31 May 2015 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

12.4.2011   

EN

Official Journal of the European Union

L 97/42

(1)

Commission Regulations (EC) No 451/2000 (2) and (EC) No 1490/2002 (3) lay down the detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list included flutriafol.

(2)

In accordance with Article 11e of Regulation (EC) No 1490/2002 the notifier withdrew its support of the inclusion of that active substance in Annex I to Directive 91/414/EEC within 2 months from receipt of the draft assessment report. Consequently, Commission Decision 2008/934/EC of 5 December 2008 concerning the non-inclusion of certain active substances in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing these substances (4) was adopted on the non-inclusion of flutriafol.

(3)

Pursuant to Article 6(2) of Directive 91/414/EEC the original notifier (hereinafter ‘the applicant’) submitted a new application requesting the accelerated procedure to be applied, as provided for in Articles 14 to 19 of Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I (5).

(4)

The application was submitted to the United Kingdom, which had been designated rapporteur Member State by Regulation (EC) No 1490/2002. The time period for the accelerated procedure was respected. The specification of the active substance and the supported uses are the same as were the subject of Decision 2008/934/EC. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008.

(5)

The United Kingdom evaluated the additional data submitted by the applicant and prepared an additional report. It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 15 January 2010. The Authority communicated the additional report to the other Member States and the applicant for comments and forwarded the comments it had received to the Commission. In accordance with Article 20(1) of Regulation (EC) No 33/2008 and at the request of the Commission, the Authority presented its conclusion on flutriafol to the Commission on 14 October 2010 (6). The draft assessment report, the additional report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 11 March 2011 in the format of the Commission review report for flutriafol.

(6)

It has appeared from the various examinations made that plant protection products containing flutriafol may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which have been examined and detailed in the Commission review report. It is therefore appropriate to include flutriafol in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive.

(7)

Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EEC provides that inclusion of a substance in Annex I may be subject to conditions. Therefore, it is appropriate to require that the applicant submit further information confirming the relevance of the impurities present in the technical specifications, the assessment as regards the residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin, and the long-term risk to insectivorous birds.

(8)

A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion.

(9)

Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of 6 months after inclusion to review existing authorisations of plant protection products containing flutriafol to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

(10)

The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (7) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives which have been adopted until now amending Annex I.

(11)

It is therefore appropriate to amend Directive 91/414/EEC accordingly.

(12)

Decision 2008/934/EC provides for the non-inclusion of flutriafol and the withdrawal of authorisations for plant protection products containing that substance by 31 December 2011. It is necessary to delete the line concerning flutriafol in the Annex to that Decision.

(13)

It is therefore appropriate to amend Decision 2008/934/EC accordingly.

(14)

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

(a)

in the case of a product containing flutriafol as the only active substance, where necessary, amend or withdraw the authorisation by 31 May 2015 at the latest; or

(b)

in the case of a product containing flutriafol as one of several active substances, where necessary, amend or withdraw the authorisation by 31 May 2015 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

12.4.2011   

EN

Official Journal of the European Union

L 97/46

(1)

On 29 October 2010, the Council adopted Decision 2010/656/CFSP.

(2)

In view of the developments in Côte d’Ivoire, the list of persons and entities subject to restrictive measures set out in Annex II to Decision 2010/656/CFSP should be amended,

12.4.2011   

EN

Official Journal of the European Union

L 97/47

(1)

In accordance with Article 2 of Regulation (EC) No 1338/2008, it applies to the production of statistics on accidents at work as defined in Annex IV.

(2)

Article 9(2) of Regulation (EC) No 1338/2008 provides, if necessary, for derogations and transition periods for Member States, both to be based upon objective grounds.

(3)

It emerges from the information provided to the Commission that the requests for derogations made by Belgium, Germany, Ireland, Greece, France, Latvia, the Netherlands and the United Kingdom result from the need for major adaptations to national administrative and statistical systems in order to comply in full with Regulation (EC) No 1338/2008.

(4)

Such derogations should therefore be granted as requested to those Member States.

(5)

The measures provided for in this Decision are in accordance with the opinion of the European Statistical System Committee,

12.4.2011   

EN

Official Journal of the European Union

L 97/49

(1)

Commission Decision 2000/367/EC of 3 May 2000 implementing Council Directive 89/106/EEC as regards the classification of the resistance to fire performance of construction products, construction works and parts thereof (2) should be amended to take into account technical progress in the development of the relevant test methods and in order to include cavity barriers.

(2)

Decision 2000/367/EC should therefore be amended accordingly,